HK40126741A - Delivery systems for stents having protruding features - Google Patents

Description

Delivery system for supports with prominent features

This application is a divisional application of patent application number 201980066102.4, filed on October 4, 2019, entitled "Conveyance System for a Support with Prominent Features". Patent application number 201980066102.4 is a PCT international application numbered PCT/US2019/054847 that entered the Chinese national phase.

Cross-references to related applications

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

Technical Field

This specification generally relates to delivery systems for expandable elements, such as scaffolds or frameworks having spikes, flails, or other prominent features for penetrating target tissue and/or delivering drugs in human patients.

Background Technology

Various devices can be used to deliver drugs to the intended treatment site within a patient's body. For example, stents (such as drug-eluting stents (DES)) can be positioned at sites of narrowing (arterial stenosis) caused by arteriosclerosis. DES typically comprise a drug-eluting polymer coated on a metallic stent or framework, or a bioresorbable stent or framework composed of a drug-eluting polymer. After the DES is delivered to the treatment site within a body lumen (such as a blood vessel), it expands against the wall of the lumen (such as the blood vessel wall), and the drug is released through direct contact with the wall. Direct delivery of the drug to the blood vessel wall achieves a significantly lower dose than required via other delivery methods (such as pills or injections).

Attached Figure Description

Figure 1 shows a partial schematic side view of an example of a conveying system.

Figure 2 shows a cross-sectional view of an example area of the conveying system of Figure 1 taken along line 2-2.

Figure 3 shows a partially enlarged schematic side view of the distal portion of the conveying system of Figure 1 with an unconstrained support.

Figure 4 shows a perspective view of an example of a support.

Figure 5 shows a side view of the bracket in Figure 4.

Figure 6 shows a front view of the bracket in Figure 4.

Figure 7 shows a perspective view of an example of the connector end of the bracket in Figure 4.

Figure 8 shows a perspective view of another example of the connector end of the bracket in Figure 4.

Figure 9 shows a perspective view of another example of the connector end of the bracket in Figure 4.

Figure 10 shows a perspective view of another example of the connector end of the bracket in Figure 4.

Figure 11 shows a side view of an example of a conveyor system in the first stage of deployment.

Figure 12 shows a side view of the conveying system of Figure 11 in its second unfolded stage.

Figure 13 shows a side view of the conveying system of Figure 11 in the third stage of unfolding.

Figure 14 shows a side view of the conveying system of Figure 11 in its fourth unfolded stage.

Figure 15 shows a cross-sectional view of an exemplary area of the conveying system.

Figure 16 shows a side view of another example of a conveyor system in the first stage of deployment.

Figure 17 shows a side view of the conveying system of Figure 16 in its second unfolded stage.

Figure 18 shows a side view of the conveying system of Figure 16 in the third stage of unfolding.

Figure 19 shows a side view of the conveying system of Figure 16 in its fourth unfolded stage.

Figure 20 shows a side view of the conveying system of Figure 16 in its fifth unfolded stage.

Figure 21 shows a side view of another example of a conveyor system in the first stage of deployment.

Figure 22 shows a side view of the conveying system of Figure 21 in its second unfolded stage.

Figure 23 shows a side view of the conveying system of Figure 21 in the third stage of unfolding.

Figure 24 shows a side view of the conveying system of Figure 21 in its fourth unfolded stage.

Figure 25 shows a side view of an example of a conveyor system in the first stage of deployment.

Figure 26 shows a side view of the conveying system of Figure 25 in its second unfolded stage.

Figure 27 shows a side view of the conveying system of Figure 25 in the third stage of unfolding.

Figure 28 shows a side view of the conveying system of Figure 25 in its fourth unfolded stage.

Figure 29 shows a side view of an example of a delivery system in a delivery state within a body lumen.

Figure 30 shows a cross-sectional view of the conveying system of Figure 29 in its unfolded state.

Figure 31 shows a cross-sectional view of the delivery system of Figure 29, in which the balloon and stent are in an expanded state within the body lumen.

Figure 32 shows a cross-sectional view of a region of the delivery system of Figure 29, in which the stent is in the treatment state and the balloon is in a collapsed state that allows fluid flow.

In one or more embodiments, not all components shown in each figure may be required, and one or more embodiments may include additional components not shown in the figures. Variations in the arrangement and type of components may be made without departing from the scope of this subject matter disclosure. Within the scope of this subject matter disclosure, additional components, different components, or fewer components may be used.

Detailed Implementation

The following detailed description is intended as a description of various embodiments and is not intended to represent only the embodiments in which the subject matter can be practiced. As those skilled in the art will recognize, the described embodiments can be modified in many different ways without departing from the scope of this disclosure. Therefore, the drawings and description are to be considered illustrative rather than restrictive in nature.

The following disclosure describes various embodiments of delivery systems, and related apparatuses and methods for expandable structures, where the expandable element is, for example, a stent or framework having a spike, flail, or other prominent features for penetrating target tissue and/or delivering medication within a human patient. Delivery systems can be configured to deliver and position expandable structures within body lumens (e.g., blood vessels). Furthermore, these delivery systems can also be configured to deploy and expand expandable structures within body lumens. Delivery systems can also be configured to engage with the expanded structure and to collapse the structure for removal from the body lumen. In some embodiments, delivery systems can be configured to deliver another expandable structure or the same expandable structure to another body lumen or the same body lumen in a single process or during multiple processes. Such delivery systems are expected to streamline and expedite transluminal procedures to more efficiently deliver and position expandable structures within target tissue. When configured to retract a deployed expandable structure, the delivery system can be used for more than one process, such as deploying the expandable structure.

Specifically, the delivery system described herein may include a support positioned above an inflatable balloon to expand and deliver the support to the target delivery site. By positioning the support above and around the inflatable balloon, the support is prepared to expand immediately through the balloon upon disengagement relative to the outer axis. Additionally or alternatively, the support may be positioned in an axially offset arrangement relative to the balloon to reduce the space requirements of overlapping components.

Some details are set forth in the following description and Figures 1-32 to provide a thorough understanding of the various embodiments of this disclosure. To avoid unnecessarily obscuring the description of the various embodiments of this disclosure, other details of known structures and systems generally associated with expandable structures, prominent features, and components or devices associated with the manufacture of such structures are not set forth below. Furthermore, many details and features illustrated in the figures are merely illustrative of specific embodiments of this disclosure. Therefore, other embodiments may have other details and features without departing from the spirit and scope of this disclosure. Accordingly, those skilled in the art will understand that this technology, including associated apparatus, systems, and processes, may include other embodiments with additional elements or steps, and/or may include other embodiments without certain features or steps shown and described below with reference to Figures 1-32. Moreover, the various embodiments of this disclosure may include structures other than those shown in the figures and are clearly not limited to those shown in the figures.

Figure 1 shows a partial schematic side view of a stent delivery system 100 in a delivery state (e.g., small profile or collapsed configuration). The delivery system 100 includes an outer shaft 120 (e.g., a catheter) having one or more lumens for receiving an inner shaft 110 and/or 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 formed of a material including polymers, high-density polyethylene (HDPE), polytetrafluoroethylene, silicone, (polyether block amide), or combinations 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.

The inner shaft 110 may 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 may be formed as a tubular structure (with or without slots), such as a spiral tube, braided tube, reinforcing tube, or a combination thereof, and may be made of a polymeric material such as polyimide. The delivery system 100 may include a guide wire within the inner shaft 110, which may be contacted at the proximal end of the delivery system 100.

In a detailed view of the distal portion 100b of the conveying system 100, a distal end 115 (e.g., a damage-resistant distal end) is disposed on the distal end portion of the inner shaft 110. As shown, the distal end 115 is adjacent to the distal end portion of the outer shaft 120. At least a portion of the distal end 115 may have the same cross-sectional dimensions as the outer shaft 120, or the distal end 115 may have different cross-sectional dimensions. In some embodiments, the distal end 115b of the distal end 115 is tapered, such that the distal end 115b has a smaller cross-sectional dimension compared to the proximal end 115a of the distal end. The distal edge and/or proximal edge of the distal end 115 may be chamfered/rounded to prevent the distal end 115 from being caught (e.g., stuck) on other portions of the conveying system 100 during conveying, positioning, unfolding, etc. The distal end 115 may 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.

The inner shaft 110 and outer shaft 120 can be sized and shaped to reach a target site (e.g., a treatment site) within a blood vessel. In some embodiments, for example, the outer shaft 110 has a length of about 150 cm to about 180 cm and suitable cross-sectional dimensions for positioning within the vascular system of the object. The length of the inner shaft 110 can be a working length, such as a length that can be positioned within the vascular system of the object. 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 cm to about 140 cm and a cross-sectional dimension of about 4 French, about 5 French, or about 6 French. The length of the outer shaft 120 can be the working length, such as the length that can be positioned within the vascular system of an object. In some embodiments, for example, the working length is about 50cm to about 200cm, about 100cm to about 150cm, or about 50cm, about 60cm, about 70cm, about 80cm, about 90cm, about 100cm, about 110cm, about 120cm, about 125cm, about 130cm, about 135cm, about 140cm, about 145cm, about 150cm, about 155cm, about 160cm, about 170cm, about 180cm, about 190cm, or about 200cm.

