Barrier devices, systems, and methods

Abstract

To provide, generally, medical devices and medical device delivery, and particularly, medical devices, systems, and methods for delivering a barrier device within a body lumen of a patient, such as the GI tract.SOLUTION: For example, a barrier device may include a distal self-expanding stent. A tubular barrier may have a proximal end, a distal end, and a lumen extending therethrough. The distal stent may be disposed at the distal end of the tubular barrier. An anchoring self-expanding stent may be disposed at the proximal end of the tubular barrier.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present disclosure relates generally to the field of medical devices and medical device delivery. In particular, the present disclosure relates to medical devices, systems, and methods for delivering barrier devices into a body lumen of a patient, such as a remote or tortuous portion of the gastrointestinal tract ("GI tract"). [Background technology]

[0002] Treatment of patients with weight-related or digestive health problems can include a Roux-en-Y procedure or other gastric bypass procedure, which can be an open, endoluminal, or laparoscopic procedure, in which the volume of and / or the pathway between the stomach, jejunum, and / or duodenum is reduced. These procedures can reduce the ability of the GI tract to absorb substances. A Roux-en-Y procedure can be associated with numerous health risks. There is a need for a non-surgical endoscopic device or procedure that can produce the same metabolic effects as, for example, a Roux-en-Y procedure, while reducing the risks.

[0003] Therefore, a variety of favorable medical outcomes may be achieved through embodiments of the present disclosure. Summary of the Invention

[0004] FIELD OF THE DISCLOSURE The present disclosure relates to medical devices, systems, and methods for delivering a barrier device within a body lumen, such as the GI tract, of a patient. An embodiment of the barrier device can include a self-expanding distal stent. The barrier device can include a tubular barrier having a proximal end, a distal end, and a lumen extending therethrough. The distal stent can be disposed at the distal end of the tubular member. A self-expanding anchor stent can be disposed at the proximal end of the tubular barrier.

[0005] In various embodiments described herein or elsewhere, the barrier device may include at least one self-expanding intermediate stent between the proximal and distal ends of the tubular barrier. The tubular barrier may cover substantially all of the distal stent and the anchor stent. The anchor stent may have a shape memory in the expanded configuration that substantially mimics the contours of the anatomical structure of the gastric outlet tract. The distal stent may have a ring-like structure in the expanded configuration. A helical wire may extend around the lumen of the tubular barrier. The tubular barrier may include a plurality of nanofibers throughout the wall of the tubular barrier. Anchoring protrusions may extend from the outer surface of the anchor stent. The tubular barrier may be semi-permeable. The tubular barrier may be substantially impermeable.

[0006] In some aspects, the barrier system can include a catheter including an outer sheath and an inner sheath. The barrier device can be slidably disposed within the outer sheath in a delivery configuration. The barrier device can include a tubular barrier having a proximal end and a distal end. A self-expanding anchor stent can be disposed at the proximal end of the tubular barrier. The inner sheath can be slidably disposed within the tubular barrier in a delivery configuration.

[0007] In various embodiments described herein and elsewhere, the barrier device may include a self-expanding distal stent at the distal end of the barrier device. The barrier device may include at least one self-expanding intermediate stent between the proximal and distal ends of the tubular barrier. Each of the at least one self-expanding intermediate stent may have a ring-like structure in the expanded configuration. The inner sheath may include a distal end of the inner sheath having a diameter substantially the same as that of the catheter.

[0008] In some aspects, a method for delivering a barrier device can include delivering a self-expanding stent disposed at a distal end of a tubular barrier of the barrier device into a body lumen of a patient, wherein at least a portion of the tubular barrier can be delivered into the body lumen, and the self-expanding stent and the portion of the tubular barrier can be moved along the body lumen of the patient by peristalsis.

