Devices, systems, and methods for modulating passage through an implantable device

Abstract

The implantable device has an adjustable passage therethrough. The passage may be adjustable to occlude or otherwise regulate access or flow of material therethrough. The elongate element may be inserted into the passage when in a closed configuration to selectively open the passage. For example, the implantable device may be a tubular device with a twisted region that closes the passage therethrough, and the elongate device may be configured to engage such twisted region and rotate to untwist the closed region. An additional tubular device with a passage may be inserted into the passage of the implantable device to hold the passage open for a selected period of time.

Description

[Technical Field]

[0001] The present disclosure relates generally to the field of implantable medical devices, systems, and methods for regulating accessibility through passageways in medical devices. More particularly, the present disclosure relates to devices, systems, and methods for controlling and / or altering passageway diameters or lumens in flow regulating devices, such as occlusion devices or lumen apposition devices. Even more particularly, the present disclosure relates to devices, systems, and methods for controlling and / or altering passageway diameters in implantable devices so that the medical device can selectively block or allow passage of substances therethrough. [Background technology]

[0002] Various implantable devices have been used to create anastomoses or to occlude passageways or lumens within a patient's body. For example, various metabolic therapies advantageously utilize stents in fully endoscopic procedures. The results of such procedures are sometimes difficult to predict, and efficacy can be inconsistent due to the wide range of patient conditions and responses to treatment. Adjustment of implantable devices may be desirable for a variety of reasons, including simply adjusting during the course of treatment, to adjust the device and modify treatment. Additionally, certain procedures result in the closure of more direct pathways to other anatomical structures to which access (at least temporary access) may later be required.

[0003] Thus, there is a need for devices and accompanying systems and procedures, which may preferably be fully endoscopic, that can be used to control and / or actively adjust the configuration of the passageway through the implantable device, such as to control or regulate the flow of nutrients through the gastrointestinal (GI) tract, allowing a physician to individualize and tailor a patient's treatment (e.g., anastomosis or occlusion) to their specific needs, and / or allowing selective access to anatomical sites that would otherwise have reduced accessibility. Summary of the Invention

[0004] This Summary of the disclosure is provided to aid in understanding, and those skilled in the art will appreciate that each of the various aspects and features of the disclosure may be used advantageously separately in some instances or in combination with other aspects and features of the disclosure in other instances. No limitation as to the scope of the claimed subject matter is intended by the inclusion or non-inclusion of elements, components, etc. in this Summary.

[0005] According to one aspect of the present disclosure, a system for controlling the size of a passageway through an implantable device includes an adjustable tubular device having an adjustable passageway formed therein, and an elongate element extendable within the adjustable passageway through the adjustable tubular device to increase the size of the adjustable passageway.

[0006] In some embodiments, the adjustable tubular device has a first end, a second end, and an intermediate region therebetween, at least the intermediate region being in a twisted closed configuration to close an adjustable passageway through the adjustable tubular device. In some embodiments, the elongate element is a passageway opening device configured to untwist the twisted intermediate region of the adjustable tubular device. In some embodiments, the passageway opening device includes an engagement feature configured to engage with a feature of the twisted intermediate region of the adjustable tubular device. In some embodiments, the engagement feature includes a plurality of protrusions extending radially outward from the distal end of the elongate element. In some embodiments, the passageway opening device is a catheter.

[0007] In some embodiments, the elongate element includes an engagement feature configured to engage with a feature of the adjustable passage of the adjustable tubular device to increase the size of the adjustable passage.

[0008] In some embodiments, the adjustable tubular device is guided over the elongate element and across the anatomy to the deployment site. In some embodiments, the system further includes a lumen control plug configured to fit within the adjustable passage of the adjustable tubular device to hold the adjustable passage in an open configuration.

[0009] According to another aspect of the present disclosure, a system for adjusting the size of a passageway through an implantable device includes an adjustable tubular device having an adjustable passageway defined therethrough, the adjustable passageway being changeable between a substantially closed configuration and an open configuration, and a first lumen control plug configured to fit within the adjustable passageway of the adjustable tubular device to hold the adjustable passageway in a first open configuration.

[0010] In some embodiments, the system further includes a second lumen control plug configured to fit within the adjustable passageway of the adjustable tubular device to hold the adjustable passageway in a second open configuration that is a different size than the first open configuration, hi some embodiments, the second lumen control plug is positionable within the first lumen control plug.

[0011] In some embodiments, the first lumen control plug is configured to mate with the adjustable tubular device to reduce movement of the first lumen control plug within the adjustable passageway through the adjustable tubular device.

[0012] In some embodiments, the adjustable tubular device has a first retention member along a first end thereof and a second retention member along a second end thereof, and the first lumen control plug has a first retention member configured to engage with the first retention member of the adjustable tubular device and a second retention member configured to engage with the second retention member of the adjustable tubular device to resist movement of the first lumen control plug relative to the adjustable tubular device.

[0013] In some embodiments, the system further includes an elongate element configured to open the adjustable passage of the adjustable tubular device to facilitate insertion of the first lumen control plug therein, hi some embodiments, the first lumen control plug is guided over the elongate element and into the adjustable tubular device.

[0014] According to another aspect of the present disclosure, a method of adjusting an implantable adjustable tubular device having an adjustable passageway defined therethrough includes inserting an elongate element into the adjustable passageway defined in the adjustable tubular device to open the adjustable passageway, and inserting a lumen control plug into the adjustable passageway to hold the adjustable passageway open.

[0015] In some embodiments, inserting the lumen control plug comprises guiding the lumen control plug over the elongate element. In some embodiments, the adjustable tubular device is twisted such that the adjustable passageway therethrough is in a closed configuration, and the method further comprises rotating the elongate element to untwist the passageway of the adjustable tubular device.

[0016] In some embodiments, the method further includes engaging a feature of the lumen control plug with a feature of the adjustable tubular device to prevent movement of the lumen control plug within the adjustable passage of the adjustable tubular device.

