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

• US 6,585,675 B1
• Filed: 11/02/2000
• Issued: 07/01/2003
• 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, Rychlick, Edward G., OʼMahony, John J.
• Primary Examiner(s): Doerrler, William C.
• Assistant Examiner(s): Zec, Filip
• Application Number:
  US09/703,702
• Time in Patent Office: 971 Days
• Field of Search: 604/4.01
• US Class Current: 604/4.01
• 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 extracorporcal circuit coupled to a blood pump 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 continues manner;

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

c. interrupting the continuous step (a), and temporarily reversing the blood pump to reverse a flow of the blood to infuse blood from the circuit into the withdrawal blood vessel after step (b), and

d. resuming step (a) after step (c).

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

3. A method for controlling blood flow as in claim 1 wherein blood flow is reversed after the blood flow is substantially reduced during step (a).

4. A method for controlling blood flow as in claim 1 wherein blood flow is reversed after the blood flow is substantially reduced to zero flow during step (a).

5. A method for controlling blood flow as in claim 1 wherein blood flow is reversed after the withdrawal blood vessel collapses.

6. A method for controlling blood flow as in claim 1 wherein the flow is temporarily reversed after an occlusion has been detected in the withdrawal blood vessel.

7. A method for controlling blood flow as in claim 1 wherein the blood flow is reversed for a predetermined duration.

8. A method for controlling blood flow as in claim 1 wherein the reversed blood flow has a predetermined flow rate.

9. A method for controlling blood flow as in claim 8 wherein the flow rate is substantially less than the flow rate during step (a) and prior to step (b).

10. A method for controlling blood flow as in claim 1 wherein the step (a) is resumed after step (c) when a flow capacity of the withdrawal blood vessel substantially increases.

11. A method for controlling blood flow as in claim 1 further comprising gradually reducing blood flow prior to step (b).

36. A method as in claim 1 wherein the extracorporeal circuit includes a blood filter and the flow reversal includes reversing a flow of blood through the filter.

37. A method as in claim 1 wherein the blood pump is a rotating roller pump, and reversing the blood pump includes reversing a rotational direction of the roller pump.

38. A method as in claim 1 wherein the reversal of flow of blood includes reversing the flow of blood throughout the extracorporeal circuit.

12. A method of controlling an extracorporeal circuit having a blood pump comprising:

a. withdrawing blood from a withdrawal blood vessel in a patient into the extracorporeal circuit, filtering the blood in a blood filter and infusing the filtered blood into the patient in a continuous manners

b. determining a withdrawal blood pressure in the extracorporeal circuit;

c. withdrawing blood at a flow rate based on an algorithm executed by the blood pump that correlates the flow rate to the withdrawal blood pressure;

d. interrupting step (a) to temporarily reverse the blood pump to reverse blood flow to infuse blood from the circuit into the withdrawal blood vessel if the flow rate determined in step (c) is reduced to below a predetermined limit, and resuming step (a) after step (d).

13. A method of controlling an extracorporeal blood circuit as in claim 12 wherein the predetermined limit is a blood flow rate of substantially zero.

14. A method of controlling an extracorporeal blood circuit as in claim 12 further comprising:

e. detecting an occlusion which at least partially blocks the withdrawal of blood from the patient, and

f. temporarily reversing a flow of the blood to infuse blood from the circuit into the withdrawal blood vessel if a pump controller executing an algorithm of withdrawal pressure as a function of is unsuccessful in maintaining significant blood flow.

39. A method as in claim 12 wherein the extracorporeal circuit includes a blood filter and the flow reversal includes reversing a flow of blood through the filter.

40. A method as in claim 12 wherein the blood pump is a rotating roller pump, and reversing the blood pump includes reversing a rotational direction of the roller pump.

41. A method as in claim 12 wherein the reversal of flow of blood includes reversing the flow of blood throughout the extracorporeal circuit.

