Transesophageal gastric reduction method and device for reducing the size of a previously formed gastric reduction pouch

Abstract

A gastric reduction pouch of a stomach is formed by gathering stomach tissue circumferentially from within the stomach to form a reduced diameter stomach section. A plurality of fasteners are deployed within the gathered stomach tissue to maintain the reduced diameter stomach portion. The gathering step may include folding the stomach tissue to produce a plurality of stomach tissue folds. A device is disclosed that is particularly adapted to permit such gastric reduction of a previously formed gastric reduction pouch.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

The features of the present invention which are believed to be novel are set forth with particularity in the appended claims. The invention, together with further features and advantages thereof, may best be understood by making reference to the following description taken in conjunction with the accompanying drawings, in the several figures of which like reference numerals identify identical elements, and wherein:

FIG. 1 is a front cross-sectional view of the esophageal-gastro-intestinal tract from a lower portion of the esophagus to the duodenum;

FIG. 2 is a perspective side view with portions cut away illustrating a reduced diameter stomach portion which may be formed according to the present invention for forming a gastric reduction pouch;

FIG. 3 is a cross sectional view of the reduced diameter stomach portion shown in FIG. 2;

FIG. 4 is another cross sectional view of the reduced diameter stomach portion shown in FIG. 2;

FIG. 5A is a cross sectional side view illustrating another reduced diameter stomach portion which may be formed according to the present invention for forming a gastric reduction pouch;

FIG. 5B is another cross sectional view of the reduced diameter stomach portion shown in FIG. 5A;

FIG. 6 is a cross sectional side view illustrating still another reduced diameter stomach portion which may be formed according to the present invention for forming a gastric reduction pouch;

FIG. 7 is a plan view of a device embodying the present invention;

FIG. 8 is a partial perspective view, with portions cut away, of the distal end of another device embodying the present invention;

FIG. 9 is a partial perspective view, with portions cut away, of the device of FIG. 8 in the process of folding stomach tissue in accordance with an embodiment of the present invention;

FIG. 10 is a partial perspective view, with portions cut away, of the device of FIG. 8 in the process of deploying a fastener through folded stomach tissue in accordance with an embodiment of the present invention;

FIG. 11 is a partial perspective view, with portions cut away, of the device of FIG. 8 after folding stomach tissue and deploying a fastener through the folded stomach tissue in accordance with an embodiment of the present invention;

FIG. 12 is a partial perspective view, with portions cut away, of the distal end of another device embodying the present invention;

FIG. 13 is a partial perspective view, with portions cut away, of the device of FIG. 12 after folding stomach tissue and deploying a pair of fasteners through the folded stomach tissue;

FIG. 14 is a partial perspective view, with portions cut away, of the distal end of another device embodying the present invention in the process of pulling stomach tissue to be folded towards the device;

FIG. 15 is a partial perspective view, with portions cut away, of the device of FIG. 14 after pulling the stomach tissue to be folded to the entrance of the device;

FIG. 16 is a partial perspective view, with portions cut away, of the device of FIG. 14 in the process of folding stomach tissue in accordance with an embodiment of the present invention;

FIG. 17 is a partial perspective view, with portions cut away, of the device of FIG. 14 in the process of deploying a fastener through folded stomach tissue in accordance with an embodiment of the present invention;

FIG. 18 is a partial perspective view, with portions cut away, of the device of FIG. 14 just after deploying a fastener through the folded stomach tissue;

FIG. 19 is a partial perspective view, with portions cut away, of the device of FIG. 14 after folding stomach tissue and deploying a fastener through the folded stomach tissue in accordance with an embodiment of the present invention;

FIG. 20 is a partial perspective view, with portions cut away, of the distal end of another device embodying the present invention in the process of folding stomach tissue in accordance with another embodiment of the present invention;

FIG. 21 is a partial perspective view, with portions cut away, of the device of FIG. 20 in the process of deploying a fastener through folded stomach tissue in accordance with an embodiment of the present invention;

FIG. 22 is a partial perspective view, with portions cut away, of the device of FIG. 20 just after deploying a fastener through the folded stomach tissue;

