Method and kit of components for delivering blood to a portable clinical analyzer

• US 6,902,534 B2
• Filed: 03/25/2002
• Issued: 06/07/2005
• Est. Priority Date: 03/30/2001
• Status: Expired due to Term

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Francavilla, Frank, Crawford, Jamieson William Maclean
• Primary Examiner(s): Hindenburg, Max F.
• Assistant Examiner(s): Szmal, Brian
• Application Number:
  US10/106,149
• Publication Number:
  US 20020143272A1
• Time in Patent Office: 1,170 Days
• Field of Search: 600/573, 600/576, 600/578, 600/584, 604/272, 604/158, 604/274, 604/161, 604/164.01, 604/164.07, 604/168.01, 604/170.02, 606/167, 606/186
• US Class Current: 600/573
• CPC Class Codes: A61B 5/150015 Source of blood
• CPC Class Codes: A61B 5/150213 Venting means
• CPC Class Codes: A61B 5/150236 Pistons, i.e. cylindrical bodies that sit inside the syringe barrel, typically with an air tight seal, and slide in the barrel to create a vacuum or to expel blood
• CPC Class Codes: A61B 5/150244 Rods for actuating or driving the piston, i.e. the cylindrical body that sits inside the syringe barrel, typically with an air tight seal, and slides in the barrel to create a vacuum or to expel blood
• CPC Class Codes: A61B 5/150305 Packages specially adapted for piercing devices or blood sampling devices kits for diabetes A61M5/003; packaging in general B65D
• CPC Class Codes: A61B 5/150847 Communication to or from blood sampling device transmitting measured data A61B5/0002
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: B01L 1/52 Transportable laboratories; Field kits
• CPC Class Codes: B01L 2200/027 for microfluidic devices
• 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 2300/0816 Cards, e.g. flat sample carriers usually with flow in two horizontal directions
• CPC Class Codes: B01L 3/0217 of the plunger pump type medical syringes A61M
• CPC Class Codes: B01L 3/502715 characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces

Abstract

A kit and a method are provided for facilitating point-of-care testing of bodily fluid. The kit includes a point-of-care testing cartridge and a plastic fitting for use with a syringe to deliver the fluid sample to the testing cartridge. In other embodiments, the kit includes a plastic cannula in place of a fitting. The syringe and plastic cannula can be used with an IV access kit to obtain a sample of fluid. The syringe and plastic cannula then can be used to deliver the fluid to the reservoir the testing cartridge.

Claims

1. A kit for obtaining a sample of fluid from a patient and enabling point-of-care testing of said sample of fluid, said kit comprising:

a syringe assembly for selectively drawing and expelling a sample of fluid, the syringe assembly including a distal end, a tip projecting at said distal end and having a passage communicating with a fluid receiving chamber of said syringe, said tip having selected outside cross-sectional dimensions;

a point-of-care testing cartridge having an internal reservoir and an inlet port, the inlet port having cross-sectional dimensions configured for receiving the tip of the syringe; and

a fitting having a proximal end configured for removable communication with the tip of said syringe, a distal end tapered to outside cross-sectional dimensions sufficiently smaller than the outside cross-sectional dimensions of the tip of the syringe for permitting removable communication in said entry port of said testing cartridge and venting of air from said entry port for delivering said sample of said fluid from said syringe to said reservoir of said testing cartridge.

2. A kit for obtaining a sample of fluid from a patient and enabling point-of-care testing of said sample of fluid, said kit comprising:

a syringe assembly for selectively drawing and expelling a sample of fluid, said syringe assembly having a distal end, a tip projecting at said distal end;

a point-of-care testing cartridge having an internal reservoir and an inlet port; and

a fitting having a proximal end configured for removable mounting to said tip of said syringe, a distal end configured for removable communication with said entry port of said testing cartridge and a lumen extending between the ends for delivering said sample of said fluid from said syringe to said reservoir of said testing cartridge, said distal end of said fitting comprises a pair of converging triangular portions meeting at said distal end and separated from one another by transverse ports communicating with said lumen through said fitting.

