Apparatus and method for non-invasive monitoring of cardiac output

• US 20040044288A1
• Filed: 09/03/2002
• Published: 03/04/2004
• Est. Priority Date: 09/03/2002
• Status: Abandoned Application

• Current Assignee: Cardiowatch Limited
• Original Assignee: Cardiowatch Limited
• Inventors: Marmor, Alon, Naroditzky, Michael, Dafni, Ehud, Rotstein, Hector, Gorenberg, Miguel
• Application Number:
  US10/234,429
• Publication Number:
  US 20040044288A1
• Time in Patent Office: Days
• US Class Current: 600/481
• CPC Class Codes: A61B 2562/0247 Pressure sensors
• CPC Class Codes: A61B 2562/043 in a linear array
• CPC Class Codes: A61B 2562/168 Fluid filled sensor housings
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/02141 Details of apparatus construction, e.g. pump units or housings therefor, cuff pressurising systems, arrangements of fluid conduits or circuits A61B5/02233, A61B5/0235 take precedence
• CPC Class Codes: A61B 5/022 by applying pressure to close blood vessels, e.g. against the skin; Ophthalmodynamometers
• CPC Class Codes: A61B 5/02233 Occluders specially adapted therefor tourniquets A61B17/132
• CPC Class Codes: A61B 5/026 Measuring blood flow A61B3/1233, A61B3/1241 take precedence

Abstract

A non-invasive apparatus for measuring cardiac mechanical performance of a patient, the apparatus comprising a pressure applying element mountable on a limb of the patient for applying pressure high enough to make a segment of an artery within the limb achieve a collapsed state and empty it from blood at least momentarily; at least one of a plurality of sensors coupled to said pressure applying element, sensing mechanical changes corresponding to volumetric changes in the artery as the artery progressively recuperates from its collapsed state; processing unit communicating with said at least one of a plurality of sensors for receiving output corresponding to the mechanical changes from said at least one of a plurality of sensors and computing factors correlated with blood flow and calculate parameters indicating heart performance.

Claims

1. A non-invasive apparatus for measuring cardiac mechanical performance of a patient, the apparatus comprising:

a pressure applying element mountable on a limb of the patient for applying pressure high enough to make a segment of an artery within the limb achieve a collapsed state and empty it from blood at least momentarily;

at least one of a plurality of sensors coupled to said pressure applying element, sensing mechanical changes corresponding to volumetric changes in the artery as the artery progressively recuperates from its collapsed state;

processing unit communicating with said at least one of a plurality of sensors for receiving output corresponding to the mechanical changes from said at least one of a plurality of sensors and computing factors correlated with blood flow and calculate parameters indicating heart performance.

2. The apparatus as claimed in claim 1, wherein the pressure applying element is an inflatable cuff.

3. The apparatus as claimed in claim 1, wherein the pressure applying element is an inflatable cuff, divided into a plurality of inflatable segments.

4. The apparatus as claimed in claim 3, wherein the inflatable cuff is divided into at least two inflatable segments, and wherein said at least one of a plurality of sensors comprise at least two sensor transducers for detecting pressure changes within the segment, each transducer corresponding to a different segment.

5. The apparatus as claimed in claim 3, wherein the pressure applying element is operated by a pneumatic system comprising a pump for increasing the pressure within the cuff, and valves for releasing the pressure from the cuff.

6. The apparatus as claimed in claim 1, wherein the pressure applying element is driven by an electrical motor.

7. The apparatus as claimed in claim 1, wherein the pressure applying element is coupled to a bracelet having a diameter which is automatically adjustable.

8. The apparatus as claimed in claim 7, wherein the bracelet consists of a strap and wherein bracelet'"'"'s diameter may be increased or decreased by turning a screw operated by a motor to which the strap is attached.

9. The apparatus as claimed in claim 7, wherein the pressure applying element is hydraulically operated.

10. The apparatus as claimed in claim 1 wherein the pressure applying element comprises said at least one of the plurality of cushions held against the limb by a rigid bridge.

11. The apparatus as claimed in claim 10, wherein the cushions are inflatable.

12. The apparatus as claimed in claim 10, wherein said at least one of the plurality of cushions consist of two such cushions, filled with filled with ferromagnetic fluid that transforms from liquid to solid by application of magnetic flux, and electromagnetic coil provided adjacent each cushion, for inducing magnetic flux.

13. The apparatus as claimed in claim 1, wherein the pressure applying element comprises at least one of a plurality of cushions held against the limb by a rigid bridge, and wherein said at least one of a plurality of sensors comprises deformation sensors, sensing deformation changes of said at least one of the plurality of cushions.

14. The apparatus as claimed in claim 13, wherein said at least one of the plurality of cushions is inflatable.

15. The apparatus as claimed in claim 13, wherein said at least one of the plurality of cushions is filled with hydraulic fluid.

16. The apparatus as claimed in claim 13, wherein the deformation sensors comprise an array of capacitors, wherein the mechanical changes are determined by measuring changes in the capacitance of the capacitors, due to deformation changes.

17. The apparatus as claimed in claim 1 wherein said at least one of a plurality of sensors include an array of piezoelectric transducers wherein the mechanical changes are determined by measuring changes in the output voltage of the transducers.

