Blood extraction and reinfusion flow control system and method

• US 5,178,603 A
• Filed: 07/24/1990
• Issued: 01/12/1993
• Est. Priority Date: 07/24/1990
• Status: Expired due to Term

• Current Assignee: Baxter International Inc.
• Original Assignee: Baxter International Inc.
• Inventors: Prince, Paul R.
• Primary Examiner(s): Pellegrino, Stephen C.
• Assistant Examiner(s): Lewis, Ralph A.
• Application Number:
  US07/556,778
• Time in Patent Office: 903 Days
• Field of Search: 604/30, 604/31, 604/65-67, 604/4-6, 604/50, 128/DIG. 12, 128/DIG. 13
• US Class Current: 604/6.01
• CPC Class Codes: A61M 1/262 rotating
• CPC Class Codes: A61M 1/30 Single needle dialysis ; Reciprocating systems, alternately withdrawing blood from and returning it to the patient, e.g. single-lumen-needle dialysis or single needle systems for hemofiltration or pheresis
• CPC Class Codes: A61M 1/303 having a reservoir for treated blood to be returned
• CPC Class Codes: A61M 1/308 Volume control, e.g. with open or flexible containers, by counting the number of pump revolutions, weighing
• CPC Class Codes: A61M 1/3621 Extra-corporeal blood circuits single-needle circuits A61M1/30
• CPC Class Codes: A61M 1/3639 Blood pressure control, pressure transducers specially adapted therefor
• CPC Class Codes: A61M 1/3643 Priming, rinsing before or after use
• CPC Class Codes: A61M 1/3644 Mode of operation
• CPC Class Codes: A61M 1/3656 Monitoring patency or flow at connection sites; Detecting disconnections
• CPC Class Codes: A61M 2205/3344 Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 2205/3351 Controlling upstream pump pressure
• CPC Class Codes: A61M 2205/3355 Controlling downstream pump pressure
• CPC Class Codes: A61M 2205/702 automatically during use
• CPC Class Codes: A61M 2205/705 Testing of filters for leaks blood in dialysate A61M1/1692

Abstract

A method and system for adaptively controlled withdrawal/infusion of a fluid, such as blood, to or from a fluid source, such as a blood vessel. An adaptive flow rate limit is established and periodically adjusted during the course of withdrawal/infusion so as to maximize and optimize the withdrawal/infusion rate while, at the same time, providing for rapid corrective adjustments in flow rate responsive to early indications of flow disruption, such as occlusion or collapse of the blood vessel during blood withdrawal. The method and system of the invention is particularly applicable to automated apheresis systems.

Claims

1. A system for controlled withdrawal of blood from a blood vessel, said system comprising:

a fluid reservoir fluidly connected to said blood vessel by a first fluid flow path;

a pump for pumping blood from said blood vessel through said first fluid flow path to said fluid reservoir;

a pressure sensor for sensing the pressure within said first fluid flow path;

a flow rate sensor for sensing the flow rate within said first fluid flow path;

an adaptive flow rate control system operatively connected to (1) said pressure sensor, (2) said flow rate sensor and (3) said pump, to receive pressure and flow rate signals from said pressure and flow rate sensors and to send control signals to said pump;

said adaptive flow rate control system comprising;

(a) means for receiving and storing a maximum flow rate limit setting entered by an operator;

(b) means for receiving said pressure and flow rate signals from said pressure sensor and said flow rate sensor and for generating therefrom and storing a standard flow rate/pressure curve defining the flow rate/pressure relationship of blood passing freely through said blood vessel and said first flow path without substantially reduced pressure within said blood vessel as determined;

(c) means for calculating a control curve in relation to, and below, said standard flow rate/pressure curve;

(d) means for setting an initial adaptive flow rate limit no greater than said maximum flow rate setting;

(e) means for signaling said pump to pump blood at a rate substantially equal to said initial adaptive flow rate, for a first timed pumping period;

(f) means for sensing whether the pressure within the first flow path has remained above the control curve throughout the immediately preceding timed pumping period and, if so, for increasing the adaptive flow rate limit by a predetermined increment amount and, thereafter, for signaling the pump to pump blood at the increased adaptive flow rate limit, for a subsequent timed pumping period;

