Use of a gastrointestinal sleeve to treat bariatric surgery fistulas and leaks

• US 8,801,647 B2
• Filed: 02/21/2008
• Issued: 08/12/2014
• Est. Priority Date: 02/22/2007
• Status: Active Grant

• Current Assignee: GI Dynamics Incorporated
• Original Assignee: GI Dynamics Incorporated
• Inventors: Melanson, David A., Neto, Manoel dos Passos Galvao
• Primary Examiner(s): MARCETICH, ADAM M
• Application Number:
  US12/070,912
• Publication Number:
  US 20080208357A1
• Time in Patent Office: 2,364 Days
• Field of Search: 604/8, 623/23.64, 623/23.65, 623/23.7, 623/23.75, 623/23.76, 606/108
• US Class Current: 604/8
• CPC Class Codes: A61F 2/04 Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts A61F2/18, A61F2/20 take precedence; devices, other than stent-grafts, providing patency to, or preventing collapsing of, tubular structures of the body other than stent-grafts, e.g. stents A61F2/82; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95
• CPC Class Codes: A61F 2002/044 Oesophagi or esophagi or gullets
• CPC Class Codes: A61F 5/0013 Implantable devices or invasive measures
• CPC Class Codes: A61F 5/0076 preventing normal digestion, e.g. Bariatric or gastric sleeves
• CPC Class Codes: A61F 5/0079 Pyloric or esophageal obstructions
• CPC Class Codes: A61F 5/0083 Reducing the size of the stomach, e.g. gastroplasty surgical interventions A61B17/00

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.

Claims

1. A method of treatment of a fistula or leak of a Roux-en-Y patient comprising the steps of:

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, who has had a Roux-en-Y gastric bypass procedure, and above the gastroesophageal (GE) 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.

2. The method of claim 1 wherein the anchor is a stent.

3. The method of claim 1, wherein the anchor has a relaxed diameter of 20 to 40 millimeters.

4. The method of claim 1, wherein the anchor has a length of 25 to 40 millimeters.

5. The method of claim 1, wherein the anchor is a wave anchor.

6. The method of claim 1, wherein the anchor is covered with a membrane.

7. The method of claim 1, wherein the anchor is sandwiched between a first inner layer of membrane and a second outer layer of membrane.

8. The method of claim 1, wherein the implant has a length of at least 150 mm.

9. The method of claim 1, wherein the sleeve and anchor are delivered using an esophageal catheter.

10. The method of claim 1, wherein the sleeve and anchor are removed transorally through the mouth.

11. The method of claim 1, wherein the anchor includes a drawstring to facilitate the removal of the anchor.

12. The method of claim 1, wherein the sleeve shields fistulas and leaks from making contact with food and fluids entering the esophagus.