Synchronization control system

• US 9,119,908 B2
• Filed: 10/23/2013
• Issued: 09/01/2015
• Est. Priority Date: 10/31/2003
• Status: Active Grant

• Current Assignee: Nuwellis, Inc.
• Original Assignee: Sunshine Heart Company Pty, Ltd. (Nuwellis, Inc.)
• Inventors: Peters, William Suttle, Parkin, Rodney Gordon
• Primary Examiner(s): MANUEL, GEORGE C
• Application Number:
  US14/060,854
• Publication Number:
  US 20140051909A1
• Time in Patent Office: 678 Days
• Field of Search: 607/18
• US Class Current: 1/1
• 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

The various embodiments herein relate to systems and methods for controlling the operation of a pulsatile heart assist device in a patient. The systems and methods include utilizing sounds and electrical signals produced by the heart to control the operation of the heart assist device.

Claims

1. A heart assist system, comprising:

(a) a heart assist device comprising an inflatable cuff configured to apply pressure to blood in a blood vessel;

(b) a pump configured to generate fluid pressure;

(c) a fluid disposed within the inflatable cuff and the pump, the fluid configured to transfer the fluid pressure between the pump and the inflatable cuff;

(d) a controller operably coupled to the pump;

(e) a phonocardiographic (“

PCG”

) lead operably coupled to the controller, the PCG lead comprising a sound sensor configured to detect heart sounds, wherein at least a portion of the sound sensor is positioned in contact with the fluid; and

(f) an electrical sensing lead operably coupled to the controller, the electrical sensing lead comprising an electrical sensor configured to detect an electrical signal of the heart,

wherein the controller is configured to use the heart sounds and the electrical signal of the heart to control the operation of the heart assist device.

2. The heart assist system of claim 1, wherein the blood vessel is an aorta, and further wherein the inflatable cuff is configured to apply the pressure to an exterior of the aorta.

3. The heart assist system of claim 1, wherein the inflatable cuff comprises a flexible membrane, wherein the flexible membrane is configured to apply the pressure to the blood in the blood vessel.

4. The heart assist system of claim 1, wherein the fluid is a liquid or a gas.

5. The heart assist system of claim 1, wherein the heart sounds comprise S1 and S2 sounds.

6. The heart assist system of claim 1, wherein the heart sounds comprise sounds created when an aortic valve of the heart closes.

7. The heart assist system of claim 1, wherein the sound sensor comprises a microphone.

8. A heart assist system, comprising:

(a) a pump configured to generate fluid pressure;

(b) an inflatable cuff operably coupled to the pump, the inflatable cuff configured to receive fluid pressure from the pump and apply pressure to blood in a blood vessel;

(c) a fluid disposed within the inflatable cuff and the pump, the fluid configured to transfer the fluid pressure between the pump and the inflatable cuff;

(d) a controller operably coupled to the pump;

(e) a digital signal processor and transmitter (DSPT) operably coupled to the controller, the DSPT comprising an ECG channel and a PCG channel;

(f) a PCG lead operably coupled to the PCG channel of the DSPT, the PCG lead comprising a sound sensor configured to detect heart sounds, wherein at least a portion of the sound sensor is positioned in contact with the fluid; and

(g) an ECG lead operably coupled to the ECG channel of the DSPT, the ECG lead comprising a sensor configured to detect an electrical signal of the heart,

wherein the DSPT is configured to transmit signals relating to the heart sounds and the electrical signal of the heart to the controller, and further wherein the controller is configured to transmit actuation instructions to the pump based on the signals relating to the heart sounds and the signals relating to the electrical signal from the DSPT.

9. The heart assist system of claim 8, wherein the sound sensor comprises a microphone.

10. The heart assist system of claim 8, wherein the DSPT is wirelessly coupled to the controller.

11. The heart assist system of claim 8, wherein the inflatable cuff comprises a flexible membrane, wherein the flexible membrane is configured to apply the pressure to the blood in the blood vessel.

12. The heart assist system of claim 8, wherein the fluid is a liquid or a gas.

13. A method of controlling a heart assist system, the method comprising:

electrically detecting an electrical signal of a heart'"'"'s rhythm with an electrical sensing lead;

transmitting a signal relating to the electrical signal to a controller;

positioning a PCG lead such that at least a portion of the PCG lead is positioned in contact with a fluid configured to transfer fluid pressure between a pump and an inflatable cuff;

detecting a heart sound with the PCG lead;

transmitting a signal relating to the heart sound to the controller; and

applying pressure to blood in a blood vessel with an inflatable cuff based on the electrical signal and the heart sound.

14. The method of claim 13, further comprising transmitting an actuation signal from the controller to the pump based on at least one of the signals relating to the electrical signal and the heart sound.

15. The method of claim 14, further comprising actuating the pump to generate fluid pressure based on the actuation signal.

16. The method of claim 15, further comprising transferring the fluid from the pump to the inflatable cuff as a result of the fluid pressure, whereby the inflatable cuff is inflated.

17. The method of claim 13, further comprising receiving the signals relating to the electrical signal and the heart sound at a digital signal processor and transmitter (DSPT) and transmitting signals relating to the electrical signal and the heart sound to the controller.

18. The method of claim 17, further comprising transmitting an actuation signal from the controller to the pump based on at least one of the signals relating to the electrical signal and the heart sound from the DSPT.