Abstract: A therapeutic agent injection device including an injection device for delivering a therapeutic agent to a patient having a body, the body having a patient face and an port face opposite the patient face, the port face having an introducer port including an introducer channel and an injection port including an injection channel, the introducer channel being in fluid communication with the injection channel through a cross channel, the injection channel defining an injection axis; a delivery tube for subcutaneous delivery of the therapeutic agent to the patient, the delivery tube projecting from and being generally perpendicular to the patient face, the delivery tube defining an introducer axis and being in fluid communication with the injection port; and a patch, the patch being attached to the patient face and being operable to adhesively attach to the patient; wherein the injection axis is parallel to the introducer axis.

Abstract: Embodiments of the invention provide analyte sensors and sensor systems such as amperometric glucose sensors used in the management of diabetes as well as optimized methods for monitoring analytes using such sensors and sensor systems.

Abstract: A connecting structure for connecting a first member in fluid flow connection with a second member may include a receptacle structure provided on the first member and having an interior chamber and an opening into the interior chamber in which a needle and a pierceable member surrounding a piercing end of the needle may be supported. The second member may include a connection portion that has a septum supported in an interior chamber having a size and shape suitable to be received at least partially into the opening of the receptacle structure upon moving the first member and the second member together to push the pierceable member toward the piercing end of the needle to cause the piercing end of the needle to pierce the pierceable member and the septum to come into fluid flow communication with the interior chamber of the connection portion.

Abstract: A delivery system for delivering fluidic media to a user having a second housing portion configured to be selectively operatively engaged with and disengaged from a first housing portion, the first housing portion and the second housing portion configured to be slidable relative to each other to operatively engage each other; and a fluid connector supported by one the housing portions in a position to engage a reservoir supported by an other of the housing portions in a case where the first housing portion and the second housing portion are slid relative to each other to operatively engage each other.

Abstract: Medical devices are typically sterilized in processes used to manufacture such products and their sterilization by exposure to radiation is a common practice. Radiation has a number of advantages over other sterilization processes including a high penetrating ability, relatively low chemical reactivity, and instantaneous effects without the need to control temperature, pressure, vacuum, or humidity. Unfortunately, radiation sterilization can compromise the function of certain components of medical devices. For example, radiation sterilization can lead to loss of protein activity and/or lead to bleaching of various dye compounds. Embodiments of the invention provide methods and materials that can be used to protect medical devices from unwanted effects of radiation sterilization.

Abstract: A housing may have a needle, plunger, and bias mechanism supported within the housing by a tab configured to retain the plunger in position and to allow the plunger to move under bias force imparted by the bias mechanism to move the needle to an insert position when the tab is removed. A base and a structure may be configured for relative movement there between and may be adapted to be secured to a user with a cannula extending through a body of the structure into the user during use of a medical device. A housing may be adapted to be secured to a user to support a medical device operable with an insertion needle, the housing having a magnifying material for increasing visibility of an injection site.

Abstract: An infusion system for infusing a liquid into a body includes an external infusion device and a remote commander. The external infusion device includes a housing, a receiver, a processor and an indication device. The receiver is coupled to the housing and for receiving remotely generated commands. The processor is coupled to the housing and the receiver to receive remotely generated commands and to control the external infusion device in accordance with the commands. The indication device indicates when a command has been received and indicates when the command is being utilized to control the external infusion device so that the external infusion device is capable of being concealed from view when being remotely commanded. The remote commander includes a commander housing, a keypad for transmitting commands, and a transmitter for transmitting commands to the receiver of the external infusion device.

Abstract: Embodiments of the present invention relates to analyte sensors. In particular, the preferred embodiments of the present invention relate to non-consuming intravascular glucose sensors based on fluorescence chemistry.

Abstract: A method for monitoring blood glucose concentration in a patient in need thereof is disclosed. The method comprises deploying an equilibrium glucose sensor within interstitial fluid in the patient in need and coupling the equilibrium glucose sensor to a monitor configured to detect a signal and configured to display the blood glucose concentration.

Abstract: Embodiments of the present invention are directed to an optical sensor capable of measuring two analytes simultaneously with a single indicator system. In preferred embodiments, the sensor comprises a fluorescent dye having acid and base forms that facilitate ratiometric pH sensing, wherein the dye is further associated with a glucose binding moiety and configured to generate a signal that varies in intensity with the concentration of glucose.

