Combination heart assist systems, methods, and devices

• US 9,042,979 B2
• Filed: 01/29/2014
• Issued: 05/26/2015
• Est. Priority Date: 04/02/2010
• Status: Active Grant

• Current Assignee: Nuwellis, Inc.
• Original Assignee: Sunshine Heart Company Pty, Ltd. (Nuwellis, Inc.)
• Inventors: Peters, William S., Parkin, Rodney G., Rosa, David, Lafontaine, Daniel M., Abraham, William T., Sun, Benjamin
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): KIMBALL, JEREMIAH T
• Application Number:
  US14/167,143
• Publication Number:
  US 20140148639A1
• Time in Patent Office: 482 Days
• Field of Search: 607/3, 623/3.1, 623/3.28
• US Class Current: 607/3
• CPC Class Codes: A61B 5/0084 for introduction into the body, e.g. by catheters A61B5/1459 takes precedence
• 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 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/026 Measuring blood flow A61B3/1233, A61B3/1241 take precedence
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61B 7/023 for introduction into the body, e.g. into the oesophagus oesophageal ECG probes A61B5/285
• CPC Class Codes: A61B 7/04 Electric stethoscopes microphones, acoustic transducers therefor H04R
• CPC Class Codes: A61M 1/777 Determination of loss or gain of body fluids due to suction-irrigation, e.g. during surgery
• CPC Class Codes: A61M 2205/33 Controlling, regulating or measuring
• CPC Class Codes: A61M 2205/3303 Using a biosensor
• 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 60/165 implantable in, on, or around the heart
• CPC Class Codes: A61M 60/40 Details relating to driving
• CPC Class Codes: A61M 60/515 Regulation using real-time patient data
• CPC Class Codes: A61M 60/538 Regulation using real-time blood pump operational parameter data, e.g. motor current
• CPC Class Codes: A61M 60/88 Percutaneous cables
• CPC Class Codes: A61N 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy
• 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 1/36521 : the parameter being derived from measurement of an electrical impedance
• CPC Class Codes: A61N 1/36542 : controlled by body motion, e.g. acceleration
• CPC Class Codes: A61N 1/3702 : Physiological parameters A61N1/365 takes precedence; evoked response A61N1/371
• CPC Class Codes: A61N 1/39622 : Pacing therapy

Abstract

The various embodiments disclosed herein relate to combination heart assist systems, methods, and devices that include both an electrical therapy device and a mechanical heart assist device. Various operational modes can be implemented using these embodiments, including a synchronized pacing mode, an internal CPR mode, and an internal workout mode.

Claims

1. A method of assisting and strengthening a heart, the method comprising:

detecting a characteristic of a heart with a sensing lead;

transmitting information about the heart characteristic to an electrical cardiac therapy device via the sensing lead;

actuating the electrical cardiac therapy device based at least in part on the information about the heart characteristic;

transmitting the information about the heart characteristic to a controller via a connecting lead coupled to the electrical cardiac therapy device and the controller;

actuating an implantable mechanical heart assist device with an actuating signal from the controller, wherein the actuating is based at least in part on the information about the heart characteristic; and

periodically timing the actuating of the mechanical heart assist device and the electrical cardiac therapy device such that a predetermined amount of resistance to contraction is created in the heart.

2. The method of claim 1, wherein the electrical cardiac therapy device is an ICD.

3. The method of claim 1, wherein the electrical cardiac therapy device is a CRT-D.

4. The method of claim 1, wherein the periodically timing the actuating of the mechanical heart assist device and the electrical cardiac therapy device further comprises timing the actuating of the devices such that the predetermined amount of resistance to contraction is created in the heart for a predetermined treatment period each day.

5. The method of claim 4, further comprising increasing or decreasing the predetermined treatment period as the heart is strengthened.

6. The method of claim 4, further comprising increasing or decreasing the predetermined treatment period after a predetermined amount of time.

7. The method of claim 1, wherein the controller is physically integral with the electrical cardiac therapy device.

8. The method of claim 1, wherein the controller is physically integral with the mechanical heart assist device.

9. The method of claim 1, wherein the mechanical heart assist device is a pulsatile device.

10. The method of claim 1, wherein the heart characteristic is chosen from the group consisting of heart vibrations, heart sounds, flow, pressure, impedance, wall stress, and optical reflectance.

11. The method of claim 1, further comprising periodically timing the actuating of the mechanical heart assist device and the electrical cardiac therapy device to operate synchronously to assist the heart based on the information about the heart characteristic.

12. The method of claim 1, wherein the periodically timing the actuating of the mechanical heart assist device and the electrical cardiac therapy device further comprises actuating the mechanical heart assist device to deflate after a left ventricle of the heart has begun to contract.

13. A method of assisting and strengthening a heart, the method comprising:

detecting a characteristic of a heart with a sensor;

transmitting a signal relating to the heart characteristic to an electrical therapy device via the sensor;

actuating the electrical therapy device based at least in part on the heart characteristic signal;

transmitting the heart characteristic signal from the electrical therapy device to a controller;

actuating a mechanical heart assist device with an actuating signal from the controller, wherein the actuating is based at least in part on the heart characteristic signal; and

periodically actuating the mechanical heart assist device to create a predetermined amount of resistance to contraction of the heart.

14. The method of claim 13, wherein the periodically actuating the mechanical heart assist device further comprises periodically timing the actuating of the mechanical heart assist device and the electrical therapy device.

15. The method of claim 14, wherein the periodically timing the actuating of the mechanical heart assist device and the electrical cardiac therapy device further comprises actuating the mechanical heart assist device to deflate after a left ventricle of the heart has begun to contract.

16. The method of claim 13, wherein the periodically actuating the mechanical heart assist device further comprises periodically actuating partial deflation of the mechanical heart assist device.

17. The method of claim 13, wherein the periodically actuating the mechanical heart assist device further comprises timing the actuating of the mechanical heart assist device such that the predetermined amount of resistance to contraction is created in the heart for a predetermined treatment period each day.

18. The method of claim 17, further comprising increasing or decreasing the predetermined treatment period as the heart is strengthened.

19. The method of claim 17, further comprising increasing or decreasing the predetermined treatment period after a predetermined amount of time.

20. A method of assisting and strengthening a heart, the method comprising:

detecting a characteristic of a heart with a sensor;

transmitting information about the heart characteristic to an electrical therapy device via the sensor;

actuating the electrical therapy device based at least in part on the information about the heart characteristic;

transmitting the information about the heart characteristic to a controller;

actuating a mechanical heart assist device with an actuating signal from the controller, wherein the actuating is based at least in part on the information about the heart characteristic; and

periodically actuating the mechanical heart assist device to create a predetermined amount of resistance to contraction of the heart.

21. The method of claim 20, wherein the periodically actuating the mechanical heart assist device further comprises periodically timing the actuating of the mechanical heart assist device and the electrical therapy device.

22. The method of claim 20, wherein the periodically actuating the mechanical heart assist device further comprises periodically actuating partial deflation of the mechanical heart assist device.

23. The method of claim 20, wherein the periodically actuating the mechanical heart assist device further comprises timing the actuating of the mechanical heart assist device such that the predetermined amount of resistance to contraction is created in the heart for a predetermined treatment period each day.