Bodily fluid sampling systems, methods, and devices

• US 8,216,155 B2
• Filed: 10/15/2008
• 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, Jolley, Lincoln
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): Lloyd, Emily
• Application Number:
  US12/252,041
• Publication Number:
  US 20090099431A1
• Time in Patent Office: 1,364 Days
• Field of Search: 600/347, 600/573, 600/576, 600/584
• 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 5/15003 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 cannula 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 one end of the test strip to be received within an analysis device to facilitate analysis of the fluid sample.

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:

the 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 housing which comprises a receptacle for the test strip, the housing comprising;

one end joined to a blunt cannula configured for insertion into the sampling port, the blunt cannula being configured to provide fluid communication of a blood sample from the sampling port into the housing receptacle;

an opposite end with an unsealed opening configured to receive said test strip end comprised of the absorbent material and reagent; and

said opposite end of the housing 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 receptacle without having to remove the test strip from the housing.

2. The blood sampling device of claim 1 wherein said test strip adapter further comprises grooves longitudinally within said receptacle at opposite sides thereof and which are configured to assist in venting air from the test strip to enable blood to readily flow into the receptacle in order to contact said test strip.

3. The blood sampling device of claim 2 wherein said grooves are adapted to assist in aligning said test strip in the receptacle.

4. The blood sampling device of claim 2 wherein said grooves are adapted to assist in holding the test strip within the receptacle.

5. The blood sampling device of claim 2 further comprising an abutment at opposing ends of each groove to assist in positioning the test strip within the receptacle by providing a tactile indication that the test strip has been fully inserted into the receptacle.

6. The blood sampling device of claim 1, wherein said housing is joined to said blunt cannula by a tapered portion of the housing.

7. The blood sampling device of claim 1 wherein said housing has a length and width so that the housing is also configured as a handle for inserting or removing the test strip adapter into or from the sampling port of the intravenous system or the glucometer, as desired.

8. The blood sampling device of claim 1 further comprising a tab at said opposite end of the housing terminating at said point which is shy of the test strip end comprised of electrical leads, the tab being configured to extend around at least a portion of the glucometer so that the glucometer is configured as an enlarged handle for the blood sampling device when inserting the device into the sample port to obtain a blood sample.

9. 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 housing which comprises a receptacle configured to receive the test strip;

one end of said housing joined to a blunt cannula configured for insertion into the sampling port, the blunt cannula being configured to provide fluid communication of a blood sample from the sampling port into the housing receptacle;

an opposite end of said housing having an unsealed opening configured to receive said test strip end configured for contacting the blood sample; and

said opposite end of the housing terminating at a point that is adapted to permit a portion of the test strip with the end adapted for coupling to the metering device to be exposed when the test strip is inserted in said receptacle so as to be capable of insertion into the metering device without having to remove the test strip from the housing.

10. The blood sampling device of claim 9 wherein said test strip adapter further comprises grooves longitudinally within said receptacle at opposite sides thereof and which are configured to assist in venting air from the test strip to enable blood to readily flow into the receptacle in order to contact said test strip.

11. The blood sampling device of claim 10 wherein said grooves are adapted to assist in aligning said test strip in the receptacle.

12. The blood sampling device of claim 11 wherein said grooves are adapted to assist in holding the test strip within the receptacle.

13. The blood sampling device of claim 12 further comprising an abutment at opposing ends of each groove, each abutment being adapted to assist in positioning the test strip within the receptacle by providing a tactile indication that the test strip has been fully inserted into the receptacle.

14. The blood sampling device of claim 9, wherein said housing is joined to said blunt cannula by a tapered portion of the housing.

15. The blood sampling device of claim 14 wherein said housing has a length and width so that the housing is also configured as a handle for inserting or removing the test strip adapter into or from the sampling port of the intravenous system or the metering device, as desired.

16. The blood sampling device of claim 15 further comprising a tab at said opposite end of the housing terminating at said point that is adapted to permit a portion of the test strip end with the end adapted for coupling to the metering device to be exposed so as to be capable of insertion into the metering device, the tab being configured to extend around at least a portion of the metering device so that the metering device is configured to serve as an enlarged handle for the blood sampling device when inserting the device into the sample port to obtain a blood sample.

17. A method for monitoring blood parameters, in which a 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 housing which comprises a receptacle configured to receive the test strip;

one end of said housing joined to a blunt cannula configured for insertion into the sampling port, the blunt cannula being configured to provide fluid communication of a blood sample from the sampling port into the housing receptacle;

an opposite end of said housing having an unsealed opening configured to receive said test strip end configured for contacting the blood sample; and

said opposite end of the housing terminating at a point that is adapted to permit a portion of the test strip with the end adapted for coupling to the metering device to be exposed when the test strip is inserted in said receptacle so as to be capable of insertion into the metering device without having to remove the test strip from the housing;

inserting the test strip end configured for contacting the blood sample into the receptacle of the housing through said opposite end of said housing;

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.

18. A method for monitoring blood parameters, in which a 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 housing which comprises a receptacle configured to receive the test strip;

one end of said housing joined to a blunt cannula configured for insertion into the sampling port, the blunt cannula being configured to provide fluid communication of a blood sample from the sampling port into the housing receptacle;

an opposite end of said housing having an unsealed opening configured to receive said test strip end configured for contacting the blood sample; and

said opposite end of the housing terminating at a point that is adapted to permit a portion of the test strip with the end adapted for coupling to the metering device to be exposed when the test strip is inserted in said receptacle so as to be capable of insertion into the metering device without having to remove the test strip from the housing;

inserting the test strip end configured for contacting the blood sample into the receptacle of the housing through said opposite end of said housing;

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

after blood is withdrawn from the patient into the fluid drawing device and sample port, and with the metering device still containing the test strip adapter with the inserted test strip, grasping the metering device and inserting the blunt cannula into the sample port to obtain a blood sample on the test strip.