Endoscopic plication devices and methods

• US 20070219571A1
• Filed: 10/03/2006
• Published: 09/20/2007
• Est. Priority Date: 10/03/2005
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Smith, Andrew, Lunsford, John, Sander, Fiona, Cole, Dave, Swope, Brett, Balbierz, Daniel, Crews, Samuel
• Granted Patent: US 9,055,942 B2
• Time in Patent Office: Days
• US Class Current: 606/153
• CPC Class Codes: A61B 17/0218 for minimally invasive surgery A61B17/0281, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/072 for applying a row of staples in a single action , e.g. the staples being applied simultaneously
• CPC Class Codes: A61B 17/07292 Reinforcements for staple line, e.g. pledgets
• CPC Class Codes: A61B 17/1114 of the digestive tract, e.g. bowels or oesophagus
• CPC Class Codes: A61B 17/115 Staplers for performing anastomosis in a single operation
• CPC Class Codes: A61B 17/1155 Circular staplers comprising a plurality of staples
• CPC Class Codes: A61B 17/1285 for minimally invasive surgery
• CPC Class Codes: A61B 2017/00535 pneumatically or hydraulically operated A61B2017/22051, A61B2090/401 take precedence
• CPC Class Codes: A61B 2017/00827 Treatment of gastro-esophageal reflux
• CPC Class Codes: A61B 2017/07214 Stapler heads
• CPC Class Codes: A61B 2017/07228 Arrangement of the staples
• CPC Class Codes: A61B 2017/1139 Side-to-side connections, e.g. shunt or X-connections
• CPC Class Codes: A61B 2017/1157 applying the staples radially
• CPC Class Codes: A61B 2017/306 holding by means of suction
• CPC Class Codes: A61F 5/0036 Intragastrical devices

Abstract

Described herein are endoscopic plicators passed transorally into the stomach and used to plicate stomach tissue by engaging tissue from inside of the stomach and drawing it inwardly. In the disclosed embodiments, the tissue is drawn inwardly into a vacuum chamber, causing sections of serosal tissue on the exterior of the stomach to be positioned facing one another. The disclosed plicators allow the opposed sections of tissue to be moved into contact with one another, and preferably deliver sutures, staples or other means for maintaining contact between the tissue sections at least until serosal bonds form between them. Each of these steps may be performed wholly from the inside of the stomach and thus can eliminate the need for any surgical or laparoscopic intervention. After one or more plications is formed, medical devices may be coupled to the plication(s) for retention within the stomach.

Claims

1. An apparatus for forming plications in tissue, the apparatus comprising:

an elongate shaft; and

a plication head positioned on the elongate shaft, the plication head including

a collapsible vacuum chamber having an opening positionable in contact with tissue to be plicated such that application of suction to the vacuum chamber draws the tissue into the vacuum chamber; and

a fastening system having a first portion and a second portion positioned such that advancement of a fastener from the first portion to the second portion advances the fastener through tissue drawn into the vacuum chamber.

2. The apparatus of claim 1, wherein the vacuum chamber is expandable in response to suction of tissue into the vacuum chamber.

3. The apparatus of claim 1, wherein the vacuum chamber is collapsible from a first position in which the first and second portions are spaced by a first distance and a second position in which the first and second portions are spaced by a second distance smaller than the first distance.

4. The apparatus of claim 1, wherein the vacuum chamber is expandable from a first position to a second position to expand the opening.

5. The apparatus of claim 1, wherein the plication head includes a proximal portion carrying the first portion of the fastening system and a distal portion carrying the second portion of the fastening system, wherein the vacuum chamber extends between the proximal and distal portions.

6. The apparatus of claim 5, wherein the plication head includes at least one structural member extending between the proximal and distal portions, and wherein the vacuum chamber includes a flexible membrane on the at least one structural member.

7. The apparatus of claim 6, wherein the structural member is a hinged member.

8. The apparatus of claim 7, wherein the hinged member is coupled to the proximal and distal portions at corresponding proximal and distal pivot points.

9. The apparatus of claim 8, wherein the hinged member includes an intermediate pivot point/

10. The apparatus of claim 1, wherein the vacuum chamber is a flexible membrane.

11. The apparatus of claim 8, wherein the hinged member is pivotable about the proximal and distal pivot points to deform the vacuum chamber.

