Device, system, and method for duodenal exclusion and stomach capacity reduction

Abstract

To provide a flow-restricting device.SOLUTION: An implantable flow-restricting device extends along a longitudinal extent which need not be linear and has a first portion and a second portion with a saddle region therebetween. At least one of the first and second portions may be angled with respect to the saddle region to resist migration of the device. At least one of the first and second portions may be configured to maintain a distance from a region of an anatomical structure in which such portion is positioned. An occluder, such as an expandable occluder, may be associated with the flow-restricting device, such as one of the first and second portions thereof. The occluder may serve to block passage of material through an anatomical passage in which the saddle region is positioned, prevent migration of the device (e.g., through such passage), and / or increase volume occupied by the device.SELECTED DRAWING: Figure 2

Description

[Technical Field]

[0001] The present disclosure relates generally to the field of implantable medical devices and related systems and methods for reducing the passage of matter through a body passage or lumen and / or obstructing a body passage or lumen. More particularly, the present disclosure relates to devices, systems, and methods for reducing the passage of matter through a body passage or lumen in the gastrointestinal tract, such as the pylorus, and / or obstructing a body passage or lumen in the gastrointestinal tract. The present disclosure further relates to devices, systems, and methods for reducing the passage of matter through the pylorus and / or obstructing the pylorus as well as creating a restrictive effect in the stomach. [Background technology]

[0002] Treatment methods for various conditions, such as obesity, diabetes, or duodenal ulcers, involve bypassing the duodenum or restricting the flow of material through the duodenum. If the treatment requires complete bypass of the duodenum, obstruction of the pylorus (e.g., complete obstruction) may be indicated, and an anastomosis may be created, such as between the stomach and the jejunum. Duodenal clearance devices may be placed within the pyloric sphincter to inhibit or block the passage of material (fluids, liquids, chyme, etc.) from the stomach through the pylorus to the duodenum. One challenge presented by such devices is preventing their movement distally into the small intestine or proximally into the stomach.

[0003] Various medical approaches to treating obesity or metabolic diseases further include restricting a portion of the stomach and / or reducing the stomach's internal volume, which has been considered an effective method of reducing food consumption by creating a feeling of fullness. Generally, duodenal expulsion devices do not address the reduction of stomach volume.

[0004] It is increasingly desirable to provide minimally invasive alternatives to existing approaches for treating gastrointestinal disorders or obesity or metabolic disorders. In particular, it is increasingly desirable to provide devices, systems, and methods that do not require open surgical procedures, but instead use transluminal or transcatheter approaches, such as endoscopic procedures (e.g., natural orifice transluminal endoscopic surgical approaches). With the above considerations in mind, the devices, systems, and / or methods of the present disclosure can achieve a variety of advantageous medical outcomes. Summary of the Invention

[0005] 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.

[0006] According to various principles of the present disclosure, a flow restriction device having a longitudinal extent and deployable within an anatomical structure includes a first portion, a second portion, and a saddle region extending between the first portion and the second portion.

[0007] According to one aspect of the present disclosure, the first portion of the flow restriction device is not collinear with the saddle region. In some embodiments, the first portion of the flow restriction device has a non-circular cross-sectional shape over at least a region of the first portion that is configured to remain spaced apart from the selected anatomical region.

[0008] In some embodiments, the flow restriction device is configured to be disposed with a saddle region extending through a passageway between a first anatomical structure in which the first portion is disposed and a second anatomical structure in which the second portion is disposed. The first portion may have a first region extending along a first region of the first anatomical structure and a second region extending along a second region of the first anatomical structure. When disposed in the first anatomical structure, the first portion may be angled relative to the saddle region in a direction away from the second region of the first anatomical structure. In some embodiments, the first region of the first portion is configured to follow the contour of the first region of the first anatomical structure, and the second region of the first portion is configured to be spaced apart from the second region of the first anatomical structure to separate the first portion from the second region of the first anatomical structure. In some embodiments, the first region is convex on its exterior, and the second region is substantially linear or concave on its exterior. In some embodiments, the cross-sectional area of ​​the first portion through the first region and the second region is smaller than the cross-sectional area of ​​the first anatomical structure through which the device cross-sectional area extends.

[0009] In some embodiments, the device is movable between a collapsed configuration and an expanded, deployed configuration, and the first portion is sized to resist movement through the passageway through which the saddle region extends.

[0010] In some embodiments, the flow restriction device is formed of a plurality of woven strands, wherein a first portion is expanded to have a larger cross-sectional dimension than a second portion, and the first portion is formed of fewer strands than the second portion.

[0011] In some embodiments, the flow restriction device includes an occluder associated with the non-collinear first portion, hi some embodiments, the occluder is expandable to increase a volume occupied by the first portion within the first anatomical structure.

[0012] According to another aspect of the present disclosure, the flow restriction device includes an occluder associated with the first portion. In some embodiments, the occluder is selectively expandable. In some embodiments, the first portion is in the form of a cage, and the occluder is disposed within the first portion. In some embodiments, the occluder is disposed within the first portion to restrict passage of material toward the saddle region. In some embodiments, the occluder is expandable to increase a volume occupied by the first portion.

[0013] According to yet another aspect of the present disclosure, the saddle region is configured to be deployed across the pylorus, the first portion is configured to fit within the stomach and is sized and configured to resist distal movement through the pylorus, the second portion is configured to fit within the duodenum and is configured to resist proximal movement through the pylorus, and the expandable occluder is disposed within the first portion to resist distal movement of the flow restriction device through the pylorus and occlude passage of matter through the pylorus.

[0014] According to yet another aspect of the present disclosure, a system for restricting the flow of a substance through an anatomical structure includes a tubular delivery device, a flow restriction device configured to transition between a collapsed configuration for fitting within a lumen in the outer tubular device and an expanded, deployed configuration when not disposed within the outer tubular device, an occluder associated with the flow restriction device, and an internal pusher extending through the tubular delivery device and configured to engage the flow restriction device. Relative movement between the internal pusher and the outer tubular delivery device can cause deployment of the flow restriction device from the tubular delivery device. In some embodiments, the occluder is expandable, and the system further includes an inflation lumen fluidly coupled to the occluder to selectively expand the occluder.

[0015] 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]

[0016] 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, a device may be enlarged so that details can be discerned, but is intended to be reduced in size to fit within the working channel of, for example, a delivery catheter or endoscope. It should be noted that in the various figures, identical, substantially identical, or equivalent elements may be labeled with the same reference numeral, and similar elements may be labeled with similar reference numerals that differ by 100, without redundant description. For clarity and conciseness, not every element is labeled in every figure, and not every element of each embodiment is shown unless illustration is necessary to enable those skilled in the art to understand the present 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 occlusion device according to various aspects of the present disclosure. [Figure 2] FIG. 2 is a perspective view of one embodiment of an occlusion device formed in accordance with various aspects of the present disclosure and disposed in a schematic representation of a gastrointestinal environment. [Figure 3] FIG. 3 is a perspective view of one embodiment of an occlusion 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 4A]4A, 4B, 4C, and 4D show alternative embodiments of cross-sectional views through line IV-IV of FIG. [Figure 4B] 4A, 4B, 4C, and 4D show alternative embodiments of cross-sectional views through line IV-IV of FIG. [Figure 4C] 4A, 4B, 4C, and 4D show alternative embodiments of cross-sectional views through line IV-IV of FIG. [Figure 4D] 4A, 4B, 4C, and 4D show alternative embodiments of cross-sectional views through line IV-IV of FIG. [Figure 5] FIG. 5 illustrates one embodiment of an occlusion device and an associated delivery device formed in accordance with various aspects of the present disclosure, the occlusion device in a collapsed, compact delivery configuration. [Figure 6] FIG. 6 illustrates one embodiment of an occlusion device and associated delivery device formed in accordance with various aspects of the present disclosure, the occlusion device in a deployed, expanded configuration. [Figure 7] FIG. 7 is a perspective view of a dilatation catheter operatively coupled to a balloon of an occlusion device in accordance with various principles of the present disclosure. [Figure 8A] FIG. 8A is a diagram showing an example of a cross-sectional view taken along line VIII-VIII in FIG. [Figure 8B] FIG. 8B is a view similar to FIG. 8A, but with the illustrated example dilatation catheter separated from the illustrated example valve. [Figure 9A] 9A and 9B are elevational views of an alternative embodiment of a balloon valve seal of an occlusion device according to various principles of the present disclosure. [Figure 9B] 9A and 9B are elevational views of an alternative embodiment of a balloon valve seal of an occlusion device according to various principles of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0017] 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.

