Abstract: An implantable infusion system includes at least two controllable fluid transfer devices that may be used to transfer different fluid flows to the same or different body sites.

Abstract: A catheter for use in delivery or withdrawal of a formulation, wherein the catheter has an outer layer comprising a bio-compatible material and a barrier layer comprising a material that provides a more effective barrier than the outer layer against inward and outward diffusion of substances that may cause destabilization of the formulation. The catheter may include a flared distal end tip to aid in the release, during a bolus delivery or catheter flush, of any obstruction situated at the distal end tip of the catheter. The catheter may also include a slit valve at the distal end tip which has one or more and, preferably a plurality of slits that may be elastically extended to an open position by the expulsion of the formulation during an IIP pump stroke. During the interval between IIP pump strokes, the slits return to a closed position and hinder the inflow of body fluid into the distal end tip.

Abstract: Methods and apparatus for translating a continuous-delivery delivery profile into a plurality of periodic bolus deliveries.

Abstract: Implantable infusion apparatus, systems and methods that involve the use of a sensor that is associated with the catheter outlet.

Abstract: An ambulatory infusion device including a fluid transfer device with a piston bore and a piston. The piston bore surface and the piston surface are configured such that they will wear at a very slow rate when cycled in the absence of a lubricant other than the infusible substance.

Abstract: Valves, valved fluid transfer devices and ambulatory infusion devices including the same.

Abstract: Valves, valved fluid transfer devices and ambulatory infusion devices including the same.

Abstract: A communication device (CD) exchanges messages with an implantable infusion pump via telemetry such that commands are supplied thereto and operational information is obtained therefrom. The CD is controlled, at least in part, by a processor IC according to a software program operating therein and provides feedback to a user via a visual display, an audio alarm, and a vibrational alarm, and allows input from the user via a touch sensitive keypad. Certain input functions are restricted by password. The visual display includes an icon and fixed element display region and a bitmap display region. The fixed element display region includes time and date displays, battery and drug level displays that decrement, and a moving delivery state display. Various screens allow operational or log information to be displayed and/or user entry of commands. Program features when disabled are removed from a series of screen options that can be scrolled through.

Abstract: A communication device (CD) exchanges messages with an implantable infusion pump via telemetry such that commands are supplied thereto and operational information is obtained therefrom. The CD is controlled, at least in part, by a processor IC according to a software program operating therein and provides feedback to a user via a visual display, an audio alarm, and a vibrational alarm, and allows input from the user via a touch sensitive keypad. Certain input functions are restricted by password. The visual display includes an icon and fixed element display region and a bitmap display region. The fixed element display region includes time and date displays, battery and drug level displays that decrement, and a moving delivery state display. Various screens allow operational or log information to be displayed and/or user entry of commands. Program features when disabled are removed from a series of screen options that can be scrolled through.

Abstract: An implantable infusion device includes of a disc-shaped housing that is made from a biocompatible material and contains a reservoir. The reservoir defines a chamber that contains at least one flexible diaphragm. A ring is provided in alignment with the peripheral edge of each diaphragm. The ring has a central opening that is aligned with the convolution and central portion of each diaphragm, to allow the diaphragm to flex within the ring. In this manner, the volume on one side of each diaphragm may be varied to correspond to a varying volume of infusion medium. Similarly, the volume within the reservoir chamber on the other side of the diaphragms is varied as the diaphragms flex, to correspond to the expansion and contraction of a propellant medium within the reservoir.

Abstract: A communication device (CD) exchanges messages with an implantable infusion pump via telemetry such that commands are supplied thereto and operational information is obtained therefrom. The CD is controlled, at least in part, by a processor IC according to a software program operating therein and provides feedback to a user via a visual display, an audio alarm, and a vibrational alarm, and allows input from the user via a touch sensitive keypad. Certain input functions are restricted by password. The visual display includes an icon and fixed element display region and a bitmap display region. The fixed element display region includes time and date displays, battery and drug level displays that decrement, and a moving delivery state display. Various screens allow operational or log information to be displayed and/or user entry of commands. Program features when disabled are removed from a series of screen options that can be scrolled through.

Abstract: A catheter for use in delivery or withdrawal of a formulation, wherein the catheter has an outer layer comprising a bio-compatible material and a barrier layer comprising a material that provides a more effective barrier than the outer layer against inward and outward diffusion of substances that may cause destabilization of the formulation. The outer surface of the barrier layer contacts at least a portion of the inner surface of the outer layer. The catheter may include a flared distal end tip to aid in the release, during a bolus delivery or catheter flush, of any obstruction situated at the distal end tip of the catheter. The larger cross-sectional area at the flared distal end tip minimizes the chances that any obstruction that develops at the distal end tip will be sufficient to hinder the flow of the formulation within the lumen of the catheter.

