Contamination-free method and apparatus for measuring body fluid chemical parameters

• US 5,145,565 A
• Filed: 05/01/1989
• Issued: 09/08/1992
• Est. Priority Date: 05/01/1989
• Status: Expired due to Fees

• Current Assignee: Spacelabs, Inc. (OSI Systems Incorporated)
• Original Assignee: Spacelabs, Inc. (OSI Systems Incorporated)
• Inventors: Kater, John, Pelikan, Glenn
• Primary Examiner(s): Niebling, John
• Assistant Examiner(s): PHASGE, ARUN S
• Application Number:
  US07/346,138
• Time in Patent Office: 1,226 Days
• Field of Search: 204/153.1, 204/153.12, 204/153.15, 204/153.17, 204/153.18, 204/416, 204/400, 204/403, 604/318, 604/319, 604/403, 604/410, 604/8, 436/809
• US Class Current: 600/341
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150251 Collection chamber divided into at least two compartments, e.g. for division of samples injection syringes having more than one chamber A61M5/19; syringes for injection of two or more media A61M5/2448, A61M5/284; sample preparation for further analysis A61B5/150755
• CPC Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150473 Double-ended needles, e.g. used with pre-evacuated sampling tubes hollow piercing element tip design A61B5/150396; needle sets for catheters A61M25/06; needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/150732 Needle holders, for instance for holding the needle by the hub, used for example with double-ended needle and pre-evacuated tube,
• CPC Class Codes: A61B 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/153 Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
• CPC Class Codes: A61B 5/154 Devices using pre-evacuated means
• CPC Class Codes: Y10S 436/809 Multifield plates or multicontainer arrays
• CPC Class Codes: Y10T 436/10 Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing

Abstract

A sample of a body fluid, such as blood, is collected in a cartridge having a sample chamber for storing the sample and one or more calibration chambers, each for storing a respective calibration fluid. The fluid sample is drawn ino the sample chamber by placing the sample chamber in fluid communication with a needle inserted into the fluid sample and applying a vacuum to the chamber using either a syringe or internal vacuum. A body fluid sample may also be drawn into the sample chamber from a syringe or capillary tube containing the fluid sample. The cartridge may be either planar or cylindrical. The chambers of a cylindrical cartridge may be either elongated voids symmetrically positioned about the longitudinal axis of the cartridge or axially spaced annular voids. One or more sensors, such as ion-sensitive electrodes, are placed in contact with the fluid sample and calibrating fluids(s) by either placing the sensor(s) in contact with externally accessible chambers or by allowing the fluid sample and calibrating fluid(s) to flow from the chambers past the sensor(s). In the event that the sensor(s) are placed in direct contact with externally accessible chambers, the sensor(s) may be scanned from one chamber to the next by an automatic drive mechanism.

Claims

1. An apparatus for obtaining a body fluid sample and allowing said sample to be analyzing comprising:

a generally cylindrical cartridge having at least two calibrating fluid chambers and a sample chamber, each of said chambers communicating with a respective fluid port opening on a common end-wall of said cartridge at locations that are symmetrically positioned about the axis of said cylindrical cartridge; and

respective calibrating fluids contained in said calibrating fluid chambers.

2. The apparatus of claim 1 wherein said externally accessible fluid port for said sample chamber includes a fitting for attaching said cartridge to a needle, said cartridge further including a second externally accessible fluid port having a fitting for attaching said cartridge to a syringe, said first and second fluid ports communicating with each other through a conduit extending along the axis of said cylindrical cartridge, said axial conduit communicating with said sample chamber through a fluid vent whereby said syringe can draw said body fluid sample through said needle and axial conduit, thereby allowing said fluid sample to flow through said fluid vent into said sample chamber.

