Anti-migration support

Abstract

An example medical device may include a stent including a radially expanding tubular frame having a radially outward surface, a radially inward surface, a first end region, a second end region, an intermediate region, and a lumen, the intermediate region is located between the first end region and the second end region, and the lumen extends from the first end region to the second end region. A first flange structure may be located proximate the first end region and a second flange structure may be located proximate the second end region. One of the first end region or the second end region may include a third flange structure.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 389,285, filed on July 14, 2022, the disclosure of which is incorporated herein by reference. Technical Field

[0002] The present disclosure generally relates to the field of implantable medical devices and related systems and methods for adjusting the accessibility of a passage through a medical device. More particularly, the present disclosure relates to devices, systems and methods for controlling and / or changing a passage using a flow regulating device such as a lumen-fitting device. Background Art

[0003] The method for treating various medical conditions (such as obesity, diabetes or duodenal ulcer) includes bypassing the duodenum or limiting the material flow through the duodenum. If treatment needs to bypass the duodenum completely, the closure of the pylorus (for example, complete closure) can be indicated, and anastomosis can be created, such as between the stomach and the jejunum. The lumen fitting device can be placed between the stomach and the jejunum to allow material (fluid, liquid, chyme, etc.) to pass through the stomach and travel to the jejunum. A challenge faced by such devices is to prevent the device from migrating far to the small intestine or migrating near to the stomach. Therefore, there is a continuous demand for providing alternative medical devices and alternative methods for manufacturing and using medical devices. Summary of the invention

[0004] The present disclosure provides designs, materials, methods of manufacture, and alternative uses of medical devices. The present invention relates to an example medical device that may include a stent that includes a radially expandable tubular frame having a radially outward surface, a radially inward surface, a first end region, a second end region, an intermediate region, and a lumen, the intermediate region being located between the first end region and the second end region, the lumen extending from the first end region to the second end region. The first flange structure may be located near the first end region, and the second flange structure may be located near the second end region. One of the first end region or the second end region may include a third flange structure.

[0005] Alternatively or in addition to any of the above embodiments, the stent may be a self-expanding stent.

[0006] Alternatively or in addition to any of the above embodiments, the first flange and the second flange may be configured to atraumatically engage body tissue.

[0007] Alternatively or in addition to any of the above embodiments, a third flange structure may be located adjacent the first end region.

[0008] Alternatively or in addition to any of the above embodiments, the second end region may comprise a fourth flange structure.

[0009] Alternatively or in addition to any of the above embodiments, the third flange structure may be longitudinally spaced apart from the first flange structure in the range of 5 mm to 75 mm.

[0010] Alternatively or in addition to any of the above embodiments, the third flange structure may be longitudinally spaced apart from the first flange structure by at least 20 mm.

[0011] Alternatively or in addition to any of the above embodiments, the first flange structure is bent towards the third flange structure such that the first end and the second end of the first flange structure are configured to engage the third flange structure.

[0012] Alternatively or in addition to any of the above embodiments, the first flange structure may include a first outer diameter, the second flange structure may include a second outer diameter, and the third flange structure may include a third outer diameter, wherein the first outer diameter, the second outer diameter and the third outer diameter are different from each other.

[0013] Alternatively or in addition to any of the above embodiments, the first, second and third flange structures each have an outer diameter that is greater than an outer diameter of the intermediate region.

[0014] Alternatively or in addition to any of the above embodiments, the third outer diameter may be greater than the first outer diameter and the second outer diameter.

[0015] Alternatively or in addition to any of the above embodiments, the radially expandable tubular frame may be formed from a woven filament braid.

[0016] Alternatively or in addition to any of the above embodiments, the braid angle of the third flange structure may be different from the braid angle of the first and second flange structures.

[0017] An example stent may include a radially expandable tubular framework formed by a woven filament braid having a first end region, a second end region, an intermediate region, and a lumen, the intermediate region being located between the first end region and the second end region, the lumen extending from the first end region to the second end region. A first flange structure having a first outer diameter may be located near the first end region, a second flange structure having a second outer diameter may be located near the second end region, and a third flange structure having a third outer diameter may be located near the first end region. The third flange structure may be spaced longitudinally from the first flange structure, and the third outer diameter may be greater than the first outer diameter and the second outer diameter.

[0018] Alternatively or in addition to any of the above embodiments, the first outer diameter, the second outer diameter, and the third outer diameter may each be greater than the outer diameter of the intermediate region.

[0019] Alternatively or in addition to any of the above embodiments, the braid angle of the third flange structure may be different from the braid angle of the first and second flange structures.

[0020] Alternatively or in addition to any of the above embodiments, the third flange structure may be longitudinally spaced apart from the first flange structure in the range of 5 mm to 75 mm.

[0021] Alternatively or in addition to any of the above embodiments, the third flange structure may be longitudinally spaced apart from the first flange structure by at least 20 mm.

[0022] An example stent may include a radially expandable tubular frame formed by a woven filament braid having a first end region, a second end region, an intermediate region, and a lumen, the intermediate region being located between the first end region and the second end region, the lumen extending from the first end region to the second end region. A first flange structure having a first outer diameter may be located near the first end region, a second flange structure having a second outer diameter may be located near the second end region, and a third flange structure having a third outer diameter may be located near the first end region. The third flange structure may be longitudinally spaced apart from the first flange structure by a range of 5 mm to 75 mm, and the first flange structure may be bent toward the third flange structure so that the first end and the second end of the first flange structure may be configured to engage the third flange structure.

[0023] Alternatively or in addition to any of the above embodiments, the third flange structure may be longitudinally spaced apart from the first flange structure by at least 20 mm.

[0024] Alternatively or in addition to any of the above embodiments, the third outer diameter may be greater than the first outer diameter and the second outer diameter.

