System and method for noninvasive hemodynamic measurements in hemodialysis shunts

• US 6,582,656 B1
• Filed: 03/28/2000
• Issued: 06/24/2003
• Est. Priority Date: 10/23/1996
• Status: Expired due to Fees

• Current Assignee: HEMA Metrics Incorporated
• Original Assignee: In-Line Diagnostics Corp.
• Inventors: Miller, David R., Steuer, Robert R.
• Primary Examiner(s): Sykes; Angela D.
• Assistant Examiner(s): Bianco; Patricia
• Application Number:
  US09/536,475
• Time in Patent Office: 1,183 Days
• Field of Search: 604/4.01,5.01,6.01,6.16,65,6.11,8,19,28 422/44,82.09 600/366,368-70,454,504 128/898 210/646-47,745,94,96.1,96.2,321.71,805,739,138-39,321.6 436/56,68 73/861.07-861.08,861.11,861.16,53.01,54.15,54.17,61.64,863
• US Class Current: 422/44
• 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 measuring access recirculation in a dialysis system having arterial and venous tubing lines, said method comprising the steps of:

ensuring that the ultrafiltration is off;

changing a blood parameter in the arterial line over a first period of time;

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

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

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 access recirculation.

2. The method of claim 1 further comprising the steps of:

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

3. The method of claim 2, wherein said factor is 100.

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

changing a blood parameter in the arterial line over a first period of time;

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

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

comparing the changed blood parameter in the aterial 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; and

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.

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

changing a blood parameter in the venuous 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 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.