In a detailed view of the proximal portion 100a of the conveying system 100 in FIG1, the proximal end 120c of the outer shaft is coupled to the outer shaft hub 140. In the illustrated embodiment, the outer shaft hub 140 is coupled to the outer shaft 120 (e.g., via adhesive). However, in other embodiments, the proximal end 120c of the outer shaft is directly coupled to the outer shaft hub 140.

The outer hub 140 is further coupled to a connector 150 (e.g., a Y-connector) having a lumen (not shown) extending therethrough. Specifically, the distal end 150b of the connector 150 may be coupled to the outer hub 140 via mating and receiving features (not shown). The mating and receiving features may 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 ports 152 extending radially and/or longitudinally therefrom. The delivery system 100 may optionally include a hemostatic connector 170 coupled to the proximal end 150a of the Y-connector 150. While the proximal end 120c is shown as having specific components arranged in a particular manner, it should be understood that additional or fewer components may be included in similar or other arrangements to meet the needs of the system.

The delivery system 100 is configured to carry a stent in a delivered/collapsed state (discussed further herein) within the distal portion of the outer shaft 120. The stent may be at least partially enclosed by the outer shaft 120. In some embodiments, the stent may 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 may also include cages, meshes, balloons, membranes, tubular structures, circumferential bodies, expandable elements, expandable membranes, expandable structures, inflatable tubular structures, and circumferentially expandable catheter tips with or without guidewire lumens.

Figure 2 shows a cross-sectional view of a region of the conveying system 100 of Figure 1 taken along line 2-2. As shown in Figure 2, the inner shaft 110 may be at least partially disposed within the lumen of the outer shaft 120, and the guide wire 162 may be at least partially disposed within 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 may have other cross-sectional shapes, such as oval, C-shaped, rectangular, triangular, etc.

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

Figure 3 shows a side view of the distal portion 100b of the delivery system 100 of Figure 1 in its deployed state. 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 mark 192 is disposed on a stabilizing filament 160 near the proximal portion of the stent 190, and a distal visualization mark 197 is disposed on the distal end 190c of the stent. In some embodiments, the proximal visualization mark 192 and/or the distal visualization mark 197 may be disposed on the stabilizing filament 160. The visualization marks 192 and/or 197 may be formed of any material that is visible when the stent 190 is positioned intravascularly (e.g., within the target vessel). For example, in one embodiment, the visualization marks 192 and/or 197 are radiopaque marks. The stabilizing filament 160 may be connected to the inner shaft 110 such that movement of the inner shaft 110 correspondingly pushes the stent 190 via the stabilizing filament 160, as discussed further herein. Alternatively, the stabilizing wire 160 can move independently relative to the inner shaft 110, as discussed further herein.

A distal end 115 is disposed on the distal portion 110c of the inner shaft 110 and may surround the distal portion 110c, the distal end extending proximally along the distal portion 110b and/or distally from the distal portion 110c. The inner shaft 110 extends distally from the distal portion 120b of the outer shaft 120, through the lumen of the support 190, and optionally extends distally from the distal end of the support 190. In the unfolded configuration, the protruding feature 194 extends radially relative to the longitudinal axis of the support 190, as discussed further herein.

As further discussed herein, the inner shaft 110 may also include an inflatable balloon (not shown). When the stent 190 is in a delivery state (e.g., small profile or collapsed configuration) within the outer shaft 120 and/or when the stent 190 is initially deployed from the delivery state, the inflatable balloon may axially overlap with, move away from or near the stent 190.

Guide wire 162 can extend through inner shaft 110 and beyond distal end 115. Therefore, guide wire 162 can advance before the rest of the conveying system 100. Inner shaft 110, support 190, and outer shaft 120 can advance over guide wire 162 until support 190 is aligned with the intended target conveying location. The length of guide wire 162 that overlaps with the rest of the conveying system 100 can be within inner shaft 110 so that it does not interfere with any other components of the conveying system 100.

As shown in Figures 4-6, the expandable stent 190 includes a frame 191 and a plurality of protrusions 194. The frame 191 and protrusions 194 may be configured to expand radially after the stent 190 has been disengaged from the outer shaft 120. The stent 190 may self-expand upon release from restraint. Additionally or alternatively, the stent 190 may expand by the radial force exerted by a balloon when it inflates within the stent 190. The frame 191 may include a plurality of struts 195 arranged to support the compression, expansion, flexibility, and bendability of the stent 190. The frame 191 may be formed in a generally cylindrical shape along at least a portion of the stent 190. At least a portion of each protrusion 194 may extend at least partially distally from the frame 191 (e.g., toward the distal end 190c). For example, at least a portion of each protrusion 194 may extend parallel to the longitudinal axis of the stent 190. At least a portion of each protrusion 194 (e.g., the distal portion) may extend at least partially radially away from the frame 191. For example, at least a portion of each protrusion 194 may extend radially outward (e.g., perpendicular to the longitudinal axis) relative to the longitudinal axis of the stent 190. Since at least a portion of each protrusion 194 extends distally from the frame 191, the protrusion 194 can be easily retracted into the outer shaft 120 by folding and extending distally as the outer shaft 120 advances over the stent 190 from its proximal side in the distal direction. The protrusion 194 may optionally include medication for delivery to a target delivery site during stent expansion. However, it should be understood that the stent 190 may omit medication for delivery and treatment of the target delivery site by inserting the protrusion 194 into the tissue.

The frame 191, pillar 195, and/or protruding feature 194 may be constructed or formed of a variety of materials, including, for example, nitinol, cobalt-chromium alloys, stainless steel, any of a variety of other metals or metal alloys, or combinations thereof. The frame 191, pillar 195, and/or protruding feature 194 may also be constructed or formed of 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 pillar 195 may be formed of a bioabsorbable material, and the protruding feature 194 may be formed of a non-bioabsorbable material, such as nitinol. In these embodiments, after the expanded frame 191 and pillar 195 are bioabsorbed, the protruding feature 194 may remain engaged with or penetrate a portion of the body lumen. After the expanded frame 191 and strut 195 are bioabsorbed, the body lumen in which the scaffold 190 has expanded is no longer partially blocked by the frame 191 and strut 195, thus allowing larger volumes of fluid (such as aqueous drug components) to pass through the body lumen and contact the lumen walls. The protruding feature 194 can also be formed of a bioabsorbable material, and once the scaffold 190 has been bioabsorbed, the space in the body lumen wall freed up by the protruding feature 194 can be contacted by fluid passing through the body lumen. In this way, the scaffold 190 can increase the surface area of the body lumen wall in contact with the fluid.

The protruding feature 194 may also be carried by more than one strut 195, frame 191, or a combination thereof. The protruding feature 194 may be integrally formed with the strut 195, for example by bending or twisting one or more struts and/or a portion of the frame 191 away from the longitudinal axis of the support 190, or alternatively, the protruding feature 194 may be a separate, independent component attached to the intended location along the strut 195 and/or frame 191.

The support 190 may include an anchoring portion 196, which is securely connected to components used for controlling, positioning, and/or adjusting the support 190. For example, the anchoring portion 196 may securely connect the support 190 to the inner shaft 110. Alternatively, the anchoring portion 196 may securely connect the support 190 to the stabilizing wire 160. The anchoring portion 196 may be offset from the central axis of the support 190. For example, the anchoring portion 196 may be radially aligned, adjacent to, or close to a portion of the frame 191 of the support 190. The frame 191 of the support 190 may be connected to the anchoring portion 196 via an intermediate portion 193. The intermediate portion 193 may include a plurality of struts of different widths to reinforce the strength of the struts for deployment and retraction, these struts extending from different portions of the frame 191, such as different circumferential portions connected to the ends of the frame 191. The struts of the intermediate portion 193 may extend along the anchoring portion 196 to the same or different axial locations. The arrangement of the struts of the intermediate portion 193 may maintain an open central space along the entire length of the support 190.

As shown in Figures 7-10, the anchoring portion 196 can be formed in one or more of a variety of arrangements. As shown in Figure 7, the anchoring portion 196 may include a plurality of ribs 902 extending circumferentially from different axial positions along the anchoring portion 196. These ribs 902 may be positioned at different axial positions to provide multiple contact points with the positioner (such as the inner shaft 110 and/or the stabilizing wire 160).

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

As shown in Figure 9, the anchoring portion 196 may include a helical winding portion 908. For example, the anchoring portion 196 may be helically wound around a central space configured to receive the locator therein. The helical winding portion 908 may include multiple turns (e.g., 2, 3, 4, 5, 6, 7, 8, or more than 8 turns). The helical winding portion 908 may include a shape in cross-section that provides a flat inner surface for engaging the locator while maintaining a small profile.

