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: Methods are provided for the determination of the concentration of biological levels of polyhydroxylated compounds, particularly glucose. The methods utilize an amplification system that is an analyte transducer immobilized in a polymeric matrix, where the system is implantable and biocompatible. Upon interrogation by an optical system, the amplification system produces a signal capable of detection external to the skin of the patient. Quantitation of the analyte of interest is achieved by measurement of the emitted signal.

Abstract: Methods are provided for the determination of the concentration of biological levels of polyhydroxylated compounds, particularly glucose. The methods utilize an amplification system that is an analyte transducer immobilized in a polymeric matrix, where the system is implantable and biocompatible. Upon interrogation by an optical system, the amplification system produces a signal capable of detection external to the skin of the patient. Quantitation of the analyte of interest is achieved by measurement of the emitted signal.

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 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: A homogenous polymer composition useful as a membrane for biosensors is disclosed. The polymer composition comprises the reaction products of a diisocyanate, a hydrophilic diol or diamine, and a silicone material. An aliphatic diol or diamine may also be included. Membranes prepared from the composition allow for increasing oxygen permeability and decreased analyte permeability (e.g. glucose). They also possess the necessary physical properties of an outer polymeric biosensor membrane.

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

Abstract: Methods and devices for dissociating multimeric proteins and their delivery to patients, along with resultant compositions, are provided. A monomeric protein delivery device is also provided, comprising a supply of a multimeric protein 4, complex, comprising multimeric protein and an aggregating agent; a flow path having a subcutaneous exit 8, fluidly coupling the multimeric protein supply to the exit; a porous surface assembly situated along the flow path comprising a porous surface 10; and an aggregating agent binding partner carried by the surface 12; whereby the aggregating agent of the multimeric protein complex passing along the surface is bound to the binding partner on the surface to create a monomeric protein flow through the subcutaneous exit.

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.

Abstract: A flow rate controller is provided for regulating the flow rate of medication delivered to a patient by an implantable medication infusion pump of the constant flow type, to minimize or prevent flow rate increases attributable to fluctuations in ambient pressure. The infusion pump comprises an implantable pump housing with a pressurized medication reservoir therein for continuous flow delivery to the patient through a baseline flow path including a restrictor such as a capillary tube. The controller comprises a pressure responsive control valve for connecting a secondary restrictor such as an additional capillary tube in series with the baseline flow path, to prevent undesired increase in the medication flow rate in the event that the patient temporarily encounters a high altitude ambient pressure.

Abstract: Methods for reducing the electrode impedance of implantable biosensors by coating the surface of the biosensor with a uniform hydrogel which allows unimpeded water movement around the sensor are provided. The surface coatings are compositions which are biocompatible and are capable of water uptake of at least 120% of their weight, more preferably at least 200% of their weight. Upon the uptake of water, the hydrogels used in the present invention will also swell and provide a layer of water around the electrodes to which the hydrogels are attached. The hydrogels can be prepared from (a) a diisocyanate, (b) a hydrophilic polymer which is a hydrophilic diol, a hydrophilic diamine, or a combination thereof, and optionally, (c) a chain extender.

Abstract: A transdermal introducer assembly is provided for quick and easy transcutaneous placement of a medical tube on a patient with reduced patient discomfort. The introducer assembly comprises a medical tube segment defining a hollow lumen extending between a distal end for placement into the subcutaneous tissue and a proximal end disposed outside the patient. The tube segment is assembled in side-by-side relation with a hollow introducer needle, and includes an elongated introducer thread at the distal end thereof folded back for slide-fit reception into the open distal end of the introducer needle. In use, the introducer needle is deployed to pierce the patient's skin at a selected placement site and to carry the tube segment to the desired transcutaneous position, after which the introducer needle can be withdrawn and slidably separated from the introducer thread to leave the tube segment and thread in place on the patient.

Abstract: Biocompatible membranes for use with biosensors are provided. The membranes are polymers which can be prepared from (a) a diisocyanate, (b) a hydrophilic polymer, (c) a siloxane polymer having functional groups at the chain termini, and optionally, (d) a chain extender.

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 occlusion detector is provided in a medication infusion pump to monitor medication delivery to a patient, and to provide an early alarm in the event of medication nondelivery. The detector comprises a force sensor and related control circuit for reading and comparing the pressure applied to the medication at the time of pump operation to administer a dose to the patient, with the same pressure at a later point in time preceding the next dose. If the difference between the pressure readings is less than a predetermined value, an occlusion of the medication delivery line is indicated and an alarm is activated.

Abstract: A medication infusion pump is provided for controlled delivery of medication to a patient, wherein the pump includes a space-efficient flexible drive plunger for advancing a piston within a medication-containing syringe or cartridge for administration of the medication to a patient. The infusion pump comprises a compact housing defining a syringe chamber for receiving and supporting the barrel of a medication-containing syringe or cartridge having a nose end adapted for luer connection to catheter tubing through which the medication is delivered to the patient. An open rear end of the syringe barrel carries a piston which can be advanced in a controlled manner to dispense the medication. In the preferred form, the flexible drive plunger comprises a spring tape with a free end adapted for removable connection to the piston.