[0009] In various embodiments described herein and elsewhere, a self-expanding anchoring stent disposed at the proximal end of the tubular barrier device can be positioned within a patient's organ. The body lumen can be the GI tract, and the organ can be the gastric outflow tract. The barrier device can be constrained within a catheter sheath in a delivery configuration. Delivering the self-expanding stent can include proximally retracting the catheter sheath from around the self-expanding stent. Delivering at least a portion of the tubular barrier into the GI tract can affect weight loss.

[0010] Non-limiting embodiments of the present disclosure are described by way of example with reference to the accompanying drawings, which are schematic and not to scale. In the drawings, each identical or nearly identical component shown is generally represented by a single reference numeral. For clarity, not every component in every drawing, or every component of each illustrated embodiment, whose description is not necessary to enable those skilled in the art to understand the present disclosure, is labeled. [Brief explanation of the drawings]

[0011] [Figure 1] 1 illustrates a barrier device in an expanded configuration according to an embodiment of the present disclosure. [Figure 2A] 1 shows a partial cross-sectional view of a barrier system in an unexpanded configuration within a catheter, according to an embodiment of the present disclosure. [Figure 2B] 2B shows the system of FIG. 2A with the self-expanding distal stent deployed. [Figure 3A] 1 illustrates a barrier system within a patient's body with a catheter extending into the GI tract, according to an embodiment of the present disclosure. [Figure 3B] 3B shows the barrier system of FIG. 3A with the self-expanding distal stent deployed. [Figure 3C] 3C shows the barrier system of FIGS. 3A and 3B with a self-expanding intermediate stent deployed. [Figure 3D]3A-3C show the barrier system of FIGS. 3A-3C with a self-expanding anchor stent delivered thereto. [Figure 4] 1 illustrates a barrier device including a helical wire according to an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0012] The present disclosure is not limited to the specific embodiments described herein. The terminology used herein is only for describing specific embodiments and does not limit the scope of the appended claims. Unless otherwise defined, all technical terms used herein have the same meaning as commonly understood by those skilled in the art to which this disclosure belongs.

[0013] Although embodiments of the present disclosure are described with specific reference to embodiments of medical device delivery systems for delivery of medical devices (e.g., barrier devices) into particular portions of the GI tract for particular purposes (e.g., to affect metabolism and weight loss), it should be appreciated that such embodiments may be used to deliver various forms of such medical devices into a variety of different body lumens and / or passageways for a variety of different purposes, including, for example, anal access to the transverse colon, ascending colon, or ileum, Roux-en-Y procedure, jejunocolic bypass, jejunoileal bypass, gastrectomy, biliary pancreatic diversion with duodenal switch (BPD-DS), gastrojejunostomy, partial colectomy, etc.

[0014] As used herein, the singular forms "a," "an," and "the" are intended to include the plural forms unless the context clearly indicates otherwise. As used herein, the terms "comprises" and / or "comprising," or "includes" and / or "including," specify the presence of stated features, regions, steps, elements, and / or components, but do not exclude the presence or addition of one or more other features, regions, integers, steps, operations, elements, components, and / or groups thereof. As used herein, the conjunction "and" includes each of the structures, components, features, etc. so coordinated, unless the context clearly indicates otherwise, and the conjunction "or" includes one or the other of the structures, components, features, etc. so coordinated, one by one and in any combination and number, unless the context clearly indicates otherwise. The term "or" is generally used in the sense of including "and / or," unless the context clearly indicates otherwise.

[0015] Various embodiments according to the present disclosure are described below: As used herein, "proximal end" refers to the end of a device along the device that is closest to a medical professional when the device is being introduced into a patient's body, and "distal end" refers to the end of a device or object along the device that is farthest from a medical professional during implantation, positioning, or delivery.

