METHODS FOR REDUCING GASTRIC VOLUME

• US 20110009887A1
• Filed: 09/03/2010
• Published: 01/13/2011
• Est. Priority Date: 03/13/2007
• Status: Active Grant

• Current Assignee: Longevity Surgical, Inc.
• Original Assignee: Longevity Surgical, Inc.
• Inventors: RABIN, Barry Hal, HARRIS, Peter S.
• Granted Patent: US 8,100,921 B2
• Time in Patent Office: Days
• US Class Current: 606/153
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/0684 having a forming anvil staying above the tissue during stapling
• CPC Class Codes: A61B 17/083 Clips, e.g. resilient
• CPC Class Codes: A61B 17/10 for applying or removing wound clamps, e.g. containing only one clamp or staple A61B17/076 takes precedence; containing multiple wound clamps A61B17/068; Wound clamp magazines containers, packaging elements or packages specially adapted for particular articles or with special means for dispensing contents B65D83/00, B65D85/00
• CPC Class Codes: A61B 2017/00349 Needle-like instruments having hook or barb-like gripping means, e.g. for grasping suture or tissue A61B17/06066 takes precedence
• CPC Class Codes: A61B 2017/00818 Treatment of the gastro-intestinal system
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61F 5/0086 using clamps, folding means or the like
• CPC Class Codes: A61F 5/0089 Instruments for placement or removal

Abstract

The present invention involves new interventional methods for reducing gastric volume, and thereby treating obesity. The procedures are generally performed laparoscopically and may generally be described as laparoscopic plication gastroplasty (LPG) in which, after obtaining abdominal access, spaced apart sites on a gastric wall are engaged, approximated and fastened to create one or more tissue folds forming one or more plications projecting into the gastrointestinal space. The serosal tissue may optionally be treated during the procedure to promote the formation of a strong serosa-to-serosa bond that ensures the long-term stability of the tissue plication. These procedures are preferably carried out entirely extragastrically (i.e. without penetrating through the gastrointestinal wall), thereby minimizing the risks of serious complications.

Claims

1. A method for reducing gastric volume comprising:

accessing an external surface of a wall of the gastrointestinal tract;

positioning the distal end of at least one device in proximity to the external surface of the wall of the gastrointestinal tract;

manipulating said device to engage at least a first tissue site and a second tissue site spaced apart from the first tissue site on the external surface of the wall of the gastrointestinal tract;

manipulating said device to approximate said engaged, spaced apart tissue sites to create at least one invaginated tissue fold extending from the approximated tissue sites into an interior space of the gastrointestinal tract; and

fastening the approximated tissue sites to one another to secure the tissue fold.

2. The method of claim 1, additionally comprising operating said device to fasten the approximated tissue sites to one another to secure the tissue fold.

3. The method of claim 1, further comprising:

repositioning the device to a second location in proximity to the external surface of the wall of the gastrointestinal tract spaced apart from the first location;

manipulating said device at the second location to engage at least a third tissue site and a fourth tissue site spaced apart from the third tissue site;

approximating said engaged third and fourth tissue sites; and

fastening the approximated third and fourth tissue sites to one another.

4. The method of claim 1, further comprising:

repositioning the device to a second location in proximity to the external surface of the wall of the gastrointestinal tract spaced apart from the first location;

manipulating said device at the second location to engage at least a third tissue site and a fourth tissue site spaced apart from one another and spaced on opposite tissue surfaces with respect to the tissue fold;

approximating the third and fourth tissue sites to form an extension of the tissue fold; and

fastening the approximated third and fourth tissue sites to one another to secure the extension of the fold.

5. The method of claim 1, further comprising approximating spaced apart third and fourth tissue sites positioned on opposite tissue surfaces with respect to the previously created tissue fold and securing the approximated third and fourth tissue sites to one another, thereby increasing the depth of the tissue fold extending into the interior space of the gastrointestinal tract.

6. The method of claim 1, wherein the tissue within said at least one tissue fold are arranged to provide substantially intimate serosa to serosa contact of at least a portion of tissue within the tissue fold.

