Apparatus and methods for treating obstructions within body lumens

摘要

An apparatus is provided that is operable in different modes to perform various functions for treating a body lumen. The apparatus includes a shaft including proximal and distal ends, a lumen extending therebetween, and a balloon on the distal end. The apparatus includes a valve on the distal end that selectively opens or closes an outlet communicating with the lumen. With the valve open, fluid introduced into the lumen exits the outlet into a body lumen. With the valve closed, fluid introduced into the lumen expands the balloon. The valve may be biased to be closed, e.g., by a spring element disposed within the balloon. Optionally, the apparatus also includes an actuator for expanding a helical member within the balloon interior, e.g., either before or after expanding the balloon, such that the helical member and balloon may adopt an expanded helical shape for removing material within a body lumen.

主权项

1. A method for treating a body lumen of a patient using a balloon apparatus comprising an outer member including a first lumen extending between proximal and distal ends thereof, an inner member having a proximal end and a distal end slidable within the first lumen, an inner member distal tip, wherein the inner member distal tip is softened, and a balloon comprising a proximal end attached to the outer member distal end, a distal end including an outlet and an interior communicating with the first lumen and the outlet, and a helical member coupled between the outer member and the inner member, wherein the inner member comprises a second lumen that is sized to slideably receive a guidewire that may be delivered into the body lumen, the method comprising, in combination:
introducing the distal end of the outer member into a body lumen with the balloon in a contracted condition and the inner member in a proximal position such that the outlet is substantially sealed by a sealing member on the inner member distal end; directing an actuator on a proximal end of the balloon apparatus to move the inner member to a distal position consequently directing the sealing member distally to open the outlet; delivering a first fluid through the first lumen such that the first fluid passes through the balloon interior and exits the open outlet into the body lumen; directing the inner member towards the proximal position to substantially seal the outlet with the sealing member, a spring element biasing the inner member to enhance the sealing member sealing the outlet; and delivering a second fluid through the first lumen with the outlet substantially sealed, thereby expanding the balloon from the contracted condition to an enlarged condition.