US20160213460A1

US20160213460A1 - Esophageal stents

Info

Publication number: US20160213460A1
Application number: US14/930,656
Authority: US
Inventors: Jon St. Germain; Cole Chen; Roland Maude-Griffin; Johann Neisz; Sean Miller
Original assignee: ValenTx Inc
Current assignee: ValenTx Inc
Priority date: 2014-10-31
Filing date: 2015-11-02
Publication date: 2016-07-28
Also published as: US20160193065A1; US20190336268A1; WO2016070199A1; US20160193063A1; US10368973B2; WO2016070198A1; US10226324B2

Abstract

Luminal devices are described. In one embodiment, a luminal device includes an esophageal stent and an anchoring membrane coupled to the esophageal stent. The anchoring membrane may be configured to be coupled to an esophageal wall with a tissue anchor placed through the anchoring membrane. The anchoring membrane may be configured to be pierced to allow the tissue anchor to be placed through the anchoring membrane.

Methods for attaching a luminal device to the esophageal wall are described. In one embodiment, a method may include forming a bulge in an anchoring membrane of the luminal device and the esophageal wall, piercing the bulge from a first side of the anchoring membrane and a first side of the esophageal wall, placing a second retention element of a tissue anchor on a second side of the esophageal wall; and placing a tension element of the tissue anchor through the anchoring membrane and the esophageal wall. The tension element may be coupled to the second retention element. The method may further include placing a first retention element on the first side of the anchoring membrane. The first retention element may be coupled to the tension element.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. provisional application Nos. 62/073,927, filed Oct. 31, 2014, and 62/147,588, filed Apr. 15, 2015. These applications are hereby incorporated by reference in their entireties.

BACKGROUND

Esophageal stents are used to treat strictures and malignances in the esophagus. Esophageal stents are also used to treat fistulas, perforations, and leaks in the esophagus.
An esophageal stent may be held in place by its own outward bias. However, the esophageal stent may migrate out of position, or migrate completely out of the esophagus. An esophageal stent may be held in place by tissue ingrowth portions which allow the esophageal wall to grow into the esophageal stent. However, the esophageal stent subsequently becomes difficult to remove or reposition.
What is needed is an esophageal stent which reduces the likelihood of migrating out of position. What is needed is an esophageal stent which reduces the likelihood of migrating out of position, and also allows subsequent removal or repositioning.

SUMMARY

Luminal devices are described. In one embodiment, a luminal device includes an esophageal stent and an anchoring membrane coupled to the esophageal stent. The anchoring membrane may be configured to be coupled to an esophageal wall with a tissue anchor placed through the anchoring membrane. The anchoring membrane may be configured to be pierced to allow the tissue anchor to be placed through the anchoring membrane.
Methods for attaching a luminal device to the esophageal wall are described. In one embodiment, a method may include forming a bulge in an anchoring membrane of the luminal device and the esophageal wall, piercing the bulge from a first side of the anchoring membrane and a first side of the esophageal wall, placing a second retention element of a tissue anchor on a second side of the esophageal wall; and placing a tension element of the tissue anchor through the anchoring membrane and the esophageal wall. The tension element may be coupled to the second retention element. The method may further include placing a first retention element on the first side of the anchoring membrane. The first retention element may be coupled to the tension element.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A shows one embodiment of luminal device 1100. FIG. 1B shows another embodiment of luminal device 1100.

FIGS. 2A-2C shows two embodiments of a tissue anchor 1300.

FIGS. 3A-3D show one embodiment of an anchor delivery device 1600.

FIGS. 4A-4J show one embodiment of a method for delivering a luminal device.