[0017] These and other features and advantages of the present disclosure will become readily apparent from the following detailed description, and the scope of the claimed invention is set forth in the appended claims. While the following disclosure is presented in terms of aspects or embodiments, it should be understood that each aspect may be claimed separately or in combination with aspects and features of that or any other embodiment. [Brief explanation of the drawings]

[0018] Non-limiting embodiments of the present disclosure are described by way of example with reference to the accompanying drawings, which are schematic and not intended to be drawn to scale. The accompanying drawings are provided for illustrative purposes only, and the dimensions, positions, order, and relative sizes reflected in the figures within the drawings may vary. For example, devices may be enlarged so that details can be discerned, but are intended to be reduced in size to fit within the working channel of, for example, a delivery catheter or endoscope. For clarity and conciseness, not every element is labeled in every drawing, and not every element of each embodiment is shown unless illustration is necessary to enable those skilled in the art to understand the disclosure. The detailed description will be better understood in conjunction with the accompanying drawings, as follows, in which like reference numerals represent like elements. [Figure 1] FIG. 1 is a perspective view of one embodiment of an adjustable tubular device formed in accordance with various aspects of the present disclosure and disposed in a schematic representation of a gastrointestinal environment with an anastomosis between the stomach and a portion of the small intestine. [Figure 2] FIG. 2 illustrates one embodiment of an adjustable tubular device formed in accordance with various aspects of the present disclosure for holding tissue walls in apposition and in a closed configuration. [Figure 3A] FIG. 3A illustrates one embodiment of an adjustable tubular device as shown in FIG. 2, but with a passageway opening device inserted therein. [Figure 3B] FIG. 3B illustrates a further position of the passageway opening device inserted within the adjustable tubular device as shown in FIG. 3A. [Figure 4A] FIG. 4A illustrates an example embodiment of a distal portion of a passageway opening device according to various principles of the present disclosure. [Figure 4B] FIG. 4B is a cross-sectional view taken along line IVB-IVB of FIG. 4A. [Figure 5A] FIG. 5A illustrates an example embodiment of a distal portion of a passageway opening device according to various principles of the present disclosure. [Figure 5B] FIG. 5B is a cross-sectional view taken along line VB-VB in FIG. 5A. [Figure 6A] FIG. 6A illustrates an example embodiment of a distal portion of a passageway opening device according to various principles of the present disclosure. [Figure 6B] FIG. 6B is a cross-sectional view taken along line VIB-VIB in FIG. 6A. [Figure 7] FIG. 7 is an enlarged cross-sectional view taken along line VII-VII in FIG. [Figure 8] FIG. 8 is an enlarged cross-sectional view taken along line VIII-VIII of FIG. 3B, illustrating an example of an embodiment of the passageway opening device as shown in FIGS. 4A and 4B. [Figure 9] FIG. 9 is a detailed view of portion IX of the embodiment of the adjustable tubular device shown in FIG. 3A. [Figure 10] FIG. 10 shows a schematic cross-sectional view along line XX of FIG. 1 showing an embodiment of a lumen control plug inserted within an embodiment of an adjustable tubular device, with the lumen control plug and wall details of the adjustable tubular device not shown for clarity of illustration. DETAILED DESCRIPTION OF THE INVENTION

[0019] The following detailed description should be read with reference to the drawings illustrating exemplary embodiments. It should be understood that the present disclosure is not limited to the particular embodiments described, and as such may vary. All devices, systems, and methods described herein are examples of devices and / or systems and / or methods implemented in accordance with one or more principles of the present disclosure. Each example embodiment is provided for illustrative purposes and is merely an example, not the only way, to implement these principles. Therefore, references to elements or structures or features in the drawings should be recognized as references to example embodiments of the present disclosure and should not be understood as limiting the disclosure to the particular 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. Indeed, it will be apparent to those skilled in the art that various modifications and variations can be made in the present disclosure without departing from the scope or spirit of the present subject matter. For example, features illustrated or described as part of one embodiment can be used with another embodiment to yield a still further embodiment. Accordingly, the present subject matter is intended to cover all such modifications and variations that come within the scope of the appended claims and their equivalents.

[0020] It will be understood that the present disclosure is described in this application with varying levels of detail. In certain instances, details not necessary for those skilled in the art to understand the present disclosure or that would make it difficult for those skilled in the art to appreciate other details may be omitted. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting beyond the scope of the appended claims. Unless otherwise defined, technical terms used herein should be understood as commonly understood by one of ordinary skill in the art to which the present disclosure belongs. 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.

[0021] As used herein, "proximal" refers to a direction or location closest to a user (e.g., a medical professional or clinician or technician or operator or physician, such terms are used interchangeably herein without any limitation and include automated controller systems, etc.) such as when using the device (e.g., when introducing the device into a patient or during implantation, placement, or delivery), and "distal" refers to a direction or location furthest from a user such as when using the device (e.g., when introducing the device into a patient or during implantation, placement, or delivery). "Longitudinal" means extending along the longer or greater dimension of an element. "Center" means at least approximately bisecting the center point, and "central axis," with respect to an opening, means a line at least approximately bisecting the center point of the opening and extending longitudinally along the length of the opening when the opening comprises, for example, a tubular element, strut, channel, cavity, or bore.

[0022] In accordance with various principles of the present disclosure, an implantable device can be used to extend across an anatomical structure and control or adjust the size of a passage therethrough. For example, an implantable device can extend across a body passageway or lumen, and such terms are used interchangeably herein without any limitation. A body passageway or lumen can include, but is not limited to, a portion of a passageway or lumen, a passageway or lumen (passageway, duct, cavity, organ, etc.) between anatomical structures, a passageway created across apposed tissue walls (such as to create an anastomosis), etc. A device has a passageway or lumen (such terms are used interchangeably herein without any limitation) therethrough that can be used to occlude, block, narrow, close, constrict, regulate, or control (such terms and variations thereof may be used interchangeably herein without any limitation) the body passageway in which the device is placed. The device may be considered and referred to as an occlusion device, or a lumen apposition device, or an anastomosis device, or a flow regulation device, or a flow control device, and such terms and various other alternatives thereto may be used interchangeably herein without any intention of limitation. It will be understood that as used herein, for convenience, and without any intention of limitation, reference is made simply to an adjustable tubular device. Furthermore, reference to an adjustable portion of an adjustable tubular device should be understood as a reference to any portion of the adjustable tubular device that can be adjusted, such as to adjust the size (e.g., diameter) of a passageway therethrough.

