Method and apparatus for non-invasively measuring hemodynamic parameters using parametrics

• US 20030149369A1
• Filed: 02/05/2002
• Published: 08/07/2003
• Est. Priority Date: 02/05/2002
• Status: Active Grant

• Current Assignee: United States GTM Medical Devices
• Original Assignee: Tensys Medical Inc. (Recorders & Medicare Systems Pvt Ltd.)
• Inventors: Voss, Gregory L., Gallant, Stuart L.
• Granted Patent: US 6,730,038 B2
• Time in Patent Office: Days
• US Class Current: 600/485
• CPC Class Codes: A61B 2562/02 Details of sensors specially adapted for in-vivo measurements
• CPC Class Codes: A61B 2562/0247 Pressure sensors
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/6843 Monitoring or controlling sensor contact pressure

Abstract

An improved method and apparatus for non-invasively assessing one or more hemodynamic parameters associated with the circulatory system of a living organism. In one aspect, the invention comprises a method of measuring a hemodynamic parameter (e.g., arterial blood pressure) by applanating or compressing portions of tissue proximate to the blood vessel of concern until a desired condition is achieved, and then measuring the hemodynamic parameter. Such applanation effectively mitigates transfer and other losses created by the tissue proximate to the blood vessel, thereby facilitating accurate and robust tonometric measurement. An algorithm adapted to maintain optimal levels of applanation is also described. Methods and apparatus for scaling such hemodynamic parameter measurements based on subject physiology, and providing treatment to the subject based on the measured parameters, are also disclosed.

Claims

1. A method of tonometrically measuring the pressure in the blood vessel of a living subject, comprising:

providing a transducer adapted for determining the pressure applied to at least one surface thereof;

disposing said at least one surface of said transducer proximate to said blood vessel;

varying the level of compression applied to said blood vessel by said transducer over time;

determining the level of compression where a desired condition of the pulse pressure associated with said blood vessel exists based on the pressure determined by said transducer;

maintaining said transducer at or near said level of compression where said desired condition exists;

measuring at least one pressure value using said transducer during at least a portion of said act of maintaining; and

scaling said at least one pressure value based on at least the body mass index (BMI) of said subject to produce a corrected value, said corrected value being substantially representative of the actual pressure within said blood vessel.

2. A method of measuring the pressure in the blood vessel of a living subject, comprising:

providing at least one transducer adapted for determining the pressure applied to at least one surface thereof;

disposing said at least one surface of said at least one transducer proximate to said blood vessel;

varying the level of compression applied to said blood vessel by said at least one transducer over time;

determining the level of compression where a desired condition of the pulse pressure associated with said blood vessel exists based on the pressure determined by said at least one transducer;

maintaining said at least one transducer at or near said level of compression where said desired condition exists; and

measuring at least one pressure value using said transducer during at least a portion of said act of maintaining.

3. The method of claim 2, wherein said act of disposing comprises disposing said at least one surface of said transducer in contact with the surface of the tissue overlying said at least one blood vessel.

4. The method of claim 2, wherein said act of varying the level of compression comprises performing an applanation sweep from a state of undercompression of said blood vessel to a state of overcompression.

5. The method of claim 4, wherein said applanation sweep comprises linearly varying the position of said transducer with respect to a reference point as a function of time.

6. The method of claim 4, wherein said applanation sweep comprises step-wise varying the position of said transducer with respect to a reference point as a function of time.

7. The method of claim 4, wherein said act of determining the level of compression comprises:

measuring at least one pressure waveform during said act of performing; and

identifying at least one artifact within said at least one waveform, said at least one artifact being associated with said desired condition.

8. The method of claim 7, wherein said act of identifying at least one artifact comprises:

analyzing said at least one waveform on a per-beat basis;

evaluating at least one parameter associated with a first beat of said at least one waveform;

evaluating said at least one parameter associated with at least one other beat of said at least one waveform; and

applying at least one criterion to said beats to identify said desired condition of pulse pressure.

