HK1240811A1 - Fixation of intraluminal device - Google Patents

Description

Intraluminal device fixation

Technical Field

The present invention relates to intraluminal devices and methods of securing intraluminal devices, and in particular, to techniques for enhancing the securement and removability of the devices. Although the present invention is shown for use with bariatric and/or metabolic devices, it may be applied to other intraluminal devices positioned within a mammalian lumen or hollow organ subject to peristalsis, such as esophageal stents, anti-reflux devices, nasogastric tubes, intestinal cannulas, etc., including devices positioned in fallopian tubes, vas deferens, etc.

Background

In commonly assigned U.S. patent nos. 7,846,174; 8,100,931, respectively; 8,372,087, respectively; 8,529,431, respectively; 8,672,831, respectively; 8,801,599, respectively; 8,894,670 and 9,055,998 and international publication No. wo 2012/044917; WO 2012/162114; intraluminal devices and methods of providing satiety and/or treating metabolic diseases in a recipient are disclosed in WO2013/134227 and WO2015/031077, the disclosures of which are hereby incorporated by reference in their entirety. These devices and methods apply stress to the gastrointestinal tract generally, and to the cardiac portion of the recipient's stomach specifically, to create satiety in the absence of food and to enhance food-induced satiety and/or to treat metabolic disease. A challenge faced by these devices and methods is securing a portion of the device on the surface of the gastrointestinal tract (such as the cardiac portion of the stomach where peristalsis exists), which tends to result in distal migration of the device.

Disclosure of Invention

While it has been found that the use of tissue ingrowth authorized in the above-mentioned patent provides a satisfactory solution for fixation to prevent distal migration, aspects of the present invention include providing short-term fixation of the device until tissue ingrowth is in place that provides long-term fixation. Such short-term fixation is easy to implement and can be accomplished within days or weeks taken to produce long-term fixation.

Aspects of the present disclosure provide techniques for removing an intraluminal device having a wall defining first and second wall portions configured to be positioned in a lumen. The first wall portion may be an esophageal portion configured to the size and shape of a portion of the esophagus. The second wall portion may be a cardiac portion configured to the size and shape of the cardiac portion of the stomach. A connector connecting the esophageal portion and the cardiac portion is positioned against luminal tissue, such as in the Gastroesophageal (GE) junction, wherein the luminal tissue bridges or encapsulates the connector during deployment of the device. Removal of the device should not significantly damage the GE junction of the recipient. Aspects of the present invention facilitate such dislodgement and provide techniques that may advantageously utilize such tissue of the bridging connection to secure the intraluminal device for an extended period of time.

According to one aspect of the present disclosure, an intraluminal device adapted to be positioned in a lumen includes a wall having: a first wall portion configured to the size and shape of a first portion of a lumen; and a second wall portion configured to the size and shape of the second portion of the lumen. The connecting member connects the first wall portion and the second wall portion. The connector is configured to be positioned against the lumen, and wherein the connector is detachably connected to one or both of the first and second wall portions. This allows the device to be removed without significant tissue damage by disconnecting the connector and axially withdrawing the connector from the tissue enclosing the connector.

The first wall portion and the second wall portion may be engaged with the connector before being disposed in the lumen. The connector may comprise at least one filament coated with a biocompatible material extending around the at least one filament from one of the wall portions to the other of the wall portions. The removable attachment may connect the connector with at least one of the wall portions, and wherein the connector can be detached by removing the removable attachment. The removable attachment may comprise a severable filament.

The device may include a fixation system configured to resist distal migration of the wall within the lumen. The fixation system can include a connector configured to promote tissue growth of the lumen around the connector. The fixation system can include a tissue-piercing fastener configured to engage the connector with tissue of the lumen. The connector may comprise at least one elongate member comprising an irregularity thereof.

The fixation system may include: a long term fixation system including a wall feature of a wall configured to facilitate tissue attachment to the wall; and a temporary fixation system that at least initially resists distal migration of the wall, wherein the temporary fixation system comprises a tissue piercing fastener. The temporary fixation system may include a looped filament extending from at least one of the wall portions and configured to be captured by the fastener. The looped filaments may be at least partially elastic and may be at least partially bioabsorbable.

The intraluminal device may be an esophageal stent, an anti-reflux device, a nasogastric tube, an intestinal cannula, an obesity treatment device, or a metabolic disease treatment device.

According to one aspect of the present invention, an intraluminal device adapted to be positioned at a gastro-esophageal (GE) region of a recipient includes a wall defining: an esophageal portion configured to the size and shape of a portion of an esophagus; and a cardiac portion configured to the size and shape of the cardiac portion of the stomach. A connector is connected with the esophageal portion and the cardiac portion and is configured to be positioned at the GE junction. The connector may be detachably connected to the esophageal portion and/or the cardiac portion.

The connector may be detachably connected with the wall with a removable attachment. The separable portion of the connector may extend along the wall, and the removable attachment may be a severable filament between the separable portion and the wall. The wall may comprise a structural mesh defining intersections and covered with a biocompatible coating, the separable portion of the connector comprising one or more openings defined by the connector, the one or more openings being aligned with the one or more intersections of the mesh, wherein the severable filaments extend between the one or more openings and the one or more intersections. The plurality of openings and intersections may be aligned and the severable filaments formed as chain stitches between the openings and the intersections.

The wall may comprise a structural mesh defining intersections and covered with a biocompatible coating, wherein the separable portion of the connector extends over and under one or more of the intersections. The removable attachment is located between the detachable portion and the mesh, thereby preventing the connector from sliding relative to the intersection. The removable attachment may be a filament located between the distal portion and the mesh. Beads may be disposed on the filaments to provide access to the filaments. The connector may extend over the plurality of intersections and under at least one intersection between the plurality of intersections.

The connector may include a filament and a biocompatible coating on the filament. The connector may include a therapeutic agent eluting coating. A therapeutic agent dispensing container may be located at a distal portion of the esophageal portion, the therapeutic agent dispensing container being adapted to dispense a therapeutic agent to the connector. The device may be an obesity treatment device for treating excessive body weight and a metabolic device for treating metabolic diseases.

According to one aspect of the present invention, an intraluminal device adapted to be disposed at a Gastroesophageal (GE) region of a recipient includes a wall defining: a cardiac portion sized and shaped to be configured as a cardiac portion of the stomach, an esophageal portion sized and shaped to be configured as a portion of the esophagus; and a connector connected with the esophageal portion and the cardiac portion. The fixation system is configured to resist distal migration of the wall and includes a short-term fixation portion and a long-term fixation portion. The long-term fixation portion includes a wall feature of the wall configured to promote tissue ingrowth. The short-term fixation portion at least temporarily resists distal migration of the wall while tissue grows into the wall due to the wall feature. The long-term fixation part and the short-term fixation part are at least partially located at the connection piece.

