BODILY FLUID SAMPLING SYSTEMS, METHODS, AND DEVICES

• US 20090099431A1
• Filed: 10/15/2008
• Published: 04/16/2009
• Est. Priority Date: 06/21/2006
• Status: Active Grant

• Current Assignee: Glucor Systems LLC
• Original Assignee: Glucor Systems LLC
• Inventors: Jolley, Lincoln, Dalebout, Corey
• Granted Patent: US 8,216,155 B2
• Time in Patent Office: Days
• US Class Current: 600/345
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150213 Venting means
• CPC Class Codes: A61B 5/150229 Pumps for assisting the blood sampling
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/150816 by tactile feedback, e.g. vibration
• CPC Class Codes: A61B 5/150992 Blood sampling from a fluid line external to a patient, such as a catheter line, combined with an infusion line; blood sampling from indwelling needle sets, e.g. sealable ports, luer couplings, valves tubing connectors and couplings A61M39/00
• 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 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

A fluid sampling system is disclosed comprising a fluid drawing device, a fluid sampling device, and an analysis device. The fluid drawing device can be used to draw bodily fluid into a sample port of an IV tube. The fluid sampling device can be used to access the sample port to obtain a fluid sample. The fluid sampling device can include a test strip housing for receiving a test strip therein. Extending from an end of the test strip housing is a blunt canula that can be inserted into the sample port to obtain the fluid sample and communicate the fluid sample to the test strip. The test strip housing is configured to allow the second end of the test strip to be received within an analysis device to facilitate analysis of the fluid sample.

Claims

1. A test strip adapter configured to convey a fluid sample from a sample port associated with a patient'"'"'s blood stream directly to a test strip associated with said test strip adapter, the test strip adapter comprising:

a test strip housing adapted to receive a portion of the test strip therein, the size and shape of said test strip housing generally corresponding to the size and shape of the test strip portion received within said test strip housing;

a blunt canula extending from said test strip housing, said blunt canula having a lumen extending therethrough, said lumen and said test strip housing being in fluid communication with one another to enable a fluid to flow therethrough to communicate a fluid to the test strip.

2. The test strip adapter of claim 1, further comprising means for venting air from said test strip housing.

3. The test strip adapter of claim 2, wherein said means for venting air comprises a groove disposed within an interior wall of said test strip housing.

4. The test strip adapter of claim 3, wherein said groove comprises an abutment portion that facilitates proper positioning of a test strip within said test strip housing.

5. The test strip adapter of claim 2, wherein said means for venting air comprises a plurality of grooves disposed within one or more interior walls of said test strip housing.

6. The test strip adapter of claim 1, wherein said blunt canula is adapted to be received within a sample port.

7. A test strip adapter configured to convey a fluid sample from a sample port associated with a patient'"'"'s blood stream directly to a test strip associated with the test strip adapter, the test strip adapter comprising:

means for holding a test strip, wherein said means for holding substantially encloses a first end of the test strip therein while allowing a second end of the test strip to extend out of said means for holding a test strip, thereby exposing said second end, wherein said second end of said test strip is adapted to be inserted into an analysis device;

means for accessing an interior of a sample port; and

means for communicating a fluid to the test strip, wherein said means for communicating extends from said means for holding.

8. The test strip adapter of claim 7, wherein said means for holding a test strip comprises a plurality of grooves.

9. The test strip adapter of claim 7, where said means for holding comprises a test strip housing having an interior portion configured to receive a portion of the test strip therein, wherein said interior portion is sized and shaped to generally corresponding to the size and shape of the test strip portion received within said interior portion of said test strip housing.

10. The test strip adapter of claim 7, wherein said means for accessing an interior of a sample port comprises a blunt canula.

11. The test strip adapter of claim 7, wherein said means for communicating a fluid comprises a lumen extending through said means for accessing.

12. The test strip adapter of claim 11, wherein said lumen is in fluid communication with said means for holding a test strip.

