Cartridge arrangement, fluid analyzer arrangement, and methods

• US 20030224523A1
• Filed: 05/30/2002
• Published: 12/04/2003
• Est. Priority Date: 05/30/2002
• Status: Abandoned Application

• Current Assignee: International Technidyne Corporation (Sphingotec GMBH)
• Original Assignee: International Technidyne Corporation (Sphingotec GMBH)
• Inventors: Thornberg, John Herbert, Sand, Ronald William, Blomberg, Scott Everett, Sin, Kee Van, Hieb, Martin Gaines
• Application Number:
  US10/160,329
• Publication Number:
  US 20030224523A1
• Time in Patent Office: Days
• US Class Current: 436/43
• CPC Class Codes: B01L 2200/10 Integrating sample preparation and analysis in single entity, e.g. lab-on-a-chip concept
• CPC Class Codes: B01L 2300/0645 Electrodes
• CPC Class Codes: B01L 2300/0816 Cards, e.g. flat sample carriers usually with flow in two horizontal directions
• CPC Class Codes: B01L 2300/087 Multiple sequential chambers
• CPC Class Codes: B01L 2400/0481 squeezing of channels or chambers
• CPC Class Codes: B01L 2400/0605 check valves
• CPC Class Codes: B01L 3/0241 Drop counters; Drop formers making arrays for combinatorial libraries B01J19/0046; automation of dispensing for analysis G01N35/10
• CPC Class Codes: B01L 3/502738 characterised by integrated valves microvalves F16K99/0001
• CPC Class Codes: G01N 27/3271 Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood amperometry per se G01N27/49; aspects concerning the enzyme reagent C12Q1/001
• CPC Class Codes: G01N 33/4925 measuring blood gas content, e.g. O2, CO2 , HCO3
• CPC Class Codes: Y10T 436/11 Automated chemical analysis

Abstract

A cartridge for analysis of fluid samples useable with an analyzer device includes an arrangement to selectively control fluid flow within the cartridge. One type of cartridge includes a fluid channel. A sensor arrangement is oriented within the fluid channel and includes at least one dry-stored sensor and at least one wet-stored sensor. The cartridge may include a first port. In some instances, the cartridge can include a second port. In some instances, the cartridge can include a third port. In some implementations, a cartridge includes a fluid reservoir in fluid communication with a port on the cartridge. The fluid reservoir defines a fluid passage and a fluid dispenser actuator. The actuator includes an over-center engageable button depressible to initiate fluid flow from an internal volume in the fluid reservoir and through the fluid passage and through the port into the sensor arrangement on the cartridge. Methods for analyzing, calibrating, and using the cartridge are provided.

Claims

1. A cartridge for analysis of fluid samples;

the cartridge being for use with an analyzer device;

the cartridge comprising;

(a) a base structure defining a fluid channel;

(b) a sensor arrangement oriented within said fluid channel;

(c) said base structure defining a first port in fluid communication with said fluid channel;

(d) said base structure defining a second port in fluid communication with said fluid channel; and

(e) a first valve arrangement operably oriented in said base structure to selectively control fluid flow through said first port to said fluid channel.

2. A cartridge according to claim 1 further including:

(a) a first fluid reservoir in fluid communication with said first port;

(i) said first valve arrangement selectively controlling fluid flow from said first fluid reservoir into said fluid channel.

3. A cartridge according to claim 2 further including:

(a) a second fluid reservoir in fluid communication with said second port;

(i) said first valve arrangement preventing flow from said second fluid reservoir into said first fluid reservoir.

4. A cartridge according to claim 3 further including:

(a) a second valve arrangement operably oriented to selectively control fluid flow through said second port to said fluid channel and to prevent fluid flow from said first fluid reservoir into said second fluid reservoir.

5. A cartridge according to claim 4 wherein:

(a) said first valve arrangement is a check valve; and

(b) said second valve arrangement is a check valve.

6. A cartridge according to claim 3 wherein:

(a) said sensor arrangement includes at least two sensors.

