Cassette-based method and apparatus for measuring the presence and concentration of pharmaceutical substances in a medical fluid

• US 8,654,318 B2
• Filed: 01/09/2012
• Issued: 02/18/2014
• 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): Pajoohi Gomez, Tara S
• Application Number:
  US13/346,249
• Publication Number:
  US 20120105850A1
• Time in Patent Office: 771 Days
• Field of Search: 356 36- 42, 3562431-246, 356335-343
• US Class Current: 356/39
• 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

A medical fluid delivery system includes a medical fluid delivery machine including a light source configured to generate a light beam; a polarizer configured to receive the light beam and to allow a portion of the light beam within the medical fluid to be transmitted through the polarizer, a photodetector to provide a measurement of an intensity of the light beam transmitted through a medical fluid and the polarizer; a medical fluid cassette operating with the medical fluid machine to pump the medical fluid, the medical fluid cassette loaded onto the medical fluid delivery machine such that the light source resides on a first side of the cassette and the photodetector resides on a second side of the cassette; and a computer configured to use the measurement of the intensity to determine whether the medical fluid can be delivered to a patient.

Claims

1. A medical fluid delivery system comprising:

a medical fluid delivery machine for delivering a medical fluid, the medical fluid delivery machine including a light source configured to generate a light beam;

a polarizer configured to receive the light beam and to allow a portion of the light beam to be transmitted through the polarizer;

a photodetector configured to provide a measurement of an intensity of the light beam transmitted through the medical fluid and the polarizer;

a medical fluid cassette operating with the medical fluid delivery machine to pump the medical fluid, the medical fluid cassette including a rigid structure defining a fluid passageway located between first and second light-transmissive sides of the medical fluid cassette, the cassette further including a pumping portion in fluid communication with the fluid passageway, the medical fluid cassette loaded onto the medical fluid delivery machine such that (i) the light source resides on the first side of the cassette, (ii) the photodetector resides on the second side of the cassette, and (iii) the light beam from the light source is transmitted into the passageway of the cassette; and

a computer configured to use the measurement of the intensity to determine whether the medical fluid can be delivered to a patient.

2. The medical fluid delivery system of claim 1, which includes a prism, the photodetector receiving a portion of the light beam refracted from the prism.

3. The medical fluid delivery system of claim 2, wherein the prism and the fluid cassette are integrally formed.

4. The medical fluid delivery system of claim 2, wherein the photodetector is a first photodetector, which includes a second photodetector, and 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 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.

5. The medical fluid delivery system of claim 2, wherein an interface surface of the prism is oriented at an angle to the light beam selected from the group consisting of forty-five degrees and Brewster'"'"'s angle.

6. The medical fluid delivery system of claim 1, wherein the medical fluid delivery machine further includes a polarization rotator disposed between the light source and the medical fluid cassette.

7. The medical fluid delivery system of claim 6, wherein the polarization rotator is a first polarization rotator, and which includes a second polarization rotator disposed between the medical fluid cassette and the photodetector.

8. The medical fluid delivery system of claim 1, wherein the polarizer is positioned between the medical fluid cassette and the photodetector.

9. The medical fluid delivery system of claim 1, wherein the polarizer is a first polarizer, and which includes a second polarizer positioned between the light source and the medical fluid cassette, wherein the second 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 ninety degree angle relative to the first polarizer.

10. The medical fluid delivery system of claim 1, wherein the medical fluid cassette is disposable.

11. The medical fluid delivery system of claim 1, wherein the medical fluid cassette is removably positioned within a recess of the medical fluid delivery machine, and wherein the light source is positioned adjacent to the recess of the medical fluid delivery machine, such that the light source is positioned to transmit the light beam through the passageway of the medical fluid cassette.

12. The medical fluid delivery system of claim 1, wherein the medical fluid delivery machine further includes a narrow pass filter configured to filter out ambient light or to pass a particular light wavelength.

13. The medical fluid delivery system of claim 12, wherein the narrow pass filter is positioned between the medical fluid cassette and the photodetector.

14. The medical fluid delivery system of claim 1, wherein the computer is configured to perform a matching check to determine if or how much of a pharmaceutical substance is present in the medical fluid.

