Stent delivery system with stent restraining structure

Abstract

An assembly for endoscope stent delivery includes a stent delivery device and a mating stent loaded therein. The stent delivery device includes an outer tubular member, an inner member slidably disposed within a lumen of the outer tubular member, and a distal tip disposed at a distal end of the inner member. A self-expanding stent is positioned in a compressed configuration within the outer tubular member with one or more suture loops constraining at least a portion of the stent. Upon deployment of the stent from the stent delivery device, the suture is withdrawn proximally to allow the one or more suture loops to spread apart.

Description

Cross-reference to related applications

[0001] This application claims priority to U.S. Provisional Patent Application Serial No. 63 / 621,400, filed January 16, 2024, the disclosure of which is incorporated herein by reference. Technical Field

[0002] This disclosure relates to medical devices, and more particularly, to stent delivery systems including stent restraint structures configured to apply radial restraint to a portion of a stent. Background Technology

[0003] Various medical devices have been developed for medical applications, including those for delivering stents. These devices can be used at multiple sites and can be manufactured and used using a variety of different methods. The accuracy of stent deployment has been found challenging because, in many cases, once deployed, the stent fails to be correctly positioned across the treatment site. Therefore, there is a continued need for alternative stent delivery devices and alternative methods for manufacturing and using these devices to control stent deployment across treatment sites. Summary of the Invention

[0004] This disclosure provides designs, materials, manufacturing methods, and alternatives for using support delivery systems.

[0005] One example is a stent delivery system. The system includes: an outer tubular member having a proximal end, a distal end, and a cavity extending to the distal end; an inner member slidably disposed within the cavity of the outer tubular member; and a distal tip disposed at the distal end of the inner member. The system also includes a self-expanding stent having a proximal end, a distal end, and a cavity extending therethrough. The self-expanding stent is capable of expanding from a radially compressed configuration to a radially expanded configuration. A suture array is disposed around at least a portion of the self-expanding stent. In the radially compressed configuration, the self-expanding stent is disposed between the outer surface of the inner member and the inner surface of the outer tubular member. The self-expanding stent expands radially when the outer tubular member is retracted proximally. In the expanded configuration, at least a portion of the self-expanded stent is radially constrained by the suture array.

[0006] As an alternative to or supplement to any example in this article, the suture array includes one or more suture loops and a release knot connected to the release suture.

[0007] As an alternative to or supplement to any of the examples in this article, the release suture extends longitudinally through the cavity of the outer tubular member.

[0008] As an alternative to or supplement to any example in this article, the release suture further includes a release handle extending from the proximal end of the outer tubular member.

[0009] As an alternative to or supplement to any of the examples in this article, when the release handle is withdrawn in the proximal direction, the release knot is untied and the suture array is unfurled.

[0010] As an alternative to or supplement to any of the examples in this article, the release handle includes a stitched loop configured to allow the user to hold the release handle.

[0011] As an alternative to or supplement to any of the examples in this article, the release knot is located at the proximal end of the suture array.

[0012] As an alternative to or supplement to any of the examples in this article, the release knot is located at the distal end of the suture array.

[0013] As an alternative to or supplement to any of the examples in this article, the suture array is arranged around the central region of the self-expanding stent.

[0014] As an alternative to or supplement to any of the examples in this article, the proximal region of the self-expanding stent does not contain a suture array, and the distal region of the self-expanding stent does not contain a suture array.

[0015] As an alternative or supplement to any example in this article, when the outer tubular member is retracted proximally, the proximal region of the expandable stent radially expands to the expansion structure and the distal region of the expandable stent radially expands to the expansion structure, while the intermediate region of the expanded stent remains radially constrained by the suture array.

[0016] As an alternative to or supplement to any of the examples in this article, the self-expanding stent further includes a coating disposed around at least a portion of the stent.

[0017] As an alternative to or supplement to any of the examples in this article, when in an expansion configuration, at least a portion of the self-expanding support is radially constrained by the coating.

[0018] As an alternative to or supplement to any of the examples in this article, the coating is a soluble coating.

[0019] Another example is a stent delivery system. The system includes: an outer tubular member having a proximal end, a distal end, and a cavity extending to the distal end; an inner member slidably disposed within the cavity of the outer tubular member; and a distal tip disposed at the distal end of the inner member. The system also includes a self-expanding stent having a proximal end, a distal end, and a cavity extending therethrough. The self-expanding stent is capable of expanding from a radially compressed configuration to a radially expanded configuration. A stent restraint member is disposed around a portion of the self-expanding stent. The outer tubular member is axially movable relative to the inner member between a delivery configuration and a deployment configuration. In the delivery configuration, the outer tubular member surrounds the self-expanding stent such that the self-expanding stent is restrained between the outer surface of the inner member and the inner surface of the outer tubular member. In the deployment configuration, the outer tubular member is retracted to the proximal side of the self-expanding stent, while a portion of the self-expanding stent remains restrained in the radially compressed configuration by the stent restraint member.

[0020] As an alternative to or supplement to any example in this article, the stent restraint member includes an array of sutures wrapped around a portion of the self-expanding stent.

[0021] As an alternative to or supplement to any of the examples in this document, the stent restraint member includes a polymer cover surrounding a portion of the self-expanding stent, the polymer cover being configured to delay the expansion of that portion of the self-expanding stent.

