Collection device adapted to accept cartridge for point of care system

• US 20040176704A1
• Filed: 03/04/2003
• Published: 09/09/2004
• Est. Priority Date: 03/04/2003
• Status: Abandoned Application

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Ellis, Robert G., Francavilla, Frank, Wilkinson, Bradley M., Hwang, Charles G., Newby, C. Mark, Stevens, Timothy A., Crawford, Jamieson W.
• Application Number:
  US10/377,620
• Publication Number:
  US 20040176704A1
• Time in Patent Office: Days
• US Class Current: 600/584
• CPC Class Codes: G01N 33/48785 Electrical and electronic details of measuring devices for physical analysis of liquid biological material not specific to a particular test method, e.g. user interface or power supply

Abstract

A system is provided which may be used for collecting and testing fluid samples at a patient point of care location. A disposable cartridge and collection device is provided for collecting a fluid sample directly into a cartridge containing testing mechanisms for immediate evaluation of the collected sample. The cartridge contains an array of electrical contacts, electrochemical sensors and circuitry configured to electrically couple with a hand-held analytical device, such as a personal digital assistant (PDA) or a stand-alone computer workstation, which controls the testing of the fluid sample within the cartridge and provides a rapid indication of test results at the point of care.

Claims

1. A cartridge assembly for collecting fluid samples and performing fluid sample analysis, comprising:

a collection device adapted to collect fluid and having opposite ends with an inlet port formed at a distal end for communicating fluids into a first passageway of said device, said first passageway extending between said ends and accessible through an outlet port formed at a proximal end, said outlet port adapted to removably engage an inlet orifice of a collection cartridge;

said collection cartridge comprising a housing having said inlet orifice and a top and bottom containment wall, said top wall mechanically coupled to said bottom wall to define a containment chamber, wherein said containment chamber is accessible through said inlet orifice, said inlet orifice further adapted to removably engage said outlet port of said collection device and allow communication of a fluid sample from said first passageway of said collection device into said containment chamber of said collection cartridge, said collection cartridge further comprising a first electrical connector;

said first electrical connector comprising a first set of electrical contacts adapted to engage a second electrical connector located on an analytical device, said first set of electrical contacts electrically coupled to sensory apparatus; and

said sensory apparatus comprising sensors adapted to detect fluid sample properties, said sensory apparatus disposed within said collection cartridge and electrically coupled to said first set of electrical contacts and accessible by said analytical device.

2. A cartridge assembly for collecting fluid samples and performing fluid sample analysis as claimed in claim 1, wherein said inlet port of said collection device comprises a collection element engagement mechanism.

3. A cartridge assembly for collecting fluid samples and performing fluid sample analysis as claimed in claim 2, wherein said inlet port of said collection device comprises a conical luer fitting.

4. A cartridge assembly for collecting fluid samples and performing fluid sample analysis as claimed in claim 2, wherein said collection element is selected from the group consisting of an intra-venous needle, intra-arterial needle, venous catheter, arterial catheter, capillary tube, microneedle array and lancet.

5. A cartridge assembly for collecting fluid samples and performing fluid sample analysis as claimed in claim 2, wherein said collection device comprises a shielding mechanism adapted to shield said collection element.

6. A cartridge assembly for collecting fluid samples and performing fluid sample analysis as claimed in claim 1, wherein said inlet orifice comprises a second passageway accessing said containment chamber of said collection cartridge.

7. A cartridge assembly for collecting fluid samples and performing fluid sample analysis as claimed in claim 1, wherein said outlet port of said collection device comprises a press fit mechanism adapted to engage said cartridge and form a leak-proof seal between said first passageway of said collection device and said second passageway of said collection cartridge.

8. A cartridge assembly for collecting fluid samples and performing fluid sample analysis as claimed in claim 7, wherein said fluid sample is communicated from said first passageway of said collection device into said containment chamber using a capillary action of at least one of said first passageway, second passageway and containment chamber.

9. A cartridge assembly for collecting fluid samples and performing fluid sample analysis as claimed in claim 7, wherein said fluid sample is communicated from said first passageway of said collection device into said containment chamber using a vacuum created within said containment chamber.

10. A cartridge assembly for collecting fluid samples and performing fluid sample analysis as claimed in claim 1, wherein said second electrical connector comprises a second set of electrical contacts, said second electrical connector adapted to engage said first electrical connector of said collection cartridge and electrically couple said first and second set of electrical contacts.