[0025] The above summary of some embodiments is not intended to describe each disclosed embodiment or every implementation of the present disclosure. The following figures and detailed description more particularly exemplify these embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] The present disclosure may be more fully understood by considering the following detailed description taken in conjunction with the accompanying drawings, in which:

[0027] Figure 1 A side view of a stent positioned between a portion of the small intestine and the stomach is shown;

[0028] Figure 2 Shown along Figure 1 A cross-sectional view of the stent located between a portion of the small intestine and the stomach, taken along line 2-2;

[0029] Figure 3 shows a side view of an exemplary stent;

[0030] Figure 4 An exemplary stent is shown positioned between a portion of the small intestine and the stomach wall;

[0031] Figure 5 An exemplary stent is shown positioned between a portion of the small intestine and the stomach wall; and

[0032] Figure 6 An exemplary stent is shown positioned between a portion of the small intestine and the stomach wall.

[0033] Although the present disclosure may be modified into various modifications and alternative forms, the details thereof have been shown by way of example in the drawings and will be described in detail. However, it should be understood that it is not intended to limit the present invention to the specific embodiments described. On the contrary, it is intended to cover all modifications, equivalents and alternatives falling within the spirit of the present disclosure. DETAILED DESCRIPTION

[0034] With respect to the following defined terms, these definitions shall apply, unless a different definition is given in the claims or elsewhere in this specification.

[0035] All numerical values ​​are assumed to be modified by the term "about" herein, whether or not explicitly indicated. The term "about" generally refers to an index range that a person skilled in the art would consider to be equivalent to the stated value (i.e., having the same function or result). In many cases, the term "about" may include numbers rounded to the nearest significant figure.

[0036] The recitation of numerical ranges by endpoints includes all numbers within that range (eg, 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0037] As used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally employed in its sense including "and / or" unless the context clearly dictates otherwise.

[0038] It should be noted that references in the specification to "one embodiment", "some embodiments", "other embodiments", etc. indicate that the described embodiments may include one or more features, structures and / or characteristics. However, such statements do not necessarily mean that all embodiments include these features, structures and / or characteristics. In addition, when features, structures and / or characteristics are described in conjunction with one embodiment, it should be understood that such features, structures and / or characteristics may also be used in conjunction with other embodiments, whether or not explicitly described, unless explicitly indicated to the contrary.

[0039] According to various principles of the present disclosure, implantable devices can be used to extend through anatomical structures to control or adjust the size of the passage through it. For example, implantable devices can extend through body passages or lumens, and such terms are used interchangeably herein and are not intended to be limited. Body passages or lumens may include but are not limited to a part of a passage or lumen, a passage or lumen between anatomical structures (passages, lumens, cavities, organs, etc.), a passage formed by passing through the fitting tissue wall (such as to form anastomosis), etc. The device has a passage or lumen passing through it (such terms are used interchangeably herein and are not intended to be limited), and the passage or lumen can be used for blocking or obstruction or narrowing or closure or constraint or regulation or control (such terms and their conjunctions can be used interchangeably herein and are not intended to be limited) body passages, and the device is positioned through the body passage. The device can be regarded as and can be referred to as blocking or lumen fitting or anastomosis or flow regulation or flow control device, and such terms and its various other alternative words can be used interchangeably herein and are not intended to be limited.

[0040] The following detailed description should be read with reference to the drawings, in which similar elements in different drawings are labeled the same. The drawings, which are not necessarily drawn to scale, illustrate exemplary embodiments and are not intended to limit the scope of the invention.

[0041] Figure 1 A side view of an exemplary stent 10 is shown positioned between a stomach 20 and a jejunum 30 (a portion of the small intestine), and Figure 2 Shown along Figure 1 2-2 of FIG. 2 , a cross-sectional view of a stent 10 located between a stomach 20 and a jejunum 30. The stent 10 may be a self-expanding stent 10 and may include a radially expandable tubular frame 13 having a radially outward surface 11 and a radially inward surface 12. The radially expandable tubular frame 13 may include a first end region 16, a second end region 17, and an intermediate region 18, wherein the intermediate region 18 is located between the first end region 16 and the second end region 17. The radially expandable tubular frame 13 may also include a lumen 14 extending from the first end region 16 to the second end region 17. The stomach 20 typically passes food material (e.g., chyme, partially digested food material, fluid, etc.) through the pylorus 60 into the duodenum 40. In some cases, treatment for a patient suffering from obesity, diabetes, or duodenal ulcers may include bypassing the duodenum 40 or restricting the flow of material through the duodenum 40. If treatment requires completely bypassing the duodenum 40 , then occlusion of the pylorus 60 (eg, complete occlusion) may be indicated, and a stoma 15 may be created between the stomach 20 and the jejunum 30 , which may be known as a gastrojejunostomy. Figure 1An example bypass procedure is shown in which a flow restriction device 50 has been positioned within the pylorus 60, thereby restricting the passage of food material from the stomach 20 into the duodenum 40 (e.g., bypassing completely). A luminal adherent metal stent (LAMS) such as stent 10 may be placed between the stomach 20 and the jejunum 30, thereby forming a stoma 15 to allow food material (fluids, liquids, chyme, etc.) to pass from the stomach 20 and into the jejunum 30, as shown in FIG. Figure 1 and Figure 2 Although shown, the stent 10 can be used to form an anastomosis 15 between the stomach 20 and the jejunum 30, it is contemplated that the stent 10 can be used to treat stenosis in a blood vessel, to maintain a fluid opening or path in a blood vessel, urethra, bile duct, tracheobronchial tube, esophagus, or renal tract, or in some cases to position a device such as an artificial valve or filter within a body cavity. Although shown as a stent, the stent 10 can be any of several devices that can be introduced endoscopically, subcutaneously, percutaneously, or surgically to be positioned within an organ, tissue, or lumen, such as the heart, artery, vein, urethra, esophagus, trachea, bronchus, bile duct, etc.