[0023] According to various principles of the present disclosure, the size or diameter of the passageway of an adjustable tubular device formed according to various principles of the present disclosure can be selectively adjustable between a closed configuration (fully closed or substantially closed, but not completely closed, e.g., understood as greater than about 80% up to about 100% closed, including 0.5% increments therebetween) and an open configuration. The passageway may be configured to be in a closed position when in a neutral / resting configuration (unaffected by another device or any action performed on the passageway) and changeable to an open position only upon the active application of a force or other action thereto. The open position can be selected, controlled, or determined by the device used to open the passageway and / or the manner in which the passageway is changed to the open position. The passageway may be opened to any of a variety of degrees of opening (e.g., variable size of opening) to regulate the flow (e.g., volume, velocity, amount, etc.) of material through the passageway. For example, the passageway can simply be changed from a closed configuration to an open configuration. Alternatively or additionally, the passageway may have a neutral open configuration, and the passageway may be stretched (e.g., enlarged or widened) beyond such neutral open configuration. For example, the passageway may be contracted from the neutral open configuration to a closed configuration by being twisted or by applying a separate closure element thereto, and may be opened to a stretched or expanded configuration beyond such neutral open configuration.

[0024] In some embodiments, implantable devices formed according to various principles of the present disclosure are used as occlusion devices and can be selectively changed to an open configuration when passage of material through an otherwise occluded passage is desired or indicated. In some embodiments, implantable devices formed according to various principles of the present disclosure are used to connect lumens or cavities or organs or other anatomical structures apposed by a lumen apposition device or another device (e.g., a separate lumen apposition device), etc., to create an anastomosis with an adjustable passageway therebetween. The principles of the present disclosure can be applied to various treatment protocols and / or various medical procedures, such as when it is desirable to adjust the rate of passage through a flow restriction device and / or portions thereof while still implanted in a patient.

[0025] Devices, systems, and methods according to various principles of the present disclosure may be used in conjunction with various gastric procedures, such as those for treating obesity or other gastrointestinal conditions, that involve controlling or obstructing the flow of gastric material from the stomach through the pylorus. For example, various protocols involve reducing and / or slowing the rate of passage of material through the pylorus and / or obstructing / excluding the pylorus from the stomach. Adjustable tubular devices formed according to various principles of the present disclosure may be structured to obstruct flow therethrough (partially or completely / completely), thereby obstructing the flow of material through the pylorus. Adjustable tubular devices formed according to various principles of the present disclosure may also be used in obesity treatments, including increasing a patient's sense of satiety, intended to reduce appetite and, consequently, caloric intake. Various approaches to increasing satiety include increasing the time food remains in the stomach and / or reducing or slowing the rate of gastric emptying (the flow of material, such as fluid or chyme, from the stomach to the duodenum), thereby inducing a feeling of fullness or satisfaction, which may result in reduced food intake and associated weight loss.

[0026] Other procedures involve selectively accessing walls of various portions of biological structures, such as tissue walls or juxtaposed tissue walls. It may be desirable to create passageways through tissue walls or juxtaposed tissue walls, allowing such passageways to be selectively opened or closed. For example, surgical bypass procedures can make it difficult to access anatomical structures, but access to such structures may be desired or required after the bypass is performed. One example is when a patient who has undergone a Roux-en-Y gastric bypass requires an endoscopic retrograde cholangiopancreatography (ERCP), and there is no longer a direct route for the physician to endoscopically access the papilla. The physician may create a temporary passageway from the gastric pouch to the expelled stomach. This new passageway, although temporary (e.g., 3-4 weeks), can reduce the effectiveness of obesity treatment by allowing gastric material (e.g., chyme) to pass through the bypassed portion of the GI tract. Depending on the disease being treated, multiple ERCPs may be required to fully treat the patient's condition, further extending the time the passageway is needed.

[0027] According to various aspects of the present disclosure, an adjustable tubular device is formed with an adjustable portion having an adjustable passageway. The adjustable passageway can be selectively opened and closed during a procedure to allow temporary access or passage (of a substance or medical device or instrument) through the adjustable tubular device, or can be held open for longer periods of time (and can be closed if desired or medically indicated). In some embodiments, the adjustable tubular device has a narrowed adjustable portion that is selectively expandable to allow passage of a substance therethrough when the passageway is expanded. In some embodiments, a portion of the adjustable tubular device is twisted such that a twist narrows or closes the passageway. Such a twist in the adjustable tubular device can be modified or adjusted, e.g., untwisted, to modify or adjust the degree of closure or obstruction of the passageway created by such a twist. In some embodiments, an elongate element is provided to extend through the passageway to adjust the adjustable portion of the adjustable tubular device. The elongate element may have a unique configuration to facilitate engagement with the configuration of the adjustable portion and may be referred to herein for convenience as a passageway opening device, without intending to be limited to a particular function. In some embodiments, the adjustable portion of the adjustable tubular device is selectively adjustable to an at least partially open configuration, such as constricted to a substantially closed configuration or twisted and untwisted. It will be understood that other configurations are within the scope and spirit of the present disclosure. In some embodiments, the passageway opening device may be shaped, configured, or provided with features that correspond to the shape or contour or other features of the closed (e.g., twisted) portion of the adjustable tubular device. It will be understood that the principles of the present disclosure extend beyond the examples of twisted closed devices and untwisting such devices, which are described in more detail below.

[0028] The adjustable tubular device may be formed from multiple strands or wires or filaments, which may be braided, woven, twisted, wrapped, intertwined, knitted, looped (e.g., bobbinette), knotted, or otherwise formed into a self-supporting structure. Alternatively, the adjustable tubular device may be formed from laser-cut tubes or joined elongated elements or another self-supporting structure. Such structures may alternatively be referred to, without limitation, as stents or frameworks or scaffolds. The adjustable tubular device may be formed from biocompatible metallic or polymeric materials or alloys. In some embodiments, the material is a shape-memory or thermoformable material, such as a nickel-titanium alloy (e.g., nitinol). In some embodiments, the passageway opening device includes various features for engaging the strictured portion of the adjustable tubular device and / or elements thereof (e.g., engaging between the wires forming the adjustable tubular device).

