Lined stent facilitating stent removal

Abstract

An implantable therapeutic device configured to facilitate removal after tissue ingrowth into a portion thereof, such as into an enlarged region having a larger diameter than an adjacent region. A liner is positioned within a lumen of the therapeutic device with a portion spaced from the enlarged region of the therapeutic device. A breach region in the liner facilitates controlled breach of the integrity of the liner to allow a portion of a removal device inserted into the liner to extend through the liner to interact with the therapeutic device. The therapeutic device can be part of a therapeutic system including a removal device having an enlarged region that corresponds to the enlarged region of the therapeutic device. A method of treatment involves breaching a breach region in a liner of the therapeutic device to allow a portion of a removal device to extend through the liner and engage a portion of the therapeutic device.

Description

[0001] priority

[0002] This application claims priority to U.S. Provisional Patent Application Serial No. 63 / 080,976, filed September 21, 2020, under 35 USC §119, the disclosure of which is incorporated herein by reference in its entirety for all purposes. Technical Field

[0003] This disclosure relates to implantable medical devices and related systems, and methods of using them. More specifically, this disclosure relates to removable implantable devices, related systems for implanting and / or removing such devices, and methods of using them, including methods for removing previously implanted devices. Background Technology

[0004] Implantable medical devices, such as radial or self-expanding stents, can be implanted into various body cavities, such as the esophagus, gastrointestinal tract, trachea and bronchi, urethra, biliary tract, and vascular system, and can be designed to provide pathways for fluid flow through them. Compressible and flexible properties that aid in positioning can also lead to device migration, such as due to movement at the implantation site (e.g., peristalsis of the esophagus or gastrointestinal tract) and / or other characteristics of the treatment site (e.g., the generally moist and inherently lubricating environment of the esophagus, intestines, colon, etc.). One approach to reducing stent migration involves allowing a certain degree of tissue inward growth to promote a proliferative response. However, it may be necessary to remove or reposition partially embedded stents. A "stent-in-stent" technique can be used to remove partially embedded stents, which involves deploying a removal stent of equal or larger diameter within and across the length of the partially embedded primary treatment stent. The radial force of the secondary removal stent causes pressure necrosis of the proliferative tissue and allows both stents to be removed simultaneously. Typically, the removal stent is longer than the primary treatment stent to span the area within the primary treatment stent where tissue inward growth occurs. A potential side effect is that secondary stenosis may occur at the protruding end of the removed stent. Furthermore, depending on various factors such as the shape and morphology of the primary treatment stent, its liner may be spaced apart from the stent wall. The liner typically has minimal elasticity (to prevent blockage in the stent lumen due to excessive tissue growth from the stent wall) and is generally considered inelastic. Therefore, the liner can delay or interfere with the expansion of the removed stent, preventing at least a portion of the removed stent from contacting the wall of the implanted treatment stent spaced outside the liner. A technique that allows the removed stent to expand as designed, and allows for the efficient removal of both stents, would be desirable, in addition to simply puncturing the liner (which may produce varying results, potentially incompletely tearing the liner and damaging tissue at the implantation site). Summary of the Invention

[0005] The overview of this disclosure is provided to aid understanding, and those skilled in the art will understand that each aspect and feature of this disclosure may be advantageously used alone in some circumstances, or in combination with other aspects and features of this disclosure in others. The inclusion or exclusion of elements, components, etc., in this overview is not intended to limit the scope of the claimed subject matter.

[0006] Based on the various principles of this disclosure, apparatus, systems, and methods are provided for more effectively removing embedded or partially embedded scaffolds.

[0007] As described in various embodiments or otherwise falling within the scope of this disclosure, a treatment device having a proximal end, a distal end, and a longitudinal extent therebetween includes a treatment device wall defining a cavity therethrough and having inner and outer sides, and a liner having a liner wall extending through at least a portion of the treatment device cavity. An enlarged gap region is defined between a portion of the liner wall and the treatment device wall, wherein the inner sides of the liner wall and the treatment device wall are spaced further apart than in other regions along the longitudinal extent of the treatment device. The liner includes a disruption zone configured to facilitate disruption of the liner wall at the disruption zone. This disruption of the liner (e.g., disruption of the liner's integrity, such as by separating or tearing a portion of the liner) allows a removal device placed within the liner cavity to interact with the treatment device wall through the liner wall (e.g., through the liner wall).

[0008] In some embodiments, the liner further includes a destroyer element located in a destruction zone, configured to facilitate the destruction of the integrity of the liner wall at the destruction zone. Optionally, the destroyer element is formed separately from the liner wall. In some embodiments, the liner wall defines a cavity therein, and the destroyer element extends from within the liner cavity through the liner wall to the outside of the liner wall. Optionally, the destroyer element repeatedly passes through the liner wall around the circumference of the liner. In some embodiments, the destroyer element includes a gripping feature configured to facilitate gripping the destroyer element to manipulate it to destroy the liner at the destruction zone. In some embodiments, the destroyer element includes an enlarged region configured to create a large pore in the liner wall when the destroyer element destroys the integrity of the liner wall. In some embodiments, the enlarged region is formed as a node in the destroyer element. In some embodiments, the enlarged region is formed separately from and connected to the destroyer element. In some embodiments, the destroyer element is a suture, wire, or filament.

[0009] In some embodiments, the lining is substantially inelastic.

[0010] In some embodiments, at least a portion of the wall of the treatment device is configured to stimulate tissue growth.

[0011] As described in various embodiments or otherwise falling within the scope of this disclosure, a treatment system for performing a stent-in-stent removal procedure at a treatment site includes a treatment device having a proximal end, a distal end, and a longitudinal extent therebetween. The treatment device includes a cavity defining a cavity therethrough and having inner and outer walls, and a liner having a liner wall extending through at least a portion of the treatment device wall cavity and defining the liner cavity therethrough; and a removal device configured to be fitted within the liner cavity. The treatment device wall includes a portion of the liner wall defining an enlarged gap region between it and the treatment device wall, where the inner sides of the liner wall and the treatment device wall are spaced further apart than other regions along the longitudinal extent of the treatment device, and the removal device has an external shape configured to conform to the shape of the inner side of the treatment device when the removal device is within the liner cavity. The liner includes a disruption zone configured to facilitate disruption of the liner wall at the disruption zone to allow the removal device to interact with the treatment device wall through the liner wall when placed within the liner cavity.