The wall feature may include the connector as an elongate filament. The wall feature may be a tissue ingrowth promoting surface configuration of the connector. The tissue ingrowth promoting surface texture may face inward away from the GE junction.

The short-term fixation portion may include a tissue-piercing fastener that at least partially secures the device at the GE junction. The tissue-piercing fastener can face outward toward the GE interface. The tissue piercing fastener can engage the GE engagement portion depending on the arrangement of the device at the GE region of the recipient. The tissue piercing fastener may be applied to tissue at the connector after the device is disposed at the GE area of the recipient. The tissue piercing fastener may be positioned partially at the esophageal portion. A tissue piercing fastener partially positioned in the esophageal portion can be configured to pierce tissue of the lumen after the device is deployed. The tissue-piercing fastener may be at least partially made of a bioabsorbable material.

The connector may include a filament and a biocompatible coating on the filament. The connector may include a therapeutic agent eluting coating. A therapeutic agent dispensing container may be located at a distal portion of the esophageal portion, the therapeutic agent dispensing container being adapted to dispense a therapeutic agent to the connector. The device may be an obesity treatment device for treating excessive body weight and a metabolic device for treating metabolic diseases.

According to one aspect of the present invention, an intraluminal device adapted to be disposed at a Gastroesophageal (GE) region of a recipient includes a wall defining: a cardiac portion sized and shaped to be configured as a cardiac portion of the stomach, an esophageal portion sized and shaped to be configured as a portion of the esophagus; and a connector connected with the esophageal portion and the cardiac portion. A fixation system is configured to inhibit distal migration of the wall. The fixation system includes a short-term fixation portion and a long-term fixation portion. The long-term fixation portion includes a wall feature of the wall configured to assist tissue ingrowth. The short-term fixation portion is configured to at least temporarily inhibit distal migration of the wall while tissue grows to the wall due to the wall feature. The short-term fixation portion includes a tissue piercing fastener.

The short-term fixation portion may include a looped filament extending proximally from at least the esophageal portion, the looped filament configured to be captured by a tissue-piercing fastener. The looped filaments may be at least partially made of an elastic material and/or a bioabsorbable material. An enlarged portion of looped filaments may be provided, wherein the fastener passes through the tissue and the enlarged portion. A retainer filament may be provided that is temporarily connected to the looping filament. A retainer filament extends from the esophagus for positioning the wall at the GE junction of the recipient. The retainer filament may be removed after the device is deployed.

The tissue-piercing fastener may comprise a suture. The tissue-piercing fastener may include barbs located on the wall and facing the GE region. The barbs engage the tissue of the GE region after the device is deployed. Barbs may be formed on the wall. The barbs may be formed on separate fasteners attached to the wall or on the wall. The fastener may be at least partially made of a bioabsorbable material. A tissue attachment surface may be disposed on the tissue piercing fastener opposite the barb to attach tissue pulled around the connector. The temporary fixation may provide a gradual decrease in resistance to distal migration after at least partially creating a long-term fixation of the wall to the GE region. The wall feature may include a tissue ingrowth opening in the wall. A therapeutic drug eluting coating may be provided at the opening in the wall.

The device may be a bariatric device for treating excess body weight or a metabolic device for treating metabolic disorders.

According to one aspect of the present invention, a method of deploying an intraluminal device to resist distal migration in a mammalian lumen or hollow organ subject to peristalsis is provided, wherein the intraluminal device includes spaced apart wall portions connected to connectors. The wall portion is configured to the size and shape of a portion of a lumen or hollow organ and the connector is configured to be positioned against the wall of the lumen or hollow organ. The intraluminal device is positioned within a mammalian lumen or hollow organ that is subject to peristalsis. The device is secured in a lumen or hollow organ to resist distal migration, wherein tissue that is an inner layer of the lumen or hollow organ bridges over the connector. Removing the device after the tissue bridges over the connector, which includes separating the connector from one or both of the wall portions and axially withdrawing the connector from the tissue bridging over the connector.

According to one aspect of the present disclosure, a method of positioning an intraluminal device at a Gastroesophageal (GE) region of a recipient against distal migration includes positioning an intraluminal device at the GE region, the intraluminal device having a wall defining an esophageal portion configured to the size and shape of a portion of the esophagus and a cardiac portion configured to the size and shape of the cardiac portion of the stomach; and a connector connected with the esophageal portion and the cardiac portion, wherein the esophageal portion is located in the esophagus, the cardiac portion is located at the cardiac portion of the stomach, and at least a portion of the connector is located in a Gastrointestinal (GE) tube junction, wherein tissue at the GE junction at least partially encloses the connector. Removing the device after the tissue has enveloped the connector includes separating the connector from the esophageal portion and/or cardiac portion and axially withdrawing the connector from the tissue enveloping a portion of the connector at the gastroesophageal junction.

According to one aspect of the present disclosure, a method of positioning an intraluminal device at a Gastroesophageal (GE) region of a recipient against distal migration includes positioning a device at the GE region, the intraluminal device having a wall defining a cardiac portion sized and shaped to be the cardiac portion of a stomach and an esophageal portion sized and shaped to be a portion of an esophagus; and a connector connected to the esophageal portion and the cardiac portion, wherein the esophageal portion is located in the esophagus, the cardiac portion is located at the cardiac portion of the stomach, and at least a portion of the connector is located at a Gastroesophageal (GE) junction. A short term fixation and a length fixation are provided for intraluminal device positioning at the GE region. The long-term fixation portion includes a wall feature of the wall configured to promote tissue ingrowth. The short-term fixation portion at least temporarily resists distal migration of the wall while tissue grows toward the wall feature. Providing the long-term fixation includes positioning the device at the GE junction with a wall feature of the wall configured to promote tissue ingrowth. Providing a short term fixation includes temporarily at least partially securing the device at the GE junction.

According to one aspect of the present disclosure, a method of positioning an intraluminal device at a Gastroesophageal (GE) region of a recipient includes positioning an intraluminal device at the GE region, the intraluminal device having a wall defining a cardiac portion sized and shaped to be the stomach and an esophageal portion sized and shaped to be a portion of the esophagus; and a connector connected to the esophageal portion and the cardiac portion, wherein the esophageal portion is located in the esophagus, the cardiac portion is located at the cardiac portion of the stomach, and at least a portion of the connector is located at a Gastroesophageal (GE) junction. The short and long term fixation of the device is positioned at the GE area. The long-term fixation portion includes a wall feature of the wall configured to promote tissue ingrowth. The short-term fixation portion at least temporarily resists distal migration of the wall while tissue grows toward the wall feature. Long-term fixation is provided that includes positioning the intraluminal device with wall features of the wall positioned against the lumen configured to promote tissue ingrowth. Short-term fixation is provided to include temporarily securing the intraluminal device within a lumen to at least temporarily resist distal migration of a wall while tissue grows toward the wall due to the feature including securing the device with a tissue piercing fastener.

