Methods and devices for endosonography-guided fundoplexy

• US 8,784,437 B2
• Filed: 06/08/2006
• Issued: 07/22/2014
• Est. Priority Date: 06/09/2005
• Status: Active Grant

• Current Assignee: Advent Medical, Inc.
• Original Assignee: Xlumena, Inc. (Boston Scientific Corporation)
• Inventors: Binmoeller, Kenneth F.
• Primary Examiner(s): McDermott, Corrine M
• Assistant Examiner(s): ORKIN, ALEXANDER J
• Application Number:
  US11/449,365
• Publication Number:
  US 20060282087A1
• Time in Patent Office: 2,966 Days
• Field of Search: 606/153, 606/220, 606/144, 606/139, 606145-148, 606/228, 606/232
• US Class Current: 606/144
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/12013 for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/00827 Treatment of gastro-esophageal reflux
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488

Abstract

The present invention relates to a tissue securement system, device and method for endoscopy or endosonography-guided transluminal interventions whereby a ligation or anchor is placed and secured into soft tissue. An objective of this invention is to provide a method to reduce gastroesophageal reflux by endosonography-guided intervention. Specifically, endosonography is used to insert a ligation element through the esophageal wall, through the diaphragmatic crus and into the fundus of the stomach. This ligation element placed from the esophagus and around the Angle of His to create a barrier to gastroesophageal reflux.

Claims

1. A method for treating gastroesophageal reflux disease comprising:

inserting a tissue securement apparatus through an esophageal wall, a diaphragmatic crura and a fundal wall of a stomach;

advancing a connecting element into the stomach;

joining the proximal end of the connecting element to a ligating element;

pulling the connecting element to position the ligating element across the esophageal wall, the diaphragmatic crura and the fundal wall of the stomach; and

fastening the esophageal wall to the fundal wall with the ligating element to capture the diaphragmatic crura between the walls.

2. A method for connecting a first body cavity having an esophageal wall to a stomach having a fundal wall comprising:

inserting a tissue securement apparatus containing a needle with proximal and distal end portions, through the esophageal and fundal walls, wherein the needle comprises a hollow needle body, a detachable sharpened needle tip, a stylet positioned coaxially inside the needle body, and a connecting element coupled to the needle tip, wherein the tip directly penetrates the walls and a diaphragmatic crura to position the needle tip in the stomach;

removing the needle body while engaging the stylet against the needle tip to disengage the needle tip from the needle body to leave the needle tip and a portion of the connecting element remaining in the stomach;

joining a proximal end of the connecting element to a ligating element,

positioning a grasping forceps inside the stomach and grasping and pulling a distal end of the connecting element to position the ligating element across the esophageal and fundal walls; and

bringing the ends of the ligating element together to form a loop that draws the esophageal and fundal walls together.

3. The method of claim 2 further comprising delivering the tissue securement apparatus to the first wall using an endoscope or echoendoscope.

4. The method of claim 2 whereby the formed loop traverses around the Angle of His.

5. The advancing step of claim 2 further comprising moving the stylet distally to detach the needle tip from the needle body and position the needle tip with a portion of the connecting element in the stomach.

6. The method of claim 2 further comprising securing the ends of the ligating element with a securement element.

7. A method for repairing a gastroesophageal flap valve comprising:

positioning a tissue securement apparatus containing a needle with proximal and distal end portions along the esophageal wall wherein the needle comprises a hollow body, a detachable sharpened tip, a stylet positioned coaxially inside the needle body and a connecting element coupled to the needle tip,

inserting the tissue securement apparatus through the esophageal wall, the diaphragmatic crura and a fundal wall of the stomach, wherein the sharpened needle tip directly penetrates the walls to position the needle tip in the stomach,

advancing the sylet to push the sharpened needle tip from the needle body so that the needle tip is left in the stomach,

advancing the connecting element into the stomach,

withdrawing the needle body,

joining a proximal end of said connecting element to a ligating element,

positioning grasping forceps inside the stomach,

grasping and pulling the connecting element to position the ligating element across the esophageal wall, the diaphragmatic crura and a fundal wall of the stomach, and

bringing the ends of the ligating element together to form a loop that encircles the gastro-esophageal flap valve and draws the esophageal and fundal walls together.

8. The method of claim 7 further comprising positioning the apparatus with an echoendoscope and using ultrasonic guidance to locate the diaphragmatic crura.

9. The advancing step of claim 7 further comprising moving the stylet distally to detach the needle tip from the needle body and position the needle tip with a portion of the connecting element in the stomach.

10. The method of claim 7 further comprising securing the ends of the ligating element with a securement element.

11. The method of claim 7 further comprising:

bringing the ends of the ligating element together to form a loop that encircles the Angle of His and draws the esophageal and fundal walls together.

12. The ligating element of claim 7 further comprising an initially folded or coiled configuration suitable for delivery and an unfolded or uncoiled configuration once deployed.

13. The ligating element of claim 7 wherein the ligating element is a suture, tie, thread, band, cord, web, strap, belt, elongated piece of mesh, wire, or a biocompatible patch.