FIG. 23 is a partial perspective view, with portions cut away, of the device of FIG. 22 after folding stomach tissue and deploying a fastener through the folded stomach tissue in accordance with an embodiment of the present invention;

FIG. 24 is a perspective view, to an enlarged scale, of a fastener which may be employed according to an embodiment of the invention;

FIG. 25 is a side plan view, with portions cut away, of the fastener of FIG. 24 being delivered for deployment;

FIG. 26 is a perspective view of the fastener of FIG. 24 fully deployed;

FIG. 27 is a perspective view, to an enlarged scale, of another fastener which may be employed according to an embodiment of the invention;

FIG. 28 is a side plan view, with portions cut away, of the fastener of FIG. 27 being delivered for deployment;

FIG. 29 is a perspective view, to an enlarged scale, of another fastener which may be employed according to an embodiment of the invention;

FIG. 30 is a side plan view, with portions cut away, of the fastener of FIG. 29 being delivered for deployment;

FIG. 31 is a perspective view of the fastener of FIG. 29 fully deployed;

FIG. 32 is a perspective view, to an enlarged scale, of still another fastener which may be employed according to an embodiment of the invention;

FIG. 33 is a side plan view, with portions cut away, of the fastener of FIG. 32 being delivered for deployment;

FIG. 34 is a cross-sectional side view of the fastener of FIG. 32 fully deployed;

FIG. 35 is a partial perspective view, with portions cut away, of the distal end of another device embodying the present invention in the process of folding stomach tissue in accordance with another embodiment of the present invention;

FIG. 36 is a partial perspective view, with portions cut away, of the device of FIG. 35 in the process of deploying a fastener through folded stomach tissue in accordance with an embodiment of the present invention;

FIG. 37 is a partial perspective view, with portions cut away, of the device of FIG. 35 after folding stomach tissue and deploying a fastener through the folded stomach tissue in accordance with an embodiment of the present invention;

FIG. 38 is a cross sectional side view illustrating another reduced diameter stomach portion which may be formed by the device of FIG. 35 according to another embodiment of the present invention;

FIG. 39 is a side plan view, with portions cut away, of the distal end of another device embodying the present invention;

FIG. 40 is a perspective view of the tissue chamber of the device of FIG. 39;

FIG. 41 is a perspective view of the duck bill valve of the device of FIG. 39;

FIG. 42 is a side plan view, with portions cut away, of the distal end of the device of FIG. 39 showing an endoscope passing there through in accordance with the present invention;

FIG. 43 is a side plan view, with portions cut away, of the device of FIG. 39 in the process of folding tissue of a stomach that previously was the subject of gastric reduction surgery in accordance with an embodiment of the present invention;

FIG. 44 is a side plan view, with portions cut away, of the device of FIG. 39 after folding stomach tissue and deploying a fastener through the folded stomach tissue in accordance with an embodiment of the present invention;

FIG. 45 is a perspective view of an alternative duck bill valve which may be employed in the device of FIG. 39;

FIG. 46 is a top plan view of the duck bill valve of FIG. 45;

FIG. 47 is a side plan view of the duck bill valve of FIG. 45; and

FIG. 48 is a side plan view, with portions cut away, of another device embodying the invention in the process of folding tissue of a stomach that previously was the subject of gastric reduction surgery and deploying a fastener through the folded stomach tissue.

Claims

1. An apparatus comprising: an elongated member having a through lumen and a distal end for transoral placement in the stomach, the lumen being dimensioned to permit an endoscope to be passed there through; anda valve at the distal end of the elongated member and communicating with the lumen, the valve being configured to permit the endoscope to pass there through into the stomach, to seal the lumen from the stomach when the endoscope is passed there through into the stomach and to seal the lumen from the stomach when the endoscope is retracted from the valve.

2. The apparatus of claim 1, wherein the valve comprises a duckbill valve.

3. The apparatus of claim 2, wherein the duckbill valve has a proximal end communicating with the elongated member lumen and a distal end, wherein the proximal end has a transverse dimension and the distal end has a transverse dimension that is greater than the proximal end transverse dimension when the endoscope is retracted from the valve.

