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1. (WO2019067222) SYSTEM AND METHOD FOR DIALYZER EVALUATION
注意: このテキストは、OCR 処理によってテキスト化されたものです。法的な用途には PDF 版をご利用ください。

CLAIMS

1. A system for evaluating a dialyzer, the system comprising:

a blood source;

a first portion of tubing, configured to connect the blood source to an input of the dialyzer;

a second portion of tubing, configured to connect to an output of the dialyzer;

a pump, configured to pump blood from the blood source through the first portion of tubing into the dialyzer, and out of the dialyzer into the second portion of tubing; and

a first blood chamber or port, disposed along the first portion of tubing, and a second blood chamber or port, disposed along the second portion of tubing, wherein the first blood chamber or port and the second blood chamber or port are configured to facilitate hematocrit measurement.

2. The system according to claim 1, further comprising:

a controller configured to determine a red blood volume loss corresponding to the dialyzer, the controller configured to determine the red blood volume loss using hematocrit associated with the input of the dialyzer, hematocrit associated with the output of the dialyzer, a flowrate of blood through the first portion of tubing, and a flowrate of blood through the second portion of tubing.

3. The system according to claim 2, wherein the controller determines the flowrate of blood through the first portion of tubing through a calibrated pumping rate of the pump.

4. The system according to claim 2, wherein the controller determines one of: the flowrate of blood through the first portion of tubing with the flowrate of blood through the second portion of tubing and an ultrafiltration rate; or

the flowrate of blood through the second portion of tubing with the flowrate of blood through the first portion of tubing and an ultrafiltration rate.

5. The system according to claim 4, wherein dialysate ports of the dialyzer are blocked, the blocked dialysate ports configuring the ultrafiltration rate to be 0.

6. The system according to claim 2, further comprising at least one of:

a first flowmeter coupled to the first portion of tubing, the first flowmeter configured to determine the flowrate of blood through the first portion of tubing; or

a second flowmeter coupled to the second portion of tubing, the second flowmeter configured to determine the flowrate of blood through the second portion of tubing.

7. The system according to claim 1, further comprising:

a first sensor assembly coupled to the first blood chamber, the first sensor assembly configured to measure hematocrit associated with the input of the dialyzer; and

a second sensor assembly coupled to the second blood chamber, the second sensor assembly configured to measure hematocrit associated with the output of the dialyzer.

8. The system according to claim 1, wherein the blood source is selected from the group consisting of: an in vitro blood source in a blood container, an in vivo blood source from a patient.

9. A method for evaluating a dialyzer using a dialyzer test system connected to a dialyzer, the method comprising:

circulating, using a pump of the dialyzer test system, blood from a blood source through the dialyzer; and

determining, using the dialyzer test system, a red blood volume loss corresponding to the dialyzer, wherein determining the red blood volume loss includes:

(a) determining a blood flowrate corresponding to an input side of the dialyzer via a calibrated pumping rate of the pump or an input flowmeter of the dialyzer test system;

(b) determining a hematocrit corresponding to the input side of the dialyzer via a first sensor assembly of the dialyzer test system attached to a first blood chamber of the dialyzer test system, wherein the first sensor clip assembly and the first blood chamber are disposed on the input side of the dialyzer;

(c) determining a blood flowrate corresponding to an output side of the

dialyzer via an ultrafiltration rate and the blood flowrate corresponding to an input side of the dialyzer; and

(d) determining a hematocrit corresponding to the output side of the dialyzer via a second sensor clip assembly of the dialyzer test system attached to a second blood chamber of the dialyzer test system, wherein the second sensor clip assembly and the second blood chamber are disposed on the output side of the dialyzer.

10. The method according to claim 9, wherein determining the blood volume loss further comprises:

(e) determining, using a controller of the dialyzer system, a difference in red blood cell volume between the input side of the dialyzer and the output side of the dialyzer according to the hematocrit corresponding to the output side of the dialyzer, the hematocrit corresponding to the input side of the dialyzer, the blood flowrate corresponding to the input side of the dialyzer, and the blood flowrate corresponding to the output side of the dialyzer.

