WO2008116207A2

WO2008116207A2 - Systems devicesand methods for a gi bypass

Info

Publication number: WO2008116207A2
Application number: PCT/US2008/057953
Authority: WO
Inventors: Marc Bessler; Luca Milone
Original assignee: Columbia University
Priority date: 2007-03-21
Filing date: 2008-03-21
Publication date: 2008-09-25
Also published as: WO2008116207A3

Abstract

A method for securing a gastric bypass sheath to the stomach. The sheath is passed into the stomach such that the sheath extends between the esophagus and the pylorus. The sheath is endoscopically anchored to the wall of a portion proximate the esophagus and to the wall of a portion proximate the pylorus. The tissue anchors may include a mesh bolster at the end outside of the gastrointestinal tract. The method may also include surgically forming a gastric bypass that encloses the sheath.

Description

SYSTEMS DEVICESAND METHODS FOR A GI BYPASS

Cross Reference to Related Applications

The present application claims priority to US Provisional Application Nos. 60/896144 filed 21.March.2007, and copending US Application No. 11/458721, filed 2OJuly.2OO6, the entireties of which are hereby incorporated by reference.

Background

This invention relates to systems, devices, and methods for affixing intralumenal devices to a body portion such as body lumen, particularly a GI tract.

Summary

Methods are described for securing a gastric bypass sheath. For example, a method embodiments includes passing a sheath intralumenally into a stomach such that the sheath extends between the esophagus and the pylorus. The sheath is endoscopically anchored at a portion proximate the esophagus and at a portion remote from the esophagus using tissue anchors having one end outside the gastrointestinal tract and one end inside the gastrointestinal tract, the ends being connected by a portion passing through the wall of the gastrointestinal tract. The portion remote from the esophagus may be, and preferably is, proximate the pylorus. The tissue anchors may include a mesh bolster at the end outside of the gastrointestinal tract. The endoscopically anchoring may include passing a needle containing a compressed mesh bolster therewithin at an oblique angle relative to the axis of the wall of the gastrointestinal tract. The tissue anchor end inside the gastrointestinal tract may include a suture that is tied to another suture connected through the wall of the gastrointestinal tract. The endoscopically anchoring may include tying together at least two sutures connected to respective elements located outside the wall of the gastrointestinal tract and passing through the wall of the gastrointestinal tract to form a knot located inside the lumen of the gastrointestinal tract. The tying may include passing at least one of the sutures through a tubular member located inside the lumen of the gastrointestinal tract. The method may also include surgically forming a gastric bypass that encloses the sheath. The sheath may have holes at opposite ends thereof.

The endoscopically anchoring may include forming protuberances inside the gastrointestinal tract and passing a suture attached to an anchor through the protuberances and the sheath.

According to an embodiment, a kit may include a gastric bypass sheath of biocompatible material with a ring of holes at a gastroesophageal and at a pyloric end thereof and a plurality of tissue anchors including a mesh basket at an end thereof and suture lines attached at an end thereof.

Brief Description of the Drawings

Figs. 1A-1E illustrate deployment of a full thickness anchor according to a preferred method.

Fig. 2 illustrates an emplaced bypass sheath secured by tissue anchors.

Fig. 3 illustrates a mechanism for anchoring a sheath without passing tissue anchors through the GI tract.

Fig. 4 illustrates an alternative method of anchoring a sheath.

Detailed Description of the Embodiments

A co-pending application for Method of Inhibiting Disruption of the Healing Process in a Physically Modified Stomach, serial No. 11/458,721 discloses a shunt positioned in a stomach. The shunt has two opposite ends. The first end is held in place at the gastro-esophageal junction. The second end is held in place at the pyloric opening to the duodenum. In the foregoing application, stents are provided at each end of the shunt to hold the shunt in place.

Referring to Fig. 1, in an alterative embodiment, bolsters are used to hold the gastroesophageal (GE) end of the shunt in place. Preferably the bolsters including an expanding element is located outside the wall of the GE region and inserted through the full thickness of the esophagus or the GE region of the stomach by means of an intralumenal delivery device such as a delivery cannula of an endoscope.

As shown in the accompanying sketches a method provides for a sheath to be held in a GI tract by affixation using bolsters on the inside of the stent and on the outside of the GI tract. The bolsters are held together by one or more sutures and tightened to a tension that permits the sheath to be held in place without causing undue pressure and thereby blocking blood flow to the wall of tissue to which the sheath is anchored.