(g) means for sensing whether the pressure within the first flow path has fallen below the control curve and, if so, for signaling the pump to decrease the flow rate to a rate at which steady-state pressure on said control curve is established for a timed stabilization period;

(h) means for determining, after completion of the timed stabilization period, whether the point on said control curve whereat steady-state pressure has been established for said stabilization time period is more than a predetermined amount below said adaptive flow rate limit, and if so, for;

decreasing the adaptive flow rate limit by a predetermined decrement amount to establish a decreased adaptive flow rate limit and, thereafter;

signaling the pump to pump at said decreased adaptive flow rate limit for a subsequent timed pumped period.

2. The system of claim 1 wherein the predetermined amount below said adaptive flow rate limit is 2 to 20 ml/min.

3. The system of claim 1 wherein the predetermined amount below said adaptive flow rate limit is 4 to 6 ml/min.

4. The system of claim 2 wherein said increment amount is between about 2 and 20 ml/min.

5. The system of claim 2 wherein said decrement amount is between about 2 and 20 ml/min.

6. The system of claim 2 wherein said increment amount is approximately 5 ml/min.

7. The system of claim 2 wherein said decrement amount is approximately 5 ml/min.

8. The system of claim 2 wherein said decrement amount is approximately 10 ml/min.

9. The system of claim 1 wherein each timed pumping period is approximately 10 to 60 seconds in length.

10. The system of claim 2 wherein each timed pumping period is approximately 15 seconds in length.

11. The system of claim 2 wherein the initial maximum flow rate limit is 150 ml/min.

12. The system of claim 2 wherein said initial adaptive flow rate limit is 120 ml/min.

13. The system of claim 12 wherein said control system further comprises:

means for calculating and monitoring the rate of change of pressure with respect to time;

means for determining when the rate of change of pressure with respect to time is indicative of progressing occlusion of said flow path; and

in response thereto,

means for signaling said pump to correctively decrease the flow rate through said first flow path so as to avert full occlusion of said flow path.

14. The system of claim 13 wherein said control system is programmed to calculate and monitor the rate of change of pressure with respect to time by calculating at least one derivative function of pressure.

15. The system of claim 14 wherein the control system is programmed to calculate and monitor the first derivative dp/dt of pressure.

16. The system of claim 14 wherein the control system is programmed to calculate and monitor pressure, and the first derivative dp/dt and the second derivative dp² /dt² of pressure.

17. The system of claim 16 wherein said control system further comprises means for generating at least one signal of at least one derivative function of pressure and to combine said signal of at least one derivative function of pressure with said pressure signal to produce a composite signal from which an indication of occlusion of said fluid flow path may be discerned.

18. The system of claim 1 wherein said timed stabilization period is approximately 10-60 seconds in length.

19. The system of claim 1 wherein said timed stabilization pumping period is about 18 seconds in length.

20. The system of claim 2 further adapted for controlled infusion of fluid into a blood vessel, through a return fluid flow path fluidly connecting said system to a blood vessel wherein said control system further comprises:

means for changing the sign of said control curve so as to establish a base infusion control curve which directly corresponds to said control curve;

means for raising said base infusion control curve by a predetermined pressure adjustment factor;

means for altering the slope of said infusion control curve by a predetermined slope adjustment factor.

21. The system of claim 20 wherein said control system is specifically programmed and to apply a predetermined pressure adjustment factor of approximately 48 mm Hg.

22. The system of claim 20 wherein said control system is specifically programmed to apply a slope adjustment factor of approximately -2.0.

23. The system of claim 2 further comprising:

at least one mathematical signal conditioner connected to said pressure sensor to condition said pressure signal to optimize the usability of said pressure signal as an indicator of blood vessel occlusion.

24. The system of claim 23 wherein said mathematical signal conditioner comprises a plurality of correlation filters.

25. The system of claim 23 wherein said mathematical signal conditioner comprises a plurality of matched filters.

26. The system of claim 25 wherein said matched filters are matched to a typical pressure signal and mismatched to typical noise.

27. The system of claim 23 wherein said mathematical signal conditioner comprises a means for analyzing said pressure signal by convolution matched filter functions.

