Stent with protruding features for anchoring

Abstract

A stent (100) may include an outwardly facing protrusion (120) that facilitates engagement with the wall of a blood vessel in the body. The protrusion (120) can unfold from the frame (110) of the stent (100) to extend radially outward. When unfolded into the blood vessel, the protrusion (120) engages and anchors against the wall of the blood vessel to ensure accurate and secure placement of the stent (100).

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of U.S. Provisional Application No. 62 / 930,461, filed November 4, 2019, entitled “STENTS HAVING PROTRUDING FEATURESFOR ANCHORING”, the entire contents of which are incorporated herein by reference. Technical Field

[0003] This specification generally relates to the treatment of body vessels using stents. Specifically, it describes devices and methods for anchoring stents within body vessels. Background Technology

[0004] Medical practitioners use stents and related endovascular devices to treat weakened or narrowed portions of the vascular system that restrict blood flow (often referred to as "stenosis"). In the venous system, stents can be used to treat narrowing within the blood vessels. Venous stenosis can be caused by blood clotting, scarring after a blood clot, or localized external pressure on the vein (such as in the femoral vein, where it crosses the inguinal ligament, or in the pelvic veins, where they are crossed by overlapping pelvic arteries). Stents in the venous system are most commonly used to "open up" blood vessels and to treat May-Thurner syndrome or other deep vein thrombosis (DVT). More generally, stents can be used to reinforce collapsed or narrowed tubular structures in other areas of the body, such as the respiratory system, reproductive system, or any other tubular body structure. Attached Figure Description

[0005] Figure 1 A perspective view of an example of a bracket according to some embodiments of the present disclosure is shown.

[0006] Figure 2 Some embodiments according to this disclosure are shown. Figure 1 Side view of the bracket.

[0007] Figure 3 Some embodiments according to this disclosure are shown. Figure 1 Front view of the bracket.

[0008] Figure 4 Some embodiments according to this disclosure are shown. Figure 1 An enlarged cross-sectional view of a portion of the support structure.

[0009] Figure 5 A perspective view of an example of a bracket according to some embodiments of the present disclosure is shown.

[0010] Figure 6 Some embodiments according to this disclosure are shown. Figure 5 Side view of the bracket.

[0011] Figure 7 The first stage of an example of a method for treating blood vessels in the body using a stent, according to some embodiments of the present disclosure, is shown.

[0012] Figure 8 The second stage of a method for treating blood vessels in the body using a stent, according to some embodiments of the present disclosure, is shown.

[0013] Figure 9 The third stage of a method for treating blood vessels in the body using a stent, according to some embodiments of the present disclosure, is shown.

[0014] Figure 10 The fourth stage of a method for treating blood vessels in the body using a stent, according to some embodiments of the present disclosure, is shown.

[0015] In one or more embodiments, not all components shown in each figure may be required, and one or more embodiments may include other components not shown in the figures. The arrangement and type of components may be changed without departing from the scope of this subject matter disclosure. Within the scope of this subject matter disclosure, other components, different components, or fewer components may be utilized. Detailed Implementation

[0016] The detailed description set forth below is intended to describe various embodiments and is not intended to represent the only embodiments in which the subject matter can be practiced. As those skilled in the art will recognize, the described embodiments can be modified in various different ways without departing from the scope of this disclosure. Therefore, the drawings and descriptions should be regarded as illustrative rather than restrictive in nature.

[0017] Many stents are designed to work within relatively small lumens and are relatively short in length. However, the lumens in venous systems can be much larger than those in coronary and peripheral arteries, and the required stent lengths can be much longer compared to arterial stents. Furthermore, the size of vessels in venous systems (e.g., veins) typically increases as they extend downstream along the direction of blood flow, compared to vessels in arterial systems (e.g., arteries). Conventional stent designs are often insufficient to adequately address these situations because conventional stent structures are typically formed from cylindrical frames with a constant axial diameter and a constant expansion force along their length. Longer stent structures in venous applications can also lead to variations in lumen size (e.g., increases), making the placement and use of stents with a single-dimensional cross-section problematic. In some stent systems, compressive / expansion forces on a modular segment tend to shorten or lengthen that particular segment, allowing relative movement between adjacent modular stent segments. This movement is undesirable, especially where proper stent placement is crucial for accommodating crossing veins.

[0018] The following disclosure describes various embodiments of devices, systems, and methods for employing scalable structures (such as stents or support frames) having spikes, flails, or other protruding features for anchoring stents within a blood vessel in a human patient. Delivery systems can be configured to deliver and position the scalable structure within a body cavity (e.g., a blood vessel). Furthermore, these delivery systems can be configured to deploy and expand the scalable structure within the body cavity. The scalable structure can be configured to be securely anchored in a fixed location within a blood vessel. Optionally, the scalable structure can be removed through controlled manipulation.

[0019] Specifically, the stent provided in this disclosure has an outwardly facing protrusion that facilitates engagement and anchoring against the vessel wall. This anchoring ensures the stable placement of the stent by preventing adjustment and migration that could otherwise occur due to forces acting on the stent (including blood flow and vessel displacement). By anchoring the stent with the protrusion, the need for anchoring the stent frame and other parts is reduced. Therefore, these other parts of the stent can be designed to provide additional properties required for any given application (e.g., venous stents). These properties may include high flexibility, high radial force, high compressive strength, large diameter, and relatively long length.