These and other objects, advantages, objects, and features of the invention will become apparent upon review of the following specification in conjunction with the accompanying drawings.

Drawings

FIG. 1 is a cross-sectional view of an intraluminal device disposed in a recipient's hollow organ or mammalian lumen, i.e., an obesity treatment device located at the Gastroesophageal (GE) region of the recipient;

FIG. 2 is the same view as FIG. 1 after the device has been disposed at the GE region for a period of time (such as weeks or months later);

FIG. 3 is a side view of the device of FIGS. 1 and 2;

FIG. 4 is the same view as FIG. 3 of an alternate embodiment thereof;

FIG. 5 is a plan view of the esophageal portion and connector portion of FIG. 3, with the esophageal portion expanded to a flattened condition;

FIG. 6 is the same view as FIG. 1 showing the short term securement of an alternative device;

FIG. 7 is a side view of the bariatric device illustrating the principle of a removable attachment between the connector portion and the cardiac portion;

FIG. 7A is the same view as FIG. 7 showing an alternative embodiment thereof;

FIG. 8 is a perspective view of the device of FIG. 7 taken from the side, proximal, or top direction showing details of the removable attachment;

FIG. 9 is an enlarged perspective view of the portion of FIG. 8 shown at IX;

FIG. 10 is the same view as FIG. 7 of an alternate embodiment thereof;

FIG. 10A is the same view as FIG. 10 of an alternate embodiment thereof;

FIG. 11 is a perspective view taken from the side and proximal or top showing the removable attachment between the connector portion and the cardiac portion of the embodiment of FIG. 10;

fig. 12 is a bottom or distal plan view of the removable attachment of fig. 11;

FIG. 13 is an enlarged view of the severable knot of FIG. 12;

FIG. 14 is a side view of an alternative embodiment of a connector portion;

FIG. 15 is a side view showing an alternative embodiment of enhanced mucosal bridging;

FIG. 16 is a sectional view taken along line XVI-XVI in FIG. 15;

FIG. 17 is a perspective view of the clamp;

FIG. 18 is the same view as FIG. 17 of an alternative embodiment thereof;

FIG. 19 is a side view of an alternative embodiment of a bariatric device;

FIG. 20 is a perspective view of a retainer capable of short term securement and facilitating long term securement;

fig. 21 is a sectional view taken along line XXI-XXI in fig. 19;

FIG. 22 is a sectional view taken along line XXII-XXII in FIG. 19;

FIG. 23 is the same view of the same device of FIG. 19 in an alternate embodiment;

FIG. 24 is the same view as FIG. 16 of an alternative embodiment;

FIG. 25 is a graph showing relative anchoring strength over time for different anchoring techniques;

fig. 26 is a sectional view taken along line XXVI-XXVI in fig. 19;

FIG. 27 is a plan view of an alternative embodiment of a clamp; and

fig. 28 is the same view as fig. 24, showing the application of the clip of fig. 27.

Detailed Description

Referring now to the drawings and the illustrative embodiments depicted therein, an intraluminal device (such as an bariatric device or a metabolic disorder treatment device) 10 has a wall 12 defining: esophageal portion 14 the esophageal portion is configured to the size and shape of a portion of a mammalian lumen or hollow organ (i.e., the esophagus); a cardiac portion 16 configured to the size and shape of a separate portion of a mammalian lumen or hollow organ (i.e., the cardiac portion of the stomach); and a connector 18 connecting the esophageal portion 14 and the cardiac portion 16 (fig. 1-5). Although shown as a bariatric device, it should be understood that the principles of the present invention may be applied to other intraluminal devices positioned in a lumen or hollow organ experiencing peristalsis, such as esophageal stents, anti-reflux devices, nasogastric tubes, intestinal cannulae. Moreover, the present invention may be applied to metabolic disease treatment devices and methods as disclosed in commonly assigned International patent application publication No. WO 2015/031077A 1, the entire disclosure of which is incorporated herein by reference.

As can be seen in fig. 1 and 2, the intraluminal device 10 is positioned in the gastroesophageal region with the esophageal portion 14 in the esophagus, the cardiac portion 16 at the cardiac portion of the stomach, and at least a portion of the connector 18 extending through the Gastroesophageal (GE) junction. In the illustrated embodiment, the connector 18 is made up of two elongate filaments 20a, 20b, the two elongate filaments 20a, 20b being in tension and may be referred to as a strut. As can be seen by comparing fig. 1 and 2, the device 10 is fixed at the gastroesophageal region to cause weight loss, and after the device 10 has been positioned in the GE region, mucosal (which may include submucosa or even muscle) tissue bridges over at least one of the two struts 20a, 20b, as shown in fig. 2. The bridging tissue can fuse sufficiently over time to achieve a significant reduction in excess body weight, which makes removal of the intraluminal device 10 difficult. Moreover, as will be discussed in detail below, the organization of bridging struts 20a, 20B may provide long-term fixation of device 10 according to the principles set forth in commonly assigned U.S. patent serial No.8,894,670B 2 (alone or in combination with other functions). In particular, the struts correspond to the bridges in the ' 670 patent and the spaces between the struts correspond to openings adjacent the bridges in the ' 670 patent, such that tissue bridging over the struts performs the mucosal capture granted in the ' 670 patent.

Securing the intraluminal device 10 against distal migration includes a securing technique 22, the securing technique 22 securing the esophageal portion 14 with the esophagus using a fastener, such as a tissue piercing fastener 24. Looped filaments 26 extending proximally from esophageal portion 14 are captured by the fastener in such a manner that fastener 24 engages the wall of the esophagus. The loops in the looped filaments are precisely engaged by the fastener so that the esophageal portion 14 is securely fastened to the esophagus by the fastener. The number of rings can vary from one to many, and the rings can be of any size or shape as long as they are closed polygons. In the illustrated embodiment, the fastener 24 is an endoscopically disposed clip sold by Ovesco and described in detail in U.S. patent No.8,721,528 directed to an endoscope cap, the entire contents of which are incorporated herein by reference. Also, while two loops and piercing fasteners are shown, one or more than two loops and piercing fasteners may be used.

