Apparatus and method for non-invasively monitoring a subject's arterial blood pressure

• US 5,848,970 A
• Filed: 12/13/1996
• Issued: 12/15/1998
• Est. Priority Date: 12/13/1996
• Status: Expired due to Term

• Current Assignee: Tensys Medical Inc. (Recorders & Medicare Systems Pvt Ltd.)
• Original Assignee: Vitalwave Corporation (Recorders & Medicare Systems Pvt Ltd.)
• Inventors: Voss, Gregory I., Somerville, Alvis J.
• Primary Examiner(s): Nasser, Robert L.
• Application Number:
  US08/766,810
• Time in Patent Office: 732 Days
• Field of Search: 600/485, 600/500-503, 600/561
• US Class Current: 600/485
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence

Abstract

Apparatus is disclosed for non-invasively monitoring a subject'"'"'s blood pressure, in which a flexible diaphragm that encloses a fluid-filled chamber is compressed against tissue overlying an artery, with sufficient force to compress the artery. A first, relatively slow servo control system optimizes the amount of artery compression, which occurs at a mean transmural pressure of about zero, by modulating the volume of fluid within the chamber and noting the resulting effect on the pressure within the chamber. Since different pressure effects are realized according to the amount of artery compression, an appropriate control signal can be produced that provides the optimum mean diaphragm pressure. In addition, a second, relatively fast servo control system supplies the fluid to and from the chamber, so as to compensate for pressure variations within artery. This minimizes variations in the artery'"'"'s effective diameter, whereby the pressure within the fluid-filled chamber closely follows the actual arterial pulse waveform.

Claims

1. Apparatus for non-invasively monitoring the pressure within a subject'"'"'s blood vessel, comprising:

a pressure sensor assembly that produces a pressure signal indicative of the pressure applied against it;

a coupling device configured to urge the pressure sensor assembly into compressive engagement with tissue overlying a subject'"'"'s blood vessel, to compress the vessel and ensure that pressure variations within the vessel are coupled through the tissue to the pressure sensor assembly; and

a controller that controllably modulates the position of the pressure sensor assembly relative to the subject'"'"'s blood vessel and that monitors the resulting effect on the pressure signal, to produce a control signal that controllably positions the pressure sensor assembly relative to the subject'"'"'s blood vessel such that the vessel is compressed by a prescribed amount.

2. Apparatus as defined in claim 1, wherein the coupling device urges the pressure sensor assembly to a position that partially compresses the blood vessel and provides a mean transmural vessel pressure of substantially zero.

3. Apparatus as defined in claim 1, wherein the pressure sensor assembly includes:

a base having an open cavity;

a flexible diaphragm extending across the open cavity of the base to define a closed, fluid-filled chamber; and

a sensor device that senses the pressure of the fluid within the closed chamber and produces the corresponding pressure signal.

4. Apparatus as defined in claim 3, wherein the controller is a fluid volume controller configured to controllably supply a fluid to and from the closed chamber, to vary the position of the flexible diaphragm relative to the tissue overlying the subject'"'"'s blood vessel, such that the blood vessel is compressed by the prescribed amount.

5. Apparatus as defined in claim 4, wherein:

the fluid volume controller is configured to modulate the volume of fluid within the closed chamber and to monitor the resulting effect on the pressure signal, and

the control signal produced by the fluid volume controller regulates the amount of fluid within the chamber.

6. Apparatus as defined in claim 5, wherein:

the fluid volume controller is configured to modulate the volume of fluid within the closed chamber at a substantially uniform ac amplitude; and

the fluid volume controller includes a device that compares the ac amplitude of the pressure signal during systole with the ac amplitude of the pressure signal during diastole and that produces the control signal in accordance with the comparison.

7. Apparatus as defined in claim 5, wherein:

the fluid volume controller is configured to modulate the volume of fluid within the closed chamber substantially sinusoidally; and

the fluid volume controller includes a device that compares the ac amplitude of the pressure signal during positive portions of the fluid volume modulation with the ac amplitude of the pressure signal during negative portions of the fluid volume modulation and that produces the control signal in accordance with the comparison.