[0018] 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.

[0019] 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, channel, cavity, or bore.

[0020] In accordance with various principles of the present disclosure, devices and related systems and methods are provided for reducing or preventing the passage of matter through a body passageway or lumen. In some embodiments, the devices, systems, and methods occlude (completely or substantially completely) the passage of matter through a body passageway or lumen. The terms body passageway and lumen may be used interchangeably herein without any limitation, and it will be understood that the broad principles of the present disclosure are applicable to various shapes and sizes of body passageways / lumens. For convenience, devices formed in accordance with various principles of the present disclosure may be referred to herein as flow-restricting devices, without any limitation. It will be understood that reference to a device as "flow-restricting" includes partially restricting the flow of matter (e.g., inhibiting or reducing the flow of matter) and completely restricting the flow of matter (e.g., preventing or blocking the flow of matter). Furthermore, it will be understood that terms such as restrict, inhibit, occlude, block, hinder, and the like (as well as their conjugations and other grammatical forms) may be used interchangeably herein without any limitation.

[0021] Where a body passageway includes a passageway of limited extent between different anatomical structures, a flow restriction device formed in accordance with various principles of the present disclosure can be thought of as having a proximal portion configured to fit or be placed within the proximal anatomical structure, a distal portion configured to fit or be placed within the distal anatomical structure, and a saddle region therebetween configured to fit or be placed within a passageway extending between the proximal and distal anatomical structures. It will be understood that terms such as "fit" or "seat" or "position" (and conjugations thereof) may be used interchangeably herein without any intended limitation, unless otherwise indicated. Furthermore, the term "anatomical structure" may be used herein to refer to any structure or section or region or area within the body, such as an organ, vessel, lumen, cavity, etc., and it will be understood that the term "anatomical structure" is used for simplicity and is not intended to be limiting.

[0022] Various portions of the flow restriction device may be shaped, configured, or provided with various additional features to resist and / or inhibit and / or prevent migration from the deployment site where the flow restriction device is deployed for patient treatment. It will be understood that terms such as resist, inhibit, and prevent, with respect to migration, may be used interchangeably herein, alone or in combination, without limitation, unless otherwise indicated. In some embodiments, some regions of the flow restriction device may be uncoated or otherwise treated to promote tissue ingrowth to stabilize the device and / or inhibit device migration. In some embodiments, the shape and structure of the flow restriction device contribute to maintaining the device in a desired deployment location or position. For example, a portion of the device configured for placement in a larger anatomical structure may be bowed, offset, curved, bent, or otherwise misaligned relative to at least an adjacent section of the device configured for placement in a narrower passageway (e.g., a saddle region of the device). Additionally or alternatively, the proximal and / or distal portions of the device may be sized, shaped, and configured to resist migration of the device. For example, at least one of the proximal or distal portions may have at least a cross-sectional dimension (e.g., cross-sectional area) greater than the saddle region therebetween, and may resist passage through the anatomical passage in which the saddle region is disposed. In some embodiments, an occluder may be associated with at least one of the proximal or distal portions and sized, shaped, and configured to resist migration of the flow restriction device.

[0023] According to one aspect of the present disclosure, at least one region of a portion of a flow restriction device may be contoured to follow or correspond to, e.g., substantially match, the contour or shape of the anatomy in which such portion of the device is to be placed. In some embodiments, such portion of the device may include at least one region that is contoured to avoid an area within the anatomy in which such portion of the device is to be placed.

[0024] According to a separate, independent aspect of the present disclosure, which may optionally be applied in conjunction with one or more of the above-described aspects, a separate occluder may be associated with at least a portion of a flow restriction device. The occluder is a plug, wall, or other structure that occludes or blocks the flow of a substance. The occluder is deliverable with a flow restriction device formed according to various principles of the present disclosure. The occluder may be configured to be expandable from a collapsed delivery configuration when deployed with the flow restriction device. One example of an occluder is an inflatable balloon, although other flow-occluding structures are within the scope and spirit of the present disclosure. The occluder may contribute to or enhance the function of the flow restriction device portion with which it is associated. For example, the occluder may contribute to occluding the flow of a substance through the flow restriction device, e.g., through its saddle region. Additionally or alternatively, the occluder may help resist movement of the flow restriction device. Additionally or alternatively, the occluder may be configured to occupy a volume and thus function to reduce the functional volume of the anatomical structure occupied by the flow restriction device. In some embodiments, the volume of the occluder is adjustable, such as during placement of the device and / or during the course of a procedure, to adjust the flow rate of material passing through the portion of the device having the occluder (e.g., through the passageway in which the device is positioned) and / or to adjust the volume occupied by the occluder. In some embodiments, the occluder is maintained in a desired location in the anatomy by its position within a portion of the flow restriction device (e.g., is "captured" or otherwise held or restrained within a portion of the flow restriction device). Thus, occluders that can be used separately from a flow restriction device formed according to various principles of the present disclosure can benefit from features of the flow restriction device, such as designs or features or structures provided to resist migration of the device from a desired deployed position within a patient.

[0025] An example of an environment in which the devices, systems, and methods of the present disclosure may be used is the gastrointestinal system. Because the pylorus is a narrowed structure distal to the stomach, in some embodiments, the stomach section of the flow restriction device may be significantly larger than the saddle region configured for placement within the pylorus to resist distal migration through the pylorus. For example, the stomach may be approximately 10 cm in diameter at its widest point, the pylorus may be approximately 2 cm or less in diameter (typically approximately 1 cm and can contract to nearly 0 cm), and the portion of the duodenum adjacent to the pylorus may be approximately 2-3 cm in diameter. Thus, the stomach section of a flow restriction device formed according to various principles of the present disclosure may have a diameter approximately 2-2.5 times the diameter of the duodenal section of the device. The diameter of the saddle region (extending through the pylorus) of a flow restriction device formed according to various principles of the present disclosure is generally not critical to the present disclosure and may be smaller than the diameter of the pylorus (e.g., as small as 1-2 mm in diameter and completely closed), and therefore may be very small relative to other sections of the device without affecting other aspects of the present disclosure.

[0026] Devices, systems, and methods according to various principles of the present disclosure may be used to reduce and / or slow the rate of passage of material through the pylorus and / or to obstruct / exclude the pylorus from the stomach, such as for gastric treatments such as obesity treatment, or to treat other gastrointestinal conditions. The gastric portion and / or saddle region of a flow restricting device formed according to various principles of the present disclosure may be structured to obstruct flow therethrough (partially or wholly / completely), thereby obstructing the flow of material through the pylorus.

