Abstract: In certain embodiments, a method samples a body fluid of a patient. The method includes providing a fluid handling system having one or more fluid passageways. The method further includes infusing an infusion fluid by way of a fluid handling system into a patient through one or more fluid passageways. The method further includes obtaining a sample of body fluid by way of a fluid handling system from a patient through one or more fluid passageways. The obtained sample is no more than 5 milliliters in volume. The method further includes analyzing at least an analyzed portion of the obtained sample by way of an analyte detection system operatively associated with the fluid handling system to determine a concentration of at least one analyte.

Abstract: In certain embodiments, an apparatus for analyzing the composition of bodily fluid includes a first fluid passageway having a patient end which is configured to provide fluid communication with a bodily fluid within a patient. The apparatus further includes at least one pump coupled to the first fluid passageway. The at least one pump has an infusion mode in which the pump is operable to deliver infusion fluid to the patient through the patient end, and a sample draw mode in which the pump is operable to draw a sample of the bodily fluid from the patient through the patient end. The apparatus further includes an analyte detection system accessible via the first fluid passageway such that the analyte detection system can receive at least one component of the drawn sample of bodily fluid and determine a concentration of at least one analyte. The analyte detection system is spaced from the patient end of the first fluid passageway.

Abstract: An apparatus is provided for monitoring a predetermined parameter of a patient's body fluid while infusing an infusion fluid into the patient. The apparatus comprises an infusion line and a catheter configured for insertion into a blood vessel of the patient, and a reversible infusion pump connected between a source of an infusion fluid and the infusion line and catheter. The apparatus further comprises a body fluid sensor assembly mounted in fluid communication with the infusion line and which includes a first sensor and a sample cell. The first sensor provides a signal indicative of a predetermined parameter of any fluid present in the infusion line. The sample cell is substantially transmissive to light comprising a wavelength ?. The apparatus further comprises a controller that is configured to operate the infusion pump in a forward direction so as to pump the infusion fluid through the infusion line and catheter for infusion into the patient.

Abstract: A method of treating a diabetic condition of a patient comprises providing a glucose detection system which is portable and usable by the patient, and which is configured to measure glucose levels with a standard error of less than about 30 mg/dL. The method further comprises making a plurality of measurements of the patient's glucose level with the portable, patient-usable glucose detection system. The method further comprises administering a diabetes treatment to the patient based on one or more of the measurements of the patient's glucose level.

Abstract: A method of extracting and analyzing bodily fluids from a patient at the point of care for the patient is provided. The method comprises establishing fluid communication between an analyte detection system and a bodily fluid in the patient. A portion of the bodily fluid is drawn from the patient. The drawn portion is separated into a first component of the bodily fluid, while the analyte detection system remains in fluid communication with the patient. The analyte detection system analyzes the first component to measure a concentration of an analyte.

Abstract: A fluid sampling and analysis system. The system comprises a fluid handling network including a patient end configured to maintain fluid communication with a bodily fluid of a patient; a sample analysis chamber accessible by the fluid handling network; and a pump unit in operative engagement with the fluid handling network. The pump unit has an infusion mode in which the pump unit is operable to deliver infusion fluid to the patient through the patient end; a sample draw mode in which the pump unit is operable to draw a sample of bodily fluid from the patient through the patient end, and provide a portion of the sample to the sample analysis chamber; and an optical calibration mode in which the pump unit is operable to supply calibration fluid to the sample analysis chamber.

Abstract: A method and apparatus are described that permit an analyte concentration to be estimated from a measurement in the presence of compounds that interfere with the measurement. The method reduces the error in the analyte concentration in the presence of interferents. The method includes the use of a set of measurements obtained for a large population having a range of known analyte and interfering compound concentrations. From a sample measurement, which may or may not be one of the population, likely present interferents are identified, and a calibration vector is calculated.

Abstract: A fluid handling and analysis system comprises a fluid transport network comprising at least a first fluid passageway. The fluid transport network includes a patient end that is configured to maintain fluid communication with a bodily fluid in a patient. A sample analysis chamber and waste container are each accessible via the fluid transport network. A pump unit is in operative engagement with the fluid transport network. The pump unit has an infusion mode in which the pump unit is operable to deliver an infusion fluid to the patient through the patient end, and a sample draw mode in which the pump unit is operable to draw a volume of the bodily fluid from the patient through the patient end, towards the sample analysis chamber. A spectroscopic fluid analyzer is configured to analyze a sample of the bodily fluid while the sample is in the sample analysis chamber, and determine a concentration of at least one analyte.

Abstract: A fluid handling and analysis system is provided. The system includes a main analysis and control instrument and a fluid handling module that are removably engageable with the main instrument. The main instrument comprises a spectroscopic bodily fluid analyzer and at least one control element. The fluid handling module includes a spectroscopic sample cell and at least one fluid handling element, and the sample cell is accessible via the fluid handling element. The fluid handling element has a control interface configured to engage the control element when the main instrument and the fluid handling module are engaged.

Abstract: In certain embodiments, a method samples a body fluid of a patient. The method includes providing a fluid handling system having one or more fluid passageways. The method further includes infusing an infusion fluid by way of a fluid handling system into a patient through one or more fluid passageways. The method further includes obtaining a sample of body fluid by way of a fluid handling system from a patient through one or more fluid passageways. The obtained sample is no more than 400 microliters in volume. The method further includes analyzing at least an analyzed portion of the obtained sample by way of an analyte detection system operatively associated with the fluid handling system to determine a concentration of at least one analyte.

