Devices, systems, and methods for regulating pathways through implantable devices

Abstract

To provide medical devices for controlling and / or changing a passage diameter in an implantable device.SOLUTION: An implantable device 100 has an adjustable passage therethrough. The passage may be adjustable to occlude or otherwise to regulate access or flow of materials therethrough. An elongated element may be inserted into the passage when in a closed configuration to selectively open the passage. For instance, the implantable device 100 may be a tubular device with a twisted region closing the passage therethrough, and the elongated device may be configured to engage such a twisted region and to be rotated to untwist the closed region. An additional tubular device with a passage therethrough may be inserted into the passage of the implantable device to hold the passage open for a selected period of time.SELECTED DRAWING: Figure 1

Description

[[Technical Field]]

[0001] The present disclosure generally relates to the field of implantable medical devices, systems, and methods for adjusting accessibility through a passage of a medical device. More specifically, the present disclosure relates to devices, systems, and methods for controlling and / or changing the passage diameter or lumen within a flow regulating device, such as an occlusion device or a luminal apposition device. Even more specifically, the present disclosure relates to devices, systems, and methods for controlling and / or changing the diameter of a passage within an implantable device such that the medical device can selectively block or allow the passage of substances therethrough. [[Background Art]]

[0002] Various implantable devices have been used to form an anastomosis or to occlude a passage or lumen within a patient's body. For example, various metabolic treatments advantageously utilize stents in completely endoscopic procedures. The outcomes of such procedures can sometimes be difficult to predict, and effects may be inconsistent due to the wide variation in patient conditions and responses to treatment. Adjustment of an implantable device may be desirable for various reasons, including simply adjusting the device over the course of treatment to modify therapy. Furthermore, certain procedures result in closing off a more direct route to other anatomical structures where access, at least temporary access, may be required later.

[0003] Accordingly, there is a need for devices, and associated systems and procedures, which can preferably be completely endoscopic, that can be used to control and / or actively adjust the configuration of a passage through an implantable device, such as controlling or regulating the flow of nutrients through the gastrointestinal (GI) tract, allow physicians to individualize and adjust a patient's treatment (e.g., anastomosis or occlusion) according to the patient's specific needs, and / or enable selective access to anatomical sites that would otherwise have reduced accessibility. [Overview of the project]

[0004] This summary of the disclosure is provided for the purpose of aiding understanding, and those skilled in the art will understand that each of the various aspects and features of the disclosure may be used advantageously in some examples separately or in other examples in combination with other aspects and features of the disclosure. No limitation on the scope of the claimed subject matter is intended by the inclusion or exclusion of elements, components, etc., in this summary.

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

[0006] In some embodiments, the adjustable tubular device has a first end, a second end, and an intermediate region between them, the intermediate region being configured to be twisted and closed in order to close an adjustable passage through the adjustable tubular device. In some embodiments, an elongated element is a passage opening device configured to untwist the twisted intermediate region of the adjustable tubular device. In some embodiments, the passage opening device includes an engaging feature configured to engage with a feature of the twisted intermediate region of the adjustable tubular device. In some embodiments, the engaging feature includes a plurality of projections extending radially outward from the distal end of the elongated element. In some embodiments, the passage opening device is a catheter.

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

[0008] In some embodiments, the adjustable tubular device is guided along an elongated element, traversing the anatomical structure to the deployment site. In some embodiments, the system further includes a lumen control plug configured to fit into an adjustable passage of an adjustable tubular device and hold it in a configuration that opens the adjustable passage.

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

[0010] In some embodiments, the system further includes a second lumen control plug configured to fit into an adjustable passage of an adjustable tubular device and hold the adjustable passage in a second open configuration of a different size than the first open configuration. In some embodiments, the second lumen control plug is locatable within the first lumen control plug.

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

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

[0013] In some embodiments, the system further includes an elongated element configured to open an adjustable passage in an adjustable tubular device, facilitating the insertion of a first lumen control plug therein. In some embodiments, the first lumen control plug is guided through the elongated element into the adjustable tubular device.

[0014] According to another aspect of the present disclosure, a method for adjusting an embedded adjustable tubular device having an adjustable passage defined therethrough includes inserting an elongated element into an adjustable passage defined within the adjustable tubular device to open the adjustable passage, and inserting a lumen control plug into the adjustable passage to hold the adjustable passage open.

[0015] In some embodiments, inserting a lumen control plug involves guiding the lumen control plug along an elongated element. In some embodiments, the adjustable tubular device is twisted such that the adjustable passage through it is in a closed configuration, and the method further includes rotating an elongated element to untwist the passage of the adjustable tubular device.

