Methods and devices for combined gastric restriction and electrical stimulation

Abstract

Disclosed are methods and apparatus for implantation into the walls of an organ such as the stomach. Deformable or inflatable anchors with a connector between are used to pull the walls of the organ together, or to implant devices in the wall of the organ. Also disclosed are surgical instruments useful in practicing the disclosed methods.

Description

RELATED APPLICATIONS [0001] The present application is a continutation of U.S. Non-Provisional patent application Ser. No. 10 / 974,248 filed Oct. 27, 2004 by Michael Gertner, M.D. entitled “Devices and Methods to Treat a Patient,” which claims priority to U.S. Provisional Patent Application Ser. No. 60 / 556,004 filed Mar. 23, 2004 by Michael Gertner, M.D., entitled “BARIATRIC DEVICES AND IMPLANTATION METHODS,” to U.S. Provisional Patent Application Ser. No. 60 / 584,219 filed Jul. 1, 2004 by Michael Gertner, M.D., entitled “DEVICES AND METHODS FOR PERCUTANEOUS GASTROPLASTY,” and to U.S. Provisional Patent Application Ser. No. 60 / 603,944 filed Aug. 23, 2004 by Michael Gertner, M.D., entitled “DEVICES AND METHODS TO TREAT MORBID OBESITY,” all of which are herein incorporated by reference in their entirety.BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] The present invention relates to methods and apparatus for implanting devices in the wall of a hollow organ, including...

AI Technical Summary

Benefits of technology

"The present invention provides a method for reducing the volume of an organ, such as a stomach, by creating a connection between two anchors placed on the exterior of the organ. The anchors are designed to be placed through the skin and into the organ, and a connector is used to join them. The connection between the anchors can be adjusted to bring the organ walls together, reducing the volume of the organ. The invention also includes a fastening assembly for easy placement of the anchors. The technical effects of the invention include reducing the size of the organ and facilitating space-making procedures."

Problems solved by technology

Many of the procedures performed in the past have proven to be impractical, dangerous, or detrimental to the health of the patients and are now of historical importance only.

While patients initially lost a great deal of weight, liver failure or liver damage occurred in over one-third of the patients which necessitated reversal of the surgical procedure.

Despite the efficacy of the Roux procedure and the recent laparoscopic improvements, it remains a highly invasive procedure with substantial morbidity including a 1-2% surgical mortality, a 20-30% incidence of pulmonary morbidity such as pneumonia, pulmonary embolism, etc., and a 1-4% chance of leak at the anastamotic site which can result in a spectrum of consequences including an extended hospital stay to death.

There is also a substantial rate of anastamotic stricture which results in severe lifestyle changes for patients.

The largest problem from the perspective of the patient is that the Roux-en-Y is not reversible, which dramatically limits the number of patients willing to undergo the procedure.

In particular, it severely limits the number of procedures which can or should be performed on adolescents.

Although less invasive than the Roux procedure and potentially reversible, the LAP-BAND™ is nonetheless quite invasive.

Endoscopic procedures to manipulate the stomach are time consuming because of the technical difficulty of the endoscopy; they also require a large endoscope through which many instruments need to be placed for these complex procedures.

Due to the large girth of the endoscope, patients typically will require general anesthesia, limiting the “non-invasive” aspects of the procedure.

Such skill adaptation can take a significant amount of time, which will limit adoption of the procedure by the physician community.

A further issue is that there is a limitation on the size of the anchors which can be placed because the endoscope has a maximum size.

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