13. A fluid sampling device configured to obtain a fluid sample from a sample port associated with a patient and directly convey information about the fluid sample to an analysis device associated with the fluid sampling device, the fluid sampling device comprising:

a test strip adapted to receive a fluid sample and convey at least one property of the fluid sample to the analysis device; and

a test strip adapter configured to receive a first portion of said test strip therein while allowing a second portion of said test strip to extend out of said test strip adapter for association with the analysis device, said test strip adapter being configured to transfer a fluid sample directly from the sample port to said test strip, said test strip adapter comprising means for venting air from said test strip adapter.

14. The fluid sampling device of claim 13, wherein said test strip comprises electrical leads, an absorbent material, a reagent, or a combination thereof.

15. The fluid sampling device of claim 13, where said test strip adapter comprises means for conveying a fluid from a sample port to said test strip.

16. The fluid sampling device of claim 15, wherein said means for conveying comprises a blunt canula.

17. The fluid sampling device of claim 16, wherein said blunt canula comprises a lumen extending therethrough.

18. The fluid sampling device of claim 16, wherein said means for conveying further comprises a tapered portion extending from said blunt canula, said tapered portion having an interior through which a fluid can pass.

19. The fluid sampling device of claim 13, wherein said test strip adapter comprises a test strip housing having a test strip receptacle for receiving said first portion of said test strip therein.

20. The fluid sampling device of claim 19, wherein said test strip is secured within said test strip receptacle.

21. The fluid sampling device of claim 19, wherein said test strip is selectively removable from within said test strip receptacle.

22. The fluid sampling device of claim 13, wherein said test strip adapter is configured to be inserted into the sample port to access a fluid supply, and wherein said test strip adapter is configured to convey a fluid from the sample port to said test strip while said test strip adapter is inserted in said sample port.

23. A fluid sampling device configured to obtain a fluid sample from a sample port associated with a patient and directly convey information about the fluid sample to an analysis device associated with the fluid sampling device, the fluid sampling device comprising:

means for detecting at least one property of the fluid sample;

means for conveying the at least one property to the analysis device; and

means for communicating a fluid sample directly from the sample port to said means for detecting while said means for communicating is simultaneously associated with the sample port and said means for detecting.

24. The fluid sampling device of claim 23, wherein said means for detecting comprises electrical leads, an absorbent material, a reagent, or a combination thereof.

25. The fluid sampling device of claim 24, wherein said electrical leads are adapted to detect a resistance, impedance, or capacitance of the fluid sample.

26. The fluid sampling device of claim 23, wherein said means for conveying comprises electrical leads adapted to communicate the at least one property of the fluid sample to the analysis device.

27. The fluid sampling device of claim 23, wherein said means for detecting are at least partially disposed within a housing.

28. The fluid sampling device of claim 23, wherein said means for detecting and means for conveying comprise the same means.

29. The fluid sampling device of claim 23, wherein said means for communicating comprises a lumen extending through a blunt canula.

30. The fluid sampling device of claim 23, wherein said means for detecting can be selectively associated with said means for communicating.

31. A fluid sampling system configured to receive a fluid sample from a patient and directly convey information about the fluid sample to an analysis device, the fluid sampling system comprising:

an intravenous tube in fluid communication with a patient'"'"'s blood stream, the intravenous tube comprising a sample port;

a test strip adapted to i) detect at least one property of a fluid sample received by said test strip, and ii) convey the at least one property of the fluid sample to the analysis device; and

a test strip adapter associated with said test strip, said test strip adapter being configured to transfer the fluid sample from said sample port directly to said test strip while said test strip is associated with said test strip adapter and said test strip adapter is associated with said sample port, said test strip adapter comprising;

a test strip housing having a first end and a second end, said first end of said test strip housing being adapted to receive a first end of said test strip therein, wherein the size and shape of said first end of said test strip housing generally corresponds to the size and shape of said first end of said test strip; and

a blunt canula extending from said second end of said test strip housing, said blunt canula having a lumen extending therethrough for communicating fluid from said sample port to said first end of said test strip.

32. The fluid sampling system of claim 31, wherein said test strip housing further comprises a groove adapted to assist in venting air from said test strip to enable said test strip to ready receive the fluid sample.

