Plasma extraction apparatus

• US 8,101,404 B2
• Filed: 10/04/2010
• Issued: 01/24/2012
• Est. Priority Date: 05/13/2005
• Status: Active Grant

• Current Assignee: ChroMedX Ltd. (Relay Medical Corp.)
• Original Assignee: ChroMedX Inc.
• Inventors: Samsoondar, James
• Primary Examiner(s): LAM, ANN Y
• Application Number:
  US12/897,581
• Publication Number:
  US 20110079547A1
• Time in Patent Office: 477 Days
• Field of Search: None
• US Class Current: 435/287.3
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/14557 specially adapted to extracorporeal circuits
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/15003 for venous or arterial 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 5/150251 Collection chamber divided into at least two compartments, e.g. for division of samples injection syringes having more than one chamber A61M5/19; syringes for injection of two or more media A61M5/2448, A61M5/284; sample preparation for further analysis A61B5/150755
• CPC Class Codes: A61B 5/150343 Collection vessels for collecting blood samples from the skin surface, e.g. test tubes, cuvettes sampling from within body cavities A61B5/150015, A61B5/150045
• CPC Class Codes: A61B 5/150351 Caps, stoppers or lids for sealing or closing a blood collection vessel or container, e.g. a test-tube or syringe barrel caps for bottles or containers in general B65D41/00
• CPC Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• 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 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• 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

Abstract

A system that is suitable for extracting plasma from blood received from a blood supply is provided. The system comprises a housing, an inlet opening for receiving the blood, a filtration chamber comprising a membrane, and a plasma compartment. The membrane forms a barrier between the blood and the plasma extracted from the blood, and the plasma compartment collects the plasma extracted from the blood. In some embodiments, the system comprises a plasma flow path compression chamber for pulling plasma across the membrane. In some embodiments, the system comprises a blood flow path compression chamber for facilitating blood flow. Some embodiments of the system further comprise means for measuring plasma and blood analytes using spectroscopic and biosensor techniques.

Claims

1. A system for extracting plasma from blood received from a blood supply, the system comprising:

a housing;

a blood flow path in the housing, the blood flow path having an inlet opening in the housing for receiving the blood, the blood flow path terminating at one of a blood flow path outlet and a blood flow path compression chamber for facilitating a blood flow in the blood flow path;

a filtration chamber within the housing for receiving the blood from the inlet opening, the filtration chamber comprising a porous membrane separating the blood flow path from a plasma compartment, the porous membrane being configured to permit passage of the extracted plasma therethrough, wherein the blood flow path intersects with the filtration chamber at a fluid intersection;

a plasma flow path beginning at the plasma compartment and terminating at a manually operable plasma flow path compression chamber for pulling the plasma across the membrane from the blood flow path to the plasma compartment, wherein the plasma flow path compression chamber defines a cavity, at least a portion of the cavity being located within the housing.

2. The system according to claim 1, wherein the membrane for separating the blood flow path from the plasma compartment comprises at least one hollow fiber filter.

3. The system according to claim 2, wherein the at least one hollow fiber filter is assembled between two flanges, and at least one of the two flanges is perforated.

4. The system according to claim 2, wherein at the fluid intersection of the blood flow path and the filtration chamber, a direction of the blood flow defined by the blood flow path is approximately orthogonal to the longitudinal axis of the at least one hollow fiber filter, and wherein the plasma compartment includes the inside of the at least one hollow fiber filter.

5. The system according to claim 2, wherein at the fluid intersection of the blood flow path and the filtration chamber, a direction of the blood flow defined by the blood flow path is approximately parallel to the longitudinal axis of the at least one hollow fiber filter, and wherein the plasma compartment includes the outside of the at least one hollow fiber filter.

6. The system according to claim 1, wherein

the blood flow path terminates at the blood flow path compression chamber, and

the blood flow path compression chamber and the plasma flow path compression chamber are fluidly connected to one another.

7. The system according to claim 1, wherein

the manually operable plasma flow path compression chamber comprises at least one flexible member that is manually operable to reduce a volume of the cavity, the cavity being at least partially enclosed by the at least one flexible member.

8. The system according to claim 1, wherein

the manually operable plasma flow path compression chamber comprises a first member and a second member, the cavity extends between the first member and the second member, the first member is flexible and is located substantially opposite the second member, the first member is manually squeezable to move toward the second member, and after being moved toward the second member the first member is resiliently biased to move away from the second member to generate a negative pressure in the plasma compartment.

9. The system according to claim 1, wherein the plasma flow path further comprises at least one of an optical chamber and a biosensor, wherein

the at least one optical chamber comprises at least one optical wall-portion to facilitate detection of an EMR-based signal derived from the plasma for measuring at least one plasma analyte, and wherein

the at least one biosensor is in electrical communication with an electrical output located on an external surface of the housing, the electrical output being operable to receive plasma biosensor data from the biosensor in the plasma flow path and to transmit the plasma biosensor data to an analysis meter.

10. The system according to claim 9, wherein the at least one optical chamber further comprises a reflective coating on one of the at least one optical wall-portion.

11. The system according to claim 1, wherein the blood flow path further comprises at least one of an optical chamber and a biosensor, wherein

the at least one optical chamber comprises at least one optical wall-portion to facilitate detection of an EMR-based signal derived from the blood for measuring at least one blood analyte, and wherein

the at least one biosensor is in electrical communication with an electrical output located on an external surface of the housing, the electrical output being operable to receive blood biosensor data from the biosensor in the blood flow path and to transmit the blood biosensor data to an analysis meter.

