Stent with features for reducing food impaction

Abstract

Stents and / or implants for reducing food impaction. An illustrative transluminal implant can include an elongated tubular body extending from a first end to a second end. The elongated tubular body can include a framework forming a plurality of cells and defining a lumen extending from the first end to the second end of the elongated tubular body, and at least one strut bisecting a lumen opening of the framework to define two or more openings, each opening having a cross-sectional dimension that is less than a cross-sectional dimension of the lumen opening.

Description

Cross-reference to related applications

[0001] This application claims the benefit and priority of U.S. Provisional Patent Application Serial No. 63 / 612,141, filed on December 19, 2023, the disclosure of which is incorporated herein by reference. Technical Field

[0002] This disclosure generally relates to methods and devices for use in a variety of diseases. More specifically, this disclosure relates to different configurations of stents, their manufacturing methods, and their uses. Background Technology

[0003] Implantable stents are devices placed in body structures (such as blood vessels, esophagus, trachea, bile ducts, colon, intestines, stomach, or body cavities) to provide support and maintain patency of that structure, or to maintain patency between two structures already connected by a stent to provide an alternative drainage pathway (e.g., transmural drainage). These devices are manufactured using any of a variety of different methods and can be used for a variety of applications depending on the method used. Each of the known medical stents, delivery systems, and methods has certain advantages and disadvantages. For example, some stents may become occluded. Occlusion events can be a combination of local factors (such as, but not limited to, inadequate stenosis resolution and abnormal bile physicochemical properties) and / or related to the stent design. In some cases, occlusion events may occur due to the stent's location within the body. For example, a stent with its tip positioned in the stomach may experience food impaction or food migration into the stent's lumen. Therefore, there is a continuous need to provide alternative stent designs that reduce or mitigate the risk of stent occlusion due to food impaction. Summary of the Invention

[0004] This disclosure relates to several alternative designs, materials, and manufacturing methods for medical device structures and components, and their uses. Example medical devices may include stents.

[0005] In a first example, a transcavitary implant may include an elongated tubular body extending from a first end to a second end. The elongated tubular body may include: a skeleton forming a plurality of chambers and defining an inner cavity extending from the first end to the second end of the elongated tubular body; and at least one strut bisects the cavity opening of the skeleton to define two or more openings, each opening having a cross-sectional dimension smaller than the cross-sectional dimension of the cavity opening.

[0006] In another example, alternative to or in addition to any of the examples above, the transcavitary implant may further include a proximal cage disposed adjacent to the first end.

[0007] In another example, instead of or in addition to any of the examples above, the at least one support may form part of the proximal cage.

[0008] In another example, instead of or in addition to any of the examples above, the proximal cage may have a generally flattened ellipsoidal shape.

[0009] In another example, instead of or in addition to any of the examples above, the proximal cage may have a generally hemispherical shape.

[0010] In another example, instead of or in addition to any of the examples above, the outer diameter of the proximal cage may be larger than the outer diameter of the second end of the elongated tubular body.

[0011] In another example, instead of or in addition to any of the examples above, the at least one pillar may form multiple rings.

[0012] In another example, which is alternative to or supplements any of the examples above, one of the rings may at least partially overlap with the previous ring of the plurality of rings.

[0013] In another example, instead of or in addition to any of the examples above, the plurality of rings may extend around the entire circumference of the cavity opening.

[0014] In another example, instead of or in addition to any of the examples above, the multiple loops may be woven.

[0015] In another example, instead of or in addition to any of the examples above, the at least one pillar may intersect with another pillar across the cavity opening.

[0016] In another example, alternative to or in addition to any of the examples above, the transcavitary implant may further include a coating disposed on at least some of the plurality of chambers.

[0017] In another example, instead of or in addition to any of the examples above, the two or more openings may be without the coating.

[0018] In another example, instead of or in addition to any of the examples above, the coating may be applied to at least some of the two or more openings.

[0019] In another example, instead of or in addition to any of the examples above, the second end of the elongated tubular body may include a flared distal region.

[0020] In another example, a transcavitary implant may include an elongated tubular body extending from a first end to a second end. The elongated tubular body may include: a skeleton forming a plurality of chambers and defining an inner cavity extending from the first end to the second end of the elongated tubular body; a proximal cage disposed adjacent to the first end of the elongated tubular body; and at least one strut forming a proximal portion of the proximal cage and bisecting the cavity opening of the skeleton to define two or more openings, each opening having a cross-sectional dimension smaller than that of the cavity opening.

[0021] In another example, alternative to or in addition to any of the examples above, the proximal cage may include a distal shoulder, a proximal end, and a curved sidewall extending between the distal shoulder and the proximal end.

[0022] In another example, instead of or in addition to any of the examples above, the distal shoulder may extend radially from the middle region of the elongated tubular body.

[0023] In another example, instead of or in addition to any of the examples above, the proximal cage may have a generally flattened ellipsoidal shape.

[0024] In another example, instead of or in addition to any of the examples above, the proximal cage may have a generally hemispherical shape.

[0025] In another example, instead of or in addition to any of the examples above, the outer diameter of the proximal cage may be larger than the outer diameter of the second end of the elongated tubular body.

[0026] In another example, instead of or in addition to any of the examples above, the at least one pillar may form multiple rings.

[0027] In another example, which is alternative to or supplements any of the examples above, one of the rings may at least partially overlap with the previous ring of the plurality of rings.

[0028] In another example, instead of or in addition to any of the examples above, the plurality of rings may extend around the entire circumference of the cavity opening.

[0029] In another example, instead of or in addition to any of the examples above, the at least one pillar may intersect with another pillar across the cavity opening.

[0030] In another example, alternative to or in addition to any of the examples above, the transcavitary implant may further include a coating disposed on at least some of the plurality of chambers.

[0031] In another example, instead of or in addition to any of the examples above, the two or more openings may be without the coating.

[0032] In another example, instead of or in addition to any of the examples above, the coating may be applied to at least some of the two or more openings.

[0033] In another example, a transluminal implant may include an elongated tubular body extending from a proximal end to a distal end. The elongated tubular body may include: a skeleton forming a plurality of chambers and defining an inner lumen extending from the proximal end of the elongated tubular body; a proximal cage disposed adjacent to the proximal end of the elongated tubular body, the proximal cage including a mesh that bisects the lumen opening of the skeleton to define a plurality of openings, each opening having a cross-sectional dimension smaller than the cross-sectional dimension of the lumen opening; and a coating disposed on a portion of the skeleton.

[0034] In another example, instead of or in addition to any of the examples above, at least some of the plurality of openings may be without the coating.

[0035] In another example, instead of or in addition to any of the examples above, the distal region of the elongated tubular body may be without the coating.

[0036] In another example, which may replace or be added to any of the examples above, the net may include one or more intersecting pillars.

[0037] In another example, instead of or in addition to any of the examples above, the net may include multiple overlapping loops.

[0038] In another example, a transluminal implant may include an elongated tubular body extending from a first end to a second end. The elongated tubular body may include: a skeleton forming a plurality of chambers and defining an inner cavity extending from the first end to the second end of the elongated tubular body; a coating disposed on at least some of the plurality of chambers; and a flexible sheath extending from a proximal end to a distal end and defining an inner cavity extending therethrough, the proximal end extending proximally beyond the first end of the elongated tubular body.

[0039] In another example, alternative to or in addition to any of the examples above, the inner diameter of the flexible sheath may decrease toward the proximal end of the flexible sheath.

[0040] In another example, instead of or in addition to any of the examples above, the flexible sheath may be fixed to the outer surface of the coating.

[0041] In another example, instead of or in addition to any of the examples above, the flexible sheath may be fixed to the inner surface of the coating.

[0042] In another example, instead of or in addition to any of the examples above, the flexible sheath may be formed with the coating as a single integral structure.

[0043] The foregoing description is provided to facilitate understanding of some of the innovative features characteristic of this disclosure and is not intended to be an exhaustive description. A full understanding of this disclosure can be obtained by considering the entire specification, claims, drawings, and abstract as a whole. Attached Figure Description

[0044] A more comprehensive understanding of this disclosure can be achieved by considering the following descriptions of various examples in conjunction with the accompanying drawings, in which:

[0045] Figure 1 This is a partial cross-sectional view of an illustrative stent implanted in the body to create a pathway between the intrahepatic (bile) bile ducts and the stomach.