15. A method for controlling withdrawal of blood from a patient into an extracorporeal circuit which continuously withdraws blood from a patient, processes the blood and infuses the processed blood into the patient, and allowing for detection of and recovery from a reduced flow capacity or total occlusion of a withdrawal blood vessel, comprising:

a. reducing blood flow being withdrawn from the patient when a withdrawal pressure of the blood in the circuit becomes more negative than an occlusion limit that is a function of blood flow through the circuit, and

b. if the reduced blood flow is reduced below a predetermined minimal flow during step (a), then interrupting the continuous withdrawal, processing and infusion of blood, to temporarily reverse the blood pump to reverse the flow of blood in the circuit and infusing blood into the withdrawal blood vessel.

16. A method as in claim 15 further comprising:

c. prior to step (a), increasing a rate of blood being withdrawn until the withdrawal blood vessel begins to collapse and occlude blood withdrawal;

d. prior to step (a), determining an occlusion withdrawal pressure corresponding to collapse of the vessel,

e. initiating step (b) when the collapse withdrawal pressure is detected.

17. A method as in the claim 16 wherein the collapse withdrawal pressure is a variable and a function of withdrawal blood flow.

18. A method as in claim 16 wherein the collapse withdrawal pressure is periodically reestablished by stopping the blood flow through the circuit pump and then performing steps (c), (d) and (e).

42. A method as in claim 15 wherein the extracorporeal circuit includes a blood filter and the flow reversal includes reversing a flow of blood through the filter.

43. A method as in claim 15 wherein the blood pump is a rotating roller pump, and reversing the blood pump includes reversing a rotational direction of the roller pump.

44. A method as in claim 15 wherein the reversal of flow of blood includes reversing the flow of blood throughout the extracorporeal circuit.

19. A system for controlling blood flow withdrawn from a patient comprising:

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

a pressure sensor coupled to said withdrawal tube and sensing a blood pressure in the withdrawal tube;

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

a pump controller receiving a blood pressure signal from the pressure sensor and controlling the pump to regulate the controlled flow rate, wherein the pump controller includes a processor and a memory storing a control algorithm of a variable withdrawal pressure target as a function of flow rate, said controller reduces the controlled flow rate based on a difference between a withdrawal pressure sensed by the pressure sensor and the withdrawal pressure target, and said controller reverses the pump to infuse blood into the patient through the withdrawal tube if the controlled flow rate is reduced below a predetermined limit.

20. A system as in claim 19 wherein the pump controller includes a proportional integral feed forward pressure controller.

21. A system as in claim 19 wherein the treatment device is a hemofilter.

22. A system as in claim 19 wherein the treatment device is a dialysis device.

23. A system as in claim 19 wherein the pressure sensor is a real time sensor providing real time pressure signals to the pump controller.

24. A system as in claim 19 wherein the pump includes a direct DC drive motor.

25. A system as in claim 24 wherein the drive motor is a brushless motor.

26. A system as in claim 19 wherein the treatment device is a blood filter.

45. A system as in claim 19 wherein the extracorporeal circuit includes a blood filter, and the reversal of the pump reverses a flow of blood through the filter.

46. A system as in claim 19 wherein the blood pump is a rotating roller pump, and reversing the blood pump includes reversing a rotational direction of the roller pump.

27. A system for controlling blood flow withdrawn from a patient comprising:

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

a pressure sensor coupled to said withdrawal tube and sensing a blood pressure in the withdrawal tube;

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

a pump controller receiving a blood pressure signal from the pressure sensor and controlling the pump to regulate the controlled flow rate, wherein the pump controller includes a processor and a memory storing a control algorithm of a variable withdrawal pressure target as a function of flow rate, said controller reduces the controlled flow rate based on a difference between a withdrawal pressure sensed by the pressure sensor and the withdrawal pressure target, and said controller reverses blood flow to infuse blood into the patient through the withdrawal tube if the controlled flow rate is reduced below a predetermined limit

wherein the pump controller alternatively controls a withdrawal pressure and an infusion pressure by synchronized switching.

