Abstract: Disclosed is an esophageal bulking device for implantation below the mucosa in the vicinity of the lower esophageal sphincter. Preferably, the bulking device comprises an expandable hydrogel implant. Also disclosed are methods of treating gastroesophageal reflux disease, by implanting an expandable bulking device below the mucosa in the vicinity of the lower esophageal sphincter. The bulking device may be subsequently explanted from the vicinity of the lower esophageal sphincter.

Abstract: Disclosed is a delivery device for controllably delivering a prosthetic bulking device below a tissue surface such as below the mucosa to treat gastroesophageal reflux disease. The delivery device may be embodied in a deployment catheter, an endoscope, or an endoscope attachment. The bulking device cooperates with residual lower esophageal sphincter (LES) function to increase LES closing pressure. Methods are also disclosed.

Abstract: Disclosed is an ambulatory system for detecting, recording, and analyzing gastroesophageal reflux or intraesophageal pressure. The system includes an implantable sensor and radiofrequency transmitter, an external receiver and recorder, and an analysis software package. This system provides for monitoring any of various physiological parameters, including pH, temperature, and pressure, within the esophagus or other body lumens.

Abstract: Disclosed is a prosthetic bulking device for implantation below the mucosa to treat gastroesophageal reflux disease. The bulking device comprises a flexible body which may have one or more attachment surfaces to allow tissue ingrowth from the adjacent tissue. The bulking device cooperates with residual lower esophageal sphincter (LES) function to increase LES closing pressure.

Abstract: The present invention is accomplished by providing a catheter with a shaft having a balloon affixed to the distal end, a core wire extending throughout the shaft and throughout the balloon, the core wire having a tube surrounding the distal end, a sleeve defining a guidewire lumen extending parallel, and exterior to the shaft and to the exterior to the balloon. In yet another embodiment the catheter shaft has a balloon affixed to the distal end and a sleeve defining a guidewire lumen extending parallel and exterior to the shaft and to the balloon exterior. In yet another embodiment the catheter shaft has a balloon affixed to the distal end and a core wire extending throughout the shaft and throughout the balloon with the core wire having a tube surrounding the distal end. In each embodiment the balloon is compressed to itself to form a compressed area just distal to the distal balloon cone for separating the balloon inflation lumen from a sleeve lumen.

Abstract: A tri-fold dilatation catheter balloon and a method for preparing the same. The disclosed balloon has a tri-fold configuration in which the longitudinal creases defined by three flaps of the balloon are softened to ensure symmetrical deflation of the balloon into its tri-fold form. The tri-fold configuration initially imparted to the balloon by drawing the balloon into an longitudinal interstitial channel defined by three substantially cylindrical pins arranged in a pyramid-type stack. While the balloon is secured within this channel, negative pressure is applied to an inflation lumen of the balloon to deflate the balloon. Negative pressure is maintained on the inflation lumen as the balloon is withdrawn from the interstitial channel, and continues to be maintained while the creases defined by the three tri-fold flaps are heated with a longitudinal heating element. This softens the balloon material in longitudinal creases, so that the same creases will tend form whenever the balloon is deflated.