Tissue anchors are described in US Patent Application number 11/404423, filed April 14, 2006 and US Patent Application number 11/773933, filed July 5, 2007, both of which are hereby incorporated by reference in their entireties. These applications describe expanding tissue anchors and methods of securing them to tissue plications via an endoscope. These tissue anchors may be used as the bolsters described in the present embodiments.

Thus, a first bolster on the outside of the GI tract and a second bolster on the inside of the stent hug the respective wall structures of the GI tract and the stent together such that there is little or no axial movement of the stent relative to the GI tract. Referring to Figs. IA- IE, preferably, bolsters 38, 40 are introduced into the GI tract and the sheath 118 endoscopically via a hollow needle 20 guided by an articulating cannula of an endoscopic tool 16. Note that bolsters 38, 40 are illustrated schematically by the X-shapes and may be of any suitable type. The needle may be guided such that it enters the GI tract wall (either at the GE or pyloric end one or both of which ends may be affixed) at an oblique angle relative to the sheath 118 axis as illustrated. The angle is preferably chosen to reduce the tendency of the needle tip 18 to cut tissue outside the GI tract wall 100 once the latter is pierced. The sheath described in US Application No. 11/458,721 may be modified by providing holes 28 to accommodate the needle 20. The needle 20 preferably houses the bolsters 35, 40 entirely within the needle lumen 20. The needle tip may be positioned perpendiculary to the sheath 118 axis, initially, and than angled as force is applied to advance it through the GI tract wall 100. Alternatively, a sheath 118 without holes may be used and the needle tip 18 may be used to pierce the sheath 118 at locations that are deemed desirable after inspection once the sheath 118 is in place.

Holes may be formed in the sheath 118 and arranged in a manner similar to the holes described in US Application No. 11/773933, which are formed in a cuff 102. The holes may be similarly formed at the pyloric end of the sheath of US Application No. 11/458,721. Preferably, the number of bolsters

Once the needle tip is located at the securement position within the GI tract and the sheath, the sharp end of the needle tip is passed through the wall of the sheath and the wall of the GI tract such that the tip of the needle 20 is outside the GI tract, as described above. A first bolster 38 is passed through the lumen of the needle and then urged through the needle tip 18 to exit into a space between the GI tract wall 100 and the adjacent tissue. The space may be obtained by insufflation or by means of a Verres needle or other suitable mechanism. The exiting bolster 38 may be provided with a trailing suture line or any other suitable connecting member. The bolster 38, which is in a compressed state while in the needle lumen, expands to a predetermined diametrical or peripheral size and shape at the outside of the GI tract that enables the bolster to remain outside the wall of the GI tract while the needle tip 18 is withdrawn into the sheath 118. As the needle tip 18 is withdrawn inside the sheath 118 the suture line 19 remains connected to the first bolster 38 and extends inwardly from the needle tip 18 into the needle lumen.

With the needle tip 18 now located within the sheath a second bolster 40. also attached to the suture line 19 connected to the first bolster 38, is urged outwardly from the needle tip 18 and placed adjacent sheath wall 118W. The second bolster 40 at the inside of the sheath 118 is connected to the first bolster 38 at the outside of the GI tract via the suture line 19. The suture line 19 includes a proximal portion 21 that extends from the second bolster 40 inside the needle lumen.

The bolsters 38, 40, after being positioned as illustrated in Fig. ID may be urged together by tying a knot in the suture line proximal portion 21 or by urging a cinch (for example as described with reference to reference numeral 102, Fig. 2OA in US Patent Application No. 11/773933). Preferably, the tension is controlled to prevent ischemia in the GI tract wall 100 under compression, the bolsters 38, 40 may be placed in a circle around the GE end of the sheath 118 and the pyloric and of the sheath 118.

Referring to Fig. 2, preferably, bolsters 110, 112 are placed in a ring pattern in sufficient quantity to support the sheath in spite of the forces associated with normal movement of the GI tract. Again, the above procedure may be repeated to affix other sets of pairs sets of bolsters 110, 112 at the GE end 132 of the sheath 118 and also, preferably, at the pyloric end 130 of the sheath. As described in the application 11/458721 incorporated by reference above, the sheath 118 may be provided for temporary support of a surgical bypass illustrated figuratively by the suture line 122 through the stomach 120.