3. An apparatus for obtaining a body fluid sample and allowing said sample to be analyzed, comprising:

a cartridge having a sample chamber, first and second calibrating fluid chambers, and first and second drying chambers positioned adjacent said first and second calibrating chambers, respectively;

a first calibrating fluid adapted to calibrate an analyzer with which said apparatus is adapted to be used, said first calibrating fluid being contained in said first calibrating fluid chamber;

a second calibrating fluid adapted to calibrate said analyzer at a different calibration point from said calibrating fluid, said second calibrating fluid being contained in said second calibrating fluid chamber;

a dry, fluid absorbent material contained in said first and second drying chambers; and

access means for allowing external access to said sample chamber, said calibrating fluid chambers and said drying chambers.

4. The apparatus of claim 3 wherein said chambers are arranged in said cartridge in the sequence of said first calibrating fluid chamber, said first drying chamber, said sample chamber, said second drying chamber, and said second calibrating fluid chamber whereby a sensor scanning across said chambers in physical contact with said chambers is dried by said dry, fluid absorbent material before and after contacting a body fluid sample in said sample chamber and after contacting said chamber containing said first calibrating fluid.

5. An apparatus for obtaining a body fluid sample and allowing said sample to be analyzed comprising:

a cartridge having a calibrating fluid chamber and a sample chamber communicating with a first externally accessible fluid port;

a calibrating fluid contained in said calibrating fluid chamber;

a fluid absorbent material contained in said calibrating fluid chamber, said fluid absorbent material being saturated with said calibrating fluid;

a reservoir chamber communicating with said calibrating fluid chamber, said reservoir chamber containing a supply of said calibrating fluid to maintain said fluid absorbent material saturated with said calibrating fluid; and

access means for allowing external access to said sample chamber and said calibrating fluid chamber.

6. An apparatus for obtaining a body fluid sample and allowing said sample to be analyzed, comprising:

a cartridge having a calibrating fluid chamber and a sample chamber communicating with a first externally accessible fluid port;

a calibrating fluid contained in said calibrating fluid chamber;

access means for allowing external access to said sample chamber and said calibrating fluid chamber;

a fitting communicating with said first externally accessible fluid port for attaching said cartridge to a needle so that said needle communicates with said sample chamber tghrough said externally accessible port; and

a second externally acessible fluid port communicating with said first externally accessible fluid port through said sample chamber, said second fluid port having a fitting for attaching said cartridge to a syringe so that said syringe can draw said fluid sample into said sample chamber through said needle.

7. An apparatus for obtaining a fluid sample and allowing said sample to be analyzed comprising:

a cartridge having a calibrating fluid chamber and a sample chamber communicating with a first externally accessible fluid port;

a calibrating fluid contained in said calibrating fluid chamber;

access means for allowing external access to said sample chamber and said calibrating fluid chamber;

a fitting communicating with said first externally accessible fluid port for attaching said cartridge to a needle so that said needle communicates with said sample champer through said externally accessible port; and

a second externally accessible fluid port communicating with said first externally accessible fluid port through a bypass conduit in fluid communication with said sample chamber, said second fluid port having a fitting for attaching said cartridge to a syringe so that said syringe can draw said body fluid sample through said needle and bypass conduit, threby allowing said fluid sample to flow into said sample chamber.

8. An apparatus for obtaining a fluid sample and allowing said sample to be analyzed, comprising:

a cartridge having a calibrating fluid chamber and a sample chamber communicating with a first externally accessible fluid port;

a calibrating fluid contained in said calibrating fluid chamber;

access means for allowing external access to said sample chamber and said calibrating fluid chamber;

a vacuum chamber communicating with said first externally accessible fluid port through said sample chamber land;

a resilient membrane covering said first fluid to maintain the vacuum in said vacuum chamber and said sample chamber, whereby a body fluid sample may be collected in said sample chamber by puncturing said membrane with a needle that has been placed in contact with said fluid sample.

9. The apparatus of claim 8 wherein said vacuum chamber and said sample chamber are separate chambers in fluid communication with each other through a fluid passage.

