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: 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 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: An improved pump is provided for controlled delivery of fluids wherein the pump includes a reservoir and a movable piston. A plunger slide is in removable contact with the movable piston. A motor, is operably coupled to a drive member, such as a drive screw. The motor is disposed in-line with the drive member and the plunger slide. The drive member is operably connected to the plunger slide and is disposed to be substantially enclosed by the plunger slide when the plunger slide is in at least one position. The drive member is adapted to advance the plunger slide in response to operation of the motor.

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.

Abstract: A cartridge for containing a fluid and for use with an electronic delivery device, includes a cartridge housing for holding the fluid, and information providing source. The information providing source is coupled to the cartridge housing to operatively couple with the electronic delivery device to provide predetermined information regarding the cartridge to the electronic delivery device. For example, the information providing source may be a set of wires and contacts, or contact bands, that provide the predetermined information to electronic delivery device by producing a binary code. Alternatively, the information providing source is a bar code that provides the predetermined information to electronic delivery device by reading of the bar code. The cartridge may be used in a system that includes an electronic delivery device, such as an electronic pen-type injector and/or infusion pump.

Abstract: An injector is provided for automatic placement of a subcutaneous insertion set such as an infusion set or the like used for delivering a selected medication to a patient. The injector comprises a spring-loaded plunger having a head for receiving and supporting the insertion set in a position for placement of a medical insertion needle through the skin of a patient at a selected insertion site. The plunger head includes a safety lock mechanism for engaging and retaining the insertion set during spring-loaded advancement with a controlled force and speed toward the patient's skin to transcutaneously place the insertion needle. When the plunger head reaches a fully advanced position, with the insertion set placed on the patient, the insertion set is releasible from the safety lock mechanism with minimal force to permit quick and easy separation of the injector.

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 medication infusion pump is provided for substantially constant flow delivery of a selected medication from a medication chamber through a catheter to a patient. The medication infusion pump comprises a compact housing adapted for implantation into the body of a patient, wherein the housing defines a hollow interior forming a medication chamber. An inlet port on the housing permits transcutaneous access to and filling of the medication chamber within the housing. A flexible propellant reservoir occupies a portion of the medication chamber volume and is filled with a selected fluid propellant to apply a substantially constant pressure to the medication for medication delivery with substantially constant flow through an elongated capillary tube and the catheter for administration to the patient.

Abstract: An improved insertion set is provided for transcutaneous placement of a sensor such as a glucose sensor at a selected site within the body of a patient. The insertion set comprises a mounting base defining an upwardly open channel for receiving and supporting a flexible thin film sensor, in combination with a cap assembled with said mounting base to capture and retain a proximal end of the sensor within said channel. The sensor further includes a distal segment with sensor electrodes thereon which protrudes from the mounting base for transcutaneous placement, wherein the sensor distal segment is slidably carried by a slotted insertion needle fitted through the assembled base and cap. Placement of the insertion set against the patient's skin causes the insertion needle to pierce the skin to carry the sensor electrodes to the desired subcutaneous site, after which the insertion needle can be slidably withdrawn from the insertion set.

Abstract: A cartridge for containing a fluid and for use with an electronic delivery device, includes a cartridge housing for holding the fluid, and information providing source. The information providing source is coupled to the cartridge housing to operatively couple with the electronic delivery device to provide predetermined information regarding the cartridge to the electronic delivery device. For example, the information providing source may be a set of wires and contacts, or contact bands, that provide the predetermined information to electronic delivery device by producing a binary code. Alternatively, the information providing source is a bar code that provides the predetermined information to electronic delivery device by reading of the bar code. The cartridge may be used in a system that includes an electronic delivery device, such as an electronic pen-type injector.

Abstract: An implantable subcutaneous set for mounting onto a skin of a user and contacting a subcutaneous placement site beneath the skin includes a base, a cannula, an insertion device and an externally extending conduit. The base is used to secure the implantable subcutaneous set to the skin of the user. The cannula is coupled to and extends from the base. Also, the cannula has at least one lumen with an end for fluid communication with the subcutaneous placement site. In addition, the cannula has at least one port formed near another end of the lumen opposite the end for fluid communication. The insertion device is operatively coupled to the implantable subcutaneous set and the cannula to facilitate insertion of the cannula to contact the subcutaneous placement site. Also, the insertion device may be withdrawn from the subcutaneous set and the cannula after placing the cannula in contact with the subcutaneous placement site.

Abstract: An improved indwelling catheter adapted for long-term usage includes a stable enzyme coating to prevent occlusion of the catheter lumen. The enzyme coating includes a fibrinolytic and/or lipolytic enzyme incorporated in a catheter coating to resist or control proteolytic degradation, thereby maintaining the enzyme in an active state for dissolving clots and occlusions within the catheter lumen over an extended period of time.