[0012] In some embodiments, the liner further includes a disruptor element located in the disruption zone, which is configured to disrupt the integrity of the liner wall at the disruption zone.

[0013] In some embodiments, at least a portion of the wall of the treatment device is configured to stimulate tissue growth.

[0014] In some embodiments, the removal device is configured to interact with the treatment device to facilitate loosening of the treatment device relative to tissue at the treatment site.

[0015] In some embodiments, the removal device can expand radially outward to interact with the treatment device and shorten within the treatment device, such that the proximal and distal ends of the removal device are located within the cavity of the treatment device and between the proximal and distal ends of the treatment device.

[0016] According to a further aspect of this disclosure, a method includes positioning a treatment device at a treatment site, the treatment device having a wall and a liner defining a cavity therethrough, the liner having a liner wall extending through at least a portion of the treatment device cavity and defining a liner cavity, wherein an enlarged gap region is defined between a portion of the liner wall and the treatment device wall, wherein the liner wall and the treatment device wall are spaced further apart than in other regions along the longitudinal extent of the treatment device, and the liner wall is substantially inelastic and includes a break zone configured to facilitate breakage of the liner wall at the break zone. The method includes actuating the break zone of the liner to allow removal of the device through the liner wall to interact with the treatment device.

[0017] According to a further aspect of this disclosure, a method includes positioning a treatment device at a treatment site, the treatment device having a wall and a liner defining a cavity therethrough, the liner having a liner wall extending through at least a portion of the treatment device cavity and defining a liner cavity, wherein an enlarged gap region is defined between a portion of the liner wall and the treatment device wall, wherein the liner wall and the treatment device wall are spaced further apart than in other regions along the longitudinal extent of the treatment device, and the liner is substantially inelastic and includes a break zone configured to facilitate breakage of the liner wall at the break zone. The break zone of the liner is actuated to allow a removal device to pass through the liner wall to interact with the treatment device.

[0018] In some embodiments, after actuating the destruction zone, the method further includes placing a removal device within a liner cavity, the removal device extending through the liner to interact with the treatment device. In some embodiments, the method includes allowing the removal device to expand to interact with the treatment device and to shorten within the treatment device, such that the proximal and distal ends of the removal device are located within the treatment device cavity and between the proximal and distal ends of the treatment device.

[0019] These and other features and advantages of this disclosure will become apparent from the following detailed description, the scope of which is set forth in the appended claims.

[0020] This disclosure is given as an overview to aid understanding, and those skilled in the art will understand that each aspect and feature of this disclosure may be advantageously used alone in some circumstances or in combination with other aspects and features of this disclosure in others. The inclusion or exclusion of elements, components, etc., in this overview is not intended to limit the scope of the claimed subject matter. Therefore, while this disclosure is presented in the form of aspects or embodiments, it should be understood that each aspect and feature may be claimed alone or in combination with that embodiment or any other embodiment. Attached Figure Description

[0021] Non-limiting embodiments of this disclosure are described with reference to the accompanying drawings, which are schematic and not intended to be drawn to scale. The drawings are provided for illustrative purposes only, and the dimensions, positions, orders, and relative sizes reflected by the numbers in the drawings may vary. For example, devices may be enlarged to make details discernible but are intended to be scaled down, for example, when fitted within the working channel of a delivery catheter or endoscope. In the drawings, identical or nearly identical or equivalent elements are generally denoted by the same reference numerals, and similar elements are generally denoted by similar reference numerals, in increments of 100, and redundant descriptions are omitted. For clarity and brevity, not every element is labeled in every drawing, nor is every element of every embodiment shown where description is unnecessary, so that those skilled in the art can understand this disclosure.

[0022] The detailed description will be better understood in conjunction with the accompanying drawings, where similar reference numerals represent similar elements, as shown below:

[0023] Figure 1 It is a schematic cross-sectional view of a part of the human body, in which an example of a treatment device formed according to the various principles of this disclosure extends through it.

[0024] Figure 2 This is a perspective view of an example of a treatment device formed in accordance with the various principles of this disclosure.

[0025] Figure 3 It is formed in accordance with the various principles of this disclosure for purposes such as Figure 2 A perspective view of the removal device of the treatment apparatus shown.

[0026] Figure 4 It is along Figure 2 A cross-sectional view of line IV-IV.

[0027] Figure 5 This is a schematic cross-sectional view of a removal device located within a treatment device formed according to various principles of this disclosure, showing the removal device extending beyond the lining of the treatment device.

[0028] Figure 6 Through Figure 2 The cross-sectional view along line VI-VI shows examples of release structures formed according to various principles of this disclosure.

[0029] Figure 7 It is a cross-section of an example of a release structure formed in accordance with the various principles of this disclosure. Detailed Implementation

[0030] The following detailed description should be read with reference to the accompanying drawings, which depict illustrative embodiments. It should be understood that this disclosure is not limited to the specific embodiments described, as these embodiments may vary. All apparatuses, systems, and methods discussed herein are examples of apparatuses and / or systems and / or methods implemented according to one or more principles of this disclosure. Each embodiment is provided by way of illustration and is not the only way to implement these principles, but merely an example. Therefore, references to elements or structures or features in the drawings must be understood as references to examples of embodiments of this disclosure and should not be construed as limiting this disclosure to the specific elements, structures, or features illustrated. Other examples of ways to implement the disclosed principles will occur to those skilled in the art upon reading this disclosure. In fact, various modifications and variations to this disclosure will be apparent to those skilled in the art without departing from the scope or spirit of the subject matter. For example, features illustrated or described as part of one embodiment may be used with another embodiment to produce further embodiments. Therefore, this subject matter is intended to cover such modifications and variations within the scope of the appended claims and their equivalents.

[0031] It is understood that this disclosure is set forth in detail at different levels. In some cases, details that are not necessary for those skilled in the art to understand this disclosure or that make other details difficult to perceive may have been omitted. The terminology used herein is for describing particular embodiments only and is not intended to limit the scope beyond the appended claims. Unless otherwise defined, the technical terms used herein should be understood as those commonly understood by those skilled in the art to which this disclosure pertains. Based on this disclosure, all the apparatuses and / or methods disclosed and claimed herein can be made and performed without excessive experimentation.