8. Apparatus as defined in claim 4, wherein:

the fluid is a liquid; and

the subject'"'"'s blood vessel is a peripheral artery.

9. Apparatus as defined in claim 1, wherein:

the subject'"'"'s blood vessel is a radial artery; and

the pressure sensor assembly is sized to extend only over the portion of the subject'"'"'s wrist that overlies the radial artery.

10. Apparatus as defined in claim 1, wherein the controller includes:

a vessel geometry sensor that produces a vessel geometry signal indicative of the actual geometry of the subject'"'"'s blood vessel;

an error signal generator that generates an error signal indicative of any difference between the actual geometry of the blood vessel and a prescribed geometry of the vessel; and

a summer, responsive to the vessel geometry signal and the error signal, that produces the control signal.

11. Apparatus as defined in claim 10, wherein:

the pressure sensor assembly includes

a base having an open cavity,

a flexible diaphragm extending across the open cavity of the base to define a closed, fluid-filled chamber, and

a sensor device that senses the pressure of the fluid within the closed chamber and produces the corresponding pressure signal; and

the vessel geometry sensor is a diaphragm position sensor and the vessel geometry signal is indicative of the actual position of the flexible diaphragm relative to the base.

12. Apparatus as defined in claim 10, wherein the error signal generator includes:

an oscillator that produces a modulation signal that is supplied to the summer, for incorporation into the control signal, to cause the controller to modulate the actual position of the pressure sensor assembly relative to a mean position; and

an analyzer, responsive to the pressure signal, for sensing any deviation of the pressure sensor assembly'"'"'s actual position from the pressure sensor assembly'"'"'s prescribed position and to produce the error signal.

13. Apparatus as defined in claim 12, wherein:

the modulation signal includes a succession of alternating positive and negative lobes; and

the analyzer is configured to compare the effect that positive lobes of the modulation signal have on pressure signal amplitude with the effect that negative lobes of the modulation signal have on pressure signal amplitude, to sense any deviation of the pressure sensor assembly'"'"'s actual position from the pressure sensor assembly'"'"'s prescribed position and to produce the error signal.

14. Apparatus as defined in claim 12, wherein:

the modulation signal has a substantially uniform ac amplitude; and

the analyzer is configured to compare the ac amplitude of the pressure signal during a first stage of the subject'"'"'s heartbeat with the ac amplitude of the pressure signal during a second stage of the subject'"'"'s heartbeat, to sense any deviation of the pressure sensor assembly'"'"'s actual position from the pressure sensor assembly'"'"'s prescribed position and to produce the error signal.

15. Apparatus as defined in claim 12, wherein:

the subject'"'"'s blood vessel is an artery; and

the modulation signal is a sine wave having a frequency substantially greater than the subject'"'"'s expected heartbeat frequency.

16. Apparatus as defined in claim 1, wherein:

the controller is configured to modulate the position of the pressure sensor assembly relative to the subject'"'"'s blood vessel at a substantially uniform ac amplitude; and

the controller includes a device that compares the ac amplitude of the pressure signal during systole with the ac amplitude of the pressure signal during diastole, to produce the control signal in accordance with the comparison.

17. Apparatus as defined in claim 1, wherein:

the controller is configured to modulate the position of the pressure sensor assembly relative to the subject'"'"'s blood vessel substantially sinusoidally; and

the controller includes a device that compares the ac amplitude of the pressure signal during positive portions of the vessel modulation with the ac amplitude of the pressure signal during negative portions of the vessel modulation, to produce the control signal in accordance with the comparison.

