Method of measuring transcutaneous access blood flow

• US 6,746,407 B2
• Filed: 12/29/2000
• Issued: 06/08/2004
• Est. Priority Date: 12/29/2000
• Status: Expired due to Term

• Current Assignee: Fresenius Medical Care Holdings Incorporated (Fresenius SE & Co. KGaA)
• Original Assignee: HEMA Metrics Incorporated
• Inventors: Miller, David R., Bell, David A., Steuer, Robert R.
• Primary Examiner(s): Nasser, Robert L.
• Application Number:
  US09/750,122
• Publication Number:
  US 20020128545A1
• Time in Patent Office: 1,257 Days
• Field of Search: 600/504, 600/505, 738/61, 604/4
• US Class Current: 600/505
• CPC Class Codes: A61B 5/0275 using tracers, e.g. dye dilution
• CPC Class Codes: A61M 1/3609 Physical characteristics of the blood, e.g. haematocrit, urea
• 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 1/3656 Monitoring patency or flow at connection sites; Detecting disconnections

Abstract

Indicator dilution techniques are used to measure vascular access flow rates during routine hemodialysis. A bolus injection port is used to infuse a specific volume (V_i) of an indicator diluent, such as saline or dye, into the patient cardiovascular circuit by one of the following:

1. Needle injection of a known volume (bolus) of indicator diluent directly into the access site in the presence or absence of the hemodialysis circuit.

2. Infusion of an indicator diluent into the arterial, venous line upstream of the venous needle.

3. Turning the ultrafiltration of the dialysis delivery system from OFF to ON and OFF again over a predetermined time period.

4. In a hemodialysis circuit, turning on the hemodialysis pump and using the priming saline volume as a single saline bolus.

A transdermal sensor is used to measure the percent change in a blood parameter. The sensor is positioned directly over the vascular access site a prescribed distance downstream of the injection site and upstream of the access-vein connection. The sensor employs emitter and detector elements at multiple spacings (d₁, d₂) for the purpose of measuring the bulk absorptivity (α) of the area immediately surrounding and including the access site, and the absorptivity (α_o) of the tissue itself.

Claims

1. A method of transcutaneously measuring access blood flow comprising the steps of:

infusing a specific volume (V_i) of an indicator diluent into a patient cardiovascular circuit at an access site in the absence of a hemodialysis circuit to effect a change in a blood parameter; and

using a transdermal sensor to measure the percent change in the parameter.

2. The method of claim 1, wherein the blood parameter is selected from the group consisting of bulk density, flow energy, hematocrit, and red cell oxygen content.

3. The method of claim 1, wherein the transdermal sensor is placed over the access site.

4. The method of claim 1, wherein the blood parameter is macroscopic.

5. The method of claim 1, wherein the blood parameter is microscopic.

6. A method of measuring a blood parameter transcutaneously in an access site of a patient comprising the steps of:

placing on the skin of the patient a sensor having a field of view so that at least a portion of the access site is within the field of view of the sensor and the tissue surrounding the access site occupies the remainder of the field of view;

injecting a diluent into the access site upstream of the sensor at an average flow rate, the diluent chosen to alter the blood parameter to be measured;

measuring a first bulk attenuation coefficient of the field of view containing both the access site portion and the surrounding tissue;

measuring a second bulk attenuation coefficient of only the tissue surrounding the access site; and

calculating the blood parameter based on the measured first and second bulk attenuation coefficients.

7. The method of claim 6, wherein the blood parameter is Hermatocrit.

8. The method of claim 6, wherein the access site is a fistula.

9. The method of claim 6, wherein the access site is a shunt.