Blood extraction flow control calibration system and method

• US 5,536,237 A
• Filed: 06/01/1992
• Issued: 07/16/1996
• Est. Priority Date: 06/01/1992
• Status: Expired due to Term

• Current Assignee: Baxter International Inc.
• Original Assignee: Baxter International Inc.
• Inventors: Huff, Robin, Prince, Paul R.
• Primary Examiner(s): Rimell, Sam
• Application Number:
  US07/891,527
• Time in Patent Office: 1,506 Days
• Field of Search: 604/4, 604/5, 604/6, 604/7, 604/54, 604/65, 604/66, 604/67, 604/245, 128/DIG. 13
• US Class Current: 604/6.11
• 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 1/306 Pressure control, e.g. using substantially rigid closed or gas buffered or elastic reservoirs
• 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 2205/3344 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: G05D 7/0682 using a plurality of flow sources
• CPC Class Codes: Y10S 128/13 Infusion monitoring

Abstract

A method and system for calibrating and controlling the withdrawal of a fluid, such as blood, from a fluid source, such as a blood vessel, includes a fluid pump, a pressure sensor, a flow rate sensor, and a microprocessor based flow control subsystem. The flow control subsystem optimizes the flow rate by sensing zero flow rate pressure within the subject, making a plurality of periodic flow path pressure measurements and extrapolating a calibration flow rate curve. A control curve is generated by utilizing the zero-flow rate pressure point, the slope of the calibration curve, and an empirically predetermined pressure. The blood pump is then operated at a maximum speed that is limited by the flow control curve to maximize flow without 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 calibrating the control of the flow of fluid in a given direction to or from a subject having a limited flow rate accommodation comprising:

a pressure cuff coupled to the subject to provide pressurization of the subject'"'"'s blood vessel to increase the dynamic range of operating internal vein pressures;

a fluid pump that is connectable in fluid pumping relationship along a fluid flow path between the subject and a fluid processor or reservoir;

pressure sensing means coupled to sense fluid pressure in the fluid flow path between the fluid pump and the subject and generate indications of the sensed pressure;

a flow rate sensor coupled to provide an indications of fluid flow rates along the first fluid flow path; and

a fluid pump control system coupled to receive the sensed pressure and flow rate indications and provide to the fluid pump flow rate control signals in response thereto, the fluid pump control system including;

(a) means for inflating and deflating the pressure cuff;

(b) means for generating a zero-flow point, including means for sensing the internal fluid pressure within the subject'"'"'s blood pressure at a zero flow rate while the pressure cuff is deflated, said zero flow point being an indication of pressure within the subject at zero flow rate;

(c) means for making periodic flow path pressure measurements while the pressure cuff is inflated and means for generating a calibration flow rate curve comprised of the plurality of periodic flow path pressure measurements;

(d) means for generating a flow rate control curve utilizing the slope of said calibration flow rate curve, said zero-flow point, and a translation from said zero-flow point corresponding to a predetermined intravascular pressure value; and

(e) means for generating control signals limiting the actual flow rate to a magnitude along the flow rate control curve.

2. The system of claim 1 wherein the predetermined pressure value is empirically determined by taking into consideration variations in zero-flow vein pressure and variations in the maximum operable vein pressure from subject to subject.

3. The system of claim 1 wherein the predetermined pressure value is a fraction of a maximum operable pressure.

4. The system of claim 1 wherein said means for generating a calibration flow rate curve includes means for pressurizing said pressure cuff and means for rapidly and uniformly accelerating said fluid pump so that a plurality of pressure measurements can be taken periodically.

5. The system of claim 1 wherein said means for generating a calibration flow rate curve includes means for pressurizing said pressure cuff and means for rapidly and uniformly accelerating and decelerating said fluid pump so that a plurality of pressure measurements can be taken periodically.

6. The system of claim 1 wherein the predetermined pressure value is between the zero-flow point value and the cuff pressure value.

7. The system of claim 6 wherein the predetermined pressure value is a fraction of the cuff pressure.

8. The system of claim 7 wherein the predetermined pressure value is one-quarter the cuff pressure.

9. The system of claim 1 wherein said means for generating a calibration flow rate curve includes means for mathematically processing the periodic flow path pressure measurements to obtain a Least-Squares slope estimation.

10. The system of claim 1 wherein said means for generating a calibration flow rate curve includes means for adjusting the slope of said calibration flow rate curve to correct for changes in internal vein pressure during the calibration period.

11. The system of claim 1 wherein said means for generating a calibration flow rate curve include means for mathematically processing the periodic flow path pressure measurements to obtain a Binomial fit having a linear portion attributable to the slope.