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

[0017] These and other features and advantages of this disclosure will be readily apparent from the following detailed description, and the scope of the claimed invention is set forth in the attached claims. The following disclosure is presented with respect to aspects or embodiments, but it should be understood that each aspect may be claimed separately or in combination with the aspects and features of that embodiment or any other embodiment. [Brief explanation of the drawing]

[0018] Non-limiting embodiments of this disclosure are described by 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 dimensions, locations, order, and relative sizes reflected in the figures within the drawings may vary. For example, devices may be enlarged to allow for the identification of details, but are intended to be reduced to fit within, for example, a delivery catheter or an endoscope's working channel. For clarity and brevity, not all elements are labeled in all figures, and not all elements of each embodiment are shown where illustration is not necessary to enable those skilled in the art to understand this disclosure. The detailed description will be better understood in conjunction with the accompanying drawings, where similar reference numerals represent similar elements, as follows. [Figure 1] Figure 1 is a perspective view of one embodiment of an adjustable tubular device, which is formed according to various aspects of the present disclosure and is positioned in a schematic diagram of the gastrointestinal environment, involving an anastomosis between the stomach and a portion of the small intestine. [Figure 2] Figure 2 shows one embodiment of an adjustable tubular device formed according to various aspects of the present disclosure, which holds tissue walls juxtaposed in a closed configuration. [Figure 3A] Figure 3A shows an embodiment of an adjustable tubular device as shown in Figure 2, in which a passage opening device is inserted. [Figure 3B] Figure 3B shows further positions of the passage opening device inserted into the adjustable tubular device as shown in Figure 3A. [Figure 4A] Figure 4A shows an example of an embodiment of the distal portion of a passage opening device based on various principles of this disclosure. [Figure 4B] Figure 4B is a cross-sectional view along the line IVB-IVB in Figure 4A. [Figure 5A] Figure 5A shows an example of an embodiment of the distal portion of a passage opening device based on various principles of this disclosure. [Figure 5B] Figure 5B is a cross-sectional view along the line VB-VB in Figure 5A. [Figure 6A] FIG. 6A is a diagram illustrating an example of an embodiment of a distal portion of a passage opening device in accordance with 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. 2. [Figure 8] FIG. 8 is an enlarged cross-sectional view taken along line VIII-VIII in FIG. 3B, illustrating an example of an embodiment of a passage opening device as shown in FIGS. 4A and 4B. [Figure 9] FIG. 9 is a detailed view of portion IX of an embodiment of the adjustable tubular device shown in FIG. 3A. [Figure 10] FIG. 10 is a schematic cross-sectional view taken along line X-X in FIG. 1, illustrating an embodiment of a lumen control plug inserted within an embodiment of an adjustable tubular device, wherein details of the lumen control plug and the wall of the adjustable tubular device are omitted for clarity of the drawing. DETAILED DESCRIPTION OF EMBODIMENTS FOR CARRYING OUT THE INVENTION

[0019] The following detailed description should be read with reference to the drawings illustrating exemplary embodiments. It should be understood that this disclosure is not limited to the specific embodiments described and is therefore subject to variation. 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 this disclosure. Each example of an embodiment is provided for illustrative purposes and is merely an example, not the only way to implement these principles. Accordingly, references to elements, structures, or features in the drawings should be recognized as references to examples of embodiments of this disclosure and should not be understood as limiting this disclosure to specific elements, structures, or features illustrated. Other examples of ways of implementing the disclosed principles will be recalled by those skilled in the art who have read this disclosure. Indeed, it will be apparent to those skilled in the art that various modifications and variations can be made in this disclosure without departing from the scope of the subject matter or the technical idea. For example, a feature illustrated or described as part of one embodiment can be used in conjunction with another embodiment to result in further embodiments. Therefore, this subject matter is intended to encompass such modifications and variations that fall within the scope of the appended claims and their equivalents.

[0020] It will be understood that this disclosure is described in varying levels of detail in this application. In certain examples, details that are not necessary for a person skilled in the art to understand this disclosure, or that would make it difficult to recognize other details, may be omitted. The terms used herein are for the purpose of describing specific embodiments only and are not intended to limit beyond the scope of the appended claims. Unless otherwise defined, the technical terms used herein should be understood as commonly understood by a person skilled in the art to which this disclosure belongs. All devices and / or methods disclosed and claimed herein are possible to manufacture and perform without undue experimentation in light of this disclosure.

[0021] As used herein, “proximal” means the direction or location closest to the user (such as a medical professional, clinician, technician, operator, or physician; such terms are used interchangeably herein without intent to limit, including automated controller systems, etc.) when using the device (e.g., when introducing the device into a patient, or during implantation, placement, or delivery); and “distal” means the direction or location furthest from the user 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” means, with respect to an opening, a line that at least approximately bisecting the center point of the opening and extending longitudinally along the length of the opening if the opening comprises, for example, a tubular element, strut, channel, cavity, or bore.

[0022] According to various principles of this disclosure, implantable devices may extend across anatomical structures to control or adjust the size of passages through which they pass. For example, an implantable device may extend across a body passage or lumen, and such terms are used interchangeably herein without limitation. A body passage or lumen may include, but is not limited to, a portion of a passage or lumen, a passage or lumen between anatomical structures (such as a passage, lumen, cavity, organ, etc.), a passage created across juxtaposed tissue walls (such as to create an anastomosis), etc. A device may have a passage or lumen through which it passes (such terms are used interchangeably herein without limitation), and it may be used to occlude, block, narrow, close, contract, adjust, or control a body passage through which the device is placed (such terms and their applications are used interchangeably herein without limitation). A device may be considered and referred to as an occlusion device, or a lumen juxtaposition device, or an anastomosis device, or a flow regulating device, or a flow control device, and such terms and various other substitutes therefor may be used interchangeably herein without intent to limit. Where used herein, for convenience, it will be understood that the term simply refers to an adjustable tubular device without intent to limit. Furthermore, a 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 for adjusting the size (e.g., diameter) of the passage through it.

