Abstract: An improved medication infusion set is provided of the type having a soft cannula for subcutaneous delivery of a selected medication to a patient. The infusion set comprises a cannula housing having a soft cannula protruding therefrom and a self-sealing septum mounted at an upstream end of the cannula. The cannula housing is initially assembled with an insertion hub having an elongated insertion needle extending through the septum and cannula for transcutaneously placing the cannula followed by separation of the insertion hub from the cannula housing. An infusion hub is then assembled with the cannula housing and includes a short infusion needle for coupling the cannula with the selected medication supplied from a source via a length of infusion tubing.

Abstract: A glucose sensor package system that includes a glucose sensor and a protective package that indicates exposure to temperature changes to indicate proper temperature control. Also covered are methods of transporting and sterilizing the package. In addition, glucose sensors directed to various sizing and positioning of the electrodes on the glucose sensor are covered.

Abstract: An occlusion detection system detects an occlusion in a fluid path of an infusion pump. The infusion pump is for delivering fluid to a user. The infusion pump includes a housing, a motor, a reservoir, one or more drive train components, a sensor, and an electronics system. The motor is contained within the housing. The reservoir contains the fluid to be delivered. The one or more drive train components react to stimulus from the motor to force the fluid from the reservoir into the user. The sensor is positioned to measure a parameter associated with the motor or a drive train component, and the sensor produces three or more output levels across a range of measurements. The electronics system processes the senor output levels to declare when an occlusion exists.

Abstract: A method of making a sensor includes the steps of providing a preformed self-supporting flexible substrate; sputter-depositing a metal layer on the substrate; etching the sputter-deposited metal layers to form a sensor electrode having a proximal segment and a distal segment; plating a metal layer on the sensor electrode; and separating the sensor electrode and at least a portion of the substrate underlying the sensor electrode from the remainder of the substrate. Sensors prepared according to the inventive methods, and sensor sets including the sensors, are also provided.

Abstract: An external infusion device system for infusing a fluid into a patient, the system including a reusable infusion device housing, a gas power source and disposable reservoir. The disposable reservoir is insertable into the reusable infusion device housing to infuse the fluid into the patient. The gas power source is for generating a gas to expel the fluid from the fluid reservoir. The disposable reservoir includes a reservoir housing, a fluid reservoir, an outlet, a gas power source, an expansion chamber and a regulating valve assembly. The fluid reservoir is within the reservoir housing for containing the fluid to be infused into the patient. The outlet is in the reservoir housing and provides a path through which the fluid is expelled to be infused into the patient. The expansion chamber is disposed between the gas power source and the fluid reservoir to receive the gas from the gas power source. The expansion member expands into the fluid reservoir to expel the fluid from the fluid reservoir.

Abstract: A transfer guard for use by an individual for transferring contents from a supply container into a receiver container includes a supply adapter, a receiver adapter, a support structure and a fluid conducting element. The supply adapter connects the supply container to the transfer guard, and the receiver adapter connects the receiver container to the transfer guard. The support structure couples the supply adapter with the receiver adapter, and supports the fluid conducting element which, passes through the supply adapter and the receiver adapter. The fluid conducting element provides a passage for the contents to transfer from the supply container into the receiver container. The fluid conducting element also includes at least one pointed end that is substantially protected by the transfer guard from contact with the individual.

Abstract: A method of calibrating glucose monitor data includes collecting the glucose monitor data over a period of time at predetermined intervals. It also includes obtaining at least two reference glucose values from a reference source that temporally correspond with the glucose monitor data obtained at the predetermined intervals. Also included is calculating the calibration characteristics using the reference glucose values and the corresponding glucose monitor data to regress the obtained glucose monitor data. And calibrating the obtained glucose monitor data using the calibration characteristics is included. In preferred embodiments, the reference source is a blood glucose meter, and the at least two reference glucose values are obtained from blood tests. In additional embodiments, the calculation of the calibration characteristics is obtained using linear regression and in particular embodiments, least squares linear regression.

Abstract: A drive mechanism for a medication delivery device includes a force receiving member, a force applying member and a shape memory alloy (SMA) actuator. The force applying member is operatively coupled to the force receiving member to move the force receiving member to a different position relative to the force applying member. The shape memory alloy actuator is formed from a shape memory alloy material and is operatively coupled to the force applying member. The shape memory alloy actuator is heat activated to distort the shape memory actuator from a first shape to a second shape to activate the force applying member to act upon the force receiving member to move the force receiving member to a different position relative to the force applying member. Also, the shape memory alloy actuator is returned to the first shape from the second shape after the force receiving member is moved to a different position relative to the force applying member.