DESCRIPTION

FIG. 1A shows one embodiment of a luminal device 1100. FIG. 1B shows another embodiment of luminal device 1100.
Luminal device 1100 may be configured to treat strictures, malignancies, fistulas, perforations, and leaks in the esophagus.
Luminal device 1100 may include an esophageal stent 1120.
Esophageal stent 1120 may be configured to be placed at least partially in the esophagus. Esophageal stent 1120 may be placed against the esophageal wall. Esophageal stent 1120 may be configured to be placed through a stricture or malignancy in the esophagus. Esophageal stent 1120 may be configured to keep the esophagus at least partially open through a stricture or malignancy in the esophagus. Esophageal stent 1120 may be configured to be placed against a fistula, perforation, or leak in the esophageal wall. Esophageal stent 1120 may be configured to reduce leakage from a fistula, perforation, or leak in the esophageal wall.
Esophageal stent 1120 may include a scaffold 1125. Scaffold 1125 may include a proximal portion 1125 p, a middle portion 1125 m, and a distal portion 1125 d.
Scaffold 1125 may be configured to have an outward bias. Scaffold 1125 may be configured to have an outward bias sufficient to keep the esophagus at least partially open through a stricture or malignancy in the esophagus. Scaffold 1125 may have an outward bias sufficient to keep the esophagus at least 10% open through the stricture or malignancy in the esophagus.
Scaffold 1125 may have a width that is constant. Scaffold 1125 may have a width greater at proximal portion 1125 p and/or distal portion 1125 d.
Scaffold 1125 may include a braid 1126. Braid 1126 may be made of plastic, metal, or other suitable material. Braid 1126 may have uniform or varying opening sizes. Scaffold 1125 may include a stent, a mesh, or other suitable structure.
Esophageal stent 1120 may include a liner 1121. Liner 1121 may be coupled to scaffold 1125. Liner 1121 may include two or more layers that sandwich scaffold 1125, such as by blow molding. Liner 1121 may include a coating formed on scaffold 1125, such as by dip coating.
Liner 1121 may be configured to line the esophagus. Liner 1121 may be configured to be placed against a fistula, perforation, or leak in the esophageal wall. Liner 1121 may be configured to reduce leakage from a fistula, perforation, or leak in the esophageal wall.
Liner 1121 may be made of silicone, polyethylene, polypropylene, a polyurethane such as PELLETHANE, or other suitable material.
Luminal device 1100 includes an anchor attachment element 1130.
Anchor attachment element 1130 may include at least one anchoring membrane 1131. Anchoring membrane 1131 may include a first side 1131′ and a second side 1131″. Anchoring membrane 1131 is coupled to esophageal stent 1120. Anchoring membrane 1131 may be coupled to proximal portion 1125 p, middle portion 1125 m, distal portion 1125 d, or any part of scaffold 1125. Anchoring membrane 1131 may interrupt scaffold 1125 and/or liner 1121.
Anchoring membrane 1131 may be configured to be placed in the esophagus. Anchoring membrane 1131 may be configured to be placed next to a wall of the esophagus. Anchoring membrane 1131 may be configured to be attached to a tissue anchor. Anchoring membrane 1131 may be configured to be attached to the wall of the esophagus with a tissue anchor placed through anchoring membrane 1131. Anchoring membrane 1131 may be configured to be pierced to allow a tissue anchor to be placed through anchoring membrane 1131 and attach anchoring membrane 1131 to the wall of the esophagus. Anchoring membrane 1131 may be configured to retain a tissue anchor placed through anchoring membrane 1131. Anchoring membrane 1131 may be sufficiently strong to prevent a tissue anchor placed through anchoring membrane from pulling through and/or tearing anchoring membrane 1131.
Anchoring membrane 1131 may be configured to be collapsible. Anchoring membrane 1131 may be configured to be pulled or collapsed with a vacuum applied to first side 1131′ of anchoring membrane 1131. Anchoring membrane 1131 may be configured to be pulled or collapsed with a grasper or hook from first side 1131′ of anchoring membrane 1131. Anchoring membrane 1131 may be configured to be pulled or collapsed toward first side 1131′ of anchoring membrane 1131.
Anchoring membrane 1131 may be flexible. Anchoring membrane 1131 may be stretchable and recover without permanent set.
Anchoring membrane 1131 may include one or more layers. Anchoring membrane 1131 may be made of silicone, polyethylene, polypropylene, a polyurethane such as PELLETHANE, or other suitable material.