The fixation technique 22 is intended to provide at least temporary fixation to hold the device 10 in place at the GE region of the recipient, with the cardiac portion 16 engaging the cardiac region of the stomach, while permanent fixation is developed. The looped filaments 26 may be at least partially elastic so as to stretch slightly when the fastener 24 is deployed to maintain upward pressure on the cardiac portion 16 after deployment. The looped filaments 26 may be at least partially bioabsorbable, or resorbable, so that the looped filaments, along with the fasteners 24, may fall out after permanent fixation has occurred, as shown in fig. 2. The looped filaments 26 may be made of monofilament or braided filaments. An enlarged portion 28 of the filament 26 may be provided and the fastener 24 applied at or near tissue of the esophageal wall that is drawn over the enlarged portion 28 by suction. Alternatively, the fastener 24 may be applied adjacent the enlarged portion 28, such as distal to the enlarged portion. The enlarged portions defining the looped filaments 26 and the loops provide engagement between the mechanical fastener and the looped filaments to prevent the looped filaments from being pulled away from the fastener. In the illustrated embodiment, the enlarged portion 28 is a bead. As shown in fig. 4, it may be desirable to position enlarged portion 28 as close as possible to esophageal member 14 to avoid entanglement between retainer filament 30, discussed below, and another retainer filament (not shown) that extends proximally from esophageal member 14.

The retainer filament 30 may be temporarily connected to the looped filament 26 and extend from the esophagus to outside the recipient of the device. The retainer filament 30 allows a physician or other medical professional to properly position the bariatric device 10 in the GE region and apply tension to the looped filaments 26 until the fasteners 24 are applied. Because the retainer filament 30 is looped only about the looped filament 26, the retainer filament 30 can be easily retracted by pulling on one side of the loop. The looped filaments 26 are directly connected to a mesh 32, which mesh 32 provides structure to the bariatric device 10. This allows the looped filaments to apply a proximal axial force to the mesh which is then distributed over the wall 12 without causing the esophageal portion 14 to become stenosed (as may occur in the case of looped filaments connected with a removal suture (not shown) that proximally encloses the esophageal portion 14 and is used to remove the bariatric device 10). If a proximal force is applied to such a removal suture, the diameter of the esophageal portion 14 may decrease upon fixation, thereby impeding mucosal capture and/or tissue ingrowth of the wall of the esophageal portion into the esophageal wall. While applying a proximal axial force to such a removal suture or loop may be a useful act to dislodge the intraluminal device 10, it cannot be used to provide fixation.

Thus, connecting the looped filaments 26 directly to the mesh 32 allows a proximal axial force to be applied to the esophageal segment 14 without inducing radially inward forces that tend to pull the wall 12 away from the esophageal wall. Although the looped filaments 26 are shown connected to the proximal portion of the mesh 32 in fig. 1 and 3, they can also be connected at the central or distal portion of the mesh, as shown in fig. 4. Although the looped filament 26 can extend from the interior of the esophageal portion 14, it can also extend from the outer surface of the esophageal member wall, as shown in FIG. 4, thereby ensuring that any tension acting on the filament 26 tends to pull the esophageal member wall toward the esophageal wall. Also, as shown in FIG. 4, cardiac portion 16 may include a transition region 17 adjacent its proximal opening 19 to prevent any irritation to the tissue of the cardiac portion of the stomach in accordance with the principles set forth in commonly assigned International patent application publication No. WO2012/044917, the entire contents of which are hereby incorporated by reference.

In an alternative technique shown in fig. 6, temporary fixation is provided by a tissue-piercing fastener in the form of a suture 24'. Each suture 24' passes through the wall of the esophageal portion 14 and at least partially through the wall of the esophagus of the recipient. The suture may be applied endoscopically, such as by using a commercially available automated suturing device, such as the automated suturing device sold by apollo endosurry. The suture is preferably made of an absorbable material so that it dissolves over time during the creation of a more permanent fixation from tissue capture. In the embodiment used in fig. 6, the looped filament 26 is used to transfer the retention force from the retainer filament 30 to the esophageal member 14, but does not form part of the temporary fixation. It is also possible to attach the retainer filament 30 directly to the esophageal portion 14.

Securing the bariatric device 10 to prevent distal migration includes: such as temporary fixation using fasteners 22 and long-term fixation formed by wall features that secure the wall to the GE region through tissue growth, such as using tissue ingrowth regions 34 formed in the wall 12.

The tissue in-growth area 34 is an opening in a cover 33 of a biocompatible material (such as silicon) on the mesh 32 that allows tissue to grow on the members of the mesh. As shown in fig. 5 AND as disclosed in U.S. patent application publication No.2014/0121585, entitled intraluminal device AND METHOD with enhanced MIGRATION resistance, the entire contents of which are incorporated herein by reference, entitled "intraluminal device AND METHOD with enhanced MIGRATION resistance", region 34 is more effective if regions 34 are spaced apart by a distance "C" along the direction of peristalsis that is at least on the order of the wavelength of the peristaltic waves. The long-term fixation with the ingrowth opening 34 can be removed to remove the device 10, such as by cauterizing tissue in the mucosal capture area 34 and by applying an inward radial force on the esophageal portion 14, such as by applying a proximal force on a removal suture (not shown) to remove the device 10. And also. An overtube of the type known in the art may be inserted between esophageal portion 14 and the wall of the esophagus to further separate wall 12 from the tissue of the esophagus. Other techniques for removing the mucosa from the opening 34, such as mechanical cutting of tissue, will be apparent to those skilled in the art.

After the bariatric device 10 has been deployed for weeks or months, as shown in fig. 2, tissue at or near the GE junction (including tissue immediately above and below the sphincter) may bridge over one or both of the struts 20a, 20b of the connector portion 18 at the GE junction. Such tissue bridging the struts 20a, 20b is difficult to remove, such as simply by applying a radially inward force on the struts. It will be appreciated that with the esophageal portion 14 near the GE junction and the cardiac portion 16 against the stomach wall, the struts 20a, 20b are not easily moved axially because the esophageal portion 14 and cardiac portion 16 are much larger than each strut 20a, 20b and therefore cannot be pulled through the opening of the bridging tissue. To remove the struts 20a, 20b to remove the device 10, the struts 20a, 20b of the connector portion 16 of the wall 12 are moved or pulled axially from the gastroesophageal junction to remove the connector from the bridging tissue for removal of the bariatric device.

This can at least theoretically be achieved by physically cutting the struts (such as using an argon knife or the like). In the illustrated embodiment, such axial movement of the struts 20a and 20b is achieved by separating the struts 20a and 20b from the portion of the device wall 12 defining the cardiac portion 16 and by separating the struts from the device wall (as shown in FIG. 7), or by separating the struts 20c and 20d from the portion of the device wall defining the esophageal portion 14 and separating the struts from the device wall (as shown in FIG. 7A). Adapted to separate the struts 20a, 20b, 20c, 20d by removably attaching a removable attachment 42 to the wall 12. The struts can be detached by removing the removable attachment.