[0027] In some instances, it may be desirable to bypass the duodenum, such as by obstructing the pylorus (completely or nearly completely) and creating an anastomosis joining the stomach with the jejunum. For example, obstructing duodenal access and rerouting food, liquids, and other nutrients through an alternative route, delaying interaction of stomach contents with digestive enzymes until further down the small intestine (and optionally effectively bypassing the pancreas), may reduce the patient's risk of obesity and / or type 2 diabetes. When a flow restriction device formed according to various principles of the present disclosure is placed across the pylorus, the gastric portion of the device may be larger than the duodenal portion of the device (e.g., taking into account the generally larger size of the stomach relative to the duodenum). According to one aspect of the present disclosure, the device is configured not only to obstruct an anatomical passageway, such as the pylorus, but also not to interfere with, obstruct, or interact with an anastomosis that bypasses the anatomical passageway. The stomach section of a flow restricting device formed according to various principles of the present disclosure may be flexible or otherwise contoured to remain spaced from the anastomosis, extend around the anastomosis, or not engage, interfere with, or block the anastomosis.

[0028] Flow restriction devices formed according to various principles of the present disclosure may be used in obesity treatment, including increasing a patient's sense of fullness, intended to reduce appetite and, consequently, caloric intake. Various approaches to increasing fullness 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 chyme, from the stomach to the duodenum). The pylorus-occluding devices and methods described above can be advantageously used for such additional purposes. Another approach to increasing fullness is to implant a device that occupies volume within the stomach. A flow restriction device having an occluder formed according to the principles of the present disclosure, as described above, may be placed across the pylorus, with the occluder associated with a proximal portion of the device placed within the stomach. The occluder thus fills a portion of the stomach, reducing the apparent volume of the stomach and, consequently, inducing a feeling of fullness or satiety, which may result in reduced food intake and associated weight loss. In some embodiments, the proximal portion of the flow restriction device can form a frame or cage around the occluder, capturing the occluder and maintaining it in a desired position within the stomach. Such a configuration can be particularly advantageous when this form of procedure is used in conjunction with gastric bypass. The flow restriction device can hold the occluder away from the gastrojejunostomy (e.g., as described above with respect to configurations of the flow restriction device that are deflected or flexed away from the anastomosis). Such a configuration can also contribute to the anti-migration effect of the enlarged proximal portion of the flow restriction device, further reducing the likelihood of the proximal portion migrating distally through the pylorus.

[0029] In some embodiments, it may be desirable to adjust a flow restriction device and / or a portion thereof, such as an occluder, even while it is implanted in a patient. For example, the volume of an expandable occluder associated with a flow restriction device formed in accordance with various principles of the present disclosure may be adjustable. Placing the occluder within a portion of the flow restriction device can advantageously maintain the occluder in a position accessible for adjustment while the flow restriction device remains in place at the desired deployment site. Additionally or alternatively, it may be desirable to remove a flow restriction device formed in accordance with various principles of the present disclosure. For example, a pylorus closure device may be removable or adjustable.

[0030] It will be understood that the devices, systems, and methods as disclosed herein can be used in endoscopic, laparoscopic, and / or open surgical procedures. Preferably, a medical professional may be able to deliver and / or remove the device endoscopically. Advantageously, the devices and systems disclosed herein can be used in minimally invasive procedures, such as natural orifice transluminal endoscopic surgery (NOTES).

[0031] An implantable treatment device formed according to the principles of the present disclosure may be provided as part of a treatment system. For example, the delivery device may be configured as an elongated, flexible delivery device capable of navigating through internal passageways within a patient to avoid open surgery. The flow restriction device may be delivered to the deployment site in a collapsed configuration within the delivery device. An additional deployment device, such as a pusher, may be provided to facilitate deployment of the flow restriction device from the delivery device (e.g., by pushing the flow restriction device out of its position with the delivery device). Once deployed, the flow restriction device moves or shifts to an expanded, deployed configuration. If an expandable occluder is provided, the treatment system may further include an inflation lumen coupleable to the occluder. The inflatable occluder may be configured to be coupleable to the inflation lumen after deployment, such as for adjustment at a later point during the course of treatment after initial deployment.

[0032] Treatment methods utilizing implantable devices include delivering the device to a deployment site, deploying the device by withdrawing the delivery device proximally, or by utilizing a pusher to move the device distally from the delivery device, or a combination thereof, etc. Optionally, the treatment method includes providing and optionally expanding an occluder to achieve desired aspects of the treatment protocol. The device may be adjusted after deployment and at any point during the course of treatment. When the treatment is deemed successful and use of a flow restriction device is no longer indicated, the device can be removed.

[0033] Although the devices, systems, and methods are described herein with respect to the gastrointestinal system, it should be understood that embodiments of the devices, systems, and methods according to the present disclosure may be advantageous for use in other procedures and / or anatomical structures. Reference may be made herein to implantable devices, devices, stents, and the like, and such terms may be used interchangeably herein without any limitation intended.

[0034] Various embodiments of flow restriction devices will now be described with reference to examples shown in the accompanying drawings. References herein to "one embodiment," "an embodiment," "some embodiments," "other embodiments," etc. indicate that one or more particular features, structures, and / or characteristics according to the principles of the present disclosure may be included in connection with the embodiments. However, such references do not necessarily imply that all embodiments include the particular feature, structure, and / or characteristic, or that one embodiment includes all features, structures, and / or characteristics. Some embodiments may include one or more such features, structures, and / or characteristics in various combinations thereof. Furthermore, references in various places herein to "one embodiment," "an embodiment," "some embodiments," "other embodiments," etc. do not necessarily all refer to the same embodiment, and separate or alternative embodiments are not necessarily mutually exclusive of other embodiments. It should be understood that when a particular feature, structure, and / or characteristic is described in connection with one embodiment, such feature, structure, and / or characteristic may also be used in connection with other embodiments, whether or not explicitly described, unless expressly stated to the contrary. Furthermore, it is understood that such features, structures, and / or characteristics may be used or presented singly or in various combinations with each other to create alternative embodiments that are considered part of this disclosure, as it would be too extensive to describe all of the many possible combinations and subcombinations of features, structures, and / or characteristics. Additionally, various features, structures, and / or characteristics are described that may be exhibited by some embodiments but not by other embodiments. Similarly, various features, structures, and / or characteristics or requirements are described that may be a feature, structure, and / or characteristic or requirement of some embodiments, but may not be a feature, structure, and / or characteristic or requirement of other embodiments. Therefore, the present invention is not limited to only the embodiments specifically described herein.

[0035] Referring now to the drawings, an example of a flow restriction device 100 formed in accordance with various principles of the present disclosure is shown in FIG. 1 , having a proximal portion 110, a distal portion 120, and a saddle region 130 therebetween. As can be seen with reference to FIG. 1 , the cross-sectional dimension of the flow restriction device 100 varies along its longitudinal extent L (extending in a direction between the proximal end 101 and the distal end 103 of the flow restriction device 100), with the saddle region 130 being narrower than the proximal and distal portions 110, 120. At least a portion of the flow restriction device 100 is configured to restrict or impede the flow of a substance through the flow restriction device 100 or through a passageway in which the flow restriction device 100 is disposed. Various structures or features known or previously known in the art can be used to provide the desired flow-restricting configuration of the flow restriction device 100. For example, in embodiments having a saddle region 130 that is narrower than the proximal and distal portions 110, 120 of the flow restriction device 100, the saddle region 130 may have a generally hollow configuration, may be twisted or turned to form a kink or closure element, or may increase the density of the material forming the wall of the saddle region 130 to occlude the flow of material therethrough. In other embodiments, the saddle region 130 may be generally solid. In some embodiments, the saddle region 130 has a negligible width relative to the proximal and distal portions 110, 120.