[0016] All numerical values ​​herein are assumed to be modified by the term "about," whether expressly stated or not. The term "about," in the context of numerical values, generally refers to a range of numbers that one of ordinary skill in the art would consider equivalent to the recited value (i.e., having the same function or result). In many cases, the term "about" may include numbers that are rounded to the nearest significant figure. Other uses of the term "about" (i.e., in contexts other than numerical values) can be assumed to have one or more of their ordinary and accustomed definitions as understood from and consistent with the context of the present specification, unless otherwise specified. The recitation of numerical ranges by endpoints includes all numbers within that range, including the endpoints (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0017] It should be noted that references herein to "embodiments," "some embodiments," "other embodiments," etc., may indicate that one or more described embodiments may include a particular feature, structure, or characteristic, but not all embodiments necessarily include the particular feature, structure, or characteristic. Moreover, such phrases do not necessarily refer to the same embodiment. Furthermore, when a particular feature, structure, or characteristic is described in connection with one embodiment, unless expressly stated to the contrary, it would be within the knowledge of one of ordinary skill in the art to operatively apply such feature, structure, or characteristic to other embodiments, whether or not expressly described. That is, various individual elements described below, even if not expressly shown in specific combinations, are nevertheless considered to be combinable or configurable with one another to form other additional embodiments or to complement and / or enhance one or more described embodiments, as would be understood by one of ordinary skill in the art.

[0018] Medical procedures that can reduce and / or delay absorption of digestible substances by the GI tract can include providing a barrier device between the digestible substance and the anatomical structures involved in absorption (e.g., the duodenal and / or jejunal portions of the small intestine). As used herein, "barrier" is intended to include impermeable, semi-permeable, and permeable walls, surfaces, membranes, and the like, unless expressly indicated otherwise. The barrier can reduce or eliminate the need to alter the patient's anatomy through invasive procedures. For example, a tubular barrier within the GI tract can allow passage of substances therethrough without significant (or substantially limited) contact with intestinal tissue and / or digestive enzymes and similar fluids along the portion of the intestine occupied by the tubular barrier. Such limited, restricted, or delayed interaction between substances (e.g., gastric chyme) and the GI tract can help reduce or at least positively affect weight (obesity) and / or diabetic complications. The natural anatomy of the GI tract can be maintained without invasive surgery while providing metabolic benefits, such as preventing the uptake of fat and nutrients throughout the length of the duodenum.

[0019] Referring to FIG. 1 , one embodiment of a barrier device 100 according to the present disclosure is shown in an expanded configuration. The device 100 includes a self-expanding distal stent 102. In the expanded configuration, the distal stent 102 has rings 105 extending around the circumference of the distal stent 102. Although the rings 105 are shown as ridges, the rings 105 may have other shapes, such as, for example, a ring-like shape, a rib, a ridge, a bolus-like shape, a chyme-like shape, a ball, or a combination thereof. In various embodiments, the cross section of the stent 102 may be cloverleaf-shaped.

[0020] The distal stent 102 is disposed at the distal end 104d of the tubular barrier 104. In embodiments, the tubular barrier 104 may be flexible, e.g., compressible and expandable, along its central longitudinal axis. While the ring 105 is shown having a diameter larger than that of the tubular barrier 104, the ring 105 may have a diameter substantially equal to or smaller than that of the tubular barrier 104. A self-expanding anchor stent 106 is connected to the proximal end 104p of the tubular barrier 104. The anchor stent 106 has a larger diameter section than the rest of the device 100 and is shaped to substantially mimic the contours of the anatomical structure of the gastric outlet tract; however, the anchor stent 106 may alternatively be shaped as a cone, frustum, funnel, hemisphere, flange, combinations thereof, or the like, to appropriately mimic the anatomical structure to which the tubular barrier 104 is intended to be anchored. The self-expanding intermediate stent 108 is connected to the tubular barrier 104 between the proximal end 104p and the distal end 104d of the tubular barrier 104 and includes rings 105 in the expanded configuration. Although one self-expanding intermediate stent 108 is shown, any number of intermediate stents 108 may be used, e.g., 0, 2, 3, 5, 8, 10, 20, etc. The tubular barrier 104 extends through all of the stents 102, 106, 108 such that the stents 102, 106, 108 are held together by the tubular barrier 104. Alternatively, the stents 102, 106, 108 may not be held together by the tubular barrier 104 or may be partially coated by the tubular barrier (e.g., coated along the interior or exterior of the stents 102, 106, 108). A lumen 109 extends through the device 100 (i.e., through the stents 102, 106, 108 and the tubular barrier 104). The term coating, in this regard, and throughout this specification, is intended to encompass various means of disposing a stent along the length of the tubular barrier 104 (e.g., by coating, dip coating, spray coating, spin coating, etc.). The device 100 can be delivered and / or deployed from an outer sheath 110.