Anchoring membrane 1131 may include one or more perforations 1132 formed in anchoring membrane 1131.
Perforations 1132 may be configured to allow at least a portion of a vacuum applied to one side of anchoring membrane 1131 to reach through anchoring membrane 1131. Perforations 1132 may be configured to allow at least a portion of a vacuum applied to anchoring membrane 1131 to reach a tissue wall placed next to anchoring membrane 1131. Perforations 1132 may be configured to allow at least a portion of a vacuum applied to first side 1131′ of anchoring membrane 1131 to reach a tissue wall placed next to second side 1131″ of anchoring membrane 1131.
Perforations 1132 may include any one or any combination of holes, slits, and other openings of any suitable shape and size.
Anchoring membrane 1131 may include one or more pulls 1133. Pulls 1133 may be coupled to anchoring membrane 1131 and/or reinforcement structure 1135. Pulls 1133 may extend from first side 1131′ of anchoring membrane 1131.
Pulls 1133 may be configured to allow anchoring membrane 1131 to be pulled or collapsed. Pulls 1133 may be configured to allow anchoring membrane 1131 to be pulled or collapsed toward first side 1131′ of anchoring membrane 1131.
Pulls 1133 may include any one or any combination of loops, tabs, and other suitable structures. Pulls 1133 may be made of a biodegradable material.
Anchoring membrane 1131 may include one or more creases 1134. Creases 1134 may be formed by scoring anchoring membrane 1131 and/or forming thinner portions of anchoring membrane 1131. Creases 1134 may be configured to allow anchoring membrane 1131 to collapse along creases 1134. Creases 1134 may allow anchoring membrane 1131 ato be more easily and/or predictably pulled or collapsed.
Anchor attachment element 1130 may include a reinforcement structure 1135. Reinforcement structure 1135 may be coupled to anchoring membrane 1131.
Reinforcement structure 1135 may be configured to reinforce anchoring membrane 1131. Reinforcement structure 1135 may be configured to retain a tissue anchor placed through reinforcement structure 1135. Reinforcement structure 1135 may be configured to reduce the likelihood of a tissue anchor placed through anchoring membrane 1131 pulling through and/or tearing anchoring membrane 1131.
Reinforcement structure 1135 may include a braid 1136. Braid 1136 may have uniform or varying opening sizes. Braid 1136 may be made of plastic, metal, or other suitable material. Reinforcement structure 1135 may include a stent, mesh, or other suitable structure.
Reinforcement structure 1135 may be coupled between two layers of anchoring membrane 1131. Reinforcement structure 1135 may be coupled between two layers of anchoring membrane 1131 blow molded to sandwich reinforcement structure 1135. Reinforcement structure 1135 may provide a substrate on which at least a portion of anchoring membrane 1131 is formed, such as by dip coating, spray coating, or other suitable methods.
Reinforcement structure 1135 may include one or more creases 1137. Creases 1137 may be formed by scoring reinforcement structure 1135 and/or forming thinner portions of reinforcement structure 1135. Creases 1137 may be configured to allow reinforcement structure 1135 to collapse along creases 1137. Creases 1137 may allow reinforcement structure 1135 ato be more easily and/or predictably pulled or collapsed.
Liner 1121 and anchoring membrane 1131 may have the same or different properties. Liner 1121 and anchoring membrane 1131 may be made of the same or different materials and/or thicknesses.
Scaffold 1125 and reinforcement structure 1135 may have the same or different properties. Scaffold 1125 and reinforcement structure 1135 may be made of the same or different materials and/or thicknesses. Scaffold 1125 may overlap with reinforcement structure 1135.
Any combination of liner 1121, anchoring membrane 1131, scaffold 1125, and reinforcement structure 1135 may be formed as one or more pieces. For example, anchoring membrane 1131 and reinforcement structure 1135 may be formed as a single piece.
Esophageal stent 1120 and anchoring membrane 1131 may have the same or different widths.
Esophageal stent 1120 may have a length of approximately 20 mm to 150 mm. Anchoring membrane 1131 may have a length of approximately 10 mm to 40 mm. Esophageal stent 1120 and anchoring membrane 1131 may have widths of approximately 15 mm to 35mm.
