Delivery system for stents with protruding features

Abstract

Delivery systems for expandable elements, such as stents or scaffolds having spikes, flail or other protruding features for piercing target tissue and / or delivering drugs in a human patient, and related methods of using such systems are described. The delivery system may be provided with a stent positioned on an inflatable balloon to expand and deliver the stent to a target delivery site. By positioning the stent above and around an inflatable balloon, the stent is ready to be expanded by the balloon upon detachment relative to the outer shaft. Additionally or alternatively, the stent may be positioned in an axially offset arrangement relative to the balloon to reduce the space demand required for overlapping components.

Description

[0001] This application is a divisional application of the patent application with application number 201980066102.4 and invention name “Delivery system for stents with outstanding features” filed on October 4, 2019. The patent application with application number 201980066102.4 is an application entering the Chinese national phase with PCT international application number PCT / US2019 / 054847.

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims the benefit of U.S. Provisional Application No. 62 / 742,852, filed on October 8, 2018, entitled “DELIVERY SYSTEMS FOR STENTSHAVING PROTRUDING FEATURES,” the entire contents of which are incorporated herein by reference. Technical Field

[0004] The present description generally relates to delivery systems for expandable elements, such as stents or scaffolds having spikes, flails, or other protruding features for penetrating target tissue and / or delivering drugs within a human patient. Background Art

[0005] A variety of devices can be used to deliver drugs to the intended treatment site in the patient. For example, a stent (such as a drug eluting stent (DES)) can be positioned at the site of stenosis (narrowing of the arteries) caused by arteriosclerosis. DES generally includes a drug-containing polymer coated on a metal stent or framework, or a bioabsorbable stent or framework consisting of a drug-containing polymer. After the DES is delivered to the treatment site in a body lumen (e.g., a vessel), it expands against the wall of the body lumen (e.g., a vessel wall), and the drug is released via direct contact with the wall. Direct delivery of the drug to the vessel wall achieves a significantly lower dose than the required dose via other delivery methods (e.g., pills or injections). BRIEF DESCRIPTION OF THE DRAWINGS

[0006] Figure 1 A partially schematic side view of an example of a delivery system is shown.

[0007] Figure 2 Shown is a view taken along line 2-2. Figure 1 A cross-sectional view of an example area of ​​a conveyor system.

[0008] Figure 3 Shows Figure 1 An enlarged schematic side view of a portion of a delivery system having an unconstrained stent.

[0009] Figure 4A perspective view of an example of a bracket is shown.

[0010] Figure 5 Shows Figure 4 Side view of the bracket.

[0011] Figure 6 Shows Figure 4 Front view of the bracket.

[0012] Figure 7 Shows Figure 4 A perspective view of an example of a connector end of a bracket.

[0013] Figure 8 Shows Figure 4 A perspective view of another example of a connector end of a bracket.

[0014] Fig. 9 Shows Figure 4 A perspective view of another example of a connector end of a bracket.

[0015] Fig.10 Shows Figure 4 A perspective view of another example of a connector end of a bracket.

[0016] Fig.11 A side view of an example of a delivery system is shown in a first stage of deployment.

[0017] Fig.12 Shown is the second stage of development Fig.11 Side view of the conveying system.

[0018] Fig.13 Shown is the third stage of development Fig.11 Side view of the conveying system.

[0019] Fig.14 Shown is the fourth stage of development Fig.11 Side view of the conveying system.

[0020] Fig.15 A cross-sectional view of an exemplary region of a delivery system is shown.

[0021] Fig.16 A side view of another example of a delivery system is shown in a first stage of deployment.

[0022] Fig.17 Shown is the second stage of development Fig.16 Side view of the conveying system.

[0023] Fig.18 Shown is the third stage of development Fig.16 Side view of the conveying system.

[0024] Fig.19 Shown is the fourth stage of development Fig.16 Side view of the conveying system.

[0025] Fig. 20 Shown is the fifth stage of development Fig.16 Side view of the conveying system.

[0026] Fig.21 A side view of another example of a delivery system is shown in a first stage of deployment.

[0027] Fig. 22 Shown is the second stage of development Fig.21 Side view of the conveying system.

[0028] Fig.23 Shown is the third stage of development Fig.21 Side view of the conveying system.

[0029] Fig.24 Shown is the fourth stage of development Fig.21 Side view of the conveying system.

[0030] Fig.25 A side view of an example of a delivery system is shown in a first stage of deployment.

[0031] Fig.26 Shown is the second stage of development Fig.25 Side view of the conveying system.

[0032] Fig. 27 Shown is the third stage of development Fig.25 Side view of the conveying system.

[0033] Fig.28 Shown is the fourth stage of development Fig.25 Side view of the conveying system.

[0034] Fig.29 A side view of an example of a delivery system in a delivery state within a body lumen is shown.

[0035] Fig.30 Shown in an expanded state Fig.29 Cross-section of the conveying system.

[0036] Fig.31 Shows Fig.29 Cross-sectional view of a delivery system with a balloon and stent in an expanded state within a body lumen.

[0037] Fig.32 Shows Fig.29 A cross-sectional view of a region of a delivery system of FIG. 1 , wherein the stent is in a treatment state and the balloon is in a collapsed state allowing fluid flow.

[0038] In one or more embodiments, all components shown in each figure may not be needed, and one or more embodiments may include additional components not shown in the figures. Without departing from the scope of the present disclosure, the arrangement and type of components may be changed. Within the scope of the present disclosure, additional components, different components or fewer components may be used. DETAILED DESCRIPTION

[0039] The following detailed description is intended as a description of various embodiments, and is not intended to represent the only embodiments that the subject technology can be practiced. As will be appreciated by those skilled in the art, the described embodiments can be modified in a variety of different ways, all of which do not depart from the scope of the present disclosure. Therefore, the drawings and description are considered to be illustrative and not restrictive in nature.

[0040] The following disclosure describes various embodiments of delivery systems for expandable structures, and related devices and methods, such as stents or frameworks with spikes, flails, or other prominent features for piercing target tissues and / or delivering drugs in human patients. The delivery system can be configured to deliver and position the expandable structure in a body lumen (e.g., a vessel). In addition, these delivery systems can also be configured to deploy and expand the expandable structure in a body lumen. The delivery system can also be configured to engage with the expanded structure and collapse the structure to remove it from the body lumen. In some embodiments, the delivery system can be configured to deliver another expandable structure or the same expandable structure to another body lumen or the same body lumen during a single process or during multiple processes. This delivery system is expected to simplify and speed up the transluminal process to more effectively deliver and position the expandable structure in the target tissue. When configured to retract the expanded expandable structure, the delivery system can be used for more than one process, such as deploying the expandable structure.

[0041] Specifically, the delivery system described herein can be provided with a stent positioned on an expandable balloon to expand and deliver the stent to a target delivery site. By positioning the stent on and around the expandable balloon, the stent is ready to be immediately expanded by the balloon when it is dislodged relative to the outer shaft. Additionally or alternatively, the stent can be positioned in an axially offset arrangement relative to the balloon to reduce the space requirements required for overlapping components.

[0042] In the following description and Figure 1-Figure 32Certain details are set forth in order to provide a thorough understanding of the various embodiments of the present disclosure. In order to avoid unnecessarily obscuring the description of the various embodiments of the present disclosure, other details of well-known structures and systems that are typically associated with expandable structures, protruding features, and components or equipment associated with the manufacture of such structures are not set forth below. In addition, many of the details and features shown in the accompanying drawings are merely illustrative of specific embodiments of the present disclosure. Therefore, other embodiments may have other details and features without departing from the spirit and scope of the present disclosure. Therefore, a person of ordinary skill in the relevant art will understand that the present technology, including associated devices, systems, and processes, may include other embodiments with additional elements or steps, and / or may include embodiments without the reference below. Figure 1-Figure 32 Other embodiments of several of the features or steps shown and described. Furthermore, various embodiments of the present disclosure may include structures other than those shown in the figures, and are expressly not limited to the structures shown in the figures.

[0043] Figure 1 A partial schematic side view of a delivery system 100 for a stent in a delivery state (e.g., a low profile or collapsed configuration) is shown. The delivery system 100 includes an outer shaft 120 (e.g., a catheter) having one or more lumens for accommodating an inner shaft 110 and / or a guidewire 162. In some embodiments, the outer shaft 120 may also include one or more layers. In these embodiments, for example, the layers of the outer shaft 120 may include an inner layer, an outer layer, a liner, or a combination thereof. Each layer may be composed of a polymer, high-density polyethylene (HDPE), polytetrafluoroethylene, silicone, (polyether block amide) or a combination thereof. In some embodiments, each layer of the outer shaft 120 is formed of the same material. However, in other embodiments, one or more layers may be formed of different materials.

[0044] The inner shaft 110 can extend from the connector 150, through the outer shaft 120, and beyond the distal portion 120b of the outer shaft 120. The inner shaft 110 can be formed as a tubular structure (with or without a slot), such as a spiral tube, a braided tube, a reinforced tube, or a combination thereof, and can be made of a polymer material such as polyimide. The delivery system 100 can include a guide wire within the inner shaft 110, which can be contacted at the proximal end of the delivery system 100.

[0045] In a detailed view of the distal portion 100b of the delivery system 100, a tip 115 (e.g., an atraumatic tip) is disposed on the distal end of the inner shaft 110. As shown, the tip 115 is adjacent to the distal end of the outer shaft 120. At least a portion of the tip 115 can have the same cross-sectional dimensions as the outer shaft 120, or the tip 115 can have a different cross-sectional dimension. In some embodiments, the distal end 115b of the tip 115 is tapered so that the distal end 115b has a smaller cross-sectional dimension than the proximal end 115a of the tip. The distal edge and / or the proximal edge of the tip 115 can be chamfered / rounded to prevent the tip 115 from being caught (e.g., stuck) on other parts of the delivery system 100 during delivery, positioning, deployment, etc. The tip 115 can be formed of the same material as the outer shaft 120. However, in other embodiments, the distal end 115 may be formed of a different material than the outer shaft 120 .

[0046] Inner shaft 110 and outer shaft 120 can be sized and shaped for intravascular access to a target site (e.g., a treatment site) of a patient. In some embodiments, for example, outer shaft 110 has a length of about 150 cm to about 180 cm and a suitable cross-sectional size for positioning within the vasculature of a subject. The length of inner shaft 110 can be a working length, such as a length that can be positioned within the vasculature of a subject. In some embodiments, for example, the working length is about 70 cm to about 300 cm, about 150 cm to about 250 cm, or about 70 cm, about 80 cm, about 90 cm, about 100 cm, about 110 cm, about 120 cm, about 130 cm, about 140 cm, about 150 cm, about 160 cm, about 170 cm, about 180 cm, about 190 cm, about 200 cm, about 210 cm, about 220 cm, about 230 cm, about 240 cm, about 250 cm, about 260 cm, about 270 cm, about 280 cm, about 290 cm, or about 300 cm. In other embodiments, the outer shaft 120 has a length of about 130 centimeters (cm) to about 140 cm and a cross-sectional size of about 4 French, about 5 French, or about 6 French. The length of the outer shaft 120 can be a working length, such as a length that can be positioned within the vascular system of a subject. In some embodiments, for example, the working length is about 50 cm to about 200 cm, about 100 cm to about 150 cm, or about 50 cm, about 60 cm, about 70 cm, about 80 cm, about 90 cm, about 100 cm, about 110 cm, about 120 cm, about 125 cm, about 130 cm, about 135 cm, about 140 cm, about 145 cm, about 150 cm, about 155 cm, about 160 cm, about 170 cm, about 180 cm, about 190 cm, about 200 cm.