[0021] Referring to FIG. 2A, an embodiment of a barrier system according to the present disclosure is shown including a barrier device 200 in an unexpanded configuration slidably disposed within a catheter. The barrier device 200 includes a tubular barrier 204, a self-expanding distal stent 202, a self-expanding anchor stent 206, and a self-expanding intermediate stent 208. The catheter includes an outer sheath 210 around the barrier device 200 and an inner sheath 212 slidably disposed within the barrier device 200 when the barrier device 200 is within the catheter for delivery. In other embodiments, the inner sheath 212 need not slide within the barrier device 200. The inner sheath 212 includes a distal end 212d having a diameter substantially the same as that of the outer sheath 210. The distal end 212d of the inner sheath 212 is tapered in diameter. The distal end 212d is configured to atraumatically guide the system distally through an anatomical structure, for example, an opening in a body lumen. The distal end 212d of the inner sheath 212 restrains the device 200 from slipping distally out of the outer sheath 210. The distal end 212d may allow the system to bend or curve atraumatically through tortuous portions of a body lumen. In this configuration, the system may extend into a patient's body while the device 200 remains undeployed.

[0022] Referring to FIG. 2B, the barrier system of FIG. 2A is shown with the catheter outer sheath 210 moved proximally away from the distal end 212d of the inner sheath 212. The inner sheath 212 includes a radial extension 214 along its length, the diameter of which is smaller than the inner diameter of the barrier device 200 to be loaded. The extension 214 may help prevent unwanted proximal movement of the device 200 during delivery of the outer sheath 210 to the target site, for example, by providing frictional resistance to proximal movement of the device 200. Alternatively, this configuration may be achieved by distally moving the distal end 212d away from the catheter outer sheath 210, or by moving the catheter outer sheath 210 proximally and the distal end 212d of the catheter inner sheath 212 distally away from each other. With the catheter outer sheath 210 separated from the distal end 212d of the inner sheath 212, the self-expanding distal stent 202 is unconstrained by the outer sheath 210 and is deployed. The device 200 is slid distally out of the outer sheath 210 by a pusher member (not shown) adjacent the device 200 and within the outer sheath 210. In some embodiments, the pusher may maintain the position of the barrier device 200 as the outer sheath 210 is retracted. With the self-expanding distal stent 202 deployed from the outer sheath 210, the distal stent 202 is in an expanded configuration having rings 205, while the remainder of the device 200 is in an unexpanded configuration. Further distal movement of distal stent 202 (by retracting outer sheath 210 and / or by moving a pusher distally relative to outer sheath 210) may move the remainder of device 200, including tubular barrier 204, anchor stent 206, and intermediate stent 208, to deploy distally from outer sheath 210. As device 200 is deployed from outer sheath 210, it is allowed to gradually transition from an unexpanded configuration to an expanded configuration.

[0023] 3A, one embodiment of a barrier system according to the present disclosure is shown, including a catheter having an outer sheath 310 that can be delivered through an endoscope and / or over a guidewire (not shown) extending into a patient's stomach 324. The outer sheath 310 and inner sheath distal end 312d of the catheter can extend some, if not all, of the distance through the pylorus 320 and distally toward and / or into the duodenum 322. A barrier device (not shown) is disposed (e.g., slidably) within the outer sheath 310 near the inner sheath distal end 312d.

