Calibrated measurement of blood vessels and endothelium after reactive hyperemia and method therefor

• US 6,152,881 A
• Filed: 03/29/1999
• Issued: 11/28/2000
• Est. Priority Date: 03/29/1999
• Status: Expired due to Fees

• Current Assignee: Vasocor, Inc.
• Original Assignee: Vasocor, Inc.
• Inventors: Insull, William Jr., Raines, Jeffrey K.
• Primary Examiner(s): O'Connor, Cary
• Assistant Examiner(s): MCPHERSON, CATHERINE E
• Application Number:
  US09/277,914
• Time in Patent Office: 610 Days
• Field of Search: 600/504, 600/485, 600/490, 600/500, 600/507, 600/481
• US Class Current: 600/507
• CPC Class Codes: A61B 5/02007 Evaluating blood vessel condition, e.g. elasticity, compliance
• CPC Class Codes: A61B 5/02141 Details of apparatus construction, e.g. pump units or housings therefor, cuff pressurising systems, arrangements of fluid conduits or circuits A61B5/02233, A61B5/0235 take precedence
• CPC Class Codes: A61B 5/022 by applying pressure to close blood vessels, e.g. against the skin; Ophthalmodynamometers
• CPC Class Codes: A61B 5/026 Measuring blood flow A61B3/1233, A61B3/1241 take precedence
• CPC Class Codes: A61B 5/0295 using plethysmography, i.e. measuring the variations in the volume of a body part as modified by the circulation of blood therethrough, e.g. impedance plethysmography
• CPC Class Codes: A61B 5/7239 using differentiation including higher order derivatives
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence

Abstract

The calibrated method for characterizing blood flow in a limb of a patient during reactive hyperemia utilizes a blood pressure cuff. The method establishes a predetermined, near diastolic, pressure in said blood pressure cuff during the reactive hyperemic episode, continually senses the pressure in the cuff and periodically changes the internal volume of said blood pressure cuff by a predetermined volumetric amount to calibrate the system. The resultant change in the pressure is a calibration pressure pulse and is used to calculates pulsatile blood volume through the blood vessel. A calibrated method for determining the condition of blood vessels and endothelium includes determining, for each calibration cycle, a respective peak value for the blood volume and comparing the peak blood volume values with peak blood volume values for healthy blood vessels and endothelium. The comparison preferably utilizes a waveform. The calibrated system for characterizing blood flow includes a computerized electronic and pneumatic system which inflates, for a predetermined pre-test time, the blood pressure cuff to a suprasystolic pressure and thereafter establishes the near diastolic pressure in the cuff during the ensuing reactive hyperemic episode. A sensor substantially continually senses the pressure and generates a pressure signal. A subsystem periodically changes the volume of said blood pressure cuff during a calibration cycle. A corrected and calibrated blood volume signal is calculated with the calibration pressure signal. A calibrated system for determining the condition of blood vessels and endothelium is also disclosed.

Claims

1. A calibrated method for characterizing blood flow in a limb of a patient during reactive hyperemia with a blood pressure cuff bound about said limb comprising the steps of:

establishing a predetermined, near diastolic, pressure in said blood pressure cuff during the reactive hyperemic episode;

substantially continually sensing the pressure in said blood pressure cuff during the reactive hyperemic episode;

during the reactive hyperemic episode, periodically changing a volume of said blood pressure cuff by a predetermined volumetric amount and substantially concurrently sensing a resultant change in the pressure as a calibration pressure pulse;

calculating pulsatile blood volume by correcting the sensed pressure with the ratio of the predetermined volumetric amount and calibration pressure pulse.

2. A calibrated method for characterizing blood flow as claimed in claim 1 wherein the step of sensing the pressure includes sensing a pressure pulse due to blood flow through the patient'"'"'s arteries and the step of periodically changing said volume of said blood pressure cuff by a predetermined volumetric amount includes the step of changing said volume based upon a periodic presence of a predetermined plurality of sensed pressure pulses.

3. A calibrated method for characterizing blood flow as claimed in claim 2 wherein the periodic presence of a predetermined plurality of sensed pressure pulses defines a cyclic calibration routine for calculating a plurality of pulsatile blood volumes during the reactive hyperemic episode.

