Methods and apparatus for control of non-invasive parameter measurements

• US 8,945,016 B2
• Filed: 06/06/2011
• Issued: 02/03/2015
• Est. Priority Date: 08/01/2002
• Status: Active Grant

• Current Assignee: United States GTM Medical Devices
• Original Assignee: Tensys Medical Inc. (Recorders & Medicare Systems Pvt Ltd.)
• Inventors: Voss, Gregory I., Martin, Gregory J., Goharlaee, Manouchehr
• Primary Examiner(s): Kahelin, Michael
• Assistant Examiner(s): TOTH, KAREN E
• Application Number:
  US13/154,315
• Publication Number:
  US 20110237961A1
• Time in Patent Office: 1,338 Days
• Field of Search: 600481-507
• US Class Current: 600/499
• 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 hemodynamic measurement apparatus configured to obtain hemodynamic data and identify a transient event which affects a coupling between a sensor and a tissue surface that at least partially overlies a blood vessel of interest, said apparatus comprising:

a pressure sensor configured to collect said hemodynamic data, said pressure sensor configured to generate a waveform related to said hemodynamic data;

an applanation and/or positioning mechanism configured to establish an optimal coupling between said sensor and said tissue surface that at least partially overlies said blood vessel of interest;

a controller in signal communication with said sensor and said applanation and/or positioning mechanism, said controller configured to detect said transient event;

a modulator process configured to, upon detection of said transient event, introduce changes in said waveform via said applanation and/or positioning mechanism, said changes being associated with a modulation of a compression applied to said tissue surface via a pseudo-random binary sequence; and

a signal restoration process configured to anticipate said changes in said waveform introduced by said modulator process and to correct at least portions of said waveform by use of a pressure correction offset to restore said waveform to a shape that is equivalent to an un-modulated waveform;

wherein upon detection of said transient event, said controller is further configured to;

(i) temporally cease collection of and/or use of said hemodynamic data during a period which said hemodynamic data is unreliable, and (ii) resume at least one of collection and/or use of said hemodynamic data upon termination of said transient event.

2. The apparatus of claim 1, wherein said controller is further configured to cease collection of and/or use of said hemodynamic data during said period which said hemodynamic data is unreliable only when a parameter related to said determination of unreliability of said hemodynamic data is of sufficient magnitude that recovery from said transient event would exceed a first criterion.

3. The apparatus of claim 2, wherein said first criterion comprises a time period or duration.

4. The apparatus of claim 2, wherein said apparatus is further configured to perform a pressure sweep to re-establish said optimal coupling when said parameter related to said determination of unreliability of said hemodynamic data is of sufficient magnitude that recovery from said transient event would exceed said first criterion.

5. The apparatus of claim 1, wherein said period during which said data is unreliable is terminated via a selective adjustment of said applanation and/or positioning mechanism via a control signal so as to re-establish said optimal coupling between said sensor and said tissue surface that at least partially overlies said blood vessel of interest.

6. The apparatus of claim 1, wherein said pseudo-random binary sequence comprises a plurality of modulation states, at least some of said modulation states configured to have a duration different from that of others of said plurality of states.

7. The apparatus of claim 1, wherein said pseudo-random binary sequence comprises a deterministic binary sequence.

8. The apparatus of claim 1, wherein said modulator process further comprises an operation thereof over a limited range around an optimal coupling point.

9. A non-transitory computer readable apparatus comprising a plurality of instructions which are configured to, when executed by a processor:

cause optimal coupling to be established between an applanation and/or positioning mechanism having at least a sensor associated therewith and a tissue surface that overlies a blood vessel of interest;

cause said sensor to collect hemodynamic data, said hemodynamic data comprising one or more parameters;

evaluate said collected hemodynamic data to identify an occurrence of a transient event which affects said optimal coupling via analysis of changes in said one or more parameters; and

when said changes to said one or more parameters meet one or more criterion;

cause said sensor to cease collection of said data;

cause said applanation and/or positioning mechanism to initiate a pressure sweep to re-establish said optimal coupling; and

cause said sensor to resume collection of said hemodynamic data upon termination of said transient event and said re-establishment of said optimal coupling.

10. The computer readable apparatus of claim 9, wherein said transient event comprises a motion initiated by a subject from which said hemodynamic data is being collected.

11. The computer readable apparatus of claim 9, wherein said plurality of instructions are further configured to, when executed, detect said occurrence of said transient event via identification of at least one artifact within a waveform related to said hemodynamic data.

12. The computer readable apparatus of claim 9, wherein said changes in said one or more parameters adversely affect an accuracy of said collected hemodynamic data.

13. The computer readable apparatus of claim 9, wherein said plurality of instructions are further configured to, when executed, detect a reduction in a magnitude of one or more pressure values.

14. The computer readable apparatus of claim 9, wherein said plurality of instructions are further configured to, when executed, detect said occurrence of said transient event via analysis of changes in said one or more parameters and via identification of one or more cardiac beats and/or absence thereof.

15. The computer readable apparatus of claim 9, wherein said hemodynamic data comprises blood pressure, and said sensor comprises a tonometric or non-invasive pressure sensor.

16. The computer readable apparatus of claim 9, wherein said blood vessel of interest comprises a radial artery.

17. The computer readable apparatus of claim 9, wherein said plurality of instructions are further configured to, when executed, detect a reduction in a magnitude of at least one of said one or more parameters represented by said hemodynamic data.

18. The computer readable apparatus of claim 17, wherein said reduction in a magnitude comprises a reduction in magnitude of a pulse pressure.

