Stent with protruding features for anchoring

Abstract

The stent 100 can include outwardly facing protruding features 120 that facilitate engagement with the wall of a body vessel. The protruding features 120 can deploy and extend radially outward from the frame 110 of the stent 100. When deployed into a body vessel, the protruding features 120 engage and anchor against the wall of the body vessel, ensuring accurate and stable placement of the stent 100.

Description

Technical Field

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 62 / 930,461, entitled "STENTS HAVING PROTRUDING FEATURES FOR ANCHORING," filed on November 4, 2019, the entire disclosure of which is incorporated herein by reference.

[0002] This specification generally relates to the treatment of body vessels with stents. In particular, described herein are devices and methods for anchoring a stent within a body vessel.

Background Art

[0003] Stents and related endoluminal devices are used by physicians to treat portions of the vasculature that are weakened or narrowed to the point where blood flow is restricted (commonly referred to as "stenosis"). In the venous system, stents can be used to treat stenoses within blood vessels. Venous stenoses can be caused by clotting, scarring after blood clots, or localized external compressive forces on the venous vessels (such as within the femoral vein crossing the inguinal ligament or within the pelvic vein where the superior passing pelvic artery crosses). Stents within the venous system are most often used to "support the vessel in an open state" as well as to treat May-Thurner syndrome or other deep vein thrombosis (DVT). More generally, stents can be used to reinforce collapsed or stenosed tubular structures in other areas of the body, such as in the respiratory system, genital system, or any other tubular body structure.

Brief Description of the Drawings

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DETAILED DESCRIPTION OF THE INVENTION

[0005] In one or more embodiments, not all of the components shown in each figure may be required, and one or more embodiments may include additional components not shown in the drawings. Without departing from the scope of the present disclosure, the configuration and type of components can be changed. Additional components, different components, or fewer components can be utilized within the scope of the present disclosure.

[0006] The detailed description below is intended to explain various embodiments and is not intended to represent only the embodiments in which the technology can be practiced. As will be understood by those skilled in the art, the embodiments described can be modified in various different ways without departing from the scope of the present disclosure. Accordingly, the drawings and description should be regarded as illustrative rather than restrictive in nature.

[0007] Many stents are designed to operate within fairly small lumens and are relatively short in length. However, venous lumens can be much longer than coronary and peripheral arteries, and the desired stent length may be longer compared to arterial stents. Further, venous vessels (e.g., veins), in contrast to arterial vessels (e.g., arteries), generally increase in size as they extend downstream in the direction of blood flow. Conventional stent designs, since conventional stent constructs are generally formed of a cylindrical frame having a constant diameter and a constant expansion force along a constant length in the axial direction, are often not suitable for adequately addressing these conditions. Stent constructs that are long also face lumen size variations (e.g., increases) over the length of the vein application, which can make it difficult to place and use a single stent of a single cross-sectional size. In some stent systems, the compression force / expansion force for one modular section causes that section to be short or long, allowing relative movement between adjacent modular stent sections. Such movement is undesirable, particularly when an appropriate stent placement is important for adapting to intersecting veins.

[0008] The following disclosure describes various embodiments of devices, systems, and methods using expandable constructs, such as stents or scaffolds, having spikes, flares, or other protruding features for anchoring a stent within the body vessels of a human patient. Delivery systems can be configured to deliver and position the expandable construct within a body cavity (e.g., a blood vessel). Additionally, these delivery systems can also be configured to deploy and expand the expandable construct within the body cavity. The expandable construct can be configured to stably anchor at a fixed position within the body vessel. Optionally, the expandable construct can be removed by a controlled operation.

[0009] In particular, the present disclosure provides a stent having an outwardly facing protrusion feature that facilitates engagement and fixation to the wall of a blood vessel. Such fixation can ensure a stable placement of the stent by resisting adjustment and migration of the stent, which may be caused by forces on the stent, including blood flow and vessel migration, in the absence of fixation. Fixing the stent with the protrusion feature reduces the need for other parts of the stent, such as the stent frame, to provide fixation. Thus, such other parts of the stent can be designed to provide other properties desirable for any given application, such as venous stent placement. Such properties can include high flexibility, high radial force, high compression resistance, large diameter, and long length.

[0010] To provide a complete understanding of the various embodiments of the disclosure, specific details are set forth in the following description and in FIGS. 1 through 6. To avoid unnecessarily obscuring the description of the various embodiments of the disclosure, other details regarding well-known structures and systems often associated with expandable structures, protrusion features, and components or devices related to the manufacture of such structures are not described herein. Further, many of the details and features shown in the drawings are merely illustrative of particular embodiments of the disclosure. Accordingly, other embodiments may have other details and features without departing from the spirit and scope of the disclosure. Thus, those of ordinary skill in the relevant art will understand that the technology, including related devices, systems, and techniques, may include other embodiments having additional elements or steps and / or may include other embodiments having some but not all of the features or steps illustrated and described below with reference to FIGS. 1 through 6. Further, the various embodiments of the disclosure can include structures other than those illustrated in the drawings and are not explicitly limited to the structures shown in the drawings.

