Stepwise expanding anti-migration stent

Abstract

An example medical device includes a stent having a radially expanding tubular frame. The radially expanding tubular frame includes a first end region, a second end region, an intermediate region positioned between the first end region and the second end region, and a lumen extending from the first end region to the second end region. The stent also includes a tubular structure positioned on the intermediate region, the tubular structure formed of a bioabsorbable material and configured to maintain the intermediate region in a first compressed configuration. Upon bioresorption of the tubular structure, the intermediate region of the tubular frame radially expands to a second expanded configuration. One of the first end region or the second end region includes a first flange structure.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 389,290, filed on July 14, 2022, the disclosure of which is incorporated herein by reference. Technical Field

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

[0003] For various medical conditions, the treatment methods such as obesity, diabetes or duodenal ulcers involve bypassing the duodenum or limiting the flow of materials through the duodenum. If treatment needs to bypass the duodenum completely, occlusion of the pylorus (e.g., complete occlusion) may be required, and anastomosis may be created, such as between the stomach and the jejunum. A cavity juxtaposition device can be placed between the stomach and the jejunum to allow material (fluid, liquid, chyme, etc.) to pass from the stomach and enter the jejunum. A challenge brought by such devices is to prevent the device from migrating to the small intestine distally or to the stomach proximally. Therefore, there is a need to provide alternative medical devices and alternative methods for making and using medical devices. Summary of the invention

[0004] The present invention provides designs, materials, manufacturing methods, and use alternatives for medical devices. An example medical device may include a stent having a radially expanded tubular frame. The radially expanded tubular frame may include a radially outward surface, a radially inward surface, a first end region, a second end region, an intermediate region positioned between the first end region and the second end region, and a cavity extending from the first end region to the second end region. The stent may also include a tubular structure positioned on the intermediate region, and the tubular structure may be configured to maintain the intermediate region in a first compressed form. One of the first end region or the second end region may include a first flange structure.

[0005] Alternatively or additionally to any of the above embodiments, the tubular structure may be formed from a bioabsorbable material.

[0006] Alternatively or additionally to any of the above embodiments, upon bioresorption of the tubular structure, the intermediate region of the tubular framework may be radially expanded to a second expanded configuration.

[0007] Alternatively or additionally to any of the above embodiments, the expansion of the intermediate region of the tubular framework may be gradual over a period of time due to bioresorption of the tubular structure.

[0008] Alternatively or additionally to any of the above embodiments, when the intermediate region is in the second expanded configuration, the intermediate region can be configured to engage a tissue surface, thereby applying a radial force to prevent migration of the stent.

[0009] Alternatively or additionally to any of the above embodiments, the intermediate region of the tubular frame can include a first inner diameter when in the first compressed configuration and a second inner diameter when in the second expanded configuration, wherein the second inner diameter is greater than the first inner diameter.

[0010] Alternatively or additionally to any of the above embodiments, the second inner diameter may be 25% greater than the first inner diameter.

[0011] Alternatively or additionally to any of the above embodiments, the second inner diameter may be 10%-25% larger than the first inner diameter.

[0012] Alternatively or additionally to any of the above embodiments, the radially expanded tubular frame may include a coating applied to the tubular frame.

[0013] Alternatively or additionally to any of the above embodiments, the other of the first end region or the second end region may include a second flange structure.

[0014] An example stent may include 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 positioned between the first end region and the second end region, and a cavity extending from the first end region to the second end region. The stent may also include a tubular structure formed of a bioabsorbable material positioned on the intermediate region, the tubular structure being configured to maintain the intermediate region in a first compressed configuration, wherein upon bioabsorption of the tubular structure, the intermediate region of the tubular frame radially expands to a second expanded configuration. The radially expandable tubular frame may include a coating applied to the tubular frame.

[0015] Alternatively or additionally to any of the above embodiments, when the intermediate region is in the second expanded configuration, the intermediate region can be configured to engage a tissue surface, thereby applying a radial force to prevent migration of the stent.

[0016] Alternatively or additionally to any of the above embodiments, the intermediate region of the tubular frame can include a first inner diameter when in the first compressed configuration and a second inner diameter when in the second expanded configuration, wherein the second inner diameter is greater than the first inner diameter.

[0017] Alternatively or additionally to any of the above embodiments, the second inner diameter may be 25% greater than the first inner diameter.

[0018] Alternatively or additionally to any of the above embodiments, the second inner diameter may be 10%-25% larger than the first inner diameter.

[0019] Alternatively or additionally to any of the above embodiments, the first end region may include a first flange structure and the second end region may include a second flange structure.

[0020] An example stent may include a radially expandable tubular frame having a first end region, a second end region, and an intermediate region positioned between the first end region and the second end region. The stent may also include a tubular structure formed of a bioabsorbable material positioned on the intermediate region, the tubular structure being configured to maintain the intermediate region in a first compressed configuration, wherein upon bioabsorption of the tubular structure, the intermediate region of the tubular frame radially expands to a second expanded configuration. Due to bioabsorption of the tubular structure, the expansion of the intermediate region of the tubular frame may be gradual over a period of time, and the intermediate region of the tubular frame may include a first inner diameter when in the first compressed configuration and a second inner diameter when in the second expanded configuration, wherein the second inner diameter may be greater than the first inner diameter.