18. The apparatus as claimed in claim 1, wherein the pressure applying element comprises at least one cushion held against the limb by at least one of a plurality of pivotal rigid bridges, each provided with gyroscopic sensor to sense rotational velocity of said at least one of a plurality of pivotal rigid bridges.

19. The apparatus as claimed in claim 18, wherein said at least one of a plurality of pivotal rigid bridges comprise two pivotal bridges.

20. The apparatus as claimed in claim 19, wherein the two pivotal bridges are coupled to a third pivotal bridge.

21. The apparatus as claimed in claim 1, further comprising output means.

22. The apparatus as claimed in claim 1, further comprising memory unit.

23. The apparatus as claimed in claim 1, further comprising means to communicate with a computer, network or a telephone system.

24. The apparatus as claimed in claim 1, wherein the pressure applying element is capable of applying pressure sufficient to cause a collapse of the artery just momentarily during a diastolic phase of the patient.

25. The apparatus as claimed in claim 1, wherein the processing unit includes algorithm comprising the following steps:

a. calculating instantaneous pressure changes within the pressure inducing member as a function of time;

b. dividing the instantaneous pressure changes into segments corresponding to pulse rate periods of the patient;

c. finding the highest pressure at which there exists no separation between the falling edge and leading edge of two consecutive segments of the normalized instantaneous pressure changes and analyzing at least one segment located within 5 pulse rates from the two consecutive segments.

26. The apparatus as claimed in claim 25, wherein the algorithm included in the processing means further comprises, in the presence of noise, measuring and tabulating values of time elapsed between two pulses at a predetermined threshold and extrapolating the highest pressure at which there exists no separation between the falling edge and leading edge of two consecutive segments of the normalized instantaneous pressure changes.

27. The apparatus as claimed in claim 25, wherein the highest pressure at which there exists no separation between the falling edge and leading edge of two consecutive segments of the normalized instantaneous pressure changes is found by first increasing the applied pressure above the desired pressure and than acquiring pressure data while gradually reducing the applied pressure.

28. The apparatus as claimed in claim 25, wherein the highest pressure at which there exists no separation between the falling edge and leading edge of two consecutive segments of the normalized instantaneous pressure changes is found by gradually increasing the applied pressure while acquiring pressure data.

29. The apparatus as claimed in claim 25, wherein a control system is used to maintain the applied pressure over a period of time substantially at the highest pressure at which where there exists no separation between the falling edge and leading edge of two consecutive segments of the normalized instantaneous pressure and factors correlated with blood flow are measured continuously.

30. The apparatus as claimed in claim 1, wherein the measurement data is used to calculate the peripheral velocity time integral PVTI.

31. The apparatus as claimed in claim 3 or 30, wherein the PVTI is calculated by a fit of a theoretical curve to the combined data of plurality of sensors, each detecting pressure changes within corresponding segment of the inflatable cuff.

32. The apparatus as claimed in claim 3 or 30, wherein the PVTI is calculated from the time difference between data of plurality of sensors, each detecting pressure changes within corresponding segment of the inflatable cuff.

33. The apparatus as claimed in claim 30, wherein the PVTI is calculated by a fit of a theoretical curve to data indicating sensor segment triggering time versus said segment position.

34. The apparatus as claimed in claim 30, wherein the PVTI data is used to calculate further factors correlated with blood flow.

35. A method for non-invasive measuring of changes in cardiac mechanical performance of a patient, the method comprising:

providing a pressure applying element mountable on a limb of the patient for applying pressure enough to make a longitudinal segment of an artery within the limb achieve a collapsed state and empty it from blood at least momentarily;

providing sensor coupled to the pressure applying element, sensing mechanical changes corresponding to volumetric changes in the artery as the artery progressively recuperates from its collapsed state;

providing processing unit communicating with the sensor for receiving output corresponding to the mechanical changes from the sensor and computing factors correlated with blood flow and calculate parameters indicating heart performance;

applying pressure on a portion a limb of a patient through which artery passes enough to collapse the artery preventing at least momentarily the flow of blood through the collapsed artery;

sensing mechanical changes corresponding to volumetric changes in the artery as the artery progressively recuperates from its collapsed state;

computing factors correlated with blood flow and calculating parameters indicating heart performance.

36. The method as claimed in claim 35, wherein the pressure applied on the portion of the limb of the patient is initially larger than needed to collapse the artery, and wherein it is gradually reduced, sensing the mechanical changes correlating to the volumetric changes while the pressure is reduced.

37. The method as claimed in claim 35, further comprising determining a best pulse period for considering a measurement, comprising the steps of:

a. calculating instantaneous pressure changes within the cuff as a function of time;

b. dividing the instantaneous pressure changes into segments corresponding to pulse rate periods of the patient and normalizing the pressure changes of each time segment;

c. finding two consecutive segments of the normalized instantaneous pressure changes where there exists no separation and analyzing at least one segment located within 5 pulse rates from the two consecutive segments.

38. The method as claimed in claim 35, further comprising measuring blood pressure of the patient.

39. The method as claimed in claim 35, further comprising measuring heart pulse rate of the patient.

40. The method as claimed in claim 35, carried out continuously over a period of time..

41. The method as claimed in claim 35, further comprising transmitting data to an external apparatus.

42. The method as claimed in claim 35, wherein it is incorporated with Holter procedure, in order to detect artifacts and enhance reliability.