Abstract: A reusable analyte sensor site for use with a replaceable analyte sensor for determining a level of an analyte includes a site housing. Preferably, the site housing material is formed to have an interior cavity with an opening and a conduit that is connected to the opening of the interior tissue ingrowth and vasuclarization, and yet be free of tissue ingress. Also, the site housing material permits the analyte to pass through the site housing material to the interior cavity to permit measurement by the replaceable analyte sensor. In addition, the conduit has a predetermined length to inhibit trauma and encapsulation of tissue occurring at the conduit, which is associated with placing the replaceable analyte sensor in the interior cavity of the site housing, from interfering with the tissue ingrowth and vascularization surrounding the interior cavity of the site housing material.

Abstract: A glucose sensor package system that includes a glucose sensor and a protective package that indicates exposure to temperature changes to indicate proper temperature control. Also covered are methods of transporting and sterilizing the package. In addition, glucose sensors directed to various sizing and positioning of the electrodes on the glucose sensor are covered.

Abstract: An insertion device and insertion set. The insertion device for inserting at least a portion of at least one piercing member of an insertion set through the skin of a patient includes a device housing, a carrier body and a driver. The carrier body is slidably received within the device housing for movement between an advanced position and a retracted position. The carrier body also includes a receiving structure to support the insertion set in a position with the at least one piercing member oriented for insertion through the skin of the patient at a predetermined angle relative to the skin of the patient upon movement of the carrier body from the retracted position to the advanced position.

Abstract: A safety circuit system for a DC driven device for use with a fluid delivery system includes a first voltage potential DC power line, a second voltage potential DC power line, a controller and a safety circuit. The first voltage potential DC power line is coupled to provide a first voltage potential to the DC driven device, and the second voltage potential DC power line is coupled to provide a second voltage potential to the DC driven device such that the second voltage potential is different relative to the first potential. The controller controls at least the first voltage potential on the first voltage potential DC power line. The safety circuit has an enable state and a disable state, in which the default state is the disable state. The safety circuit is coupled to the controller, and the controller controls the safety circuit to place the safety circuit in the enable state independently of controlling the first voltage potential on the first voltage potential DC power line.

Abstract: A transfer guard for use by an individual for transferring contents from a supply container into a receiver container includes a supply adapter, a receiver adapter, a support structure and a needle. The supply adapter connects the supply container to the transfer guard, and the receiver adapter connects the receiver container to the transfer guard. The support structure couples the supply adapter with the receiver adapter, and the needle passes through the supply adapter and the receiver adapter. The needle is attached to one of the adapters for support and provides a passage for the contents to transfer from the supply container into the receiver container. The needle also includes at least one pointed end that is substantially protected by the transfer guard from contact with the user.

Abstract: There is provided a method of supplying a fluid to a placement site. For instance, a sensor set is first mounted onto a skin of a user, and a placement site is contacted with the sensor set. The sensor set includes a base to secure the sensor set to the skin of the user; a cannula coupled to and extending from the base; an insertion device operatively coupled to the sensor set and the cannula to facilitate insertion of the cannula to contact the placement site; an externally extending conduit; and a sensor. The cannula has at least one lumen with an end for fluid communication with the placement site, and also has at least one port formed near another end of the lumen opposite the end for fluid communication. The conduit is in fluid communication with the at least one port of the cannula. The sensor has a sensor portion exposed by the at least one port in the at least one lumen of the cannula to determine a body characteristic of the user at the placement site.

Abstract: A Holter-type monitor system includes a remotely located data receiving device, an analyte sensor for producing signal indicative of a characteristic of a user, and a Holter-type recording device. The Holter-type recording device includes a housing, a sensor connector, a processor, and a data port. The sensor connector receives the produced signals from the analyte sensor. The processor is coupled to the sensor connector and stores the signals from the analyte sensor for delivery to the remotely located data receiving device. The recording device is coupled to the processor for downloading the stored signals to the remotely located data receiving device. The data receiving device may be a characteristic monitor, a data receiver that provides data to another device, an RF programmer, a medication delivery device (such as an infusion pump), or the like.