[0023] According to various principles of this disclosure, the size or diameter of a passage in an adjustable tubular device formed in accordance with various principles of this disclosure is selectively adjustable between a closed configuration (understood to be completely closed, or substantially closed but not completely closed, e.g., closed from about 80% to a maximum of about 100%, with increments of 0.5% in between) and an open configuration. The passage may be in a closed position when in a neutral / stationary configuration (unaffected by another device or any action performed on the passage) and may be configured to change to an open position only upon active application of force or another action thereto. The open position may be selected, controlled, or determined by the device used to open the passage and / or the manner in which the passage is changed to an open position. The passage may be opened to any of a range of degrees of opening (e.g., the size of the opening is variable) to regulate the flow of material through the passage (e.g., volume, velocity, quantity, etc.). For example, the passage can be simply changed from a closed configuration to an open configuration. Alternatively or additionally, the passage may have a neutral open configuration, and the passage may extend beyond such a neutral open configuration (e.g., expand or widen). For example, the passage may contract from a neutral open configuration to a closed configuration by twisting or by applying a separate closing element thereto, and may open to an extension or expansion configuration beyond such a neutral open configuration.

[0024] In some embodiments, implantable devices formed according to various principles of the present disclosure can be used as occluding devices and selectively converted to an open configuration if the passage of material through the otherwise occluded passage is desired or instructed. 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 juxtaposed by a lumen juxtaposition device or another device (e.g., a separate lumen juxtaposition device), creating an anastomosis with an adjustable passage between them. 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 at which material passes through a flow limiting device and / or a portion thereof while it remains implanted in the patient.

[0025] Devices, systems, and methods based on various principles of this disclosure may be used in conjunction with various gastric procedures, including controlling or obstructing the flow of gastric material from the stomach through the pylorus, such as in the treatment of obesity or other gastrointestinal conditions. For example, various protocols include reducing and / or delaying the rate of passage of material through the pylorus and / or obstructing / removing the pylorus from the stomach. Adjustable tubular devices formed according to various principles of this disclosure may be structured to obstruct (partially or completely) the flow through them, thereby obstructing the flow of material through the pylorus. Adjustable tubular devices formed according to various principles of this disclosure may also be used in the treatment of obesity, including increasing satiety in patients, with the intention of reducing appetite and consequently reducing calorie 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 fluid or material such as oatmeal from the stomach to the duodenum), which may result in a feeling of fullness or satisfaction, leading to reduced food intake and associated weight loss.

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

[0027] According to various aspects of this disclosure, an adjustable tubular device is formed comprising an adjustable portion having an adjustable passage. The adjustable passage can be selectively opened and closed during treatment to allow temporary access or passage (of a substance or medical device or instrument) through the adjustable tubular device, or can be kept open for a longer period of time (and can be closed if desired or medically instructed). In some embodiments, the adjustable tubular device has a narrowed adjustable portion that is selectively expandable to allow a substance to pass through when the passage is expanded. In some embodiments, the portion of the adjustable tubular device is twisted such that the twist narrows or closes the passage. Such twist in the adjustable tubular device may be modified or adjusted to modify or adjust the degree of closure or blockage of the passage produced by such twist, for example, by untwisting. In some embodiments, an elongated element is provided extending through the passage to adjust the adjustable portion of the adjustable tubular device. Elongated elements may have unique configurations to facilitate engagement with the configuration of the adjustable portion, and may, for convenience, be referred to herein as passage-opening devices without the intention of limiting them to a particular function. In some embodiments, the adjustable portion of an adjustable tubular device is selectively adjustable to at least a partially open configuration, such as being narrowed to a substantially closed configuration or being twisted and untwisted. It will be understood that other configurations are included within the scope and technical concept of this disclosure. In some embodiments, the passage-opening device may be molded or configured or provided with features corresponding 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 this disclosure extend beyond the examples of twisted closed devices and untwisting such devices, which will be 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, woven, looped (e.g., bobbinette type), tied, 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 as stents, frameworks, or scaffolds, without being intended to limit them. The adjustable tubular device may be formed from biocompatible metals or polymer materials or alloys. In some embodiments, the material is a shape-memory material or thermoformable material such as a nickel-titanium alloy (e.g., Nitinol). In some embodiments, the passage opening device includes various features for engaging with the constricted portion and / or elements of the adjustable tubular device (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 passage through the adjustable tubular device. For example, the adjustable passage of the adjustable tubular device can have its diameter increased, and an additional tubular device can be inserted therein to hold the passage of the adjustable tubular device open to a range smaller than the fully open range of the passage of the adjustable tubular device.