Once the cardiac portion 16 is released, the struts 20a, 20b may be axially withdrawn or pulled proximally through the bridging tissue of the GE junction by axial proximal movement of the esophageal portion 14 in the manner discussed above. Once the struts are retracted, the esophageal portion 14 can be retracted proximally using a removal suture (not shown) or the like. The cardiac portion 16 can be removed from the stomach by pulling it into an overtube inserted in the esophagus or using other such methods. Once the esophageal portion 14 is released, the struts 20c, 20d may be proximally withdrawn or pulled through the bridging tissue of the GE junction by moving the cardiac portion 16 axially distally into the stomach (where the cardiac portion 16 can be removed by the methods discussed above). The esophageal portion 14 can be retracted proximally. Although the embodiment disclosed in fig. 7A requires the application of force to the cardiac portion 16 in order to axially separate the struts 20c, 20d from the bridging tissue, an advantage of this embodiment is that the removable attachment 42 is located at the esophageal portion 14 where it is more easily accessible for removal of the attachment 42.

Each of the struts 20a, 20b, 20c, 20d may be made from a single continuous wire filament 38, such as nitinol or stainless steel, that is twisted distally to proximally as shown in fig. 4. As the filaments 38 are wound, a plurality of openings 40 may be formed in the struts 20a, 20b, 20c, 20d, as will be described below. The ends of the filaments 38 may be woven with the mesh 32 of the esophageal portion 14, or woven with the mesh of the cardiac portion 16, or otherwise attached, as shown in fig. 5. The struts 20a, 20b, 20c, 20d are coated with silicone or other biocompatible material to facilitate axial withdrawal from the tissue bridging the struts. Moreover, the struts 20a, 20b, 20c, 20d may have an optional resilient portion (not shown) to enhance the proximal force on the cardiac portion 16 to ensure satiety. Moreover, the struts 20a, 20b, 20c, 20d may include a therapeutic agent eluting coating that applies a therapeutic agent, such as an anesthetic or the like. Such a coating may elute therapeutic agent for a limited time (e.g., two weeks) after deployment to ensure painless embedding of the struts in the recipient. Alternatively, a therapeutic agent dispensing container can be located at a distal portion of the esophageal portion 14 in order to dispense a controlled amount of a therapeutic agent (such as an anesthetic) to the tissue engaging the struts. In addition to the struts, a therapeutic agent eluting coating may be applied to the area surrounding the tissue ingrowth region 34 and possibly other areas of the device 10. For example, different types of therapeutic agents (such as promoting tissue fibrosis and ingrowth) may be eluted to promote earlier and more robust long-term fixation.

In one embodiment, removable attachment 42 comprises separable portions of struts 20a, 20b, 20c, 20d extending along the surface of wall 12, as shown in fig. 8 and 9. The openings 40 are arranged to align with intersections 44 in the portion of the web 32 of the wall 12. Removable attachment 42 is shown as a chain stitch 46 between one or more openings 40 and a corresponding intersection 44. Chain stitches are formed from filaments, such as high strength suture material. An advantage of the chain stitch known in the art is that it can be completely removed by cutting its filament at any position along the filament (such as with endoscopic scissors or a heating device). Once the removable attachment 42 is severed at the separable portion of the two struts 20a, 20b, the esophageal portion 14 can be withdrawn proximally, axially releasing the struts from the captured tissue at the GE junction. Once the removable attachment 42 is severed at the separable portion of the two struts 20c, 20d, the cardiac portion 16 can be withdrawn distally, axially releasing the struts from the captured tissue at the GE junction.

As described above, cardiac portion 16 will be located in the stomach and can be removed transorally. In addition to the separate chain stitch 46 for each strut as shown above, the chain stitch can be extended to envelope the separable portions of two struts (not shown) so that the filaments of the chain stitch need only be cut after the strut separated from the wall portion is severed. Moreover, tissue bridging can occur in only one of the strut pairs 20a, 20b (such as strut 20b) or in one of the strut pairs 20c, 20d positioned against the GE sphincter at the angle of HIS. As such, the removable attachment 42 may be provided for only one strut.

In an alternative embodiment, the intraluminal device 110 includes a wall 112 that: defining an esophageal portion 114 configured to the size and shape of a portion of the esophagus; a cardiac portion 116 configured to the size and shape of a portion of the cardiac portion of the stomach; and a connector 118 (fig. 10-13), at least a portion of which passes through the GE junction. The tissue ingrowth openings 134 provide long-term fixation. The intraluminal device 110 is substantially identical to device 10, except that connector portion 118 is removably connected to wall 112 by an alternative removable attachment 142. In fig. 10, the separable portions of the struts 120a, 120b that make up the connector portion 118 extend above some of the intersections 114 of the web 132 of the cardiac portion 116 and below some other of the intersections 144 at the cardiac portion 116, as seen in fig. 10-13. In fig. 10A, the separable portions of struts 120c, 120d extend above some of the intersections of the web of esophageal portion 114 and below some other of the intersections at esophageal portion 114 of wall 112.

The removable attachment 142 includes a severable knotted filament 150 at the distal end of each strut, the severable knotted filament 150 securing one end of the separable portion of the strut to the wall, as shown in fig. 11-13. In this manner, severing the knotted filament 150 allows each strut to be pulled away from the wall portion. Severable knotted filament 150 may include an extender, such as bead 152, to improve access to the filament to aid in severing the filament. Beads 152 are strung on filaments 150. The filament 150 may extend between the two separable ends of the struts such that it is necessary to cut the filament at one location to separate the two struts from the wall.

It should be appreciated that tissue bridging the struts 20a, 20b, 20c, 20d, 120a, 120b, 120c, 120d, which are elongate filaments providing wall features that secure the walls of the respective struts to the GE region by tissue growth, can be useful as all or part of the long-term fixation of the device 10, 110. This long term fixation may be enhanced by increasing the length of similar struts 220a, 220b shown in fig. 14. This may be accomplished by providing the struts with a knee, such as branching a filament as shown in fig. 14. This may be accomplished by leaving the filaments untwisted so that each filament forms a separate outwardly bent bridge. Once the attachment piece attached to the wall portion (not shown in fig. 14) is cut off, the multiple filament branches of the struts can be pulled individually through the same opening formed in the mucosa caused by the bridging. The struts 20a, 20b, 20c, 20d, 220a, 220b, 220c, 220d can have an outward knee to further engage the mucosa to promote bridging of the tissue.