[0022] Another example is a stent delivery system. The system includes an outer tubular member having a proximal end, a distal end, and a cavity extending to the distal end. An inner member is slidably disposed within the cavity of the outer tubular member. A distal tip is disposed at the distal end of the inner member. A self-expanding stent can be positioned around the distal region of the inner member, proximal to the distal tip. The self-expanding stent has a proximal end, a distal end, and a cavity extending therethrough. The self-expanding stent can expand from a radially compressed configuration to a radially expanded configuration. A suture array is disposed around the intermediate region of the self-expanding stent. When the self-expanding stent is disposed between the outer surface of the inner member and the inner surface of the outer tubular member, the self-expanding stent is constrained in the radially compressed configuration. When the outer tubular member is retracted proximally, the proximal region of the self-expanding stent expands radially and the distal region of the self-expanding stent expands radially, while the intermediate region of the self-expanding stent remains constrained in the radially compressed configuration by the suture array.

[0023] Another example is a method for deploying a stent across a narrowing within a body cavity. The method includes: advancing a stent delivery catheter through the body cavity such that a self-expanding stent disposed within an outer tubular member of the stent delivery catheter crosses the narrowing; and subsequently, retracting the outer tubular member proximally relative to the self-expanding stent such that the distal region of the self-expanding stent expands radially distally to the narrowing, and the proximal region of the self-expanding stent expands radially proximal to the narrowing, while the intermediate region of the self-expanding stent remains radially constrained by an array of sutures. The suture array is then released to allow the intermediate region of the self-expanding stent to expand radially across the narrowing.

[0024] As an alternative to or supplement to any of the examples in this article, the method includes pulling the release suture proximally to untie the release knot, thereby releasing the suture array.

[0025] As an alternative to or supplement to any of the examples in this article, the intermediate region of the self-expanding stent is positioned within the stenotic area before the outer tubular member is retracted proximally relative to the self-expanding stent.

[0026] The above overview of some embodiments, aspects, and / or examples is not intended to describe every embodiment or implementation of this disclosure. These embodiments are illustrated more specifically in the following figures and detailed description. Attached Figure Description

[0027] This disclosure can be more fully understood by considering the following detailed description of several embodiments in conjunction with the accompanying drawings, in which:

[0028] Figure 1 A perspective view of one embodiment of the support conveying system is shown;

[0029] Figures 2A-2D This illustrates the shortening phenomenon that occurs when a stent is deployed from a conventional stent delivery catheter.

[0030] Figure 3 A support delivery system including a support constraint structure is shown.

[0031] Figures 4A-4D This illustrates several aspects of deploying supports using a support delivery system with a support constraint structure.

[0032] Figure 5 Another support delivery system including a support constraint structure is shown.

[0033] Figures 6A-6B This illustrates several aspects of the deployment of a stent with a scaffold constraint structure within a body cavity.

[0034] While various aspects of this disclosure are adaptable to numerous modifications and alternatives, their specific details have been illustrated by way of example in the accompanying drawings and will be described in detail. However, it should be understood that this disclosure is not intended to limit its aspects to specific embodiments. Rather, it is intended to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention. Detailed Implementation

[0035] The following definitions shall apply to the use of the terms, unless otherwise defined in the claims or elsewhere in this specification.

[0036] Whether explicitly stated or not, all numerical values ​​herein are assumed to be modifiable by the term "about". In the context of numerical values, the term "about" generally refers to a range of numerical values ​​that a person skilled in the art would consider equivalent to the referenced value (e.g., having the same function or result). In many cases, the term "about" may include numbers rounded to the nearest significant figure. Unless otherwise specified, the term "about" (e.g., in contexts other than numerical values) may be assumed to have its common and customary definition, as understood and consistent with the context of this specification.

[0037] References to numerical ranges indicated by endpoints include all numbers within that range, including the endpoint (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5). While some suitable dimensions, ranges, and / or values ​​for various components, characteristics, and / or specifications are disclosed, it will be understood by those skilled in the art as per this disclosure that desired dimensions, ranges, and / or values ​​may differ from those explicitly disclosed.

[0038] The singular forms “a,” “an,” and “the” used in this specification and the appended claims include plural references unless expressly stated otherwise in the text. The term “or” as used in this specification and the appended claims is generally used to include the meaning of “and / or” unless expressly stated otherwise in the text. It should be noted that, for ease of understanding, certain features of this disclosure may be described in the singular, even if those features may be plural or repeated in the disclosed embodiments. Each instance of a feature may include and / or contain the singular disclosure unless expressly stated otherwise. For simplicity and clarity, not all elements of this disclosure need to be shown in every figure or discussed in detail below. However, it will be understood that, unless expressly stated otherwise, the following discussion applies equally to any and / or all of more than one component. Additionally, for clarity, not all instances of some elements or features may not be shown in each figure.

[0039] Relative terms, such as “proximal,” “distal,” “advance,” “retract,” and variations thereof, can generally be considered in relation to the positioning, orientation, and / or operation of various elements relative to the user / operator / manipulator of the device, wherein “proximal” and “retract” indicate or refer to being closer to or towards the user, and “distal” and “advance” indicate or refer to being farther from or away from the user. In some instances, the terms “proximal” and “distal” may be arbitrarily assigned to facilitate understanding of this disclosure, and such instances will be obvious to those skilled in the art. Other related terms, such as “upstream,” “downstream,” “inflow,” and “outflow,” refer to the direction of fluid flow within a cavity, such as a body cavity, blood vessel, or device.

