HK1240811B - Fixation of intraluminal device - Google Patents

Description

Fixation of intraluminal devices

Technical Field

The present invention relates to intraluminal devices and methods for securing intraluminal devices, and in particular, to techniques for enhancing the securement and removability of such devices. Although the present invention is illustrated for use with obesity treatment devices and/or metabolic devices, it can be applied to other intraluminal devices positioned within the lumen or hollow organs of mammals subject to peristalsis, such as esophageal stents, anti-reflux devices, nasogastric tubes, intestinal cannulas, and the like, including devices positioned within the fallopian tubes, vas deferens, and the like.

Background Art

Intraluminal devices and methods for providing satiety and/or treating metabolic diseases in a recipient are disclosed in commonly assigned U.S. Patent Nos. 7,846,174; 8,100,931; 8,372,087; 8,529,431; 8,672,831; 8,801,599; 8,894,670 and 9,055,998 and International Publication Nos. WO2012/044917; WO2012/162114; WO2013/134227 and WO2015/031077, the disclosures of which are hereby incorporated by reference in their entireties. These devices and methods apply stress to the gastrointestinal tract in general, and to the cardiac portion of the stomach of a recipient in particular, to induce satiety in the absence of food and to enhance satiety caused by food and/or to treat metabolic diseases. A challenge faced by these devices and methods is securing a portion of the device to the surface of the gastrointestinal tract (such as in the cardiac portion of the stomach where peristalsis occurs), which tends to result in distal migration of the device.

Summary of the Invention

While the use of tissue ingrowth as claimed in the aforementioned patents has been found to provide 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 providing long-term fixation is in place. Such short-term fixation is simple to implement and can be accomplished within the days or weeks that would be required to produce long-term fixation.

Aspects of the present invention provide techniques for removing an intraluminal device having a wall defining a first wall portion and a second wall portion configured to be positioned in the lumen. The first wall portion can be an esophageal portion configured to the size and shape of a portion of the esophagus. The second wall portion can be a cardia portion configured to the size and shape of the cardia portion of the stomach. A connector connecting the esophageal portion and the cardia portion is positioned against luminal tissue, such as in the gastroesophageal (GE) junction, wherein the luminal tissue bridges or encapsulates the connector during the arrangement of the device. Removing the device should not significantly damage the recipient's GE junction. Aspects of the present invention facilitate such removal and provide techniques that can advantageously utilize such tissue bridging connectors to secure the intraluminal device for a long term.

According to one aspect of the present invention, an intraluminal device adapted to be positioned in a lumen includes a wall having: a first wall portion configured to be the size and shape of the first portion of the lumen; and a second wall portion configured to be the size and shape of the second portion of the lumen. A connector 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 wall portion and the second wall portion. This allows the device to be removed by disconnecting the connector and axially retracting the connector from tissue enclosing the connector without significantly damaging the tissue.

The first wall portion and the second wall portion can be engaged with the connector before being arranged in the lumen. The connector can include at least one filament coated with a biocompatible material, the biocompatible material extending around the at least one filament from one of the wall portions to the other of the wall portions. A removable attachment can connect the connector to at least one of the wall portions, and wherein the connector can be separated by removing the removable attachment. The removable attachment can include a cuttable filament.

The device may include a fixation system configured to resist distal migration of a wall within the lumen. The fixation system may include a connector configured to promote growth of tissue within the lumen around the connector. The fixation system may include a tissue-piercing fastener configured to engage the connector with tissue within the lumen. The connector may include at least one elongated member including an irregular portion thereof.

The fixation system may include a long-term fixation system comprising wall features configured to promote 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 filament may be at least partially elastic and at least partially bioabsorbable.

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

According to one aspect of the present invention, an intraluminal device adapted for positioning at the gastroesophageal (GE) region of a recipient includes a wall defining an esophageal portion sized and shaped like a portion of the esophagus and a cardiac portion sized and shaped like the cardiac portion of the stomach. A connector is coupled to the esophageal and cardiac portions and configured to be positioned at the GE junction. The connector can be detachably coupled to the esophageal and/or cardiac portions.

The connector can be detachably connected to the wall using a removable attachment. The detachable portion of the connector can extend along the wall, and the removable attachment can be a cuttable filament between the detachable portion and the wall. The wall can include a structural mesh that defines an intersection and is covered with a biocompatible coating, and the detachable portion of the connector includes 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 cuttable filament extends between the one or more openings and the one or more intersections. The multiple openings and intersections can be aligned, and the cuttable filaments are formed as a chain stitch between the openings and the intersections.

The wall can include a structural mesh that defines an intersection and is covered with a biocompatible coating, wherein the detachable portion of the connector extends above one or more intersections and below one or more intersections. A removable attachment is located between the detachable portion and the mesh, thereby preventing the connector from sliding relative to the intersection. The removable attachment can be a filament between the distal portion and the mesh. Beads can be provided on the filament to provide access to the filament. The connector can extend above multiple intersections and below at least one intersection between the multiple 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 the therapeutic agent to the connector. The device may be an obesity treatment device for treating excess weight or a metabolic device for treating metabolic diseases.

According to one aspect of the present invention, an intraluminal device adapted for placement at the gastroesophageal (GE) region of a recipient includes a wall defining: a cardiac portion configured to be the size and shape of the cardiac portion of the stomach, an esophageal portion configured to be the size and shape of a portion of the esophagus; and a connector connecting the esophageal portion and the cardiac portion. A 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 portion and the short-term fixation portion are at least partially located at the connector.