As shown in Figure 10, the anchoring portion 196 may include an arrangement of multiple supports 910. The supports 910 may define a cylindrical shape in general for receiving and attaching to the locator. The supports 910 may extend circumferentially and/or longitudinally about the space for receiving the locator. The supports 910 may form any number of units, which may vary in length and/or width relative to each other.

Anchor portion 196 securely connects bracket 190 to a locator, such as inner shaft 110 and/or stabilizing wire 160. For example, anchor portion 196 can be pressed onto the locator. Alternatively, anchor portion 196 can be glued to the locator. Additionally or alternatively, a sleeve can be provided around at least a portion of anchor portion 196 and/or the locator. For example, a tube—such as a shrink tube molded from one or more flexible materials (including polyurethane and (e.g., 35D))—can be provided as a sleeve on anchor portion 196 and/or the locator. Additionally or alternatively, stabilizing wire 160 can be connected to inner shaft 110 by one or more methods, including laser welding, bonding, crimping, forging, reflowing, etc. Additionally or alternatively, anchor portion 196 can removably or reversibly connect bracket 190 to the locator. For example, the anchoring portion 196 may be provided with one or more separation mechanisms (e.g., electrolytic, mechanical, or chemical) to controllably separate the support 190 from the positioner. In this way, the support 190 can be controllably separated and left at the target delivery location.

The method described herein provides the transport of the support 190 to the target transport section through the operation of the transport system 100. Although this document discusses and illustrates methods at different stages, it should be understood that various variations of each method are also conceivable. For example, these methods can be performed with various sequences of operations, by additional operations, or by fewer operations.

As shown in Figures 11-14, the delivery system 100 may be equipped with a support 190 positioned above the inflatable balloon 180 for expanding and delivering the support 190 to the target delivery site. By positioning the support 190 above and around the inflatable balloon 180, the support 190 is prepared to expand immediately through the balloon 180 upon disengagement relative to the outer shaft 120.

As shown in Figure 11, the conveying system 100 is provided with an outer shaft 120 that covers or encloses other components of the conveying system 100. For example, the outer shaft 120 may extend to a distal end 115 located at the distal end of an inner shaft 110. The inner shaft 110 may extend within the outer shaft 120, having a length accessible proximally to the proximal end of the outer shaft 120 (e.g., at the outer shaft hub 140). Additionally or alternatively, a connector 150 may be accessible proximally to the proximal end of the outer shaft 120 (e.g., at the outer shaft hub 140). As described above, a guide wire may advance prior to the distal end 115 (e.g., through the inner shaft 110), thereby providing a path for the advancement of other components of the conveying system 100.

As shown in Figures 12 and 13, the outer shaft 120 is movable to disengage the support 190 and other components of the delivery system 100. For example, once the distal region of the delivery system 100 is positioned as intended, the outer shaft 120 is configured to retract at least partially proximally relative to the inner shaft 110 by retracting the outer shaft hub 140 relative to the connector 150. Once the outer shaft 120 is partially retracted, at least a portion of the support 190 and/or the balloon 180 disengages, and the protruding feature 194 of the support 190 is configured to expand radially outward away from the inner shaft 110.

As used herein, the movement of individual components can be relative to other components of delivery system 100 and/or to locations outside delivery system 100 (e.g., within the patient's anatomy, the target delivery site, and/or tissue). Directions “proximal” and “distal” can be relative to delivery system 100, its components, and/or locations outside delivery system 100. For example, the movement of guidewire 162 can be relative to outer axis 120, inner axis 110, stent 190, and/or balloon 180. It should be understood that as guidewire 162 moves, outer axis 120, inner axis 110, stent 190, and/or 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, inner shaft 110, stent 190, and/or balloon 180 move, the guidewire 162 may be stationary, move in the same direction (e.g., at different speeds), or move in different (e.g., opposite) directions. Additionally, for example, the movement of the outer shaft 120 may be relative to the inner shaft 110, stent 190, and/or balloon 180. It should also be understood that when the outer shaft 120 moves, the inner shaft 110, stent 190, and/or balloon 180 may be stationary, move in the same direction (e.g., at different speeds), or move in different (e.g., opposite) directions. Additionally, for example, the movement of the inner shaft 110, stent 190, and/or balloon 180 may be relative to the outer shaft 120. It should be understood that when the inner shaft 110, the support 190 and/or the balloon 180 move, the outer shaft 120 may be stationary, move in the same direction (e.g., at different speeds), or move in different (e.g., opposite) directions.

As shown in Figure 14, the outer shaft 120 has been retracted, and the stent 190 has disengaged. A stabilizing wire 160, connected to the inner shaft 110 via an anchoring portion 196, is configured to engage with the proximal end of the stent 190 and control the position of the stent 190 during and after the retraction of the outer shaft 120. Therefore, the position of the stent 190 relative to the inner shaft 110 (including the balloon 180) remains constant. For example, while some adjustments to the length and/or axial position of the stent 190 may 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 around and axially aligned with at least a portion of the balloon 180. The balloon 180 may have an axial length greater than the axial length of the stent 190, such that the entire stent 190 overlaps with the balloon 180. As shown in Figure 14, the stabilizing wire 160 can connect the stent 190 to the portion of the inner shaft 110 near the balloon 180. Alternatively or additionally, the stabilizing cable 160 may connect the bracket 190 to the portion of the inner shaft 110 remote from the balloon 180.

When both stent 190 and balloon 180 are disengaged and exposed via outer shaft 120, balloon 180 can inflate to expand or further expand stent 190. For example, the internal region of the balloon can be fluidly connected to port 152 of connector 150 via inner shaft 110. By supplying fluid via port 152, balloon 180 can inflate, thereby expanding or further expanding stent 190. Expansion relative to target anatomical structures will be discussed further herein.

After one or more of the above operations, balloon 180 may deflate. Stent 190 may be maintained in the expanded state for any duration. For example, stent 190 may 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 the deflated balloon without fluid obstruction at the treatment site.

Additionally or alternatively, the delivery system 100 can be deployed at multiple locations. The support 190 can be collapsed by moving the outer shaft 120 on the support 190. The support 190 and the balloon 180 can be moved to other target locations, and one or more of the above operations can be repeated.

Alternatively or additionally, the delivery system 100 can be removed. The stent 190 can be collapsed by moving the outer shaft 120 on the stent 190. Components of the delivery system 100 can be removed from the patient by retracting proximally on the guidewire.

Alternatively or additionally, the stent 190 can be detached from the inner shaft 110 and remain in the patient's body as an implant. After detachment, the other components of the delivery system 100 can be removed from the patient's body by retracting them proximally over the guidewire.

Although delivery system 100 is shown with its support 190 positioned on balloon 180 in the delivery state, it should be understood that other arrangements are conceivable. For example, the support may be positioned axially offset relative to the balloon to reduce the space requirements of overlapping components. Refer to delivery system 200 as shown in Figures 16-20, delivery system 300 as shown in Figures 21-24, and delivery system 500 as shown in Figures 25-28. While each of delivery systems 200 and 300 differs from delivery system 100 in some respects, it should be understood that the components and features of delivery system 100 described herein can be applied to any one or both of delivery systems 200 and 300. Similar or analogous items may perform the same functions as those shown in delivery system 100, and for the sake of brevity, the features of these items will not be discussed in full below.

Referring now to FIG. 15, and further to FIG. 1, a cross-sectional view of a region of the delivery system 200 is shown, wherein the delivery system 200 is similar in at least some respects to the delivery system 100 shown in FIG. 1. For example, the cross-sectional view of FIG. 15 can be taken along a line positioned similarly to line 2-2 in FIG. 1. As shown in FIG. 15, the inner shaft 210 can be at least partially disposed within the lumen of the outer shaft 220. Furthermore, 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 lumen space and the stiffness and/or flexibility of the shaft without changing the material thickness of the shaft. A guide wire 262 can be at least partially disposed within the lumen of the inner shaft 210. The lumen defined between or within the outer shaft 220 and the inner shaft 210 can provide fluid communication for the balloon's inflation and deflation. In some embodiments, the outer shaft 220, inner shaft 210, guidewire 262, and/or reinforcing wire 264 each have a circular cross-sectional shape and a single lumen. However, in other embodiments, the outer shaft 220, inner shaft 210, guidewire 262, and/or reinforcing wire 264 may have other cross-sectional shapes, such as oval, "C"-shaped, rectangular, triangular, etc., and have multiple lumens. For example, the reinforcing wire 264 may have a shape adapted to fit within the space between the outer shaft 220 and the inner shaft 210. For example, the cross-sectional shape of the reinforcing wire 264 may be polygonal (e.g., rectangular) or crescent-shaped. The inner surface of the outer shaft 220 and/or the outer surface of the inner shaft 210 may have a cross-sectional shape that accommodates and/or guides the reinforcing wire 264. The support shaft 230 may also be circumferentially positioned around the inner shaft 210 or the outer shaft 220 to increase the column strength and stiffness of the conduit region. In some embodiments, the support shaft 230 may have a large inner diameter and be attached to the outer shaft 220 to extend the entire length of the conduit and accommodate a larger proximal segment of the inner conduit 210 or reinforcing wire 264. The arrangement of the support shaft may vary from the entire length of the inner shaft 210 to specific 10cm, 20cm, 30cm, and 40cm segments (with varying lengths of 10cm, 20cm, 30cm, and 40cm) to increase overall conduit stiffness. Attachment mechanisms may include adhesive bonding, remelting, braiding, winding, laser welding, etc. The support shaft 230 may also be made of materials such as nylon, high-hardness plastics, stainless steel, nickel-titanium, polyetheretherketone (PEEK), etc.

