Perorally removeable anti-reflux valve implantation

Abstract

Disclosed are esophageal anti-reflux valve prostheses, and tools and procedures for peroral implantation and extraction of the prostheses. The prostheses disclosed have a semipermeable membrane to allow retrograde passage of gas, magnets disposed at a distal end of the sleeve to facilitate closure, and an outwardly bendable array of spikes that are longitudinally aligned for peroral insertion and lockable into a radially outwardly deployed configuration to keep the prosthesis from dislocating after implantation. The implantation tool has inner and outer concentric tubes, the inner tube releasably threadably connected to the prosthesis, the outer tube reverse threaded with the inner tube to advance a distal headpiece to engage, deploy and lock the spikes into the deployed configuration. A vacuum assist can be used to help impact the lumen wall on the spikes. The extraction tool is similar to the implantation tool with an inner tube for threadably engaging the prosthesis, an outer tube with a distal crown with a plurality of shoes to unseat and unlock the spikes, and an overtube shield to receive the spikes and facilitate extraction of the prosthesis.

Description

CROSS REFERENCE TO RELATED APPLICATIONS [0001] The present application claims the benefit of U.S. Provisional application Ser. No. 60 / 302,870, filed Jul. 3, 2001, and entitled Perorally Insertable / Removable Anti-Reflux Valve, which is hereby incorporated by reference in its entirety.BACKGROUND OF INVENTION [0002] This invention relates to a device and non-invasive surgical method for treating gastroesophageal reflux disease. More specifically, it relates to an anti-reflux valve prosthesis and associated instrumentation for its peroral placement and in situ fixing at the gastroesophageal junction, to prevent the reflux of gastric contents into the esophagus. The invention further relates to the instrumentation and methodology for peroral removal of such a prosthesis. [0003] Gastroesophageal reflux disease (GERD) is the commonest cause of dyspepsia, affecting some 30% of the United States adult population intermittently and some 10% on a continuous and troublesome basis. Gastroesophag...

AI Technical Summary

Benefits of technology

"The present invention provides an anti-reflux valve prosthesis that can be perorally implanted in the esophagus of a patient with gastroesophageal reflux disease (GERD) without the need for open or laparoscopic surgery. The prosthesis has an annular fixation element for fixing it in place and a one-way valve for allowing orthograde passage of gastric contents and inhibiting retrograde passage of gastric contents. The valve can be easily removed or replaced using a peroral extraction tool. The prosthesis is made of a biologically inert material and can be implanted in a patient with cancer in the esophagus. The invention also provides a tool for implanting the prosthesis and a method of using it."

Problems solved by technology

It may also lead to alteration of the lining of the esophagus (Barrett″s Esophagus), which may in turn lead to esophageal cancer.

Furthermore, medication-based therapies are not always fully effective, as reflux is not prevented and the esophagus may continue to be exposed to gastric content.

Although surgical interventions can be curative, these treatments are seriously invasive and have the attendant risk of such procedures.

Invasive surgical interventions are too frequently complicated by problems such as stricture formation, “gas bloat,” or recurrent symptoms of reflux disease.

Additionally, the results obtained by gross surgical treatment can be technique-dependent and vary significantly from surgeon to surgeon.

Images