The wall feature may include a connector that is an elongated filament. The wall feature may be a surface configuration of the connector that promotes tissue ingrowth. The surface configuration that promotes tissue ingrowth may face inwardly 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 may face outward toward the GE junction. The tissue-piercing fastener may engage the GE junction based on the placement 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 placed at the GE region of the recipient. The tissue-piercing fastener may be partially positioned at the esophageal portion. The tissue-piercing fastener partially positioned in the esophageal portion may be configured to puncture tissue within 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 the therapeutic agent to the connector. The device may be an obesity treatment device for treating excess weight and a metabolic device for treating metabolic diseases.

According to one aspect of the present invention, an intraluminal device adapted for placement at the gastroesophageal (GE) region of a recipient includes a wall defining: a cardiac portion configured to be the size and shape of the cardiac portion of the stomach, an esophageal portion configured to be the size and shape of a portion of the esophagus; and a connector connecting the esophageal portion and the cardiac portion. A fixation system is configured to prevent 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 in tissue ingrowth. The short-term fixation portion is configured to at least temporarily prevent distal migration of the wall while tissue grows into 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 being configured to be captured by the tissue piercing fastener. The looped filament may be made at least in part of an elastic material and/or a bioabsorbable material. An enlarged portion of the looped filament may be provided, wherein the fastener passes through the tissue and the enlarged portion. A retainer filament may be provided, the retainer filament being temporarily connected to the looped filament. The 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 comprise a barb located on the wall and facing the GE region. The barb engages tissue in the GE region after the device is deployed. The barb may be formed on the wall. The barb may be formed on a separate fastener attached to the wall, or formed on the wall. The fastener may be made at least in part of a bioabsorbable material. A tissue attachment surface may be provided on the tissue piercing fastener opposite the barb to attach tissue drawn around the connector. The temporary fixation portion may gradually reduce resistance to distal migration after at least partially producing long-term fixation of the wall to the GE region. The wall feature may comprise 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 an obesity treatment device for treating excess body weight or a metabolic device for treating metabolic diseases.

According to one aspect of the present invention, there is provided a method for arranging an intraluminal device to resist distal migration in a lumen or hollow organ of a mammal that is subject to peristalsis, wherein the intraluminal device comprises spaced-apart wall portions connected to a connector. The wall portions are configured to be the size and shape of a portion of the 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 in a lumen or hollow organ of a mammal that is subject to peristalsis. The device is secured in the lumen or hollow organ to resist distal migration, wherein tissue that forms an inner layer of the lumen or hollow organ is bridged over the connector. The device is removed after the tissue is bridged over the connector, which includes separating the connector from one or both of the wall portions and axially retracting the connector from the tissue that is bridged over the connector.

According to one aspect of the present invention, a method for deploying an intraluminal device at the gastroesophageal (GE) region of a recipient to resist distal migration includes positioning the intraluminal device at the GE region, the intraluminal device having a wall defining an esophageal portion sized and shaped like a portion of the esophagus and a cardiac portion sized and shaped like the cardiac portion of the stomach; 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 in the gastrointestinal (GE) junction, wherein tissue at the GE junction at least partially encapsulates the connector. After the tissue has encapsulated the connector, removing the device includes separating the connector from the esophageal portion and/or the cardiac portion and axially retracting the connector from tissue at the GE junction that encapsulates a portion of the connector.

According to one aspect of the present invention, a method for placing an intraluminal device at the gastroesophageal (GE) region of a recipient to resist distal migration includes positioning a device at the GE region, the intraluminal device having a wall defining a cardiac portion configured to be the size and shape of the cardiac portion of the stomach and an esophageal portion configured to be the size and shape of a portion of the esophagus; and a connector connecting 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 the gastroesophageal (GE) junction. A short-term fixation portion and a length fixation portion are provided for positioning the intraluminal device 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 portion includes positioning the device at the GE junction using the wall feature of the wall configured to promote tissue ingrowth. Providing a short-term fixation includes temporarily at least partially fixing the device at the GE junction.

According to one aspect of the present invention, a method for placing an intraluminal device at the gastroesophageal (GE) region of a recipient includes positioning the intraluminal device at the GE region, the intraluminal device having a wall defining a cardiac portion configured to be the size and shape of the cardiac portion of the stomach and an esophageal portion configured to be the size and shape of a portion of the esophagus; and a connector connecting 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 the gastroesophageal (GE) junction. A short-term fixation portion and a long-term fixation portion of the device are positioned 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. The long-term fixation is configured to include positioning the intraluminal device using the wall feature of the wall configured to promote tissue ingrowth positioned against the lumen. Short-term fixation is provided including temporarily securing the intraluminal device within the lumen to at least temporarily resist distal migration of the wall while tissue grows toward the wall due to the features including securing the device with tissue-piercing fasteners.

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

BRIEF DESCRIPTION OF THE DRAWINGS

FIG1 is a cross-sectional view of an intraluminal device deployed in a hollow organ or lumen of a mammalian subject, i.e., a bariatric device located at the gastroesophageal (GE) region of a subject;

FIG2 is the same view as FIG1 after the device has been placed at the GE area for a period of time, such as after several weeks or months;

FIG3 is a side view of the apparatus of FIG1 and FIG2;

FIG4 is a view similar to FIG3 showing an alternative embodiment thereof;

FIG5 is a plan view of the esophagus portion and the connector portion of FIG3 , wherein the esophagus portion is unfolded into a flat state;

FIG6 is the same view as FIG1 showing an alternative arrangement for short-term fixation;

FIG7 is a side view of the bariatric device illustrating the principle of the removable attachment between the connector portion and the cardiac portion;

FIG7A is the same view as FIG7 , showing an alternative embodiment thereof;

FIG8 is a perspective view of the device of FIG7 taken from a side, proximal or top direction showing details of the removable attachment;