Stabilizing wire 260 can be coupled to a 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 plastics, including nylon, polyetheretherketone (PEEK)), metal, metal alloys (such as nitinol), and/or combinations thereof. Stabilizing wire 260 can be configured to position the stent (not shown) at the intended treatment location and, at least substantially, maintain the stent's position when the outer shaft 220 is withdrawn, as described in more detail below.

The size and shape of the stabilizing wire 260 can be configured 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 approximately 150 cm to approximately 180 cm and a suitable cross-sectional size for positioning within the patient's body lumen. The stabilizing cable 260 can have a working length of approximately 70cm to approximately 300cm, approximately 150cm to approximately 250cm, or approximately 70cm, approximately 80cm, approximately 90cm, approximately 100cm, approximately 110cm, approximately 120cm, approximately 130cm, approximately 140cm, approximately 150cm, approximately 160cm, approximately 170cm, approximately 180cm, approximately 190cm, approximately 200cm, approximately 210cm, approximately 220cm, approximately 230cm, approximately 240cm, approximately 250cm, approximately 260cm, approximately 270cm, approximately 280cm, approximately 290cm, or approximately 300cm (i.e., the length that can be positioned within the target body cavity).

As shown in Figures 16-20, the delivery system 200 may be equipped with a support 290 positioned proximal to the inflatable balloon 280 for expanding and delivering the support 290 to the target delivery location. By positioning the support 290 proximal to the inflatable balloon 280, the support 290 and the balloon 280 do not overlap (e.g., are axially offset) when in the delivery state within the outer shaft 220, thereby reducing the space requirement within the outer shaft 220.

As shown in Figure 16, the conveying system 200 includes an outer shaft 220 that covers or encloses other components of the conveying system 200. For example, the outer shaft 220 may extend to a distal end 215 located at the distal end of the inner shaft 210. The inner shaft 210 may extend within the outer shaft 220, having a length accessible proximally to the proximal end of the outer shaft 220 (e.g., at the outer shaft hub 240). Additionally or alternatively, the connector 250 may be accessible proximally to the proximal end of the outer shaft 220 (e.g., at the outer shaft hub 240). The stabilizing wire 260 may also be accessible proximally to the proximal end of the outer shaft 220 (e.g., at the outer shaft hub 240). The guide wire may advance prior to the distal end 215 (e.g., through the inner shaft 210), thereby providing a path for the advancement of other components of the conveying system 200.

As shown in Figure 17, the outer shaft 220 can be moved to dislodge the inflatable balloon 280. For example, once the distal region of the delivery system 200 is positioned as intended, the outer shaft 220 is configured to retract at least partially proximally 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.

As shown in Figure 18, 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 dislodges, and the protruding feature 294 of the stent 290 is 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 a smaller outer cross-sectional dimension than that 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 if the stent 290 collapsed onto the balloon 280.

As shown in Figure 19, the outer shaft 220 has been retracted, and the support 290 has disengaged. A user-accessible stabilizing cable 260 is configured to engage with the proximal end of the support 290 and control the position of the support 290 during and after the retraction of the outer shaft 220. When the outer shaft 220 is retracted, the user can fix the stabilizing cable 260 relative to the inner shaft 210 such that the position of the support 290 remains unchanged relative to the inner shaft 210 (including the balloon 280) during the retraction of the outer shaft 220.

As shown in Figure 20, when the stent 290 and balloon 280 are dislodged and exposed via 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, proximal retraction of the inner shaft 210 relative to the stent 290 enables axial alignment of the balloon 280 with the stent 290. The balloon 280 may have an axial length greater than the axial length of the stent 290, such that the entire stent 290 overlaps with the balloon 280 during axial alignment. Additionally or alternatively, the inner shaft 210 and the outer shaft 220 may retract together relative to the stent 290.

The balloon 280 can be inflated to expand or further expand the stent 290. For example, the internal region of the balloon can be fluidly connected to port 252 of the connector 250 via the inner shaft 210. By supplying fluid via port 252, the balloon 280 can be inflated, thereby expanding or further expanding the stent 290. Expansion relative to the target anatomical structure will be discussed further herein.

After one or more of the above-described operations, balloon 280 may deflate. Stent 290 may be maintained in the expanded state for any duration. For example, stent 290 may be maintained for a duration effective for delivering therapeutic treatments (e.g., remodeling and/or drug delivery) to the target anatomical structure.

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

Alternatively or additionally, 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 before collapsing over the outer shaft 220. Components of the delivery system 200 can be removed from the patient by retracting proximally over the guidewire.

Alternatively, the stent 290 can be detached from the stabilizing wire 110 and remain in the patient's body as an implant. After detachment, the other components of the delivery system 200 can be removed from the patient's body by retracting them proximally over the guidewire.

As shown in Figures 21-24, the delivery system 300 may be equipped with a support 390 positioned distal to the inflatable balloon 380 to expand and deliver the support 390 to the target delivery location. By positioning the support 390 distal to the inflatable balloon 380, the support 390 and the balloon 380 do not overlap (e.g., are axially offset) when in the delivery state within the outer shaft 320, thereby reducing the space requirement within the outer shaft 320.

As shown in Figure 21, the conveying system 300 includes an outer shaft 320 that covers or encloses other components of the conveying system 300. For example, the outer shaft 320 may extend to a distal end 315 located at the distal end of an inner shaft 310. The inner shaft 310 may extend within the outer shaft 320, having a length accessible proximally to the proximal end of the outer shaft 320 (e.g., at the outer shaft hub 340). Additionally or alternatively, a connector 350 may be accessible proximally to the proximal end of the outer shaft 320 (e.g., at the outer shaft hub 340). A stabilizing wire 360 may also be accessible proximally to the proximal end of the outer shaft 320 (e.g., at the outer shaft hub 340). A guide wire may advance prior to the distal end 315 (e.g., through the inner shaft 310), thereby providing a path for the advancement of other components of the conveying system 300.

As shown in Figure 22, the outer shaft 320 is movable to dislodge the inflatable balloon 380. For example, once the distal region of the delivery system 300 is positioned as intended, the outer shaft 320 is configured to retract at least partially proximally 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 support 390 dislodges, and the protruding feature 394 of the support 390 is configured to expand radially outward away from the inner shaft 310. A user-accessible stabilizing cable 360 is configured to engage with the proximal end of the support 390 and control the position of the support 390 during and after the retraction of the outer shaft 320. When the outer shaft 320 is retracted, the user can fix the stabilizing cable 360 relative to the inner shaft 310 such that the position of the support 390 relative to the inner shaft 310 (including the balloon 380) remains unchanged during the retraction of the outer shaft 320.

As shown in Figure 23, the outer shaft 320 can be further moved to dislodge the balloon 280. Once the outer shaft 320 is further retracted, at least a portion of the balloon 380 is dislodged. 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 310. The distal portion 310a of the inner shaft 310 can have a smaller outer cross-sectional dimension than 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.

As shown in Figure 24, when the stent 390 and balloon 380 are dislodged and exposed via 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, distal movement of the inner shaft 310 relative to the stent 390 enables 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, such that the entire stent 390 overlaps with the balloon 380 during axial alignment.

The balloon 380 can be inflated to expand or further expand the stent 390. For example, the internal region of the balloon can be fluidly connected to port 352 of the connector 350 via the inner axis 310. By supplying fluid via port 352, the balloon 380 can be inflated, thereby expanding or further expanding the stent 390. Expansion relative to the target anatomical structure will be discussed further herein.

After one or more of the above-described operations, balloon 380 may deflate. Stent 390 may remain in the expanded state for any duration. For example, stent 390 may be maintained for a duration that is effective for delivering therapeutic treatments (e.g., remodeling and/or drug delivery) to the target anatomy.

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

Alternatively or additionally, the delivery system 300 can be removed. The stent 390 can be collapsed by moving the outer shaft 320 on the stent 390. Optionally, the stent 390 can be axially realigned with the proximal portion 310a of the inner shaft 310 before collapsing via the outer shaft 320. Components of the delivery system 300 can be removed from the patient by retracting proximally on the guidewire.

Alternatively or additionally, the stent 390 can be detached from the stabilizing wire 360 and remain in the patient's body as an implant. After detachment, the other components of the delivery system 300 can be removed from the patient's body by retracting them proximally along the guidewire.

As shown in Figures 25-28, the delivery system 500 may be equipped with a support 590 positioned above an inflatable balloon 580 for expanding and delivering the stent 190 to the target delivery site. By positioning the stent 590 above and around the inflatable balloon 580, the stent 590 is prepared to expand immediately through the balloon 580 upon partial or complete dislodgement relative to the outer shaft 520. Any released portion of the stent 590 can be expanded through a similarly released portion of the balloon 580 below.