[0011] As shown in FIGS. 1 to 4, the expandable stent 100 includes a frame 110 and a plurality of outwardly extending protruding features 120. The frame 110 can be configured to expand radially outward after the stent 100 is withdrawn from the delivery shaft. The protruding features 120 can be configured to expand radially outward from the frame 110 as the stent 100 is withdrawn from the delivery shaft and / or as the frame 110 expands radially outward.

[0012] The stent 100 can be self-expanding when released from restraint. Additionally or alternatively, the stent 100 can be expandable by a radial force applied by a balloon inflated while within the stent 100. The frame 110 can include a plurality of struts 112 arranged in a pattern that accommodates compression, expansion, flexibility, and bendability of the stent 100. The struts 112 can be connected to each other to form an opening 108 that extends through the frame 110, such as from a lumen within the frame 110 to the exterior of the frame 110. In certain embodiments, the frame 110 forms the outermost portion of the stent 100. For example, the stent 100 can omit a graft material or other coating, such that the opening 108 remains exposed to an adjacent structure. Alternatively, the stent 100 can be combined with other structures, such as a graft material or other coating that extends along at least a portion of its length. The frame 110 can form a generally cylindrical shape along at least a portion of the stent 100. At least a portion of each of the protruding features 120 can extend at least partially outwardly from the frame 110 (e.g., toward the distal or proximal end of the stent 100). For example, at least a portion of each of the protruding features 120 can extend parallel to the longitudinal axis of the stent 100. At least a portion (e.g., the end portion) of each of the protruding features 120 can extend at least partially radially outwardly from the frame 110. By further example, at least a portion of each of the protruding features 120 can extend in a distal direction and / or a proximal direction from the frame 110.

[0013] When at least a portion of each of the projecting features 120 extends distally from the frame 110, the projecting features 120 can be easily retracted into the delivery device by folding and extending distally when the delivery device is advanced distally from the proximal side of the stent 100 beyond the stent 100. The projecting feature 194 can optionally include a drug to be delivered to the target delivery location when expanding the stent 100. However, it will be understood that the stent 100 can omit the drug to be delivered and treat the target delivery location by penetrating the projecting feature 120 into the tissue.

[0014] Frame 110, strut 112, and / or protruding feature 120 can be made of or formed from a variety of materials, including, for example, any of nitinol, cobalt chrome, stainless steel, various other metals or alloys, or combinations thereof. Frame 110, strut 112, and / or protruding feature 120 can also be made of or formed from a bioabsorbable, biodegradable, nanoporous, or non-bioabsorbable, non-biodegradable, non-nanoporous material, including, for example, one or more polymers, nitinol, plastic materials, etc., or combinations thereof. In some embodiments, frame 110 and strut 112 can be formed from a bioabsorbable material, and protruding feature 120 can be formed from a non-bioabsorbable material such as nitinol. In these embodiments, protruding feature 120 can remain engaged with or penetrate into a portion of the body cavity after the expanded frame 110 and struts 112 have been bioabsorbed. After the expanded frame 110 and struts 112 have been bioabsorbed, the body cavity in which stent 100 was expanded is no longer partially occluded by frame 110 and struts 112, allowing a greater volume of fluid, such as an aqueous pharmaceutical composition, to pass through the body cavity and contact the body cavity wall. Protruding feature 120 can also be formed of a bioabsorbable material, and when stent 100 is bioabsorbed, the fluid passing through the body cavity can be brought into contact with the space in the body cavity wall vacated by protruding feature 120. In this way, stent 100 can increase the surface area of the body cavity wall that is contacted by the fluid.

[0015] The projecting feature 120 may also be equipped by more than one strut 112, frame 110, or a combination thereof. The projecting feature 120 may be integrally and / or monolithically formed with the frame (e.g., strut 112), for example, by bending or twisting one or more struts and / or a portion of the frame 110 in a direction towards the longitudinal axis of the stent 100, or the projecting feature 120 may be a separate and independent component that is attached at a desired position along the strut 112 and / or frame 110.

[0016] The projecting feature 120 can include one or more of a variety of shapes and features. For example, the projecting feature 120 or a portion thereof can be linear, curved, helical, and / or spiral. The projecting features 120 can have the same or different sizes, shapes, and / or features from each other.

[0017] The projecting feature 120 can be accommodated within the outer periphery of the frame 110 while the stent 100 is in a folded configuration and / or when the stent 100 is in an expanded configuration. For example, the projecting feature 120 can be positioned within the opening 108 between the plurality of struts 112. Each of the projecting features 120 can be moved to extend at least partially away from the central axis 190 of the stent 100.

[0018] The protruding features 120 can be localized within separate portions along the length of the frame 110 and / or grouped together. As shown in FIGS. 1 and 2, the stent 100 can include a proximal section 102 that is at or defines the proximal end portion of the stent 100, and a distal section 106 that is at or defines the distal end portion of the stent 100. The stent 100 can further include an intermediate section 104 between the proximal section 102 and the distal section 106. The proximal section 102 and the distal section 106 can include a number of protruding features 120 extending from the frame 110. In contrast, the intermediate section 104 can omit the protruding features, such that the radially outermost portion of the stent along the intermediate section 104 is defined by the frame 110. Thus, the protruding features 120 in the proximal section 102 and the distal section 106 can fix the stent 100 at the ends, and the intermediate section 104 can remain relatively free for movement, bending, flexing, and / or stretching.