19. The computer readable apparatus of claim 9, wherein said plurality of instructions are farther configured to, when executed, analyze changes in said one or more parameters via comparison of at least one of:

(i) a measured pulse pressure, (ii) a measured diastolic pressure (iii) a measured velocity and/or (iv) a measured acceleration, with one or more predetermined values.

20. The computer readable apparatus of claim 9, wherein said plurality of instructions are further configured to, when executed, analyze changes in said one or more parameters via comparison of at least one of:

(i) a pulse pressure difference between a current pulse pressure and a previous qualified pulse pressure, and (ii) a diastolic pressure difference between a current diastolic pressure and a previously qualified past diastolic pressure, with said one or more criterion.

21. A non-transitory computer readable apparatus comprising a plurality of instructions which are configured to, when executed by a processor:

establish an optimal coupling between a sensor and a tissue surface that at least partially overlies a blood vessel of interest;

generate a waveform related to a plurality of hemodynamic data collected by said sensor;

detect a transient event which affects said coupling between said sensor and said tissue surface that at least partially overlies said blood vessel of interest;

upon detection of said transient event;

introduce changes in said waveform via an applanation and/or positioning mechanism, said changes being associated with a modulation of a compression applied to said tissue surface via a pseudo-random binary sequence;

anticipate said changes in said waveform and correct at least portions of said waveform by use of a pressure correction offset to restore said waveform to a shape that is equivalent to an un-modulated waveform;

temporally cease collection of and/or use of said hemodynamic data during a period which said hemodynamic data is unreliable; and

resume at least one of collection and/or use of said hemodynamic data upon termination of said transient event.

22. The computer readable apparatus of claim 21, wherein said plurality of instructions are further configured to, when executed, cease collection of and/or use of said hemodynamic data during said period which said hemodynamic data is unreliable only when a parameter related to said determination of unreliability of said hemodynamic data is of sufficient magnitude that recovery from said transient event would exceed a first criterion.

23. The computer readable apparatus of claim 22, wherein said first criterion comprises a time period or duration.

24. The computer readable apparatus of claim 22, wherein said plurality of instructions are further configured to, when executed, perform a pressure sweep to re-establish said optimal coupling when said parameter related to said determination of unreliability of said hemodynamic data is of sufficient magnitude that recovery from said transient event would exceed said first criterion.

25. The computer readable apparatus of claim 21, wherein said period during which said data is unreliable is terminated via a selective adjustment of said applanation and/or positioning mechanism via a control signal so as to re-establish said optimal coupling between said sensor and said tissue surface that at least partially overlies said blood vessel of interest.

26. The computer readable apparatus of claim 21, wherein said pseudo-random binary sequence comprises a plurality of modulation states, at least some of said modulation states configured to have a duration different from that of others of said plurality of states.

27. The computer readable apparatus of claim 21, wherein said pseudo-random binary sequence comprises a deterministic binary sequence.

28. The computer readable apparatus of claim 21, wherein said plurality of instructions are further configured to, when executed, operate over a limited range around an optimal coupling point.

29. A method of operating a hemodynamic assessment apparatus comprising an applanation and/or positioning mechanism, a sensor, and computerized logic configured to identify a transient event affecting a coupling between said sensor and a tissue surface overlying a blood vessel of interest, said method comprising:

establishing an optimal coupling via said applanation and/or positioning mechanism;

collecting hemodynamic data using said sensor, said hemodynamic data comprising one or more parameters;

detecting, using said computerized logic, an occurrence of said transient event affecting said optimal coupling by determining that changes in said one or more parameters of said collected hemodynamic data meet one or more criterion; and

during said transient event;

ceasing collection of said data by said sensor; and

initiating a pressure sweep to re-establish said optimal coupling via said applanation and/or positioning mechanism; and

upon termination of said transient event, said sensor resuming collection of said hemodynamic data and said re-establishing said optimal coupling.

30. The method of claim 29, wherein said transient event comprises a motion initiated by a subject from which said hemodynamic data is being collected.

31. The method of claim 29, wherein said act of detecting the occurrence of said transient event comprises identifying at least one artifact within a waveform related to said hemodynamic data.

32. The method of claim 29, wherein said changes in said one or more parameters adversely affect an accuracy of said collected hemodynamic data.

33. The method of claim 29, wherein said act of detecting further comprises detecting a reduction in a magnitude of one or more pressure values.

34. The method of claim 29, wherein said act of detecting an occurrence of said transient event comprises identifying one or more cardiac beats and/or absence thereof.

35. The method of claim 29, wherein said hemodynamic data comprises blood pressure, and said sensor comprises a tonometric or non-invasive pressure sensor.

36. The method of claim 29, wherein said blood vessel of interest comprises a radial artery.

37. The method of claim 29, wherein said act of detecting comprises detecting a reduction in a magnitude of at least one of said one or more parameters represented by said hemodynamic data.

38. The method of claim 37, wherein said act of detecting said reduction in a magnitude comprises detecting a reduction in magnitude of a pulse pressure.

39. The method of claim 29, wherein said act of detecting said occurrence of said transient event comprises comparing at least one of:

(i) a measured pulse pressure, (ii) a measured diastolic pressure (iii) a measured velocity and/or (iv) a measured acceleration, with one or more predetermined values.

40. The method of claim 29, wherein said act of detecting said occurrence of said transient event comprises comparing at least one of:

(i) a pulse pressure difference between a current pulse pressure and a previous qualified pulse pressure, and (ii) a diastolic pressure difference between a current diastolic pressure and a previously qualified past diastolic pressure, with said one or more criterion.