Differential conductivity recirculation monitor

• US 5,510,716 A
• Filed: 11/01/1994
• Issued: 04/23/1996
• Est. Priority Date: 09/30/1992
• Status: Expired due to Term

• Current Assignee: Gambro Renal Products, Inc. (Baxter International Inc.)
• Original Assignee: COBE Laboratories Incorporated (Terumo Corporation)
• Inventors: Brugger, James M., Buffaloe, George W. IV, Ogawa, Francis T.
• Primary Examiner(s): Wieder, Kenneth A.
• Assistant Examiner(s): Tobin, Christopher M.
• Application Number:
  US08/332,647
• Time in Patent Office: 539 Days
• Field of Search: 324/439, 324/445, 324/450, 324/722, 210/96.1, 210/646, 436/150, 604/30, 604/4, 604/65, 604/246, 73/861.07, 73/861.11, 73/861.08, 73/861.16
• US Class Current: 324/445
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/3603 in the same direction
• CPC Class Codes: A61M 1/361 before treatment
• CPC Class Codes: A61M 1/3612 after treatment
• 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: A61M 1/3669 Electrical impedance measurement of body fluids; transducers specially adapted therefor
• CPC Class Codes: G01F 1/7046 using electrical loaded particles as tracer, e.g. ions or electrons
• CPC Class Codes: G01F 1/708 Measuring the time taken to traverse a fixed distance
• CPC Class Codes: G01F 1/7088 using electrically charged particles as tracers

Abstract

A differential conductivity recirculation monitor quantitatively determines the degree of recirculation in a fistula by comparing the conductivity of blood entering the fistula to the conductivity of blood being withdrawn from the fistula. A discrete quantity of a high conductivity marker fluid is injected into the blood entering the fistula, altering the conductivity of the blood entering the fistula. The altered conductivity blood enters the fistula and, if recirculation is present, co-mingles with blood in the fistula, altering the conductivity of the blood ion the fistula in proportion to the degree of recirculation. Blood withdrawn from the fistula has an altered conductivity related to the degree of recirculation. Quantitative values of the conductivity of the altered conductivity blood entering the fistula and the conductivity of the blood being withdrawn from the fistula are measured and a difference determined. The determined difference between the conductivities is used to determine a quantitative measurement of the degree of recirculation in the fistula.

Claims

1. A method for quantitatively determining a degree of recirculation flow within a zone of a vessel into which a first fluid having a first electrical conductivity is being inserted and from which a second fluid having a second electrical conductivity is simultaneously being withdrawn, comprising:

altering the electrical conductivity of the first fluid;

measuring the electrical conductivity of the first fluid after the conductivity is altered and before the first fluid is inserted into the zone of the vessel;

measuring the electrical conductivity of the second fluid after it is withdrawn from the zone of the vessel; and

comparing the conductivity of the first fluid with the conductivity of the second fluid to quantitatively determine the degree of recirculation flow in the zone of the vessel.

2. A method as defined in claim 1 wherein:

the step of altering the electrical conductivity of the first fluid further comprises;

injecting a marker fluid having an electrical conductivity different from the conductivity of the first fluid into the first fluid.

3. A method as defined in claim 1 wherein the steps of measuring the conductivity of the first fluid and the second fluid further comprise:

flowing the first fluid through a first conduit, said first conduit comprising a first conductivity cell with a continuous path configuration;

flowing the second fluid through a second conduit, said second conduit comprising a second conductivity cell with a continuous path configuration;

inducing a first electrical current in the first fluid in the first conductivity cell and a second electrical current in the second fluid in the second conductivity cell;

sensing the first electrical current in the first fluid in the first conductivity cell and the second electrical current in the second fluid in the second conductivity cell; and

subtracting the second electrical current from the first electrical current to produce a signal representative of the difference in the conductivities between the first and the second fluids.