10. The apparatus of claim 9 wherein said cartridge is cylindrical and sized for insertion into a sleeve having a radially extending flange at one end and an opposite end closed by an end wall containing a double-ended hypodermic needle adapted to puncture an object, inserted into said sleeve, and wherein said first fluid port is located an one end wall of said cylindrical cartridge centered at the axis of said cylindrical cartridge so that insertion of said cartridge in said cylindrical sleeve allows the needle of said sleeve to puncture said membrane.

11. An apparatus for obtaining a fluid sample and allowing said sample to be analyzed, comprising:

a cartridge having a calibrating fluid chamber and a sample chamber communicating with a first externally accessible fluid port;

a calibrating fluid contained in said calibrating fluid chamber;

access means for allowing external access to said sample chamber and said calibrating fluid chamber; and

a tapered needle shield attached to said cartridge adjacent said first externally accessible fluid port, said needle shield flaring outwardly from an aperture communicating with said first fluid port so that a needle mounted on a syringe containing a body fluid sample can be inserted into said first externally accessible fluid port to inject said fluid sample into said sample chamber.

12. An apparatus for obtaining a fluid sample and allowing said sample to be analyzed, comprising:

a cartridge having a calibrating fluid chamber and a sample chamber communicating with a first externally accessible fluid port;

a calibrating fluid contained in said calibrating fluid chamber;

access means for allowing external access to said sample chamber and said calibrating fluid chamber; and

a reagent contained within said sample chamber, said reagent being chemically reactive with said body fluid sample to alter the chemical or optical properties of said reagent as a function of a chemical parameter of said fluid sample.

13. A system for obtaining and analyzing a body fluid sample, comprising:

a disposable cartridge having a sample chamber communicating with a first externally accessible fluid port through which said body fluid sample may flow into said sample chamber and a calibrating chamber containing a calibrating fluid, said cartridge further including sample means for drawing a body fluid sample into said sample chamber through said first externally accessible fluid port, and access means for allowing external access to the body fluid sample drawn into said sample chamber and the calibrating fluid contained in said calibrating chamber; and

an analysis device adapted to temporarily interface with said access means to allow said body fluid sample in said sample chamber to be analyzed, said analysis device having a sensor in fluid communication with said access means to allow said fluid sample and said calibrating fluid to contact said sensor when said access means is temporarily placed in fluid communication with said sensor, said analysis device further including electoronic means connected to said sensor for providing an electrical indication of the results of an analysis of a body fluid sample in contact with said sensor whereby said analysis device can be repetitively used to analyze a large number of body fluid samples contained in respective disposable cartridges using a single reusable sensor contained in said analysis device.

14. The system of claim 13 wherein said access means includes an externally accessible opening for each of said chambers so that said chambers are externally accessible to said sensor.

15. The system of claim 14 wherein said externally accessible openings are covered by a removable membrane to seal said chambers until after said fluid sample has been drawn.

16. The system of claim 14 wherein said cartridge is of a generally planar configuration having a planar, rectangularly shaped surface on which said externally accessible openings are formed.

17. The system of claim 16 wherein said chambers have an elongated configuration and are positioned with their longitudinal axes in parallel with each other.

18. The system of claim 14, further including scanning means for causing said sensor to sequentially access each of said chambers, said scanning means including drive means for causing relative movement between said sensor and said cartridge so that said sensor is sequentially positioned adjacent each of said externally accessible openings.

19. The system of claim 18 wherein said scanning means further includes actuating means for moving said sensor and cartridge away from each other as said sensor is scanned from one externally accessbile openinng to the next and for moving said sensor and cartridge toward each other when said sensor and opening are positioned adjacent each other.

20. The system of claim 18 wherein said sensor is stationary and said drive means moves said cartridge relative to said electrode.