[0042] Figure 3 A side view of an exemplary stent 100 is shown. Stent 100 may be Figure 1 and Figure 2 The stent 100 may be a self-expanding stent 100 and may include a radially expandable tubular frame 105 having a radially outward surface 101 and a radially inward surface ( Figure 3 The radially inward surface may be considered as an example of the radially inward surface 12, such as Figure 2 As shown. The term "radially expandable tubular frame 105" may be referred to as "tubular frame 105" hereinafter. Stent 100 may include a height of 10 millimeters (mm) and an outer diameter (e.g., width) of 20 mm. In some cases, the height of stent 100 may be 12 mm, 15 mm, 18 mm, or any other suitable height. In some cases, the outer diameter of stent 100 may be 18 mm, 22 mm, 25 mm, or any other suitable diameter. Tubular frame 105 may include a first end region 110, a second end region 120, and a middle region 130, wherein middle region 130 is located between first end region 110 and second end region 120. Tubular frame 105 may also include a lumen 140 extending from first end region 110 to second end region 120. Lumen 140 may be considered an example of lumen 14, such as Figure 2As shown. In some cases, the first end region 110 may be a distal end region, and the second end region 120 may be a proximal end region. In some cases, the first end region 110 may be a proximal end region, and the second end region 120 may be a distal end region. The first end region 110 may include a first end 111, and the second end region 120 may include a second end 121. The first end region 110 may extend from the first end 111 to the middle region 130, and the second end region 120 may extend from the second end 121 to the middle region 130. In some cases, the middle region 130 may define the midpoint of the tubular frame 105, such that the first end region 110 and the second end region 120 may have the same length. In some cases, as Figure 3 As shown, the intermediate region 130 may be disposed at a location other than the midpoint such that the first and second end regions 110 , 120 have different lengths.

[0043] In some cases, the first end region 110 may include a first flange structure 115, and the second end region 120 may include a second flange structure 125. The intermediate region 130 may be located between the first flange structure 115 and the second flange structure 125. The intermediate region 130 may be configured to engage the tissue surface, thereby applying a radial force to help prevent migration of the stent 100. The first end region 110 may also include a third flange structure 135, which is longitudinally spaced from the first flange structure 115. The third flange structure 135 may provide additional radial force to the first end 110 of the stent 100 during peristalsis, thereby preventing the stent 100 from migrating from the stomach to the jejunum during peristalsis or turbulence caused by the digestion of food boluses. The third flange structure 135 may be longitudinally spaced from the first flange structure 115 by a range of 5 mm (millimeter) to 75 mm. In some cases, the third flange structure 135 may be longitudinally spaced from the first flange structure 115 by at least 20 mm. The longitudinal spacing between the first flange structure 115 and the third flange structure 135 may vary depending on the desired pull-out force.

[0044] The first flange structure 115, the second flange structure 125, and the third flange structure 135 may be retaining members configured to help hold the stent 100 in place. Therefore, the first, second, and third flange structures 115, 125, 135 may include a width (e.g., an outer diameter) sufficient to provide retention strength. For example, the width of the first, second, and third flange structures 115, 125, 135 may be in the range of 20 mm to 70 mm (millimeters). In some cases, the first, second, and third flange structures 115, 125, 135 may include a larger width (e.g., an outer diameter) than the first end 111, the second end 121, and the middle region 130 of the tubular frame 105. In some cases, the first, second, and third flange structures 115, 125, 135 may include the same width as each other, such as Figure 3 In some cases, the first and second flange structures 115, 125 may include the same width as each other, and the third flange structure 135 may include a width different from the width of the first and second flange structures 115, 125. In some cases, the first, second, and third flange structures 115, 125, 135 may each include different widths.

[0045] In some cases, the first, second, and third flange structures 115, 125, 135 may include any of a variety of shapes, such as concave, convex, disc-shaped, cylindrical (e.g., with a longer longitudinal extent as shown), etc., or other configurations, and the present disclosure is not limited to specific shapes and configurations. Although it is shown that the first flange structure 115 and the third flange structure 135 are located near the first end region 110, and the second flange structure 125 is located near the second end region 120, it is contemplated that the first flange structure 115 and the third flange structure 135 are located near the second end region 120, and the second flange structure 125 is located near the first end region 110. In some cases, it is contemplated that the tubular frame 105 includes only one flange structure (e.g., the first flange structure 115, the second flange structure 125, or the third flange structure 135).

[0046] The stent 100 may be configured to be implanted between the patient's stomach and jejunum to form an anastomosis. In some cases, the first flange structure 115 may abut a tissue surface (e.g., the stomach), the second flange structure 125 may abut a second tissue surface (e.g., the jejunum), and the middle region 130 of the stent 100 may extend through openings in the stomach and jejunum and may be configured to engage tissue surfaces to form an anastomosis. In such cases, the third flange structure may be configured to extend into the stomach. In other embodiments, the stent 100 may be configured to be implanted in, for example, the urethra, bile duct, tracheobronchial tube, esophagus, or renal tract. Because the stent 100 or a portion thereof may be intended to be permanently implanted in a body cavity, the stent 100 may be made at least in part of a biostable material. Examples of biostable metal materials may include, but are not limited to, stainless steel, tantalum, tungsten, niobium, platinum, nickel-chromium alloys, cobalt-chromium alloys (such as and ), nitinol (e.g., 55% nickel, 45% titanium), and other alloys based on titanium (including nickel-titanium alloys), or other suitable metals, or combinations or alloys thereof. Some suitable biostable polymer materials include, but are not necessarily limited to, polyamides, polyether block amides, polyethylene, polyethylene terephthalate, polypropylene, polyvinyl chloride, polyurethane, polytetrafluoroethylene, polysulfone, and copolymers, blends or mixtures or combinations thereof.

