Abstract: A sensor is provided that includes at least one functional coating layer that includes a UV-absorbing polymer. Methods for making the inventive sensors are also provided.

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 cavity to provide access to the interior cavity. The site housing material is selected to promote 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 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: A sensor and method of making the same for implantation in a body that includes a substrate with notches cut in the substrate to form a necked down region in the substrate; and at least one sensor electrode formed from one or more conductive layers. Preferably, the thickness of the substrate ranges from approximately 25 &mgr; to 350 &mgr;, but the thickness of the substrate can range from 5 &mgr; to 750 &mgr;. The sensor may be incorporated in to a sensor assembly includes a slotted needle having a slot. The notches creating the necked down region allow the substrate to slide into the slotted needle, which that has the slot narrow enough to permit passage of the necked down region. However, a non-necked down region of the substrate is prevented from pulling out of the slotted needle through the slot. The slot of the slotted needle may also permit the necked down region of the substrate to slide down the slot.

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: 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: 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.

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: 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: An 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 slotted 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 defining conductive contacts adapted for electrical connection to a suitable monitor, and a distal segment protruding from the mounting base with sensor electrodes for transcutaneous placement. The distal segment of the sensor extends within a protective cannula, a portion of which is slidably disposed within the insertion needle. 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.

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.

Abstract: A connector is provided for electrical connection to a flex circuit in a hermetically sealed manner. The flex circuit comprises thin film conductors encased between layers of insulative material, and including a proximal end with conductive contact pads exposed through one of the insulative layers. In a preferred form, the proximal ends of the two flex circuits are assembled in face-to-face relation and compressed by a clamp fixture against opposite side faces of a compressible terminal block. The terminal block is formed from a resilient insulative elastomer such as silicone rubber with embedded conductive strips having opposite edges exposed at the opposite side faces of the terminal block for electrically connecting aligned pairs of the contact pads on the two flex circuits.

Abstract: An improved near-infrared quantitative analysis instrument is disclosed comprising a removable finger insert which facilitates properly aligning and fitting and individual user's finger into the optical system of the analysis instrument. The finger insert according to the present invention also prevents the analysis instrument's optical system from being damaged by foreign matter typically introduced by a user's finger. The finger insert can also be provided with filters which will enable the insert to be used to as an optical standard for the analysis instrument.

Abstract: A method of improving the utility of electrochemical glucose sensors by decreasing either or both their settling time and their sensitivity to interfering compounds. In particular, the settling time of an electrochemical glucose sensor is improved by pretreating the operating electrode with a negative electric current at a constant current density. The sensor's sensitivity to intefering compounds is reduced by operating the sensor at a reduced voltage while the glucose concentration measurement is being made.

Abstract: An 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 slotted 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 defining conductive contacts adapted for electrical connection to a suitable monitor, and a distal segment protruding from the mounting base with sensor electrodes for transcutaneous placement. The proximal and distal segments of the sensor are linearly offset or misaligned, with the distal segment fitted within the insertion needle for transcutaneous sensor placement with the needle as the mounting base is pressed onto the patient's skin. The insertion needle can then be withdrawn to leave the sensor distal segment at the selected insertion position with the sensor electrodes in contact with patient blood or other extracellular fluid.