[0047] exist Figure 1 In the detailed view of the proximal portion 100a of the delivery system 100 in FIG. 1 , the proximal end 120c of the outer shaft is coupled to the outer hub 140. In the illustrated embodiment, the outer hub 140 is coupled to the outer shaft 120 (e.g., via bonding). However, in other embodiments, the proximal end 120c of the outer shaft is directly coupled to the outer hub 140.

[0048] The outer hub 140 is further coupled to a connector 150 (e.g., a y-shaped connector) having a lumen (not shown) extending therethrough. In particular, the distal end 150b of the connector 150 can be coupled to the outer hub 140 via mating features and receiving features (not shown). The mating features and receiving features can be coupled to a proximal portion of the outer shaft 120 or the distal end 150b of the connector 150. The connector 150 also includes a port 152 extending radially and / or longitudinally therefrom. The delivery system 100 can optionally include a hemostasis connector 170 coupled to the proximal end 150a of the y-shaped connector 150. Although the proximal end 120c is shown as having specific components in a specific arrangement, it should be understood that additional or fewer components can be included in similar or other arrangements to meet the needs of the system.

[0049] The delivery system 100 is configured to carry a stent in a delivery / collapsed state within a distal portion of an outer shaft 120 (discussed further herein). The stent can be at least partially encased by the outer shaft 120. In some embodiments, the stent can be fixedly or removably coupled to the inner shaft 110. Although the delivery system 100 is shown as a delivery system for a stent, it should be understood that embodiments of the present technology can also include cages, meshes, balloons, membranes, tubular structures, circumferential bodies, expandable elements, expandable membranes, expandable structures, expandable tubular structures, and circumferentially expandable catheter tips with and without guidewire lumens.

[0050] Figure 2 Shown is a view taken along line 2-2. Figure 1 A cross-sectional view of a region of a conveying system 100. Figure 2 As shown, the inner shaft 110 can be at least partially disposed in the lumen of the outer shaft 120, and the guide wire 162 can be at least partially disposed in the lumen of the inner shaft 110. In some embodiments, the outer shaft 120, the inner shaft 110 and / or the guide wire 162 each have a circular cross-sectional shape. However, in other embodiments, the outer shaft 120, the inner shaft 110 and / or the guide wire 162 can have other cross-sectional shapes, such as oval, "C" shape, rectangular, triangular, etc.

[0051] The guidewire 162 and the inner shaft 110 can be positioned in the lumen of the outer shaft 120 in any configuration, such as in the front and rear as shown, or in the middle and the side. In addition, as shown, the guidewire 162 and the inner shaft 110 can be positioned relative to each other in the lumen of the outer shaft 120, or the guidewire 162 can be positioned outside the inner shaft 110. A fluid path can be defined in the lumen of the inner shaft 110, for example, along the length of the guidewire 162. The fluid path can be connected to the port 152 of the connector 150 and / or can be accessed via the port of the connector.

[0052] Figure 3 Shown in an expanded state Figure 1 100b of the delivery system 100. In the illustrated embodiment, the stent 190 extends over the balloon 180 and is coupled to the delivery catheter shaft and has been disengaged from the distal portion 120b of the outer shaft. A proximal visualization marker 192 is disposed on the stabilizing wire 160 near the proximal portion of the stent 190, and a distal visualization marker 197 is disposed on the distal end 190c of the stent. In some embodiments, the proximal visualization marker 192 and / or the distal visualization marker 197 may be disposed on the stabilizing wire 160. The visualization markers 192 and / or 197 may be formed of any material that can be visualized when the stent 190 is positioned intravascularly (e.g., within a target vessel). For example, in one embodiment, the visualization markers 192 and / or 197 are radiopaque markers. The stabilizing wire 160 may be connected to the inner shaft 110 so that the movement of the inner shaft 110 pushes the stent 190 accordingly via the stabilizing wire 160, as further discussed herein. Alternatively, the stabilization wire 160 can be independently movable relative to the inner shaft 110, as discussed further herein.

[0053] The distal end 115 is disposed on and may surround the terminal end 110c of the inner shaft 110, extending proximally along the distal portion 110b and / or extending distally from the terminal end 110c. The inner shaft 110 extends distally from the distal portion 120b of the outer shaft 120, through the lumen of the stent 190, and optionally, extends distally from the distal end of the stent 190. In the deployed configuration, the protruding features 194 extend radially relative to the longitudinal axis of the stent 190, as further discussed herein.

[0054] As discussed further herein, the inner shaft 110 can also include an expandable balloon (not shown) that can axially overlap, be distal to, or be proximal to the stent 190 when the stent 190 is in a delivery state (e.g., a low profile or collapsed configuration) within the outer shaft 120 and / or when the stent 190 is initially deployed from the delivery state.

[0055] The guidewire 162 can extend through the inner shaft 110 and beyond the distal end 115. Thus, the guidewire 162 can be advanced ahead of the other parts of the delivery system 100. The inner shaft 110, the stent 190, and the outer shaft 120 can be advanced over the guidewire 162 until the stent 190 is aligned with the intended target delivery site. The length of the guidewire 162 that overlaps with the other parts of the delivery system 100 can be within the inner shaft 110 so that it does not interfere with any other components of the delivery system 100.

[0056] like Figure 4-Figure 6 As shown, the expandable stent 190 is provided with a frame 191 and a plurality of protruding features 194. The frame 191 and the protruding features 194 can be configured to expand radially after the stent 190 has been disengaged from the outer shaft 120. The stent 190 can self-expand when released from the constraint. Additionally or alternatively, the stent 190 can be expanded by the radial force applied by the balloon when the balloon is expanded in the stent 190. The frame 191 can include a plurality of struts 195, which are arranged in a manner to support the compression, expansion, flexibility and bendability of the stent 190. The frame 191 can form a generally cylindrical shape along at least a portion of the stent 190. At least a portion of each protruding feature 194 can at least partially extend distally from the frame 191 (e.g., toward the distal end 190c). For example, at least a portion of each protruding feature 194 can extend parallel to the longitudinal axis of the stent 190. At least a portion of each protruding feature 194 (e.g., the end portion) can at least partially extend radially away from the frame 191. For example, at least a portion of each protruding feature 194 can extend radially outward relative to the longitudinal axis of the stent 190 (e.g., perpendicular to the longitudinal axis). Since at least a portion of each protruding feature 194 extends distally from the frame 191, when the outer shaft 120 is advanced on the stent 190 in the distal direction from the proximal side of the stent 190, the protruding features 194 can be easily retracted into the outer shaft 120 by folding up and extending distally. The protruding features 194 can optionally include drugs for delivery to the target delivery site when the stent 190 is expanded. However, it should be understood that the stent 190 can omit the drug for delivery and treat the target delivery site by piercing the tissue with the protruding features 194.

[0057] The frame 191, struts 195, and / or protruding features 194 can be constructed or formed from 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 191, struts 195, and / or protruding features 194 can also be constructed or formed from bioabsorbable, biodegradable, nanoporous 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 191 and struts 195 can be formed from a bioabsorbable material, and the protruding features 194 can be formed from a non-bioabsorbable material, such as nitinol. In these embodiments, the protruding features 194 can remain engaged with or penetrate a portion of a body lumen after the expanded frame 191 and struts 195 are bioabsorbed. After the expanded frame 191 and struts 195 are bioabsorbed, the body lumen in which the stent 190 has been expanded is no longer partially blocked by the frame 191 and struts 195, thereby allowing a larger volume of fluid (such as an aqueous drug composition) to pass through the body lumen and contact the lumen wall. The protruding features 194 can also be formed of a bioabsorbable material, and when the stent 190 has been bioabsorbed, the space in the body lumen wall vacated by the protruding features 194 can be contacted by the fluid passing through the body lumen. In this way, the stent 190 can increase the surface area of ​​the body lumen wall that the fluid contacts.

[0058] The protruding features 194 may also be carried by more than one strut 195, frame 191, or a combination thereof. The protruding features 194 may be formed integrally with the struts 195, such as by bending or twisting a portion of one or more struts and / or frame 191 away from the longitudinal axis of the stent 190, or alternatively, the protruding features 194 may be separate, independent components attached to desired locations along the struts 195 and / or frame 191.

[0059] The stent 190 may include an anchoring portion 196 that is securely connected to a component for controlling, positioning, and / or adjusting the stent 190. For example, the anchoring portion 196 may securely connect the stent 190 to the inner shaft 110. Alternatively, the anchoring portion 196 may securely connect the stent 190 to the stabilizing wire 160. The anchoring portion 196 may be offset from the central axis of the stent 190. For example, the anchoring portion 196 may be radially aligned, adjacent, or close to a portion of the frame 191 of the stent 190. The frame 191 of the stent 190 may be connected to the anchoring portion 196 via the middle portion 193. The middle portion 193 may include a plurality of struts with different widths to enhance the column strength for deployment and retrieval, and these struts may extend from different portions of the frame 191, such as different circumferential portions connected to the ends of the frame 191. The struts of the middle portion 193 may extend to the same or different axial positions along the anchoring portion 196. The arrangement of the struts of the middle portion 193 may maintain an open central space along the entire length of the stent 190.

[0060] like Figure 7-10 As shown, the anchor portion 196 can be formed in one or more of a variety of arrangements. Figure 7 As shown, the anchor portion 196 can include a plurality of ribs 902 extending circumferentially from different axial locations along the anchor portion 196. The ribs 902 can be positioned at different axial locations to provide multiple contact points with a locator (such as the inner shaft 110 and / or the stabilization wire 160).

[0061] like Figure 8 As shown, the anchor portion 196 may include different portions extending in different directions. For example, the anchor portion 196 may include a longitudinal portion 904 and a circumferential portion 906. Axially adjacent pairs of longitudinal portions 904 may be connected together by corresponding circumferential portions 906. Similarly, axially adjacent pairs of circumferential portions 906 may be connected together by corresponding longitudinal portions 904. Different longitudinal portions 904 may have different circumferential positions to surround the coupled members positioned at different circumferential positions thereon.

[0062] like Fig. 9 As shown, the anchor portion 196 can include a helical wrap 908. For example, the anchor portion 196 can be helically wrapped around a central space that is configured to receive a locator therein. The helical wrap 908 can include multiple turns (e.g., 2, 3, 4, 5, 6, 7, 8, or more than 8 turns). The helical wrap 908 can include a shape in cross-section that provides a flat inner side for engaging a locator while maintaining a low profile.

