WHOLE BLOOD VOLUME ANALYZER

• US 20200132677A1
• Filed: 10/30/2019
• Published: 04/30/2020
• Est. Priority Date: 10/31/2018
• Status: Active Application

• Current Assignee: Daxor Corp.
• Original Assignee: Daxor Corp.
• Inventors: Feldschuh, Jonathan, Cacheiro, Ronald
• Application Number:
  US16/667,981
• Publication Number:
  US 20200132677A1
• Time in Patent Office: Days
• CPC Class Codes: A61B 2505/01 Emergency care
• CPC Class Codes: A61B 2505/03 Intensive care
• CPC Class Codes: A61B 2505/05 Surgical care
• CPC Class Codes: A61B 5/0071 by measuring fluorescence emission
• CPC Class Codes: A61B 5/02042 Determining blood loss or bleeding, e.g. during a surgical procedure
• CPC Class Codes: A61B 5/14535 for measuring haematocrit
• CPC Class Codes: G01N 2035/00752 bar codes
• CPC Class Codes: G01N 2035/0091 GUI [graphical user interfaces]
• CPC Class Codes: G01N 33/5094 for blood cell populations red blood cells G01N33/80
• CPC Class Codes: G01N 33/582 with fluorescent label
• CPC Class Codes: G01N 33/583 with non-fluorescent dye label
• CPC Class Codes: G01N 33/80 involving blood groups or blood types or red blood cells white blood cells G01N33/56972
• CPC Class Codes: G01N 35/00732 Identification of carriers, materials or components in automatic analysers
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 40/63 for local operation

Abstract

Systems and methods are provided for measuring blood volume of a living being.

Claims

1. A system for automatically analyzing blood of a living subject, comprising a concentration counter configured to analyze one or more samples, a user interface operatively connected to the concentration counter and configured for entry and display of information, one or more processors operatively coupled to a memory and configured to execute programmed instructions stored in the memory to carry out a method comprising the steps of:

a. measuring a flow-through quantitative blood collection vial containing whole blood from the subject in the concentration counter to determine a background count;

b. injecting the subject with a precise, known volume of tracer;

c. at one or more timed intervals after the injection, drawing blood from the subject into a quantitative flow-through vial, and counting said blood in the detector;

d. calculating, by the one or more processors, a blood volume (BV), plasma volume (PV), and red cell volume (RCV) for the patient;

e. calculating, by the one or more processors, an ideal blood volume (iBV), ideal plasma volume (iPV), and red cell volume (iRCV) for the patient based on patient descriptive data such as height, weight, and gender; and

f. displaying, by the one or more processors, at the user interface, the results.

2. The system of claim 1, where the tracer is a radioactive isotope, and the counter is a radiation counter.

3. The system of claim 1, where the tracer is a light-emitting (fluorescent) or light-absorbent (dye), and the counter is capable of measuring light emission or absorption.

4. The system of claim 1, where a single flow-through quantitative blood collection vial is utilized for steps (a) and (c), where said vial is continuously connected to the patient via an IV line, and where sufficient blood is drawn through the vial using vacuum pressure (via a syringe, pump, or other means) to ensure that any saline present in the line is cleared out of the vial and thus does not affect counting accuracy.

5. The system of claim 4, where a hematocrit measuring device is a component of the system.

6. The system of claim 5, where the hematocrit measuring device is used to verify that the line is sufficiently clear of saline (by comparing the current measurement of Hct to a previous or baseline value) in steps (a) and/or steps (c).

7. The system of claim 4, where the quantitative vials are sterile, and blood is returned to the patient after it has passed through the quantitative vial after steps (a) and/or steps (c).

8. The system of claim 4, where the drawing of blood in steps (a) and/or steps (c) is accomplished by means of an automated pump that is controlled by the analyzer system.

9. The system of claim 1, where interim results from step (e) are reported at the user interface immediately after the first sample is counted in step (c), and updated after each iteration of step (c).

10. The system of claim 1, where the injectate in step (b) is contained in an identical quantitative vial and is measured in the detector before the injection to determine the quantity of injectate.

11. The system of claim 1, where a calibrated standard is prepared by precise dilution into a known volume of injectate from the same manufacturing lot as the injectate in step (b), is contained in a dimensionally identical quantitative vial, and is measured in the detector to determine the quantity of injectate.

12. The system of claim 1, where the analyzer is a handheld device containing a detector module and a touchscreen interface, with an associated charging base.

14. A method of measuring the blood volume of a subject using the system of claim 1, the method comprising the steps of:

a. measuring a flow-through quantitative blood collection vial containing whole blood from the subject in the concentration counter to determine a background count;

b. injecting the subject with a precise, known volume of tracer;

c. at one or more timed intervals after the injection, drawing blood from the subject into a quantitative flow-through vial, and counting said blood in the detector; and

d. calculating a blood volume (BV), plasma volume (PV), and red cell volume (RCV) for the patient.

15. The method of claim 14, using in addition a kit consisting of a number of dimensionally equivalent quantitative vials, where one of the vials contains an injectate used in step (14)(b), and the injectate vial is measured directly in the analyzer to determine the precise volume of tracer injected in step (14)(b).

16. The method of claim 14, using in addition a kit consisting of a number of dimensionally equivalent quantitative vials, where one of the vials contains an injectate used in step (14)(b), and one of the vials contains a calibrated standard prepared (by precise dilution into a known volume) from the same manufacturing lot as the injectate, where the standard vial is measured in the detector before the injection to determine the precise volume of tracer injected in step (14)(b).

17. The method of claim 14, where a barcode reader operatively connected to or integrated with the analyzer is used to facilitate the method, by ensuring that standard and injectate bear the same matching identification, and allowing the standard to be optionally counted (with the results stored in the analyzer, or in a data store operatively connected to the analyzer) prior to any interaction with a subject, shortening the time necessary to achieve a measurement.

13. The system of claim 13, where the analyzer includes an integrated barcode reader capable of reading codes on vials.