Apparatus, method, system for the determination of the aggregation rate of red blood cells

• US 8,647,886 B1
• Filed: 01/14/2013
• Issued: 02/11/2014
• Est. Priority Date: 01/13/2012
• Status: Active Grant

• Current Assignee: Alcor Scientific Incorporated
• Original Assignee: Alcor Scientific Incorporated
• Inventors: Sacchetti, Peter, Frappa, Francesco
• Primary Examiner(s): Kosson, Rosanne
• Application Number:
  US13/740,843
• Time in Patent Office: 393 Days
• Field of Search: 436/165, 436/70, 435/2
• US Class Current: 436/165
• CPC Class Codes: G01N 15/00 Investigating characteristics of particles; Investigating permeability, pore-volume or surface-area of porous materials identification of microorganisms C12Q
• CPC Class Codes: G01N 15/05 in blood
• CPC Class Codes: G01N 2015/0092 Monitoring flocculation or agglomeration
• CPC Class Codes: G01N 2015/012 Red blood cells
• CPC Class Codes: G01N 21/51 inside a container, e.g. in an ampoule G01N21/53 takes precedence
• CPC Class Codes: G01N 21/82 producing a precipitate or turbidity
• CPC Class Codes: G01N 33/4905 Determining clotting time of blood by chemical methods G01N33/86, C12Q1/54
• CPC Class Codes: G01N 33/4915 using flow cells flow cytometry G01N15/14

Abstract

The present invention generally relates to an apparatus, method, system for the determination of the aggregation rate of red blood cells. More specifically, the invention concerns a method, system, and the relative apparatus used to determine the aggregation rate of red blood cells, and other parameters related to these, such as viscosity, deformability, elasticity, density, in the field of in vitro medical analyses, using optical systems after or during inducted forces for red blood cell disruption and redistribution generated by ultrasound waves.

Claims

1. An apparatus for determining the aggregation rate of red blood cells, comprising:

a) mixer device configured for mixing a blood sample within a collection tube;

b) a needle configured for insertion within the collection tube for withdrawal of a portion of the blood sample, the needle connected to a hydraulic circuit for transporting the blood sample portion using a pump;

c) a reading cell container operationally connected to the hydraulic circuit configured for receipt of the blood sample portion;

d) a light emitter source positioned about the reading cell to pass light through the blood sample portion;

e) an optical receiver positioned opposite the light emitter source and about the reading cell to detect scattered light passing through the blood sample portion;

f) a disruption mechanism connected to the reading cell container for disruption of the red blood cells within the blood sample portion to assist in recording the disruption rate; and

g) a main controller operationally connected to the disruption mechanism, the main controller configured to activate the disruption mechanism for the disruption of the red blood cells within the blood sample portion until scattered light detected stops decreasing indicating the complete disruption of aggregates within the blood sample portion,

whereby, in a method of using the apparatus, after the disruption mechanism is stopped, an aggregation rate of the blood sample portion for a predetermined time is recorded based upon detected scattered light variation.

2. The apparatus of claim 1, further comprising:

a fluid reservoir connected to the reading cell container for receipt of an evacuated blood sample portion from the reading cell container.

3. The apparatus of claim 1, wherein the apparatus comprises an evacuation mechanism to evacuate the blood sample portion from the reading cell container.

4. The apparatus of claim 1, wherein the evacuation mechanism is configured to provide ultrasound stress.

5. The apparatus of claim 1, wherein the apparatus determines an aggregation index of the red blood cells for the subsequent estimation of the erythrocyte sedimentation rate, the estimation being comparable with the Westergren method.

6. The apparatus of claim 1, wherein the apparatus determines a disruption index of the red blood cells as rheological parameters usable for pathologic detection purposes.

7. The apparatus of claim 1, wherein the apparatus determines a mean red blood cell shape recovery ability.

8. The apparatus of claim 1, wherein the apparatus determines the plasma viscosity.

9. The apparatus of claim 1, wherein the reading cell container is non-disposable.

10. The apparatus of claim 1, wherein the reading cell container is configured for the optical detection of aggregation reaction.

11. The apparatus of claim 1, wherein the disruption mechanism is an actuator.

12. The apparatus of claim 1, wherein the disruption mechanism is an ultrasonic inducted mechanism for the disruption of red blood cells aggregates.

13. The apparatus of claim 1, wherein the disruption mechanism is electricity from a piezoceramic material which is initially ramped up to a level where cell emulsification is detected through the reading cell.

14. The apparatus of claim 1, wherein the red blood cell portion is a low volume or percentage of the overall blood sample.

15. A method of measuring the disruption rate and the aggregation rate of a sample of red blood cells, comprising:

a) providing a blood sample within a collection tube;

b) mixing the blood sample within the collection tube;

c) removing a portion of the blood sample from the collection tube;

d) delivering the blood sample portion into a reading cell container;

e) disrupting the blood sample portion within the reading cell container to evenly distribute and re-suspend the red blood cells in the blood;

f) passing light through the blood sample portion within the reading cell container;

g) receiving and detecting scattered light emitted from the reading cell container;

h) recording a disruption rate of the red blood cells within the blood sample portion based upon the scattered light variation;

i) discontinuing the disruption of the blood sample portion within the reading cell until the variation in scattered light detected stops decreasing indicating the complete disruption of aggregates within the blood sample portion;

j) recording an aggregation rate of the blood sample portion for a predetermined time based upon detected scattered light variation; and

k) evacuating the blood sample portion from the reading cell container.

16. The method of claim 15, wherein disrupting the blood sample portion comprises applying electricity from a piezoceramic material initially ramped up to a level where cell emulsification is detected through the reading cell.