Luminal device 1100 may include one or more drawstrings 1152. Drawstrings 1152 may be coupled to esophageal stent 1120 and/or anchoring membrane 1131. Drawstrings 1152 may be at least partially coupled around esophageal stent 1120 and/or anchoring membrane 1131. Drawstrings 1152 may be configured to reduce a width of esophageal stent 1120 and/or anchoring membrane 1131 for delivery and/or removal of luminal device 1100. Drawstrings 1152 may be removable or non-removable. One or more drawstrings 1152 may include a loose portion forming a loop 1152′ which may facilitate grasping drawstring 1152.
Luminal device 1100 may include at least one stiffening member 1154. Stiffening member 1154 may be coupled along at least a portion of a length of luminal device 1100. Stiffening member 1154 may be configured to reduce the likelihood of esophageal stent 1120 and/or anchoring membrane 1131 inverting. Stiffening member 1154 may be bonded to esophageal stent 1120 and/or anchoring membrane 1131. Stiffening member 1154 may be elongate. Stiffening member 1154 be made of metal, plastic, or other suitable material. Stiffening member 1154 may be radiopaque.
Luminal device 1100 may include one or more radiopaque markers 1156. Radiopaque markers 1156 may be coupled to esophageal stent 1120 and/or anchoring membrane 1131. Radiopaque markers 1156 may be configured to facilitate delivery of luminal device 1100.
Luminal device 1100 may include one or more tissue ingrowth elements 1180. Tissue ingrowth elements 1180 may be configured to allow the esophageal wall to grow into esophageal stent 1120 and/or anchoring membrane 1131.
Tissue ingrowth elements 1180 may include one or more holes 1181 formed in esophageal stent 1120 and/or anchoring membrane 1131. Holes 1181 may be configured to allow tissue ingrowth. Tissue ingrowth elements 1180 may include exposed portions of scaffold 1125. Tissue ingrowth elements 1180 may include exposed portions of reinforcement structure 1135.
Luminal device 1100 may include a tissue anchor 1300. Luminal device 1100 may include any of the tissue anchors described in U.S. patent application nos. VALENTX 028A1 and VALENTX 028A2, filed Oct. 31, 2015, and U.S. patent application publication nos. 2009/0012541 and 2015/0018745, each of which are incorporated by reference.
FIGS. 2A-2C show embodiments of a tissue anchor 1300. FIGS. 2A-2B show perspective and side views, respectively, of one embodiment of tissue anchor 1300. FIG. 2C shows another embodiment of tissue anchor 1300.
Tissue anchor 1300 may be configured to attach a device to a tissue wall. Tissue anchor 1300 may be configured to attach a luminal device to the esophageal wall.
Tissue anchor 1300 may include a first retention element 1310. First retention element 1310 may be configured to be placed on a first side of an anchoring membrane of a luminal device. First retention element 1310 may be configured to be placed on a proximal side of an anchoring membrane of a luminal device.
First retention element 1310 may include a T-tag 1311. T-tag 1311 may include a longitudinal cylindrical segment, such as one-third or one-fourth of a cylindrical tube cut lengthwise. T-tag 1311 may be configured to fit between the outside of a delivery needle and an inside of a catheter lumen. T-tag 1311 may be configured to fit in a gap between a delivery needle and a catheter lumen. T-tag 1311 may include a pull 1312 to facilitate removal. First retention element 1310 may include a button or other suitable device.
Tissue anchor 1300 includes a second retention element 1320. Second retention element 1320 may be configured to be placed on a second side of a tissue wall. Second retention element 1320 may be configured to be placed on a distal side of a tissue wall.
Second retention element 1320 may include a hub 1323. Hub 1323 may include a proximal portion 1323 p, a distal portion 1323 d, and a longitudinal axis 1323 a.
Second retention element 1320 may include one or more petals 1324. Petals 1324 may be coupled to hub 1323. Petals 1324 may extend from distal portion 1323 d of hub 1323. Petals 1324 may be configured to be collapsed inside a delivery needle. Petals 1324 may be coupled to hub 1323 by being at least partially inserted into opening 1324. Petals 1324 may be coupled to hub 1323 with any one or any combination of an adhesive, solder, weld, compression fit, and other suitable methods. Petals 1324 may be formed of lengths of wire. Hub 1323 and petals 1324 may be formed as one or more pieces.