[0030] It should be noted that in some embodiments, opening a closed (e.g., twisted closed) region of the device may result in other changes to the device, such as changes in the axial length or other dimensions or properties of the device. For example, in some embodiments, retaining members are provided at the ends of the device to hold tissue walls juxtaposed and / or to hold the device in place relative to the anatomical site where the device is deployed / placed (e.g., to prevent or stop the device from moving). In various examples, opening a closed region of the device may affect the position of one or both retaining members (e.g., relative position and / or orientation, such as the axial distance between retaining members) and / or the configuration of one or both retaining members (e.g., dimensions of the retaining members, such as the diameter of one or both of them, which may be influenced by the dimensions of other regions of the device, such as the regulated region). Adjustability of the configuration of the closed region of an implantable device that affects the retaining members may be advantageous in order to affect the retaining force of the retaining members against tissue walls that are in contact with the retaining members (e.g., held juxtaposed by the retaining members). Such adjustments may be independent of whether the device allows the passage of material. Therefore, if additional devices are inserted (or otherwise modified) into an adjustable tubular device formed according to various principles of this disclosure in order to maintain adjustment to the configuration of the adjustable tubular device other than the size of the passage through the adjustable tubular device, such additional devices do not need to include a passage through the adjustable tubular device if the passage of material through it is undesirable.

[0031] According to various principles of this disclosure, the adjustable tubular device may be sized and configured for transtubal, transcatheter, or endoscopic delivery. Accordingly, according to one aspect of this disclosure, the adjustable tubular device may be folded to pass through a tubular delivery device used in minimally invasive procedures (as opposed to open surgery), or its cross-sectional dimensions may be reduced in other ways. The adjustable tubular device may be expandable once deployed. For example, the adjustable tubular device may be formed to be self-expanding (in which case, advantageously formed from a shape-memory material that expands the device once it is no longer held or constrained within a delivery device), or may be expanded with the assistance of another expandable device, such as an expandable balloon. To allow for the option of removal from the deployment site, the adjustable tubular device may be formed to be selectively foldable from its expanded deployment configuration by any of the various methods known in the art or previously known.

[0032] Referring here to the drawings, Figure 1 shows an adjustable tubular device 100, formed according to various principles of the present disclosure, placed in an example of an environment in which the principles of the present disclosure can be applied to a stomach S that has undergone Roux-en-Y gastric bypass or other types of bypass. As can be understood, the stomach S is divided into a functional portion of the stomach S, which can be referred to as the gastric pouch GP, and a bypassed portion BP of the stomach, which is generally excluded from or closed off from the passage of food along the digestive tract. More specifically, the bypassed portion BP of the stomach is the lower portion of the stomach S that typically allows food material (e.g., porridge, partially digested food material, etc.) to pass into the duodenum D. The gastric pouch GP is directly connected to the jejunum J. Thus, typical access to the duodenum D, as well as the proximal regions of the intestines such as the pancreas and the pancreatic and bile ducts, is blocked through the pylorus P. If easier access to such anatomical structures is desired, an anastomosis A to the bypassed portion BP of the stomach can be created using an adjustable tubular device 100, as shown in Figure 1, which is formed according to the principles of the present disclosure. An adjustable tubular device 100 formed according to the principles of this disclosure may be used in conjunction with other types of gastric bypass procedures, such as gastrojejunostomy (which will be readily apparent to those skilled in the art, for example, by referring to U.S. Patent Application Publication No. 2018 / 08271530, filed March 26, 2018 and published September 27, 2018, although not illustrated, and which is incorporated herein by reference in its entirety for all purposes). In such procedures, it is generally desirable that the device forming the gastrojejunostomy remain open (and therefore generally not a typical site for the adjustable tubular device 100 formed according to the principles of this disclosure), but generally it is still desirable to close or at least restrict access to the duodenum D through the pylorus P in order to facilitate bypass to the jejunum J. An adjustable tubular device 100 formed according to various principles of this disclosure may be positioned across the pylorus P to result in a desired degree of closure of the pylorus P, while allowing selective adjustment of the degree of closure of the adjustable tubular device 100.Another potential use of the adjustable tubular device 100, formed according to various principles of this disclosure, is to regulate gastric emptying by regulating the flow through the pylorus P by arranging the adjustable tubular device 100 formed according to various principles of this disclosure.

[0033] As can be more readily understood by referring to Figure 2, an example of an adjustable tubular device 100 formed according to the principles of the present disclosure has a first end 101, a second end 103, and a lumen 105 extending between them. The first end 101 may widen to form a first retaining member 102, and the second end 103 may widen to form a second retaining member 104. The retaining members 102, 104 (which may alternatively be referred to as flanges, without intent to limit) are preferably formed to be sufficiently wide and have sufficient retaining strength to hold the adjustable tubular device 100 in place, according to various tissue juxtaposition devices or stents known or previously known in the art. The retaining members 102, 104 may be any of various shapes, such as concave, convex, disc-shaped, cylindrical (e.g., having a longitudinal range longer than shown), or other configurations, and no particular shapes and configurations are limited by the present disclosure. It will be understood that the lumen bore does not need to be completely closed (i.e., have a bore of 0 mm) when in the neutral configuration. Generally, the bore of the lumen 105 when closed is less than 5 mm. The lumen 105 may be open to a size that allows a medical device or instrument to pass through it, or for a desired volume or flow rate of substance (e.g., body matter or ingested substance) to pass through it. In some embodiments, the maximum bore of the lumen 105 may be about 20 mm. In some embodiments, the diameters of the retaining members 102, 104 may be at least about 30 mm and at most about 40 mm. Details of such features are not important to this disclosure and are therefore left to those skilled in the art to determine for a given environment in which the adjustable tubular device 100 is to be used.