[0046] Figure 2 A side view of an illustrative implant in an expanded state is shown, which is adapted for fluidly connecting two different body lumens;

[0047] Figure 3 Showing Figure 2 A proximal view of an illustrative stent;

[0048] Figure 4 A side view of another illustrative implant in its expanded state is shown;

[0049] Figure 5 Demonstrates alternative coating arrangements Figure 4 A side view of the illustrative bracket;

[0050] Figure 6 A side view of another illustrative implant (such as, but not limited to, a stent) in an expanded state is shown;

[0051] Figure 7 Showing Figure 6 A cross-sectional view of the illustrative bracket; and

[0052] Figure 8 It demonstrates an alternative placement with a flexible sleeve. Figure 6 A cross-sectional view of the illustrative bracket.

[0053] While this disclosure is adaptable to various modifications and alternatives, its details have been shown by way of example in the accompanying drawings and will be described in detail. However, it should be understood that this disclosure is not intended to be limited to the specific examples described. Rather, it is intended to cover all modifications, equivalents, and alternatives falling within the spirit and scope of this disclosure. Detailed Implementation

[0054] The following description should be read with reference to the accompanying drawings, in which the same elements in different drawings are represented by the same reference numerals. The drawings (not necessarily drawn to scale) depict examples that are not intended to limit the scope of this disclosure. Although examples are shown for various elements, those skilled in the art will recognize that many of the examples provided have suitable alternatives that can be utilized.

[0055] Unless the context clearly indicates otherwise, all numerical values ​​in this document should be considered as being modified by the term “about”. Enumerating numerical ranges by endpoints includes all numerical values ​​contained within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0056] As used in this specification and the appended claims, unless the context clearly indicates otherwise, the singular forms “a / an” and “the” include plural references. As used in this specification and the appended claims, unless the context clearly indicates otherwise, the term “or” is generally used in its sense that it includes “and / or”.

[0057] It should be noted that references to "embodiments," "some embodiments," "other embodiments," etc., in the specification indicate that the described embodiments may include specific features, structures, or characteristics, but each embodiment may not necessarily include that specific feature, structure, or characteristic. Furthermore, these phrases do not necessarily refer to the same embodiment. Moreover, when a specific feature, structure, or characteristic is described in connection with an embodiment, it is contemplated that such feature, structure, or characteristic, whether explicitly described or not, can be applied to other embodiments unless clearly stated otherwise.

[0058] In some cases, it may be desirable to provide an endoluminal implant or stent that can ensure patency within the pancreatobiliary tree. The relatively narrow bile ducts consist of a series of bifurcations that connect the liver, gallbladder, and pancreas to the duodenal space via papillae for transporting bile and related enzymes to perform many metabolic functions, but most commonly the body's ability to digest and absorb fats and vitamins D and K. However, obstructions can occur in the pancreatobiliary tree due to etiologies such as tumor-associated stenosis, stricture formation, infection, or the formation of stones and sludge. Endoscopic retrograde cholangiopancreatography (ERCP) is used to diagnose and treat these biliary strictures, regardless of the malignant or benign nature of the disease. However, ERCP may not always be an option, or may be unsuccessful in difficult anatomical structures or challenging disease states. If ERCP is not an option or fails, hepatogastric cholangiostomy (HGS) can be used. Other procedures, such as, but not limited to, choledochoduodenostomy (CDS), can be used to directly connect the common bile duct to the duodenum.

[0059] HGS is a procedure that directly targets the intrahepatic bile ducts through the stomach and places a stent to create an artificial pathway (bridging the peritoneal cavity) to facilitate continuous intrabiliary drainage. Figure 1This is a partial cross-sectional view of an illustrative stent 100 implanted in the body to create a pathway between the intrahepatic (bile) bile duct 12 and the stomach 10. The HGS procedure is performed using an endoscopic ultrasound or another endoscope 16 advanced through the esophagus 18, which allows the endoscopist to “see” through the wall of the stomach 10 and visualize the liver 14 before entry. The endoscopist can position the endoscope 16 to have a properly clear trajectory to the intrahepatic bile duct 12. A guidewire is then inserted into the bile duct 12 using a needle, followed by balloon and / or bladder knife dilation of the bile duct. Alternatively, a dedicated multi-functional all-in-one device can also be used for entry. The guidewire 22 is advanced from the stomach 10 into the bile duct 12. Finally, the stent 100 is advanced and deployed to create and maintain a bridging between the bile duct 12 and the interior 20 of the stomach 10, thus facilitating continuous intrabiliary drainage. Another factor that endoscopists weigh when positioning endoscope 16 for this procedure is the proximal positioning of stent 100 within the stomach to minimize food impaction / migration into the stent lumen. This disclosure relates to alternative stent designs that reduce and / or mitigate the risk of stent occlusion due to food impaction. While this disclosure is described in relation to the HGS procedure, the devices, systems, and / or methods described herein can be used in stents, endoluminal implants, or transluminal implants where the proximal end terminates in the upper GI tract. This can include devices placed during CDS procedures or during successful ERCP procedures, as well as other devices. Furthermore, while this disclosure is described in relation to the pancreatobiliary system, the devices, systems, and / or methods described herein can be used in stents, endoluminal implants, or transluminal implants positioned in other parts of the body, such as, but not limited to, body tissues, body organs, vascular lumens, nonvascular lumens, and combinations thereof, including, but not limited to, the coronary or peripheral vascular system, trachea, bronchi, colon, small intestine, esophagus, biliary tract, urinary tract, prostate, brain, stomach, etc.

[0060] Figure 2 A side view of an illustrative implant 100 (such as, but not limited to, a stent) in an expanded state is shown, which is adapted for fluidly connecting two different body lumens. Figure 3 Showing Figure 2The illustrative stent 100 is shown in a proximal view. In some instances, the stent 100 may be formed of an elongated tubular member 102. Although the stent 100 is described as generally tubular, it is contemplated that the stent 100 may adopt any desired cross-sectional shape. The stent 100 may have a first end or proximal end 104, a second end or distal end 106, and an intermediate region 108 disposed between the first end 104 and the second end 106. The stent 100 may include a lumen 110 extending from a first opening adjacent to the first end 104 to a second opening adjacent to the second end 106 to allow bile, fluids, etc., to pass through it. In some cases, as will be described in more detail herein, the first opening adjacent to the first end 104 may include one or more openings.

[0061] The support 100 can radially expand from a first radially collapsed configuration (not explicitly shown) to a second radially expanded configuration, such as... Figure 2 As shown. The scaffold 100 can be configured to extend across two non-adhesive structures / tissues and apply radially outward pressure to create an opening or channel between the two non-adhesive structures / tissues, thereby forming an anastomosis between two separate anatomical structures.

[0062] The tubular member 102 of the support 100 may have a skeleton structure made of one or more interwoven filaments or struts 112. The skeleton structure may extend from a first end 104 of the support 100 to a second end 106. For example, the skeleton structure, and therefore its filaments, may extend continuously from the first end 104 of the support 100 to the second end 106. In some embodiments, the support 100 may be formed (e.g., knitted) from a single filament interwoven with itself to form the skeleton structure. In other embodiments, the support 100 may be formed (e.g., woven) from a plurality of interwoven filaments to form the skeleton structure. Thus, in these instances, one or more of the filaments forming the skeleton structure may extend continuously from the first end 104 of the support 100 to the second end 106. In yet another embodiment, the support 100 may include a laser-cut tubular member to form the skeleton structure. The laser-cut tubular member may have an open-cell and / or closed-cell geometry comprising one or more interconnected struts formed integrally by the tubular member. In these examples, the laser-cut tubular component forming the skeleton structure can extend continuously from the first end 104 of the support 100 to the second end 106.