12. The system according to claim 1, wherein one of the inlet opening and the blood flow path outlet is configured to engage a syringe for facilitating the blood flow in the blood flow path.

13. The system according to claim 1, wherein the blood flow path outlet is a vent that provides an outflow path for air.

14. A system for extracting plasma from blood, comprising:

a housing;

a blood flow path in the housing, the blood flow path having an inlet opening in the housing for receiving the blood, the blood flow path terminating at a manually operable blood flow path compression chamber for facilitating a blood flow in the blood flow path, wherein the blood flow path compression chamber defines a cavity, at least a portion of the cavity being located within the housing;

a filtration chamber within the housing for receiving the blood from the inlet opening, the filtration chamber comprising a porous membrane separating the blood flow path from a plasma compartment, the porous membrane being configured to permit passage of the extracted plasma therethrough, wherein the blood flow path intersects with the filtration chamber at a fluid intersection; and

a first plasma flow path beginning at the plasma compartment and terminating at one of a first plasma flow path outlet and a first plasma flow path compression chamber for drawing the plasma across the membrane, from the blood flow path to the plasma compartment.

15. The system according to claim 14, wherein the membrane separating the blood flow path from the plasma compartment comprises at least one hollow fiber filter.

16. The system according to claim 15, wherein the at least one hollow fiber filter is assembled between two flanges, and at least one of the two flanges is perforated.

17. The system according to claim 15, wherein at the fluid intersection of the blood flow path and the filtration chamber, a direction of the blood flow defined by the blood flow path is approximately orthogonal to the longitudinal axis of the at least one hollow fiber filter, and wherein the plasma compartment includes the inside of the at least one hollow fiber filter.

18. The system according to claim 15, wherein at the fluid intersection of the blood flow path and the filtration chamber, a direction of the blood flow defined by the blood flow path is approximately parallel to the longitudinal axis of the at least one hollow fiber filter, and wherein the plasma compartment includes the outside of the at least one hollow fiber filter.

19. The system according to claim 14, wherein

the first plasma flow path terminates at the first plasma flow path compression chamber, and

the first plasma flow path compression chamber and the blood flow path compression chamber are fluidly connected to one another.

20. The system according to claim 14, wherein

the manually operable blood flow path compression chamber comprises at least one flexible member that is manually operable to reduce a volume of the cavity, the cavity being at least partially enclosed by the at least one flexible member.

21. The system according to claim 14, wherein

the manually operable blood flow path compression chamber comprises a first member and a second member, the cavity extends between the first member and the second member, the first member is flexible and is located substantially opposite the second member, the first member is manually squeezable to move toward the second member, and after being moved toward the second member the first member is resiliently biased to move away from the second member to generate a negative pressure in the blood flow path.

22. The system according to claim 14, wherein the first plasma flow path further comprises at least one of an optical chamber and a biosensor, wherein

the at least one optical chamber comprises at least one optical wall-portion to facilitate detection of an EMR-based signal derived from the plasma for measuring at least one plasma analyte of the plasma in the plasma flow path, and wherein

the at least one biosensor is in electrical communication with an electrical output located on an external surface of the housing, the electrical output being operable to receive plasma biosensor data from the biosensor in the first plasma flow path to transmit the plasma biosensor data to an analysis meter.

23. The system according to claim 22, wherein the at least one optical chamber further comprises a reflective coating on one of the at least one optical chamber wall-portion.

24. The system according to claim 14, wherein the blood flow path further comprises at least one of an optical chamber and a biosensor, wherein

the at least one optical chamber comprises at least one optical wall-portion to facilitate detection of an EMR-based signal derived from the blood for measuring at least one blood analyte of the blood in the blood flow path, and wherein

the at least one biosensor is in electrical communication with an electrical output located on an external surface of the housing, the electrical output being operable to receive blood biosensor data from the biosensor in the blood flow path and to transmit the blood biosensor data to an analysis meter.

25. The system according to claim 14, further comprising:

a second plasma flow path beginning at the plasma compartment and terminating at a second plasma flow path outlet; and

a cap, wherein

the first plasma flow path terminates at the first plasma flow path compression chamber, and

when the cap covers the second plasma flow path outlet, the second plasma flow path outlet is in a closed state for impeding plasma flow out of the plasma compartment via the second plasma flow path outlet, and wherein when the cap is removed from the second plasma flow path outlet, the second plasma flow path outlet is in an open state for facilitating plasma flow out of the plasma compartment via the second plasma flow path outlet, and wherein

when the second plasma flow path outlet is in the closed state, the first plasma flow path compression chamber is operable to generate a negative pressure in the plasma compartment to draw the plasma across the membrane, from the blood flow path to the plasma compartment, and

when the second plasma flow path outlet is in the open state, the first plasma flow path compression chamber is operable to push at least some of the plasma out of the plasma compartment via the second plasma flow path outlet.

26. The system according to claim 14, wherein the first plasma flow path outlet is configured to engage a syringe, the syringe is operable to generate a negative pressure in the plasma compartment to draw the plasma across the membrane, from the blood flow path to the plasma compartment.