[0034] As shown in Figure 2, the intermediate region 106 of the adjustable tubular device 100 between the first end 101 and the second end 103 (which may be referred to herein, for the purposes of this specification, as the saddle region 106) may be constricted to reduce the cross-sectional size (e.g., diameter) of the lumen 105 and thereby affect (e.g., reduce or regulate) the flow through it. 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 through it, are also within the scope and technical concept of this disclosure (such an elastic band or sleeve may be expandable to adjust the size of the lumen 105 according to various principles of this disclosure, which will be described in further detail below).

[0035] As shown in Figures 3A and 3B, according to aspects of the present disclosure, an elongated 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 extend the intermediate region 106 of the adjustable tubular device 100. It will be understood that the elongated element 200 is generally inserted into the ends 101, 103 of the adjustable tubular device 100, which are more easily accessible. Thus, although the elongated element 200 is shown in Figure 3A as being inserted into the second end 103, the elongated element 200 may instead be inserted into the first end 101. The distal end 201 of the elongated element 200 is inserted into the elongated element 200, and the proximal end 203 is positioned to be accessible to a medical professional to control the advancement and manipulation of the elongated element 200. The elongated element 200 may extend proximal such that its proximal end 203 is outside the patient, and may be connected to a control handle or the like. For example, natural orifice transendoscopic surgery (NOTES) may be used to adjust the adjustable tubular device 100 according to various principles of this disclosure, and the elongated element 200 may extend proximal through the patient's esophagus and extend outside the patient's mouth. Alternative points of entry and access to treatment sites, such as transcatheter or vascular, are included in the scope and concept of this disclosure. For example, rectal access to the adjustable tubular device 100 used in the gastrointestinal system, or vascular access to the adjustable tubular device 100 used in the vascular system, are included in the scope and concept of this disclosure. A guidewire (such as one inserted through a lumen passing through the elongated element 200) may be used to assist in guiding the elongated element 200 to the adjustable tubular device 100. The distal end 201 of the elongated element 200 is preferably sufficiently strong in the longitudinal direction (e.g., has sufficient compressive resistance) and advanced into the contracted adjustable portion of the intermediate region 106 of the adjustable tubular device 100, thereby adjusting the size of the lumen 105 passing through it, and consequently adjusting the ability of material to pass through the lumen 105 of the adjustable tubular device 100. For example, the distal end 201 of the elongated element 200 may be reinforced with a braided coil or other structure (e.g., a composite structure) to increase compressive resistance.

[0036] In one embodiment of the adjustable tubular device 100, as shown in Figure 2, where the intermediate region 106 is twisted, the distal end 201 of the elongated element 200 shown in Figures 3A and 3B preferably has sufficient torsional strength to untwist the twisted adjustable portion of the intermediate region 106 in order to adjust the amount or degree to which the lumen 105 opening through the adjustable tubular device 100. Various reinforcing materials as described above can increase the torsional resistance of the elongated element 200. The elongated element 200 configured to adjust the lumen 105 in the example of the adjustable tubular device 100 shown in Figure 2 is advanced into the adjustable portion of the intermediate region 106 (for example, along its longitudinal axis L) as shown in Figure 3A, and rotated (for example, around its longitudinal axis L) to untwist the adjustable portion of the intermediate region 106, as shown in Figure 3B. It will be understood that other configurations of elongated elements corresponding to other configurations of the adjustable portion of an adjustable tubular device formed according to the various principles of this disclosure are included in the scope and technical concept of this disclosure.

[0037] The distal end 201 of an elongated element 200 configured to untwist a twisted intermediate region 106 of an adjustable tubular device 100 may be provided with one or more engaging features structured and configured to engage with the twisted configuration of the intermediate region 106 of the adjustable tubular device 100 and untwist such configuration. For example, the engaging features may be projections, ridges, or grooves that engage with or engage between the twists of the twisted intermediate region 106. Various embodiments of examples of engaging features that may be provided on an elongated element 200 structured and configured to engage with a twisted intermediate region 106 of an adjustable tubular device 100 formed according to the principles of this disclosure are shown in Figures 4A, 4B, 5A, 5B, 6A, 6B, 7A, and 7B.

[0038] In the embodiments shown in Figures 4A and 4B, the distal end 201' of an example of an elongated element 200'' has an engaging feature portion 206' in the form of a longitudinal projection along the distal end 201' of the elongated element 200'. As can be understood by referring to Figure 4A, the engaging feature portion 206' is twisted (e.g., helical or non-linear) around the longitudinal axis L of the elongated element 200' to accommodate the twist in the adjustable tubular device 100 in which the elongated element 200' is used. As can be understood by referring to Figure 4B, the engaging feature portion 206' extends radially outward from the elongated element 200' and is optionally curved radially (e.g., circumferentially around the longitudinal axis L of the elongated element 200') along at least a portion thereof. In other words, an example of the embodiment of the engagement feature portion 206' shown in Figure 4B extends radially outward from the distal end 201' of the elongated element 200' and is curved at least at its free end (along the end or edge of the engagement feature portion 206' that is furthest from the distal end 201' of the elongated element 200' and not attached there).

