Blood testing deivce

• US 20040116830A1
• Filed: 10/03/2003
• Published: 06/17/2004
• Est. Priority Date: 08/24/2001
• Status: Abandoned Application

• Current Assignee: Bulldog Medical Products, Inc.
• Original Assignee: Bulldog Medical Products, Inc.
• Inventors: Trudeau, William M, Boulgardies, James W
• Application Number:
  US10/474,082
• Publication Number:
  US 20040116830A1
• Time in Patent Office: Days
• US Class Current: 600/584
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes

Abstract

A blood testing device (10) comprising a proximal end (12) and a distal end (14); an intermediate portion (20) between the proximal end (12) and the distal end (14); a pressure compensation system to regulate the pressure in the intermediate portion (20), and a distal end cap (60) at the distal end (14) comprising a first opening (62) configured to receive a test strip (104). The intermediate portion (20) comprises a proximal end (36) comprising one or more than one opening (44), a distal end (38) of the intermediate portion (20) and, between the proximal end (36) and the distal end (38), comprises a hollow, central chamber (40) surrounded by an outer wall (42). The one or more than one opening (44) may optionally comprise a flow valve (118).

Claims

1. A blood testing device for testing blood for the presence or for the amount of one or more than one constituent, or for testing blood to determine the level of one or more than one parameter, or for testing blood for a combination of the preceding, the blood testing device comprising:

a) a proximal end of the blood testing device and a distal end of the blood testing device;

b) an intermediate portion between the proximal end of the blood testing device and the distal end of the blood testing device; and

c) a pressure compensation system to regulate the pressure in the intermediate portion; and

where the intermediate portion comprises a proximal end of the intermediate portion comprising one or more than one opening, a distal end of the intermediate portion and, between the proximal end of the intermediate portion and the distal end of the intermediate portion, comprises a hollow, central chamber surrounded by an outer wall.

2. The blood testing device of claim 1, where the pressure compensation system comprises a distal portion between the proximal end of the blood testing device and the distal end of the blood testing device, an inner membrane separating the intermediate portion from the distal portion;

and where the distal portion comprises a proximal end of the distal portion and a distal end of the distal portion and, between the proximal end of the distal portion and the distal end of the distal portion, comprises a hollow, central chamber surrounded by an outer wall.

3. The blood testing device of claim 1, where the pressure compensation system comprises a pressure compensation valve.

4. The blood testing device of claim 3, where the pressure compensation valve is a duck bill valve.

5. The blood testing device of claim 2, further comprising a distal end cap at the distal end of the blood testing device comprising a first opening configured to receive a test strip.

6. The blood testing device of claim 1, where the outer wall of the intermediate portion is generally cylindrical.

7. The blood testing device of claim 2, where the outer wall of the distal portion is generally cylindrical.

8. The blood testing device of claim 1, further comprising a proximal portion between the proximal end of the blood testing device and the proximal end of the intermediate portion;

where the proximal portion comprises a hollow, central chamber surrounded by an outer wall; and

where the proximal portion is configured to mate with a blood containing apparatus.

9. The blood testing device of claim 8, where the blood containing apparatus is selected from the group consisting of a syringe and the introducer part of an intravascular access apparatus.

10. The blood testing device of claim 8, where the outer wall of the proximal portion is generally cylindrical.

11. The blood testing device of claim 2, where the hollow, central chamber of the intermediate portion and the hollow, central chamber of the distal portion comprise generally rectangular inferior parts that communicate with each other and that are configured to accept a test strip.

12. The blood testing device of claim 11, where the hollow, central chamber of the distal portion further comprises one or more than one ridge axially along the proximal to distal axis.

13. The blood testing device of claim 1, where the outer wall of the intermediate portion is substantially transparent.

14. The blood testing device of claim 5, where the distal end cap is an integral part of the distal portion of the blood testing device.

15. The blood testing device of claim 5, where the distal end cap is removably affixed to the distal portion of the blood testing device.

16. The blood testing device of claim 5, where the distal end cap further comprises one or more than one second opening to allow the venting of air externally out of the distal portion of the blood testing device.

17. The blood testing device of claim 5, where the distal end cap is a semipermeable member.

18. The blood testing device of claim 5, where the distal end cap is a non-permeable member.

19. The blood testing device of claim 2, where the inner membrane is a semipermeable member.

20. The blood testing device of claim 2, where the inner membrane comprises one or more than one vent.

21. The blood testing device of claim 1, where the outer wall of the intermediate portion comprises one or more than one vent.