[0020] In the following description and Figures 1-6Certain details are set forth in this disclosure to provide a comprehensive understanding of the various embodiments thereof. To avoid unnecessarily obscuring the description of the various embodiments thereof, further details describing well-known structures and systems generally associated with scalable structures, prominent features, and components or devices associated with the manufacture of these structures are not set forth below. Furthermore, many details and features illustrated in the figures are merely illustrative of specific embodiments of this disclosure. Therefore, other embodiments may have other details and features without departing from the spirit and scope of this disclosure. Accordingly, those skilled in the art will understand that this technology, including associated devices, systems, and programs, may include other embodiments with additional elements or steps, and / or may include embodiments without the references herein. Figures 1-6 Other embodiments of several features or steps are shown and described. Furthermore, various embodiments of this disclosure may include structures other than those shown in the figures, and are clearly not limited to the structures shown in the figures.

[0021] like Figures 1-4 As shown, the expandable support 100 is provided with a frame 110 and a plurality of outwardly extending protrusions 120. The frame 110 can be configured to extend radially outward after the support 100 is disengaged from the transport shaft. The protrusions 120 can be configured to extend radially outward from the frame 110 when the support 100 is disengaged from the transport shaft and / or when the frame 110 extends radially outward.

[0022] The stent 100 can self-expand upon release of restraint. Additionally or alternatively, the stent 100 can be expanded by radial forces applied by a balloon expanding within the stent 100. The frame 110 may include a plurality of struts 112 arranged in a pattern supporting the compression, expansion, flexibility, and bendability of the stent 100. The struts 112 may be connected to each other to form a plurality of openings 108 extending through the frame 110 (e.g., from a lumen within the frame 110 to the exterior of the frame 110). In some embodiments, the frame 110 forms the outermost extent of the stent 100. For example, the stent 100 may omit graft material or other coverings, thereby exposing the openings 108 to adjacent structures. Alternatively, the stent 100 may be combined with other structures, such as graft material or other coverings extending along at least a portion of its length. The frame 110 may be formed in a generally cylindrical shape along at least a portion of the stent 100. At least a portion of each protruding feature 120 may extend at least partially outward from the frame 110 (e.g., toward a distal or proximal end of the stent 100). For example, at least a portion of each protruding feature 120 may extend parallel to the longitudinal axis of the support 100. At least a portion of each protruding feature 120 (e.g., the end portion) may extend at least partially radially outward from the frame 110. By further example, at least a portion of each protruding feature 120 may extend distally and / or proximally from the frame 110.

[0023] With at least a portion of each protrusion 120 extending distally from the frame 110, the protrusion 120 can be easily retracted into the delivery device by folding downwards and extending distally as the delivery device advances above the stent 100 from the proximal side along the distal direction. The protrusion 194 may optionally include medication for delivery to the target delivery site as the stent 100 extends. However, it should be understood that the stent 100 may omit medication for delivery and treatment of the target delivery site by inserting the protrusion 120 into the tissue.

[0024] The frame 110, pillars 112, and / or protruding features 120 may be constructed or formed of a variety of materials, including, for example, nitinol, cobalt-chromium alloys, stainless steel, any of a variety of other metals or metal alloys, or combinations thereof. The frame 110, pillars 112, and / or protruding features 120 may also be constructed or formed of bioabsorbable, biodegradable, nanoporous materials, or non-bioabsorbable, non-biodegradable, non-nanoporous materials, including, for example, one or more polymers, nitinol, plastic materials, etc., or combinations thereof. In some embodiments, the frame 110 and pillars 112 may be formed of bioabsorbable materials, and the protruding features 120 may be formed of non-bioabsorbable materials, such as nitinol. In these embodiments, after the extended frame 110 and pillars 112 are bioabsorbed, the protruding features 120 may remain engaged with and penetrate a portion of the body cavity. After the extended frame 110 and strut 112 are bioabsorbed, the body cavity at the location where the scaffold 100 was extended is no longer partially blocked by the frame 110 and strut 112, thereby allowing a larger volume of fluid (such as an aqueous pharmaceutical composition) to pass through the body cavity and contact the cavity walls. The protruding feature 120 can also be formed of a bioabsorbable material, and once the scaffold 100 is bioabsorbed, the space in the body cavity wall freed up by the protruding feature 120 can contact the fluid passing through the body cavity. In this way, the scaffold 100 can increase the surface area of ​​the body cavity walls in contact with the fluid.

[0025] The protruding feature 120 may also be supported by more than one strut 112, frame 110, or combination thereof. The protruding feature 120 may be integrally formed with the frame (e.g., strut 112), for example, by bending or twisting one or more struts and / or portions of the frame 110 toward the longitudinal axis of the support 100, or alternatively, the protruding feature 120 may be a separate, discrete component attached to a desired location along the strut 112 and / or frame 110.

[0026] The prominent feature 120 may include one or more of a variety of shapes and features. For example, the prominent feature 120 or a portion thereof may be straight, curved, spiral, and / or coiled. The prominent features 120 may have the same or different dimensions, shapes, and / or features relative to each other.

[0027] When the support 100 is in a collapsed configuration and / or when the support 100 is in an extended configuration, the protruding feature 120 may be contained within the outer periphery of the frame 110. For example, the protruding feature 120 may be positioned within an opening 108 between a plurality of struts 112. Each protruding feature 120 may be movable to extend at least partially away from the central axis 190 of the support 100.