21. The system of claim 20 wherein said cartridge has indexing apertures formed on said planar, rectangularly shaped surface and wherein said drive means includes a rotatably driven wheel having cogs projecting from its periphery, said cogs engaging said indexing apertures to propel said cartridge across said sensor.

22. The system of claim 21 wherein said chambers are filled with a fluid absorbent material saturated with a body fluid sample or a calibrating fluid, and wherein the fluid absorbent material in said chambers bulges outwardly against a flexible membrane opposite said externally accessible openings, and wherein said cartridge slides along a planar surface having a cam surface positioned beneath said sensor, said cam surface projecting toward said sensor to contact said flexible membrane and force the outwardly bulging, fluid-absorbent material into said chambers, thereby forcing said fluid-absorbent material out of said chambers through said externally acessible openings to contact said sensor as each chamber is positioned between said cam surface and said sensor.

23. The system of claim 18 wherein said cartridge is stationary and said drive means moves said sensor relative to said cartridge.

24. The system of claim 23 wherein said cartridge is positioned on a base member and wherein said drive means includes a bracket on which said sensor is mounted and means for sequentially moving said bracket across said cartridge.

25. The system of claim 24 wherein said chambers are filled with a fluid-absorbent material saturated with a body fluid sample or a calibrating fluid, and wherein the fluid-absorbent material in said chambers bulges outwardly against a flexible membrane opposite said externally accessible openings, said scanning means further including means for forcing said cartridge away from said sensor against said base to force the outwardly bulging, fluid-absorbent material into said chambers, thereby forcing said fluid-absorbent material out of said chambers through said externally accessible openings to allow said sensor to contact said material as said sensor is positioned adjacent each of said extenally accessible openings in said chambers.

26. The system of claim 13 wherein said cartridge is of a generally cylindrical configuration.

27. The system of claim 26 wherein said chambers are symmetrically positioned about the axis of said cylindrical cartridge.

28. The system of claim 26 wherein said chambers are in the form of axially spaced annular voids formed in said cartridge.

29. The system of claim 26 wherein said access means includes an extenally accessible opening for each of said chambers so that said chambers are externally accessible to said sensor.

30. The system of claim 29 wherein said externally accessible openings are covered by a removable shield to seal said chambers until at least said body fluid sample has been drawn.

31. The system of claim 26 wherein said chambers are sealed by respective resilient membranes positioned along one axial surface of said cartridge and wherein said access means includes a needle sequentially puncturing each of said membranes to allow the fluid in its respective chamber to flow from said chamber and through said needle, said access means further including a conduit communicating with the lumen of said needle to allow said fluid sample to flow through said conduit, said sensor being mounted in said conduit so that the fluids in said chamber sequentially communicate with said sensor.

32. The system of claim 31 wherein said access means further includes means for venting each of said chambers as said needle punctures its respective membrane so that the fluid in said chamber can flow through said needle and said conduit by gravity.

33. The system of claim 13 wherein said sensor is an electrode that is sensitive to a specific chemical ion.

34. The system of claim 33, further including a plurality of electrodes, each of which is sensitive to a different chemical ion so that said system can simultaneously perform an analysis for a plurality of chemical parameters.

35. The system of claim 13, further including a plurality of sensors, each of which is sensitive to a different chemical constituent in said sample so that said system can simultaneously analyze a plurality of chemical parameters.

36. The system of claim 13, further including a reagent contained within said sample chamber, said reagent being chemically reactive with said body fluid sample to alter the chemical or optical properties of said reagent as a function of a chemical parameter of said fluid sample.

46. The system of claim 13 wherein said cartridge further includes a fluid absorbent material contained in said sample chamber and said calibrating fluid chamber, said fluid absorbent material absorbing said body fluid sample and said calibrating fluid to retain said body fluid sample and said calibrating fluid in said cartridge.

47. The system of claim 13 wherein said cartridge further includes a second calibrating chamber containing a second calibrating fluid, and wherein said access means further allows external access to said second calibrating fluid in said second calibration chamber.

