Abstract: A sensor set is provided for sensing of a body characteristic, such as glucose. The sensor set includes a mounting base for the sensor including a shim adapted to prevent pull up of the sensor and a connector to connect to the mounting base and has an improved structure for connecting the mounting base to the connector. The connector may contain sensor electronics for wired or wireless communication to an external monitor or display. The mounting base includes latch arms and the connector adapted to fit and lock into latch recesses on the connector and includes anti-rotation arms adapted to fit into anti-rotation arm recesses on the connector.

Abstract: A simple, disposable sensing device for sensing an analyte is housed in a single case. The sensing device can transmit sensor data to monitoring device(s). The sensing device includes: a case having a lower major wall adapted to be mounted against a patient's skin, and an upper opposing major wall; a sensor extending from the case and having a distal end sensitive to the analyte to produce an electrical signal, and a proximal end within the case having electrical contacts; a printed circuit board assembly within the case supported by one of the major walls to receive the electrical signal via the electrical contacts; and an elastomeric pad disposed in the case and biased by the other major wall to urge the proximal end of the sensor into contact with the printed circuit board assembly and maintain an electrical connection between the electrical contacts and the printed circuit board assembly.

Abstract: Embodiments relate to an insertion device that includes: a plunger coupled with a lock collar. The insertion device houses contents including: a striker including self-locking striker snap arm(s) where the striker is kept from firing by a striker spring captured between the plunger and the striker when the insertion device is in a cocked position; a sensor assembly; and a needle carrier that holds a piercing member, the needle carrier captured between the striker and a needle carrier spring where a self-releasing snap(s) keeps the needle carrier cocked, where the plunger prevents the self-releasing snap(s) from repositioning and releasing the needle carrier. The striker fires the needle carrier such that the self-locking striker snap arm(s) are positioned to allow the striker to snap down. The needle carrier is then retracted when the user releases the plunger and the piercing member is encapsulated within the insertion device.

Abstract: A medical sensor device includes a sensor assembly including an underside surface for attachment against a patient's skin, a sensor portion to detect a characteristic of the patient, and sensor assembly contacts which in operation carry signals representing the detected characteristic. The device also includes a transmitter assembly removably engageable with the sensor assembly and including circuitry to take the signals from the sensor assembly contacts and to transmit readings of the detected characteristic to external equipment. The device also includes mechanical interface components on the sensor assembly and the transmitter assembly which allow the transmitter assembly to be brought into abutment with the sensor assembly at a first angular position via relative axial movement between them, and then allow a relative rotation of the assemblies with respect to one another towards a second angular position and presents axial separation of the assemblies in the second angular position.

Abstract: A simple sensing device includes a case with one or more indicators to indicate levels of an analyte such as glucose. The sensing device for self-monitoring an analyte includes a single, flexible case adapted to adhere to a skin of a patient. It also includes a printed circuit board assembly inside the case. It further includes a first sensor extending from the flexible case and electrically coupled to the printed circuit board, and one or more indicators in the flexible case, where the indicator(s) are adapted to indicate whether a level of an analyte is within a normal range.

Abstract: This disclosure generally relates to medical devices that include a transmitter assembly positioned on top of a sensor assembly. A sensor assembly includes a sensor base having a bottom surface and a top surface having an interface. The interface accommodates a sensor stack that includes at least one sensor head having electrical contact pads connected to an elastomeric connector. The sensor assembly further includes a mounting base having a first side that attaches to the bottom surface of the sensor base, and a second side that adheres to a patient's skin. A transmitter assembly includes a transmitter shell and a transmitter cap having an interface that engages with the sensor base. Also, the transmitter assembly includes electrical contacts disposed on the transmitter cap that connect with the electrical contact pad(s) of the sensor assembly.

Abstract: This disclosure generally relates to medical devices that include a sensor transmitter assembly that includes a sensor assembly including a sensor module where a first sensor including a first sensor head having at least one first sensor contact pad is combined with a second sensor including a second sensor head having at least one second sensor contact pad. The sensor transmitter assembly also includes a transmitter assembly positioned on a top of the sensor assembly to form a single unit, the transmitter assembly having at least one transmitter contact disposed on a base of the transmitter assembly, where the first sensor contact pad(s) and the second sensor form a connection path with the transmitter contact(s).

Abstract: A product allows gaseous manufacturing by-products to be vented from the inside a sealed package tray. An exemplary method for packaging a device includes sealing the device inside a package tray with a gas-permeable sealing material, resulting in a sealed package tray. The sealing material allows volatile substances to vent from inside the sealed package tray to outside the sealed package tray.

Abstract: An infusion set component of a fluid infusion device and/or a fluid infusion port component for delivery of fluid to a patient is compatible with a cooperating fluid channel module. The fluid channel module includes a body section having coupling features to mate with a base of the component. The fluid channel module also includes an interior fluid flow channel formed within the body section to receive fluid from the fluid infusion device and/or from a syringe or pen delivery device. The fluid channel module also includes a conduit having a first end in fluid communication with the interior fluid flow channel, and having a second end to deliver the fluid to the patient.

Abstract: An improved sensor set is provided for sensing of a body characteristic, such as glucose. The sensor set includes a mounting base for the sensor and a connector to connect to the mounting base. The connector may contain sensor electronics for wired or wireless communication to an external monitor or display. The mounting base includes a connector fitting adapted to fit into a tubular recess in the connector, wherein the connector fitting includes a key. In some embodiments, the proximal end of the sensor folds around the key such that there are contact pads on both sides of the key. The mounting base and connector include additional features, such as pegs and prongs that allow for unique fitting of compatible mounting bases and connectors, while locking out non-compatible components.