[0040] The term "extent" can be understood as the maximum measured value of an identified dimension, unless the extent and dimension in question are preceded by "minimum" or identified as "minimum," in which case it can be understood as the minimum measured value representing the identified dimension. For example, "outer extent" can be understood as the maximum outer dimension, "radial extent" as the maximum radial dimension, "longitudinal extent" as the maximum longitudinal dimension, and so on. Each instance of "extent" can be different (e.g., axial, longitudinal, lateral, radial, circumferential, etc.) and will become apparent to a person skilled in the art depending on the context of its individual use. Generally, "extent" can be considered as the maximum possible dimension measured according to its intended use, while "minimum extent" can be considered as the minimum possible dimension measured according to its intended use. In some instances, "extent" can typically be measured orthogonally in a plane and / or cross-section, but as will be apparent from the specific context, it can also be measured differently, such as, but not limited to, angularly, radially, circumferentially (e.g., along an arc), etc. Additionally, the term "substantially" when used to refer to two sizes being "substantially the same" generally means that the difference is less than or equal to 5%.

[0041] The terms "integral" and "monolithic" should generally refer to one or more elements made or composed of a single structural or basic unit / element. Integral and / or monolithic elements should exclude structures and / or features resulting from assembling or otherwise combining multiple discrete elements.

[0042] It should be noted that the embodiments described by references to "one embodiment," "some embodiments," "other embodiments," etc., in the specification may include specific features, structures, or characteristics, but each embodiment may not necessarily include that specific feature, structure, or characteristic. Furthermore, such phrases do not necessarily refer to the same embodiment. In addition, when a specific feature, structure, or characteristic is described in conjunction with an embodiment, whether or not it is explicitly described, implementing such a feature, structure, or characteristic in conjunction with other embodiments is within the knowledge of those skilled in the art, unless the contrary is explicitly stated. That is, even if not explicitly shown in a specific combination, the various individual elements described below are still considered to be combinable or arranged with each other to form other additional embodiments or supplementary and / or enriching embodiments, as will be understood by those skilled in the art.

[0043] For clarity, a distinctive numerical designation (e.g., first, second, third, fourth, etc.) may be used throughout the specification and / or claims to name and / or distinguish various described and / or claimed features. It should be understood that the numerical designation is not intended to be limiting and is merely exemplary. In some embodiments, for brevity and clarity, the numerical designation may be modified and deviated from previously used. That is, a feature identified as a “first” element may later be referred to as a “second” element, a “third” element, etc., or may be omitted entirely, and / or different features may be referred to as a “first” element. The meaning and / or name in each case will be obvious to those skilled in the art.

[0044] The following description should be read with reference to the accompanying drawings (which are not necessarily drawn to scale), in which similar elements have the same numbering in different drawings. The detailed description and drawings are intended to be illustrative and not to limit the scope of this disclosure. Those skilled in the art will recognize that the various elements described and / or shown can be arranged in various combinations and configurations without departing from the scope of this disclosure. The detailed description and drawings illustrate exemplary embodiments of this disclosure. However, for purposes of clarity and ease of understanding, although not every feature and / or element may be shown in every drawing, features and / or elements may be understood to be present unless otherwise stated.

[0045] Referring to the attached diagram, Figure 1 A perspective view of a stent delivery system 10 according to one embodiment of the present disclosure is shown. The stent delivery system 10 may include a stent delivery device 15 having a stent 20 loaded therein for delivery to an anatomical site. Figure 1As shown, the stent 20 is loaded within an outer sheath 30, which may be attached to or become part of an outer tubular member 60 extending proximally to a distal handle 69. In some cases, the outer sheath 30 may be formed separately from the outer tubular member 60 and secured thereto at a connection joint 62. In other cases, the outer sheath 30 may be the distal region of the outer tubular member 60, sized to surround the compressed stent 20 prior to deployment. The stent delivery conduit 15 may include an inner member 50 slidably disposed within the lumen of the outer tubular member 60. A distal tip 40 may be secured to or otherwise coupled to the distal end of the inner member 50. The distal tip 40 may have a distal end 12 at the distal end of the stent delivery device 15. The inner member 50 may extend through the outer tubular member 60, with the proximal region of the inner member 50 secured to a proximal handle 80. The proximal handle 80 may be located proximal to the distal handle 69, such that the distal handle 69 may be axially translated relative to the proximal handle 80, thereby longitudinally actuating the outer sheath 60 relative to the support 20 and the inner member 50, and thereby deploying the support 20. It should be noted that when the support 20 is radially constrained around the inner member 50 and loaded in the outer sheath 30 for delivery, the distal end of the outer sheath 30 may adjoin and / or surround the proximal region of the distal tip 40. While many aspects of this disclosure are applicable to the delivery of numerous intracavitary devices, its use for delivering a self-expanding support 20 will be described.

[0046] During delivery, the stent 20 is typically radially compressed and longitudinally extended within the outer sheath 30 to implant it into the body cavity. The degree of elongation can vary considerably depending on the stent's structure and intended function. The stent 20 may be configured to self-expand upon release from its radially compressed state (e.g., when radial restraints are removed from the stent by withdrawing the outer sheath 30 from it). Furthermore, in some cases, the stent 20 may be repositionable, removable, and / or re-restrained. In some cases, the stent 20 may comprise one or more interwoven metal wires or filaments, forming a braided, knitted, or other interwoven structure. In other cases, the stent 20 may be an integral structure comprising a plurality of interconnected struts and the space between them. Thus, a variety of stent types and structures can be employed, and the stent delivery system 10 can be configured to accommodate stents of various sizes and configurations.

