Process for predicting hematocrit of whole blood using IR light

• US 9,164,078 B2
• Filed: 03/07/2013
• Issued: 10/20/2015
• Est. Priority Date: 06/15/2012
• Status: Active Grant

• Current Assignee: Fenwal Incorporated (Fresenius SE & Co. KGaA)
• Original Assignee: Fenwal Incorporated (Fresenius SE & Co. KGaA)
• Inventors: Min, Kyungyoon, Kusters, Benjamin, Wegener, Christopher
• Primary Examiner(s): Taningco, Marcus
• Assistant Examiner(s): Malevic, Djura
• Application Number:
  US13/788,164
• Publication Number:
  US 20130334420A1
• Time in Patent Office: 957 Days
• Field of Search: 250/341.5, 250/339.11, 250/339.12, 250/338.1, 210645-347, 210/748.08, 604/4.01, 604/6.08
• US Class Current: 1/1
• CPC Class Codes: A61B 5/14535 for measuring haematocrit
• CPC Class Codes: A61B 5/14557 specially adapted to extracorporeal circuits
• CPC Class Codes: G01N 21/3577 for analysing liquids, e.g. polluted water
• CPC Class Codes: G01N 33/49 Blood chemical methods for determining blood cell populations G01N33/5094; chemical analysis of blood groups or blood types G01N33/80

Abstract

A separation device is disclosed along with systems and methods employing the device in blood processing procedures. In one embodiment, a spinning membrane separator is provided. Automated systems and methods are disclosed for separating a unit of previously-collected whole blood into selected blood components, such as concentrated red cells and plasma, including prediction of the hematocrit of the whole blood using a light source and an optical sensor.

Claims

1. In a blood processing procedure in which blood is processed into one or more blood components with a single-use processing kit, the processing kit including tubing through which the blood is flowed, and a reusable hardware module onto which the processing kit is mounted, the reusable hardware module including a sensing field defined by an infrared light source and an infrared reflectance sensor that receives a segment of the tubing, a method for predicting the hematocrit of the blood comprising:

loading the processing kit onto the hardware module with a segment of the tubing positioned in the sensing field defined by the infrared light source and the infrared reflectance sensor;

obtaining an infrared reflectance measurement of the segment of the tubing with either no fluid or a non-reflecting fluid within said segment;

flowing blood through the segment of the tubing;

obtaining an infrared reflectance measurement of the segment of the tubing with said blood;

deriving the natural log of the infrared reflectance measurement attributable to the presence of blood in the segment of the tubing;

inputting the natural log of the infrared reflectance attributable to the blood in the segment of the tubing into a correlation equation to arrive at the hematocrit of the blood;

outputting the predicted hematocrit of the blood.

2. The method of claim 1 further comprising a method for creating the correlation equation for a processing kit comprising:

separately flowing a plurality of samples of blood through the segment of the tubing of the processing kit, each of the samples having a known hematocrit different from the hematocrit of the other samples;

obtaining an infrared reflectance measurement of the segment of the tubing filled with blood for each sample;

deriving the natural log of the infrared reflectance measurement attributable to the presence of blood in the segment of the tubing for each sample;

deriving the correlation equation based on a linear fit of a plot of the known hematocrit for each sample and the natural log of the infrared reflectance measurement for each sample.

3. The method of claim 1 in which the correlation equation is developed at a time different from the processing of the blood and is pre-programmed into a controller for the reusable module.

4. The method of claim 2 in which the correlation equation is developed at a time different from the processing of the blood and is pre-programmed into a controller for the reusable module.

5. The method of claim 1 wherein the blood comprises whole blood.

6. The method of claim 2 wherein the blood comprises whole blood.

7. The method of claim 3 wherein the blood comprises whole blood.

8. The method of claim 4 wherein the blood comprises whole blood.

9. The method of claim 1 wherein the blood comprises concentrated red blood cells.

10. The method of claim 2 wherein the blood comprises concentrated red blood cells.

11. The method of claim 3 wherein the blood comprises concentrated red blood cells.

12. The method of claim 4 wherein the blood comprises concentrated red blood cells.

13. The method of claim 1 wherein the blood comprises a blood product including red blood cells.

14. The method of claim 2 wherein the blood comprises a blood product including red blood cells.

15. The method of claim 3 wherein the blood comprises a blood product including red blood cells.

16. The method of claim 4 wherein the blood comprises a blood product including red blood cells.

17. A reusable hardware module for use with a single-use processing kit for processing blood, the reusable module comprising:

a programmable controller with an input for receipt of a first signal corresponding to an infrared reflectance measurement obtained from the processing kit and an output for transmitting a second signal corresponding to a predicted hematocrit for the blood being processed, the programmable controller being configured to derive the natural log of the infrared reflectance measurement, inputting the natural log of the infrared reflectance measurement into a predetermined correlation equation, generating the second signal corresponding to the predicted hematocrit, and transmitting the second signal to an interface.