[0021] Alternatively or additionally to any of the above embodiments, when the intermediate region is in the second expanded configuration, the intermediate region can be configured to engage a tissue surface, thereby applying a radial force to prevent migration of the stent.

[0022] Alternatively or additionally to any of the above embodiments, the second inner diameter may be 25% greater than the first inner diameter.

[0023] Alternatively or additionally to any of the above embodiments, the second inner diameter may be 10%-25% larger than the first inner diameter.

[0024] The above summary of some embodiments is not intended to describe each disclosed embodiment or every implementation of the present invention. The following figures and detailed description more particularly exemplify these embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] The present invention may be more fully understood by considering the following detailed description taken in conjunction with the accompanying drawings, in which:

[0026] Figure 1 shows a side view of a stent positioned between the stomach and a portion of the small intestine;

[0027] Figure 2 Shown in Figure 1A cross-sectional view of the stent positioned between the stomach and the portion of the small intestine taken at line 2-2 of FIG.

[0028] Figure 3 shows a side view of an exemplary stent;

[0029] Figure 4 shows a perspective view of an exemplary tubular structure;

[0030] Figure 5 Shows Figure 4 A top view of an exemplary tubular structure;

[0031] Figure 6 An exemplary stent is shown that includes a tubular structure positioned between the stomach wall and a portion of the small intestine;

[0032] Figure 7 Shows Figure 6 of an exemplary stent positioned between the stomach wall and the portion of the small intestine wherein an anastomosis has been formed;

[0033] Figure 8 shows a top view of an exemplary stent including a tubular structure;

[0034] Fig. 9 Shows Figure 8 A side view of an exemplary stent including a tubular structure;

[0035] Fig.10 It shows that when the bioabsorbable tubular structure Figure 8 A top view of an exemplary stent of ;

[0036] Fig.11 It shows that when the bioabsorbable tubular structure Figure 8 A side view of an exemplary stent;

[0037] Fig.12 shows a side view of an exemplary stent including a tubular structure;

[0038] Fig.13 Shows Fig.12 A top view of an exemplary stent including a tubular structure;

[0039] Fig.14 It shows that when the bioabsorbable tubular structure Fig.12 A side view of an exemplary bracket of ; and

[0040] Fig.15 It shows that when the bioabsorbable tubular structure Fig.12 A top view of an exemplary bracket.

[0041] Although the present invention is suitable for various modifications and alternative forms, its specific details have been shown in the drawings by way of example and will be described in more detail. However, it should be understood that the present invention is not intended to limit the present invention to the specific embodiments described. On the contrary, the present invention is intended to cover all modifications, equivalents and substitutes that fall within the spirit of the present invention. DETAILED DESCRIPTION

[0042] For the following defined terms, these definitions shall apply unless a different definition is given in the claims or elsewhere in this specification.

[0043] All numerical values ​​herein are assumed to be modified by the term "about", whether or not expressly indicated otherwise. The term "about" generally refers to a range of numbers that one skilled in the art would consider equivalent to the cited numerical value (i.e., having the same function or result). In many cases, the term "about" may include numbers rounded to the nearest significant figure.

[0044] 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).

[0045] As used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally employed in a sense including "and / or" unless the content clearly dictates otherwise.

[0046] It should be noted that references to "one embodiment," "some embodiments," "other embodiments," etc., in this specification indicate that the described embodiments may include one or more specific features, structures, and / or characteristics. However, these descriptions do not necessarily mean that all embodiments include the specific features, structures, and / or characteristics. Additionally, when specific 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 stated to the contrary.

[0047] According to various principles of the present invention, an implantable device can be used to extend across anatomical structures to control or adjust the size of the passage through it. For example, an implantable device can extend across a body passage or cavity, and such terms are used interchangeably herein and are not intended to be limited. A body passage or body cavity may include, but is not limited to, a portion of a passage or cavity, a passage or cavity between anatomical structures (passages, cavities, cavities, organs, etc.), a passage created across juxtaposed tissue walls (such as for creating anastomosis), etc. The device has a passage or cavity through it (these terms are used interchangeably herein and are not intended to be limited), which can be used to occlude or block or narrow or close or tighten or adjust or control (these terms and their word forms can be used interchangeably herein and are not intended to be limited) a body passage, and the device is positioned through a body passage. The device can be considered and referred to as an occluding device or a cavity juxtaposition device or anastomosis device or a flow regulating device or a flow control device, and these terms and their various other alternatives can be used interchangeably herein and are not intended to be limited.

[0048] It should be understood that the devices, systems and methods disclosed herein can be used in endoscopic, laparoscopic and / or open surgical procedures. Preferably, a medical professional can deliver and / or remove the device endoscopically. Advantageously, the devices and systems disclosed herein can be used in minimally invasive surgery, such as natural orifice endoscopic surgery.

[0049] The following detailed description should be read with reference to the drawings, in which similar elements in different drawings have the same reference numerals. The drawings, which are not necessarily drawn to scale, depict illustrative embodiments and are not intended to limit the scope of the invention.