4. A device for forming and maintaining tissue folds from within the stomach comprising: an elongated member having a distal end for transoral placement in the stomach;a tissue gatherer carried on the distal end of the elongated member for placement into the stomach, the tissue gatherer defining a tissue chamber including an opening to permit tissue to be pulled into the tissue chamber under vacuum to form a tissue fold within the tissue chamber, the tissue chamber having a cross-sectional dimension, the cross-sectional dimension being greater proximal from the opening than distal from the opening; anda fastener deployer that directs a fastener into the tissue chamber and through the folded tissue for binding the tissue fold.

5. The device of claim 4, wherein the tissue chamber has an upper chamber portion proximal to the opening and a lower chamber portion distal to the opening, and wherein the upper chamber portion is greater in volume than the lower chamber portion.

6. The device of claim 4, wherein the tissue chamber is defined by a wall opposite the opening arranged to engage the tissue fold to seal the chamber distal to the opening under vacuum.

7. The device of claim 6, wherein the wall arranged to engage the tissue fold to seal the chamber distal to the opening under vacuum comprises a tapered wall portion opposite the opening.

8. The device of claim 4, further comprising a valve at the distal end of the elongated member and communicating with the tissue chamber, the valve being configured to permit an endoscope to pass through into the stomach from the tissue chamber, to seal the tissue chamber from the stomach when the endoscope is passed there through into the stomach and to seal the tissue chamber from the stomach when the endoscope is retracted from the valve.

9. The device of claim 8, wherein the valve comprises a duckbill valve.

10. The device of claim 9, wherein the duckbill valve has a proximal end communicating with the tissue chamber and a distal end, wherein the proximal end has a transverse dimension and the distal end has a transverse dimension that is greater than the proximal end transverse dimension when the endoscope is retracted from the valve.

11. The device of claim 4, wherein the fastener deployer directs a fastener into the tissue chamber and through the folded tissue adjacent to the opening.

12. The device of claim 11, further comprising a valve at the distal end of the elongated member and communicating with the tissue chamber, the valve being configured to permit an endoscope to pass through into the stomach from the tissue chamber, to seal the tissue chamber from the stomach when the endoscope is passed there through into the stomach and to seal the tissue chamber from the stomach when the endoscope is retracted from the valve.

13. The device of claim 12, wherein the valve comprises a duckbill valve.

14. The device of claim 13, wherein the fastener deployer includes a guide lumen that guides a fastener deployment stylet through the stomach tissue fold, the fastener deployment stylet having a distal end and arranged to guide a fastener through the stomach tissue fold, and wherein the valve is arranged to receive the distal end of the stylet.

15. The device of claim 14, wherein the valve has a center axis and a major transverse axis, and wherein the guide lumen is arranged to direct the stylet along a line through the major transverse axis and substantially parallel to the center axis.

16. The device of claim 7, wherein the fastener deployer includes a guide lumen that guides a fastener deployment stylet through the stomach tissue fold, the fastener deployment stylet having a pointed distal end and arranged to guide a fastener through the stomach tissue fold, and wherein the tapered wall portion has an inner surface including a plate structure arranged to deflect the pointed distal end of the stylet.

17. A method of reducing a gastric reduction pouch of a stomach in size, comprising: gathering stomach tissue from within the stomach to form a stomach tissue fold;deploying at least one fastener within the gathered stomach tissue to maintain the stomach tissue fold; andrepeating the gathering and deploying steps until a gastric reduction pouch of a desired size is formed.

18. The method of claim 17, wherein the repeated gathering steps include forming stomach tissue folds that are substantially parallel to each other.

19. The method of claim 17, wherein the repeated gathering steps include forming stomach tissue folds that are substantially axially disposed.

20. The method of claim 17, wherein the repeated gathering steps include forming stomach tissue folds that are substantially non-axially disposed.

21. The method of claim 17, wherein the gathering step comprises pulling the stomach tissue through an elongated opening.

22. The method of claim 21, wherein the pulling step includes applying a vacuum to the stomach tissue.