7. A cartridge according to claim 6 wherein:

(a) said sensor arrangement includes no more than 20 sensors.

8. A cartridge according to claim 3 wherein:

(a) said sensor arrangement includes at least one electrochemical sensor.

9. A cartridge according to claim 3 wherein:

(a) said sensor arrangement includes at least one enzymatic sensor.

10. A cartridge according to claim 3 wherein:

(a) said sensor arrangement includes;

(i) at least one enzymatic sensor;

(ii) at least one amperometric sensor; and

(iii) at least one ion selective electrode sensor.

11. A cartridge according to claim 10 wherein:

(a) said sensor arrangement further includes at least one conductometric sensor.

12. A cartridge according to claim 3 wherein:

(a) said sensor arrangement includes at least one sensor selected from the group consisting of;

pH;

carbon dioxide;

oxygen;

sodium;

calcium;

potassium;

hematocrit;

blood urea nitrogen;

chloride;

glucose;

lactate; and

creatinine.

13. A cartridge according to claim 3 wherein:

(a) said first fluid reservoir is constructed and arranged for removably mounting on said base structure.

14. A cartridge according to claim 13 wherein:

(a) said first fluid reservoir defines a fluid passage and a fluid dispenser actuator;

(i) said actuator being constructed and arranged to initiate fluid flow from an internal volume in said first fluid reservoir and through said fluid passage and through said first port.

15. A cartridge according to claim 14 wherein:

(a) said first fluid reservoir includes a base and a lid mounted on said base;

(i) said lid including said actuator;

said actuator including an over-center engageable button.

16. A cartridge according to claim 15 wherein:

(a) said over-center engageable button includes a dome-shaped portion depressible in a direction toward said base.

17. A cartridge according to claim 13 wherein:

(a) said first fluid reservoir includes calibration fluid therein.

18. A cartridge according to claim 3 wherein:

(a) said second fluid reservoir is constructed and arranged for removably mounting on said base structure.

19. A cartridge according to claim 18 wherein:

(a) said second fluid reservoir includes blood therein.

20. A cartridge according to claim 18 wherein:

(a) said second fluid reservoir includes a syringe.

21. A cartridge according to claim 3 further including:

(a) a third port in fluid communication with said fluid channel.

22. A cartridge according to claim 21 further including:

(a) a septum and duct in fluid communication with said third port.

23. A cartridge according to claim 22 wherein:

(a) said sensor arrangement includes a plurality of sensors; and

(b) said third port and said sensor arrangement is constructed and arranged to allow fluid flow through the third port into said fluid channel to provide fluid flow over only some of said sensors and disallow fluid flow over remaining sensors.

24. A cartridge according to claim 22 wherein:

(a) said sensor arrangement includes;

(i) an oxygen sensor; and

(ii) at least one of a creatinine sensor and a blood urea nitrogen sensor; and

(iii) a glucose sensor; and

(iv) at least one of a sodium sensor, pH sensor, carbon dioxide sensor, calcium sensor, potassium sensor, hematocrit sensor, chloride sensor, and lactate sensor;

(b) said oxygen sensor being downstream of said second port and upstream of said first port and said third port;

(c) said at least one of a creatinine sensor and a blood urea nitrogen sensor being;

downstream of said first port and said second port; and

upstream of said third port; and

(d) said glucose sensor and said at least one of a sodium sensor, pH sensor, carbon dioxide sensor, calcium sensor, potassium sensor, hematocrit sensor, chloride sensor, and lactate sensor being downstream of said first port, said second port, and said third port.

25. A cartridge according to claim 1 further including:

(a) a conductor arrangement in electrical contact with said sensor arrangement;

said conductor arrangement being constructed and arranged to connect the sensor arrangement to the analyzer device, when the cartridge is mounted in the analyzer device.

26. A cartridge according to claim 1 further including:

(a) a waste chamber defined by said base structure;

said waste chamber being in fluid communication with said fluid channel.