48. The system of claim 13 wherein said access means includes a port in said sample chamber through which said sensor is adapted for insertion into said sample chamber to make contact with said body fluid sample contained therein.

49. The system of claim 48 wherein said port through which said sensor is adapted for insertion is said first externally accessible fluid port.

50. The system of claim 13 wherein said access means includes a port in said calibrating chamber through which said sensor is adapted for insertion into said calibration chamber to make contact with said calibrating fluid contained therein.

51. The system of claim 13 wherein said sample means includes a second fluid port communicating with said sample chamber, and means for creating a vacuum at said second fluid port to draw said body fluid sample into said sample chamber through said first fluid port.

52. The system of claim 51 wherein said means for creating a vacuum at said second fluid port includes a syringe coupled to said second fluid port.

37. A method of collecting and analyzing a body fluid sample, comprising:

collecting a plurality of body fluid samples in respective cartridges directly from respective patients,

temporarily placing each of said cartridges in contact with an analyzer having a sensor and electronic circuitry connected to said sensor to provide an electrical indication of an analysis of a body fluid sample in communication with said sensor, said cartridges being placed in contact with said analyzer so that said sensor is in communication with said body fluid sample in said cartridge while said sample is contained in said cartridge and disposing of said cartridges.

38. The method of claim 37 wherein said cartridge further contains at least one calibrating fluid and wherein said method further includes the step of placing said sensor in contact with said calibrating fluid either before or after placing said sensor in contact with said body fluid sample.

39. The method of claim 37 wherein said cartridge is of a generally cylindrical configuration sized for insertion into a cylindrical sleeve having a radially extending flange at one end and an opposite end closed by and end wall containing a double-ended hypodermic needle adapted to puncture an object inserted into said sleeve, said cartridge having an internal sample chamber that is at least partially evacuated and in communication with an externally accessible fluid port located on one end wall of said cylindrical cartridge centered at the axis of said cylindrical cartridge, said fluid port being sealed with a resilient membrane to maintain the vacuum in said sample chamber, and wherein said sample is collected by inserting said cartridge into said cylindrical sleeve so that the needle of said sleeve punctures said membrane, thereby allowing the vacuum in said sample chamber to draw said body fluid through said first fluid port into said sample chamber.

40. The method of claim 37 wherein said ion sensor is placed in contact with said body fluid sample by inserting a needle into said cartridge to withdraw said fluid sample and allowing said fluid sample to flow from said needle across said sensor.

41. The method of claim 37 wherein said body fluid sample is stored in said cartridge in an externally accessible chamber and wherein said sensor is placed in contact with said fluid sample by placing said sensor in contact with said chamber.

42. The method of claim 41 wherein a removable membrane covers said externally accessible chamber of said cartridge, and said method further includes removing said membrane prior to placing said sensor in contact with said body fluid sample.

43. The method of claim 41 wherein said cartridge further contains a calibrating fluid and wherein said method further includes placing said sensor in contact with said calibrating fluid before or after placing said sensor in contact with said fluid sample.

44. The method of claim 37, further including simultaneously placing a plurality of sensors electrodes in contact with said body fluid sample while said fluid sample is contained in said cartridge.

45. The method of claim 37 wherein said sensor is an ion sensitive electrode.

53. The method of claim 37 wherein said body fluid samples are collected in said cartridges by the method of:

placing said body fluid sample in fluid communication with a sample chamber in said cartridge; and

applying a vacuum to said sample fluid chamber thereby drawing said body fluid sample into said cartridge.

54. The method of claim 37 wherein said sensor is placed in communication with said body fluid sample by inserting said sensor through a port in said cartridge into said cartridge to physically contact said body fluid sample.

55. The method of claim 37 wherein said cartridge further contains a calibrating fluid, and wherein said method further includes placing said sensor in contact with said calibrating fluid before or after placing said sensor in contact with said fluid sample.