[0047] like Figures 2A-2D As shown, traditional support system delivery systems are prone to support shortening during deployment. For example... Figure 2AAs shown, during delivery (e.g., via guidewire 90), the stent can be positioned in a radially constrained, longitudinally elongated configuration within the distal region of the outer tubular member 60 (e.g., within the outer sheath 30), such that the radially constrained stent tightly surrounds the inner member 50. In the radially constrained configuration, the distal end 32 of the stent is located adjacent to the distal tip 40. The distal end of the outer sheath 30 may adjoin and / or surround the proximal region of the distal tip 40. The stent delivery catheter can be advanced through the body cavity 82 such that the radially constrained stent 20 is positioned across the narrow portion 84. Therefore, the distal region 32 of the constrained stent 32 may be located distal to the narrow portion 84, and the proximal region 34 of the constrained stent 32 may be located proximal to the narrow portion 84. The outer tubular member 60 (along with the outer sheath 30) retracts proximally relative to the inner member 50, the distal tip 40, and the stent, moving the distal end of the outer sheath 30 to the proximal side of the distal tip 40, thereby exposing the distal region 32 of the stent 20. Figure 2B As shown, when the outer sheath 30 retracts proximally, the exposed distal region 32 of the stent 20 is released from the radial constraint structure. As the exposed distal region 32 of the stent 20 begins to expand radially, it also begins to shorten proximally. In other words, as the distal region 32 of the stent 20 is deployed, it moves proximally away from the distal tip 40. The middle region 36 of the stent 20 also begins to move proximally away from the distal tip 40. Further proximal retraction of the outer sheath 30 further deploys additional length of the stent 20, thereby causing radial expansion as the additional length of the stent 20 is exposed, as... Figure 2C As shown, with the increase in the exposed length of stent 20, the amount of shortening of stent 20 also increases. As stent 20 expands radially and shortens longitudinally, the distal region 32 of stent 20 further shifts proximally away from the distal tip 40. The further shortening of stent 20 with the exposure of its additional length also causes the middle region 36 of stent 20 to continue to shift proximally. Because the middle region 36 of stent 20 shifts proximally during stent 20 deployment, it is difficult to accurately position stent 20 across the narrow portion 84. Figure 2D As shown, when fully deployed, the stent deviates from the center of the desired deployment location (e.g., a stenotic site). For example, the central region 36 may be deployed too close to the proximal or distal side of the stenotic site 84, preventing the stent 20 from extending across the stenotic site 84 as desired. In some embodiments, the user can compensate for stent shortening by advancing the stent delivery catheter to move the stent 20 across the target deployment location, taking into account axial displacement (i.e., shortening) of the distal region of the stent 20 during deployment. However, in many cases, accurate positioning of the expanded stent 20 across the stenotic site 84 may not be achieved. Incorrect stent deployment or placement can lead to complications and / or the need for stent removal and replacement.

[0048] Figures 2A-2D The shortening phenomenon shown can be remedied by adding a support restraint member, such as a support restraint suture, band, cover or other structural element, and placed around a portion of the self-expanding support 20. Figure 3 A stent delivery system 310 is shown, which may be similar to stent delivery system 10 in many respects. For example, stent delivery system 310 may include a stent delivery catheter 315 and a stent 320 loaded therein for deployment at a treatment site. Stent delivery catheter 315 may include an outer tubular member 360 defining an outer sheath 330 at its distal end. As described above, the outer sheath 330, which may surround stent 320, may be integrally formed as a distal region of the outer tubular member 360, may be a separate component attached to the outer tubular member 360, or may otherwise be disposed at the distal end of the outer tubular member 360. Stent delivery catheter 315 may also include an inner member 350 slidably disposed within the lumen of the outer tubular member 360. A distal tip 340 may be disposed distal to the inner member 350. The stent 320 can be loaded into the stent delivery conduit 315, wherein the stent 320 is radially compressed around the distal region of the inner member 350 on the proximal side of the distal tip 340, such that the radially compressed stent 320 is radially positioned in the delivery configuration between the outer surface of the inner member 350 and the inner surface of the outer tubular member 360.

[0049] The proximal end of the outer tubular member 360 may be secured to a first distal handle 369, and the proximal end of the inner member 350 may be secured to a second proximal handle 380. Longitudinal actuation of the first handle 369 relative to the second handle 380 may cause longitudinal translation of the outer tubular member 360 relative to the inner member 350. For example, proximal actuation of the outer tubular member 360 relative to the inner member 350 may move the distal end of the outer tubular member 360 to the proximal side of the support 320, into a deployment configuration in which the support 320 protrudes from the outer tubular member 360. In the deployment configuration, the outer tubular member is retracted to the proximal side of the self-expanding support, a portion of the self-expanding support constrained by the support constraining member remaining constrained by the support constraining member in a radially compressed configuration.

[0050] In one implementation, the scaffold restraint member can be a scaffold restraint suture, such as... Figure 3 The suture array 370 is shown and described herein. The suture array 370 may include one or more sutures wound around a portion of the support 320 and located within the outer sheath 330 and around the inner tubular member 350 when the support 320 is loaded therein. The suture array 370 may surround any desired portion of the support 320, and in some cases around a first portion of the support 320, while the remaining portion of the support 320 is not radially constrained by the suture array 370. For example, as... Figure 3As shown, the intermediate region of the stent 320 can be radially constrained by the suture array 370, while the proximal and / or distal regions of the stent 320 do not contain the suture array 370 and are therefore not radially constrained by it. In other cases, only the proximal region can be radially constrained by the suture array 370, only the distal region can be radially constrained by the suture array 370, or both the proximal and distal regions can be radially constrained by the suture array 370 while the intermediate region of the stent 320 remains unconstrained by it.

