Diagnosis of body metabolic emergency state

• US 20050234315A1
• Filed: 03/06/2003
• Published: 10/20/2005
• Est. Priority Date: 03/20/2002
• Status: Active Grant

• Current Assignee: CritiSense Ltd.
• Original Assignee: CritiSense Ltd.
• Inventors: Deutsch, Assaf, Manor, Tamar, Pewzner, Eliahu, Mayevsky, Avraham
• Granted Patent: US 7,313,424 B2
• Time in Patent Office: Days
• 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 for monitoring in a non-vital organ at least one tissue viability parameter including at least one of NADH and Flavoprotein (Fp) concentration corresponding to said organ being monitored, for the early diagnosis of body metabolic emergency state, wherein the state of said at least one tissue viability parameter of said non-vital organ is indicative of degree of said body metabolic emergency state, the apparatus comprising:

—

illumination means for illuminating a first part of said organ with at least one illuminating radiation via at least one illumination location with respect to said tissue;

radiation receiving means for receiving a radiation from a second part of said organ as a result of an interaction between said illuminating radiation and said tissue;

correlating means adapted for correlating at least a part of said received radiation to said at least one tissue viability parameter; and

indicating means for indicating the degree of body metabolic emergency state based on said at least one tissue viability parameter.

2. Apparatus as claimed in claim 1, wherein a said at least one tissue viability parameter is NADH concentration, wherein said radiation received by said radiation receiving means comprises an NADH fluorescence emitted by the tissue in response to illumination thereof by said illuminating radiation, said at least one tissue viability parameter being provided by the intensity of said NADH fluorescence.

3. Apparatus as claimed in claim 1, wherein a said at least one tissue viability parameter is Fp concentration, wherein said radiation received by said radiation receiving means comprises an Fp fluorescence emitted by the tissue in response to illumination thereof by said illuminating radiation, said at least one tissue viability parameter being provided by the intensity of said Fp fluorescence

4. Apparatus as claimed in claim 1, wherein said correlating means is further adapted for correlating at least a part of said received radiation to at least one other tissue viability parameter including at least one of blood flow rate, blood volume and oxy-deoxy state tissue viability parameter.

5. Apparatus as claimed in claim 4, wherein said illuminating means comprises a plurality of illuminating radiation wavelengths corresponding to the number of different tissue viability parameters being monitored.

6. Apparatus as claimed in claim 5, wherein said illuminating means comprises an illuminating radiation of wavelength in the range of between about 315 nm to about 400 nm, and preferably about 366 nm, about 375 nm, about 380 nm or about 390 nm, for monitoring NADH tissue viability parameter.

7. Apparatus as claimed in claim 5, wherein said illumination means comprises a suitable LED for providing an illuminating radiation of wavelength in the range of between about 315 nm to about 400 nm, and preferably about 366 nm, about 375 nm, about 380 nm or about 390 nm, for monitoring NADH tissue viability parameter.

8. Apparatus as claimed in claim 5, wherein said illuminating means comprises an illuminating radiation of wavelength between about 430 nm and about 470 nm for monitoring flavoprotein concentration tissue viability parameter.

9. Apparatus as claimed in claim 5, wherein said illuminating means comprises two illuminating radiations, one at an isosbestic wavelength, and the other at a non-isosbestic wavelength, for monitoring blood oxygenation tissue viability parameter.

10. Apparatus as claimed in claim 5, wherein said illuminating means comprises at least two illuminating radiations for monitoring blood oxygenation tissue viability parameter, wherein one said illumination radiation has a wavelength of about 525 nm or about 585 nm, and wherein the other one said illumination radiation has a wavelength of about 430 nm or about 577 nm.

11. Apparatus as claimed in claim 5, wherein said illuminating means comprises an illuminating radiation of wavelength between about 550 nm and 800 nm, and preferably about 655 nm or 785 nm, for monitoring blood flow rate tissue viability parameter.

12. 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.

13. Apparatus as claimed in claim 12, wherein said radiation receiving means 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.

14. Apparatus as claimed in claim 13, wherein said at least one excitation optical fiber and said at least one receiving optical fiber are housed in a suitable probe head.

15. Apparatus as claimed in claim 14, 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.

16. Apparatus as claimed in claim 15, 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.

17. Apparatus as claimed in claim 16, wherein said probe is disposable.

18. Apparatus as claimed in claim 16, wherein said probe is sterilisable.

19. Apparatus as claimed in claim 9, wherein said blood flow rate tissue viability parameter is provided by applying a laser Doppler flowmetry technique to said radiation received by said radiation receiving means.

