Stacked sensor assembly for fluid analyzer

Abstract

A sensor assembly for analysis of physical parameters and chemical constituents of small volume samples of bodily fluids with at least two analyte sensors. The sensor assembly including a separation panel with an upper surface and a lower surface and upper and lower fluid channels disposed within the upper and lower surfaces respectively. The fluid channels extending substantially between the first and second ends and when in an operating mode bodily fluid is in fluid communication with both the upper and lower fluid channels. The sensor assembly including a potentiometric chip positioned atop and an amperometric chip positioned beneath the separation panel with at least one analyte sensor positioned above and beneath each of the fluid channels and when the sensor assembly is in an operating mode the fluid is in fluid communication with the analyte sensors. A bonding media is disposed beneath the amperometric chip.

Claims

1. A sensor assembly for analysis of physical parameters and chemical constituents of small volume samples of bodily fluids with at least two analyte sensors comprising: a separation panel, the separation panel further comprising an upper surface with an upper fluid channel for passage there through of the sample volume as well as a lower surface with a lower fluid channel in fluid communication with the upper fluid channel; a first chip disposed atop the separation panel, the first chip including at least one analyte sensor disposed over the upper fluid channel and one or more electrical contact points for connecting the analyte sensor with an analyzer; and a second chip disposed beneath the separation panel, the second chip including at least one analyte sensor disposed over the lower fluid channel and one or more electrical contact points for connecting the analyte sensor with an analyzer; wherein a bodily fluid sample traverses through the entire extent of the upper and lower fluid channels in fluid communication with the analyte sensors of the first and second chips.

2. The sensor assembly of claim 1, wherein the separation panel comprises first and second longitudinally disposed ends.

3. The sensor assembly of claim 2, wherein the upper and lower fluid channels span between the first and second longitudinally disposed ends.

4. The sensor assembly of claim 1, wherein the upper and lower fluid channels further comprise a first wall and a second wall.

5. The sensor assembly of claim 4, wherein the first and second walls of the upper and lower fluid channels are separated by a distance in a range of from 0.200 to 1.000 mm.

6. The sensor assembly of claim 1, wherein the sensor assembly has an inlet port configured for fluid communication with the lower fluid channel.

7. The sensor assembly of claim 1, wherein the sensor assembly has a fluid outlet in fluid communication with the upper fluid channel.

8. The sensor assembly of claim 1, wherein the separation panel is fabricated from an engineered plastic.

9. The sensor assembly of claim 1, wherein a total combined volume of the upper and lower fluid channels is in a range of from 30 μl to 40 μl.

10. The sensor assembly of claim 1, wherein a thickness of the separation panel is in a range of from 1.0 to 3.0 mm.

11. The sensor assembly of claim 1, wherein the at least one analyte sensor in each of the first and second chips is at least two adjacent analyte sensors.

12. The sensor assembly of claim 11, wherein the at least two adjacent sensor's are separated from each other by a distance in a range of from 0.200 to 2.000 mm.

13. The sensor assembly of claim 1, wherein the analyte sensors of the first chip are potentiometric sensors.

14. The sensor assembly of claim 1, wherein the analyte sensors of the second chip are amperometric sensors.

15. The sensor assembly of claim 1, wherein the upper and lower fluid channels are rectangular in cross-section.

16. The sensor assembly of claim 15, wherein the upper and lower fluid channels are arcuate in cross-section in proximity to a through hole leading from the lower to the upper fluid channel.

17. A sensor assembly for analysis of physical parameters and chemical constituents of small volume samples of bodily fluids with at least two analyte sensors comprising: a separation panel with an upper surface and a lower surface, the separation panel further comprising first and second longitudinally disposed ends with upper and lower fluid channels disposed within the upper and lower surfaces, respectively, and extending between the first and second longitudinally disposed ends and when in an operating mode bodily fluid is in fluid communication with both the upper and lower fluid channels; a first chip positioned atop the separation panel with at least one analyte sensor positioned over the upper fluid channel and when the sensor assembly is in an operating mode the bodily fluid is in fluid communication with the at least one analyte sensor; and a second chip positioned beneath the separation channel with at least one analyte sensor positioned beneath the lower fluid channel and when the sensor assembly is in an operating mode the bodily fluid is in fluid communication with the at least one analyte sensor, wherein the bodily fluid sample traverses through the entire extent of the upper and lower fluid channels in fluid communication with the analyte sensors of the first and second chips.