28. An extracorporeal blood processing system wherein blood is withdrawn from a blood vessel through a first flow path, processed in an extracorporeal processing apparatus and at least a portion of the blood is then infused from said blood processing apparatus through a second flow path into a blood vessel, said system comprising:

a blood processing apparatus for effecting a desired processing of blood;

a first flow path fluidly connectable between a blood vessel and said blood processing apparatus to permit withdrawal of blood from said blood vessel into said blood processing apparatus;

a second flow path fluidly connectable between said blood processing apparatus and a blood vessel for infusing at least a portion of said blood from said blood processing apparatus into a blood vessel;

a withdrawal pump operatively mounted to said first flow path to pump blood from said blood vessel to said blood processing means;

an infusion pump operatively mounted to said second flow path to pump blood from said blood processing means to said blood vessel;

a first pressure sensor for sensing pressure within said first flow path;

a first flow rate sensor for sensing flow rate within said first flow path;

a second pressure sensor for sensing pressure within said second flow path;

a second flow rate sensor for sensing flow rate within said second flow path;

a flow rate control system operatively connected to (1) said first and second pressure sensors;

(2) said first and second flow rate sensors; and

(3) said withdrawal and infusion pumps to receive pressure and flow rate signals from said first and second pressure sensors and said first and second flow rate sensors and to send control signals to said pump(s);

said flow rate control system comprising;

(a) means for receiving and storing a maximum withdrawal flow rate limit setting entered by the operator;

(b) means for receiving and storing a maximum infusion flow rate limit set by the operator;

(c) means for utilizing pressure and flow rate signals from said first flow path to generate a standard withdrawal flow rate/pressure curve defining the flow rate/pressure relationship of blood being withdrawn through said first flow path;

(d) means for calculating a withdrawal control curve in relation to, and below, said standard withdrawal flow rate/pressure curve;

(e) means for changing the sign of said withdrawal control curve to establish a base infusion control curve;

(f) means for raising said base reinfusion control curve by a predetermined adjustment factor to establish an upwardly adjusted infusion control curve prior to beginning infusion through said second flow path;

(g) means for altering the slope of said adjusted infusion control curve by a predetermined slope adjustment factor prior to beginning infusion through said second flow path.

29. The system of claim 28 wherein said blood processing apparatus comprises an apparatus for separating the blood into at least first and second constituent portions and wherein at least one of said constituent portion is infused from said blood processing apparatus through said second flow path.

30. The system of claim 29 wherein said blood processing apparatus is an apheresis apparatus.

31. The system of claim 30 wherein said apheresis apparatus comprises a plasmapheresis apparatus for separating and removing a portion of the plasma from the withdrawn blood.

32. The system of claim 30 wherein said apheresis apparatus comprises a plasmapheresis apparatus for separating and removing a portion of the plasma from the withdrawn blood.

33. The system of claim 28 wherein said blood processing apparatus comprises apparatus for effecting therapeutic plasma exchange wherein a quantity of autologous plasma is separated and removed from said blood and, thereafter, a quantity of diluent fluid is added to the plasma depleted blood and, thereafter, the admixture of said plasma depicted blood and said diluent fluid is reinfused through said second flow path.

34. The system of claim 28 wherein said flow rate control system further comprises:

(h) means for setting an initial adaptive withdrawal flow rate limit no greater than said maximum withdrawal flow rate setting entered by the operator;

p1 (i) means for signaling said withdrawal pump to withdraw blood at a rate substantially equal to said initial adaptive withdrawal flow rate for a first timed pumping period;

(j) means for sensing whether the pressure within said first flow path has remained above the withdrawal control curve throughout the immediately preceding timed pumping period and, if so, for increasing the adaptive withdrawal flow rate limit by a predetermined increment amount and, thereafter, for signaling the pump to pump blood at the increased adaptive withdrawal flow rate limit for a subsequent timed pumping period;

(k) means for sensing whether the pressure within the first flow path has fallen below the control curve and, if so, for signaling the pump to decrease the withdrawal flow rate to a rate at which steady-state pressure on said withdrawal control curve is established for a timed stabilization period.