[0051] The suture array 370 may surround the support 320 and be constructed in any desired manner to allow release from the support 320, thereby allowing radial expansion of the portion of the support 320 constrained by the suture array 370. For example, the suture array 370 may consist of any number of suture connecting loops 372 (which circumferentially surround the support 320). The suture array 370 may include an actuation mechanism configured to be actuated by a user to release the suture array 370 from the support 320, thereby allowing radial expansion of the lower portion of the support 320. For example, the suture array 370 may include a pulling member, such as a release suture 376 connected to a release knot 374. The release suture 376 and release knot 374 may be located anywhere along the suture array 370, and any number of release sutures 376 and / or release knots 374 may be provided. For example, in some cases, the release knot 374 may be provided at the proximal end of the suture array 370. In other cases, the release knot 374 may be positioned at the distal end of the suture array 370 or at another desired location. Actuation of a pulling member (such as release suture 376) may untie, stretch, or otherwise release the suture array 370 to relieve radial constraint on the support 320. For example, actuation of a pulling member (such as release suture 376) may untie or release the release knot 374, thereby releasing the suture array 370 from the radially constrained support 320. In some cases, a release handle 378 may be attached to the proximal end of the release suture 376 or other pulling member and may be accessible to actuate the release suture 376 or other pulling member by a user. The release handle 378 may be any form of ring, knob, lever, pry bar, or other design that gives the user the ability to release the suture array 370 when needed.

[0052] Release suture 376 or other pulling member can extend proximally from the suture array 370 wrapped around the restraint portion of the stent 320 to the proximal portion of the stent delivery conduit 315 for user operation. For example, release suture 376 or other pulling member can extend through the lumen of the outer tubular member 360 and reach a position near handle 369 or handle 380. In other cases, release suture 376 or other pulling member can extend through the lumen of the inner member 350 and reach a position proximal to handle 369 or handle 380.

[0053] The suture array 370 can be configured to be released from the stent 320 independently of the proximal retraction of the outer tubular member 360 relative to the inner member 350 and the stent 320. In other words, the stent 320 can be exposed from the outer tubular member 360 by retracting the outer tubular member 360 proximally to expose the stent 320 from its distal end, while a portion of the stent 320 radially constrained by the suture array 370 remains constrained.

[0054] During delivery (e.g., over a guidewire), the stent 320 may be positioned in a radially constrained, longitudinally elongated configuration within the distal region of the outer tubular member 360 (e.g., within the outer sheath 330), such that the radially constrained stent 320 tightly surrounds the inner member 350. The distal end of the outer sheath 330 may adjoin and / or surround the proximal region of the distal tip 340. A suture array 370 may further constrain a portion of the stent 320, such as the central portion. In some embodiments, the suture array 370 may be arranged toward one end of the stent 320, or multiple arrays 370 may be present at multiple locations along the length of the stent 320. As described above, the suture array 370 may surround the proximal and / or distal regions of the stent 320. The number and arrangement of the suture arrays 370 may assist a physician in advancing the stent distally after deployment or in pulling the stent proximally to reposition it after deployment. One or more suture arrays 370 may have the same or different release mechanisms (such as release suture 376 and / or release handle 378) to allow the suture arrays 370 to be released independently and / or in a controlled manner at different times.

[0055] Figures 4A-4D This illustrates several aspects of using a stent delivery system 310 to deliver and deploy a stent 320 across a narrow portion 484 of a body cavity 482. The stent delivery device 315 can advance through the body cavity 482 with the stent 320 in a delivery configuration, in which the stent 320 is loaded in an outer tubular member 360 (e.g., an outer sheath 330 of the outer tubular member 360) prior to stent deployment. In some cases, the stent delivery system 310 can advance along a guidewire 390 extending through a guidewire lumen of the stent delivery device 315. For example... Figure 4AAs shown, the stent delivery device 315 can be positioned such that the stent restraint member (e.g., suture array 370) is in a predetermined position relative to the stenosis 484 (e.g., ensuring that the center of the stent 320 is approximately centered on the stenosis). In some cases, the stent 320 and / or the stent delivery device 315 may include one or more radiopaque markers to observe the arrangement of the stent 320 across the stenosis 484. Additionally or alternatively, the suture array 370 or other stent restraint structure may be formed of and / or implanted with radiopaque material to assist stent placement and enable visualization during and after stent 320 deployment.

[0056] The retraction of the outer tubular member (e.g., the outer sheath 330) relative to the inner member 350, the distal tip 340, and the stent 320 in a proximal direction causes the distal end of the outer sheath 330 to move proximal to the distal tip 340, exposing the distal region of the stent 432, as shown. Figure 4B As shown. Distal shortening was observed, and although the total length of the stent 320 decreased, the portion of the stent 320 radially constrained by the suture array 370 (or other stent constraint member) (e.g., the middle region of the stent) remained in place. In other words, the length of the constrained portion of the stent 320 surrounded and radially constrained by the suture array 370 (or other stent constraint member) did not move longitudinally relative to the inner member 350, and therefore did not move longitudinally relative to the narrow portion 484.

[0057] As the distal end of the outer tubular member (e.g., the outer sheath 330) retracts further proximally, more of the stent 320 is exposed from the distal end of the outer sheath 330 until the entire length of the stent 320 is exposed, as... Figure 4C As shown. Once the multiple portions of the support 320 not surrounded by the suture array 370 (or other support restraint members) are exposed from the distal end of the outer sheath 330, they can immediately and automatically expand radially, while the support portions surrounded and radially restrained by the suture array 370 (or other support restraint members) remain restrained in the radial compression configuration by the suture array 370 (or other support restraint members).