18. The sensor assembly of claim 17, wherein the upper and lower fluid channels in the upper and lower surfaces of the separation panel are arcuate in cross-section.

19. The sensor assembly of claim 17, wherein the upper and lower fluid channels in the upper and lower surfaces of the separation panel are rectangular in cross-section.

20. The sensor assembly of claim 17, wherein the upper and lower fluid channels are linear along the entire span of said channels.

21. The sensor assembly of claim 17, wherein a first gasket is positioned between the first chip and the separation panel to prevent leakage of the bodily fluid sample.

22. The sensor assembly of claim 17, wherein a second gasket is positioned between the second chip and the separation panel to prevent leakage of the bodily fluid sample.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) Illustrative embodiments of the disclosed technology are described in detail below with reference to the attached drawing figures, which are incorporated by reference herein and wherein:

(2) FIG. 1 is a perspective view of an embodiment of an exploded cartridge with case and cover and including an embodiment of a sensor assembly;

(3) FIG. 2 is an exploded topside view of an embodiment of the sensor assembly components;

(4) FIG. 3 is an exploded bottom side view of an embodiment of the sensor assembly components;

(5) FIG. 4 is a plan view of an embodiment of a separation panel of the sensor assembly disclosed herein;

(6) FIG. 5 is a cross-sectional view of the separation panel of FIG. 4 taken along line 5-5;

(7) FIG. 6 is a cross-sectional view of the separation panel of FIG. 4 taken along line 6-6;

(8) FIG. 7 is an exploded view of the potentiometric chip, separation panel and amperometric chip;

(9) FIG. 8 is a cross sectional view of the fully assembled cartridge with sensor assembly installed therein; and

(10) FIG. 9 is a perspective view of a fully assembled fluid sensor assembly.

DETAILED DESCRIPTION

(11) Disclosed herein is a stacked sensor assembly 10 for determining partial pressures of gases, concentrations of electrolytes and metabolites in a fluid sample. The stacked sensor configuration is ideal for minimizing the surface area required for the sensor assembly without sacrificing the functionality of the sensor assembly. In clinical laboratory settings where available space may be at a premium due to the large number of instruments utilized, this stacked sensor configuration offers an attractive option for reducing the footprint of the sensor assembly. Fluids, such as whole blood, can be analyzed for many analytes, including the electrolytes potassium (K.sup.+), sodium (Na.sup.+), and calcium (Ca.sup.2+) and metabolites such as glucose, lactate, blood urea nitrogen (BUN), and creatine. The sensors used for these measurements are ion-specific or ion-selective electrodes (ISE).

(12) An embodiment of the stacked sensor assembly 10 disclosed herein is depicted in FIG. 1. The stacked sensor assembly 10 is shown ready for loading onto the cartridge base 20 and the cartridge cover 30 located atop the stacked sensor assembly 10. The fully assembled cartridge 40 includes the stacked sensor assembly 10 as well as the cartridge base 20 and the cartridge cover 30. The cartridge 40 is sold as a unit for installation in a fluid gas analyzer, such as a blood gas analyzer, that is well known in the industry and sold by several manufacturers.

(13) As shown in FIG. 2, the stacked sensor assembly 10 is comprised of multiple layers. The uppermost layer may be comprised of solely a potentiometric chip 102 or a combination of potentiometric sensors and other types of sensors. The discussion below details the utilization of potentiometric and amperometric chip sets; however, it should be understood that the disclosure herein contemplates the combination of many types of sensors to include potentiometric, and amperometric, sensors on each chip. The potentiometric chip 102 operates pursuant to a form of electrochemical analysis. In potentiometry, the potential or voltage is measured between the two electrodes in a solution. These potentials can also be produced when a metal and ions of that metal are present in a solution. By using a membrane that is semipermeable to the ion, different concentrations of the ion can be separated. These systems use a reference and a measuring electrode as is well understood by those skilled in the art. A constant voltage is applied to the reference electrode; the difference in voltage between the reference and measuring electrode is used to calculate the concentration of the ion in solution.