[0032] As used herein, “proximal” refers to the direction or location closest to the user (medical professional, clinician, technician, operator, or physician, etc.; these terms are used interchangeably without limitation or other intent), such as when using the device (e.g., introducing the device into a patient, or during implantation, positioning, or delivery), and “distal” refers to the direction or location furthest from the user, such as when using the device (e.g., introducing the device into a patient, or during implantation, positioning, or delivery). “Longitudinal” means extending along the longer or greater dimension of the element. “Center” means at least substantially bisects a center point, and “central axis” refers to a line extending longitudinally along the length of an opening, when the opening includes, for example, a tubular element, a strut channel, or a hole, at least substantially bisects the center point of the opening.

[0033] According to the various principles of this disclosure, the implantable treatment device has a wall defining an inner cavity and a liner extending through the cavity. The treatment device may have different diameters (inner and / or outer diameters) and at least one enlarged region. The treatment device may have a treatment device wall having more than one outer diameter along its length from the proximal end to the distal end of the device. Among the different diameter sizes, the inner or outer diameter along most of the length of the device (the diameter of the longest continuous range of the device, or the diameter existing in different regions of the device whose lengths are the longest of other regions with different diameters) (depending on whether the wall thickness of the treatment device is constant or variable, it may vary proportionally or disproportionately along the length of the device relative to each other) is referred herein to as the main inner diameter or total inner diameter, main inner diameter or total outer diameter, or device body diameter of the treatment device wall. For convenience and not for limitation, the intermediate region of the treatment device may be referred to herein as the saddle region, the outer diameter of which may be substantially the same as the main diameter of the treatment device wall. The dimensions of the liner may match the main inner diameter of the treatment device and / or the inner diameter of the saddle region (e.g., the outer diameter is slightly smaller than its inner diameter). It is understood that other forms of treatment devices, such as treatment device walls with a substantially uniform diameter but with a liner of a variable diameter, thereby defining gaps of different sizes between the treatment device walls and the liner, are all within the scope of this disclosure. Therefore, within one or more ranges of treatment devices to which the principles of this disclosure can be applied, the distance between the outer side of the liner and the inner side of the treatment device wall is greater than the distance between the liner and other areas of the treatment device wall along the longitudinal direction of the treatment device. For simplicity, this document refers to "enlarged gap areas" as one or more areas of the treatment device in which the gap between a portion of the treatment device wall and the liner is larger, increased, or enlarged relative to the gaps (including no gaps) between the treatment device wall and the liner in other areas of the treatment device (e.g., along the longitudinal direction between the two ends of the treatment device).

[0034] According to one aspect of this disclosure, the liner has a predetermined breakage zone to facilitate breakage of the liner (fracture, tear, crack, etc., these terms are used interchangeably herein and are not intended to be limiting). Thus, after the liner is interrupted along the breakage zone, a removal device inserted into the treatment device can expand beyond the liner wall to apply pressure to the inside of the treatment device, including the enlarged gap region therein. For example, in one embodiment, the breakage zone is formed at a location adjacent to the enlarged gap region of the treatment device wall and is located within the liner of substantially the same diameter. Therefore, the liner in this embodiment can be broken at a location adjacent to the enlarged gap region of the treatment device wall to allow the removal device to pass through that location and engage with the treatment device wall.

[0035] In some embodiments, the implantable therapeutic device is partially coated to inhibit tissue growth. In some embodiments, the implantable therapeutic device is partially uncoated to promote inward tissue growth. In some embodiments, the implantable therapeutic device may have an enlarged gap region between a portion of the therapeutic device wall and a liner disposed therein, in which the therapeutic device wall is at least partially uncoated to promote tissue growth in that region. Therefore, providing a disruptive zone in the liner is particularly useful in allowing the removal device to extend into and effectively apply pressure to the proliferating tissue to release the implantable therapeutic device (e.g., after the proliferating tissue portion ingrained into the implantable therapeutic device has necrotized). Additionally, or alternatively, the provision of the disruptive zone allows the removal device to expand radially and thus shorten, such that the proximal and distal ends of the removal device are within the therapeutic device (i.e., the resulting length of the removal device is shorter than the length of the therapeutic device). Thus, inward tissue growth into both ends of the removal device that might occur in prior art removal devices can be reduced or inhibited, and preferably prevented.

[0036] This document may refer to implantable devices, apparatuses, scaffolds, etc., and their walls may be described herein as support frames. These terms should be understood not as specific structures necessary to limit this disclosure to the broad principles of this disclosure. While this disclosure refers to scaffolds with a specific morphology (e.g., an enlarged spherical region), the principles of this disclosure apply to other forms and morphologies of scaffolds or other implantable devices, including scaffolds with different forms and shapes of retaining structures that may have different diameters relative to other body regions, thus presenting a relatively enlarged gap region between the liner and the larger-diameter retaining structure. In some embodiments, the scaffold may be a braided or interwoven scaffold with gaps between filaments, sequential patterns, boundary wires, etc., forming the wall of the treatment device. A coating or covering for inhibiting inward tissue growth may be provided on a portion of the implantable treatment device to reduce the forces required to allow removal of the implantable device, such as by creating a physical barrier between the tissue at the implantation site and the outer surface of the implantable device to reduce inward tissue growth. The coating may be applied to the exterior of the implantable treatment device, and if the implanted device is in the form of an interwoven or braided scaffold, the coating may fill the gaps in the treatment device wall. Various partially covered stents are known, such as U.S. Patent 10,682,220 entitled "Esophageal Stent Including Liner," issued June 16, 2020; U.S. Patent Application 2018 / 0280166 entitled "Stent with Dual Tissue Wall Anchoring Features," issued October 4, 2018; and U.S. Patent Application No. 16 / 930,411 entitled "Stent, System, and Method for the Gastrointestinal Tract," filed July 16, 2020; each of these is incorporated herein by reference in its entirety for all purposes. Implantable therapeutic devices may have exposed portions (parts not covered, coated, or otherwise covered) to facilitate inward tissue growth, such as reducing migration of the implantable device relative to the implantation site. In some cases, inward tissue growth into or into the device wall may be required without a passage of material through the gaps in the device wall. In such cases, a coating may form a liner within the lumen or internal channel of the device, spaced inwardly from the device wall. This lining can be used to facilitate the passage of materials (e.g., food or bodily fluids, such as those used to aid digestion) through the internal channels of the device without leaking through or from the walls of the device.

