IP Library Granted Patent US 9,022,966
Granted Patent B2
US 9,022,966 · App. 13/174,192 · Granted May 5, 2015

Regional citrate anticoagulation

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Quick Facts
Patent No.
US 9,022,966
App. No.
13/174,192
Granted
May 5, 2015
Kind
B2
Abstract

A system or method automates and optimizes citrate anticoagulant supplementation in a blood filtration circuit during CRRT. A processor-based control system interfaces with a blood filtration circuit to detect patient blood flow into the circuit, detect fluid loss through a hemofilter, and sense vital electrolyte concentrations in the blood flow, and in response, control the addition of citrate, substitution fluid, and electrolyte supplements to ensure stability of plasma concentrations in post-dilution flow returned to the patient. The controller executes the method embodied as process control algorithms for calculating an optimal citrate flow rate as a function of selected, detected, and calculated system parameters. Citrate may be added to the circuit separately, or as part of a substitution solution or a dialysate.

Claims (70)

1. A blood filtration system, comprising:

a filtration circuit including a filter having a dialysis solution chamber;

a blood pump configured to pump blood through the filtration circuit;

a source of citrate anticoagulant solution having a predetermined citrate anticoagulant solution concentration;

a citrate anticoagulant pump positioned and arranged to pump citrate anticoagulant solution from the citrate anticoagulant solution source into the filtration circuit;

a dialysis solution pump positioned and arranged to pump a citrate dialysis solution into the dialysis solution chamber of the filter;

a controller configured to control the citrate anticoagulant pump to control the flow rate of the citrate anticoagulant solution from the citrate anticoagulant pump according to an algorithm that takes into account at least:

(i) a blood flow rate,

(ii) a concentration of the citrate anticoagulant solution, and

(iii) an electrolyte concentration; and

an electrolyte sensor that detects an configured to detect the electrolyte concentration, wherein

the controller includes a processor that is configured to receive an input from the electrolyte sensor that represents the detected electrolyte concentration.

2. The system of claim 1 , wherein the controller further includes:

software, executable by the processor, for executing the algorithm.

3. The system of claim 1 , which includes a blood flow detector for detecting a flow of blood from the patient, and wherein the controller controls a flow from the citrate anticoagulant pump as a function of the detected blood flow rate, and the concentration of the citrate anticoagulant solution.

4. The system of claim 1 , wherein the electrolyte sensor detects concentration in the blood flow of an ion selected from the group consisting of bicarbonate, calcium, chloride, copper, glucose, iron, magnesium, manganese, phosphate, potassium, sodium, and zinc.

5. The system of claim 4 , wherein the algorithm includes a citrate anticoagulant pump flow rate, E, determined according to E(A, B, C, D)=Ax(B+D)/C, wherein A is a detected blood flow rate, B is a calcium ion concentration detected by the electrolyte sensor, C is the concentration of the citrate solution, and D is a magnesium ion concentration detected by the electrolyte sensor.

6. The system of claim 1 , further comprising:

a blood flow detector for detecting a flow of blood from the patient;

a sensor for detecting fluid loss rate in the blood filtration circuit;

an electrolyte solution having a selected calcium ion concentration and a selected magnesium ion concentration; and

an electrolyte pump positioned and arranged to pump the electrolyte solution to supplement post-filtration blood flow, wherein

the controller controls the flow from the electrolyte pump as a function of the detected blood flow, the detected fluid loss rate, the selected calcium ion concentration, and the selected magnesium ion concentration.

7. The system of claim 1 , wherein the controller further includes:

software, executable by the processor, (i) for accepting a detected fluid loss rate in the blood filtration circuit, (ii) for determining a desired citrate anticoagulant pump flow rate and a desired electrolyte pump flow rate, and (iii) for calculating an ultrafiltration rate as a function of the detected fluid loss rate, the desired citrate anticoagulant pump flow rate, and the desired electrolyte pump flow rate.

8. The system of claim 7 , wherein

the citrate anticoagulant solution has a selected trisodium citrate concentration, the system further including;

a substitution solution having a selected sodium concentration;

a substitution solution pump positioned and arranged to pump the substitution solution to supplement the blood flow;

a sensor for detecting substitution solution flow rate; and

the controller is further configured to determine a post-dilution flow rate as a function of the detected blood flow rate, the selected trisodium citrate concentration, the calculated ultrafiltration rate, the selected sodium concentration of the substitution solution, and the detected substitution solution flow rate.

9. The system of claim 1 , which is configured to use the citrate anticoagulant solution to supplement the blood flow as a pre-dilution solution in the blood filtration circuit.

10. The system of claim 1 , wherein the citrate anticoagulant solution enters the blood filtration circuit as part of a dialysate.

