Method and apparatus for control of non-invasive parameter measurements

• US 6,974,419 B1
• Filed: 08/01/2002
• Issued: 12/13/2005
• Est. Priority Date: 08/01/2002
• Status: Expired due to Fees

• Current Assignee: Tensys Medical Inc. (Recorders & Medicare Systems Pvt Ltd.)
• Original Assignee: Tensys Medical Inc. (Recorders & Medicare Systems Pvt Ltd.)
• Inventors: Voss, Gregory I., Martin, Gregory J., Goharlaee, Manouchehr
• Primary Examiner(s): Hindenburg, Max F.
• Assistant Examiner(s): MALLARI, PATRICIA C
• Application Number:
  US10/211,115
• Time in Patent Office: 1,230 Days
• Field of Search: 600481-508, 600/300, 600/301, 600309-331, 600/347
• US Class Current: 600/485
• CPC Class Codes: A61B 5/02007 Evaluating blood vessel condition, e.g. elasticity, compliance
• CPC Class Codes: A61B 5/02028 Determining haemodynamic parameters not otherwise provided for, e.g. cardiac contractility or left ventricular ejection fraction
• CPC Class Codes: A61B 5/022 by applying pressure to close blood vessels, e.g. against the skin; Ophthalmodynamometers
• CPC Class Codes: A61B 5/024 Detecting, measuring or recording pulse rate or heart rate A61B5/0205, A61B5/021 take precedence
• CPC Class Codes: A61B 5/684 Indicating the position of the sensor on the body
• CPC Class Codes: A61B 5/6843 Monitoring or controlling sensor contact pressure
• CPC Class Codes: A61B 5/7203 for noise prevention, reduction or removal
• CPC Class Codes: A61B 5/7207 of noise induced by motion artifacts
• CPC Class Codes: A61B 5/7264 Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems neural networks per se G06N3/00; expert systems per se G06N5/00

Abstract

Improved methods and apparatus for non-invasively assessing one or more parameters associated with fluidic systems such as the circulatory system of a living organism. In a first aspect, an improved method of continuously measuring pressure from a compressible vessel is disclosed, wherein a substantially optimal level of compression for the vessel is achieved and maintained using perturbations (e.g., modulation) of the compression level of the vessel. In one exemplary embodiment, the modulation is conducted according to a pseudo-random binary sequence (PBRS). In a second aspect, an improved apparatus for determining the blood pressure of a living subject is disclosed, the apparatus generally comprising a pressure sensor and associated processor with a computer program defining a plurality of operating states related to the sensed pressure data. Methods for pressure waveform correction and reacquisition, as well as treatment using the present invention, are also disclosed.

Claims

1. A method of transient event compensation during hemodynamic parameter measurement from a compressible blood vessel, comprising:

establishing an initial substantially optimal level of compression of said blood vessel for at least a first epoch;

measuring pressure data from said blood vessel using a sensor;

detecting the occurrence of a transient event by analyzing changes in said pressure data, said transient event altering the mechanical coupling between said blood vessel and sensor;

initiating a pressure sweep to identify a second substantially optimal level of compression based on said altered coupling; and

establishing the second substantially optimal level of compression of said blood vessel for at least a second epoch.

2. The method of claim 1, further comprising waiting for said transient event to subside before initiating said sweep.

3. The method of claim 1, wherein said act of initiating a pressure sweep comprises:

analyzing pressure data relating to at least two time periods occurring before and after said transient event, respectively;

comparing changes in said pressure data from said at least two time periods to a criterion; and

initiating said pressure sweep when said criterion is satisfied.

4. A method of operating a continuous non-invasive blood pressure measurement system adapted for use on the radial artery of a living subject and having a tonometric pressure sensor in contact with the tissue overlying said artery, comprising:

operating said system in a non-transient mode, wherein blood pressure data is obtained using said sensor;

detecting at least one transient event using said blood pressure data; and

operating said system in a transient recovery mode subsequent to said detection of said event.

5. The method of claim 4, wherein said non-transient mode comprises a mode wherein a level of compression applied to said artery is varied in order to maintain said artery in a substantially optimal state of compression for said act of obtaining blood pressure data.

