Methods and devices for anchoring to tissue

• US 20070135825A1
• Filed: 12/14/2006
• Published: 06/14/2007
• Est. Priority Date: 06/09/2005
• Status: Active Grant

• Current Assignee: Advent Medical, Inc.
• Original Assignee: Advent Medical, Inc.
• Inventors: Binmoeller, Kenneth
• Granted Patent: US 8,777,967 B2
• Time in Patent Office: Days
• US Class Current: 606/153
• 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 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0482 Needle or suture guides guides for drills, pins or wire A61B17/17; for puncturing needles A61B17/3403
• CPC Class Codes: A61B 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 17/0625 the needle being specially adapted to interact with the manipulator, e.g. being ridged to snap fit in a hole of the manipulator A61B17/06109 takes precedence
• 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
• CPC Class Codes: A61B 2017/0454 the anchor being crimped or clamped on the suture
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/06176 with protrusions, e.g. barbs

Abstract

The present invention relates to a tissue securement system, device and method for endoscopy or endosonography-guided transluminal interventions whereby a ligation is placed and secured into tissue. An objective of this invention is to provide a stable securement platform for the coupling of secondary anchors to the gastro-intestinal tract. Specifically, endosonography is used to insert an anchoring element through the walls of adjacent body cavities. The ends of the anchoring element are coupled together to form a loop. This anchoring element can be used to secure other anchors or devices to the gastro intestinal tract.

Claims

1. An apparatus for securing an anchor to adjacent body cavities in the gastrointestinal tract comprising:

a hollow tube with proximal and distal end portions, a connecting element having proximal and distal ends positioned inside the tube and extending from the proximal tube end portion to the distal tube end portion,

the tube configured to be inserted through a wall of a first body cavity and through a wall of a second body cavity and then withdrawn leaving behind a portion of the connecting element in the second body cavity.

2. The apparatus of claim 1 whereby the hollow tube is a needle, sheath or catheter.

3. The apparatus of claim 2 further comprising a stylet positioned inside the hollow tube wherein the stylet includes a lumen and wherein the connecting element passes through the lumen of the stylet.

4. The apparatus of claim 3 further comprising a detachable needle tip coupled to a distal end of the connecting element whereby when the stylet is distally advanced, the needle tip separates from the needle 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 an anchoring element having proximal and distal end portions, the distal end portion of the anchoring element attached to the proximal end of the connecting element, said anchoring element capable of being pulled through the first and second body cavity walls by the connecting element,

the distal end portion of the anchoring element coupled to the proximal end portion of the anchoring element to form a loop.

6. The apparatus of claim 1 further comprising a removable diathermy stylet positioned inside the hollow tube, said stylet capable of moving along a longitudinal axis of the hollow tube and cutting and coagulating tissue as the hollow tube is inserted through the wall of a first body cavity and through the wall of a second body cavity.

7. The apparatus of claim 5 where the first body cavity is the esophagus and the second body cavity is the stomach.

8. The apparatus of claim 5 where the first body cavity is the antrum of the stomach and the second body cavity is the duodenum.

9. The apparatus of claim 5 where the first body cavity is a portion of the intestine and the second body cavity is another portion of the intestine.

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

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

12. The anchoring element of claim 5 wherein the anchoring element is coated with a coating.

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

14. The apparatus of claim 12 further comprising a securement element, said securement element coupling the proximal and distal ends of the anchoring element together.

15. The anchoring element of claim 5 having an anchoring portion inside the stomach whereby other devices may attach to it.

16. A method for creating a soft tissue anchor by 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 tube with proximal and distal end portions, through the first and second walls,

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

joining a proximal end of said connecting element to an anchoring element,

pulling the connecting element to position the anchoring element across the first and second walls, and

bringing the ends of the anchoring element together to form a loop.

17. The method of claim 16 wherein insertion further comprises using an echoendoscope to assist the delivery of the tissue securement apparatus through the first and second walls.

18. The method of claim 16 whereby the hollow tube is a hollow needle, sheath or catheter.

19. The method of claim 16 wherein forming a loop further comprises drawing the first and second walls together.

20. The method of claim 17 whereby the first wall is an esophageal wall and the second wall is a fundal wall of the stomach.

21. The method of claim 17 whereby the first wall is a wall of the antrum of the stomach and the second wall is a duodenal wall.

22. The method of claim 17 whereby the first wall is an intestinal wall and the second wall is an intestinal wall.

23. The method of claim 18 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.

24. The advancing step of claim 16 further comprising moving the stylet distally to detach the needle tip from the needle body and positioning the needle tip with a portion of the connecting element in the second body cavity.

25. The method of claim 16 further comprising securing the ends of the anchoring element with a securement element.

26. The insertion method of claim 16 wherein inserting further comprises applying current to a diathermy stylet positioned inside the hollow tube, said stylet capable of moving along a longitudinal axis of the hollow tube,

and cutting and coagulating tissue while advancing the hollow tube through the wall of a first body cavity and through the wall of a second body cavity.

27. A method for providing an anchor to the stomach wall comprising:

positioning a tissue securement apparatus having 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 into the stomach and removing the tissue securement apparatus,

joining a proximal end of said connecting element to an anchoring element,

positioning grasping forceps inside the stomach and grasping and pulling the connecting element to position the anchoring element across the esophageal wall, the diaphragmatic crura and a fundal wall of the stomach,

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

28. The method of claim 27 further comprising positioning the apparatus with an echoendoscope and using ultrasonic guidance to locate the diaphragmatic crura.

29. The method of claim 28 wherein said tissue securement apparatus comprises a hollow needle and 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.

30. The advancing step of claim 27 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.

31. The method of claim 27 further comprising securing the ends of the anchoring element with a securement element.

37. The method of claim 29 wherein the two body cavities are the esophagus and the stomach.

38. The method of claim 29 wherein the two body cavities are the antrum and the duodenum.

39. The method of claim 29 wherein the two body cavities are the portions of the intestines.

32. A device for anchoring an object to a portion of the gastro intestinal tract having at least two adjacent body cavities having at least two adjacent walls comprising:

an anchoring element having proximal and distal end portions, said anchoring element capable of being disposed across the walls of the body cavities,

wherein said proximal and distal end portions of the anchoring element are coupled together to form a loop.

33. The device of claim 32 wherein a portion of the loop is disposed in a body conduit connecting the at least two adjacent body cavities.

34. A method of anchoring an object to a portion of the gastro intestinal tract having at least two adjacent body cavities comprising:

positioning an anchoring element having proximal and distal ends across the walls of the body cavities and,

bringing the ends of the anchoring element together to form a loop,

and coupling the object to the anchoring element.

35. The method of claim 34 wherein a portion of the loop is disposed in a body conduit connecting the at least two adjacent body cavities.

36. The method of claim 34 further comprising threading the anchoring element through an anchor fixture before bringing the ends together to form a loop and coupling the object to the anchor fixture.