[0063] In some instances, the inner and / or outer surfaces of the scaffold structure of the stent 100 may be completely, substantially, or partially covered with a polymer cover or layer 114. For example, the cover or coating 114 may extend across the openings of the scaffold structure to prevent tissue from growing inward into the lumen 110 of the stent 100. In some cases, the cover or coating 114 may prevent food or particles from entering the lumen 110 or prevent fluid from leaking from the lumen 110 along the coated area. Although not explicitly shown, the cover or coating 114 may include an outer layer disposed on the outer surface of the scaffold structure and / or an inner layer disposed on the inner surface of the scaffold structure (e.g., the lumen surface). In some embodiments, the stent 100 may include only an external polymer cover on the outer surface of the scaffold structure. In other embodiments, the stent 100 may include only an internal polymer cover on the inner surface of the scaffold structure. In some instances, the inner and outer layers may be formed as a single integral structure to form the cover or coating 114. In other embodiments, the inner and outer layers may be formed as separate layers to collectively form the cover or coating 114. Depending on the requirements, the inner and outer layers can be formed of the same or different materials. The covering or coating 114 can span or be disposed within openings or gaps defined between adjacent scaffold filaments or struts 112 of the scaffold structure. It is understood that, as the inner and outer layers extend outward and inward respectively, they can touch and / or form interface regions within spaces (e.g., openings, chambers, gaps) in the walls of the scaffold structure of the scaffold 100. For example, the inner and outer layers can extend into openings 116 defined between adjacent scaffold struts 112 and form interface regions. Further, the inner and outer layers can additionally extend between adjacent filaments or struts 112, thereby filling any space between adjacent filaments or struts 112 and thus preventing tissue from growing inward into the lumen of the scaffold 100. The covering or coating 114 can extend along the entire length of the scaffold 100 from a first end 104 to a second end 106. In other embodiments, the covering or coating 114 can extend only along a portion of the scaffold 100. For example, the covering or coating 114 may extend from a first end 118, remote from the proximal end 104 of the stent 100, to a second end 120, near the distal end 106 of the stent 100, to define a proximal region 122 without the covering or coating 114, an intermediate coated region 124, and a distal region 126 without the covering or coating 114. It is contemplated that the proximal region 122 may remain uncoated to allow fluid or bile to pass through the lumen 110 of the stent 100 and exit at the proximal region 122, while limiting the entry of large particles. In some embodiments, the length of the uncoated distal region 126 may be greater than that of the uncoated proximal region 122. However, this is not desirable. In some examples, the length of the uncoated proximal region 122 may be greater than that of the uncoated distal region 126.In other examples, the uncoated proximal region 122 and the uncoated distal region 126 may have approximately the same length. It is contemplated that the lengths of the uncoated proximal region 122, the coated intermediate region 124, and / or the uncoated distal region 126 may be determined based on the desired application, implant location, etc. In some examples, the stent 100 may be fully coated with openings for fluid flow into the portion processed into the coating 114.

[0064] It is envisioned that the skeletal structure of the stent 100 (e.g., filaments and / or struts) can be made of a variety of different materials (e.g., but not limited to metals, metal alloys, shape memory alloys, and / or polymers) as needed, allowing the stent 100 to expand and take shape when precisely positioned within the body. In some instances, the materials can be selected such that the stent 100 can also be relatively easily removed. For example, the stent 100 can be formed of alloys (e.g., but not limited to nitinol and Elgiloy®). Depending on the materials selected for construction, the stent 100 can be self-expanding or require external force to expand radially. In some embodiments, filaments can be used to manufacture the stent 100; these filaments can be composite filaments, for example, having a shell made of nitinol and a platinum core. It is further envisioned that the filaments of the stent 100 can be formed of polymers, including but not limited to polyethylene terephthalate (PET).

[0065] In some instances, in a radially expanded configuration, the stent 100 may include a first end region 128 near the first end 104 and a second end region 130 near the second end 106. In some embodiments, the first end region 128 may include a proximal cage 132 located adjacent to the first end 104, and the second end region 130 may include a distal region 134 located adjacent to the second end 106 of the stent 100. It is contemplated that the proximal cage 132 and / or the distal region 134 may be formed simultaneously with the elongated tubular member 102 of the stent 100. For example, the proximal cage 132 and / or the distal region 134 may be formed from one or more filaments or struts forming a skeletal structure, which extend continuously from the first end 104 to the second end 106 of the stent 100 when the elongated tubular member 102 is woven, knitted, laser-cut, etc. The proximal cage 132 may be configured to engage an internal portion of the wall of a body cavity or body tubule. For example, the proximal cage 132 can be positioned against the interior of the first body lumen (e.g., the wall of the stomach 10). The distal region 134 can be configured to be positioned within another lumen separate from the first body lumen (e.g., the bile duct 12). However, the diameter of the distal region 134 can be increased relative to the intermediate region 108 to apply a radially outward force on the surface of the lumen of the bile duct 12, thereby aiding in the anchoring of the stent 100. Thus, the stent 100 can be positioned to traverse between two separate anatomical structures. For example, in Figure 1 In this configuration, the stent 100 is positioned such that it extends between the stomach 10 and the intrahepatic bile duct 12. A proximal cage 132 may be positioned within the stomach 10, and a distal region 134 may be positioned within the intrahepatic bile duct 12. An intermediate region 108 of the stent 100, extending between the proximal cage 132 and the distal region 134, may extend through the wall of the stomach 10 and into the lumen of the intrahepatic bile duct 12, thereby interconnecting the two anatomical structures. In some cases, at least a portion of the proximal cage 132 may contact the interior of the wall of the stomach 10 and / or the distal region 134 may contact the inner surface of the intrahepatic bile duct 12. The proximal cage 132 and / or the distal region 134 may anchor the stent 100 against the stomach wall and the intrahepatic bile duct 12, thereby inhibiting or preventing stent 100 migration. However, this is not desirable.

[0066] The outer diameter 136 of the proximal cage 132 may be larger than the outer diameter 138 of the intermediate region 108. In some examples, the proximal cage 132 may have a generally ellipsoidal shape, such as, but not limited to, a generally flattened ellipsoidal shape, which includes a proximal end 142, a distal shoulder 144, and a curved sidewall 146 extending between the proximal end 142 and the distal shoulder 144. It is contemplated that the proximal cage 132 may take other shapes, such as, but not limited to, spherical, hemispherical, rectangular prism, irregular shapes, etc. The distal shoulder 144 of the proximal cage 132 may extend radially from the intermediate region 108 of the elongated tubular member 102. It is contemplated that, as needed, the transition from the cross-sectional region of the intermediate region 108 to the proximal cage 132 may occur gradually, obliquely, or abruptly. In some examples, the distal shoulder 144 may extend generally orthogonally to the longitudinal axis of the elongated tubular member 102. However, it is envisioned that the distal shoulder 144 may extend at a non-orthogonal angle as needed. The angle of the distal shoulder 144 may be selected based on the target anatomical structure. In some cases, the distal shoulder 144 may provide a mechanical stop between the proximal cage 132 and the target anatomical structure. The curved sidewall 146 may have a curved semicircular shape with a gradually increasing cross-sectional dimension that then gradually decreases in a direction parallel to the longitudinal axis of the elongated tubular body 102. However, the curved sidewall 146 may take other shapes as needed, including curved, linear, or irregular shapes.

