Joint-diagnostic in vivo & in vitro apparatus

• US 20050203356A1
• Filed: 03/04/2005
• Published: 09/15/2005
• Est. Priority Date: 03/09/2004
• Status: Abandoned Application

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: ChroMedX Inc.
• Inventors: Samsoondar, James
• Application Number:
  US11/071,247
• Publication Number:
  US 20050203356A1
• Time in Patent Office: Days
• US Class Current: 600/322
• CPC Class Codes: A61B 5/00 Measuring for diagnostic purposes radiation diagnosis A61B6/00; diagnosis by ultrasonic, sonic or infrasonic waves A61B8/00; Identification of persons

Abstract

In vivo testing for analytes in a life-form is an attractive concept because a biological sample does not have to be removed from the life-form. However, in vivo testing alone is unable to provide information that is accurate, complete and/or reliable enough to safely replace in vitro testing. In contrast to performing either in vivo or in vitro testing independently and alone, some embodiments of the present invention provide a joint-diagnostic apparatus for combined in vivo and in vitro testing. In some specific embodiments results from an in vitro measurement module are used in combination with subsequent in vivo measurements/observations obtained at a later time, and/or vice versa. Accordingly, in some embodiments in vitro measurements are used to compliment and/or partially compensate for some of the limitations of in vivo testing, and at the same time enabling some of the benefits of in vivo testing by reducing the number of biological samples taken.

Claims

1. A joint-diagnostic apparatus comprising:

an in vivo measurement module for analysis of a first analyte in a life-form;

an in vitro measurement module for analysis of a second analyte in the life-form; and

,

a processor module having computer readable program code means embodied thereon for producing (i) a first parameter having a first value derived from the analysis of the first analyte, (ii) a second parameter so having a second value derived from the analysis of the second analyte; and

(iii) a combined result based on the first value and the second value.

2. An apparatus according to claim 1 further comprising a display module for displaying the combined result.

3. An apparatus according to claim 1 wherein the processor module comprises a Boolean operator for determining (i) if the first value meets an in vivo value threshold, (ii) the combined result to be the second value if the first value meets the in vivo value threshold, and (iii) the combined result to be a Boolean flag when the first value does not meet the in vivo value threshold.

4. An apparatus according to claim 1 wherein the processor module comprises a Boolean operator for determining (i) if the second value meets an in vitro value threshold, (ii) the combined result to be the first value if the second value meets the in vitro value threshold, and (iii) the combined result to be a Boolean flag when the second value does not meet the in vitro value threshold.

5. An apparatus according to claim 1, wherein the first and second analytes are the same.

6. An apparatus according to claim 1, wherein the first value is obtained by measuring a first measurable characteristic related to the first analyte, and the second value is obtained by measuring a second measurable characteristic related to the second analyte, and wherein the first observable characteristic differs from second observable characteristic.

7. An apparatus according to claim 1, wherein the processor module comprises a computer readable program code means embodied therein for jointly analyzing the values of the first and second parameters, the computer readable program code means having computer readable instructions for determining a relationship between the first and second values.

8. An apparatus according to claim 7, wherein the combined result includes a third parameter having a value related to the relationship between the first and second values.

9. An apparatus according to claim 1, wherein the first and second parameters do represent measurements of the same observable characteristic.

10. An apparatus according to claim 8, wherein a third value for the third parameter represents a measurement of the same observable characteristic as at least one of the first and second parameters.

11. An apparatus according to claim 8, wherein a third value for the third parameter represents a measurement of an observable characteristic different from both the first and second parameters.

12. An apparatus according to claim 8, wherein the value of the third parameter is indicative of one of an agreement, a confirmation, a correction-factor and an integrity-assessment of the first value in view of the second value.

13. An apparatus according to claim 8, wherein the value of the third parameter is indicative of one of an agreement, a confirmation, a correction-factor and an integrity-assessment of the second value in view of the first value.

14. An apparatus according to claim 7 further comprising:

a remotely operable satellite device for collecting data; and

a data-communication link for connecting the remotely operable satellite device to at least one of the in vivo measurement module, the in vitro measurement module, and the processor.

15. An apparatus according to claim 14, wherein the data-communication link includes at least one of a wireless modem, a USB port, an Ethernet modem, a fiber-optic modem, a twisted-pair modem and a wire connection.

16. An apparatus according to claim 15, wherein the data-communication link is also operable to transmit data to the remotely operable satellite device.