[0024] Referring to FIG. 3B, the barrier system of FIG. 3A is shown with the outer sheath 310 retracted proximally away from the distal end 312d of the inner sheath 312, exposing the self-expanding distal stent 302 and / or a portion of the tubular barrier 304 to the duodenum 322 and / or other portions of the intestine. A medical professional may wish to ensure that the self-expanding distal stent 302 is deployed entirely within the duodenum 322. For example, a medical professional may wish to ensure that the self-expanding distal stent 302 does not migrate proximally, either entirely or partially, into the stomach 324 by extending the outer sheath 310 and inner sheath 312 of the catheter beyond the pylorus 320 and into the duodenum 322. The rings 305 of the distal stent 302 may contact the wall of the GI tract, for example, the duodenum 322. The ring 305 may be shaped similarly to a mass of stomach contents, causing the smooth muscle of the intestine 322 to contract and generate peristaltic waves, pulling on the tubular barrier 304 and moving the distal stent 302 distally through the intestine 322. A medical professional may monitor the device as it moves through the GI tract. The device may be visualized through an endoscope, such as by fluoroscopy, by observing a distinguishable portion or marking of the device as it slides out of the catheter outer sheath 310.

[0025] Referring to Figure 3C, the barrier system of Figures 3A and 3B is shown with the self-expanding distal stent 302 being moved further distally through the intestine 322 by peristalsis. The inner sheath 312 and outer sheath 310 can be extended further into the duodenum in preparation for deployment of the self-expanding intermediate stent 308, such that further proximal retraction of the outer sheath 310 can assist in the deployment of the self-expanding intermediate stent 308. Distal movement of the distal stent 302 withdraws the connected tubular barrier 304 and connected self-expanding intermediate stent 308 distally from the outer sheath 310, with or without partial retraction of the outer sheath 310. Additionally or alternatively, the catheter's outer sheath 310 can be retracted proximally to assist in the deployment of the intermediate stent 308. The distal end 312d of the inner sheath 312 resides within the lumen 309 of the barrier device 300 when the device 300 is moved distally. The distal end 312d may be operated to assist in the movement and / or orientation of the device 300, or the distal end 312d may play no role in positioning the device 300. The additional rings 305 on the intermediate stent 308 may provide additional surface area for peristaltic waves to move the device 300 through the intestine 322 and further distally out the outer sheath 310. In various embodiments, the intermediate rings 308 may be around a center point along the device, but may also be significantly proximal or significantly distal to the center point of the device.