4. A method as defined in claim 3 wherein the inducing step further comprises:

positioning an exciting electromagnetic coil in proximity with the first and second conductivity cells at an inducing location;

inducing the first electrical current in an electrical direction along the continuous path of the first conductivity cell; and

simultaneously inducing the second electrical current to flow in the same electrical direction along the continuous path of the second conductivity cell as the direction of the first electrical current.

5. A method as defined in claim 4 further comprising:

alternating the electrical direction of each of the electrical currents in the first and the second conductivity cells.

6. A method as defined in claim 5 wherein the sensing and subtracting steps further comprise:

positioning a sensing electromagnetic coil in proximity with the first and second conductivity cells at a sensing location with the first conductivity cell oriented at the sensing location with the first electrical current in an opposite electrical direction with respect to the sensing electromagnetic coil from the electrical direction of the second electrical current with respect to the sensing electromagnetic coil.

7. A method as defined in claim 6 wherein:

the exciting electromagnetic coil defines a window through which the first and the second conductivity cells pass; and

the sensing electromagnetic coil defines a window through which the first and the second conductivity cells pass.

8. A method as defined in claim 4 wherein the sensing and subtracting steps further comprise:

positioning a sensing electromagnetic coil in proximity with the first and second conductivity cells at a sensing location, the first conductivity cell being oriented at the sensing location with the first electrical current in an opposite electrical direction with respect to the sensing electromagnetic coil from the electrical direction of the second electrical current with respect to the sensing electromagnetic coil.

9. A method as defined in claim 3 wherein:

the zone of the vessel is a surgically formed arteriovenous fistula;

the first conduit is an outlet line of a medical device for blood processing;

the second conduit is an inlet line of the medical device for blood processing;

the first fluid is blood processed by the medical device for blood processing; and

the second fluid is blood to be processed by the medical device for blood processing.

10. A method as defined in claim 9 wherein the medical device for blood processing is a hemodialysis device.

11. A method as defined in claim 9 wherein the step of altering the conductivity of the first fluid further comprises:

injecting hypertonic saline solution into the blood processed by the medical device for blood processing at a point in the outlet line before the blood passes through the first conductivity cell.

12. A method as defined in claim 3 further comprising:

determining a value representative of a normal difference between the electrical conductivity of the first fluid and the electrical conductivity of the second fluid before the step of altering the electrical conductivity of the first fluid is performed; and

subtracting the value representative of the normal differences between the conductivity of the first fluid and the conductivity of the second fluid from the signal representative of the difference in the conductivities between the first and the second fluids.

13. A method as defined in claim 12 further comprising:

integrating the difference in conductivity from the beginning of a recirculation test until an altered conductivity portion of the first fluid has completely passed through the first conductivity cell to produce a first steady state value;

integrating the difference in conductivity from the beginning of a recirculation test until a portion of the second fluid with conductivity altered by recirculation of the first fluid in the vessel has completely passed through the second conductivity cell to produce a second steady state value; and

dividing the second steady state value by the first steady state value to produce a value of recirculation efficiency.

14. A method as defined in claim 13 further comprising:

visually displaying the value of recirculation efficiency.

17. An apparatus as defined in claim 13 wherein the means for measuring the conductivity of the first fluid and the second fluid and comparing the conductivities further comprises:

a first conduit through which the first fluid flows to the zone of the vessel, said first conduit comprising a first conductivity cell with a first conductivity cell upstream connection, a first conductivity cell downstream connection, and two branches connecting the upstream connection to the downstream connection with a continuous path configuration from the upstream connection to the downstream connection through one of the two branches and returning to the upstream connection through the other one of the two branches;

a second conduit through which the second fluid flows from the zone of the vessel, said second conduit comprising a second conductivity cell with a second conductivity cell upstream connection, a second conductivity cell downstream connection, and two branches connecting the upstream connection to the downstream connection with a continuous path configuration from the upstream connection to the downstream connection through one of the two branches and returning to the upstream connection through the other one of the two branches;

means for inducing a first electrical current in the first fluid in the first conductivity cell and a second electrical current in the second fluid in the second conductivity cell;

means for sensing the first electrical current in the first fluid in the first conductivity cell and the second electrical current in the second fluid flowing in the second conductivity cell, and subtracting the second electrical current from the first electrical current to produce a signal representative of the difference in the conductivities between the first and the second fluids.