27. A cartridge for analysis of fluid samples;

the cartridge being for use with an analyzer device;

the cartridge comprising;

(a) a base structure defining a fluid channel;

(b) a sensor arrangement oriented within said fluid channel;

said sensor arrangement including;

(i) at least one dry-stored sensor; and

(ii) at least one wet-stored sensor;

(c) said base structure defining a first port in fluid communication with said fluid channel; and

(d) said base structure defining a second port in fluid communication with said fluid channel.

28. A cartridge according to claim 27 wherein:

(a) said base structure defines a third port in fluid communication with said fluid channel.

29. A cartridge according to claim 28 wherein:

(b) said base structure and said sensor arrangement are constructed and arranged such that;

(i) said at least one dry-stored sensor is downstream of said second port and said first port and upstream of said third port; and

(ii) said at least one wet-stored sensor is downstream of said first port, said second port, and said third port.

30. A cartridge according to claim 28 wherein:

(a) said sensor arrangement further includes at least one enzymatic sensor;

(i) said at least one enzymatic sensor being downstream of said first port and said second port and upstream of said third port.

31. A cartridge according to claim 27 further including:

(a) a first check valve operably oriented with said base structure to selectively control fluid flow through said first port to said fluid channel.

32. A cartridge according to claim 31 further including:

(a) a second check valve operably oriented with said base structure to selectively control fluid flow through said second port to said fluid channel.

33. A cartridge according to claim 27 further including:

(a) a first fluid reservoir in fluid communication with said first port;

said first fluid reservoir defining a fluid passage and a fluid dispenser actuator;

(i) said actuator being constructed and arranged to initiate fluid flow from an internal volume in said first fluid reservoir and through said fluid passage and through said first port.

34. A cartridge according to claim 28 wherein:

(a) said dry-stored sensor includes;

(i) at least one of;

an oxygen sensor;

a blood urea nitrogen sensor;

and a creatinine sensor; and

(b) said wet-stored sensor includes;

(i) a glucose sensor; and

(ii) at least one of a blood gases sensor and a blood electrolytes sensor.

35. A cartridge according to claim 34 wherein:

(a) said dry-stored sensor includes both said oxygen sensor and said at least one of a blood urea nitrogen sensor and a creatinine sensor;

(i) said oxygen sensor being downstream of said second port and upstream of said first and third ports;

(ii) said at least one of a blood urea nitrogen sensor and a creatinine sensor being downstream of said second port and said first port and upstream of said third port; and

(c) said glucose sensor and said at least one of a blood gases sensor and a blood electrolytes sensor is downstream of each of said first port, second port, and third port.

36. A cartridge for analysis of fluid samples;

the cartridge being for use with an analyzer device;

the cartridge comprising;

(a) a base structure defining a fluid channel;

(b) a sensor arrangement oriented within said fluid channel;

(c) said base structure defining a first port in fluid communication with said fluid channel; and

(d) a first fluid reservoir in fluid communication with said first port;

said first fluid reservoir defining a fluid passage and a fluid dispenser actuator;

(i) said actuator comprising an over-center engageable button depressible to initiate fluid flow from an internal volume in said first fluid reservoir and through said fluid passage and through said first port.

37. A cartridge according to claim 36 wherein:

(a) said first fluid reservoir includes a base and a lid mounted on said base;

(i) said lid including said over-center engageable button.

38. A cartridge according to claim 37 wherein:

(a) said over-center engageable button includes a dome-shaped portion depressible in a direction toward said base.

39. A cartridge according to claim 36 wherein:

(a) said sensor arrangement includes at least one sensor selected from the group consisting of;

pH;

carbon dioxide;

oxygen;

sodium;

calcium;

potassium;

hematocrit;

blood urea nitrogen;

chloride;

glucose;

lactate; and

creatinine.

40. A cartridge according to claim 36 wherein:

(a) said sensor arrangement includes;

(i) at least one enzymatic sensor;

(ii) at least one amperometric sensor; and

(iii) at least one ion selective electrode sensor.