[0050] Figure 1 A perspective view of an illustrative stent 10 positioned between a stomach 20 and a jejunum 30 (a portion of the small intestine) is shown, and Figure 2 Shown in Figure 12-2 of FIG. 2 , a cross-sectional view of a stent 10 positioned between a stomach 20 and a jejunum 30, taken at line 2-2 of FIG. The stent 10 may be a self-expanding stent 10 and may include a radially expanded tubular frame 13 having a radially outward surface 11 and a radially inward surface 12. The radially expanded tubular frame 13 may include a first end region 16, a second end region 17, and an intermediate region 18 positioned between the first end region 16 and the second end region 17. The radially expanded 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, fluids, etc.) through the pylorus 60 into the duodenum 40. In some instances, treatment for patients with obesity, diabetes, or duodenal ulcers may involve bypassing the duodenum or restricting the flow of material through the duodenum 40. If treatment requires completely bypassing the duodenum 40 , occlusion of the pylorus 60 (eg, complete occlusion) may be required, and an anastomosis 15 may be created between the stomach 20 and the jejunum 30 , which may be referred to as a gastrojejunostomy. Figure 1 An example bypass procedure is shown in which a flow restricting device 50 is positioned within the pylorus 60, thereby restricting the passage of food material from the stomach 20 into the duodenum 40 (eg, complete bypass). Figure 1 and Figure 2 As shown, a cavity-apposed metal stent (LAMS), such as stent 10, can be placed between the stomach 20 and the jejunum 30 to allow food material (fluid, liquid, chyme, etc.) to pass from the stomach 20 and into the jejunum 30. Although stent 10 is shown as being used to form an anastomosis 15 between the stomach 20 and the jejunum 30, in some cases, it is contemplated that stent 10 can be used to treat stenosis in a blood vessel, to maintain a fluid opening or path in a blood vessel, urinary tract, biliary tract, tracheobronchial, esophageal or renal tract, or to position a device, such as an artificial valve or filter, within a body cavity. Although illustrated as a stent, stent 10 can be any of a variety of devices that can be introduced endoscopically, subcutaneously, percutaneously, or surgically to be positioned within an organ, tissue, or cavity, such as the heart, artery, vein, urethra, esophagus, trachea, bronchus, bile duct, etc.

[0051] Figure 3 A side view of an exemplary stent 100 is shown. Stent 100 may be Figure 1 to Figure 2 The stent 100 may include a radially expandable tubular frame 105 having a radially outward surface 101 and a radially inward surface (at Figure 3 ). Figure 2As shown, the radially inward surface can be considered an example of the radially inward surface 12. The term "radially expanded tubular frame 105" may be referred to as "tubular frame 105" hereinafter. The 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 the stent 100 may be 12 mm, 15 mm, 18 mm, between 12 mm and 18 mm, or any other suitable height. In some cases, the outer diameter of the stent 100 may be 18 mm, 22 mm, 25 mm, between 18 mm and 25 mm, or any other suitable diameter. The tubular frame 105 may include a first end region 110, a second end region 120, and an intermediate region 130 positioned between the first end region 110 and the second end region 120. The tubular frame 105 may also include a cavity 140 extending from the first end region 110 to the second end region 120. The cavity 140 may be considered an example of the cavity 14, such as Figure 2 As shown. In some cases, the first end region 110 can be considered a distal region, and the second end region 120 can be considered a proximal region. In alternative cases, the first end region 110 can be considered a proximal region, and the second end region 120 can be considered a distal 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. The middle region 130 may define a midpoint in the tubular frame 105, so that the first end region 110 and the second end region 120 may have the same length. Alternatively, the middle region 130 may be disposed at a position other than the midpoint, so that the first end region 110 and the second end region 120 have different lengths.

[0052] 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 positioned between the first flange structure 115 and the second flange structure 125. The first flange structure 115 and the second flange structure 125 may be considered as a retaining member, which is configured to help keep the stent 100 in place. Therefore, the first and second flange structures 115, 125 may include a width (e.g., outer diameter) sufficient to provide retention strength. For example, the width of the first and second flange structures 115, 125 may be in the range of 20 to 70 mm. In some cases, the width of the first and second flange structures 115, 125 may be greater than the width of the first end 111, the second end 121 and the intermediate region 130 of the tubular frame 105. In some cases, the first and second flange structures 115, 125 may include the same width. In some cases, the first and second flange structures 115, 125 may include different widths. In some cases, the first and second flange structures 115, 125 can include any of a variety of shapes, such as concave, convex, disc-shaped, cylindrical (e.g., having a longer longitudinal extent than shown), etc., or other forms, and the specific shapes and forms are not limited by the present invention. Although the first flange structure 115 is shown as being positioned near the first end region 110 and the second flange structure 125 is positioned near the second end region 120, it is contemplated that the first flange structure 115 is positioned near the second end region 120 and the second flange structure 125 is positioned 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 or the second flange structure 125).

[0053] The stent 100 can be configured to be implanted between the patient's stomach and jejunum to form an anastomosis. In other embodiments, the stent 100 can be configured to be implanted in, for example, the urinary tract, the biliary tract, the tracheobronchial tube, the esophagus, or the renal tract. Since the stent 100 or a portion thereof may be intended to be permanently implanted in a body cavity, the stent 100 can be made at least in part of a biostable material. Examples of biostable metallic materials can 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), cisplatin and other titanium-based alloys (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, polysulfones, and copolymers, blends, mixtures, or combinations thereof.

