Submucosal gastric implant device and method

Abstract

A device, system and method for diagnosing and treating gastric disorders is provided. A submucosal gastric implant device is placed within the submucosal layer of a patient's stomach wall. The device in one embodiment provides electrical stimulation of the stomach wall and may use multiple electrode pairs for sequential stimulation. The device may also have other functional aspects such as a sensor for sensing various parameters of the stomach or stomach environment, or a therapeutic delivery device. The implant may be programmed to respond to sensed information or signals. The device may be modular with a portion of the device accessible outside the stomach wall for removal and replacement. An endoscopic delivery system prepares and delivers the functional device through the esophagus and into the stomach where it is placed through an opening in the mucosa into the submucosal layer of the stomach wall. The endoscopic instruments may be used to prepare a cavity in the submucosal layer of the stomach wall and deliver the device to the prepared cavity and if appropriate close the opening in the mucosa.

Description

CROSS REFERENCE TO RELATED APPLICATION DATE[0001]This application is a divisional of U.S. patent application Ser. No. 10 / 109,296, filed Mar. 26, 2002, which claims the benefit of U.S. Provisional Application No. 60 / 337,194, filed Dec. 6, 2001, and is a continuation-in-part of U.S. patent application Ser. No. 09 / 847,884, filed May 1, 2001, now U.S. Pat. No. 6,535,764; the full disclosures of which are incorporated herein by reference in their entirety for all purposes.FIELD OF THE INVENTION[0002]This invention relates to an implantable device, a system and a method for electrically stimulating the stomach wall to effect gastric motility or otherwise treat gastrointestinal related disorders. One aspect in particular relates to a device and method for implanting a gastric stimulator in the submucosal layer of the stomach wall. This invention also relates to treating or diagnosing stomach conditions or disorders by implanting a functional device in a submucosal layer of the stomach wall...

AI Technical Summary

Benefits of technology

[0023]One aspect of the invention may include a means for maintaining the device in proper orientation so that the electrodes, sensors or other transducers on the device maintain contact with a preferred area or layer of the stomach wall, i.e., so that the electrodes, sensors or other transducers are preferentially facing a desired wall within a submucosal space, e.g. a muscle layer. An anti-rotation means may be provided that prevents rotation of the implant around axes that would move electrodes, sensors or transducers away from intimate contact with a desired area of the stomach wall, such as, e.g., a muscle layer or mucosal layer.

[0026]In an alternative embodiment, an anti-rotation means may be provided that prevents rotation of the implant about an axis parallel to an intended tissue plane of contact. A device in one variation is dimensioned so that the aspect ratio of the device viewed along an axis parallel to the intended plane of contact is greater than one and preferably greater than 1.4 and more preferably greater than 1.8. The aspect ratio as used herein is the width to height ratio of the aspect viewed along a particular axis. In another variation, the anti-rotation device comprises and extendible or expandable portion or member that extends into a position that prevents rotation of the electrodes away from contact with the muscle layer.

[0027]In another embodiment, an anti-rotation means may be provided that prevents rotation of the implant about an axis parallel to a common plane on which the pair of surface stimulating electrodes lie. Accordingly, a device in such embodiment is dimensioned so that the aspect ratio of the device viewed along an axis parallel to plane on which a pair of surface stimulating electrodes lie is greater than one and preferably greater than 1.4 and more preferably greater than 1.8. The width in this particular embodiment may be defined by a plane on which a pair of surface stimulating electrodes lies.

[0029]The surface of the implant may be designed to promote encapsulation or tissue ingrowth, e.g. by choice of material, coatings or surface texture. It may be desirable to provide tissue ingrowth at or near the electrodes to ensure good contact between the electrodes and the tissue to be stimulated. Such encapsulation or tissue ingrowth may help prevent movement of the implant and in particular, a rotational movement in which the contact between the electrodes and stomach muscle layer may be lost. Thus the electrodes or surrounding area may be coated with a material such as P-15, which is a commercially available compound that promotes cellular adhesion and tissue ingrowth.

Problems solved by technology

In general, the currently proposed gastric electrical stimulation procedures are relatively invasive and require accessing the stomach through the abdomen, e.g., in an open or a laparoscopic procedure.

The machine places the tag through the stomach wall and back into the stomach in a manner that causes folding of the stomach wall and may cause tissue damage when the smooth muscle of the stomach wall contracts.

Images