Abstract: Methods and apparatus for a medical imaging system are disclosed. The imaging system is particulary suited for surgical procedures performed with respect to a lesion in a breast, although application of the invention is not so limited. An image of a portion of a patient's anatomy can be displayed on a computer. A surgical instrument and a lesion within the patient's anatomy can be displayed, showing the relative positions of each. A portion of the patient's anatomy can be monitored using markers or sensors that report position relative to an external reference point. Movement of a lesion within soft tissue can be calculated and displayed in response to changes in position or shape of the soft tissue. Accordingly, position of a lesion within a breast can be tracked in response to changes in the shape of the breast as the patient is moved or the breast is manipulated during the procedure.

Abstract: Novel methods and devices are provided involving at least one chamber, at least one capillary, and at least one reagent involved in a system providing for a detectable signal. As appropriate, the devices provide for measuring a sample, mixing the sample with reagents, defining a flow path, and reading the result. Of particular interest is the use of combinations of specific binding pair members which result in agglutination information, where the resulting agglutination particles may provide for changes in flow rate, light patterns of a flowing medium, or light absorption or scattering. A fabrication technique particularly suited for forming internal chambers in plastic devices is also described along with various control devices for use with the basic device.

Abstract: A liquid control system for a diagnostic cartridge that is insertable into an analytical instrument, which has a liquid control region located at a border between interior and exterior surfaces of the cartridge when the cartridge is inserted into a slot in the analytical instrument, wherein the region is adapted to fit with an edge formed by exterior surfaces of the analytical instrument and the slot, thereby providing a capillary gap at the edge having a gap width smaller than any gap width of any space contiguous to the gap in the interior of the slot when the cartridge is inserted in the instrument.

Abstract: A capillary stop-flow junction located in a housing at an end of a capillary passageway used to transport a liquid and at the beginning of a non-capillary internal chamber in the housing, in which the stop-flow junction contains an improvement which comprises 1) means for selectively trapping a gas in the capillary passageway and non-capillary chamber, wherein when the means for trapping is activated and the liquid enters the capillary passageway, the gas is compressed by the liquid as the liquid flows through the capillary channel and stops flowing at the stop-flow junction; or 2) a stop-flow nozzle surrounding the capillary passageway and projecting into the chamber; or 3) the stop-flow junction being formed from a single housing body member; or 4) a rupture junction in the capillary pathway, wherein the rupture junction is a stop-flow junction providing less maximum available back pressure than the capillary stop-flow junction.

Abstract: A capillary mixing device, comprising a liquid impervious housing; an interior space in the housing comprising a chamber in the housing having capillary spacing in one dimension and non-capillary spacing in other dimensions; and a plurality of magnetic or magnetically inducible particles in the chamber. The chamber is normally accessed through one or more capillary passageways leading to a surface of the housing and is adapted to be retained by a magnetic device that comprises means for generating a moving magnetic field and means for retaining the chamber device in an orientation so that the magnetic field has a field vector that intersects the capillary chamber perpendicular to the dimension having capillary spacing.

Abstract: A diagnosis system, which comprises a monitor, comprising a detector providing multiple reflectance readings in an array of individual locations, registering an analytical cartridge in the monitor at a fixed location and orientation relative to the array, and determines and displays analytical results from reflectance readings; and an analytical cartridge, comprising a liquid impervious housing, a sample application site in the housing located outside the monitor when the cartridge is registered in the monitor by the means for registering, one or more reflectance reading sites in the housing that register with one or more of the locations in the array, a capillary pathway in the housing leading from the sample application site to each of the reflectance reading sites, and a reflectance matrix located in at least one of the reflectance reading sites.

Abstract: Novel methods and devices are provided involving at least one chamber, at least one capillary, and at least one reagent involved in a system providing for a detectable signal. As appropriate, the devices provide for measuring a sample, mixing the sample with reagents, defining a flow path, and reading the result. Of particular interest is the use of combinations of specific binding pair members which result in agglutination information, where the resulting agglutination particles may provide for changes in flow rate, light patterns of a flowing medium, or light absorption or scattering. A fabrication technique particularly suited for forming internal chambers in plastic devices is also described along with various control devices for use with the basic device.

Abstract: A method for separating plasma from red blood cells and a device utilizing the method in which a low-pressure filter is interposed in a pathway between an inlet port and a reaction area. The sole driving force for the movement of plasma from the filter to the reaction area is capillary force provided by a tubular capillary. The filter is selected from glass microfiber filters of specified characteristics, which can operate in the absence of agglutinins, and filters capable of separating agglutinated red cells from plasma, which require the use of an agglutinin.

Abstract: A dilution and mixing cartridge is provided that allows single (or multiple) dilutions of a sample with a diluent in a disposable cartridge in which a measurement, such as optical density, is made. Addition of sample to the device automatically measures the sample, and addition of diluent automatically causes a fixed ratio of sample and diluent to enter a receiving chamber, in which mixing and measurement can take place. A number of preferred embodiments are provided in which the diluent application site is located at a vertical height below the sample application site, flow directing chambers are provided to control flow of desired volumes of sample or diluted sample at the appropriate locations in the device and to direct excess sample and diluent to waste locations, or control mechanism are provided at flow directing chambers and other internal locations to verify correct operation of the device.