[0037] Some stent designs may have unique shapes suited to specific treatments and / or implantation sites. For example, some stents are configured for the treatment of post-bariatric surgery leakage (PBSL). The body of such a stent may include a knitted stent wall with a specific body shape (e.g., with an enlarged region, such as a region including a spherical segment) to interact with the leakage site / leakage area to aid in leakage healing. Bariatric leakage typically occurs high in the fundus region of the stomach, which is often poorly vascularized and therefore poorly healed. The principle surrounding PBSL stent design is that the area of ​​interaction is exposed, which allows the wires forming the stent to interact with the tissue surrounding the leakage site, stimulating tissue proliferation and promoting healing of the leakage site. A continuous central lumen through the stent is maintained across this region. A liner, such as one formed of a coating material used to cover the stent to inhibit inward tissue growth, is formed or disposed within the stent lumen to isolate the leakage site from any nutrient contents that may pass through the stent from the esophagus to the lower part of the stomach. An enlarged gap region may be defined between a portion of the stent wall and the liner, adjacent to the enlarged region of the stent wall along the longitudinal extent of the stent (between the two ends of the stent).

[0038] An implantable therapeutic device formed according to the principles of this disclosure can be provided as a therapeutic system together with a removal device. In some embodiments, the shape (at least the external shape) of the removal device is configured to conform to the shape (at least the internal shape) of the implantable therapeutic device (generally match or at least have a common area with corresponding variations in diameter or other shape or geometry). In some embodiments, the implantable therapeutic device and the removal device form a system of stents within stents, which facilitates the removal of the implantable therapeutic device and, if necessary, the insertion and implantation of the removal device therein.

[0039] According to the principles of this disclosure, a treatment method utilizing an implantable therapeutic device with a destructive region includes implanting the implantable therapeutic device with a liner having a destructive region at the treatment site, determining whether and when removal of the implantable therapeutic device is necessary, and destructing the destructive region to allow a removal device inserted into the therapeutic device to expand beyond the liner. The removal device may be inserted into the therapeutic device and allowed to expand to contact the inner side of the therapeutic device, including the inner side of an expanded region of the therapeutic device spaced from the liner, the spaced distance being greater than the spacing between other regions of the therapeutic device and the liner before liner destruction. The removal device may be allowed to shorten within the therapeutic device. The removal device and the therapeutic device remain in place, allowing contact between the removal device and the inner side of the therapeutic device to loosen the therapeutic device (e.g., pressure-induced tissue necrosis). Once the therapeutic device is sufficiently loosened, the therapeutic device and the removal device may be removed independently or simultaneously without damaging the tissue at the treatment site.

[0040] Various embodiments of a treatment device, removal device, treatment system, and their associated methods of use will now be described with reference to the embodiments illustrated in the accompanying drawings. References in this specification to "one embodiment," "embodiment," "some embodiments," "other embodiments," etc., indicate that one or more specific features, structures, and / or characteristics according to the principles of this disclosure may be included in that embodiment. However, such references do not necessarily mean that all embodiments include the specific features, structures, and / or characteristics, or that one embodiment includes all features, structures, and / or characteristics. Some embodiments may include one or more such features, structures, and / or characteristics in different combinations thereof. Furthermore, references to "one embodiment," "embodiment," "some embodiments," "other embodiments," etc., throughout this specification do not necessarily refer to the same embodiment, and individual or alternative embodiments are not necessarily mutually exclusive with other embodiments. When a specific feature, structure, and / or characteristic is described in relation to one embodiment, it should be understood that such feature, structure, and / or characteristic may also be used in relation to other embodiments, whether explicitly described or not, unless explicitly stated otherwise. It should be further understood that these features, structures, and / or characteristics may be used alone or present, or combined in various ways to produce alternative embodiments considered part of this disclosure, as describing all possible combinations and sub-combinations of features, structures, and / or characteristics would be overly cumbersome. Furthermore, the various features, structures, and / or characteristics described may be shown in some embodiments but not in others. Similarly, the various features, structures, and / or characteristics or requirements described may be features, structures, and / or characteristics or requirements of some embodiments but may not be features, structures, and / or characteristics or requirements of other embodiments. Therefore, the invention is not limited to the embodiments specifically described herein.

[0041] Now turn to the attached diagram, Figure 1 The example of a treatment site TS in the gastrointestinal tract (“GI”) of the human body illustrates an example of a treatment device 100 formed according to the principles of this disclosure. In this non-limiting example, the treatment device 100 is a stent implanted in a portion of the GI tract that has undergone gastric reduction surgery, such as gastric bypass surgery, in which a portion of the stomach S is reduced, such as by stapled or sutured a segment of the stomach S, to form a functional gastric pouch P through which food passes (and the remnant R on the other side of the stapled line SL). However, it is understood that other forms of stents or other types of treatment devices may incorporate one or more aspects of this disclosure. Figure 1The illustrated treatment device 100 has a treatment device wall 102 that defines a treatment device cavity 105 through which materials, such as food, can pass through the treatment device 100. In some embodiments, the treatment device wall 102 can be considered as a support frame. The illustrated treatment device 100 has a treatment device wall 102 that extends along its length from the proximal end 101 of the treatment device 100 to the distal end 103 of the treatment device 100, and / or has regions and / or shapes or morphologies with different diameters (outer diameter and / or inner diameter of the treatment device wall 102). The transition between regions of different diameters may be inclined or otherwise shaped and / or configured to present a non-invasive outer surface. For convenience and not for limitation, the diameter of the maximum longitudinal extent of the treatment device wall 102 (the sum of the continuous extent or the discontinuous areas of the treatment device between the proximal end 101 and the distal end 103 of the treatment device 100) (e.g., the outer diameter of the treatment device wall 102) is referred to herein as the main diameter D. A first enlarged region 110 (which may be alternatively referred to as a flange, without limitation) may be provided near the proximal end 101 of the treatment device 100. This region is shaped and configured to be located in a proximal region of the GI tract, such as in the esophagus E. A second enlarged region 120 (which may be alternatively referred to as a sphere, without limitation) may be located between the proximal end 101 and the distal end 103 of the treatment device 100. This region is shaped and configured to contact the gastric wall at the treatment site TS, where leakage, perforation, or tear (or other defect requiring treatment) along the staple line SL occurs (this site is alternatively referred to herein as a "leakage area"). The second enlarged region 120 may be uncoated or partially uncoated to promote tissue growth, such as hyperplasia, to facilitate healing of the treatment site TS. A saddle region 130 may extend between the first enlarged region 110 and the second enlarged region 120. An intermediate diameter segment 112 may extend further downward into the GI tract, in this example referring to the gastric pouch P.

