Systems, methods, and devices for sampling bodily fluid

• US 8,216,156 B2
• Filed: 02/17/2011
• Issued: 07/10/2012
• Est. Priority Date: 06/21/2006
• Status: Expired due to Fees

• Current Assignee: Glucor Systems LLC
• Original Assignee: Glucor Systems LLC
• Inventors: Dalebout, Corey, Sybrowsky, Josh
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): LLOYD, EMILY M
• Application Number:
  US13/030,012
• Publication Number:
  US 20110166433A1
• Time in Patent Office: 509 Days
• Field of Search: 600/347, 600/573, 600/576, 600/587
• US Class Current: 600/584
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150213 Venting means
• CPC Class Codes: A61B 5/150221 Valves
• CPC Class Codes: A61B 5/150259 Improved gripping, e.g. with high friction pattern or projections on the housing surface or an ergonometric shape
• 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 5/150786 Optical identification systems, e.g. bar codes, colour codes
• 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 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

A fluid sampling system is disclosed comprising a fluid drawing device and a fluid sampling device. In one embodiment, the fluid sampling device has a base portion having a cannula, a handle, and a ridge extending around at least a portion of an outer surface. A top portion has a flange adapted to engage the ridge to couple the top portion to the base portion. In another embodiment, the fluid sampling device has a base portion having a cannula, a handle, a mounting portion, and a test strip coupled to the base portion at least partially within the mounting portion. In yet another embodiment, the fluid sampling device has a test strip housing for receiving an end of a test strip therein. Extending from an end of the test strip housing is a blunt cannula.

Claims

1. In a glucose monitoring system adapted for monitoring blood glucose, in which the glucose monitoring system includes a glucometer and an intravenous system which includes an intravenous line for administering fluids to a patient and through which blood samples are capable of being withdrawn, a sample port connected in the intravenous line and through which fluids are capable of flowing to the patient and through which blood is capable of being withdrawn from the patient, and a fluid drawing device connected into the intravenous line for controlling in one direction flow of fluids into the patient and for controlling in an opposite direction flow of blood from the patient through the sample port and into the fluid drawing device, an improved blood sampling device for coupling to the sample port to permit a blood sample to be deposited onto a test strip for analyzing blood glucose levels, the improved blood sampling device comprising in combination:

a test strip having one end comprised of an absorbent material and a reagent adapted for detecting blood characteristics indicative of glucose levels, and another end comprised of electrical leads adapted for electronic coupling to the glucometer; and

a test strip adapter configured for coupling the test strip in fluid communication with the sampling port of the intravenous line, the test strip adapter comprising;

a base portion with a platform which has on a top side of the platform an unsealed mounting area, and the bottom side of said platform being joined to a blunt cannula configured for insertion into the sampling port, the blunt cannula providing fluid communication of a blood sample from the sampling port into the mounting area of the platform;

the unsealed mounting area being configured to receive said test strip end comprised of the absorbent material and reagent; and

said unsealed mounting area of the platform terminating at a point that is adapted to permit coupling of the test strip end comprised of electrical leads to the glucometer when the test strip is inserted in said mounting area without having to remove the test strip from the adapter.

2. The blood sampling device of claim 1 wherein said test strip adapter further comprises grooves formed within said mounting area which are configured to assist in venting air from the test strip to enable blood to readily flow to the mounting area in order to contact said test strip.

3. The blood sampling device of claim 1 further comprising a one-way valve positioned at the blunt cannula and adapted to limit reflux of air into the intravenous line.

4. The blood sampling device of claim 1 wherein said mounting area is formed by two opposing side walls and an end wall.

5. The blood sampling device of claim 4 wherein at least one side wall includes a projecting portion that extends toward the middle of the mounting area and is configured to fit around a specific shape of said test strip.

6. The blood sampling device of claim 1, wherein said adapter further comprises a top portion coupled to the base portion.

7. The blood sampling device of claim 6 wherein the top portion is biased toward the base portion so that when the test strip is removed the top portion moves toward the base portion.

8. The blood sampling device of claim 7 wherein said test strip adapter further comprises grooves formed within said mounting area which are configured to assist in venting air from the test strip to enable blood to readily flow to the mounting area in order to contact said test strip.

9. The blood sampling device of claim 8 further comprising a one-way valve positioned at the blunt cannula and adapted to limit reflux of air into the intravenous line.

10. The blood sampling device of claim 9 wherein said mounting area is formed by two opposing side walls.

11. In a blood monitoring system adapted for monitoring blood parameters, in which the blood monitoring system includes a metering device for metering parameters of the blood, and an intravenous system which includes an intravenous line for administering fluids to a patient and through which blood samples are capable of being withdrawn, a sample port connected in the intravenous line and through which fluids are capable of flowing to the patient and through which blood is capable of being withdrawn from the patient, and a fluid drawing device connected into the intravenous line for controlling in one direction flow of fluids into the patient and for controlling in an opposite direction flow of blood from the patient through the sample port and into the fluid drawing device, and a test strip having one end configured for contacting the blood sample to permit detecting blood characteristics indicative of a desired blood parameter to be tested, and another end adapted for coupling to the metering device,

a test strip adapter configured for coupling the test strip in fluid communication with the sampling port of the intravenous line, the test strip adapter comprising:

a base portion with a platform which has on a top side of the platform an unsealed mounting area, and the bottom side of said platform being joined to a blunt cannula configured for insertion into the sampling port, the blunt cannula providing fluid communication of a blood sample from the sampling port into the mounting area of the platform;

the unsealed mounting area being configured to receive said test strip end comprised of the absorbent material and reagent; and

said unsealed mounting area of the platform terminating at a point which is shy of the test strip end adapted for coupling to the metering device, so that a portion of the test strip with the end adapted for coupling to the metering device is exposed so as to be capable of insertion into the metering device without having to remove the test strip from the adapter.