[0067] For further reference Figure 3The proximal end 142 of the proximal cage 132 may include further supports (e.g., filaments) 112 of the elongated body 102 that extend across the proximal opening of the lumen 110 of the support 100. In other words, the supports or filaments 112 may bisect the proximal opening of the support 100 to form a mesh or sieve across the proximal opening of the lumen 110 of the support 100. The supports or filaments 112 may extend transversely to the longitudinal axis of the support 100. One or more supports or filaments 112 may intersect or overlap each other to define a plurality of openings 148, each opening having a cross-sectional dimension smaller than the cross-sectional dimension of the proximal opening of the elongated tubular member 102. For clarity and simplicity, not every opening 148 is labeled. It is contemplated that the density or number of supports or filaments 112 extending across the proximal opening may be inversely proportional to the size of the opening 148. For example, the denser the struts or filaments 112 (e.g., the greater the number of struts 112 or the greater the number of intersections or overlaps), the smaller the opening 148. In other words, increasing the density of the struts or filaments 112 can reduce the size of the opening 148. Furthermore, increasing the density of the struts or filaments 112 can increase the number of openings 148. The density of the struts or filaments 112 extending across the proximal opening of the lumen 110 can be determined by the viscosity of the fluid to be passed through the lumen 110. In this example, the density of the struts or filaments 112 can be selected to allow bile to flow from the intrahepatic bile duct 12 through the lumen 110 into the stomach 10, while preventing food particles from entering the lumen 110 from the stomach 10. However, the density of the struts or filaments 112 can be determined by the placement of the support 100. For example, a fluid with higher viscosity or containing particles may require a larger opening 148 (lower density of struts or filaments 112), while a fluid with lower viscosity or without particles can flow through a smaller opening 148 (higher density of struts 112). The struts or filaments 112 can overlap in any number of patterns or irregularly as needed. In the illustrated embodiment, the struts or filaments 112 can be arranged as a plurality of rings 150a-l having a generally teardrop shape. While the illustrated embodiment shows twelve rings 150a-l, the proximal cage 132 can include fewer or more than twelve rings 150a-l as needed. The struts or filaments 112 can be positioned such that a selected ring 150b at least partially overlaps with a preceding ring 150a. The overlapping pattern can continue around the circumference of the proximal end 142 such that each ring overlaps with a preceding ring, and the ring overlaps with subsequent rings. It is contemplated that overlapping the rings 150a-l could allow a clinician to temporarily manipulate the proximal cage 132 endoscopically (e.g., move one or more of its struts or filaments 112), if desired. For example, one or more of the rings 150a-l can be temporarily displaced to allow the device to temporarily access the stent lumen. The device can be larger than the device that the near-side cage 132 can allow in a no-bias or no-manipulation configuration.In some cases, the struts or filaments 112 may be knitted or braided to interlock adjacent loops 150a-l. In other examples, the struts or filaments 112 may be wound such that successive loops are positioned on the preceding loop. It is contemplated that the loops 150a-l may take other shapes, such as, but not limited to, circles, ovals, squares, rectangles, rhombuses, polygons, irregular shapes, etc. In other examples, the struts or filaments 112 may be braided or otherwise extended across the proximal cavity opening such that the struts or filaments 112 have a generally linear orientation. In some examples, the loops 150a-l (or a linearly arranged pattern) may be formed from a single continuous strut or filament 112. In other examples, the loops 150a-l (or a linearly arranged pattern) may be formed from two or more struts or filaments 112. The loops 150a-l may extend around the entire circumference of the proximal end 142 of the proximal cage 132 or around the entire proximal cavity opening. In other examples, the ring 150a-l may extend less than 360° around the circumference of the proximal end 142 of the proximal cage 132 or around the entire proximal cavity opening.

[0068] The distal region 134 may include a flare, or its outer diameter may gradually increase from the proximal end 152 of the distal region 134, having an outer diameter similar to or approximately equal to that of the intermediate region, to the distal end 106 adjacent to the support 100, or to a second outer diameter 140 at that distal end. However, this is not desirable. In some examples, the diameter of the distal region 134 may be the same as the diameter 138 of the intermediate region 108 along the entire length of the distal region 134. In other examples, the distal region 134 may include an abrupt or stepped transition between the first outer diameter and the second outer diameter 140.

[0069] In some embodiments, the proximal cage 132 may have a first outer diameter 136, and the distal region 134 may have a second outer diameter 140. The outer diameter 136 of the proximal cage 132 and / or the outer diameter 140 of the distal region 134 may be larger than the outer diameter 138 of the intermediate region 108. The inner diameter of at least a portion of the proximal cage 132 and / or the distal region 134 may be larger than the inner diameter of the intermediate region 108. In some instances, the first outer diameter 136 and the second outer diameter 140 may be substantially the same, while in other instances, the first outer diameter and the second outer diameter may be different. For example, in some cases, the outer diameter 136 of the proximal cage 132 may be larger than the outer diameter 140 of the distal region 134. The support 100 may take other shapes as needed. In some embodiments, the distal region 134 of the support 100 may include a structure similar to the proximal cage 132. In other embodiments, the support 100 may have a substantially uniform outer diameter from its proximal end 104 to its distal end 106. It is envisioned that the outer diameter of the support 100 can be varied to suit the desired application.

[0070] Figure 4 A side view of another illustrative implant 200 (such as, but not limited to, a stent) in an expanded state is shown. In some instances, the stent 200 may be formed from an elongated tubular member 202. While the stent 200 is described as generally tubular, it is contemplated that the stent 200 may adopt any desired cross-sectional shape. The stent 200 may have a first end or proximal end 204, a second end or distal end 206, and an intermediate region 208 disposed between the first end 204 and the second end 206. The stent 200 may include a lumen 210 extending from a first opening adjacent to the first end 204 to a second opening adjacent to the second end 206 to allow bile, fluids, etc., to pass through it. In some cases, as will be described in more detail herein, the first opening adjacent to the first end 204 may include one or more openings.

[0071] The support 200 can radially expand from a first radially collapsed configuration (not explicitly shown) to a second radially expanded configuration, such as... Figure 4 As shown. The scaffold 200 can be configured to extend across two non-adhesive structures / tissues and apply radially outward pressure to create an opening or channel between the two non-adhesive structures / tissues, thereby forming an anastomosis between two separate anatomical structures.

[0072] The tubular member 202 of the support 200 may have a skeleton structure made of one or more interwoven filaments or struts 212. The skeleton structure may extend from a first end 204 of the support 200 to a second end 206. For example, the skeleton structure, and therefore its filaments, may extend continuously from the first end 204 of the support 200 to the second end 206. In some embodiments, the support 200 may be formed (e.g., knitted) from a single filament interwoven with itself to form the skeleton structure. In other embodiments, the support 200 may be formed (e.g., woven) from several interwoven filaments to form the skeleton structure. Thus, in these instances, one or more of the filaments forming the skeleton structure may extend continuously from the first end 204 of the support 200 to the second end 206. In yet another embodiment, the support 200 may include a laser-cut tubular member to form the skeleton structure. The laser-cut tubular member may have an open-cell and / or closed-cell geometry comprising one or more interconnected struts formed integrally by the tubular member. In these examples, the laser-cut tubular component forming the skeleton structure can extend continuously from the first end 204 of the support 200 to the second end 206.

[0073] In some instances, the inner and / or outer surfaces of the scaffold structure of the scaffold 200 may be completely, substantially, or partially covered with a polymer cover or layer 214. For example, the cover or coating 214 may extend across the openings of the scaffold structure to prevent tissue from growing inward into the lumen 210 of the scaffold 200. In some cases, the cover or coating 214 may prevent food or particles from entering the lumen 210 or prevent fluid from leaking from the lumen 210 along the coated area. Although not explicitly shown, the cover or coating 214 may include an outer layer disposed on the outer surface of the scaffold structure and / or an inner layer disposed on the inner surface of the scaffold structure (e.g., the lumen surface). In some embodiments, the scaffold 200 may include only an external polymer cover on the outer surface of the scaffold structure. In other embodiments, the scaffold 200 may include only an internal polymer cover on the inner surface of the scaffold structure. In some instances, the inner and outer layers may be formed as a single integral structure to form the cover or coating 214. In other embodiments, the inner and outer layers may be formed as separate layers to collectively form the cover or coating 214. Depending on the requirements, the inner and outer layers can be formed of the same or different materials. The covering or coating 214 can span or be disposed within openings or gaps 216 defined between adjacent scaffold filaments or struts 212 of the scaffold structure. It is understood that, as the inner and outer layers extend outward and inward respectively, they can touch and / or form interface regions within spaces (e.g., openings, chambers, gaps) in the walls of the scaffold structure of the scaffold 200. For example, the inner and outer layers can extend into openings 216 defined between adjacent scaffold struts 212 and form interface regions. Further, the inner and outer layers can additionally extend between adjacent filaments or struts 212, thereby filling any space between adjacent filaments or strut members 212 and thus preventing tissue from growing inward into the lumen of the scaffold 200. The covering or coating 214 can extend along the entire length of the scaffold 200 from a first end 204 to a second end 206. In other embodiments, the covering or coating 214 can extend only along a portion of the scaffold 200. For example, a covering or coating 214 may extend distally from a first end 218 remote from the proximal end 204 of the stent 200 to the distal end 206 of the stent 200 to define a proximal region 222 without the covering or coating 214 and a coated region 224. In other embodiments, the covering or coating 214 may terminate near the distal end 206 of the stent 200 to define a distal region without the covering or coating 214. It is contemplated that the proximal region 222 may remain uncoated to allow fluid or bile to pass through the lumen 210 of the stent 200 and exit at the proximal region 222, while limiting the entry of large particles. In some embodiments, the stent 200 may include an uncoated distal region (not explicitly shown).It is envisioned that the lengths of the uncoated proximal region 222, the coated region 224, and / or any other coated or uncoated regions can be determined based on the desired application, implant location, etc. In some examples, the stent 200 may be fully coated with openings for fluid flow in portions processed into the coating 214.