11. The method according to claim 10, wherein determining the blood volume loss further comprises:

repeatedly performing steps (a) to (e) multiple times to obtain multiple differences in red blood cell volume; and

accumulating the multiple differences in red blood cell volume to obtain the blood volume loss in the dialyzer.

12. The method according to claim 11, wherein accumulating the multiple differences in red blood cell volume comprises:

multiplying each difference in red blood cell volume in the multiple differences in red blood cell volume by a respective time slice to obtain multiple time period residual loss of blood; and

summing the multiple time period residual loss of blood to obtain the accumulated red blood loss in the dialyzer.

13. The method according to claim 11, wherein accumulating the multiple differences in red blood cell volume comprises:

determining, through mathematical regression, a function relating difference in red blood cell volume between the input port and the output port and time; and

integrating the function over a time interval of interest.

14. The method according to claim 9, further comprising:

determining, using the dialyzer test system, a red blood volume loss corresponding to a second dialyzer;

determining, using the controller of the dialyzer test system, that the red blood volume loss corresponding to the dialyzer is greater than the red blood volume loss corresponding to the second dialyzer; and

determining that the second dialyzer is of higher quality than the dialyzer.

15. A method for evaluating a dialyzer using a dialyzer test system connected to a dialyzer, the method comprising:

circulating, using a pump of the dialyzer test system, blood from a blood source through the dialyzer; and

determining, using the dialyzer test system, a red blood volume loss corresponding to the dialyzer, wherein determining the red blood volume loss includes:

(a) determining a blood flowrate corresponding to an input side of the dialyzer by via a calibrated pumping rate of the pump or an input flowmeter of the dialyzer test system;

(b) determining a hematocrit corresponding to the input side of the dialyzer based on blood drawn from a first port of the dialyzer test system, wherein the first port is on the input side of the dialyzer;

(c) determining a blood flowrate corresponding to an output side of the

dialyzer via an ultrafiltration rate and the blood flowrate corresponding to an input side of the dialyzer; and

(d) determining a hematocrit corresponding to the output side of the dialyzer based on blood drawn from a second port of the dialyzer test system, wherein the second port is on the input side of the dialyzer.

16. The method according to claim 15, wherein determining the blood volume loss further comprises:

(e) determining, using a controller of the dialyzer system, a difference in red blood cell volume between the input side of the dialyzer and the output side of the dialyzer according to the hematocrit corresponding to the output side of the dialyzer, the hematocrit corresponding to the input side of the dialyzer, the blood flowrate corresponding to the input side of the dialyzer, and the blood flowrate corresponding to the output side of the dialyzer.

17. The method according to claim 16, wherein determining the blood volume loss further comprises:

repeatedly performing steps (a) to (e) multiple times to obtain multiple differences in red blood cell volume; and

accumulating the multiple differences in red blood cell volume to obtain the blood volume loss in the dialyzer.

18. The method according to claim 17, wherein accumulating the multiple differences in red blood cell volume comprises:

multiplying each difference in red blood cell volume in the multiple differences in red blood cell volume by a respective time slice to obtain multiple time period residual loss of blood; and

summing the multiple time period residual loss of blood to obtain the accumulated red blood loss in the dialyzer.

19. The method according to claim 17, wherein accumulating the multiple differences in red blood cell volume comprises:

determining, through mathematical regression, a function relating difference in red blood cell volume between the input port and the output port and time; and

integrating the function over a time interval of interest.

20. The method according to claim 15, further comprising:

determining, using the dialyzer test system, a red blood volume loss corresponding to a second dialyzer;

determining, using the controller of the dialyzer test system, that the red blood volume loss corresponding to the dialyzer is greater than the red blood volume loss corresponding to the second dialyzer; and

determining that the second dialyzer is of higher quality than the dialyzer.