[0029] In some embodiments, additional tubular devices are provided to adjust the size of the passageway through the adjustable tubular device, for example, the adjustable passageway of the adjustable tubular device can increase in diameter and additional tubular devices can be inserted therein to hold the passageway of the adjustable tubular device open to less than the full extent of the passageway of the adjustable tubular device.

[0030] It should be noted that in some embodiments, opening a closed (e.g., twisted) region of a device may result in other changes to the device, such as changes in the axial length or other dimensions or characteristics of the device. For example, in some embodiments, retention members are provided at the ends of the device to hold tissue walls in apposition and / or to hold the device in a predetermined position relative to the anatomical site where the device is deployed (e.g., to inhibit or prevent device migration). In various examples, opening a closed region of a device may affect the position of either or both of the retention members (e.g., relative position and / or orientation, such as the axial distance between the retention members) and / or the configuration of either or both of the retention members (e.g., dimensions of the retention members, such as either or both of their diameters, which may be influenced by dimensions of other regions of the device, such as the region being adjusted). Adjustability of the configuration of a closed region of an implantable device that affects the retention members can be advantageous for affecting the retention force of the retention members against tissue walls that contact (e.g., are held in apposition by) the retention members. Such adjustment may be independent of whether the device allows passage of material. Thus, if additional devices are inserted (or otherwise modified) within an adjustable tubular device formed in accordance with various principles of the present disclosure to maintain adjustment to the configuration of the adjustable tubular device other than the size of the passageway therethrough, such additional devices need not include a passageway therethrough if passageway of a substance therethrough is not desired.

[0031] According to various principles of the present disclosure, the adjustable tubular device may be sized and configured for transluminal, transcatheter, or endoscopic delivery. Thus, according to one aspect of the present disclosure, the adjustable tubular device may be collapsed or otherwise reduced in cross-sectional dimension to fit through a tubular delivery device used in minimally invasive (as opposed to open) procedures. The adjustable tubular device may be expandable upon deployment. For example, the adjustable tubular device may be formed to be self-expanding (in which case, advantageously, formed from a shape-memory material that causes the device to expand when no longer held or constrained within the delivery device) or may be expanded with the assistance of another expandable device, such as an expandable balloon. To allow for removal options from the deployment site, the adjustable tubular device may be formed to be selectively collapsible from its expanded, deployed configuration in any of a variety of ways known or previously known in the art.

[0032] Referring now to the drawings, an adjustable tubular device 100 formed in accordance with various principles of the present disclosure is shown in FIG. 1 disposed in an example of an environment in which the principles of the present disclosure may be applied to a stomach S that has undergone a Roux-en-Y gastric bypass or other type of bypass procedure. As will be appreciated, the stomach S is divided into a functional portion of the stomach S, which may be referred to as the gastric pouch GP, and a bypassed portion of the stomach BP, which is generally excluded or closed from the passage of food along the digestive tract. More specifically, the bypassed portion of the stomach BP is typically the lower portion of the stomach S that passes food material (e.g., chyme, partially digested food material, etc.) into the duodenum D. The gastric pouch GP is directly connected to the jejunum J. Thus, typical access through the pylorus P to the duodenum D and proximal regions of the intestine, such as the pancreas and pancreatic duct and bile duct, is blocked. If easier access to such anatomical structures is desired, an anastomosis A to the bypassed portion of the stomach BP may be created using an adjustable tubular device 100 formed in accordance with the principles of the present disclosure and shown in FIG. 1. Adjustable tubular device 100 formed in accordance with principles of the present disclosure may also be used in conjunction with other types of gastric bypass procedures, such as gastrojejunostomy (not shown, but readily understood by those skilled in the art, e.g., by reference to U.S. Patent Application Publication No. 2018 / 08271530, filed March 26, 2018, and published September 27, 2018, which published application is incorporated herein in its entirety for all purposes). In such procedures, while it is generally desirable for the device forming the gastrojejunostomy to remain open (and thus generally not a typical site for adjustable tubular device 100 formed in accordance with principles of the present disclosure), it is still generally desirable to close or at least limit access to the duodenum D through the pylorus P to facilitate bypass to the jejunum J. Adjustable tubular device 100 formed in accordance with various principles of the present disclosure may be positioned across pylorus P to effect a desired degree of closure of pylorus P, while allowing for selective adjustment of the degree of closure of adjustable tubular device 100.Positioning an adjustable tubular device 100 formed in accordance with various principles of the present disclosure to regulate flow through the pylorus P and thereby regulate gastric emptying is yet another potential use of an adjustable tubular device 100 formed in accordance with various principles of the present disclosure.

[0033] As can be more readily understood with reference to FIG. 2 , an example of an adjustable tubular device 100 formed in accordance with the principles of the present disclosure has a first end 101, a second end 103, and a lumen 105 extending therebetween. First end 101 may be flared to form a first retention member 102, and second end 103 may be flared to form a second retention member 104. Retention members 102, 104 (which may alternatively, without limitation, be referred to as flanges) are preferably formed to be sufficiently wide and have sufficient retention strength to hold adjustable tubular device 100 in place in accordance with various tissue apposition devices, stents, and the like, known or previously known in the art. Retention members 102, 104 may be any of a variety of shapes, such as concave, convex, disc-shaped, cylindrical (e.g., having a longer longitudinal extent than shown), or other configurations, and the particular shapes and configurations are not limited by the present disclosure. It will be understood that the lumen inner diameter need not be completely closed (i.e., have an inner diameter of 0 mm) when in the neutral configuration. Generally, the inner diameter of lumen 105 when closed is less than 5 mm. Lumen 105 may be open to a size that allows the passage of a medical device or instrument therethrough, or for a desired volume or flow rate of a substance (e.g., bodily substance or ingested substance) therethrough. In some embodiments, the maximum inner diameter of lumen 105 may be about 20 mm. In some embodiments, the diameter of retention members 102, 104 may be at least about 30 mm and at most about 40 mm. The details of such characteristics are not critical to the present disclosure and are therefore left to those skilled in the art to determine for a given environment in which adjustable tubular device 100 is to be used.