As shown in Figure 25, the conveying system 500 is provided with an outer shaft 520 that covers or encloses other components of the conveying system 500. For example, the outer shaft 520 may extend to a distal end 515 located at the distal end of the inner shaft 510. The inner shaft 510 may extend within the outer shaft 520, having a length accessible proximally to the proximal end of the outer shaft 520 (e.g., at the outer shaft hub 540). Additionally or alternatively, a connector 550 may be accessible proximally to the proximal end of the outer shaft 520 (e.g., at the outer shaft hub 540). As described above, a guide wire may advance prior to the distal end 515 (e.g., through the inner shaft 510), thereby providing a path for the advancement of other components of the conveying system 500.

As shown in Figure 26, the outer shaft 520 is movable to disengage other components of the delivery system 500 and a portion of the support 590. For example, once the distal region of the delivery system 500 is positioned as intended, the outer shaft 520 is configured to retract at least partially proximally relative to the inner shaft 510 by retracting the outer shaft hub 540 relative to the connector 550. Once the outer shaft 520 is partially retracted, a portion of the support 590 and/or the balloon 580 disengages, and the protruding feature 594 of the exposed portion of the support 590 is configured to expand radially outward away from the inner shaft 510.

The bracket 590 can be fixedly attached to other components of the conveyor system 500, such as the inner shaft 510 (e.g., via an anchoring portion). Alternatively, the bracket 590 can be adjustablely positioned relative to one or more other components of the conveyor system 500. For example, the bracket 590 can be coupled to a stabilizing cable that a user can access at a proximal end of the conveyor system 500, and the user can adjust the position of the bracket 590 by manipulating the stabilizing cable.

As shown in Figure 27, the outer shaft 520 has been partially retracted, and the support 590 has been partially disengaged. The support 590 may be connected to the inner shaft 510, for example, via a stabilizing wire (not shown), as described herein. Therefore, the position of the support 590 may be maintained relative to the inner shaft 510 (including the balloon 580). For example, while some adjustments to the length and/or axial position of the support 590 may be made during radial expansion, it should be understood that the stabilizing wire can maintain the position of at least a portion of the support 590 around and axially aligned with at least a portion of the balloon 580. Additionally or alternatively, the support 590 may be secured relative to the outer shaft 520 by locking the outer shaft hub 540 relative to the inner shaft 510 at a proximal portion of the delivery system 500. For example, the locking member may 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, this locking member prevents the outer shaft 520 from retracting proximally as the balloon 580 (including the portion of the balloon 580 within the outer shaft 520) expands. The balloon 580 may have an axial length greater than the axial length of the stent 590, such that the entire stent 590 overlaps with the balloon 580.

The extent of dislodgement (e.g., partial dislodgement) of the stent 590 and/or balloon 580 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 coupled to one or more of the aforementioned components may include visual markings, such as radiopaque markings. The positions of these components relative to each other and/or the target location 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 relative positions of the outer shaft hub 540, inner shaft 510, and/or stabilizing cable (not shown) can be compared to determine the relative positions of the outer shaft 520, balloon 580, and/or stent 590 accordingly. Appropriate markings, detents, or other indicators may be provided at the proximal end of the conveyor system 500 on the stabilizing wire (not shown), the outer hub 540, and/or the inner shaft 510 for user reference. For example, such markings, detents, or other indicators may be incrementally spaced to indicate the position of the outer hub 540 relative to the inner shaft 510 to the user. This indication may be correlated with the degree of disengagement of the bracket 590.

When both stent 590 and balloon 580 are partially disengaged via outer shaft 520, the initially exposed portion of balloon 580 can inflate to expand or further expand stent 590. For example, the internal region of the initially exposed portion of balloon 580 can be fluidly connected to port 552 of connector 550 via inner shaft 510. By supplying fluid via port 552, the initially exposed portion of balloon 580 can inflate, thereby expanding or further expanding the initially exposed portion of stent 590. Other portions of stent 590 and/or balloon 580 can remain within outer shaft 520. For example, expansion can be made when outer shaft 520 is locked relative to inner shaft 510 (e.g., using outer shaft hub 540). This locking prevents outer shaft 520 from further retracting in response to forces generated by the expansion of the partially exposed stent 590 and/or balloon 580. Expansion relative to target anatomical structures will be discussed further herein.

Following the initial deployment, additional operations can be performed in subsequent stages of the same process to expand the stent 590. For example, different lengths and/or portions of the stent 590 can be used in subsequent operations. As shown in Figure 28, the outer shaft 520 has been further retracted, and the stent 590 has been further disengaged. When both the stent 590 and the balloon 580 have been more fully disengaged via the outer shaft 520, the more fully exposed portion of the balloon 580 can be inflated, thereby expanding or further expanding the more fully exposed portion of the stent 590, for example via port 552, as described herein. Other portions of the stent 590 and/or the balloon 580 can remain within the outer shaft 520. As described above, inflation can be performed while the outer shaft 520 is locked relative to the inner shaft 510 (e.g., via the outer shaft hub 540) to stabilize the system during the expansion of the balloon 580.

The extent of dislodgement (e.g., further dislodgement) of the stent 590 and/or balloon 580 can again be determined by one or more of a variety of mechanisms, such as those described above regarding the determination of the extent of partial dislodgement.

In some embodiments, the operating length of the stent 590 during the dislodgement, exposure, and/or expansion described above can be different. For example, the operating length can be shorter in the initial stage and longer in subsequent stages. Alternatively, the operating length can be longer in the initial stage and shorter in subsequent stages.

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

Between the initial expansion (e.g., the expansion shown in FIG. 27) and subsequent expansion (e.g., the expansion shown in FIG. 28), the stent 590 and/or balloon 580 may contract, be compressed, and/or at least partially retracted into the outer axis 520. Alternatively, the stent 590 and/or balloon 580 may be further exposed by unlocking the outer axis 520 from the inner axis 510 and allowing the outer axis 520 to retract further in response to forces from the inflated balloon 580.

A transition from initial expansion to subsequent expansion can be performed to adjust the operational length of stent 590, thereby more adequately addressing the target area. For example, the initial operational length of stent 590 can be exposed and expanded. The user can then assess the effectiveness of the operation (e.g., via imaging techniques such as angiography). If the initial operational length of stent 590 is determined to be insufficient, stent 590 and/or balloon 580 can be further exposed to increase the operational length of stent 590. This adjustment can be made as needed until a sufficient operational length is provided. It will be appreciated that the ability to perform such adjustments avoids the need to remove stents found to be unsuitable and replace them with different stents or other devices that provide a sufficient operational length. By eliminating these steps, the overall operation time can be reduced. Furthermore, the user may wish to deploy the device to a length sufficient (e.g., across the target area) rather than a length longer than required (e.g., to avoid operating on areas outside the target area). It will be appreciated that the user can provide a single stent 590 with an adjustable operational length to adequately address a target area with an initially uncertain length, or in cases where the required operational length of the stent is unknown or uncertain. This capability reduces the burden on users to accurately select a device with the correct operating length at the start of operation. Furthermore, the capability described herein reduces the need to provide a large number of devices (offering different performance characteristics), as a single device or a reduced number of devices can operate as described herein to provide the desired wide range of performance characteristics.

A transition from initial to subsequent expansion can be performed to accommodate the varying operational lengths required for different target regions. Between initial and subsequent expansion, the stent 590 and/or balloon 580 can be repositioned to different locations. For example, the stent 590 can be repositioned to align with different target regions. In cases where new target regions have different lengths or other characteristics relative to the initial target region, the operational length of the stent 590 can be selected and/or modified accordingly to adequately address each target region. It will be appreciated that the ability to perform such adjustments avoids the need to remove a stent suitable for the initial target region and replace it with a different stent suitable for different target regions. By eliminating these steps, the overall process time can be reduced, thereby reducing the risks associated with long process times. Furthermore, it should be recognized that although each target region has potentially different requirements for the operational length of the stent 590, the user can provide a single stent 590 with an adjustable operational length to adequately address each different target region. This allows the user greater flexibility and options throughout the process using a single device.

After one or more of the above operations, balloon 580 may deflate. Stent 590 may be maintained in the expanded state for any duration. For example, stent 590 may 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 the deflated balloon without fluid blockage at the treatment site.

Alternatively or additionally, the delivery system 500 can be deployed at multiple locations. The support 590 can be collapsed by moving the outer shaft 520 on the support 590. The support 590 and the balloon 580 can be moved to other target locations, and one or more of the above operations can be repeated.

Alternatively or additionally, the delivery system 500 can be removed. The stent 590 can be collapsed by moving the outer shaft 520 on the stent 590. Components of the delivery system 500 can be removed from the patient by retracting them proximally on the guidewire.

Alternatively or additionally, the stent 590 can be detached from the inner shaft 510 and remain in the patient's body as an implant. After detachment, the other components of the delivery system 500 can be removed from the patient's body by retracting them proximally over the guidewire.