[0019] The sections can be defined by whether or not they provide a protruding feature. For example, the frame 110 can include a proximal section 102, an intermediate section 104, and a distal section 106. The intermediate section 104 (e.g., having no protruding feature) can extend over a significant proportion of the total length of the frame 110 and / or the stent 100. For example, the intermediate section length 144 defined by the intermediate section 104 of the frame 110 can extend over at least 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, or 90% of the total length of the frame 110 and / or the stent 100. By further example, the intermediate section length 144 can be longer than each of the proximal section length 142 of the proximal section 102 of the frame 110 and the distal section length 146 of the distal section 106 of the frame 110. By further example, the intermediate section length 144 can be longer than the length obtained by combining the proximal section length 142 and the distal section length 146. The pattern and / or shape formed by the frame 110 can be the same across the proximal section 102, the intermediate section 104, and the distal section 106. Thus, whether or not the protruding feature 120 is present can optionally be the only thing that differentiates the proximal section 102, the intermediate section 104, and / or the distal section 106. It will be understood that any number of sections can be provided. For example, one, two, three, four, five, six, or seven or more sections having a protruding feature 120 can be provided. Each pair of adjacent ones of such sections in the axial direction can optionally be separated by a section having no protruding feature 120.

[0020] The protruding features 120 can 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 can be axially aligned and arranged at different circumferential positions and / or orientations. By further example, at least some of the protruding features 120 can be circumferentially aligned and arranged at different axial positions and / or orientations. By further example, at least some of the protruding features 120 can have the same orientation and be arranged at different axial and / or circumferential positions. At least some of the protruding features 120 can have different axial and circumferential positions. At least some of the protruding features 120 can have different axial positions and orientations. At least some of the protruding features 120 can have different circumferential positions and orientations.

[0021] As shown in FIGS. 1 and 2, the protruding features 120 of the proximal section 102 and the distal section 106 can have one or more common features. For example, at least some of the protruding features 120 of the proximal section 102 and the distal section 106 can have the same orientation, and a portion of them extends in the same or similar direction. By further example, a portion of each of the protruding features 120 can extend toward either the distal end or the proximal end of the stent 100. Such a configuration can provide a consistent anchoring against forces and / or migration in a given direction (e.g., downstream of a blood vessel). Alternatively, the protruding features 120 can extend in different (e.g., opposite) directions to provide anchoring against forces and / or migration in their respective different directions.

[0022] The stent 100 can vary in size along its length. For example, the proximal section 102 (upstream) of the stent 100 can have a proximal cross-sectional dimension (e.g., diameter) 132 that is smaller than the distal cross-sectional dimension (e.g., diameter) 136 of the distal section 106 of the frame 110 of the stent 100. This can facilitate better engagement with the vessel wall by conforming to the overall expanding vessel size in the downstream direction. The cross-sectional dimension (e.g., diameter) of the stent 100 can gradually taper from one end to the opposite end. Additionally or alternatively, the stent 100 can provide flared end portions at each of its opposing ends. The stent 100 can provide variable radially outward forces along its different longitudinal segments. For example, the end portions of the stent 100 can provide a greater radial force than its intermediate section. Further other (larger and / or smaller) force profiles can be provided along different longitudinal sections of the stent 100.

[0023] In one embodiment, the stent 100 can include a material (such as polyamide, silicone, etc., such as PTFE, Dacron, nylon, and / or polyurethane-based materials) positioned, for example, on the struts of the frame 110. In one embodiment, the material covers the entire outer surface area of the frame 110. In one embodiment, the material covers the outer surface area of the frame 110 only along the intermediate section 104 between the proximal section 102 and the distal section 106. The material can be a mesh or braid. In one embodiment, the material can further be configured to allow blood flow through the lumen of the stent 100 and / or to restrict blood flow to the outer dimensions of the stent 100. Additionally, the material can be configured to prevent debris from the body cavity wall from entering the blood stream.

[0024] As shown in FIG. 4, the protruding features 120 or portions thereof can form an angle when extending radially outward from the frame 110. The angle can be any angle (e.g., from 0 degrees to 90 degrees). The angle can be selected during formation such that the angle is formed when the stent 100 expands during deployment. The angle can be equal to an angle of 0 degrees, 10 degrees, 20 degrees, 30 degrees, 40 degrees, 50 degrees, 60 degrees, 70 degrees, 80 degrees, or 90 degrees, an angle smaller than that, and / or an angle larger than that. The angles can be the same or different for any two protruding features 120.

[0025] As shown in FIG. 4, the struts 112 can be connected to each other and arranged such that a plurality of struts 112 (e.g., two, three, four, five, six, seven, eight, or nine or more struts) are all connected together at the apexes 114. The protruding features 120 can each extend from a corresponding apex 114. For example, the protruding feature 120 can extend from the apex 114 at the end of the opening 108. Thus, the protruding feature 120 can be connected to the frame 110 at only one end.

