Use of a gastrointestinal sleeve to treat bariatric surgery fistulas and leaks
Inventors
Melanson, David A. • Neto, Manoel dos Passos Galvao
Assignees
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Publication Number
US-8801647-B2
Publication Date
2014-08-12
Expiration Date
Abstract
Method for treating a Roux-en-Y patient having fistulas and leaks as a result of bariatric surgery. A gastrointestinal implant device is anchored in the esophagus and extends through a stomach pouch into an intestine anastomosed to the stomach pouch to prevent fistulas and other damaged tissue from making contact with food and fluids entering the esophagus. The gastrointestinal implant device includes an unsupported flexible sleeve and an anchor coupled to a proximal portion of the sleeve. The flexible sleeve is open at both ends, and adapted to extend below a jejunum. The anchor is adapted to be retained within the esophagus, preferably just above the gastroesophageal (GE) Junction. The anchor can include a stent such as a wave anchor and is collapsible for catheter-based delivery and removal.
Core Innovation
A gastrointestinal implant system is provided for treating a fistula or leak of a Roux-en-Y patient as a result of bariatric surgery. The implant includes a collapsible, self-expanding anchor coupled to a proximal portion of a flexible, floppy sleeve that is open at both ends, and a distal portion of the sleeve extends beyond the anchor and is unsupported. The anchor is positioned within the esophagus and above the gastroesophageal Junction of the patient.
The flexible, floppy sleeve extends through a stomach pouch of the patient past the fistula or leak into an intestine anastomosed to the stomach pouch. The sleeve shields the fistula or leak from contact with food and fluids entering the esophagus. The sleeve is described as slippery, low-friction, and low-permeability to minimize irritation and outward pressure, and to support healing.
In some embodiments, the self-expanding anchor is a wave anchor and may include compliant flexure. The anchor and/or the sleeve may be covered or sandwiched by membranes for tissue-growth prevention and fluid sealing. Optional drawstrings are described for repositioning or removal transorally via catheter-based delivery systems, and the document contrasts the device with rigid, hard-to-remove, migration-prone esophageal stents.
Claims Coverage
The document contains one independent claim directed to a method of treatment for a Roux-en-Y fistula or leak, refined by multiple dependent limitations. The independent claim centers on a collapsible self-expanding anchor coupled to a flexible, floppy open-ended sleeve, positioning the anchor in the esophagus above the GE Junction, and extending the sleeve through the stomach pouch past the fistula or leak into an intestine anastomosed to the stomach pouch.
Treating Roux-en-Y fistula or leak with a collapsible anchor and unsupported flexible sleeve
A method of treatment of a fistula or leak of a Roux-en-Y patient comprising selecting a Roux-en-Y patient having a fistula or leak as a result of bariatric surgery; providing an implant comprising a collapsible, self-expanding anchor coupled to a proximal portion of a flexible, floppy sleeve, open at both ends, a distal portion of the flexible, floppy sleeve extending beyond the anchor and being unsupported; positioning the anchor within the esophagus of the patient above the gastroesophageal Junction of the patient; and extending the flexible, floppy sleeve through a stomach pouch of the patient past the fistula or leak into an intestine anastomosed to the stomach pouch.
Anchor relaxed diameter range
The method further specifies that the anchor used has a relaxed diameter between 20 and 40 millimeters.
Implant length threshold
The method further specifies that the implant has a length of at least 150 mm.
Wave anchor selection
The method is specified such that the anchor used is a wave anchor.
Shielding the fistula or leak from food and fluids entering the esophagus
The method further includes using a sleeve to shield fistulas and leaks so they do not contact food and fluids entering the esophagus.
Transoral removal route
The method further specifies that the sleeve and anchor are removed transorally through the mouth.
Overall, the claim coverage is focused on treating Roux-en-Y fistulas or leaks by placing a collapsible, self-expanding anchor in the esophagus above the GE Junction and extending an open-ended flexible, floppy sleeve through the stomach pouch past the fistula or leak into the anastomosed intestine, with dependent limitations specifying dimensional ranges, a wave anchor, functional shielding from food and fluids, and transoral removal.
Stated Advantages
Shields the fistula or leak from contact with food and fluids entering the esophagus.
Minimizes irritation and outward pressure.
Supports healing.
Documented Applications
Treatment of a fistula or leak in a Roux-en-Y patient as a result of bariatric surgery using an endoluminal gastrointestinal implant system.
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