Disposable extracorporeal conduit for blood constituent monitoring

• US 5,456,253 A
• Filed: 09/27/1994
• Issued: 10/10/1995
• Est. Priority Date: 10/06/1990
• Status: Expired due to Term

• Current Assignee: Fresenius Medical Care Holdings Incorporated (Fresenius Medical Care AG)
• Original Assignee: In-Line Diagnostics Corp.
• Inventors: Harris, David H., Steuer, Robert R.
• Primary Examiner(s): Sykes, Angela D.
• Application Number:
  US08/312,712
• Time in Patent Office: 378 Days
• Field of Search: 128/632-634, 128/637, 128/664-667, 128/673, 128/675, 128/748, 356/39-41
• US Class Current: 600/322
• CPC Class Codes: A61B 5/14535 for measuring haematocrit
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/14557 specially adapted to extracorporeal circuits
• CPC Class Codes: A61B 5/6826 Finger
• CPC Class Codes: A61B 5/6838 Clamps or clips
• CPC Class Codes: A61B 5/6843 Monitoring or controlling sensor contact pressure
• CPC Class Codes: A61M 1/361 before treatment
• CPC Class Codes: A61M 1/3612 after treatment
• CPC Class Codes: G01N 2021/036 transformable, modifiable
• CPC Class Codes: G01N 21/0303 Optical path conditioning in cuvettes, e.g. windows; adapted optical elements or systems; path modifying or adjustment G01N21/031 - G01N21/15 take precedence

Abstract

A disposable cuvette through which to pass pulsatile flowing blood. The cuvette has a conduit with two opposed walls having a predetermined separation therebetween that varies with each pulse of the flowing blood. A sealed air pocket damps the variation of the predetermined separation. The conduit is comprised of materials which permit passage therethrough of wavelengths of selected electromagnetic radiation. The radiation is emitted from a photoemitter which, and after passing through the cuvette, is detected by a photodetector. The quantities of detected radiation are operated on by a computer which uses a spectrophotometry technique to derive therefrom a blood constituent concentration value. Preferably, both cuvette and spectrophotometry technique are used during hemodialysis to derive changes in the hematocrit value of the blood of a dialyzed patient, thereby to deduce therefrom changes in the blood volume of the patient during dialysis. The technique enables a clinician to monitor a desired biologic constituent concentration value, such as the hematocrit, oxygen saturation, or oxygen content values by deriving and displaying the same as digital values in real time.

Claims

1. A system for determining a concentration of a biologic constituent present in the blood of a patient undergoing a hemodialysis treatment, the hemodialysis treatment incorporating a dialyzer means for cleaning the blood of the patient, a pump means, and an input and an output catheter means for respectively conducting the blood of the patient from the patient to an input port of the dialyzer means and from an output port of the dialyzer means back to the patient, the pump means being for pumping the blood of the patient in a pulsatile fashion into the input port of the dialyzer through the input catheter means and out of the output port of the dialyzer means through the output catheter means, the system comprising:

a. a first spectrophotometry means for defining a blood flow path, for emitting radiation into the blood in the flow path, and for detecting radiation passing through both the blood and the flow path, comprising;

i. cuvette means, in fluid communication with the dialyzer means, for defining a fluid passageway which contains and conducts therethrough the blood flowing in a pulsatile fashion, and comprising;

(1) an inlet;

(2) an outlet;

(3) a conduit, in fluid communication both between and with said inlet and outlet and being comprised of materials which permit transmission of electromagnetic radiation at a first and a second radiation wavelength therethrough, comprising;

(a) first and second opposed walls, having a predetermined separation therebetween, and constraining the pulsatile flowing fluid therebetween; and

(b) a transducer means, located in said first wall of said conduit, for varying said predetermined separation responsive to pressure pulsations in the fluid;

ii. emitter-sensor means for emitting radiation into the blood in the flow path, and for sensing radiation passing through both the blood and the cuvette means, comprising;

(1) emission means for directing radiation at said first and second wavelengths into the pulsatile flowing blood within the cuvette means, said emission means being situated so as to direct said radiation into the conduit of said cuvette means, said radiation directed by said emission means defining a directed radiation comprising;

(a) a first quantity of a radiation at said first radiation wavelength which, when directed into the flowing blood,

(i) has a first extinguishment value which varies with the desired biologic constituent concentration in the flowing blood; and

(ii) has a second extinguishment value which varies with the concentration of components other than the desired biologic constituent in the flowing blood, which second extinguishment value is at least ten times smaller than said first extinguishment value; and

(b) a first quantity of a radiation at said second radiation wavelength, distinct from said first wavelength, which, when directed into the flowing blood;

(i) has a third extinguishment value which for varying concentrations in the flowing blood of the desired blood constituent is a non fixed multiple of said first extinguishment value; and

(ii) has a fourth extinguishment value which varies with the concentration of components other than the desired biologic constituent in the flowing blood, which fourth extinguishment value is at least ten times greater than said second extinguishment value;

(c) detection means for detecting the portion of said directed radiation which passes through both said conduit of said cuvette means and the pulsatile flowing blood therein, said detection means being situated so as to detect said radiation passing through the conduit of said cuvette means, the detected portion of each said directed radiation comprising;

(i) a second quantity of a radiation at the first radiation wavelength; and

(ii) a second quantity of a radiation at the second radiation wavelength; and

(2) calculation means, in electrical communication with said first spectrophotometry means, for determining the desired biologic constituent concentration by operating on the second quantities of the first and second radiation wavelengths.