[0074] It is envisioned that the skeletal structure of the scaffold 200 (e.g., filaments and / or struts) can be made from a variety of different materials (e.g., but not limited to metals, metal alloys, shape memory alloys, and / or polymers) as needed, allowing the scaffold 200 to expand and take shape when precisely positioned within the body. In some instances, the materials can be selected such that the scaffold 200 can also be relatively easily removed. For example, the scaffold 200 can be formed from alloys (e.g., but not limited to nitinol and Elgiloy®). Depending on the materials chosen for construction, the scaffold 200 can be self-expanding or require external force to expand radially. In some embodiments, filaments can be used to manufacture the scaffold 200; these filaments can be composite filaments, for example, having a shell made of nitinol and a platinum core. It is further envisioned that the filaments of the scaffold 200 can be formed from polymers, including but not limited to polyethylene terephthalate (PET).

[0075] In some instances, in a radially expanded configuration, the stent 200 may include a first end region 228 near the first end 204 and a second end region 230 near the second end 206. In some embodiments, the first end region 228 may include a proximal cage 232 positioned adjacent to the first end 204, and the second end region 230 may include a distal region 234 positioned adjacent to the second end 206 of the stent 200. It is contemplated that the proximal cage 232 and / or the distal region 234 may be formed simultaneously with the elongated tubular member 202 of the stent 200. For example, the proximal cage 232 and / or the distal region 234 may be formed when the elongated tubular member 202 is woven, knitted, laser-cut, etc. The proximal cage 232 may be configured to engage an internal portion of the wall of a body cavity or body lumen. For example, the proximal cage 232 may be positioned against the interior of a first body lumen (e.g., the wall of the stomach 10). The distal region 234 can be configured to be located within another separate lumen (e.g., bile duct 12). However, although not explicitly shown, it is similar to the description of... Figure 2The distal region 134, shown and described, may have a diameter increased relative to the intermediate region 208 to apply a radially outward force on the surface of the lumen, thereby facilitating the anchorage of the stent 200. The stent 200 may be positioned to traverse between two separate anatomical structures. In one example, the proximal cage 232 may be positioned in the stomach 10, and the distal region 234 may be positioned in the intrahepatic bile duct 12. The intermediate region 208 of the stent 200, extending between the proximal cage 232 and the distal region 234, may extend through the wall of the stomach 10 and into the lumen of the intrahepatic bile duct 12, thereby interconnecting the two anatomical structures. In some cases, at least a portion of the proximal cage 232 may be configured to contact the interior of the wall of the stomach 10 and / or the distal region 234 may contact the inner surface of the intrahepatic bile duct 12. The proximal cage 232 and / or distal region 234 can anchor the stent 200 against the gastric wall and intrahepatic bile duct 12, thereby inhibiting or preventing stent 200 migration. However, this is not desirable.

[0076] The outer diameter 236 of the proximal cage 232 may be larger than the outer diameter 238 of the intermediate region 208. In some examples, the proximal cage 232 may have a generally hemispherical shape, which includes a proximal end 242, a distal shoulder 244, and a curved sidewall 246 extending between the proximal end 242 and the distal shoulder 244. It is contemplated that the proximal cage 232 may take other shapes, such as, but not limited to, spherical, ellipsoidal, rectangular prism, irregular shapes, etc. The hemispherical shape of the proximal cage 232 can increase the surface area through which fluid can pass through the cavity 210 of the support 200 (e.g., flowing in a distal to proximal direction), while still restricting the flow of food particles in the opposite direction (e.g., in a proximal to distal direction) relative to the ellipsoidal shape. For example, increasing the surface area of ​​the proximal cage 232 can increase the surface area of ​​the opening 248 through which fluid can pass when compared to a proximal cage with a smaller surface area and an opening of the same size. In other words, increasing the total surface area of ​​the proximal cage 232 can increase the number of openings 248 through which fluid can flow, while maintaining the same size of openings (relative to a proximal cage with a smaller total surface area).

[0077] The distal shoulder 244 of the proximal cage 232 can extend radially from the intermediate region 208 of the elongated tubular member 202. It is contemplated that the transition from the cross-sectional area of ​​the intermediate region 208 to the proximal cage 232 can occur gradually, obliquely, or abruptly, as needed. In some examples, the distal shoulder 244 can extend approximately orthogonally to the longitudinal axis of the elongated tubular member 202. However, it is contemplated that the distal shoulder 244 can extend at a non-orthogonal angle as needed. The angle of the distal shoulder 244 can be selected based on the target anatomical structure. In some cases, the distal shoulder 244 can provide a mechanical stop between the proximal cage 232 and the target anatomical structure. The curved sidewall 246 can have a curved shape with a gradually increasing cross-sectional dimension that then gradually decreases in a direction parallel to the longitudinal axis of the elongated tubular body 202. However, the curved sidewall 246 can take other shapes as needed, including curved, linear, or irregular shapes.

[0078] The curved sidewalls 246 and / or proximal end 242 of the proximal cage 232 may be further supported by struts 212 of the elongated body 202, which extend across the proximal opening of the cavity 210 of the support 200. In other words, the struts 212 may bisect the proximal cavity opening of the support 200 to form a mesh or sieve. The struts 212 may extend transversely to the longitudinal axis of the support 200. One or more struts 212 may intersect or overlap each other to define a plurality of openings 248, each opening having a cross-sectional dimension smaller than that of the elongated tubular member 202 or the cavity opening. For clarity and simplicity, not every opening 248 is labeled. An opening 248 may resemble an opening 216. At least some of the openings 248 of the proximal cage 232 are located radially inward of the intermediate region 208 of the support 200. It is contemplated that the density or number of struts 212 extending across the proximal opening may be inversely proportional to the size of the opening 248. For example, the denser the struts 212 (e.g., the greater the number of struts 212 or the greater the number of intersections or overlaps), the smaller the opening 248. In other words, increasing the density of the struts 212 can reduce the size of the opening 248. Furthermore, increasing the density of the struts 212 can increase the number of openings 248. The density of the struts 212 extending across the proximal opening of the lumen 210 can be determined by the viscosity of the fluid to be passed through the lumen 210. In this example, the density of the struts 212 can be selected to allow bile to flow from the intrahepatic bile duct 12 through the lumen 210 into the stomach 10, while preventing food particles from entering the lumen 210 from the stomach 10. However, the density of the struts 212 can be determined by the placement of the stent 200.

[0079] The supports 212 can overlap in any number of patterns or irregularly as needed. In the illustrated embodiment, the supports 212 can be arranged in a manner similar to the central region 208 of the support 200. For example, the supports 212 of the proximal cage 232 can be interwoven (or laser-cut) into the skeletal structure. In other examples, the proximal cage 232 may include structures similar to... Figure 3 The proximal cage 132 has multiple rings or winding structures of ring 150a-l. The opening 248 of the proximal cage 232 can take any desired shape, such as, but not limited to, circular, elliptical, square, rectangular, rhomboid, polygonal, irregular shapes, etc. In other examples, the struts 212 can be woven or otherwise extended across the proximal lumen opening, such that the struts 212 have a generally linear orientation. It is contemplated that, if desired, the struts 212 of the proximal cage 132 can be temporarily manipulated by a clinician under endoscopy (e.g., moving one or more struts 212). For example, one or more of the struts 212 can be temporarily displaced to allow a device to temporarily access the stent lumen. The device can be larger than the device that the proximal cage 232 can allow in an unbiased or unmanipulated configuration.

