Abstract: In connection with a fluidic medical diagnostic device that permits measurement of the coagulation time of blood, software, methods and associated devices for quality control are provided. The fluidic device preferably includes a test strip with one end having a sample port for introducing a sample and a bladder at the other end for drawing the sample to a measurement area. A channel carries sample from the sample port to an assay measurement area and first and second control measurement areas. Preferably a stop junction, between the measurement areas and bladder, halts the sample flow for measurement. If results from measurements taken for each control fall within a predetermined zone or defined limits, the assay measurement is qualified. If not, an error is registered and the test strip is counted as unfit.

Abstract: A medical diagnostic device has a non-absorbent substrate that has a hydrophilic target area on which a reagent is deposited by non-impact printing of microdroplets. During deposition, the device is moved relative to the stream of microdroplets to form a substantially uniform reagent layer on the substrate. The device is particularly well adapted for measuring blood coagulation times. In a preferred embodiment, coagulation times are determined by monitoring the optical transmission of light through the target area as an applied blood sample interacts with the reagent.

Abstract: An analyte (e.g., glucose) is tested in a sample (e.g., blood or blood-free interstitial fluid) having both the analyte and other constituents (e.g., protein). The analyte has an absorption peak over a narrow bandwidth at a characteristic wavelength. The other constituents have an absorption over a broad bandwidth. The broad bandwidth includes and is broader than the narrow bandwidth. Radiant energy (e.g., IR radiation) is directed at the sample. The energy has a source bandwidth including the broad bandwidth. The sample absorbs a portion of the energy. A remainder of the energy is available for analysis. The remainder is analyzed by filtering the remainder into an analyte portion and a reference portion. The analyte portion contains substantially only the narrow bandwidth. The reference portion contains substantially only the broad bandwidth. The analyte portion and the reference portion are measured and compared to calculate an amount of the analyte in the sample.

Abstract: An apparatus for collecting a body fluid for testing for an analyte includes a needle for penetrating a patient's skin to access the fluid within the skin. The needle has a hollow body extending from a first end to a second end. An interior surface of the body defines a fluid pathway extending between the ends. The second end is positioned to deposit fluid for testing. The first end has a beveled face on a front side of the body. The beveled face terminates at a penetration tip with the beveled face having an opening in communication with the fluid pathway. The penetration tip is burnished to a rounded shape and bent to facilitate low pain and rapid fluid collection.

Abstract: Methods and systems are provided for determining whether a volume of biological sample is adequate to produce an accurate electrochemical analyte concentration measurement. Certain such methods and systems provide the additional function of compensating for a sample volume determined to be less than adequate in order to proceed with an accurate analyte concentration measurement. The present invention is employed with a biosensor, such as an electrochemical test strip to which the sample volume of biological solution is deposited, and a meter configured to receive such test strip and to measure the concentration of selected analytes within the biological sample.

Abstract: A device for sampling at least one biological fluid constituent and measuring at least one target constituent within the biological fluid. The device has at least one micro-needle having an open distal end used to penetrate the skin to a depth where pain and bleeding are minimized. The device further includes a hydrophilic gel within the micro-needle for sampling the biological fluid constituents and an electrochemical cell for measuring the concentration of targeted constituents within the sampled biological fluid constituents. In certain embodiments, the electrochemical cell is integrated within the micro-needle whereby the steps of sampling and measuring are performed completely in-situ. In other embodiments, the electrochemical cell is located external to the micro-needle at its proximal end. Constituent sampling and measurement systems, methods and kits are also provided.

Abstract: Reflectance based methods and devices are provided for determining the concentration of an analyte in a fluid sample. In practicing the subject methods, a fluid sample is applied to a matrix impregnated with a signal producing system. The signal producing system produces a detectable product in an amount proportional to the amount of analyte in the sample. A surface of the matrix is then illuminated and a reflectance measurement is obtained therefrom, generally following a predetermined incubation period. An optical component, preferably the illumination or light detection means, is also employed to obtain a temperature value corresponding to the ambient temperature of the matrix. The analyte concentration of the sample is then obtained from the reflectance measurement using an algorithm that employs the optical component derived temperature value.