18. An apparatus as defined in claim 17 wherein:

the inducing means comprises an exciting electromagnetic coil in proximity with the first and second conductivity cells at an exciting location, the first conductivity cell being oriented at the exciting location with respect to the second conductivity cell with first electrical current in an electrical direction with respect to the exciting electromagnetic coil and the second electrical current in the same electrical direction with respect to the exciting electromagnetic coil.

19. An apparatus as defined in claim 18 wherein:

the electrical direction of the first and second electrical currents in the first and the second conductivity cells alternates.

20. An apparatus as defined in claim 19 wherein:

the sensing and subtracting means further comprises;

a sensing electromagnetic coil in proximity with the first and second conductivity cells at a sensing location, the first conductivity cell being oriented at the sensing location with respect to the second conductivity cell with the electrical direction of the first electrical current with respect to the sensing electromagnetic coil opposite the electrical direction of the second electrical current with respect to the sensing electromagnetic coil.

21. An apparatus as defined in claim 20 wherein:

the exciting electromagnetic coil defines a window through which one branch of each of the first and the second conductivity cells pass; and

the sensing electromagnetic coil defines a window through which the other branch of each of the first and the second conductivity cells pass.

22. An apparatus as defined in claim 21 wherein:

each one of the sensing and the exciting electromagnetic coils comprises a front and a rear half core, separable to insert the branch of each of the first and second conductivity cells into the window of the coil and to remove the branch of each of first and second conductivity cells from the window of the coil.

23. An apparatus as defined in claim 22 further comprising:

a front acceptor plate having a rear side to which the front sensing coil half core and the front exciting coil half core are mounted, each half core being mounted so that the window is formed to the rear of the front half core;

a rear acceptor plate having a front side to which the rear sensing coil half core and the rear inducing coil half core are mounted, each half core being mounted so that the window is formed to the front of the rear half core; and

joining means for joining the front acceptor plate to the rear acceptor plate in a parallel relationship with the front half core of the exciting coil mated with the rear half core of the exciting coil and the front half core of the sensing coil mated with the rear half coil of the sensing coil.

24. An apparatus as defined in claim 23 wherein the joining means further comprises:

a hinge joining the front acceptor plate to the rear acceptor plate; and

a latch to hold the front acceptor plate in the parallel relationship with the rear acceptor plate.

25. An apparatus as defined in claim 18 wherein the sensing and subtracting means further comprises:

a sensing electromagnetic coil in proximity with the first and second conductivity cells at a sensing location, the first conductivity cell being oriented with respect to the second conductivity cell at the sensing location with the electrical direction of the first electrical current with respect to the sensing electromagnetic coil opposite the electrical direction of the second electrical current with respect to the sensing electromagnetic coil.

26. An apparatus as defined in claim 17 wherein:

the zone of the vessel is a surgically formed fistula;

the first conduit is an outlet line of a medical device for blood processing;

the second conduit is an inlet line of the medical device for blood processing;

the first fluid is blood processed by the medical device for blood treatment; and

the second fluid is blood to be processed by the medical device for blood processing.

27. An apparatus as defined in claim 26 wherein the medical device for blood processing is a hemodialysis device.

28. An apparatus as defined in claim 26 wherein the means for altering the conductivity of the first fluid further comprises:

a hypodermic needle access site at a point in the outlet line before the blood passes through the first conductivity cell.

15. An apparatus for quantitatively determining a degree of recirculation flow within a zone of a vessel into which a first fluid having a first electrical conductivity is being inserted and from which a second fluid having a second electrical conductivity is simultaneously being withdrawn, comprising:

means for altering the electrical conductivity of the first fluid; and

means for measuring the electrical conductivity of the first fluid after the conductivity is altered and before the first fluid is inserted into the zone of the vessel, for measuring the electrical conductivity of the second fluid after it is withdrawn from the zone of the vessel, and for comparing the conductivity of the first fluid with the conductivity of the second fluid to quantitatively determine the degree of recirculation flow in the zone of the vessel.

