Method and apparatus for the non-invasive detection of medical conditions by monitoring peripheral arterial tone

• US 6,322,515 B1
• Filed: 06/02/1999
• Issued: 11/27/2001
• Est. Priority Date: 07/30/1996
• Status: Expired due to Term

• Current Assignee: Itamar Medical Ltd. (Asahi Kasei Corporation)
• Original Assignee: Itamar Medical Ltd. (Asahi Kasei Corporation)
• Inventors: Sheffy, Jacob, Goor, Daniel A., Schnall, Robert P., Lavie, Peretz
• Primary Examiner(s): Winakur, Eric F.
• Assistant Examiner(s): Natnithithadha, Navin
• Application Number:
  US09/324,529
• Time in Patent Office: 909 Days
• Field of Search: 600/485, 600/481, 600/490, 600/499, 600/479, 600/480, 600/454, 600/504, 600/500, 600/507, 600/483
• US Class Current: 600/485
• CPC Class Codes: A61B 5/02007 Evaluating blood vessel condition, e.g. elasticity, compliance
• CPC Class Codes: A61B 5/02241 of small dimensions, e.g. adapted to fingers
• CPC Class Codes: A61B 5/1073 Measuring volume, e.g. of limbs
• CPC Class Codes: A61B 5/6806 Gloves
• CPC Class Codes: A61B 5/6826 Finger
• CPC Class Codes: A61B 5/6838 Clamps or clips
• CPC Class Codes: A61F 2007/0036 Hand

Abstract

A method and apparatus for non-invasively determining a physiological condition. The method can include steps of monitoring peripheral arterial tone using an external sensor, detecting a change in the peripheral arterial tone, and determining the physiological condition when a specific change in the peripheral arterial tone has been detected. The physiological condition may be a cardiovascular disease state or endothelial dysfunction, for example. The apparatus can include a probe applied to a subject'"'"'s digit for sensing peripheral arterial tone and outputting a corresponding signal, and a processor which processes the signal and provides an output from which the physiological condition can be determined or which determines the physiological condition based on the signal.

Claims

1. A method for non-invasively determining a physiological condition, comprising:

monitoring peripheral arterial tone using an external sensor;

detecting a change in the peripheral arterial tone; and

determining the physiological condition when a specific change in the peripheral arterial tone has been detected.

2. The method recited in claim 1, wherein the physiological condition is a cardiovascular disease state.

3. The method recited in claim 1, wherein the physiological condition is endothelial dysfunction.

4. The method recited in claim 3, wherein said monitoring comprises viewing a peripheral arterial tone signal wave.

5. The method recited in claim 4, wherein the specific change is an early attenuation of the peripheral arterial tone signal wave during exercise and/or a slow amplitude increase of the peripheral arterial tone signal wave during recovery.

6. The method recited in claim 1, wherein said monitoring is performed during a stress test.

7. The method recited in claim 6, wherein the stress test is a mental stress test.

8. The method recited in claim 2, wherein the cardiovascular disease state is coronary artery disease.

47. The method recited in claim 6, wherein the stress test is a pharmacological stress test for diagnostic purposes.

48. The method recited in claim 6, wherein the stress test is to pharmacologically elicit sympathetic nervous system reactivity.

49. The method recited in claim 1, wherein the physiological condition is a patient'"'"'s reaction to a pharmacological agent.

9. An apparatus for non-invasively determining a physiological condition, comprising:

a probe to be applied to a digit of a subject, said probe sensing the peripheral arterial tone of the digit and outputting signals indicative of the peripheral arterial tone; and

a processor receiving the signals output from said probe and either providing an output indicating changes in the peripheral arterial tone from which the physiological state can be determined or determining the physiological state from changes in the peripheral arterial tone and providing an output indicating the physiological state.

10. The apparatus recited in claim 9, further comprising a pulse oximeter for measuring oxygen saturation of blood.

11. The apparatus recited in claim 10, wherein said pulse oximeter is housed in said probe.

12. The apparatus recited in claim 9, wherein the physiological condition is a cardiovascular disease state.

13. The apparatus recited in claim 9, wherein the physiological condition is endothelial dysfunction.

14. The apparatus recited in claim 12, wherein the cardiovascular disease state is coronary artery disease.

15. A method for non-invasive detection of a change in a physiological state of a patient, comprising:

detecting a change in peripheral arterial tone of the patient; and

determining the physiological or patho-physiological state of the patient when a specific change in the peripheral arterial tone has been detected.

16. The method recited in claim 15, wherein said detecting comprises viewing variations in a peripheral arterial tone signal.

17. The method recited in claim 15, wherein said detecting comprises viewing time-course of a peripheral arterial tone signal.

18. The method recited in claim 15, wherein the physiological state is a cardiovascular disease state.

19. The method recited in claim 15, wherein the physiological state is endothelial dysfunction.

20. The method recited in claim 19, wherein the specific change is an attenuation of a peripheral arterial tone signal during exercise with or without an increase of the peripheral arterial tone signal during recovery.

