Feedback control of ultrafiltration to prevent hypotension

• US 6,706,007 B2
• Filed: 12/29/2000
• Issued: 03/16/2004
• Est. Priority Date: 12/29/2000
• Status: Active Grant

• Current Assignee: Gambro Lundia AB (Baxter International Inc.)
• Original Assignee: CHF Solutions, Inc.
• Inventors: OʼMahoney, John, Levin, Howard R., Gelfand, Mark
• Primary Examiner(s): Shaver, Kevin
• Assistant Examiner(s): Ramana, Anuradha
• Application Number:
  US09/755,298
• Publication Number:
  US 20020085951A1
• Time in Patent Office: 1,173 Days
• Field of Search: 604/4.01, 604/5-1-, 604/6.09, 604/6.16, 604/6.11, 604/65-67, 422/44, 422/105, 422/107, 210/645-47, 210/650-52, 210/739, 210/744, 210/85, 210/87, 210/90, 210/321.6, 210/321.72, 210/348, 210/416.1, 210/418, 210/420, 210/741, 210/743, 128/905, 128/898, 128/923, 600/301, 600/309, 600/310, 600/322, 600/323, 600/334, 600/333, 600/366, 600/486, 600/437-439, 600/454, 600/459, 600/468
• US Class Current: 604/4.01
• 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 1/36 Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
• CPC Class Codes: A61M 2205/3303 Using a biosensor
• CPC Class Codes: A61M 2205/3306 Optical measuring means
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/3375 Acoustical, e.g. ultrasonic, measuring means
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2230/005 Parameter used as control input for the apparatus
• CPC Class Codes: A61M 2230/205 partial oxygen pressure (P-O2)

Abstract

A method and system for the extracorporeal treatment of blood to remove fluid from the fluid overloaded patient is disclosed that non-invasively measures an oxygen level in the venous blood. The oxygen blood level is used to detect when hypotension is about to occur in a patient. The oxygen level measurements are used as feedback signals. These feedback signals are applied to automatically control the rate of fluid extraction to achieve the desired clinical outcome and avoid precipitating a hypotensive crisis in the patient.

Claims

1. A method for preventing hypotension in a mammalian patient whose blood is withdrawn, treated in a blood treatment device having an extracorporeal blood circuit for removal of ultrafiltrate fluid, and infused into the patient, said method comprising:

a. withdrawing blood from a peripheral vein of the patient into the blood circuit, treating the withdrawn blood flowing through the circuit to remove the ultrafiltrate fluid from the blood, and infusing the treated blood into a peripheral vein of the patient;

b. monitoring oxygen concentration in the blood withdrawn from the peripheral vein and flowing through the circuit;

c. determining a baseline oxygen concentration level in the blood during an initial phase of the treatment;

d. automatically reducing filtrate flow from a first filtration rate of the ultrafiltrate fluid extracted from blood to a second filtration rate, if the oxygen concentration in blood varies from a predetermined target oxygen value below the baseline level, and

e. automatically resuming the first filtration rate when the oxygen concentration level returns to the baseline level.

2. A method as in claim 1 where oxygen concentration is measured at a peripheral vein blood withdrawal tube of the extracorporeal circulation circuit between a patient connection and a blood pump.

3. A method for preventing hypotension as in claim 1 wherein the initial phase of treatment is before the filtrate flow starts.

4. A method for preventing hypotension as in claim 1 wherein the oxygen concentration is determined using an optical biosensor.

5. A method for preventing hypotension as in claim 1 wherein the oxygen concentration is applied to estimate cardiac output and, in step d, reducing filtration if the estimated cardiac output falls a predetermined amount.

6. A method for preventing hypotension as in claim 1 wherein the oxygen concentration is relative to an initial oxygen concentration level.

7. A method for preventing hypotension as in claim 1 wherein the oxygen concentration is an oxygen concentration of blood in the circuit.

