Ventricular partitioning device

Abstract

This invention is directed to a partitioning device for separating a patient's heart chamber into a productive portion and a non-productive portion. The device is particularly suitable for treating patients with congestive heart failure. The partitioning device has a frame-reinforced, expandable membrane which separates the productive and non-productive portions of the heart chamber. The proximal ends of the ribs of the frame have tissue penetrating elements about the periphery thereof which are configured to penetrate tissue lining the heart wall at an angle approximately perpendicular to a longitudinal axis of the partitioning device. The partitioning device has a hub with a non-traumatic distal end to engage the ventricular wall.

Description

FIELD OF THE INVENTION [0001] The present invention relates generally to the field of treating congestive heart failure and more specifically, to a device and method for partitioning a patient's heart chamber and a system for delivering the treatment device. BACKGROUND OF THE INVENTION [0002] Congestive heart failure (CHF) is characterized by a progressive enlargement of the heart, particularly the left ventricle and is a major cause of death and disability in the United States. Approximately 500,000 cases occur annually in the U.S. alone. As the patient's heart enlarges, it cannot efficiently pump blood forward with each heart beat. In time, the heart becomes so enlarged the heart cannot adequately supply blood to the body. Even in healthy hearts only a certain percentage of the blood in a patient's left ventricle is pumped out or ejected from the chamber during each stroke of the heart. The pumped percentage, commonly referred to as the “ejection fraction”, is typically about sixt...

AI Technical Summary

Benefits of technology

[0009] The present invention is directed to a ventricular partitioning device and method of employing the device in the treatment of a patient with congestive heart failure (CHF). Specifically, the device partitions a chamber of the patient's heart into a main productive portion and a secondary non-productive portion. This partitioning reduces the total volume of the heart chamber, reduces the stress applied to the heart and, as a result, improves the ejection fraction thereof.

[0012] The ribs of the expandable frame have distal ends secured to the central hub and free proximal ends. The distal ends are preferably secured to the central hub to facilitate radial self expansion of the free proximal ends of the ribs away from a centerline axis. The distal ends of the ribs may be pivotally mounted to the hub and biased outwardly or fixed to the hub and formed of material such as superelastic NiTi alloy which allows for compressing the free proximal ends of the ribs toward a centerline axis into a contracted configuration and when released allow for their self expansion to an expanded configuration.

[0013] The free proximal ends of the ribs are configured to engage and preferably penetrate the tissue lining the heart chamber to be partitioned so as to secure the peripheral edge of the partitioning component to the heart wall and fix the partitioning component within the chamber so as to partition the chamber in a desired manner. The tissue penetrating proximal tips are configured to penetrate the tissue lining at an angle approximately perpendicular to a center line axis of the partitioning device. The tissue penetrating proximal tips of the ribs may be provided with barbs, hooks and the like which prevent withdrawal from the tips from the heart wall.

[0017] The partitioning device embodying features of the invention is relatively easy to install and it substantially improves the pumping action of the heart and provides an increase in the ejection fraction of the patient's heart chamber. These and other advantages of the invention will become more apparent from the following detailed description of the invention and the accompanying exemplary drawings.

Problems solved by technology

Congestive heart failure (CHF) is characterized by a progressive enlargement of the heart, particularly the left ventricle and is a major cause of death and disability in the United States.

As the patient's heart enlarges, it cannot efficiently pump blood forward with each heart beat.

In time, the heart becomes so enlarged the heart cannot adequately supply blood to the body.

As a result of the low ejection fraction, a patient with congestive heart failure is fatigued, unable to perform even simple tasks requiring exertion and experiences pain and discomfort.

Further, as the heart enlarges, the internal heart valves such as the mitral valve, cannot adequately close.

An incompetent mitral valve allows regurgitation of blood from the left ventricle back into the left atrium, further reducing the heart's ability to pump blood forewardly.

Prolonged ischemia and occlusion of coronary arteries can result in myocardial tissue in the ventricular wall dying and becoming scar tissue.

As the disease progresses, a local area of compromised myocardium may bulge out during the heart contractions, further decreasing the heart's ability to pump blood and further reducing the ejection fraction.

Drug therapy typically treats the symptoms of the disease and may slow the progression of the disease, but it can not cure the disease.

Presently, the only permanent treatment for congestive heart disease is heart transplantation, but heart transplant procedures are very risky, extremely invasive and expensive and are performed on a small percentage of patients.

Many patient's do not qualify for heart transplant for failure to meet any one of a number of qualifying criteria, and, furthermore, there are not enough hearts available for transplant to meet the needs of CHF patients who do qualify.

This procedure is highly invasive, risky and expensive and is commonly only done in conjunction with other procedures (such as heart valve replacement or coronary artery by-pass graft).

Additionally, the surgical treatment is usually limited to Class IV patients and, accordingly, is not an option for patients facing ineffective drug treatment prior to Class IV.

While this procedure has been found to be successful in providing some relief from CHF symtoms and slowed the progression of the disease, it has not been able to stop the disease.

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