Moreover, short-term and/or long-term fixation using struts can be enhanced by applying tissue-piercing fasteners in the form of retainers 54 to the bridging mucosa (fig. 15-17). The retainer 54 comprises a U-shaped body having a tip with a barb 55. This allows insertion of the retainer through the mucosa and onto the muscle, and allows the barbs to hold the retainer in place. The bioabsorbable retainers 54 can be bioabsorbable so that they fall off when the mucosal bridge is stabilized over a period of time. Alternatively, the holder 154 includes coupled U-shaped portions, each having a barb 155 to enhance attachment to the muscle, as shown in fig. 18. Application of suction to the recipient's esophagus will tend to cause the tissue of the GE junction to gather around the respective struts to assist in placement of the holder 154 to bring the tissue portions around the struts to facilitate tissue capture of the struts using the principles disclosed in commonly assigned U.S. patent serial No.8,894,670, the entire contents of which are hereby incorporated by reference herein.

Other forms of tissue piercing fasteners can be used, such as EZ clips or quick clip piercing, available from Olympus. In addition to promoting tissue bridging over the strut(s) 20a, 20b, 20c, 20d, 120a, 120b, 120c, 120d, the retainers 54, 154 may resist distal migration of the esophageal member 14. This helps to provide tension on the struts, thereby ensuring that the cardiac member 16, 116 is in contact with the cardiac portion of the stomach. Thus, the clips 54, 154 may provide medium short term fixation of the bariatric device and facilitate long term fixation via tissue fusion of the bridging struts 20a, 20b, 20c, 20d, 120a, 120b, 120c, 120 d.

An intraluminal device 210 is shown in fig. 19-23, where another technique is shown to secure the intraluminal device against creep in the lumen. The device 210 includes a wall 112 defining: an esophageal portion 214 having a size and shape corresponding to a portion of the esophagus at the GE region; a cardiac portion 116 having a size and shape corresponding to the cardiac portion of the stomach or a portion of the cardiac; and a connector 218 connecting the esophageal portion to the cardiac portion. At least a portion of the connector 218 passes through the GE junction. The connector 218 is made up of two elongated posts 220a, 220b, both of which 220a, 220b pass through the GE junction. The elongated shape of the struts provides wall features that provide, at least in part, long-term fixation of the wall 212 to the GE region through tissue growth around each strut. The posts 220a, 220b include a biocompatible coating, such as silicone or the like, that allows the posts to be axially separated from the GE junction once the posts are separated from the wall portion 212 by severing a removable connector (not shown in fig. 19) in the manner previously described.

Alternatively, the tissue piercing fastener 256 about each strut 220a, 220b includes a series of tissue piercing barbs 257 that are capable of piercing the mucosa, mucosal layer, and/or muscle at the GE junction when pressed against tissue. Piercing barb 257 may feature a fish hook or arrow to avoid retracting the barb after insertion. The fastener 256 may be formed around the post as part of manufacture or may be a separate device having a slot that allows the separate device to be positioned around the post when deployed, as shown in fig. 20.

In addition to the dimensions of each strut that provide the wall features that cause tissue to grow around the strut, each fastener 256 may have a wall feature 259 of the tissue facing away from the GE junction, the wall feature 259 enhancing the long-term fixation of the wall 212 to the GE region by promoting tissue growth around the respective strut. The wall features 259 may be rough or porous surfaces, surfaces impregnated with tissue growth agents, and the like. The wall feature 259 may include a stem similar to the barb 257 so that application of suction to the recipient's esophagus tends to pull tissue of the GE junction around the wall feature 259 where the barb of the wall feature 259 captures the tissue to further enhance short-term fixation. The fastener 256 may be made in whole or in part of a bioabsorbable material to resorb after tissue growth around the struts to provide long term fixation of the device 210. The resorption of the fastener 256 avoids the fastener 256 interfering with axially retracting the post for removal of the device.

Another tissue piercing fastener 258 having a tissue piercing barb 257 may be located at a portion of the esophageal member 214 (such as at a distal edge thereof) to provide additional temporary fixation of the device 210 at the GE region. Fastener 258 is shown as being formed at or otherwise attached to the distal edge of esophageal portion 214, and can be located at any portion of esophageal portion 214. The fasteners 258 provide only temporary fixation of the device 210 and therefore do not include the wall features 259 that enhance the long-term fixation of the wall 212 to the GE region. Fastener 258 is made, in whole or in part, of a bioabsorbable material for resorption after long-term fixation in place to avoid interference with explantation device 240.

As shown in FIG. 23, device 210 may include fasteners 256 at one or both of the struts 220a, 220b that make up the connector 218, but no fasteners 258 at the esophageal portion 214. Of course, device 210 may include tissue-piercing fastener 258 without a combination of temporary and permanent fixation of cassette 256, since the elongate nature of struts 220a, 220b is a wall feature that secures wall 212 to the GE region by tissue growth to provide long-term fixation.

An alternative holder 354 shown in fig. 24 is a clamp that closes around the struts 20a, 20b, 20c, 20d, 2120a, 120b, 120c, 120d or only around the struts 20a and 20b shown after the device 10 is positioned at the GE region. The clip 354 may be spring loaded or made of a memory material to close around the post when positioned in tissue or may be mechanically deformed by a mechanism arranged through the endoscope. Suction applied to the esophagus of the recipient may be used to assist in pulling tissue around the struts to facilitate insertion of the clip into the tissue.

Fig. 26 illustrates another tissue-piercing fastener 258b that may be used, in whole or in part, with the short-term fixation device 210 to prevent distal migration. Fastener 258b may be placed at the proximal portion of esophageal portion 214. The fastener 258b has barbs 257b that at least partially penetrate the tissue of the esophagus to provide short term fixation. The fastener 258b may be made, in whole or in part, of a resorbable material to be absorbed within the recipient after long-term fixation has occurred. Barbs 257b are shown as being distally angled to enable proximal adjustment of device 210 during deployment, while not interfering with the barbs, which can still resist distal migration.

Fig. 27 and 28 illustrate another alternative tissue-piercing holder 454, which tissue-piercing holder 454 can be used to short-term secure an intraluminal device 10, 110, 210. The holder 454 is positioned up the strut against the esophageal portion. The holder 454 has barbs to be held in the tissue of the GE junction as shown in fig. 28, and includes a tissue attachment portion 454 a. After the holder 454 is positioned on the post and inserted into the tissue (either as part of positioning the device or after positioning the device), suction may be applied to the esophagus that will tend to pull the tissue around the post where it is held by barbs or other surfaces of the tissue attachment portion 454 b.