[0080] The outer diameter of the distal region 234 may be similar to or approximately equal to the outer diameter 238 of the intermediate region 208. However, this is not desirable. In some embodiments, the distal region may include a flare, or the outer diameter may gradually increase from the proximal end of the distal region 234 having an outer diameter similar to or approximately equal to the outer diameter 238 of the intermediate region to the distal end 206 adjacent to the support 200 or at that distal end. In other examples, the distal region 234 may include an abrupt or stepped transition between the first and second outer diameters.

[0081] In some embodiments, the outer diameter 236 of the proximal cage 232 and / or the outer diameter of the distal region 234 may be larger than the outer diameter 238 of the intermediate region 208. The inner diameter of at least a portion of the proximal cage 232 and / or the distal region 234 may be larger than the inner diameter of the intermediate region 208. In some instances, the first and second outer diameters of the proximal cage 232 and the distal region 234 may be substantially the same, while in other instances, the first and second outer diameters may be different. For example, in some cases, the outer diameter 236 of the proximal cage 232 may be larger than the outer diameter of the distal region 234. The stent 200 may take other shapes as needed. In some embodiments, the distal region 234 of the stent 200 may include a structure similar to the proximal cage 232. In other embodiments, the stent 200 may have a substantially uniform outer diameter from its proximal end 204 to its distal end 206. It is contemplated that the outer diameter of the stent 200 may vary to suit a desired application.

[0082] Figure 5 It shows an alternative coating arrangement 214'. Figure 4 A side view of the illustrative bracket 200. Figure 5 In the illustrated embodiments, coating 214' extends proximally over a portion of the proximal cage 232 to the proximal end 242 of the proximal cage. For example, coating 214' may extend radially over a portion 252 of the proximal cage 232. In some examples, stent 200 may be deployed intramuscularly such that the coated portion 252 of the proximal cage 232 is positioned to shield the lumen 210 of stent 200 from food as it leaves the esophagus. The stent delivery system may include visual markers to aid clinicians in locating stent 200, wherein the coated portion 252 of the proximal cage 232 is in a desired orientation relative to the patient's anatomy. In some examples, coating 214' may be applied to selectively drain the lumen 210 in a desired direction. It is contemplated that one or more areas of stent 200 may remain uncoated with coating 214' to control fluid flow. One or more uncoated areas 214' of the support 200 may be positioned at any location along the length of the support 200 and / or its circumference and / or at the proximal cage 232 where it is desired to control fluid flow and / or restrict or prevent particle ingress. Figure 5 As shown, a first portion of the proximal cage 232 may be covered with coating '214, while a second portion of the proximal cage 232 may remain uncovered, thereby allowing fluid to flow through the gaps in the uncovered portion of the proximal cage 232. When implanted, the covered portion of the proximal cage 232 may be oriented toward the lower end of the esophagus, thereby shielding the proximal cage 232 from particles (e.g., food, fluid, etc.) entering the cage from the esophagus.

[0083] Figure 6 A side view of another illustrative implant 300 (such as, but not limited to, a stent) in an expanded state is shown. Figure 7 Showing Figure 6 A cross-sectional view of an illustrative stent 300. In some instances, the stent 300 may be formed of an elongated tubular member 302. Although the stent 300 is described as generally tubular, it is contemplated that the stent 300 may adopt any desired cross-sectional shape. The stent 300 may have a first end or proximal end 304, a second end or distal end 306, and an intermediate region 308 disposed between the first end 304 and the second end 306. In some cases, the intermediate region 308 may be referred to as a saddle region. The stent 300 may include an inner lumen 310 extending from a first opening adjacent to the first end 304 to a second opening adjacent to the second end 306 to allow bile, fluids, etc., to pass through it.

[0084] The support 300 can radially expand from a first radially collapsed configuration (not explicitly shown) to a second radially expanded configuration, such as... Figures 6 to 7As shown. The scaffold 300 can be configured to extend across two non-adhesive structures / tissues and apply radially outward pressure to create an opening or channel between the two non-adhesive structures / tissues, thereby forming an anastomosis between two separate anatomical structures.

[0085] The tubular member 302 of the support 300 may have a skeleton structure made of one or more interwoven filaments or struts 312. The skeleton structure may extend from a first end 304 of the support 300 to a second end 306. For example, the skeleton structure, and therefore its filaments, may extend continuously from the first end 304 of the support 300 to the second end 306. In some embodiments, the support 300 may be formed (e.g., knitted) from a single filament interwoven with itself to form the skeleton structure. In other embodiments, the support 300 may be formed (e.g., woven) from several interwoven filaments to form the skeleton structure. Thus, in these instances, one or more of the filaments forming the skeleton structure may extend continuously from the first end 304 of the support 300 to the second end 306. In yet another embodiment, the support 300 may include a laser-cut tubular member to form the skeleton structure. The laser-cut tubular member may have an open-cell and / or closed-cell geometry comprising one or more interconnected struts formed integrally by the tubular member. In these examples, the laser-cut tubular component forming the skeleton structure can extend continuously from the first end 304 of the support 300 to the second end 306.

[0086] In some instances, the inner and / or outer surfaces of the scaffold structure of the scaffold 300 may be completely, substantially, or partially covered with a polymer covering or layer 314, 316 (see example...). Figure 7For example, a covering or coating may extend across the openings of the scaffold structure to prevent tissue from growing inward into the lumen of the scaffold 300. In some cases, the covering or coating 314, 316 may prevent food or particles from entering the lumen 310 or prevent fluid from leaking from the lumen 310 along the coated area. However, in some embodiments, one or both of the polymer coverings 314, 316 may be omitted. For example, in some embodiments, the scaffold 300 may include only the outer polymer covering 316 on the outer surface of the scaffold structure. In other embodiments, the scaffold 300 may include only the inner polymer covering 314 on the inner surface of the scaffold structure. In some instances, the inner layer 314 and the outer layer 316 may be formed as a single integral structure. In other embodiments, the inner layer 314 and the outer layer 316 may be formed as separate layers. The inner layer 314 and the outer layer 316 may be formed of the same or different materials, as needed. The inner layer 314 and / or the outer layer 316 may span or be disposed within openings or gaps defined between adjacent scaffold filaments or struts 312 of the scaffold structure. It is understood that, as the inner layer 314 and the outer layer 316 extend outward and inward respectively, they may touch and / or form interface regions within spaces (e.g., openings, chambers, gaps) 318 in the walls of the scaffold structure of the scaffold 300. For example, the inner layer 314 and the outer layer 316 may extend into openings 318 defined between adjacent scaffold struts 312 and form interface regions. Further, the inner layer 314 and the outer layer 316 may additionally extend between adjacent filaments or struts 312, thereby filling any space between adjacent filaments or strut members 312 and thus preventing tissue from growing inward into the lumen of the scaffold 300.

[0087] It is envisioned that the skeletal structure of the stent 300 (e.g., filaments and / or struts) can be made from a variety of different materials (e.g., but not limited to metals, metal alloys, shape memory alloys, and / or polymers) as needed, allowing the stent 300 to expand and take shape when precisely positioned within the body. In some instances, the materials can be selected such that the stent 300 can also be relatively easily removed. For example, the stent 300 can be formed from alloys (e.g., but not limited to nitinol and Elgiloy®). Depending on the materials selected for construction, the stent 300 can be self-expanding or require external force to expand radially. In some embodiments, filaments can be used to manufacture the stent 300; these filaments can be composite filaments, for example, having a shell made of nitinol and a platinum core. It is further envisioned that the filaments of the stent 300 can be formed from polymers, including but not limited to polyethylene terephthalate (PET).

