Methods and devices for endosonography-guided fundopexy

• US 20060282087A1
• Filed: 06/08/2006
• Published: 12/14/2006
• Est. Priority Date: 06/09/2005
• Status: Active Grant

• Current Assignee: Advent Medical, Inc.
• Original Assignee: Advent Medical, Inc.
• Inventors: Binmoeller, Kenneth F.
• Granted Patent: US 8,784,437 B2
• Time in Patent Office: Days
• US Class Current: 606/139
• 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

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 that may create a barrier to gastroesophageal reflux.

Claims

1. A tissue securement apparatus for creating a gastric fundoplexy comprising:

a hollow needle with proximal and distal end portions, the needle comprising a needle body and a detachable needle tip, a stylet positioned coaxially inside the needle body with a connecting element positioned inside the needle and extending from the proximal needle end portion to the distal needle end portion, said connecting element coupled to the needle tip at one end,

the needle configured to be inserted through an esophageal and fundal wall and then withdrawn to leave behind the distal portion of the connecting element in the fundus.

2. The apparatus of claim 1 whereby the needle is sized to be placed inside the working lumen of an endoscope.

3. The apparatus of claim 1 wherein the stylet includes a lumen and wherein the connecting element passes through the lumen of the stylet.

4. The apparatus of claim 3 whereby when the stylet is distally advanced, the needle tip separates from the needle body and the needle tip with a portion of the connecting element are moved apart from the needle body.

5. The apparatus of claim 4 further comprising a ligating element that can be attached to the proximal end of the connecting element and drawn down the esophagus, through the esophageal and fundal walls, into the stomach and connected to itself to form a loop.

6. The ligating element of claim 5 wherein the ligating element is a suture, tie, thread, band, cord, web, strap, belt, elongated piece of mesh, wire, or a biocompatible patch.

7. The ligating element of claim 5 further comprising an initially folded or coiled configuration suitable for delivery and an unfolded or uncoiled configuration once deployed.

8. The ligating element of claim 5 wherein the ligating element is biodegradable or coated with a coating.

9. The ligating element of claim 5 further comprising a dilating element positioned between the proximal end of the connecting element and the distal end of the ligating element, the dilating element sized to dilate a tissue tunnel so that the ligating element may be drawn through the tunnel by the connecting element.

10. The apparatus of claim 9 further comprising a securement element, said securement element engaging the proximal and distal ends of the ligating element together.

11. A method for connecting a first body cavity having a first wall to a second body cavity having a second wall comprising:

inserting a tissue securement apparatus containing a hollow needle with proximal and distal end portions, through the first and second walls,

advancing a connecting element through the needle and into the second body cavity and removing the needle,

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

positioning grasping forceps inside the second body cavity and grasping and pulling the connecting element to position the ligating element across the first and second walls,

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

12. The method of claim 11 further comprising delivering the tissue securement apparatus to the first wall using an endoscope or echoendoscope.

13. The method of claim 12 whereby the first wall is the esophageal wall and the second wall is the fundal wall of the stomach.

14. The method of claim 13 further comprising inserting the tissue securement apparatus through the esophageal wall, the diaphragmatic crura and the fundal wall of the stomach.

15. The method of claim 11 whereby the formed loop traverses around the Angle of His.

16. The method of claim 11 wherein said hollow needle comprises a needle body, a detachable needle tip and a stylet positioned coaxially inside the needle body with the needle tip coupled to the connecting element.

17. The advancing step of claim 11 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.

18. The method of claim 11 further comprising securing the ends of the ligating element with a securement element.

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

positioning a tissue securement apparatus containing a hollow needle with proximal and distal end portions along the esophageal wall,

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

advancing a connecting element through the needle and into the stomach and removing the needle,

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

positioning grasping forceps inside the stomach and 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,

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.

20. The method of claim 19 further comprising positioning the apparatus with an echoendoscope and using ultrasonic guidance to locate the diaphragmatic crura.

21. The method of claim 20 wherein said hollow needle comprises a needle body, a detachable needle tip and a stylet positioned coaxially inside the needle body with the needle tip coupled to the connecting element.

22. The advancing step of claim 19 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.

23. The method of claim 19 further comprising securing the ends of the ligating element with a securement element.

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

positioning a ligating element through the esophageal wall, the diaphragmatic crus and a fundal wall of the stomach,

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

25. The method of claim 24 wherein the loop encircles the Angle of His.