System and method for noninvasive hemodynamic measurements in hemodialysis shunts

• US 6,117,099 A
• Filed: 12/03/1997
• Issued: 09/12/2000
• Est. Priority Date: 10/23/1996
• Status: Expired due to Term

• Current Assignee: Fresenius Medical Care Holdings Incorporated (Fresenius SE & Co. KGaA)
• Original Assignee: In-Line Diagnostics Corp.
• Inventors: Miller, David R., Steuer, Robert R.
• Primary Examiner(s): BIANCO, PATRICIA
• Assistant Examiner(s): Huseman, Cheryl L
• Application Number:
  US08/984,095
• Time in Patent Office: 1,014 Days
• Field of Search: 604/4, 422/44
• US Class Current: 604/4.01
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/361 before treatment
• CPC Class Codes: A61M 1/3612 after treatment
• CPC Class Codes: A61M 1/3621 Extra-corporeal blood circuits single-needle circuits A61M1/30
• 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 1/3649 using dialysate as priming or rinsing liquid
• 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 1/3659 Cannulae pertaining to extracorporeal circulation
• CPC Class Codes: A61M 1/3661 for haemodialysis
• CPC Class Codes: A61M 1/3663 Flow rate transducers; Flow integrators
• CPC Class Codes: A61M 2205/3306 Optical measuring means

Abstract

Access recirculation in a shunt is determined quantitatively by a method in which a standard solution, such as a saline, is injected into a patient'"'"'s bloodstream upstream of the shunt. At a point in the access line, a photometric measurement is conducted of the change in hematocrit (ΔH) with respect to time. Electronic circuitry receives signals from the detector and compares the integrated area of ΔH with respect to time of the standard solution initially flowing through the access and of the recirculated solution and provides display of access recirculation. In another aspect, access recirculation and access blood flow are quantitatively determined without injecting a solution into the bloodstream. In this aspect the extent of access recirculation and/or access blood flow is determined quantitatively by a method in which the dialyzer blood flow rate or the ultrafiltration rate (UFR) is changed and the corresponding change in concentration of a blood constituent is measured. In this technique, the concentration of a blood constituent is measured as a function of dialyzer blood flow rate or UFR and electronic circuitry converts these measurements into quantitative determinations of access recirculation and/or access blood flow that can be displayed.

Claims

1. A method for determining access blood flow (Q_a) in a dialysis system having arterial and venous tubing lines reversed, said method comprising the steps of:

selecting an initial ultrafiltration rate (UFR);

measuring the post dialyzer hematocrit, H_a, at the initial UFR;

changing the value of the UFR to a second UFR;

measuring a post dialyzer hematocrit, H_o, at the second UFR with the dialyzer blood flow being fixed and known; and

solving the equation ##EQU6##

2. The method of claim 1, wherein said dialyzer blood flow rate is known by measurement.

3. A method for determining access blood flow (Q_a) in a dialysis system having arterial and venous tubing lines reversed, said method comprising the steps of:

selecting an initial ultrafiltration rate (UFR);

measuring a pre-dialyzer hematocrit, H_a, at the initial UFR;

changing the value of the UFR to a second UFR;

measuring a pre-dialyzer hematocrit, H_i, at the second UFR; and

solving the equation Q_a =H_i (UFR)/(H_i -H_a).

4. A method for measuring access recirculation in a dialysis system having arterial and venous tubing lines, said method comprising the steps of:

ensuring that ultrafiltration is off;

introducing a predetermined amount of saline into an injection site in the arterial line over a predetermined period of time;

measuring a percentage change in hematocrit over a first period of time;

measuring a percentage change in hematocrit over a second period of time taking place after the first period of time; and

comparing the measured change in hematocrit over the second period of time to the measured change in hematocrit over the first period of time to yield a signal that is directly proportional to access recirculation.

5. The method for claim 4, further comprising the steps of:

measuring the area (Area_m) under a curve that is indicative of the percentage change in hematocrit over the first and second periods of time;

determining the uncorrected blood flow rate (Q_i (raw));

determining the area of push rate of the saline injection (Area_p) as a function of Q_i (raw) and span where span equals the time interval from the start of the saline injection to the end of the injection, in seconds;

measuring the volume of the injected saline;

dividing the volume of the injected saline by (Area_m -Area_p) times a measurement unit conversion factor to yield a result that is indicative of the corrected blood flow rate.

6. The method of claim 5, wherein the uncorrected blood flow rate (Q_i (raw)) is determined from the Area_m value.

7. The method of claim 5, wherein the step of determining the Area_p includes solving the formula Area_p =[(-0.018)Q_i (raw)+1.22][-(2013/span)-Q_i (raw)(0.3661)].

8. The method of claim 4 further comprising the steps of:

multiplying the signal by a predetermined factor to yield percentage change in access recirculation.

9. The method of claim 8, wherein said factor is 100.

10. The method of claim 4, further comprising the step of locating a blood chamber in the arterial line downstream from the point of introduction of the saline into the arterial line;

and

carrying out each of the two measuring steps by photometrically measuring hematocrit for the blood passing through the chamber.