18. Apparatus for non-invasively monitoring the pressure within a subject'"'"'s blood vessel, comprising:

a base having an open cavity;

a flexible diaphragm extending across the open cavity of the base to define a closed, fluid-filled chamber;

a coupling device configured to urge the diaphragm into compressive engagement with tissue overlying a subject'"'"'s blood vessel, to compress the vessel and ensure that pressure variations within the vessel are coupled through the tissue to the diaphragm;

a fluid volume controller that supplies a fluid to and from the closed chamber in accordance with a modulation signal, such that the flexible diaphragm oscillates about an actual mean position;

a pressure sensor that senses the pressure of the fluid within the closed chamber and produces a corresponding pressure signal;

an analyzer, responsive to the pressure signal, for sensing any deviation of the flexible diaphragm'"'"'s actual position from a prescribed position and to produce a corresponding error signal that is coupled to the fluid volume controller, to cause the volume controller to supply fluid to or from the closed chamber, to move the flexible diaphragm toward the prescribed position;

a filter that filters the pressure signal to produce a filtered pressure signal indicative of the pressure within the subject'"'"'s blood vessel.

19. Apparatus as defined in claim 18, wherein:

the apparatus further includes a diaphragm position sensor that produces a diaphragm position signal indicative of the flexible diaphragm'"'"'s actual position relative to the base; and

the fluid volume controller is configured to supply the fluid to and from the closed chamber in accordance with the diaphragm position signal, such that the position of the portion of the flexible diaphragm overlying the subject'"'"'s blood vessel remains substantially fixed despite pressure variations within the blood vessel.

20. Apparatus as defined in claim 18, wherein:

the modulation signal has a substantially uniform ac amplitude; and

the analyzer is configured to compare the amplitude of the pressure signal during a first stage of the subject'"'"'s heartbeat with the amplitude of the pressure signal during a second stage of the subject'"'"'s heartbeat, to sense any deviation of the flexible diaphragm'"'"'s actual position from the flexible diaphragm'"'"'s prescribed position and to produce the error signal.

21. Apparatus as defined in claim 18, wherein:

the modulation signal includes a succession of alternating positive and negative lobes; and

the analyzer is configured to compare the effect that positive lobes of the modulation signal have on pressure signal amplitude with the effect that negative lobes of the modulation signal have on pressure signal amplitude, to sense any deviation of the flexible diaphragm'"'"'s actual mean position from the flexible diaphragm'"'"'s prescribed mean position and to produce the error signal.

22. Apparatus for non-invasively monitoring the pressure within a subject'"'"'s blood vessel, comprising:

a base having an open cavity;

a flexible diaphragm extending across the open cavity of the base to define a fluid-filled chamber;

a coupling device configured to urge the diaphragm into compressive engagement with tissue overlying a subject'"'"'s blood vessel, to compress the vessel and ensure that pressure variations within the vessel are coupled through the tissue to the diaphragm;

a first control system that supplies fluid to and from the fluid-filled chamber such that the portion of the flexible diaphragm overlying the subject'"'"'s blood vessel has a prescribed position that optimally compresses the blood vessel;

a second control system that supplies fluid to and from the fluid-filled chamber so as to servo control the position of the flexible diaphragm and maintain the diaphragm in its prescribed position despite pressure variations within the subject'"'"'s blood vessel; and

a pressure sensor that senses the pressure of the fluid within the fluid-filled chamber and produces a corresponding pressure signal indicative of the pressure within the subject'"'"'s blood vessel.

23. An apparatus for non-invasively monitoring the pressure within a subject'"'"'s blood vessel, comprising:

a base having an open cavity;

a flexible diaphragm extending across the open cavity of the base to define a closed, fluid-filled chamber;

a coupling device configured to urge the diaphragm into compressive engagement with tissue overlying a subject'"'"'s blood vessel, to compress the vessel and ensure that pressure variations within the vessel are coupled through the tissue to provide a variable force against the diaphragm;

a fluid volume controller that controllably supplies fluid to and from the closed chamber, to substantially balance the variable force applied to the diaphragm by any pressure variations in the subject'"'"'s blood vessel;

a sensor that senses the pressure of the fluid within the closed chamber and produces a corresponding pressure signal indicative of the pressure within the subject'"'"'s blood vessel; and

a filter that filters the pressure signal to produce a filtered pressure signal indicative of the pressure within the subject'"'"'s blood vessel;

wherein the fluid volume controller includes

a fluid source that applies fluid to and from the closed chamber in accordance with a modulation signal, such that the flexible diaphragm oscillates about an actual position, wherein this oscillation induces a corresponding oscillation in the pressure signal produced by the sensor, and

an analyzer, responsive to the pressure signal, for sensing any deviation of the flexible diaphragm'"'"'s actual position from a prescribed position and to produce a corresponding error signal that is coupled to the fluid source, to cause the fluid source to supply fluid to or from the closed chamber to move the diaphragm toward the prescribed position.