[0054] The tubular frame 105 may include a plurality of interconnected struts 106 to form a mesh 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 include, for example, a diameter of 0.0762 mm to 0.3556 mm. The tubular frame 105 may include a coating 107 applied to the struts 106 of the tubular frame 105, so that the entirety of the stent 100 may be covered with the coating 107. The coating 107 may be formed of silicone and may be configured to prevent food materials from leaking during anastomosis formation. In some cases, the coating 107 may be applied to the struts 106 in the middle region 130. In some cases, the coating 107 may be applied to the struts 106 within the first end region 110 and the middle region 130, and in some cases, the coating 107 may be applied to the struts 106 within the second end region 120 and the middle region 130. These are merely examples.

[0055] In some cases, stent 100 may include a tubular structure 150 positioned at intermediate region 130, such as Figure 4 and Figure 5 shown. Figure 4 A perspective view of an exemplary tubular structure 150 is shown, and Figure 5 A top view of an exemplary tubular structure 150 is shown. Figure 6 , Figure 8 , Fig. 9 , Fig.12 and Fig.13 As shown, the tubular structure 150 can be formed of a bioabsorbable material and can be configured to maintain the intermediate region 130 in a first compressed state. Examples of suitable bioabsorbable materials can include polymers such as polyglucamine, poly-L-lactide (PLLA), polyglycolide (PGA), polylactide (PLA), poly-D-lactide (PDLA), polycaprolactone, polydioxanone, polyglucose ester, polylactic acid-polyethylene oxide copolymer, modified cellulose, collagen, polyhydroxybutyrate, polyanhydride, polyphosphate, polyamino acid, and combinations thereof.

[0056] In a period of time after the stent 100 is implanted in the body, the bioabsorbable material of the tubular structure 150 can be absorbed by the patient's body through the bloodstream, other fluids and / or other natural components. The tubular structure 150 can have a thickness in the range of 0.102mm to 0.203mm. In this case, when the stent 100 is implanted between the stomach wall and the jejunum of the stomach, the bioabsorbable material of the tubular structure 150 can be completely absorbed within six weeks after insertion. In some cases, the tubular structure 150 can have a thickness of 0.05mm, 0.075mm, 0.25mm, 0.30mm or any other suitable thickness. In some cases, the bioabsorbable material of the tubular structure 150 can be completely absorbed within two weeks, four weeks, eight weeks or any other suitable time frame. In some cases, the time frame for the bioabsorption of the tubular structure 150 can be adjusted by changing the thickness of the tubular structure 150 and / or by changing the composition of the tubular structure 150, such as by including various additives. As previously described, the tubular structure 150 can be configured to maintain the middle region 130 of the tubular frame 105 in the first compressed configuration. The middle region 130 of the tubular frame 105 can be biased to the second expanded configuration. Figure 7 , Fig.10 , Fig.11 , Fig.14 and Fig.15 As shown, the middle region 130 of the tubular framework 105 can radially expand to a second expanded configuration upon bioresorption of the tubular structure 150. Thus, expansion of the middle region 130 of the tubular framework 105 due to bioresorption of the tubular structure 150 can be gradual over a period of time.

[0057] Figure 6 An exemplary stent 200 is shown, which includes a tubular structure 250 positioned between a stomach wall 260 (e.g., stomach) and a portion of a small intestine 270 (e.g., jejunum). The stent 200 may include a radially expandable tubular framework 205 having a radially outward surface 201 and a radially inward surface (at Figure 6 ). Figure 2As shown, the radially inward surface can be considered an example of the radially inward surface 12. The term "radially expanded tubular frame 205" may be referred to as "tubular frame 205" hereinafter. The stent 200 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 200 may be 12 mm, 15 mm, 18 mm, or any other suitable height. In some cases, the outer diameter of the stent 200 may be 18 mm, 22 mm, 25 mm, or any other suitable diameter. The tubular frame 205 may include a first end region 210, a second end region 220, and an intermediate region 230 positioned between the first end region 210 and the second end region 220. The tubular frame 205 may also include a cavity 240 extending from the first end region 210 to the second end region 220. The cavity 240 may be considered an example of the cavity 14, such as Figure 2 As shown. In some cases, the first end region 210 can be considered as a distal region, and the second end region 220 can be considered as a proximal region. In some cases, the first end region 210 can be considered as a proximal region, and the second end region 220 can be considered as a distal 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 include a midpoint in 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 set at a position other than the midpoint, so that the first end region 210 and the second end region 220 have different lengths.