[0042] Reference Figure 2A more detailed perspective view of an example embodiment of the treatment device 100 shown illustrates that a liner 140 is disposed within a treatment device cavity 105. The liner 140 may extend the length of the treatment device cavity 105 from a proximal end 101 of the treatment device 100 to a distal end 103 of the treatment device 100. The liner 140 may have a liner cavity 145 extending through it from a proximal end 141 of the liner 140 (located adjacent to or near the proximal end 101 of the treatment device 100) to a distal end 143 of the liner 140 (located adjacent to or near the distal end 103 of the treatment device 100). The liner 140 may be formed and configured as similar to known or previously known liners in implantable treatment devices and may be substantially impermeable to fluids, thus preventing or minimizing leakage from the treatment site TS into the treatment device cavity 105. Additionally or alternatively, the liner 140 may be formed of a substantially inelastic material, so that if significant inward tissue growth occurs at the second enlarged region 120, the liner 140 may inhibit or prevent excessive tissue growth into the treatment device cavity 105 and thus block or narrow the treatment device 100.

[0043] In some cases, it may be necessary to remove the treatment device 100 after a predetermined amount of time has elapsed since its implantation into the treatment site TS, following the principles of this disclosure. In some embodiments, it is envisioned that the removal of the treatment device 100 be performed using a "stent-in-stent" technique, wherein a removal device is implanted within the treatment device cavity 105 and applies pressure to the inner side 102i of the treatment device wall 102, causing the outer side 102e of the treatment device wall 102 to apply pressure to the inwardly growing tissue, thereby causing loosening of the treatment device 100, such as by inducing necrosis of the inwardly growing tissue. According to one embodiment, as... Figure 3 As shown, a removal device 200, shaped and configured to substantially conform to the shape of the treatment device 100, is used to remove the treatment device 100. In some embodiments, at least the outer shape of the removal device 200 is configured to conform to the shape of the inner side 102i of the treatment device wall 102. For example, the removal device 200 is shaped and configured to have one or more enlarged regions conforming to an enlarged region of the treatment device 100 (such as an enlarged region of the treatment device 100 configured, for example, by being uncoated / exposed, to stimulate tissue growth / inward growth) to effectively contact the treatment device 100, thereby applying pressure to the treatment device wall 102 to allow for the eventual removal of the partially embedded treatment device 100. Figure 3In the illustrated embodiment, the illustrated example of the removal device 200 has at least one enlarged removal region 220, which is shaped and configured to correspond (similar in shape and / or morphology) to the second enlarged region 120 of the illustrated example of the treatment device 100, and this enlarged region is generally configured to be positioned at the treatment site TS. The enlarged removal region 220 is positioned relative to the proximal end 201 and distal end 203 of the removal device 200 so that, when the removal device 200 is placed within the treatment device 100, the enlarged removal region 220 is positioned within and adjacent to the second enlarged region 120 of the treatment device 100. The removal device 200 may be expandable so that, once inserted into the treatment device 100, the removal device 200 can expand to allow the enlarged removal region 220 (e.g., the outer side 202e of the removal device wall 202) to contact the second enlarged region 120 of the treatment device 100 (e.g., the inner side 102i of the treatment device wall 102). The removal device 200 may be sized and / or configured to apply a sufficient amount of radially outward expansion force, such as applying sufficient force (e.g., about 0 to 10 N) to the treatment device 100 once it is positioned within the treatment device 100, to loosen the treatment device 100 for subsequent removal from the treatment site TS. It is understood that other forms of the removal device configured to interact with other forms of the treatment device are also within the scope of this disclosure.

[0044] like Figure 5 As shown, the removal device 200 can be configured to be shorter than (e.g., shortened during placement) the total length of the treatment device 100, so that during deployment, the removal device 200 is completely contained within or enclosed by the treatment device 100. This reduces the chance of further tissue stenosis due to abrasion at the proximal and distal ends of the removal device 200.

[0045] As described above, the lining 140 of the treatment device 100 generally does not have significant expandability and / or elasticity, and therefore may delay, impede, or otherwise interfere with the ability of the removal device 200 to contact the treatment device wall 102 along the enlarged gap region G (such as by the expansion of the removal device 200) along the longitudinal extent of the treatment device 100 (where the lining 140, particularly the outer side 142e of the lining wall 142, is spaced from the inner side 102i of the treatment device wall 102 by a greater margin than it is spaced from other areas along the longitudinal extent of the treatment device 100). Without sufficient expansion of the liner 140, the removal device 200 may not be able to fully interact with the treatment device 100 (which may have bare wires for stimulating tissue growth at the leakage area and optionally within the treatment device 100) (e.g., engaging, contacting, applying pressure, etc.), for example by extending across the gap between the liner wall 142 and the treatment device wall 102 to engage, contact the inner side 102i of the treatment device wall 102, apply pressure to the inner side 102i of the treatment device wall 102, etc., to facilitate the removal of the treatment device 100, such as by causing pressure necrosis of the surrounding tissue at the leakage area.

[0046] In accordance with the principles of this disclosure, Figure 2 and Figure 4 The liner 140 of the embodiment illustrated in the figure is formed with a disruption zone 150. The disruption zone 150 is configured to allow the liner 140 to be disrupted, broken, or torn in a controlled manner, or to fracture (these terms are used interchangeably herein and are not intended to be limiting, referring to a manner that alters the integrity of the liner 140 structure to allow the removal device 200 to pass through or otherwise traverse the liner wall 142), allowing the removal device 200 to extend through the liner 140 to contact areas of the treatment device wall 102, such as areas of the treatment device wall 102 spaced apart from the outer side 142e of the liner wall 142, the extent or degree of which this spaced-apart area is greater than other areas extending longitudinally along the treatment device 100. In some embodiments, the disruption zone 150 is positioned along the liner 140 such that it is near or adjacent to a leakage area when the treatment device 100 is placed at the treatment site TS. Liner 140 may be moved (displaced, axially contracted, or otherwise) away from the path of removal device 200, such as at rupture zone 150, to allow expansion of removal device 200 to perform the desired or indicated interaction with treatment device 100. Although rupture zone 150 is shown positioned along an enlarged region 220 of liner 140, which corresponds to a second enlarged region 120 of the illustrated example of treatment device 100, other locations of rupture zone 150 that allow sufficient movement (e.g., expansion) of removal device 200 through liner 140 are within the scope and spirit of this disclosure.