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

[0040] In the embodiments shown in Figures 6A and 6B, the distal end 201''' of an example of an elongated element 200''' has engaging features 206''' in the form of a plurality of individual protrusions spaced apart along the distal end 201''' of the elongated element 200'''. As can be understood by referring to Figures 6A and 6B, the engaging features 206''' extend radially outward from the distal end 201''' of the elongated element 200'''. As can be understood by referring to Figure 6A, the engaging features 206''' may be spaced apart from each other longitudinally along the longitudinal axis L of the elongated element 200'''. As can be further understood by referring to Figure 6A, adjacent engaging features 206''' may be aligned linearly and / or radially with respect to each other.

[0041] It will be understood that the engaging feature portion 206 may be formed by any method known or previously known in the art, such as molding, bonding, extrusion, machining, stamping, or cutting. Embodiments in Figures 5A and 5B, particularly in Figure 5B, show an example of an engaging feature portion 206 formed by cutting or quilling, where a notch is formed (generally non-radially) on the face of the distal end 201'' of the elongated element 200'', and the notch is widened to pull the section apart to form a projection (e.g., a quill or fin) that forms the elongated element 200''. It will be further understood that any number of engaging feature portions 206 may be provided to engage with the twisted portion of the adjustable tubular device 100. The shape or configuration or number of the engaging feature portions 206', 206'', 206'''' are not limited to those illustrated and described herein.

[0042] In some embodiments, the adjustable tubular device 100 is formed by a plurality of wires 108, as can be understood from the schematic cross-sectional view of Figure 7 along line VII-VII in Figure 2. One or more engaging features 206 may be configured to engage with the wires 108, such as in one-to-one correspondence or between groups of adjacent wires 108, as shown in Figure 8, which shows a schematic cross-sectional view along line VIII-VIII in Figure 3A. When the elongated element 200 is fitted into 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 away (and become more closely aligned with the longitudinal axis L of the adjustable tubular device 100), and twisting the elongated element 200 moves the wires 108 further away, opening the lumen 105.

[0043] In some embodiments, where the adjustable portion of the adjustable tubular device 100 is twisted / untwisted, it may be desirable to retain the distal portion of the adjustable tubular device 100 with respect to the tissue or body passage in which the adjustable tubular device 100 is positioned. Various retaining features 110 may be provided and / or formed on the adjustable tubular device 100 to engage and / or secure it to the tissue or body passage. For example, tissue engagement projections (e.g., barbs, anchors, etc.), tissue intrinsic growth 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 with the tissue into which the adjustable tubular device 100 is deployed. Embodiments of the adjustable tubular device 100 shown in Figures 3A and 3B show an adjustable tubular device 100 that holds a tissue wall T (such as the walls of the stomach and jejunum, if the adjustable tubular device 100 is positioned between the stomach wall and the jejunal wall as in Figure 1). As can be understood by referring to detail X in Figure 3A shown in Figure 9, at least one retaining feature portion 110 (such as in the form of a tissue-engaging projection like a barb) is on the surface of the retaining member 102 that abuts against or engages with 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 portion 110 is located on the portion of the retaining member 102 facing the intermediate region 106 (for example, an inward-facing portion that abuts against or contacts one of the tissues held juxtaposed by the adjustable tubular device 100). However, it will be understood that other locations of the retaining feature portion 110 are included in the scope and technical concept of this disclosure, such as being selected based on the environment or procedure in which the adjustable tubular device 100 is used. For example, if the adjustable tubular device 100 is positioned across a body passage or lumen such as the pylorus P, the retaining feature 110 may be provided on a portion located laterally outward of the adjustable tubular device 100, such as by engaging with the inner wall of the body passage in which the adjustable tubular device 100 is positioned or across.Generally, at least one retaining feature 110 is provided on the distal portion of the adjustable tubular device 100, such as on a distal retaining member 102, thereby allowing the proximal portion of the adjustable tubular device 100 (generally more easily accessible by a medical professional) to rotate while the distal portion of the adjustable tubular device 100 is held in place relative to the body (e.g., a tissue wall T).

[0044] According to a separate and independent aspect of this disclosure, as schematically shown in Figure 10 (certain features such as wall details are omitted for the sake of simplicity in the figure), when the lumen 105 of the adjustable tubular device 100 is opened (by an elongated 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 is 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 from the same or a different device used to open the adjustable tubular device 100 (e.g., to untwist it). For example, the lumen control plug 300 may be deployed using an elongated element 200 used to open the lumen 105 of the adjustable tubular device 100, thereby allowing the adjustable tubular device 100 to be opened and the adjustable tubular device 100 to be supported or inserted into and opened by the lumen control plug 300 in a single step without prior removal of the elongated element 200 from within the lumen 105. The term “plug” will be understood to be used in relation to the positioning of the lumen control plug 300 within the lumen 105 in order to plug into, or more specifically, to plug into and open, the lumen control plug 300 (e.g., plugging into, or more specifically, plugging into and opening, the lumen 105).

