Self-calibrating single-use sensing device for clinical chemistry and method of use
First Claim
1. A disposable single use sensing device for use with a clinical chemistry analyzer which determines a concentration of a selected chemical species in a sample fluid based upon sensor signals received at a receptacle, the sensing device comprising:
- a carrier;
a calibrant chamber for containing a calibrant fluid;
a sample chamber for containing the sample fluid;
a capillary passage supported by the carrier and having an inlet and having an outlet which is open to ambient air;
first rupturable seal means for sealing an end of the calibrant chamber;
second rupturable seal means for sealing an end of the sample chamber;
means for defining a start position in which neither the calibrant chamber nor the sample chamber is connected to the inlet, a calibrant test position in which the calibrant chamber is connected to the inlet, and a sample test position in which the sample chamber is connected to the inlet;
means for rupturing the first seal means to permit the calibrant chamber to be connected to the inlet and rupturing the second seal means to permit the sample chamber to be connected to the inlet;
mounting means for mounting the calibrant and sample chambers to permit sequential relative movement of the chambers with respect to the inlet of the capillary passage from the start position to one of the test positions to draw the fluid from one of the chambers into the capillary passage and then to the other of the test positions to draw the fluid from the other chamber into the capillary passage, the fluid being drawn at least in part by capillary action; and
sensing means for sensing concentration of the chemical species, the sensing means being positioned in communication with the capillary passage to provide sensor signals which are a function of sensed concentrations of the chemical species in the calibrant fluid and in the sample fluid.
0 Assignments
0 Petitions
Accused Products
Abstract
A single-use sensing device for a clinical chemistry analyzer system includes a carrier which supports a capillary passage. Species selective sensors are located within a test chamber portion of the capillary passage. A rotatable multichamber reservoir having a calibrant chamber for holding calibrant fluid and a sample chamber for containing a sample fluid is rotated first to a calibrant test position and then to a sample test position. In the calibrant test position, the calibrant chamber is connected to the inlet end of the capillary passage to draw calibrant fluid into the test chamber. In the sample test position, the sample chamber is connected to the inlet end to draw sample fluid into the test chamber and purge the calibrant fluid from the test chamber. A set of sensor readings are taken at each position, and concentration values are derived from the two sets of readings.
347 Citations
56 Claims
-
1. A disposable single use sensing device for use with a clinical chemistry analyzer which determines a concentration of a selected chemical species in a sample fluid based upon sensor signals received at a receptacle, the sensing device comprising:
-
a carrier; a calibrant chamber for containing a calibrant fluid; a sample chamber for containing the sample fluid; a capillary passage supported by the carrier and having an inlet and having an outlet which is open to ambient air; first rupturable seal means for sealing an end of the calibrant chamber; second rupturable seal means for sealing an end of the sample chamber; means for defining a start position in which neither the calibrant chamber nor the sample chamber is connected to the inlet, a calibrant test position in which the calibrant chamber is connected to the inlet, and a sample test position in which the sample chamber is connected to the inlet; means for rupturing the first seal means to permit the calibrant chamber to be connected to the inlet and rupturing the second seal means to permit the sample chamber to be connected to the inlet; mounting means for mounting the calibrant and sample chambers to permit sequential relative movement of the chambers with respect to the inlet of the capillary passage from the start position to one of the test positions to draw the fluid from one of the chambers into the capillary passage and then to the other of the test positions to draw the fluid from the other chamber into the capillary passage, the fluid being drawn at least in part by capillary action; and sensing means for sensing concentration of the chemical species, the sensing means being positioned in communication with the capillary passage to provide sensor signals which are a function of sensed concentrations of the chemical species in the calibrant fluid and in the sample fluid. - View Dependent Claims (2, 3, 4, 5)
-
-
6. A sensing device comprising:
-
a carrier; a calibrant chamber for containing a calibrant fluid; a sample chamber for containing a sample fluid; a capillary passage supported by the carrier and having an inlet and an outlet; mounting means for mounting the calibrant and sample chambers to permit sequential relative movement of the chambers with respect to the inlet of the capillary passage to draw the fluid from one of the chambers and then the fluid from the other chamber into the capillary passage; a rupturable seal at an end of each of the chambers; a plow containing the inlet of the capillary passage for rupturing each seal and extending into each chamber as relative movement brings that chamber into alignment with the inlet; and sensing means for sensing concentration of chemical species, the sensing means being positioned in communication with the capillary passage to provide sensor signals which are a function of sensed concentrations of the chemical species in the calibrant fluid and in the sample fluid.