[0058] In some cases, the first end region 210 may include a first flange structure 215, and the second end region 220 may include a second flange structure 225. The middle region 230 may be positioned between the first flange structure 215 and the second flange structure 225. The first flange structure 215 and the second flange structure 225 may be regarded as a retaining member, which is configured to help keep the stent 200 in place. Therefore, the first and second flange structures 215, 225 may include a width (e.g., outer diameter) sufficient to provide retention strength. For example, the width of the first and second flange structures 215, 225 may be in the range of 20 to 70 mm. In some cases, the width of the first and second flange structures 215, 225 may be greater than the width of the first end 211, the second end 221 and the middle region 230 of the tubular frame 205. In some cases, the first and second flange structures 215, 225 may include the same width. In some cases, the first and second flange structures 215, 225 may include different widths. In some cases, the first and second flange structures 215, 225 can include any of a variety of shapes, such as concave, convex, disc-shaped, cylindrical (e.g., having a longer longitudinal extent than shown), etc., or other forms, and the specific shapes and forms are not limited by the present invention. Although the first flange structure 215 is shown as being positioned near the first end region 210 and the second flange structure 225 is positioned near the second end region 220, it is contemplated that the first flange structure 215 is positioned near the second end region 220 and the second flange structure 225 is positioned 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 or the second flange structure 225).

[0059] The tubular frame 205 may include a plurality of interconnected struts 206 to form a mesh 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 entirety of the stent 200 may be covered with the coating 207. The coating 207 may be formed of silicone and may be configured to prevent food material from leaking during anastomosis 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 merely examples.

[0060] In some cases, stent 200 may include a tubular structure 250 positioned at intermediate region 230, such as Figure 6 In this case, the middle region 230 and the tubular structure 250 of the stent 200 can be positioned between the stomach and the jejunum, thereby being configured to engage with the walls of the cavities formed in the stomach and the jejunum. Figure 6 As shown, the tubular structure 250 can be formed of a bioabsorbable material and can be configured to maintain the intermediate region 230 in the first compressed state 290. Examples of suitable bioabsorbable materials can include polymers such as polyglycamine, poly-L-lactide (PLLA), polyglycolide (PGA), polylactide (PLA), poly-D-lactide (PDLA), polycaprolactone, polydioxanone, polyglucose ester, polylactic acid-polyethylene oxide copolymer, modified cellulose, collagen, polyhydroxybutyrate, polyanhydride, polyphosphate, polyamino acid, and combinations thereof.

[0061] In a period of time after the stent 200 is implanted in the body, the bioabsorbable material of the tubular structure 250 can be absorbed by the patient's body through the bloodstream, other fluids and / or other natural components. The tubular structure 250 can have a thickness in the range of 0.102mm to 0.203mm. In this case, when the stent 200 is implanted between the stomach wall and the jejunum of the stomach, the bioabsorbable material of the tubular structure 250 can be completely absorbed within six weeks after insertion. In some cases, the tubular structure 250 can have a thickness of 0.05mm, 0.075mm, 0.25mm, 0.30mm or any other suitable thickness. In some cases, the bioabsorbable material of the tubular structure 250 can be completely absorbed within two weeks, four weeks, eight weeks, ten weeks, twelve weeks or any other suitable time frame. In some cases, the time frame for the bioabsorption of the tubular structure 250 can be adjusted by changing the thickness of the tubular structure 250 and various additives. As previously described, the tubular structure 250 can be configured to maintain the intermediate region 230 of the tubular frame 205 in the first compressed configuration 290. When in the first compressed configuration 290, the intermediate region 230 can include an inner diameter of approximately 15 millimeters (mm). In some cases, the intermediate region 230 can include an inner diameter of approximately 10 mm, 12 mm, 18 mm, or any other suitable diameter.

[0062] During bioresorption of the tubular structure 250, the intermediate region 230 of the tubular framework 205 can radially expand to a second expanded configuration 295, such as Figure 7As shown. Due to the bioabsorption of the tubular structure 250, the expansion of the middle region 230 of the tubular framework 205 can be gradual over a period of time, thereby allowing the formation of the anastomosis 280. When the middle region 230 is in the first compressed state, the anastomosis 280 is formed around the middle region 230. Therefore, when the tubular structure 250 decays and the middle region 230 is in the second expanded state 295, the middle region 230 can be configured to engage with a tissue surface (e.g., anastomosis), thereby applying a radial force to prevent the migration of the stent 200, as shown. Figure 7 In some cases, the gradually increasing axial force on the anastomosis 280 can promote faster patency, thereby reducing the migration of the stent 200.

[0063] When the bioabsorbable tubular structure 250 is absorbed into the human body, the middle region 230 of the tubular frame 205 can expand by 25%. In some cases, the middle region 230 of the tubular frame 205 can expand by 10% to 25%, or any other suitable percentage. Thus, when the middle region 230 is in the second expanded configuration, the middle region 230 can include an inner diameter of 20 mm. In some cases, the middle region 230 can include an inner diameter of 12.5 mm, 15 mm, 22.5 mm, between 12 mm and 23 mm, or any other suitable diameter.