Petals 1324 may include a contact portion 1325. Contact portion 1325 may be configured to be substantially perpendicular to longitudinal axis 1323 a of hub 1323. Contact portion 1325 may be configured to be proximal to proximal portion 1323 p of hub 1323.
Alternatively, second retention element 1320 may include a T-tag 1321, as shown in FIG. 2C. T-tag 1321 may be configured to be loaded in a delivery needle. Second retention element 1320 may include any of the retention elements described in U.S. patent application nos. VALENTX 028A1 and VALENTX 028A2, filed Oct. 31, 2015, and U.S. patent application publication nos. 2009/0012541 and 2015/0018745, each of which are incorporated by reference.
Tissue anchor 1300 includes a tension element 1350. Tension element 1350 may be configured to couple first retention element 1310 and second retention element 1320. Tension element 1350 may be configured to placed through an anchoring membrane and a tissue wall.
Tension element 1350 may include a suture 1351. Suture 1351 may have a proximal portion 1351 p and a distal portion 1351 d. Proximal portion 1351 p of suture 1351 may be coupled to first retention element 1310. Proximal portion 1351 p of suture 1351 may be coupled to T-tag 1311, such as with an adhesive and/or a knot. Distal portion 1351 d of suture 1351 may be coupled to second retention element 1320. Distal portion 1351 d of suture 1351 may be coupled to hub 1323 of second retention element 1320. Tension element 1350 may include a wire, a stent, or other suitable device. Tension element 1350 may be made of a polymer or other suitable material.
Alternatively, tissue anchor 1300 may include no first retention element 1310, and proximal portion 1351 p of suture 1351 may be coupled to a luminal device.
FIGS. 3A-3D show one embodiment of an anchor delivery device 1600. FIG. 3A shows a perspective view of anchor delivery device 1600. FIG. 3B shows an enlarged view of an anchoring cavity 1630 of anchor delivery device 1600. FIG. 3C shows an enlarged view of a delivery needle 1660. FIG. 3D shows a cross-sectional view of delivery needle 1660. FIGS. 3C-3D show delivery needle 1660 loaded with a tissue anchor 1300. FIGS. 3C-3D show delivery needle 1660 advanced out of a secondary lumen 1622 of a catheter 1620.
Anchor delivery device 1600 may be configured to place tissue anchors through a device and a tissue wall. Anchor delivery device 1600 may be configured to place tissue anchors through an esophageal stent and an esophageal wall.
Anchor delivery device 1600 may include a catheter 1620. Catheter 1620 may include a proximal portion 1620 p, a distal portion 1620 d, and a longitudinal axis 1620 a.
Catheter 1620 may include a primary lumen 1621. Primary lumen 1621 may be configured to accommodate an endoscope or other instrument.
Catheter 1620 may include at least one secondary lumen 1622. Secondary lumen 1622 may be formed in a wall of catheter 1620. Secondary lumen 1622 may include a proximal portion 1622 p and a distal portion 1622 d. Secondary lumen 1622 may be configured to accommodate a delivery needle.
Distal portion 1622 d of secondary lumen 1622 may be angled and/or curved inward toward longitudinal axis 1620 a of catheter 1620. Distal portion 1622 d of secondary lumen 1622 may be angled and/or curved inward toward longitudinal axis 1620 a from approximately 0 degrees to 10 degrees.
Catheter 1620 may have a width of approximately 10 mm to 20 mm.
Anchor delivery device 1600 may include an anchoring cavity 1630 formed in catheter 1620. Anchoring cavity 1630 may include a proximal side 1630 p and a distal side 1630 d. Anchoring cavity 1630 may be at or near distal portion 1620 d of catheter 1620. Anchoring cavity 1630 may be proximal to tip 1626. Anchoring cavity 1630 may be in communication with primary lumen 1621 and secondary lumen 1622.
Anchoring cavity 1630 may be configured to draw in a portion of an anchoring membrane. Anchoring cavity 1630 may be configured to draw in a portion of an anchoring membrane and a tissue wall.
Anchoring cavity 1630 may cut completely through distal portion 1622 d of secondary lumen 1622. Distal portion 1622 d of secondary lumen 1622 may be positioned at a proximal side 1630 p of anchoring cavity 1630.
Anchoring cavity 1630 may have a length of approximately 10 mm to 40 mm. Anchoring cavity 1630 may have a width of approximately 10 mm to 20 mm.
Anchor delivery device 1600 may include a delivery needle 1660. Delivery needle 1660 may include a proximal portion 1660 p and a distal portion 1660 d. Delivery needle 1660 may be slidably disposed within secondary lumen 1622. Delivery needle 1660 may be configured to be advanced out of and withdrawn into secondary lumen 1622.