[0047] In one embodiment, a destructive element 152, formed separately from the liner 140, is provided at the destruction zone 150, and the destructive element 152 is configured to interact with the liner 140 at the destruction zone 150 to cause physical destruction of the liner 140, such as by manipulating the liner 140 to cause or otherwise facilitate destruction of the liner 140, such as by disrupting the integrity of the liner wall 142. For example, manipulation / movement of the destructive element 152 relative to the liner 140 can disrupt the structural integrity of the liner 140. In some embodiments, radial inward pulling of the destructive element 152, such as pulling from within the cavity 105 of the treatment device 100, results in the desired destruction of the liner 140. In some embodiments, the destructive element 152 includes a suture, or filament or wire (such elements are used interchangeably herein and are not intended to be limiting), which has a morphology at the destruction zone 150 that facilitates destruction of the destruction zone 150 upon movement of the suture relative to the destruction zone 150. Figure 6 In the example shown, the breaker element 152 may pass radially from the inside of the liner to the outside or be fixed from the inside of the liner to the outside (e.g., as a continuous stitch). In some embodiments, the breaker element 152 repeatedly passes radially from the inside to the outside around the circumference of the liner 140 at the rupture zone 150. Radial inward pulling of the breaker element 152, such as pulling from within the cavity 105 of the treatment device 100, causes the breaker element 152 to tear the liner 140 along the rupture zone 150 (optionally retracting or clamping the liner 140 radially inward) and pull generally around the liner 140 circumferentially to position the removal device 200 within the treatment device 100 to penetrate and extend through the liner 140. Figure 5 As schematically shown, the removal device 200 can expand toward the treatment device 100 or otherwise extend, such as in the area of ​​the leakage zone, engaging with the treatment device 100 more effectively than prior art devices.

[0048] Once the lining wall 142 is breached, the disruptor element 152 can be removed, or it can be allowed to pass naturally through the body. In some embodiments, such as in Figure 6 In the illustrated embodiment, the breaker element 152 may include a gripping feature 154, such as a ring, configured to facilitate gripping the breaker element 152 to manipulate or actuate the breaker element 152 to destroy the liner 140.

[0049] Alternative embodiments of the breaker element 152 form are possible within the scope and spirit of this disclosure. For example, multiple breaker elements 152 may be used, such as multiple stitches or filaments or wires. The breaker element 152 may have a pattern (e.g., diagonal path, longitudinal path, etc.) that follows an alternative path or trajectory or form relative to the lining 140.

[0050] In some embodiments, the enlarged area may be formed on the disruptor element 152, such as along the length of the disruptor element 152. Figure 7 An example of an embodiment of a breaker element 152 having an enlarged region 154 is illustrated. This enlarged region can create larger pores in the liner 140 when the breaker element 152 actuates the breaker region 150 to break the liner 140, and when the breaker element 152 is retracted, and can further promote the breakage of the liner 140. This enlarged region can be formed in various ways, such as a segment knotted on the outer region of the suture, a beaded component screwed in during manufacturing, another component formed separately from the breaker element and applied to or otherwise attached thereto (e.g., in the form of a liquid that solidifies when applied to the breaker element 152, or a solid component otherwise attached to the breaker element 152), and so on.

[0051] Reference Figure 5 It is understood that the destruction zone 150 provides several advantages compared to prior art treatment and removal devices. According to the principles of this disclosure, removal of the liner 140 with the aid of the destruction zone 150 allows for radial expansion of the removal device 200 within the treatment device 100. This radial expansion of the removal device 200 is generally accompanied by a shortening of the removal device 200 so that the proximal end 201 and distal end 203 of the removal device 200 are within the cavity 105 of the treatment device 100 and located between the proximal end 101 and distal end 103 of the treatment device 100. Therefore, the possibility of tissue growing inward into the proximal end 201 and distal end 203 of the removal device 200 (which could lead to secondary stenosis in prior art removal devices) is reduced, if not eliminated. Furthermore, the destruction of the liner 140 allows the removal device 200 to extend across an enlarged gap region G to effectively engage with the treatment device 100. Thus, the removal device 200 can operate effectively across the entire length of the treatment device 100. In embodiments where the treatment device 100 is used to repair a leaking area by stimulating tissue to grow inward into the treatment device 100, the destruction of the liner 140 allows the removal device 200 to effectively engage with substantially all areas along the length of the treatment device 100, including the leaking area region (located along the leaking area), which presents a challenge in prior art devices given the large distance between the treatment device 100 and the liner 140 (and the subsequent removal device, while the liner remains intact and in place) in the leaking area region.

[0052] The medical devices, instruments, tools, etc., that can be used with the treatment device 100 and removal device 200 of this disclosure are not limited, and may include various medical devices, instruments, tools, etc., for accessing the body, including, for example, duodenoscopes, catheters, ureteroscopes, bronchoscopes, colonoscopes, arthroscopes, cystoscopes, hysteroscopes, etc. The treatment device 100 and removal device 200 can be placed according to procedures for the disease to be treated by the treatment device 100, as known or currently medically accepted. The scheme for determining the timing of delivery and removal can follow generally accepted medical protocols for the disease to be treated.

[0053] The delivery device used herein can be of any suitable size, cross-sectional shape or area, and / or form that allows the introduction and passage of a medical instrument through the distal end of the delivery device. Generally, steerability of the delivery device is advantageous, and the delivery device may have different areas of varying flexibility or stiffness to facilitate steerability. The delivery device may include one or more working channels extending substantially longitudinally (axially) between the proximal and distal ends of the delivery device. The delivery device and / or the associated transition tube may be made of any suitable biocompatible material known to those skilled in the art and have sufficient flexibility to traverse non-linear or tortuous anatomical structures. Such materials include, but are not limited to, rubber, silicone, synthetic plastics, stainless steel, metal polymer composites; metallic alloys of nickel, titanium, copper-cobalt, vanadium, chromium, and iron; hyperelastic or shape-memory materials, such as nitinol; and different material layers and reinforcement layers. Such materials may be made of or coated with polymers or lubricants to enable or facilitate the passage of the delivery device therein. In some embodiments, the working channel may be made of or coated with polymers or lubricants to facilitate the passage of the introduced medical instrument through the working channel.