35. The system of claim 34 wherein the flow rate control system further comprises:

(1) means for determining, after completion of the timed stabilization period, whether the point on said withdrawal control curve whereat steady-state pressure has been established for said stabilization time period is more than a predetermined amount below said adaptive flow rate limit, and if so, for;

decreasing the adaptive withdrawal flow rate limit by a predetermined decrement amount to establish a decreased adaptive withdrawal flow rate limit and, thereafter,

signaling the pump to withdraw blood at said decreased adaptive withdrawal flow rate limit for a subsequent timed pumping period.

36. The system of claim 28 wherein said flow rate control system further comprises:

(h) means for setting an initial adaptive infusion flow rate limit no greater than said maximum infusion flow rate setting entered by the operator;

(i) means for signaling said infusion pump to infuse blood at a rate substantially equal to said initial adaptive infusion flow rate for a first timed pumping period;

(j) means for sensing whether the pressure within said second flow path has remained above the infusion control curve throughout the immediately preceding timed pumping period and, if so, for increasing the adaptive infusion flow rate limit by a predetermined increment amount and, thereafter, for signaling the pump to pump blood at the increased adaptive infusion flow rate limit for a subsequent timed pumping period;

(k) means for sensing whether the pressure within the second low path has fallen below the control curve and, if so, for signaling the pump to decrease the infusion flow rate to a rate at which steady-state pressure on said infusion control curve is established for a timed stabilization period.

37. The system of claim 36 wherein the flow rate control system further comprises:

(1) means for determining, after completion of the timed stabilization period, whether the point on said infusion control curve whereat steady-state pressure has been established for said stabilization time period is more than a predetermined amount below said adaptive flow rate limit, and if so, for;

decreasing the adaptive infusion flow rate limit by a predetermined decrement amount to establish a deceased adaptive infusion flow rate limit and, thereafter,

signaling the pump to infuse blood at said decreased adaptive infusion flow rate limit for a subsequent timed pumping period.

38. The system of claim 28 wherein said means for raising said base reinfusion control curve by a predetermined adjustment factor comprise means for raising said withdrawal control curve by approximately 48 mm Hg.

39. The system of claim 28 wherein said means for altering the slope of said adjusted infusion control curve comprises means for multiplying the slope of said adjusted infusion control curve by a slope correction factor of approximately -2.0.

40. The system of claim 28 wherein said system is a two-needle apheresis system wherein said first flow path is connectable to a blood vessel by way of a first needle and said second flow path is connectable to a blood vessel by way of a second needle.

41. The system of claim 28 wherein said first flow path is fluidly connectable to a first blood vessel by way of a first needle and said second flow path is fluidly connectable to a second blood vessel by wa of a second needle.

42. The system of claim 28 further comprising:

at least one mathematical signal conditioner connected to said first pressure sensor to condition the pressure signal received from said first pressure sensor as to optimize the usability of said pressure signal received from said first pressure sensor as an indicator of blood vessel occlusion.

43. The system of claim 42 wherein said mathematical signal conditioner comprises a plurality of correlation filters.

44. The system of claim 42 wherein said mathematical signal conditioner comprises a plurality of matched filters.

45. The system of claim 44 wherein said matched filters are matched to typical withdrawal pressure signals and mismatched to typical noise.

46. The system of claim 42 wherein said mathematical signal conditioner comprises a means for analyzing the pressure signal received from said first pressure sensor by convolution matched filter functions.

47. The system of claim 28 further comprising:

at least one mathematical signal conditioner connected to said second pressure sensor to condition the pressure signal received from said second pressure sensor to optimize the usability of said pressure signal received from said second pressure sensor as an indicator of overpressurization during infusion.

48. The system of claim 47 wherein said mathematical signal conditioner comprises a plurality of correlation filters.

49. The system of claim 47 wherein said mathematical signal conditioner comprises a plurality of matched filters.

50. The system of claim 49 wherein said matched filters are matched to typical infusion pressure signals and mismatched to typical noise.

51. The system of claim 47 wherein said mathematical signal conditioner comprises a means for analyzing the pressure signal received from said second pressure sensor by convolution matched filter functions.