FIG9 is an enlarged perspective view of the portion shown at IX in FIG8;

FIG10 is a view similar to FIG7 of an alternative embodiment thereof;

FIG10A is the same view as FIG10 of an alternative embodiment thereof;

FIG11 is a perspective view taken from the side and proximal side or top, illustrating the removable attachment between the connector portion and the cardiac portion of the embodiment of FIG10;

FIG12 is a bottom or distal plan view of the removable attachment of FIG11;

FIG13 is an enlarged view of the severable knot of FIG12;

FIG14 is a side view of an alternative embodiment of a connector portion;

FIG15 is a side view showing an alternative embodiment of enhanced mucosal bridging;

FIG16 is a cross-sectional view taken along line XVI-XVI in FIG15;

FIG17 is a perspective view of the clamp;

FIG18 is a view similar to FIG17 of an alternative embodiment thereof;

FIG19 is a side view of an alternative embodiment of a bariatric device;

FIG20 is a perspective view of a retainer capable of short-term fixation and contributing to long-term fixation;

FIG21 is a cross-sectional view taken along line XXI-XXI in FIG19;

FIG22 is a cross-sectional view taken along line XXII-XXII in FIG19;

FIG23 is the same view of the same apparatus of FIG19 of an alternative embodiment;

FIG24 is a view similar to FIG16 of an alternative embodiment;

FIG25 is a graph showing the relative anchor strength of different anchoring techniques over time;

FIG26 is a cross-sectional view taken along line XXVI-XXVI in FIG19;

FIG27 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 clamp of FIG. 27 .

DETAILED DESCRIPTION

Referring now to the drawings and the illustrative embodiments depicted herein, an intraluminal device (such as a bariatric device or a metabolic disease treatment device) 10 has a wall 12 defining: an esophageal portion 14 configured to be the size and shape of a portion of a mammalian lumen or hollow organ (i.e., the esophagus); a cardiac portion 16 configured to be 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 (FIGS. 1-5). Although shown as a bariatric device, it should be understood that the principles of the present invention are applicable to other intraluminal devices positioned in a lumen or hollow organ that experiences peristalsis, such as an esophageal stent, an anti-reflux device, a nasogastric tube, or an intestinal sleeve. Furthermore, the present invention may be applied to metabolic disease treatment devices and methods as disclosed in commonly assigned International Patent Application Publication Serial No. WO 2015/031077 A1, the entire disclosure of which is hereby incorporated by reference into this application.

As can be seen in Figures 1 and 2, the intraluminal device 10 is positioned in the gastroesophageal region, wherein the esophageal portion 14 is located in the esophagus, the cardiac portion 16 is located at the cardiac portion of the stomach, and at least a portion of the connector 18 extends through the gastroesophageal (GE) junction. In the illustrated embodiment, the connector 18 is composed of two elongated filaments 20a, 20b, which are in tension and can be referred to as struts. As can be seen by comparing Figures 1 and 2, the device 10 is fixed in the gastroesophageal region to cause weight loss. After the device 10 has been positioned in the GE region, mucosal (which may include submucosa and even muscle) tissue bridges over at least one of the two struts 20a, 20b, as shown in Figure 2. The bridging tissue can fully fuse over time to achieve a significant reduction in excess weight, which makes it difficult to remove the intraluminal device 10. Furthermore, as will be discussed in detail below, in accordance with the principles set forth in commonly assigned U.S. Patent Serial No. 8,894,670 B2 (alone or in combination with other features), the tissue bridging struts 20a, 20b can provide long-term fixation of the device 10. In particular, the struts correspond to the bridges of the '670 patent and the spaces between the struts correspond to the openings adjacent to the bridges of the '670 patent, such that the tissue bridging the struts implements the mucosal capture granted in the '670 patent.

Fixing the intraluminal device 10 to resist distal migration includes such a fixing technique 22 that utilizes a fastener (such as a tissue puncture fastener 24) to fasten the esophageal portion 14 to the esophagus. A looped filament 26 extending proximally from the esophageal portion 14 is captured by the fastener in such a way that the fastener 24 engages the wall of the esophagus. The loops in the looped filament are precisely engaged by the fastener so that the esophageal portion 14 is firmly fixed to the esophagus by the fastener. The number of loops can vary from one to multiple, and as long as they are closed polygons, the loops can be of any size or shape. In the illustrated embodiment, the fastener 24 is a clamp disposed by an endoscope and is sold by Ovesco and is described in detail in U.S. Patent No. 8,721,528 for an endoscope cap, the entire contents of which are incorporated herein by reference. Moreover, although two loops and puncture fasteners are shown, one or more than two loops and puncture fasteners can be used.

The fixation technique 22 is intended to provide at least temporary fixation to maintain the device 10 in a suitable position at the GE region of the recipient, wherein the cardiac portion 16 engages the cardiac region of the stomach while developing permanent fixation. The looped filament 26 can be at least partially elastic so as to be slightly stretched when the fastener 24 is arranged to maintain upward pressure on the cardiac portion 16 after arrangement. The looped filament 26 can be at least partially bioabsorbable or reabsorbable so that the looped filament and fastener 24 can fall off after permanent fixation occurs, as shown in Figure 2. The looped filament 26 can be made of monofilament or braided wire. An enlarged portion 28 of the filament 26 can be provided, and the fastener 24 is applied to or near the tissue of the esophageal wall, and the tissue of the esophageal wall is pulled on the enlarged portion 28 by suction. Alternatively, the fastener 24 can be applied near the enlarged portion 28, such as, located distal to the enlarged portion. The enlarged portion and the loop defining the looped filament 26 provide engagement between the mechanical fastener and the looped filament to prevent the looped filament from being pulled apart from the fastener. In the illustrated embodiment, the enlarged portion 28 is a bead. As shown in FIG4 , it is desirable to position the enlarged portion 28 as close as possible to the esophageal member 14 to avoid entanglement between the retainer filament 30 discussed below and another retainer filament (not shown) that extends proximally from the esophageal member 14.