11. A method for measuring dialyzer blood flow in a dialysis system having arterial and venous tubing lines, said method comprising the steps of:

introducing a predetermined amount of saline into the arterial line over a predetermined period of time;

measuring the percentage change in hematocrit over a first period of time;

comparing the volume of saline introduced to the product of the measured change in hematocrit over the first period of time and a predetermined conversion factor to yield a signal that is indicative of dialyzer blood flow rate.

12. A method for measuring priming dialyzer circuit volume in a dialysis system having arterial and venous tubing lines, said method comprising the steps of:

introducing a predetermined amount of saline into the arterial line over a first period of time;

measuring the percentage change in hematocrit over a second period of time;

measuring the percentage change in hematocrit over a third period of time;

comparing the volume of saline introduced into the arterial line to the product of the measured change in hematocrit over the first period of time and a predetermined conversion factor to yield a signal that is indicative of dialyzer blood flow rate;

multiplying the dialyzer blood flow rate by the sum of the first, second and third periods of time and dividing the result by 60 to yield a signal that is indicative of the priming dialysis circuit volume.

13. A method for eliminating injection-induced transients when injecting a solution into an arterial or venous line, the method comprising the steps of:

ensuring that ultrafiltration is off;

introducing a predetermined amount of a solution into at least one of the arterial and venous lines over a predetermined period of time;

measuring the area (Area_m) under a curve that is indicative of the percentage change in hematocrit over a period of time;

determining the uncorrected blood flow rate (Q_i (raw));

determining the area of push rate of the solution injection (Area_p) as a function of Q_i (raw) and span where span equals the time interval from the start of the solution injection to the end of the injection, in seconds;

measuring the volume of the injected solution;

dividing the volume of the injected solution by (Area_m -Area_p) times a measurement unit conversion factor to yield a result that is indicative of the corrected blood flow rate.

14. The method of claim 13, wherein the uncorrected blood flow rate (Q_i (raw)) is determined from the Area_m value.

15. The method of claim 13, wherein the step of determining the Area_p includes solving the formula Area_p =[(-0.018)Q_i (raw)+1.22][-(2013/span)-Q_i (raw)(0.3661)].

16. A method for determining percentage access recirculation (AR) in a dialysis system having arterial and venous tubing lines, said method comprising the steps of:

selecting an initial ultrafiltration rate (UFR);

measuring an initial dialyzer blood flow rate (Q_i);

determining the access hematocrit (H_a) at either the initial UFR or the initial dialyzer blood flow rate;

changing one of the UFR or the dialyzer blood flow rate to a second value;

measuring the arterial hematocrit (H_i) at the second value;

computing percentage access recirculation (AR) as a function of a change in either the UFR or the dialyzer blood flow rate.

17. The method of claim 16, wherein said step of measuring dialyzer blood flow comprises the steps of:

selecting an initial UFR;

determining the pre and post dialyzer hematocrit values; and

solving Q_i =UFR/(1-H_i /H_a).

18. The method of claim 16, said step of computing percentage access recirculation comprises the steps of:

solving the equation AR=100(H_i -H_a)[(Q_i /Q_i -UFR))H_i -H_a ]^-1.

19. A method for measuring access blood flow in a dialysis system having arterial and venous tubing lines, said method comprising the steps of:

introducing a predetermined amount of saline into the venous line over a first period of time;

determining dialyzer blood flow rate;

measuring the percentage change in hematocrit over a second period of time;

measuring the percentage change in hematocrit over a third period of time;

comparing the measured change in hematocrit over the third period of time to the measured change in hematocrit over the second period of time to yield a signal that is directly proportional to reversed access recirculation (RAR);

subtracting the 1 from the inverse of the RAR and multiplying that result by the dialyzer blood flow rate to yield a signal indicative of access blood flow rate.

20. A method for determining access blood flow in a dialysis system having arterial and venous tubing lines, said method comprising the steps of:

selecting an initial ultrafiltration rate (UFR);

determining the access hematocrit at the initial UFR;

changing the value of the UFR to a second UFR;

measuring the arterial hematocrit at the second UFR;

multiplying the arterial hematocrit by the second UFR and dividing the result by the arterial hematocrit minus the access hematocrit to compute the access blood flow.

21. A method for determining percentage access recirculation (AR) in a dialysis system having arterial and venous tubing lines, said method comprising the steps of:

selecting an initial ultrafiltration rate (UFR);

measuring an initial dialyzer blood flow rate (Q_i);

determining the access hematocrit (H_a) at either the initial UFR or the initial dialyzer blood flow rate;

changing one of the UFR or the dialyzer blood flow rate to a second value;

measuring the arterial hematocrit (H_i) at the second value;

computing percentage access recirculation (AR) as a function of a change in either the UFR or the dialyzer blood flow rate.

22. The method of claim 21, wherein said step of measuring dialyzer blood flow comprises the steps of:

measuring a percentage change in hematocrit over a first period of time;

comparing the volume of saline introduced to the product of the measured change in hematocrit over the first period of time and a predetermined conversion factor to yield a signal that is indicative of dialyzer blood flow rate.

23. The method of claim 21, wherein said step of computing percentage access recirculation comprises the steps of:

solving the equation AR=100(H_i -H_a)[(Q_i /Q_i -UFR)H_i -H_a ]^-1.