[0045] An example of a lumen control plug 300 shown in Figure 10 extends through the lumen 105 of the adjustable tubular device 100, with its distal end 201 adjacent to the distal end 101 of the adjustable tubular device 100 and somewhat separated inward (towards the intermediate region 106), and its proximal end 103 adjacent to the proximal end 103 of the adjustable tubular device 100 and somewhat separated inward (towards the intermediate region 106). 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 each other (e.g., substantially aligned) than shown in Figure 10. In the embodiment shown in Figure 10, the lumen control plug 300 is molded and / or configured to fit, adapt to, or correspond to the shape and / or configuration of the adjustable tubular device 100 in order to reduce the movement of the lumen control plug 300 within the adjustable tubular device 100 (e.g., relative movement in the axial and / or radial directions). For example, the embodiment of the lumen control plug 300 shown in Figure 10 has a first retaining member 302 configured to connect to (e.g., engage, correspond in shape, fit, etc.) a first retaining member 102 of the adjustable tubular device 100, and a second retaining member 304 configured to connect to (e.g., engage, correspond in shape, fit, etc.) a first retaining member 104 of the adjustable tubular device 100. In the illustrated example, the retaining members 302 and 304 of the lumen control plug 300 are fitted into the separated walls of the retaining members 102 and 104 of the adjustable tubular device 100, but other configurations are also within the scope and technical concept of the present invention. For example, while the retaining members 102 and 104 of the adjustable tubular device 100 are shown as double walls, it should be noted that the retaining members 302 and 304 of the lumen control plug 300 may be formed as single walls. Various methods can be used to retain the inner stent within the outer stent, and such features are not important to the basic principles of this disclosure.

[0046] The diameter of the lumen 305 of the lumen control plug 300, for example, the diameter of the intermediate region 306 of the lumen control plug 300, may be selected from a range of diameters depending on the intended course of treatment in which the adjustable tubular device 100 and the lumen control plug 300 are provided / used. The lumen control plug 300 preferably has sufficient radial or hoop strength to withstand any contractile forces from the adjustable tubular device 100, which is configured to close in a resting position, along with any contractile forces from the juxtaposed tissue, so that the lumen control plug 300 can hold the otherwise closed adjustable portion of the adjustable tubular device 100 in an open position. In some embodiments, the lumen control plug 300 may have higher radial or hoop strength than the corresponding adjustable tubular device 100. In some embodiments, a kit or system is provided with two or more lumen control plugs 300, which allow for adjustment of the size of the lumen 105 of the adjustable tubular device 100 at various stages during the course of treatment by inserting lumen control plugs 300 of different sizes into the lumen 105 of the adjustable tubular device 100. For example, if an adjustable tubular device 100 formed according to the principles of the present disclosure is positioned to reduce the flow rate of material passing through it (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 adjust the flow rate of material according to the patient's progress or response to treatment. A lumen control plug 300 of a first diameter may be replaced with a second lumen control plug 300 of a different diameter. Additionally or alternatively, a first lumen control plug 300 having lumens 305 having a first diameter may be inserted first, and a second lumen control plug 300 having lumens 305 having 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 initially be placed together within the adjustable tubular device 100, and the second lumen control plug 300 may be removed if desired. Alternatively, the first lumen control plug 300 may be placed within the adjustable tubular device 100, and the second lumen control plug 300 may be placed within the first lumen control plug 300 at a later time (e.g., several hours, several days, several weeks, etc., depending on the course of the procedure). Additionally or alternatively, the adjustable tubular device 100 may be left inside the patient's body in a closed configuration, and the lumen control plugs 300 may be inserted into the lumens 105 of the adjustable tubular device 100 only for the duration of a procedure, and then removed once such procedure is complete, leaving the adjustable tubular device 100 in place once again in a closed configuration. Since the size of the instrument through which the adjustable tubular device 100 can pass may vary depending on the procedure (for example, based on the instrument through which the adjustable tubular device 100 can pass), lumen control plugs 300 of different sizes are provided for use with a given adjustable tubular device 100, allowing for the selective opening of internal passages 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 pass over the elongated element 200 so that the lumen control plug 300 is mounted over the elongated element 200 and delivered by the elongated element 200 (for example, the elongated element 200 may be made to pass through the lumens 305 of the lumen control plug 300). Alternatively, the lumen control plug 300 may be delivered via another delivery device or mechanism known in the art or previously known.

[0048] The lumen control plug 300 may be in the form of a braided stent, a laser-cut tubular stent, or any other configuration that enables a compact delivery configuration thereof, but as described above, when deployed within the adjustable tubular device 100, it expands with sufficient stability to hold the lumen 105 of the adjustable tubular device 100 open. Removability can be enhanced by using a retractable feature 307 such as a suture or a gripping loop or tightening cord, as known in the art or previously known. The configuration of such a retractable feature is not important to understanding the basic principles of the present disclosure, and therefore the elongated element 200 may have a passage through it for a guidewire or the like to facilitate the guidance of the elongated element 200 to the treatment site. In some embodiments, the elongated element 200 is a catheter.

[0049] As described above, the various structures and features of the embodiments described herein and shown in the figures have several distinct, independent, and unique advantages. Therefore, not all of the various structures and features described herein are necessary to achieve at least some of the desired characteristics and / or benefits described herein. Furthermore, the various features described herein may be used individually or in any combination. It will be understood that the various features described in reference to one embodiment may be applied to another embodiment, whether or not they are explicitly shown. Therefore, it should be understood that one or more of the features described with reference to one embodiment may be combined with one or more of the features of any other embodiment described herein. That is, any of the features described herein can be mixed and harmonized to create a hybrid design, and such a hybrid design is within the scope of this disclosure. Therefore, the present invention is not limited to the embodiments specifically described herein. The above description is merely an example for illustrating embodiments and is not intended to limit broader aspects of this disclosure.