The retainer filament 30 can be temporarily connected to the looping filament 26 and extend from the esophagus to the outside of the recipient of the device. The retainer filament 30 allows the physician or other medical personnel to properly position the bariatric device 10 in the GE region and apply tension to the looping filament 26 until the fastener 24 is applied. Because the retainer filament 30 is looped only near the looping filament 26, it can be easily retracted by pulling on one side of the loop. The looping filament 26 is directly connected to the mesh 32, which provides structure to the bariatric device 10. This allows the looping filament to apply a proximal axial force to the mesh, which is then distributed across the wall 12 without causing stenosis of the esophageal portion 14 (as might occur if the looping filament was connected to 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 hindering mucosal capture and/or tissue ingrowth of the wall of the esophageal portion into the esophageal wall. Although applying a proximal axial force to such a removal suture or ring can be a useful action for removing the intraluminal device 10, it cannot be used to provide fixation.

Thus, directly connecting the looping filament 26 to the mesh 32 allows a proximal axial force to be applied to the esophageal portion 14 without causing a radially inward force that would tend to pull the wall 12 away from the esophageal wall. Although the looping filament 26 is shown connected to the proximal portion of the mesh 32 in Figures 1 and 3, it can also be connected to the central portion or distal portion of the mesh, as shown in Figure 4. Although the looping 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 Figure 4, thereby ensuring that any tension acting on the filament 26 tends to pull the esophageal member wall toward the esophageal wall. Furthermore, as shown in Figure 4, in accordance with the principles set forth in commonly assigned International Patent Application Publication Serial No. WO 2012/044917 (the entire contents of which are hereby incorporated by reference into this application), the cardiac portion 16 can 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 the alternative technique shown in Figure 6, temporary fixation is provided by tissue piercing fasteners in the form of sutures 24'. Each suture 24' passes through the wall of the esophagus portion 14 and at least partially through the wall of the recipient's esophagus. Sutures can be applied endoscopically, such as by using a commercially available automatic suturing device, such as the automatic suturing device sold by Apollo Endosurgery. Sutures are preferably made of absorbable material so that they dissolve over time during the period of more permanent fixation from tissue capture. In the embodiment used in Figure 6, looped filaments 26 are used to transfer the holding force from the retainer filaments 30 to the esophageal member 14, but do not form part of the temporary fixation. It is also possible to attach the retainer filaments 30 directly to the esophageal portion 14.

Securing the bariatric device 10 to prevent distal migration includes temporary fixation, such as using fixators 22 , and long-term fixation 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 .

Tissue ingrowth regions 34 are openings in a biocompatible material (e.g., silicone) covering 33 on mesh 32 that allow tissue to grow on the mesh components. As shown in FIG. 5 and disclosed in U.S. Patent Application Publication No. 2014/0121585, entitled “INTRALUMINAL DEVICE AND METHOD WITH ENHANCED ANTI-MIGRATION” (incorporated herein by reference in its entirety), regions 34 are more effective if they are spaced apart along the peristaltic direction by a distance “C” that is at least on the order of the wavelength of the peristaltic wave. Long-term fixation using ingrowth openings 34 can be removed to remove the device 10, such as by cauterizing the tissue in the mucosal capture regions 34 and applying an inward radial force to the esophageal portion 14, such as by applying a proximal force to a removal suture (not shown) to remove the device 10. Furthermore, An overtube of a type known in the art may be inserted between the esophageal portion 14 and the wall of the esophagus to further separate the wall 12 from the tissue of the esophagus. For those skilled in the art, other techniques (such as mechanical cutting of the tissue) for removing the mucosa from the opening 34 will be apparent.

After the obesity treatment device 10 has been deployed for several weeks or months, as shown in Figure 2, tissue at or near the GE junction (including tissue immediately above and below the sphincter) may bridge onto one or both of the struts 20a, 20b of the connector portion 18 at the GE junction. It is difficult to remove such tissue bridging onto the struts 20a, 20b, such as by simply applying a radially inward force to 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 the cardiac portion 16 are much larger than each strut 20a, 20b and therefore cannot be pulled through the opening of the bridging tissue. In order 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 axially moved or pulled away from the gastroesophageal junction to remove the connector from the bridging tissue so that the obesity treatment device can be removed.

This can, at least in theory, be achieved by physically severing the struts (such as with an argon gas knife). In the illustrated embodiment, this axial movement of the struts is achieved by separating struts 20a and 20b from the portion of the device wall 12 defining the cardiac portion 16 and separating the struts from the device wall (as shown in FIG7 ), or by separating 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 FIG7A ). The struts 20a, 20b, 20c, 20d are adapted to be separated by removably attaching a removable attachment 42 to the wall 12. The struts can be separated by removing the removable attachment.

Once the cardiac portion 16 is released, the struts 20a, 20b can be proximally retracted or pulled through the bridging tissue of the GE junction by axially proximally moving the esophageal portion 14 in the manner discussed above. Once the struts are retracted, the esophageal portion 14 can be proximally retracted using a removal suture (not shown) or the like. The cardiac portion 16 can be removed from the stomach by pulling the cardiac portion into an overtube inserted in the esophagus or using other such methods. Once the esophageal portion 14 is released, the struts 20c, 20d can be proximally retracted or pulled through the bridging tissue of the GE junction by axially moving the cardiac portion 16 distally into the stomach (where the cardiac portion 16 can be removed by the methods discussed above). The esophageal portion 14 can be proximally retracted. Although the embodiment disclosed in FIG. 7A requires 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.

