Apparatus for control of non-invasive parameter measurements

• US 7,955,267 B2
• Filed: 12/13/2005
• Issued: 06/07/2011
• Est. Priority Date: 08/01/2002
• Status: Active Grant

• Current Assignee: Zhejiang Shanshi Biological Medical Devices Company Limited
• Original Assignee: Tensys Medical Inc. (Recorders & Medicare Systems Pvt Ltd.)
• Inventors: Martin, Gregory J., Goharlaee, Manouchehr, Voss, Gregory I.
• Primary Examiner(s): Mallari; Patricia C
• Application Number:
  US11/300,019
• Publication Number:
  US 20060094965A1
• Time in Patent Office: 2,002 Days
• Field of Search: 600/485
• 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 non-invasive and continuous blood pressure measurement apparatus, comprising:

a non-invasive pressure sensor coupled to an applanation apparatus, said applanation apparatus controlled at least in part by a computing apparatus adapted to collect hemodynamic data from said sensor, said computing apparatus capable of operating in a plurality of modes, said plurality of modes comprising;

a first mode, wherein blood pressure data is obtained via said sensor from the circulatory system of a living subject;

a second mode, wherein at least one transient event is detected based on said blood pressure data; and

either

a third 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

a fourth 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.

2. The apparatus of claim 1, wherein said third mode further comprises operating in said third mode only if said event is determined to originate from said circulatory system of said living subject.

3. The apparatus of claim 1, wherein said fourth mode further comprises operating in said fourth mode only if said event is determined not to originate from said circulatory system of said living subject.

4. The apparatus of claim 1, wherein said first criterion comprises a time period or duration.

5. The apparatus of claim 1, wherein said event comprises a movement of at least a portion of said apparatus relative to said subject.

6. A non-invasive hemodynamic measurement system, comprising:

a pressure sensor adapted to measure pressure data originating from an artery of a living subject;

an applanation apparatus operatively coupled to said pressure sensor;

a controller in signal communication with said sensor and said applanation apparatus, said controller capable of (i) detecting at least one transient event within hemodynamic data obtained from said sensor, and (ii) operating in a plurality of modes, said modes comprising;

a first mode, wherein hemodynamic data is obtained from said sensor;

a second mode, entered subsequent to said detection of said event if said event does not have a first characteristic; and

a third mode, entered 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.

7. The system of claim 6, wherein:

said second mode comprises a mode adapted to selectively vary a level of compression by said applanation apparatus via a control signal; and

said varying level of compression is applied via said pressure sensor.

8. The system of claim 6, wherein said first criterion comprises a time period or duration.

9. The system of claim 6, wherein said at least one transient event comprises a movement of at least a portion of said applanation apparatus relative to said living subject.

10. A non-invasive hemodynamic measurement system, comprising:

a pressure sensor adapted to measure pressure data originating from an artery of a living subject;

an applanation apparatus operatively coupled to said pressure sensor;

a controller in signal communication with said sensor and said applanation apparatus, said controller capable of (i) identifying at least one artifact within a waveform related to hemodynamic data obtained from said sensor, said artifact indicating at least one a motion initiated by a subject from which said hemodynamic data is being obtained, and (ii) operating in a plurality of modes, said modes comprising;

a first mode, wherein hemodynamic data is obtained from said sensor;

a second mode, entered subsequent to said detection of said event if said event does not have a first characteristic; and

a third mode, entered subsequent to said detection if said event has said first characteristic.

11. The system of claim 10, wherein said 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.

12. The system of claim 10, wherein said second averaged pressure value comprises a value obtained from a moving cardiac beat window.

13. The system of claim 10, wherein said first characteristic comprises said event being not of physiologic origin, and wherein said event is not of sufficient magnitude that recovery from said event in said second mode would exceed a first criterion.

14. A non-invasive hemodynamic measurement system, comprising:

a non-invasive sensor adapted to obtain hemodynamic data;

an applanation mechanism; and

a controller apparatus, said controller apparatus in signal communication with said sensor and adapted to detect at least one transient event within said hemodynamic data;

wherein;

said hemodynamic data is obtained in a non-transient mode of operation; and

in a transient recovery mode entered into by said system subsequent to said detection of said event, a control signal generated by said controller causes said applanation mechanism to modulate compression applied to a blood vessel from which said hemodynamic data is obtained according to a substantially randomized sequence.

15. The system of claim 14, wherein said randomized sequence comprises a Pseudo Random Binary Sequence (PRBS).

16. The system of claim 14, wherein said transient event comprises non-optimal positioning of said applanation mechanism with respect to said blood vessel.