12. The system of claim 1 wherein said means for inflating and deflating the pressure cuff further comprises means for inflating the pressure cuff to pressurize the subject'"'"'s blood vessel prior to venipuncture.

13. A method of controlling a flow rate of a bodily fluid along a flow path between a subject and a processor or reservoir comprising the steps of:

placing a deflated pressure cuff on the subject;

sensing the internal fluid pressure within the subject'"'"'s blood vessel at zero flow rate while the pressure cuff is deflated and generating a zero-flow pressure point;

inflating the pressure cuff, waiting until the vein pressure stabilizes, initiating a blood draw, and making a plurality of periodic flow path pressure measurements;

using the flow path pressure measurements to generate a calibration flow rate curve;

generating a flow rate control curve utilizing the slope of said calibration flow rate curve, said zero-flow pressure point, and a translation from said zero-flow pressure point corresponding to a predetermined intravascular pressure value; and

generating during conditions of normal operation flow rate control signals limiting the actual flow rate to a magnitude along the flow rate control curve.

14. The method of controlling according to claim 13 wherein the step of sensing the internal fluid pressure includes adjusting for gravitational effects due to the position of the donor.

15. The method of controlling according to claim 13 wherein the step of making periodic flow path measurements includes the step of rapidly and uniformly accelerating pumping of the fluid from the subject so that a plurality of pressure measurements can be taken periodically.

16. The method of controlling according to claim 13 wherein the step of generating a calibration flow rate curve includes the step of mathematically processing the periodic flow path pressure measurements to obtain a Least-Squares slope estimation.

17. The method of controlling according to claim 13 wherein the step of generating a flow rate control curve includes the step of adjusting the slope of said calibration flow rate curve to reflect changes in internal vein pressure during the calibration period.

18. The method of controlling according to claim 13 wherein the step of using flow path measurements to generate a calibration flow rate curve includes the step of mathematically processing the periodic flow path pressure measurements to obtain a Binomial fit having a linear portion attributable to the slope of said calibration flow rate curve.

19. The method of controlling according to claim 13 wherein the step of generating a flow rate control curve includes the step of empirically determining a pressure offset value by taking into consideration variations in zero-flow vein pressure and variations in the maximum operable vein pressure from subject to subject.

20. The method of controlling according to claim 13 wherein the step of generating a control curve includes the step of utilizing a predetermined pressure offset that is between the zero-flow rate pressure point and a maximum operable value.

21. The method of controlling according to claim 20 wherein the step of generating a control curve includes that step of utilizing a predetermined pressure offset that is a fraction of a maximum operable value.

22. The method of controlling according to claim 21 wherein the step of generating a control curve includes that step of utilizing a predetermined pressure offset that is one-quarter of a maximum operable value.

23. The method of controlling according to claim 13 wherein the step of making periodic flow path measurements includes the steps of pressurizing the pressure cuff and rapidly and uniformly accelerating the pumping of fluid from the subject so that a plurality of pressure measurements can be taken rapidly.

24. The method of controlling according to claim 13 wherein the step of making periodic flow path measurements includes the steps of pressurizing the pressure cuff and rapidly and uniformly accelerating and decelerating the pumping of fluid from the subject so that a plurality of pressure measurements can be taken rapidly.

25. The method of controlling according to claim 13 wherein the step of generating a calibration flow rate curve includes the step of mathematically processing the periodic flow path pressure measurements to obtain a Least-Squares slope estimation.

26. The method of controlling according to claim 13 wherein the step of generating a calibration flow rate curve includes the step of generating a slope for said calibration flow rate curve which reflects changes in internal vein pressure during the calibration period.

27. The method of controlling according to claim 26 wherein the step of generating the slope of said calibration flow rate curve include the step of mathematically processing the periodic flow path pressure measurements to obtain a Binomial fit having a linear portion attributable to the slope.

28. The method of controlling according to claim 13 wherein the step of generating a control curve includes the step of utilizing a predetermined pressure offset that is between the zero-flow rate pressure point and the cuff pressure.

29. The method of controlling according to claim 28 wherein the step of generating a control curve includes the step of utilizing a predetermined pressure offset that is equal to a fraction of the cuff pressure.

30. The method of controlling according to claim 29 wherein the step of generating a control curve includes the step of utilizing a predetermined pressure that is equal to one-quarter the cuff pressure.

31. The method of controlling according to claim 13 wherein the step of making periodic flow path measurements includes the step of rapidly and uniformly accelerating and decelerating pumping of the fluid from the subject so that a plurality of pressure measurements can be taken periodically.

32. The method of claim 13 further comprising the steps of inflating the pressure cuff to pressurize the subject'"'"'s blood vessel prior to venipuncture, initiating the venipuncture and deflating the pressure cuff prior to sensing the internal fluid pressure within the subject'"'"'s blood vessel.