Delivery needle 1660 may include a needle lumen 1661. Needle lumen 1661 may be configured to be loaded with a second retention element of a tissue anchor in a collapsed or delivery configuration. Needle lumen 1661 may also be configured to be loaded with a first retention element and/or a second retention element of a tissue anchor in a collapsed or delivery configuration. Needle lumen 1661 may also be configured to be loaded with a therapeutic agent. Therapeutic agent may include any one or any combination of a phospholipid gel, hyaluronic acid, and other agents.
Delivery needle 1660 may include a tip 1668. Tip 1668 may be coupled to distal portion 1660 d of delivery needle 1660. Tip 1668 may be configured to pierce an anchoring membrane. Tip 1668 may be configured to pierce a tissue wall. Tip 1668 may be sharp.
Delivery needle 1660 may include a slot 1669. Slot 1669 may be formed longitudinally at distal portion 1660 d of delivery needle 1660. Slot 1669 may be configured to allow a tension element of a tissue anchor to pass through so that a second retention element of a tissue anchor may be loaded inside of needle lumen 1661 and a first retention element of a tissue element may be loaded outside of needle lumen 1661.
Distal portion 1660 d of delivery needle 1660 may be angled and/or curved inward toward longitudinal axis 1620 a of catheter 1620. Distal portion 1660 d of delivery needle 1660 may be angled and/or curved inward toward longitudinal axis 1620 a from approximately 0 degrees to 10 degrees. This may reduce the likelihood of contacting bodily parts on the other side of a tissue wall.
Delivery needle 1660 and secondary lumen 1622 may be configured to define a gap 1623 when delivery needle 1660 is slidably disposed within secondary lumen 1622. Delivery needle 1660 and secondary lumen 1622 may have sizes selected to define a gap 1623 when delivery needle 1660 is slidably disposed within secondary lumen 1622. Gap 1623 may be configured to be loaded with a proximal delivery element of a tissue anchor. Gap 1623 may be configured to be loaded with a proximal delivery element such as a T-tag that is thin and elongate. Gap 1623 may be configured to be loaded with proximal delivery element such as a T-tag such as T-tag 1311 of tissue anchor 1300.
Anchor delivery device 1600 may include a pushrod 1670. Pushrod 1670 may include a proximal portion 1670 p and a distal portion 1670 d. Pushrod 1670 may be slidably disposed within needle lumen 1661.
Pushrod 1670 may be configured to push a second retention element of a tissue anchor out of needle lumen 1661 of delivery needle 1660. Pushrod 1670 may be configured to push a first retention element of a tissue anchor out of needle lumen 1661.
Pushrod 1670 may include a channel 1679. Channel 1679 may be formed longitudinally at distal portion 1670 d of pushrod 1670. Channel 1679 may be configured to allow a tension element of a tissue anchor to pass through. Channel 1679 may be aligned with slot 1669 of delivery needle 1660.
FIGS. 4A-4J show one embodiment of a method for delivering a luminal device. Although delivery of luminal device 1000 is shown as an example, the method may also be used to deliver other luminal devices and esophageal stents.
FIG. 4A shows loading luminal device 1100 onto anchor delivery device 1600. Distal portion 1620 d of catheter 1620 is inserted into the lumen of luminal device 1100.
FIG. 4B shows coupling luminal device 1100 to anchor delivery device 1600. Drawstring 1152 may be cinched to couple luminal device 1100 to anchor delivery device 1600.
FIG. 4C shows positioning luminal device 1100 at an attachment point. Catheter 1620 is advanced into the esophagus E to position anchoring membrane 1131 of luminal device 1100 in the esophagus E. An endoscope may be used in primary lumen 1621 to guide catheter 1620. A tether T may be used to adjust the position of luminal device 1100 and/or control drawstring 1152. Tissue marks made previously by tissue marking device 1400 may be used as a guide.
FIG. 4D shows releasing luminal device 1100 from anchor delivery device 1600. Drawstring 1152 may be uncinched to release luminal device 1100 from anchor delivery device 1600.
FIG. 4E shows positioning anchoring cavity 1630 of anchor delivery device 1600 next to anchoring membrane 1131 and the tissue wall W.