9. The method of claim 8, wherein said at least one parameter comprises the pressure amplitude, and said desired condition comprises maximum pulse pressure.

10. The method of claim 9, wherein said at least one other beat comprises two consecutive beats, said two consecutive beats being sequential with said first beat, said criterion comprising a difference in the pressure amplitude of a predetermined percentage.

11. The method of claim 2, further comprising:

determining a first physiologic parameter of said subject;

determining a second physiologic parameter of said subject;

forming a relationship between said first and second parameters; and

using said relationship to scale said at least one pressure value.

12. The method of claim 11, wherein said first physiologic parameter comprises the body mass index (BMI) of said subject.

13. The method of claim 12, wherein said second physiologic parameter comprises the pulse pressure measured from said subject.

14. The method of claim 13, wherein said act of forming comprises forming a ratio of said BMI to said PP.

15. The method of claim 12, wherein said second physiologic parameter comprises the circumference of said subject'"'"'s wrist (WC).

16. The method of claim 15, wherein said act of forming comprises forming a ratio of said BMI to said WC.

17. The method of claim 14, wherein said act of using comprises (i) correlating said ratio to a scale factor;

and (ii) multiplying said at least one pressure value by said scale factor.

18. The method of claim 2, wherein said act of varying the level of compression over time comprises varying the level of compression at a rate which is at least in part a function of the heart rate of said subject.

19. The method of claim 2, further comprising:

determining at least one physiologic parameter of said subject;

identifying a relationship between said at least one parameter and a scaling factor for said at least one pressure value measured from said blood vessel; and

using said scaling factor to scale said at least one pressure value.

20. The method of claim 19, wherein said at least one parameter comprises body fat content.

21. The method of claim 2, further comprising varying the position of said at least one transducer in a substantially lateral direction relative to said blood vessel so as to optimize said desired condition of said act of determining.

22. The method of claim 21, further comprising varying the position of said at least one transducer in a substantially proximal direction relative to said blood vessel so as to optimize said desired condition of said act of determining.

23. The method of claim 22, wherein said desired condition comprises maximum pulse pressure, and at least one of said acts of varying comprises:

measuring at least one pressure waveform during said act of varying;

varying the position of said at least one transducer over a range of positions; and

identifying that position where said pulse pressure is maximized for a given level of compression.

24. The method of claim 19, further comprising determining a mean pressure within said at least one waveform;

and

wherein said act of using said scaling factor to scale said at least one pressure value comprises applying said scaling factor to pressure values above and below said mean.

25. The method of claim 24, wherein said act of applying scaling factors to pressure values above and below said mean comprises applying a positive (+) scaling factor to systolic pressures above said mean, and a negative (−

) scaling factor to diastolic pressures below said mean.

26. A method of biasing tissue during a blood pressure measurement, said tissue substantially overlying a blood vessel from which said pressure is determined, comprising:

determining that value of a biasing force at which a first condition relating to said blood pressure occurs concurrently with a second condition; and

applying said determined first biasing force to at least a portion of said tissue.

27. The method of claim 26, wherein said first condition comprises maximum pulse pressure, and said second condition comprises lowest end diastolic pressure or lowest mean pressure.

28. The method of claim 26, further comprising:

disposing a pressure transducer in contact with said tissue during said act of applying, said pressure transducer being adapted to determine the pressure applied to at least one active surface thereof; and

measuring said blood pressure using said pressure transducer.

29. The method of claim 28, further comprising varying said bias force as a function of time so as to maintain said first and second conditions.

30. The method of claim 29, wherein said first condition comprises maximum pulse pressure and said second condition comprises lowest diastolic pressure.

31. The method of claim 28, further comprising:

determining at least one physiologic parameter of said subject;

identifying a relationship between said at least one parameter and a scaling factor for said pressure measured using said transducer; and

using said scaling factor to scale said measured pressure.

