Method and apparatus for measuring the presence and concentration of pharmaceutical substances in a medical fluid administered by a medication delivery system

• US 8,094,307 B2
• Filed: 07/05/2007
• Issued: 01/10/2012
• Est. Priority Date: 07/05/2007
• Status: Active Grant

• Current Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Original Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Inventors: Slepicka, James S.
• Primary Examiner(s): Chowdhury, Tarifur
• Assistant Examiner(s): Pajoohi, Tara S
• Application Number:
  US11/773,581
• Publication Number:
  US 20090009764A1
• Time in Patent Office: 1,650 Days
• Field of Search: 356 36- 42, 356335-343, 3562431-246
• US Class Current: 356/364
• CPC Class Codes: A61M 1/152 Details related to the interface between cassette and machine
• CPC Class Codes: A61M 1/1561 at least one cassette surface or portion thereof being flexible, e.g. the cassette having a rigid base portion with preformed channels and being covered with a foil
• CPC Class Codes: A61M 1/159 specially adapted for peritoneal dialysis
• CPC Class Codes: A61M 1/28 Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
• CPC Class Codes: A61M 1/288 Priming priming in extracorporeal blood circuits A61M1/3643
• CPC Class Codes: A61M 2205/123 with incorporated reservoirs
• CPC Class Codes: A61M 2205/125 with incorporated filters
• CPC Class Codes: A61M 2205/128 with incorporated valves
• CPC Class Codes: A61M 2205/3306 Optical measuring means
• CPC Class Codes: A61M 2205/3313 used specific wavelengths
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps
• CPC Class Codes: G01N 2021/4153 Measuring the deflection of light in refractometers
• CPC Class Codes: G01N 21/05 Flow-through cuvettes G01N21/09 takes precedence; handling fluid samples G01N1/10
• CPC Class Codes: G01N 21/21 Polarisation-affecting properties G01N21/19 takes precedence
• CPC Class Codes: G01N 21/274 Calibration, base line adjustment, drift correction
• CPC Class Codes: G01N 21/4133 Refractometers, e.g. differential
• CPC Class Codes: G01N 21/4788 Diffraction for sizing particles G01N15/0205

Abstract

Test equipment determines the contents of medical fluids to be delivered to a patient by a medication delivery system by measuring optical properties of the fluids. One system provides a non-invasive test that uses optical rotation caused by optically active pharmaceutical substances to determine the presence or absence of the pharmaceutical substances within a medical fluid. Another system provides a non-invasive test that uses refractive index properties to determine the concentration of a pharmaceutical substance within the fluid. A method for use is also disclosed.

Claims

1. A system for detecting a presence of a pharmaceutical substance during a medical therapy, comprising:

a light source configured to generate a light beam;

a prism for receiving the light beam from the light source, the prism adjacent the medical fluid;

a polarization rotator disposed between the light source and the medical fluid;

a first photodetector and a second photodetector to provide a measurement of an intensity of a portion of the light beam influenced by contact with the medical fluid; and

a computer configured to use the measurement of the intensity to perform a matching check to determine whether the pharmaceutical substance is present in the medical fluid.

2. The system of claim 1, wherein the first photodetector is positioned to receive and measure an intensity of light from the light beam that is transmitted through the prism and the medical fluid and the second photodetector is positioned to receive and measure an intensity of light from the light beam that is reflected or refracted by the prism or by the prism and the medical fluid.

3. The system of claim 1,wherein the light beam generated by the light source is randomly polarized or has a wavelength from about 350 to about 900 nm.

4. The system of claim 1, further including a polarizer disposed between the light source and the medical fluid, wherein the polarizer is at least one of:

(i) configured to polarize the light beam prior to the light beam being transmitted through the medical fluid; and

(ii) configured to polarize the light beam at a 90°

angle relative to the first polarizer.

5. The system of claim 1, wherein the polarization rotator is a liquid crystal device.

6. The system of claim 1, wherein the photodetectors are selected from the group consisting of silicon photodiodes and photodetector arrays.

7. The system of claim 1, further including a narrow pass filter between the medical fluid and at least one of the photodetectors configured to filter out ambient light or to pass a particular wavelength.

8. The system of claim 1, wherein the medical fluid is contained within tubing.

9. The system of claim 1, wherein an interface surface of the prism is oriented at an angle to the light beam selected from the group consisting of 45 degrees and Brewster'"'"'s angle.

10. The system of claim 1, wherein the computer is configured to generate an output signal to a medication delivery system to provide an alert or to prevent the medication delivery system from delivering the medical fluid to a patient if the matching check determines that the pharmaceutical substance is present in the medical fluid in a concentration higher or lower than preset limits.

11. The system of claim 1, wherein the computer is at least one of:

(i) configured to utilize the measurement of intensity to calculate a concentration of a phannaceutical substance within the medical fluid;

(ii) configured to include a memory having a look-up table stored therein, wherein the look-up table includes an acceptable range of calculated concentrations of the pharmaceutical substance within the medical fluid;

(iii) configured to be operatively connected to an externally located database having a look-up table stored therein, wherein the look-up table includes an acceptable range of calculated concentrations of the pharmaceutical substance within the medical fluid;

(iv) configured to generate an output signal to the medication delivery system to provide an alert or to prevent the medical fluid from being delivered to a patient if the calculated concentration of the pharmaceutical substance is outside an acceptable range; and

(v) configured to generate an output signal to the medication delivery system to proceed with normal function if the calculated concentration of the pharmaceutical substance is within an acceptable range.