15. The medical fluid delivery system of claim 14, wherein the computer is configured to generate an output signal to provide an alert or to prevent the medical fluid delivery system from delivering the medical fluid to the patient if the matching check determines that the pharmaceutical substance is present in the medical fluid in a concentration higher or lower than expected.

16. The medical fluid delivery 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 pharmaceutical 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 medical fluid delivery system to provide an alert or to prevent the medical fluid from being delivered to the patient if the calculated concentration of the pharmaceutical substance is outside an acceptable range;

or

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

17. The medical fluid delivery system of claim 1, where the medical fluid delivery machine is a dialysis machine or a drug delivery machine.

18. A medical fluid delivery system comprising:

a medical fluid delivery machine including a laser beam light source configured to generate a laser beam;

a medical fluid cassette operating with the medical fluid delivery machine to pump a medical fluid, the medical fluid cassette including a rigid structure defining a fluid passageway located between first and second light-transmissive sides of the medical fluid cassette, the cassette further including a pumping portion in fluid communication with the fluid passageway, the medical fluid cassette loaded onto the medical fluid delivery machine such that (i) the laser beam light source resides on the first side of the medical fluid delivery cassette and (ii) a photodetector resides on the second side of the medical fluid delivery cassette, the photodetector configured to provide a measurement of an intensity of the laser beam transmitted through the medical fluid flowing through the passageway of the medical fluid cassette; and

a computer configured to use the measurement of the intensity to determine whether the medical fluid can be delivered to a patient.

19. A medical fluid delivery system comprising:

a medical fluid delivery machine for delivering a medical fluid, the medical fluid delivery machine including a light source configured to generate a light beam;

a polarizer configured to receive the light beam and to allow a portion of the light beam within the medical fluid to be transmitted through the medical fluid and the polarizer;

a photodetector configured to provide a measurement of an intensity of the light beam transmitted through the medical fluid and the polarizer;

medical fluid tubing operating with the medical fluid delivery machine to pump the medical fluid, the medical fluid tubing loaded onto the medical fluid delivery machine adjacent the polarizer, such that the light source resides on a first side of the medical fluid tubing and the photodetector resides on a second side of the medical fluid tubing, wherein the light beam from the light source is transmitted through the medical fluid tubing; and

a computer configured to use the measurement of the intensity to determine whether the medical fluid can be delivered to a patient.

20. The medical fluid delivery system of claim 19, where the medical fluid delivery machine is a dialysis machine or a drug delivery machine.

21. A dialysis system comprising:

a dialysis machine for delivering a dialysis fluid, the dialysis machine including a light source configured to generate a light beam;

a polarizer configured to receive the light beam and to allow a portion of the light beam within the dialysis fluid to be transmitted through the polarizer;

a photodetector configured to provide a measurement of an intensity of the light beam transmitted through the medical fluid and the polarizer;

a dialysis fluid cassette operating with the dialysis machine to pump the dialysis fluid, the dialysis fluid cassette including a rigid structure defining a fluid passageway located between first and second light-transmissive sides of the dialysis fluid cassette, the cassette further including a pumping portion in fluid communication with the fluid passageway, the dialysis fluid cassette loaded onto the dialysis machine such that (i) the light source resides on the first side of the dialysis fluid cassette, (ii) the photodetector resides on the second side of the dialysis fluid cassette, and (iii) the light beam from the light source is transmitted into the passageway of the cassette; and

a computer configured to use the measurement of the intensity to determine whether the dialysis fluid can be delivered to a patient.

22. A drug delivery system comprising:

a drug delivery machine for delivering a drug, the drug delivery machine including a light source configured to generate a light beam;

a polarizer configured to receive the light beam and to allow a portion of the light beam within the drug to be transmitted through the polarizer;

a photodetector configured to provide a measurement of an intensity of the light beam transmitted through the drug and the polarizer;

a drug delivery cassette operating with the drug delivery machine to pump the drug, the drug delivery cassette including a rigid structure defining a fluid passageway located between first and second light-transmissive sides of the drug delivery cassette, the cassette further including a pumping portion in fluid communication with the fluid passageway, the drug delivery cassette loaded onto the drug delivery machine such that the light source resides on the first side of the drug delivery cassette and the photodetector resides on the second side of the drug delivery cassette, wherein the light beam from the light source is transmitted through the passageway of the cassette; and

a computer configured to use the measurement of the intensity to determine whether the drug can be delivered to a patient.