17. An apparatus according to claim 14, wherein a portion of the in vivo spectroscopic measurement module is included within the remotely operable satellite device.

18. An apparatus according to claim 14, wherein a portion of the in vitro measurement module is included within the remotely operable satellite device.

19. An apparatus according to claim 14, wherein a portion of the processor is included within the remotely operable satellite device.

20. An apparatus according to claim 7, wherein the in vivo measurement module includes a receptor for accepting a portion of the life-form for spectroscopic analysis.

21. An apparatus according to claim 20, wherein the in vivo measurement module includes an electromagnetic radiation (EMR) source and detector arranged within the receptor.

22. An apparatus according to claim 21, wherein the detector is arranged to detect EMR that has travelled through the portion of the life-form accepted into the receptor.

23. An apparatus according to claim 21, wherein the detector is arranged to detect EMR that has reflected from the portion of the life-form accepted into the receptor.

24. An apparatus according to claim 21 further comprising:

a remotely operable satellite device housing the receptor, the EMR source and detector; and

a data-communication link for connecting the remotely operable satellite device to at least one of the in vivo measurement module, the in vitro measurement module, and the processor.

25. An apparatus according to claim 21, wherein the EMR source is operable to produce EMR at at least one wavelength in the approximate range of 300 nm to 2500 nm.

26. An apparatus according to claim 21, wherein the EMR source includes at least one of a tungsten lamp, a laser and a Light Emitting Diode (LED).

27. An apparatus according to claim 7, wherein the in vitro measurement module includes a receptor for accepting a biological sample from the life-form for analysis.

28. An apparatus according to claim 27, wherein the receptor is arranged to accept a vessel containing a biological sample.

29. An apparatus according to claim 28, wherein the vessel contains at least one reagent in combination with the biological sample.

30. An apparatus according to claim 29, wherein the biological sample includes at least one of whole blood, a portion of whole blood, interstitial fluid, serum, plasma, urine, cerebrospinal fluid, sputum, synovial fluid, lymphatic fluid and feces.

31. An apparatus according to claim 7, wherein the in vitro measurement module includes an electromagnetic radiation (EMR) source and detector for spectroscopic analysis.

32. An apparatus according to claim 31, wherein the detector is arranged to detect EMR that has travelled through the biological sample.

33. An apparatus according to claim 31, wherein the detector is arranged to detect EMR that has reflected from the biological sample.

34. An apparatus according to claim 31 further comprising:

a remotely operable satellite device defining a slot, and housing the EMR source and detector; and

a data-communication link for connecting the remotely operable satellite device to at least one of the in vivo measurement module, the in vitro measurement module, and the processor.

35. An apparatus according to claim 31, wherein the EMR source is operable to produce EMR at at least one wavelength in the approximate range of 300 nm to 2500 nm.

36. An apparatus according to claim 31, wherein the EMR source includes at least one of a tungsten lamp, a laser and a Light Emitting Diode (LED).

37. An apparatus according to claim 8, wherein the first parameter is an in vivo absorbance measurement of a body part of the life-form taken at at least one wavelength of electromagnetic radiation (EMR), the second parameter is an in vitro absorbance measurement of a blood sample of the life form taken at at least one wavelength of EMR, the third parameter is a measure of hemoglobin oxygen saturation (SaO₂) derived from the first parameter, and the computer readable program code means includes computer readable instructions for:

determining respective relative amounts of different hemoglobin species present in the blood sample from the in vitro absorbance measurement of the blood sample;

comparing each of the relative amounts of the different hemoglobin species present in the blood sample to a corresponding threshold value; and

returning an indication about the measure of hemoglobin oxygen saturation (SaO₂) derived from the first parameter as a result of the comparison of each relative amount of hemoglobin species to its corresponding threshold value.

38. An apparatus according to claim 37, wherein the indication is at least one of an error message, a confirmation message, and a signal that disables the in vivo measurement module.

39. An apparatus according to claim 37, wherein the computer readable program code means also includes computer readable instructions for disabling the in vivo measurement module until an in vitro measurement is repeated.

40. An apparatus according to claim 39, wherein the instructions for disabling the in vivo measurement module, until an in vitro measurement is repeated, occurs after at least one of a predetermined number of in vivo measurements, a predetermined amount of time and if the measure of hemoglobin oxygen saturation (SaO₂) derived from the first parameter breaches a corresponding threshold value.