[0028] The prominent feature 120 can be positioned and / or combined within discrete sections along the length of the frame 110. For example... Figure 1 and Figure 2 As shown, the support 100 may include a proximal segment 102 located at or defining a proximal end portion of the support 100 and a distal segment 106 located at or defining a distal end portion of the support 100. The support 100 may further include an intermediate segment 104 between the proximal segment 102 and the distal segment 106. The proximal segment 102 and the distal segment 106 may include a plurality of protruding features 120 extending from the frame 110. Conversely, the intermediate segment 104 may omit the protruding features, such that the support is defined by the frame 110 along the radially outermost extent of the intermediate segment 104. Thus, the protruding features 120 at the proximal segment 102 and the distal segment 106 may provide anchorage for the support 100 at the ends of the support, while the intermediate segment 104 may retain relatively more freedom for movement, flexion, bending and / or stretching.

[0029] Each segment can be defined based on whether it provides a prominent feature. For example, frame 110 may include a proximal segment 102, a middle segment 104, and a distal segment 106. The middle segment 104 (e.g., without a prominent feature) may extend a significant portion of the total length of frame 110 and / or support 100. For example, the middle segment length 144 defined by the middle segment 104 of frame 110 may extend at least 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, or 90% of the total length of frame 110 and / or support 100. By a further example, the middle segment length 144 may be greater than each of the proximal segment length 142 of the proximal segment 102 of frame 110 and the distal segment length 146 of the distal segment 106 of frame 110. By a further example, the middle segment length 144 may be greater than the combined length of the proximal segment length 142 and the distal segment length 146. The pattern and / or shape formed by the frame 110 can be identical on the proximal segment 102, the intermediate segment 104, and the distal segment 106. Therefore, the presence or absence of the protruding feature 120 may optionally be the only difference between the proximal segment 102, the intermediate segment 104, and / or the distal segment 106. It should be understood that any number of segments can be provided. For example, one, two, three, four, five, six, or more than six segments with the protruding feature 120 may be provided. Each pair of axially adjacent segments may optionally be separated by a segment without the protruding feature 120.

[0030] The protruding features 120 may have the same or different axial positions, circumferential positions, and / or orientations (e.g., facing proximal or distal). For example, at least some of the protruding features 120 may be axially aligned and arranged in different circumferential positions and / or orientations. By further example, at least some of the protruding features 120 may be circumferentially aligned and arranged in different axial positions and / or orientations. By further example, at least some of the protruding features 120 may have the same orientation and be arranged in different axial positions and / or circumferential positions. At least some of the protruding features 120 may have different axial positions and circumferential positions. At least some of the protruding features 120 may have different axial positions and orientations. At least some of the protruding features 120 may have different circumferential positions and orientations.

[0031] like Figure 1 and Figure 2As shown, the protruding features 120 of the proximal segment 102 and the distal segment 106 may have one or more common features. For example, at least some of the protruding features 120 of the proximal segment 102 and the distal segment 106 may have the same orientation, with portions extending in the same or similar directions. By further example, portions of each protruding feature 120 may extend toward the distal or proximal end of the stent 100. This configuration can provide consistent anchoring against forces and / or migration in a given direction (e.g., downstream of the vessel). Alternatively, the protruding features 120 may extend in different (e.g., opposite) directions to provide anchoring against forces and / or migration in each different direction.

[0032] The stent 100 may vary its dimensions along its length. For example, the proximal segment 102 (upstream) of the stent 100 may have a smaller proximal cross-sectional dimension (e.g., diameter) 132 than the distal cross-sectional dimension (e.g., diameter) 136 of the distal segment 106 of the frame 110 of the stent 100. This can facilitate better vessel wall adhesion by matching the typically increasing vessel size in the downstream direction. The cross-sectional dimension (e.g., diameter) of the stent 100 may taper gradually from one end to the opposite end. Additionally or alternatively, the stent 100 may provide a flared end portion at each of its opposite ends. The stent 100 may provide variable radially outward forces along its different longitudinal segments. For example, the end segments of the stent 100 may provide higher radial forces than its intermediate segments. Other (higher and / or lower) force distributions may also be provided along the different longitudinal segments of the stent 100.

[0033] In some embodiments, the stent 100 may include a material (e.g., PTFE, polyester, polyamide, such as nylon and / or polyurethane-based materials, silicone, etc.) located above, for example, the struts of the frame 110. In some embodiments, the material covers the entire outer surface area of ​​the frame 110. In some embodiments, the material covers only the outer surface area of ​​the frame 110 along the intermediate segment 104 between the proximal segment 102 and the distal segment 106. The material may be a mesh or a braid. In some embodiments, the material may be further configured to allow blood flow through the inner lumen of the stent 100 and / or restrict blood flow to the outer dimensions of the stent 100. Furthermore, the material may be configured to prevent debris from the walls of the body cavity from entering the bloodstream.

[0034] like Figure 4As shown, when the protruding feature 120 or a portion thereof extends radially outward from the frame 110, the protruding feature or a portion thereof may form an angle. This angle can be any angle (e.g., from 0 to 90 degrees). The angle can be selected during the forming process such that it is formed when the support 100 is deployed. This angle can be equal to, less than, and / or greater than 0, 10, 20, 30, 40, 50, 60, 70, 80, or 90 degrees. For any two protruding features 120, the angle can be the same or different.

