System and method for dialyzer evaluation

Patent metadata

Field	Value
Publication number	US-11141515-B2
Application number	US-202016943794-A
Country	US
Kind code	B2
Filing date	Jul 30, 2020
Priority date	Sep 29, 2017
Publication date	Oct 12, 2021
Grant date	Oct 12, 2021

Abstract

Embodiments of the disclosure provide a method for evaluating dialyzers used in different medical applications (e.g., hemodialysis). Red blood cell volume lost in a dialyzer is monitored by obtaining blood flowrate measurements and hematocrit measurements at input ports and output ports of the dialyzer. The flowrate and hematocrit measurements are used to determine an accumulation of red cell blood volume in the dialyzer. The measurements may be obtained in a lab environment with an in-vitro blood source or may be obtained in a clinical setting with an in-vivo blood source from a patient.

First claim

The invention claimed is:

1. A system, comprising:
a first sensor connected to a first portion of a blood flow path disposed on an input side of a dialyzer, wherein the first sensor is configured to obtain measurements relating to a characteristic of blood in the first portion of the blood flow path;
a second sensor connected to a second portion of the blood flow path disposed on an output side of the dialyzer, wherein the second sensor is configured to obtain measurements relating to a characteristic of blood in the second portion of the blood flow path; and
a controller configured to determine a red blood cell volume loss corresponding to an amount of red blood cells remaining in the dialyzer based on the measurements from the first and second sensors.

2. The system according to claim 1 , wherein the measurements relating to the characteristic of the blood in the first portion of the blood flow path are hemoglobin measurements, and the measurements relating to the characteristic of the blood in the second portion of the blood flow path are hemoglobin measurements.

3. The system according to claim 1 , wherein a flowrate of the blood in the first portion of the blood flow path is equal to a flowrate of the blood in the second portion of the blood flow path.

4. The system according to claim 1 , wherein the controller is further configured to determine a flowrate of the blood in the first portion of the blood flow path;
wherein determining the red blood cell volume loss is further based on the determined flowrate of the blood in the first portion of the blood flow path.

5. The system according to claim 4 , wherein the flowrate of the blood in the first portion of the blood flow path is equal to a flowrate of the blood in the second portion of the blood flow path;
wherein the controller is further configured to:
determine an input red blood cell volume flow and an output red blood cell volume flow based on a measurement from the first sensor, a measurement from the second sensor, and the flowrate; and
determine a difference ΔR between the input red blood cell volume flow and the output red blood cell volume flow; and

wherein determining the red blood cell volume loss is further based on using one or more ΔR values over a period of time to determine an accumulated red blood cell volume loss value.

6. The system according to claim 4 , wherein determining the flowrate of the blood in the first portion of the blood flow path is based on a pumping rate of a pump configured to pump the blood in the first portion of the blood flow path into the dialyzer.

7. The system according to claim 4 , further comprising:
a flowmeter coupled to the first portion of the blood flow path;
wherein the controller is configured to determine the flowrate of the blood in the first portion of the blood flow path using the flowmeter.

8. The system according to claim 1 , wherein the controller is further configured to:
determine a flowrate of the blood in the first portion of the blood flow path;
determine a flowrate of the blood in the second portion of the blood flow path;
determine an input red blood cell volume flow corresponding to blood flowing into the dialyzer based on a measurement from the first sensor and the flowrate of the blood in the first portion of the blood flow path;
determine an output red blood cell volume flow corresponding to blood flowing out of the dialyzer based on a measurement from the second sensor and the flowrate of the blood in the second portion of the blood flow path; and
determine a difference ΔR between the input red blood cell volume flow and the output red blood cell volume flow; and
wherein determining the red blood cell volume loss is further based on using one or more ΔR values over a period of time to determine an accumulated red blood cell volume loss value.

9. The system according to claim 8 , wherein determining the flowrate of the blood in the second portion of the blood flow path is based on an ultrafiltration rate and the flowrate of the blood in the first portion of the blood flow path.

10. The system according to claim 1 , wherein the controller is further configured to output a rating for the dialyzer based on the red blood cell volume loss.

11. The system according to claim 1 , wherein the controller is further configured to output a comparison of the dialyzer to one or more other dialyzers based on respective red blood cell volume losses determined for each dialyzer.

12. The system according to claim 1 , wherein the first and second sensors are hematocrit measurement devices.

13. A system, comprising:
a first port disposed in a first portion of a blood flow path disposed on an input side of a dialyzer, wherein the first port is configured to permit blood to be drawn from the first portion of the blood flow path;
a second port disposed in a second portion of the blood flow path disposed on an output side of the dialyzer, wherein the second port is configured to permit blood to be drawn from the second portion of the blood flow path; and
a controller configured to determine a red blood cell volume loss corresponding to an amount of red blood cells remaining in the dialyzer based on measurements relating to a characteristic of blood in the first portion of the blood flow path and measurements relating to a characteristic of blood in the second portion of the blood flow path, wherein the measurements relating to the characteristic of the blood in the first portion of the blood flow path correspond to blood drawn from the first portion of the blood flow path, and wherein the measurements relating to the characteristic of the blood in the second portion of the blood flow path correspond to blood drawn from the second portion of the blood flow path.

14. The system according to claim 13 , wherein the measurements relating to the characteristic of the blood in the first portion of the blood flow path are hemoglobin measurements, and the measurements relating to the characteristic of the blood in the second portion of the blood flow path are hemoglobin measurements.

15. The system according to claim 13 , wherein the measurements relating to the characteristic of the blood in the first portion of the blood flow path are hematocrit measurements, and the measurements relating to the characteristic of the blood in the second portion of the blood flow path are hematocrit measurements.

16. The system according to claim 13 , wherein a flowrate of the blood in the first portion of the blood flow path is equal to a flowrate of the blood in the second portion of the blood flow path.

17. The system according to claim 13 , wherein the controller is further configured to: determine a flowrate of the blood in the first portion of the blood flow path; and
wherein determining the red blood cell volume loss is further based on the determined flowrate of the blood in the first portion of the blood flow path.

18. The system according to claim 17 , wherein the flowrate of the blood in the first portion of the blood flow path is equal to a flowrate of the blood in the second portion of the blood flow path;
wherein the controller is further configured to:
determine an input red blood cell volume flow and an output red blood cell volume flow based on a measurement corresponding to the blood in the first portion of the blood flow path, a measurement corresponding to the blood in the second portion of the blood flow path, and the flowrate; and
determine a difference ΔR between the input red blood cell volume flow and the output red blood cell volume

Assignees

• Fresenius Medical Care Holdings Inc

Inventors

• Barrett Louis Leegrande
• Ho Chih-Hu
• Stroup Eric

Classifications

• B01D65/109

  Testing of membrane fouling or clogging, e.g. amount or affinity · CPC title

• A61M2205/702

  automatically during use · CPC title

• B01D61/22 Primary

  Controlling or regulating · CPC title

• A61M2230/207

  hematocrit · CPC title

• A61M2205/3334

  Measuring or controlling the flow rate · CPC title