Diagnostic whole blood and plasma apparatus

• US 7,816,124 B2
• Filed: 05/12/2006
• Issued: 10/19/2010
• 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:
  US11/432,616
• Publication Number:
  US 20060254962A1
• Time in Patent Office: 1,621 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

An apparatus suitable for measuring at least one plasma analyte in plasma extracted from a whole blood sample within the apparatus is provided. The apparatus can be adapted for insertion into a slot in a meter, which can preferably perform at least spectroscopic or biosensor measurement. The apparatus comprises a whole blood flow path, which begins at the inlet opening of the apparatus, and terminates at a vent or a suction chamber. Included in the blood flow path is a flow-through filtration chamber. The filtration chamber comprises at least one membrane separating a blood compartment from a plasma compartment. The apparatus further comprises a plasma flow path, which begins at the plasma compartment and terminates at a vent or a suction chamber. The plasma flow path includes a plasma analyte signal providing means. The signal is transmitted to a processor in the meter for preparing analyte measurements.

Claims

1. A disposable apparatus adapted for insertion into the slot of a meter for measuring at least one plasma analyte in plasma extracted from a blood sample within the apparatus, the apparatus comprising:

a housing;

an inlet opening in the housing for receiving the blood sample;

a first groove in the housing defining a blood flow path beginning at the inlet opening and terminating at a manually operable first compression suction chamber for facilitating blood flow in the blood flow path, wherein the first compression suction chamber comprises a first cavity within the housing, wherein a wall portion of the first cavity is defined by the housing;

a filtration chamber comprising a membrane separating a plasma compartment from the blood flow path, wherein the blood flow path fluidly intersects with the filtration chamber, and a blood flow direction defined by the blood flow path at the intersection with the filtration chamber is substantially parallel to a surface of the membrane; and

a second groove in the housing defining a plasma flow path beginning at the plasma compartment and terminating at a manually operable second compression suction chamber for pulling the plasma across the membrane from the blood flow path into the plasma flow path, wherein the second compression suction chamber comprises a second cavity within the housing, wherein a wall portion of the second cavity is defined by the housing, and wherein the plasma flow path comprises at least one of;

an optical chamber defining a void for containing the plasma for analysis,

wherein the optical chamber comprises at least one optical wall-portion to facilitate detection of an EMR-based signal derived from the plasma for measuring the at least one plasma analyte, and a plasma biosensor chamber comprising at least one biosensor for measuring the at least one plasma analyte, 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 and to transmit the biosensor data to the meter when the apparatus is inserted in the slot.

2. The disposable apparatus according to claim 1, wherein the blood flow path further comprises a blood analyte signal providing means in the blood flow path for providing a signal to the meter for measuring at least one blood analyte.

3. The disposable apparatus according to claim 1, wherein the optical chamber comprises two optical chamber wall-portions for performing spectroscopic measurement on the plasma, wherein the average internal distance between the two optical chamber wall-portions is in an approximate range of 0.02 mm to 5 mm.

4. The disposable apparatus according to claim 3, further comprising a reflective coating on one of the optical chamber wall-portions.

5. The disposable apparatus according to claim 1, wherein the plasma flow path further comprises a reagent.

6. The disposable apparatus according to claim 1, wherein the blood flow path includes an anticoagulant.

7. The disposable apparatus according to claim 1, wherein the blood flow path terminates at the first compression suction chamber, and the plasma flow path terminates at a the second compression suction chamber, and wherein the second compression suction chamber is not fluidly connected to the first compression suction chamber such that the first compression suction chamber and the second compression suction chamber are operable to generate different pressures in the blood flow path and the plasma flow path.

8. The disposable apparatus according to claim 1, further comprising at least one visible guide line for indicating a compression level for the compression suction chamber.

9. The disposable apparatus according to claim 1, further comprising a barcode containing at least information regarding calibration for measurement of an analyte.

10. The disposable apparatus according to claim 1, wherein the biosensor comprises a transducer for converting at least one property of the plasma into an electrical signal.

11. The disposable apparatus according to claim 10, wherein the transducer comprises at least one active surface for contacting the fluid.

12. The disposable apparatus according to claim 11, wherein the at least one active surface is one of a chemical sensitive surface and an ionic sensitive surface.

13. A disposable apparatus according to claim 1, wherein the at least one biosensor comprises at least one of a transistor, an ion-selective membrane, a membrane-bound enzyme, a membrane-bound antigen, a membrane-bound antibody and a membrane-bound strand of nucleic acid.

14. The disposable apparatus according to claim 1, wherein the membrane is in the form of a hollow fiber filter, and the filtration chamber comprises at least one hollow fiber filter.

15. The disposable apparatus according to claim 14, wherein at the fluid intersection of the blood flow path and the filtration chamber, the direction of blood flow defined by the blood flow path is substantially parallel to the longitudinal axis of the at least one hollow fiber filter.

16. The disposable apparatus according to claim 1, wherein

at least one of the manually operable first compression suction chamber and the manually operable second compression chamber comprise a first member and a second member, the first or second 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 or the plasma flow path to facilitate blood flow or plasma flow, respectively.

17. The disposable apparatus according to claim 16, wherein the first member is manually squeezable to move toward the second member by a force applied by a portion of a human hand.

18. The disposable apparatus according to claim 16, wherein the first member is manually squeezable to move toward the second member by a force applied by a single finger.

19. A disposable apparatus adapted for insertion into the slot of a meter for measuring at least one plasma analyte in plasma extracted from a blood sample within the apparatus, the apparatus comprising:

a housing;

an inlet opening in the housing for receiving the blood sample;

a first groove in the housing defining a blood flow path beginning at the inlet opening and terminating at a vent for facilitating blood flow in the blood flow path;

a filtration chamber comprising a membrane separating a plasma compartment from the blood flow path, wherein the blood flow path fluidly intersects with the filtration chamber; and

,

a second groove in the housing defining a plasma flow path beginning at the plasma compartment and terminating at a manually operable compression suction chamber for pulling the plasma across the membrane from the blood flow path into the plasma flow path, wherein the manually operable compression suction chamber comprises a cavity within the housing, wherein a wall portion of the cavity is defined by the housing, and wherein the plasma flow path comprises at least one of;

an optical chamber defining a void for containing the plasma for analysis, wherein the optical chamber comprises at least one optical wall-portion to facilitate detection of an EMR-based signal derived from the plasma for measuring the at least one plasma analyte, and a plasma biosensor chamber comprising at least one biosensor for measuring the at least one plasma analyte, 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 and to transmit the biosensor data to the meter when the apparatus is inserted in the slot.

20. The disposable apparatus according to claim 19, wherein

the manually operable compression suction 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 flow path to facilitate plasma flow.