[0026] The frame 110 can form a gap 116 at the apex 114 that facilitates folding and expansion of the frame 110. For example, the struts 112 can be allowed to move towards and away from each other to facilitate the transition of the frame 110. Such movement can be enhanced by providing the gap 116 as shown in FIG. 4. The gap 116 can be positioned, for example, on the side of the apex 114 opposite the corresponding protruding feature 120 that extends from the apex 114. In some examples, the gap 116 can have parallel edges and extend longitudinally, although other shapes are envisioned. Thus, the frame 110 can provide sufficient flexibility to transition between a folded configuration and an expanded configuration.

[0027] Figures 5 and 6 show a modified expandable stent 100 having some features common to the stent 100 shown in FIGS. 1-4. Accordingly, the common features are designated with the same numbers as used in FIGS. 1-4, and the foregoing description will be understood to apply to the stent 100 of FIGS. 5 and 6.

[0028] As shown in FIGS. 5 and 6, the stent 100 can include projecting features 120 evenly distributed along its length, including those along its intermediate section. As described above, the projecting features 120 can have the same features, similar features, and / or different features relative to each other.

[0029] It will be understood that the stents described herein have the illustrated features, but that various different stents and other devices can be used with the delivery systems described herein. The following are described by way of example and not limitation with respect to various features.

[0030] With respect to such stents and other devices, the materials forming the frame 110, struts 112, and / or projecting features 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, rigidity, emissivity, thermal conductivity, specific heat, thermal diffusivity, thermal expansivity, any of various other properties, or combinations thereof. When formed from a material having thermal properties, the material can be activated to deliver thermal therapy to a desired treatment site. Regardless of the material, the frame 110, struts 112, and / or projecting features 120 can be formed from a tube or from a wire such as a solid wire by laser cutting or other suitable techniques. When formed from a wire, a portion of the wire can be removed by chemical etching or another suitable method to create the inner dimensions of the stent.

[0031] The stent 100 (e.g., frame 110 and struts 112) can be sized and shaped to be positioned within various body cavities containing blood vessels without rupturing the blood vessels. For example, some stents and other structures can have radial strength without causing dissociation or damage. Examples of blood vessels for which the size and shape of the stents described herein are determined to be disposed therein include arteries such as the coronary artery, peripheral artery, carotid artery, circle of Willis, anterior cerebral artery, middle cerebral artery, posterior cerebral artery, lenticulostriate artery, renal artery, femoral artery, etc., veins such as the cerebral vein, cavernous vein, arteriovenous fistula, or any other blood vessel that may include the treatment site. The stent 100 can have various shapes including a cube, rectangular prism, cylinder, cone, pyramid, or variations thereof.

[0032] The stent 100 with the prominent feature 120 can include various dimensions (in both a thin delivery form and an expanded deployment form). These embodiments can result in an expansion that enables use in a wide variety of situations covering a wide range of dimensions, such as for the treatment and / or prevention of dissociation. Regardless of the 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. Additionally, a stent shaped like a cube, rectangular prism, or pyramid can have a width of about 0.25 mm, about 0.5 mm, about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 12 mm, about 14 mm, about 16 mm, about 18 mm, about 20 mm, about 25 mm, or about 30 mm. Further, a stent shaped like a cylinder or cone can have a cross-sectional dimension (e.g., diameter) of about 0.25 mm, about 0.5 mm, about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 12 mm, about 14 mm, about 16 mm, about 18 mm, about 20 mm, about 25 mm, about 30 mm, about 35 mm, about 40 mm, or about 50 mm. The cross-sectional dimension (e.g., diameter) of the stent 100 can decrease gradually along the length of the stent 100. Additionally, the stent 100 can be sized and shaped to prepare a body cavity for a particular procedure, such as a stent implantation procedure.

[0033] The stent 100 and / or other expandable structures can have a cross-sectional dimension of from about 2 mm to about 10 mm in the expanded state. For example, the frame 110 can have a cross-sectional dimension of from about 1 mm to about 9 mm, and each of the protruding features 120 can have a length of from about 0.1 mm to about 4.5 mm. In one embodiment, the stent 100 has a total cross-sectional dimension of about 4 mm in combination with a frame 110 having a cross-sectional dimension of about 2 mm and protruding features 120 each having a length of about 1 mm. In one embodiment, the stent 100 has a total cross-sectional dimension of about 6 mm in combination with a frame 110 having a cross-sectional dimension of about 4 mm and protruding features 120 each having a length of about 1.5 mm. In a further embodiment, the protruding features 120 can have multiple lengths such that the lengths of the protruding features 120 of the stent or other expandable structure are different. For example, the stent can include protruding features 120 having 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.

[0034] The outer shape of the stent 100 can be sized so that the stent 100 is compatible with a wide range of catheter sizes. Embodiments according to the present technology can include a stent or other structure designed to receive a guide wire such as a guide wire having a diameter of 0.25 mm (0.010 inches), 0.36 mm (0.014 inches), 0.46 mm (0.018 inches), 0.89 mm (0.035 inches), or 0.97 mm (0.038 inches). In some embodiments, the stent 100 can be sized and designed to be delivered via a micro-catheter through which it is pushed. In one embodiment, the stent 100 can be incorporated into a delivery system, including a modular or single-unit delivery system.