12. The apparatus of claim 1, wherein the first portion of the fastening system includes a staple cartridge including at least one staple, and a second portion of the fastening system includes a staple anvil.

13. The apparatus of claim 1, wherein the first portion of the fastening system includes a needle having a fastener thereon, and wherein the second portion of the fastening system includes a catch for engaging a portion of the needle or fastener.

14. The apparatus of claim 1, wherein the proximal portion of plication head includes a pusher positioned to push a reinforcing element into position between layers of tissue positioned in the vacuum chamber.

15. The apparatus of claim 14, wherein the reinforcing element is a tubular reinforcing element having a pair of ends, and wherein the vacuum chamber is deformable to impart pressure against the ends to laterally expand the reinforcing element.

16. The apparatus of claim 14, wherein the tubular reinforcing element comprises a mesh element.

17. The apparatus of claim 12, wherein the fastening system includes a reinforcing element positioned in proximity to the anvil such that a staple passing through the tissue into contact with the anvil will fold around the reinforcing element.

18. The apparatus of claim 12, wherein the fastening system includes a reinforcing element positioned in proximity to the staple cartridge such that a staple passing from the staple cartridge to the tissue will engage the reinforcing element.

19. The apparatus of claim 17, wherein the stapling cartridge includes an array of staples in a generally annular arrangement, and wherein the reinforcing element is a reinforcing ring.

20. The apparatus of claim 18, wherein the stapling cartridge includes an array of staples in a generally annular arrangement, and wherein the reinforcing element is a reinforcing ring.

21. The apparatus or claim 1, further including a piercing element extendable through tissue in the vacuum chamber to form a hole in tissue layers fastened together by fastening system.

22. The apparatus of claim 21, wherein the piercing element is positioned to form a hole bounded by fasteners delivered by the fastening system.

23. The apparatus of claim 1, wherein the proximal portion of plication head includes a tube positioned to inject a sclerosing element into position between layers of tissue positioned in the vacuum chamber.

24. The apparatus of claim 1, wherein the vacuum chamber is formed of silicone.

25. The apparatus of claim 13, wherein the fastening system further includes an anchor positioned in the vacuum chamber, wherein the catch comprises a portion of the anchor.

26. A method of forming a tissue plication in stomach wall tissue, comprising the steps of:

providing a plication head on an elongate shaft;

advancing the plication head transorally into a stomach;

applying suction to the plication head to draw tissue into a vacuum chamber in the plication head, said tissue including two generally opposed serosal tissue surfaces;

deforming the vacuum chamber to draw the serosal tissue surfaces into proximity with one another to form a plication; and

passing at least one fastener through the plication.

27. The method according to claim 26, wherein the method further includes the step of forming a cutout in the plication.

28. The method according to claim 27, wherein a perimeter of the cutout is sealed by the at least one fastener.

29. The method according to claim 28, wherein the passing step includes passing at least one suture through the plication.

30. The method according to claim 28, wherein the passing step includes passing at least one staple through the plication.

31. The method according to claim 28, wherein the passing step further includes positioning a reinforcing element in proximity to the anvil such that staples passing through the tissue into contact with the anvil will fold around the reinforcing element.

32. The method according to claim 28, wherein the passing step further includes positioning a reinforcing element in proximity to the staple cartridge such that a staple passing from the staple cartridge to the tissue will engage the reinforcing element.

33. The method according to claim 26, wherein the method is further for coupling an anchor to the plication, wherein vacuum chamber includes a flexible anchor positioned within a chamber, wherein the applying step draws the tissue into the anchor, and wherein the passing step passes the fastener through the plication and the anchor.

34. The method according to claim 26, wherein the deforming step is performed prior to the passing step.

35. The method according to claim 26, wherein the deforming step is performed after the passing step.

36. The method according to claim 26, wherein the method includes the step of positioning a reinforcing element between the serosal surfaces, wherein the passing step retains the reinforcing element between the serosal surfaces.

37. The method according to claim 36, wherein the reinforcing element is a mesh element.

38. The method according to claim 26, wherein the method includes the step of applying a sclerosing agent between the serosal surfaces.