24. Apparatus as defined in claim 23, wherein:

the apparatus further includes a diaphragm position sensor that produces a diaphragm position signal indicative of the flexible diaphragm'"'"'s actual position relative to the base; and

the fluid source is configured to supply the fluid to and from the closed chamber in accordance with the diaphragm position signal, such that the position of the portion of the flexible diaphragm overlying the subject'"'"'s blood vessel remains substantially fixed despite pressure variances within the blood vessel.

25. Apparatus as defined in claim 23, wherein:

the modulation signal has a substantially uniform ac amplitude; and

the analyzer is configured to compare the amplitude of the pressure signal during a first stage of the subject'"'"'s heartbeat with the amplitude of the pressure signal during a second stage of the subject'"'"'s heartbeat, to sense any deviation of the flexible diaphragm'"'"'s actual position from the flexible diaphragm'"'"'s prescribed position and to produce the error signal.

26. Apparatus as defined in claim 23, wherein:

the modulation signal includes a succession of alternating positive and negative lobes; and

the analyzer is configured to compare the effect that positive lobes of the modulation signal have on pressure signal amplitude with the effect that negative lobes of the modulation signal have on pressure signal amplitude, to sense any deviation of the flexible diaphragm'"'"'s actual position from the flexible diaphragm'"'"'s prescribed position and to produce the error signal.

27. Apparatus as defined in claim 23, wherein:

the subject'"'"'s blood vessel is an artery; and

the modulation signal is a sine wave having a frequency substantially greater than the subject'"'"'s expected heartbeat frequency.

28. Apparatus as defined in claim 23, wherein:

the fluid is a liquid; and

the subject'"'"'s blood vessel is a peripheral artery.

29. Apparatus as defined in claim 28, wherein:

the peripheral artery is a radial artery; and

the diaphragm is sized to extend only over the portion of the subject'"'"'s wrist that overlies the radial artery.

30. An apparatus for non-invasively monitoring the pressure within a subject'"'"'s blood vessel, comprising:

a base having an open cavity;

a flexible diaphragm extending across the open cavity of the base to define a closed, fluid-filled chamber;

a coupling device configured to urge the diaphragm into compressive engagement with tissue overlying a subject'"'"'s blood vessel, to compress the vessel and ensure that pressure variations within the vessel are coupled through the tissue to provide a variable force against the diaphragm;

a fluid volume controller that controllably supplies fluid to and from the closed chamber, to substantially balance the variable force applied to the diaphragm by any pressure variations in the subject'"'"'s blood vessel, wherein the fluid volume controller is configured to maintain the subject'"'"'s blood vessel optimally compressed continuously, without the need for separate calibration; and

a sensor that senses the pressure of the fluid within the closed chamber and produces a corresponding pressure signal indicative of the pressure within the subject'"'"'s blood vessel.

31. A method for non-invasively monitoring the pressure within a subject'"'"'s blood vessel, comprising:

providing a pressure sensor assembly that produces a pressure signal indicative of the pressure applied against it;

urging the pressure sensor assembly into compressive engagement with tissue overlying a subject'"'"'s blood vessel, to compress the vessel and ensure that pressure variations within the vessel are coupled through the tissue to the pressure sensor assembly; and

controllably modulating the position of the pressure sensor assembly relative to the subject'"'"'s blood vessel and monitoring the resulting effect on the pressure signal, to produce a control signal that controllably positions the pressure sensor assembly relative to the subject'"'"'s blood vessel such that the vessel is compressed by a prescribed amount.

32. A method as defined in claim 31, wherein urging includes the pressure sensor assembly to a position that partially compresses the blood vessel and provides a mean transmural vessel pressure of substantially zero.