[0035] The stent 100 can include markers for visualizing the stent 100 in a body cavity, such as one or more X-ray contrast markers. The X-ray contrast markers can be formed from Clearfil Photo Core PLT (registered trademark), tantalum, titanium, tungsten, barium sulfate, and zirconium oxide, or another suitable X-ray contrast marker. The markers can be formed on the proximal portion, distal portion, intermediate portion, or combinations thereof of the stent 100. The markers can be bands, coils, clips that are filled in one or more portions of the tube of the stent 100, plated on one or more portions of the stent 100, or a combination thereof. Regardless of the type of marker, the marker can be imprinted, swaged, wound, or accommodated together along or on any portion of the stent 100.

[0036] The stent 100 can be flexible enough to navigate through various anatomical forms, including those having curvatures. The flexibility of the stent 100 can be provided by the materials from which they are formed. Additionally, the flexibility can also be provided by breaking one or more of the members that engage two or more columns of the struts 112 and extend therebetween. Additionally, the stent 100 can be easily deployed and expanded, and also retracted and contracted. The stent 100 can also be easily repositioned within a blood vessel or other body cavity.

[0037] In one embodiment, the drug eluting compound is coated on at least a portion of the protruding feature 120, the frame 110, and / or the strut 112. The coating can be any suitable coating known to those skilled in the art that is suitable for delivering the drug. For example, suitable coatings include, but are not limited to, a snow coating or a crystalline coating having an edge configured to remain within the wall. The drug eluting compound can be a synthetic or biological polymer that is coated in various different patterns and thicknesses suitable for delivering the drug contained therein. In one embodiment, the protruding feature 120 itself may be composed of a drug eluting material. The drug carried by the drug eluting compound and / or the protruding feature 120 according to the present technology can be any drug suitable for treating the treatment site where the stent 100 is disposed, and may or may not contain an excipient. For example, the drug can be an anti-proliferative agent, an anti-tumor agent, a migration inhibitor, an enhanced healing factor, an immunosuppressant, an anti-thrombotic agent, a blood thinner, or a radioactive compound. In one embodiment, the drug eluting compound and / or the protruding feature 120 can carry two or more drugs.

[0038] In one embodiment, the protruding feature 120 can include a textured (e.g., ribbed) surface that is expected to provide a larger surface area for drug delivery. Further, any of the protruding features 120 can include a textured surface, such as a ribbed surface (perpendicular, horizontal, radial, or circular to the longitudinal plane of the protruding feature), a cross-hatch surface, an isotropic surface, or other surface types suitable for providing a larger surface area for vascular attachment.

[0039] The projecting feature can be sized and shaped to engage and / or penetrate an occlusion, neointima, intima, internal elastic lamina (IEL), media, external elastic lamina (EEL), adventitia, or combinations thereof. The projecting feature can also be sized and shaped to engage and / or penetrate tissue and / or structures adjacent to the body cavity into which the stent is disposed without rupturing the body cavity. For example, the stent can include a square projecting feature sized and configured to penetrate the intima and / or media of the body cavity, and a pointed projecting feature sized and configured to penetrate and extend into the media and / or IEL. Additionally, the projecting feature can be configured to bend in one or more directions relative to the longitudinal axis of the stent to engage and / or penetrate a portion of the body cavity described herein. In some embodiments, the projecting feature can penetrate deeper into the wall of the diseased body cavity, such as a blood vessel, compared to a stent without the projecting feature. Additionally, the stent can be configured to allow blood to flow while in the expanded position.

[0040] Furthermore, it will be appreciated that the stent 100 can be equipped with one or more projecting features 120 on one or more portions of the stent 100. For example, the stent 100 can be equipped with about 5 projecting features, about 10 projecting features, about 15 projecting features, about 20 projecting features, about 30 projecting features, about 40 projecting features, about 50 projecting features, about 60 projecting features, about 70 projecting features, about 80 projecting features, about 90 projecting features, or about 100 projecting features. The projecting features 120 can be equipped by the frame 110, struts 112, or combinations thereof. The number of projecting features 120 can vary depending on, for example, the target treatment site and / or the size of the stent 100. Additionally, the projecting features 120 equipped by the stent 100 can be of different types of the projecting features 120 disclosed herein.

[0041] The embodiments described herein provide a delivery system for one or more structures having means for delivering a drug to a particular region within a body cavity, such as a vascular structure, while allowing fluid (e.g., blood) to flow through a treatment area where the structure is disposed and / or within a body cavity adjacent to other devices or treatment means. In certain embodiments, fluid flow through the treatment area is temporarily prevented while one or more regions of the system are being delivered, deployed, positioned, and / or removed from the body cavity. Additionally, the delivery system can be configured to prepare the body cavity for treatment by tilting, pulling, rotating, or combinations thereof, a stent proximal or distal to the treatment site. In certain embodiments, the delivery system can be configured to rotate a stent when a mechanical force is applied.