21. The method recited in claim 15, wherein said detecting is performed during a stress test.

22. The method recited in claim 21, wherein the stress test is a mental stress test.

23. The method recited in claim 21, wherein the stress test is to elicit hyperemia.

24. The method recited in claim 21, wherein the stress test is to elicit sympathetic nervous system reactivity.

25. The method recited in claim 18, wherein the cardiovascular disease state is coronary artery disease.

26. An apparatus for determining a physiological state of a patient, comprising:

a pressure applicator comprising a tubular socket for receiving a predetermined length of a distal end of a digit of the patient'"'"'s body, including an extreme distal tip of the digit,

said pressure applicator comprising an end cup for receiving the extreme distal tip of the digit to prevent venous blood from pooling in the extreme distal tip,

said pressure applicator further comprising at least one pressure cuff having a membrane configured to exert pressure on part of the digit preceding the extreme distal tip of the digit, to function as a venous tourniquet to prevent venous pooling and venous shock wave propagation in the digit;

a pressure source for applying a static pressure field around the distal end of the digit of the patient'"'"'s body when received in said tubular socket, which static pressure is sufficient to substantially prevent venous pooling and propagation of venous shock waves in the distal end of the digit and to partially unload but not occlude arteries therein;

a measuring device for measuring changes in the distal end of the digit accompanying blood pressure waves; and

a processor receiving a signal output from said measuring device and either providing an output indicating changes in peripheral arterial tone from which the physiological state can be determined or determining the physiological state from changes in the peripheral arterial tone and providing an output indicating the physiological state.

27. The apparatus recited in claim 26, further comprising a pulse oximeter for measuring oxygen saturation of arterial blood.

28. The apparatus recited in claim 27, wherein said pulse oximeter is housed in said apparatus.

29. The apparatus recited in claim 26, further comprising a device for determining whether the patient is in a sleep or awake state.

30. The apparatus recited in claim 29, wherein the device for determining whether the patient is in the sleep or awake state is an actigraph.

31. The apparatus recited in claim 27, further comprising a device for determining whether a patient is in a sleep or awake state.

32. The apparatus recited in claim 26, wherein the physiological state is a cardiovascular disease state.

33. The apparatus recited in claim 26, wherein the physiological state is endothelial dysfunction.

34. The apparatus recited in claim 32, wherein the cardiovascular disease state is coronary artery disease.

35. The apparatus recited in claim 26, wherein the physiological state is sympathetic nervous system reactivity.

36. The apparatus recited in claim 31, wherein the physiological state is a sleep disordered breathing condition.

37. The apparatus recited in claim 36, wherein the sleep disordered breathing condition is upper airway resistance syndrome.

38. The apparatus recited in claim 36, wherein the sleep disordered breathing condition is hypopnea.

39. The apparatus recited in claim 36, wherein the sleep disordered breathing condition is obstructive sleep apnea.

40. The apparatus recited in claim 35, wherein the physiological state is that of the time-course of sympathetic nervous tone.

41. The apparatus recited in claim 35, wherein the output provided by said processor is a time-course of a peripheral arterial tone signal which is viewed so as to obtain biological information of the patient'"'"'s level of sympathetic nervous activity.

42. The apparatus recited in claim 35, wherein the output provided by said processor is a time-course of a peripheral arterial tone signal which is viewed so as to provide a patient with information regarding the patient'"'"'s level of sympathetic nervous activity for therapeutic purpose of biofeedback treatment.

43. The apparatus recited in claim 40, wherein the physiological state is that of variations of sympathetic nervous tone during a tilt test.

44. The apparatus recited in claim 40, wherein the physiological state is that of the time-course of sympathetic nervous tone during a tilt test.

45. A method for calibrating a blood pressure measuring instrument, the instrument comprising an end cap for receiving a patient'"'"'s digit, the end cap having a pressure compartment configured to exert pressure on a distal part of the digit including an extreme tip of the digit, to prevent venous blood pooling in the digit, a contiguous pressure cuff having a membrane configured to exert pressure on the digit preceding the distal part of the digit, to prevent venous blood pooling in the digit, and a sensor for detecting pulsatile volume changes of the arteries in the part of the digit contained within the instrument, said method comprising generating a compliance curve of measured arterial blood vessels by inducing and monitoring transmural pressure changes within the blood vessels by changing an applied external pressure generated within the instrument, and measuring corresponding volumes and other volume correlated features of the blood vessels and then plotting said volumes and features.

46. A method for calibrating a blood pressure measuring instrument, comprising the generation of a compliance curve of the measured arterial blood vessels by inducing and monitoring transmural pressure changes within the blood vessels by changing an applied external pressure generated within the instrument and by altering intra-vascular hydrostatic pressure, and measuring corresponding volumes and other volume correlated features of such arterial blood vessels and then plotting such measured values and induced hydrostatic pressure changes.

50. A method for determining the effect of a pharmacological agent on peripheral arterial tone, comprising:

monitoring peripheral arterial tone using an external sensor;

detecting a change in the peripheral arterial tone; and

determining the effect of the pharmacological agent when a specific change in the peripheral arterial tone has been detected.