(14) Ion-selective electrodes are based on a modification of the principle of potentiometry. The potential difference or electron flow is created by selectively transferring the ion to be measured from the sample solution to the membrane phase. The ion-selective electrode measures the free ion concentration of the desired analyte on a selectively produced membrane. Membranes have a complex composition and contain organic solvents, inert polymers, plasticizers, and ionophores wherein the ionophores are molecules that increase the membrane's permeability to the specific ion.

(15) As seen in FIG. 2, disposed beneath the potentiometric chip 102 is the separation panel 104. The separation panel 104 includes an upper surface 106 with an upper fluid channel 108 for passage there through of the sample fluid. The separation panel 104 also reduces the potential for unintended electromagnetic cross-talk between sensors located on the oppositely disposed chip thereby improving the accuracy and reliability of the sensor data. As seen in FIG. 3, the separation panel 104 includes a lower surface 110 with a lower fluid channel 112. The lower fluid channel 112 is in fluid communication with the upper fluid channel 108, as will be discussed in greater detail below. Optionally disposed between the potentiometric chip 102 and the separation panel 104 may be an upper gasket 114. The upper gasket 114 seals the separation panel 104 against leakage of the sample fluid and is preferably comprised of a flexible fluid resistant material capable of forming a seal against leakage. The upper gasket 114 may include a series of perforations 116 located on each side of a centralized cutout 118. The perforations 116 in the upper gasket 114 may provide an opening for the lower protruding surface 122 of the analyte sensor contact points 124, 125.

(16) As previously discussed, the potentiometric chip 102 is positioned atop the separation panel 104 and includes, as shown in FIG. 3, at least one analyte sensor 136, and preferably many more are positioned over the upper fluid channel 108. Each analyte sensor 136 includes two electrical contact points 124, 125 for connecting the analyte sensor 136 to an analyzer (not shown).

(17) The upper fluid channel 108 serves as a conduit for the fluid being measured by an upper analyte sensor 136. This fluid channel 108 is narrow and generally linear in configuration and is preferably rectangular as shown at cross section 5-5 and 6-6 as seen in FIGS. 4-6. Other cross-sectional configurations, such as arcuate, are also contemplated by this disclosure. In order to reduce the volume of the fluid sample required for analysis to no more than roughly 30 μl, the upper fluid channel must be very narrow. Cross section 5-5 also details the through hole 138 that leads from the upper fluid channel 108 to the exit point 140 on the lower chip which is discussed in greater detail below.

(18) As seen in FIGS. 2 and 3 a second chip 152 is disposed beneath the separation panel 104. In a preferred embodiment, the chip 152 is comprised of all amperometric sensors; however, a combination of amperometric, potentiometric and other sensor options placed upon the chip 152 are also contemplated with this disclosure. The discussion below is directed to a chip comprised solely of amperometric sensors; however, this characterization should not be considered limiting. Amperometric methods measure the electrical current flow produced from oxidation-reduction reactions. Types of amperometry include enzyme electrodes, such as the glucose oxidase method and the Clark pO.sub.2 electrode. These types of designs are well known as biosensors and are adaptable for testing in the clinical laboratory as well as for point of care testing.

(19) Enzyme-based biosensor technology was first developed to measure blood glucose. A solution of glucose oxidase is placed between the gas permeable membrane of the pO.sub.2 electrode and an outer membrane that is semipermeable. Glucose in the blood diffuses through the semipermeable membrane and reacts with the glucose oxidase. Glucose is converted by glucose oxidase to hydrogen peroxide and gluconic acid.

(20) A polarizing voltage is applied to the electrode, which oxidizes the hydrogen peroxide and contributes to the loss of electrons. Oxygen is consumed near the surface of the pO.sub.2 electrode and its rate of consumption is measured. The loss of electrons and rate of decrease of pO.sub.2 is directly proportional to the glucose concentration in the sample. The basic principles of operation for laboratory fluid analyzers are the same as for the previously described electrodes for pH, pCO.sub.2, and pO.sub.2; and ion specific electrodes for the measurement of electrolytes.