[0054] The treatment device 100 can be constructed in a variety of non-limiting ways. In some embodiments, the treatment device 100 may be a balloon or self-expanding. Examples of self-expanding treatment devices may include a stent with a rigid and / or semi-rigid stent structure formed by a combination of one or more strut members. For example, the strut members may be formed from one or more wires or filaments, and the stent structure may be formed by braiding, wrapping, winding, interlacing, weaving, knitting, looping (e.g., corrugated), knotting, etc. Alternatively, the treatment device 100 may be an integral structure formed from cylindrical tubular members, such as a single, cylindrical, laser-cut tubular member (e.g., formed of a nickel-titanium alloy), wherein the remainder of the tubular member forms the strut members. Openings or gaps through the walls of the treatment device may be defined between adjacent strut members.

[0055] The treatment device 100 may be made of a variety of non-limiting materials, such as, but not limited to, metals, metal alloys, polymers (some examples of which are disclosed below), metal-polymer composites, ceramics, combinations thereof, or other suitable materials. For example, the treatment device 100 may be made of metal / metal alloys (stainless steel, such as 304V, 304L, and 316LV stainless steel; low-carbon steel; nickel-titanium alloys, such as linear elastic and / or hyperelastic nickel-titanium alloys; other nickel alloys, such as nickel-chromium-molybdenum alloys (e.g., UNS: N06625, such as...). 625, UNS: N06022, as UNS: N10276, as other alloys, etc.), nickel-copper alloys (such as UNS: N04400, etc.) 400 400 400, etc.), nickel-cobalt-chromium-molybdenum alloys (such as UNS: R30035, etc.) (etc.), nickel-molybdenum alloys (such as UNS: N10665, such as...) ALLOY Other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, etc.; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (such as UNS: R30003, etc.). (etc.); platinum-rich stainless steel; titanium; combinations thereof; etc.; or any other suitable material etc.) constitute.

[0056] In other examples, the treatment device 100 may be made of polymeric materials (e.g., polyethylene terephthalate (PET), polymethyl methacrylate, polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., available from DuPont). Polyether block esters, polyurethanes (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), and polyether esters (e.g., available from DSM Engineering Plastics). ), ether- or ester-based copolymers (e.g., butene / poly(alkylene ether) phthalates and / or other polyester elastomers, such as those available from DuPont). ), polyamide (e.g., available from Bayer) Alternatively, it can be purchased from Elf Atochem. ), elastomer polyamide, block polyamide / ether, polyether block amide (PEBA, for example, can be used in...) (obtained under the trade name below), ethylene vinyl acetate copolymer (EVA), silicone resin, polyethylene (PE), Malex high-density polyethylene, Malex low-density polyethylene, linear low-density polyethylene (e.g. Polyester, polybutylene terephthalate (PBT), polypropylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), polyterephthalamide (e.g., Polysulfone, nylon, nylon 12 (e.g., purchased from EMS American Grilon) The treatment device 100 may be composed of perfluoropropyl vinyl ether (PFA), ethylene vinyl alcohol, polyolefins, polystyrene, epoxy resins, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS 50A), polycarbonate, ionomers, biocompatible polymers, other suitable materials or mixtures, combinations, copolymers, polymer / metal composites, or other suitable polymeric materials. In other examples, the treatment device 100 may be composed of a combination of metallic and polymeric materials, such as core fibers or composite fibers, for example, having a nickel-titanium alloy shell and a platinum core. Examples of core fibers or composite fibers are disclosed in U.S. Patents 7,101,392 and 6,527,802, each of which is incorporated herein by reference in its entirety for all purposes. In other examples, the treatment device 100 may include bioabsorbable and / or biodegradable materials (e.g., poly(lactic-co-glycolic acid) polymers).

[0057] In at least some embodiments, some or all of the devices disclosed herein, and other components of the devices described herein, may also incorporate, be made of, or otherwise include radiopaque materials. Radiopaque materials are understood to be materials capable of producing a relatively bright image on a fluorescent screen or other imaging technology during medical procedures. This relatively bright image helps the user determine the location of the device. Some examples of radiopaque materials may include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymeric materials loaded with radiopaque fillers, etc. Furthermore, other radiopaque marking strips and / or coils may also be incorporated into the design of the device to achieve the same effect.

[0058] In some embodiments, a degree of magnetic resonance imaging (MRI) compatibility is imparted to the device described herein. For example, the device and other components or portions thereof may be made of a material that substantially does not distort images or produce a large number of artifacts (e.g., gaps in the image). The device may also be made of materials that can be imaged by an MRI machine. Some materials exhibiting these properties include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS: R30003, such as...). (etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035, for example) (etc.), nickel-titanium alloys, etc., and others.

[0059] As disclosed herein, the liner 140 formed according to the principles of this disclosure can be understood as a coating, wherein a portion of the coating is coupled to at least a portion of the support, and a portion of the coating is spaced inwardly relative to the treatment device wall 102 (e.g., floating). In various embodiments, the liner 140 may be a polymeric material, such as silicone, polyurethane, polyvinylidene fluoride (PVDF), etc. Or a similar biocompatible polymer formulation. In other embodiments, the liner 140 may include a fibrous coating (not shown) along the side 102i of the treatment device wall 102 and inwardly spaced regions from the treatment device wall 102. As shown, portions of the liner 140 may extend between the strut members or filaments of the treatment device wall 102, thereby filling any spaces or gaps between adjacent strut members or filaments of the treatment device wall 102.

[0060] The foregoing discussion is of broad applicability and is presented for illustrative and descriptive purposes, not to limit the content of this disclosure to the forms or shapes disclosed herein. It is understood that various additions, modifications, and substitutions can be made to the embodiments disclosed herein without departing from the concept, spirit, and scope of this disclosure. In particular, the principles of this disclosure may be embodied in other forms, structures, arrangements, proportions, and other elements, materials, and components by those skilled in the art without departing from its concept, spirit, or scope, or its characteristics. For example, to simplify the disclosure, various features of this disclosure are combined in one or more aspects, embodiments, or shapes. However, it should be understood that various features of certain aspects, embodiments, or shapes of this disclosure may be combined in other aspects, embodiments, or shapes. Although this disclosure is presented in the form of embodiments, it should be understood that not all of the various individual features of this subject matter are necessarily present in order to achieve at least some of the desired features and / or benefits of the subject matter, or such individual features. Those skilled in the art will understand that many modifications or alterations can be made to the structure, arrangement, proportions, materials, components, and other aspects used in the practice of this disclosure, which are particularly suitable for specific environments and operational requirements without departing from the principles, spirit, or scope of this disclosure. For example, an element shown as integrally formed may be composed of multiple parts, or an element shown as multiple parts may be integrally formed; the operation of the element may be reversed or otherwise changed; and the size or dimensions of the element may be changed. Similarly, although the operations or actions or procedures are described in a specific order, this should not be construed as requiring such a specific order, or that all operations or actions or procedures be performed to achieve the desired result. Furthermore, other embodiments are also within the scope of the following claims. In some cases, the actions recited in the claims may be performed in a different order and may still achieve the desired result. Therefore, the embodiments disclosed herein should be considered illustrative in all respects, not restrictive, and the scope of the claimed subject matter is indicated by the appended claims, but is not limited to the specific embodiments or arrangements described above or herein. In view of the foregoing, any single feature of any embodiment may be used, and a single feature may be claimed individually or in combination with a feature of that embodiment or any other embodiment. The scope of the inventive subject matter is indicated by the appended claims, but is not limited to the foregoing description.

