Methods and systems for treating acute heart failure by neuromodulation

• US 9,480,790 B2
• Filed: 11/20/2013
• Issued: 11/01/2016
• Est. Priority Date: 09/12/2005
• Status: Active Grant

• Current Assignee: Cleveland Clinic Foundation
• Original Assignee: Cleveland Clinic Foundation
• Inventors: Machado, Sandra, Penn, Marc, Rezai, Ali R.
• Primary Examiner(s): Alter, Alyssa M
• Application Number:
  US14/085,311
• Publication Number:
  US 20140074069A1
• Time in Patent Office: 1,077 Days
• Field of Search: 607/2
• US Class Current: 1/1
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2018/00267 having a basket shaped structure
• CPC Class Codes: A61B 2018/00351 Heart
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00648 using more than one sensed parameter
• CPC Class Codes: A61B 2018/00827 Current
• CPC Class Codes: A61B 2018/00892 Voltage
• CPC Class Codes: A61M 5/14212 Pumping with an aspiration and an expulsion action
• CPC Class Codes: A61N 1/0565 Electrode heads
• CPC Class Codes: A61N 1/0568 with drug delivery
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• 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 1/36585 controlled by two or more physical parameters

Abstract

Methods of treating acute heart failure in a patient in need thereof. Methods include inserting a therapy delivery device into a pulmonary artery of the patient and applying a therapy signal to autonomic cardiopulmonary fibers surrounding the pulmonary artery. The therapy signal affects heart contractility more than heart rate. Specifically, the application of the therapy signal increases heart contractility and treats the acute heart failure in the patient. The therapy signal can include electrical or chemical modulation.

Claims

1. A therapy delivery device for treating cardiovascular medical conditions, comprising:

a plurality of insulated electrical conductors each having a distal end;

a plurality of electrodes, each said electrode of the plurality of electrodes being in electrical communication with one said insulated electrical conductor of plurality of insulated electrical conductors;

a collapsible frame connected to the distal ends of the plurality of insulated electrical conductors, the collapsible frame defining a closed circular loop joined by a plurality of connectors, the plurality of electrodes proximal to the collapsible frame;

the collapsible frame configured to expand from a first position when positioned within a catheter lumen to a second position when positioned outside the catheter lumen and collapses back to the first position within the catheter lumen when retracted back into the catheter lumen, where in use the plurality of electrodes are configured to substantially contact one or more portions of a pulmonary artery of a subject and to deliver a therapy signal to at least one autonomic fiber in proximity to the pulmonary artery to affect one or more of cardiac output and hemodynamics, wherein the therapy signal can, when in use, both increase heart contractility and affect heart contractility more than heart rate;

a controller in electrical communication with one or more of the plurality of conductors and plurality of electrodes; and

one or more sensors for measuring biological parameters and generating one or more sensor signals, the one or more sensors operationally connected to the controller, wherein the biological parameters comprise one or more of arterial blood pressure, central venous pressure, capillary pressure, systolic pressure variation, arterial blood gases, cardiac output, systemic vascular resistance, pulmonary artery wedge pressure, and mixed venous oxygen saturation, wherein the controller adjusts the therapy signal delivered by the therapy delivery device in response to the one or more sensor signals.

2. The device of claim 1, wherein the plurality of electrodes serve as cathodes and the collapsible frame serves as an anode.

3. The device of claim 1, wherein the collapsible frame comprises a superelastic material.

4. The device of claim 3, wherein the superelastic material comprises nitinol.

5. The device of claim 1, wherein the frame comprises an open stent-like configuration at a distal end.

6. The device of claim 5, wherein the configuration comprises diamond shapes connected to each other the connectors, sufficient to create the closed circular loop.

7. The device of claim 1, wherein the frame is capable of delivering a bioactive agent prior to, concurrent with or subsequent to electrical modulation.

8. The device of claim 7, where the controller operates one or more drug ports for delivery of bioactive agents.

9. The device of claim 1, wherein the at least one autonomic fiber comprises at least one of sympathetic fibers and parasympathetic fibers.

10. The device of claim 9, wherein the sympathetic fibers comprise one or more of right sympathetic nerves and left sympathetic nerves.

11. The device of claim 10, wherein the right sympathetic nerves comprise one or more of right dorsal medial cardiopulmonary nerves and right dorsal lateral cardiopulmonary nerves.

12. The device of claim 10, wherein the left sympathetic nerves comprise one or more of left ventral cardiopulmonary nerves, left dorsal medial cardiopulmonary nerves, left dorsal lateral cardiopulmonary nerves and left stellate cardiopulmonary nerves.

13. The device of claim 1, wherein each of the plurality of electrodes is annularly disposed on one of the plurality of insulated electrical conductors.

14. A therapy delivery device for treating cardiovascular medical conditions, the therapy delivery device comprising:

a plurality of insulated electrical conductors each having a distal end;

a plurality of electrodes, each said electrode of the plurality of electrodes being in electrical communication with one said insulated electrical conductor of the plurality of insulated electrical conductors, the plurality of electrodes being configured to contact one or more portions of a pulmonary artery of a subject and configured to deliver a therapy signal to at least one autonomic fiber proximate to the pulmonary artery to affect one or more of cardiac output and hemodynamics; and

a frame connected to the distal ends of the plurality of insulated electrical conductors at a plurality of coupling points, the frame changeable between a first collapsed configuration in a catheter lumen and a second expanded configuration out of the catheter lumen, the plurality of electrodes proximal to the coupling points.

15. The device of claim 14, further comprising:

a controller in electrical communication with the plurality of electrodes; and

a sensor configured to measure a biological parameter and to generate sensor signals receivable by the controller.

16. The device of claim 15, wherein the biological parameter comprises one or more of arterial blood pressure, central venous pressure, capillary pressure, systolic pressure variation, arterial blood gases, cardiac output, systemic vascular resistance, pulmonary artery wedge pressure, and mixed venous oxygen saturation.

17. The device of claim 16, wherein the controller is configured to adjust the therapy signal delivered by the therapy delivery device in response to the sensor signals.

18. The device of claim 14, wherein the plurality of electrodes is spaced from a proximal end of the frame by segments of the plurality of insulated electrical conductors.

19. The device of claim 14, wherein the plurality of electrodes is proximate to a proximal end of the frame.

20. The device of claim 14, wherein each of the plurality of electrodes is annularly disposed on one of the plurality of insulated electrical conductors.