Fluid Access Interface

• US 20080275324A1
• Filed: 05/23/2006
• Published: 11/06/2008
• Est. Priority Date: 05/23/2006
• Status: Active Grant

• Current Assignee: Intellectual Discovery Co., Ltd.
• Original Assignee: IntelliDx, Inc.
• Inventors: Johnson, Larry, Siebrecht, Wayne, Nagar, Ron, Shreve, Eric, Larson, Robert, Klomhaus, Jill, Bitton, Gabby, Pesach, Gidi, Argaman, Dalia, Bellomo, Stephen, Goldberger, Daniel, Pesach, Benny
• Granted Patent: US 8,092,385 B2
• Time in Patent Office: Days
• US Class Current: 600/365
• 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 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150221 Valves
• CPC Class Codes: A61B 5/150229 Pumps for assisting the blood sampling
• 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 5/150358 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 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/15087 short range, e.g. between console and disposable using implanted devices A61B5/150877
• 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 5/155 Devices specially adapted for continuous or multiple sampling, e.g. at predetermined intervals devices loaded with multiple lancets simultaneously A61B5/15146
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

The present invention relates generally to systems, apparatuses, and methods for obtaining a fluid sample from a patient. In particular, the present invention relates to a various types of fluid access interfaces for enabling contact between a patient blood sample and blood parameter sensors for the measurement of physiological parameters and blood constituents.

Claims

1. A device for accessing blood from a patient and measuring blood constituents, comprising a transfer tube having a shape, wherein the transfer tube is used to provide a direct flow path to a test substrate and wherein an alteration in the shape of the tube causes the tube to move from an open state to a closed state.

2. The device of claim 1 wherein said transfer tube is flexible.

3. The device of claim 1 wherein said device further comprises a test strip holder.

4. The device of claim 3 wherein the test strip holder positions a test strip for fluid dispensing and mechanical handling.

5. The device of claim 1 wherein a distal end is an end-access capillary test strip for glucose measurement.

6. A device for accessing blood from a patient and measuring blood constituents, comprising a transfer tube, wherein said transfer tube is used to access fluid from a fluid line to determine the concentration of at least one analyte, wherein the fluid line is used with:

a tube originating from a vascular access point;

a pump fixedly attached to the tube;

a valve fixedly attached to the tube and located above the pump mechanism;

at least one measurement element; and

an electronic meter.

7. A device for periodically monitoring at least one predetermined parameter of blood from a patient, comprising a transfer tube, wherein said transfer tube is used to access blood and provide a blood sample from a fluid line to determine the concentration of at least one analyte, wherein the fluid line is used with:

access device for gaining access to said blood with a catheter;

a pump to withdraw blood from the patient in a predetermined schedule;

at least one sensor capable of being placed in contact with said blood sample; and

a signal processor to measure a signal produced by the at least one sensor upon contact with the blood sample where the signal is indicative of said at least one predetermined parameter.

8. A device for accessing blood from a patient and measuring blood constituents, comprising a transfer tube with a closed end used to deliver fluid to a test substrate.

9. The device of claim 8, wherein the closed end of the transfer tube is a bulb which can be expanded and contracted to access a fluid sample.

10. The device of claim 8 wherein the transfer tube comprises a micro-syringe, wherein the micro-syringe comprises a plunger to remove and deposit a fluid sample.

11. The device of claim 8, wherein said closed-end transfer tube is used to access fluid from a fluid line to determine the concentration of at least one analyte, wherein the fluid line is used with:

a tube originating from a vascular access point;

a pump fixedly attached to the tube;

a valve fixedly attached to the tube and located above the pump mechanism;

at least one measurement element; and

an electronic meter.

12. The device of claim 8, wherein said closed-end transfer tube is used to access blood from a fluid line to determine the concentration of at least one analyte, wherein the fluid line is used with:

access device for gaining access to said blood with a catheter;

a pump to withdraw blood from the patient in a predetermined time schedule;

at least one sensor capable of being placed in fluid contact with said blood by said closed-end transfer tube; and

a signal processor to measure a signal produced by the at least one sensor upon contact with the blood where the signal is indicative of said at least one predetermined parameter.

13. The device for accessing blood from a patient and measuring blood constituents of claim 8, further comprising a piston pump, wherein the piston pump is connected to a transfer tube and said piston pump is used to remove a fluid sample and deliver the fluid sample to a test substrate.