[0063] like Fig.10As shown, the anchoring portion 196 can include an arrangement of a plurality of struts 910. The struts 910 can define a generally cylindrical shape for receiving and coupling to a locator. The struts 910 can extend circumferentially and / or longitudinally around a space for receiving the locator. The struts 910 can form any number of units that can vary in length and / or width relative to each other.

[0064] The anchoring portion 196 can securely connect the stent 190 to a positioner, such as the inner shaft 110 and / or the stabilizing wire 160. For example, the anchoring portion 196 can be pressed onto the positioner. For another example, the anchoring portion 196 can be bonded to the positioner. Additionally or alternatively, a sleeve can be disposed around at least a portion of the anchoring portion 196 and / or the positioner. For example, a tube, such as one or more flexible materials (including polyurethane and (For example, 35D)) can be provided as a sleeve over the anchoring portion 196 and / or the locator. Additionally or alternatively, the stabilizing wire 160 can be connected to the inner shaft 110 by one or more of a variety of methods, including laser welding, bonding, crimping, forging, soft melting, etc. Additionally or alternatively, the anchoring portion 196 can removably or reversibly connect the stent 190 to the locator. For example, the anchoring portion 196 can be provided with one or more separation mechanisms (e.g., electrolytic, mechanical, or chemical) to controllably separate the stent 190 from the locator. In this way, the stent 190 can be controllably separated and retained at the target delivery site.

[0065] The methods described herein provide for the delivery of a stent 190 to a target delivery site through the operation of a delivery system 100. Although the methods are discussed and described herein at various stages, it should be understood that multiple variations of each method are also contemplated. For example, the methods may be performed in various orders of operations, by additional operations, or by fewer operations.

[0066] like Figure 11-Figure 14 As shown, the delivery system 100 can be provided with a stent 190 positioned above an expandable balloon 180 for expanding and delivering the stent 190 to a target delivery site. By positioning the stent 190 above and around the expandable balloon 180, the stent 190 is ready to be expanded by the balloon 180 immediately when it is dislodged relative to the outer shaft 120.

[0067] like Fig.11As shown, the delivery system 100 is provided with an outer shaft 120 that covers or wraps the other components of the delivery system 100. For example, the outer shaft 120 can extend to a distal end 115 positioned at the distal end of the inner shaft 110. The inner shaft 110 can extend within the outer shaft 120, having a length accessible proximally of the proximal end of the outer shaft 120 (e.g., at the outer shaft hub 140). Additionally or alternatively, the connector 150 can be accessible proximally of the proximal end of the outer shaft 120 (e.g., at the outer shaft hub 140). As described above, a guidewire can be advanced before the distal end 115 (e.g., through the inner shaft 110), thereby providing a path for the advancement of the other components of the delivery system 100.

[0068] like Fig.12 and Fig.13 As shown, the outer shaft 120 can be moved to dislodge the stent 190 and other components of the delivery system 100. For example, once the distal region of the delivery system 100 is positioned at the desired location, the outer shaft 120 is configured to be at least partially proximally retracted relative to the inner shaft 110 by retracting the outer hub 140 relative to the connector 150. Once the outer shaft 120 is partially retracted, at least a portion of the stent 190 and / or balloon 180 is dislodged, and the protruding features 194 of the stent 190 are configured to expand radially outward away from the inner shaft 110.

[0069] As used herein, the movement of various components can be relative to other components of the delivery system 100 and / or relative to a location external to the delivery system 100 (e.g., a location within the patient's anatomy, a target delivery site, and / or tissue). The directions "proximal" and "distal" can be relative to the delivery system 100, its components, and / or a location external to the delivery system 100. For example, the movement of the guidewire 162 can be relative to the outer shaft 120, the inner shaft 110, the stent 190, and / or the balloon 180. It should be understood that when the guidewire 162 moves, the outer shaft 120, the inner shaft 110, the stent 190, and / or the balloon 180 can be stationary, move in the same direction (e.g., at different speeds), or move in different (e.g., opposite) directions. It should also be understood that when the outer shaft 120, the inner shaft 110, the support 190 and / or the balloon 180 move, the guide wire 162 can be stationary, move in the same direction (e.g., at different speeds), or move in different (e.g., opposite) directions. For another example, the movement of the outer shaft 120 can be relative to the inner shaft 110, the support 190 and / or the balloon 180. It should be understood that when the outer shaft 120 moves, the inner shaft 110, the support 190 and / or the balloon 180 can be stationary, move in the same direction (e.g., at different speeds), or move in different (e.g., opposite) directions. For another example, the movement of the inner shaft 110, the support 190 and / or the balloon 180 can be relative to the outer shaft 120. It should be appreciated that the outer shaft 120 can be stationary, move in the same direction (eg, at a different speed), or move in a different (eg, opposite) direction while the inner shaft 110, stent 190, and / or balloon 180 move.

[0070] like Fig.14 As shown, the outer shaft 120 has been retracted and the stent 190 has been dislodged. The stabilizing wire 160 connected to the inner shaft 110 via the anchoring portion 196 is configured to engage the proximal end of the stent 190 and control the position of the stent 190 during and after retraction of the outer shaft 120. Thus, the position of the stent 190 relative to the inner shaft 110 (including the balloon 180) is maintained unchanged. For example, while some adjustments to the length and / or axial position of the stent 190 can be made during radial expansion of the stent 190, it should be understood that the stabilizing wire 160 can maintain the position of at least a portion of the stent 190 to surround at least a portion of the balloon 180 and be axially aligned therewith. The balloon 180 can have an axial length that is greater than the axial length of the stent 190 such that the entirety of the stent 190 overlaps with the balloon 180. As shown Fig.14As shown, the stabilizing wire 160 can connect the stent 190 to a portion of the inner shaft 110 that is proximal to the balloon 180. Additionally or alternatively, the stabilizing wire 160 can connect the stent 190 to a portion of the inner shaft 110 that is distal to the balloon 180.

[0071] When both stent 190 and balloon 180 are dislodged and exposed through outer shaft 120, balloon 180 can be inflated to expand or further expand stent 190. For example, the interior region of the balloon can be fluidly connected to port 152 of connector 150 via inner shaft 110. By providing fluid via port 152, balloon 180 can be expanded, thereby expanding or further expanding stent 190. Expansion relative to a target anatomical structure will be discussed further herein.

[0072] After one or more of the above operations, balloon 180 can be deflated. Stent 190 can be maintained in the expanded state for any duration. For example, stent 190 can be maintained for a duration that is effective for providing therapeutic treatment (e.g., remodeling and / or drug delivery) to the target anatomical structure and the stent allows fluid to flow through the expanded stent and deflated balloon without fluid blockage when passing through the treatment site.

[0073] Additionally or alternatively, delivery system 100 may be deployed at multiple locations. Stent 190 may be collapsed by moving outer shaft 120 over stent 190. Stent 190 and balloon 180 may be moved to other target locations, and one or more of the above operations may be repeated.

[0074] Additionally or alternatively, the delivery system 100 can be removed. The stent 190 can be collapsed by moving the outer shaft 120 over the stent 190. The components of the delivery system 100 can be removed from the patient by retracting proximally over a guidewire.

[0075] Additionally or alternatively, the stent 190 can be separated from the inner shaft 110 and left in the patient as an implant. After separation, the other components of the delivery system 100 can be removed from the patient by retracting proximally over the guidewire.

[0076] Although the delivery system 100 is shown with its stent 190 positioned on the balloon 180 in the delivery state, it should be understood that other arrangements are contemplated. For example, the stent can be positioned in an axially offset arrangement relative to the balloon to reduce the space requirements required for overlapping components. Figure 16-Figure 20 The conveying system 200 shown in FIG. Figure 21-24 The delivery system 300 shown, and Figure 25-28Although each of delivery system 200 and delivery system 300 differs from delivery system 100 in certain respects, it should be understood that the components and features of delivery system 100 described herein can be applied to either or both of delivery system 200 and delivery system 300. Similar or analogous items can perform the same functions as those shown in delivery system 100, and for the sake of brevity, the features of these items are not discussed in full below.

[0077] Reference now Fig.15 , and additionally refer to Figure 1 , showing a cross-sectional view of a region of a delivery system 200, wherein the delivery system 200 is similar in at least some respects to Figure 1 The delivery system 100 shown. For example, Fig.15 The cross-section of Figure 1 The line 2-2 in the figure is used for interception. Fig.15As shown, the inner shaft 210 can be at least partially disposed in the lumen of the outer shaft 220. In addition, a reinforcing wire 264 is disposed between the outer shaft 220 and the inner shaft 210. The reinforcing wire 264 can be stainless steel or other materials, and can affect the rigidity and / or flexibility of the lumen space and the shaft without changing the material thickness of the shaft. The guide wire 262 can be at least partially disposed in the lumen of the inner shaft 210. The lumen defined between the outer shaft 220 and the inner shaft 210 or within the inner shaft 210 can provide fluid communication for the balloon for the expansion and contraction of the balloon. In some embodiments, the outer shaft 220, the inner shaft 210, the guide wire 262 and / or the reinforcing wire 264 each have a circular cross-sectional shape and a single lumen. However, in other embodiments, the outer shaft 220, the inner shaft 210, the guide wire 262 and / or the reinforcing wire 264 can have other cross-sectional shapes, such as oval, "C" shape, rectangular, triangular, etc., and have multiple lumens. For example, the reinforcing wire 264 can have a shape that fits in the space between the outer shaft 220 and the inner shaft 210. For example, the cross-sectional shape of the reinforcing wire 264 can be a polygon (e.g., rectangle) or a crescent. The inner surface of the outer shaft 220 and / or the outer surface of the inner shaft 210 can have a cross-sectional shape that accommodates and / or guides the reinforcing wire 264. The support shaft 230 can also be placed circumferentially around the inner shaft 210 or the outer shaft 220 to increase the column strength and rigidity of the catheter area. In certain embodiments, the support shaft 230 can have a larger inner diameter and is attached to the outer shaft 220 to extend the entire catheter length and accommodate the larger proximal section of the inner catheter 210 or the reinforcing wire 264. The arrangement of the support shaft can change from the entire length of the inner shaft 210 to the specific 10cm, 20cm, 30cm, 40cm section of the inner shaft (it has a change gap of 10cm, 20cm, 30cm, 40cm length), to increase the overall catheter rigidity. The attachment mechanism may include bonding, reflow, braiding, winding, laser welding, etc. The support shaft 230 may also be made of a material such as nylon, It is made of high-hardness plastic, stainless steel, Nitinol, polyetheretherketone (PEEK), etc.

[0078] Stabilizing wire 260 can be coupled to the stent. Stabilizing wire 260 is slidably disposed within outer shaft 220, and is sized and shaped to extend distally from the proximal end of the outer shaft and proximally from the proximal end of the port. Stabilizing wire 260 can be formed of plastic (such as high-hardness plastic, including nylon, polyetheretherketone (PEEK)), metal, metal alloy (such as nitinol) and / or a combination thereof. Stabilizing wire 260 can be configured to position a stent (not shown) at an intended treatment position and at least generally maintain the position of the stent when outer shaft 220 is withdrawn, as described in more detail below.

