Occlusive implant system

Abstract

A delivery system for an occluding implant may include a delivery sheath having a delivery lumen extending proximally from a distal end of the delivery sheath, the delivery sheath formed of a polymeric material; and a core wire slidably disposed within the delivery lumen. The core wire may be configured to releasably engage an occlusive implant. The delivery sheath may include a circumferential ring formed integrally therewith at a distal end of the delivery sheath and a plurality of longitudinal slots disposed proximal to the circumferential ring. An occlusive implant system may include an occlusive implant configured to transition between a delivery configuration and a deployed configuration, and a delivery system for the occlusive implant. In the delivery configuration, an occluding implant may be disposed within the distal portion of the delivery lumen.

Description

[0001] Cross-references to related applications

[0002] This application claims the benefit of priority to U.S. Provisional Application No. 63 / 458,541, filed April 11, 2023, the entire disclosure of which is incorporated herein by reference. Technical Field

[0003] This disclosure relates generally to medical devices, and more specifically to medical devices suitable for use in percutaneous medical procedures, including implantation in the left atrial appendage (LAA) of the heart. Background Technology

[0004] The left atrial appendage is a small organ attached to the left atrium of the heart. During normal heart function, the left atrial appendage contracts and forces blood into the left atrium as the left atrium contracts and forces blood into the left atrium. The ability of the left atrial appendage to contract helps improve the filling of the left ventricle, thus playing a role in maintaining cardiac output. However, in patients with atrial fibrillation, the left atrial appendage may not be able to contract or empty properly, causing stagnant blood to pool inside, which can lead to the unintended formation of blood clots within the left atrial appendage.

[0005] Blood clots that form in the left atrial appendage can detach from that area and enter the bloodstream. These clots can migrate through blood vessels and eventually block smaller downstream vessels, potentially leading to a stroke or heart attack. Clinical studies have shown that most blood clots in patients with atrial fibrillation originate in the left atrial appendage. As a treatment option, medical devices have been developed to deploy and block the left atrial appendage. Each known medical device and method has its own advantages and disadvantages. There remains a need for alternative medical devices and alternative methods for manufacturing and using these devices. Summary of the Invention

[0006] In one example, a delivery system for an occlusive implant may include: a delivery sheath having a delivery lumen extending proximally from a distal end of the delivery sheath, the delivery sheath being formed of a polymer material; and a core wire slidably disposed within the delivery lumen, the core wire being configured to releasably engage an occlusive implant. The delivery sheath may include a circumferential ring integrally formed therewith at the distal end of the delivery sheath and a plurality of longitudinal slots disposed proximally to the circumferential ring.

[0007] In addition to or as an alternative to any of the examples disclosed herein, multiple longitudinal slots are configured as adjacent circumferential rings.

[0008] In addition to or as an alternative to any of the examples disclosed herein, multiple longitudinal slots extend partially through the sidewalls of the delivery sheath.

[0009] Except for any examples disclosed herein or as alternatives, multiple longitudinal slots extend completely through the sidewalls of the delivery sheath.

[0010] In addition to or as an alternative to any of the examples disclosed herein, a second polymer material different from the polymer material is disposed in at least one of the plurality of longitudinal slots.

[0011] In addition to or as an alternative to any example disclosed herein, the plurality of longitudinal slots includes a first plurality of longitudinal slots having a first length and a second plurality of longitudinal slots having a second length different from the first length.

[0012] Except for or alternative to any examples disclosed herein, the first plurality of longitudinal slots and the second plurality of longitudinal slots are arranged alternately around the circumference of the delivery sheath.

[0013] In addition to or as an alternative to any examples disclosed herein, the plurality of longitudinal slots include longitudinal slots in a first circumferential row and longitudinal slots in a second circumferential row disposed proximal to the longitudinal slots in the first circumferential row.

[0014] Except for or alternative to any examples disclosed herein, adjacent longitudinal slots in the longitudinal slots of the second circumferential row are spaced further apart in the circumferential direction than adjacent longitudinal slots in the longitudinal slots of the first circumferential row.

[0015] Except for or alternative to any examples disclosed herein, the longitudinal slots of the first circumferential row include a first number of longitudinal slots, while the longitudinal slots of the second circumferential row include a second number of longitudinal slots that is less than the first number of longitudinal slots.

[0016] Except for or alternative to any examples disclosed herein, each longitudinal slot in the second circumferential row is axially aligned with one longitudinal slot in the first circumferential row.

[0017] In addition to or as an alternative to any of the examples disclosed herein, the delivery sheath further includes a second circumferential ring integrally formed with the delivery sheath. The second circumferential ring may be axially disposed between the longitudinal slots of the first circumferential row and the longitudinal slots of the second circumferential row.

[0018] Except for or alternative to any examples disclosed herein, at least one of the plurality of longitudinal slots is wider at the distal end of at least one longitudinal slot than at the proximal end of at least one longitudinal slot.

[0019] Except for any examples disclosed herein or as an alternative, at least one longitudinal slot tapers from the proximal end to the distal end.

