Device and method for qualitative and quantitative determination of intravenous fluid components

• US 6,847,899 B2
• Filed: 10/04/2002
• Issued: 01/25/2005
• Est. Priority Date: 04/26/2002
• Status: Expired due to Fees

• Current Assignee: Dean O Allgeyer Md Inc
• Original Assignee: Dean O Allgeyer Md Inc
• Inventors: Allgeyer, Dean O.
• Primary Examiner(s): Assouad, Patrick
• Assistant Examiner(s): SUAREZ, FELIX E
• Application Number:
  US10/264,666
• Publication Number:
  US 20030204330A1
• Time in Patent Office: 844 Days
• Field of Search: 702/32, 702/38, 702/50, 702/75, 702/76, 702/115, 702/183, 356/301, 356/432, 356/436, 356/440, 600/532, 600/538, 128/92, 128/95
• US Class Current: 702/32
• CPC Class Codes: A61B 5/0059 using light, e.g. diagnosis by transillumination, diascopy, fluorescence A61B5/0093, A61B5/1455, A61B5/02416 and A61B5/0261 take precedence
• CPC Class Codes: A61M 2005/1405 Patient controlled analgesia [PCA]
• CPC Class Codes: A61M 2205/60 with identification means
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps
• CPC Class Codes: G01J 3/10 Arrangements of light sources specially adapted for spectrometry or colorimetry
• CPC Class Codes: G01N 2021/651 Cuvettes therefore
• CPC Class Codes: G01N 21/15 Preventing contamination of the components of the optical system or obstruction of the light path
• CPC Class Codes: G01N 21/31 Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry G01N21/72 takes precedence
• CPC Class Codes: G01N 21/65 Raman scattering
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/60 for the operation of medical equipment or devices

Abstract

A device and process for preventing medical errors due to the improper administration of an intravenously delivered medication includes the spectroscopic analysis of intravenous fluid components. An emission source and detector are placed adjacent to the intravenous tubing of an administration set to generate signals for spectroscopic analysis. The signals are processed to identify the medication and, in certain embodiments of the invention, can determine the medication'"'"'s concentration. In a preferred embodiment, the emission source, detector, and hardware and software for the spectroscopic analysis are placed in an infusion pump.

Claims

1. An infusion pump system for delivering an intended intravenous fluid to a patient comprising:

a pump housing with an exterior and an interior;

means for inputting the identification of at least one component of interest in an intended intravenous fluid;

a memory device for storing at least one parametric value uniquely associated with said at least one component of interest,

a fluid path disposed within the interior of the housing for conducting the intravenous fluid to be delivered;

a first emission source positioned adjacent to the fluid path for directing electromagnetic radiation into the fluid to enable the electromagnetic radiation to interact with at least one component of interest;

a first detector positioned adjacent to the fluid path for detecting the electromagnetic radiation emerging from the fluid therein and for generating a signal for use in spectroscopically analyzing at least one component of the fluid in the fluid path, and

means responsive to said signal for permitting said infusion only if said signal is substantially indicative of an intravenous fluid in the fluid path having said at least one component of interest.

2. The pump system of claim 1, further comprising at least one of electronic hardware and software adapted to process the detector signal to spectroscopically analyze the at least one component of the fluid.

3. The pump system of claim 1, further comprising an optical chamber disposed adjacent the emission source and the detector and through which the fluid passes during spectroscopic analysis.

4. The pump system of claim 3, wherein the optical chamber is disposed between the emission source and the detector.

5. The pump system of claim 2, wherein said inputting means includes controls disposed on the exterior of the pump housing for controlling at least one parameter related to the spectroscopic analysis.

6. The pump system of claim 5, further comprising a display disposed on the exterior of the pump housing for displaying the at least one parameter.

7. The pump system of claim 6, wherein one parameter is representative of the identity of the at least one component of the fluid.

8. The pump system of claim 7, wherein the emission source comprises at least two light-emitting diodes.

9. The pump system of claim 8, wherein a second parameter is representative of a maximum dosage of the at least one component of the fluid.

10. The pump system of claim 9, further comprising a connection means to at least one of remote electronic hardware and remote software adapted to spectroscopically analyze the at least one component of the fluid.

11. The pump system of claim 1 wherein the detector includes means for detecting a spectral characteristic of fluid within the fluid path at at least two substantially non-overlapping electromagnetic radiation frequency ranges, and for producing a signal indicative of the detected spectral characteristic associated with at least two of said ranges.

12. The pump system of claim 11 including means for determining the ratio of the characteristic-indicative signals obtained for two substantially non-overlapping frequency ranges.

13. The pump system of claim 11 wherein the frequency ranges are respectively the frequency ranges within which the component of interest in the intended fluid produces a substantially minimum and substantially maximum signal level relative to all other frequency ranges.

14. The pump system of claim 1 wherein the inputting means is selected from the group consisting of at least one of (a) barcode reader means for scanning the barcode on a container of intravenous solution to transfer data indicative of the label-stated content of the container, (b) keypad entry means for entering data indicative of the desired content of the container, and (c) barcode reader means for scanning the barcode on a container of intravenous solution to transfer data indicative of the label-stated content of the container and keypad entry means for entering data indicative of the desired content of the container.

15. The pump system of claim 14 wherein the signal responsive means is responsive to the data supplied by the inputting means to permit infusion only if the inputted data and the spectral analysis of the fluid in the fluid path are all in accord.

16. The pump system of claim 1 including means for determining the concentration of the component of interest in the fluid contained in the fluid path.

17. The pump system of claim 16 including

means for inputting a parameter indicative of the desired concentration of the component of interest,

a second emission source for directing electromagnetic radiation at the fluid within the fluid path, and

a second detector for detecting the electromagnetic radiation emerging from the fluid in the fluid path, and

means for permitting delivery of fluid having said component of interest to the patient only if the level of detected radiation is substantially equivalent to the level that would be detected from the desired concentration of the component of interest.