[0036] In the illustrated embodiment, the configuration of proximal portion 110 differs from the configuration of distal portion 120, although other configurations are within the scope of the present disclosure. Furthermore, proximal portion 110 and distal portion 120 of the illustrated embodiment have cross-sectional dimensions (e.g., width or area) that are generally larger than the cross-sectional dimensions of saddle region 130 (e.g., corresponding cross-sectional dimensions, such as width in generally the same direction). In such embodiments, saddle region 130 may be disposed across a passageway between a proximal anatomical structure in which proximal portion 110 of flow restriction device 100 is disposed and a distal anatomical structure in which distal portion 120 of flow restriction device 100 is disposed. The proximal and distal anatomical structures may have different cross-sectional shapes or dimensions or volumes. Thus, proximal portion 110 and distal portion 120 may not be symmetrical and / or may not have the same dimensions (e.g., cross-sectional or longitudinal dimensions). At least one, and preferably both, of proximal portion 110 and distal portion 120 are shaped, configured, and / or include one or more features to inhibit movement of flow restriction device 100 through a body passageway in which saddle region 130 is positioned or deployed. It will be understood that terms such as positioned, deployed, and the like (including conjugations thereof) may be used interchangeably herein without any limitation intended.

[0037] Various features of a flow restriction device 100 formed in accordance with various principles of the present disclosure are described herein with reference to illustrations and examples of environments in which a flow restriction device 100 formed in accordance with principles of the present disclosure may be used. However, it will be understood that the principles of the present disclosure have broader application than the illustrated examples and their description.

[0038] Flow restriction device 100 may be at least partially formed from a plurality of strands or wires or filaments, which may be braided, woven, twisted, wrapped, intertwined, knitted, looped (e.g., bobbin-style), knotted, or otherwise formed into a self-supporting structure. Alternatively, flow restriction device 100 may be formed at least partially from laser-cut tubes or scaffolds or bonded elongated elements, or a combination of self-expanding metal stents and laser-cut tubes or scaffolds, or another self-supporting structure. Such structures may be referred to, without limitation, as stents or frameworks or scaffolds. Flow restriction device 100 may also be at least partially formed from a biocompatible metallic or polymeric material or alloy. In some embodiments, the material is a shape-memory or thermoformable material, such as a nickel-titanium alloy (e.g., Nitinol). According to various principles of the present disclosure, flow restriction device 100 may be sized and configured for transluminal, transcatheter, or endoscopic delivery. Thus, according to one aspect of the present disclosure, flow restriction device 100 may be folded or otherwise reduced in cross-sectional dimension to fit through a tubular delivery device used in minimally invasive (as opposed to open) procedures. Flow restriction device 100 may expand upon deployment. For example, flow restriction device 100 may be formed to be self-expanding (in which case, advantageously, formed from a shape-memory material that causes the device to expand upon being no longer retained 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, flow restriction device 100 may be formed to be selectively collapsible from its expanded, deployed configuration (shown in FIG. 1 ).The flow restriction device 100 preferably has a cross-sectional dimension X of the proximal portion 110 . P (expanded configuration) and the cross-sectional dimension X of the distal portion 120 D (expanded configuration), and a mechanism for folding flow restriction device 100 are configured to inhibit or prevent collapse of flow restriction device 100 and distal or proximal movement of flow restriction device 100. Various known sheaths or coatings, such as polymeric coatings, elastomeric coatings, silicone coatings, lubricious coatings, or other previously known coatings, may be applied to selected regions of flow restriction device 100 to impart structural stability and / or contribute to the mechanism of the device, such as to inhibit tissue ingrowth. Selected regions of flow restriction device 100 may be left uncoated to allow tissue ingrowth to resist movement of flow restriction device 100, with the coated regions having structural stability to promote sufficient immobility to allow time for tissue ingrowth into the uncoated regions.

[0039] FIG. 2 illustrates an example of a flow restriction device 100 formed in accordance with the principles of the present disclosure, as shown in FIG. 1, in place within a schematic representation of an example gastrointestinal ("GI") tract within a human body. In the non-limiting example illustrated in FIG. 2, flow restriction device 100 is positioned across the pylorus P, with proximal portion 110 disposed within stomach S, distal portion 120 disposed within duodenum D, and saddle region 130 extending between proximal portion 110 and distal portion 120 and disposed within pylorus P.

[0040] In the illustrated example embodiment of flow restriction device 100, distal portion 120 has a corresponding cross-sectional dimension X S (e.g., area or linear dimension in the same general direction) DThus, when flow restriction device 100 is deployed, distal portion 120 fits securely within duodenum D and cannot easily and unintentionally pass or migrate proximally through pylorus P. In some embodiments, additional anti-migration features may be provided in association with distal portion 120. For example, regions or areas of distal portion 120, such as the proximally-facing section positioned against pylorus P, may be uncoated to allow tissue growth into such regions. Other regions of distal portion 120 may be coated with biocompatible coatings, such as those known or previously known in the art, to inhibit tissue ingrowth and / or to strengthen the structure of distal portion 120 (e.g., to resist collapse and proximal migration through pylorus P). The most distal end of distal portion 120, at distal end 103 of flow restriction device 100, may be coated, such as to cover the tips or ends of wires forming flow restriction device 100.

[0041] Distal portion 120 may have a longer extent than shown, extending further into duodenum D. Alternatively, a generally flexible sleeve portion (e.g., formed from a knitted or braided material as known or previously known in the art) may extend distally from distal portion 120 of flow restriction device 100 to exclude portions of the duodenum (such as initially after deployment of flow restriction device 100) if matter passes flow restriction device 100 and the pylorus P. Flow restriction device 100 may be made of nitinol, cobalt chromium, stainless steel, or other biocompatible metals known or previously known in the art, or any of a variety of plastics, such as polytetrafluoroethylene (PTFE), polyether block amide (e.g., PEBAX®), polyether ether ketone (PEEK), high density polyethylene (HDPE), polyurethane, or other biocompatible plastics known or previously known in the art, or other suitable materials known or previously known in the art. The flow restriction device 100 may be coated with silicone or another elastomeric material, or with PTFE or another thin polymeric material.

[0042] In accordance with various principles of the present disclosure, a flow restriction device 100 configured for placement across the pylorus P (or across another anatomical passageway between anatomical regions of different sizes) may be configured with a corresponding cross-sectional dimension X of distal portion 120. D Cross-sectional dimension X is significantly larger than P The proximal portion 110 has a cross-sectional dimension X P The proximal portion 110 may be configured to inhibit or impede distal passage or movement of the flow restriction device 100 through the pylorus P. The proximal portion 110 may have additional features, as described herein, that further inhibit or impede distal movement of the flow restriction device 100 through the pylorus P.

[0043] 1 and 2 are formed from a plurality of wires or strands or filaments (referred to herein for convenience and without limitation as wires). The wires may extend continuously from the proximal portion 110 to the distal portion 120 of the flow restriction device 100. Alternatively or additionally, separate wires may be used for the proximal and distal portions 110, 120 of the flow restriction device 100, and the wires may be welded, glued, or otherwise attached to each other or otherwise joined (e.g., in separate sections along the saddle region 130) to form the flow restriction device 100. The spacing between the wires in the larger (at least in cross-section) proximal portion 110 of the flow restriction device 100 may be greater than the spacing between the wires in the smaller (at least in cross-section) distal portion 120 of the flow restriction device 100. This allows the proximal portion 110 to have a cross-sectional dimension that is small enough in the collapsed configuration for delivery, but large enough to remain placed within the stomach S (or other body cavity or anatomical structure at the end of a body passageway into which the flow restriction device 100 is to be placed). If the spacing between the wires in the proximal portion 110 were the same as the spacing between the wires in the distal portion 120, the collapsed proximal portion 110 might have too many wires to have a small enough cross-sectional diameter to fit within a tubular delivery device that could be passed through a body lumen (e.g., the mouth and esophagus, as opposed to cutting into a patient). Alternatively or additionally, the diameter of the wires in the proximal portion 110 of the flow restriction device 100 may be different (e.g., larger) than the diameter of the wires in the distal portion 120 of the flow restriction device 100. For example, a continuous wire extending through both the proximal and distal portions 110, 120 may have different ground diameters along its length (for placement in different sections 110, 120 of the flow restriction device 100). Alternatively or additionally, different wires may be used in each section 110, 120 of the flow restriction device 100.