[0058] Once the stent 320 has been deployed and emerged from the outer sheath 330 of the outer tubular member 360, the suture array 370 (or other stent restraint member) can be operated, thereby subsequently allowing the restrained portion of the stent 320 to expand radially. For example, when the proximal retraction of the outer sheath 330 exposes the entire length of the stent 320, the suture array 370 can be untied, unpacked, or otherwise released by actuation of the suture 376 (e.g., by proximal retraction of the suture release handle 378), which may open (e.g., untie) the release knot 374 or otherwise release the suture array 370 to release the radial restraint of the stent portion surrounded by the suture array 370, such as... Figure 4D As shown. When the suture array 370 is untied, dispersed, or otherwise released and withdrawn, the portion of the stent 320 constrained by the suture array 370 can be further radially expanded to widen the passage through the stenotic site 484. Before deployment, the physician can determine which portion of the stent 320, if any, they wish to remain constrained after deployment. Due to differences in anatomical dimensions between individuals and different surgical procedures, the portion of the stent 320 that is desired to remain constrained may vary depending on the procedure.

[0059] Figure 5 A stent delivery system 310 is shown, which includes another configuration of a stent constraint structure for constraining portions of a stent 320. The stent delivery system 310 may be similar in many respects to... Figure 3 The support conveying system 310 is shown. (As shown) Figure 5 As shown, the constraint structures of multiple stents can be arranged at multiple spaced locations along the length of the stent 320. For example, a first stent constraint member (shown as a first suture array 370a) can surround and radially constrain the proximal region of the stent 320; and / or a second stent constraint member (shown as a second suture array 370b) can surround and radially constrain the distal region of the stent 320. The intermediate region of the stent 320 located between the first suture array 370a (or other stent constraint member) and the second suture array 370b (or other stent constraint member) may contain no stent constraint member or be radially constrained by the suture arrays 370a and 370b.

[0060] Each of the suture arrays 370a and 370b may be configured to be similar to and have similar functions to the suture array 370 described above. For example, the suture arrays 370a and 370b may surround the support 320 and be configured in any desired manner so that they can be released from the support 320, thereby allowing radial expansion of a portion of the support 320 constrained by the suture arrays 370a and 370b. For example, each of the suture arrays 370a and 370b may consist of any number of suture connecting loops 372a and 372b surrounding the support 320 circumferentially. Each suture array 370a and 370b may include an actuation mechanism configured to be actuated by a user to release the suture arrays 370a and 370b from the support 320, thereby allowing radial expansion of the lower portion of the support 320. For example, suture arrays 370a, 370b may include pull members (such as release sutures 376a, 376b) connected to release knots 374a, 374b. Release sutures 376a, 376b and release knots 374a, 374b may be located anywhere along suture arrays 370a, 370b, and any number of release sutures 376a, 376b and / or knots 374a, 374b may be provided. Actuation of the pull members (such as release sutures 376a, 376b) may release, stretch, or otherwise release the respective suture arrays 370a, 370b to relieve radial constraint on the support 320. For example, actuation of a pulling member (such as release suture 376a) can untie or release release knot 374a, thereby releasing the first suture array 370a to relieve radial constraint in the proximal region of the stent 320; and / or actuation of a pulling member (such as release suture 376b) can untie or release release knot 374b, thereby releasing the second suture array 370b to relieve radial constraint in the distal region of the stent 320.

[0061] In some cases, release handles 378a, 378b may be connected to the proximal end of the corresponding release stitches 376a, 376b or other pulling components, and may be accessible to the user to actuate the release stitches 376a, 376b or other pulling components. Release handles 378a, 378b may be any form of ring, knob, lever, pry bar, or other design that gives the user the ability to release the stitch arrays 370a, 370b when needed.

[0062] Release sutures 376a, 376b, or other pulling members may extend proximally from the corresponding suture arrays 370a, 370b wrapped around the restraint portion of the stent 320 to the proximal portion of the stent delivery conduit 315 for user operation. For example, release sutures 376a, 376b, or other pulling members may extend through the lumen of the outer tubular member 360 and reach a position near the handle 369 or handle 380. In other cases, release sutures 376a, 376b, or other pulling members may extend through the lumen of the inner member 350 and reach a position near the handle 369 or handle 380.

[0063] In some cases, the first suture array 370a may be configured to be untied, stretched, or otherwise released from the support 320 independently of the second suture array 370b. In other cases, a single pulling member (such as a single release suture) may be actuated to release the first suture array 370a and the second suture array 370b simultaneously or sequentially.

[0064] Each of the suture arrays 370a and 370b can be configured to be released from the stent 320 without retracting the outer tubular member 360 proximally relative to the inner member 350 and the stent 320. In other words, by retracting the outer tubular member 360 proximally to expose the stent 320 from its distal end, the stent 320 can be exposed from the outer tubular member 360, while the portions of the stent 320 radially constrained by the suture arrays 370a and 370b remain constrained. Subsequently, the suture arrays 370a and 370b can be released from the corresponding constrained portions of the stent 320 to allow these lower portions of the stent 320 to expand radially.

[0065] Other support restraint components can be used to selectively restrain a portion of the support when deploying it across narrow areas. For example, such as... Figure 6A As shown, a portion of the stent 520 may be constrained by a cover (e.g., a coating) 538, which may temporarily hold a portion of the stent 520 in its constrained configuration after deployment from the stent delivery conduit (e.g., after deployment from the distal end of the outer tubular member of the stent delivery conduit as described above). Figure 6A As shown, in some cases, the stent 520 can be deployed across a narrow portion 584 of the body cavity 582, such that the constrained portion of the stent 520, constrained by the cover 538, extends across the narrow portion 584. Although Figure 6AIt is shown that the intermediate region of the stent 520 can be radially constrained by the cover 538, while the proximal and / or distal regions of the stent 520 do not contain the cover 538 and are therefore not radially constrained by the cover 538. However, in other cases, only the proximal region can be radially constrained by the cover 538, only the distal region can be radially constrained by the cover 538, or both the proximal and distal regions can be radially constrained by the cover 538, while the intermediate region of the stent 520 remains unconstrained by the cover 538.