33. The fluid sampling system of claim 31, wherein a longitudinal axis of said blunt canula is generally parallel to a longitudinal axis of said test strip housing.

34. The fluid sampling system of claim 31, further comprising a fluid drawing device associated with said intravenous tube, said fluid drawing device being adapted to draw a fluid from a patient to said sample port.

35. The fluid sampling system of claim 34, wherein the fluid drawing device is adapted to create a negative pressure within said intravenous tube to draw the fluid from the patient.

36. The fluid sampling system of claim 31, further comprising an analysis device for analyzing the at least one property of the fluid sample, wherein said analysis device is adapted to receive said second end of said test strip while said first end of said test strip is positioned within said test strip housing.

37. The fluid sampling system of claim 36, wherein said analysis device comprises a glucometer.

38. The fluid sampling system of claim 36, wherein said analysis device is adapted to analyze at least one of a resistance, an impedance, a capacitance, a luminescence, or a color change of the fluid sample.

39. A fluid sampling system configured to receive a fluid sample from a patient and directly convey information about the fluid sample to an analysis device, the fluid sampling system comprising:

an intravenous tube in fluid communication with a patient'"'"'s blood stream, the intravenous tube comprising a sample port;

a test strip adapted to detect at least one property of a fluid sample obtained through said sample port and convey the at least one property to the analysis device; and

a test strip adapter having a first end and a second end, said first end being configured to receive a first portion of said test strip therein while allowing a second portion of said test strip to extend out of said test strip adapter, said second end of said test strip adapter being configured to be inserted into said sample port, said test strip adapter being configured to communicate a fluid sample from said sample port directly to said test strip while said first portion of said test strip is within said first end of said test strip adapter and said second end of said test strip adapter is inserted with said sample port, and

an analysis device configured to receive said second portion of said test therein while said first portion of said test strip is within said first end of said test strip adapter, wherein said analysis device is adapted to analyze the at least one detected property of the fluid sample.

40. The fluid sampling system of claim 39, wherein said test strip adapter comprises:

a test strip housing having adapted to receive said first portion of said test strip therein; and

a blunt canula extending from said second end of said test strip housing, said blunt canula having a lumen extending therethrough for communicating fluid from said sample port to said test strip.

41. The fluid sampling system of claim 39, wherein said test strip is adapted to be simultaneously inserted within said analysis device and said test strip adapter, and wherein said second end of said test strip adapter is adapted to be inserted within said sample port while said test strip is simultaneously inserted within said analysis device and said test strip adapter.

42. A method for sampling and analyzing a bodily fluid, comprising:

inserting a first end of a test strip into a first end of a test strip adapter;

inserting a second end of the test strip adapter into a sample port that is in fluid communication with a patient'"'"'s bodily fluid to obtain a fluid sample, wherein the test strip adapter comprises a fluid pathway for communicating the fluid sample to the test strip; and

inserting a second end of the test strip into an analysis device while the first end of the test strip is positioned in the test strip adapter.

43. The method of claim 42, further comprising detecting at least one property of said fluid sample.

44. The method of claim 43, wherein the at least one property of the fluid sample comprises an electrical property of the fluid sample.

45. The method of claim 43, further comprising analyzing the at least one property of the fluid sample.

46. The method of claim 42, further comprising drawing the bodily fluid into the sample port prior to inserting the second end of the test strip adapter into the sample port.

47. A method for sampling and analyzing a bodily fluid, comprising:

inserting a first end of a test strip into an analysis device;

inserting a second end of the test strip into a first end of a test strip adapter;

inserting a second end of the test strip adapter into a sample port that is in fluid communication with a patient'"'"'s bodily fluid to obtain a fluid sample;

communicating the fluid sample through the test strip adapter to the test strip; and

communicating at least one property of the fluid sample from the test strip to the analysis device.

48. The method of claim 47, further comprising detecting the at least one property of the fluid sample prior to communicating the at least one property to the analysis device.

49. The method of claim 47, wherein the analysis device comprises a glucometer.

50. The method of claim 49, further comprising removing the second end of the test strip adapter from the sample port once the fluid sample has been obtained.