[0044] According to one aspect of the present disclosure, as shown in FIG. 3 , the longitudinal extent L of a flow restriction device 100 formed in accordance with the principles of the present disclosure need not be linear (e.g., straight). Because various anatomical passageways are not precisely straight, the longitudinal extent L of a flow restriction device 100 formed in accordance with various aspects of the present disclosure may follow the non-linear configuration of the anatomical passageway in which the flow restriction device 100 is disposed. For example, at least the saddle region 130 may be somewhat curved. According to a further aspect of the present disclosure, if at least a portion of the flow restriction device 100 is to be disposed in an enlarged anatomical region, such as a body cavity like the stomach S, such portion of the flow restriction device 100 may be offset from or not aligned with the saddle region 130. More specifically, the saddle region 130 can be considered to have a major or longitudinal axis that extends along the longitudinal extent L of the flow restriction device 100 and in the direction in which the saddle region 130 extends through the pylorus (generally along the largest / longest dimension of the saddle region 130). The proximal portion 110 and / or the distal portion 120 of the flow restriction device 100 can extend at an angle / be oblique to the major or longitudinal axis of the saddle region 130. Such a configuration can reduce the ability of such proximal portion 110 or distal portion 120 to move through the body passageway through which the saddle region 130 extends. In particular, if such portions of the flow restriction device 100 are enlarged and angled or misaligned with respect to the saddle region 130, such portions will have more difficulty moving through the body passageway than if such portions were collinear (e.g., aligned, coextensive, and substantially parallel) with the saddle region 130.

[0045] In the embodiment shown in FIG. 3 , in which flow restriction device 100 is configured for placement across the pylorus P, the angle of proximal portion 110 relative to saddle region 130 can also serve to maintain proximal portion 110 at a distance from anastomosis A (such as a gastrojejunostomy). In particular, proximal portion 110 may be angled relative to saddle region 130 in a direction away from anastomosis A. In some embodiments, the outer contour of at least a portion of proximal portion 110 of flow restriction device 100 may generally follow (e.g., generally match or correspond to) the contour of stomach S. Given the typical natural contour of stomach S, if first region 112 of flow restriction device 100 follows the lesser curvature LC of stomach S (the upper region of the stomach having a generally concave contour between the esophageal sphincter and the pyloric sphincter), such first region 112 can be considered to be generally concave along the longitudinal extent L of flow restriction device 100. When such first region 112 is rotated toward anastomosis A, the concave curvature of such region of proximal portion 110 will generally maintain space between the wall of proximal portion 110 and anastomosis A. Also, given the typical natural contour of the stomach S, concave region 112 and its slope relative to saddle region 130 may contribute to inhibiting or preventing flow restriction device 100 from rotating within the pylorus. In particular, due to the generally convex curvature of the greater curvature GC of the stomach S, the corresponding concave curvature within such portion of the stomach S extends inward more than the opposite side along the lesser curvature LC of the stomach S, leaving little or no room for the concave region 112 of flow restriction device 100 to move into such region of the stomach S. At least proximal portion 110 of flow restriction device 100 may be sufficiently resistant to bending to further inhibit proximal portion 110 from bending and rotating out of position when contacting the inside of the stomach S along the greater curvature GC. It will be appreciated that radiopaque or other markings, or other techniques (e.g., platinum core wires) visible under fluoroscopy or other imaging techniques known to those skilled in the art, may be used to position the flow restriction device 100 with the proximal portion 110 in a desired initial orientation.

[0046] Alternatively or additionally, according to various aspects of the present disclosure, a flow restriction device 100 formed according to various principles of the present disclosure may be configured with other contours or contoured sections or regions to avoid or maintain distance between the walls of the flow restriction device 100 and another region of the anatomical structure. Such contours or contoured sections or regions may be shaped differently from surrounding regions of the flow restriction device 100 (e.g., the walls of the flow restriction device 100). For example, at least a portion of the longitudinal extent L of the proximal portion 110 of the flow restriction device 100 may have a cross-sectional shape having a first region 112 (e.g., a convex outer cross-sectional shape) configured to follow the contour of a first area or region of the anatomical section in which the proximal portion 110 is disposed, and a second region 114 configured to be spaced apart from a second area or region of the anatomical section in which the proximal portion 110 is disposed. The second region 114 may be substantially straight (at least relative to the first region 112), or may be concave, or may be configured to leave a space between the second region 114 and the anatomical region along which the flow restriction device 100 is to be placed to avoid. In some embodiments, the outer cross-section of the flow restriction device 100 extending through the second region 114 is non-circular.

[0047] In the embodiment shown in Figure 3, the flow restriction device 100 is positioned across the pylorus P of a stomach S in which an anastomosis A (e.g., a gastrojejunostomy) has been formed. As can be seen with reference to Figure 3, the proximal portion 110 of the flow restriction device 100 has a first region 112 facing away from the anastomosis A and a second region 114 that is contoured or shaped to be spaced away from the anastomosis A. The first region 112 may be contoured or shaped to follow the contour of the inner wall of the stomach S, as shown. At a given location along the longitudinal extent of the stomach between the esophageal and pyloric sphincters, the stomach S has a generally circular cross-sectional shape with a generally concave inner wall along its periphery. Thus, the first region 112 of the proximal portion 110 of the flow restriction device 100 shown in FIG. 3 has a generally concave curvature along the longitudinal extent L of the flow restriction device 100 (to follow the internal shape of the lesser curvature LC of the stomach S) and further has a generally convex outer cross-sectional shape to follow the concave cross-sectional shape of the stomach S. The second region 114 of the proximal portion 110 of the flow restriction device 100 is configured to avoid certain regions of the stomach S in accordance with various principles of the present disclosure. In some embodiments, the second region 114 may have a non-convex outer cross-sectional shape. Various embodiments of the cross-sectional shapes of the flow restriction device 100, such as along line IV-IV of FIG. 3, are shown in FIGS. 4A, 4B, 4C, and 4D. As will be appreciated, the cross-sectional area of ​​the proximal portion 110 of the flow restriction device 100 in the area of ​​the anatomical region to be avoided (e.g., anastomosis A) may not occupy the entire cross-sectional area of ​​the anatomical region in which it is placed. For example, proximal portion 110 may occupy an area excluding the anatomical region to be avoided, and the cross-sectional area of ​​proximal portion 110 may be less than or equal to half the cross-sectional area of ​​the anatomical region to be avoided (e.g., a cross-section taken along a plane in which the area to be avoided lies).