16. An apparatus as defined in claim 15 wherein:

the means for altering the electrical conductivity of the first fluid further comprises;

means for injecting a marker fluid having an electrical conductivity different than the conductivity of the first fluid into the first fluid.

38. An apparatus as defined in claim 15 further comprising:

a tubing set wherein the means for measuring the electrical conductivity of the first fluid after the conductivity is altered and before it is inserted into the zone of the vessel, for measuring the electrical conductivity of the second fluid after it is withdrawn from the zone of the vessel, and for comparing the conductivity of the first fluid with the conductivity of the second fluid comprises;

a first conduit adapted to convey the flow of the first fluid after its conductivity is altered and before it is inserted into the zone of the vessel and within which the conductivity of the first fluid is measured, said first conduit comprising a first conductivity cell with a first conductivity cell upstream connection, a first conductivity cell downstream connection, and two branches connecting the upstream connection to the downstream connection with a continuous path configuration from the upstream connection to the downstream connection through one of the two branches and returning to the upstream connection through the other one of the two branches; and

a second conduit adapted to convey the flow of the second fluid after it is withdrawn from the zone of the vessel and within which the conductivity of the second fluid is measured, said second conduit comprising a second conductivity cell with a second conductivity cell upstream connection, a second conductivity cell downstream connection, and two branches connecting the upstream connection to the downstream connection with a continuous path configuration from the upstream connection to the downstream connection through one of the two branches and returning to the upstream connection through the other one of the two branches.

39. An apparatus as defined in claim 38 wherein the first conductivity cell is adjacent to the second conductivity cell at a first junction in a generally parallel relationship.

40. An apparatus as defined in claim 39 wherein the first conductivity cell is adjacent to the second conductivity cell at a second junction in a generally angular relationship.

41. An apparatus as defined in claim 40 wherein:

each of the first and the second conductivity cells comprise tubing with cross-sectional configuration defined by a generally semicircular sidewall and an adjacent flat sidewall;

the flat sidewall of the first conductivity cell adjoins the flat sidewall of the second conductivity cell at the first junction; and

the flat sidewall of the first conductivity cell adjoins the flat sidewall of the second conductivity cell at the second junction.

42. An apparatus as defined in claim 38 wherein:

the zone of the vessel is a surgically formed arteriovenous fistula;

the first conduit is an outlet line of a medical device for blood processing; and

the second conduit is an inlet line of the medical device for blood processing.

43. An apparatus as defined in claim 42 wherein the medical device for blood processing is a hemodialysis device.

44. An apparatus as defined in claim 38 wherein:

the means for altering the electrical conductivity of the first fluid comprises;

a hypodermic needle access site in the first conduit of the tubing set in fluid communication with the first conductivity cell upstream connection.

29. An apparatus for determining a degree of recirculation flow of blood in a surgically formed fistula in a patient, the fistula being connected to a blood processing device by an inlet conduit for withdrawing blood from the fistula and delivering the blood to the blood processing device and an outlet conduit for returning blood to the fistula from the blood processing device, comprising:

an outlet conductivity cell formed in the outlet conduit, the outlet conductivity cell having an upstream connection in fluid communication with the blood processing device, a downstream connection in fluid communication with the fistula and two branches connecting the upstream connection to the downstream connection with a continuous path configuration from the upstream connection to the downstream connection through one of the two branches and returning to the upstream connection through the other one of the two branches;

an inlet conductivity cell formed in the inlet conduit, the arterial conductivity cell having an upstream connection in fluid communication with the fistula, a downstream connection in fluid communication with the blood processing device and two branches connecting the upstream connection to the downstream connection with a continuous path configuration from the upstream connection to the downstream connection through one of the two branches and returning to the upstream connection through the other one of the two branches;