(21) As seen in FIGS. 2 and 3, the amperometric chip 152 includes at least one analyte sensor 154 disposed over the lower fluid channel 112 and two electrical contact points 156, 158 for connecting the analyte sensor 154 with an analyzer (not shown). As seen in FIG. 3, positioned above the amperometric chip 152 is the separation panel 104. The separation panel 104 includes a lower surface 110 with a lower fluid channel 112 for passage of the sample fluid. As seen in FIG. 3, the separation panel 104 includes a lower surface 110 with a lower fluid channel 112, in fluid communication with the upper fluid channel 108. Optionally disposed between the amperometric chip 152 and the separation panel 104 is a lower gasket 160. The lower gasket 160 seals the separation panel 104 against leakage of the sample fluid and is preferably comprised of flexible fluid resistant material capable of forming a seal against leakage. The gasket 160 includes a cutout area 162 that coincides with the location and configuration of the lower fluid channel 112.

(22) As seen in FIG. 3, the separation panel 104 also includes a pair of optional adjacent channels 164, 166 that straddle the lower fluid channel 112. These channels may facilitate the fabrication of the separation panel 104 by inhibiting warping that may otherwise result from excess molded material. The amperometric chip 152 is positioned beneath the separation panel 104 and includes, as shown in FIG. 2, at least one analyte sensor 154, and preferably many more, are positioned beneath the lower fluid channel 112. Each analyte sensor 154 includes two electrical contact points 156, 158 for connecting each analyte sensor 154 with an analyzer (not shown).

(23) The lower fluid channel 112 serves as a conduit for the fluid being analyzed by at least one lower analyte sensor 154. This fluid channel 112 is narrow and generally linear in configuration and may be viewed at cross sections 5-5 and 6-6 as seen in FIGS. 5-6. In order to reduce the volume of the fluid sample required for analysis to no more than about 30 μl, the lower fluid channel 112, just like the upper fluid channel 108, must be very narrow. For example, at cross section 5-5, as shown in FIG. 5, the lower fluid channel 112 has a very narrow rectangular profile. Cross section 5-5 also details the through hole 138 that leads from the upper fluid channel 108 to the exit point 140 on the amperometric chip which is discussed in greater detail below.

(24) Fluid 170 undergoing analysis enters the channel 112, as best seen in FIGS. 7 and 8 at the far extent of the channel through an opening 172. The fluid 170 then travels along the lower fluid channel 112 providing access to one or more amperometric analyte sensors 154. The fluid sample 170 then traverses through an opening 148 in the separation panel prior to entering the upper fluid channel 108. After entering the upper fluid channel 108 the fluid sample 170 traverses beneath at least one analyte sensor 136 prior to transiting through the exit opening 138 in the separation panel 104. FIG. 8 reveals a cross section view of the overall cartridge assembly 40 and details the fluid path through the sensor assembly 10.

(25) As shown in FIG. 9, the sensor assembly 10 when fully assembled reveals analyte sensor contacts 124, 125 156, 158. These sensor contacts feed electrical signals to contact points located on the analyzer (not shown) where the voltage and current levels from each analyte sensor are separately analyzed. Following analysis, the pertinent details regarding the fluid analytes are reported out to the user to effectuate a diagnostic assessment.

(26) Many different arrangements of the various components depicted, as well as components not shown, are possible without departing from the spirit and scope of the disclosed technology. Embodiments of the disclosed technology have been described with the intent to be illustrative rather than restrictive. Alternative embodiments will become apparent to those skilled in the art that do not depart from its scope. A skilled artisan may develop alternative means of implementing the aforementioned improvements without departing from the scope of the disclosed technology.

(27) It will be understood that certain features and sub combinations are of utility and may be employed without reference to other features and sub combinations and are contemplated within the scope of the claims. Not all steps listed in the various figures need be carried out in the specific order described.