4. A calibrated method for characterizing blood flow as claimed in claim 3 including the step of selecting at least one of said sensed pressure pulses during each cyclic calibration and calculating said pulsatile blood volume based thereon, said step of calculating a plurality of pulsatile blood volumes during the reactive hyperemic episode including the step of utilizing said at least one of said sensed pressure pulses for each said cyclic calibration.

5. A calibrated method for characterizing blood flow as claimed in claim 4 including the step of reducing motion artifacts by averaging one from the group of a predetermined number of sensed pressure pulses in each cyclic calibration and a predetermined number of pulsatile blood volumes in each cyclic calibration.

6. A calibrated method for characterizing blood flow as claimed in claim 4 including the step of correlating an episodic time with each cyclic calibration.

7. A calibrated method for characterizing blood flow as claimed in claim 6 wherein said pulsatile blood volume is a wave and the method includes the step of calculating a plurality of peak values for the pulsatile blood volume during the reactive hyperemic episode.

8. A calibrated method for characterizing blood flow as claimed in claim 7 including the step of graphically presenting said plurality of peak values for the pulsatile blood volume with respect to the correlated episodic time for substantially the entire reactive hyperemic episode.

9. A calibrated method for characterizing blood flow as claimed in claim 8 wherein the step of changing said volume based upon a periodic presence of a predetermined plurality of sensed pressure pulses includes the step of counting sensed pressure pulses.

10. A calibrated method for characterizing blood flow as claimed in claim 9 changing said volume based upon counting a periodic presence of a predetermined plurality of sensed pressure pulses includes the step of counting at least three substantially similar pressure pulses and subsequently changing said volume with said predetermined volumetric amount.

11. A calibrated method for characterizing blood flow as claimed in claim 10 including the step of ignoring a second predetermined plurality of sensed pressure pulses subsequent to changing said volume with said predetermined volumetric amount.

12. A calibrated method for characterizing blood flow as claimed in claim 11 wherein said steps of counting at least three substantially similar pressure pulses, subsequently changing said volume with said predetermined volumetric amount, and ignoring a second predetermined plurality of sensed pressure pulses subsequent to changing said volume defines a cyclic calibration period.

13. A calibrated method for characterizing blood flow as claimed in claim 12 including the step of obtaining said patient'"'"'s diastolic blood pressure prior to said reactive hyperemic episode and utilizing one of said patient'"'"'s diastolic pressure and a predetermined, step-down diastolic pressure in the step of establishing said predetermined pressure in said blood pressure cuff during the reactive hyperemic episode.

14. A calibrated method for characterizing blood flow as claimed in claim 13 including the step of occluding blood flow through the limb of said patient for a predetermined time period prior to the step of establishing said predetermined pressure in said blood pressure cuff thereby creating said reactive hyperemic episode in the limb of said patient.

15. A calibrated method for characterizing blood flow as claimed in claim 14 wherein all the steps are noninvasive with respect to said patient and said patient'"'"'s limb.

16. A calibrated method for characterizing blood flow as claimed in claim 15 including the step of calculating pulsatile blood flow as a volumetric quantity with respect to time.

17. A calibrated method for characterizing blood flow as claimed in claim 15 wherein the step of periodically changing the volume includes one step from the group consisting of adding said predetermined volume and subtracting said predetermined volume to and from said blood pressure cuff.

18. A calibrated method for characterizing blood flow as claimed in claim 8 wherein the step of graphically comparing said plurality of peak values for the pulsatile blood volume with respect to the correlated episodic time includes the step of illustrating said plurality of peak values as a episodic blood volume waveform, and the method includes graphically comparing said episodic blood volume waveform of said patient with a predetermined waveform illustrating a healthy blood volume waveform.

19. A calibrated method for characterizing blood flow as claimed in claim 3 wherein the step of changing said volume based upon a periodic presence of a predetermined plurality of sensed pressure pulses includes the step of counting sensed pressure pulses.

20. A calibrated method for characterizing blood flow as claimed in claim 19 wherein the step of changing said volume based upon counting a periodic presence of a predetermined plurality of sensed pressure pulses includes the step of counting at least three substantially similar pressure pulses and subsequently changing said volume with said predetermined volumetric amount.

21. A calibrated method for characterizing blood flow as claimed in claim 20 including the step of ignoring a second predetermined plurality of sensed pressure pulses subsequent to changing said volume with said predetermined volumetric amount.