[0048] In the example shown in FIG. 4A , the proximal portion 110A of the flow restriction device 100 configured as shown in FIG. 3 to avoid a region of the stomach S has a cross-sectional shape along line IV-IV and has a second region 114A that is spaced apart from the region of the stomach S to be avoided (such as gastrojejunostomy A). The second region 114A in this embodiment has an outer cross-sectional shape that is generally at least linear. As can be seen with reference to FIG. 4B , which shows another embodiment of a cross-section of the flow restriction device 100 of FIG. 3 taken along line IV-IV, the second region 114B may have an outer cross-sectional shape that is generally convex so as to remain spaced apart from the anatomical region to be avoided. As can be seen with reference to the embodiments of FIGS. 4A and 4B , the cross-sectional areas of the proximal portions 110A, 110B, respectively, of the flow restriction device 100 as in FIG. 3 can occupy an area excluding the anatomical region to be avoided and can occupy half or less than half of the cross-sectional area along a plane that intersects the region to be avoided. It will be appreciated that the second regions 114A, 114B need not be generally linear, or even concave, provided they are sufficiently spaced from the anatomical region to be avoided.

[0049] In other embodiments, such as those shown in Figures 4C and 4D, proximal portions 110C, 110D may extend a greater distance across the cross-section of flow restriction device 100 intersecting the region to be avoided and may have second regions 114C, 114D that are more specifically shaped to avoid the region to be avoided. For example, as shown in Figure 4C, the cross-sectional area of ​​proximal portion 110C may occupy more than half of the cross-sectional area of ​​the anatomical region if the outer cross-sectional shape of second region 114C is concave and is sufficiently far from the region to be avoided, as shown in Figure 4C. As will be appreciated, first region 112 has a substantially convex outer cross-sectional shape, as does the majority of the circumference of proximal portion 110 along line IV-IV. 4D , the cross-sectional area of ​​proximal portion 110D may occupy less than half of the cross-sectional area of ​​the anatomical structure intersecting the anatomical region to be avoided, but may still extend across more than half of the cross-section if the outer cross-sectional shape of second region 114D is sufficiently concave. As shown, the outer contour of second region 114D may substantially follow the outer contour of first region 112D, and the walls of these portions may remain substantially equidistant from one another, thereby keeping the outer surface of second region 114D sufficiently spaced from the anatomical region to be avoided. In light of the above discussion, when proximal portions 110C, 110D of flow restriction device 100 are curved to follow the lesser curvature of stomach S, rotation of proximal portions 110C, 110D is generally inhibited by such curvature contacting the generally concave inner contour of stomach S in the region of the greater curvature of stomach S.

[0050] It will be understood that further variations in the cross-sectional shape of proximal portion 110 of flow restriction device 100 along line IV-IV as shown in Figure 3 are within the scope of the present disclosure. Note that in the embodiment shown in Figure 3, proximal portion 110 may have first region 112 extending longitudinally with a concave curvature (e.g., concave along the longitudinal extent of flow restriction device 100), as well as first region 114 having a cross-sectional shape configured to be spaced away from the anatomical region to be avoided. However, in other embodiments, proximal portion 110 may have only one of such features or contours.

[0051] According to a separate and independent aspect of the present disclosure, an occluder 140 may be associated with the flow restriction device 100, such as the proximal portion 110, as shown in FIG. 3 . It will be appreciated that the occluder 140 may comprise any combination (including none) of the above-described aspects, such as a portion of the flow restriction device 100 being angled relative to the saddle region 130 and / or a portion of the flow restriction device 100 being configured to avoid a region of the anatomy in which such portion of the flow restriction device 100 is disposed. In the embodiment shown in FIG. 3 , the occluder 140 is associated with the proximal portion 110 of the flow restriction device 100. As will be appreciated, the occluder 140 can contribute to the volume and / or structural integrity of the proximal portion 110 to resist collapse and resist distal migration through the pylorus P. The occluder 140 may be positioned to occlude the passage of matter through a body passageway in which the flow restriction device 100 (e.g., its saddle region 130) is disposed. Additionally or alternatively, occluder 140 may occupy a volume within the anatomical region in which it is placed to achieve various treatment effects. Occluder 140 is preferably adjustable in size and / or position relative to proximal portion 110. For example, occluder 140 may be selectively expandable to different extents to vary the extent to which occluder 140 blocks the passage of matter and / or to vary the volume occupied by occluder 140.

[0052] As described above, the embodiment of the flow restriction device 100 shown in FIG. 3 is positioned across the pylorus P to restrict the flow of matter through the pylorus P. In some embodiments, the saddle region 130 has a lumen therethrough that is narrower than the passageway in which the saddle region 130 is positioned, restricting the flow of matter through the lumen. In some embodiments, the lumen through the saddle region 130 may be substantially completely closed, occluding (e.g., completely blocking) the flow of matter therethrough. In other embodiments, the lumen through the saddle region 130 only partially reduces flow therethrough, and / or the saddle region 130 only partially reduces flow through the pylorus P, and the proximal portion 110 may include additional features that restrict the flow of matter. The occluder 140 can contribute to restricting the flow of matter through the pylorus P by obstructing the flow of matter into the pylorus P. As described above, in some instances, it may be desirable to reduce the volume of the stomach S in which the flow restriction device 100 is positioned, such as in obesity treatment. The occluder 140 occupies additional volume within the stomach S for such a treatment mode.

[0053] According to one aspect of the present disclosure, the occluder 140 may be selectively expandable to achieve and impart a prescribed amount of occlusion and / or to occupy a prescribed volume. For example, the occluder 140 may be fully expanded to completely occlude the entrance to the passageway (e.g., the pylorus P) in which the flow restriction device 100 (e.g., the saddle region 130 of the flow restriction device 100) is positioned, or may be partially expanded to reduce but not completely occlude the passageway. When the occluder 140 is used in the course of bariatric treatment, the volume of the occluder 140 may be adjusted over the course of treatment if the patient is successfully losing weight (and does not require a significant reduction in stomach volume created by the inflated occluder 140) or if increased weight loss is indicated (and increased filling of the stomach volume by increasing the volume of the occluder 140 is desired).

[0054] In accordance with various principles of the present disclosure, the occluder 140 can be formed of a resilient material that allows for expansion of the occluder 140. For example, the occluder 140 may be a balloon that can be selectively filled with air, saline, or another suitable substance (e.g., a gas or fluid) to occupy all or only a portion of the interior volume of the proximal portion 110 of the flow restriction device 100. The material may be compliant or non-compliant, generally depending on the desired application of the occluder 140. In some embodiments, the occluder 140 is formed of a flexible material that facilitates its folding into a compact configuration for transcatheter or transluminal delivery, and various degrees of expansion (as medically indicated) when delivered to the deployment site, as described in further detail below. It will be understood that the occluder 140 can have an outer cross-sectional shape that matches the inner cross-sectional shape of the portions 110, 120 of the flow restriction device 100 in which the occluder 140 is disposed, for example, any of the shapes shown in FIG. 4A, 4B, 4C, or 4D. Alternatively, the occluder 140 may have an outer cross-sectional shape that is different from the inner cross-sectional shape of the portions 110, 120 of the flow restriction device 100 in which the occluder 140 is disposed, for example, a shape (e.g., circular or elliptical) that occupies less than the total cross-sectional area of ​​the portions 110, 120.

[0055] The occluder 140 may be located on one or both of the proximal portion 110 and the distal portion 120 of the flow restriction device 100. In the embodiment shown in FIG. 3 , the occluder 140 is located only on the proximal portion 110 within the stomach S. It will be appreciated that the structure of the portion of the flow restriction device 100 in which the occluder 140 is located may form a cage or frame that holds or maintains the occluder 140 in a desired position or location at the deployment site. For example, if it is desirable to keep the flow restriction device 100 away from a particular region of the anatomy in which the flow restriction device 100 is deployed, the proximal portion 110 may be configured as described above to avoid such region and to keep the occluder 140 away from such region. Additionally or alternatively, the proximal portion 110 may keep the occluder 140 within the general region of the anatomy in which the flow restriction device 100 is to be placed for other reasons. For example, if it is desired to adjust the volume of the occluder 140 (e.g., during the course of a procedure), the portion of the flow restriction device 100 in which the occluder 140 is disposed can generally keep the occluder 140 stable enough for access thereto. When housed within a portion of the flow restriction device 100, the occluder 140 will not drift significantly, thereby facilitating access thereto for adjustment thereof, etc.