Referring now to Figures 29-32, an example of the delivery system 400 is shown in different configurations for delivering, positioning, deploying, and/or retracting a stent. The operations described with respect to the delivery system 400 can be applied to delivery systems 100, 200, 300, and/or 500. As shown in Figure 29, the delivery system 400 is in a delivery state within a body lumen 710 (e.g., a blood vessel) of a human patient. In this embodiment, the delivery system 400 is configured for intraluminal (e.g., intravascular) delivery through a blood vessel (e.g., the femoral artery) of a human patient. The femoral artery can be accessed by introducing a sheath (e.g., a 5F or 6F) into the lumen of the femoral artery. The delivery system 400 is delivered into the body lumen by guiding the distal portion 410b of the inner sheath on a guidewire and advancing the delivery system 400 distally to the intended location 720 within the blood vessel. In some embodiments, an angioplasty procedure is performed at the intended location 720 before the delivery system 400 advances to the intended location 720.

Once the delivery system 400 is positioned at the desired location 720, the distal portion 420b of the outer sheath retracts proximally to disengage the support 490. In the illustrated embodiment, the body of the support 490 expands at least partially upon disengagement, while the protruding feature 494 collapses. However, the protruding feature 494 may be configured to expand once the distal portion 420b of the outer sheath retracts proximally. In other embodiments, a stabilizing wire (not shown) may advance distally and be secured, for example, held or pinned, or fixed at a desired location to position the support before, during, and/or after the outer sheath retracts proximally to deploy the support. As shown, the distal end 415 of the delivery system 400 is positioned distal to the distal end of the support, and the inner shaft 410 remains positioned within at least a portion of the lumen of the support 190.

In the deployed state, the protruding feature 494 of the stent 490 is configured to expand radially and is further configured to puncture the lumen wall at the intended location once the deployed stent 490 expands to contact the vessel wall (see Figures 29 and 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 stent and other expandable structures are at least partially disengaged from the outer axis, 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 further expand when coupled to an expansion mechanism. Regardless of whether the stent and other expandable structures are self-expanding or expand when coupled to an expandable element, 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.

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

Figure 30 shows a cross-sectional view of a region of the delivery system 400 in its deployed state within a body lumen. As shown in Figure 30, the stent 490 expands within the blood vessel via a balloon 480. To expand the deployed stent 490, the balloon 480 is coupled to an inner shaft 410 and advanced distally into the lumen of the deployed stent 490 until the distal end 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 at other locations within the delivery system 400, or may be omitted from the delivery system 400.

Figure 31 shows a cross-sectional view of a portion of the delivery system 400 in its deployed state, wherein a protruding feature 494 of the stent 490 expands and punctures a portion of the vessel wall. As shown in Figure 31, the balloon 480 deploys and expands radially to engage with the stent 490 and further expand the stent 490 to contact the luminal vessel. As the stent 490 expands, the protruding feature 494 further penetrates into the wall.

Figure 32 shows a cross-sectional view of the delivery system 400 in the treatment state. 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 deflates, the stent 490 remains expanded to contact the lumen wall, and the protrusion 494 remains inserted into the lumen wall. Any medication carried by the protrusion 494 is at least partially released into the body lumen wall in the treatment state. Optionally, the stent 490 can be secured to the balloon 480, for example by crimping the stent 490 to at least partially surround the balloon 480, such that the stent 490 expands and collapses accordingly by inflating and deflating the balloon 480.

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

For such scaffolds and other devices, the materials used to form the frames, struts, and/or protrusions 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 one of a variety of other properties, or combinations thereof. If formed from a material with thermal properties, the material can be activated to deliver heat treatment to the intended treatment site. Regardless of the material, the frames, struts, and/or protrusions can be formed from tubes or wires (e.g., solid wires) using laser cutting or other suitable techniques. When formed from wires, a portion of the wire can be removed by chemical etching or other suitable methods to produce the internal scaffold dimensions.

Stents (such as frames and struts) can be sized and shaped for placement in various body lumens, including blood vessels, without rupturing the vessels. For example, multiple stents and other structures can have radial strength that allows features of the body lumen (e.g., vessel walls) to receive medication without being cut open or damaged. The stents described herein can be sized and shaped to accommodate vessels including: arteries such as coronary arteries, peripheral arteries, carotid arteries, the circle of Willis, anterior cerebral artery, middle cerebral artery, posterior cerebral artery, any type of lenticulostriate artery, renal artery, femoral artery; veins such as cerebral veins, saphenous veins, arteriovenous fistulas; or any other vessels that may include a treatment site. Stents can have a variety of shapes, including cubes, rectangular prisms, cylinders, cones, pyramids, or variations thereof.

Stents and other structures with prominent features can include a variety of sizes (both in a small-profile delivery state and in an expanded, deployed state). These embodiments can provide expansions that can be used in a variety of situations covering a wide range of sizes, such as for treatment and/or prevention of incision. Regardless of shape, stents can have lengths of approximately 0.25 mm, approximately 0.5 mm, approximately 1 mm, approximately 2 mm, approximately 3 mm, approximately 4 mm, approximately 5 mm, approximately 6 mm, approximately 7 mm, approximately 8 mm, approximately 9 mm, approximately 10 mm, approximately 12 mm, approximately 14 mm, approximately 16 mm, approximately 18 mm, approximately 20 mm, approximately 30 mm, approximately 40 mm, approximately 50 mm, approximately 60 mm, approximately 70 mm, approximately 80 mm, approximately 90 mm, or approximately 100 mm. Additionally, supports shaped as cubes, rectangular prisms, or pyramids can have widths of approximately 0.25 mm, 0.5 mm, 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 12 mm, 14 mm, 16 mm, 18 mm, 20 mm, 25 mm, or 30 mm. Furthermore, supports shaped as cylinders or cones can have diameters of approximately 0.25 mm, 0.5 mm, 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 12 mm, 14 mm, 16 mm, 18 mm, 20 mm, 25 mm, 30 mm, 35 mm, 40 mm, or 50 mm. The width or diameter of the support can decrease progressively along its length. In addition, the size and shape of the stent can be configured to prepare the body lumen for certain procedures, such as stent placement.

The expanded support and/or other expandable structure (including expanded protrusions) 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 protrusion can have a length of about 0.1 mm to about 1.5 mm. In some embodiments, the support has a total cross-sectional dimension of about 4 mm, wherein the frame has a cross-sectional dimension of about 2 mm and each protrusion has a length of about 1 mm. In some embodiments, the support has a total cross-sectional dimension of about 6 mm, wherein the frame has a cross-sectional dimension of about 4 mm and each protrusion has a length of about 1 mm. In other embodiments, the protrusions can have multiple lengths, such that the lengths of the protrusions of the support or other expandable structure are different. For example, the support may include protrusions with lengths of about 0.2 mm, about 0.5 mm, and about 1 mm.

The profile of a stent or other structure can be sized to be compatible with various catheter sizes. Embodiments of the present technology may include stents or other structures designed to receive guidewires (e.g., guidewires with dimensions of 0.010, 0.014, 0.018, 0.035, or 0.038 inches). In several embodiments, the stent or framework structure may be sized and designed for delivery via a microcatheter through which the stent or framework structure is pushed. In some embodiments, the stent or structure may be integrated into a delivery system, including modular or single-unit delivery systems.

The stents and other structures described herein may include markings for visualizing the stent within a body lumen, such as one or more radiopaque markings. Radiopaque markings may be formed from Clearfil Photo Core tantalum, titanium, tungsten, barium sulfate, and zirconium oxide, or other suitable radiopaque markings. These markings may be formed on the proximal, distal, intermediate, or combined portions of the stent. These markings may be in one or more portions of a tube incorporated into the stent, or as tapes, coils, clips, or combinations thereof plated onto one or more portions of the stent. Regardless of the type of marking, the markings may be cast, forged, covered, or wrapped along any portion of the stent, or cast, forged, covered, or wrapped on any portion of the stent.

Scaffolds and other structures can be flexible enough to traverse various anatomical features, including those with a degree of curvature. This flexibility can be provided by the materials that form them. Furthermore, flexibility can be provided by fracturing one or more components that engage with and extend between two or more rows of struts. Additionally, scaffolds or other structures can be easily deployed and expanded, as well as retracted and contracted. Scaffolds or other structures can also be easily repositioned within blood vessels or other body lumens.