22. A calibrated method for characterizing blood flow as claimed in claim 21 wherein said steps of counting at least three substantially similar pressure pulses, subsequently changing said volume with said predetermined volumetric amount, and ignoring a second predetermined plurality of sensed pressure pulses subsequent to changing said volume defines a cyclic calibration period.

23. A calibrated method for characterizing blood flow as claimed in claim 1 wherein the step of periodically changing the volume includes one step from the group consisting of adding said predetermined volume and subtracting said predetermined volume to and from said blood pressure cuff.

24. A calibrated method for determining the condition of blood vessels and endothelium in a limb of a patient during reactive hyperemia with a blood pressure cuff bound about said limb comprising the steps of:

establishing a predetermined, near diastolic, pressure in said blood pressure cuff during the reactive hyperemic episode;

substantially continually sensing the pressure in said blood pressure cuff during substantially the entire reactive hyperemic episode;

periodically changing a volume of said blood pressure cuff by a predetermined volumetric amount and substantially concurrently sensing a resultant change in the pressure as a calibration pressure pulse at a predetermined plurality of calibration cycles during said reactive hyperemic episode;

determining, for each of said plurality of calibration cycles, a respective peak value for a blood volume, said blood volume obtained by correcting the sensed pressure, at each of said plurality of calibration cycles, with the ratio of the predetermined volumetric amount and calibration pressure pulse obtained during said respective calibration cycle; and

comparing said peak values for said plurality of calibration cycles with a plurality of predetermined peak blood volume values for healthy blood vessels and endothelium during reactive hyperemia.

25. A calibrated method for determining the condition of blood vessels and endothelium as claimed in claim 24 wherein the step of determining respective peak blood volume values for said plurality of calibration cycles includes the step of correlating the plurality of peak blood volume values for each of said plurality of calibration cycles to an episodic time for said reactive hyperemia.

26. A calibrated method for determining the condition of blood vessels and endothelium as claimed in claim 25 including the step of mapping the episodic correlated plurality of peak blood volume values to said episodic time and wherein said plurality of predetermined peak blood volume values for healthy blood vessels and endothelium is a time-based map including said plurality of predetermined peak blood volume values for healthy blood vessels and endothelium.

27. A calibrated method as claimed in claim 26 wherein said step of continually sensing includes the step of sensing a pressure pulse, and the method includes the step of selecting at least one of said sensed pressure pulses during each calibration cycle and calculating said blood volume based thereon.

28. A calibrated method as claimed in claim 27 including the step of averaging a predetermined number of sensed pressure pulses in each calibration cycle.

29. A calibrated method as claimed in claim 27 wherein the step of changing said volume is based upon detecting a periodic presence of a predetermined plurality of sensed pressure pulses which establishes said calibration cycle and includes the step of counting sensed pressure pulses.

30. A calibrated method as claimed in claim 29 including the step of ignoring a second predetermined plurality of sensed pressure pulses during each calibration cycle subsequent to changing said volume with said predetermined volumetric amount in the same calibration cycle.

31. A calibrated method as claimed in claim 30 including the step of obtaining said patient'"'"'s diastolic blood pressure prior to said reactive hyperemic episode and utilizing one of said patient'"'"'s diastolic pressure and a predetermined, step-down diastolic pressure in the step of establishing said predetermined pressure in said blood pressure cuff during the reactive hyperemic episode.

32. A calibrated method as claimed in claim 31 including the step of occluding blood flow through the limb of said patient for a predetermined time period prior to the step of establishing said predetermined pressure in said blood pressure cuff thereby creating said reactive hyperemic episode in the limb of said patient.

33. A calibrated method as claimed in claim 32, including the step of calculating pulsatile blood flow as a volumetric quantity with respect to time.

34. A calibrated method as claimed in claim 33, wherein the step of periodically changing the volume includes one step from the group consisting of adding said predetermined volume and subtracting said predetermined volume to and from said blood pressure cuff.

35. A calibrated method for determining the condition of blood vessels and endothelium as claimed in claim 25 including the step of mapping the episodic correlated plurality of peak blood volume values as a waveform and the method includes the step of graphically displaying the mapped episodic correlated plurality of peak blood volume values as a waveform.

