Method for esophageal invagination and devices useful therein

A method for invaginating the gastroesophageal junction of a patient, said method comprising the steps of:

• introducing an invagination device transorally into the esophagus, the invagination device including an introducer guide and an engagement assembly;
• the introducer guide having an outside diameter approximating that of the esophagus, the introducer guide further having a plurality of needle-receiving lumens extending to the outer diametric surface of the guide;
• the engagement assembly including a plurality of needles, the needles having a retracted position in which the needles lie within the needle-receiving lumens, and an extended position in which the needles extend out of the lumens and project radially from the guide, the engagement assembly further including means for projecting the needles out of the lumens and into engagement with the esophagus in the vicinity of the gastroesophageal junction;
• activating the engagement assembly to place the needles in their extended position in engagement with the esophagus in the vicinity of the gastroesophageal junction;
• advancing the engaged invagination device toward the stomach to invaginate the gastroesophageal junction into the stomach, involuting the surrounding fundic wall;
• introducing a remotely operable fastening assembly into the stomach and operating the fastening assembly to secure the invaginated gastroesophageal junction to the surrounding involuted fundic wall;
• deactivating the engagement assembly to retract the needles from engagement and back into the needle-receiving lumens of the introducer guide;
• and
• removing the invagination device and the fastening assembly from the body of the patient.

A method for invaginating the gastroesophageal junction of a patient, said method comprising the steps of:

• opening at least one operating channel port into the stomach, said port being of sufficient size to accommodate a remotely operable fastening assembly;
• introducing an invagination device transorally into the esophagus, the invagination device including an introducer guide and an engagement assembly;
• the introducer guide having an outside diameter approximating that of the esophagus, the introducer guide further having a plurality of needle-receiving lumens extending to the outer diametric surface of the guide;
• the engagement assembly including a plurality of needles, the needles having a retracted position in which the needles lie within the needle-receiving lumens, and an extended position in which the needles extend out of the lumens and project radially from the guide, the engagement assembly further including means for projecting the needles out of the lumens and into engagement with the gastroesophageal junction;
• activating the engagement assembly to place the needles in their extended position in engagement with the gastroesophageal junction;
• advancing the engaged invagination device toward the stomach to invaginate the gastroesophageal junction into the stomach, involuting the surrounding fundic wall;
• introducing a remotely operable fastening assembly through the opened operating channel port into the stomach and operating the fastening assembly to secure the invaginated gastroesophageal junction to the surrounding involuted fundic wall;
• deactivating the engagement assembly to retract the needles from the gastroesophageal junction and back into the needle-receiving lumens of the introducer guide;
• and
• removing the invagination device and the fastening assembly from the body of the patient, and closing said operating channel port.

A method for invaginating the gastroesophageal junction of a patient, said method comprising the steps of:

• implanting at least one operating channel/insufflation port, the operating channel/insufflation port providing percutaneous access into the stomach for a remotely operable fastening assembly through an operating channel, and further providing a second access into the stomach for insufflating the stomach through an insufflation lumen;
• insufflating the stomach through the insufflation lumen of the implanted operating channel/insufflation port;
• introducing an invagination device transorally into the esophagus, the invagination device including an introducer guide and an engagement assembly;
• the introducer guide having an outside diameter approximating that of the esophagus;
• the engagement assembly including means for retractably engaging the esophagus in the vicinity of the gastroesophageal junction;
• activating the engagement assembly to engage the esophagus in the vicinity of the gastroesophageal junction;
• advancing the engaged invagination device toward the stomach to invaginate the gastroesophageal junction into the stomach, involuting the surrounding fundic wall;
• introducing a remotely operable fastening assembly through the operating channel of the implanted operating channel/insufflation port into the stomach and operating the fastening assembly to secure the invaginated gastroesophageal junction to the surrounding involuted fundic wall;
• retracting the engagement assembly from engagement with the gastroesophageal junction;
• and
• removing the invagination device and the fastening assembly from the body of the patient.

An operating channel/insufflation port assembly comprising:

• an operating channel/insufflation port member, said operating channel/insufflation port member defining an operating channel sized to receive remotely operable instrumentation, said port member further defining an insufflation lumen connecting to an insufflation port located on the exterior of said port member;
• anchoring means for anchoring said port member in place extending percutaneously into the stomach, with remotely operable instrumentation being advanceable through said operating channel and into the stomach, and with CO.sub.2 being passable into the stomach through said insufflation lumen;
• an insufflation valve member, connectable to said insufflation port, said insufflation valve member including means for variably controlling the supply of CO.sub.2 into the stomach through said insufflation lumen;
• and
• operating channel sealing means for preventing gas leakage during operation/insufflation, said sealing means including means for providing a seal between said operating channel/insufflation port member and remotely operable instrumentation received therethrough.