Combination heart assist systems, methods, and devices

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.

1 . A heart assist system comprising:
 (a) a mechanical heart assist device;   (b) a controller operably coupled to the mechanical heart assist device, the controller configured to transmit an actuating signal to the mechanical heart assist device; and   (c) an electrical therapy device operably coupled to the controller, the electrical therapy device comprising:
 (i) at least one sensor operably coupled to the electrical therapy device, wherein the sensor is configured to detect a heart characteristic and transmit a signal relating to the heart characteristic to the electrical therapy device; and 
 (ii) at least one pacing component operably coupled to the electrical therapy device, the pacing lead configured to pace the heart. 
   
     
     
         2 . The heart assist system of  claim 1 , wherein the sensor is a sensing lead, wherein the sensing lead is configured to be positionable in or adjacent to the heart. 
     
     
         3 . The heart assist system of  claim 1 , wherein the sensor is physically integral with the electrical therapy device. 
     
     
         4 . The heart assist system of  claim 1 , wherein the pacing component is a pacing lead, wherein the pacing lead is configured to be positionable in or adjacent to the heart. 
     
     
         5 . The heart assist system of  claim 1 , wherein the pacing component is physically integral with the electrical therapy device. 
     
     
         6 . The heart assist system of  claim 1 , wherein the controller is physically integral with the electrical therapy device. 
     
     
         7 . The heart assist system of  claim 1 , wherein the controller is physically integral with the mechanical heart assist device. 
     
     
         8 . The heart assist system of  claim 1 , wherein the mechanical heart assist device is a pulsatile device. 
     
     
         9 . The heart assist system of  claim 1 , wherein the electrical therapy device is an implantable cardiac resynchronization therapy and defibrillation device (“CRT-D”). 
     
     
         10 . The heart assist system of  claim 1 , wherein the electrical therapy device is an implantable cardioverter-defibrillator device (“ICD”). 
     
     
         11 . The heart assist system of  claim 1 , wherein the sensor is an electrical sensing lead configured to sense a loss or reduction of ventricular contraction and transmit information to the electrical therapy device, wherein the electrical therapy device is configured to transmit an actuating signal to the controller, wherein the controller is configured to transmit an actuating signal to the mechanical heart device to operate to provide circulatory support until the heart is defibrillated or normal cardiac rhythm is restored. 
     
     
         12 . The heart assist system of  claim 1 , wherein the sensor is an electrical sensing lead configured to sense a loss or reduction of ventricular contraction and transmit information to the electrical therapy device, wherein the electrical therapy device is configured to transmit an actuating signal to the controller, wherein the controller is configured to transmit an actuating signal to the mechanical heart device to operate to provide circulatory support until the electrical therapy device defibrillates the heart. 
     
     
         13 . The heart assist system of  claim 1 , wherein the electrical therapy device is configured to actuate the at least one pacing component to electrically stimulate a ventricle of the heart in synchronization with the controller being configured to actuate the mechanical heart assist device. 
     
     
         14 . The heart assist system of  claim 1 , wherein the sensor is chosen from a group consisting of an electrical sensor; an ECG sensor; heart vibration sensor, a heart acoustics sensor, a flow sensor, a pressure sensor, an impedance sensor, a wall stress sensor, and an optical reflectance sensor, wherein the sensor is positionable within or adjacent to the heart or a great vessel of the heart. 
     
     
         15 . The heart assist system of  claim 1 , wherein the sensor is an acoustic sensor, wherein the acoustic sensor is an aortic valve acoustic sensor configured to detect sounds of an aortic valve in the heart. 
     
     
         16 . A method of controlling a heart assist device, 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 to transmit a pacing signal to a pacing component based at least in part on the heart characteristic signal;   transmitting a signal to a controller, wherein the transmitting the signal to the controller is based at least in part on the heart characteristic signal; and   actuating a mechanical heart assist device with an actuating signal from the controller, wherein the actuating is based at least in part on the signal to the controller.   
     
     
         17 . The method of  claim 16 , wherein the transmitting the signal to the controller further comprises transmitting the signal to the controller via a connecting lead coupled to the electrical therapy device and the controller. 
     
     
         18 . The method of  claim 16 , wherein the sensor is a sensing lead. 
     
     
         19 . The method of  claim 16 , wherein the pacing component is a pacing lead. 
     
     
         20 . The method of  claim 16 , wherein the controller is physically integral with the electrical therapy device. 
     
     
         21 . The method of  claim 16 , wherein the controller is physically integral with the mechanical heart assist device. 
     
     
         22 . The method of  claim 16 , wherein the mechanical heart assist device is a pulsatile device. 
     
     
         23 . The method of  claim 16 , further comprising actuating both the mechanical heart assist device and the electrical therapy device to operate synchronously to assist the heart based on the information about the heart characteristic. 
     
     
         24 . The method of  claim 16 , wherein the heart characteristic comprises a loss or reduction of ventricular contraction, wherein the actuating the electrical therapy device further comprises actuating the electrical therapy device to transmit a defibrillation discharge to the heart via a ventricular lead based on the information about the heart characteristic, and wherein the actuating the mechanical heart assist device further comprises actuating the mechanical heart assist device to provide circulatory support until the heart is defibrillated or normal cardiac rhythm is restored. 
     
     
         25 . The method of  claim 16 , wherein the heart characteristic comprises a loss or reduction of ventricular contraction, wherein the actuating the electrical therapy device further comprises actuating the electrical therapy device to transmit a defibrillation discharge to the heart via a ventricular lead based on the information about the heart characteristic, and wherein the actuating the mechanical heart assist device further comprises actuating the mechanical heart assist device to provide circulatory support until the electrical therapy device transmits the defibrillation charge to the heart. 
     
     
         26 . The method of  claim 16 , wherein the electrical therapy device is an ICD. 
     
     
         27 . The method of  claim 16 , wherein the electrical therapy device is a CRT-D. 
     
     
         28 . The method of  claim 16 , wherein the actuating the electrical therapy device and the actuating the mechanical heart assist device further comprises synchronously actuating the mechanical heart assist device to operate the aortic compression structure to compress the ascending aorta while actuating the electrical therapy device to transmit the pacing signal to the heart via the pacing component, whereby the mechanical heart assist device and the electrical therapy device operate in conjunction to assist the heart. 
     
     
         29 . The method of  claim 16 , wherein the heart characteristic is chosen from the group consisting of heart vibrations, heart sounds, flow, pressure, impedance, wall stress, and optical reflectance. 
     
     
         30 . 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.   
     
     
         31 . The method of  claim 30 , wherein the electrical cardiac therapy device is an ICD. 
     
     
         32 . The method of  claim 30 , wherein the electrical cardiac therapy device is a CRT-D. 
     
     
         33 . The method of  claim 30 , 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. 
     
     
         34 . The method of  claim 33 , further comprising increasing or decreasing the predetermined treatment period as the heart is strengthened. 
     
     
         35 . The method of  claim 33 , further comprising increasing or decreasing the predetermined treatment period after a predetermined amount of time. 
     
     
         36 . A method of controlling a heart assist device, 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 to transmit a signal to a lead based at least in part on the heart characteristic signal;   transmitting a signal to a controller, wherein the transmitting the signal to the controller is based at least in part on the heart characteristic signal; and   actuating a mechanical heart assist device with an actuating signal from the controller, wherein the actuating is based at least in part on the signal to the controller.   
     
     
         37 . The method of  claim 36 , wherein the signal is a pacing signal. 
     
     
         38 . The method of  claim 36 , wherein the signal is a defibrillation signal.