a hypodermic needle access site in the inlet conduit located between the upstream connection of the inlet conductivity cell and the blood processing means;

an exciting electromagnetic coil encircling one of the branches of the outlet conductivity cell at an exciting location and one of the branches of the inlet conductivity cell at the exciting location to induce a first electrical current in blood in the outlet conductivity cell in an electrical direction with respect to the exciting coil and to induce a second electrical current in blood in the inlet conductivity cell in the same electrical direction with respect to the exciting coil as the first electrical current;

a sensing electromagnetic coil encircling the other one of the branches of the outlet conductivity cell at a sensing location and the other one of the branches of the inlet conductivity cell at the sensing location, the other branches being oriented with the first electrical current and the second electrical current in opposite electrical directions with respect to the sensing coil; and

means electrically connected to the sensing electromagnetic coil for producing a signal representative of the difference between the magnitude of the first electrical current and the magnitude of the second electrical current.

30. An apparatus as defined in claim 29 wherein:

the electrical direction of each of the first and second electrical currents alternates with respect to the exciting coil.

31. An apparatus as defined in claim 29 wherein:

the exciting electromagnetic coil defines a window through which one branch of each of the outlet and inlet conductivity cells pass;

the sensing electromagnetic coil defines a window through which the other branch of each of the outlet and inlet conductivity cells pass; and

each one of the sensing and the exciting electromagnetic coils comprises a front and a rear half core, separable to insert the corresponding branch of each of the outlet and inlet conductivity cells into the window of the coil and to remove the corresponding branch of each of the conductivity cells from the window of the coil.

32. An apparatus as defined in claim 31 further comprising:

a front acceptor plate having a rear side to which the sensing coil front half core and the exciting coil front half core are mounted, each half core being mounted so that the window is formed to the rear of the front half core;

a rear acceptor plate having a front side to which the sensing coil rear half core and the exciting coil rear half core are mounted, each half core being mounted so that the window is formed to the front of the rear half core; and

joining means for joining the front half plate to the rear half plate in a parallel relationship with the front half core of the exciting coil mated with the rear half core of the exciting coil and the front half core of the sensing coil mated with the rear half core of the sensing coil.

33. An apparatus as defined in claim 29 wherein the blood processing device is a hemodialysis device.

34. A method for quantitatively determining a degree of recirculation flow of fluids having a physical property within a zone of a vessel into which a first fluid having a first initial value of the physical property is being inserted and from which a second fluid having a second initial value of the physical property is simultaneously being withdrawn, comprising:

altering the value of the physical property of the first fluid;

measuring the value of the physical property of the first fluid after the value of the physical property is altered and before the first fluid is inserted into the zone of the vessel;

measuring the value of the physical property of the second fluid after it is withdrawn from the zone of the vessel; and

comparing the measured altered value of the physical property of the first fluid with the measured value of the physical property of the second fluid to quantitatively determine the degree of recirculation flow in the zone of the vessel.

35. A method as defined in claim 34 wherein:

the step of altering the value of the physical property of the first fluid further comprises;

injecting a marker fluid having a value of the physical property different from the value of the physical property of the first fluid.

36. An apparatus for determining a degree of recirculation flow of fluids having a physical property within a zone of a vessel into which a first fluid having a first initial value of the physical property is being inserted and from which a second fluid having a value of the physical property is simultaneously being withdrawn, comprising:

means for altering the value of the physical property of the first fluid;

means for measuring the value of the physical property of the first fluid after the value of the property is altered and before the first fluid is inserted into the zone of the vessel;

means for measuring the value of the physical property of the second fluid after it is withdrawn from the zone of the vessel; and

means for comparing the measured altered value of the physical property of the first fluid with the measured value of the physical property of the second fluid to quantitatively determine the degree of recirculation flow in the zone of the vessel.

37. An apparatus as defined in claim 36 wherein:

the means for altering the value of the physical property of the first fluid further comprises;

means for injecting a marker fluid having a value of the physical property different than the first initial value of the physical property.