[0079] The size and shape of the stabilizing wire 260 can be arranged to extend proximally from the proximal end of the port when the stent is positioned at the target site. For example, the stabilizing wire 260 can have a length of about 150 cm to about 180 cm and a suitable cross-sectional size for positioning in a patient's body lumen. The stabilizing wire 260 can have a working length (i.e., the length that can be positioned within a target body lumen) of about 70 cm to about 300 cm, about 150 cm to about 250 cm, or about 70 cm, about 80 cm, about 90 cm, about 100 cm, about 110 cm, about 120 cm, about 130 cm, about 140 cm, about 150 cm, about 160 cm, about 170 cm, about 180 cm, about 190 cm, about 200 cm, about 210 cm, about 220 cm, about 230 cm, about 240 cm, about 250 cm, about 260 cm, about 270 cm, about 280 cm, about 290 cm, or about 300 cm.

[0080] like Figure 16-Figure 20 As shown, the delivery system 200 can be provided with a stent 290, which is positioned proximal to the expandable balloon 280, for expanding and delivering the stent 290 to a target delivery position. By positioning the stent 290 proximal to the expandable balloon 280, the stent 290 and the balloon 280 do not overlap (e.g., axially offset) when in the delivery state within the outer shaft 220, thereby reducing the space requirement within the outer shaft 220.

[0081] like Fig.16 As shown, the delivery system 200 is provided with an outer shaft 220 that covers or wraps the other components of the delivery system 200. For example, the outer shaft 220 can extend to a distal end 215 positioned at the distal end of the inner shaft 210. The inner shaft 210 can extend within the outer shaft 220, having a length accessible proximally of the proximal end of the outer shaft 220 (e.g., at the outer shaft hub 240). Additionally or alternatively, the connector 250 can be accessible proximally of the proximal end of the outer shaft 220 (e.g., at the outer shaft hub 240). The stabilizing wire 260 can also be accessible proximally of the proximal end of the outer shaft 220 (e.g., at the outer shaft hub 240). The guidewire can be advanced before the distal end 215 (e.g., through the inner shaft 210), thereby providing a path for the advancement of the other components of the delivery system 200.

[0082] like Fig.17 As shown, the outer shaft 220 can be moved to dislodge the expandable balloon 280. For example, once the distal region of the delivery system 200 is positioned at the desired location, the outer shaft 220 is configured to be at least partially proximally retracted relative to the inner shaft 210 by retracting the outer shaft hub 240 relative to the connector 250. Once the outer shaft 220 is partially retracted, at least a portion of the balloon 280 is dislodged.

[0083] like Fig.18 As shown, the outer shaft 220 can be further moved to dislodge the stent 290. Once the outer shaft 220 is further retracted, a portion of the stent 290 is dislodged, and the protruding features 294 of the stent 290 are configured to expand radially outward away from the inner shaft 210. As shown, the balloon 280 is positioned at the distal portion 210b of the inner shaft 210, and the stent 290 is positioned at the proximal portion 210a of the inner shaft 210. The proximal portion 210a of the inner shaft 210 can have an outer cross-sectional dimension that is smaller than the outer cross-sectional dimension of the balloon 280, thereby allowing the stent 290 to collapse onto the proximal portion 210a with a smaller profile than the profile that would be achieved by collapsing the stent 290 onto the balloon 280.

[0084] like Fig.19 As shown, outer shaft 220 has been retracted and stent 290 is disengaged. User-accessible stabilizing wire 260 is configured to engage with the proximal end of stent 290 and control the position of stent 290 during and after retraction of outer shaft 220. When outer shaft 220 is retracted, the user can fix stabilizing wire 260 relative to inner shaft 210 so that the position of stent 290 can remain unchanged relative to inner shaft 210 (including balloon 280) during retraction of outer shaft 220.

[0085] like Fig. 20 As shown, when the stent 290 and the balloon 280 are dislodged and exposed by the outer shaft 220, the stent 290 can be axially aligned with the balloon 280. Because the inner shaft 210 extends through the stent 290, the proximal retraction of the inner shaft 210 relative to the stent 290 can achieve the axial alignment of the balloon 280 with the stent 290. The balloon 280 can have an axial length greater than the axial length of the stent 290, so that when axially aligned, the entirety of the stent 290 overlaps with the balloon 280. Additionally or alternatively, the inner shaft 210 and the outer shaft 220 can be retracted together relative to the stent 290.

[0086] Balloon 280 can be inflated to expand or further expand stent 290. For example, the interior region of the balloon can be fluidly connected to port 252 of connector 250 via inner shaft 210. By providing fluid via port 252, balloon 280 can be expanded, thereby expanding or further expanding stent 290. Expansion relative to a target anatomical structure will be discussed further herein.

[0087] After one or more of the above operations, balloon 280 can be deflated. Stent 290 can be maintained in an expanded state for any duration. For example, stent 290 can be maintained for a duration that is effective for providing therapeutic treatment (e.g., remodeling and / or drug delivery) to the target anatomical structure.

[0088] Additionally or alternatively, the delivery system 200 can be deployed at multiple locations. The stent 290 can be collapsed by moving the outer shaft 220 over the stent 290. Optionally, the stent 290 can be axially realigned with the proximal portion 210a of the inner shaft 210 before being collapsed by the outer shaft 220. The stent 290 and balloon 280 can be moved to other target locations, and one or more of the above operations can be repeated.

[0089] Additionally or alternatively, the delivery system 200 can be removed. The stent 290 can be collapsed by moving the outer shaft 220 over the stent 290. Optionally, the stent 290 can be axially realigned with the proximal portion 210a of the inner shaft 210 prior to collapse by the outer shaft 220. The components of the delivery system 200 can be removed from the patient by retracting proximally over the guidewire.

[0090] Additionally or alternatively, the stent 290 can be separated from the stabilizing wire 110 and left in the patient as an implant. After separation, the other components of the delivery system 200 can be removed from the patient by retracting proximally over the guidewire.

[0091] like Figure 21-24 As shown, the delivery system 300 can be provided with a stent 390, which is positioned distally of the expandable balloon 380 to expand and deliver the stent 390 to the target delivery site. By positioning the stent 390 distally of the expandable balloon 380, the stent 390 and the balloon 380 do not overlap (e.g., axially offset) when in the delivery state within the outer shaft 320, thereby reducing the space requirement within the outer shaft 320.

[0092] like Fig.21 As shown, the delivery system 300 is provided with an outer shaft 320 that covers or wraps the other components of the delivery system 300. For example, the outer shaft 320 can extend to a distal end 315 positioned at the distal end of the inner shaft 310. The inner shaft 310 can extend within the outer shaft 320, having a length accessible proximally of the proximal end of the outer shaft 320 (e.g., at the outer shaft hub 340). Additionally or alternatively, the connector 350 can be accessible proximally of the proximal end of the outer shaft 320 (e.g., at the outer shaft hub 340). The stabilizing wire 360 ​​can also be accessible proximally of the proximal end of the outer shaft 320 (e.g., at the outer shaft hub 340). The guidewire can be advanced before the distal end 315 (e.g., through the inner shaft 310), thereby providing a path for the advancement of the other components of the delivery system 300.

[0093] like Fig. 22As shown, the outer shaft 320 can be moved to dislodge the expandable balloon 380. For example, once the distal region of the delivery system 300 is positioned at the desired location, the outer shaft 320 is configured to be at least partially proximally retracted relative to the inner shaft 310 by retracting the outer shaft hub 340 relative to the connector 350. Once the outer shaft 320 is partially retracted, a portion of the stent 390 is disengaged, and the protruding features 394 of the stent 390 are configured to expand radially outward away from the inner shaft 310. The user-accessible stabilizing wire 360 ​​is configured to engage with the proximal end of the stent 390 and control the position of the stent 390 during and after the retraction of the outer shaft 320. When the outer shaft 320 is retracted, the user can fix the stabilizing wire 360 ​​relative to the inner shaft 310 so that during the retraction of the outer shaft 320, the position of the stent 390 can remain unchanged relative to the inner shaft 310 (including the balloon 380).

[0094] like Fig.23 As shown, the outer shaft 320 can be further moved to make the balloon 280 come out. Once the outer shaft 320 is further retracted, at least a portion of the balloon 380 comes out. As shown, the balloon 380 is positioned at the proximal portion 310a of the inner shaft 310, and the stent 390 is positioned at the distal portion 310b of the inner shaft 210. The distal portion 310a of the inner shaft 310 can have an outer cross-sectional dimension smaller than the outer cross-sectional dimension of the balloon 380, thereby allowing the stent 390 to collapse onto the distal portion 310b with a smaller profile than the profile achieved by the stent 390 collapsing onto the balloon 380.

[0095] like Fig.24 As shown, when the stent 390 and the balloon 380 are dislodged and exposed by the outer shaft 320, the stent 390 can be axially aligned with the balloon 380. Because the inner shaft 310 extends through the stent 390, the distal movement of the inner shaft 310 relative to the stent 390 can achieve the axial alignment of the balloon 380 with the stent 390. The balloon 380 can have an axial length greater than the axial length of the stent 390, so that the entirety of the stent 390 overlaps with the balloon 380 when axially aligned.

[0096] Balloon 380 can be inflated to expand or further expand stent 390. For example, the interior region of the balloon can be fluidly connected to port 352 of connector 350 via inner shaft 310. By providing fluid via port 352, balloon 380 can be expanded, thereby expanding or further expanding stent 390. Expansion relative to a target anatomical structure will be discussed further herein.

[0097] After one or more of the above operations, balloon 380 can be deflated. Stent 390 can be maintained in an expanded state for any duration. For example, stent 390 can be maintained for a duration that is effective for providing therapeutic treatment (e.g., remodeling and / or drug delivery) to the target anatomical structure.

[0098] Additionally or alternatively, the delivery system 300 can be deployed at multiple locations. The stent 390 can be collapsed by moving the outer shaft 320 over the stent 390. Optionally, the stent 390 can be axially realigned with the proximal portion 310a of the inner shaft 310 before being collapsed by the outer shaft 320. The stent 390 and balloon 380 can be moved to other target locations, and one or more of the above operations can be repeated.

[0099] Additionally or alternatively, the delivery system 300 can be removed. The stent 390 can be collapsed by moving the outer shaft 320 over the stent 390. Optionally, the stent 390 can be axially realigned with the proximal portion 310a of the inner shaft 310 prior to collapse by the outer shaft 320. The components of the delivery system 300 can be removed from the patient by retracting proximally over the guidewire.

[0100] Additionally or alternatively, the stent 390 can be separated from the stabilizing wire 360 ​​and left in the patient as an implant. After separation, the other components of the delivery system 300 can be removed from the patient by retracting proximally over the guidewire.

[0101] like Figure 25-28 As shown, the delivery system 500 can be provided with a stent 590 positioned above an expandable balloon 580 for expanding and delivering the stent 590 to a target delivery site. By positioning the stent 590 above and around the expandable balloon 580, the stent 590 is ready to be expanded by the balloon 580 immediately upon partial or complete dislodgement relative to the outer shaft 520. Any released portion of the stent 590 can be expanded by a similarly released portion of the balloon 580 below.