20. Apparatus as claimed in claim 1, further comprising first detection means for detecting said received radiation received by said radiation receiving means.

21. Apparatus as claimed in claim 5, wherein said at least one tissue viability parameter further comprises blood volume within said organ, and said corresponding radiation received by said radiation receiving means comprises a reflectance from the organ in response to illumination thereof by said illuminating radiation, the said at least one tissue viability parameter being provided by the intensity of said reflectance.

22. Apparatus as claimed in claim 5, wherein said at least one tissue viability parameter further comprises blood volume within said organ, and said corresponding radiation received by said radiation receiving means comprises a reflectance from the organ in response to illumination thereof by said illuminating radiation, the said at least one tissue viability parameter being provided by the intensity of said reflectance, wherein said illumination radiation is at an isosbestic wavelength.

23. Apparatus as claimed in claim 5, wherein said at least one tissue viability parameter further comprises blood volume within said organ, and said corresponding radiation received by said radiation receiving means comprises two separate reflectance from the organ in response to illumination thereof by two different illuminating radiations, the said at least one tissue viability parameter being provided by the intensity of each said reflectance, wherein each said illuminating radiation is at a different isosbestic wavelength.

24. Apparatus as claimed in claim 12, wherein said probe head is adapted for optical measurement in organs comprising tubular vessels.

25. Apparatus as claimed in claim 12, wherein said probe head is adapted for optical measurement in organs comprising tubular vessels, including the esophagus, urethra, blood vessels, the stomach and bladder.

26. Apparatus as claimed in claim 25, wherein said probe is incorporated in a suitable urethral catheter including a Folley catheter.

27. Apparatus as claimed in claim 12, wherein said probe head is adapted for optical measurement on organs comprising skin.

28. Apparatus as claimed in claim 27, wherein said probe head is attached to the skin via a suitable gel.

29. Apparatus as claimed in claim 27, wherein said probe head is attached to the skin via a suitable adhesive.

30. Apparatus as claimed in claim 12, wherein said probe head is adapted for fetal distress monitoring.

31. Apparatus as claimed in claim 12, wherein said probe head is adapted for soft tissue insertion.

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

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

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

35. 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 any one of claims 1 to 34.

36. A system as claimed in claim 35, wherein said plurality of organs are different organs within the same organism.

37. A system as claimed in claim 35, wherein plurality of organs are different organs within different organisms.

38. A system as claimed in claim 35, wherein said plurality of organs include donor organs.

39. 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 any one of claims 1 to 35.

40. A method for diagnosing the degree of body metabolic emergency state, comprising:

—

(a) choosing a non-vital organ with respect to the said metabolic emergency state;

(b) monitoring in said non-vital organ at least one tissue viability parameter including at least one of NADH and Flavoprotein (Fp) concentration; and

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

41. A method as claimed in claim 40, wherein in step (c), said determination is correlated to the direction of change in the value of said at least one tissue viability parameter.

42. A method as claimed in claim 40, wherein in step (c) 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.

43. A method as claimed in claim 40, wherein said at least one tissue viability parameter is NADH concentration, and an increase in the value thereof is indicative of the presence of a said body metabolic emergency state.

44. A method as claimed in claim 40, wherein said at least one tissue viability parameter is Flavoprotein concentration, and a reduction in the value thereof is indicative of the presence of a said body metabolic emergency state.

45. A method as claimed in claim 40, wherein said at least one tissue viability parameter is blood flow rate, and a reduction in the value thereof is indicative of the presence of a said body metabolic emergency state.

46. A method as claimed in claim 40, wherein said at least one tissue viability parameter is blood volume, and a reduction in the value thereof is indicative of the presence of a said body metabolic emergency state.

47. A method as claimed in claim 40, wherein said at least one tissue viability parameter is blood oxygenation level, and a reduction in the value thereof is indicative of the presence of a said body metabolic emergency state.

48. A method as claimed in any one of claims 40 to 47, wherein said non-vital organ is an organ chosen from among the skin, muscles, gastrointestinal tract and urogenital system.

49. A method as claimed in any one of claims 40 to 47, wherein said body metabolic emergency state includes any one of sepsis, respiratory distress syndrome, hypoxemia, hypotension, dysoxia and cardiac arrest.

50. A method as claimed in any one of claims 40 to 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.

51. A method as claimed in claim 50, wherein said body metabolic emergency state arises in patients hospitalized in various clinical wards.