[0026] Referring to Figure 3D, the barrier system of Figures 3A-3C is shown with the device 300 delivered in a deployed, expanded configuration. After the self-expanding stents 302, 308, including the rings 305, are deployed to their expanded configuration and moved through the intestine 322 by peristalsis, the catheter's outer sheath 310 can be moved proximally (e.g., retracted) so that the distal end 310d of the outer sheath 310 is within or near the gastric outlet tract 324. With the distal end 310d of the outer sheath 310 near the gastric outlet tract 324, peristaltic waves acting on the rings 305 can pull and slide the self-expanding anchor stent 306 distally out of the outer sheath 310. Additionally or alternatively, the outer sheath 310 may be retracted proximally to expose the self-expanding anchor stent 306 and allow it to deploy and expand. The outer diameter of the anchor stent 306 is larger than the gastric outlet tract 324, as shown, so that any peristaltic movement that may move the stents 305, 308 distally may pull the anchor stent 306 into engagement with the gastric outlet tract 324. In some embodiments, the anchor stent 306 may extend across the pylorus 320. In various embodiments, the distal end of the anchor stent 306 may extend partially or completely across the pylorus 320. The anchor stent 306 may be anchored in the duodenal bulb distal to the pylorus 320 to allow access to the pylorus 320. The anchor stent 306 extending into or across the pylorus may include a flexible section in the region of the pylorus 320, thereby helping to maintain normal pylorus 320 function. In various embodiments, the distal end 306d of the anchor stent 306 extending across the pylorus 320 may be softer (e.g., thinner, fewer wires, etc.) than the remainder of the proximal anchor 306 to allow the pylorus 320 to at least partially perform its digestive function. The anchor stent 306 may substantially mimic the contours of the gastric outlet tract 324 for engagement of the outer surface 306s of the anchor stent 306 with the gastric outlet tract 324. The outer surface 306s may include additional anchoring features, such as adhesive or one or more protrusions, such as barbs, hooks, or other fasteners, to improve engagement with the gastric outlet tract 324.With the device 300 deployed, the distal end 312d of the inner sheath may be withdrawn proximally from the lumen 309 to the distal end 310d of the outer sheath 310. The outer sheath 310 (and endoscope or other device, if used) may be withdrawn from the patient, and the delivered barrier device 300 is left behind within the patient so that material such as chyme moves through the lumen 309 of the tubular barrier 304 of the device 300. The tubular barrier 304 may be sufficiently elastic to allow peristaltic muscle movement to move chyme through the device 300 and into the intestine 322 distal to the device 300, such that absorption and / or even digestion of the chyme is reduced and / or delayed. In various embodiments, the ring 305 may be permeable to allow fluid to flow through the ring 305 and along the outer surface of the tubular barrier 304, thereby allowing digestive enzymes to interact with the digestible material at the distal end of the device 300.

[0027] Referring to FIG. 4, an embodiment of a barrier device 400 according to the present disclosure is shown. The barrier device includes a tubular barrier 404 connected at each end to two self-expanding stents 402. The tubular barrier 404 includes two helical wires 405, 406 that surround a lumen 409 of the device 400. The helical wires 405, 406 help keep the lumen 409 open and maintain the overall orientation of the device 400, thereby substantially preventing any significant kinking or distortion. While two helical wires 405, 406 are shown, any number of wires may be used, e.g., 1, 2, 3, 5, 10, 20, etc., and the wires may be helical, curved, longitudinally straight, circumferential, combinations thereof, etc.

[0028] In various embodiments described herein, or within the scope of the present disclosure, the tubular barrier may comprise an elastic material, such as silicone, polyethylene terephthalate (PET), nylon, rubber, combinations thereof, or the like. The tubular barrier may allow substances to pass through the lumen of the tubular barrier. Due to the malleability of the tubular barrier, smooth muscles contract to create peristaltic waves, moving substances through the tubular barrier. The tubular barrier may be permeable, allowing a portion of the substance to pass through the barrier along the device. The permeability of the tubular barrier may be limited by pore size, which may allow the passage of some substances but restrict the passage of other substances. The tubular barrier may comprise nanofibers, which may increase the stiffness and / or elasticity of the tubular barrier compared to a barrier without fibers. The nanofibers may be oriented in a pattern, such as a cross.

[0029] In various embodiments described herein, or within the scope of the present disclosure, a stent may comprise a shape-memory material, such as stainless steel, nitinol, another alloy, a polymer, a combination thereof, or the like. The stent may be bare, partially covered, or fully covered with a tubular barrier that may enhance the barrier properties of the stent. The stent and / or barrier device may have a variety of diameters, e.g., from about 18 millimeters to about 25 millimeters. The length of the device may vary along the duodenum or duodenal absorption length, e.g., the device length may be greater than about 0 centimeters to about 150 centimeters, from about 20 centimeters to about 35 centimeters, from about 25 centimeters to about 30 centimeters, etc. The stent may be knitted, braided, laser-cut, or the like. The stent may have sufficient radial force to substantially clear a body lumen, e.g., a radial force greater than about 1.9 Newtons per centimeter. In various embodiments, the stent may have a variety of pore sizes, e.g., a pore size of less than about 5 microns.