11. A cartridge assembly for collecting fluid samples and performing fluid sample analysis as claimed in claim 1, wherein said first electrical connector is adapted to engage said second electrical connector while said inlet orifice of said collection cartridge is removably engaged with said outlet port of said collection device.

12. A cartridge assembly for collecting fluid samples and performing fluid sample analysis as claimed in claim 1, wherein said analytical device is adapted to perform user directed analytical tests on said fluid sample using said sensory apparatus via said first and second sets of electrical contacts.

13. A cartridge assembly for collecting fluid samples and performing fluid sample analysis as claimed in claim 1, wherein said fluid sample properties include at least one of a pH, pCO₂, pO₂, pCl, pNO₃, Na⁺, Ca⁺⁺, K⁺, hematocrit and glucose level in said sample.

14. A collection cartridge for collecting fluid samples and performing fluid sample analysis, comprising:

a cartridge housing having an inlet orifice and a top and bottom containment wall, said top wall mechanically coupled to said bottom wall to define a containment chamber, wherein said containment chamber is accessible through said inlet orifice, said housing further adapted to removably engage a collection device such that said inlet orifice allows communication of a fluid sample provided by said collection device to said containment chamber, said collection cartridge further comprising a first electrical connector;

said first electrical connector comprising a first set of electrical contacts adapted to engage a second electrical connector located on an analytical device, said first set of electrical contacts electrically coupled to sensory apparatus; and

said sensory apparatus comprising sensors adapted to detect fluid sample properties, said sensory apparatus disposed within said collection cartridge and electrically coupled to said first set of electrical contacts and accessible by said analytical device.

15. A collection cartridge for collecting fluid samples and performing fluid sample analysis as claimed in claim 14, wherein said inlet orifice comprises at least one passageway accessing said containment chamber of said cartridge housing.

16. A collection cartridge for collecting fluid samples and performing fluid sample analysis as claimed in claim 15, wherein said inlet orifice is adapted to form a leakproof seal between said collection device and said at least one passageway of said inlet orifice of said cartridge housing.

17. A collection cartridge for collecting fluid samples and performing fluid sample analysis as claimed in claim 14, wherein said fluid sample is communicated from said collection device into said containment chamber using a capillary action of at least one of said inlet orifice and containment chamber.

18. A collection cartridge for collecting fluid samples and performing fluid sample analysis as claimed in claim 14, wherein said fluid sample is communicated from said collection device into said containment chamber using a vacuum created within said containment chamber.

19. A collection cartridge for collecting fluid samples and performing fluid sample analysis as claimed in claim 14, wherein said second electrical connector comprises a second set of electrical contacts, said second electrical connector adapted to engage said first electrical connector of said collection cartridge and electrically couple said first and second set of electrical contacts.

20. A collection cartridge for collecting fluid samples and performing fluid sample analysis as claimed in claim 14, wherein said first electrical connector is adapted to engage said second electrical connector while said inlet orifice of said collection cartridge is removably engaged to said outlet port of said collection device.

21. A collection cartridge for collecting fluid samples and performing fluid sample analysis as claimed in claim 14, wherein said analytical device is adapted to perform user directed analytical tests on said fluid sample using said sensory apparatus via said first and second sets of electrical contacts.

22. A collection cartridge for collecting fluid samples and performing fluid sample analysis as claimed in claim 14, wherein said fluid sample properties include at least one of a pH, pCO₂, pO₂, pCl, pNO₃, Na⁺, Ca⁺⁺, K⁺, hematocrit and glucose level in said sample.

23. A collection device for collecting fluid samples into a test cartridge assembly, comprising:

a device housing adapted to collect fluid, said device housing having opposite proximate and distal ends with an inlet port formed at said distal end for communicating fluids into a first passageway of said device housing, said first passageway extending between said proximate and distal ends and accessible through an outlet port; and

an outlet port adapted to removably engage a collection cartridge such that said collection cartridge communicates a fluid sample from said first passageway of said collection device via an inlet orifice of said collection cartridge.

24. A collection device for collecting fluid samples into a test cartridge assembly as claimed in claim 23, wherein said inlet port of said collection device comprises a collection element engagement mechanism.