FIG. 4F shows forming a bulge 1130 b in anchoring membrane 1131 and the tissue wall W. Delivery needle 1660 is retracted completely within secondary lumen 1622. A vacuum may be applied to anchoring cavity 1630 to draw anchoring membrane 1131 and the tissue wall W into anchoring cavity 1630 to form bulge 1130 b. The vacuum may be approximately 50 mmHg to 500 mmHg.
Alternatively, anchoring membrane 1131 and tissue wall W may be pulled into anchoring cavity 1630 by a grasper or other suitable device to form bulge 1130 b. Alternatively, anchoring membrane 1131 and the tissue wall W may be allowed to enter anchoring cavity 1630 without assistance, such as from muscle activity of the tissue wall W, to form bulge 1130 b.
FIG. 4G shows piercing bulge 1130 b from first a side 1131′ of anchoring membrane 1131 and a first side W′ of the tissue wall W. Delivery needle 1660 may be advanced a set distance out of secondary lumen 1622 of catheter 1620. Delivery needle 1660 may be advanced through bulge 1130 b to position tip 1668 of delivery needle 1660 on a second side W″ of the tissue wall W.
Delivery needle 1660 may be advanced in a direction substantially parallel to longitudinal axis 1620 a of catheter. Delivery needle 1660 may be advanced in a direction substantially parallel to the tissue wall W other than bulge 1130 b. Delivery needle 1660 may be advanced in a direction approximately 0 degrees to 10 degrees from parallel toward longitudinal axis 1620 a of catheter. Delivery needle 1660 may be advanced in a direction approximately 0 degrees to 10 degrees from parallel away from the tissue wall W other than bulge 1130 b.
FIG. 4H shows placing second retention element 1320 of tissue anchor 1300 on a second side W″ of the tissue wall W. Delivery needle 1660 may be pulled back over pushrod 1670 to release second retention element 1320 from needle lumen 1661. Alternatively, pushrod 1670 may be advanced a set distance through delivery needle 1660 to release second retention element 1320 from needle lumen 1661. A therapeutic agent may also be released from needle lumen 1661. Second retention element 1320 expands.
FIG. 41 shows placing tension element 1350 of tissue anchor 1300 through anchoring membrane 1131 and the tissue wall W. Delivery needle 1660 and pushrod 1670 may be pulled back through the tissue wall W and pulled back through anchoring membrane 1131 to place tension element 1350 through the tissue wall W and anchoring membrane 1131.
FIG. 4J shows placing first retention element 1310 of tissue anchor 1300 on first side 1131′ of anchoring membrane 1131. Bulge 1130 b may be released. Vacuum applied to anchoring cavity 1630 may be stopped. First retention element 1310 is placed on first side 1131′ of anchoring membrane 1131. First retention element 1310 may be pulled out of secondary lumen 1622 of catheter 1620 by tension element 1350.
Alternatively, delivery needle 1660 may be advanced through bulge 1130 b at both proximal side 1630 p and distal side 1630 d of anchoring cavity 1630, to position tip 1668 of delivery needle 1660 back on first side 1131′ of anchoring membrane 1131. Second retention element 1320 may be placed on first side 1131′ of anchoring membrane 1131, tension element 1350 may be placed through anchoring membrane 1131 and the tissue wall W at two points, and first retention element 1310 may also be placed on first side 1131′ of anchoring membrane 1131.
Alternatively, delivery needle 1660 may be advanced only partially through bulge 1130 b at proximal side 1630 p of anchoring cavity 1630. Delivery needle 1660 may be advanced through anchoring membrane 1131 and only partially through the tissue wall W, to position tip 1668 of delivery needle 1660 within the tissue wall W, such as between layers of the tissue wall W. Second retention element 1320 may be placed within the tissue wall W, tension element 1350 may be placed through anchoring membrane 1131 and part of the thickness of tissue wall W, and first retention element 1310 may be placed on first side 1131′ of anchoring membrane 1131.
Anchor delivery device 1600 may be rotated within luminal device 1100 to deliver one or more additional tissue anchors. Delivery needle 1660 may be removed from secondary lumen 1622 to be reloaded with another tissue anchor, or exchanged for another delivery needle 1660 that has already been loaded.
While the foregoing has been with reference to particular embodiments of the invention, it will be appreciated by those skilled in the art that changes in these embodiments may be made without departing from the principles and spirit of the invention.