[0035] like Figure 4 As shown, the supports 112 can be connected to each other and arranged such that multiple supports 112 (e.g., 2, 3, 4, 5, 6, 7, 8, or more than 8 supports) are connected together at vertex 114. Protruding features 120 can each extend from their respective vertex 114. For example, a protruding feature 120 can extend from vertex 114 at the end of opening 108. Therefore, a protruding feature 120 can be connected to frame 110 at only one end.

[0036] The frame 110 may have gaps 116 formed at vertices 114 to facilitate the collapse and expansion of the frame 110. For example, this may allow the supports 112 to move toward and away from each other to facilitate the transformation of the frame 110. Figure 4 As shown, this movement can be enhanced by providing a gap 116. For example, the gap 116 can be located on one side of vertex 114, opposite to a corresponding protruding feature 120 extending from vertex 114. In some examples, the gap 116 can extend longitudinally and have parallel edges, but other shapes are also considered. Thus, the frame 110 can provide sufficient flexibility for transitions between collapsed and expanded configurations.

[0037] Figure 5 and Figure 6 An improved expandable support 100 is shown, which has the same... Figures 1-4 The bracket 100 shown has several features identical to those of the bracket shown. Therefore, the same features are used with Figures 1-4 The same labels used in the text will be used to indicate this, and the above description will be understood to apply to... Figure 5 and Figure 6 The bracket is 100.

[0038] like Figure 5 and Figure 6 As shown, the support 100 may include protruding features 120 evenly distributed along its length (including along its middle segment). As described above, the protruding features 120 may have the same, similar and / or different features from each other.

[0039] While the supports described herein have the features shown, it should be understood that various different supports and other devices can be used with the delivery system described herein. The various features are illustrated below by way of example rather than limitation.

[0040] Regarding such supports and other devices, the materials used to form the frame 110, pillar 112, and / or protruding feature 120 described herein can be selected based on mechanical and / or thermal properties (such as strength, ductility, hardness, elasticity, flexibility, flexural modulus, flexural strength, plasticity, stiffness, emissivity, thermal conductivity, specific heat, thermal diffusivity, thermal expansion, any other properties, or combinations thereof). If formed from a material with thermal properties, the material can be activated to transfer heat treatment to the desired treatment site. Regardless of the material, the frame 110, pillar 112, and / or protruding feature 120 can be formed from tubing or wire (e.g., solid wire) by laser cutting or other suitable techniques. When formed from wire, a portion of the wire can be removed by chemical etching or other suitable methods to establish the internal dimensions of the support.

[0041] The size and shape of the stent 100 (e.g., frame 110 and strut 112) can be adapted for placement within various body cavities, including blood vessels, without causing rupture of the vessels. For example, several stents and other structures can have radial strength without causing dissection or damage. Blood vessels (in which the stents described herein can be sized and shaped for placement) include arteries (such as coronary arteries, peripheral arteries, carotid arteries, circle of Willis, anterior cerebral artery, middle cerebral artery, posterior cerebral artery, any lenticulostriate artery, renal artery, femoral artery), veins (such as cerebral veins, saphenous vein), arteriovenous fistulas, or any other blood vessel that may contain a treatment site. The stent 100 can have a variety of shapes, including cubes, rectangular prisms, cylinders, pyramids, or variations thereof.

[0042] The stent 100 with protruding feature 120 can include various sizes (in a low-profile delivery state and an extended deployment state). These embodiments can provide extensions that can be used in a variety of situations covering a wide range of sizes, such as for treatment and / or prevention of dissection. Regardless of shape, the stent can have a length of about 10 mm, about 20 mm, about 30 mm, about 40 mm, about 50 mm, about 60 mm, about 70 mm, about 80 mm, about 90 mm, about 100 mm, about 110 mm, about 120 mm, about 130 mm, about 140 mm, about 150 mm, about 160 mm, about 170 mm, about 180 mm, about 190 mm, about 200 mm, about 210 mm, about 220 mm, about 230 mm, about 240 mm, or about 250 mm. Furthermore, the supports shaped as cubes, rectangular prisms, or pyramids can have widths of approximately 0.25 mm, 0.5 mm, 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 12 mm, 14 mm, 16 mm, 18 mm, 20 mm, 25 mm, or 30 mm. Additionally, the supports shaped as prisms or pyramids can have cross-sectional dimensions (e.g., diameter) of approximately 0.25 mm, 0.5 mm, 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 12 mm, 14 mm, 16 mm, 18 mm, 20 mm, 25 mm, 30 mm, 35 mm, 40 mm, or 50 mm. The cross-sectional dimensions (e.g., diameter) of the stent 100 may decrease along the length of the stent 100. Furthermore, the size and shape of the stent 100 may be adapted to prepare the body cavity for certain procedures (such as stent placement procedures).

[0043] The extended support 100 and / or other expandable structures may have a cross-sectional dimension of about 2 mm to about 10 mm. For example, the frame 110 may have a cross-sectional dimension of about 1 mm to about 9 mm, and each of the protruding features 120 may have a length of about 0.1 mm to about 4.5 mm. In some embodiments, the support 100 has an overall cross-sectional dimension of about 4 mm, the frame 110 has an overall cross-sectional dimension of about 2 mm, and each of the protruding features 120 has a length of about 1 mm. In some embodiments, the support 100 has an overall cross-sectional dimension of about 6 mm, the frame 110 has an overall cross-sectional dimension of about 4 mm, and each of the protruding features 120 has a length of about 1.5 mm. In further embodiments, the protruding features 120 may have multiple lengths, such that the lengths of the protruding features 120 of the support or other expandable structures vary. For example, the support may include protruding features 120 with lengths of about 0.2 mm, about 0.5 mm, about 1.0 mm, about 1.5 mm, about 2.0 mm, about 2.5 mm, about 3.0 mm, about 3.5 mm, about 4.0 mm, about 4.5 mm and / or about 5.0 mm.

