Methods and systems for treating hiatal hernias

• US 8,034,063 B2
• Filed: 07/14/2008
• Issued: 10/11/2011
• Est. Priority Date: 07/13/2007
• Status: Active Grant

• Current Assignee: Advent Medical, Inc.
• Original Assignee: Xlumena, Inc. (Boston Scientific Corporation)
• Inventors: Binmoeller, Kenneth F.
• Primary Examiner(s): Erezo; Darwin
• Assistant Examiner(s): Dornbusch; Dianne
• Application Number:
  US12/172,967
• Publication Number:
  US 20090018576A1
• Time in Patent Office: 1,184 Days
• Field of Search: 606/151, 606/153, 606/139, 623/23.72, 623/23.64, 623/23.7, 623/23.74, 600/37
• US Class Current: 606/151
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 2017/00619 Locking means for locking the implement in expanded state
• CPC Class Codes: A61B 2017/00827 Treatment of gastro-esophageal reflux
• CPC Class Codes: A61B 2017/00862 elastic or resilient
• CPC Class Codes: A61B 2017/0419 H-fasteners
• CPC Class Codes: A61B 2017/0445 cannulated, e.g. with a longitudinal through-hole for passage of an instrument
• CPC Class Codes: A61B 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence

Abstract

The present invention relates generally to medical methods and systems used to restore the angle of His and treat hiatal hernias and other conditions of the lower esophagus. More particularly, the present invention relates to a method and system that allows fixation of the distal esophagus and fundus of the stomach directly to the diaphragmatic crus muscle. The present invention provides a method where the diaphragmatic crus muscle is identified and precisely located from within and through the gastrointestinal lumen followed by the placement of a translumenal anchor which connects and secures the esophagus and stomach to the diaphragmatic crus muscle. This procedure reduces the hiatal hernia, restores the normal anatomy and treats conditions associated with the lower esophagus.

Claims

1. A method for treating a hiatal hernia which extends into a patient'"'"'s esophagus and restoring a GEV and the angle of His, said method comprising:

moving the hiatal hernia downwardly to capture a crus muscle between a lower esophageal wall and a gastric fundus;

visually confirming that the crus muscle is located between the lower esophageal wall and the gastric fundus at a target site; and

fastening at least the lower esophageal wall to the gastric fundus with a fastener that passes through the crus muscle at a target site to restore the GEV and the angle of His.

2. A method as in claim 1, wherein moving the hiatal hernia comprises:

advancing an instrument down the esophagus;

engaging the end of the instrument against the herniated portion of the esophageal wall; and

;

repositioning the hernia toward the stomach.

3. A method of claim 1, wherein visually confirming comprises ultrasonic imaging.

4. A method as in claim 1, wherein fastening comprises:

deploying a delivery device; and

advancing the fastener through the delivery device.

5. A method as in claim 4, wherein the fastener comprises a central portion having two expandable end anchors which expand and engage the esophagus and fundus, respectively.

29. A method of claim 1 or claim 14 wherein the fastening occurs in the direction from the esophagus toward the fundus.

30. A method of claim 1 or claim 14 wherein the fastening occurs in the direction from the fundus toward the esophagus.

6. A method for restoring a GEV and the angle of His, said method comprising:

positioning an instrument in the esophagus;

visually confirming a crus muscle is captured between the lower esophageal wall and the gastric fundus at a target site; and

fastening the lower esophageal wall to the gastric fundus with a fastener that passes through the diaphragmatic crus muscle at the target site to restore the GEV and the angle of His.

7. A method of claim 6, wherein fastening comprises advancing the fastener through a delivery device.

8. A method of claim 6, wherein the fastener is passed from the thoracic cavity to the abdominal cavity.

9. A method of claim 6, wherein the fastening restores the gastro-esophageal flap valve.

10. A method of claim 6, wherein the fastening repositions the lower esophageal sphincter against the diaphragmatic crus muscle.

11. A method of claim 6, wherein the fastening enhances the function of the lower esophageal sphincter.

12. A method of claim 6, wherein the fastening restores the anti-reflux barrier.

13. A method of claim 6, wherein the angle of His is restored by treating a hiatal hernia.

14. A method for treating a hiatal hernia and restoring a GEV and the angle of His, said method comprising:

visually identifying a target site through the lower esophageal wall and the gastric fundus where the crus muscle is positioned therebetween; and

fastening the lower esophageal wall to the gastric fundus with a fastener that passes through the diaphragmatic crus muscle to restore the GEV and the angle of His.

15. A method of claim 14, wherein the hiatal hernia is first repositioned downwardly to capture the crus muscle at the angle of His.

16. A method of claim 14, that results in reducing the hernia.

17. A method of claim 15, wherein pushing the hiatal hernia comprises engaging the hernia with the expanded cuff of the endoscope and pushing the hernia downward.

18. A method of claim 14, wherein the hiatal hernia can be pushed or pulled down by mechanical pushers or pullers, vacuum apparatus, inflatable members, pins, traction devices or the like, either associated with an endoscope or as separate devices.

19. A method of claim 14, wherein fastening comprises advancing the fastener through the endoscope.

20. A method of claim 14, wherein the fastening comprises delivery of the fastener using a catheter.

21. A method of claim 14, wherein the fastener is passed from the thoracic cavity to the abdominal cavity.

22. A method of claim 14, wherein the fastening restores the gastro-esophageal flap valve.

23. A method of claim 14, wherein the fastening repositions the lower esophageal sphincter against the diaphragmatic crus muscle.

24. A method of claim 14 wherein the fastening enhances the function of the lower esophageal sphincter.

25. A method of claim 14 wherein the fastening restores the anti-reflux barrier.

26. A method of claim 14 wherein the angle of His is restored by treating a hiatal hernia.

27. A method of claim 6 or claim 14 wherein the fastener comprises a central portion having two expandable end anchors which expand and engage the esophagus and gastric fundus, respectively.

28. A method of claim 6 or claim 14 wherein the fastener is removable.