Claims

What is claimed is:

1. A luminal device, comprising:

an esophageal stent; and

an anchoring membrane coupled to the esophageal stent, the anchoring membrane configured to be attached to an esophageal wall with a tissue anchor placed through the anchoring membrane.

2. The luminal device of claim 1, wherein the anchoring membrane is configured to be pierced to allow the tissue anchor to be placed through the anchoring membrane.

3. The luminal device of claim 1, wherein the anchoring membrane is configured to retain a tissue anchor placed through the anchoring membrane.

4. The luminal device of claim 1, further comprising:

a braid coupled to the anchoring membrane, the braid configured to reinforce the anchoring membrane.

5. The luminal device of claim 1, wherein the anchoring membrane is collapsible.

6. The luminal device of claim 1, further comprising:

one or more perforations formed in the anchoring membrane, the perforations configured to allow a vacuum to reach through the anchoring membrane.

7. The luminal device of claim 1, further comprising:

one or more pulls coupled to the anchoring membrane, the pulls configured to allow the anchoring membrane to be pulled.

8. The luminal device of claim 1, further comprising:

one or more creases formed in the anchoring membrane, the creases configured to allow the anchoring membrane to collapse along the creases.

9. A luminal device, comprising:

an esophageal stent; and

an anchor retaining means coupled to the esophageal stent, the anchor attachment means configured to be attached to a wall of an esophagus with a tissue anchor placed through the anchor retaining means.

10. The luminal device of claim 9, further comprising:

a reinforcement means coupled to the anchor retaining means, the reinforcement means configured to reinforce the anchor retaining means.

11. A method for attaching a luminal device to an esophageal wall, the method comprising:

forming a bulge in an anchoring membrane of the luminal device and the esophageal wall;

piercing the bulge from a first side of the anchoring membrane and a first side of the esophageal wall;

placing a second retention element of a tissue anchor on a second side of the esophageal wall; and

placing a tension element of the tissue anchor through the anchoring membrane and the esophageal wall, the tension element coupled to the second retention element.

12. The method of claim 11, wherein forming a bulge includes drawing the anchoring membrane and the esophageal wall with a vacuum.

13. The method of claim 11, wherein forming a bulge includes pulling the anchoring membrane and the esophageal wall with a grasper.

14. The method of claim 11, wherein piercing the bulge includes advancing a delivery needle through the bulge to position a tip of the delivery needle on a second side of the esophageal wall.

15. The method of claim 14, wherein advancing a delivery needle includes advancing a delivery needle in a direction between 0 degrees and 10 degrees from parallel to the esophageal wall other than the bulge.

16. The method of claim 11, wherein placing a second retention element includes pushing the second retention element out of a lumen of the delivery needle.

17. The method of claim 16, wherein placing a tension element includes pulling the delivery needle back through the bulge.

18. The method of claim 11, further comprising:

placing a first retention element on the first side of the anchoring membrane, the first retention element coupled to the tension element.