Abstract: An electronic injector including an electronic on-body injector for use with a patient to deliver a fluid through an injection device. The electronic on-body injector includes a fluid reservoir; a MEMS pump; a bolus injection needle, the bolus injection needle having a bolus injection needle tip aligned with the injection port, the bolus injection needle being slideably biased away from the injection port to define a gap; and a bolus needle button operably connected to the bolus injection needle to slide the bolus injection needle along the injection axis. The bolus needle button is operable to advance the bolus injection needle tip to close the gap and advance the bolus injection needle tip into the injection port to form a bolus injection flow path. The bolus needle button is further operable to activate the MEMS pump to deliver a predetermined bolus volume.

Abstract: An on-body injector and method of use including an on-body injector for use with an injection device. The on-body injector includes a bolus reservoir; a bolus injection needle in fluid communication with the bolus reservoir, the bolus injection needle having a bolus injection needle tip aligned with the injection port, the bolus injection needle being slideably biased away from the injection port to define a gap between the bolus injection needle tip and the injection port; and a button operably connected to the bolus injection needle to slide the bolus injection needle along the injection axis. The button is operable to advance the bolus injection needle tip to close the gap and advance the bolus injection needle tip into the injection port. The button is further operable to advance a plunger through the bolus reservoir to deliver a predetermined bolus volume to the patient through the injection flow path.

Abstract: A portable electronic device, such as a fluid infusion device, obtains its operating power from a primary battery and a secondary battery. The primary battery may be a replaceable battery, and the secondary battery may be a rechargeable battery that can be charged with the primary battery under certain conditions. The device utilizes a power management scheme that transitions between the primary battery and/or the secondary battery to prolong the useful life of the primary battery. The device may also generate an intelligent battery life indicator that displays an accurate representation of the remaining life of the primary battery.

Abstract: Disclosed are embodiments that relate to algorithms and methods for calibrating an analyte sensor, and more particularly, to algorithms for calibrating an optical glucose sensor comprising an equilibrium fluorescent chemical indicator system. In particular, a method of detecting an analyte concentration is disclosed where a modified Michaelis-Menten equation comprising Michaelis-Menten parameters is used to characterize the signal generated by the analyte sensor.

Abstract: Apparatus are provided for sensor assemblies and related medical devices. An embodiment of a sensor assembly includes a rigid structure and a beam structure having an outer portion in contact with the rigid structure and an inner portion. The beam structure includes one or more beams extending between the outer portion and the inner portion of the beam structure and a cantilevered portion extending from the inner portion to inhibit displacement of the inner portion toward the rigid structure. Each beam has a sensing element disposed thereon.

Abstract: Systems and methods are provided for updating medical devices. An exemplary system includes a medical device and a remote device. The medical device is operable to regulate a condition of a user. The remote device receives measurement data correlative to the condition of the user, determines control information for the medical device based at least in part on the measurement data, and transmits the control information via a first peer-to-peer communication session. The medical device receives the control information via a second peer-to-peer communication session and thereafter regulates the condition of the user based at least in part on the control information and subsequent measurement data.

Abstract: A safety coupling for a fluid infusion device is provided. The device includes a first coupling device coupled to a drive system of the fluid infusion device, and a second coupling device coupled to a stopper of a fluid reservoir associated with the fluid infusion device. The first coupling device and the second coupling device cooperate to resist the movement of the stopper relative to the drive system.

Abstract: Apparatus are provided for medical devices and related operating systems and methods. An exemplary medical device includes a motor, one or more data storage elements to maintain control information, and a control module coupled to the motor and the one or more data storage elements. The control module is configured to obtain updated control information via a peer-to-peer communication session over a network, store the updated control information in the one or more data storage elements, and thereafter operate the motor based at least in part on the updated control information.

Abstract: Apparatuses and methods for medical monitoring physiological characteristic values such as blood glucose levels for the treatment of diabetes, are presented. The apparatuses and methods provide advanced alarm and reminder functions, as well as advanced data presentation tools to further facilitate convenient and efficient management of various physiological conditions. For example, an alarm repeat delay can be used to prevent redundant alarms for a specified period and an alarm snooze function can be used to prevent alarms generally for a specified period.

Abstract: Apparatus are provided for infusion devices and related operating methods. An exemplary device includes a sensing arrangement to provide an output indicative of a characteristic that is influenced by operation of the device, and a control module that is coupled to the sensing arrangement to apply a matched filter corresponding to a condition associated with the operation of the device to the output of the sensing arrangement and detect that condition based on the filtered output. In one example, the device includes a motor coupled to a plunger of a reservoir and operable to displace the plunger, wherein the characteristic is a force opposing displacement of the plunger and the control module detects an occlusion condition in a fluid path from the reservoir based on filtered force measurements.