In several embodiments, a drug-eluting compound is coated onto at least a portion of the balloon, frame, strut, and/or protruding feature. This coating can be any suitable coating known to those skilled in the art for delivering a drug to the wall. For example, suitable coatings include, but are not limited to, snow coatings or crystalline coatings having edges configured to remain within the wall. The drug-eluting compound can be a synthetic polymer or biopolymer coated in various patterns and thicknesses to suit delivery of the contained drug. In other embodiments, the protruding feature itself can be composed of a drug-eluting material. The drug carried by the protruding feature and/or drug-eluting compound according to the present technology can be any drug suitable for treating the treatment site where the stent will be placed, and the drug may or may not include excipients. For example, the drug can be an antiproliferative agent, an antitumor agent, a migration inhibitor, a healing-enhancing factor, an immunosuppressant, an antithrombotic agent, a blood thinner, or a radioactive compound. Examples of antitumor agents include, but are not limited to, sirolimus, tacrolimus, everolimus, leflunomide, M-prednisolone, dexamethasone, cyclosporine, mycophenolate mofetil, imidazolidin, interferon, and tranilast. Examples of antiproliferative agents include, but are not limited to, paclitaxel, actinomycin, methotrexate, angiotensin, vincristine, mitmycine, statins, c-myc antisense, Abbott ABT-578, RestinASE, 2-chlorodeoxyadenosine, and PCNA ribozymes. Examples of migration inhibitors include, but are not limited to, batimistat, prolylhydrosylase, halofunginone, C-preprotein 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 elution compound and/or protrusion may carry more than one drug.

In some embodiments, a prominent feature may include a textured (e.g., ribbed) surface for providing a larger surface area for drug delivery. Furthermore, any prominent feature may include a textured surface, such as a ribbed surface (perpendicular to, horizontal to, radial to, or circular relative to the longitudinal plane of the prominent feature), a crosshair surface, an isotropic surface, or other surface types suitable for providing a larger surface area for drug delivery.

The size and shape of the protruding feature can be designed to engage and/or penetrate occlusions, neointimacy, intima, internal elastic lamina (IEL), media, external elastic lamina (EEL), adventitia, or combinations thereof. The size and shape of the protruding feature can be designed to engage and/or penetrate tissue and/or structures adjacent to the body lumen where the stent will be placed, without rupturing the lumen. For example, the stent may include: a square protruding feature sized and configured to penetrate the intima and/or media of the body lumen; a pointed protruding feature sized and configured to penetrate and extend into the media and/or IEL. Furthermore, the protruding feature can be configured to bend relative to the longitudinal axis of the stent in one or more directions to engage and/or penetrate a portion of the body lumen described herein. In several embodiments, the protruding feature can penetrate deeper into the wall of a diseased body lumen (e.g., a blood vessel) compared to a stent without a protruding feature. Furthermore, the stent can allow blood flow even in an dilated position and in the event of drug elution.

Compared to possible approaches via angioplasty balloons or other existing devices, the various protrusions described herein can deliver drugs deeper into the vessel wall. In addition to carrying one or more drugs for site-specific treatment, the protrusions may also carry molecules suitable for degrading occlusions, neointima, and/or a portion of the intima, allowing the protrusions to penetrate deeper into the vessel wall compared to the absence of said 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 sulfatases, hyaluronidases, lysyl oxidases, lysyl hydroxylases, or combinations thereof.

Furthermore, it should be understood that a stent may carry one or more protruding features on one or more portions of the stent. For example, a stent may carry approximately 5 protruding features, approximately 10 protruding features, approximately 15 protruding features, approximately 20 protruding features, approximately 30 protruding features, approximately 40 protruding features, approximately 50 protruding features, approximately 60 protruding features, approximately 70 protruding features, approximately 80 protruding features, approximately 90 protruding features, or approximately 100 protruding features. The protruding features may be carried by a frame, struts, or a combination thereof. The number of protruding features may vary depending on, for example, the target treatment site, the type of drug being delivered, and the size of the stent. Furthermore, the protruding features carried by the stent may be of the different types disclosed herein.

In some embodiments, once positioned against a body lumen wall (e.g., a blood vessel wall), tissue and/or fluid can interact with the protrusion to dissolve the drug and selectively release it from the reservoir. In other embodiments, the protrusion can be configured to deliver the drug via multiple mechanisms during stent expansion. Therefore, the protrusion is intended to provide an effective means of selectively delivering the drug to the desired site while minimizing unintentional loss or release of the drug. In other embodiments, the stent may include more than one protrusion, or include protrusions with more than one reservoir. In several embodiments, a stent including a protrusion may allow the protrusion (e.g., a coating or reservoir) to be concealed (e.g., recessed) before the stent is positioned at the treatment site. Once positioned at the target site, the protrusion may be exposed during and/or after stent expansion (e.g., expansion/protrusion, etc.). This is intended to minimize any loss of the drug carried by the protrusion during delivery to the treatment site.

In some embodiments, the stent may further comprise a material (e.g., PTFE, Dacron, polyamides such as nylon and/or polyurethane-based materials, silicone, etc.) positioned on the stent, framework, or other structure having protruding features covering at least a portion of the outer surface area. In some embodiments, the material covers the entire outer surface area. The material may be a mesh or braid. In some embodiments, the material may be configured to increase the surface area of the stent to provide additional surface area for coating the drug. In other embodiments, the material may also be configured to allow blood flow through the inner diameter of the stent and/or restrict blood flow to the outer dimensions of the stent. In further embodiments, the material may form a barrier between fluid flow (e.g., blood flow) and the drug delivery site. Furthermore, the material may be configured to prevent debris from the walls of body lumens from entering the bloodstream. In such embodiments, associated systems and devices may be used to tacking areas that may have been perforated or temporarily opened during the procedure.

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

The systems disclosed herein can be provided for the adjustment, retraction, and/or re-deployment of associated stents or other structures, and/or the deployment of different stents or other structures, thereby allowing physicians to treat the intended area more effectively, accurately, and prudently. In several embodiments, a stent or other delivery structure can be deployed temporarily for a period of time (e.g., less than 24 hours) and then retracted and removed. In these embodiments, protruding features can engage and/or puncture the lumen wall and remain in the lumen wall after removal of the stent or other delivery structure, or can be retracted and removed together with the stent or other delivery structure. The stent can be configured to self-expand or partially self-expand when deployed from the delivery system, and can also be configured to further expand within the body lumen as the balloon expands within the body lumen. The stent can also be configured to post-expand when removed from the body lumen. In other embodiments, a stent or other delivery structure can be deployed temporarily for a longer period of time (e.g., less than 2 weeks, less than 1 month, less than 6 months, less than 1 year) and then retracted and removed. In some embodiments, different stents or delivery structures can be deployed after the first stent or delivery structure has been retracted and removed. The duration of deployment, and the duration after removal but before the deployment of the different supports or transport structures, can range from minutes to hours, days, weeks, months, or years. In these embodiments, the removal of the first support or transport structure and the deployment of the different supports or transport structures can occur once, twice, three times, four times, five times, six times, seven times, eight times, nine times, or ten times. Furthermore, the embodiments described herein can allow for a system with a smaller profile compared to currently available systems.

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

While 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 pierce a portion of a body lumen or blood vessel. For example, the spikes may pierce the blood vessel wall, thereby reducing and/or eliminating the elasticity of the blood vessel wall. In these embodiments, the protruding members may be configured to prevent the blood vessel wall from advancing inward toward the body lumen and to restrict and/or constrain flow therein. The protruding members may be integrally formed with the strut or disposed on the surface of the strut, extending radially outward from the strut toward the target tissue.

For convenience, various examples of aspects of this disclosure are described below as items. These are provided by way of example and do not limit the technical subject matter.

Item A: A delivery system comprising: an outer shaft; an inner shaft slidably disposed within the outer shaft and including an inflatable balloon; a guidewire slidably disposed within the inner shaft; and a support surrounding the balloon and fixedly connected to the inner shaft.

Item B: A method for delivering a stent within a patient's body lumen, the method comprising: delivering an outer shaft encompassing an inner shaft and a stent to a target treatment site within the patient's body lumen, the stent being disposed around and securely coupled to the inner shaft via a balloon; retracting the outer shaft proximally 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.

Item C: A delivery system comprising: an outer shaft; an inner shaft slidably disposed within the outer shaft and including an inflatable balloon on a distal portion of the inner shaft; a guidewire slidably disposed within the inner shaft; and a support slidably disposed within the outer shaft and on a proximal portion of the inner shaft near the balloon, the support being connected to a stabilizing wire slidably disposed within the outer shaft.

Item D: A method for delivering a stent within a patient's body lumen, the method comprising: delivering an outer shaft encompassing an inner shaft and a stent to a target treatment site within the patient's body lumen, the stent being slidably disposed within the outer shaft and on a proximal portion of a balloon near the inner shaft; retracting the outer shaft proximally to at least partially dislodge the stent and 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 inflating the balloon; and piercing a portion of the wall of the body lumen with one or more protruding features of the stent.

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 guidewire slidably disposed within the inner shaft; and a support slidably disposed within the outer shaft and on a distal portion of the inner shaft remote from the balloon, the support being connected to a stabilizing wire slidably disposed within the outer shaft.

Item F: A method for delivering a stent within a patient's body lumen, the method comprising: delivering an outer shaft encompassing an inner shaft and a stent to a target treatment site within the patient's body lumen, the stent being slidably disposed within the outer shaft and on a distal portion of a balloon on the inner shaft distal to the inner shaft; retracting the outer shaft proximally to at least partially dislodge the stent and 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 inflating the balloon; and piercing a portion of the wall of the body lumen with one or more protruding features of the stent.