[0042] Referring now to FIGS. 7 - 10, the methods described herein deliver the stent 100 to a target delivery position by operation of the delivery device 90 of the delivery system 10. While the methods are considered and illustrated herein in their various steps, it will be understood that multiple variations of each method are also contemplated. For example, the methods can be performed in various orders of operation and can include additional operations or fewer operations.

[0043] As shown in FIG. 7, the delivery device 90 is carried to a position within the blood vessel 40 that includes the target position for treatment. The position can include a stenosis or other feature to be improved by the placement of the stent and / or other procedures. The delivery device 90 can be positioned upstream or downstream from the target position. The delivery device 90 can be positioned with the stent contained therein. Alternatively, the delivery device 90 can be positioned and the stent advanced within the delivery device 90 at a later stage. The delivery device 90 can be positioned with the aid of a guide wire and / or one or more other devices.

[0044] As shown in FIG. 8, while maintaining the stent 100 at a given position, the delivery device 90 can be retracted proximally. Alternatively, while extruding the stent 100 distally from the delivery device 90, the delivery device 90 can be held in place. As the delivery device 90 extracts the stent 100, the stent 100 can expand radially. Such expansion can include expansion of the frame and / or the protruding features. In the expanded configuration, the frame and / or the protruding features can engage the wall of the blood vessel 40. As further shown in FIG. 8, the inflatable device 80 can optionally carry (e.g., the stent 100 mounted thereon) or advance to the position of the stent 100. The stent 100 can be temporarily fixed to the inflatable device 80 and / or other elements of the delivery system 10 (e.g., a control shaft extending within and / or along the delivery device 90). For example, the stent 100 can be positioned using the inflatable device 80 and / or using other elements, for example, independently of the inflatable device 80. When the stent 100 can be positioned separately from and / or simultaneously with the inflatable device 80, a mechanical connection to the stent 100 that facilitates their positioning can be provided to the user. The connection can facilitate the positioning and repositioning of the stent 100, as needed, before, during, and / or after expansion of the stent 100 and / or the inflatable device 80. Such connection can be temporary and / or detachable, for example, by mechanical, electrolytic, chemical, thermal, and / or other detachment mechanisms between the stent 100 and the inflatable device 80 and / or other elements. After detachment from the inflatable device 80 and / or other elements, the stent 100 can maintain its position (e.g., be fixed) and remain independent of the inflatable device 80 and / or other elements.

[0045] As shown in FIG. 9, the expandable device 80 can be expanded or otherwise extended to urge the stent 100 to expand radially and engage or further engage the wall of the blood vessel 40. For example, the expandable device 80 can push or further push the protruding feature into the wall of the blood vessel 40. It will be understood that providing and / or using the expandable device 80 can be optional, such as when the stent 100 provides sufficient self-expansion characteristics to engage the wall of the blood vessel 40. When applicable, the stent 100 can be repositioned as needed after expansion of the stent 100 and / or the expandable device 80. If a mechanical connection to the stent 100 is maintained at least temporarily, the stent 100 can be adjusted as needed. Detachment of the stent 100 from any such mechanical connection can be performed before, during, and / or after expansion of the stent 100 and / or the expandable device 80. After detachment, the stent 100 can stably adhere to the blood vessel 40. Optionally, additional operations can be performed to adjust and / or remove the stent 100 after separation and / or expansion of the stent 100.

[0046] As shown in FIG. 10, the expandable device 80 and the delivery device 90 can be removed from the blood vessel 40 with the stent 100 remaining in place. Blood can 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 position, regardless of blood flow 50 and the movement of the blood vessel 40.

[0047] Optionally, the stent 100 can be removed from the blood vessel 40. For example, the stent 100 can remain attached to and / or integral with a positioner (not shown). The positioner can optionally extend at least partially through the delivery device 90. After any duration, the stent 100 can be positioned within the blood vessel and / or removed from the blood vessel. If the stent 100 is separate from or detached (e.g., by detachment) from the positioner, the stent 100 can be retrieved by another device such as a grasping device.

[0048] Accordingly, the present disclosure provides a stent having outwardly facing protrusion features that facilitate engagement and fixation to the wall of a blood vessel. By fixing the stent with the protrusion features, the need for the stent frame and other parts to provide fixation is reduced. Therefore, such other parts of the stent can be designed to provide other characteristics desirable for any given application, such as venous stent placement. Such characteristics can include high flexibility, high radial force, high compression resistance, large diameter, and long length.

[0049] Various examples of aspects of the disclosure are presented below in list form for convenience. These are provided as examples and do not limit the technology.

[0050] Section A: A frame having struts and configured to expand from a folded configuration to an expanded configuration, the frame forming a proximal section, a distal section, and an intermediate section between the proximal and distal sections, and a protrusion feature that extends radially outward from the frame when the frame is in the expanded configuration, the protrusion feature being connected only to the proximal and distal sections of the frame.

[0051] Section B: An expandable device and a stent extending around the expandable device, the stent having struts and a frame configured to expand from a folded configuration to an expanded configuration, the frame forming a proximal section, a distal section, and an intermediate section between the proximal section and the distal section, and, when the frame is in the expanded configuration, a projecting feature extending radially outward from the proximal and distal sections of the frame of the stent, and a delivery system having the expandable device and the stent.