[0088] In some instances, in a radially expanded configuration, the stent 300 may include a first end region 320 near the first end 304 and a second end region 322 near the second end 306. In some embodiments, the first end region 320 and the second end region 322 may include shoulder or enlarged regions, such as flanges 324, 326 positioned adjacent to the first end 304 and the second end 306 of the stent 300. The flanges 324, 326 may be configured to engage internal portions of the walls of a body cavity or lumen. For example, the first flange 324 may abut against the interior of a first body lumen, and the second flange 326 may abut against the interior of a second body lumen, different from the first body lumen. Thus, the stent 300 may be positioned to traverse between two separate anatomical structures. The first flange 324 and / or the second flange 326 may anchor the stent 300 against the anatomical structure, thereby inhibiting or preventing stent 300 migration. However, this is not desirable.

[0089] Flanges 324, 326 may extend circumferentially around the support 300 and define annular recesses extending circumferentially around the interior of the support 300. The annular recesses may have enlarged inner diameters relative to portions of the flanges 324, 326 on their lateral sides. In some embodiments, the diameters of the flanges 324, 326 may be larger than the intermediate region or saddle 308 of the support 300 located between the end regions 320, 322, to prevent or help prevent stent migration once the stent is placed within or across a body cavity or body canal. It is contemplated that, as needed, the transition from the cross-sectional region of the intermediate region or saddle 308 to the retention feature or flanges 324, 326 may occur gradually, obliquely, or abruptly. In some cases, flanges 324, 326 may have a curved semi-circular cross-sectional shape, the cross-sectional dimensions of which gradually increase and then gradually decrease in a certain direction, such that the first end 304 and / or the second end 306 have cross-sectional dimensions similar to the intermediate region or saddle 308. However, this is not required. Other shapes and / or configurations may be used as needed. For example, in some cases, the distal side of the proximal flange 324 and the proximal side of the distal flange 326 may have a generally concave shape. In some examples, one or both of flanges 324, 326 may be omitted. In some embodiments, the support 300 may be similar in form and function to the supports 100, 200 described herein. For example, the support 300 may include a proximal cage comprising a strut that bisects the distal region of the proximal cavity opening and / or flare.

[0090] In some embodiments, the first flange 324 may have a first outer diameter, and the second flange 326 may have a second outer diameter. The outer diameters of the first flange 324 and / or the second flange 326 may be larger than the outer diameter of the intermediate region or saddle 308. The inner diameters of the first flange 324 and / or the second flange 326 may be larger than the inner diameter of the intermediate region or saddle 308. In some instances, the inner diameter of the first flange 324 may be larger than the inner diameter at the first end 304 of the bracket 300, and / or the inner diameter of the second flange 326 may be larger than the inner diameter at the second end 306 of the bracket 300. Therefore, the inner diameter of the first flange 324 may be larger than the portion of the bracket 300 extending in the opposite direction from the first flange 324, and / or the inner diameter of the second flange 326 may be larger than the portion of the bracket 300 extending in the opposite direction from the second flange 326. In some instances, the first outer diameter and the second outer diameter may be substantially the same, while in other instances, the first outer diameter and the second outer diameter may be different. In some embodiments, the bracket 300 may include only one flange 324, 326, or the bracket 300 may not include any flanges, if desired. For example, the first end region 320 may include a flange 324, while the outer diameter of the second end region 322 may be similar to the outer diameter of the intermediate region or saddle 308. Further, it is contemplated that the second end region 322 may include a flange 326, while the outer diameter of the first end region 320 may be similar to the outer diameter of the intermediate region or saddle 308. In some embodiments, the bracket 300 may have a uniform outer diameter from the first end 304 to the second end 306. It is contemplated that the outer diameter of the bracket 300 may vary to suit a desired application.

[0091] The stent 300 may further include a flexible sleeve 328 extending from a proximal end 330 to a distal end 332. The flexible sleeve 328 may be formed of a highly flexible polymer that is robust in a thin segment, such as, but not limited to, polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), low-density polyethylene (LDPE), very low-density polyethylene (VLDPE), linear low-density polyethylene (LLDPE), polyvinyl chloride (PVC), silicone, etc. The proximal end 330 of the flexible sleeve 328 may extend proximally to the proximal end 304 of the stent 300. In some cases, the distal end 332 of the flexible sleeve 328 may be positioned close to the distal end 306 of the stent 300. However, this is not desirable. In other embodiments, the distal end 332 of the flexible sleeve 328 may extend to the distal end 306 of the stent 300. The flexible sleeve 328 may have a generally tubular configuration, thereby defining an inner lumen 334 extending from its proximal end 330 to its distal end 332. The inner cavity 334 of the flexible sleeve 328 is in fluid communication with the inner cavity 310 of the support 300.

[0092] The flexible sleeve 328 may be flexible such that, in the absence of a support structure, the wall 336 of the flexible sleeve 328 hangs over the proximal opening of the stent 300. In other words, the proximal end 330 of the flexible sleeve 328 may droop below the longitudinal axis of the stent 300. In some embodiments, the flexible sleeve 328 may collapse flat against itself unless internal fluid leaks from the lumen 310 of the stent 300 and / or is pushed into the lumen 334 of the flexible sleeve. It is contemplated that the flexible sleeve 328 may selectively block the proximal opening of the stent 300. For example, fluid may easily pass through the lumen 310 of the stent 300 in a distal-to-proximal direction, thereby exiting the flexible sleeve at the proximal opening 338 of the flexible sleeve 328. However, in an example of a stent 300 implanted between the stomach 10 and the intrahepatic bile duct 12, food may not be able to enter the proximal opening 338 of the flexible sleeve 328. For example, external forces in the stomach (e.g., food or fluid) may not be able to open the flexible sleeve 328, and therefore food or fluid from the stomach may not be able to flow backward into the proximal opening 338 of the flexible sleeve 328. In this way, the flexible sleeve 328 can be used as a one-way valve that controls the direction of material flow through the lumen 310 of the support 300.

[0093] In some embodiments, the flexible sleeve 328 can be fixed to the outer surface of the bracket 300, such as Figure 7 As shown. It is envisioned that the flexible sleeve 328 can be attached to the outer polymer coating 316 using suitable techniques (such as thermal bonding, adhesives, etc.). In other examples, the flexible sleeve 328 may be formed as a single integral structure with the outer polymer coating 316.

[0094] Brief Reference Figure 8 The figure is a cross-sectional view of an illustrative support 300 with an alternative placement of a flexible sleeve 328, which may be disposed within the cavity 310 of the support and coupled to an internal polymer coating 314. It is contemplated that the flexible sleeve 328 can be coupled to the internal polymer coating 314 using suitable techniques (such as thermal bonding, adhesives, etc.). In other examples, the flexible sleeve 328 may be formed as a single integral structure with the internal polymer coating 314. Although Figure 8 The flexible sleeve 328 is shown to conform to the inner surface of the support 300, but in some embodiments, the flexible sleeve 328 may not extend into the flange 324. In other words, the flexible sleeve 328 may have a uniform or substantially constant inner diameter.

[0095] In some examples, the inner diameter of the flexible sleeve 328 can be reduced in the proximal direction, regardless of whether the flexible sleeve 328 is fixed relative to the outer surface or the inner surface of the support 300. It is envisioned that reducing the inner diameter of the flexible sleeve 328 can increase its valve-like characteristics. For example, fluid can easily pass through the inner cavity 310 of the support 300 in the distal to proximal direction and enter the inner cavity 334 of the sleeve 328, while a smaller proximal opening 338 (relative to the proximal opening of the support 300) can further inhibit the flow of food, particles, fluids, etc., in the proximal to distal direction.

[0096] Materials that may be used in the different components and elements of the medical stents disclosed herein may include those typically associated with medical devices. For simplicity, the following discussion refers to devices. However, this is not intended to limit the devices and methods described herein, as the discussion can be applied to other elements, components, parts, or devices disclosed herein, such as, but not limited to, medical stents, filaments, coverings, flexible sleeves, and / or their elements or parts.