Item G: A method for delivering a stent within a patient's body lumen, the method comprising: delivering an outer shaft encompassing an inner shaft and a stent to a target treatment site within the patient's body lumen, the stent being disposed around and securely coupled to the inner shaft via a balloon; retracting the outer shaft proximally to partially dislodge the stent; radially expanding a first length of the stent to an expanded state by inflating the balloon, while a portion of the stent remains within the outer shaft until one or more protruding features of the stent pierce a first portion of the wall of the body lumen; retracting the outer shaft proximally to further dislodge the stent; and radially expanding a second length of the stent to an expanded state by inflating the balloon until one or more protruding features of the stent pierce a second portion of the wall of the body lumen.

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 items below may be combined with each other in any way and placed into the corresponding independent items, such as items A, B, C, D, E, F, or G.

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

Item 2: Markings with increasing intervals are present on the proximal portion of the inner shaft, wherein the outer shaft hub can slide along the proximal portion on the inner shaft.

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

Item 4: The balloon can be inflated through the lumen containing the guidewire within the inner shaft.

Item 5: Reinforce the radial positioning of the wire between the inner and outer shafts.

Item 6: The support includes: a radially expandable columnar frame including struts; and a protruding feature carried by one or more struts.

Item 7: The bracket is fixedly connected to the inner shaft by an anchoring portion that extends around at least a portion of the inner shaft.

Item 8: The anchoring portion is connected to the inner shaft on the proximal side of the balloon.

Item 9: The balloon comprises multiple segments at different axial positions along a certain length of the inner axis, each of which can be inflated independently.

Item 10: To inflate the balloon; to advance the outer axis on the stent; and to remove the stent from the body lumen.

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 fluid communication with the balloon; and an outer shaft hub is located at the proximal end of the outer shaft, through which the inner shaft and stabilizing wire extend.

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 axis proximally to further dislodge the stent.

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

Item 14: Before retracting the outer axis proximally to further dislodge the stent, inflate the balloon and re-insert the stent.

Item 15: Lock the outer shaft relative to the inner shaft before the first length of the radially expanded support.

Item 16: Lock the outer shaft relative to the inner shaft before the second length of the radially expanding bracket.

Unless otherwise stated, mentioning an element in the singular does not mean "one and only one," but rather "one or more." For example, a "one" module can refer to one or more modules. Without further restriction, an element beginning with "a," "an," "the," or "the" does not preclude the presence of additional identical elements.

Titles and subtitles (if any) are used for convenience only and do not limit the invention. The word "exemplary" is used to indicate that it is used as an example or illustration. When the terms "comprising," "having," etc., are used, such terms are intended to be inclusive in a manner similar to how "comprising" is interpreted when used as a transition word in the claims. Related terms such as "first" and "second" can be used to distinguish one entity or action from another without necessarily requiring or implying any actual such relationship or order between these entities or actions.

The terms such as aspect, that aspect, on the other hand, some aspects, one or more aspects, implementation, that implementation, another implementation, some implementations, one or more implementations, embodiment, that embodiment, another embodiment, some embodiments, construction, that construction, another construction, some constructions, one or more constructions, subject matter, disclosure, this disclosure, other variations thereof, etc., are for convenience and do not imply that the disclosure associated with such terms is necessary for the subject matter or that such disclosure applies to all configurations of the subject matter. Disclosures associated with such terms may apply to all configurations, or one or more of the terms. Disclosures associated with such terms may provide one or more examples. Terms such as aspect or some aspects may refer to one or more aspects, and vice versa, and this similarly applies to other foregoing terms.

The phrase "at least one" preceding a series of items (separating any item from the terms "and" or "or") modifies the entire list, not each member of the list. The phrase "at least one" does not require the selection of at least one item; rather, it allows for the inclusion of at least one of any of the items, and/or at least one of any combination of items, and/or at least one of each item. 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.

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

In one respect, the term "linkage" can refer to a direct connection. In another respect, the term "linkage" can refer to an indirect connection.

Terms such as top, bottom, front, back, side, horizontal, and vertical refer to arbitrary frames of reference, not ordinary gravitational frames of reference. Therefore, such terms can extend upward, downward, diagonally, or horizontally within a gravitational frame of reference.

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

All structural and functional equivalents of elements throughout the various aspects described herein, which are known or will be known hereafter by one of ordinary skill in the art, are expressly incorporated herein by reference and are intended to be included in the claims. Furthermore, nothing disclosed herein is intended to be contributed to the public, whether or not such disclosure is expressly stated in the claims. No element of any claim shall be interpreted based on the provisions of paragraph 6 of 35 U.S.C. § 112 unless the element is expressly stated using the phrase “means for…” or, in the case of a method claim, using the phrase “step for…”.

The title, background art, description of the drawings, abstract, and figures are incorporated herein by reference and are provided as illustrative examples rather than as limiting descriptions. It should be understood that they are not intended to limit the scope or meaning of the claims. Furthermore, as can be seen in the detailed description, illustrative examples are provided, and features are combined in various implementations to simplify the disclosure. The disclosed methods should not be construed as reflecting an intention to require more features than expressly stated in each claim. Rather, as reflected in the claims, the inventive subject matter lies in fewer features than those required in a single disclosure of construction or operation. The claims are thus incorporated into the detailed description, wherein each claim exists independently as a separately claimed subject matter.

The claims are not intended to be limited to the aspects described herein, but rather to encompass the full scope consistent with the language of the claims and to include all legal equivalents. Nevertheless, no claim is intended to include subject matter that does not meet the requirements of the applicable patent law, nor should they be interpreted in this manner.

Claims (20)

1. A system comprising: outer shaft; An inner shaft, slidably disposed within the outer shaft and including an inflatable balloon on the inner shaft, wherein the inflatable balloon comprises a plurality of segments at different axial positions along the length of the inner shaft, the plurality of segments being capable of independently inflating; and A bracket, which is slidably disposed within the outer shaft and extends about a portion of the inner shaft. 2. The system of claim 1, further comprising a stabilizing wire slidably disposed within the outer shaft, wherein the support is fixedly coupled to the stabilizing wire by an anchoring portion extending around at least a portion of the stabilizing wire. 3. The system of claim 1, wherein the support is fixedly coupled to the inner shaft by an anchoring portion, the anchoring portion being connected to the proximal end of the support and extending around at least another portion of the inner shaft. 4. The system of claim 1, wherein the support comprises: Including a radially expandable columnar frame with supports; and A prominent feature carried by one or more pillars. 5. The system of claim 1, further comprising a reinforcing wire radially positioned 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 comprising: outer shaft; An inner shaft, which is slidably disposed within the outer shaft and includes an inflatable balloon on the inner shaft; A guidewire, slidably disposed within the lumen of the inner shaft, wherein the inflatable balloon expands through the lumen of the inner shaft containing the guidewire; and The bracket is slidably disposed within the outer shaft and extends about a portion of the inner shaft. 8. The system of claim 7, further comprising a stabilizing wire slidably disposed within the outer shaft, wherein the support is fixedly coupled to the stabilizing wire by an anchoring portion extending around at least a portion of the stabilizing wire. 9. The system of claim 7, wherein the support is fixedly coupled to the inner shaft by an anchoring portion connected to the proximal end of the support and extending around at least another portion of the inner shaft. 10. The system of claim 7, wherein the support comprises: Including a radially expandable columnar frame with supports; and A prominent feature carried by one or more pillars. 11. The system of claim 7, further comprising a reinforcing wire radially positioned between the inner shaft and the outer shaft. 12. A system comprising: outer shaft; An inner shaft, slidably disposed within the outer shaft and comprising an inflatable balloon on the inner shaft; and A stent, slidably disposed within the outer axis and extending about a first portion of the inner axis, the stent being fixedly coupled to the inner axis by an anchoring portion connected to the proximal end of the stent and extending about a second portion of the inner axis near the inflatable balloon. 13. The system of claim 12, wherein the support comprises: Including a radially expandable columnar frame with supports; and A prominent feature carried by one or more pillars. 14. The system of claim 12, further comprising a reinforcing wire radially positioned between the inner shaft and the outer shaft. 15. The system of claim 12, further comprising a guide wire slidably disposed within the lumen of the inner shaft. 16. A system comprising: outer shaft; An inner shaft, which is slidably disposed within the outer shaft and includes an inflatable balloon on the inner shaft; A bracket, which is slidably disposed within the outer shaft and extends about a portion of the inner shaft; A stabilizing filament, slidably disposed within the outer shaft, wherein the support is fixedly connected to the stabilizing filament; and A reinforcing wire is radially positioned between the inner shaft and the outer shaft. 17. The system of claim 16, wherein the support is fixedly connected to the stabilizing wire by an anchoring portion extending around at least a portion of the stabilizing wire. 18. The system of claim 16, wherein the support is fixedly coupled to the inner shaft by an anchoring portion connected to the proximal end of the support and extending around at least another portion of the inner shaft. 19. The system of claim 16, wherein the support comprises: Including a radially expandable columnar frame with supports; and A prominent 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.