Abstract: A micro-needle is provided which is particularly useful for the minimally invasive sampling of a biological fluid and/or the minimally invasive delivery of a drug or other formulation across the skin. The micro-needle has a structure having a base at a proximal end and a vertex at a distal end, and an open lumen extending there through and through which fluid may be transferred. The structure defines a structural axis that intersects the lumenal axis defined by the open lumen. The point of intersection between these axes is at a point below the vertex of the micro-needle to provide a sharp apex at the distal end of the micro-needle and defines the general configuration of the distal end of the micro-needle, which may be selected or customized depending on the intended use of the microneedle.

Abstract: A system for drying chemical reagents on material, particularly for producing product used in making reagent test strips is described. By drying selected chemicals on substrate drawn past a radiant energy source (preferably an IR source), rapid drying may be achieved while obtaining high-quality product. Airflow sufficient to break or disturb a vapor boundary layer above drying solution may be provided to increase drying speeds. Any airflow provided should not disturb the surface of the solution. Still, air-impingement drying techniques may be employed in the system to finish drying reagent material once it is sufficiently dry to be stable in shape. The substrate upon which chemicals are dried may include a reflective coating to facilitate its use with high levels of radiant energy. A metallic or metalized substrate is advantageously used in producing electrochemical test strips. Such test strips may be used in conjunction with various kits and be conveniently read using known hand-held meters.

Abstract: Compositions, methods, devices and kits for use in the calibration of coagulation tests. The control compositions include particles capable of aggregating in plasma and calcium ions which, when mixed with plasma, simulate the behavior of whole blood in a coagulation test. The methods include providing calcium ions and particles capable of aggregating in plasma, combining the particles and calcium ions with plasma to form a control composition, and applying the control composition to a coagulation test. The devices include a container having at least two compartments, with one compartment including particles that promote or induce aggregation of a protein or proteins in plasma, and the other compartment includes a solution of calcium ions. The kits include a control composition including a container of calcium ions, a container of particles capable of inducing aggregation of proteins in plasma, and one or more coagulation test devices.

Abstract: Compositions, reagent test strips, analyte detection systems and kits of the same, as well as methods for their use in the detection of an analyte in a sample, are provided. The subject compositions are characterized by having a positively charged porous matrix and a urea derivative dye on at least one surface of the matrix, where in many preferred embodiments the urea derivative dye is a negatively charged urea derivative dye. In many preferred embodiments, the subject compositions further include at least one additional reagent member of a peroxide producing signal producing system, e.g., an analyte oxidase and/or a peroxidase. The subject compositions, test strips, analyte detection systems and kits find use in the detection of a wide variety of analytes in a sample, such as a physiological sample, e.g., blood or a fraction thereof.

Abstract: Anastomosis systems include fittings and compression mechanisms for effecting end-end or end-side couplings of biological or synthetic bypass grafts to vessel locations. The fittings are tubular and surround end regions of the graft. In some applications an end region of the graft is everted and surrounds an exterior of the fitting, in which case the preferred compression mechanism is a retaining ring. A tool is used to evert the graft end region. In other applications, the fitting has an interior groove that receives an expandable retaining ring that urges the graft end region radially outwardly against the fitting. A graft deploying and securing system includes a needle for puncturing vessel tissue, a dilator, and a sheath adapted for containing a graft/fitting combination and guiding the combination into the vessel through an opening formed by the needle and dilator.

Abstract: A method of monitoring the concentration of an analyte in a host or portion thereof over a given period of time. The method includes the steps of: (a) making a first analyte concentration measurement at a first point of time using a single use analyte concentration measuring device; (b) making a second analyte concentration measurement at a second point in time using a single use analyte concentration measuring device; and (c) making one or more additional analyte concentration measurements using another single use measuring device, wherein the analyte concentration measurements are made according to a selected schedule to monitor the concentration of analyte in a host over a given portion of time.