[0097] In some instances, the device and / or its components may be made of metal, metal alloy, polymer (some examples of which are disclosed below), metal-polymer composites, ceramics, combinations thereof, or other suitable materials.

[0098] Examples of suitable polymers may include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene copolymer (ETFE), fluorinated ethylene propylene copolymer (FEP), polyoxymethylene (POM, such as DELRIN® commercially available from DuPont), polyether block esters, polyurethanes (such as polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether esters (such as ARNITEL® commercially available from DSM Engineering Plastics), ether- or ester-based copolymers (such as butene / poly(alkylene ether) phthalates and / or other polyester elastomers, such as HYTREL® commercially available from DuPont), and polyamides (such as DURETHAN® or Elf commercially available from Bayer). Atochem commercially available CRISTAMID®, elastomer polyamides, block polyamides / ethers, polyether block amides (PEBA, e.g., commercially available under the trade name PEBAX®), ethylene-vinyl acetate copolymer (EVA), silicones, polyethylene (PE), MARLEX® high-density polyethylene, MARLEX® low-density polyethylene, linear low-density polyethylene (e.g., REXELL®), polyesters, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polypropylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene ether (PPO), poly(p-phenylene terephthalamide) (e.g., KEVLAR®), polysulfone, nylon, nylon-12 (e.g., EMS American) Commercially available Grilon materials include GRILAMID®, perfluoro(propyl vinyl ether) (PFA), ethylene-vinyl alcohol copolymers, polyolefins, polystyrene, epoxy resins, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS 50A), polycarbonate, polyurethane silicone copolymers (e.g., Aortech Biomaterials' ElastEon® or AdvanSource Biomaterials' ChronoSil®), biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers thereof, polymer / metal composites, etc. In some embodiments, the sheath may be blended with a liquid crystal polymer (LCP). For example, the blend may contain up to about 6% LCP.

[0099] Some examples of suitable metals and metal alloys include stainless steels such as 304V, 304L, and 316LV stainless steels; low-carbon steels; nickel-titanium alloys such as linearly elastic and / or hyperelastic nickel-titanium; other nickel alloys such as nickel-chromium-molybdenum alloys (e.g., UNS: N06625, such as INCONEL® 625; UNS: N06022, such as HASTELLOY® C-22®; UNS: N10276, such as HASTELLOY® C276®; other HASTELLOY® alloys, etc.), nickel-copper alloys (e.g., UNS: N04400, such as MONEL® 400, NICKELVAC® 400, NICORROS® 400, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035, such as MP35-N®, etc.), and nickel-molybdenum alloys (e.g., UNS: N10665, such as HASTELLOY® ALLOY). B2®), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, etc.; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS: R30003, such as ELGILOY®, PHYNOX®, etc.); platinum-rich stainless steel; titanium; platinum; palladium; gold; combinations thereof; or any other suitable material.

[0100] In at least some instances, parts or all of the device and / or its components may be doped with, made of, or otherwise include a radiopaque material. A radiopaque material should be understood as a material capable of producing a relatively bright image on a fluoroscopic screen or other imaging technique during medical procedures. This relatively bright image helps the user of the device determine its location. Some examples of radiopaque materials may include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymeric materials doped with radiopaque fillers, etc. Additionally, other radiopaque marking strips and / or coils may be incorporated into the design of the device to achieve the same result.

[0101] In some instances, a degree of magnetic resonance imaging (MRI) compatibility is incorporated into the devices and / or other components disclosed herein. For example, the devices and / or their components or portions may be made of materials that substantially do not distort the image and do not produce substantial artifacts (e.g., gaps in the image). For example, certain ferromagnetic materials may be unsuitable because they can produce artifacts in MRI images. The devices or portions thereof may also be made of materials that an MRI machine can image. Some materials exhibiting these properties include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS: R30003, such as ELGILOY®, PHYNOX®, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035, such as MP35-N®, etc.), nickel-titanium, and other materials.

[0102] In some instances, the devices and / or other components disclosed herein may include suitable therapeutic agents and / or be treated with suitable therapeutic agents. Examples of suitable therapeutic agents may include antithrombotic agents (such as heparin, heparin derivatives, urokinase, and PPack (d-phenylalanine-proline-arginine chloromethyl ketone)); antiproliferative agents (such as enoxaparin, angiotensin, monoclonal antibodies that block smooth muscle cell proliferation, hirudin, and acetylsalicylic acid); anti-inflammatory agents (such as dexamethasone, prednisolone, corticosteroids, budesonide, estrogens, sulfasalazine, and mesalazine); antitumor / antiproliferative / antimitotic agents (such as paclitaxel, 5-fluorouracil, cisplatin, vincristine, epoch-forming agents, endostatin, angiostatin, and thymidine kinase inhibitors); anesthetics (such as lidocaine, bupivacaine, and ropivacaine); and anticoagulants (such as D-Phe-Pro- Arg chloromethyl ketone, compounds containing RGD peptides, heparin, antithrombin compounds, platelet receptor antagonists, antithrombin antibodies, antiplatelet receptor antibodies, aspirin, prostaglandin inhibitors, platelet inhibitors, and tick antiplatelet peptides; angiogenesis promoters (such as growth factor inhibitors, growth factor receptor antagonists, transcription activators, and translation promoters); angiogenesis inhibitors (such as growth factor inhibitors, growth factor receptor antagonists, transcription repressors, translation repressors, replication inhibitors, inhibitory antibodies, antibodies against growth factors, bifunctional molecules composed of growth factors and cytotoxins, and bifunctional molecules composed of antibodies and cytotoxins); cholesterol lowering agents; vasodilators; and agents that interfere with endogenous vasoactive mechanisms.

[0103] Therefore, having described several illustrative examples of this disclosure, those skilled in the art will readily understand that other examples may be practiced and used within the scope of the appended claims. However, it should be understood that this disclosure is illustrative in many respects only. Changes in detail may be made, particularly in the shape, size, arrangement of parts, and the omission and sequence of steps, without departing from the scope of this disclosure. Of course, the scope of this disclosure is defined by the language of the appended claims.

Claims

1. A transcavitary implant, comprising: An elongated tubular body extending from a first end to a second end and comprising: A skeleton, the skeleton forming a plurality of chambers and defining an inner cavity extending from a first end to a second end of the elongated tubular body; and At least one support column bisects the cavity opening of the skeleton to define two or more openings, each opening having a cross-sectional dimension smaller than that of the cavity opening.

2. The transcavitary implant of claim 1, further comprising a proximal cage disposed adjacent to the first end.

3. The transcavitary implant as described in claim 2, wherein, The at least one support forms part of the proximal cage.

4. The transcavitary implant as described in any one of claims 2 to 3, wherein, The proximal cage has a roughly flattened ellipsoidal shape.

5. The transcavitary implant as described in any one of claims 2 to 3, wherein, The proximal cage has a generally hemispherical shape.

6. The transcavitary implant as described in any one of claims 2 to 5, wherein, The outer diameter of the proximal cage is greater than the outer diameter of the second end of the elongated tubular body.

7. The transcavitary implant as described in any one of claims 1 to 6, wherein, The at least one pillar forms multiple rings.

8. The transcavitary implant of claim 7, wherein, One of the rings overlaps at least partially with the preceding ring of the plurality of rings.

9. The transcavitary implant as described in any one of claims 7 to 8, wherein, The plurality of rings extend around the entire circumference of the cavity opening.

10. The transcavitary implant as described in any one of claims 7 to 9, wherein, The multiple rings are woven.

11. The transcavitary implant as described in any one of claims 1 to 6, wherein, The at least one pillar intersects with another pillar across the cavity opening.

12. The transcavitary implant as claimed in any one of claims 1 to 11, further comprising a coating disposed on at least some of the plurality of chambers.

13. The transcavitary implant of claim 12, wherein, The two or more openings are not covered by the coating.

14. The transcavitary implant of claim 12, wherein, The coating is applied to at least some of the two or more openings.

15. The transcavitary implant as described in any one of claims 1 to 14, wherein, The second end of the elongated tubular body includes a flared distal region.

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