[0102] like Fig.25As shown, the delivery system 500 is provided with an outer shaft 520 that covers or wraps the other components of the delivery system 500. For example, the outer shaft 520 can extend to a distal end 515 positioned at the distal end of the inner shaft 510. The inner shaft 510 can extend within the outer shaft 520, having a length accessible proximally of the proximal end of the outer shaft 520 (e.g., at the outer shaft hub 540). Additionally or alternatively, the connector 550 can be accessible proximally of the proximal end of the outer shaft 520 (e.g., at the outer shaft hub 540). As described above, a guidewire can be advanced before the distal end 515 (e.g., through the inner shaft 510), thereby providing a path for the advancement of the other components of the delivery system 500.

[0103] like Fig.26 As shown, the outer shaft 520 can be moved to dislodge other components of the delivery system 500 and a portion of the stent 590. For example, once the distal region of the delivery system 500 is positioned at the desired location, the outer shaft 520 is configured to be at least partially proximally retracted relative to the inner shaft 510 by retracting the outer hub 540 relative to the connector 550. Once the outer shaft 520 is partially retracted, a portion of the stent 590 and / or balloon 580 is dislodged, and the protruding features 594 of the exposed portion of the stent 590 are configured to expand radially outward away from the inner shaft 510.

[0104] Stent 590 can be fixedly attached to other components of delivery system 500, such as inner shaft 510 (e.g., via an anchoring portion). Alternatively, stent 590 can be adjustably positioned relative to one or more other components of delivery system 500. For example, stent 590 can be coupled to a stabilizing wire that a user can access at the proximal end of delivery system 500, and the user can adjust the position of stent 590 by manipulating the stabilizing wire.

[0105] like Fig. 27As shown, the outer shaft 520 has been partially retracted and the stent 590 is partially disengaged. The stent 590 can be connected to the inner shaft 510, for example, by a stabilizing wire (not shown), as described herein. Therefore, the position of the stent 590 can be maintained relative to the inner shaft 510 (including the balloon 580). For example, although some adjustments to the length and / or axial position of the stent 590 can be made during the radial expansion of the stent 590, it should be understood that the stabilizing wire can maintain the position of at least a portion of the stent 590 around at least a portion of the balloon 580 and axially aligned with it. Additionally or alternatively, the stent 590 can be fixed relative to the outer shaft 520 by locking the outer shaft hub 540 relative to the inner shaft 510 at the proximal portion of the delivery system 500. For example, the locking member can be controllably engaged and disengaged to selectively lock the relative axial position and / or movement of the outer shaft hub 540 and the inner shaft 510. When engaged, such locking members can prevent outer shaft 520 from retracting proximally when balloon 580 (including the portion of balloon 580 within outer shaft 520) is expanded. Balloon 580 can have an axial length greater than the axial length of stent 590, such that the entirety of stent 590 overlaps balloon 580.

[0106] The extent to which the stent 590 and / or balloon 580 are dislodged (e.g., partially dislodged) can be determined by one or more of a variety of mechanisms. For example, the stent 590, balloon 580, outer shaft 520, and / or one or more other components connected to one or more of the above-mentioned components may include a visual marker, such as a radiopaque marker. The positions of these components relative to each other and / or the target position can be visually determined, for example, by imaging techniques (e.g., angiography). Additionally or alternatively, the relative positions of the stent 590, balloon 580, and / or outer shaft 520 can be determined and / or inferred by corresponding components at the proximal end of the delivery system 500. For example, the positions of the outer shaft hub 540, the inner shaft 510, and / or the stabilizing wire (not shown) can be compared to determine the relative positions of the outer shaft 520, the balloon 580, and / or the stent 590 accordingly. Appropriate markings, detents, or other indicators may be provided on the stabilizing wire (not shown), the outer hub 540, and / or the inner shaft 510 at the proximal end of the delivery system 500 for reference by the user. For example, such markings, detents, or other indicators may be incrementally spaced apart from one another to indicate to the user the position of the outer hub 540 relative to the inner shaft 510. Such indications may be associated with the degree of dislodgment of the stent 590.

[0107] When both the stent 590 and the balloon 580 are partially dislodged through the outer shaft 520, the initially exposed portion of the balloon 580 can be inflated to expand or further expand the stent 590. For example, the internal region of the initially exposed portion of the balloon 580 can be fluidly connected to the port 552 of the connector 550 via the inner shaft 510. By providing fluid via the port 552, the initially exposed portion of the balloon 580 can be expanded, thereby expanding or further expanding the initially exposed portion of the stent 590. Other portions of the stent 590 and / or the balloon 580 can be retained within the outer shaft 520. For example, when the outer shaft 520 is locked relative to the inner shaft 510 (e.g., using the outer shaft hub 540), expansion can be performed. This locking can prevent the outer shaft 520 from further retracting in response to the force generated by the expansion of the partially exposed stent 590 and / or the balloon 580. The expansion relative to the target anatomical structure will be further discussed herein.

[0108] After the initial deployment, additional operations may be performed at subsequent stages of the same process to expand the stent 590. For example, different lengths and / or portions of the stent 590 may be used in subsequent operations. Fig.28 As shown, the outer shaft 520 has been further retracted and the stent 590 has been further removed. When both the stent 590 and the balloon 580 are more completely removed through the outer shaft 520, the more completely exposed portion of the balloon 580 can be inflated to expand or further expand the more completely exposed portion of the stent 590, for example, via the port 552, as described herein. Other portions of the stent 590 and / or balloon 580 can remain within the outer shaft 520. As described above, when the outer shaft 520 is locked relative to the inner shaft 510 (e.g., by the outer shaft hub 540), the expansion can be performed to stabilize the system during the expansion of the balloon 580.

[0109] The extent of dislodgment (eg, further dislodgment) of the stent 590 and / or balloon 580 may again be determined by one or more of a variety of mechanisms, such as those described above with respect to determining the extent of partial dislodgment.

[0110] In some embodiments, the operating length of stent 590 that is dislodged, exposed and / or expanded in the above-mentioned operation can be different lengths. For example, the operating length can be shorter in the initial stage and longer in the subsequent stage. Alternatively, the operating length can be longer in the initial stage and shorter in the subsequent stage.

[0111] When different operating lengths are required, the balloon 580 can optionally include multiple independently expandable segments. For example, the balloon 580 can include multiple segments aligned at different axial positions along the inner shaft 510. The inner shaft 510 can provide multiple lumens, each of which is connected to a corresponding port. Fluid can be provided through a selected number of ports to expand only the corresponding balloon segments. For example, only the balloon segments outside the outer shaft 520 can expand to expand the corresponding portion of the stent 590. Additionally or alternatively, the balloon segments can be in fluid communication with each other so that they expand sequentially.

[0112] During initial expansion (e.g. Fig. 27 expansion shown) and subsequent expansion (e.g., Fig.28 ), the stent 590 and / or balloon 580 can be collapsed, compressed, and / or at least partially retracted into the outer shaft 520. Alternatively, the stent 590 and / or balloon 580 can be further exposed by unlocking the outer shaft 520 from the inner shaft 510 and allowing the outer shaft 520 to further retract in response to the force from the inflated balloon 580.

[0113] The transition from initial expansion to subsequent expansion can be performed to adjust the operating length of the stent 590 to more fully address the target area. For example, the initial operating length of the stent 590 can be exposed and expanded. The user can then evaluate the effectiveness of the operation (e.g., via imaging techniques, such as angiography). In the case where the initial operating length of the stent 590 is determined to be insufficient, the stent 590 and / or the balloon 580 can be further exposed to increase the operating length of the stent 590. This adjustment can be performed as needed until sufficient operating length is provided. It will be appreciated that the ability to perform such adjustments can avoid the need to remove a stent that is found to be inappropriate and replace it with a different stent or other device that provides sufficient operating length. By eliminating these steps, the total operating time can be reduced. In addition, the user may wish to expand the device to be long enough (e.g., across the target area) rather than longer than the required length (e.g., to avoid operating on an area outside the target area). It will be appreciated that the user can provide a single stent 590 with an adjustable operating length to fully address a target area with an initial uncertain length, or a situation where the required operating length of the stent is unknown or uncertain. This capability reduces the burden on the user to accurately select a device with the correct operating length at the beginning of operation. In addition, the capabilities described herein also reduce the need to provide a large number of devices (providing different performance characteristics) because a single device or a reduced number of devices can be operated as described herein to provide a desired wide range of performance characteristics.

[0114] The transition from initial expansion to subsequent expansion can be performed to cope with the different operating lengths required by different target areas. Between initial expansion and subsequent expansion, support 590 and / or balloon 580 can be repositioned to different positions. For example, support 590 can be repositioned to align with different target areas. In the case where the new target area has different lengths or other features relative to the initial target area, the operating length of support 590 can be selected and / or changed accordingly to fully cope with each target area. It will be appreciated that the ability to perform this adjustment can avoid the necessity of removing the support suitable for the initial target area and replacing it with different supports suitable for different target areas. By eliminating these steps, the total process time can be reduced, thereby reducing the risks associated with long process time. In addition, it should be appreciated that although each target area has potential different requirements for the operating length of support 590, the user can provide a single support 590 with an adjustable operating length to fully cope with each different target area. This allows the user to have more flexibility and options in the whole process using a single device.

[0115] After one or more of the above operations, balloon 580 can be deflated. Stent 590 can be maintained in an expanded state for any duration. For example, stent 590 can be maintained for a duration effective for providing therapeutic treatment (e.g., remodeling and / or drug delivery) to the target anatomical structure, and the stent allows fluid to flow through the expanded stent and deflated balloon without fluid blockage at the treatment site.

[0116] Additionally or alternatively, delivery system 500 can be deployed at multiple locations. Stent 590 can be collapsed by moving outer shaft 520 over stent 590. Stent 590 and balloon 580 can be moved to other target locations, and one or more of the above operations can be repeated.

[0117] Additionally or alternatively, delivery system 500 can be removed. Stent 590 can be collapsed by moving outer shaft 520 over stent 590. The components of delivery system 500 can be removed from the patient by proximally withdrawing over a guidewire.

[0118] Additionally or alternatively, the stent 590 can be separated from the inner shaft 510 and left in the patient as an implant. After separation, the other components of the delivery system 500 can be removed from the patient by retracting proximally over the guidewire.

[0119] Now refer to Figure 29-Figure 32, an example of a delivery system 400 is shown in different configurations for delivering, positioning, deploying, and / or retrieving a stent. The operations described with respect to delivery system 400 may be applied to delivery system 100, delivery system 200, delivery system 300, and / or delivery system 500. Fig.29 As shown, the delivery system 400 is in a delivery state in a body lumen 710 (e.g., a blood vessel) of a human patient. In this embodiment, the delivery system 400 is configured to be used for intraluminal (e.g., intravascular) delivery through a blood vessel (e.g., a femoral artery) of a human patient. The femoral artery can be entered by introducing a sheath (e.g., 5F or 6F) into the lumen of the femoral artery. The delivery system 400 is delivered to the body lumen by guiding the distal portion 410b of the inner sheath on the guide wire and advancing the delivery system 400 distally to the desired position 720 in the vessel. In some embodiments, before the delivery system 400 advances to the desired position 720, an angioplasty process is performed at the desired position 720.

