Fluid sample analyte collector and calibration assembly
First Claim
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1. A fluid collection, sensing and calibrating apparatus, comprising:
- calibrator having a base and holder portion adapted to hold at least one container containing calibration fluid,calibration container securely held in the holder of the calibrator, wherein the container is sealed to contain calibration fluid,fluid collection means adapted for fluid communication with the container but removable from the calibrator for fluid collection where the collector has a body portion defining a chamber at one end and has an actuating means slidable within the body portion at the other end to provide a variable volume for the chamber and having at the end of the chamber opposite the *actuating means a connecting means for fluid engagement with means for withdrawing calibration fluid, andat least one sensing means attached to the collector for fluid communication with the container and in fluid communication with the collection means so that when calibration fluid is withdrawn from the container by the actuating means of the collector and into the chamber the fluid contacts the sensor, andmeans for withdrawing calibration fluid by puncturing the seal of the container when the means is attached to the connecting means of the collector.
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Abstract
A fluid sample collector, sensing, and calibration device contains a collector like a syringe, with one or more analyte sensors, and a calibrator for calibrating the sensor. These can be pre-assembled and are particularly adapted to be disposable after a single use; the analyte sensor may be connected to a self-contained monitoring instrument or analyzer which processes the signals from the sensor and displays the information to the operator.
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Citations
39 Claims
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1. A fluid collection, sensing and calibrating apparatus, comprising:
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calibrator having a base and holder portion adapted to hold at least one container containing calibration fluid, calibration container securely held in the holder of the calibrator, wherein the container is sealed to contain calibration fluid, fluid collection means adapted for fluid communication with the container but removable from the calibrator for fluid collection where the collector has a body portion defining a chamber at one end and has an actuating means slidable within the body portion at the other end to provide a variable volume for the chamber and having at the end of the chamber opposite the *actuating means a connecting means for fluid engagement with means for withdrawing calibration fluid, and at least one sensing means attached to the collector for fluid communication with the container and in fluid communication with the collection means so that when calibration fluid is withdrawn from the container by the actuating means of the collector and into the chamber the fluid contacts the sensor, and means for withdrawing calibration fluid by puncturing the seal of the container when the means is attached to the connecting means of the collector. - View Dependent Claims (2, 3, 4, 5, 6, 28, 29, 30)
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7. In combination, a syringe having a body portion having first and second fluid communicating chambers with a first fluid seal therebetween, said first chamber defining a cylinder with a piston slidable therein,
means for actuating said piston, said actuating means carrying a first seal puncturing means, said second chamber defining a housing for a sensing means and terminating in connecting means for fluid engagement with means for withdrawing a sample of fluid defining a connecting conduit in fluid communication with said second chamber, said connecting conduit sealed by a second fluid seal, sensing means disposed in said second chamber for sensing at least one analyte in the sample of fluid, and a calibrator for calibrating said sensing means, said calibrator having a body portion defining a cylinder open at one end for receiving at least a portion of said body portion of said syringe, a movable member carrying a second seal puncturing means that is slidable in said cylinder of said calibrator, and a sealed container containing calibration solution supported in the end of said cylinder of said calibrator opposite said opening.
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31. A syringe having a body portion having first and second fluid communicating chambers with a first fluid seal therebetween, said first chamber defining a cylinder with a piston slidable therein, means for actuating said piston, said actuating means carrying a firs seal puncturing means, said second chamber defining a housing for a sensing means and terminating in connecting means for fluid engagement with means for withdrawing a sample of fluid defining a connecting conduit in fluid communication with said second chamber, said connecting conduit sealed by a second fluid seal, sensing means disposed in said second chamber for sensing at least one analyte in the sample of fluid.
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32. The method of determining arterial pH, pC02 and p02 in whole blood using a disposable prepackaged syringe having a body portion having first and second fluid communicating chambers with a first fluid seal therebetween, said first chamber defining a cylinder with a piston slidable therein, means for actuating said piston, said actuating means carrying a first seal puncturing means, said second chamber defining a housing for a sensing means and terminating in connecting means for fluid engagement with means for withdrawing a sample of fluid defining a connecting conduit in fluid communication with said second chamber, said connecting conduit sealed by a second fluid seal, sensing means disposed in said second chamber for sensing pH, p02 and pC02 in the sample of whole blood and a calibrator for calibrating said sensing means, said calibrator having a body portion defining a cylinder open at one end for receiving at lest a portion of said body portion of said syringe, a movable member, carrying a second seal puncturing means, slidable in said cylinder of said calibrator, a sealed container containing calibration solution supported in the end of said cylinder of said calibrator opposite said opening, comprising the steps of:
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unpackaging the syringe and calibrator, progressively moving said syringe and said calibrator one relative to the other, puncturing the said first fluid seal, said second fluid seal and said seal of said sealed container containing calibration solution, aspirating the calibration solution from the container into contact with the sensing means, calibrating said sensing means, removing said syringe from said calibrator and attaching the syringe to a hypodermic needle or a arterial catheter, drawing of the whole blood, determining of arterial pH, pC02 and p02 in the withdrawn whole blood; and disposing of said syringe.
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33. A fluid calibrator for calibrating a syringe having an electronic sensing means for sensing at least one analyte in the sample of fluid;
- said calibrator comprising;
body portion defining a cylinder open at one end for receiving at least a portion of the body of a syringe, movable member, carrying a seal puncturing means, slidable in said cylinder of said calibrator, sealed container containing calibration solution supported in the end of said cylinder opposite said opening, wherein said movable member is adapted to be fluidly coupled to and to be urged by the slidably received syringe toward said container whereby said seal puncturing means punctures the seal of said sealed container to achieve fluid communication between said container and the syringe for drawing said solution from said container into the syringe for calibrating the sensing means. - View Dependent Claims (34, 35, 36, 37, 38, 39)
- said calibrator comprising;
Specification