Devices and methods for treatment of heart failure via electrical modulation of a splanchnic nerve

• US 10,207,110 B1
• Filed: 10/13/2016
• Issued: 02/19/2019
• Est. Priority Date: 10/13/2015
• Status: Active Grant

• Current Assignee: Axon Therapies, Inc.
• Original Assignee: Axon Therapies, Inc.
• Inventors: Gelfand, Mark, Baynham, Tamara Colette, Levin, Howard
• Primary Examiner(s): Porter, Jr., Allen
• Application Number:
  US15/293,021
• Time in Patent Office: 859 Days
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 5/02007 Evaluating blood vessel condition, e.g. elasticity, compliance
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/024 Detecting, measuring or recording pulse rate or heart rate A61B5/0205, A61B5/021 take precedence
• CPC Class Codes: A61B 5/029 Measuring or recording blood output from the heart, e.g. minute volume A61B8/065 takes precedence
• CPC Class Codes: A61B 5/1116 Determining posture transitions
• CPC Class Codes: A61B 5/1118 Determining activity level
• CPC Class Codes: A61B 5/1123 Discriminating type of movement, e.g. walking or running A61B5/1116, A61B5/112 take precedence
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/388 Nerve conduction study, e.g. detecting action potential of peripheral nerves
• CPC Class Codes: A61B 5/4806 Sleep evaluation A61B5/4821 takes precedence; devices for inducing sleep A61M21/02
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/4848 Monitoring or testing the effects of treatment, e.g. of medication
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61N 1/0556 Cuff electrodes
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/36135 using physiological parameters
• CPC Class Codes: A61N 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy
• CPC Class Codes: G16H 20/30 relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
• CPC Class Codes: G16H 20/40 relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 40/63 : for local operation

Abstract

Disclosed herein is a device, and method for treating heart failure by electrically modulating a splanchnic nerve with an implantable device.

Claims

1. A method of treating heart failure or symptoms associated with heart failure in a human patient, comprising:

in a patient with heart failure or symptoms associated with heart failure;

thoracoscopically accessing at least one greater splanchnic nerve; and

affixing an implantable neuromodulation device with a tripolar nerve cuff to the at least one greater splanchnic nerve, the tripolar nerve cuff including first, second and third electrodes axially spaced from at least one of the other electrodes, and the axial spacing between adjacent electrodes is 1 to 2 mm the implantable neuromodulation device further comprising a pulse generator, a detection member for detecting at least one physiological parameter, and at least one lead for delivering stimulus to the at least one greater splanchnic nerve through the tripolar nerve cuff,

wherein the delivered stimulus has a frequency of at least 6 kHz and an amplitude of at least 10 mA to cause a reversible blockage to conduction along the at least one greater splanchnic nerve.

2. The method of claim 1, wherein the at least one greater splanchnic nerve is at least one of a left greater splanchnic nerve and a right greater splanchnic nerve.

3. The method of claim 1, wherein thoracoscopically accessing is selected from the group consisting of transthoracic, transabdominal, percutaneous, access or any combination thereof.

4. The method of claim 1, wherein the patient has diastolic heart failure or symptoms associated with diastolic heart failure.

5. The method of claim 1, wherein said implantable neuromodulation device further comprises a cardiac pulse generator configured to generate electrical stimulation pulses for delivery by one or more cardiac leads.

6. The method of claim 1, wherein the implantable neuromodulation device further comprises a programmable microcontroller configured to control at least one operation of the implantable neuromodulation device.

7. The method of claim 6, wherein the programmable microcontroller controls at least one operation chosen from the group consisting of logic processing, application of nerve blocking therapy, physiological monitoring, electroneurogram sensing, cardiac sensing, and any combination thereof.

8. The method of claim 7, wherein the method of treatment further comprises an exercise detection step whereby the application of nerve blocking therapy may be arrested by the detection of exercise.

9. The method of claim 1, wherein the detection member for detecting at least one physiological parameter is configured to detect a physiological parameter selected from the group consisting of orientation, acceleration, cardiac preload, cardiac afterload, cardiac output, stroke volume, blood pressure, venous congestion, pulmonary congestion, sense of dyspnea, heartrate, end-diastolic volume, end-systolic volume, venous return or any combination thereof.

10. The method of claim 9, further comprising monitoring the physiological parameters to determine a therapy effectiveness.

11. The method of claim 9, further comprising selecting at least one physiological parameter to be transmitted from the implantable neuromodulation device to an external programmer or display.

12. The method of claim 1, further comprising deflating the lung proximate to the at least one greater splanchnic nerve.