8. A method as in claim 1 wherein the blood is withdrawn from a peripheral vein of the patient and infused into a peripheral vein of the patient.

9. A method as in claim 1 applied to treat congestive heart failure in the patient.

10. A method as in claim 1 wherein the flow rate of the ultrafiltrate is automatically adjusted to decrease the rate of filtration to maintain the oxygen level above the target value and to increase the rate of filtration when the oxygen level is at least the base line value.

11. A method as in claim 1 wherein the flow rate of the ultrafiltrate is adjusted while blood flows continuously through the blood treatment device.

12. A method for preventing hypotension in a mammalian patient whose blood is being withdrawn, treated in a blood treatment device of an extracorporeal blood circuit for removal of ultrafiltrate fluid, and infused into the patient, said method comprising:

a. monitoring oxygen concentration in blood flowing in a peripheral blood vessel;

b. automatically reducing a flow rate of the ultrafiltrate fluid extracted from blood if the oxygen concentration in blood drops to a predetermined target value, and

c. automatically increasing the reduced flow rate of the ultrafiltrate fluid if the oxygen concentration in blood increases to a baseline value.

13. A method for preventing hypotension in a mammalian patient whose blood is withdrawn, treated in a blood treatment device having an extracorporeal blood circuit for removal of ultrafiltrate fluid, and infused into the patient, said method comprising:

a. withdrawing blood from a peripheral vein of the patient, treating the withdrawn blood flowing through the circuit to remove the ultrafiltrate fluid from the blood and infusing the treated blood into a peripheral vein of the patient;

b. monitoring oxygen concentration in the blood withdrawn from the peripheral vein and flowing through the circuit;

c. determining a baseline oxygen concentration level in the withdrawn blood during an initial phase of the treatment;

d. automatically reducing filtrate flow from a first rate of the ultrafiltrate fluid to a reduced rate if the oxygen concentration in blood varies from a predetermined target oxygen value, wherein the predetermined target oxygen value is a function of the baseline level, and

wherein the oxygen concentration is a mixed venous oxygen saturation (SvO₂) level.

14. A method for preventing hypotension as in claim 13 wherein the oxygen concentration is a venous oxygen saturation (SvO₂) level of blood taken from a peripheral vein.

15. A method for preventing hypotension as in claim 13 wherein the target value is a sum of the baseline level and a predetermined oxygen change value.

16. A method for preventing hypotension as in claim 15 wherein the predetermined change value is a percentage of the baseline level.

17. A method for preventing hypotension as in claim 15 wherein the predetermined change value is no greater than a seven percent less than the baseline level.

18. A method of controlling an extracorporeal blood circuit comprising:

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

b. filtering fluids from blood flowing through the circuit at a controlled filtration rate;

c. detecting a reduction in cardiac output level of the patient, wherein the reduction in cardiac output level is determined by monitoring oxygen level of venous blood in or taken from a peripheral vein of the patient;

d. automatically reducing the filtration flow rate if the measured cardiac output falls below a first threshold level, and

e. automatically stopping the filtration flow rate if, after step d, the measured cardiac output falls below a second threshold level, wherein the second threshold level is below the first threshold level.

19. A method of controlling an extracorporeal blood circuit as in claim 18 wherein the blood circuit includes an oxygen saturation sensor having an emitter and a receiver mounted on opposite sides of a bloodline of said circuit.

20. A method of controlling an extracorporeal blood circuit as in claim 18, further comprising increasing the filtration flow after step (d) if the measured cardiac output rises above a second threshold level higher than the first threshold level.

21. A method of controlling an extracorporeal blood circuit as in claim 18 wherein the controlled filtration rate is reduced by slowing an ultrafiltration pump.

22. A method of controlling an extracorporeal blood circuit as in claim 18 wherein the controlled filtration rate is determined by cyclically starting and stopping the filtration of fluids in accordance with a duty cycle, and the filtration rate is reduced by reducing an ON period of the duty cycle.