Method and apparatus for blood withdrawal and infusion using a pressure controller

• US 20050230313A1
• Filed: 06/17/2005
• Published: 10/20/2005
• Est. Priority Date: 11/02/2000
• Status: Active Grant

• Current Assignee: Gambro Lundia AB (Baxter International Inc.)
• Original Assignee: CHF Solutions, Inc.
• Inventors: Gelfand, Mark, O'Mahony, John J., Rychlick, Edward G.
• Granted Patent: US 7,462,161 B2
• Time in Patent Office: Days
• US Class Current: 210/645
• CPC Class Codes: A61M 1/1692 Detection of blood traces in dialysate
• CPC Class Codes: A61M 1/34 Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
• CPC Class Codes: A61M 1/341 by measuring the filtrate rate or volume
• CPC Class Codes: A61M 1/3639 Blood pressure control, pressure transducers specially adapted therefor
• CPC Class Codes: A61M 1/3656 Monitoring patency or flow at connection sites; Detecting disconnections
• CPC Class Codes: A61M 2205/15 Detection of leaks
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: B01D 61/22 Controlling or regulating

Abstract

A method and apparatus for controlling blood withdrawal and infusion flow rate with the use of a pressure controller. The pressure controller uses pressure targets based upon occlusion limits that are calculated as a function of flow. The controller has the ability to switch from controlling withdrawal pressure to controlling infusion pressure based upon the detection of an occlusion. The controller distinguishes between partial and total occlusions of the withdrawal vein providing blood access. Depending on the nature of occlusion, the controller limits or temporarily reverses blood flow and, thus, prevents withdrawal vessel collapse or reverses blood flow to quickly infuse blood into the vessel without participation from operator.

Claims

1. A method for controlling blood flow through an extracorporeal circuit coupled comprising:

a. continuously withdrawing the blood from a withdrawal blood vessel in a patient into the extracorporeal circuit, processing the blood in the circuit, and infusing the processed blood into the patient in a continuous manner;

b. detecting an occlusion which at least partially blocks the withdrawal of blood from the patient;

c. interrupting the continuous step (a), and automatically and temporarily ceasing the withdrawal of the blood to after step (b), and

d. resuming step (a) automatically after step (c) to resume withdrawal of the blood.

2. The method for controlling blood flow in claim 1 wherein the occlusion is detected based on a pressure measurement of the blood in the circuit.

3. The method for controlling blood flow in claim 1 wherein blood flow is ceased after the blood flow is reduced below a predetermined percentage limit of a maximum blood flow.

4. The method for controlling blood flow in claim 1 wherein blood flow is ceased after the blood flow is reduced below a predetermined flow condition during step (b).

5. The method for controlling blood flow in claim 4 wherein the blood flow is gradually reduced to maintain a pressure of the blood in the circuit above a withdrawal pressure target before temporarily ceasing blood flow.

6. The method for controlling blood flow in claim 5 wherein the maximum withdrawal pressure target varies from a lower negative pressure value at a minimal flow rate to a higher negative pressure value at a maximum high flow rate.

7. The method for controlling blood flow in claim 1 wherein blood flow is ceased for a period in a range of 0.1 to 60 seconds before being restarted.

8. The method for controlling blood flow in claim 1 wherein blood flow is ceased for a period in a range of 0.1 to 60 seconds after the occlusion is detected.

9. The method for controlling blood flow in claim 1 wherein the steps (a) to (d) are repeated and then the blood flow through the circuit is ceased and not automatically resumed.

10. The method for controlling blood flow in claim 1 wherein the circuit is coupled to a blood pump and the withdrawal of blood is ceased by stopping the pump.

11. A method to control blood flow in an extracorporeal blood system that withdraws blood from a vascular system of a patient, said method comprising:

a. withdrawing blood from the vascular system into the system;

b. determining a withdrawal pressure of the withdrawn blood;

c. comparing the withdrawal pressure to a withdrawal pressure target;

d. adjusting the flow rate if the withdrawal pressure is less than a withdrawal pressure target;

e. temporarily ceasing the flow if the adjusted flow rate becomes less than a predefined flow rate limit, and

f. automatically restarting the flow after the temporary cessation.

12. The method in claim 11 wherein the blood is withdrawn at a predefined maximum flow rate prior to adjusting the flow rate.

13. The method in claim 11 further comprising:

g. infusing the withdrawn blood from the system into the vascular system;

h. determining an infusion pressure of the blood being infused, and

i. adjusting the flow rate if the infusion pressure is greater than the infusion pressure target.

14. The method in claim 13 further comprising:

j. switching control of the flow rate adjustment from adjusting due to the withdrawal pressure being less than the withdrawal target to adjusting due to the infusion pressure being greater than the infusion pressure, and

k. applying substantially the same adjusted flow rate last used to control withdrawal pressure as the adjusted flow rate to begin control infusion pressure.

15. The method in claim 13 wherein the flow rate is at a predetermined maximum flow rate if the withdrawal pressure is above the withdrawal pressure target and the infusion pressure is below the infusion pressure target.

16. The method in claim 13 wherein the flow rate adjustment is a gradual reduction in flow rate.

17. The method in claim 13 wherein the flow rate is a flow rate set by a user of the system if the withdrawal pressure is above the withdrawal pressure target.

18. A system for controlling blood flow withdrawn from and infused back into a patient comprising:

an extracorporeal circuit having a blood passage including a blood withdrawal tube, a blood treatment device and an infusion tube;

a withdrawal pressure sensor sensing a blood pressure in the withdrawal tube and an infusion pressure sensor sensing a blood pressure in the infusion tube;

a pump coupled to the circuit and adapted to move blood through the circuit at a controlled flow rate, and

a pump controller receiving blood pressure signals from the withdrawal and infusion pressure sensors and using the pressure signals to control the pump to regulate the controlled flow rate, wherein the pump controller includes a processor and a memory storing a control algorithm of a withdrawal pressure target and an infusion pressure target, said controller reduces the controlled flow rate based on a difference between a withdrawal pressure sensed by the withdrawal pressure sensor and the withdrawal pressure target and based on a difference between an infusion pressure sensed by the infusion pressure sensor and the infusion pressure target.

19. The system of claim 18 wherein the control algorithm includes a predetermined maximum flow rate applied as the controlled flow rate when the withdrawal pressure is above the withdrawal pressure target and the infusion pressure is below the infusion pressure target.

20. The system of claim 19 wherein the predetermined maximum flow rate is selected by a user of the system.

21. The system of claim 18 wherein the withdrawal tube is connectable to a blood vessel.

22. The system of claim 18 wherein the infusion tube is connectable to a blood vessel.

23. The system of claim 18 wherein the pump controller includes a closed loop pressure controller with a predefined maximum flow rate.

24. The system of claim 23 wherein the predefined maximum flow rate is selected by a user of the system.

25. The system of claim 18 wherein the withdrawal pressure target varies with blood flow rate.

26. The system of claim 18 wherein the infusion pressure target varies with blood flow rate.

27. The system of claim 23 whereby the pump ceases flow for a duration of time when the flow rate is controlled below a percentage of the predefined maximum flow rate.

28. The system of claim 23 wherein the controller reverses the pump and thereby reverses the flow in the circuit if the controlled flow rate is reduced to below a predefined percentage of the predefined maximum flow rate.

29. The system of claim 18 wherein the controller reverses the pump and thereby reverses the flow in the circuit if the controlled flow rate is reduced to below a predefined condition stored in the controller, and further the withdrawal pressure target and infusion pressure target are inverted while flow is reversed.