[0020] In addition to or as an alternative to any examples disclosed herein, an occlusive implant system may include an occlusive implant configured to switch between a delivery configuration and a deployment configuration, and a delivery system for the occlusive implant. The delivery system may include: a delivery sheath having a delivery lumen extending proximally from a distal end of the delivery sheath, the delivery sheath being formed of a polymer material; and a core wire slidably disposed within the delivery lumen, the core wire being releasably engaged with the occlusive implant at its distal end. The delivery sheath may include a circumferential ring integrally formed therewith at the distal end of the delivery sheath and a plurality of longitudinal slots disposed proximal to the circumferential ring. In the delivery configuration, the occlusive implant may be disposed within the distal portion of the delivery lumen.

[0021] In addition to or as a substitute for any of the examples disclosed herein, occlusive implants include an expandable frame and an occlusive element fixed to the expandable frame.

[0022] In addition to or as an alternative to any of the examples disclosed herein, the distal end of the delivery sheath is configured to expand radially outward during recapture of the occlusive implant.

[0023] Except for any examples disclosed herein or as alternatives, the circumferential ring extends uninterruptedly around the delivery lumen.

[0024] In addition to or as an alternative to any examples disclosed herein, a delivery system for an occlusive implant may include: a delivery sheath having a delivery lumen extending proximally from a distal end of the delivery sheath, the delivery sheath being formed of a polymeric material; and a core wire slidably disposed within the delivery lumen, the core wire being configured to releasably engage an occlusive implant. The delivery sheath may include a circumferential ring integrally formed therewith at the distal end of the delivery sheath and a plurality of longitudinal strips formed of a second polymeric material different from the polymeric material. The plurality of longitudinal strips may be embedded within a sidewall of the delivery sheath located proximal to the circumferential ring.

[0025] Except for or as a substitute for any example disclosed herein, the second polymer material has a lower hardness than the polymer material described herein.

[0026] The above overview of some embodiments, aspects, and / or examples is not intended to describe every embodiment or every implementation of this disclosure. The following figures and detailed description illustrate these embodiments in more specific terms. Attached Figure Description

[0027] This disclosure will be more fully understood in light of the following detailed description taken in conjunction with the accompanying drawings, in which:

[0028] Figures 1-2This is a side view of a selected aspect of an occlusive implant system;

[0029] Figure 3 It shows the use of Figures 1-2 The selection of the configuration of the delivery system for the occlusive implant system;

[0030] Figure 4A It is shown Figure 3 A cross-sectional view of a selected aspect of the configuration of the conveying system;

[0031] Figure 4B It is shown Figure 3 A cross-sectional view of a selected aspect of the configuration of the conveying system;

[0032] Figure 5 It shows the use of Figures 1-2 The selection of the delivery system for occlusive implants;

[0033] Figure 6 It is shown Figure 5 A cross-sectional view of a selected aspect of the configuration of the conveying system;

[0034] Figure 7 It shows the use of Figures 1-2 The selection of the delivery system for occlusive implants;

[0035] Figure 8 It shows the use of Figures 1-2 The selection of the delivery system for occlusive implants;

[0036] Figure 9 It shows the use of Figures 1-2 The selection of the delivery system for occlusive implants;

[0037] Figure 10 It shows the use of Figures 1-2 The selection of the delivery system for occlusive implants;

[0038] Figure 11 It is shown Figure 10 A cross-sectional view of a selected aspect of the configuration of the conveying system; and

[0039] Figures 12-13 Selected aspects of recapturing an occlusive implant using a delivery system according to this disclosure are illustrated schematically.

[0040] While various modifications and alternatives may be made to aspects of this disclosure, examples are shown in the accompanying drawings and described herein. However, it should be understood that this disclosure is not intended to limit aspects of the disclosure to the specific embodiments described. Rather, this disclosure should cover all modifications, equivalents, and alternatives falling within its spirit and scope. Detailed Implementation

[0041] The following description should be read with reference to the accompanying drawings, which are not necessarily drawn to scale, wherein similar reference numerals indicate similar elements throughout several views. The detailed description and drawings are intended to illustrate, not limit, 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 clarity and ease of understanding, although each feature and / or element may not be shown in every drawing, it is understood that features and / or elements are present in all cases unless otherwise specified.

[0042] The following definitions shall apply unless otherwise specified in the claims or elsewhere in this specification.

[0043] All numerical values ​​herein are assumed to be modified by the term "approximately," whether explicitly indicated or not. In the context of numerical values, the term "approximately" generally refers to a range of numbers that a person skilled in the art would consider equivalent to the stated value (e.g., having the same function or result). In many cases, the term "approximately" may include numbers rounded to the nearest significant figure. Unless otherwise specified, other uses of the term "approximately" (e.g., in contexts other than numerical values) may be assumed to have their common and customary definition, as understood from and consistent with the context of the specification.

[0044] A description of a range of numbers by endpoints includes all numbers in that range, including the endpoints (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0045] Although some suitable dimensions, ranges and / or values ​​related to various components, features and / or specifications are disclosed, those skilled in the art will understand, inspired by this disclosure, that expected dimensions, ranges and / or values ​​may deviate from those explicitly disclosed dimensions, ranges and / or values.

