Abstract: An apparatus adherable to a user's skin, such as a wearable medical device, is presented here. An embodiment of the apparatus includes a durable component having a periphery defining a footprint of the durable component, and a skin adhesive component coupled to the durable component to facilitate securing the durable component to the user's skin. The skin adhesive component includes a first region and a second region removably attached to the first region. The first region of the skin adhesive component resides completely within the footprint of the durable component. After removal of the second region of the skin adhesive component, the first region remains intact and protected underlying the durable component.

Abstract: A temporary pacing lead device comprises: an elongate body having a distal portion and a proximal end; an electrode array at the distal portion configured to deliver a pacing signal to target tissue; a displacement member attached to a first side of the distal portion; at least one anchoring element deployable from a second opposite side; and an interface at the proximal end of the elongate body. The interface is configured to couple to a pacing signal generator and/or a control handle to actuate the displacement member and/or anchoring element. The pacing generator can be a miniature pacing signal generator and/or a standard pacemaker device, and the interface can switch between providing the pacing signal from either of the two sources. The miniature pacing signal generator can include a protective element for the control and/or actuation elements at the proximal end.

Abstract: Embodiments of the invention provide amperometric analyte sensors having optimized elements such as interference rejection membranes, and associated architectures, as well as methods for making and using such sensors. While embodiments of the innovation can be used in a variety of contexts, typical embodiments of the invention include glucose sensors used in the management of diabetes.

Abstract: An insertion device configured to implant a first medical device and a second medical device in a user. The first medical device may be a fluid delivery cannula configured to deliver a fluid (e.g., insulin) to the user. The second medical device may be an analyte sensor (e.g., a glucose sensor) configured to detect a physiological characteristic of the user (e.g., a glucose level). The insertion device may be configured to be worn by the user. The insertion device includes a first linkage assembly configured to extend and retract a first insertion needle to implant the first medical device and a second linkage assembly configured to extend and retract a second insertion needle to implant the second medical device. The insertion device includes a user input device configured to cause the insertion device to initiate the implantation when activated by the user.

Abstract: An infusion device configured to implant a cannula and a sensor in a user. The infusion device includes a first unit defining a first housing and a second unit defining a second housing. The second housing is configured to engage the first housing. The infusion device includes a first insertion needle configured to implant the cannula in the user and a second insertion needle configured to implant the sensor in the user when the second unit engages the first unit. The infusion device includes processing circuitry in electrical communication with the sensor and a fluid reservoir in fluid communication with the cannula. In examples, the first unit and the second unit are configured to engage using an inserter.

Abstract: A system for a physiological characteristic sensor deployed with a sensor inserter includes an adhesive skin patch coupled to the physiological characteristic sensor. The adhesive patch is to couple the physiological characteristic sensor to an anatomy. The system includes a gravity resistance system coupled to the adhesive patch and to be coupled to the sensor inserter. The gravity resistance system maintains the adhesive patch substantially perpendicular to a longitudinal axis of the sensor inserter prior to deployment of the physiological characteristic sensor and the gravity resistance system is to be removable from the sensor inserter by the adhesive patch upon deployment of the physiological characteristic sensor.

Abstract: In some embodiments, an apparatus may comprise a first insertion needle and a second insertion needle. The first insertion needle may be configured to carry a first medical device (e.g., a sensor) through an opening in an apparatus housing. The second insertion needle may be configured to carry a second medical device (e.g., a cannula) along a curved path that passes through the opening in the apparatus housing such that a distal end of the first medical device becomes increasingly displaced from the distal end of the second medical device as the distal end of the second medical device is carried along the curved path.

Abstract: Wearable medical devices are provided. An exemplary wearable medical device includes a flexible printed circuit board assembly (PCBA), a battery cell having a first terminal and a second terminal, a sensor, and a uniaxially electrically conductive adhesive electrically connected to the flexible PCBA, to the first terminal and the second terminal of the battery cell, and to the sensor.

Abstract: Wearable medical devices are provided. An exemplary wearable medical device includes a printed circuit board assembly (PCBA) comprising a dielectric layer having a top surface and conductive features on the top surface of the dielectric layer. Further, the exemplary wearable medical device includes a top housing mounted directly to the top surface of the PCBA. Also, the wearable medical device includes a power source located between the top housing and the PCBA. The top housing and the dielectric layer of the PCBA encapsulates the conductive features and power source and define an outer surface of the wearable medical device.

Abstract: Removable devices wearable on a user's skin and methods for using such devices are provided. An exemplary removable device includes a skin adhesive configured to adhere to the skin, a durable component, and an interface component interconnecting the durable component and the skin adhesive. The device separates at the interface component to remove the durable component from the skin adhesive upon application of a removal force to the device.