[0034] As shown in FIG. 2 , the intermediate region 106 (which may alternatively be referred to herein, without limitation, as the saddle region 106) of the adjustable tubular device 100 between the first end 101 and the second end 103 may be constricted to reduce the cross-sectional size (e.g., diameter) of the lumen 105 to affect (e.g., reduce or adjust) flow therethrough. In the illustrated example, the intermediate region 106 of the adjustable tubular device 100 is twisted to close the intermediate region 106. However, it should be understood that other constrictions, such as using an elastic band or sleeve covering the intermediate region 106 to constrict the portion of the lumen 105 extending therethrough, are within the scope and spirit of the present disclosure (such elastic band or sleeve being expandable to adjust the size of the lumen 105 in accordance with various principles of the present disclosure, as described in further detail below).

[0035] As shown in FIGS. 3A and 3B , according to embodiments of the present disclosure, an elongate element 200 may be inserted into one end of the adjustable tubular device 100 and into the lumen 105 of the adjustable tubular device 100 to expand the intermediate region 106 of the adjustable tubular device 100. It will be understood that the elongate element 200 will generally be inserted into the more easily accessible ends 101, 103 of the adjustable tubular device 100. Thus, although the elongate element 200 is shown in FIG. 3A as being inserted into the second end 103, the elongate element 200 may instead be inserted into the first end 101. The distal end 201 of the elongate element 200 is inserted into the elongate element 200, and the proximal end 203 is positioned to be accessible to a medical professional to control the advancement and manipulation of the elongate element 200. The elongate element 200 may extend proximally so that its proximal end 203 is outside the patient and may be coupled to a control handle or the like. For example, natural orifice transluminal endoscopic surgery (NOTES) may be used to adjust the adjustable tubular device 100 according to various principles of the present disclosure, with the elongate element 200 extending proximally through the patient's esophagus and out of the patient's mouth. Alternative points of entry and access to the treatment site, such as transluminal or vascular, are within the scope and spirit of the present disclosure. For example, rectal access for an adjustable tubular device 100 used in the gastrointestinal system or vascular access for an adjustable tubular device 100 used in the vascular system are within the scope and spirit of the present disclosure. A guidewire (such as inserted through a lumen through the elongate element 200) may be used to assist in guiding the elongate element 200 into the adjustable tubular device 100. The distal end 201 of the elongate element 200 is preferably sufficiently strong longitudinally (e.g., has sufficient compression resistance) to be advanced into the contracted adjustable portion of the intermediate region 106 of the adjustable tubular device 100 to adjust the size of the lumen 105 therethrough and, consequently, the ability of material to pass through the lumen 105 of the adjustable tubular device 100. For example, the distal end 201 of the elongate element 200 may be reinforced with a braided coil or other structure (e.g., a composite structure) to increase compression resistance.

[0036] In one example embodiment of the adjustable tubular device 100, as shown in FIG. 2, in which the intermediate region 106 is twisted, the distal end 201 of the elongate element 200, as shown in FIGS. 3A and 3B, preferably has sufficient torsional strength to untwist the twisted adjustable portion of the intermediate region 106 to adjust the amount or degree to which the lumen 105 through the adjustable tubular device 100 is opened. Various reinforcements, as described above, can increase the kink resistance of the elongate element 200. The elongate element 200 configured to adjust the lumen 105 of the example adjustable tubular device 100 shown in FIG. 2 is advanced into the adjustable portion of the intermediate region 106 (e.g., along its longitudinal axis L), as shown in FIG. 3A, and rotated (e.g., about its longitudinal axis L) to untwist the adjustable portion of the intermediate region 106, as shown in FIG. 3B. It will be understood that other configurations of elongate elements corresponding to other configurations of adjustable portions of adjustable tubular devices formed according to various principles of the present disclosure are within the scope and spirit of the present disclosure.

[0037] The distal end 201 of the elongate element 200 configured to untwist the twisted intermediate region 106 of the adjustable tubular device 100 may be provided with one or more engagement features structured and configured to engage with and untwist the twisted configuration of the intermediate region 106 of the adjustable tubular device 100. For example, the engagement feature may be a protrusion or ridge or groove that engages with or during the twist of the twisted intermediate region 106. Various embodiments of example engagement features that may be provided on the elongate element 200 structured and configured to engage with the twisted intermediate region 106 of the adjustable tubular device 100 formed in accordance with the principles of the present disclosure are shown in Figures 4A, 4B, 5A, 5B, 6A, 6B, 7A, and 7B.

[0038] In the embodiment shown in FIGS. 4A and 4B , the distal end 201′ of one example of elongate element 200′ has an engagement feature 206′ in the form of a longitudinal protrusion along the distal end 201′ of elongate element 200′. As can be seen with reference to FIG. 4A , engagement feature 206′ is twisted (e.g., helical or non-linear) about longitudinal axis L of elongate element 200′ to accommodate twists in adjustable tubular device 100 in which elongate element 200′ is used. As can be seen with reference to FIG. 4B , engagement feature 206′ extends radially outward from elongate element 200′ and, optionally, is curved radially (e.g., circumferentially about longitudinal axis L of elongate element 200′) along at least a portion thereof. In other words, the example embodiment of the engagement feature 206' shown in FIG. 4B extends radially outward from the distal end 201' of the elongate element 200' and is curved at least at its free end (along the end or edge of the engagement feature 206' that is farthest from and not attached to the distal end 201' of the elongate element 200').

[0039] Instead of extending in a curved direction, such as a spiral, around the distal end 201 of the elongate element 200, the engagement feature 206 may extend substantially longitudinally along the longitudinal axis L of the elongate element 200, as in the example embodiment of the elongate element 200'' shown in FIGS. 5A and 5B. In particular, the engagement feature 206'' of the elongate element 200'' is shown in FIG. 5A as extending substantially longitudinally along the longitudinal axis L of the elongate element 200''. Additionally or alternatively, the engagement feature 206'' may extend radially from the distal end 201'' of the elongate element 200'' in a generally straight direction, without curvature, as in the embodiment shown in FIG. 4B.