[0047] The tubular frame 105 may include several interconnected struts 106 to form a woven filament braided structure of the tubular frame 105. The struts 106 may be configured to transition from a compressed state to an expanded state. The struts 106 may be formed, for example, of a metal material, such as nitinol or a nitinol-containing material, or another nickel-titanium alloy. The struts 106 may include, for example, a diameter of 0.0762 mm to 0.3556 mm. In some cases, the struts 106 may have, for example, a diameter of about 0.011 inches. The number of struts 106 and the diameter of the struts 106 (which may be the same or different) are unlimited, and other numbers of struts 106 and other wire diameters may be appropriately used. Ideally, an average number of struts 106 may be used, for example, about 10 to about 36 struts 106. In some cases, the tubular frame 105 may include a variety of braiding angles to form a woven filament braided structure. For example, in some cases, the third flange structure 135 may include a braid angle that is different from the braid angles of the first flange structure 115 and the second flange structure 125. This may allow the third flange structure 135 to be stiffer, thereby acting as an anchor for the stent 100, whereas the first flange structure 115 may be softer, thereby providing greater creep resistance. In some cases, the braid angles of the first, second, and third flange structures 115, 125, 135 may be the same. In some cases, the braid angles of the first, second, and third flange structures 115, 125, 135 may be different.

[0048] The tubular frame 105 may include a coating 107 applied to the struts 106 of the tubular frame 105, so that the entire portion of the stent 100 can be covered by the coating 107. The coating 107 can be formed of silicone and can be configured to prevent leakage of food materials during stoma formation. In some cases, the coating 107 can be applied to the struts 106 in the middle region 130. In some cases, the coating 107 can be applied to the struts 106 in the first end region 110 and the middle region 130, and in some cases, the coating 107 can be applied to the struts 106 in the second end region 120 and the middle region 130. These are just examples.

[0049] The first flange structure 115 may include a first end 116 and a second end 117, the second flange structure 125 may include a first end 126 and a second end 127, and the third flange structure 135 may include a first end 136 and a second end 137. The first ends 116, 126, 136 and the second ends 117, 127, 137 may be formed by bending the struts 106 of the tubular frame 105 to form atraumatic flange structures (e.g., the first flange structure 115, the second flange structure 125, the third flange structure 135). Thus, the first ends 116, 126, 136 and the second ends 117, 127, 137 may be rounded and atraumatic, so that the first flange structure 115, the second flange structure 125, and the third flange structure 135 are configured to atraumatically engage body tissue (e.g., the stomach 20, the jejunum 30).

[0050] Figure 4 An exemplary stent 200 is shown positioned between a portion of the small intestine 270 (e.g., the jejunum) and a stomach wall 260 (e.g., the stomach). The stent 200 can be a self-expanding stent 200 and can include a radially expandable tubular frame 205 having a radially outward surface 201 and a radially inward surface ( Figure 4 The radially inward surface may be considered as an example of the radially inward surface 12, such as Figure 2As shown. The term "radially expandable tubular frame 205" may be referred to as "tubular frame 205" hereinafter. Stent 200 may include a height of 10 millimeters (mm) and an outer diameter (e.g., width) of 20 mm. In some cases, the height of stent 200 may be 12 mm, 15 mm, 18 mm, or any other suitable height. In some cases, the outer diameter of stent 200 may be 18 mm, 22 mm, 25 mm, or any other suitable diameter. Tubular frame 205 may include a first end region 210, a second end region 220, and a middle region 230, wherein middle region 230 is located between first end region 210 and second end region 220. Tubular frame 205 may also include a lumen 240 extending from first end region 210 to second end region 220. Lumen 240 may be considered an example of lumen 14, such as Figure 2 As shown. In some cases, the first end region 210 may be a distal end region, and the second end region 220 may be a proximal end region. In some cases, the first end region 210 may be a proximal end region, and the second end region 220 may be a distal end region. The first end region 210 may include a first end 211, and the second end region 220 may include a second end 221. The first end region 210 may extend from the first end 211 to the middle region 230, and the second end region 220 may extend from the second end 221 to the middle region 230. The middle region 230 may define the midpoint of the tubular frame 205, so that the first end region 210 and the second end region 220 may have the same length. Alternatively, the middle region 230 may be disposed at a position other than the midpoint, so that the first and second end regions 210, 220 have different lengths.

[0051] In some cases, the first end region 210 may include a first flange structure 215 having a first outer diameter, and the second end region 220 may include a second flange structure 225 having a second outer diameter. The intermediate region 230 may be located between the first flange structure 215 and the second flange structure 225. The intermediate region 230 may be configured to engage the tissue surface, thereby applying a radial force to help prevent migration of the stent 200. The first end region 210 may also include a third flange structure 235 having a third outer diameter, the third flange structure 235 being longitudinally spaced apart from the first flange structure 215 by a first distance, as indicated by D1. The third flange structure 235 may provide additional radial force to the first end region 210 of the stent 200, thereby preventing migration of the stent 200 from the stomach 260 to the jejunum 270 during peristalsis or turbulence caused by digestion of a food bolus. The third flange structure 235 may be longitudinally spaced apart from the first flange structure 215 by D1, a range of 5 mm (millimeter) to 75 mm. In some cases, third flange structure 235 can be longitudinally spaced apart D1 by at least 20 mm from first flange structure 215. The longitudinal spacing between first flange structure 215 and third flange structure 235 can vary depending on the desired pull-out force.

