Device and method for treating disorders of the cardiovascular system or heart

Abstract

A device and method are provided to treat heart failure by stimulating to cause diaphragm contraction.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application is a divisional of U.S. application Ser. No. 12 / 082,057 filed Apr. 8, 2008, which claims priority of U.S. Application Ser. No. 60 / 925,024 filed Apr. 18, 2007, and is a continuation in part U.S. application Ser. No. 12 / 069,823 filed Feb. 13, 2008 (now abandoned), and of U.S. application Ser. No. 12 / 044,932 filed Dec. 21, 2007; and of U.S. application Ser. No. 11 / 981,342 filed Oct. 31, 2007 (now U.S. Pat. No. 8,140,164); and of U.S. application Ser. No. 11 / 480,074 filed Jun. 29, 2006 (now U.S. Pat. No. 8,160,711); and of U.S. application Ser. No. 11 / 271,315 filed Nov. 10, 2005 (now U.S. Pat. No. 8,244,358); and of U.S. application Ser. No. 11 / 271,554 filed Nov. 10, 2005; and of U.S. application Ser. No. 11 / 271,353 filed Nov. 10, 2005; and of U.S. application Ser. No. 11 / 271,264 filed Nov. 10, 2005 (now U.S. Pat. No. 7,979,128); and of U.S. application Ser. No. 10 / 966,487 filed Oct. 15, 2004 (now abandoned); and of U.S. appl...

AI Technical Summary

Benefits of technology

[0018]In accordance with the invention, stimulation is provided to the diaphragm or phrenic nerve to elicit a diaphragm response to thereby provide a therapeutic effect for a heart failure or other cardiac or cardiovascular patient.

[0020]In accordance with another aspect of the invention stimulation is provided to control breathing to reduce respiration rate and thereby reduce hypertension, reduce sympathetic nerve bias, and / or provide improved blood gas levels.

[0022]In accordance with another aspect of the invention, stimulation is provided to create a deep inspiration or an increased tidal volume to thereby reduce sympathetic nerve bias, improve blood gas levels, stimulate reflexes for example the Hering-Bruer reflex related to activating, stretch receptors, increase lung volume, normalize or reset breathing or provide other beneficial therapies to improve cardiovascular function or heart failure condition.

Problems solved by technology

Current treatments for heart failure are available to slow the progress of the disease but do not cure the disease.

Despite all the current therapeutic options, studies show that more than half of heart failure patients die within 5 years of their diagnosis.

Defibrillators are primarily used to prevent sudden cardiac death and therefore have not improved the status of heart failure patients nor have they improved quality of life.

There are many heart failure patients who may not substantially benefit from one or more of these treatments or may not have an improved quality of life from such treatments.

For example, CRTs have not been approved for patients with ejections fractions greater than 35% and thus are not available for diastolic heart failure patients who typically have ejection fractions greater than 50%, or for systolic patients with an ejection fraction greater than 35%.

However, not all are useful to treat all heart failure patients.

Furthermore, due to side effects some patients withdraw from treatment.

Pharmacological therapeutic approaches to diastolic heart failure currently recommend diuretics and nitrates while the efficacy is uncertain for all diastolic heart failure patients with calcium channel blockers, beta blockers, ACE inhibitors.

Inotropic agents are not recommended for diastolic patients.

Hypertension is believed to worsen heart failure.

It is also believed that hypertension may lead to diastolic heart failure.

These conditions are believed to worsen progression of heart failure.

Oxygen desaturations at night, changes in intrathoracic pressure, and arousals may adversely affect cardiac function and eventually result in an imbalance between myocardial oxygen delivery and consumption.

The untreated central sleep apnea may trigger a negative chain of events that leads to worsening of heart failure.

In addition, its cardiovascular effects are currently unclear and some researchers believe that it can exacerbate heart failure in some patients, particularly where positive forced pressure has a negative effect on a heart failure patient, such as, for example, in patients where a reduced ventricular filling would significantly reduce cardiac output.

But it is believed would not provide additional benefit to heart failure patients other than that of treating the obstructive apnea.

However, they require patient compliance and diligence.

Furthermore, because they require patient compliance, the therapy can only occur during waking hours.

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