[0044] The dimensions of the stent 100 can be designed to be compatible with a wide range of catheter sizes. Embodiments of the present technology may include stents or other structures designed to receive guidewires (e.g., guidewires with diameters of 0.010, 0.014, 0.018, 0.035, or 0.038 inches). In several embodiments, the size and design of the stent 100 may be adapted for delivery via a microcatheter through which it is pushed. In some embodiments, the stent 100 may be incorporated into a delivery system, including modular or single-unit delivery systems.

[0045] The stent 100 may include markers for visualization of the stent 100 within a body cavity, such as one or more radiopaque markers. Radiopaque markers can be created using Clearfil Photo Core. Tantalum, titanium, tungsten, barium sulfate, and zirconium oxide, or other suitable radiopaque markings, may be formed. These markings may be formed on the proximal, distal, intermediate, or combined portions of the support 100. The markings may be strips, coils, clips, or combinations thereof, inserted into one or more portions of a tube within the support 100, or plated onto one or more portions of the support 100. Regardless of the type of marking, the markings may be cast, forged, packaged, or wrapped along any portion of the support 100, or cast, forged, packaged, or wrapped thereon.

[0046] The stent 100 can be sufficiently flexible to traverse various anatomical features, including those with curvature. The flexibility of the stent 100 can be provided by the materials forming them. Furthermore, flexibility can be provided by breaking one or more members that are engaged with and extend between two or more rows of struts 112. Additionally, the stent 100 can be easily deployed and expanded, as well as retracted and contracted. The stent 100 can also be easily repositioned within blood vessels or other body cavities.

[0047] In some embodiments, a drug-eluting compound is coated onto at least a portion of the protrusion 120, frame 110, and / or strut 112. The coating can be any suitable coating known to those skilled in the art for drug delivery. For example, suitable coatings include, but are not limited to, snow coatings or crystallizing coatings, with edges configured to remain within the wall. The drug-eluting compound can be a synthetic polymer or biopolymer coated with various patterns and thicknesses suitable for delivering the contained drug. In some embodiments, the protrusion 120 itself can be composed of a drug-eluting material. According to this technology, the drug carried by the drug-eluting compound and / or the protrusion 120 can be any drug suitable for treating the treatment site where the stent 100 is to be placed, and may or may not include excipients. For example, the drug can be an antiproliferator, an antitumor agent, a migration inhibitor, a healing-enhancing factor, an immunosuppressant, an antithrombotic agent, a blood thinner, or a radioactive compound. In some embodiments, the drug-eluting compound and / or the protrusion 120 can carry more than one drug.

[0048] In some embodiments, the salient feature 120 may include a textured (e.g., ridged) surface intended to provide a large surface area for drug delivery. Furthermore, any salient feature 120 may include a textured surface, such as a ridged surface (vertical, horizontal, radial, or circular relative to the longitudinal plane of the salient feature), a cross-shaded surface, an isotropic surface, or other surface types suitable for providing a large surface area for vascular anchoring.

[0049] The size and shape of the protruding feature may be adapted to engage and / or penetrate occlusions, neointimacy, intima, internal elastic lamina (IEL), media, external elastic lamina (EEL), adventitia, or combinations thereof. The size and shape of the protruding feature may also be adapted to engage and / or puncture tissues and / or structures adjacent to the body cavity where the stent will be placed without rupturing the body cavity. For example, the stent may include a square protruding feature sized and configured to puncture the intima and / or media of the body cavity, or a pointed protruding feature sized and configured to penetrate and extend into the media and / or IEL. Furthermore, the protruding feature may be configured to bend relative to the longitudinal axis of the stent in one or more directions to engage and / or penetrate a portion of the body cavity described herein. In several embodiments, the protruding feature may penetrate deeper into the wall of a diseased body cavity (such as a blood vessel) compared to a stent without a protruding feature. Furthermore, the stent may allow blood flow even in an extended position.

[0050] Furthermore, it should be understood that the stent 100 may carry one or more protruding features 120 on one or more portions of the stent 100. For example, the stent 100 may carry about 5 protruding features, about 10 protruding features, about 15 protruding features, about 20 protruding features, about 30 protruding features, about 40 protruding features, about 50 protruding features, about 60 protruding features, about 70 protruding features, about 80 protruding features, about 90 protruding features, or about 100 protruding features. The protruding features 120 may be carried by the frame 110, the strut 112, or a combination thereof. The number of protruding features 120 may vary depending on, for example, the target treatment site and / or the size of the stent 100. Furthermore, the protruding features 120 carried by the stent 100 may be of different types of protruding features 120 disclosed herein.