[0040] In the embodiment shown in FIGS. 6A and 6B , the distal end 201''' of one example of elongate element 200''' has engagement features 206''' in the form of a plurality of individual protrusions spaced along the distal end 201''' of elongate element 200'''. As can be seen with reference to FIGS. 6A and 6B , the engagement features 206''' extend radially outward from the distal end 201''' of elongate element 200'''. As can be seen with reference to FIG. 6A , the engagement features 206''' can be longitudinally spaced apart from one another along the longitudinal axis L of elongate element 200'''. As can be further seen with reference to FIG. 6A , adjacent engagement features 206''' can be linearly and / or radially aligned with one another.

[0041] It will be understood that the engagement features 206 may be formed by any method known or previously known in the art, such as molding, gluing, extruding, machining, stamping, or cutting. The embodiment of FIGS. 5A and 5B, particularly FIG. 5B, illustrates an example of an engagement feature 206 formed by cutting or quilling, whereby notches are made (generally non-radially) in the face of the distal end 201" of the elongate element 200" and the notches are expanded to pull sections apart into protrusions (e.g., quills or fins) that form the elongate element 200". It will further be understood that any number of engagement features 206 may be provided to engage a twisted portion of the adjustable tubular device 100. The shape or configuration or number of the engagement features 206', 206", 206'" are not limited to those shown and described herein.

[0042] In some embodiments, the adjustable tubular device 100 is formed by a plurality of wires 108, as can be seen from the schematic cross-sectional view of Figure 7 taken along line VII-VII of Figure 2. One or more engagement features 206 may be configured to engage the wires 108, such as in a one-to-one correspondence or between groups of adjacent wires 108, as shown in Figure 8, which shows a schematic cross-sectional view taken along line VIII-VIII of Figure 3A. When the elongate element 200 is fitted within the lumen 105, the wires 108 (which are twisted and not generally parallel to the longitudinal axis L of the adjustable tubular device 100) are moved apart (and more closely aligned with the longitudinal axis L of the adjustable tubular device 100), twisting the elongate element 200 moves the wires 108 further apart and opens the lumen 105.

[0043] In some embodiments where the adjustable portion of the adjustable tubular device 100 is kinked / unkinked, it may be desirable to hold a distal portion of the adjustable tubular device 100 against the tissue or body passageway into which the adjustable tubular device 100 is disposed. Various retention features 110 may be provided and / or formed on the adjustable tubular device 100 to engage and / or secure the adjustable tubular device 100 against the tissue or body passageway. For example, tissue-engaging protrusions (e.g., barbs, anchors, etc.), tissue ingrowth features, micropatterns, threads, and / or other mechanical or tissue-based locking features may be provided on the surface of the adjustable tubular device 100 to engage the tissue into which the adjustable tubular device 100 is deployed. In the embodiment of the adjustable tubular device 100 shown in FIGS. 3A and 3B, the adjustable tubular device 100 is shown holding tissue walls T in apposition (such as the stomach wall and the jejunum wall when the adjustable tubular device 100 is disposed between those walls as in FIG. 1). As can be seen with reference to Detail X of FIG. 3A shown in FIG. 9, at least one retaining feature 110 (e.g., in the form of a tissue-engaging protrusion such as a barb) is on a surface of the retention member 102 that abuts or engages a tissue wall. The tissue wall may surround or be adjacent to the tissue in which the adjustable tubular device 100 is placed. In the illustrated example configuration, the retaining feature 110 is provided on a portion of the retention member 102 facing the intermediate region 106 (e.g., an inwardly facing portion that abuts or contacts one of the tissues held in apposition by the adjustable tubular device 100). However, it will be understood that other locations for the retaining feature 110 are within the scope and spirit of the present disclosure, such as may be selected based on the environment or procedure in which the adjustable tubular device 100 is used. For example, when the adjustable tubular device 100 is positioned across a body passageway or lumen, such as the pylorus P, the retention feature 110 may be provided on a portion of the adjustable tubular device 100 located laterally outward, such as to engage the inner wall of the body passageway through which the adjustable tubular device 100 is positioned or across.Generally, at least one retaining feature 110 is provided on a distal portion of the adjustable tubular device 100, such as on the distal retaining member 102, which allows a proximal portion of the adjustable tubular device 100 (which is generally more easily accessible by a medical professional) to be rotated while the distal portion of the adjustable tubular device 100 is held in place against the body (e.g., tissue wall T).

[0044] According to a separate and independent aspect of the present disclosure, as shown schematically in FIG. 10 (with certain features such as wall details omitted for simplicity), once the lumen 105 of the adjustable tubular device 100 has been opened (such as by elongate element 200 as described above), an additional tubular element 300 may be positioned within the adjustable tubular device 100 to maintain a desired opening through the lumen 105 of the adjustable tubular device 100. For convenience, to distinguish it from the adjustable tubular device 100, the additional tubular element will be referred to herein as a lumen diameter control plug or lumen control plug 300. In some examples, the lumen control plug 300 may be deployed from the same or a different device used to deploy and / or position the adjustable tubular device 100 and / or the same or a different device used to open (e.g., untwist) the adjustable tubular device 100. For example, the lumen control plug 300 may be deployed using the elongate element 200 used to open the lumen 105 of the adjustable tubular device 100, such that opening the adjustable tubular device 100 and supporting or plugging the adjustable tubular device 100 open with the lumen control plug 300 can be accomplished in a single step without first removing the elongate element 200 from within the lumen 105. It will be understood that the term "plug" is used in reference to the lumen control plug 300 being disposed within the lumen 105 in which it is disposed (e.g., plugging into the lumen 105, and more specifically, plugging into and opening the lumen 105) to plug into the lumen 105, and more specifically, to plug into and open the lumen 105.