36. A calibrated method for determining the condition of blood vessels and endothelium as claimed in claim 35 including the step of graphically displaying said mapped episodic correlated plurality of peak blood volumes as a waveform substantially simultaneously with a time-based waveform of said plurality of predetermined peak blood volume values for healthy blood vessels and endothelium.

37. A calibrated system for characterizing blood flow in a limb of a patient during reactive hyperemia with a blood pressure cuff bound about said limb comprising:

means, coupled to said blood pressure cuff, for inflating, for a predetermined pre-test time, said blood pressure cuff to a suprasystolic pressure and thereafter establishing a predetermined, near diastolic, pressure in said blood pressure cuff during the ensuing reactive hyperemic episode;

a sensor, pneumatically coupled to said blood pressure cuff, substantially continually sensing the pressure in said cuff and generating a pressure signal during the reactive hyperemic episode;

means, coupled to said blood pressure cuff, for periodically changing a volume of said blood pressure cuff by a predetermined volumetric amount during the reactive hyperemic episode;

means, coupled to said sensor, for generating a calibration pressure pulse signal based upon a resultant change in the pressure signal during the periodic change of volume;

means for calculating a blood volume signal by correcting the sensed pressure signal with a ratio of the predetermined volumetric amount and said calibration pressure pulse signal; and

means for quickly releasing said suprasystolic pressure in said blood pressure cuff prior to establishing said predetermined, near diastolic, pressure in said cuff.

38. A calibrated system for characterizing blood flow during reactive hyperemia as claimed in 37 wherein said means for quickly releasing includes an exhaust valve.

39. A calibrated system for characterizing blood flow during reactive hyperemia as claimed in claim 38 wherein said sensor generates pressure pulse signals as part of said pressure signal during said reactive hyperemic episode and the system includes means for counting said pressure pulse signals to establish a calibration cycle.

40. A calibrated system for characterizing blood flow during reactive hyperemia as claimed in claim 39 wherein said reactive hyperemic episode includes a plurality of calibration cycles and the system includes means, coupled to said means for calculating, for correlating said blood volume signal with its respective calibration cycle.

41. A calibrated system for characterizing blood flow during reactive hyperemia as claimed in claim 40 wherein said means for calculating includes means for averaging one of said sensed pressure pulse signals and said blood volume signals in each of said plurality of calibration cycles.

42. A calibrated system for characterizing blood flow during reactive hyperemia as claimed in claim 40 including means, coupled to said means for calculating, for determining pulsatile blood flow as a volumetric quantity with respect to time.

43. A calibrated system for characterizing blood flow during reactive hyperemia as claimed in claim 40 wherein said means for counting is part of means for establishing said calibration cycle, the system including means, coupled to said means for establishing said calibration cycle, for correlating an episodic time of said reactive hyperemic episode with said plurality of calibration cycles.

44. A calibrated system for characterizing blood flow during reactive hyperemia as claimed in claim 43 wherein each said calibration cycle includes a first and a second plurality of pressure pulse signals with said calibration pulse interposed therebetween, said means for calculating said blood volume signal utilizing said first plurality of pressure pulse signals during the respective calibration cycle to calculate said blood volume signal for said respective calibration cycle.

45. A calibrated system for characterizing blood flow during reactive hyperemia as claimed in claim 44 wherein said sensor is noninvasive with respect to said patient'"'"'s limb and wherein said blood volume signal is a blood volume pulse signal which is based upon said pressure pulse signal.

46. A calibrated system for characterizing blood flow during reactive hyperemia as claimed in claim 45 including means, coupled to said means for calculating, for computing peak blood volume values based upon the blood volume signal for each of said plurality of calibration cycles.

47. A calibrated system for characterizing blood flow during reactive hyperemia as claimed in claim 46 including means, coupled to said means for computing peak blood volume values and said means for correlating an episodic time of said reactive hyperemic episode with said plurality of calibration cycles, for graphically presenting the plurality peak blood volume values with respect to said episodic time was a reactive hyperemic blood flow waveform.

48. A calibrated system for characterizing blood flow during reactive hyperemia as claimed in claim 47 including means for storing a predetermined waveform illustrating a healthy blood flow waveform and the system includes means, coupled to said means for storing and said means for graphically presenting, for graphically comparing and presenting said reactive hyperemic blood flow waveform of said patient with said predetermined waveform illustrating a healthy blood flow.