Abstract: A sensor set is provided for sensing of a body characteristic, such as glucose. The sensor set includes a mounting base for the sensor and a connector to connect to the mounting base and has an improved structure for connecting the mounting base to the connector. The connector may contain sensor electronics for wired or wireless communication to an external monitor or display. The mounting base includes latch arms and the connector adapted to fit and lock into latch recesses on the connector and includes anti-rotation arms adapted to fit into anti-rotation arm recesses on the connector.

Abstract: A glucose sensor product maintains the sterility of the glucose sensor while allowing gaseous manufacturing by-products to be vented from the inside of the glucose sensor package. An exemplary glucose sensor product includes a plastic package tray and a glucose sensor assembly in the plastic package tray. The glucose sensor assembly includes an electrochemical sensor with glucose oxidase enzyme, a sensor base formed at least in part from plastic, a sensor mounting pedestal formed at least in part from plastic, and a sensor introducer formed at least in part from plastic. The glucose sensor product also includes a microbial barrier material coupled to the plastic package tray to seal the glucose sensor assembly in the plastic package tray. The microbial barrier material maintains sterility of the glucose sensor assembly while venting substances outgassed from the plastic package tray, the sensor base, the sensor mounting pedestal, and the sensor introducer.

Abstract: An infusion set component of a fluid infusion device and/or a fluid infusion port component for delivery of fluid to a patient is compatible with a cooperating fluid channel module. The fluid channel module includes a body section having coupling features to mate with a base of the component. The fluid channel module also includes an interior fluid flow channel formed within the body section to receive fluid from the fluid infusion device and/or from a syringe or pen delivery device. The fluid channel module also includes a conduit having a first end in fluid communication with the interior fluid flow channel, and having a second end to deliver the fluid to the patient.

Abstract: An introducer is provided for introducing a sensor into the body of a patient. The introducer connects to a sensor hub. When the sensor hub and introducer are connected, the introducer needle is exposed. When the sensor hub and introducer are disconnected, a needle cover and the needle move with respect to each other so that the needle cover substantially covers the needle, protecting a user from being injured by the needle.

Abstract: An introducer is provided for introducing a sensor into the body of a patient. The introducer connects to a sensor hub. When the sensor hub and introducer are connected, the introducer needle is exposed. When the sensor hub and introducer are disconnected, a needle cover and the needle move with respect to each other so that the needle cover substantially covers the needle, protecting a user from being injured by the needle.

Abstract: A glucose sensor product maintains the sterility of the glucose sensor while allowing gaseous manufacturing by-products to be vented from the inside of the glucose sensor package. An exemplary glucose sensor product includes a plastic package tray and a glucose sensor assembly in the plastic package tray. The glucose sensor assembly includes an electrochemical sensor with glucose oxidase enzyme, a sensor base formed at least in part from plastic, a sensor mounting pedestal formed at least in part from plastic, and a sensor introducer formed at least in part from plastic. The glucose sensor product also includes a microbial barrier material coupled to the plastic package tray to seal the glucose sensor assembly in the plastic package tray. The microbial barrier material maintains sterility of the glucose sensor assembly while venting substances outgassed from the plastic package tray, the sensor base, the sensor mounting pedestal, and the sensor introducer.

Abstract: A glucose sensor product is manufactured by a process that maintains the sterility of the glucose sensor while allowing gaseous manufacturing by-products to be vented from the inside of the glucose sensor package. The method begins by placing a glucose sensor assembly into a plastic package tray having a sealing surface surrounding an opening. The method continues by covering the opening with a microbial barrier material such that the microbial barrier material overlies the sealing surface, forming a seal between the sealing surface and the microbial barrier material, resulting in a sealed package tray containing the glucose sensor assembly, and sterilizing the glucose sensor assembly inside the sealed package tray. The microbial barrier material maintains sterility of the glucose sensor assembly while allowing volatile by-products outgassed from the glucose sensor assembly and the plastic package tray to pass therethrough.

Abstract: A device for detection or measurement of a carbohydrate analyte in fluid comprises: an optical sensor comprising components of an assay for carbohydrate analyte, the readout of which is a detectable or measurable optical signal, and a light guide having a distal portion optically coupled to the assay components and a proximal portion; and a reader for interrogating the optical sensor, the reader comprising an assay interrogating system including a lens; and an interface portion forming part of at least one of the optical sensor and the reader, the interface portion being capable of removably constraining the proximal portion of the light guide and the lens of the assay interrogating system in an optically coupled arrangement. The device may be combined with an insulin-infusion system.

Abstract: A synchronous rectifier circuit rectifies an AC input voltage to produce a DC output voltage. The synchronous rectifier circuit comprises MOSFET (metal-oxide-semiconductor field-effect transistor) switches coupled within secondary transformer windings resulting in a shortened AC current path compared to conventional synchronous rectifier circuits. The shortened current path mitigates skin and proximity effects, substantially improving the power efficiency of the synchronous rectifier circuit. A rectifier assembly integrates one or more synchronous rectifier circuits within a magnetic core.

Abstract: Embodiments of the invention provide analyte sensors having optimized elements and/or configurations of elements as well as methods for making and using such sensors. Typical embodiments of the invention include glucose sensors used in the management of diabetes.