32. A method scaling an unscaled blood pressure measurement derived from a living subject, comprising:

determining a first physiologic parameter of said subject;

determining a second physiologic parameter of said subject;

forming a relationship between said first and second parameters; and

using said relationship to scale said unscaled blood pressure measurement.

33. The method of claim 32, wherein said first physiologic parameter comprises the body mass index (BMI) of said subject.

34. The method of claim 33, wherein said second physiologic parameter comprises the circumference of said subject'"'"'s wrist (WC).

35. The method of claim 34, wherein said act of forming comprises forming a ratio of said BMI to said WC.

36. The method of claim 35, wherein said act of using comprises (i) correlating said ratio to a scale factor;

and (ii) multiplying said unscaled measurement by said scale factor.

37. The method of claim 36, wherein said act of correlating comprises:

providing a plurality of discrete intervals of the value of said ratio;

providing a value of said scale factor for each of said intervals; and

obtaining one of said values of said scale factor based on the corresponding value of said ratio.

38. The method of claim 36, wherein said act of correlating comprises:

providing a first functional relationship between at least said scale factor and said ratio; and

determining said scale factor based on said ratio and said first functional relationship.

39. The method of claim 38, wherein said first functional relationship is linear.

40. The method of claim 38, wherein said first functional relationship relates said scale factor, said BMI, and said WC.

41. The method of claim 32, wherein said first and second physiologic parameters are substantially unrelated to the blood pressure of said subject.

42. A method scaling an unscaled blood pressure measurement derived from a living subject, comprising:

determining a first physiologic parameter of said subject, said first parameter being related to the body mass of said subject;

determining a second physiologic parameter of said subject, said second parameter being related to the location on said subject where said unscaled blood pressure measurement is obtained;

functionally relating said first and second parameters to produce a third parameter;

correlating said third parameter to a fourth parameter; and

scaling said unscaled blood pressure measurement using at least said fourth parameter.

43. The method of claim 42, wherein said second parameter comprises a measure of distance, and said fourth parameter comprises a scaling factor.

44. An apparatus for measuring the pressure within the blood vessel of a living subject comprising:

a pressure transducer adapted to detect the pressure associated with said blood vessel and generate a signal relating thereto;

at least one storage device associated with said pressure transducer, said at least one storage device having scaling data stored therein;

at least one applanation assembly adapted to bias a portion of tissue proximate to said blood vessel;

a controller operatively coupled to said at least one applanation assembly and adapted to control the position thereof; and

a processor operatively connected to said transducer, at least one storage device, and said controller, said processor configured to generate an estimate of said blood pressure within said vessel based at least in part on said signal and said scaling data.

45. The apparatus of claim 44, wherein said blood vessel comprises the radial artery of a human being, and said portion of tissue is disposed on the wrist of said subject.

46. The apparatus of claim 44, wherein said pressure transducer is physically coupled to said at least one applanation assembly, and comprises at least one active surface which contacts said portion of said tissue, said portion of tissue at least partly overlying said blood vessel.

47. The apparatus of claim 44, wherein said controller and processor comprise a single integrated circuit (IC) device.

48. The apparatus of claim 44, further comprising at least one computer program adapted to control the level of bias applied to said portion of tissue.

49. The apparatus of claim 48, wherein said at least one computer program is further adapted to maintain said bias level such that the pulse pressure associated with said blood vessel is substantially maximized.

50. The apparatus of claim 44, wherein said scaling data is selected based at least in part on at least one physical parameter associated with said living subject.

51. The apparatus of claim 50, wherein said at least one physical parameter comprises the body mass index of said subject.

52. The apparatus of claim 50, wherein said at least one physical parameter comprises an index based at least in part on the wrist circumference of said subject.

53. The apparatus of claim 44, wherein said pressure transducer and said at least one storage device comprise a substantially unitary assembly adapted for removal from said apparatus.

54. The apparatus of claim 53, wherein said at least one storage device contains scaling data adapted for use on a subject having a physical parameter falling within a predetermined range.