Accordingly, it has been found that aspects of the present invention encompass both short-term and long-term fixation of an intraluminal device, such as a bariatric device in a lumen of a gastroesophageal region of a recipient. Long-term immobilization uses the body's reaction to the presence of the device to provide long-term immobilization. Short term fixation (such as one or more tissue piercing fasteners) provides for fixation of the device while long term fixation is developed. Once long-term immobilization is developed, it can be discarded or absorbed when it is no longer needed. Even a number of different types of long-term fixation may be provided in order to provide an optimal fixation at different times after deployment. For example, fig. 25 shows relative fixation (shown on the Y-axis) for different time intervals (shown on the Y-axis) after placement. After deployment of the device, at the origin of the curve, a temporary fixation F holds the intraluminal device in place. After deployment, tissue ingrowth T1 begins to develop and increase over time. Some time after deployment, the temporary fixation F may be eliminated (as shown by the dashed horizontal lines), such as by absorbing resorbable sutures or filament loops. By that time, the tissue ingrowth T1 should be strong enough to provide long-term fixation. Another form of long-term fixation may be provided by mucosal capture of the MC around the struts of the bariatric device. Although mucosal capture MC may take longer to develop compared to tissue ingrowth TI, it may still provide long-term fixation even if the tissue ingrowth fixation TI weakens over time.

It should be understood that fig. 25 is intended to illustrate conceptual relationships and is not based on physical measurements. It should also be understood that the timeline in fig. 25 may be measured for days, weeks, and months. However, it is expected that the tissue ingrowth TI or mucosal entrapment MC should be sufficient to provide fixation by itself within about 4 days to one or more weeks.

It also eliminates tissue ingrowth TI and relies solely on the mucosa to capture MC in order to provide long term fixation. Such alternatives may include the use of one of the illustrated retainers around one or both of the struts to provide short term fixation while developing long term fixation such as by capturing the MC through the mucosa around each of the struts. By providing both short-term and long-term fixation at the struts, the intraluminal device should be more easily deployed and removed. Deployment may be performed by inserting a holder clamp at one or both of the struts or by a self-deploying holder that pierces the tissue at the GE junction when the device is positioned in the recipient's lumen. In the case where long-term fixation is provided only at the struts, the device can be removed by disengaging the detachable struts and axially retracting the struts from the GE junction by proximally withdrawing the esophageal member from the esophagus. The cardiac member can then be easily withdrawn from the stomach. Because tissue ingrowth is not employed in this embodiment, there is no need to remove tissue from the tissue ingrowth area.

The intraluminal device 10, 110, 210 may be made adjustable to adjust or titrate the stress acting on the cardiac portion of the stomach, such as by using one or more bladders located on the proximal surface of the cardiac portion using the principles disclosed in international application publication No. wo2015/031077 (the entire contents of which are hereby incorporated by reference). In addition to providing adjustability, such a bladder may be filled with a fluid made of a gas that is lighter than air (such as helium, hydrogen, etc.) to assist in urging the cardiac member against the cardiac portion of the stomach to at least partially provide short or long term fixation.

While the foregoing description has described several embodiments of the present invention, it will be understood by those skilled in the art that variations and modifications of these embodiments may be made without departing from the spirit and scope of the invention as defined in the following claims. The present invention encompasses all combinations of the various embodiments or aspects of the invention described herein. It should be understood that any and all embodiments of the present invention may be combined with any other embodiment to describe additional embodiments of the present invention. Moreover, any element of an embodiment may be combined with any and all other elements of any of the embodiments to describe additional embodiments.

Claims (55)

1. An intraluminal device adapted to be positioned in a lumen, comprising:

a wall having: a first wall portion configured to the size and shape of the first portion of the lumen; and a second wall portion configured to the size and shape of the second portion of the lumen; and a connector connecting the first wall portion and the second wall portion; and is

Wherein the connector is configured to be positioned against the lumen, and wherein the connector is detachably connected with at least one of the first wall portion and the second wall portion.

2. The intraluminal device of claim 1, wherein the first and second wall portions are joined with the connector prior to being disposed in the lumen.

3. The intraluminal device of claim 1, wherein the connector comprises at least one filament coated with a biocompatible material, wherein the biocompatible material extends around the at least one filament from one of the first and second wall portions to the other of the first and second wall portions.

4. The intraluminal device of claim 1, comprising a removable attachment connecting the connector with the at least one of the first and second wall portions, and wherein the connector is separable by the removable attachment.

5. The intraluminal device of claim 4, wherein the removable attachment comprises a severable filament.

6. The intraluminal device of claim 1, comprising a fixation system configured to resist distal migration of the wall within the lumen, wherein the fixation system comprises the connector configured to facilitate tissue growth of the lumen around the connector.

7. The intraluminal device of claim 6, wherein the fixation system comprises a tissue piercing fastener configured to engage a connector with tissue of the lumen.

8. The intraluminal device of claim 6, wherein the connector comprises at least one elongate member including an irregularity of the at least one elongate member.

9. The intraluminal device of claim 6, wherein the fixation system comprises: a long term fixation system including a wall feature configured to facilitate tissue adhesion to the wall; and a temporary fixation system that resists distal migration of the wall at least initially, wherein the temporary fixation system comprises a tissue piercing fastener.

10. The intraluminal device of claim 9, wherein the temporary fixation system comprises a looped filament extending from the at least one of the first and second wall portions and configured to be captured by the tissue piercing fastener.

11. The intraluminal device of claim 10, wherein the looped filaments are at least partially elastic.

12. The intraluminal device of claim 10, wherein the looped filaments are at least partially bioabsorbable.

13. The intraluminal device of any one of the preceding claims, comprising an esophageal stent, an anti-reflux device, a nasogastric tube, an intestinal cannula, a bariatric device, or a metabolic disorder treatment device.

14. An intraluminal device adapted to be positioned at a gastro-esophageal (GE) region of a recipient, comprising:

a wall defining: an esophageal portion of an intraluminal device configured to a size and shape of a portion of an esophagus; and a cardiac portion of an intraluminal device configured to the size and shape of the cardiac portion of the stomach; and

a connector connected with an esophageal portion of the intraluminal device and a cardiac portion of the intraluminal device, the connector configured to be positioned at a GE junction, wherein the connector is detachably connectable with at least one selected from the esophageal portion of the intraluminal device and the cardiac portion of the intraluminal device.

15. The intraluminal device of claim 14, wherein the connector is detachably connected with a cardiac portion of the intraluminal device.

16. The intraluminal device of claim 14, wherein the connector is detachably connected to an esophageal portion of the intraluminal device.

17. The intraluminal device of claim 14, wherein the separable portions of the connector are separably connected to the wall with a removable attachment.

18. The intraluminal device of claim 17, wherein the separable portion of the connector extends along the wall, and wherein the removable attachment comprises a severable filament between the separable portion and the wall.

19. The intraluminal device of claim 18, wherein the wall comprises a structural mesh defining intersections and covered with a biocompatible coating, and wherein the separable portion of the connector comprises at least one opening defined by the connector, the at least one opening aligned with the at least one intersection of the structural mesh, and wherein the severable filament extends between the at least one opening and the at least one intersection.