[0052] The first flange structure 215, the second flange structure 225, and the third flange structure 235 may be a retaining member configured to help hold the stent 200 in place. Therefore, the first, second, and third flange structures 215, 225, 235 may include first, second, and third outer diameters, respectively, sufficient to provide retention strength. For example, the first, second, and third outer diameters of the first, second, and third flange structures 215, 225, 235 may be in the range of 20 mm to 70 mm (millimeters). In some cases, the first, second, and third flange structures 215, 225, 235 may include first, second, and third outer diameters that are larger than the first end 211, the second end 221, and the middle region 230 of the tubular frame 205. In some cases, the first, second, and third outer diameters of the first, second, and third flange structures 215, 225, 235 may be different from each other. In some cases, the third outer diameter of the third flange structure 235 can be larger than the first outer diameter and the second outer diameter of the first flange structure 215 and the second flange structure 225, respectively. In some cases, the first flange structure 215 and the second flange structure 225 can have substantially the same outer diameter, such as Figure 4As shown. For example, the third outer diameter of the third flange structure 235 may include an outer diameter of 55 mm, and the first outer diameter of the first flange structure 215 and the second outer diameter of the second flange structure 225 may include a width of 35 mm. In some cases, the third outer diameter of the third flange structure 235 may include an outer diameter of 45 mm, 60 mm, 65 mm, 70 mm, 45 mm to 70 mm, or any other suitable width. The first outer diameter of the first flange structure 215 and the second outer diameter of the second flange structure 225 may include an outer diameter of 25 mm, 30 mm, 40 mm, 45 mm, 25 mm to 45 mm, or any other suitable width. In some cases, when the third outer diameter of the third flange structure 235 is greater than the first outer diameter of the first flange structure 215, such as Figure 4 As shown, the risk of migration can be mitigated. For example, if the stent 200 begins to migrate from the stomach 260 to the jejunum 270, the third flange structure 235 will have a wide enough outer diameter to potentially prevent such migration. In some cases, the first, second and third outer diameters of the first, second and third flange structures 215, 225, 235 can be the same as each other.

[0053] In some cases, the first, second, and third flange structures 215, 225, 235 may include any of a variety of shapes, such as concave, convex, disc-shaped, cylindrical (e.g., with a longer longitudinal extent as shown), etc., or other configurations, and the present disclosure is not limited to such shapes and configurations. Although it is shown that the first flange structure 215 and the third flange structure 235 are located near the first end region 210, and the second flange structure 225 is located near the second end region 220, it is contemplated that the first flange structure 215 and the third flange structure 235 are located near the second end region 220, and the second flange structure 225 is located near the first end region 210. In some cases, it is contemplated that the tubular frame 205 includes only one flange structure (e.g., the first flange structure 215, the second flange structure 225, or the third flange structure 235).

[0054] The tubular frame 205 may include a plurality of interconnected struts 206 to form a woven filament braid structure of the tubular frame 205. The struts 206 may be configured to transition from a compressed state to an expanded state. The struts 206 may include, for example, a diameter of 0.0762 mm to 0.3556 mm. The tubular frame 205 may include a coating 207 applied to the struts 206 of the tubular frame 205, so that the entire portion of the stent 200 may be covered by the coating 207. The coating 207 may be formed of silicone and may be configured to prevent leakage of food materials during stoma formation. In some cases, the coating 207 may be applied to the struts 206 in the middle region 230. In some cases, the coating 207 may be applied to the struts 206 in the first end region 210 and the middle region 230, and in some cases, the coating 207 may be applied to the struts 206 in the second end region 220 and the middle region 230. These are examples only.

[0055] The first flange structure 215 may include a first end 216 and a second end 217, the second flange structure 225 may include a first end 226 and a second end 227, and the third flange structure 235 may include a first end 236 and a second end 237. The first ends 216, 226, 236 and the second ends 217, 227, 237 may be formed by bending the struts 206 of the tubular frame 205 to form atraumatic flange structures (e.g., the first flange structure 215, the second flange structure 225, the third flange structure 235). Therefore, the first ends 216, 226, 236 and the second ends 217, 227, 237 may be rounded and atraumatic, so that the first flange structure 215, the second flange structure 225, and the third flange structure 235 are configured to atraumatically engage body tissue (e.g., stomach 20, jejunum 30).

[0056] Figure 5 An exemplary stent 300 is shown positioned between a portion of the small intestine 370 (e.g., the jejunum) and a stomach wall 360 (e.g., the stomach). The stent 300 can be a self-expanding stent 300 and can include a radially expandable tubular frame 305 having a radially outward surface 301 and a radially inward surface ( Figure 5 The radially inward surface may be considered as an example of the radially inward surface 12, such as Figure 2As shown. The term "radially expandable tubular frame 305" may be referred to as "tubular frame 305" hereinafter. The stent 300 may include a height of 10 mm and an outer diameter (e.g., width) of 20 mm. In some cases, the height of the stent 300 may be 12 mm, 15 mm, 18 mm, 12 mm to 18 mm, or any other suitable height. In some cases, the outer diameter of the stent 300 may be 18 mm, 22 mm, 25 mm, 18 mm to 25 mm, or any other suitable diameter. The tubular frame 305 may include a first end region 310, a second end region 320, and a middle region 330, wherein the middle region 330 is located between the first end region 310 and the second end region 320. The tubular frame 305 may also include a lumen 340 extending from the first end region 310 to the second end region 320. The lumen 340 may be considered an example of a lumen 14, such as Figure 2 As shown. In some cases, the first end region 310 may be a distal end region, and the second end region 320 may be a proximal end region. In some cases, the first end region 310 may be a proximal end region, and the second end region 320 may be a distal end region. The first end region 310 may include a first end 311, and the second end region 320 may include a second end 321. The first end region 310 may extend from the first end 311 to the middle region 330, and the second end region 320 may extend from the second end 321 to the middle region 330. The middle region 330 may define the midpoint of the tubular frame 305, so that the first end region 310 and the second end region 320 may have the same length. Alternatively, the middle region 330 may be disposed at a position other than the midpoint, so that the first and second end regions 310, 320 have different lengths.

