Access flow monitoring using reversal of normal blood flow

• US 6,189,388 B1
• Filed: 11/12/1997
• Issued: 02/20/2001
• Est. Priority Date: 11/12/1997
• Status: Expired due to Fees

• Current Assignee: Gambro Renal Products, Inc. (Baxter International Inc.)
• Original Assignee: Gambro, Inc. (DaVita Incorporated)
• Inventors: Cole, Eugene, Brugger, James
• Primary Examiner(s): Fuller, Benjamin R.
• Assistant Examiner(s): THOMPSON, JEWEL VERGIE
• Application Number:
  US08/976,325
• Time in Patent Office: 1,196 Days
• Field of Search: 738/610.7, 738/611.1, 738/610.8, 738/611.6, 324/445, 324/722, 604/52, 600/584
• US Class Current: 73/861.07
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/3653 Interfaces between patient blood circulation and extra-corporal blood circuit
• CPC Class Codes: A61M 1/3655 Arterio-venous shunts or fistulae
• CPC Class Codes: A61M 1/3658 Indicating the amount of purified blood recirculating in the fistula or shunt
• CPC Class Codes: G01F 1/704 using marked regions or existing inhomogeneities within the fluid stream, e.g. statistically occurring variations in a fluid parameter G01F1/76, G01F25/00 take precedence
• CPC Class Codes: G01F 1/7046 using electrical loaded particles as tracer, e.g. ions or electrons

Abstract

A method and apparatus in which the blood flow in a fistula is determined by comparing the property of blood entering the fistula to the property of blood being withdrawn from the fistula as the blood in the fistula flows in the direction which is the reverse of the predominant flow. A property marker fluid is injected into the blood entering the fistula in order to alter the property of the blood. Aseptic conditions are maintained during the reversal of the blood flow by maintaining a closed blood loop exterior to the patient. The blood loop closure is maintained by reversing the action of the pump which induces blood flow in the closed blood loop.

Claims

1. Apparatus for measuring flow rate of a fluid through a fistula, the apparatus comprising

a fluid loop having a first end connectable to the fistula and a second end connectable to the fistula wherein when the fluid loop is connected to fistula at the first and second ends the fistula and fluid loop form a closed fluid loop;

a pump for moving the fluid through the fluid loop in a first direction and a second direction opposite said first direction;

means for altering a property of the fluid in fluid loop; and

first means for measuring the altered property of the fluid to determine the flow rate of the fluid through the fistula when connected after passage of the fluid through the fistula during movement of the fluid in one of the first or second directions.

2. The apparatus of claim 1 further comprising a fluid treatment device in the fluid loop.

3. The apparatus of claim 2 wherein the fluid treatment device comprises a dialyzer.

4. The apparatus of claim 1 wherein the means for altering the property of a fluid is located in the fluid loop on the opposite side of the fistula when connected from the means for measuring the altered property of the fluid.

5. The apparatus of claim 4 where in the means for altering a property of the fluid comprises

means for injecting a bolus of marker fluid into the fluid to alter the property of the fluid.

6. The apparatus of claim 2 wherein said pump moves the fluid in said first direction for treatment of the fluid with the fluid treatment device and in said second direction for measurement of the altered property of the fluid.

7. The apparatus of claim 6 further comprising means for measuring recirculation of the fluid through the fistula when connected.

8. The apparatus of claim 7 wherein said means for measuring recirculation measures the recirculation of the fluid when the fluid is moving in said first direction.

9. The apparatus of claim 1 further comprising means for measuring recirculation of the fluid through the fistula when connected.

10. The apparatus of claim 9 further comprising second mean for measuring the altered property of the fluid during movement of the fluid opposite said one direction.

28. The apparatus of claim 7 wherein said means for measuring recirculation measures the recirculation of the fluid when the fluid is moving in said first direction.

11. A method of measuring the flow rate of a fluid through a fistula in a closed fluid loop wherein the fluid normally flows in a first flow direction through the fistula and the closed fluid loop, the method comprising

reversing the flow of fluid through the closed fluid loop and the fistula from the first flow direction to a second flow direction opposite the first flow direction while maintaining the closed fluid loop;

altering a property of the fluid prior to passage through the fistula in the second flow direction;

measuring the altered property of the fluid after passage through the fistula in the second flow direction.

12. The method of claim 11 further comprising

measuring the property of the fluid prior to passage through the fistula in the second flow direction; and

comparing the measurement of the property of the fluid prior to passage through the fistula to the measurement of the property after passage through the fistula to determine the flow rate through the fistula.

13. The method of claim 11 wherein the step of altering a property of the fluid further comprises injecting a bolus of marker fluid into the fluid to alter the property of the fluid.

14. The method of claim 13 wherein said step of altering the property of the fluid further comprises injecting a bolus of marker fluid to alter the property of the fluid.

15. A method of measuring recirculation of fluid through a fistula in a closed fluid loop and flow rate of the fluid through the fistula, the method comprising

flowing the fluid in a first flow direction wherein the fluid leaves the fistula at one end of the fistula, passes through the closed fluid loop, and returns to the fistula at a second end of the fistula;

reversing the flow of fluid to a second flow direction opposite said first direction wherein the fluid flows from the closed fluid loop to the fistula at the second end of the fistula, passes through the fistula, and returns to the closed fluid loop from the first end of the fistula;

altering a property of the fluid;

measuring the altered property of the fluid after the fluid leaves the fistula when the fluid flows in the first flow direction to determine recirculation of the fluid through the fistula;

measuring the altered property of the fluid after the fluid passes through the fistula in the second flow direction to determine flow rate of the fluid through the fistula.