[0066] The covering (e.g., coating) 538 may be configured to dissolve, degrade, or be absorbed over time, or the covering (e.g., coating) 538 may remain intact, so that a portion of the support 538 maintains radial restraint indefinitely. Figure 6B As shown, at a later time, after the stent 520 is deployed in the body cavity 582, the covering 538 can be released from the stent 520 (e.g., absorbed or dissolved), thereby allowing the lower portion of the stent 520 to expand radially. In some cases, the covering, or a portion thereof, may be formed of a soluble material, such as gelatin, glucose, or similar water-soluble substances, which dissolves over time to release the constrained portion of the stent 520. The applied covering 538 may also be implanted or otherwise comprised of a radiopaque material to help the stent be properly positioned across the narrow site 584 into the body cavity 582. The covering 538 may be used alone or in combination with the suture array 370 described above.

[0067] It should be understood that the dimensions described in conjunction with the above figures are illustrative only, and other dimensions of the slits and filter sheaths are contemplated. The materials used in the various components (and / or other systems or components disclosed herein) that can be used in the stent delivery device and for capturing lesion particles, as well as the various elements thereof disclosed herein, may include materials generally associated with medical devices. For simplicity, the following discussion refers to the stent delivery device (and variations, systems, or components disclosed herein). However, this is not intended to limit the devices and methods described herein, as the discussion can also apply to other elements, components, parts, or devices disclosed herein.

[0068] In some implementations, the support delivery device (and its variations, systems or components disclosed herein) may be made of metal, metal alloy, ceramic, zirconium oxide, polymer (some examples of which are disclosed below), metal-polymer composites, combinations thereof, or other suitable materials. Some examples of suitable metals and metal alloys include: stainless steels such as 444V, 444L, and 314LV stainless steels; low-carbon steels; nickel-titanium alloys such as linearly elastic and / or hyperelastic nickel-titanium alloys; cobalt-chromium alloys; titanium and its alloys; alumina; metals with diamond-like carbon (DLC) or titanium nitride coatings; other nickel alloys such as nickel-chromium-molybdenum alloys (e.g., UNS:N06625 such as INCONEL® 625; UNS:N06022 such as HASTELLOY® C-22®; UNS:N10276 such as HASTELLOY® C276®; other HASTELLOY® alloys, etc.); and nickel-copper alloys (e.g., UNS:N04400 such as MONEL® 400, NICKELVAC® 400, NICORROS®). Nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R44035 such as MP35-N®), nickel-molybdenum alloys (e.g., UNS:N10665 such as HASTELLOY® ALLOY B2®), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, etc.; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS:R44003 such as ELGILOY®, PHYNOX®, etc.); platinum-rich stainless steels; titanium; platinum; palladium; gold; combinations thereof, etc.; or any other suitable material.

[0069] In at least some embodiments, part or all of the stent delivery device (and its variants, systems, or components disclosed herein) may be doped with, made of, or otherwise include a radiopaque material. A radiopaque material is understood to be capable of producing a relatively bright image on a fluorescent examination screen or other imaging technique during medical procedures. This relatively bright image helps the user determine the location of the stent delivery device (and its variants, systems, or components disclosed herein). Some examples of radiopaque materials may include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymeric materials loaded with radiopaque fillers, etc. Furthermore, other radiopaque marking strips and / or coils may be incorporated into the design of the stent delivery device (and its variants, systems, or components disclosed herein) to achieve the same result.

[0070] In some embodiments, the stent delivery device (and its variations, systems, or components disclosed herein) and / or portions thereof may be made of or comprise polymers or other suitable materials. Examples of suitable polymers may include polytetrafluoroethylene (PTFE), ethylene-tetrafluoroethylene (ETFE), fluorinated ethylene-propylene (FEP), polyoxymethylene (POM, e.g., DELRIN® available from DuPont), polyether block esters, polyurethanes (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether esters (e.g., ARNITEL® available from DSM Engineering Plastics), ether-based or ester-based copolymers (e.g., butene / poly(alkylene ether) phthalates and / or other polyester elastomers, such as HYTREL® available from DuPont), polyamides (e.g., DURETHAN® available from Bayer, or available from Elf). Atochem's CRISTAMID®, elastomer polyamides, block polyamides / ethers, polyether block amides (PEBA, e.g., available under the trade name PEBAX®), ethylene-vinyl acetate copolymers (EVA), silicone resins, polyethylene (PE), Marlex® high-density polyethylene, Marlex® low-density polyethylene, linear low-density polyethylene (e.g., REXELL®), polyesters, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), 1,3-propylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene ether (PPO), poly(p-phenylene terephthalamide) (e.g., KEVLAR®), polysulfone, nylon, nylon-12 (e.g., available from EMS American) Grilon's GRILAMID®, perfluoro(propyl vinyl ether) (PFA), ethylene-vinyl alcohol, polyolefins, polystyrene, epoxides, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS 50A), polycarbonate, ionomers, polyurethane silicone copolymers (e.g., Elast-Eon® from AorTech Biomaterials or ChronoSil® from AdvanSource Biomaterials), biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers, polymer / metal composites, etc. In some embodiments, the sheath may be blended with a liquid crystal polymer (LCP). For example, the blend may contain up to about six percent LCP.