[0057] In some cases, the first end region 310 may include a first flange structure 315 having a first outer diameter, and the second end region 320 may include a second flange structure 325 having a second outer diameter. The intermediate region 330 may be located between the first flange structure 315 and the second flange structure 325. The intermediate region 330 may be configured to engage the tissue surface, thereby applying a radial force to help prevent migration of the stent 300. The first end region 310 may also include a third flange structure 335 having a third outer diameter, the third flange structure 335 being longitudinally spaced apart from the first flange structure 315 by a first distance, as indicated by D1. The second end region 320 may also include a fourth flange structure 345, the fourth flange structure 345 being longitudinally spaced apart from the second flange structure 325 by a second distance, as indicated by D2. The third flange structure 335 and the fourth flange structure 345 can provide additional radial force to the first end region 310 and the second end region 320, respectively, thereby preventing the migration of the stent 300 from the stomach 360 to the jejunum 370 during peristalsis or turbulence caused by the digestion of food boluses. The third flange structure 335 can be longitudinally spaced D1 from the first flange structure 315, in the range of 5mm to 75mm. In some cases, the third flange structure 335 can be longitudinally spaced D1 from the first flange structure 315, at least 20mm. The fourth flange structure 345 can be longitudinally spaced D2 from the second flange structure 325, in the range of 5mm to 75mm. In some cases, the fourth flange structure 345 can be longitudinally spaced D2 from the second flange structure 325, at least 20mm. The longitudinal spacing between the first flange structure 315 and the third flange structure 335, and the longitudinal spacing between the second flange structure 325 and the fourth flange structure 345 can vary according to the required pull-out force.

[0058] The first flange structure 315, the second flange structure 325, the third flange structure 335, and the fourth flange structure 345 can be a retaining member configured to help retain the stent 300 in place. Therefore, the first, second, third, and fourth flange structures 315, 325, 335, 345 can include first, second, third, and fourth outer diameters, respectively, sufficient to provide retention strength. For example, the first, second, third, and fourth outer diameters of the first, second, third, and fourth flange structures 315, 325, 335, 345 can be in the range of 20 mm to 70 mm. In some cases, the first, second, third, and fourth flange structures 315, 325, 335, 345 can include first, second, third, and fourth outer diameters that are larger than the first end 311, the second end 321, and the middle region 330 of the tubular frame 305. In some cases, the first, second, third, and fourth outer diameters of the first, second, third, and fourth flange structures 315, 325, 335, 345, respectively, may be the same as one another, such as Figure 4As shown. In some cases, the first, second, third and fourth outer diameters of the first, second, third and fourth flange structures 315, 325, 335, 345 may be different from each other. In some cases, the third outer diameter of the third flange structure 335 may be greater than the first outer diameter, the second outer diameter and the fourth outer diameter of the first flange structure 315, the second flange structure 325 and the fourth flange structure 345, respectively. For example, the third outer diameter of the third flange structure 335 may include an outer diameter of 55 mm, and the first outer diameter of the first flange structure 315, the second outer diameter of the second flange structure 325 and the fourth outer diameter of the fourth flange structure 345 may include a width of 35 mm. In some cases, the third outer diameter of the third flange structure 335 may include an outer diameter of 45 mm, 60 mm, 65 mm, 70 mm, 45 mm to 70 mm, or any other suitable width. The first outer diameter of the first flange structure 315, the second outer diameter of the second flange structure 325, and the fourth outer diameter of the fourth flange structure 345 may include outer diameters of 25 mm, 30 mm, 40 mm, 45 mm, or any other suitable width.

[0059] In some cases, the first, second, third, and fourth flange structures 315, 325, 335, 345 may include any of a variety of shapes, such as concave, convex, disc-shaped, cylindrical (e.g., with a longer longitudinal extent as shown), etc., or other configurations, and the present disclosure is not limited to such shapes and configurations. Although it is shown that the first flange structure 315 and the third flange structure 335 are located near the first end region 310, and the second flange structure 325 and the fourth flange structure 345 are located near the second end region 320, it is contemplated that the first flange structure 315 and the third flange structure 335 are located near the second end region 320, and the second flange structure 325 and the fourth flange structure 345 are located near the first end region 310. In some cases, it is contemplated that the tubular frame 305 includes only one flange structure (e.g., the first flange structure 315, the second flange structure 325, the third flange structure 335, or the fourth flange structure 345).

[0060] The tubular frame 305 may include a plurality of interconnected struts 306 to form a woven filament braid structure of the tubular frame 305. The struts 306 may be configured to transition from a compressed state to an expanded state. The struts 306 may include, for example, a diameter of 0.0762 mm to 0.3556 mm. The tubular frame 305 may include a coating 307 applied to the struts 306 of the tubular frame 305, so that the entire portion of the stent 200 may be covered by the coating 307. The coating 307 may be formed of silicone and may be configured to prevent leakage of food materials during anastomosis formation. In some cases, the coating 307 may be applied to the struts 306 in the middle region 330. In some cases, the coating 307 may be applied to the struts 306 in the first end region 310 and the middle region 330, and in some cases, the coating 307 may be applied to the struts 306 in the second end region 320 and the middle region 330. These are examples only.

[0061] Figure 6 An exemplary stent 400 is shown positioned between a portion of the small intestine 470 (e.g., the jejunum) and a stomach wall 460 (e.g., the stomach). The stent 400 can be a self-expanding stent 400 and can include a radially expandable tubular frame 405 having a radially outward surface 401 and a radially inward surface ( Figure 6 The radially inward surface may be considered as an example of the radially inward surface 12, such as Figure 2 As shown. The term "radially expandable tubular frame 405" may be referred to as "tubular frame 405" hereinafter. Stent 400 may include a height of 10 mm and an outer diameter (e.g., width) of 20 mm. In some cases, the height of stent 400 may be 12 mm, 15 mm, 18 mm, 12 mm to 18 mm, or any other suitable height. In some cases, the outer diameter of stent 400 may be 18 mm, 22 mm, 25 mm, 18 mm to 25 mm, or any other suitable diameter. Tubular frame 405 may include a first end region 410, a second end region 420, and a middle region 430, wherein middle region 430 is located between first end region 410 and second end region 420. Tubular frame 405 may also include a lumen 440 extending from first end region 410 to second end region 420. Lumen 440 may be considered an example of lumen 14, such as Figure 2As shown. In some cases, the first end region 410 may be a distal end region, and the second end region 420 may be a proximal end region. In some cases, the first end region 410 may be a proximal end region, and the second end region 420 may be a distal end region. The first end region 410 may include a first end 411, and the second end region 420 may include a second end 421. The first end region 410 may extend from the first end 411 to the middle region 430, and the second end region 420 may extend from the second end 421 to the middle region 430. In some cases, the middle region 430 may define the midpoint of the tubular frame 405, so that the first end region 410 and the second end region 420 may have the same length. In some cases, as Figure 6 As shown, the intermediate region 430 may be disposed at a location other than the midpoint such that the first and second end regions 410 , 420 have different lengths.

