Synchronization control system

• US 20070060787A1
• Filed: 10/28/2004
• Published: 03/15/2007
• Est. Priority Date: 10/31/2003
• Status: Active Grant

• Current Assignee: Sunshine Heart Company Pty, Ltd. (Nuwellis, Inc.)
• Original Assignee: Sunshine Heart Company Pty, Ltd. (Nuwellis, Inc.)
• Inventors: Peters, William, Parkin, Rodney
• Granted Patent: US 7,765,003 B2
• Time in Patent Office: Days
• US Class Current: 600/17
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/25 Bioelectric electrodes therefor
• CPC Class Codes: A61B 5/316 Modalities, i.e. specific diagnostic methods
• CPC Class Codes: A61B 5/352 Detecting R peaks, e.g. for synchronising diagnostic apparatus; Estimating R-R interval
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 7/00 Instruments for auscultation
• CPC Class Codes: A61B 7/04 Electric stethoscopes microphones, acoustic transducers therefor H04R
• CPC Class Codes: A61M 60/148 in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices
• CPC Class Codes: A61M 60/161 mechanically acting upon the outside of the patient's blood vessel structure, e.g. compressive structures placed around a vessel
• CPC Class Codes: A61M 60/178 drawing blood from a ventricle and returning the blood to the arterial system via a cannula external to the ventricle, e.g. left or right ventricular assist devices
• CPC Class Codes: A61M 60/191 mechanically acting upon the outside of the patient's native heart, e.g. compressive structures placed around the heart
• CPC Class Codes: A61M 60/274 the inlet and outlet being the same, e.g. para-aortic counter-pulsation blood pumps
• CPC Class Codes: A61M 60/289 Devices for mechanical circulatory actuation assisting the residual heart function by means mechanically acting upon the patient's native heart or blood vessel structure, e.g. direct cardiac compression [DCC] devices
• CPC Class Codes: A61M 60/468 the force acting on the actuation means being hydraulic or pneumatic
• CPC Class Codes: A61M 60/515 Regulation using real-time patient data
• CPC Class Codes: A61M 60/531 using blood pressure data, e.g. from blood pressure sensors
• CPC Class Codes: A61M 60/569 synchronous with the native heart beat
• CPC Class Codes: A61M 60/873 specially adapted for wireless or transcutaneous energy transfer [TET], e.g. inductive charging
• CPC Class Codes: A61M 60/88 Percutaneous cables
• CPC Class Codes: A61N 1/36514 controlled by a physiological quantity other than heart potential, e.g. blood pressure controlled by two or more physical parameters A61N1/36585
• CPC Class Codes: A61N 1/36528 : the parameter being measured by means of ultrasound
• CPC Class Codes: A61N 1/36578 : controlled by mechanical motion of the heart wall, e.g. measured by an accelerometer or microphone
• CPC Class Codes: A61N 1/3702 : Physiological parameters A61N1/365 takes precedence; evoked response A61N1/371

Abstract

A method of controlling the operation of a pulsatile heart assist device (14) in a patient (10). The method consisting of utilising sounds produced by the heart (12) to control the operation of the heart assist device (14).

Claims

1. A method of controlling the operation of a pulsatile heart assist device in a patient, consisting of utilizing sounds produced by the heart to control the operation of the heart assist device.

2. The method as claimed in claim 1, wherein the method uses a combination wave detection and heart sound detection to control the operation of the heart assist device.

3. The method as claimed in claim 1, wherein the heart assist device is completely controlled by utilizing both the and S2 sounds of the heart to both stop and start the heart assist device.

4. A method of controlling the operation of a pulsatile heart assist device in a patient, consisting of electrically detecting the R-wave of the patient'"'"'s heart rhythm and producing a signal to initiate a change in the pulsatile status of the heart assist device, and detecting a sound or pressure wave created by the closure of the patient'"'"'s aortic valve and producing a signal to return the heart assist device to the pulsatile status it had before the preceding R-wave.

5. A method of controlling the operation of a pulsatile heart assist device with a multi-channel digital signal processor and transmitter (DSPT), the DSPT being of the type having an ECG channel and a phonocardiographic (PCG) the DSPT being at least adapted to normally sense an electrical signal indicative of cardiac rhythm through the ECG channel, and to normally sense heart sounds through the PCG channel, and to transmit signals to an external receiver, the method comprising the steps operatively connecting the DSPT bipolar ECG lead to a patients heart;

and operatively connecting the DSPT microphone to the patients heart, whereby, after detecting an R-wave via the ECG channel, the DSPT issues a R-wave signal to the heart assist device controller to control the timing of the pulsation of the heart assist device, and whereby, after detecting a heart sound via the PCG channel, the DSPT issues a heart sound signal to the heart assist device controller to control the timing of the pulsation of the heart assist device.

6. The method as claimed in claim 5, wherein the DSPT is adapted to normally sense heart sounds through the PCG channel in the range of 20-500 Hz.

