Vacuum device and method for treating tissue adjacent a body cavity

A system for treating tissue adjacent a body cavity, comprising:

• a. an elongated shaft having proximal and distal portions and having an inflation lumen, a vacuum lumen and a therapeutic agent delivery lumen in at least a distal portion of the shaft;
• b. an inner balloon assembly having a distensible inner balloon wall defining an interior chamber in fluid communication with the inflation lumen so as to allow for passage of inflation fluid through the inflation lumen into the interior chamber;
• c. an outer sheath assembly having a fluid-permeable sheath wall enclosing at least in part the inner balloon wall defining an intermediate space between the inner balloon wall and the sheath wall and configured to be in fluid communication with the vacuum lumen and provide vacuum to the intermediate space;
• and
• d. a vacuum source operatively configured to be in fluid communication with the vacuum lumen.

A method for treating tissue defining at least in part a body cavity, comprising:

• a. providing a device having an elongated shaft with an inflation lumen, a vacuum lumen and a therapeutic agent delivery lumen, an inflatable inner balloon member in fluid communication with the inflation lumen, a fluid permeable outer sheath surrounding at least part of the inner balloon member and in fluid communication with the vacuum lumen and a receptacle configured to receive a therapeutic agent through the therapeutic agent delivery lumen;
• b. inserting the device into the body cavity;
• c. inflating the inner balloon within the body cavity;
• d. providing a therapeutic agent within the receptacle provided in the interior of the inner balloon;
• e. applying a vacuum to the interior of the outer sheath to engage tissue defining the body cavity.