14. The device of claim 13, wherein said piston pump is used to access fluid from a main fluid line to determine the concentration of at least one analyte, wherein the main fluid line is used with:

a tube originating from a vascular access point;

a pump fixedly attached to the tube;

a valve fixedly attached to the tube and located above the pump mechanism;

at least one measurement element; and

an electronic meter.

15. The device of claim 13, wherein said piston pump is used to access blood from a main fluid line to determine the concentration of at least one analyte, wherein the fluid line is used with:

access device for gaining access to said blood with a catheter;

a pump to withdraw blood from the patient in a predetermined time schedule;

at least one sensor placed in contact with said blood by said transfer tube; and

a signal processor to measure a signal produced by the at least one sensor upon contact with said blood where the signal is indicative of said at least one predetermined parameter.

16. A device for accessing blood from a patient and measuring blood constituents, comprising a shuttle, wherein said shuttle is used to facilitate drawing a fluid sample through a sampling port without passing back through the sampling port.

17. The device of claim 16 wherein said shuttle device penetrates through a needle-less port.

18. The device of claim 16, wherein said shuttle device is used to access fluid from a fluid line to determine the concentration of at least one analyte, wherein the fluid line is used with:

a tube originating from a vascular access point;

a pump fixedly attached to the tube;

a valve fixedly attached to the tube and located above the pump mechanism;

at least one measurement element; and

an electronic meter.

19. The device of claim 16, wherein said shuttle device is used to access blood from a fluid line to determine the concentration of at least one analyte, wherein the fluid line is used with:

access device for gaining access to said blood with a catheter;

a pump to withdraw blood from the patient in a predetermined time schedule;

at least one sensor placed in contact with said blood by said shuttle device; and

a signal processor to measure a signal produced by the at least one sensor upon contact with said blood where the signal is indicative of said at least one predetermined parameter.

20. A device for accessing blood from a patient and measuring blood constituents, comprising an air jet fluid access port, which further comprises a valve and a low volume air pump.

21. The device of claim 20, wherein said air jet fluid access port is used to access fluid from a main fluid line to determine the concentration of at least one analyte, wherein the main fluid line further comprises:

a tube originating from a vascular access point;

a pump fixedly attached to the tube;

a valve fixedly attached to the tube and located above the pump mechanism;

at least one measurement element; and

an electronic meter.

22. The device of claim 20, wherein said air jet fluid access port is used to access blood from a fluid line to determine the concentration of at least one analyte, wherein the fluid line is used with:

access device for gaining access to said blood with a catheter;

a pump to withdraw blood from the patient in a predetermined time schedule;

at least one sensor placed in contact with said blood by said air jet fluid access port; and

a signal processor to measure a signal produced by the at least one sensor upon contact with said blood where the signal is indicative of said at least one predetermined parameter.

23. A device for accessing blood from a patient and measuring blood constituents, comprising a distribution valve wherein said distribution valve is used to redirect a main flow of fluid to a side path and wherein said side path leads to an exit port in fluid communication with a test substrate.

24. The device of claim 23 wherein said distribution valve is a by-pass valve.

25. The device of claim 23 wherein said distribution valve has low dead volume.

26. The device of claim 23 wherein a micro-filter isolates the fluid inside the valve from contamination.

27. The device of claim 26 wherein the micro-filter is cleaned by purging fluid before and after sample collection.

28. The device of claim 23 further comprising a sterile filter.

29. The device of claim 23 further comprising a dispensing pump.

30. The device of claim 23, wherein said distribution valve is used to access fluid from a fluid line to determine the concentration of at least one analyte, wherein said fluid line further comprises:

a tube originating from a vascular access point;

a pump fixedly attached to the tube;

a valve fixedly attached to the tube and located above the pump mechanism;

at least one measurement element; and

an electronic meter.

31. The device of claim 23, wherein said distribution valve is used to access blood from a fluid line to determine the concentration of at least one analyte, wherein said fluid line further comprises:

access device for gaining access to said blood with a catheter;

a pump to withdraw blood from the patient in a predetermined time schedule;

at least one sensor placed in contact with said blood by an action of said distribution valve; and

a signal processor to measure a signal produced by the at least one sensor upon contact with said blood where the signal is indicative of said at least one predetermined parameter.