7. A method for reducing gastric volume comprising, sequentially:

accessing an external surface of a wall of the gastrointestinal tract;

engaging at least two spaced apart tissue sites on the external surface of a wall of the gastrointestinal tract;

approximating the engaged, spaced apart tissue sites to create at least one invaginated tissue fold; and

applying a fastener to fasten the approximated tissue sites to one another to secure the tissue fold, thereby creating at least one plication extending into the interior space of the gastrointestinal tract, wherein the fastener is selected from the group consisting of;

sutures, staples, screws, tacks, clips, hooks, clamps, t-tags, and helical fasteners, and combinations of the foregoing.

8. The method of claim 7, comprising accessing the abdominal cavity through a laparoscopic incision.

9. The method of claim 7, comprising accessing the abdominal cavity through an endoscopic incision.

10. The method of claim 7, wherein approximating the tissue sites involves moving at least one engaged tissue site toward another tissue site using a type of motion selected from the group consisting of pulling motions, pushing motions, twisting motions, shearing motions, and combinations of the foregoing.

11. The method of claim 7, wherein approximating the tissue sites involves moving at least one engaged tissue site toward another tissue site using a pulling motion and moving tissue between the tissue sites using a pushing motion.

12. The method of claim 11, wherein said pulling motion and said pushing motion are performed sequentially.

13. The method of claim 11, wherein said pulling motion and said pushing motion are performed simultaneously.

14. A method for reducing gastric volume comprising:

accessing an external surface of a wall of the gastrointestinal tract;

engaging the external surface of a wall of the gastrointestinal tract at a first tissue site and at a second tissue site spaced apart from the first tissue site;

manipulating tissue at the engaged first and/or second tissue sites to approximate the first and second tissue sites and form an invaginated tissue fold; and

fastening tissue in proximity to the approximated first and second tissue sites to secure the tissue fold, thereby creating at least one plication extending into the interior space of the gastrointestinal tract.

15. The method of claim 14, comprising fastening tissue by application of at least one fastener selected from the group consisting of:

sutures, staples, screws, tacks, clips, hooks, clamps, t-tags, and helical fasteners, and combinations of the foregoing.

16. The method of claim 14, additionally comprising engaging, approximating and fastening tissue by penetrating at least the serosal layer while penetrating fewer than all of the layers of the wall of the gastrointestinal tract.

17. The method of claim 14, additionally comprising treating at least a portion of the external surface of the wall of the gastrointestinal tract to promote serosa to serosa bonding within the plication.

18. The method of claim 17, wherein the treatment is selected from the group consisting of physically disrupting the tissue surface, administering an agent to the tissue surface, or applying energy to the tissue surface, and combinations of the foregoing.

19. The method of claim 14, further comprising manipulating tissue at the first tissue site and/or second tissue site to approximate the first and second tissue sites by moving at least one engaged tissue site toward another tissue site.

20. The method of claim 14, further comprising manipulating tissue at the first tissue site and/or second tissue site to approximate the first and second tissue sites by moving at least two engaged tissue sites toward one another.

21. The method of claim 14, wherein the portion of the external surface of a wall of the gastrointestinal tract is a portion of the external surface of the stomach.

22. The method of claim 14, wherein the portion of the external surface of a wall of the gastrointestinal tract is selected from the group consisting of:

the anterior surface of the stomach, the posterior surface of the stomach, and a combination of both the anterior and posterior surfaces of the stomach.

23. The method of claim 14, wherein forming and securing the invaginated tissue fold produces contacting of at least a portion of the tissue surfaces within said at least one plication, thereby providing substantially intimate serosa to serosa contact of at least a portion of the tissue surfaces within said at least one plication.

24. The method of claim 14, wherein the gastrointestinal tract is the stomach and the plication decreases the functional volume of the stomach by at least 20%.

25. The method of claim 14, wherein the gastrointestinal tract is the stomach and the plication decreases the functional volume of the stomach by at least 30%.

26. The method of claim 14, wherein the gastrointestinal tract is the stomach and the plication decreases the functional volume of the stomach by at least 40%.

27. The method of claim 14, wherein the gastrointestinal tract is the stomach and the plication decreases the functional volume of the stomach by at least 50%.