Abstract: A system for monitoring a concentration of an analyte in a fluid or tissue sample. The system comprises a sensor module adapted to be borne on a patient. The sensor module includes a power supply adapted to provide a transmission power, a first transceiver adapted to transmit analyte-concentration information, and a memory. The system further comprises a remote monitoring device adapted to wirelessly communicate with the sensor module. The remote monitoring device includes a second transceiver adapted to receive the analyte-concentration information transmitted by the sensor module and adapted to transmit a signal to the sensor module confirming that the analyte-concentration information was received. The information is stored in the memory until the signal is received by the sensor module.

Abstract: An optical reagent format with a precise capillary channel is made by molding a format on a carrier of a precise predetermined thickness. The carrier includes an insert at least a portion of which is molded in the format. Once the format is made, the insert is detached from the carrier and removed from the format leaving a precisely dimensioned capillary channel with an inlet and vent. A reagent may be applied in the capillary channel and the format used to measure the analyte in a fluid such as blood. An electrochemical sensor with a capillary channel is formed by placing a sacrificial insert and electrodes on a sensor base and applying plastic material. After the plastic material is cured, the sacrificial is removed leaving a capillary channel in the sensor. The inserts may be removed by a tool including a clamp for clamping and holding each insert stationary and a sliding block to which the sensor is secured.

Abstract: An optical waveguiding optical format enables consistent optical analysis of small sample volumes with minimal variation in light path length among optical formats. The optical format is comprised of an input guide, an output guide, and a sample cavity adapted to allow light to pass through a sample on its way from the input guide to the output guide. A lid removed from the light pathway within the format may be provided with a reagent for assisting fluid analysis.

Abstract: A lancet needle for lancing finger tips and other sites on a body to draw small samples of blood has a multisided body. The body has one end that has a portion at an angle to define a sharp edge adapted to lance a finger tip or other body site.

Abstract: A method of manufacturing a fluid collection apparatus having an integrated lance and reaction area. The method includes providing a sheet of material and then coating the sheet with a photoresist in a pattern on one side of the sheet. The pattern defines a lance and a reaction area. At least one side of the sheet is placed in a solvent. After corroding the sheet in areas not covered by the photoresist, the sheet is removed from the solvent and reveals an integrated lance and reaction area.

Abstract: A lancing mechanism for puncturing skin is provided. The lancing mechanism comprises a lance having a penetration end which is adapted to puncture skin. The penetration end of the lance is movable from a first position to a second position during a forward stroke and between the second position and the first position during a return stroke. A forcing plunger applies a force to the lance to move the lance from the first position to the second during the forward stroke. The forcing plunger is adapted to engage the lance during the forward stroke to move the penetration end of the lance from the first position to the second position and to disengage the lance when the penetration end of the lance approaches the second position. A first resilient member coupled to the lance moves the first end of the lance from the second position to the first position during the return stroke.

Abstract: An optical reagent format with a precise capillary channel is made by molding a format on a carrier of a precise predetermined thickness. The carrier includes an insert at least a portion of which is molded in the format. Once the format is made, the insert is detached from the carrier and removed from the format leaving a precisely dimensioned capillary channel with an inlet and vent. A reagent may be applied in the capillary channel and the format used to measure the analyte in a fluid such as blood.

Abstract: A lancing mechanism for puncturing skin is provided. The lancing mechanism comprises a lance having a penetration end which is adapted to puncture skin. The penetration end of the lance is movable from a first position to a second position during a forward stroke and between the second position and the first position during a return stroke. A forcing plunger applies a force to the lance to move the lance from the first position to the second during the forward stroke. The forcing plunger is adapted to engage the lance during the forward stroke to move the penetration end of the lance from the first position to the second position and to disengage the lance when the penetration end of the lance approaches the second position. A first resilient member coupled to the lance moves the first end of the lance from the second position to the first position during the return stroke.

Abstract: A vacuum assisted lancing device (10) for obtaining capillary blood from body sites includes a plunger (12) mounted in a barrel or upper housing (24) that upon being pressed by a user, drives a lancet (18) to puncture skin at a body site. A vacuum member such as a diaphragm (38, 66) or bellows (66) is displaced by the plunger (12) and displaces air in the lancing device (10) to create a vacuum. The vacuum draws skin partially into the lancing device (10) causing blood to form at the puncture. The vacuum is then released and the blood is tested.

Abstract: A sensor for use in a sensor dispensing instrument so that fluids can be tested when the sensor is ejected from within a sensor cavity of a sensor pack sealed by a foil. The sensor has a generally flat, rectangular shape, is formed by a base and a lid, and has perpendicularly extending longitudinal and transverse axes. A notch in a rear end of the sensor is engaged by a knife blade within the sensor dispensing instrument as the sensor is being ejected through the foil. A front testing edge of the lid overhangs a front testing edge of the base of the sensor. One side edge of the sensor adjacent the front edges of the base and lid is beveled at about a 25.degree. angle. The front base edge extends from the beveled side portion across the entire remaining width of the sensor at an angle of approximately 10.degree. with respect to the transverse axis. A portion of the front lid edge extends from the beveled side portion across a significant portion of the width of the sensor at an angle of about 15.degree.

Abstract: A reagent format having an inverse funnel shaped body which includes a central capillary tube that opens into a flow passageway. The flow passageway is formed, in part, by providing a recessed flow surface at one end of the inverse funnel shaped body which is surrounded by a stepped shoulder. A test substrate, such as reagent film, is secured to the shoulder so as to form one surface of the flow passageway. The device is suitable for both drawing and spreading a fluid test sample onto a test substrate in one step. Additionally, one or more small diameter vent passageways open into the flow passage to allow for air to escape when fluid is drawn into the flow passage through capillary action. The pen-shaped body is also formed of a clear or translucent material such that the flow of the test fluid can be observed by the user.

Abstract: A reagent format having an inverse funnel shaped body which includes a central capillary tube that opens into a flow passageway. The flow passageway is formed, in part, by providing a recessed flow surface at one end of the inverse funnel shaped body which is surrounded by a stepped shoulder. A test substrate, such as reagent film, is secured to the shoulder so as to form one surface of the flow passageway. The device is suitable for both drawing and spreading a fluid test sample onto a test substrate in one step. Additionally, one or more small diameter vent passageways open into the flow passage to allow for air to excape when fluid is drawn into the flow passage through a capillary action. The pen-shaped body is also formed of a clear or translucent material such that the flow of the test fluid can be observed by the user.

Abstract: Separation device and method for the fractionation and separation of finely divided solid particulate material suspended in a liquid are disclosed. The separation device comprises upper and lower portions which are joined together to form an inner cavity retaining liquid and a capillary gap which extends outwardly radially from said cavity. During rotation solid particles present in the suspending liquid pass outwardly along and/or become entrapped in the capillary gap(s).