6. The method of claim 5, wherein said transient recovery mode comprises performing a sweep across a plurality of levels of said compression of said artery in order to reacquire said substantially optimal state.

7. The method of claim 5, wherein said compression of said artery is applied using said sensor.

8. A method of operating a non-invasive blood pressure measurement system adapted for use on the radial artery of a living subject and having a tonometric pressure sensor in contact with the tissue at least partly overlying said artery, comprising:

operating said system in a non-transient mode, wherein blood pressure data is obtained using said sensor;

detecting at least one transient event during said act of obtaining said blood pressure data;

operating, for at least a period of time, said system in a transient recovery mode subsequent to said detection of said event; and

subsequently returning to operating in said non-transient mode.

9. A method of operating a non-invasive hemodynamic measurement system, comprising:

operating said system in a first mode, wherein hemodynamic data is obtained;

detecting at least one transient event within said hemodynamic data; and

(i) operating said system in a second mode subsequent to said detection of said event if said event does not have a first characteristic; and

(ii) operating said system in a third mode subsequent to said detection if said event has said first characteristic;

wherein said first characteristic comprises parameters indicating that said event is not (a) physiologic in origin, and (b) of sufficient magnitude that recovery from said event in said second mode would exceed a first criterion.

10. The method of claim 9, wherein said hemodynamic data comprises pressure data, and said act of obtaining said data comprises using a non-invasive pressure sensor to obtain said data.

11. The method of claim 9, wherein said second mode comprises a mode adapted to selectively vary a level of compression applied via said pressure sensor.

12. The method of claim 9, wherein said transient event comprises a motion initiated by a subject from which said hemodynamic data is being obtained, and said act of detecting comprises identifying at least one artifact within a waveform related to said hemodynamic data.

13. The method of claim 12, wherein said act of identifying at least one artifact within a waveform related to said hemodynamic data comprises detecting changes in a pressure waveform where diastolic pressure increases and pulse pressure decreases significantly over a given time period.

14. The method of claim 12, wherein said act of identifying at least one artifact within a waveform related to said hemodynamic data comprises detecting changes in a first averaged pressure value with respect to a second averaged pressure value.

15. The method of claim 14, wherein said second average pressure value comprises a value obtained from a moving cardiac beat window.

16. The method of claim 9, wherein said first criterions comprises a maximum time value.

17. A method of operating a non-invasive and continuous blood pressure measurement apparatus, comprising:

operating said apparatus in a first mode, wherein blood pressure data is obtained from the circulatory system of a living subject;

detecting at least one transient event based on said blood pressure data; and

operating said system in a second mode subsequent to said detection of said event if said event is determined not to be of sufficient severity that recovery from said event in said second mode would exceed a first criterion;

or

operating said system in a third mode subsequent to said detection if said event is determined to be of sufficient severity that recovery from said event in said second mode would exceed said first criterion.

18. The method of claim 17, wherein said act of operating in a second mode further comprises operating in said second mode only if said event is determined to originate from said circulatory system of said living subject.

19. The method of claim 17, wherein said act of operating in a third mode further comprises operating in said third mode only if said event is determined not to originate from said circulatory system of said living subject.

20. The method of claim 17, wherein said first criterion comprises a time period or duration.

21. The method of claim 17, wherein said event comprises a movement of at least a portion of said apparatus relative to said subject.

22. The method of claim 17, wherein said event comprises a movement of at least a portion of said apparatus and said subject.

23. A method of operating a pressure determining apparatus under transient conditions, comprising:

determining a first substantially optimal initial level of compression of a compressible vessel from which said pressure is measured;

operating said apparatus at said first substantially optimal level of compression for at least a first epoch;

detecting the occurrence of a transient event;

determining a second substantially optimal level of compression of said vessel, said second level being different from said first level, said difference resulting at least in part from said transient event; and

operating said apparatus at said second substantially optimal level of compression for at least a second epoch, said first and second epochs occurring at different times.

24. A method of claim 23, wherein said vessel comprises a blood vessel within the circulatory system of a living subject.

25. A method of claim 23, wherein said vessel comprises a pressure-containing vessel not within the circulatory system of a living subject.