49. A calibrated system as claimed in claim 48 including means, coupled to said means for calculating, for determining pulsatile blood flow as a volumetric quantity with respect to time.

50. A calibrated system as claimed in claim 49 wherein said means for periodically changing a volume of said blood pressure cuff includes one from the group consisting means for adding said predetermined volumetric amount and means for subtracting said predetermined volumetric amount to and from said blood pressure cuff.

51. A calibrated system for determining the condition of blood vessels and endothelium in a limb of a patient during reactive hyperemia with a blood pressure cuff bound about said limb comprising:

means, coupled to said blood pressure cuff, for inflating, for a predetermined pre-test time, said blood pressure cuff to a suprasystolic pressure and thereafter establishing a predetermined, near diastolic, pressure in said blood pressure cuff during the ensuing reactive hyperemic episode;

a sensor, pneumatically coupled to said blood pressure cuff, substantially continually sensing the pressure in said cuff and generating a pressure signal during the reactive hyperemic episode, said pressure signal including a plurality of pressure pulse signals therein;

means, coupled to said blood pressure cuff, for periodically changing a volume of said blood pressure cuff by a predetermined volumetric amount at a predetermined plurality of calibration cycles during the reactive hyperemic episode;

means, coupled to said sensor and said means for periodically changing volume, for generating a calibration pressure pulse signal during each of said calibration cycles based upon a resultant change in the pressure signal;

means, coupled to said sensor and said means for generating said calibration pulse signal, for determining, for each of said plurality of calibration cycles and during said reactive hyperemic episode, a respective peak value for a blood volume signal, said blood volume signal obtained by correcting the pressure pulse signal, at each of said plurality of calibration cycles, with the ratio of the predetermined volumetric amount and said calibration pressure pulse signal obtained during said respective calibration cycle; and

means, coupled to said means for determining, for comparing the peak blood volume values for said plurality of calibration cycles with a plurality of predetermined peak blood volume values for healthy blood vessels and endothelium during reactive hyperemia.

52. A calibrated system for determining the condition of blood vessels and endothelium during reactive hyperemia as claimed in claim 51 wherein the system includes means for monitoring an episodic time for said reactive hyperemia, and the means for determining respective peak blood volume values for said plurality of calibration cycles includes means, coupled to said means for monitoring, for correlating the plurality of peak blood volume values for each of said plurality of calibration cycles to said episodic time for said reactive hyperemia.

53. A calibrated system for determining the condition of blood vessels and endothelium during reactive hyperemia as claimed in claim 52 including means, coupled to said means for correlating, for mapping the episodic correlated plurality of peak blood volume values, and wherein said plurality of predetermined peak blood volume values for healthy blood vessels and endothelium is a time-based map of predetermined blood flow.

54. A calibrated system for determining the condition of blood vessels and endothelium during reactive hyperemia as claimed in claim 53 including means for graphically displaying the mapped episodic correlated plurality of peak blood volume values as a blood flow waveform and a time-based predetermined blood flow waveform for healthy blood vessels and endothelium.

55. A calibrated system for determining the condition of blood vessels and endothelium during reactive hyperemia as claimed in claim 54 including means, coupled to said means for determining, for averaging a predetermined number of pressure pulse signals in each said calibration cycle.

56. A calibrated system for determining the condition of blood vessels and endothelium during reactive hyperemia as claimed in claim 54 wherein said means for changing said volume includes means for counting pressure pulse signals in order to establish said calibration cycle.

57. A calibrated system for determining the condition of blood vessels and endothelium during reactive hyperemia as claimed in claim 56 wherein each said calibration cycle includes a first and a second plurality of pressure pulse signals with said calibration pulse interposed therebetween, said means for determining said blood volume signal utilizing said first plurality of pressure pulse signals during the respective calibration cycle to calculate said blood volume signal for said respective calibration cycle.

58. A calibrated system for determining the condition of blood vessels and endothelium during reactive hyperemia as claimed in claim 57 including means, coupled to said means for determining, for calculating pulsatile blood flow as a volumetric quantity with respect to time.

59. A calibrated system for determining the condition of blood vessels and endothelium during reactive hyperemia as claimed in claim 58 wherein said means for changing the volume includes one from the group consisting means for adding said predetermined volumetric amount and means for subtracting said predetermined volumetric amount to and from said blood pressure cuff.