Diagnosis of body metabolic emergency state

• US 7,313,424 B2
• Filed: 03/06/2003
• Issued: 12/25/2007
• Est. Priority Date: 03/20/2002
• Status: Expired due to Fees

• Current Assignee: CritiSense Ltd.
• Original Assignee: CritiSense Ltd.
• Inventors: Deutsch, Assaf, Pewzner, Eliahu, Manor, Tamar, Mayevsky, Avraham
• Primary Examiner(s): Winakur; Eric F
• Application Number:
  US10/508,232
• Publication Number:
  US 20050234315A1
• Time in Patent Office: 1,755 Days
• Field of Search: 600/309, 600/310, 600/322, 600/317, 600/323, 600/324
• US Class Current: 600/310
• 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: A61B 5/0084 for introduction into the body, e.g. by catheters A61B5/1459 takes precedence
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/412 Detecting or monitoring sepsis
• CPC Class Codes: A61B 5/4519 Muscles A61B5/389, A61B5/224 take precedence

Abstract

An apparatus, system and method are provided for diagnosing the degree of body metabolic emergency state. A non-vital organ with respect to the metabolic emergency state is first chosen. One or more tissue viability parameters including at least one of NADH and Flavoprotein (Fp) concentration are monitored in the non-vital organ, whereupon the degree of body metabolic emergency state may be determined based on the monitored tissue viability parameters.

Claims

1. Apparatus which monitors in a non-vital organ at least one tissue viability parameter of a body tissue, the apparatus comprising:

a) a light source for illuminating a first part of said tissue with at least one illuminating radiation via at least one illumination location;

b) a light collector for receiving radiation from a second part of said tissue, the same as or different from the first part, as a result of an interaction between said illuminating radiation and said tissue, the light collector comprising a filter which preferentially admits a range of wavelengths comprising a portion of, but not all of, the fluorescent emission spectrum of NADH or Fp;

c) a correlator adapted for correlating at least a part of said received radiation with said at least one tissue viability parameter; and

d) an analyzer adapted for generating an indication of a degree of body metabolic emergency state based on said correlating;

wherein the at least one tissue viability parameters comprise at least one of NADH or flavoprotein (Fp) concentration, and the received radiation comprises at least one of NADH and Fp fluorescence emitted by said tissue.

2. Apparatus as claimed in claim 1, wherein the at least one tissue viability parameter comprises an NADH concentration, and the received radiation comprises NADH fluorescence emitted by said tissue.

3. Apparatus as claimed in claim 1, wherein the at least one tissue viability parameter comprises an Fp concentration, and the received radiation comprises Fp fluorescence emitted by said tissue.

4. Apparatus as claimed in claim 1, wherein the at least one tissue vitality parameter also comprises at least one of blood flow rate, blood volume, and oxy-deoxy state.

5. Apparatus as claimed in claim 1, wherein said illuminating radiation comprises a plurality of wavelengths corresponding to the number of different tissue viability parameters being monitored.

6. Apparatus as claimed in claim 1, wherein said at least one tissue viability parameter comprises NADH concentration, arid said illuminating radiation comprises radiation having a wavelength in the range of between about 315 nm to about 400 nm, for monitoring NADH concentration.

7. Apparatus as claimed in claim 6, wherein said light source comprises a suitable LED for providing an illuminating radiation of said wavelength.

8. Apparatus of claim 7, wherein the wavelength is selected from the group consisting of about 366 nm, about 375 nm, about 380 nm, and about 390 nm.

9. Apparatus of claim 6, wherein the wavelength is selected from the group consisting of about 366 nm, about 375 nm, about 380 nm, and about 390 nm.

10. Apparatus as claimed in claim 1, wherein said at least one tissue viability parameter comprises flavoprotein concentration and said illuminating radiation comprises radiation having a wavelength between about 430 nm and about 470 nm for monitoring flavoprotein concentration.

11. Apparatus as claimed in claim 1, wherein said at least one tissue viability parameter also comprises blood oxygenation, and said illuminating radiation comprises radiation peaked around an isosbestic wavelength, and radiation having a non-isosbestic wavelength, for monitoring blood oxygenation.

