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

Abstract

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

Description

CROSS REFERENCE TO RELATED APPLICATIONS[0001]This application is a continuation of U.S. patent application Ser. No. 15 / 293,021 filed Oct. 13, 2016 which claims the benefit of the filing date of U.S. Provisional Application No. 62 / 240,864, filed Oct. 13, 2015, each of which application is incorporated by reference in its entirety.INCORPORATION BY REFERENCE[0002]All publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.FIELD[0003]The present disclosure is directed generally to devices, systems and methods for treating patients suffering from heart failure by electrically modulating a greater splanchnic nerve.BACKGROUND[0004]Heart failure (HF) is a medical condition that occurs when the heart is unable to pump sufficiently to sustain the organs of the body. Heart failure is a serious co...

AI Technical Summary

Benefits of technology

[0015]The present disclosure provides improved treatment options for patients suffering from heart failure by blocking or inhibiting the nerve activity of the splanchnic nerves (e.g., greater, lesser and least) that innervate organs and vasculature of the abdominal compartment and the greater splanchnic nerve (GSN) in particular. By selectively blocking activity of specific nerves, the disclosure provides methods and devices that can affect circulating blood volume, pressure, blood flow and overall heart and circulatory system functions. In this way, the present disclosure helps to introduce solutions to treat HF and particularly heart failure with preserved ejection fraction (HFpEF) based on the most contemporary physiological theories regarding heart failure.

[0037]Compared to present methods of nerve blocking, the disclosure aims to create reliable and consistent methods of nerve blocking that are safe and cause no adverse effects, such as pain, sensation or nerve damage. Additionally, the present disclosure fulfills a long desired need to provide a treatment for heart failure, especially for patients of diastolic or heart failure with preserved ejection fraction (HFpEF) and particularly the need to reduce or moderate the increase of pulmonary pressure and relieve dyspnea (shortness of breath).

Problems solved by technology

Heart failure is a serious condition and affects millions of patients in the United States and around the world.

Under conditions of heart failure, the weakened heart cannot supply the body with enough blood and results in cardiomyopathy (heart muscle disease) characterized by fatigue and shortness of breath, making even everyday activities such as walking very difficult.

These changes include the enlargement of heart chamber, increased cardiac musculature, increased heart rate, raised blood pressure, poor blood flow, and imbalance of body fluids in the limbs and lungs.

However, these compensatory mechanisms are eventually exceeded by continued weakening of the heart and CO decreases resulting in the physiologic manifestations of heart failure.

The left side of the heart cannot pump with enough force to push a sufficient amount of blood into the systemic circulation.

This leads to fluid backing up into the lungs and pulmonary congestion.

This subsequent muscle hypertrophy leads to even further inadequate filling.

Diastolic dysfunction may lead to edema or fluid accumulation, especially in the feet, ankles, and legs.

Furthermore, some patients may also have pulmonary congestion as result of fluid buildup in the lungs.

While a number of drug therapies are successfully targeting systolic dysfunction and heart failure with reduced ejection fraction (HFrEF), drug therapies may have pervasive side effects in some patients and are ineffective or dangerous to others.

Recurrent admissions for ADHF utilize the largest part of current health care resources and could continue to generate enormous costs.

While the physiology of heart failure is increasingly becoming better understood, modern medicine has, thus far, failed to develop new therapies for chronic management of HF or recurrent ADHF episodes.

Coexisting renal dysfunction with diuretic resistance often complicates the treatment of HF and occurs more frequently in patients with increased cardiac filling pressures.

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