System and method for dialyzer evaluation

Patent metadata

Field	Value
Publication number	US-10765792-B2
Application number	US-202016801666-A
Country	US
Kind code	B2
Filing date	Feb 26, 2020
Priority date	Sep 29, 2017
Publication date	Sep 8, 2020
Grant date	Sep 8, 2020

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 dialyzer analysis 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 a measurement corresponding to hematocrit 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 a measurement corresponding to hematocrit 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 controller is further configured to:
determine a flowrate of the blood in the first portion of the blood flow path; and
determine a flowrate of the blood in the second 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 and the determined flowrate of the blood in the second portion of the blood flow path.

3. The system according to claim 2 , wherein the controller is further configured to:
determine an input red blood cell volume flow corresponding to blood flowing into the dialyzer based on the 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 the 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;
wherein determining the red blood cell volume loss is further based on the difference ΔR.

4. The system according to claim 3 , 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.

5. The system according to claim 4 , wherein using one or more ΔR values over a period of time to determine an accumulated red blood cell volume loss value comprises:
multiplying each ΔR value by a respective time slice and summing respective red blood cell volume losses corresponding to each respective time slice.

6. The system according to claim 4 , wherein using one or more ΔR values over a period of time to determine an accumulated red blood cell volume loss value comprises:
determining a function for ΔR and integrating the function over the period of time.

7. The system according to claim 2 , 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.

8. The system according to claim 2 , 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.

9. The system according to claim 2 , further comprising:
a flowmeter coupled to the second portion of the blood flow path;
wherein the controller is configured to determine the flowrate of the blood in the second portion of the blood flow path using the flowmeter.

10. The system according to claim 2 , wherein the controller is further configured to:
determine the flowrate of the blood in the first portion of the blood flow path based on an ultrafiltration rate and the flowrate of the blood in the second portion of the blood flow path; or
determine the flowrate of the blood in the second portion of the blood flow path based on the ultrafiltration rate and the flowrate of the blood in the first portion of the blood flow path.

11. 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.

12. 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.

13. A method for dialyzer analysis, comprising:
obtaining, by a first sensor of a dialyzer analysis system connected to a first portion of a blood flow path disposed on an input side of a dialyzer, a measurement corresponding to hematocrit of blood in the first portion of the blood flow path;
obtaining, by a second sensor of the dialyzer analysis system connected to a second portion of the blood flow path disposed on an output side of the dialyzer, a measurement corresponding to hematocrit of blood in the second portion of the blood flow path; and
determining, by a controller of the dialyzer analysis system, 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.

14. The method according to claim 13 , further comprising:
determining a flowrate of the blood in the first portion of the blood flow path; and
determining a flowrate of the blood in the second 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 and the determined flowrate of the blood in the second portion of the blood flow path.

15. The method according to claim 14 , further comprising:
determining an input red blood cell volume flow corresponding to blood flowing into the dialyzer based on the measurement from the first sensor and the flowrate of the blood in the first portion of the blood flow path;
determining an output red blood cell volume flow corresponding to blood flowing out of the dialyzer based on the measurement from the second sensor and the flowrate of the blood in the second portion of the blood flow path; and
determining a difference ΔR between the input red blood cell volume flow and the output red blood cell volume flow;
wherein determining the red blood cell volume loss is further based on the difference ΔR.

16. The method according to claim 15 , 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.

17. A non-transitory computer-readable medium having processor-executable instructions stored thereon for dialyzer analysis, the processor-executable instructions, when executed, facilitating:
obtaining, by a first sensor of a dialyzer analysis system connected to a first portion of a blood flow path disposed on an input side of a dialyzer, a measurement corresponding to hematocrit of blood in the first portion of the blood flow path;
obtaining, by a second sensor of the dialyzer analysis system connected to a second portion of the blood flow path disposed on an output side of the dialyzer, a measurement corresponding to hematocrit of blood in the second portion of the blood flow path; and
determining, by a controller of the dialyzer analysis system, 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.

18. The non-transitor

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

• B01D2311/246

  Concentration control · CPC title

• B01D2311/16

  Flow or flux control · CPC title

• B01D61/22 Primary

  Controlling or regulating · CPC title

• A61M2209/02

  Equipment for testing the apparatus · CPC title