[0052] Section C: Positioning within a body vessel a delivery system having a delivery device that houses a stent that is in a folded configuration while within the lumen of the delivery device, and expanding the stent outside of the delivery device until the projecting feature of the stent penetrates the wall of the body vessel, the projecting feature extending radially outward from the proximal and distal sections of the frame of the stent, and the proximal and distal sections being joined by an intermediate section of the frame that abuts the body vessel without penetrating the body vessel, and removing the delivery device from the body vessel.

[0053] One or more of the above sections can include one or more of the features described below. It is noted that any of the following sections can be combined in any combination with each other and placed in each independent section, for example, Section A, B, or C.

[0054] Section 1: The intermediate section is longer than each of the proximal and distal sections.

[0055] Section 2: The cross-sectional dimension of the distal section is larger than the cross-sectional dimension of the proximal section.

[0056] Section 3: The proximal and distal sections are configured to apply a radially outward force to the body vessel, the intermediate section is configured to apply a radially outward force to the body vessel, and the radially outward force applied by the intermediate section is less than the radially outward force applied by the proximal and distal sections.

[0057] Section 4: The protruding features each extend in the same longitudinal direction from the frame, and the protruding features further extend radially outward in a direction away from the frame.

[0058] Section 5: The struts are arranged such that a plurality of struts are connected to each other to form vertices, and one of the protruding features extends from a vertex.

[0059] Section 6: The struts form a gap on the side of the vertex opposite to one of the protruding features.

[0060] Section 7: In the folded configuration, the protruding features extend longitudinally within the openings formed between the struts, and in the expanded configuration, the protruding features extend radially outward.

[0061] Section 8: The protruding features are formed monolithically with the frame.

[0062] Section 9: The expandable device extends across the proximal and distal sections of the frame.

[0063] Section 10: In the folded configuration, the protruding features extend longitudinally within the openings formed between the struts, and in the expanded configuration, the protruding features extend radially outward.

[0064] Section 11: Expanding includes positioning the expandable device within the stent and expanding the expandable device relative to the stent until the protruding features penetrate the body vessel.

[0065] Section 12: The distal section is positioned within the body vessel downstream of the proximal section.

[0066] Section 13: The proximal and distal sections of the frame apply a radially outward force to the body vessel that is greater than the radially outward force applied by the intermediate section to the body vessel.

[0067] References to elements in the singular are not intended to mean “only one” unless specifically defined otherwise, but rather “one or more.” For example, “a” module may refer to one or more modules. Elements following “a,” “an,” “the,” or “said” do not, without further limitation, preclude the further existence of the same element.

[0068] Headings, and subheadings if any, are for convenience only and do not limit the present invention. The term “exemplary” is used to mean serving as an example or illustration. To the extent that terms such as “comprising” or “having” are used, such terms are to be construed in a manner similar to the way the term “comprising” is construed when used as a transitional phrase in claims, to be inclusive. Relative terms such as “first” and “second” may be used to distinguish one such entity or action from another, without necessarily requiring or implying any actual relationship or order between entities or acts.

[0069] Phrases such as “aspect,” “the aspect,” “another aspect,” “an aspect,” “one or more aspects,” “embodiment,” “the embodiment,” “another embodiment,” “an embodiment,” “one or more embodiments,” “example,” “the example,” “another example,” “an example,” “one or more examples,” “configuration,” “the configuration,” “another configuration,” “a configuration,” “one or more configurations,” “the present technology,” “disclosure,” “the present disclosure,” and other variations thereof are for convenience only and do not imply that the disclosure related to such phrases is essential to the present technology or that such disclosure applies to all configurations of the present technology. The disclosure related to such phrases may apply to all configurations, or one or more configurations. The disclosure related to such phrases may provide one or more examples. Phrases such as “aspect” or “an aspect” may refer to one or more “aspects,” and vice versa, and this applies equally to other aforementioned phrases.

[0070] The phrase "at least one" before a series of items modifies the entire list rather than each element of the list, accompanied by the terms "and" or "or" that separate any of the items. The phrase "at least one" does not require selecting at least one item, but rather enables the meaning of including at least one of any one of the items, and / or at least one of any combination of the items, and / or at least one of each of the items. By way of example, the phrases "at least one of A, B, and C" or "at least one of A, B, or C" each refer to 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.

[0071] It is understood that the specific order or hierarchy of the disclosed steps, operations, or processes are examples of illustrative techniques. Unless otherwise specified, it is understood that the specific order or hierarchy of steps, operations, or processes may be performed in a different order. Some of the steps, operations, or processes may be performed simultaneously. If there are method claims in the appended claims, presenting the elements of various steps, operations, or processes in an example order does not mean being limited to the specific order or hierarchy presented. These may be performed sequentially, continuously, in parallel, or in a different order.

[0072] In one aspect, terms such as "coupled" may refer to being directly coupled. In another aspect, terms such as "coupled" may refer to being indirectly coupled.