[0051] The embodiments described herein provide delivery systems for one or more structures having means for delivering medication to specific regions within a body cavity (such as vascular systems) while still allowing fluid (e.g., blood) to flow through the treatment area where the structure is placed and / or other devices or therapeutic instruments within adjacent body cavities. In some embodiments, fluid flow through the treatment area is temporarily blocked when one or more regions of the system are delivered, deployed, positioned, and / or removed from the body cavity. Furthermore, the delivery system can be configured to prepare the body cavity for treatment by tilting, pulling, rotating, or a combination thereof proximally or distally to the treatment site. In some embodiments, the delivery system can be configured to rotate the stent upon application of mechanical force.

[0052] For reference Figures 7-10The method described herein transports the support 100 to the target transport position through the operation of the transport device 90 of the transport system 10. While methods at different stages are discussed and illustrated herein, it should be understood that various variations of each method are also conceivable. For example, these methods may be performed in different sequences of operations, may have additional operations, or may have fewer operations.

[0053] like Figure 7 As shown, the delivery device 90 can be placed within the blood vessel 40 at a location containing a target site for treatment. This site may include stenosis or other features to be improved by stent placement and / or other procedures. The delivery device 90 can be located upstream or downstream of the target site. The delivery device 90 can be positioned while a stent is contained therein. Alternatively, the delivery device 90 can be positioned and a stent advanced within the delivery device 90 at a later stage. The delivery device 90 can be positioned with the assistance of a guidewire and / or one or more other devices.

[0054] like Figure 8 As shown, the delivery device 90 can retract proximally while the stent 100 is held in a given position. Alternatively, the delivery device 90 can be held in place while the stent 100 is pushed distally from the delivery device 90. When the delivery device 90 disengages from the stent 100, the stent 100 can extend radially. This extension may include the extension of a frame and / or protruding features. In the extended configuration, the frame and / or protruding features may engage the wall of the blood vessel 40. Figure 8 As further shown, the expandable device 80 may optionally be provided with a support 100 (e.g., the support 100 is mounted thereon) or advanced into position to the support 100. The support 100 may be temporarily fixed to the expandable device 80 and / or other components of the conveying system 10 (e.g., within the conveying device 90 and / or along a control shaft extending from the conveying device). For example, the support 100 may be positioned together with the expandable device 80 and / or with other components (e.g., independently of the expandable device 80). Where the support 100 can be positioned separately from and / or simultaneously with the expandable device 80, a mechanical connection to the support 100 may be provided to the user to facilitate its positioning. This connection may facilitate positioning and repositioning of the support 100 as needed before, during, and / or after the expansion of the support 100 and / or the expandable device 80. This connection may be temporary and / or separable, for example, utilizing mechanical, electrolytic, chemical, thermal, and / or other separation mechanisms between the support 100 and the expandable device 80 and / or other components. After being detached from the expandable device 80 and / or another element, the support 100 can retain its position (e.g., anchored) and remain independent of the expandable device 80 and / or another element.

[0055] like Figure 9 As shown, the expandable device 80 can expand or otherwise extend to cause the stent 100 to expand radially and engage or further engage the wall of the vessel 40. For example, the expandable device 80 can drive a protruding feature into or further into the wall of the vessel 40. It should be understood that the provision and / or use of the expandable device 80 can be optional, such as when the stent 100 provides sufficient self-expanding properties to engage the wall of the vessel 40. Where applicable, the stent 100 can be repositioned as needed after the stent 100 and / or the expandable device 80 have expanded. The stent 100 can be adjusted as needed while maintaining at least a temporary mechanical connection with the stent 100. The stent 100 can be disengaged from any such mechanical connection before, during, and / or after the stent 100 and / or the expandable device 80 have expanded. After disengagement, the stent 100 can be securely anchored to the vessel 40. Optionally, after the stent 100 has been disengaged and / or expanded, additional operations can be performed to adjust and / or remove the stent.

[0056] like Figure 10 As shown, the expandable device 80 and delivery device 90 can be removed from the blood vessel 40, while the stent 100 remains in place. Blood can be allowed to flow through the lumen defined by the stent 100. The stent 100 can provide sufficient engagement with the wall of the blood vessel 40 to resist migration from the target location, even if blood flow 50 and blood vessel 40 are displaced.

[0057] Optionally, the stent 100 can be removed from the blood vessel 40. For example, the stent 100 can remain attached to and / or integrated with a locator (not shown). The locator may optionally extend at least partially through the delivery device 90. After any duration, the stent 100 can be positioned within and / or removed from the blood vessel. In the event that the stent 100 is separated from or detached from the locator (e.g., by disassembly), the stent 100 can be retrieved by other means (such as a gripping device).

[0058] Therefore, this disclosure provides a stent with an outwardly facing protrusion that facilitates engagement and anchorage against the vessel wall. By anchoring the stent with the aid of the protrusion, the need to provide anchorage to other parts of the stent and the frame is reduced. Therefore, these other parts of the stent can be designed to provide additional properties required for any given application (such as a venous stent). These properties may include high flexibility, high radial force, high compressive strength, large diameter, and long length.

[0059] For convenience, various examples of the aspects of this disclosure are described below as multiple items. These items are provided as examples and do not limit the technology of this subject matter.

[0060] Item A: A support comprising a frame and a protruding feature, the frame including a strut and configured to extend from a collapsed configuration to an extended configuration, the frame forming: a proximal segment; a distal segment; and an intermediate segment between the proximal segment and the distal segment; the protruding feature extending radially outward from the frame when the frame is in the extended configuration, the protruding feature being connected only to the proximal segment and the distal segment of the frame.