20. The intraluminal device of claim 19, wherein the at least one opening comprises a plurality of openings and the at least one intersection comprises a plurality of intersections, the plurality of intersections being aligned with the plurality of openings, and the severable filament is formed as a chain stitch between the plurality of openings and the plurality of intersections.

21. The intraluminal device of claim 17, wherein the wall comprises a structural mesh defining intersections and covered with a biocompatible coating, wherein the separable portion of the connector extends above at least one of the intersections and below at least one other of the intersections, and wherein the removable attachment is located between the separable portion and the structural mesh to prevent the connector from sliding relative to the intersections.

22. The intraluminal device of claim 21, wherein the removable attachment comprises a filament between a distal portion and the structural mesh.

23. The intraluminal device of claim 22, comprising a bead disposed on the filament so as to provide access to the filament.

24. The intraluminal device of claim 21, wherein the connector extends above a plurality of intersections and below at least one intersection between the plurality of intersections.

25. The intraluminal device of claim 14, wherein the connector comprises a filament and a biocompatible coating on the filament.

26. The intraluminal device of claim 14, wherein the connector comprises a therapeutic agent eluting coating.

27. The intraluminal device of claim 14, comprising a therapeutic agent dispensing container located at a distal portion of the esophageal portion and adapted to dispense a therapeutic agent to the connector.

28. The intraluminal device of any one of claims 14 to 27, wherein the intraluminal device comprises an obesity treatment device for treating excess body weight or a metabolic device for treating metabolic disease.

29. An intraluminal device adapted to be disposed at a gastro-esophageal (GE) region of a recipient, comprising:

a wall defining: a cardiac portion of an intraluminal device configured to the size and shape of the cardiac portion of the stomach; an esophageal portion of an intraluminal device configured to a size and shape of a portion of an esophagus; and a connector connected to an esophageal portion of the intraluminal device and a cardiac portion of the intraluminal device;

a fixation system configured to resist distal migration of the wall, and comprising a short-term fixation and a long-term fixation;

the long-term fixation comprises a wall feature of the wall configured to assist tissue ingrowth;

the short-term fixation portion is configured to at least temporarily resist distal migration of the wall while tissue grows toward the wall due to the wall feature; and is

The long term fixation and the short term fixation are at least partially located at the connector.

30. The intraluminal device of claim 29, wherein the wall features of the wall comprise the connectors as elongate filaments.

31. The intraluminal device of claim 29, wherein the wall features of the wall comprise a tissue ingrowth-promoting surface configuration of the connector.

32. The intraluminal device of claim 31, wherein the tissue ingrowth promoting surface formations face inwardly away from the GE junction.

33. The intraluminal device of claim 32, wherein the short fixation portion comprises a tissue piercing fastener that at least partially secures the intraluminal device at the GE junction.

34. The intraluminal device of claim 33, wherein the tissue piercing fastener faces outwardly toward the GE interface.

35. The intraluminal device of claim 33, wherein the tissue piercing fastener engages the GE interface according to placement of the intraluminal device at a GE region of the recipient.

36. The intraluminal device of claim 33, wherein the tissue piercing fastener is applied to tissue at the connector after the intraluminal device is disposed at the GE region of the recipient.

37. The intraluminal device of claim 33, wherein the tissue piercing fastener is positioned partially at an esophageal portion of the intraluminal device.

38. The intraluminal device of claim 37, wherein the tissue piercing fastener positioned partially at an esophageal portion of the intraluminal device is configured to pierce tissue of a lumen when the intraluminal device is deployed.

39. The intraluminal device of any one of claims 32 to 38, wherein the tissue piercing fastener is at least partially made of a bioabsorbable material.

40. The intraluminal device of claim 29, wherein the connector comprises a filament and a biocompatible coating on the filament.

41. The intraluminal device of claim 29, wherein the connector comprises a therapeutic agent eluting coating.

42. The intraluminal device of any one of claims 29 to 41, wherein the intraluminal device comprises an obesity treatment device for treating excess body weight or a metabolic device for treating metabolic disease.

43. An intraluminal device adapted to be disposed at a gastro-esophageal (GE) region of a recipient, comprising:

a wall defining: a cardiac portion of an intraluminal device configured to the size and shape of the cardiac portion of the stomach; an esophageal portion of an intraluminal device configured to a size and shape of a portion of an esophagus; and a connector connected to an esophageal portion of the intraluminal device and a cardiac portion of the intraluminal device;

a fixation system configured to resist distal migration of the wall, the fixation system comprising a short-term fixation portion and a long-term fixation portion;

the long-term fixation comprises a wall feature of the wall configured to assist tissue ingrowth;

the short-term fixation portion is configured to at least temporarily resist distal migration of the wall while tissue grows toward the wall due to the wall feature; and is

Wherein the short-term fixation portion comprises a tissue piercing fastener.

44. The intraluminal device of claim 43, wherein the short-term fixation portion comprises looped filaments extending proximally from at least an esophageal portion of the intraluminal device, the looped filaments configured to be captured by the tissue piercing fastener.

45. The intraluminal device of claim 44, wherein the looped filaments are at least partially made of at least one selected from an elastic material and a bioabsorbable material.

46. The intraluminal device of claim 44, comprising an enlarged portion of the looped filaments, wherein the tissue piercing fastener passes through tissue and the enlarged portion.

47. The intraluminal device of claim 43, comprising a retainer filament temporarily connected with the looped filament, the retainer filament extending from the esophagus for positioning the wall at the GE junction of the recipient, and wherein the retainer filament is removed after deployment of the intraluminal device.

48. The intraluminal device of claim 43, wherein the tissue piercing fastener comprises a suture.

49. The intraluminal device of claim 43, wherein the tissue penetrating fastener includes barbs on the wall and facing the GE region, the barbs engaging tissue of the GE region when the intraluminal device is deployed.

50. The intraluminal device of claim 49, wherein the barbs are formed on separate fasteners attached with the wall and/or on the wall.

51. The intraluminal device of claim 49, comprising a tissue attachment surface on the tissue piercing fastener opposite the barbs to attach tissue pulled around the connector.

52. The intraluminal device of claim 43, wherein the tissue penetrating fastener is at least partially made of a bioabsorbable material, wherein the temporary fixation portion has a gradually decreasing resistance to distal migration after at least partially creating long term fixation of the wall to the GE region.

53. The intraluminal device of claim 43, wherein the wall feature comprises tissue ingrowth openings in the wall.

54. The intraluminal device of claim 52, comprising a therapeutic drug eluting coating disposed at the tissue ingrowth openings in the wall.

55. The intraluminal device of any one of claims 43 to 53, wherein the intraluminal device comprises an obesity treatment device for treating excess body weight or a metabolic device for treating metabolic disease.