-
-
7. A sensing device comprising:
-
a carrier; a calibrant chamber for containing a calibrant fluid; a sample chamber for containing a sample fluid; a capillary passage supported by the carrier and having an inlet and an outlet; mounting means for mounting the calibrant and sample chambers to permit sequential relative movement of the chambers with respect to the inlet of the capillary passage to draw fluid from one of the chambers and then the fluid from the other chamber into the capillary passage, wherein the mounting means rotatably connects the calibrant chamber and the sample chamber with the carrier, wherein the mounting means includes a cylindrical guide sleeve supported by the carrier, and wherein the calibrant and sample chambers are within a cylinder which is rotatably mounted in the cylindrical guide sleeve; and sensing means for sensing concentration of chemical species, the sensing means being positioned in communication with the capillary passage to provide sensor signals which are a function of sensed concentrations of the chemical species in the calibrant fluid and in the sample fluid. - View Dependent Claims (8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22)
-
-
23. A sensing device for sensing concentration of a chemical species, the sensing device comprising:
-
a capillary passage having an inlet and having an outlet which is open to ambient air; a plurality of sensors positioned in fixed space relationship in communication with the capillary passage to produce sensor signals, wherein at least one of the sensors is a species sensor having a sensing portion which is capable of selective interaction with a selected chemical species so that the species sensor exhibits a predetermined measurable characteristic which is a function of concentration of that selected chemical species; a first sealed chamber containing a calibrant fluid; a second chamber for receiving a sample fluid; means for sequentially connecting the first and second chambers to the inlet of the capillary passage to draw one of the fluids into the passage and into contact with the plurality of sensors, and then the other fluid into the capillary passage to purge the one fluid from contact with the plurality of sensors and bring the other fluid into contact with the plurality of sensors;
said means for sequentially connecting being manually movable from a start position in which neither chamber is connected to the inlet, to a first test position in which one of the chambers is connected to the inlet, and then to a second test position in which the other chamber is connected to the inlet; andmeans for rupturing a seal of the first sealed chamber to permit calibrant fluid to be drawn from the first sealed chamber into the passage. - View Dependent Claims (24, 25, 26, 27, 28, 29, 30)
-
-
31. A sensing device for sensing concentration of a chemical species, the sensing device comprising:
-
a capillary passage having an inlet; a plurality of sensors positioned in fixed space relationship in communication with the capillary passage to produce sensor signals, wherein at least one of the sensors is a species sensor having a sensing portion which is capable of selective interaction with a selected chemical species so that the species sensor exhibits a predetermined measurable characteristic which is a function of concentration of that selected chemical species; a source of a calibrant fluid; a source of a sample fluid; and means for sequentially connecting the source of a calibrant fluid and the source of a sample fluid to the inlet of the capillary passage to draw one of the fluids into the passage and into contact with the plurality of sensors, and then the other fluid into the capillary passage to purge the one fluid from contact with the plurality of sensors and bring the other fluid into contact with the plurality of sensors; wherein the sources of calibrant fluid and sample fluid comprises a multichamber reservoir having a calibrant chamber for containing the calibrant fluid and a sample chamber for containing the sample fluid; wherein the means for sequentially connecting mounts the multichamber reservoir for relative movement with respect to the inlet of the capillary passage; wherein the multichamber reservoir is a cylindrical reservoir having a generally vertical axis and having a generally vertical dividing wall for dividing an interior of the reservoir into the calibrant and sample chambers; wherein the means for sequentially connecting comprises means for rotatably mounting the reservoir for rotation about the generally vertical axis, and means for applying force to the reservoir to rotate the reservoir about the vertical axis to sequentially bring a lower end of the calibrant chamber and a lower end of the sample chamber into connection with the inlet of the capillary passage; and wherein the means for applying force comprises a cap for fitting over an upper end of the cylinder, the cap including means for engaging the dividing wall to transmit rotational force from the cap to the reservoir when the cap is rotated. - View Dependent Claims (32, 33, 34, 35, 36, 37, 38, 39)
-
-
40. A disposable single use sensing device for use with a clinical chemistry analyzer which determines a concentration of a selected chemical species in a sample fluid, the sensing device comprising:
-
a multichamber reservoir having a sealed calibrant chamber for containing a calibrant fluid and a sample chamber for receiving the sample fluid; first rupturable seal means for sealing an end of the calibrant chamber; - View Dependent Claims (42, 44, 46)
-
-
41. second rupturable seal means for sealing an end of the sample chamber;
-