12. Apparatus as claimed in claim 11, wherein said radiation peaked around an isosbestic wavelength is green.

13. Apparatus as claimed in claim 10, wherein the isosbestic wavelength is about 525 nm.

14. Apparatus as claimed in claim 9, wherein the radiation of non-isosbestic wavelength has wavelength between about 430 nm and 470 nm.

15. Apparatus as claimed in claim 1, wherein said at least one tissue viability parameter also comprises blood flow rate, and said illuminating radiation comprises radiation having a wavelength between about 550 nm and 800 nm, for monitoring blood flow.

16. Apparatus as claimed in claim 15, wherein said illuminating radiation is of a wavelength and a coherence suitable for laser Doppler flowmetry, and said correlator is adapted to correlate said received radiation to said blood flow rate tissue viability parameter by applying a laser Doppler flowmetry technique to said received radiation.

17. Apparatus of claim 15, wherein the wavelength is about 655 nm or about 785 nm.

18. Apparatus as claimed in claim 1, wherein said illumination location is provided by at least one excitation optical fiber having a free end capable of being brought into registry with said first part of said tissue.

19. Apparatus as claimed in claim 18, wherein said light collector comprises at least one suitable receiving optical fiber having a free end capable of being brought into registry with said second part of said tissue.

20. Apparatus as claimed in claim 19, wherein said at least one excitation optical fiber and said at least one receiving optical fiber are housed in a suitable probe head.

21. Apparatus as claimed in claim 20, wherein said at least one excitation fiber comprises a suitable first connector at an end thereof opposed to said free end thereof, said first connector capable of selectively coupling and decoupling said excitation fiber from the rest of the said apparatus.

22. Apparatus as claimed in claim 21, wherein said at least one collection fiber comprises a suitable second connector at an end thereof opposed to said free end thereof, said second connector capable of selectively coupling and decoupling said collection fiber from the rest of the said apparatus.

23. Apparatus as claimed in claim 22, wherein said probe is disposable.

24. Apparatus as claimed in claim 22, wherein said probe is sterilizable.

25. Apparatus as claimed in claim 20, wherein said probe bead is adapted for optical measurement in organs comprising tubular vessels.

26. Apparatus as claimed in claim 25, wherein said probe head is adapted for optical measurement in at least one of the esophagus, urethra, blood vessels, stomach and bladder.

27. Apparatus as claimed in claim 26, wherein said probe is incorporated in a suitable urethral catheter including a Foley catheter.

28. Apparatus as claimed in claim 20, wherein said probe bead is adapted for optical measurement on organs comprising skin.

29. Apparatus as claimed in claim 28, wherein said probe bead is adapted to be attached to the skin via a suitable gel.

30. Apparatus as claimed in claim 28, wherein said probe head is adapted to be attached to the skin via a suitable adhesive.

31. Apparatus as claimed in claim 20, wherein said probe head is adapted for fetal distress monitoring.

32. Apparatus as claimed in claim 20, wherein said probe head is adapted for soft tissue insertion.

33. Apparatus as claimed in claim 1, further comprising a first detector for detecting said received radiation received by said light collector.

34. Apparatus as claimed in claim 1, wherein said at least one tissue viability parameter also comprises blood volume, and said radiation received by said light collector comprises a reflectance from said tissue in response to illumination thereof by said illuminating radiation, the said blood volume being provided by the intensity of said reflectance.

35. Apparatus as claimed in claim 34, wherein said illuminating radiation is peaked around an isosbestic wavelength.

36. Apparatus as claimed in claim 35, wherein said radiation received by said light collector comprises two separate reflectances from said tissue in response to illumination thereof by two different illuminating radiations, the blood volume being provided by the intensity of each said reflectance, wherein each said illuminating radiation is peaked around a different isosbestic wavelength.

37. Apparatus as claimed in claim 1, wherein said first part and said second part are at the same location of said tissue.

38. Apparatus as claimed in claim 1, wherein said first part of said tissue is different from said second part of said tissue.

39. Apparatus as claimed in claim 1, wherein said body metabolic emergency state is sepsis.

40. A system for selectively monitoring in a plurality of organs at least one tissue viability parameter including at least one of NADH and Flavoprotein (Fp) concentration corresponding to each said organ being monitored, for the early diagnosis of body metabolic emergency state, said system comprising a plurality of monitoring probes, each said probe comprising an apparatus as claimed in claim 1.

