Therapeutic agent delivery apparatus with direct mechanical ventricular assistance capability

Abstract

A therapeutic apparatus for delivering at least one therapeutic agent directly and preferentially to a desired tissue to be treated, comprising at least one membrane adapted to deliver the therapeutic agent to the desired tissue, wherein the membrane is in contact with at least a part of the desired tissue to be treated; and at least one shell surrounding the membrane, wherein the shell isolates the membrane from tissues other than the desired tissue to be treated. In one embodiment, the apparatus is a direct mechanical ventricular assistance apparatus comprising a liner in which the membrane is formed.

Description

CROSS-REFERENCE TO RELATED PATENT APPLICATIONS [0001] This application is a divisional application of copending patent application U.S. Ser. No. 10 / 607,434, filed on Jun. 26, 2003, the disclosure of which is incorporated herein by reference.[0002] This invention relates in one embodiment to devices that deliver at least one therapeutic agent directly and preferentially to a desired tissue to be treated, and more particularly to devices for delivering a therapeutic agent to a heart while providing assistance to the pumping function of the heart. BACKGROUND OF THE INVENTION [0003] 1. Field of the Invention [0004] A therapeutic apparatus for delivering at least one therapeutic agent directly and preferentially to a desired tissue to be treated in a living body. [0005] 2. Description of Related Art [0006] Traditional medical and surgical treatment of patients with failing pump function of the heart is limited to blood-contacting devices which are technically difficult to install and res...

AI Technical Summary

Benefits of technology

[0084] The DMVA device of the present invention described above is advantageous because compared to other prior art devices, it precisely drives the mechanical actuation of the ventricular chambers of the heart without damaging the tissue thereof, or the circulating blood; it may be installed by a simple procedure that can be quickly performed; it provides functional performance and image data of the heart; and it can provide electrophysiological monitoring and control of the heart, including pacing and cardioversion-defibrillation electrical signals to help regulate and/or synchronize

Problems solved by technology

Traditional medical and surgical treatment of patients with failing pump function of the heart is limited to blood-contacting devices which are technically difficult to install and result in complications related to such blood contact as well as technical aspects of device installation.

Inadequate cardiac output remains a cause of millions of deaths annually in the United States.

However, all currently available devices require too much time to implant to be of value in acute resuscitation situations, resulting in loss of life before adequate circulatory support can be provided.

Furthermore, other non-blood contacting devices similar to the current invention provide inadequate augmentation of cardiac function.

DCC devices have been shown to only benefit hearts with substantial degrees of LV failure.

Specifically, DCC techniques only substantially improve the systolic function of hearts in moderate to severe heart failure.

DCC techniques clearly have a negative effect on diastolic function (both RV and LV diastolic function).

This is exhibited by reductions in diastolic volume that, in part, explains DCC's inability to effectively augment the heart without at least moderate degrees of failure.

This also explains DCC's efficacy being limited to sufficient degrees of LV size and/or dilatation, with significant dependence on preload, and/or ventricular filling pressures.

In addition, DCC devices have negative effects on the dynamics of diastolic relaxation and, in effect, reduce the rate of diastolic pressure decay (negative dP/dt max), increasing the time required for ventricular relaxation.

First, and foremost, these techniques do not provide any means to augment diastolic function of the heart necessary to overcome their inherent drawback of “effectively” increasing ventricular stiffness.

Clearly, RV diastolic function is impaired to a far greater degree by DCC due to the nature both the RV wall and intra-cavity pressures.

Furthermore, studies of DCC devices have all overlooked the relevant and dependent impact these techniques have on right ventricular dynamics, septal motion and overall cardiac_function.

Because the r

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