7. The method as claimed in claim 5, wherein the DSPT is able to receive as well as transmit.

9. The method as claimed in claim 5, wherein the ECG lead connected to the patient'"'"'s heart is epicardial or endocardial or attached to an implanted heart assist device itself.

10. The method as claimed in claim 5, wherein sensors for the collection of an ECG signal are embedded into the surface of a heart assist device applied to the heart or another part of the patient'"'"'s body from which an ECG signal may be received.

11. The method as claimed in claim 5, wherein the DSPT microphone is internal to the patient'"'"'s body.

12. The method as claimed in claim 11, wherein the connection to the patients heart is epicardial.

13. The method as claimed in claim 11, wherein the connection to the patients heart is endocardial.

14. The method as claimed in claim 11, wherein the connection to the patient'"'"'s heart is in the manner of a pacing lead.

15. The method as claimed in claim 11, wherein the connection to the patient'"'"'s heart is attached to the implanted device itself.

16. The method as claimed in claim 11, wherein the connection to the patients heart is located within 50 mm of the cardiac valves.

17. The method as claimed in claim 11, wherein the connection to the patients heart is without the lung between the microphone and the patient'"'"'s heart.

18. The method as claimed in claim 5, wherein the microphone is positioned outside the body of the patient.

19. The method as claimed in claim 18, wherein the heart sounds and ECG control an external gas-driven extra-aortic balloon pump using an external microphone placed in the lumen of the extra aortic balloon or the gas line leading to the extra aortic balloon.

20. The method as claimed in claim 19, wherein the implanted gas line and balloon acts as a ‘

stethoscope,’ and

heart sounds can be detected intermittently or continuously, and sent directly to a controller positioned outside the patient'"'"'s body.

21. The method as claimed in claim 20, wherein a percutaneous ECG lead is used to directly transmit the ECG signal to the controller.

22. The method as claimed in claim 21, wherein the ECG lead is combined with the percutaneous gas line.

23. The method as claimed in claim 21 wherein the ECG lead is separate from the percutaneous gas line.

24. The method as claimed in claim 22, further including a releasable and salable connection for the percutaneous gas line and the ECG lead under the skin.

25. The method as claimed in claim 5, wherein the DSPT is able to receive signals from an external device to adjust digital signal processing variables within the DSPT for detecting and heart sounds.

26. The method as claimed in claim 5, wherein the DSPT has a battery of sufficient life that the DSPT can be removed and replaced, independent of the cardiac sensing leads.

27. The method as claimed in claim 5, wherein the DSPT has a rechargeable battery that can be recharged by induction, or Transcutaneous Energy Transfer (TET).

28. The method as claimed in claim 5, wherein the DSPT can communicate directly with an implanted controller.

29. The method as claimed in claim 28, wherein the controller and the ECG and microphone are contained within the pump and the pump is positioned in the medial right chest, with one aspect of the pump (containing hermetically sealed microphone and EGG electrodes) against the right heart structures.

8. The method as claimed in claim 8, wherein the DSPT has parameter settings adjusted within ranges, for detecting the R-wave and the heart sounds, and for the output signals.

30. A dual channel DSPT configured for use in controlling the operation of a pulsatile heart assist device, the DSPT being of the type having an ECG channel and a phonocardiographic (PCG) channel, the DSPT being at least adapted to normally sense an electrical signal indicative of cardiac rhythm through the ECG channel, and to normally sense heart sounds through the PCG channel, and to transmit signals to an external receiver to control the timing of the pulsation of the heart assist device.

31. The DSPT as claimed in claim 30, wherein, signals are directly sent to an implanted controller.

32. The DSPT as claimed in claim 30, wherein the DSPT is adapted to normally sense heart sounds through the PCG channel in the range of 20-500 Hz.

33. The DSPT as claimed in claim 30, wherein the DSPT is able to receive as well as transmit.

34. The DSPT as claimed in claim 30, wherein the DSPT has parameter settings adjustable within ranges, for detecting the R-wave and the Heart Sounds, and for the output signals.

35. The DSPT as claimed in claim 30, wherein the DSPT has other channels for detecting aortic and left ventricular blood pressure and for movement of the aortic or ventricular walls, and signals from these channels can also be interpreted to control heart assist device functioning.

36. Means for controlling a co-pulsation or counter-pulsation heart assist device, the means including:

a co-or counter-pulsation heart assist device;

a controller for the heart assist device; and

a DSPT of the type at least adapted to normally sense an electrical signal indicative of cardiac rhythm through an ECG channel and a sound signal indicative of heart sounds S1 S2 through a PCG channel, and to issue identifiable signals to the controller, in which the DSPT is set to issue pacing signals from the ventricular circuit at a minimum rate which is below a sensible rate in the event that the atrial circuit is unable to sense a rhythm signal from the patient'"'"'s ventricle, and the controller is set to turn off the heart assist device in the event that the pacing signals that the controller receives from the DSPT are at a rate below a predetermined rate which is above the minimum rate.