17. The system of claim 14, wherein said transient event comprises an abrupt dislocation of said applanation mechanism.

18. The system of claim 17, wherein said system further comprising a notification entity configured to, in response to said abrupt dislocation of said applanation mechanism, alert a user of said dislocation.

19. An apparatus for use in transient event compensation during hemodynamic parameter measurement from a compressible blood vessel, comprising:

applanation apparatus adapted to establish an initial substantially optimal level of compression of said blood vessel for at least a first epoch;

a pressure sensor adapted to measure pressure data from said blood vessel; and

a computing apparatus having a computer program running thereon, said computer program adapted to receive pressure data from said pressure sensor and detect 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 said sensor;

wherein said computing apparatus initiates a pressure sweep to identify a second substantially optimal level of compression of said blood vessel based on said altered coupling when said transient event has substantially subsided; and

wherein said computing apparatus controls said applanation apparatus to establish the second substantially optimal level of compression of said blood vessel for at least a second epoch.

20. The apparatus of claim 19, wherein said initiation of a pressure sweep by said computing apparatus comprises:

utilizing said computer program to analyze 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

sending a control signal to said applanation apparatus to initiate said pressure sweep when said criterion is satisfied.

21. The apparatus of claim 19, wherein said detection of the occurrence of a transient event comprises comparison of a measured pressure, velocity and acceleration with a predetermined value.

22. The apparatus of claim 21, wherein said predetermined value comprises a first value for said pressure, velocity, and acceleration during a systolic pressure upstroke, and a second value for said pressure, velocity and acceleration during a diastolic pressure downstroke.

23. The apparatus of claim 19, wherein if said pressure sweep does not produce a comparable pulse pressure, then a reacquisition state is entered.

24. The apparatus of claim 23, wherein said reacquisition state comprises reacquiring at least one of said optimal level of compression, or an optimal lateral or proximal position.

25. A non-invasive hemodynamic measurement system, comprising:

an applanation mechanism adapted to be controlled by a processing apparatus; and

a hemodynamic sensor adapted to obtain hemodynamic data from a blood vessel of a living subject for use by at least said processing apparatus;

wherein said processing apparatus is adapted to operate the system in at least two modes, said at least two modes comprising;

a servo mode, wherein hemodynamic data is obtained by said system; and

a transient recovery mode initiated by said processing apparatus subsequent to the detection of at least one transient event within said hemodynamic data, said transient recovery mode being adapted to;

(i) perform an applanation sweep of said blood vessel using said applanation mechanism, and (ii) return said system to said servo mode; and

wherein said servo mode further comprises continuously identifying time varying changes in compression coupling, and controllably adjusting an applanation position accordingly.

26. The system of claim 25, wherein said applanation sweep is performed after said processing apparatus:

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

compares changes in said pressure data from said at least two time periods to a criterion.

27. The system of claim 25, wherein said at least one transient event comprises a sudden change in the mechanical coupling between the applanation mechanism and said blood vessel of said living subject.

28. The system of claim 25, wherein said return of said system to said servo mode comprises utilizing a control signal generated by said processing apparatus to cause said applanation mechanism to vary the compression applied to said blood vessel over time.

29. A non-invasive hemodynamic measurement apparatus, comprising:

applanation means adapted to be controlled by a processing apparatus; and

hemodynamic sensor means adapted to obtain hemodynamic data from a blood vessel of a living subject for use by at least said processing apparatus;

wherein said processing apparatus is adapted to operate the system in at least two modes, said at least two modes comprising;

a first mode, wherein hemodynamic data is obtained by said hemodynamic measurement apparatus; and

a second mode initiated by said processing apparatus subsequent to the detection of at least one transient event within said hemodynamic data, said second mode being adapted to;

(i) perform an applanation sweep of said blood vessel using said applanation means, and (ii) return said system to said first mode; and

wherein said first mode further comprises substantially continuously identifying time varying changes in compression coupling, and controllably adjusting said applanation means accordingly.

30. The apparatus of claim 29, wherein said applanation sweep is performed after said processing apparatus:

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

compares changes in said pressure data from said at least two time periods to a criterion.

31. The apparatus of claim 29, wherein said at least one transient event comprises a sudden change in the mechanical coupling between the applanation means and said blood vessel of said living subject

32. The apparatus of claim 29, wherein said return of said hemodynamic measurement apparatus to said first mode comprises utilizing a control signal generated by said processing apparatus to cause said applanation means to vary the compression applied to said blood vessel over time.