[0073] Terms such as "top", "bottom", "front", "rear", "side", "horizontal", "vertical", etc. refer to any reference system rather than the normal gravity reference system. Thus, such terms may extend in an upward, downward, diagonal, or horizontal direction in a gravity reference system.

[0074] The disclosure is provided to enable any person skilled in the art to implement the various aspects described herein. In some cases, well-known structures and components are shown in block diagram form to avoid obscuring the concepts of the technology. The disclosure provides various examples of the technology, but the technology is not limited to these examples. Various modifications to these aspects will be readily apparent to those skilled in the art. Also, the principles described herein may be applied to other aspects.

[0075] All structural and functional equivalents to the elements of the various aspects described throughout the disclosure that are known or later become known to those skilled in the art are hereby expressly incorporated by reference herein and are intended to be encompassed by the claims. Further, nothing disclosed herein is to be considered available to the public whether or not such disclosure is expressly recited in the claims. No claim element is to be construed under 35 U.S.C. § 112, ¶ 6 unless the element is expressly recited using the phrase "means for" or, in the case of a method claim, the element is expressly recited using the phrase "steps of".

[0076] The title, background, brief description of the drawings, summary, and drawings are hereby incorporated into the disclosure and provided as illustrative examples of the disclosure rather than as limiting descriptions. It is submitted with the understanding that they are not used to limit the scope or meaning of the claims. Additionally, in the detailed description, the description provides illustrative examples and it can be seen that various features are grouped in various embodiments for the purpose of streamlining the disclosure. The method of the disclosure is not to be construed as reflecting an intention that the claimed subject matter requires more features than those expressly recited in each claim. Rather, the subject matter of the invention lies in less than all of the features of a single disclosed configuration or operation, as reflected by the claims. The claims are hereby incorporated into the detailed description, and each claim stands on its own as a separately claimed subject matter.

[0077] The claims are not limited to the aspects described in this specification, but the full scope consistent with the language of the claims should be recognized and all legal equivalents should be included. Nevertheless, none of the claims is intended to cover, nor should be construed to cover, subject matter that fails to meet the requirements of the applicable patent law.

Claims

1. A frame having a plurality of struts and configured to expand from a folded configuration to an expanded configuration, wherein the struts are connected to each other to form a plurality of vertices, a proximal section, a distal section, and an intermediate section between the proximal section and the distal section forming a frame, and a plurality of spikes that, when the frame is in the expanded configuration, each extend radially outward from a corresponding one of the plurality of vertices and from the frame, the plurality of spikes being connected only to the proximal section and the distal section of the frame having, the struts form a plurality of gaps that allow the struts to move toward and away from each other to facilitate the transition between the folded configuration and the expanded configuration, each gap being on the side of the corresponding one of the vertices opposite to the corresponding one of the plurality of spikes, and each gap being defined by parallel edges of the struts on both sides of the corresponding one of the plurality of gaps, a stent.

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

3. The stent according to claim 1, wherein the diameter of the distal section is larger than the diameter of the proximal section.

4. The proximal section and the distal section are configured to apply a radially outward force to a body blood vessel, the intermediate section is configured to apply a radially outward force to the body blood vessel, and the radially outward force applied by the intermediate section is smaller than the radially outward force applied by the proximal section and the distal section, the stent according to claim 1.

5. The stent according to claim 1, wherein each of the spikes extends in the same longitudinal direction from the frame, and the spikes further extend radially outward away from the frame.

6. In the folded configuration, the spikes extend longitudinally within an opening formed between the struts, In the expanded configuration, the spikes extend radially outward, the stent according to claim 1.

7. The stent according to claim 1, wherein the spikes are formed integrally with the frame.

8. An inflatable device, A stent extending around the expandable device, having a plurality of struts and a frame configured to expand from a folded configuration to an expanded configuration, the struts being connected to each other to form a plurality of vertices, the frame forming a proximal section, a distal section, and an intermediate section between the proximal section and the distal section, the frame, and a plurality of spikes that, when the frame is in the expanded configuration, extend radially outward from a corresponding one of the plurality of vertices and from the proximal and distal sections of the frame, the spikes being connected only to the proximal and distal sections of the frame, the struts forming a plurality of gaps that allow the struts to move toward and away from each other to facilitate the transition between the folded configuration and the expanded configuration, each gap being on the side of the corresponding one of the vertices opposite to a corresponding one of the plurality of spikes, and each gap being defined by parallel edges of the struts on both sides of the corresponding one of the plurality of gaps. A plurality of spikes having a stent; a delivery device for accommodating the expandable device and the stent having a delivery system. **Claim 9** The delivery system according to claim 8, wherein the expandable device extends across the proximal and distal sections of the frame. **Claim 10** In the folded configuration, the spikes extend longitudinally within an opening formed between the struts, In the expanded configuration, the spikes extend radially outward. The delivery system according to claim 8. **Claim 11** The delivery system according to claim 8, wherein the spikes are formed integrally with the frame. **Claim 12** The delivery system according to claim 8, wherein the intermediate section is longer than each of the proximal and distal sections. **Claim 13** The delivery system according to claim 8, wherein the diameter of the distal section is larger than the diameter of the proximal section.

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