Systems and methods for treating acute and chronic heart failure
Systems and methods and devices are provided for arresting or reversing the effects of myocardial remodeling and degeneration after cardiac injury, without the potential drawbacks associated with previously existing systems and methods, by at least partially occluding flow through the superior vena cava over multiple cardiac cycles, and more preferably, by adjusting the interval or degree of occlusion responsive to a sensed level of patient activity. In some embodiments, a controller is provided that actuates a drive mechanism responsive to a sensed level of patient activity to provide at least partial occlusion of the patient's superior vena cava, while a data transfer circuit of the controller provides bi-directional transfer of physiologic data to the patient's smartphone or tablet to permit display and review of such data.
1. A system for unloading a heart, the system comprising:
a catheter having a proximal end and a distal region, the distal region configured to be disposed in a superior vena cava of a patient;
a flow limiting element disposed at the distal region of the catheter such that the flow limiting element is positionable in the superior vena cava; and
a controller operatively coupled to the catheter, the controller configured to intermittently actuate the flow limiting element to cause the flow limiting element to expand to maintain at least partial occlusion of the superior vena cava for a predetermined interval over multiple cardiac cycles and to cause the flow limiting element to contract, thereby unloading the heart.
2. The system of claim 1 , further comprising a sensor configured to generate a signal corresponding to a physiologic parameter indicative of the patient's hemodynamic state,
wherein the controller is configured to permit adjustment of actuation of the flow limiting element responsive to the signal.
3. The system of claim 2 , wherein the controller adjusts actuation of the flow limiting element by adjusting the predetermined interval of actuation.
4. The system of claim 3 , wherein the controller is configured to actuate the flow limiting element only once at the predetermined interval after adjusting the predetermined interval of actuation.
5. The system of claim 2 , wherein the controller adjusts actuation of the flow limiting element by adjusting a predetermined degree of expansion of the flow limiting element.
6. The system of claim 2 , wherein the physiologic parameter indicative of the patient's hemodynamic state comprises at least one of blood flow rate, blood volume, pressure including cardiac filling pressure, or central venous pressure.
7. The system of claim 2 , further comprising a data transfer circuit configured to receive data from the sensor and to provide the signal to the controller.
8. The system of claim 7 , wherein the data transfer circuit is configured to bi-directionally communicate physiologic data to a computing device of the patient for display to the patient.
9. The system of claim 2 , wherein the sensor comprises at least one of a blood pressure sensor or electrodes for detecting a heart rate of the patient.
10. The system of claim 1 , wherein the controller is configured to intermittently actuate the flow limiting element to cause the flow limiting element to expand to a predetermined degree of expansion.
11. The system of claim 1 , wherein the flow limiting element comprises a balloon.
12. The system of claim 1 , wherein the controller is configured to intermittently actuate the flow limiting element to cause the flow limiting element to expand to impede blood flow in the superior vena cava by at least 50%.
13. The system of claim 1 , wherein the controller comprises a drive mechanism configured to be coupled to the flow limiting element.
14. The system of claim 1 , wherein the controller is configured to continue to intermittently actuate the flow limiting element between expanded and contracted states over a course of a treatment after causing the flow limiting element to contract.
15. A system for treating a heart condition, the system comprising:
a catheter having a proximal end and a distal region, the distal region configured to be disposed in a superior vena cava of a patient;
a flow limiting element disposed at the distal region of the catheter such that the flow limiting element is positionable in the superior vena cava; and
a controller operatively coupled to the catheter to intermittently actuate the flow limiting element to cause the flow limiting element to expand to maintain at least partial occlusion of the superior vena cava, and to cause the flow limiting element to contract, the controller configured to apply a stored value corresponding to a predetermined interval over multiple cardiac cycles during which the flow limiting element is to be actuated.
16. The system of claim 15 , wherein the controller intermittently actuates the flow limiting element to cause the flow limiting element to expand to a predetermined degree of expansion.
17. The system of claim 15 , further comprising a sensor configured to generate a signal corresponding to a physiologic parameter indicative of the patient's hemodynamic state,
wherein the controller is configured to permit adjustment of actuation of the flow limiting element responsive to the signal.
18. The system of claim 17 , wherein the controller adjusts actuation of the flow limiting element by adjusting a predetermined degree of expansion of the flow limiting element.
19. The system of claim 17 , wherein the controller is configured to receive at a data transfer circuit the signal corresponding to the physiologic parameter and to transmit the signal to the controller.
20. The system of claim 15 , wherein the controller intermittently actuates the flow limiting element to cause the flow limiting element to expand to impede blood flow in the superior vena cava by at least 50%.