3. A kit for use with a syringe to obtain a sample of fluid from a patient and to enable point-of-care testing of said sample of fluid, said kit comprising:

a point-of-care testing cartridge having an internal reservoir and an inlet port; and

a fitting having a proximal end configured for removable communication with said syringe, a distal end configured for removable communication with said entry port of said testing cartridge and a lumen extending between said ends for delivering said sample of said fluid from said syringe to said reservoir of said testing cartridge, said distal end of said fitting comprising a pair of converging triangular portions meeting at said distal end and separated from one another by transverse ports communicating with said lumen through said fitting.

4. A method for delivering a sample of fluid to a testing cartridge of a point-of-care blood testing system, said testing cartridge including an internal reservoir for retaining a sample of fluid and an entry port extending from an external location on said testing cartridge into communication with said reservoir, said entry port having selected cross-sectional dimensions, said method comprising:

employing a syringe to obtain a sample of fluid;

providing a plastic fitting having a proximal end configured for mating with said syringe, a narrow tapered distal end and a lumen extending between said ends of said plastic fitting, said narrow tapered distal end of said plastic fitting having outside cross-sectional dimensions smaller than said cross-sectional dimensions of said entry port;

mounting said proximal end of said plastic fitting to said syringe such that said lumen through said plastic fitting can be placed in communication with said fluid in said syringe;

placing said narrow tapered distal end of said plastic fitting into said entry port of said testing cartridge so that at least portions of said narrow tapered distal end are spaced from inner peripheral portions of said entry port to define space for venting of air;

urging fluid from said syringe through said plastic fitting and into said reservoir of said testing cartridge while simultaneously venting air between said narrow tapered distal end of said plastic fitting and said entry port;

separating said syringe and said plastic fitting from said testing cartridge; and

closing said entry port.

5. The method of claim 4, wherein said syringe includes a distal tip having a tapered outer surface and a passage extending therethrough, said proximal end of said plastic fitting having a tapered entry to said lumen, said step of mounting said proximal end of said plastic fitting to said syringe comprising placing said tip of said syringe into fluid-tight frictional engagement with said tapered entry to said lumen of said plastic fitting.

6. The method of claim 5, wherein said plastic fitting has a safety cap mounted over said distal end, said method further comprising the step of removing said safety cap from said plastic fitting after mounting said plastic fitting to said syringe and before placing said distal end of said plastic fitting into communication with said entry port of said testing cartridge.

7. The method of claim 6, wherein the syringe comprises a needle assembly mounted thereto for obtaining said sample of fluid, said method further comprising the step of separating said needle assembly from said syringe prior to mounting said plastic fitting to said syringe.

8. A method for delivering a sample of bodily fluid for testing, comprising:

providing a point-of-care testing cartridge, said testing cartridge including an internal reservoir for retaining a sample of fluid and an entry port extending from an external location on said testing cartridge into communication with said reservoir;

providing a syringe with a fluid receiving chamber;

providing a plastic cannula having a proximal end configured for mounting on said syringe, a tapered distal end and a lumen between the ends, the lumen having opposed side ports at said distal end;

drawing a sample of said fluid into said fluid receiving chamber; and

employing said plastic cannula with said syringe for delivering said sample of said fluid such that said lumen communicates from said fluid receiving chamber, through said lumen and said point-of-care testing cartridge, said employing step comprising urging a selected volume of fluid from the fluid receiving chamber, through the side ports of said plastic cannula and into said entry port of said testing cartridge.

9. The method of claim 8, further comprising the steps of providing an accessing means for accessing the fluid, and placing said syringe in communication with said accessing means prior to drawing said sample.

10. The method of claim 9, further comprising the step of removing said syringe and said plastic cannula from said testing cartridge after urging the selected volume of fluid into said reservoir of said testing cartridge and disposing of said syringe and said plastic cannula.