18. The pump system of claim 17 including memory means for storing digital values pertaining to the levels of detected radiation that are expected from fluids of respective concentrations of the component of interest, and

memory access means responsive to the parameter inputting means to provide the delivery-permitting means with the value of said desired concentration.

19. The pump system of claim 16 including

means for inputting a parameter indicative of the desired concentration of the component of interest,

a second emission source for directing electromagnetic radiation at the fluid within the fluid path, and

a second detector for detecting the electromagnetic radiation emerging from the fluid in the fluid path,

integration means responsive to the infusion rate of the pump and the duration of the infusion to indicate the dosage of the component of interest infused into the patient,

means for inputting the desired dosage of the component of interest, and

means responsive to the integration means and the inputting means for permitting delivery of the fluid to the patient so long as the desired dosage of the component of interest has not been exceeded.

20. The pump system of claim 17 wherein said first emission source is capable of emitting electromagnetic radiation over a first range of frequencies, and

wherein said first emission source functions as said second emission source by emitting electromagnetic radiation within a second frequency range that is substantially non-overlapping with said first frequency range.

21. The pump system of claim 20 wherein the first detector is capable of detecting electromagnetic radiation within said first range of frequencies, and

wherein said first detector functions as said second detector by detecting electromagnetic radiation within said second frequency range.

22. The pump system of claim 1 wherein the detector is disposed within the housing interior.

23. The pump system of claim 22 wherein the emission source is disposed within the housing interior.

24. The pump system of claim 1 wherein the emission source is disposed within the housing interior.

25. The pump system of claim 1, further comprising a cassette-like case defining an optical chamber through which the fluid passes during spectroscopic analysis, said case being disposed adjacent the emission source and the detector and having at least one optical window through which the fluid therein is optically coupled to the emission source and detector.

26. The pump system of claim 25 wherein the optical chamber defines a fixed length optical path between the emission source and detector.

27. The pump system of claim 3 wherein the optical chamber is defined within a cassette-like case sized to fit within the interior of the pump housing.

28. The pump system of claim 27 wherein the cassette-like case includes at least one optical window through which the emission source and detector are optically coupled to the fluid.

29. The pump system of claim 27 wherein the case includes a pair of opposing walls, with at least one optical window being recessed into at least one of the walls.

30. The pump system of claim 27 wherein the optical chamber is defined between at least two parallel case walls, and includes an optical window in each wall through which a respective one of the emission source and detector are optically coupled to the fluid.

31. The pump system of claim 27 wherein the pump housing includes a hinged door through which access to the cassette-like case is provided from the exterior of the housing.

32. The pump system of claim 31 wherein the hinged door includes means for substantially optically aligning the optical chamber with the emission source and detector when the door is closed.

33. The pump system of claim 27 wherein the cassette-like case includes means for securing a fluid-conducting tube in substantial optical alignment with the emission source and detector, and

means for fluidically coupling said tube to a source of intravenous fluid.

34. A process for reducing the risk of erroneously provided intravenous fluid delivered to a patient, comprising the steps of:

providing an intended intravenous fluid to a pump for intravenous delivery to a patient;

inputting the identification of at least one component of interest in the intended intravenous fluid to an intravenous pump controller;

positioning an administration set for fluidic communication with the intended intravenous fluid;

connecting the administration set to the patient to provide the fluid intravenously to the patient;

spectroscopically analyzing the fluid as the fluid is delivered to the patient to test for the presence of at least one component of the fluid and

permitting delivery to the patient only if the spectroscopic analysis is substantially indicative of an intravenous fluid in the fluid path having said at least one component of interest.

35. The process of claim 34, wherein the step of spectroscopic analysis includes providing an emission source and a detector adjacent to the administration set to generate an electronic signal for use in the spectroscopic analysis.

36. The process of claim 35 wherein the analysis uses a reflectance-based method of signal analysis.

37. The process of claim 35 wherein the spectroscopic analysis uses a Raman method of signal analysis.

38. The process of claim 34, wherein in the step of spectroscopic analysis is performed inside the pump housing.

39. The process of claim 35, wherein the emission source comprises at least two light-emitting diodes.

40. The process of claim 35, wherein the analysis of the electronic signal is performed at a location remote from the pump.

41. The process of claim 35, wherein the step of spectroscopic analysis includes providing an emission source and a detector adapted to analyze two or more components of the fluid.

42. The process of claim 41, wherein the emission source is a broadband emitter.

43. The process of claim 42, wherein the detector is a broadband detector.

44. A system for spectroscopically analyzing the components of an intravenous fluid to be delivered to a patient, comprising:

an intravenous administration set for delivering the fluid, the administration set having an optical window;

a spectroscopic analyzer operatively connected to the administration set, the analyzer including an emission source for directing electromagnetic radiation through the optical window at the fluid and a detector for detecting the electromagnetic radiation emerging from the fluid.

45. The system of claim 44, wherein the administration set passes between the emission source and the detector.

46. The system of claim 45, wherein the emission source comprises at least two light-emitting diodes.

47. The system of claim 45 further comprising at least one of electronic hardware and software associated with the spectroscopic analyzer.

48. The system of claim 47, wherein the at least one of electronic hardware and software is remote from the spectroscopic analyzer.

49. In an intravenous administration set having tubing to supply intravenous fluid to a patient, the improvement comprising:

an optical window adapted to permit the transmittance and detection of electromagnetic radiation for use in a spectroscopic analysis of the fluid.

50. The improved intravenous administration set of claim 49, further comprising an optical chamber containing the optical window.