[0062] In some cases, the first end region 410 may include a first flange structure 415 having a first outer diameter, and the second end region 420 may include a second flange structure 425 having a second outer diameter. The intermediate region 430 may be located between the first flange structure 415 and the second flange structure 425. The intermediate region 430 may be configured to engage a tissue surface, thereby applying a radial force to help prevent migration of the stent 400. The first end region 410 may also include a third flange structure 435 having a third outer diameter, the third flange structure 435 being longitudinally spaced apart from the first flange structure 415 by a first distance, as indicated by D1. The third flange structure 435 may provide additional radial force to the first end region 410 of the stent 400, thereby preventing migration of the stent 400 from the stomach 460 to the jejunum 470 during peristalsis or turbulence caused by digestion of a food bolus. The third flange structure 435 may be longitudinally spaced apart from the first flange structure 415 by D1, a range of 5 mm to 75 mm. In some cases, third flange structure 435 can be longitudinally spaced apart D1 by at least 20 mm from first flange structure 415. The longitudinal spacing between first flange structure 415 and third flange structure 435 can vary depending on the desired pull-out force.

[0063] The first flange structure 415, the second flange structure 425, and the third flange structure 435 can be a retaining member configured to help hold the stent 400 in place. Therefore, the first, second, and third flange structures 415, 425, 435 can include first, second, and third outer diameters, respectively, sufficient to provide retention strength. For example, the first, second, and third outer diameters of the first, second, and third flange structures 415, 425, 435 can be in the range of 20 mm to 70 mm. In some cases, the first, second, and third flange structures 415, 425, 435 can include first, second, and third outer diameters that are larger than the first end 411, the second end 421, and the middle region 430 of the tubular frame 405. In some cases, the first, second, and third outer diameters of the first, second, and third flange structures 415, 425, 435 can be the same as each other. In some cases, the first, second, and third outer diameters of the first, second, and third flange structures 415, 425, 435, respectively, may be different from each other, such as Figure 6 As shown. In some cases, the third outer diameter of the third flange structure 435 may be larger than the first outer diameter and the second outer diameter of the first flange structure 415 and the second flange structure 425, respectively. For example, the third outer diameter of the third flange structure 435 may include an outer diameter of 55 mm, and the first outer diameter of the first flange structure 415 and the second outer diameter of the second flange structure 425 may include a width of 35 mm. In some cases, the third outer diameter of the third flange structure 435 may include an outer diameter of 45 mm, 60 mm, 65 mm, 70 mm, 45 mm to 70 mm, or any other suitable width. The first outer diameter of the first flange structure 415 and the second outer diameter of the second flange structure 425 may include an outer diameter of 25 mm, 30 mm, 40 mm, 45 mm, 25 mm to 45 mm, or any other suitable width. In some cases, when the third outer diameter of the third flange structure 435 is larger than the first outer diameter of the first flange structure 415, as Figure 6 As shown, the risk of migration can be mitigated. For example, if the stent 400 begins to migrate from the stomach 460 into the jejunum 470, the third flange structure 435 will have a wide enough outer diameter to prevent such migration.

[0064] In some cases, the first, second, and third flange structures 415, 425, 435 may include any of a variety of shapes, such as concave, convex, disc-shaped, cylindrical (e.g., with a longer longitudinal extent as shown), etc., or other configurations, and the present disclosure is not limited to such shapes and configurations. Although it is shown that the first flange structure 415 and the third flange structure 435 are located near the first end region 410, and the second flange structure 425 is located near the second end region 420, it is contemplated that the first flange structure 415 and the third flange structure 435 are located near the second end region 420, and the second flange structure 425 is located near the first end region 410. In some cases, it is contemplated that the tubular frame 405 includes only one flange structure (e.g., the first flange structure 415, the second flange structure 425, or the third flange structure 435).

[0065] The tubular frame 405 may include a plurality of interconnected struts 406 to form a woven filament braid structure of the tubular frame 405. The struts 406 may be configured to transition from a compressed state to an expanded state. The struts 406 may include, for example, a diameter of 0.0762 mm to 0.3556 mm. The tubular frame 405 may include a coating 407, which is applied to the struts 406 of the tubular frame 405, so that the entire portion of the stent 400 can be covered by the coating 407. The coating 407 may be formed of silicone and may be configured to prevent leakage of food materials during anastomosis formation. In some cases, the coating 407 may be applied to the struts 406 in the middle region 430. In some cases, the coating 407 may be applied to the struts 406 in the first end region 410 and the middle region 430, and in some cases, the coating 407 may be applied to the struts 406 in the second end region 420 and the middle region 430. These are only examples.

[0066] The first flange structure 415 may include a first end 416 and a second end 417, the second flange structure 425 may include a first end 426 and a second end 427, and the third flange structure 435 may include a first end 436 and a second end 437. The first ends 416, 426, 436 and the second ends 417, 427, 437 may be formed by bending the struts 406 of the tubular frame 405 to form atraumatic flange structures (e.g., the first flange structure 415, the second flange structure 425, the third flange structure 435). Thus, the first ends 416, 426, 436 and the second ends 417, 427, 437 may be rounded and atraumatic, so that the first flange structure 415, the second flange structure 425, and the third flange structure 435 are configured to atraumatically engage body tissue (e.g., the stomach 20, the jejunum 30).