16. Dialysis apparatus wherein the dialysis apparatus is connectable to a fistula, the dialysis apparatus comprising

a dialyzer for treating fluid passed therethrough;

a first tubing loop connected to the dialyzer and connectable to the fistula;

a second tubing loop connected to the dialyzer and connectable to the fistula wherein the fistula when connected, the first tubing loop, the dialyzer, and the second tubing loop form a closed fluid loop for passage of a fluid;

a pump in one of said tubing loops for moving fluid through the closed fluid loop wherein the pump moves the fluid in a first direction for treatment of the fluid by the dialyzer and in a second direction opposite said first direction;

first means for altering a property of the fluid when the fluid flows in the second direction;

first means for measuring the altered property of the fluid after passage of the fluid through the fistula when connected when the fluid flows in the second direction.

17. The dialysis apparatus of claim 16 wherein said first means for altering a property comprises a bolus for injecting marker fluid into the fluid to alter the property of the fluid.

18. The dialysis apparatus of claim 16 further comprising means for measuring recirculation through the fistula when connected, said means for measuring recirculation comprising

second means for altering a property of the fluid when the fluid flows in the first direction; and

second means for detecting said altered property of fluid when the fluid flows in said first direction.

19. The dialysis apparatus of claim 18 wherein said second means for altering a property of the fluid comprise a bolus for injecting marker fluid into the fluid to alter the property of the fluid.

20. Apparatus for measuring flow rate of a fluid through a fistula wherein the fluid normally flows through the fistula in a first direction, the apparatus comprising

a fluid loop having a first end connectable to a fistula and a second end connectable to the fistula wherein the fluid loop and the fistula when connected form a closed fluid loop;

means for reversing the fluid flow through the fluid loop from the first flow direction to a second flow direction opposite said first flow direction while maintaining the closed fluid loop;

means for altering a property of the fluid in the fluid loop;

means for measuring the altered property of the fluid to determine the flow rate of the fluid through the fistula when connected after passage of the fluid through the fistula when connected during movement of the fluid in one of the first or second flow directions.

21. The apparatus of claim 20 further comprising a fluid treatment device in the closed fluid loop.

22. The apparatus of claim 21 wherein the fluid treatment device comprises a dialyzer.

23. The apparatus of claim 20 wherein the means for altering the property of a fluid is located in the closed fluid loop on the opposite side of the fistula when connected from the means for measuring the altered property of the fluid.

24. The apparatus of claim 20 wherein the means for reversing direction of fluid flow comprises valve mean in the closed fluid loop reversing the fluid flow so that fluid enters the fistula when connected at one of its ends in the first flow direction and fluid exits the fistula when connected from said one end in the second flow direction.

25. The apparatus of claim 20 wherein the means for altering a property of the fluid comprises means for injecting a bolus of marker fluid into the fluid to alter the property of the fluid.

26. The apparatus of claim 22 wherein said means for reversing the fluid flow moves the fluid in said first flow direction for treatment of the fluid with the fluid treatment device and in said second flow direction for measurement of the altered property of the fluid.

27. The apparatus of claim 26 further comprising means for measuring recirculation of the fluid through the fistula when connected.

29. The apparatus of claim 20 further comprising means for measuring recirculation of the fluid through said fistula when connected.

30. The apparatus of claim 29 further comprising second means for measuring the altered property of the fluid during movement of the fluid opposite said one direction.

31. The apparatus of claim 30 further comprising a bubble detector located in the closed fluid loop between the means for altering a property and the fistula when connected.

33. The apparatus of claim 31 further comprising a dialyzer for treating the fluid in the closed fluid loop.

35. The apparatus of claim 33 further comprising a monitor device for measuring recirculation of the fluid through the fistula when connected in said first direction.

36. The apparatus of claim 33 further comprising a second injection site for injecting material to alter the property of the fluid for the measurement of recirculation in said second direction.

32. Apparatus for measuring flow rate of a fluid through a fistula, the apparatus comprising

a fluid loop having a first end connectable to a fistula and a second end connectable to the fistula wherein the fluid loop and the fistula when connected form a closed fluid loop;

a pump for moving the fluid through the closed fluid loop in a first direction and in a second direction opposite said first direction;

an injection site in the closed loop for passage of material into the fluid to alter the property of the fluid;

a monitoring device for measuring the altered property of the fluid to determine the flow rate of the fluid through the fistula when connected after passage of the fluid having the altered property through the fistula when connected in one of the first or second directions.

34. The apparatus of claim 32 wherein said pump moves the fluid in said first direction for treatment of the fluid in the dialyzer and in said second direction for measurement of the altered fluid.

37. Dialysis apparatus for treating fluid connectable to a fistula having an arterial side and a venous side, the dialysis apparatus comprising

a dialyzer for treating the fluid;

an arterial line connected to the dialyzer and connectable to the fistula at the arterial side for passing the fluid between the fistula, when connected, and the dialyzer;

a venous line connected to the dialyzer and connectable to the fistula at the venous side;

an ultrasonic bubble detector in the arterial line for detecting bubbles in the fluid.

38. The dialysis apparatus of claim 37 further comprising an injection site in the arterial line for injecting a material into the fluid as it passes through the arterial line wherein the material alters the property of the fluid.

39. The dialysis apparatus of claim 38 further comprising a detector in the venous line for detecting the altered property of the fluid.