Each of the struts 20a, 20b, 20c, 20d can be made from a single, continuous metal filament 38, such as nitinol or stainless steel, that is twisted from distal to proximal, as shown in FIG4 . As the filament 38 is coiled, a plurality of openings 40 can be formed in the struts 20a, 20b, 20c, 20d, as will be described below. The ends of the filaments 38 can be braided with the mesh 32 of the esophageal portion 14, or with the mesh of the cardiac portion 16, or attached by other methods, as shown in FIG5 . The struts 20a, 20b, 20c, 20d are coated with silicone or other biocompatible materials to facilitate axial retraction from the tissue bridging the struts. Furthermore, the struts 20a, 20b, 20c, 20d can have optional elastic portions (not shown) to enhance the proximal force acting on the cardiac portion 16 to ensure satiety. Furthermore, the struts 20a, 20b, 20c, 20d can include a therapeutic agent eluting coating that applies a therapeutic agent, such as an anesthetic, etc. Such a coating can elute the therapeutic agent for a limited time (e.g., two weeks) after deployment to ensure that the struts are painlessly embedded in the recipient. Alternatively, a therapeutic agent dispensing container can be located at a distal portion of the esophageal portion 14 to dispense a controlled amount of a therapeutic agent, such as an anesthetic, to the tissue engaging the struts. In addition to the struts, the therapeutic agent eluting coating can 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 those that promote tissue fibrosis and ingrowth, can be eluted to promote earlier and more robust long-term fixation.

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

As described above, the cardiac portion 16 will be located in the stomach and can be removed perorally. In addition to the separation chain stitch 46 for each strut as shown above, the chain stitch can be extended to enclose the detachable portion of the two struts (not shown) so that the filaments of the chain stitch need only be cut after breaking the strut separated from the wall portion. Moreover, tissue bridging can be generated in only one strut (such as strut 20b) in the strut pair 20a, 20b or in one strut in the strut pair 20c, 20d positioned to abut against the GE sphincter at an angle to the HIS. In this way, the removable attachment 42 can be provided for only one strut.

In an alternative embodiment, an intraluminal device 110 includes a wall 112 that defines an esophageal portion 114 that is sized and shaped like a portion of the esophagus; a cardiac portion 116 that is sized and shaped like a portion of the cardiac portion of the stomach; and a connector 118 (FIGS. 10-13), at least a portion of which passes through the GE junction. Tissue ingrowth openings 134 provide long-term fixation. The intraluminal device 110 is substantially identical to the device 10, except that the connector portion 118 is removably connected to the wall 112 via an alternative removable attachment 142. In FIG. 10, the detachable portions of the struts 120a, 120b comprising the connector portion 118 extend above some of the intersections 114 of the mesh 132 of the cardiac portion 116 and below other intersections 144 at the cardiac portion 116, as seen in FIG. 10-13. In FIG. 10A , the detachable portions of struts 120 c , 120 d extend above some of the intersections of the mesh at the esophageal portion 114 and below other of the intersections at the esophageal portion 114 of the wall 112 .

The removable attachment 142 includes a cuttable knotted filament 150 at the distal end of each pillar that secures one end of the detachable portion of the pillar to the wall, as shown in Figures 11 to 13. In this way, cutting the knotted filament 150 allows each pillar to be partially pulled apart from the wall. The cuttable knotted filament 150 can include an expander, such as a bead 152, to improve access to the filament to facilitate cutting the filament. The bead 152 is strung on the filament 150. The filament 150 can extend between the two detachable ends of the pillar so that it is necessary to cut the filament at one position to separate the two pillars from the wall.

It should be understood that the tissue bridged on pillars 20a, 20b, 20c, 20d, 120a, 120b, 120c, 120d can be useful as all or part of the long-term fixation of device 10, 110, wherein the pillars are elongated filaments that provide wall features that fix the walls of the corresponding pillars to the GE region by tissue growth. This long-term fixation can be enhanced by increasing the length of similar pillars 220a, 220b shown in Figure 14. This can be accomplished by providing a knee-shaped portion (such as branching the filaments as shown in Figure 14) to the pillars. This can be accomplished by not twisting the filaments so that each filament forms a separate, outwardly curved bridge. Once the attachments attached to the wall portions (not shown in Figure 14) are cut off, the multiple filament branches of the pillars can be individually pulled through the same opening formed in the mucosa by the bridging. The struts 20a, 20b, 20c, 2Od, 220a, 220b, 220c, 22Od can have outward knees to further engage the mucosa to promote bridging of tissue.

Furthermore, short-term and/or long-term fixation using struts can be enhanced by applying a tissue-piercing fastener in the form of a retainer 54 to the bridging mucosa (Figures 15 to 17). Retainer 54 comprises a U-shaped body having a pointed end with barbs 55. This allows the retainer to be inserted through the mucosa onto the muscle and allows the barbs to hold the retainer in place. Bioabsorbable retainers 54 can be bioabsorbable so that they fall out after a period of time when the mucosal bridge is secure. Alternatively, retainer 154 comprises a coupled U-shaped portion, each having barbs 155 to enhance attachment to the muscle, as shown in Figure 18. Applying suction to the recipient's esophagus will tend to cause tissue at the GE junction to gather around the corresponding struts, assisting in the placement of retainer 154 so that tissue portions can be brought around the struts to facilitate tissue capture of the struts using the principles disclosed in commonly assigned U.S. Patent No. 8,894,670 (the entire contents of which are incorporated herein by reference).