[0120] Once the delivery system 400 is positioned at the desired position 720, the distal portion 420b of the outer sheath is retracted proximally to allow the stent 490 to come out. In the illustrated embodiment, the body of the stent 490 is at least partially expanded when coming out, and the prominent feature 494 collapses. However, the prominent feature 494 can be configured to expand once the distal portion 420b of the outer sheath is retracted. In other embodiments, a stabilizing wire (not shown) can be advanced distally and fixed, such as being held or pinned, or fixed at a desired position to position the stent before, during and / or after the outer sheath is retracted proximally to deploy the stent. As shown, the distal end 415 of the delivery system 400 is positioned distal to the distal end of the stent, and the inner shaft 410 remains positioned within at least a portion of the stent 190 lumen.

[0121] In the deployed state, the protruding features 494 of the stent 490 are configured to expand radially and are further configured to puncture the lumen wall at a desired location once the deployed stent 490 expands into contact with the vessel wall (see Fig.29 and Fig.30). As will be explained in more detail below, stents and other expandable structures can be configured to at least partially self-expand when the stents and other expandable structures are at least partially released from the outer shaft, such as expanding outward from a collapsed / delivery state to a deployed and / or expanded state. In some embodiments, stents and other expandable structures are configured to expand when operatively coupled to an expandable element or mechanism (such as a balloon). In other embodiments, self-expanding stents and other structures are configured to expand further when coupled to an expansion mechanism. Regardless of whether the stents and other expandable structures are self-expanding or expand when coupled to an expandable element, the stents and other expandable structures can be configured to expand radially (symmetrically or asymmetrically). In some embodiments, at least partially expanded stents and other expandable structures can be configured to position at least some protruding features perpendicular to the vessel wall.

[0122] like Fig.29 and Fig.30 As shown, the delivery system 400 is configured for insertion of a balloon 480 coupled to the inner shaft 410. The balloon 480 is also configured to be positioned in the stent lumen and expanded therein to further expand the stent 490 between the delivery state and the expanded deployed state. In some embodiments, the balloon 480 can be coated with a drug delivery coating and a drug, such as the coating and drug described herein. As further discussed elsewhere herein, the stent 490 can be operably coupled to an actuation mechanism, such as a mechanical actuation mechanism (e.g., a stabilizing wire, a stent puller wire, a pusher shaft, or a combination thereof), which is configured to position, expand, retract, reposition the stent 490 and / or remove the stent 490 from the body lumen.

[0123] Fig.30 4 shows a cross-sectional view of a region of the delivery system 400 in an expanded state within a body lumen. Fig.30 As shown, the stent 490 is expanded within the vessel by the balloon 480. To expand the deployed stent 490, the balloon 480 is coupled to the inner shaft 410 and advanced distally into the lumen of the deployed stent 490 until the distal tip 415 of the inner shaft 410 is positioned near the distal end 490b of the deployed stent 490. As shown, the distal end 490b of the stent 490 may include a radiopaque marker 490c. Additionally or alternatively, the radiopaque marker 490c may be located elsewhere in the delivery system 400, or may be omitted from the delivery system 400.

[0124] Fig.31 A cross-sectional view of a portion of a delivery system 400 is shown in an expanded state, wherein a protruding feature 494 of a stent 490 expands within and punctures a portion of a vessel wall. Fig.31As shown, balloon 480 is deployed and radially expanded to engage with stent 490 and further expand stent 490 into contact with the luminal vessel. As stent 490 expands, protruding features 494 penetrate further into the wall.

[0125] Fig.32 A cross-sectional view of the delivery system 400 in a treatment state is shown. In the treatment state, the balloon 480 has been deflated. As shown, the distal portion 410b of the inner shaft 410 remains in the body lumen. After the balloon 480 is deflated, the stent 490 remains expanded to contact the lumen wall, and the protruding features 494 remain inserted into the lumen wall. Any drug carried by the protruding features 494 is at least partially released into the body lumen wall in the treatment state. Optionally, the stent 490 can be fixed to the balloon 480, such as by crimping the stent 490 to at least partially surround the balloon 480, so that the stent 490 expands and collapses by expanding and contracting the balloon 480 accordingly.

[0126] Although the stents described herein have the features shown, it should be understood that a variety of different stents and other devices may be used with the delivery systems described herein. Various features are described below by way of example and not limitation.

[0127] With respect to such stents and other devices, the materials used to form the frameworks, pillars and / or prominent features 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 of a variety of other properties, or a combination thereof. If formed by a material having thermal properties, the material can be activated to deliver heat treatment to the intended treatment site. Regardless of the material, the framework, pillars and / or prominent features can be formed by tubes or wires (such as solid wires) by laser cutting or other suitable techniques. When formed by wires, a portion of the wires can be removed by chemical etching or other suitable methods to produce internal stent dimensions.

[0128] The size and shape of the stent (e.g., framework and strut) can be configured to be placed in various body lumens including blood vessels without rupturing the vessels. For example, multiple stents and other structures can have radial strength that allows the characteristics of the body lumen (e.g., vessel wall) to receive drugs without being cut open or damaged. The stent described herein can be sized and shaped to be placed in vessels including: arteries, such as coronary arteries, peripheral arteries, carotid arteries, Willis circles, anterior cerebral arteries, middle cerebral arteries, posterior cerebral arteries, any lenticulostriate arteries, renal arteries, femoral arteries; veins, such as cerebral veins, saphenous veins, arteriovenous fistulas; or any other vessels that can include treatment sites. The stent can have a variety of shapes, including cubes, rectangular prisms, cylinders, cones, pyramids, or variants thereof.

[0129] Stents and other structures with outstanding features can include a variety of sizes (both in a low-profile delivery state and in an expanded, expanded state). These embodiments can provide expansions that can be used in a variety of situations (such as for treatment and / or prevention of dissection) covering a wide range of sizes. Regardless of the shape, the stent can have a length of about 0.25mm, about 0.5mm, about 1mm, about 2mm, about 3mm, about 4mm, about 5mm, about 6mm, about 7mm, about 8mm, about 9mm, about 10mm, about 12mm, about 14mm, about 16mm, about 18mm, about 20mm, about 30mm, about 40mm, about 50mm, about 60mm, about 70mm, about 80mm, about 90mm, or about 100mm. In addition, the support shaped as a cube, a rectangular prism or a pyramid can have a width of about 0.25mm, about 0.5mm, about 1mm, about 2mm, about 3mm, about 4mm, about 5mm, about 6mm, about 7mm, about 8mm, about 9mm, about 10mm, about 12mm, about 14mm, about 16mm, about 18mm, about 20mm, about 25mm or about 30mm. In addition, the support shaped as a cylinder or a cone can have a diameter of about 0.25mm, about 0.5mm, about 1mm, about 2mm, about 3mm, about 4mm, about 5mm, about 6mm, about 7mm, about 8mm, about 9mm, about 10mm, about 12mm, about 14mm, about 16mm, about 18mm, about 20mm, about 25mm, about 30mm, about 35mm, about 40mm or about 50mm. The width or diameter of the support can be reduced along the length of the support. Additionally, the size and shape of the stent can be used to prepare a body lumen for certain procedures, such as a stent placement procedure.

[0130] The stent and / or other expandable structure in the expanded state (including the expanded protruding features) can have a cross-sectional dimension of about 2 mm to about 10 mm. For example, the frame can have a cross-sectional dimension of about 1 mm to about 9 mm, and each protruding feature can have a length from about 0.1 mm to about 1.5 mm. In some embodiments, the stent has a total cross-sectional dimension of about 4 mm, wherein the frame has a cross-sectional dimension of about 2 mm, and each protruding feature has a length of about 1 mm. In some embodiments, the stent has a total cross-sectional dimension of about 6 mm, wherein the frame has a cross-sectional dimension of about 4 mm, and each protruding feature has a length of about 1 mm. In other embodiments, the protruding features can have a variety of lengths, so that the lengths of the protruding features of the stent or other expandable structure are different. For example, the stent can include protruding features having lengths of about 0.2 mm, about 0.5 mm, and about 1 mm.

[0131] The profile of the stent or other structure can be sized so that the stent or other structure is compatible with various catheter sizes. According to embodiments of the present technology, stents or other structures designed to receive guide wires (such as guide wires with 0.010, 0.014, 0.018, 0.035 or 0.038 inches) can be included. In multiple embodiments, stents or framework structures can be sized and designed to be delivered via microcatheters (described stents or framework structures are pushed through the microcatheters). In certain embodiments, stents or structures can be integrated into delivery systems, including modular or single-unit delivery systems.

[0132] The stents and other structures described herein may include markers, such as one or more radiopaque markers, for visualization of the stent within a body lumen. The radiopaque markers may be provided by Clearfil Photo Core Tantalum, titanium, tungsten, barium sulfate and zirconium oxide, or other suitable radiopaque markers are formed. The markers can be formed on the proximal portion, distal portion, middle portion, or a combination thereof of the stent. These markers can be bands, coils, clips, or combinations thereof that are filled into one or more portions of the tube in the stent, plated on one or more portions of the stent. Regardless of the type of marker, the marker can be cast, forged, coated or wrapped along any portion of the stent, or cast, forged, coated or wrapped on any portion of the stent.

[0133] Stents and other structures can be flexible enough to pass through various anatomical features, including anatomical features with a certain curvature. The flexible properties of stents and other structures can be provided by the materials from which they are formed. In addition, the flexible properties can also be provided by breaking one or more members that engage with two or more rows of struts and extend between these struts. In addition, stents or other structures can be easily deployed and expanded, as well as retracted and retracted. Stents or other structures can also be easily repositioned in vessels or other body lumens.

[0134] In a number of embodiments, a drug eluting compound is coated onto at least a portion of the balloon, frame, strut and / or protruding features. The coating may be any suitable coating known to those of ordinary skill in the art suitable for delivering drugs to the wall. For example, suitable coatings include, but are not limited to, snow coatings or crystalline coatings having edges configured to remain in the wall. The drug eluting compound may be a synthetic polymer or biopolymer coated in a variety of patterns and thicknesses suitable for delivering the drugs contained therein. In other embodiments, the protruding features themselves may be composed of drug eluting materials. The drug carried by the protruding features and / or drug eluting compounds according to the present technology may be any drug suitable for treating the treatment site in which the stent will be placed, and the drug may or may not include an excipient. For example, the drug may be an anti-proliferative agent, an anti-tumor agent, a migration inhibitor, a healing enhancing factor, an immunosuppressant, an anti-thrombotic agent, a blood thinner, or a radioactive compound. Examples of anti-tumor agents include, but are not limited to, sirolimus, tacrolimus, everolimus, leflunomide, M-prednisolone, dexamethasone, cyclosporin, mycophenolic acid, mizoribine, interferon and tranilast. Examples of anti-proliferative agents include, but are not limited to, taxol / paclitaxel, actinomycin, methotrexate, angiopeptide, vincristine, mitmycine, statins, c-myc antisense, Abbot ABT-578, RestinASE, 2-chloro-deoxyadenosine and PCNA ribozyme. Examples of migration inhibitors include, but are not limited to, batimistat, prolylhydrosylase, halofunginone, c-proproteinase inhibitors and probucol. Examples of healing enhancing factors include, but are not limited to, BCP 671, VEGF, estradiol, NO donor compounds and EPC antibodies. Examples of radioactive compounds include, but are not limited to, strontium-89 chloride Samarium-153 Radium-223 dichloride Yttrium-90 and iodine- 131. In some embodiments, the drug eluting compound and / or the prominent feature may carry more than one drug.