Abstract: A physiological characteristic sensor assembly includes a flexible top housing including a needle port having a central opening, and a flexible lower housing defining a sensor bore through the lower housing, the sensor bore coaxial with the central opening of the needle port. The physiological characteristic sensor assembly also includes an electrical subsystem disposed between the top housing and the lower housing. The electrical subsystem includes a flexible printed circuit board having a sensor contact pad, a physiological characteristic sensor and an electrically conductive adhesive patch. The physiological characteristic sensor has a distal end that extends through the needle port and a proximal end that includes at least one electrical contact. The conductive adhesive patch electrically and physically couples the at least one electrical contact of the physiological characteristic sensor to the sensor contact pad of the flexible printed circuit board.

Abstract: Methods for operating sensing devices, methods for correcting sensor glucose measurement signals, methods for detecting interferents in body fluid, and analyte monitoring apparatuses are provided. An exemplary method for operating a sensing device includes storing a library of changes in electrochemical impedance spectroscopy (EIS) signals correlated to known concentrations of the interferent within bodies of study subjects, wherein the library is accessible to a controller. The method also includes monitoring EIS signals of the user with the controller. Further, the method includes matching, with the controller, a change in an EIS signal of the user with a change in a selected EIS signal from the library. The method determines a concentration of an interferent within the body of a user based on the selected EIS signal from the library.

Abstract: A disposable medical introduction system including a medical device and a disposable inserter. The disposable inserter includes a carrier to receive the medical device. The carrier includes at least one annular projection. The disposable inserter includes a retractor received within the at least one annular projection and movable relative to the at least one annular projection. The retractor has at least one retaining arm. The disposable inserter includes a needle cartridge coupled to the retractor that includes an insertion needle. The at least one retaining arm cooperates with the needle cartridge to maintain the insertion needle in a first, extended state. A movement of the retractor relative to the at least one annular projection releases the at least one retaining arm to move the insertion needle from the first, extended state to a second, retracted state.

Abstract: A liner associated with an adhesive skin patch of a physiological characteristic sensor deployed with a sensor inserter having a housing with a removable cover includes a surface to couple to the adhesive skin patch. The liner includes a removal portion to couple the liner to the removable cover of the sensor inserter such that a separation of the removable cover from the housing removes the liner from the adhesive skin patch.

Abstract: An analyte sensor apparatus including a sensing portion including one or more electrodes including a working electrode and one or more contacts for electrically connecting the sensor portion to control circuitry (e.g., a printed circuit board assembly, PCBA); and a circuit comprising the one or more contacts; wherein the circuit detects an electrical connection between the control circuitry without requiring exposure of the sensing portion to a fluid.

Abstract: A sensor introducer for a physiological characteristic sensor assembly includes a sensor introducer body that includes an outer housing that defines an opening to receive the physiological characteristic sensor assembly and an inner housing surrounded by the outer housing. The sensor introducer includes a cradle movable relative to the inner housing from a first position to a second position to deploy the physiological characteristic sensor assembly. The cradle has a cradle flange to receive the physiological characteristic sensor assembly and a cradle body that receives a needle assembly. The cradle body includes at least one locking projection that engages the inner housing to inhibit the movement of the cradle relative to the inner housing in the first position and the at least one locking projection is movable relative to the inner housing to enable the cradle to move from the first position to the second position.

Abstract: Methods, systems, and devices for continuous glucose monitoring. More particularly, the methods, systems, and devices describe a working electrode with a GOx sensor and a background electrode in which the background electrode has no GOx sensor. The system may then compare the first signal and the second signal to detect ingestion of a medication by the user. The system may generate a sensor glucose value based on the comparison.

Abstract: A liner associated with an adhesive skin patch of a physiological characteristic sensor deployed with a sensor inserter having a housing with a removable cover includes a surface to couple to the adhesive skin patch. The liner includes a removal portion to couple the liner to the removable cover of the sensor inserter such that a separation of the removable cover from the housing removes the liner from the adhesive skin patch.

Abstract: A liner associated with an adhesive skin patch of a physiological characteristic sensor includes a first end opposite a second end. The liner includes a first side opposite a second side. The liner includes a surface to couple to the adhesive skin patch, at least a portion of which extends from the first end to the second end. The liner includes at least one graspable member defined between the first side and the second side that extends beyond the first end or the second end to initiate a peel of the liner from the adhesive patch at a center of the liner.

Abstract: A medical device includes a sensor to observe a characteristic of an anatomy, and a sensor base coupled to the sensor. The medical device includes a coupling system to couple the sensor base to the anatomy. The coupling system includes a first adhesive member and a second adhesive member. The first adhesive member is coupled to the sensor base and the second adhesive member is to couple to the anatomy. The second adhesive member includes at least one cut-out to direct moisture to an ambient environment surrounding the medical device.