[0061] The following will be understood from the foregoing description and the following claims. The phrases “at least one,” “one or more,” and “and / or” as used herein are open-ended expressions and are operationally both conjunctions and antonymous conjunctions. The terms “a,” “an,” “the,” “first,” “second,” etc., do not exclude multiple entities. For example, the term “a” or “an” as used herein refers to one or more of that entity. Therefore, the terms “a” (or “an”), “one or more,” and “at least one” are used interchangeably herein. All directional references (e.g., proximal, distal, upper, lower, upward, downward, left, right, lateral, longitudinal, front, rear, top, bottom, above, below, vertical, horizontal, radial, axial, clockwise, counterclockwise, and / or similar) are used only for identification purposes to aid the reader in understanding this disclosure and / or to distinguish areas of related elements, and do not limit the related elements, particularly regarding the location, orientation, or use of this disclosure. Unless otherwise stated, connecting references (e.g., attachment, connection, link, and combination) are to be interpreted broadly and may include intermediate members between sets of elements and relative movement between elements. Therefore, a ligature does not necessarily imply that two elements are directly connected and have a fixed relationship with each other. Identifying references (e.g., primary, secondary, first, second, third, fourth, etc.) are not intended to suggest importance or priority, but are used to distinguish one feature from another. The following claims are incorporated herein by reference, each claim existing independently as a separate embodiment of this disclosure. Reference numerals in the claims are provided as clarifying examples only and should not be construed as limiting the scope of the claims in any way.

[0062] The following claims are incorporated herein by reference, each existing independently as a separate embodiment of this disclosure. In the claims, the term "comprising / including" does not exclude the presence of other elements or steps. Furthermore, although individual features may be included in different claims, these features may be advantageously combined, and inclusion in different claims does not imply that such combination of features is impractical and / or advantageous. Moreover, singular references do not exclude plurals. The terms "a," "an," "the," "first," "second," etc., do not exclude a plurality. Reference numerals in the claims are provided only as clarifying examples and should not be construed as limiting the scope of the claims in any way.

Claims

1. A treatment device having a proximal end, a distal end, and a longitudinal range therebetween, the treatment device comprising: A treatment device wall, the treatment device wall defining a cavity therethrough and having an inner side and an outer side; and A liner having a liner wall that extends at least a portion of a cavity through the wall of the treatment device; in: An enlarged gap region is defined between a portion of the lining wall and the treatment device wall, wherein the inner sides of the lining wall and the treatment device wall are spaced further apart than in other areas along the longitudinal range of the treatment device; and The lining includes a damage zone configured to facilitate damage to the lining wall.

2. The treatment device of claim 1, wherein the liner further includes a disruptor element located at the disruption zone, and the disruptor element is configured to disrupt the integrity of the liner wall at the disruption zone.

3. The treatment device of claim 2, wherein the disruptor element is formed separately from the lining wall.

4. The treatment device of claim 2, wherein the liner wall defines a liner cavity therein, and the disruptor element extends from within the liner cavity through the liner wall to the outside of the liner wall.

5. The treatment device of claim 2, wherein the disruptor element repeatedly passes through the liner wall around the circumference of the liner.

6. The treatment device of claim 2, wherein the destroyer element includes a gripping feature configured to facilitate gripping the destroyer element to manipulate the destroyer element to destroy the liner at the destruction zone.

7. The treatment device of claim 2, wherein the disruptor element includes an enlarged region configured to create large pores in the liner wall when the disruptor element disrupts the integrity of the liner wall.

8. The treatment device of claim 7, wherein the enlarged region is formed as a node in the disruptor element.

9. The treatment device of claim 7, wherein the enlarged region is formed separately from and connected to the destroyer element.

10. The treatment device of claim 2, wherein the breaker element is a suture or a metal thread.

11. The treatment device of claim 2, wherein the breaker element is a filament.

12. The treatment device of claim 1, wherein the lining is substantially inelastic.

13. The treatment device of claim 1, wherein at least a portion of the wall of the treatment device is configured to stimulate tissue growth.

14. A treatment system for performing a stent-in-stent removal procedure at a treatment site, the system comprising: A treatment device having a proximal end, a distal end, and a longitudinal extent therebetween, and the treatment device including a treatment device wall defining a cavity therethrough and having an inner side and an outer side, and a liner having a liner wall extending through at least a portion of the cavity of the treatment device wall and defining a liner cavity therethrough. as well as A removal device configured to be fitted within the liner cavity; in An enlarged gap region is defined between a portion of the lining wall and the treatment device wall, wherein the inner sides of the lining wall and the treatment device wall are spaced further apart than in other areas along the longitudinal range of the treatment device; The removal device has an external shape configured to conform to the shape of the inner side of the treatment device when the removal device is within the liner cavity; and The lining includes a distress zone configured to facilitate the disruption of the lining wall.

15. The treatment system of claim 14, wherein the liner further includes a disruptor element located at the disruption zone, and the disruptor element is configured to disrupt the integrity of the liner wall at the disruption zone.

16. The treatment system of claim 14, wherein the removal device is radially expandable to interact with the treatment device and shorten within the treatment device, such that the proximal and distal ends of the removal device are located within a cavity of the treatment device wall and between the proximal and distal ends of the treatment device.

17. The treatment system of claim 14, wherein at least a portion of the wall of the treatment device is configured to stimulate tissue growth.

18. The treatment system of claim 17, wherein the removal device is configured to interact with a portion of the treatment device to facilitate loosening of the treatment device relative to tissue at the treatment site.

Images