[0030] In various embodiments, the device can be delivered entirely by peristalsis or with peristaltic assistance. Peristaltic device deployment can take approximately six hours, depending on the length of the device and the number of stents. Peristaltic movement can vary from patient to patient. In some embodiments, all of the stents and anchors can be deployed within minutes, and peristalsis can transform the device into its post-procedure delivered configuration. The length of the device can be anywhere within one or more body lumens, for example, from about 25 cm to about 200 cm. For another example, the device can be about 150 cm in length.

[0031] In various embodiments, the inner sheath may be a solid, hollow, elastic, compressible wire of uniform diameter and / or variable diameter. The inner sheath may provide internal mounting support for the barrier device in the delivery configuration.

[0032] In various embodiments, the present disclosure is not limited to anchoring a medical device within the gastric outflow tract. For example, a medical device of the present disclosure may be anchored within the esophagus, pylorus, lesser curvature, gastric antrum, etc. In various embodiments, the device, or a portion of the device, such as one or more stents, may be stapled, glued, adhesive, sewn, friction-fit, or otherwise adhered to the anatomical structure.

[0033] In various embodiments, a method for a medical professional to deliver a barrier device can include delivering a self-expanding stent disposed at a distal end of a tubular barrier of the device into a body lumen of a patient. At least a portion of the tubular barrier can be delivered into the body lumen. The self-expanding stent and the portion of the tubular barrier can be moved along the body lumen of the patient by peristalsis. A self-expanding anchoring stent disposed at a proximal end of the tubular barrier device can be positioned within an organ of the patient. The body lumen can be the GI tract, and the organ can be the gastric outlet tract. The barrier device can be constrained within a catheter sheath in the delivery configuration. Delivering the self-expanding stent can include retracting the catheter sheath proximally from around the self-expanding stent. The patient can be obese, and delivering at least a portion of the tubular barrier into the GI tract can affect weight loss.

[0034] (Addendum) As a preferred embodiment, the technical concept that can be grasped from the above embodiment will be described below. [Item 1] 1. A barrier device comprising: the barrier device comprises a self-expanding distal stent having a radially outwardly extending ring extending circumferentially around the distal stent and spaced proximally from a distal end; The barrier device comprises a tubular barrier having a proximal end, a distal end, and a lumen extending therethrough, the distal stent being disposed at the distal end of the tubular barrier; the barrier device comprises a self-expanding anchor stent, the self-expanding anchor stent being disposed at the proximal end of the tubular barrier; The ring is shaped similarly to a mass of stomach contents; A barrier device, wherein the self-expanding distal stent is configured to move distally through the intestine when intestinal smooth muscle contracts to generate peristaltic waves, pulling the tubular barrier. [Item 2] Item 10. The barrier device of item 1, further comprising at least one self-expanding intermediate stent between the proximal and distal ends of the tubular barrier. [Item 3] 3. The barrier device of item 2, wherein each of the at least one self-expanding intermediate stent has a ring-like structure in an expanded configuration. [Item 4] 4. The barrier device of any one of items 1 to 3, wherein the tubular barrier covers substantially all of the distal stent and the fixed stent. [Item 5] 4. The barrier device of any one of items 1 to 3, wherein the ring is a bolus-like shape or a combination of a bolus-like shape and one of a ridge, a ring-like shape, a rib, a chyme-like shape, or a ball. [Item 6] 6. The barrier device of any one of items 1 to 5, further comprising a helical wire extending around the lumen of the tubular barrier. [Item 7] 7. The barrier device of any one of items 1 to 6, further comprising a plurality of nanofibers throughout the wall of the tubular barrier. [Item 8] 8. The barrier device according to any one of items 1 to 7, further comprising anchoring projections extending from the outer surface of the anchoring stent. [Item 9] 9. The barrier device according to any one of items 1 to 8, wherein the tubular barrier is semi-permeable. [Item 10] 9. The barrier device according to any one of items 1 to 8, wherein the tubular barrier is substantially impermeable. [Item 11] 1. A barrier system comprising: The barrier system comprises a catheter, the catheter including an outer sheath and an inner sheath; The barrier system comprises a barrier device according to any one of items 1 to 10, A barrier system wherein the inner sheath is slidably disposed within the tubular barrier of the barrier device in a delivery configuration. [Item 12] 12. The barrier system of claim 11, wherein the inner sheath has a distal end with a diameter substantially the same as the diameter of the outer sheath of the catheter. All of the devices and / or methods disclosed and claimed herein can be made and executed without undue experimentation in light of the present disclosure. While the devices and methods of the present disclosure have been described in terms of preferred embodiments, it may be apparent to those skilled in the art that modifications can be made to the devices and / or methods, and in the steps or sequence of steps of the methods described herein, without departing from the concept, spirit and scope of the present disclosure. All such similar substitutes and modifications apparent to those skilled in the art are deemed to be within the spirit, scope and concept of the present disclosure as defined by the appended claims.