Other forms of tissue piercing fasteners can be used, such as EZ clamps or quick clamp piercings available from Olympus. In addition to promoting tissue bridging on the struts (multiple struts) 20a, 20b, 20c, 20d, 120a, 120b, 120c, 120d, the retainers 54, 154 can resist distal migration of the esophageal member 14. This helps 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 clamps 54, 154 can provide moderate short-term fixation of the bariatric device and promote long-term fixation via tissue fusion of the bridging struts 20a, 20b, 20c, 20d, 120a, 120b, 120c, 120d.

In Figures 19 to 23, an intraluminal device 210 is shown, which illustrates another technique for securing an intraluminal device against peristalsis within 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 cardia; 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 comprised of two elongated struts 220a, 220b, each of which passes 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 struts 220a, 220b include a biocompatible coating, such as silicone, that allows the struts to be axially separated from the GE junction once they are separated from the wall portion 212 by severing the removable connector (not shown in Figure 19) in the manner previously described.

Alternatively, the tissue piercing fastener 256 around each pillar 220a, 220b includes a series of tissue piercing barbs 257 that can penetrate the mucosa, mucosal sublayer, and/or muscle at the GE junction when pressed against the tissue. The piercing barbs 257 can have the characteristics of a fishhook or an arrowhead to avoid having to retract the barbs after insertion. The fastener 256 can be formed around the pillar as a part of manufacturing or can be a separate device with a slit as shown in Figure 20 that allows the separate device to be positioned around the pillar when arranged.

In addition to the dimensions of each strut providing wall features that promote tissue growth around the strut, each fastener 256 can have a wall feature 259 facing away from the tissue at the GE junction, which enhances long-term fixation of the wall 212 to the GE region by promoting tissue growth around the corresponding strut. Wall feature 259 can include a roughened or porous surface, a surface impregnated with a tissue growth agent, or the like. Wall feature 259 can include a stem similar to barbs 257 so that applying suction to the recipient's esophagus tends to pull tissue at the GE junction around wall feature 259, where the barbs of wall feature 259 capture the tissue to further enhance short-term fixation. Fastener 256 can be made of a bioresorbable material in whole or in part so that it resorbs after tissue growth around the strut to provide long-term fixation of device 210. Resorption of fastener 256 prevents fastener 256 from interfering with axial retrieval of the strut for device removal.

Another tissue-piercing fastener 258 having tissue-piercing barbs 257 can be located at a portion of the esophageal member 214, such as at its distal edge, to provide additional temporary fixation of the device 210 at the GE region. The fastener 258 is shown as being formed at or otherwise attached to the distal edge of the esophageal portion 214 and can be located at any portion of the esophageal portion 214. The fastener 258 provides only temporary fixation of the device 210 and therefore does not include the wall features 259 that enhance long-term fixation of the wall 212 to the GE region. The fastener 258 is made of a bioabsorbable material, in whole or in part, so as to be resorbed after being permanently fixed in place to avoid interference with the removal device 240.

23 , the device 210 may include fasteners 256 located at one or both of the struts 220a, 220b that comprise the connector 218, but may not include fasteners 258 at the esophageal portion 214. Of course, the device 210 may include tissue-piercing fasteners 258 without the combined temporary and permanent fixation cassette 256, as the elongated nature of the struts 220a, 220b is a wall feature that secures the wall 212 to the GE region via tissue growth to provide long-term fixation.

An alternative retaining member 354 shown in FIG24 is a clamp that closes around struts 20a, 20b, 20c, 20d, 2120a, 120b, 120c, 120d, or only around struts 20a and 20b shown, after the device 10 is positioned at the GE region. The clamp 354 can be spring-loaded or made of a memory material so as to close around the struts when positioned in the tissue, or can be mechanically deformed by a mechanism deployed through the endoscope. Suction applied to the recipient's esophagus can be used to assist in drawing the tissue around the struts to facilitate insertion of the clamp into the tissue.

FIG26 illustrates another tissue-piercing fastener 258b that can be used, in whole or in part, to provide short-term fixation of the device 210 to prevent distal migration. Fastener 258b can be placed at the proximal portion of the esophageal portion 214. Fastener 258b has barbs 257b that at least partially penetrate the tissue of the esophagus to provide short-term fixation. Fastener 258b can be made, in whole or in part, of a resorbable material so that it is absorbed within the recipient's body after long-term fixation. Barbs 257b are shown as being distally angled to allow proximal adjustment of the device 210 during deployment without obstructing the barbs, which can still prevent distal migration.

Figures 27 and 28 show another alternative tissue piercing retainer 454 that can be used for short-term fixation of the intraluminal device 10, 110, 210. The retainer 454 is positioned upwardly along the pillar against the esophagus. The retainer 454 has barbs so that it is retained in the tissue of the GE junction as shown in Figure 28, and the retainer includes a tissue attachment portion 454a. After the retainer 454 is located on the pillar and inserted into the tissue (as part of or after positioning the device), suction can be applied to the esophagus, which will tend to pull the tissue around the pillar where it is held by the barbs or other surfaces of the tissue attachment portion 454b.