Abstract: Embodiments of medical infusion pumps are provided that include structural elements for providing sources of compliance within a fluid path within the pump. Some preferred embodiments provide implantable infusion pumps with compliance positioned between an exit port of a pumping mechanism and an outlet (e.g. an opening in a catheter) of the infusion pump. Other embodiments provide compliance in fluid path in proximity to entrance port of the pumping mechanism. Insertion of compliance in a flow path that is down stream of the pumping mechanism may aid in minimizing negative effects associated with attempting to force fluid through a restricted flow path that is further down-stream, such as that offered by a catheter or other outlet component. Insertion of compliance before the pumping mechanism may aid in reducing negative effects associated with an up stream restricted flow path, such as that which might be offered by a rigid filter located between the reservoir and the pumping mechanism.

Abstract: An implantable infusion device includes of a disc-shaped housing that is made from a biocompatible material. The housing contains a reservoir for holding a volume of infusion medium, such as a medication to be administered to the patient. A reservoirs for an implantable infusion devices may be configured to reduce the thickness requirements of the device, without compromising volume capacity of the device. In addition, such a reservoir configuration can allow multiple dispensing and fill or re-fill operations, with reduced risk of damage to the reservoir components. The reservoir defines a chamber that contains at least one flexible diaphragm. Each diaphragm has an outer peripheral edge within the chamber, a convolution adjacent the peripheral edge and a generally smooth central portion that is free to flex within the chamber, wherein the convolution enhances the flexibility of the diaphragm. A ring is provided in alignment with the peripheral edge of each diaphragm.

Abstract: A medication infusion pump includes a housing, a medication chamber defined within the housing, a medication delivery device in fluid communication with the medication chamber, a propellant chamber defined within the housing and adapted to apply a predetermined positive pressure to a medication in the medication chamber, and a non-ozone depleting, non-toxic propellant within the propellant chamber. The propellant preferably has a vapor pressure between about 11 psig and about 50 psig at 37° C.

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: A medication infusion device such as a programmable infusion pump includes data input regarding a selected patient parameter such as a current blood glucose reading. The infusion device includes a controller responsive to this data input to develop a medication delivery protocol which can be implemented automatically, recommended via a display for subsequent approval or rejection upon manipulation of control switches, or otherwise overridden in favor of a different medication delivery protocol.

Abstract: An improved glucose sensor adapted for in vivo implantation includes one or more optical fiber optrodes mounted within a semipermeable probe housing designed for differential diffusion of glucose and oxygen. In a preferred form, an enzyme optrode comprises an optical fiber with an enzyme coating such as glucose oxidase for catalyzing glucose in the presence of oxygen (O.sub.2) to produce gluconic acid and hydrogen peroxide. An oxygen sensitive coating such as a fluorescent dye is provided on the enzyme optrode in close proximity with the enzymatic reaction, and also on a reference optrode at a position spaced substantially from the enzymatic reaction. Optical monitoring of the fluorescent activity of the optrode coatings provides an indication of oxygen depletion as a result of the enzymatic reaction, and thus also indicates glucose concentration level. The semipermeable housing is designed to ensure that the reaction proceeds with a stoichiometric excess of oxygen (O.sub.2).

Abstract: An infusion pump system includes a removable in vivo glucose sensor for monitoring glucose concentration level in a patient, and for signaling an infusion pump to deliver a selected medication such as insulin to a patient. The glucose sensor comprises a sensor cable for placement through a catheter to position a distal sensor tip at a selected in vivo sensor site. A proximal end of the sensor cable seats within a connector fitting mounted on the catheter at a convenient and accessible subcutaneous position. The connector fitting couples the sensor cable to an implanted control unit which signals the infusion pump to deliver the patient medication. In a preferred system, the infusion pump is also implanted and receives control signals via a direct or telemetric connection. The sensor cable is easily accessed at the connector fitting for periodic sensor removal and replacement, without requiring removal or replacement of other system components.

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 an insertion needle extending through a mounting base adapted for mounting onto the patient's skin. A flexible thin film sensor includes a proximal segment carried by the mounting base and adapted for electrical connection to a suitable monitor or the like, and a distal segment protruding from the mounting base with sensor electrodes thereon for transcutaneous placement. The distal segment of the sensor and a distal segment of the insertion needle are positioned within a flexible cannula which extends from the mounting base, whereby placement of the mounting base onto the patient's skin causes the insertion needle to pierce the skin for transcutaneous placement of the cannula with the sensor therein.