[0135] In some embodiments, the protruding features may include a textured (e.g., ribbed) surface for providing a greater surface area for drug delivery. In addition, any protruding feature may include a textured surface, such as a ribbed surface (vertical, horizontal, radial, or circular relative to the longitudinal plane of the protruding feature), a cross-hatched surface, an isotropic surface, or other surface types suitable for providing a greater surface area for drug delivery.

[0136] The size and shape of the protruding features can be designed to engage and / or penetrate an occlusion, neointimal, intima, internal elastic lamina (IEL), media, external elastic lamina (EEL), adventitia, or a combination thereof. The size and shape of the protruding features can be designed to engage and / or penetrate tissue and / or structure adjacent to the body lumen where the stent is to be placed without rupturing the body lumen. For example, the stent can include: a square protruding feature that is sized and configured to penetrate the intima and / or media of the body lumen; a pointed protruding feature that is sized and configured to penetrate and extend into the media and / or IEL. In addition, the protruding features 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 lumen described herein. In several embodiments, the protruding features can penetrate deeper into the wall of a diseased body lumen (such as a vessel) compared to a stent without the protruding features. In addition, the stent can allow blood flow even in an expanded position and when drug elution is performed.

[0137] Various outstanding features described herein can deliver drugs deeper into the vessel wall than possible solutions via angioplasty balloons or other existing devices. In addition to carrying one or more drugs for the treatment of the position, the outstanding features can also carry molecules suitable for degrading occlusions, neointima and / or a part of the intima to allow the outstanding features to penetrate deeper into the vessel wall than without the molecules. For example, the molecules suitable for degradation can be enzymes, such as elastase, collagenase, or proteases, such as metalloproteinases, serine proteases, cysteine ​​proteases, extracellular sulfatase, hyaluronidase, lysyl oxidase, lysyl hydroxylase, or a combination thereof.

[0138] In addition, it should be understood that the stent can carry one or more prominent features on one or more parts of the stent. For example, the stent can carry about 5 prominent features, about 10 prominent features, about 15 prominent features, about 20 prominent features, about 30 prominent features, about 40 prominent features, about 50 prominent features, about 60 prominent features, about 70 prominent features, about 80 prominent features, about 90 prominent features or about 100 prominent features. The prominent features can be carried by the frame, the pillars or a combination thereof. The number of prominent features can be varied according to, for example, the target treatment site, the type of drug delivered, and the size of the stent. In addition, the prominent features carried by the stent can be different types of prominent features disclosed herein.

[0139] In some embodiments, once positioned against a body lumen wall (e.g., a vessel wall), tissue and / or fluid can interact with the protruding features to dissolve the drug and selectively release it from the reservoir. In other embodiments, the protruding features can be configured to deliver the drug via a variety of methods when the stent is expanded. Therefore, the protruding features are expected to provide an effective means for selectively delivering the drug to the desired site while reducing the unintentional loss or release of the drug. In other embodiments, the stent may include more than one protruding feature, or include a protruding feature with more than one reservoir. In several embodiments, a stent including a protruding feature can make the protruding feature (such as a coating or a reservoir) hidden (e.g., recessed) before the stent is positioned at the treatment site. Once it is determined to be at the target site, the protruding feature can be exposed (e.g., expanded / protruded, etc.) during and / or after the stent expansion. It is expected to reduce any loss of the drug carried by the protruding feature during delivery to the treatment site.

[0140] In some embodiments, the stent may further include a material (e.g., PTFE, Dacron, polyamide, such as nylon and / or polyurethane-based materials, silicone, etc.) positioned on a stent, a framework, or other structures having a prominent feature covering at least a portion of the surface area. In some embodiments, the material covers the entire surface area. The material may be a mesh or a braid. In some embodiments, the material may be configured to increase the surface area of ​​the stent to provide an additional surface area of ​​the stent for coating drugs. In other embodiments, the material may also be configured to allow blood to flow through the inner diameter of the stent and / or limit blood flow to the outer dimensions of the stent. In other embodiments, the material may form a barrier between fluid flow (e.g., blood flow) and a drug delivery site. In addition, the material may be configured to prevent debris from the wall of a body lumen from entering the bloodstream. In such embodiments, associated systems and devices may be used to cover the tacking of an area that may have been perforated during the process or a temporary dissection site.

[0141] Embodiments described herein provide a delivery system for one or more structures having a device for delivering a drug to a specific area (such as the vasculature) within a body lumen while still allowing fluid (e.g., blood) to flow through the treatment area where the structure has been placed and / or other devices or therapeutic devices within an adjacent body lumen. In some embodiments, fluid is temporarily prevented from flowing through the treatment area while one or more areas of the system are delivered, deployed, positioned, and / or removed from the body lumen. In addition, the delivery system can be configured to prepare the body lumen for treatment by raking the stent together, pulling the stent, rotating the stent, or a combination thereof proximally or distally of the treatment site. In other embodiments, the delivery system can be configured to rotate the stent when a mechanical force is applied.

[0142] The system disclosed herein can be provided for the adjustment, retraction and / or re-expansion of related stents or other structures, and / or the expansion of different stents or other structures, thereby allowing physicians to treat the expected area more effectively, more accurately and more prudently. In multiple embodiments, stents or other conveying structures can be deployed for a temporary period of time (e.g., less than 24 hours), and then be retracted and removed. In these embodiments, the protruding features can engage and / or puncture the lumen wall with the lumen wall, and remain in the lumen wall after removing the stent or other conveying structure, or can be retracted and removed together with the stent or other conveying structure. The stent can be configured to self-expand or partially self-expand when deployed from the conveying system, and can also be configured to further expand in the body lumen when the balloon expands in the body lumen. The stent can also be configured to perform post-expansion when removed from the body lumen. In other embodiments, stents or other conveying structures can be deployed for a temporary longer period of time (e.g., less than 2 weeks, less than 1 month, less than 6 months, less than 1 year), and then be retracted and removed. In some embodiments, different stents or conveying structures can be deployed after the first stent or conveying structure is retracted and removed. The duration of deployment and the duration after removal before deployment of the different stent or delivery structure can vary from minutes to hours, days, weeks, months, or years. In these embodiments, removal of the first stent or delivery structure and deployment of the different stent or delivery structure can occur once, twice, three times, four times, five times, six times, seven times, eight times, nine times, or ten times. In addition, the embodiments described herein can allow for a smaller profile system than currently available systems.

[0143] In the embodiments described herein and other embodiments constructed according to the present technology, stents and other expandable structures can include non-protruding features, such as deployable and / or expandable features, that are not configured to deliver drugs to a target site. For example, stents and other expandable structures constructed according to the present technology can include one or more protruding features, one or more non-protruding features, or a combination thereof.

[0144] Although many embodiments of the stents and / or structures described herein include stents, additional embodiments of expandable elements (such as stents and / or structures) may include non-drug eluting stents and / or non-drug eluting structures. In these embodiments, the non-drug eluting stent may include one or more protruding members, such as spikes. The spikes may be configured to engage and / or penetrate a portion of a body lumen or vessel. For example, the spikes may penetrate the vessel wall, thereby reducing and / or eliminating the elasticity of the vessel wall. In these embodiments, the protruding members may be configured to prevent the vessel wall from advancing inwardly toward the body lumen and to limit and / or constrain the flow therein. The protruding members may be formed integrally with the struts, or be disposed on the surface of the struts, extending radially outward from the struts toward the target tissue.

[0145] For convenience, various examples of various aspects of the present disclosure are described below as items. These are provided as examples and do not limit the subject technology.

[0146] Item A: A delivery system comprising: an outer shaft; an inner shaft, which is slidably disposed within the outer shaft and includes an expandable balloon; a guide wire, which is slidably disposed within the inner shaft; and a stent, which is disposed around the balloon and fixedly connected to the inner shaft.

[0147] Item B: A method for delivering a stent within a patient's body lumen, the method comprising: delivering an outer shaft encasing an inner shaft and a stent to a target treatment site within the patient's body lumen, the stent being disposed around a balloon of the inner shaft and fixedly connected to the inner shaft; proximally retracting the outer shaft to at least partially dislodge the stent; radially expanding the stent to an expanded state by inflating the balloon; and piercing a portion of the wall of the body lumen with one or more protruding features of the stent.

[0148] Item C: A delivery system comprising: an outer shaft; an inner shaft, which is slidably disposed within the outer shaft and includes an expandable balloon on a distal portion of the inner shaft; a guide wire, which is slidably disposed within the inner shaft; and a stent, which is slidably disposed within the outer shaft and disposed on a proximal portion of the inner shaft adjacent to the balloon, the stent being connected to a stabilizing wire slidably disposed within the outer shaft.

[0149] Item D: A method for delivering a stent into a body lumen of a patient, the method comprising: delivering an outer shaft enclosing an inner shaft and the stent into a target treatment site within the body lumen of the patient, the stent being slidably disposed within the outer shaft and on a proximal portion of the inner shaft adjacent to a balloon of the inner shaft; retracting the outer shaft proximally to at least partially disengage the stent and the balloon; moving the inner shaft proximally relative to the stent until the stent is axially aligned with the balloon; radially expanding the stent to an expanded state by expanding the balloon; and piercing a portion of the wall of the body lumen with one or more protruding features of the stent.

[0150] Item E: A delivery system, comprising: an outer shaft; an inner shaft slidably disposed within the outer shaft and including an inflatable balloon on a proximal portion of the inner shaft; a guide wire slidably disposed within the inner shaft; and a stent slidably disposed within the outer shaft and on a distal portion of the inner shaft remote from the balloon, the stent being connected to a stabilizing wire slidably disposed within the outer shaft.

[0151] Item F: A method for delivering a stent into a body lumen of a patient, the method comprising: delivering an outer shaft enclosing an inner shaft and the stent into a target treatment site within the body lumen of the patient, the stent being slidably disposed within the outer shaft and on a distal portion of the inner shaft distal to a balloon of the inner shaft; retracting the outer shaft proximally to at least partially disengage the stent and the balloon; moving the inner shaft distally relative to the stent until the stent is axially aligned with the balloon; radially expanding the stent to an expanded state by expanding the balloon; and piercing a portion of the wall of the body lumen with one or more protruding features of the stent.