Thus, it has been discovered that various aspects of the present invention encompass both short-term and long-term fixation of an intraluminal device (such as a bariatric device in the lumen of the gastroesophageal region of a recipient). Long-term fixation utilizes the body's response to the presence of the device to provide long-term fixation. Short-term fixation (such as one or more tissue-piercing fasteners) provides device fixation while long-term fixation develops. Once long-term fixation has developed, the short-term fixation can be discarded or absorbed when it is no longer needed. It is even possible to provide multiple different types of long-term fixation to provide optimal fixation at different times after deployment. For example, FIG25 illustrates relative fixation (shown on the Y-axis) for different time intervals (shown on the Y-axis) after deployment. After the device is deployed, at the origin of the curve, temporary fixation F maintains the intraluminal device in place. After deployment, tissue ingrowth T1 begins to develop and increase over time. Some time after deployment, temporary fixation F can be eliminated (as shown by the dashed horizontal line), such as by absorption of a resorbable suture or filament loop. By that time, tissue ingrowth T1 should be sufficiently strong to provide long-term fixation. Another form of long-term fixation can be provided by mucosal capture MCs around the struts of the bariatric device. Although mucosal capture MCs may take longer to develop than tissue ingrowth TIs, mucosal capture MCs can provide long-term fixation even if tissue ingrowth fixation TIs weaken over time.

It should be understood that FIG25 is intended to illustrate conceptual relationships and is not based on physical measurements. It should also be understood that the timeline in FIG25 may be measured over days, weeks, and months. However, it is expected that tissue ingrowth TIs or mucosal capture MCs should be sufficient to provide fixation by themselves for approximately 4 days to a week or more.

It is also possible to eliminate tissue ingrowth TI and rely solely on mucosal capture MC to provide long-term fixation. This alternative can include using one of the shown retainers around one or two of the pillars to provide short-term fixation, while developing long-term fixation, such as by mucosal capture MC around each of the pillars. By providing both short-term and long-term fixation at the pillars, the intraluminal device should be easier to deploy and remove. The deployment can be implemented by inserting a retainer clamp at one or two pillars or by self-deployed retainers that puncture the tissue at the GE junction when positioning the device in the recipient's lumen. In the case where long-term fixation is only provided at the pillars, the device can be removed by separating the detachable pillars and axially retracting the pillars from the GE junction by retracting the esophageal member proximally from the esophagus. The cardiac member can then be easily retrieved from the stomach. Because tissue ingrowth is not used in this embodiment, there is no need to remove tissue from the tissue ingrowth area.

The intraluminal device 10, 110, 210 can 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. WO 2015/031077 (the entire contents of which are hereby incorporated by reference into this application). In addition to providing adjustability, such bladders can be filled with a fluid made of a gas that is lighter than air (such as helium, hydrogen, etc.) to assist in pushing the cardiac member against the cardiac portion of the stomach to at least partially provide short-term or long-term fixation.

Although 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 may be made to these embodiments without departing from the spirit and scope of the present invention as defined in the following claims. The present invention encompasses all combinations of the various embodiments or aspects of the present invention described herein. It will 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. Furthermore, any element of an embodiment may be combined with any and all other elements of any embodiment in the embodiments to describe additional embodiments.

Claims (55)