11. The system of claim 1 , which includes a source of citrate dialysis solution.

12. The system of claim 11 , wherein the citrate dialysis solution is pumped from the source of citrate dialysis solution with the dialysis solution pump.

13. A blood filtration system comprising:

a filter including a dialysis solution chamber;

a blood pump configured to pump blood to the filter;

a supply of citrate anticoagulant solution;

a citrate anticoagulant pump connected to the supply of citrate anticoagulant solution, the citrate anticoagulant pump positioned and arranged to pump the citrate anticoagulant solution into the filter;

a dialysis solution pump positioned and arranged to pump a dialysis solution including citrate into the dialysis solution chamber of the filter to filter the blood; and

a controller configured to control the citrate anticoagulant pump to control the flow rate of citrate anticoagulant solution from the citrate anticoagulant pump according to an algorithm that takes into account at least one of:

(i) a blood flow rate,

(ii) a concentration of the citrate anticoagulant solution, and

(iii) an electrolyte concentration; and

an electrolyte sensor configured to detect the electrolyte concentration, wherein

the controller includes a processor that is configured to receive an input from the electrolyte sensor that represents a detected electrolyte concentration.

14. The system of claim 13 , wherein the controller further includes:

software, executable by the processor, for determining a desired flow of citrate anticoagulant solution from the supply of citrate anticoagulant solution.

15. The system of claim 13 , which includes a blood flow detector for detecting a flow of blood from the patient, and wherein the controller controls the flow from the citrate anticoagulant pump as a function of the detected blood flow rate and the concentration of the citrate anticoagulant solution.

16. The system of claim 13 , wherein the electrolyte sensor detects concentration in the blood flow of an ion selected from the group consisting of bicarbonate, calcium, chloride, copper, glucose, iron, magnesium, manganese, phosphate, potassium, sodium, and zinc.

17. The system of claim 16 , wherein the algorithm includes a citrate anticoagulant pump flow rate, E, determined according to E(A, B, C, D)=Ax(B+D)/C, wherein A is a detected blood flow rate, B is a calcium ion concentration detected by the electrolyte sensor, C is the concentration of the citrate solution, and D is a magnesium ion concentration detected by the electrolyte sensor.

18. The system of claim 13 , which includes:

a blood flow detector for detecting a flow of blood from the patient;

a sensor for detecting fluid loss rate in a blood filtration circuit including the filter;

an electrolyte solution having a selected calcium ion concentration and a selected magnesium ion concentration; and

an electrolyte pump positioned and arranged to pump the electrolyte solution to supplement post-filtration blood flow, wherein

the controller controls the flow from the electrolyte pump as a function of the detected blood flow, the detected fluid loss rate, the selected calcium ion concentration, and the selected magnesium ion concentration.

19. The system of claim 18 , wherein the controller further includes:

software, executable by the processor, for (i) accepting a detected fluid loss rate in a blood filtration circuit including the blood filter, (ii) determining a desired citrate anticoagulant pump flow rate and a desired electrolyte pump flow rate, and (iii) for calculating an ultrafiltration rate as a function of the detected fluid loss rate, the desired citrate anticoagulant pump flow rate, and the desired electrolyte pump flow rate.

20. The system of claim 19 , further comprising:

the citrate solution having a selected trisodium citrate concentration;

a substitution solution having a selected sodium concentration;

a substitution solution pump causing flow of the substitution solution supplementing the blood flow; and

a sensor for detecting substitution solution flow rate, wherein

the controller further determines a post-dilution flow rate as a function of the detected blood flow rate, the selected trisodium citrate concentration; the calculated ultrafiltration rate, the selected sodium concentration of the substitution solution, and the detected substitution solution flow rate.

21. The system of claim 13 , wherein the citrate anticoagulant solution supplements the blood flow as a pre-dilution solution in the blood filtration circuit.

22. The system of claim 13 , wherein the citrate solution enters the blood filtration circuit as part of a dialysate.

23. The system of claim 13 , which includes a supply of citrate dialysis solution.

24. The system of claim 23 , wherein the dialysis solution including citrate is pumped from the supply of citrate dialysis solution with the dialysis solution pump.

Assignments (4)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 28, 2025
From: NIKKISO CO., LTD.
To: TYHC INTERNATIONAL PTE. LTD.
Reel/Frame 070368/0127 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 10, 2014
From: BAXTER HEALTHCARE SA; BAXTER INTERNATIONAL INC.
To: NIKKISO CO., LTD.
Reel/Frame 032210/0629 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 21, 2011
From: LANNOY, JEAN-MICHEL
To: EDWARDS LIFESCIENCES CORPORATION
Reel/Frame 026943/0674 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 21, 2011
From: EDWARDS LIFESCIENCES CORPORATION
To: BAXTER INTERNATIONAL INC.; BAXTER HEALTHCARE S.A.
Reel/Frame 026943/0734 →