[0061] Item B: A conveying system comprising: an expandable device, a support extending around the expandable device, and a conveying means including the expandable device and the support, the support including: a frame and a protruding feature, the frame including a strut and configured to expand from a collapsed configuration to an extended configuration, the frame forming a proximal section, a distal section, and an intermediate section between the proximal section and the distal section; when the frame is in the extended configuration, the protruding feature extends radially outward from the proximal and distal sections of the frame.

[0062] Item C: A method comprising: positioning a delivery system within a body blood vessel, the delivery system including a delivery device comprising a stent in a collapsed configuration when located within the lumen of the delivery device; extending the stent outside the delivery device until a protruding feature of the stent pierces the wall of the body blood vessel, the protruding feature extending radially outward from a proximal and a distal portion of a frame of the stent, the proximal and distal portions being connected by a middle portion of the frame, the middle portion being adjacent to the body blood vessel without penetrating the body blood vessel; and removing the delivery device from the body blood vessel.

[0063] One or more of the above items may include one or more of the following features. It should be noted that any of the following items may be combined with each other in any combination and placed within the corresponding independent items (e.g., items A, B, or C).

[0064] Item 1: The intermediate segment is longer than each of the proximal segment and the distal segment.

[0065] Item 2: The cross-sectional dimension of the distal segment is larger than the cross-sectional dimension of the proximal segment.

[0066] Item 3: The proximal segment and the distal segment are configured to apply a radially outward force on the body blood vessel, and the intermediate segment is configured to apply a radially outward force on the body blood vessel, wherein the radially outward force applied by the intermediate segment is less than the radially outward force applied by the proximal segment and the distal segment.

[0067] Item 4: Each of the protruding features extends from the frame along the same longitudinal direction, and the protruding part extends further radially outward away from the frame.

[0068] Item 5: The pillars are arranged such that multiple pillars are connected to each other to form a vertex, wherein one of the protruding features extends from the vertex.

[0069] Item 6: The support forms a gap on one side of the apex, the side being opposite to one side of the protruding feature.

[0070] Item 7: In the collapsed configuration, the protruding feature extends longitudinally within the opening formed between the pillars; and in the expanded configuration, the protruding feature extends radially outward.

[0071] Item 8: The salient feature is integrally formed with the frame.

[0072] Item 9: The expandable device extends through the proximal and distal sections of the frame.

[0073] Item 10: In the collapsed configuration, the protruding feature extends longitudinally within the opening formed between the pillars; and in the expanded configuration, the protruding feature extends radially outward.

[0074] Item 11: The expansion includes: placing the expandable device within the support; expanding the expandable device against the support until the protruding feature penetrates the body's blood vessel.

[0075] Item 12: The distal segment is located within a blood vessel downstream of the proximal segment.

[0076] Item 13: The radially outward force exerted on the body blood vessels by the proximal and distal segments of the frame is greater than the radially outward force exerted on the body blood vessels by the intermediate segment.

[0077] Unless otherwise specified, references to singular elements are not intended to mean "one and only one," but rather "one or more." For example, a "one" module can refer to one or more modules. Without further restriction, elements beginning with "a," "an," "the," or "the" do not exclude the existence of other identical elements.

[0078] Titles and subtitles (if any) are used for convenience only and do not limit the invention. The word "exemplary" is used to indicate that it is used as an example or illustration. With regard to the use of the terms "comprising," "having," or similar terms, such terms are intended to be inclusive in a similar way to how the term "comprising" is interpreted when used as a transition word in the claims. For example, relational terms such as first and second may be used to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between these entities or actions.

[0079] Phrases such as "aspect," "this aspect," "on the other hand," "some aspects," "one or more aspects," "one implementation," "this implementation," "another implementation," "some implementations," "one or more implementations," "an embodiment," "this embodiment," "another embodiment," "some embodiments," "one or more embodiments," "a configuration," "this configuration," "another configuration," "some configurations," "one or more configurations," "the subject matter," "disclosure," "this disclosure," and other variations thereof are used for convenience and do not imply that the disclosure associated with these phrases is necessary for the subject matter or that such disclosure applies to all configurations of the subject matter. The disclosure associated with these phrases can apply to all configurations, or one or more configurations. The disclosure associated with these phrases can provide one or more examples. For example, phrases such as "aspect" or "some aspects" can refer to one or more aspects, and vice versa, and this also applies to other foregoing phrases.

[0080] The phrase “at least one of…” preceding a series of items (with the terms “and” or “or” separating any of the items) modifies the listed items as a whole, not each member of the listed items. The phrase “at least one of…” does not require the selection of at least one item; rather, it allows for the inclusion of at least one of any of the items, and / or at least one of any combination of the items, and / or at least one of each of the items. For example, each of the phrases “at least one of A, B, and C” or “at least one of A, B, or C” means only A, only B, or only C; any combination of A, B, and C; and / or at least one of each of A, B, and C.

[0081] It should be understood that the specific order or hierarchy of the disclosed steps, operations, or processes is illustrative in an exemplary manner. Unless otherwise expressly stated, it should be understood that the specific order or hierarchy of steps, operations, or processes may be performed in a different order. Some steps, operations, or processes may be performed simultaneously. The appended method claims (if any) present the elements of various steps, operations, or processes in a sample order and are not intended to limit one to the specific order or hierarchy presented. These may be performed sequentially, linearly, in parallel, or in a different order.