[0152] Item G: A method for delivering a stent into a body lumen of a patient, the method comprising: delivering an outer shaft enclosing an inner shaft and the stent into a target treatment site within the body lumen of the patient, the stent being disposed around a balloon of the inner shaft and fixedly coupled to the inner shaft; retracting the outer shaft proximally to partially disengage the stent; expanding the balloon to radially expand a first length of the stent to an expanded state while a portion of the stent remains within the outer shaft until one or more protruding features of the stent pierce through a first portion of the wall of the body lumen; retracting the outer shaft proximally to further disengage the stent; expanding the balloon to radially expand a second length of the stent to an expanded state until one or more protruding features of the stent pierce through a second portion of the wall of the body lumen.

[0153] One or more of the above items may include one or more of the features described below. It should be noted that any of the following items may be combined in any combination with each other and placed into the corresponding independent items, such as item A, B, C, D, E, F or G.

[0154] Item 1: A connector is located at the proximal end of the inner shaft, through which the guidewire extends, the connector including a port in fluid communication with the balloon; and an outer hub is located at the proximal end of the outer shaft, through which the inner shaft extends.

[0155] Item 2: Having incrementally spaced markings on a proximal portion of the inner shaft, wherein the outer hub is slidable on the inner shaft along the proximal portion.

[0156] Item 3: The locking member is configured to lock the outer shaft hub to the proximal portion of the inner shaft such that when the balloon is inflated, the position of the outer shaft relative to the inner shaft is maintained.

[0157] Item 4: The balloon can be inflated through the lumen of the inner shaft containing the guidewire.

[0158] Item 5: The reinforcing wire is radially positioned between the inner shaft and the outer shaft.

[0159] Item 6: A stent comprising: a radially expandable cylindrical framework including struts; and a protruding feature carried by one or more struts.

[0160] Item 7: The stent is fixedly coupled to the inner shaft via an anchor portion extending around at least a portion of the inner shaft.

[0161] Item 8: The anchoring portion is coupled to the inner shaft on the proximal side of the balloon.

[0162] Item 9: The balloon comprises a plurality of segments at different axial locations along a length of the inner shaft, each of the plurality of segments being independently expandable.

[0163] Item 10: deflation of the balloon; advancement of the outer shaft over the stent; and removal of the stent from the body lumen.

[0164] Item 11: A connector is located at the proximal end of the inner shaft, through which a guide wire extends, the connector including a port in communication with balloon fluid; and an outer hub is located at the proximal end of the outer shaft, through which the inner shaft and stabilizing wire extend.

[0165] Item 12: The target treatment site is a first target treatment site, and the method further includes: repositioning the stent to a second target treatment site before retracting the outer shaft proximally to further dislodge the stent.

[0166] Item 13: The second length of the stent includes the first length of the stent.

[0167] Item 14: Deflate the balloon and re-sheath the stent before proximally retracting the outer shaft to further remove the stent.

[0168] Item 15: Locking the outer shaft relative to the inner shaft prior to radially expanding the stent to a first length.

[0169] Item 16: Locking the outer shaft relative to the inner shaft prior to radially expanding the stent to the second length.

[0170] Unless otherwise stated, referring to an element in the singular is not intended to mean "one and only one", but "one or more". For example, "a" module may refer to one or more modules. Without further limitation, an element beginning with "a", "an", "the" or "said" does not exclude the presence of additional identical elements.

[0171] Headings and subheadings, if any, are used for convenience only and do not limit the invention. The word "exemplary" is used to mean used as an example or illustration. Where the terms "including," "having," and the like are used, such terms are intended to be inclusive in a manner similar to how "comprising" is interpreted when used as a transitional word in a claim. Relative terms such as first and second, and the like, may be used to distinguish one entity or action from another without necessarily requiring or implying any actual such relationship or order between such entities or actions.

[0172] Wordings such as aspect, this aspect, on the other hand, some aspects, one or more aspects, embodiment, this embodiment, another embodiment, some embodiments, one or more embodiments, example, this embodiment, another example, some examples, construction, this construction, another construction, some constructions, one or more constructions, subject technology, disclosure, the present disclosure, other variations thereof, etc. are for convenience and do not imply that the disclosure associated with such (these) words is necessary for the subject technology, or that such disclosure is applicable to all configurations of the subject technology. The disclosure associated with such words may be applicable to all configurations, or one or more configurations. The disclosure associated with such words may provide one or more examples. Wordings such as aspect or some aspects may refer to one or more aspects, and vice versa, and this applies similarly to other aforementioned words.

[0173] The phrase "at least one" preceding a list of items (with the terms "and" or "or" separating any of the items) modifies the list as a whole, rather than each member of the list. The phrase "at least one" does not require selection of at least one item; rather, the phrase permits a meaning that includes 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. For example, each of the phrases "at least one of A, B, and C" or "at least one of A, B, or C" refers 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.

[0174] It is understood that the specific order or hierarchy of the disclosed steps, operations or processes is an illustration of an exemplary method. Unless otherwise expressly stated, it should be understood that the specific order or hierarchy of steps, operations or processes can be performed in a different order. Some of the steps, operations or processes can be performed simultaneously. The attached method claims (if any) present the elements of various steps, operations or processes in an exemplary order and are not meant to be limited to the specific order or hierarchy presented. These can be performed sequentially, linearly, in parallel or in a different order. It should be understood that the instructions, operations and systems described can generally be integrated together in a single software / hardware product, or packaged into multiple software / hardware products.

[0175] In one aspect, the term "coupled" or the like may refer to a direct coupling. In another aspect, the term "coupled" or the like may refer to an indirect coupling.

[0176] Terms such as top, bottom, front, back, side, horizontal, vertical, etc. refer to an arbitrary reference frame other than the ordinary gravitational reference frame. Thus, such terms may extend upward, downward, diagonally, or horizontally in a gravitational reference frame.

[0177] The present 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 blurring the concept of the subject technology. The present disclosure provides various examples of the subject technology, and the subject technology 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 may be applied to other aspects.

[0178] All structural and functional equivalents to the elements of the various aspects described throughout this disclosure that are known or later become known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the claims. In addition, nothing disclosed herein is intended to be dedicated to the public regardless of whether such disclosure is explicitly stated in the claims. No element of any claim is to be interpreted based on the provisions of 35 U.S.C. §112, sixth paragraph, unless the element is explicitly recited using the phrase "means for..." or, in the case of a method claim, is recited using the phrase "step for..."

[0179] Title, background technology, figure description, abstract and drawings are incorporated into this disclosure and are provided as illustrative examples of the disclosure, rather than as limiting descriptions. It should be understood that they will not be used to limit the scope or meaning of the claims. In addition, in the detailed description, it can be seen that the description provides illustrative examples, and the various features are combined together in various implementations to simplify the disclosure. The disclosed method should not be interpreted as reflecting the intention that the claimed subject matter requires more features than the features explicitly stated in each claim. On the contrary, as reflected in the various claims, the inventive subject matter lies in less than all the features of a single disclosed construction or operation. The various claims are thus incorporated into the detailed description, wherein each claim exists independently as a subject matter claimed separately.

[0180] The claims are not intended to be limited to the aspects described herein, but are to be accorded the full scope consistent with the language of the claims and including all legal equivalents. Nevertheless, no claim is intended to encompass subject matter that does not satisfy the requirements of applicable patent law, nor should they be interpreted in such a manner.

Claims

1. A system, include: External axis; an inner shaft slidably disposed within the outer shaft and comprising an expandable balloon on the inner shaft, wherein the expandable balloon comprises a plurality of segments at different axial positions along the length of the inner shaft, the plurality of segments being each independently expandable; and A bracket is slidably disposed within the outer shaft and extends around a portion of the inner shaft.

2. The system of claim 1, further comprising a stabilization wire slidably disposed within the outer shaft, wherein the stent is fixedly coupled to the stabilization wire via an anchor portion extending around at least a portion of the stabilization wire.

3. The system of claim 1, wherein the stent is fixedly coupled to the inner shaft via an anchor portion connected to a proximal end of the stent and extending around at least another portion of the inner shaft.

4. The system of claim 1, wherein the support include: a radially expandable cylindrical frame including struts; as well as A protruding feature carried by one or more pillars.

5. The system of claim 1, further comprising a reinforcing wire positioned radially between the inner shaft and the outer shaft.

6. The system of claim 1, further comprising a guidewire slidably disposed within the lumen of the inner shaft.

7. A system, include: External axis; an inner shaft slidably disposed within the outer shaft and including an expandable balloon on the inner shaft; a guidewire slidably disposed within a lumen of the inner shaft, wherein the inflatable balloon is inflated through the lumen of the inner shaft containing the guidewire; and A bracket is slidably disposed within the outer shaft and extends around a portion of the inner shaft.

8. The system of claim 7, further comprising a stabilization wire slidably disposed within the outer shaft, wherein the stent is fixedly coupled to the stabilization wire via an anchor portion extending around at least a portion of the stabilization wire.

9. The system of claim 7, wherein the stent is fixedly coupled to the inner shaft via an anchor portion connected to a proximal end of the stent and extending around at least another portion of the inner shaft.

10. The system of claim 7, wherein the support include: a radially expandable cylindrical frame including struts; as well as A protruding feature carried by one or more pillars.

11. The system of claim 7, further comprising a reinforcing wire positioned radially between the inner shaft and the outer shaft.

12. A system, include: External axis; an inner shaft slidably disposed within the outer shaft and including an expandable balloon on the inner shaft; and A stent is slidably disposed within the outer shaft and extends around a first portion of the inner shaft, the stent being fixedly coupled to the inner shaft via an anchor portion connected to a proximal end of the stent and extending around at least a second portion of the inner shaft proximate the expandable balloon.

13. The system of claim 12, wherein the support include: a radially expandable cylindrical frame including struts; as well as A protruding feature carried by one or more pillars.

14. The system of claim 12, further comprising a reinforcing wire positioned radially between the inner shaft and the outer shaft.

15. The system of claim 12, further comprising a guidewire slidably disposed within the lumen of the inner shaft.

16. A system, include: External axis; an inner shaft slidably disposed within the outer shaft and including an expandable balloon on the inner shaft; a bracket slidably disposed within the outer shaft and extending around a portion of the inner shaft; a stabilizing wire slidably disposed within the outer shaft, wherein the stent is fixedly coupled to the stabilizing wire; and A reinforcing wire is radially positioned between the inner shaft and the outer shaft.

17. The system of claim 16, wherein the stent is fixedly coupled to the stabilization wire via an anchor portion extending around at least a portion of the stabilization wire.

18. The system of claim 16, wherein the stent is fixedly coupled to the inner shaft via an anchor portion connected to a proximal end of the stent and extending around at least another portion of the inner shaft.

19. The system of claim 16, wherein the support include: a radially expandable cylindrical frame including struts; as well as A protruding feature carried by one or more pillars.

20. The system of claim 16, further comprising a guidewire slidably disposed within the lumen of the inner shaft.

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