[0045] The example lumen control plug 300 shown in Figure 10 is shown extending through the lumen 105 of the adjustable tubular device 100, with a distal end 201 adjacent to and spaced some distance inward (toward the intermediate region 106) from the distal end 101 of the adjustable tubular device 100, and a proximal end 103 adjacent to and spaced some distance inward (toward the intermediate region 106) from the proximal end 103 of the adjustable tubular device 100. However, if desired, the length of the lumen control plug 300 may more closely match the length of the adjustable tubular device 100, such that the corresponding distal ends 101, 301 and proximal ends 103, 303 are closer to one another (e.g., substantially aligned) than shown in Figure 10. In the example embodiment shown in Figure 10, the lumen control plug 300 is shaped and / or configured to mate or match or correspond with the shape and / or configuration of the adjustable tubular device 100 so as to reduce movement (e.g., relative axial and / or radial movement) of the lumen control plug 300 within the adjustable tubular device 100. For example, the embodiment of the lumen control plug 300 shown in Figure 10 includes a first retention member 302 configured to connect (e.g., engage, conform to, mate with, etc.) with the first retention member 102 of the adjustable tubular device 100, and a second retention member 304 configured to connect (e.g., engage, conform to, mate with, etc.) with the first retention member 104 of the adjustable tubular device 100. In the illustrated example, the retention members 302, 304 of the lumen control plug 300 fit within the spaced-apart walls of the retention members 102, 104 of the adjustable tubular device 100, although other configurations are within the scope and spirit of the present invention. For example, it should be noted that while the retention members 102, 104 of the adjustable tubular device 100 are shown as double-walled, the retention members 302, 304 of the lumen control plug 300 may be formed of a single wall. Various methods of retaining the inner stent within the outer stent may be used, and such features are not critical to the underlying principles of the present disclosure.

[0046] The diameter of the lumen 305 of the lumen control plug 300, e.g., the diameter of the intermediate region 306 of the lumen control plug 300, may be selected from a range of diameters depending on the adjustable tubular device 100 and the intended course of treatment for which the lumen control plug 300 is provided / used. The lumen control plug 300 preferably has sufficient radial or hoop strength to withstand any retraction forces from the adjustable tubular device 100 configured to be closed in a rest position, as well as any retraction forces from apposing tissue, such that the lumen control plug 300 can hold open an otherwise closed adjustable portion of the adjustable tubular device 100. In some embodiments, the lumen control plug 300 may have a higher radial or hoop strength than the corresponding adjustable tubular device 100. In some embodiments, a kit or system with two or more lumen control plugs 300 is provided, allowing adjustment of the size of the lumen 105 of the adjustable tubular device 100 at various stages during the treatment process by inserting different sized lumen control plugs 300 into the lumen 105 of the adjustable tubular device 100. For example, when an adjustable tubular device 100 formed in accordance with the principles of the present disclosure is positioned to reduce the flow of a substance therethrough (e.g., positioned across the pylorus P in obesity treatment to reduce the rate of gastric emptying), it may be desirable to adjust the diameter of the lumen 105 of the adjustable tubular device 100 to regulate the flow of the substance depending on the patient's progress or responsiveness to treatment. A lumen control plug 300 of a first diameter may be exchanged for a lumen control plug 300 of a second, different diameter. Additionally or alternatively, a first lumen control plug 300 having a lumen 305 with a first diameter may be inserted first, and a second lumen control plug 300 having a lumen 305 with a second diameter smaller than the first diameter may be inserted into the first lumen control plug 300 to narrow the passage created by the first lumen control plug 300.Such a set of lumen control plugs 300 having different diameters may be initially placed together within the adjustable tubular device 100, with the second lumen control plug 300 being removed if desired. Alternatively, a first lumen control plug 300 may be placed within the adjustable tubular device 100, with the second lumen control plug 300 being placed within the first lumen control plug 300 at a later time (e.g., hours, days, weeks, etc., depending on the course of treatment). Additionally or alternatively, the adjustable tubular device 100 may be left within the patient's body in a closed configuration, with the lumen control plug 300 inserted within the lumen 105 of the adjustable tubular device 100 only for a limited period of treatment, and removed once such treatment is completed, with the adjustable tubular device 100 once again left in place in the closed configuration. Because the size of the instrument that can be passed through the adjustable tubular device 100 can vary depending on the procedure (e.g., based on the instrument being passed through the adjustable tubular device 100), different sizes of lumen control plugs 300 can be provided for use with a given adjustable tubular device 100 to selectively open the passageway within the body that was intended to be closed by the adjustable tubular device 100.

[0047] To deliver the lumen control plug 300 to the adjustable tubular device 100, the lumen control plug 300 may be passed over the elongate element 200 (e.g., the elongate element 200 may be threaded through the lumen 305 of the lumen control plug 300) such that the lumen control plug 300 is mounted over the elongate element 200 and delivered by the elongate element 200. Alternatively, the lumen control plug 300 may be delivered via another delivery device or mechanism known or heretofore known in the art.

[0048] Lumen control plug 300 may be in the form of a braided stent, a laser-cut tubular stent, or any other configuration that allows for its compact delivery configuration, but as described above, when deployed within adjustable tubular device 100, expands with sufficient stability to hold open lumen 105 of adjustable tubular device 100. Removal can be facilitated using a constriction feature 307, such as a suture or a grasping loop or tightening cord, as known or previously known in the art. The configuration of such a constriction feature is not important to an understanding of the underlying principles of the present disclosure; thus, elongate element 200 may have a passage therethrough for a guidewire or the like to facilitate navigation of elongate element 200 to the treatment site. In some embodiments, elongate element 200 is a catheter.

[0049] As noted above, the various structures and features of the embodiments described herein and illustrated in the figures have several distinct and independent inherent advantages. Thus, the various structures and features described herein need not all be present to achieve at least some of the desired properties and / or benefits described herein. Furthermore, the various features described herein may be used alone or in any combination. It will be understood that various features described with respect to one embodiment may be applied to another embodiment, whether or not explicitly indicated. Thus, it will be understood that one or more of the features described with reference to one embodiment can be combined with one or more of the features of any of the other embodiments described herein. That is, any of the features described herein can be mixed and matched to create hybrid designs, and such hybrid designs are within the scope of the present disclosure. Therefore, the present invention is not limited to only the embodiments specifically described herein. The above descriptions are merely illustrative examples of embodiments and are not intended to limit the broader aspects of the present disclosure.