[0056] Delivery and deployment of a flow restriction device 100 formed in accordance with various principles of the present disclosure will now be described with reference to the example delivery device 200 shown in FIGS. 5 and 6. As noted above, the flow restriction device 100 (including the occluder 140 included therein) may be configured to be collapsed for transcatheter or transluminal delivery. In the embodiment shown in FIG. 5, the delivery device 200 includes a flexible tubular element 210 (such as a catheter or other flexible elongate member having a lumen 212 therethrough) that can easily fit within and be transported through a lumen of a delivery device extending through the body (e.g., through a passageway within the body rather than through a surgically formed opening in the body). The flow restriction device 100 is shown in a collapsed or compact configuration within the lumen 212 of the flexible tubular element 210. In the illustrated embodiment, the occluder 140 is disposed within the proximal portion 110 of the flow restriction device 100. Thus, the total cross-sectional area of ​​the proximal portion 110 with the occluder 140 therein may be larger than the total cross-sectional area of ​​either the distal portion 120 or the saddle region 130. Nevertheless, the total cross-sectional area of ​​the proximal portion 110 with the occluder 140 therein is sized to fit within and be transported through the lumen 212 of the delivery device 200.

[0057] Delivery device 200, with flow restriction device 100 folded therein, preferably is flexible enough to be navigated through a patient's natural body passageways or lumens to the delivery / deployment site (e.g., without surgical intervention, such as cutting the patient open to facilitate entry and delivery of delivery device 200). Once at the deployment site, inner tube 220 (slidably disposed within outer or outer flexible tubular element 210) may be used as a pusher to assist in pushing flow restriction device 100 out of flexible tubular element 210. Flexible tubular element 210 and inner tube 220 extend proximally to a location outside the patient for control thereof by a medical professional. A lumen or other passageway may be provided (e.g., provided within delivery device 200) for a guidewire that may be used to assist in placement and / or deployment of flow restriction device 100 in its final location. In some embodiments, as shown in Figures 5 and 6, the proximal end 211 of the flexible tubular element 210 terminates in a control handle 214. Similarly, in some embodiments, as shown in Figures 5 and 6, the proximal end 221 of the inner tube 220 terminates in a control handle 224. The control handles 214, 224 may be provided on a common control handle assembly or may be formed separately. Preferably, the control handles 214, 224 are configured to separately control the movement of the flexible tubular element 210 and the inner tube 220 relative to one another, as will be understood with reference to the following description of the deployment of the flow restriction device 100.

[0058] Once the distal end 213 of the flexible tubular element 210 reaches the desired delivery site, the flow restriction device 100 is advanced distally therefrom, out of the lumen 212 of the flexible tubular element 210 and into the delivery site. The inner tube 220 can be used as a pusher to advance the flow restriction device 100 by retracting the flexible tubular element 210 proximally relative to the inner tube 220, by advancing the inner tube 220 distally relative to the flexible tubular element 210, or by a combination of such movements. The control handles 214, 224 can be used to move the flexible tubular element 210 and the inner tube 220, respectively, as described above. The flow restriction device 100 is shown advanced out of the flexible tubular element 210 in FIG. 6. If the flow restriction device 100 is self-expanding, the flow restriction device 100 can begin to expand, as shown in FIG. 6, to the expanded, deployed configuration shown in FIG. 1. If the flow restriction device 100 is expanded by an expandable device, such as an expandable occluder 140, the expandable device can be expanded to expand the flow restriction device 100. If the flow restriction device 100 includes an occluder 140, once the flow restriction device 100 is advanced from the flexible tubular element 210 and positioned at the desired deployment site, the occluder 140 can be expanded (e.g., to expand the flow restriction device 100 and / or to help block or restrict the passage of matter through the passageway in which the flow restriction device 100 is positioned and / or to occupy a volume within the anatomical structure in which the occluder 140 is positioned).

[0059] 5 and 6, an inflation tube 230 may be provided for an expandable device provided for expanding the flow restriction device 100 and / or for maintaining an inflated (or partially inflated) state within a portion of the flow restriction device 100 in accordance with various principles of the present disclosure as described above. The inflation tube 230 has a proximal end 231 that can be coupled to an inflation control handle 234 that can be provided on a common control handle assembly with one or both of the control handles 214, 224, or that can be formed separately from one or both of the control handles 214, 224. An inflation valve or port, such as a luer lock 236, can be provided on the inflation control handle 234 for coupling to a source of inflation medium (e.g., gas or fluid, or even a semi-solid inflation material).

[0060] A distal end 233 of inflation tube 230 is coupled to occluder 140, such as via port 142, as shown in the detailed view of FIG. 7. Inflation tube 230 may include an infusion tube 232 at its distal end 233, extending through port 142 and configured to facilitate passage of a filling medium through inflation tube 230 and into occluder 140. As can be seen with reference to the further detailed views of FIGS. 8A and 8B taken along line VIII-VIII of FIG. 7 (FIG. 8B shows a later inflation stage than shown in FIG. 8A), port 142 may include a frame or clip receiving component 144 configured to mate with a clip insert component 234. Clip receiving component 144 may include a retention structure 146 for holding clip insert component 234 in a fixed position relative to port 142 during inflation. The clip insertion component 234 can be removed from the clip receiving component 144 by withdrawing the inflation tube 230 proximally to remove the clip receiving component 144 from the clip insertion component 234, as illustrated in FIG. 8B . As can be understood with reference to FIG. 8B , the port 142 may include a seal 148, such as a valve seal, that selectively allows the inflation tube 230 and / or the infusion tube 232 to access the interior of the occluder 140 for filling the occluder 140 with inflation media. The seal 148 may be configured to be a self-closing one-way valve for sealing the interior of the occluder 140 upon withdrawal of the inflation tube 230 and / or the infusion tube 232 after the occluder 140 has been inflated to a desired or medically indicated extent. In some embodiments, the seal 148 may be in the form of an elastomeric element (e.g., an elastomeric disk) extending across an opening in the port 142 and having a slit therein to allow selective access therethrough. The slits may be provided in any configuration acceptable to one skilled in the art, examples of which are shown in Figures 9A and 9B. For example, as shown in Figure 9A, multiple slits 149A may be provided in seal 148A, or as shown in Figure 9B, only one slit 149B may be provided in seal 148B.Although the slits 149A are shown as being substantially straight and substantially equidistant from one another, other configurations are within the scope and spirit of the present disclosure.

[0061] In view of the above, it should be understood that the various embodiments shown in the drawings have several distinct and independent features, each of which, at least alone, has its own inherent advantages that are desirable but not necessary for the flow restriction devices of the present disclosure. Thus, it is not necessary for all of the various distinct features described herein to be present in order to achieve at least some of the desired properties and / or advantages described herein. Only one of the various features may be present in a flow restriction device formed in accordance with the various principles of the present disclosure. Alternatively, one or more of the features described with reference to one embodiment may be combined with one or more of the features of any of the other embodiments provided herein. That is, any of the features described herein may be mixed and matched to create hybrid designs, and such hybrid designs are within the scope of the present disclosure. Furthermore, throughout this disclosure, reference numbers are used to indicate generic elements or features of the disclosed embodiments. The same reference numbers may be used to indicate elements or features that are not identical in form, shape, structure, etc., but that provide similar functions or advantages. Additional reference characters (such as letters rather than numbers) may be used to distinguish similar elements or features from one another.