2. The system as defined in claim 1, wherein the conduit further comprises means, responsive to pressure pulsations in the fluid, for damping the variations of the predetermined separation.

3. The system as defined in claim 1, wherein said conduit further comprises a third wall, said first wall being disposed between said second and third walls, said third wall and said transducer means having a means, situated therebetween and responsive to pressure pulsations in the fluid, for damping the variations of the predetermined separation.

4. The system as defined in claim 3, wherein said second and third walls are essentially immobile with respect to said transducer means for each pulse of said pulsatile flowing blood.

5. A system as defined in claim 1, further comprising a second spectrophotometry means, in electrical communication with said calculation means, being situated in fluid communication with said output catheter means and downstream of said dialyzer means, said first spectrophotometry means being situated in fluid communication with said input catheter means and upstream of said dialyzer means, whereby said calculator means determines the desired biologic constituent concentration in the blood of the patient, both before and after the dialyzer means, by operating on the second quantities of the first and second radiation wavelengths respectively detected by the first and second spectrophotometry means.

6. A system as defined in claim 1, wherein the second radiation wavelength has a third extinguishment value substantially the same amount for oxyhemoglobin and for reduced hemoglobin in the flowing blood and has a fourth extinguishment value, which is approximately the same as said third extinguishment value for the plasma in the flowing blood.

7. A system as defined in claim 1, wherein the first radiation wavelength is in the range from about 780 nanometers to about 850 nanometers and the second radiation wavelength is in the range from about 1200 nanometers to about 1600 nanometers.

8. A system as defined in claim 1, wherein the first radiation wavelength is in the range from about 520 nanometers to about 600 nanometers and the second radiation wavelength is in the range from about 1200 nanometers to about 1600 nanometers.

9. A system as defined in claim 1, wherein the flowing blood includes a competing biologic constituent relative to the hemoglobin in the flowing blood, wherein:

a. said directed radiation further comprises a first quantity of a radiation at a third radiation wavelength, distinct from said first and second radiation wavelengths and transmissive through the conduit of said cuvette means, and which, when directed into the flowing blood in said cuvette means;

i. has a fifth extinguishment value which varies with the competing biologic constituent concentration in the flowing blood, said fifth extinguishment value being at least five times greater than said second extinguishment value; and

ii. has a sixth extinguishment value which varies with the concentration of components other than the competing biologic constituent concentration in the flowing blood;

b. said detected portion of said directed radiation further comprises a second quantity of a radiation at the third radiation wavelength;

c. said calculation means mathematically operating on the second quantities of the first, second, and third radiation wavelengths;

i. such that the spatial, geometric, and tissue variations are eliminated in each radiation wavelength; and

ii. to compensate for the effect of the competing biologic constituent.

10. A system as defined in claim 9, wherein the third radiation wavelength is extinguished approximately the same amount by oxyhemoglobin and reduced hemoglobin in the flowing blood and is substantially extinguished by plasma in the flowing blood.

11. A system as defined in claim 9, wherein the third radiation wavelength is in the range from about 900 nanometers to about 1000 nanometers.

12. A system as defined in claim 9, wherein:

a. said directed radiation further comprises a first quantity of a radiation at a fourth radiation wavelength, distinct from said first, second and third radiation wavelengths and transmissive through the conduit of said cuvette means, which when directed into the flowing blood in said cuvette means;

i. has a seventh extinguishment value which varies substantially with the oxyhemoglobin and reduced oxyhemoglobin concentrations in the flowing blood; and

which

ii. has an eighth extinguishment value, which is at least ten times smaller than said seventh extinguishment value for the plasma in the flowing blood;

b. said detected portion of said directed radiation further comprises a second quantity of a radiation at the fourth radiation wavelength;

c. and wherein said calculation means;

i. mathematically operates on the second quantity of the fourth radiation wavelength such that the spatial, geometric, and tissue variations are eliminated in the fourth radiation wavelength; and

ii. determines a blood oxygen saturation value which is independent of hematocrit by mathematically operating on the second quantities of the first, second, third, and fourth radiation wavelengths.

13. A system as defined in claim 12, wherein the fourth radiation wavelength is in the range from about 600 nanometers to about 700 nanometers.

14. A system as defined in claim 9, wherein:

a. said directed radiation further comprises a first quantity of a radiation at a fourth radiation wavelength, distinct from said first, second and third radiation wavelengths, which when directed into the flowing blood in said cuvette means;

i. has a seventh extinguishment value which varies substantially with the oxyhemoglobin and reduced hemoglobin concentrations in the flowing blood, and which

ii. has an eighth extinguishment value, which is at least ten times smaller than said seventh extinguishment value for the plasma in the flowing blood;

b. said detected portion of said directed radiation further comprises a second quantity of a radiation at the fourth radiation wavelength;

c. and wherein said calculation means;

i. mathematically operates on the second quantity of the fourth radiation wavelength such that the spatial, geometric, and tissue variations are eliminated in the fourth radiation wavelength; and

ii. determines a blood oxygen saturation value which is independent of hematocrit by mathematically operating on the second quantities of the first, second, third, and fourth radiation wavelengths.

15. A system as defined in claim 14, wherein the fourth radiation wavelength is in the range from about 600 nanometers to about 700 nanometers.