Abstract: A descender (10) comprising a base (11) having a connection means (26), a pivotal member (12) pivotally mounted on the base (11) about a pivot axis (1), the pivotal member (12) defining first and second spaced projections (14, 15) for engaging a rope (5), the base (11) defining a stop member (18) and a lever (23) pivotable between first and second end positions, the lever (23) and the pivotal member (12) defining complementary cam surfaces (24) to regulate the distance between the stop member (18) and the second projection (15), a resistance force applied to the rope (5) being at a minimum when the second projection (15) is moved away from the stop member (18) and the lever (23) is located in a mid-position, and is at a maximum when the lever (23) moves towards either end position wherein the rope (5) is pressed between the second projection (15) and a braking surface (22).

Abstract: Test strips, and methods for their manufacture and use in the determination of the concentration of at least one analyte in a physiological sample are provided. The subject test strips have a plurality of reaction zones defined by a hydrophobic barrier. The reagent compositions present in each reaction zone may be the same or different. In addition, each reaction zone may have a separate fluid channel, or two or more of the reaction zones may have separate channels that merge into a single channel. In use, sample is applied to a subject test strip, a signal is detected and then related to the amount of analyte in the sample. Also provided are methods for manufacturing the subject test strips using thermal transfer technology to apply the hydrophobic barrier. Finally, kits are provided for use in practicing the subject methods.

Abstract: A device for sampling a biological fluid and measuring at least one target constituent within the biological fluid. The device has at least one electrochemical cell having an inner electrode and an outer electrode in a concentrically-spaced relationship. In a preferred embodiment, the outer electrode has a cylindrical configuration having an open distal end and the inner electrode has an elongated configuration positioned coaxially within the outer electrode and a distal end configured to penetrate the skin. The spacing between the electrodes exerts a capillary force on biological fluid present at the open distal end of the outer electrode. A system is also provided which includes a control unit in electrical communication with the electrochemical cell for controlling the selection and measurement of the target constituent. Methods of sampling of biological fluids within the skin and measuring the sampled fluids are also provided, as well as kits comprising one or more of the inventive devices and/or systems.

Abstract: Electrochemical test strips and methods for their use in the detection of an analyte in a physiological sample are provided. The subject test strips have a reaction zone defined by opposing metal electrodes separated by a thin spacer layer. The metal surface of at least one of the electrodes is modified by a homogenous surface modification layer made up of linear self-assembling molecules having a first sulfhydryl end group and a second sulfonate end group separated by a short chain alkyl linking group, where 2-mercaptoethane sulfonic acid or a salt thereof is preferred in certain embodiments. The subject electrochemical test strips find application in the detection of a wide variety of analytes, and are particularly suited for use the detection of gluose.

Abstract: A sampling apparatus for interstitial fluid includes a pressure ring surrounding a collection needle. The pressure ring and needle are movable relative to one another for the ring to first engage a patient's skin surface prior to insertion of the needle.

Abstract: End-side anastomosis fittings are described which may be deployed over a guidewire, in a sheath, or by feeding the fitting through an opening in a host vessel wall. When a fitting as described is deployed within a host vessel, the exterior surface of the leading petal contacts the interior surface of the host vessel. The leading petal is configured so that it is capable of dilating the host vessel wall opening while being being advanced through the opening. The fitting also includes links which define spaces throughout the leading petal. A deflectable rear petal anchors the fitting within the host vessel once it is advanced through the host vessel wall. Additional petals may be included to provide more complete contact. The fitting also includes extensions fitted around the base to improve hemostasis and the fitting itself may be inserted by a deployment sheath which may also serve as a dilator.

Abstract: An apparatus for collecting a body fluid for testing for an analyte includes a needle for penetrating a patient's skin to access the fluid within the skin. The needle has a hollow body extending from a first end to a second end. An interior surface of the body defines a fluid pathway extending between the ends. The second end is positioned to deposit fluid for testing. The first end has a beveled face on a front side of the body. The beveled face terminates at a penetration tip with the beveled face having an opening in communication with the fluid pathway. The penetration tip is burnished to a rounded shape and bent to facilitate low pain and rapid fluid collection.