Intragastric device for treating obesity

Abstract

An apparatus and method comprising at least one intragastric member or artificial bezoar made of a digestive-resistant or substantially indigestible material that is introduced into a gastric lumen of a mammal for the treatment of obesity. The intragastric member or artificial bezoar is typically at inserted into the gastric lumen in a partially compacted configuration, whereby it is then manipulated into, or allowed to assume, a second expanded configuration sufficiently large to remain within the reservoir of the stomach during normal activities and not be passed through the pylorus into the intestines. In animals, the present invention has been found to be effective in achieving weight loss over a several month period, while being easy to place and retrieve.

Description

RELATED APPLICATIONS [0001] This application is a continuation of c-pending U.S. patent application Ser. No. 10 / 151,720, filed May 17, 2002, which claims the benefit of U.S. Provisional Application No. 60 / 291,790, filed May 17, 2001, and U.S. Provisional Application No. 60 / 360,353, filed Feb. 27, 2002, each of which are entitled “Intragastric Device For Treating Obesity”.TECHNICAL FIELD [0002] This invention relates to medical devices, and more particularly to obesity treatment devices that can be placed in the stomach of a patient to reduce the size of the stomach reservoir. BACKGROUND OF THE INVENTION [0003] It is well known that obesity is a very difficult condition to treat. Methods of treatment are varied, and include drugs, behavior therapy, and physical exercise, or often a combinational approach involving two or more of these methods. Unfortunately, results are seldom long term, with many patients eventually returning to their original weight over time. For that reason, obes...

AI Technical Summary

Benefits of technology

[0008] The foregoing problems are solved and a technical advance is achieved by an illustrative obesity treatment apparatus comprising at least one intragastric member or artificial bezoar made of a digestive-resistant or substantially indigestible material that is introduced into a gastric lumen of a mammal in a first configuration. The intragastric member or artificial bezoar is typically inserted into the gastric lumen in a partially compacted configuration, whereby it is then manipulated into, or allowed to assume, a second expanded configuration sufficiently large to remain within the reservoir of the stomach during normal activities and not be passed through the pylorus and into the intestines. In animals, the present invention has been found to be effective in achieving weight loss over a several month period, while being easy to place and retrieve. Another advance is that the present invention can be effective at a smaller volume within the stomach than existing intragastric members, such as balloons.

[0014] In yet another aspect of the invention, the intragastric member can comprise a plurality of expandable members that are constrained into a first configuration for introduction into the gastric lumen, whereby the device is manipulated to allow it to assume a second, expanded configuration for residing in the stomach. One such example is an intragastric member having a plurality of strips arranged concentrically and secured at each end with a tether fixedly attached at the first end and extending through an internal portion of the device. The second end attachment is adapted to slide over the tether, and can be drawn or urged toward the first end attachment to cause the expandable members to bow outward so as to increase the overall volume of the device.

[0016] In yet another aspect of the invention, the intragastric member can comprise a single strip of material having a series of apertures space along the length thereof, wherein the strip of material is bundled into a series of folds by passing a nylon thread through the apertures and cinching the strip of material together. The intragastric member is inserted into the gastric lumen by passing the apertures of the strip of material over a wire guide, preferably in separate bundles, until the entire strip has been accumulated and bundled together inside the gastric lumen with a nylon thread. The nylon thread can be cut to allow the bundles to separate, thereby facilitating its removal by grasping and pulling one end of the strip.

Problems solved by technology

It is well known that obesity is a very difficult condition to treat.

Unfortunately, results are seldom long term, with many patients eventually returning to their original weight over time.

However, these procedures carry high risks, and are therefore not appropriate for most patients.

While some studies demonstrated modest weight loss, the effects of these balloons often diminished after three or four weeks, possibly due to the gradual distension of the stomach or the fact that the body adjusted to the presence of the balloon.

However, the disadvantages of having a inflation tube exiting the nose are obvious.

The experience with balloons as a method of treating obesity has provided uncertain results, and has been frequently disappointing.

Some trials failed to show significant weight loss over a placebo, or were ineffective unless the balloon placement procedure was combined with a low-calorie diet.

In many cases, bezoars can cause indigestion, stomach upset, or vomiting, especially if allowed to grow sufficiently large.

It has also been documented that certain individuals having bezoars are subject to weight loss, presumably due to the decrease in the size of the stomach reservoir.

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