41. An apparatus according to claim 37, wherein the computer readable program code means also includes computer readable instructions for deriving the measure of hemoglobin oxygen saturation (SaO₂) from the first parameter according to a Pulse Oximetry technique that employs the use of at least two wavelengths of EMR.

42. An apparatus according to claim 8, wherein the first parameter is an in vivo absorbance measurement of a body part of the life-form taken at at least one wavelength of electromagnetic radiation (EMR), the second parameter is an in vitro absorbance measurement of a blood sample of the life form taken at at least one wavelength of EMR, the third parameter is a relative amount of Met-hemoglobin present in the life-form derived from the first parameter, and the computer readable program code means includes computer readable instructions for:

determining a fourth parameter that is a relative amount of Met-hemoglobin present in the blood sample from the in vitro absorbance measurement of the blood sample;

calculating a correction factor which is a ratio of the fourth parameter to the third parameter; and

applying the correction factor to subsequent in vivo measurements of the third parameter.

43. An apparatus according to claim 42, wherein the relative amounts of Met-hemoglobin are calculated as a ratio of the amount of Met-hemoglobin to the total-hemoglobin.

44. An apparatus according to claim 42, wherein the computer readable program code means also includes computer readable instructions for disabling the in vivo measurement module until an in vitro measurement is repeated.

45. An apparatus according to claim 44, wherein the instructions for disabling the in vivo measurement module, until an in vitro measurement is repeated, occurs after at least one of a predetermined number of in vivo measurements, a predetermined amount of time and if the relative amount Met-hemoglobin derived from the first parameter breaches a corresponding threshold value in subsequent in vivo measurements.

46. An apparatus according to claim 42, wherein the computer readable program code means also includes computer readable instructions for deriving the relative amount of Met-hemoglobin from a ratio of absorbance measurements at two wavelengths.

47. An apparatus according to claim 8, wherein the first parameter is an in vivo absorbance measurement of a body part of the life-form taken at at least one wavelength of electromagnetic radiation (EMR), the second parameter is an in vitro absorbance measurement of a blood sample of the life form taken at at least one wavelength of EMR, the third parameter is a relative amount of Met-hemoglobin present in the life-form derived from the first parameter, and the computer readable program code means includes computer readable instructions for:

determining a concentration of Methylene Blue in the blood sample from the in vitro absorbance measurement of the blood sample;

comparing the concentration of Methylene Blue in the blood sample to a corresponding threshold value; and

returning an indication about the concentration of Methylene Blue in the blood sample as a result of the comparison.

48. An apparatus according to claim 47, wherein the indication is at least one of an error message, a confirmation message, a toxicity measurement, the concentration of Methylene Blue, the time the in vitro measurement was made and a signal that disables the in vivo measurement module.

49. An apparatus according to claim 47, wherein the computer readable program code means also includes computer readable instructions for disabling the in vivo measurement module until an in vitro measurement is repeated.

50. An apparatus according to claim 49, wherein the instructions for disabling the in vivo measurement module, until an in vitro measurement is repeated, occurs after at least one of a predetermined number of in vivo measurements, a predetermined amount of time, and if the relative amount Met-hemoglobin derived from the first parameter breaches a corresponding threshold value in subsequent in vivo measurements.

51. An apparatus according to claim 47, wherein the computer readable program code means also includes computer readable instructions for deriving the relative amount of Met-hemoglobin from a ratio of absorbance measurements at two wavelengths.

52. An apparatus according to claim 8, wherein the first parameter is an in vivo absorbance measurement of a body part of the life-form taken at at least one wavelength of electromagnetic radiation (EMR), the second parameter is an in vitro absorbance measurement of a blood sample of the life form taken at at least one wavelength of EMR, the third parameter is a relative amount of hemoglobin-based blood substitute in Met-hemoglobin form present in the life-form derived from the first parameter, and the computer readable program code means includes computer readable instructions for:

determining a fourth parameter that is a relative amount hemoglobin-based blood substitute in Met-hemoglobin form present in the blood sample from the in vitro absorbance measurement of the blood sample;

calculating a correction factor which is a ratio of the fourth parameter to the third parameter; and

applying the correction factor to subsequent in vivo measurements of the third parameter.

53. An apparatus according to claim 52, wherein the relative amounts of hemoglobin-based blood substitute in Met-hemoglobin form are calculated as a ratio of a concentration of hemoglobin-based blood substitute and a concentration of hemoglobin-based blood substitute in Met-hemoglobin form.