[0050] The preceding discussions are presented for illustrative and explanatory purposes, with broad applicability, and are not intended to limit this disclosure to one or more forms disclosed herein. It will be understood that various additions, modifications, and substitutions can be made to the embodiments disclosed herein without departing from the concepts, ideas, and scope of this disclosure. In particular, it will be apparent to those skilled in the art that the principles of this disclosure can be embodied in other forms, structures, arrangements, proportions, and using other elements, materials, and components without departing from its concepts, ideas, scope, or characteristics. For example, various features of this disclosure are grouped together into one or more aspects, embodiments, or configurations for the purpose of streamlining this disclosure. However, it should be understood that various features of a particular aspect, embodiment, or configuration of this disclosure can be combined in alternative aspects, embodiments, or configurations. While this disclosure is presented with respect to embodiments, it should be understood that various distinct features of the subject matter do not all need to be present to achieve at least some of the desired characteristics and / or advantages of the subject matter or such individual features. Those skilled in the art will understand that this disclosure can be used with numerous modifications, or modifications to the structure, arrangement, proportions, materials, components, etc., used in the implementation of this disclosure, without departing from the principles, technical ideas, or scope of this disclosure, or particularly adapted to specific environmental and operating requirements. For example, an element shown as being formed as a whole may consist of multiple parts, or an element shown as multiple parts may be formed as a whole; the operation of an element may be reversed or modified; and the size or dimensions of an element may be modified. Similarly, while an operation or action or procedure is described in a particular order, this should not be understood as requiring such a particular order to achieve a desired result, or as meaning that all operations or actions or procedures should be performed. In addition, other forms of implementation are within the scope of the following claims. In some cases, the operations described in the claims may be performed in a different order, and the desired result may still be achieved.Accordingly, the embodiments currently disclosed should be considered in all respects to be illustrative and not limiting, and the scope of the claimed subject matter is indicated by the appended claims and is not limited to the foregoing description or any specific embodiment or configuration described or illustrated herein. In consideration of the foregoing, individual features of any embodiment may be used, 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 the following claims, it will be understood that: The terms “at least one,” “one or more,” and “and / or” as used herein are open-ended expressions that are both conjunctive and disjunctive in their function. Terms such as “a,” “an,” “the,” “first,” and “second” do not exclude plurals. For example, the term “a” or “an” entity, as used herein, refers to one or more of those entities. Thus, the terms “a” (or “an”), “one or more,” and “at least one” can be used interchangeably herein. References to all directions (e.g., proximal, distal, top, bottom, upward, downward, left, right, lateral, longitudinal, front, rear, top, bottom, up, down, vertical, horizontal, radial, axial, clockwise, counterclockwise, etc.) are used solely for identification purposes to aid the reader's understanding of this disclosure and / or to distinguish areas of related elements from one another, and do not limit the elements relevant in particular with respect to the position, orientation, or use of this disclosure. References to connections (e.g., attached, joined, connected, and joined) should be interpreted broadly and, unless otherwise indicated, may include intermediate members between sets of elements and relative movement between elements. Thus, references to connections do not necessarily imply that two elements are directly connected and have a fixed relationship with respect to one another. Identification references (e.g., primary, secondary, first, second, third, fourth, etc.) are not intended to imply importance or priority and are used to distinguish one feature from another.

[0052] The following claims are incorporated by reference into this detailed description, and each claim stands independently as a distinct embodiment of the present disclosure. In the claims, the term “equipped with / possesses” does not exclude the presence of other elements or steps. In addition, individual features may be included in different claims, but they may be advantageously combined, and inclusion in different claims does not mean that the combination of features is unfeasible and / or unfavorable. In addition, singular references do not exclude plurals. Reference numerals in the claims are provided merely as examples for clarity and should never be construed as limiting the claims.

Claims

1. A system for adjusting the size of a passage through which an implantable device passes, An adjustable tubular device having an adjustable passage defined therethrough, wherein the adjustable passage is changeable between a substantially closed configuration and an open configuration, A first lumen control plug configured to fit into the adjustable passage of the adjustable tubular device and to hold the adjustable passage in a first open configuration. A system equipped with these features.

2. The system according to claim 1, further comprising a second lumen control plug configured to fit into the adjustable passage of the adjustable tubular device and to hold the adjustable passage in a second open configuration of a different size than the first open configuration.

3. The system according to claim 2, wherein the second lumen control plug is configurable within the first lumen control plug.

4. The system according to any one of claims 1 to 3, wherein the first lumen control plug is configured to mate with the adjustable tubular device to reduce the movement of the first lumen control plug in the adjustable passage through the adjustable tubular device.

5. The adjustable tubular device has a first retaining member along its first end and a second retaining member along its second end. The system according to any one of claims 1 to 3, wherein the first lumen control plug comprises a first retaining member configured to engage with a first retaining member of the adjustable tubular device, and a second retaining member configured to engage with a second retaining member of the adjustable tubular device, in order to resist movement of the first lumen control plug relative to the adjustable tubular device.

6. The system according to any one of claims 1 to 3, further comprising an elongated element configured to open the adjustable passage of the adjustable tubular device, thereby facilitating the insertion of the first lumen control plug therein.

7. The system according to claim 6, wherein the first lumen control plug is guided through the elongated element into the adjustable tubular device.

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