[0064] Figure 8 and Fig. 9 An exemplary stent 300 is shown in a first compressed configuration 360, wherein the stent 300 includes a tubular structure 350. The stent 300 may be Figure 6 and Figure 7An example of the stent 200 shown. The stent 300 may include a radially expanded tubular framework 305 having a radially outward surface 301 and a radially inward surface. The term "radially expanded tubular framework 305" may be referred to as "tubular framework 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 between 12 mm, 15 mm, 18 mm, 12 mm and 18 mm, or any other suitable height. In some cases, the outer diameter of the stent 300 may be between 18 mm, 22 mm, 25 mm, 18 mm and 25 mm, or any other suitable diameter. The tubular framework 305 may include a first end region 310, a second end region 320, and an intermediate region 330 positioned between the first end region 310 and the second end region 320. The tubular framework 305 may also include a cavity 340 extending from the first end region 310 to the second end region 320. In some cases, the first end region 310 can be considered a distal region, and the second end region 320 can be considered a proximal region. In some cases, the first end region 310 can be considered a proximal region, and the second end region 320 can be considered a distal region. The first end region 310 can include a first end 311, and the second end region 320 can include a second end 321. The first end region 310 can extend from the first end 311 to the middle region 330, and the second end region 320 can extend from the second end 321 to the middle region 330. The middle region 330 can define a midpoint in the tubular frame 305, so that the first end region 310 and the second end region 320 can have the same length. Alternatively, the middle region 330 can be disposed at a position other than the midpoint, so that the first end region 310 and the second end region 320 have different lengths.

[0065] In some cases, the first end region 310 may include a first flange structure 315, and the second end region 320 may include a second flange structure 325. The middle region 330 may be positioned between the first flange structure 315 and the second flange structure 325. The first flange structure 315 and the second flange structure 325 may be regarded as a retaining member, which is configured to help keep the stent 300 in a proper position. Therefore, the first and second flange structures 315, 325 may include a width (e.g., outer diameter) sufficient to provide retention strength. For example, the width of the first and second flange structures 315, 325 may be in the range of 20 to 70 mm. In some cases, the width of the first and second flange structures 315, 325 may be greater than the width of the first end 311, the second end 321 and the middle region 330 of the tubular frame 305. In some cases, the first and second flange structures 315, 325 may include the same width. In some cases, the first and second flange structures 315, 325 may include different widths. In some cases, the first and second flange structures 315, 325 can include any of a variety of shapes, such as concave, convex, disc-shaped, cylindrical (e.g., having a longer longitudinal extent than shown), etc., or other forms, and the specific shapes and forms are not limited by the present invention. Although the first flange structure 315 is shown as being positioned near the first end region 310 and the second flange structure 325 is positioned near the second end region 320, it is contemplated that the first flange structure 315 is positioned near the second end region 320 and the second flange structure 325 is positioned 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 or the second flange structure 325).

[0066] The tubular frame 305 may include a plurality of interconnected struts 306 to form a mesh 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 entirety of the stent 300 may be covered with the coating 307. The coating 307 may be formed of silicone and may be configured to prevent food materials from leaking 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 merely examples.

[0067] As described above, the stent 300 may include a tubular structure 350 positioned at the intermediate region 330, such as Fig. 9 The tubular structure 350 can be formed of a bioabsorbable material and can be configured to maintain the middle region 330 in the first compressed configuration 360. When the middle region 330 is in the first compressed configuration 360, the middle region 330 of the tubular frame 305 can include a first inner diameter D1 of about 15 mm. In some cases, the middle region 330 can include a first inner diameter D1 of about 10 mm, 12 mm, 18 mm, between 10 mm and 18 mm, or any other suitable diameter.

[0068] The bioabsorbable material of the tubular structure 350 can be absorbed by the patient's body through the bloodstream, other fluids and / or other natural components within a period of time after the stent 300 is implanted in the body. The tubular structure 350 can have a thickness in the range of 0.102 mm to 0.203 mm. In this case, when the stent 300 is implanted between the stomach wall and the jejunum of the stomach, the bioabsorbable material of the tubular structure 350 can be completely absorbed within six weeks after insertion. In some cases, the bioabsorbable material of the tubular structure 350 can be completely absorbed within two weeks, four weeks, eight weeks, or any other suitable time frame. In some cases, the time frame for bioabsorption of the tubular structure 350 can be adjusted by changing the thickness of the tubular structure 350 and various additives.

[0069] When the tubular structure 350 is bioabsorbed, the middle region 330 of the tubular framework 305 can radially expand to a second expanded configuration 370, such as Figure 10 to Figure 11 As shown. Due to the bioabsorption of the tubular structure 350, the expansion of the middle region 330 of the tubular framework 305 can be gradual over a period of time, thereby allowing the anastomosis to be formed. When the middle region 330 is in the first compressed configuration 360, the anastomosis is formed around the middle region 330. Therefore, when the tubular structure 350 decays and the middle region 330 is in the second expanded configuration 370, the middle region 330 can be configured to engage with a tissue surface (e.g., anastomosis) to apply radial force to prevent migration of the stent 300. In some cases, the gradually increasing axial force on the anastomosis can promote faster patency, thereby reducing migration of the stent 300.

[0070] Fig.10 and Fig.11 The second expanded configuration 370 is shown. Figure 8 and Fig. 9. When in the second expanded configuration 370, the middle region 330 of the tubular frame 305 can expand by 25% when the bioabsorbable tubular structure 350 is absorbed into the human body. In some cases, the middle region 330 of the tubular frame 305 can expand by 10% to 25%, or any other suitable percentage. In other words, the middle region 330 of the tubular frame 305 can include a first inner diameter D1 when in the first compressed configuration 360 and a second inner diameter D2 when in the second expanded configuration 370. Therefore, when the middle region 330 is in the second expanded configuration 370, the middle region 330 can include a second inner diameter D2 of 20 mm. In some cases, the middle region 330 can include a second inner diameter D2 of 12.5 mm, 15 mm, 22.5 mm, between 12 mm and 23 mm, or any other suitable diameter. In some cases, the second inner diameter D2 can be 25% larger than the first inner diameter D1. In some cases, the second inner diameter D2 can be 10% to 25% larger than the first inner diameter D1. In some cases, the second inner diameter D2 can be 30% larger than the first inner diameter D1.