54. An apparatus according to claim 52, wherein the computer readable program code means also includes computer readable instructions for disabling the in vivo measurement module until an in vitro measurement is repeated.

55. An apparatus according to claim 54, wherein the instructions for disabling the in vivo measurement module, until an in vitro measurement is repeated, occurs after at least one of a predetermined number of in vivo measurements, a predetermined amount of time, and if the relative amount hemoglobin-based blood substitute in Met-hemoglobin form derived from the first parameter breaches a corresponding threshold value in subsequent in vivo measurements.

56. An apparatus according to claim 52, wherein the computer readable program code means also includes computer readable instructions for deriving the relative amount of hemoglobin-based blood substitute in Met-hemoglobin form from a ratio of absorbance measurements at two wavelengths.

57. An apparatus according to claim 8, wherein the first parameter is an in vivo absorbance measurement of a body part of the life-form taken at at least one wavelength of electromagnetic radiation (EMR), the second parameter is an in vitro absorbance measurement of a blood sample of the life form taken at at least one wavelength of EMR, the third parameter is a relative amount of Carboxy-hemoglobin form present in the life-form derived from the first parameter, and the computer readable program code means includes computer readable instructions for:

determining a fourth parameter that is a relative amount of Carboxy-hemoglobin present in the blood sample from the in vitro absorbance measurement of the blood sample;

calculating a transforming factor which is a ratio of the fourth parameter to the third parameter; and

applying the correction factor to subsequent in vivo measurements of the third parameter.

58. An apparatus according to claim 57, wherein the relative amounts of Carboxy-hemoglobin are calculated as a ratio of a concentration of total-hemoglobin and a concentration of Carboxy-hemoglobin.

59. An apparatus according to claim 57, wherein the computer readable program code means also includes computer readable instructions for disabling the in vivo measurement module until an in vitro measurement is repeated.

60. An apparatus according to claim 59, wherein the instructions for disabling the in vivo measurement module, until an in vitro measurement is repeated, occurs after at least one of a predetermined number of in vivo measurements, a predetermined amount of time, and if the relative amount Carboxy-hemoglobin derived from the first parameter breaches a corresponding threshold value in subsequent in vivo measurements.

61. An apparatus according to claim 57, wherein the computer readable program code means also includes computer readable instructions for deriving the relative amount of Carboxy-hemoglobin from a ratio of absorbance measurements at two wavelengths.

62. An apparatus according to claim 8, wherein the first parameter is an in vivo absorbance measurement of a body part of the life-form taken at at least one wavelength of electromagnetic radiation (EMR), the second parameter is an in vitro absorbance measurement of a blood sample of the life form taken at at least one wavelength of EMR, the third parameter is a ratio of biliverdin and bilirubin present in the life-form derived from the first parameter, and the computer readable program code means includes computer readable instructions for:

determining a fourth parameter that is a ratio of biliverdin and bilirubin present in the blood sample from the in vitro absorbance measurement of the blood sample;

calculating a transforming factor which is a ratio of the fourth parameter to the third parameter; and

applying the transforming factor to subsequent in vivo measurements of the third parameter.

63. An apparatus according to claim 62, wherein the ratios of biliverdin and bilirubin are calculated from a concentration of biliverdin and a concentration of bilirubin.

64. An apparatus according to claim 62, wherein the computer readable program code means also includes computer readable instructions for disabling the in vivo measurement module until an in vitro measurement is repeated.

65. An apparatus according to claim 64, wherein the instructions for disabling the in vivo measurement module, until an in vitro measurement is repeated, occurs after at least one of a predetermined number of in vivo measurements, a predetermined amount of time, and if the third parameter breaches a corresponding threshold value in subsequent in vivo measurements.

66. An apparatus according to claim 62, wherein the computer readable program code means also includes computer readable instructions for deriving the ratio of biliverdin and bilirubin from a ratio of absorbance measurements at two wavelengths.

67. A joint-diagnostic in vivo and in vitro spectroscopic apparatus comprising:

an in vivo spectroscopic measurement module for producing a first plurality of parameters, each having a value related to the spectroscopic analysis of a first plurality of analytes;

an in vitro measurement module for producing a second plurality of parameters, each having a value related to the analysis of a second plurality of analytes; and

,

a computer usable medium having computer readable program code means embodied therein for jointly analyzing some of each of the first and second pluralities of parameters thereby producing a third plurality of parameters from values of some of the first and second parameters, the third plurality of parameters being indicative of a clinical-relationship between some of the first and second pluralities of parameters.