41. A cartridge according to claim 36 wherein:

(d) said base structure defines a second port in fluid communication with said fluid channel.

42. A method for analyzing a fluid sample;

the method comprising;

(a) providing a cartridge including a plurality of sensors in a fluid channel therein;

the plurality of sensors including at least one wet-stored sensor and at least one dry-stored sensor; and

(b) calibrating the sensors by dispensing a calibration fluid into the fluid channel to flow over the at least one wet-stored sensor and the at least one dry-stored sensor.

43. A method according to claim 42 further including:

(a) dispensing the fluid sample into the fluid channel to flow over each of the sensors in the plurality of sensors; and

(b) preventing the fluid sample from mixing with the calibration fluid when the fluid sample is in the fluid channel.

44. A method according to claim 43 wherein:

(a) said step of calibrating includes dispensing a calibration fluid through a first port and into the fluid channel; and

(b) said step of preventing includes blocking flow of the fluid sample from the fluid channel into and through the first port.

45. A method according to claim 43 further including:

(a) before said step of dispensing the fluid sample into the fluid channel, moving the calibration fluid from the fluid channel and into a waste chamber.

46. A method according to claim 45 wherein:

(a) said step of moving the calibration fluid includes pushing the calibration fluid with an air pocket from the fluid channel into the waste chamber.

47. A method according to claim 44 wherein:

(a) said step of dispensing includes dispensing the fluid sample through a second port and into the fluid channel; and

(b) the method further includes a step of preventing flow of the calibration fluid from the fluid channel and through the second port.

48. A method according to claim 47 wherein:

(a) said step of blocking flow of the fluid sample from the fluid channel into and through the first port includes using a first check valve in the first port to block flow; and

(b) said step of preventing flow of the calibration fluid from the fluid channel and through the second port includes using a second check valve in the second port to block flow of the calibration fluid from the fluid channel and through the second port.

49. A method according to claim 42 further including:

(a) operably orienting the cartridge into an analyzer device.

50. A method according to claim 42 wherein:

(a) said step of calibrating the sensors includes dispensing a calibration fluid into the fluid channel to flow over all of the sensors except for one of the sensors.

51. A method according to claim 50 wherein:

(a) said step of dispensing a calibration fluid into the fluid channel to flow over all of the sensors except for one of the sensors includes dispending a calibration fluid into the fluid channel to flow over all of the sensors except for an oxygen sensor.

52. A method for analyzing a fluid sample;

the method comprising;

(a) providing a cartridge including a plurality of sensors in a fluid channel therein; and

(b) depressing an over-center button to force calibration fluid from a calibration fluid reservoir and into the fluid channel to flow over at least selected ones of the sensors.

53. A method for analyzing a fluid sample;

the method comprising;

(a) providing a cartridge including a plurality of sensors in a fluid channel therein;

the plurality of sensors including at least one wet-stored sensor and at least one dry-stored sensor;

(b) calibrating the plurality of sensors by;

(i) dispensing a calibration fluid into the fluid channel to flow over the at least one wet-stored sensor; and

(ii) preventing flow of calibration fluid over the at least one dry-stored sensor and exposing the at least one dry-stored sensor to ambient air.

54. A method according to claim 53 wherein:

(a) said step of providing a cartridge includes providing a cartridge having at least a first dry-stored sensor and a second dry-stored sensor; and

(b) said step of calibrating includes dispensing calibration fluid into the fluid channel to flow over one of the first and second dry-stored sensors and preventing flow of the calibration fluid over the other of the first and second dry-stored sensors.

55. A method according to claim 54 further including:

(a) dispensing the fluid sample into the fluid channel to flow over each of the sensors in the plurality of sensors; and

(b) preventing the fluid sample from mixing with the calibration fluid when the fluid sample is in the fluid channel.

56. A method according to claim 55 wherein:

(a) said step of calibrating includes dispensing a calibration fluid through a first port and into the fluid channel; and

(b) said step of dispensing the fluid sample includes dispensing the fluid sample through a second port and into the fluid channel.