Devices for material delivery, electroporation, sonoporation, and/or monitoring electrophysiological activity

Abstract

The invention relates generally to systems and devices for material delivery, energy delivery, and / or monitoring electrophysiological activity, and method of use thereof. In particular, the present invention provides devices and systems, and methods of use thereof, configured to deliver therapeutic compositions, to provide electroporation and / or sonoporation to increase therapeutic efficiency, and to monitor electrophysiological activity, for example, before and after treatment.

Description

CROSS-REFERENCE TO RELATED APPLICATION[0001]The present application is a Continuation-In-Part of U.S. patent application Ser. No. 12 / 959,864, filed Dec. 3, 2010, which claims priority to U.S. Provisional Application 61 / 266,280, filed Dec. 3, 2009, each of which is herein incorporated by reference in its entirety.STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT[0002]This invention was made with government support under Grant No. K08 HL074192 awarded by the National Institutes of Health, the National Heart, Lung, and Blood Institute. The government has certain rights in the invention.FIELD OF THE INVENTION[0003]The invention relates generally to systems and devices for material delivery, energy delivery, and / or monitoring electrophysiological activity, and method of use thereof. In particular, the present invention provides devices and systems, and methods of use thereof, configured to deliver therapeutic compositions, to provide electroporation and / or sonoporation to i...

AI Technical Summary

Benefits of technology

[0009]In some embodiments, the present invention provides a system comprising 1) a material delivery device, wherein said device comprises an elongate structure configured to access a treatment site within a subject and deliver physical material (e.g., therapeutic agent (e.g., nucleic acid)) to that site; and 2) an energy deliver / monitoring device comprising (a) an elongate member configured for providing access to a treatment site within a subject, (b) an energy-delivery element configured to deliver energy to the treatment site within a subject, and (c) an electrophysiology monitoring element configured to monitor electrical signals (e.g. at or around the treatment site within said subject, such as the heart (e.g., epicardium, endocardium, etc.) or other organs, organ systems, and body systems. In some embodiments, a material delivery device comprises an inner lumen through which material (e.g., therapeutic agent (e.g., nucleic acid)) can pass. In some embodiments, a material delivery device comprises a catheter. In some embodiments, the present invention provides methods for treating a subject wherein (a) a material delivery device is used to deliver therapeutic material (e.g., nucleic acids) to a treatment site (e.g. the heart or other organ systems); and (b) an energy deliver / monitoring device delivers energy (e.g., electric, ultrasound, etc.) to the treatment site to enhance the therapeutic effect of the therapeutic material. In some embodiments, a first device provides delivery of a therapeutic agent to a site within a subject (e.g., heart (e.g., epicardium, endocardium) or other tissue or organ system) and a second device provides sonoporation or electroporation to enhance the therapeutic effect of the therapeutic agent.

Problems solved by technology

However, targeting a gene ‘cargo’ to an organ of interest presents a variety of challenges.

In addition, systemic delivery carries the risk of unwarranted gene expression in organs that are remote from the region of interest, with the potential for significant side effects.

It is a cause of significant morbidity (such as cerebrovascular embolism or ‘stroke’) and also contributes to increased mortality (Balasubramaniam & Kistler.

The diagnosis and management of AF have therefore become an important and challenging aspect of cardiovascular medicine.

Unfortunately, current approaches to cure this arrhythmia are inadequate (Gerstenfeld et al.

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