[0071] In some embodiments, the stent delivery device (and its variants, systems, or components disclosed herein) may include and / or be treated with a suitable therapeutic agent. Examples of suitable therapeutic agents include antithrombotic agents (such as heparin, heparin derivatives, urokinase, and PPack (d-phenylalanine-proline-arginine-chloromethyl ketone)); antiproliferative agents (such as enoxaparin, angiotensin, monoclonal antibodies that block smooth muscle cell proliferation, hirudin, and acetylsalicylic acid); anti-inflammatory agents (such as dexamethasone, prednisolone, corticosteroids, budesonide, estrogens, sulfasalazine, and mesalazine); antitumor / antiproliferative / antimitotic agents (such as paclitaxel, 5-fluorouracil, cisplatin, vincristine, epoch-forming acid, endostatin, angiostatin, and thymidine kinase inhibitors); anesthetics (such as lidocaine, bupivacaine, and ropivacaine); and anticoagulants (such as D-Phe-Pro-Ar). γ-chloromethyl ketone, compounds containing RGD peptides, heparin, antithrombin compounds, platelet receptor antagonists, antithrombin antibodies, antiplatelet receptor antibodies, aspirin, prostaglandin inhibitors, platelet inhibitors, and tick antiplatelet peptides; angiogenesis promoters (such as growth factor inhibitors, growth factor receptor antagonists, transcription activators, and translation promoters); angiogenesis inhibitors (such as growth factor inhibitors, growth factor receptor antagonists, transcription repressors, translation repressors, replication inhibitors, inhibitory antibodies, antibodies against growth factors, bifunctional molecules composed of growth factors and cytotoxins, and bifunctional molecules composed of antibodies and cytotoxins); cholesterol lowering agents; vasodilators; and agents that interfere with endogenous vasoactive mechanisms.

[0072] It should be understood that this disclosure is illustrative in many respects only. Changes in detail, particularly in terms of shape, size, and arrangement of steps, may be made without departing from the scope of this disclosure. To the appropriate extent, this may include the use of any feature of an exemplary embodiment used in other embodiments. The scope of the invention is, of course, defined by the language expressed in the appended claims.

Claims

1. A support delivery system, the system comprising: An outer tubular member having a proximal end, a distal end, and a cavity extending to the distal end; An internal component, which is slidably disposed within the cavity of the outer tubular component; The distal tip is located at the distal end of the inner member; A self-expanding stent having a proximal end, a distal end, and a cavity extending therethrough, the self-expanding stent being capable of expanding from a radially compressed configuration to a radially expanded configuration; A suture array disposed around at least a portion of the self-expanding stent; In the radial compression configuration, the self-expanding support is disposed between the outer surface of the inner member and the inner surface of the outer tubular member. Specifically, when the outer tubular member retracts proximally, the self-expanding support expands radially; and In the expanded configuration, at least a portion of the expanded scaffold is radially constrained by the suture array.

2. The system of claim 1, wherein the suture array comprises one or more suture loops and a release knot connected to the release suture.

3. The system of claim 2, wherein the release suture extends longitudinally through the cavity of the outer tubular member.

4. The system of claim 3, wherein the release suture further comprises a release handle extending from the proximal end of the outer tubular member.

5. The system of claim 4, wherein when the release handle is retracted in the proximal direction, the release knot is untied and the suture array disperses.

6. The system of claim 4, wherein the release handle includes a stitched loop configured to allow a user to hold the release handle.

7. The system according to any one of claims 2 to 6, wherein the release knot is located at the proximal end of the suture array.

8. The system according to any one of claims 2 to 6, wherein the release knot is located at the distal end of the suture array.

9. The system according to any one of the preceding claims, wherein the suture array is disposed around the intermediate region of the self-expanding stent.

10. The system of claim 9, wherein the proximal region of the self-expanding stent does not contain the suture array, and the distal region of the self-expanding stent does not contain the suture array.

11. The system of claim 10, wherein when the outer tubular member is retracted proximally, the proximal region of the self-expanding stent radially expands to the expansion structure and the distal region of the self-expanding stent radially expands to the expansion structure, while the intermediate region of the self-expanded stent remains radially constrained by the suture array.

12. The system according to any one of the preceding claims, further comprising a second suture array configured to apply radial constraint to a portion of the self-expanding stent.

13. The system according to any one of the preceding claims, wherein the self-expanding stent further comprises a soluble coating disposed around at least a portion of the stent.

14. The system of claim 13, wherein, when in the expanded configuration, at least a portion of the self-expanding support is radially constrained by the soluble coating.

15. A support delivery system, the system comprising: An outer tubular member having a proximal end, a distal end, and a cavity extending to the distal end; An internal component, which is slidably disposed within the cavity of the outer tubular component; The distal tip is located at the distal end of the inner member; A self-expanding stent having a proximal end, a distal end, and a cavity extending therethrough, the self-expanding stent being capable of expanding from a radially compressed configuration to a radially expanded configuration; A support constraint member is disposed around at least a portion of the self-expanding support; The outer tubular member is axially movable relative to the inner member between the conveying structure and the deployment structure; In the conveying structure, the outer tubular member surrounds the self-expanding support, such that the self-expanding support is constrained between the outer surface of the inner member and the inner surface of the outer tubular member; and In the deployment configuration, the outer tubular member is retracted to the proximal side of the self-expanding support, while the portion of the self-expanding support remains constrained by the support constraint member within the radial compression configuration.

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