[0082] On the one hand, the term "link" or similar terms can refer to a direct link. On the other hand, the term "link" or similar terms can refer to an indirect link.

[0083] For example, terms such as top, bottom, front, back, side, horizontal, and vertical refer to any frame of reference, not just a typical gravitational frame of reference. Therefore, such terms can extend upwards, downwards, diagonally, or horizontally within a gravitational frame of reference.

[0084] This disclosure is provided to enable any person skilled in the art to practice the various aspects described herein. In some cases, well-known structures and components are shown in block diagram form to avoid obscuring the concept of the subject matter. This disclosure provides various examples of the subject matter, and the subject matter is not limited to these examples. Various modifications to these aspects will be apparent to those skilled in the art, and the principles described herein can be applied to other aspects.

[0085] All structural and functional equivalents of elements throughout the various aspects described herein that are known or will be known hereafter by one of ordinary skill in the art are expressly incorporated herein by reference and are intended to be included in the claims. Furthermore, nothing disclosed herein is intended to be contributed to the public, whether or not such disclosure is expressly stated in the claims. No claim element should be construed under paragraph 6 of section 112 of 35 U.S.SC unless the element is expressly stated using the phrase “means for…” or, in the case of a method claim, using the phrase “steps for…”.

[0086] The title, background art, brief description of the drawings, abstract, and drawings are thus incorporated into this disclosure and are provided as illustrative examples rather than limiting descriptions. It should be understood that they are not intended to limit the scope or meaning of the claims. Furthermore, as can be seen in the detailed description, it provides illustrative examples and combines various features in various embodiments for the purpose of simplification. The approach of this disclosure should not be construed as reflecting an intention that the claimed subject matter requires more features than expressly stated in each claim. Rather, as reflected in the claims, the subject matter of the invention lies in fewer than all features of a single disclosed configuration or operation. The claims are thus incorporated into the detailed description, each claim existing independently as a separate claimed subject matter.

[0087] The claims are not intended to be limited to the aspects described herein, but rather to conform to the full scope consistent with the language of the claims and to cover all legal equivalents. Nevertheless, none of the claims are intended to include subject matter that does not meet the requirements of applicable patent law, nor should they be interpreted in this manner.

Claims

1. A stent, comprising: A frame, comprising pillars and configured to expand from a collapsed configuration to an extended configuration, the pillars being capable of connecting to each other to form a plurality of openings extending through the frame, the frame forming: Proximal segment; Distal segment; as well as The middle section between the proximal section and the distal section; A prominent feature, when the frame is in an extended configuration, extends radially outward from the frame, and the prominent feature connects only to the proximal and distal segments of the frame. The pillars are arranged such that a plurality of the pillars are connected to each other to form a vertex, wherein one of the protruding features extends from the vertex, and the pillars are allowed to move toward and away from each other to facilitate transitions between the collapsed and expanded configurations, forming a gap at the vertex and the gap being located on one side of the vertex opposite a corresponding protruding feature extending from the vertex, to facilitate the collapse and expansion of the frame and enhance such movement.

2. The stent according to claim 1, wherein, The middle segment is longer than each of the proximal segment and the distal segment.

3. The stent according to claim 1, wherein, The cross-sectional dimension of the distal segment is larger than that of the proximal segment.

4. The stent according to claim 1, wherein, The proximal and distal segments are configured to apply a radially outward force to the blood vessels of the body, and the intermediate segment is configured to apply a radially outward force to the blood vessels of the body, wherein the radially outward force applied by the intermediate segment is less than the radially outward force applied by the proximal and distal segments.

5. The stent according to claim 1, wherein, Each protruding feature extends from the frame along the same longitudinal direction, and the protruding feature further extends radially outward away from the frame.

6. The stent according to claim 1, wherein: In the collapsed configuration, the protruding feature extends longitudinally within the opening formed between the struts; and In the extended configuration, the protruding feature extends radially outward.

7. The stent according to claim 1, wherein, The prominent feature is integrally formed with the framework.

8. A conveying system, comprising: Expandable device; A support extending around the expandable device, the support comprising: A frame including pillars and configured to extend from a collapsed configuration to an expanded configuration, the pillars being capable of being connected to each other to form a plurality of openings extending through the frame, the frame having a proximal section, a distal section, and an intermediate section between the proximal section and the distal section; A prominent feature, when the frame is in an extended configuration, extends radially outward from the proximal and distal segments of the frame; and A conveying device including the expandable device and the support. The pillars are arranged such that a plurality of the pillars are connected to each other to form a vertex, wherein one of the protruding features extends from the vertex, and the pillars are allowed to move toward and away from each other to facilitate transitions between the collapsed and expanded configurations, forming a gap at the vertex and the gap being located on one side of the vertex opposite a corresponding protruding feature extending from the vertex, to facilitate the collapse and expansion of the frame and enhance such movement.

9. The conveying system according to claim 8, wherein, The expandable device extends through the proximal and distal sections of the frame.

10. The conveying system according to claim 8, wherein: In the collapsed configuration, the protruding feature extends longitudinally within the opening formed between the supports; and In the extended configuration, the protruding feature extends radially outward.

11. The conveying system according to claim 8, wherein, The prominent feature is integrally formed with the framework.

12. The conveying system according to claim 8, wherein, The middle segment is longer than each of the proximal segment and the distal segment.

13. The conveying system according to claim 8, wherein, The cross-sectional dimension of the distal segment is larger than that of the proximal segment.

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