12. The system of claim 1, wherein the polarization rotator is a first polarization rotator disposed between the light source and the medical fluid, and wherein the method further includes a second polarization rotator disposed between the medical fluid and the second photodetector.

13. A system for detecting a presence of a pharmaceutical substance during a medical therapy, comprising:

a light source located adjacent to a medical fluid, the fluid within a medical delivery system and the light source configured to generate a light beam having a propagation axis;

a prism having an incidence surface, a reflective surface, and an interface surface for receiving, reflecting and refracting the light beam from the light source;

a polarization rotator between the light source and the prism;

a first photodetector and a second photodetector configured to receive and measure at least one of an intensity and a position of the light beam transmitted or refracted through the medical fluid and a portion of the medical delivery system, the photodetectors each configured to generate an output signal representing at least one of the intensity and position of a portion of the light beam, wherein the first and second photodetectors are positioned adjacent different surfaces of the prism; and

a computer operatively connected to the photodetectors, the computer configured to receive the output signals and perform a matching check to determine a quantity of the pharmaceutical substance within the medical fluid.

14. The system of claim 13, wherein the interface surface comprises a diffraction grating.

15. The system of claim 13, wherein the interface surface is formed at one of:

(i) Brewster'"'"'s angle relative to the incidence surface; and

(ii) an angle relative to the incidence surface to allow for total transmission of the light beam through the medical fluid.

16. The system of claim 13, wherein a portion of the light beam is refracted through the medical fluid, wherein at least one of:

(i) the refracted portion of the light beam is measured by at least one of the first and second photodetectors; and

(ii) at least one of the first and second photodetectors generates an output signal to the computer corresponding to the intensity and the position of the refracted portion of the light beam received by at least one of the first and second photodetectors.

17. The system of claim 13, wherein the polarization rotator is a liquid crystal device.

18. The system of claim 13, wherein at least one of:

(i) a portion of the light beam is reflected from the interface surface through the reflective surface, and the second photodetector is positioned and configured to receive a reflected portion of the light beam;

(ii) the second photodetector is configured to generate an output signal to the computer representing at least one of intensity and position measured from the reflected portion of the light beam; and

(iii) the computer is configured to utilize the output signal from the first photodetector and the output signal from the second photodetector to calculate a refractive index of the medical fluid.

19. The system of claim 13, wherein the second photodetector is a linear photodetector array.

20. The system of claim 13, wherein the matching check compares at least one of:

(i) a calculated concentration of the pharmaceutical substance with an acceptable range, and if the calculated concentration is outside the acceptable range the computer is configured to generate an output signal to the medication delivery system to provide an alert or to prevent delivery of the medical fluid to a patient; and

(ii) the calculated concentration of the pharmaceutical substance with an acceptable range, and if the calculated concentration is within the acceptable range the computer is configured to generate an output signal to the medication delivery system to proceed with normal function of the medication delivery system.

21. The system of claim 13, further including a beam expanding lens disposed between the light source and the prism, the beam expanding lens configured to receive the light beam and to produce multiple rays of light from the light beam.

22. The system of claim 13, wherein the first photodetector comprises a first array for detecting reflected light and a second array for detecting refracted light.

23. The system of claim 13, wherein the medical fluid has a target refractive index from about 1.3 to about 1.5.

24. A system for detecting a presence of a pharmaceutical substance during a medical therapy, comprising:

a light source positioned adjacent to a medical fluid, the medical fluid within a medication delivery system and the light source configured to generate a light beam directed through the medical fluid and a portion of the medical delivery system;

a first polarization rotator configured to receive the light beam, rotate at least a portion of the light beam, and pass the light beam to a medical delivery system and a medical fluid;

a photodetector for providing a measurement of at least one of intensity, relative position, and relative optical rotation, of the light beam that was transmitted through the medical fluid and the portion of the medical fluid;

a second polarization rotator disposed between the medical fluid and the photodetector;

a memory configured to store signals from the photodetector or results from calculations performed on the signals, including signals or calculations from a baseline measurement, the baseline measurement optionally including a portion of the medical delivery system present between the light source and the photodetector; and

a computer operably connected to the memory and configured to use the signals or results stored in the memory to perform a matching check with respect to the baseline measurement to determine at least one of;

(i) whether the pharmaceutical substance is present in the medical fluid; and

(ii) if the pharmaceutical substance is present, a concentration of the pharmaceutical substance present in the medical fluid.

25. The system of claim 24, further including a prism having an incidence surface, a reflective surface, and an interface surface, wherein the photodetector receives a portion of the light beam refracted from the prism.

26. The system of claim 24, wherein the computer is operatively connected to a pharmacological database that includes a look-up table for use in the matching check for determining the concentration of the pharmaceutical substance present in the medical fluid, the look-up table including an acceptable range of calculated concentrations of the pharmaceutical substance within the medical fluid.

27. The system of claim 24, wherein the portion of the medical delivery system comprises a medication container or tubing for use with the container.