33. A system for calibrating the control of the flow of fluid in a given direction to or from a subject having a limited flow rate accommodation comprising:

a pressure cuff coupled to the subject to provide pressurization of the subject'"'"'s blood vessel to increase the dynamic range of operating internal vein pressures;

a fluid pump that is connectable in fluid pumping relationship along a fluid flow path between the subject and a fluid processor or reservoir;

pressure sensing means coupled to sense fluid pressure in the fluid flow path between the fluid pump and the subject and generate indications of the sensed pressure;

a flow rate sensor coupled to provide an indications of fluid flow rates along the first fluid flow path; and

a fluid pump control system coupled to receive the sensed pressure and flow rate indications and provide to the fluid pump flow rate control signals in response thereto, the fluid pump control system including;

(a) means for inflating and deflating the pressure cuff;

(b) means for generating a zero-flow point, including means for sensing the internal fluid pressure within the subject'"'"'s blood pressure at a zero flow rate while the pressure cuff is deflated, said zero flow point being an indication of pressure within the subject at zero flow rate;

(c) means for generating a calibration flow rate curve including means for rapidly and uniformly accelerating said fluid pump while the pressure cuff is inflated so that a plurality of flow path pressure measurements can be taken periodically;

(d) means for generating a flow rate control curve utilizing the slope of said calibration flow rate curve, said zero-flow point, and a translation from said zero-flow point corresponding to a predetermined intravascular pressure value; and

(e) means for generating during conditions of normal operation flow rate control signals limiting the actual flow rate to a magnitude along the flow rate control curve.

34. The system of claim 33 wherein said means for generating a calibration flow rate curve includes means for mathematically processing the periodic flow path pressure measurements to obtain a Least-Squares slope estimation.

35. The system of claim 33 wherein said means for generating a calibration flow rate curve includes means for adjusting the slope of said calibration flow rate curve to correct for changes in internal vein pressure during the calibration period.

36. The system of claim 33 wherein said means for generating a calibration flow rate curve include means for mathematically processing the periodic flow path pressure measurements to obtain a Binomial fit having a linear portion attributable to the slope.

37. The system of claim 33 wherein said means for inflating and deflating the pressure cuff further comprises means for inflating the pressure cuff to pressurize the subject'"'"'s blood vessel prior to venipuncture.

38. A system for calibrating the control of the flow of fluid in a given direction to or from a subject having a limited flow rate accommodation comprising:

a pressure cuff coupled to the subject to provide pressurization of the subject'"'"'s blood vessel to increase the dynamic range of operating internal vein pressures;

a fluid pump that is connectable in fluid pumping relationship along a fluid flow path between the subject and a fluid processor or reservoir;

pressure sensing means coupled to sense fluid pressure in the fluid flow path between the fluid pump and the subject and generate indications of the sensed pressure;

a flow rate sensor coupled to provide an indications of fluid flow rates along the first fluid flow path; and

a fluid pump control system coupled to receive the sensed pressure and flow rate indications and provide to the fluid pump flow rate control signals in response thereto, the fluid pump control system including;

(a) means for inflating and deflating the pressure cuff;

(b) means for generating a zero-flow point, including means for sensing the internal fluid pressure within the subject'"'"'s blood pressure at a zero flow rate while the pressure cuff is deflated, said zero flow point being an indication of pressure within the subject at zero flow rate;

(c) means for generating a calibration flow rate curve including means for rapidly and uniformly accelerating and decelerating said fluid pump while the pressure cuff is inflated so that a plurality of flow path pressure measurements can be taken periodically;

(d) means for generating a flow rate control curve utilizing the slope of said calibration flow rate curve, said zero-flow point, and a translation from said zero-flow point corresponding to a predetermined intravascular pressure value; and

(e) means for generating during conditions of normal operation flow rate control signals limiting the actual flow rate to a magnitude along the flow rate control curve.

39. The system of claim 38 wherein said means for generating a calibration flow rate curve includes means for mathematically processing the periodic flow path pressure measurements to obtain a Least-Squares slope estimation.

40. The system of claim 38 wherein said means for generating a calibration flow rate curve includes means for adjusting the slope of said calibration flow rate curve to correct for changes in internal vein pressure during the calibration period.

41. The system of claim 38 wherein said means for generating a calibration flow rate curve include means for mathematically processing the periodic flow path pressure measurements to obtain a Binomial fit having a linear portion attributable to the slope.

42. The system of claim 38 wherein said means for inflating and deflating the pressure cuff further comprises means for inflating the pressure cuff to pressurize the subject'"'"'s blood vessel prior to venipuncture.