Intragastric implants with duodenal anchors

Abstract

Intragastric fluid transfer devices and related methods for operation thereof are disclosed. The intragastric fluid transfer devices and related methods are intended to assist a patient in maintaining a healthy body weight by stimulating the inner stomach walls and / or the inner duodenum walls. Features of the intragastric fluid transfer device include insertion of the devices transorally and without invasive surgery, without associated patient risks of invasive surgery, and without substantial patient discomfort. The life span of these intragastric fluid transfer devices may be material-dependent upon long-term survivability within an acidic stomach, but is intended to last one year or longer.

Description

RELATED APPLICATIONS[0001]The present application claims priority under 35 U.S.C. §119 to U.S. Provisional Application No. 61 / 394,228, filed Oct. 18, 2010, to U.S. Provisional Application No. 61 / 485,009, filed May 11, 2011, and to 61 / 394,592, filed Oct. 19, 2010, the disclosures of which are incorporated by reference herein.FIELD OF THE INVENTION[0002]The present invention generally relates to medical systems, apparatus and uses thereof for treating obesity and / or obesity-related diseases, and more specifically, relates to intragastric fluid transfer devices designed to treat obesity.BACKGROUND OF THE INVENTION[0003]Over the last 50 years, obesity has been increasing at an alarming rate and is now recognized by leading government health authorities, such as the Centers for Disease Control (CDC) and National Institutes of Health (NIH), as a disease. In the United States alone, obesity affects more than 60 million individuals and is considered the second leading cause of preventable d...

AI Technical Summary

Benefits of technology

[0010]An intragastric fluid transfer device that advantageously induces weight loss in a patient in one or more ways including those described herein. The intragastric fluid transfer device functions as a volume occupying device in the patient's stomach, thereby reducing food ingested during a meal and reducing the sensation of pre-prandial hunger. Additionally, the portion of the intragastric fluid transfer device residing inside the patient's duodenum may sufficiently alter the antroduodenal pressure gradient to slow gastric emptying, thereby reducing the total volume of food ingested during a meal and inducing cessation of feeding at an earlier time-point during the meal. Further additionally, the portion of the intragastric fluid transfer device residing inside the patient's duodenum may slow the passage of ingested food through the proximal duodenum, thereby leading to a mechanical slowing of gastric content released into the proximal small intestine.

[0012]The advantageous intragastric fluid transfer device providing the benefits described herein generally allows for easy and quick placement and removal. Surgery is usually not required or very minimal.

[0017]A still further passive intragastric obesity treatment implant of the present application has an inflatable member having an inflated size sufficient to occupy space within the stomach and preventing passage down the pylorus or back up through the esophageal sphincter. A duodenal sleeve for positioning in the duodenum and reinforced to prevent kinking attaches to the inflatable member via a tether. The implant is formed of a material which permits it to be compressed into a substantially linear delivery configuration and that will resist degradation over a period of at least six months within the stomach. The inflatable member further may include a valve member for filling and emptying the member with a fluid. The duodenal sleeve preferably comprises a flexible sleeve wall reinforced by a plurality of spaced loops. The tether may comprise a strong inner member coated with a material that resists degradation in the stomach.

[0019]The gastric balloon may be fluid filled (e.g., saline filled). If the inner stomach walls of the patient exerts a pressure on the gastric balloon (e.g., during stomach contractions when the patient is consuming food), the pressure exerted on the gastric balloon may cause fluid or air within the gastric balloon to be transferred via the tether to the intra-duodenal balloon residing in the duodenum. In this way, the intra-duodenal balloon begins to inflate and expand, and as a result may increase pressure on the patient's duodenum thereby allowing the patient to feel more satiated.

Problems solved by technology

Additionally, the portion of the intragastric fluid transfer device residing inside the patient's duodenum may sufficiently alter the antroduodenal pressure gradient to slow gastric emptying, thereby reducing the total volume of food ingested during a meal and inducing cessation of feeding at an earlier time-point during the meal.

Further additionally, the portion of the intragastric fluid transfer device residing inside the patient's duodenum may slow the passage of ingested food through the proximal duodenum, thereby leading to a mechanical slowing of gastric content released into the proximal small intestine.

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