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Submucosal esophageal bulking device
| Details |
Inventors: Johnson, George; Tsukashima, Ross;
Assignee: Endonetics, Inc. (San Diego, CA)
Primary Examiner: Hindenburg; Max
Assistant Examiner: Szmal; Brian
Attorney, Agent or Firm: Knobbe, Martens, Olson & Bear, LLP
Disclosed is a prosthetic bulking device for implantation below the mucosa to treat gastroesophageal reflux disease. The bulking device comprises a flexible body which may have one or more attachment surfaces to allow tissue ingrowth from the adjacent tissue. The bulking device cooperates with residual lower esophageal sphincter (LES) function to increase LES closing pressure. |
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DETAILED DESCRIPTION There is provided in accordance with one aspect of the present invention, a method of treating gastroesophageal reflux disease.
The method comprises the steps of identifying a patient having gastroesophageal reflux disease, and assessing the esophageal sphincter closing pressure.
A submucosal esophageal bulking device is selected, for increasing the esophageal sphincter closing pressure.
The device is inserted below the mucosa in the vicinity of the lower esophageal sphincter.
The submucosally inserting step preferably comprises providing access through the mucosa and creating a space in the submucosa for receiving the esophageal bulking device.
In accordance with another aspect of the present invention, there is provided a method of treating gastroesophageal reflux disease.
The method comprises the steps of providing an esophageal bulking device having a predetermined form, and inserting the gastroesophageal bulking device below the mucosa in the vicinity of the lower gastroesophageal sphincter.
Preferably, the bulking device elevates the LES closing pressure to above about 15 mm Hg, more preferably to at least about 18 mm Hg, and optimally within the range of from about 20 mm to about 30 mm Hg.
Two or three or more gastroesophageal bulking devices may be implanted to achieve the desired closing pressure elevation.
The method may further comprise the step of attaching the esophageal bulking device to adjacent submucosal or other tissue, such as by permitting cellular ingrowth into a porous surface on the esophageal bulking device.
The method may further comprise the step of explanting the esophageal bulking device from the vicinity of the lower gastroesophageal sphincter.
Preferably, the bulking device comprises a flexible, compressible preformed structure.
In accordance with another aspect of the present invention, there is provided an esophageal bulking device for implantation below the mucosa in the vicinity of the lower gastroesophageal sphincter.
The bulking device comprises a flexible, compressible body, which comprises a compressible filler and an outer layer
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