28. A method for controlling blood flow in a closed loop extracorporeal blood circulation system where blood is withdrawn and returned into a blood vessel in the same body in the process of treatment comprising:

a. withdrawing blood from a blood vessel of the patient at a controlled flow rate;

b. measuring a withdrawal pressure of the withdrawn blood;

c. infusing the withdrawn blood into the patient;

e. measuring the infusion pressure of the blood;

f. comparing the withdrawal pressure to a withdrawal pressure target, and comparing the infusion pressure to an infusion pressure target;

g. adjusting the flow rate to reduce a difference between the withdrawal pressure and a withdrawal pressure target, if the infusion pressure is less than an infusion pressure target, and

h. adjusting the flow rate to reduce a difference between the infusion pressure and an infusion pressure target, if the infusion pressure is greater than the infusion pressure target.

29. A method as in claim 28 wherein step (h) includes applying a difference between the infusion pressure and the infusion pressure target as feedback to adjust the flow rate of the blood being withdrawn.

30. A method as in claim 28 wherein the blood is withdrawn through a withdrawal needle and infused through an infusion needle.

31. A method as in claim 30 wherein the blood is withdrawn through a needle and infused through said needle.

32. A method as in 28 wherein blood is withdrawn from and infused into a peripheral vein of a patient.

33. A method for limiting pump pressure in an extracorporeal blood circuit coupled to a pump driven by a direct DC drive motor, wherein the method comprises:

a. measuring current used by the motor,

b. limiting pressure in said blood circuit by controlling said current, and

c. controlling the current based on a difference between a measured blood pressure in the circuit and a pressure target.

34. A method for controlling blood infusion into a mammalian patient in an air-free extracorporeal blood circuit comprising:

a. infusing blood from the circuit into a blood vessel of the patient at a controlled infusion flow rate;

b. measuring an infusion pressure of the blood being infused;

c. comparing the measured infusion pressure to a disconnect pressure target;

d. sensing for air in the blood being infused;

e. generating a disconnection alarm if both the measured infusion pressure is no greater than the disconnect pressure target and air is sensed in the blood being infused.

35. A method for controlling blood infusion as in claim 34, further comprising the step of reducing a rate of infusing blood if the measured infusion pressure is greater than the disconnect pressure target and air is not sensed in the blood being infused.

47. A method for automatically controlling blood flow through an extracorporeal circuit coupled to a blood pump and a controller, said method comprising:

a. withdrawing the blood from a withdrawal blood vessel in a patient into the extracorporeal circuit;

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

c. the controller automatically and temporarily ceasing the blood pump to temporarily cease a flow of the blood being withdraw after step (b), and

d. the controller automatically resuming the pump and the flow of blood being withdrawn after a predetermined period of time.

48. A method for controlling blood flow as in claim 47 wherein the occlusion is detected based on a pressure measurement of the blood flowing in the circuit and made by the controller based on a pressure sensor in the blood circuit.

49. A method for controlling blood flow as in claim 47 wherein blood flow is temporarily ceased after the blood flow is substantially reduced during step (a).

50. A method for controlling blood flow as in claim 47 wherein the blood flow is temporarily ceased after the withdrawal blood vessel collapses.

51. A method for controlling blood flow as in claim 47 wherein the flow is temporarily ceased after an occlusion has been detected in the withdrawal blood vessel.

52. A method for controlling blood flow as in claim 47 wherein the blood flow is reversed for a predetermined duration of no more than two seconds.

53. A method for controlling blood flow as in claim 47 further comprising gradually reducing blood flow prior to step (b).

54. A method of controlling an extracorporeal blood circuit having a blood pump and a pump controller comprising:

a. withdrawing blood from a withdrawal blood vessel in a patient into the extracorporeal circuit;

b. determining a withdrawal blood pressure in the extracorporeal circuit;

c. withdrawing blood at a flow rate determined by the blood pump controller;

d. the pump controller automatically and temporarily ceasing the blood pump to cease the withdrawal of blood from the withdrawal blood vessel if the pressure determined in step (b) reduces to below a predetermined limit, and

e. the pump controller automatically restarting the blood pump to resume the withdrawal of blood from the withdrawal blood vessel.