Preferably, bolsters 38, 40, 110, 112 are mesh type anchors that facilitate ingrowth of tissue and/or promote scar formation to help distribute the stresses of the supporting function they provide. Examples of such bolsters are the mesh-type anchors described in US Patent Application No. 11/773933.

Referring to Fig. 3, in addition to the anchor technique described above, the GI tract may be protracted intralumenally, perhaps sufficiently to form plications, and anchored on both sides of the resulting folds or protuberances 219 thereby formed. The sheath 218 may anchored to the folds or protuberances 219 by opposing pairs of bolsters 202. For example, as described in US Patent Application No. 10/954665, filed 29.September.2004 and described with reference to Figs. 3A-3G or UP Patent No. 7229428, filed 23.October.2002 (Note Fig. 5D and related text and figures which show an annular protrusion or stoma to which may be formed at the GE portion and pyloric portions of the GI tract to anchor the sheath 118). The applications 10/954665 and patent 7229428 are hereby incorporated by reference.

The methods for emplacement may be similar to those described in US Patent Application Nos. 11/773933, 11/035,702 (filed 14January.2OO5), hereby incorporated by reference, and others in the patents and applications incorporated by reference above.

Additional bolsters can also be used around the circumference of the sheath at any longitudinal location of the sheath and the GI tract in the manner previously described. Referring to Fig. 4, another way to secure sheath 118 using bolsters 312, located outside the GI tract, only, is to tie suture lines 314 together within the sheath 118. At 307, suture lines 314 are shown, before being tied, run through a supporting tubular member 310, such as a cylindrical basket or plastic tube, provided to prevent the suture lines 314 tearing the sheath 118. At 305, the suture lines 314 have been tied and tightened holding the tubular member 310 against the sheath 118. Although only a few bolster 312 are shown, any number can be tied together to provide support. Any number of bolsters 312 can be sutured together at the inside of the sheath thus providing a ring of bolsters 312 located outside the GI tract and supporting the sheath while preventing excessive stress on the GI tract. In this embodiment bolsters may also be used inside the sheath for relieving stress on the wall of the sheath 118.

Note that the sheath 118 may extend well beyond the pylorus in alternative embodiments. Note also that in embodiments, the sheath may be used in a method that provides a temporary support for a surgical bypass formed surgically without permanent artificial fixtures. The sheath may be made of any suitable biocompatible material such as silicone or polyurethane.

Claims

1. A method of securing a gastric bypass sheath, comprising: passing a sheath intralumenally into a stomach such that the sheath extends between the esophagus and the pylorus; endoscopically anchoring the sheath at a portion proximate the esophagus and at a portion remote from the esophagus using tissue anchors having one end outside the gastrointestinal tract and one end inside the gastrointestinal tract, the ends being connected by a portion passing through the wall of the gastrointestinal tract.

2. The method of claim 1, wherein the portion remote from the esophagus is proximate the pylorus.

3. The method of claim 1, wherein the tissue anchors include a mesh bolster at the end outside of the gastrointestinal tract.

4. The method of claim 1, wherein the endoscopically anchoring includes passing a needle containing a compressed mesh bolster therewithin at an oblique angle relative to the axis of the wall of the gastrointestinal tract.

5. The method of claim 4, wherein the tissue anchor end inside the gastrointestinal tract includes a suture that is tied to another suture connected through the wall of the gastrointestinal tract.

6. The method of 1, wherein the endoscopically anchoring includes tying together at least two sutures connected to respective elements located outside the wall of the gastrointestinal tract and passing through the wall of the gastrointestinal tract to form a knot located inside the lumen of the gastrointestinal tract.

7. The method of claim 6, wherein the tying includes passing at least one of the sutures through a tubular member located inside the lumen of the gastrointestinal tract. 10

8. The method of claim 1, further comprising surgically forming a gastric bypass that encloses the sheath.

9. The method of claim 1, wherein the sheath has holes at opposite ends thereof.

10. The method of claim 1, wherein the endoscopically anchoring includes forming protuberances inside the gastrointestinal tract and passing a suture attached to an anchor through the protuberances and the sheath.

11. A gastric bypass sheath kit, comprising: a sheath of biocompatible material with a ring of holes at a gastroesophageal and at a pyloric end thereof; a plurality of tissue anchors including a mesh basket at an end thereof and suture lines attached at an end thereof.