a capillary passage having an inlet, an outlet which is open to ambient air, a test chamber connected to the inlet, and a downstream channel connected between the test chamber and the outlet; sensing means for sensing concentration of the chemical species, the sensing means being positioned in the test chamber; mounting means for mounting the reservoir with respect to the inlet of the capillary passage to permit manual movement of the calibrant and sample chambers with respect to the inlet of the capillary passage from a start position in which neither chamber is connected to the inlet, to a first test position in which one of the chambers is connected to the inlet, and then to a second test position in which the other chamber is connected to the inlet to draw the fluid from one of the chambers and then the fluid from the other chamber into the capillary passage and into contact with the sensing means; and seal opening means for rupturing the first and second seal means. - View Dependent Claims (43, 45)
-
-
47. A sensing device comprising:
-
a multichamber reservoir having a sealed calibrant chamber for containing a calibrant fluid and a sample chamber for receiving a sample fluid; a capillary passage having an inlet, an outlet, a test chamber connected to the inlet, and a downstream channel connected between the test chamber and the outlet; sensing means for sensing concentration of chemical species, the sensing means being positioned in the test chamber; mounting means for mounting the reservoir with respect to the inlet of the capillary passage to permit sequential connection of the calibrant and sample chambers with respect to the inlet of the capillary passage to draw the fluid from one of the chambers and then the fluid from the other chamber into the capillary passage and into contact with the sensing means; a rupturable bottom seal at a bottom end of each of the chambers; and a plow containing the inlet of the capillary passage for rupturing each bottom seal and extending into each chamber as relative movement brings that chamber into alignment with the inlet. - View Dependent Claims (49, 51)
-
-
48. A sensing device comprising:
-
a multichamber reservoir having a sealed calibrant chamber for containing a calibrant fluid and a sample chamber for receiving a sample fluid; a capillary passage having an inlet, an outlet, a test chamber connected to the inlet, and a downstream channel connected between the test chamber and the outlet; sensing means for sensing concentration of the chemical species, the sensing means being positioned in the test chamber; and mounting means for mounting the reservoir with respect to the inlet of the capillary passage to permit sequential connection of the calibrant and sample chambers with respect to the inlet of the capillary passage to draw the fluid from one of the chambers and then the fluid from the other chamber into the capillary passage and into contact with the sensing means;
wherein the reservoir is a cylinder having a generally vertical axis and a generally vertical dividing wall for dividing an interior of the reservoir into the calibrant and sample chambers;
wherein the mounting means rotatably mounts the reservoir for rotation about the vertical axis;
wherein the mounting means includes a cylindrical guide sleeve; and
wherein a lower end of the reservoir is rotatably mounted in the cylindrical guide sleeve.
-
-
50. A sensing device comprising:
-
a multichamber reservoir having a sealed calibrant chamber for containing a calibrant fluid and a sample chamber for receiving a sample fluid; a capillary passage having an inlet, an outlet, a test chamber connected to the inlet, and a downstream channel connected between the test chamber and the outlet; sensing means for sensing concentration of the chemical species, the sensing means being positioned in the test chamber; and mounting means for mounting the reservoir with respect to the inlet of the capillary passage to permit sequential connection of the calibrant and sample chambers with respect to the inlet of the capillary passage to draw the fluid from one of the chambers and then the fluid from the other chamber into the capillary passage and into contact with the sensing means;
wherein the reservoir is a cylinder having a generally vertical axis and a generally vertical dividing wall for dividing an interior of the reservoir into the calibrant and sample chambers;
wherein the mounting means rotatably mounts the reservoir for rotation about the vertical axis; and
wherein the cylinder has a vertical dividing wall for dividing an interior of the cylinder into the calibrant and sample chambers, and has a generally V-shaped bottom which includes a pair of inclined walls which are generally perpendicular to the dividing wall; andmeans for defining a start position in which neither the calibrant chamber nor the sample chamber is aligned with the inlet, a calibrant test position in which the calibrant chamber is aligned with the inlet, and a sample test position in which the sample chamber is aligned with the inlet.
-
-
52. A disposable single use sensing device for use with a clinical chemistry analyzer which determines a concentration of a selected chemical species in a sample fluid based upon sensor signals received at a receptacle, the sensing device comprising:
-
a carrier; a multichamber reservoir having a calibrant chamber for containing a calibrant fluid and a sample chamber for containing the sample fluid; first seal means for sealing an end of the calibrant chamber; second seal means for sealing an end of the sample chamber; a capillary passage supported by the carrier and having an inlet, an outlet which is open to ambient air, a test chamber connected to the inlet, and a downstream channel connected between the test chamber and the outlet; sensing means for providing the sensor signals as a function of sensed concentration of the chemical species, the sensing means being positioned in the test chamber; mounting means for mounting the reservoir to permit manual movement of the calibrant and sample chambers with respect to the inlet of the capillary passage from a start position in which neither chamber is connected to the inlet, to a first test position in which one of the chambers is connected to the inlet, and then to a second test position in which the other chamber is connected to the inlet to draw the fluid from one of the chambers and then the fluid from the other chamber into the capillary passage and into contact with the sensing means; and means proximate the inlet for breaking the first and second seal means.