[0071] Fig.12 and Fig.13 An exemplary stent 400 is shown in a first compressed configuration 460, wherein the stent 400 includes a tubular structure 450. The stent 400 may be Figure 6 and Figure 7An example of the stent 200 shown. The stent 400 may include a radially expanded tubular framework 405 having a radially outward surface 401 and a radially inward surface 402. The term "radially expanded tubular framework 405" may be referred to as "tubular framework 405" hereinafter. The stent 400 may include a height of 10 millimeters (mm) and an outer diameter (e.g., width) of 20 millimeters. In some cases, the height of the stent 400 may be 12mm, 15mm, 18mm, between 12mm and 18mm, or any other suitable height. In some cases, the outer diameter of the stent 400 may be 18mm, 22mm, 25mm, between 18mm and 25mm, or any other suitable diameter. The tubular framework 405 may include a first end region 410, a second end region 420, and an intermediate region 430 positioned between the first end region 410 and the second end region 420. The tubular framework 405 may also include a cavity 440 extending from the first end region 410 to the second end region 420. In some cases, the first end region 410 can be considered a distal region, and the second end region 420 can be considered a proximal region. In some cases, the first end region 410 can be considered a proximal region, and the second end region 420 can be considered a distal region. The first end region 410 can include a first end 411, and the second end region 420 can include a second end 421. The first end region 410 can extend from the first end 411 to the middle region 430, and the second end region 420 can extend from the second end 421 to the middle region 430. The middle region 430 can define a midpoint in the tubular frame 405, such that the first end region 410 and the second end region 420 can have the same length. Alternatively, the middle region 430 can be disposed at a position other than the midpoint, such that the first end region 410 and the second end region 420 have different lengths. In some cases, the first end region 410 and the second end region 420 can each have an outer diameter that is larger than the outer diameter of the middle region 430. As Fig.12 and Fig.14 As noted in , the stent 400 may include a “bow tie” shape. Thus, the diameter of the first end region 410 may gradually increase from the middle region 430 to the first end 411, and the diameter of the second end region 420 may gradually increase from the middle region 430 to the second end 421.

[0072] The tubular frame 405 may include a plurality of interconnected struts 406 to form a mesh 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 applied to the struts 406 of the tubular frame 405, so that the entirety of the stent 400 may be covered with the coating 407. The coating 407 may be formed of silicone and may be configured to prevent food material from leaking 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 within the first end region 410 and the middle region 430, and in some cases, the coating 407 may be applied to the struts 406 within the second end region 420 and the middle region 430. These are merely examples.

[0073] As described above, the stent 400 may include a tubular structure 450 positioned at the intermediate region 430, such as Fig.12 The tubular structure 450 can be formed of a bioabsorbable material and can be configured to maintain the middle region 430 in the first compressed configuration 460. When the middle region 430 is in the first compressed configuration 460, the middle region 430 of the tubular frame 405 can include a first inner diameter D1 of about 15 mm. In some cases, the middle region 430 can include a first inner diameter D1 of about 10 mm, 12 mm, 18 mm, or any other suitable diameter.

[0074] In a period of time after the stent 400 is implanted in the body, the bioabsorbable material of the tubular structure 450 can be absorbed by the patient's body through the bloodstream, other fluids and / or other natural components. The tubular structure 450 can have a thickness in the range of 0.102mm to 0.203mm. In this case, when the stent 400 is implanted between the stomach wall and the jejunum of the stomach, the bioabsorbable material of the tubular structure 450 can be completely absorbed within six weeks after insertion. In some cases, the bioabsorbable material of the tubular structure 450 can be completely absorbed within two weeks, four weeks, eight weeks, or any other suitable time frame. In some cases, the time frame for bioabsorption of the tubular structure 450 can be adjusted by changing the thickness of the tubular structure 450 and various additives.

[0075] When the tubular structure 450 is bioabsorbed, the middle region 430 of the tubular framework 405 can radially expand to a second expanded configuration 470, such as Fig.14 and Fig.15As shown. Due to the bioabsorption of the tubular structure 450, the expansion of the middle region 430 of the tubular frame 405 can be gradual over a period of time, thereby allowing the anastomosis to be formed. When the middle region 430 is in the first compressed configuration 460, the anastomosis is formed around the middle region 430. Therefore, when the tubular structure 450 decays and the middle region 430 is in the second expanded configuration 470, the middle region 430 can be configured to engage with a tissue surface (e.g., anastomosis) to apply radial force to prevent migration of the stent 400. In some cases, the gradually increasing axial force on the anastomosis can promote faster patency, thereby reducing migration of the stent 400.