1. An intraluminal device suitable for positioning in a tissue-lined lumen, comprising: The wall has: a first wall portion having dimensions and shape configured as a first part of the lumen; and a second wall portion having dimensions and shape configured as a second part of the lumen; and a connector that connects the first wall portion and the second wall portion; and During the arrangement of the intraluminal device within the lumen, the connector is configured to be positioned against the lumen and configured to bridge tissue within the lumen to at least a portion of the connector, wherein the connector is detachably connected to at least one of the first wall portion and the second wall portion, and wherein the connector is configured to be detached within the lumen and axially retracted from the tissue bridging the portion of the connector in order to remove the intraluminal device. 2. The intracavitary device according to claim 1, wherein the first wall portion and the second wall portion are connected to the connector before being disposed in the cavity. 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 wall portion and the second wall portion to the other of the first wall portion and the second wall portion. 4. The intraluminal device of claim 1, comprising a removable attachment that allows the connector to be connected to at least one of the first wall portion and the second wall portion, wherein the connector can be detached by removing the removable attachment. 5. The intraluminal device of claim 4, wherein the removable attachment comprises a cuttable filament. 6. The intraluminal device of claim 1, further comprising a fixation system configured to resist distal migration of the wall within the lumen, wherein the fixation system includes the connector configured to facilitate tissue growth of the lumen around the connector. 7. The intraluminal device of claim 6, wherein the fixation system includes a tissue puncture fastener configured such that the connector engages with tissue in the lumen. 8. The intraluminal device according to claim 6, wherein the connector comprises at least one elongated member, the at least one elongated member comprising an irregular portion thereof. 9. The endoluminal device of claim 6, wherein the fixation system comprises: a long-term fixation system including wall features configured to facilitate tissue attachment to the wall; and a temporary fixation system resisting distal migration of the wall at least initially, wherein the temporary fixation system includes a tissue puncture fastener. 10. The intraluminal device of claim 9, wherein the temporary fixation system includes a looping filament extending from at least one of the first wall portion and the second wall portion, and the looping filament is configured to be captured by the tissue puncture fastener. 11. The intraluminal device of claim 10, wherein the looping filament is at least partially elastic. 12. The intraluminal device of claim 10, wherein the looped filament is at least partially bioabsorbable. 13. The endoluminal device according to any one of the preceding claims, comprising an esophageal stent, an anti-reflux device, a nasogastric tube, an intestinal cannula, an obesity treatment device, or a metabolic disease treatment device. 14. The endoluminal device according to any one of claims 1 to 12, wherein the wall is adapted to be positioned in the gastroesophageal (GE) region of the recipient and wherein the first wall portion defines: an esophageal portion of the endoluminal device, the esophageal portion of the endoluminal device being configured to the size and shape of a portion of the esophagus; and the second wall portion defines: a cardia portion of the endoluminal device, the cardia portion of the endoluminal device being configured to the size and shape of the cardia portion of the stomach; and The connector is connected to the esophageal portion and the cardia portion of the intraluminal device, wherein the connector is configured to be positioned at the GE junction and, after use, the connector is detached in the GE region from at least one of the esophageal portion and the cardia portion of the intraluminal device. 15. The intraluminal device according to claim 14, wherein the connector is detachably connected to the cardia portion of the intraluminal device. 16. The intraluminal device according to claim 14, wherein the connector is detachably connected to the esophageal portion of the intraluminal device. 17. The intraluminal device of claim 14, wherein the detachable portion of the connector is detachably connected to the wall by means of the 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 cutable filament located 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 includes at least one opening defined by the connector, the at least one opening being aligned with 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 cross portion comprises a plurality of cross portions aligned with the plurality of openings, and the cuttable filament is formed as a chain stitch between the plurality of openings and the plurality of cross portions. 21. The intraluminal device of claim 17, wherein the wall comprises a structural mesh defining intersections and covered with a biocompatible coating, wherein a separable portion of the connector extends above at least one of the intersections and below at least one other intersection, 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 filaments located between the distal portion and the structural mesh. 23. The intraluminal device of claim 22, comprising beads disposed on the filament to provide access to the filament. 24. The intraluminal device of claim 21, wherein the connector extends above the 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 eluent coating. 27. The endoluminal 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 according to any one of claims 15 to 27, wherein the intraluminal device comprises an obesity treatment device for treating excess weight or a metabolic device for treating metabolic diseases. 29. The intraluminal device of claim 14, comprising a fixation system configured to resist distal migration of the wall, and the fixation system comprising a short-term fixation portion and a long-term fixation portion; The long-term fixed portion includes the wall structure configured to facilitate inward tissue growth; The short-term fixation portion is configured to at least temporarily resist distal migration of the wall while the tissue grows towards the wall due to the wall characteristics; and The long-term fixing part and the short-term fixing part are at least partially located at the connector. 30. The intraluminal device of claim 29, wherein the wall feature of the wall includes the connector as an elongated filament. 31. The intraluminal device of claim 29, wherein the wall features of the wall include a surface structure of the connector that promotes inward tissue growth. 32. The intraluminal device of claim 31, wherein the surface structure promoting inward tissue growth faces inward away from the GE junction. 33. The intraluminal device of claim 32, wherein the short-term fixation portion comprises a tissue puncture fastener that at least partially secures the intraluminal device at the GE junction. 34. The intraluminal device of claim 33, wherein the tissue puncture fastener faces outward toward the GE junction. 35. The intraluminal device of claim 33, wherein the tissue puncture fastener engages the GE junction according to the arrangement of the intraluminal device at the GE region of the recipient. 36. The intraluminal device of claim 33, wherein the tissue puncture fastener is applied to the tissue at the connector after the intraluminal device is positioned at the recipient's GE region. 37. The intraluminal device of claim 33, wherein the tissue puncture fastener is partially positioned at the esophageal portion of the intraluminal device. 38. The intraluminal device of claim 37, wherein the tissue puncture fastener, partially positioned at the esophageal portion of the intraluminal device, is configured to puncture tissue of the lumen during placement of the intraluminal device. 39. The endoluminal device according to any one of claims 32 to 38, wherein the tissue puncture 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 eluent coating. 42. The intraluminal device according to any one of claims 29 to 38 and 40 to 41, wherein the intraluminal device comprises an obesity treatment device for treating excess weight or a metabolic device for treating metabolic diseases. 43. The intraluminal device of claim 14, comprising 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 fixed portion includes the wall structure configured to facilitate inward tissue growth; The short-term fixation portion is configured to at least temporarily resist distal migration of the wall while the tissue grows towards the wall due to the wall characteristics; and The short-term fixation part includes a tissue puncture fastener. 44. The intraluminal device of claim 43, wherein the short-term fixation portion comprises a looping filament extending at least proximally from the esophageal portion of the intraluminal device, the looping filament being configured to be captured by the tissue puncture fastener. 45. The intraluminal device of claim 44, wherein the looping filament is at least partially made of at least one selected from elastic materials and bioabsorbable materials. 46. The intraluminal device of claim 44, comprising an amplified portion of the looping filament, wherein the tissue puncture fastener passes through the tissue and the amplified portion. 47. The intraluminal device of claim 43, comprising a retaining filament temporarily connected to the looping filament, the retaining filament extending from the esophagus for positioning the wall at the GE junction of the recipient, and wherein the retaining filament is removed after the intraluminal device has been arranged. 48. The intraluminal device of claim 43, wherein the tissue puncture fastener comprises a suture. 49. The intraluminal device of claim 43, wherein the tissue puncture fastener includes a barb located on the wall and facing the GE region, the barb engaging tissue in the GE region when the intraluminal device is arranged. 50. The intraluminal device of claim 49, wherein the barb is formed on a separate fastener attached to the wall and/or formed on the wall. 51. The intraluminal device of claim 49, comprising a tissue attachment surface on the tissue puncture fastener, the tissue attachment surface being opposite the barb to attach tissue pulled around the connector. 52. The intraluminal device of claim 43, wherein the tissue puncture fastener is at least partially made of a bioabsorbable material, wherein, after at least partially establishing long-term fixation of the wall toward the GE region, the resistance of the short-term fixation portion to distal migration gradually decreases. 53. The intraluminal device of claim 43, wherein the wall feature includes an inward tissue growth opening in the wall. 54. The intraluminal device of claim 52, comprising a therapeutic drug eluent coating disposed in the wall at the tissue inward growth opening. 55. The intraluminal device according to any one of claims 43 to 53, wherein the intraluminal device comprises an obesity treatment device for treating excess weight or a metabolic device for treating metabolic diseases.