55. The apparatus of claim 54, wherein said physical parameter comprises a body mass index.

56. The apparatus of claim 54, wherein said physical parameter comprises body fat content.

57. The apparatus of claim 54, wherein said unitary assembly is visibly coded to identify the range of said physical parameter for which it may be used.

58. The apparatus of claim 57, wherein said visible coding comprises color coding, with the unitary assembly associated with each range having a different color.

59. The apparatus of claim 44, wherein said storage device contains a plurality of scaling data, and the scaling data retrieved from said storage device and applied to a given subject is selected based on the measurement of at least one physical parameter obtained from said subject and provided to said apparatus.

60. The apparatus of claim 59, wherein said act of providing comprises entering said measurement(s) into said apparatus using an input device.

61. An information storage device, comprising;

a data storage medium;

a plurality of data stored on said medium, said plurality of data comprising a computer program adapted to run on a data processor, said data processor being operatively coupled to a controller which controls the position of a pressure transducer, said computer program, processor and controller being configured for determining the blood pressure of a living subject using the method comprising;

varying the level of compression applied to said blood vessel by at least one pressure transducer over time;

determining the level of compression where a desired condition of the pulse pressure associated with said blood vessel exists based on the pressure determined by said at least one transducer;

maintaining said at least one transducer at or near said level of compression where said desired condition exists; and

measuring at least one pressure value using said transducer during at least a portion of said act of maintaining.

62. A method of positioning a pressure sensor with respect to a blood vessel, comprising:

disposing said sensor proximate to said blood vessel such that at least some degree of pressure coupling between said blood vessel and said sensor exists;

moving said sensor in at least a first direction with respect to said blood vessel while obtaining a first pressure signal from said sensor;

moving said sensor in at least a second direction with respect to said blood vessel while obtaining at least a second pressure signal; and

analyzing said first and second signals to identify at least one relationship therebetween.

63. The method of claim 62, wherein said first and second directions are substantially transverse to the longitudinal axis of said blood vessel.

64. The method of claim 63, wherein said first and second directions are substantially co-linear.

65. The method of claim 62, wherein said acts of moving each comprise moving said sensor with respect to said blood vessel at a substantially constant rate.

66. The method of claim 62, wherein said act of analyzing comprises:

identifying a first artifact within said first pressure signal;

identifying a second artifact within said second pressure signal; and

comparing the location of said first and second artifacts to determine the spatial relationship between them with respect to said blood vessel.

67. The method of claim 66, wherein said first and second artifacts each comprise a pulse pressure (PP) maximum.

68. The method of claim 67, further comprising rejecting either said first or second signals if said act of determining the spatial relationship indicates that the two maxima occur at locations separated by greater than a predetermined distance.

69. The method of claim 67, wherein said act of analyzing comprises rejecting at least one of said first or second signals if no PP maximum is detected.

70. The method of claim 62, further comprising moving said sensor in at least said first and second directions a plurality of additional times to generate corresponding ones of additional signals respectively before said act of analyzing is performed, said additional signals being analyzed along with said first and second signals to identify a spatial location of said sensor where a pulse pressure (PP) maximum exists.

71. A method of qualifying physiologic pressure data, comprising:

obtaining a plurality of pressure data from a subject;

obtaining a plurality of second data relating to at least one physiologic event within said subject; and

qualifying at least a portion of said pressure data based at least in part on said second data.

72. The method of claim 71, wherein said act of obtaining a plurality of pressure data comprises obtaining at least one pressure waveform tonometrically, and said act of obtaining a plurality of second data comprises obtaining an ECG from said subject.

73. The method of claim 72, wherein said act of qualifying comprises:

extracting heart rate information from said ECG; and

correlating variations in said pressure waveform to said heart rate information.

74. The method of claim 73, said act of qualifying further comprising:

identifying at least one of said variations in said pressure waveform which is not due to the cardiac cycle of said subject; and

eliminating said at least one variation from use in a subsequent blood pressure calculation.