12. The blood sampling device of claim 11 wherein said test strip adapter further comprises grooves formed within said mounting area which are configured to assist in venting air from the test strip to enable blood to readily flow to the mounting area in order to contact said test strip.

13. The blood sampling device of claim 11 further comprising a one-way valve positioned at the blunt cannula and adapted to limit reflux of air into the intravenous line.

14. The blood sampling device of claim 11 wherein said mounting area is formed by two opposing side walls and an end wall.

15. The blood sampling device of claim 14 wherein at least one side wall includes a projecting portion that extends toward the middle of the mounting area and is configured to fit around a specific shape of said test strip.

16. The blood sampling device of claim 11, wherein said adapter further comprises a top portion coupled to the base portion.

17. The blood sampling device of claim 16 wherein the top portion is biased toward the base portion so that when the test strip is removed the top portion moves toward the base portion.

18. The blood sampling device of claim 17 wherein said test strip adapter further comprises grooves formed within said mounting area which are configured to assist in venting air from the test strip to enable blood to readily flow to the mounting area in order to contact said test strip.

19. The blood sampling device of claim 18 further comprising a one-way valve positioned at the blunt cannula and adapted to limit reflux of air into the intravenous line.

20. The blood sampling device of claim 19 wherein said mounting area is formed by two opposing side walls.

21. A method for use in a blood monitoring system adapted for monitoring blood parameters, in which the blood monitoring system includes a metering device for metering parameters of the blood, and an intravenous system which includes an intravenous line for administering fluids to a patient and through which blood samples are capable of being withdrawn, a sample port connected in the intravenous line and through which fluids are capable of flowing to the patient and through which blood is capable of being withdrawn from the patient, and a fluid drawing device connected into the intravenous line for controlling in one direction flow of fluids into the patient and for controlling in an opposite direction flow of blood from the patient through the sample port and into the fluid drawing device, and a test strip having one end configured for contacting the blood sample to permit detecting blood characteristics indicative of a desired blood parameter to be tested, and another end adapted for coupling to the metering device,

the method comprising:

obtaining a test strip adapter configured for coupling the test strip in fluid communication with the sampling port of the intravenous line, the test strip adapter comprising;

a base portion with a platform which has on a top side of the platform an unsealed mounting area, and the bottom side of said platform being joined to a blunt cannula configured for insertion into the sampling port, the blunt cannula providing fluid communication of a blood sample from the sampling port into the mounting area of the platform;

the unsealed mounting area being configured to receive said test strip end comprised of the absorbent material and reagent; and

said unsealed mounting area of the platform terminating at a point that is adapted to permit coupling of the test strip end comprised of electrical leads to the glucometer when the test strip is inserted in said mounting area without having to remove the test strip from the adapter;

inserting the test strip end configured for contacting the blood sample into the mounting area of the base portion;

after blood is withdrawn from the patient into the fluid drawing device and sample port, inserting the blunt cannula into the sample port to obtain a blood sample on the test strip;

removing the test strip adapter with the inserted test strip from the sample port; and

without removing the test strip from the adapter, inserting the exposed end of the test strip into the metering device.

22. A method for use in a blood monitoring system adapted for monitoring blood parameters, in which the blood monitoring system includes a metering device for metering parameters of the blood, and an intravenous system which includes an intravenous line for administering fluids to a patient and through which blood samples are capable of being withdrawn, a sample port connected in the intravenous line and through which fluids are capable of flowing to the patient and through which blood is capable of being withdrawn from the patient, and a fluid drawing device connected into the intravenous line for controlling in one direction flow of fluids into the patient and for controlling in an opposite direction flow of blood from the patient through the sample port and into the fluid drawing device, and a test strip having one end configured for contacting the blood sample to permit detecting blood characteristics indicative of a desired blood parameter to be tested, and another end adapted for coupling to the metering device,

the method comprising:

obtaining a test strip adapter configured for coupling the test strip in fluid communication with the sampling port of the intravenous line, the test strip adapter comprising;

a base portion with a platform which has on a top side of the platform an unsealed mounting area, and the bottom side of said platform being joined to a blunt cannula configured for insertion into the sampling port, the blunt cannula providing fluid communication of a blood sample from the sampling port into the mounting area of the platform;

the unsealed mounting area being configured to receive said test strip end comprised of the absorbent material and reagent; and

said unsealed mounting area of the platform terminating at a point that is adapted to permit coupling of the test strip end comprised of electrical leads to the glucometer when the test strip is inserted in said mounting area without having to remove the test strip from the adapter; and

a top portion coupled to the base portion;

inserting the test strip end configured for contacting the blood sample between the top and bottom portions and into the mounting area of the bottom portion;

without removing the test strip from the adapter, inserting the exposed end of the test strip into the metering device;

removing the test strip adapter with the inserted test strip from the sample port; and

removing the test strip from the adapter, and inserting the end of the test strip configured for contacting the blood sample into the metering device.