[0076] Fig.14 and Fig.15 The second expanded configuration 470 is shown. Fig.12 and Fig.13 . When in the second expanded configuration 470, the middle region 430 of the tubular frame 405 can expand by 25% when the bioabsorbable tubular structure 450 is absorbed into the human body. In some cases, the middle region 430 of the tubular frame 405 can expand by 10% to 25%, or any other suitable percentage. In other words, the middle region 430 of the tubular frame 405 can include a first inner diameter D1 when in the first compressed configuration 460 and a second inner diameter D2 when in the second expanded configuration 470. Therefore, when the middle region 330 is in the second expanded configuration 470, the middle region 430 can include a second inner diameter D2 of 20 mm. In some cases, the middle region 430 can include a second inner diameter D2 of 12.5 mm, 15 mm, 22.5 mm, 12 mm to 23 mm, or any other suitable diameter. In some cases, the second inner diameter D2 can be 25% larger than the first inner diameter D1. In some cases, the second inner diameter D2 can be 10% to 25% larger than the first inner diameter D1. In some cases, second inner diameter D2 may be 30% greater than first inner diameter D1.

[0077] 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), polyoxyethylene (POM, e.g., commercially available from DuPont), polyoxyethylene (POM), polyoxyethylene (POM), polyoxyethylene (POM), polyoxyethylene (POM), polyoxyethylene (POM), polyoxyethylene (POM), polyoxyethylene (POM), polyoxyethylene (POM), polyoxyethylene (POM), polyoxyethylene (POM), polyoxyethylene (POM), polyoxyethylene (POM), polyoxyethylene (POM), polyoxyethylene (POM), polyoxyethylene (POE ... ), polyether block esters, polyurethanes (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether esters (e.g., commercially available from DSM Engineering Plastics ), ether- or ester-based copolymers (e.g., butylene phthalate / poly(alkylene ether) and / or other polyester elastomers, such as those commercially available from DuPont ), polyamide (for example, commercially available from Bayer or commercially available from Elf Atochem ), elastomeric polyamides, block polyamide / ether, polyether block amide (PEBA, for example, available under the trade name Commercially available), 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), polytrimethylene 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 commercially 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 can be mixed with a liquid crystal polymer (LCP). For example, the mixture can contain up to about 6% LCP.

[0078] In at least some embodiments, part or all of the stent 10, 100, 200, 300, 400 may also be doped with, made of, or otherwise include a radiopaque material. Radiopaque materials should be understood as materials that can produce relatively bright images on a fluorescent screen or with another imaging technique during a medical procedure. This relatively bright 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 loaded with radiopaque fillers, and the like. Additionally, 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.

[0079] 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 create a substantial amount of artifacts (i.e., gaps in the image). For example, certain ferromagnetic materials may not be suitable because they may create artifacts in the MRI image. The stent 10, or portions thereof, may also be made of a material that is capable of being imaged 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, etc.

[0080] It should be understood that the present invention is in many respects merely illustrative. Changes may be made in details, particularly in matters of arrangement of shape, size and steps, without exceeding the scope of the present invention. To the extent appropriate, this may include using any of the features of an example embodiment used in other embodiments. Of course, the scope of the present invention is defined by the language of the appended claims.

Claims

1. A bracket, comprising: a radially expanded tubular frame having a radially outward surface, a radially inward surface, a first end region, a second end region, an intermediate region positioned between the first end region and the second end region, and a lumen extending from the first end region to the second end region; and a tubular structure positioned over the intermediate region, the tubular structure configured to retain the intermediate region in a first compressed configuration; Wherein, one of the first end region or the second end region comprises a first flange structure.

2. The bracket according to claim 1, wherein: The tubular structure is formed of a bioabsorbable material.

3. The bracket according to claim 2, wherein: Upon bioresorption of the tubular structure, the intermediate region of the radially expandable tubular framework radially expands to a second expanded configuration.

4. The stent according to any one of claims 2 or 3, wherein: The expansion of the intermediate region of the radially expandable tubular framework occurs gradually over a period of time due to bioresorption of the tubular structure.

5. The stent according to any one of claims 2 to 4, wherein: The bioabsorbable material of the tubular structure is completely absorbed within six weeks after insertion.

6. The stent according to any one of claims 2 to 5, wherein: The intermediate region of the radially-expanded tubular frame includes a first inner diameter in the first compressed configuration and a second inner diameter in the second expanded configuration, wherein the second inner diameter is greater than the first inner diameter.

7. The bracket according to claim 6, wherein: The second inner diameter is 10%-25% larger than the first inner diameter.

8. The stent according to any one of claims 6 or 7, wherein: The second inner diameter is 25% greater than the first inner diameter.

9. The stent according to any one of claims 6 or 8, wherein: The second inner diameter of the middle region is 20 mm.

10. The stent according to any one of claims 1 to 9, wherein: The tubular structure comprises a thickness in the range of 0.102 mm to 0.203 mm.

11. The stent according to any one of claims 1 to 10, wherein: The radially expanded tubular frame includes a coating applied to the radially expanded tubular frame.

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

13. The stent according to any one of claims 1 to 12, wherein: The first flange structure comprises an outer diameter of 20 mm to 70 mm.

14. The stent according to any one of claims 12 or 13, wherein: The second flange structure comprises an outer diameter of 20 mm to 70 mm.

15. The stent according to any one of claims 12 to 14, wherein: The first flange structure and the second flange structure include different outer diameters.

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