[0062] In general, as described herein, it should be understood that an "embodiment" (as shown in the accompanying drawings) may refer to an exemplary representation of an environment or article or component in which a disclosed concept or feature may be provided or embodied, or a representation of the manner in which only the concept or feature may be provided or embodied. However, such illustrated embodiments should be understood as examples (unless otherwise stated), and other ways of embodying the described concepts or features, as one of ordinary skill in the art would understand upon acquiring the concept or feature from the present disclosure, are within the scope of the present disclosure. In addition, while the drawings may show one or more embodiments of a concept or feature together in a single embodiment of an environment, article, or component incorporating such concept or feature, it will be understood that such concepts or features should be understood as independent and separate from one another (unless otherwise specified), are shown together for convenience, and are not intended to be limited to existing or used together. For example, features illustrated or described as part of one embodiment can be used separately or with one or more other features to yield further embodiments. Thus, it is intended that the present subject matter covers such modifications and variations as come within the scope of the appended claims and their equivalents.

[0063] 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 one or more forms disclosed herein. It will be understood that various aspects of the above disclosure may be applied to other passages within the body to reduce flow through such passages. 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 will 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 separate 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 appreciate that the present disclosure can be used with numerous 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, spirit, or scope of the present 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, while operations or actions or procedures 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 procedures must be performed. Additionally, other implementations are within the scope of the following claims.In some cases, the actions recited in the claims can be performed in a different order and still achieve desirable results. Accordingly, the presently disclosed embodiments are 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.

[0064] 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.

[0065] 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.

[0066] The technical ideas included in this disclosure are described below as appendices. [Appendix 1] 1. A flow restriction device having a longitudinal extent and deployable within an anatomical structure, comprising: A first part; A second part; a saddle region extending between the first portion and the second portion; Equipped with The flow restriction device, wherein the first portion is not collinear with the saddle region.

[0067] [Appendix 2] 2. The flow restriction device of claim 1, wherein the first portion has a non-circular cross-sectional shape across at least a region of the first portion configured to remain spaced apart from a selected anatomical region.

[0068] [Appendix 3] the flow restriction device is configured to be positioned with the saddle region extending through a passageway between a first anatomical structure in which the first portion is positioned and a second anatomical structure in which the second portion is positioned; the first portion has a first region extending along a first region of the first anatomical structure and a second region extending along a second region of the first anatomical structure; 3. The flow restriction device of claim 1 or 2, wherein the first portion, when positioned in the first anatomical structure, is angled relative to the saddle region in a direction away from the second region of the first anatomical structure.

[0069] [Appendix 4] the first region of the first portion is configured to follow a contour of the first region of the first anatomical structure; 4. The flow restriction device of any one of claims 1 to 3, wherein the second region of the first portion is configured to be spaced apart from the second region of the first anatomical structure to space the first portion from the second region of the first anatomical structure.

[0070] [Appendix 5] the first region has a convex outer surface; 5. The flow restriction device of any one of claims 1 to 4, wherein the second region has an outer surface that is substantially linear or concave.

[0071] [Appendix 6] the device is movable between a collapsed configuration and an expanded, deployed configuration; 4. The flow restriction device of any one of claims 1 to 3, wherein the first portion is sized to resist movement through a passageway through which the saddle region extends.

[0072] [Appendix 7] the flow restriction device is formed from a plurality of woven strands; the first portion is expanded to have a larger cross-sectional dimension than the second portion; 7. The flow restriction device of any one of claims 1 to 6, wherein the first portion is formed of fewer strands than the second portion.

[0073] [Appendix 8] 8. The flow restriction device of any one of claims 1 to 7, further comprising an occluder associated with the first portion that is expandable to restrict the passage of matter through a passageway through which the saddle region extends and / or to increase a volume occupied by the first portion within the first anatomical structure.

[0074] [Appendix 9] 1. A flow restriction device having a longitudinal extent and deployable within an anatomical structure, comprising: A first part; A second part; a saddle region extending between the proximal and distal portions; an occluder associated with the first portion; A flow restriction device comprising:

[0075] [Appendix 10] the first portion is in the form of a cage; 10. The flow restriction device of claim 9, wherein the occluder is disposed within the first portion.

[0076] [Appendix 11] 11. The flow restriction device of claim 9 or 10, wherein the occluder is positioned within the first portion to restrict passage of matter toward the saddle region.

[0077] [Appendix 12] 12. The flow restriction device of any one of claims 9 to 11, wherein the occluder is selectively expandable.

[0078] [Appendix 13] the saddle region is configured to be deployed across the pylorus; the first portion is configured to fit within the stomach and is sized and configured to resist distal movement through the pylorus; the second portion is configured to fit within the duodenum and to resist proximal movement through the pylorus; 13. The flow restriction device of any one of claims 9 to 12, wherein the occluder is expandable within the first portion to occupy a volume in the stomach to cause a feeling of satiety and / or to resist distal movement of the flow restriction device through the pylorus and occlude passage of matter through the pylorus.

[0079] [Appendix 14] 1. A system for restricting the flow of a substance through an anatomical structure, comprising: a tubular delivery device; a flow restriction device configured to transition between a collapsed configuration for fitting within a lumen in an outer tubular device and an expanded, deployed configuration when not disposed within the outer tubular device; an occluder associated with the flow restriction device; an internal pusher extending through the tubular delivery device and configured to engage the flow restriction device; Equipped with A system wherein movement of the inner pusher and the outer tubular delivery device relative to one another causes deployment of the flow restriction device from the tubular delivery device.

[0080] [Appendix 15] 15. The system of claim 14, wherein the occluder is expandable, the system further comprising an inflation lumen fluidly coupled to the occluder to selectively expand the occluder.

Claims

1. 1. A flow restriction device having a longitudinal extent and deployable within an anatomical structure, comprising: a first portion; and a second part; and a saddle region extending between the proximal and distal portions; an occluder associated with the first portion; A flow restriction device comprising:

2. the first portion is in the form of a cage; The flow restriction device of claim 1 , wherein the occluder is disposed within the first portion.

3. 3. The flow restriction device of claim 1, wherein the occluder is positioned within the first portion to restrict passage of material toward the saddle region.

4. The flow restriction device of claim 1 or 2, wherein the occluder is selectively expandable.

5. the saddle region is configured to be deployed across the pylorus; the first portion is configured to fit within the stomach and is sized and configured to resist distal movement through the pylorus; the second portion is configured to fit within the duodenum and to resist proximal movement through the pylorus; 3. The flow restriction device of claim 1, wherein the occluder is expandable within the first portion to occupy a volume within the stomach to induce a feeling of satiety and / or to resist distal movement of the flow restriction device through the pylorus and occlude passage of matter through the pylorus.

6. 1. A system for restricting the flow of a substance through an anatomical structure, comprising: a tubular delivery device; a flow restriction device configured to transition between a collapsed configuration for fitting within a lumen in an outer tubular device and an expanded, deployed configuration when not disposed within the outer tubular device; an occluder associated with the flow restriction device; an internal pusher extending through the tubular delivery device and configured to engage the flow restriction device; Equipped with A system wherein movement of the inner pusher and the outer tubular delivery device relative to one another causes deployment of the flow restriction device from the tubular delivery device.

7. The system of claim 6 , wherein the occluder is expandable, the system further comprising an inflation lumen fluidly connectable with the occluder to selectively expand the occluder.

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