Abstract: A dilution and mixing cartridge comprising a sample application site, a mixing chamber in fluid receiving relationship to the sample application site, a diluent application site in fluid donating relationship to the mixing chamber, a first valve means selectively preventing flow from the diluent application site to the mixing chamber, and a mixture isolating chamber hydrostatically connected to the mixing chamber is provided along with a method for using this cartridge to sequentially dilute a sample with the same or different diluents.

Abstract: Methods and devices are provided for carrying out activated partial thromboplastin time (APTT) analysis on a whole blood sample to which no anticoagulant has been added by applying the sample to a capillary track contained in a housing, wherein the capillary track comprises sample entry and venting ports, at least one capillary track connecting the entry and venting ports, and reagents capable of initiating an APTT analysis, wherein clotting time is measured by the cessation of blood flow in the capillary track.

Abstract: A mixing system comprising (1) a mixing cartridge comprising a housing containing: (a) an internal chamber, (b) access means for entry of a liquid into the internal chamber, and (c) a magnetically movable detached mixing member contained in the chamber; and (2) a control device comprising a second housing containing: (a) a detection system adapted to measure a property of a liquid at a prespecified first location in the chamber of the mixing cartridge, (b) means for holding the cartridge so as to register the chamber with the detection system, and (c) means for magnetically imparting linear reciprocal motion to the mixing member, whereby the mixing member sweeps out a portion but less than all of the volume of the chamber, the motion generally occurring at a second location in the chamber different from the first location. The mixing cartridge itself is also a part of the present invention.

Abstract: Novel methods and devices are provided involving at least one chamber, at least one capillary, and at least one reagent involved in a system providing for a detectable signal. As appropriate, the devices provide for measuring a sample, mixing the sample with reagents, defining a flow path, and reading the result. Of particular interest is the use of combinations of specific binding pair members which result in agglutination information, where the resulting agglutination particles may provide for changes in flow rate, light patterns of a flowing medium, or light absorption or scattering. A fabrication technique particularly suited for forming internal chambers in plastic devices is also described along with various control devices for use with the basic device.

Abstract: A shield is provided for isolating excess liquid on the surface of a diagnostic cartridge from a monitor with which the cartridge is used. In a preferred embodiment the shield is a strip of flexible, resilient material which can lie flat while the cartridge is in its packaged condition but which automatically springs up to serve as a shielding surface when the cartridge is unpackaged and inserted into the monitor.

Abstract: Novel methods and devices are provided involving at least one chamber, at least one capillary, and at least one reagent involved in a system providing for a detectable signal. As appropriate, the devices provide for measuring a sample, mixing the sample with reagents, defining a flow path, and reading the result. Of particular interest is the use of combinations of specific binding pair members which result in agglutination information, where the resulting agglutiniation particles may provide for changes in flow rate, light patterns of a flowing medium, or light absorption or scattering. A fabrication technique particularly suited for forming internal chambers in plastic devices is also described along with various control devices for use with the basic device.

Abstract: An apparatus for diluting a sample with a diluent, comprising a fixed volume measuring chamber, a fixed volume receiving chamber and fluid receiving relationship to the measuring chamber, a gas vent in the receiving chamber, a stop flow junction between the measuring chamber and the receiving chamber, a sample application site in fluid donating relationship to the measuring chamber, wherein the vertical height difference between the sample application site and the stop flow junction is insufficient to provide a hydrostatic pressure capable of overcoming backpressure at the stop flow junction when sample is applied to the sample application site, and the diluent application site and fluid donating relationship to the measuring chamber. Sample and diluent are added sequentially to the apparatus of the invention without requiring any intervening operations. Various means are provided for restarting flow, which causes diluent to wash the sample into the receiving chamber, where the two can be mixed.

Abstract: An apparatus for diluting a sample with a diluent, comprising a fixed volume measuring chamber, a fixed volume receiving chamber and fluid receiving relationship to the measuring chamber, a gas vent in the receiving chamber, a stop flow junction between the measuring chamber and the receiving chamber, a sample application site in fluid donating relationship to the measuring chamber, wherein the vertical height difference between the sample application site and the stop flow junction is insufficient to provide a hydrostatic pressure capable of overcoming backpressure at the stop flow junction when sample is applied to the sample application site, and the diluent application site and fluid donating relationship to the measuring chamber. Sample and diluent are added sequentially to the apparatus of the invention without requiring any intervening operations. Various means are provided for restarting flow, which causes diluent to wash the sample into the receiving chamber, where the two can be mixed.

Abstract: A method of detecting the presence and/or amount (concentration) of an analyte in a sample is provided by forming a reaction medium containing (1) a sample; (2) a plurality of particles having a binding pair member bound to their surfaces; and (3) a monovalent complementary partner to the binding pair member to which is bound an analyte mimic or analyte binding partner; and detecting the presence or amount of agglutination of the particles in the reaction medium. In some cases a polyvalent receptor capable of binding to the analyte (and to the analyte mimic, if present) is also present in the reaction medium.