[0067] exist Figure 6In the example shown, the first end 416 of the first flange structure 415 and the second end 417 of the first flange structure 415 can be bent toward the third flange structure 435 (and away from the second flange structure 425) so that the first end 416 and the second end 417 of the first flange structure 415 can be configured to engage a surface of the third flange structure 435. As the first end 416 and the second end 417 engage the third flange structure 435, the third flange structure 435 provides resistance during peristalsis, thereby preventing migration of the stent 400 from the stomach 460 into the jejunum 470.

[0068] The stents 10, 100, 200, 300, 400 may be made of metals, metal alloys, polymers (some examples of which are disclosed below), metal-polymer composites, ceramics, combinations thereof, or the like, or other suitable materials. Some examples of suitable polymers may include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., available from DuPont), polyoxymethylene (POM ... ), polyether block esters, polyurethanes (e.g., Polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether esters (e.g., available from DSM Engineering Plastics) ), ether- or ester-based copolymers (e.g., butylene / poly(alkylene ether) phthalate and / or other polyester elastomers such as those available from DuPont ), polyamides (e.g., available from Bayer or available from Elf Atochem ), elastic polyamides, block polyamide / ether, polyether block amide (PEBA, for example, available under the trade name Obtained), ethylene vinyl acetate copolymer (EVA), silicone resin, polyethylene (PE), High density polyethylene, Low-density polyethylene, linear low-density polyethylene (e.g. ), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polybutylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly(p-phenylene terephthalamide) (e.g., ), polysulfone, nylon, nylon-12 (such as, available from EMS American Grilon) ), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefins, polystyrene, epoxy resins, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS 50A), polycarbonate, ionomers, biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers, polymer / metal composites thereof, etc. In some embodiments, the sheath may be blended with a liquid crystal polymer (LCP). For example, the mixture may contain up to about 6% LCP.

[0069] In at least some embodiments, some or all of the stents 10, 100, 200, 300, 400 may also be doped with, made of, or otherwise include radiopaque materials. Radiopaque materials should be understood as materials that are capable of producing a brighter image on a fluorescent screen or another imaging technique during a medical procedure. This brighter image helps the user of the stent 10, 100, 200, 300, 400 determine its position. Some examples of radiopaque materials may include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymer materials with radiopaque fillers, and the like. In addition, other radiopaque marker bands and / or coils may also be incorporated into the design of the stent 10, 100, 200, 300, 400 to achieve the same results.

[0070] In some embodiments, a degree of magnetic resonance imaging (MRI) compatibility is imparted to the stent 10, 100, 200, 300, 400. For example, the stent 10, 100, 200, 300, 400, or portions thereof, may be made of a material that does not substantially distort the image and does not form significant artifacts (e.g., gaps in the image). For example, certain ferromagnetic materials may be unsuitable because they may produce artifacts on MRI images. The stent 10, 100, 200, 300, 400, or portions thereof, may also be made of a material that is imageable by an MRI machine. Some materials that exhibit these properties include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS: R30003, such as etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035, such as etc.), Nitinol, Cisplatin, etc., and others.

[0071] It should be understood that the present disclosure is in many respects merely exemplary. Changes may be made in detail without exceeding the scope of the present disclosure, particularly with respect to shape, size, and step arrangement. To an appropriate degree, this may include the use of any one of the features of an example embodiment being used in other embodiments. Of course, the scope of the present invention is defined in the language of the appended claims.

Claims

1. A bracket, comprising: a radially expandable tubular frame having a first end region, a second end region, a middle region, and a lumen, the middle region being located between the first end region and the second end region, the lumen extending from the first end region to the second end region; a first flange structure located adjacent the first end region; and a second flange structure, the second flange structure being located adjacent the second end region; Wherein, one of the first end region or the second end region includes a third flange structure.

2. The bracket according to claim 1, wherein: The first flange and the second flange are configured to atraumatically engage body tissue.

3. The bracket according to claim 1 or 2, wherein: The first flange structure includes a first outer diameter, the second flange structure includes a second outer diameter, and the third flange structure includes a third outer diameter, wherein at least one of the first outer diameter, the second outer diameter, and the third outer diameter is different from the other outer diameters.

4. The bracket according to claim 3, wherein: The third outer diameter is larger than the first outer diameter and the second outer diameter.

5. The stent according to any one of claims 1 to 4, wherein: The first, second and third flange structures each have an outer diameter that is greater than the outer diameter of the intermediate region.

6. The stent according to any one of claims 1 to 5, wherein: The radially expandable tubular frame is formed from a woven filament braid.

7. The bracket according to claim 6, wherein: The braiding angle of the third flange structure is different from the braiding angles of the first flange structure and the second flange structure.

8. The stent according to any one of claims 1 to 7, wherein: The third flange structure is located adjacent the first end region.

9. The bracket according to claim 8, wherein: The third flange structure is longitudinally spaced apart from the first flange structure in the range of 5 mm to 75 mm.

10. The bracket according to claim 8, wherein: The third flange structure is longitudinally spaced apart from the first flange structure by at least 20 mm.

11. The bracket according to claim 8, wherein: The first flange structure is bent toward the third flange structure such that the first end and the second end of the first flange structure are configured to engage the third flange structure.

12. The stent according to any one of claims 1 to 11, wherein: The second end region includes a fourth flange structure.

13. The bracket according to claim 12, wherein: The fourth flange structure is longitudinally spaced apart from the second flange structure in the range of 5 mm to 75 mm.

14. The stent according to any one of claims 1 to 13, wherein: The intermediate region is configured to engage a tissue surface, thereby applying a radial force to prevent migration of the stent.

15. The stent according to any one of claims 1 to 14, wherein: The radially expandable tubular frame includes a coating applied thereto.

Images