22. The blood testing device of claim 2, where the inner membrane comprises an opening configured to allow passage of a test strip from the distal portion of the blood testing device into the intermediate portion of the blood testing device.

23. The blood testing device of claim 1, where the intermediate portion is integrally affixed to an introducer portion of an intravascular access apparatus.

24. The blood testing device of claim 1, where the intermediate portion is configured to affix to an introducer portion of an intravascular access apparatus.

25. The blood testing device of claim 1, where the distal end is integrally affixed to a blood collection apparatus.

26. The blood testing device of claim 1, where the distal end is configured to affix to a blood collection apparatus.

27. The blood testing device of claim 23, where the distal end is integrally affixed to a blood collection apparatus.

28. The blood testing device of claim 23, where the distal end is configured to affix to a blood collection apparatus.

29. The blood testing device of claim 28, where the blood collection apparatus is a syringe.

30. The blood testing device of claim 24, where the distal end is integrally affixed to a blood collection apparatus.

31. The blood testing device of claim 24, where the distal end is configured to affix to a blood collection apparatus.

32. The blood testing device of claim 31, where the blood collection apparatus is a syringe.

33. A blood testing apparatus comprising a plurality of interconnected blood testing devices according to claim 1.

34. A method for testing blood for the presence or for the amount of one or more than one constituent, or for testing blood to determine the level of one or more than one parameter, or for testing blood for a combination of the preceding, the method comprising the steps of:

a) providing a blood testing device according to claim 1, a test strip comprising a proximal end and a distal end, a test strip reader configured to accept the distal end of the test strip and a blood containing apparatus;

b) affixing the blood testing device to the blood containing apparatus and allowing blood present in the blood containing apparatus to enter into the intermediate portion of the blood testing device;

c) inserting the distal end of the test strip into the test strip reader and the proximal end of the test strip into the intermediate portion of the blood testing device; and

d) using information provided by the test strip reader to determine the presence or the amount of one or more than one constituent of the blood, or to determine the level of one or more than one parameter, or to determine a combination of the preceding.

35. The method of claim 34, where the blood containing apparatus provided in step a) is selected from the group consisting of an intravascular access apparatus and a syringe.

36. The method of claim 34, further comprising selecting a patient whose blood is to be tested and intravascularly accessing the patient'"'"'s blood with the blood containing apparatus.

37. The method of claim 34, where the blood testing device and blood containing apparatus are affixed integrally in step b).

38. The method of claim 34, further comprising the step of discarding the blood testing device after step c).

41. The blood testing device of claim 1, where the one or more than one opening in the proximal end of the intermediate portion comprises a flow valve.

42. The blood testing device of claim 41, where the flow valve is a duck-bill valve.

43. The blood testing device of claim 41, where the flow valve is a flap valve.

39. Means for testing blood for the presence or for the amount of one or more than one constituent, or for testing blood to determine the level of one or more than one parameter, or for testing blood for a combination of the preceding, the means comprising:

a) a proximal end of the blood testing device and a distal end;

b) an intermediate portion between the proximal end and the distal end;

c) end means to receive a test strip; and

d) means to compensate for pressure changes within the intermediate portion; and

where the intermediate portion comprises a proximal end of the intermediate portion comprising one or more than one opening, a distal end of the intermediate portion and, between the proximal end of the intermediate portion and the distal end of the intermediate portion, comprises a hollow, central chamber surrounded by an outer wall.

44. The means for testing blood of claim 39, where the one or more than one opening in the proximal end of the intermediate portion comprises a flow valve.

45. The means for testing blood of claim 44, where the flow valve is a duck-bill valve.

46. The means for testing blood of claim 44, where the flow valve is a flap valve.

40. A method for testing blood for the presence or for the amount of one or more than one constituent, or for testing blood to determine the level of one or more than one parameter, or for testing blood for a combination of the preceding, the method comprising the steps of:

a) providing a blood testing means, a test strip comprising a proximal end and a distal end, a test strip reader configured to accept the distal end of the test strip and a blood containing apparatus;

b) affixing the blood testing means to the blood containing apparatus and allowing blood present in the blood containing apparatus to enter into the intermediate portion of the blood testing device;

c) inserting the proximal end of the test strip into the intermediate portion of the blood testing means and the distal end of the test strip into the test strip reader; and

d) using information provided by the test strip reader to determine the presence or the amount of one or more than one constituent of the blood, or to determine the level of one or more than one parameter, or to determine a combination of the preceding.