[0050] The foregoing discussion has broad applicability and is presented for purposes of illustration and explanation, and is not intended to limit the present disclosure to the form or forms disclosed herein. It will be understood that various additions, modifications, and substitutions may be made to the embodiments disclosed herein without departing from the concept, spirit, and scope of the present disclosure. In particular, it will be apparent to those skilled in the art that the principles of the present disclosure may be embodied in other forms, structures, arrangements, proportions, and with other elements, materials, and components without departing from the concept, spirit, or scope or characteristics thereof. For example, various features of the present disclosure are grouped together in one or more aspects, embodiments, or configurations for the purpose of streamlining the disclosure. However, it should be understood that various features of a particular aspect, embodiment, or configuration of the present disclosure may be combined in alternative aspects, embodiments, or configurations. While the present disclosure is presented in terms of embodiments, it should be understood that various individual features of the present subject matter need not all be present to achieve at least some of the desired properties and / or advantages of the present subject matter or such individual features. Those skilled in the art will understand that the present disclosure can be used with many modifications, or modifications of the structure, arrangement, proportions, materials, components, and the like used in implementing the disclosure, that are particularly adapted to particular environments and operating requirements, without departing from the principles or spirit or scope of the disclosure. For example, elements shown as integrally formed may be comprised of multiple pieces, or elements shown as multiple pieces may be integrally formed, operations of elements may be reversed or changed, and sizes or dimensions of elements may be changed. Similarly, although operations or actions or steps are described in a particular order, this should not be construed as requiring such a specific order to achieve desirable results, or that all operations or actions or steps should be performed. Additionally, other implementations are within the scope of the following claims. In some cases, the operations recited in the claims can be performed in a different order and still achieve desirable results.The presently disclosed embodiments are therefore to be considered in all respects as illustrative and not restrictive, and the scope of the claimed subject matter is indicated by the appended claims and is not limited to the foregoing description or to the specific embodiments or configurations described or illustrated herein. In view of the above, individual features of any embodiment may be used and claimed separately or in combination with features of that embodiment or any other embodiment, and the scope of the subject matter is indicated by the appended claims and is not limited to the foregoing description.

[0051] In the foregoing description and in the claims that follow, it will be understood that: As used herein, the terms "at least one," "one or more," and "and / or" are open-ended expressions that are both conjunctive and disjunctive in operation. Terms such as "a," "an," "the," "first," and "second" do not exclude a plurality. For example, the term "a" or "an" entity, as used herein, refers to one or more of that entity. Thus, the terms "a" (or "an"), "one or more," and "at least one" can be 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, etc.) are used for identification purposes only to aid the reader's understanding of this disclosure and / or serve to distinguish regions of related elements from one another and do not limit the related elements, particularly with respect to the location, orientation, or use of this disclosure. Connection references (e.g., attached, coupled, connected, and joined) should be interpreted broadly and may include intermediate members between and relative movement between a collection of elements unless otherwise indicated. Thus, connection references do not necessarily suggest that two elements are directly connected and in a fixed relationship to one another. Identification references (e.g., primary, secondary, first, second, third, fourth, etc.) are not intended to imply importance or priority, but are used to distinguish one feature from another.

[0052] The following claims are incorporated by reference into this detailed description, with each claim standing on its own as a separate embodiment of the present disclosure. In the claims, the term "comprises / comprising" does not exclude the presence of other elements or steps. In addition, although individual features may be included in different claims, they may be advantageously combined, and their inclusion in different claims does not imply that a combination of features is not feasible and / or advantageous. In addition, a reference to the singular does not exclude a plurality. Reference signs in the claims are provided merely as a clarifying example and should not be construed as limiting the scope of the claims in any way.

Claims

1. A system for controlling the size of a passageway through an implantable device while it is implanted within a patient's body, comprising: an adjustable tubular device having an adjustable passageway formed therein; With elongated elements the adjustable tubular device having a first end, a second end, and an intermediate region therebetween, at least the intermediate region being in a twisted closed configuration to close the adjustable passageway through the adjustable tubular device; The system includes an elongated element extendable within the adjustable passageway formed through the adjustable tubular device in an expanded deployed configuration, the elongated element including an engagement feature configured to engage the adjustable passageway, and the elongated element rotatable within the adjustable passageway with the engagement feature engaged with the adjustable passageway to untwist the twisted adjustable passageway and increase the size of the adjustable passageway.

2. The system of claim 1 , wherein the elongated element is a passageway opening device configured to untwist the twisted intermediate region of the adjustable tubular device.

3. The system of claim 2 , wherein the passageway opening device comprises an engagement feature configured to engage with a feature of the twisted intermediate region of the adjustable tubular device.

4. The system of claim 3 , wherein the engagement feature comprises a plurality of protrusions extending radially outward from the distal end of the elongate element.

5. The system of claim 2 , wherein the passageway opening device is a catheter.

6. 6. The system of claim 1, wherein the elongate element comprises an engagement feature configured to engage with a feature of the adjustable passage of the adjustable tubular device to increase the size of the adjustable passage.

7. 6. The system of claim 1, further comprising a first lumen control plug configured to fit within the adjustable passage of the adjustable tubular device to hold the adjustable passage in a first open configuration.

8. 8. The system of claim 7, further comprising a second lumen control plug configured to fit within the adjustable passage of the adjustable tubular device to hold the adjustable passage in a second open configuration that is a different size than the first open configuration.

9. The system of claim 8 , wherein the second lumen control plug is positionable within the first lumen control plug.

10. 8. The system of claim 7, wherein the first lumen control plug is configured to mate with the adjustable tubular device to reduce movement of the first lumen control plug within the adjustable passageway through the adjustable tubular device.

11. the adjustable tubular device having a first retention member along a first end thereof and a second retention member along a second end thereof; 8. The system of claim 7, wherein the first lumen control plug has a first retention member configured to engage the first retention member of the adjustable tubular device and a second retention member configured to engage the second retention member of the adjustable tubular device to resist movement of the first lumen control plug relative to the adjustable tubular device.

12. The system of claim 7 , wherein the first lumen control plug is routed over the elongate element and into the adjustable tubular device.

Images