25. A collection device for collecting fluid samples into a test cartridge assembly as claimed in claim 24, wherein said inlet port of said collection device comprises a conical luer fitting.

26. A collection device for collecting fluid samples into a test cartridge assembly as claimed in claim 24, wherein said collection element is selected from the group consisting of an intra-venous needle, intra-arterial needle, venous catheter, arterial catheter, capillary tube, microneedle array and lancet.

27. A collection device for collecting fluid samples into a test cartridge assembly as claimed in claim 24, wherein said collection device comprises a shielding mechanism adapted to shield said collection element.

28. A collection device for collecting fluid samples into a test cartridge assembly as claimed in claim 23, wherein said outlet port comprises a press fit mechanism adapted to form a leakproof seal between said first passageway of said collection device and said inlet orifice of said collection cartridge.

29. A collection device for collecting fluid samples into a test cartridge assembly, comprising:

a device housing having opposite proximate and distal ends with a recessed port formed adjacent to said distal end for removably securing a collection cartridge, said housing further comprises a lancet mechanism; and

said lancet mechanism adapted to expose fluid from a patient such that said collection cartridge communicates a fluid sample from said exposed fluid into a containment chamber via an inlet orifice array of said collection cartridge.

30. A collection device for collecting fluid samples into a test cartridge assembly as claimed in claim 29, wherein said inlet orifice array comprises at least one passageway accessing said containment chamber of said collection cartridge.

31. A collection device for collecting fluid samples into a test cartridge assembly as claimed in claim 29, wherein said recessed port comprises a press fit mechanism adapted to removably secure said collection cartridge.

32. A collection device for collecting fluid samples into a test cartridge assembly as claimed in claim 29, wherein said fluid sample is communicated from said exposed fluid into said containment chamber of said collection cartridge using a capillary action of at least one of said inlet orifice array and containment chamber.

33. A collection cartridge for collecting fluid samples and performing fluid sample analysis, comprising:

a cartridge housing having an inlet orifice and a top and bottom containment wall, said top wall mechanically coupled to said bottom wall to define a containment chamber, wherein said containment chamber is accessible through said inlet orifice, said housing further adapted to removably engage a collection device such that said inlet orifice allows communication of a fluid sample provided by said collection device into said containment chamber, said collection cartridge further comprising a first electrical connector;

said first electrical connector comprising a first set of electrical contacts adapted to engage a second electrical connector located on an analytical device, said first set of electrical contacts electrically coupled to sensory apparatus; and

said sensory apparatus comprising sensors adapted to detect fluid sample properties, said sensory apparatus disposed within said collection cartridge and electrically coupled to said first set of electrical contacts and accessible by said analytical device.

34. A collection cartridge for collecting fluid samples and performing fluid sample analysis as claimed in claim 33, wherein said inlet orifice comprises at least one passageway accessing said containment chamber of said cartridge housing.

35. A collection cartridge for collecting fluid samples and performing fluid sample analysis as claimed in claim 33, wherein said inlet orifice is adapted to seal a vacuum within said containment chamber.

36. A collection cartridge for collecting fluid samples and performing fluid sample analysis as claimed in claim 33, wherein said inlet orifice is adapted to release a vacuum within said containment chamber when said housing is removably engaged with said collection device.

37. A collection cartridge for collecting fluid samples and performing fluid sample analysis as claimed in claim 36, wherein said release of said vacuum urges said communication of said fluid sample provided by said collection device into said containment chamber.

38. A collection cartridge for collecting fluid samples and performing fluid sample analysis as claimed in claim 35, wherein said inlet orifice is a valve mechanism adapted to seal said vacuum within said containment chamber and release said vacuum through said engagement with said collection device.

39. A collection cartridge for collecting fluid samples and performing fluid sample analysis as claimed in claim 38, wherein at least one of said top and bottom walls are pliable and is adapted to displace air within said containment chamber via said valve mechanism.

40. A collection cartridge for collecting fluid samples and performing fluid sample analysis as claimed in claim 38, wherein at least one of said top and bottom walls are pliable and is adapted to return to an original position after displacement and create said vacuum within said containment chamber via said valve mechanism.

41. A collection cartridge for collecting fluid samples and performing fluid sample analysis as claimed in claim 35, wherein said inlet orifice is a seal adapted to release said vacuum through said engagement with said collection device.