41. A system as claimed in claim 40, wherein said plurality of organs are different organs within the same organism.

42. A system as claimed in claim 40, wherein said plurality of organs are different organs within different organisms.

43. A system as claimed in claim 40, wherein said plurality of organs include donor organs.

44. A system for selectively monitoring in a plurality of locations in the same organ at least one tissue viability parameter including at least one of NADH and Flavoprotein (Fp) concentration corresponding to each said location of the organ being monitored, for the early diagnosis of body metabolic emergency state, said system comprising a plurality of monitoring probes, each said probe comprising an apparatus as claimed in claim 1.

45. Apparatus as claimed in claim 1, wherein the correlator uses a measurement of reflectance of the illuminating radiation from the tissue to calibrate the intensity of the fluorescence.

46. Apparatus according to claim 1, wherein the filter preferentially admits substantially only a single contiguous band of optical wavelengths.

59. A method as claimed in claim 40, wherein determining a given degree of body emergency metabolic state comprises determining whether the at least one tissue viability parameter has changed by an amplitude exceeding a threshold for a duration exceeding a threshold.

60. A method as claimed in claim 59, wherein monitoring comprises monitoring a hospitalized patient in a clinical situation sufficiently continuously so as to be unlikely to miss a change in the at least one tissue viability parameter exceeding said thresholds in amplitude and duration, during the time the clinical situation persists.

47. A method for diagnosing a degree of body metabolic emergency state, comprising:

a) choosing a non-vital organ to monitor;

(b) exciting at least one of NADH and Flavoprotein (Fp) fluorescence in tissue of said non-vital organ by radiation in the fluorescent excitation spectrum of at least one of NADH and Fp;

(c) monitoring in said non-vital organ at least one tissue viability parameter including at least one of NADH and Flavoprotein (Fp) concentration, by measuring radiation emitted from said excited tissue that passes through a filter that preferentially admits wavelengths in a range comprising a portion of, but not all of, the fluorescent emission spectrum of NADH or Fp;

(d) determining the degree of body metabolic emergency state based on said at least one tissue viability parameter monitored in (c); and

(e) indicating to a user the degree of body metabolic emergency state, at least when the degree is greater than a threshold.

48. A method as claimed in claim 47, wherein determining the degree of body metabolic emergency state is correlated to the direction of change in the value of said at least one tissue viability parameter.

49. A method as claimed in claim 47, wherein said degree of body metabolic emergency state is correlated to the amplitude and duration of a change in said value of said at least one tissue viability parameter.

50. A method as claimed in claim 47, wherein the at least one tissue vitality parameter includes NADH concentration, and an increase in the value thereof is indicative of the presence of a said body metabolic emergency state.

51. A method as claimed in claim 47, wherein said at least one tissue viability parameter includes Flavoprotein concentration, and a reduction in the value thereof is indicative of the presence of a said body metabolic emergency state.

52. A method as claimed in claim 47, wherein said at least one tissue viability parameter comprises blood flow rate, and a reduction in the value thereof is indicative of the presence of a said body metabolic emergency state.

53. A method as claimed in claim 47, wherein said at least one tissue viability parameter also comprises blood volume, and a reduction in the value thereof is indicative of the presence of a said body metabolic emergency state.

54. A method as claimed in claim 47, wherein said at least one tissue viability parameter also comprises blood oxygenation level, and a reduction in the value thereof is indicative of the presence of a said degree of body metabolic emergency state.

55. A method as claimed in claims 47, wherein said non-vital organ is chosen from among the skin, muscles, gastrointestinal tract and urogenital system.

56. A method as claimed in claims 47, wherein said body metabolic emergency state includes any one of sepsis, respiratory distress syndrome, hypoxemia, hypotension, dysoxia and cardiac arrest.

57. A method as claimed in claims 47, wherein said body metabolic emergency state arises from at least one clinical situation including those that develop in a respiratory ICU, Neurosurgical ICU, delivery room both for a mother and her neonate, neonatal ICU, cardiac surgery operative room as well as post-operative period thereof, neuro surgery operative as well as post-operative period thereof, organ transplantation operative as well as post-operative period thereof, elderly and critical ill clinical situations.

58. A method as claimed in claim 47, wherein monitoring comprises calibrating said emitted radiation by measuring reflection of radiation in the excitation spectrum from said tissue.