-
-
53. A method for determining a concentration of a selected chemical species in a sample fluid using a sensing device which includes a multichamber reservoir having a sealed calibrant chamber which contains a calibrant fluid and a sample chamber, a capillary passage having an inlet, an outlet, a test chamber connected to the inlet, and a downstream channel connected between the test chamber and the outlet, and a species selective sensor which exhibits a predetermined measurable characteristic which is a function of concentration of the selected chemical species, the method comprising:
-
placing sample fluid in the sample chamber; moving the reservoir from a start position in which neither the calibrant chamber nor the sample chamber is connected to the inlet to a first test position in which a first seal is broken so that one of the calibrant and sample chambers is connected to the inlet to cause fluid from that chamber to be drawn into the test chamber; measuring the predetermined measurable characteristic while the fluid from the one chamber is in the test chamber; moving the reservoir from the first test position to a second test position in which a second seal is broken so that the other of the calibrant and sample chambers is connected to the inlet to cause the fluid from the other chamber to be drawn into the test chamber and purge the fluid from the one chamber from the test chamber into the downstream channel; measuring the predetermined measurable characteristic while the fluid from the other chamber is in the test chamber; and deriving a concentration of the selected chemical species in the sample fluid based upon the predetermined measurable characteristic as measured when the calibrant fluid was in the test chamber and when the sample fluid was in the test chamber.
-
-
54. A disposable single use sensing device for use with a clinical chemistry analyzer which determines a concentration of a selected chemical species in a sample fluid based upon sensor signals, the sensing device comprising:
-
a carrier; a calibrant chamber for containing a calibrant fluid, the calibrant chamber having a rupturable seal; a sample chamber for containing the sample fluid, the sample chamber having a rupturable seal; a capillary passage supported by the carrier and having an inlet, having an outlet which is open to ambient air, having a test chamber area located adjacent the inlet, and having a collection area located between the test chamber area and the outlet; mounting means for movably mounting the calibrant and sample chambers with respect to the carrier and generally above the carrier and the inlet to permit sequential manual movement of the chambers with respect to the inlet of the capillary passage to draw the fluid from one of the chambers into the test chamber area and then to draw the fluid from the other chamber into the test chamber area while moving the fluid previously to the test chamber area into the collection area; means for rupturing the seals of the calibrant and sample chamber; and sensing means for sensing concentration of the chemical species, the sensing means being positioned in communication with the test chamber area of capillary passage to provide sensor signals which are a function of sensed concentrations of the chemical species in the calibrant fluid and in the sample fluid.
-
-
55. A disposable single use sensing device for use with a clinical chemistry analyzer which determines a concentration of a selected chemical species, the sensing device comprising:
-
a multichamber reservoir having a sealed calibrant chamber for containing a calibrant fluid and a sample chamber for receiving the sample fluid; a capillary passage having an inlet, an outlet which is open to ambient air, a test chamber connected to the inlet, and a downstream channel connected between the test chamber and the outlet; sensing means for sensing concentration of the chemical species, the sensing means being positioned in the test chamber; mounting means for rotatably mounting the reservoir with respect to the inlet of the capillary passage to permit manual rotation of the reservoir to cause sequential connection of the calibrant and sample chambers with respect to the inlet of the capillary passage to draw the fluid from one of the chambers and then the fluid from the other chamber into the capillary passage and into contact with the sensing means; and means proximate the inlet for rupturing a seal of the sealed calibrant chamber.
-
-
56. A disposable single use sensing device for use with a clinical chemistry analyzer which determines a concentration of a selected chemical species in a sample fluid based upon sensor signals, the sensing device comprising:
-
a carrier; a multichamber reservoir having a calibrant chamber for containing a calibrant fluid and a sample chamber for containing the sample fluid; a capillary passage supported by the carrier and having an inlet, an outlet which is open to ambient air, a test chamber connected to the inlet, and a downstream channel connected between the test chamber and the outlet, the inlet having a substantially smaller cross-sectional area than the test chamber so as to stop capillary flow when a rearward gas-liquid interface reaches the inlet; sensing means for providing the sensor signals as a function of sensed concentration of the chemical species, the sensing means being positioned in the test chamber; and mounting means for mounting the reservoir generally above the carrier and the inlet to permit manual movement of the reservoir with respect to the carrier to cause sequential connection of the calibrant and sample chambers to the inlet of the capillary passage to draw the fluid from one of the chambers and then the fluid from the other chamber into the capillary passage and into contact with the sensing means.
-
Specification