Abstract: A fluid handling module is configured for removable engagement with a reusable main fluid handling instrument. The module comprises a housing, an infusion fluid passageway, a sample fluid passageway, and a fluid component separator. The infusion fluid passageway has a first port and a second port spaced from the first port, and a lumen extending from the first port to the second port. The sample fluid passageway is connected to the infusion fluid passageway. The fluid component separator is connected to the sample fluid passageway.

Abstract: An apparatus is provided for monitoring a predetermined parameter of a patient's body fluid while infusing an infusion fluid into the patient. The apparatus comprises an infusion line and a catheter configured for insertion into a blood vessel of the patient, and a reversible infusion pump connected between a source of an infusion fluid and the infusion line and catheter. The apparatus further comprises a body fluid sensor assembly mounted in fluid communication with the infusion line and which includes a first sensor and a sample cell. The first sensor provides a signal indicative of a predetermined parameter of any fluid present in the infusion line. The sample cell is substantially transmissive to light comprising a wavelength B. The apparatus further comprises a controller that is configured to operate the infusion pump in a forward direction so as to pump the infusion fluid through the infusion line and catheter for infusion into the patient.

Abstract: A fluid handling module is configured for removable engagement with a reusable main fluid handling instrument. The module includes a module housing and a first fluid passageway extending from the module housing. The first fluid passageway has a patient end remote from the housing. The first fluid passageway is configured to provide fluid communication with a bodily fluid in a patient. A fluid component separator is in fluid communication with the first fluid passageway. The fluid component separator is configured to separate at least one component from a portion of the bodily fluid drawn from the patient. A spectroscopic sample cell is configured to hold at least a portion of the first component.

Abstract: An apparatus for analyzing the composition of bodily fluid. The apparatus comprises a fluid handling network including a patient end configured to maintain fluid communication with a bodily fluid in a patient; and a pump unit in operative engagement with the fluid handling network. The pump unit has an infusion mode in which the pump unit is operable to deliver infusion fluid to the patient through the patient end, and a sample draw mode in which the pump unit is operable to draw a sample of the bodily fluid from the patient through the patient end. The apparatus further comprises a spectroscopic analyzer positioned to analyze at least a portion of the sample; a processor in communication with or incorporated into the spectroscopic analyzer; and stored program instructions executable by the processor to obtain measurements of two or more properties of the sample.

Abstract: In some embodiments, a system for bodily fluid sampling and analysis comprises a first fluid passageway having a patient end which is configured to provide fluid communication with a bodily fluid within a patient. A sample analysis chamber is accessible via the first fluid passageway. At least one pump is in operative engagement with the first fluid passageway such that the system is operable to periodically draw a sample of the bodily fluid from the patient through the first fluid passageway and toward the sample analysis chamber. A separator is accessible via the first fluid passageway and configured to remove at least one component from the sample of bodily fluid. A spectroscopic analyte detection system is configured to analyze the component of bodily fluid while the component of bodily fluid is in the sample analysis chamber, and determine a concentration of at least one analyte.

Abstract: A method and device are described for applying a microprotrusion member (44) including a plurality of microprotrusions (90) to the stratum corneum with impact. The method and device are used to improve transport of an agent across the skin for agent delivery or sampling. The applicator (10, 60, 80) causes the microprotrusion member (44) to impact the stratum corneum with a certain amount of impact determined to effectively pierce the skin with the microprotrusions (90). The preferred applicator (10, 60, 80) impacts the stratum corneum with the microprotrusion member (44) with an impact of at least 0.05 joules per cm2 of the microprotrusion member (44) in 10 msec or less.

Abstract: An applicator device (10) is provided for applying a patch (44) having an array of microprotrusions (90) to the stratum corneum. The applicator device (10) includes a device body (12) and a piston moveable within the device body (12). A cap (16) is provided on the device body (12) for activating the device (10) to impact the stratum corneum with a microprotrusion array (44,90). The device (10) is capable of being cocked by one handed operation of the user which allows the device (10) to be used by patients having neither the strength nor the manual dexterity to cock other types of applicator devices.

Abstract: A method and device are described for applying a microprotrusion member (44) including a plurality of microprotrusions (90) to the stratum corneum with impact. The method and device are used to improve transport of an agent across the skin for agent delivery or sampling. The applicator (10, 60, 80) causes the microprotrusion member (44) to impact the stratum corneum with a certain amount of impact determined to effectively pierce the skin with the microprotrusions (90). The preferred applicator (10, 60, 80) impacts the stratum corneum with the microprotrusion member (44) with an impact of at least 0.05 joules per cm2 of the microprotrusion member (44) in 10 msec or less.

Abstract: A retainer (34) is provided for holding a microprotrusion member (44) for application of the microprotrusion member (44) to the stratum corneum with an impact applicator (10). The microprotrusion member (44) includes a plurality of microprotrusions (90) which penetrate the stratum corneum to improve transport of an agent across the stratum corneum.

Abstract: The present invention features calcilytic compounds. “Calcilytic compounds” refer to compounds able to inhibit calcium receptor activity. Also described are the use of calcilytic compounds to inhibit calcium receptor activity and/or achieve a beneficial effect in a patient; and techniques which can be used to obtain additional calcilytic compounds.