33. A method as defined in claim 31, wherein:

the pressure sensor assembly includes

a base having an open cavity,

a flexible diaphragm extending across the open cavity of the base to define a closed, fluid-filled chamber, and

a sensor device that senses the pressure of the fluid within the closed chamber and produces the corresponding pressure signal; and

controlling includes controllably supplying fluid to and from the closed chamber, to vary the position of the flexible diaphragm relative to the tissue overlying the subject'"'"'s blood vessel, such that the blood vessel is compressed by the prescribed amount.

34. A method as defined in claim 33, wherein:

controlling includes modulating the volume of fluid within the closed chamber and monitoring the resulting effect on the pressure signal, and

the control signal regulates the mean amount of fluid within the chamber.

35. A method as defined in claim 34, wherein:

controlling includes modulating the volume of fluid within the closed chamber at a substantially uniform ac amplitude; and

controlling further includes comparing the ac amplitude of the pressure signal during systole with the ac amplitude of the pressure signal during diastole and producing the control signal in accordance with the comparison.

36. A method as defined in claim 34, wherein:

controlling includes modulating the volume of fluid within the closed chamber substantially sinusoidally; and

controlling further includes comparing the ac amplitude of the pressure signal during positive portions of the fluid volume modulation with the ac amplitude of the pressure signal during negative portions of the fluid volume modulation and producing the control signal in accordance with the comparison.

37. A method as defined in claim 31, wherein controlling includes:

sensing vessel geometry and producing a vessel geometry signal indicative of the actual geometry of the subject'"'"'s blood vessel;

generating an error signal indicative of any difference between the actual geometry of the blood vessel and a prescribed geometry of the vessel; and

producing the control signal based on the vessel geometry signal and the error signal.

38. A method as defined in claim 37, wherein:

the pressure sensor assembly includes

a base having an open cavity,

a flexible diaphragm extending across the open cavity of the base to define a closed, fluid-filled chamber, and

a sensor device that senses the pressure of the fluid within the closed chamber and produces the corresponding pressure signal; and

sensing vessel geometry sensor includes sensing the position of the diaphragm sensor, such that the vessel geometry signal is indicative of the actual position of the flexible diaphragm relative to the base.

39. A method as defined in claim 37, wherein generating includes:

modulating the actual position of the pressure sensor assembly relative to a mean position, the modulation being in accordance with a modulation signal; and

monitoring the modulation signal and the pressure signal, to sense any deviation of the pressure sensor assembly'"'"'s actual position from the pressure sensor assembly'"'"'s prescribed position and to produce the error signal.

40. A method as defined in claim 39, wherein:

the modulation signal includes a succession of alternating positive and negative lobes; and

monitoring includes comparing the effect that positive lobes of the modulation signal have on pressure signal amplitude with the effect that negative lobes of the modulation signal have on pressure signal amplitude, and sensing any deviation of the pressure sensor assembly'"'"'s actual position from the pressure sensor assembly'"'"'s prescribed position, to produce the error signal.

41. A method as defined in claim 39, wherein:

the modulation signal has a substantially uniform ac amplitude; and

monitoring includes comparing the ac amplitude of the pressure signal during a first stage of the subject'"'"'s heartbeat with the ac amplitude of the pressure signal during a second stage of the subject'"'"'s heartbeat, and sensing any deviation of the pressure sensor assembly'"'"'s actual position from the pressure sensor assembly'"'"'s prescribed position, to produce the error signal.

42. A method as defined in claim 31, wherein:

controlling includes modulating the position of the pressure sensor assembly relative to the subject'"'"'s blood vessel at a substantially uniform ac amplitude; and

controlling further includes comparing the ac amplitude of the pressure signal during systole with the ac amplitude of the pressure signal during diastole, and producing the control signal in accordance with the comparison.

43. A method as defined in claim 31, wherein:

controlling includes modulating the position of the pressure sensor assembly relative to the subject'"'"'s blood vessel substantially sinusoidally; and

controlling further includes comparing the ac amplitude of the pressure signal during positive portions of the vessel modulation with the ac amplitude of the pressure signal during negative portions of the vessel modulation, and producing the control signal in accordance with the comparison.