Claims

1. 1. A barrier device comprising: The barrier device comprises a self-expanding distal stent having a ring extending circumferentially around the distal stent and extending radially outward from the distal stent and spaced proximally from a distal end of the distal stent; The barrier device comprises a tubular barrier having a proximal end, a distal end, and a lumen extending therethrough, the distal stent being disposed at the distal end of the tubular barrier; the barrier device comprises a self-expanding anchor stent, the self-expanding anchor stent being disposed at the proximal end of the tubular barrier; A barrier device, wherein the self-expanding distal stent is configured to move distally through the intestine under the pull of the tubular barrier by peristaltic waves of the intestine.

2. 10. The barrier device of claim 1, wherein the barrier device further comprises at least one self-expanding intermediate stent between the proximal and distal ends of the tubular barrier.

3. The barrier device of claim 2 , wherein each of the at least one self-expanding intermediate stent has a ring-like structure in an expanded configuration.

4. 4. The barrier device of claim 1, wherein the tubular barrier covers substantially all of the distal stent and the fixed stent.

5. 5. A barrier device according to any one of claims 1 to 4, wherein the ring is bolus-like in shape.

6. 6. The barrier device of claim 1, wherein the ring is one of a ridge, a ring-like shape, a rib, a chyme-like shape, or a ball.

7. 7. The barrier device of claim 1, wherein the ring has a shape that combines a bolus-like shape with one of a ridge, a ring-like shape, a rib, a chyme-like shape, or a ball.

8. The barrier device of any one of claims 1 to 7, further comprising a helical wire extending around the lumen of the tubular barrier.

9. 9. The barrier device of any one of claims 1 to 8, further comprising a plurality of nanofibers throughout the wall of the tubular barrier.

10. The barrier device of any one of claims 1 to 9, further comprising anchoring projections extending from an outer surface of the anchoring stent.

11. A barrier device according to any preceding claim, wherein the tubular barrier is semi-permeable.

12. A barrier device according to any preceding claim, wherein the tubular barrier is substantially impermeable.

13. 13. The barrier device of any one of claims 1 to 12, wherein the tubular barrier is flexible, compressible, or expandable along the central longitudinal axis, or wherein the tubular barrier is flexible, compressible, and expandable along the central longitudinal axis.

14. 1. A barrier system comprising: The barrier system comprises a catheter, the catheter including an outer sheath and an inner sheath; The barrier system comprises a barrier device according to any one of claims 1 to 13, A barrier system wherein the inner sheath is slidably disposed within the tubular barrier of the barrier device in a delivery configuration.

15. 15. The barrier system of claim 14, wherein the inner sheath has a distal end with a diameter substantially the same as the diameter of the outer sheath of the catheter.

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