26. A method of operating a non-invasive pressure monitoring apparatus under changing conditions, comprising:

determining a first substantially optimal initial level of compression of a blood vessel from which said pressure is measured;

operating said apparatus at said first substantially optimal level of compression for at least a first epoch;

detecting the occurrence of at least one sudden event;

determining a second substantially optimal level of compression of said blood vessel, said second level being different from said first level, said difference resulting at least in part from said at least one sudden event; and

operating said apparatus at said second substantially optimal level of compression for at least a second epoch, said first and second epochs occurring at different times.

27. The method of claim 26, wherein said act of detecting the occurrence of at least one sudden event comprises detecting an externally-induced transient.

28. The method of claim 26, wherein said act of detecting the occurrence of at least one sudden event comprises detecting a significant change in the coupling between a sensor associated with said apparatus used for monitoring said pressure and said blood vessel.

29. The method of claim 26, wherein said act of determining a second substantially optimal level comprises varying the level of compression of said blood vessel over time, and evaluating blood pressure data obtained during said act of varying.

30. A method of operating a non-invasive blood pressure measurement system adapted for use on a blood vessel of a living subject and having a means for sensing pressure in contact with the tissue at least partly overlying said vessel, comprising:

a step for operating said system in a non-transient mode, wherein blood pressure data is obtained using said means for sensing;

a step for detecting at least one transient event during said act of obtaining said blood pressure data; and

a step for operating, for at least a period of time, said system in a transient recovery mode subsequent to said detection of said event.

31. A method of operating a means for determining pressure under transient conditions, comprising:

a step for determining a first substantially optimal initial level of compression of a compressible vessel from which said pressure is measured;

a step for operating said means at said first substantially optimal level of compression for at least a first epoch;

a step for detecting the occurrence of a transient event;

a step for determining a second substantially optimal level of compression of said vessel, said second level being different from said first level, said difference resulting at least in part from said transient event; and

a step for operating said apparatus at said second substantially optimal level of compression for at least a second epoch, said first and second epochs occurring at different times.

32. A method of operating a non-invasive hemodynamic measurement system, comprising:

operating said system in a servo mode, wherein hemodynamic data is obtained;

detecting at least one transient event within said hemodynamic data; and

operating said system in a transient recovery mode subsequent to said detection of said event, said transient recovery mode being adapted to promptly return said system to said servo mode.

33. The method of claim 32, wherein said act of obtaining hemodynamic data comprises obtaining said hemodynamic data from a blood vessel, and said transient recovery mode comprises at least the act of performing an applanation sweep of said blood vessel.

34. A method of operating a non-invasive hemodynamic measurement system, comprising:

operating said system in a non-transient mode, wherein hemodynamic data is obtained;

detecting at least one transient event within said hemodynamic data; and

operating said system in a transient recovery mode subsequent to said detection of said event;

wherein said non-transient mode comprises modulating compression applied to a blood vessel from which said hemodynamic data is maintained.

35. The method of claim 34, wherein said modulating compression comprises modulating according to a substantially randomized sequence.

36. The method of claim 35, wherein said act of obtaining hemodynamic data comprises obtaining said hemodynamic data from a blood vessel, and said transient recovery mode comprises at least the act of performing an applanation sweep of said blood vessel.

37. A method of operating a non-invasive hemodynamic measurement system, comprising:

operating said system in a non-transient mode, wherein hemodynamic data is obtained;

detecting at least one transient event within said hemodynamic data;

operating said system in a transient recovery mode subsequent to said detection of said event; and

operating in a second non-transient mode when non-transient induced changes occur, said non-transient changes being detected at least in part by modulating a compression level of a blood vessel from which said hemodynamic data is obtained.

38. A method of operating a non-invasive blood pressure measurement apparatus comprising:

collecting pressure data in a non-transient mode;

detecting the occurrence of at least one transient event based at least in part on said data;

operating said apparatus in a transient recovery mode subsequent to said detection of said event; and

operating in a second non-transient mode when non-transient induced changes occur, said non-transient changes being detected at least in part by modulating a compression level of a blood vessel from which said data is obtained.