[0046] As used in this specification and the appended claims, the singular forms “a (an)” and “the” include plural references unless the context clearly indicates otherwise. As used in this specification and the appended claims, the term “or” is generally used to mean “and / or” unless the context clearly indicates otherwise. It should be noted that, for ease of understanding, certain features of this disclosure may be described in the singular, even if such features may be plural or repeated in the disclosed embodiments. Each instance of a feature may include and / or be covered by a single 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 should be understood that the following discussion can be equally applied to any and / or all components beyond one component unless expressly stated otherwise. Furthermore, for clarity, not all instances of some elements or features can be shown in every figure.

[0047] For example, relative terms such as “proximal,” “distal,” “advancing,” “receding,” and variations thereof are generally 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 “receding” indicate or refer to being closer to or towards the user, while “distal” and “advancing” indicate or refer to being farther from or away from the user. In some cases, the terms “proximal” and “distal” may be arbitrarily designated to aid in understanding this disclosure, and such cases will be apparent to those skilled in the art. Other relative terms, such as “upstream,” “downstream,” “inflow,” and “outflow,” refer to the direction of fluid flow within a lumen (such as a body lumen or blood vessel) or device. Other related terms, such as “axial,” “circumferential,” “longitudinal,” “transverse,” “radial,” and / or variations thereof, generally refer to the direction and / or orientation relative to the central longitudinal axis of the disclosed structure or device.

[0048] The term "range" can be understood as referring to the largest possible measurement of the stated or determined dimension, unless the range or dimension in question is preceded by "minimum" or is determined to be "minimum," in which case it can be understood as referring to the smallest possible measurement of the stated or determined dimension. For example, "outer range" can be understood as referring to an outer dimension, "radial range" as referring to a radial dimension, "longitudinal range" as referring to a longitudinal dimension, and so on. Each instance of "range" can be different (e.g., axial, longitudinal, transverse, radial, circumferential, etc.), and will be obvious to a person skilled in the art from the context of its individual use. Generally, "range" can be considered as the largest possible dimension measured according to its intended use, while "minimum range" can be considered as the smallest possible dimension measured according to its intended use. In some cases, "range" can often be measured orthogonally within a plane and / or cross-section, but it is obvious from the specific context that it can be measured differently, such as, but not limited to, angularly, radially, circumferentially (e.g., along an arc), etc.

[0049] The terms "integral" and "single" generally refer to one or more elements made or constituted by a single structural or basic unit / element. Integrated and / or single elements should exclude structures and / or features made by assembling or otherwise connecting multiple discrete elements together.

[0050] It should be noted that references to "embodiments," "some embodiments," "other embodiments," etc., in the specification indicate that the described embodiments may include specific features, structures, or characteristics, but each embodiment does not necessarily include those specific features, structures, or characteristics. Furthermore, such phrases do not necessarily refer to the same embodiment. Moreover, when a specific feature, structure, or characteristic is described in connection with an embodiment, unless explicitly stated otherwise, its use in conjunction with other embodiments will be within the knowledge of those skilled in the art, whether explicitly described or not. That is, the various individual elements described below, even if not explicitly shown in a specific combination, are considered to be combinable or arrangeable to form other additional embodiments or to supplement and / or enrich the described embodiments, as understood by those skilled in the art.

[0051] For clarity, certain identifying numerical designations (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 these numerical designations are not intended to be limiting but are merely exemplary. In some embodiments, for brevity and clarity, previously used numerical designations may be modified and deviated from. 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 a skilled practitioner.

[0052] The following figures illustrate an implant for occluding the left atrial appendage, selected components of a system for occluding the left atrial appendage, and / or methods of placement and / or use of the implant and / or system. It should be noted that in any given figure, some features may not be shown or may be shown schematically for simplicity. Additional details regarding some components of the implant and / or system may be shown in more detail in other figures. Although discussed in the context of occluding the left atrial appendage, the implant and / or system can also be used in other interventional and / or percutaneous medical procedures within the patient. Similarly, the percutaneous deployment devices and methods described herein can be suitably used in other types of surgical procedures. For example, in some examples, the device can be used in non-percutaneous procedures. The devices and methods according to this disclosure can also be adapted and configured for other uses within anatomical structures.

[0053] Figures 1-2 Selected components and / or arrangements of an occlusive implant system are schematically illustrated. It should be noted that, for simplicity, some features of the occlusive implant system may not be shown in any given figure, or may be shown schematically. Additional details regarding some components of the occlusive implant system may be shown in more detail in other figures. Occlusive implant systems can be used to deliver and / or deploy various medical implants (e.g., cardiovascular implants, occlusive implants, etc.) to one or more sites within an anatomical structure, which in some embodiments include, but are not limited to, the heart and / or the left atrial appendage. For clarity, the following discussion refers to occlusive implants; however, other medical implants may be used with and / or considered in conjunction with occlusive implant systems.

[0054] An occlusive implant system may include a delivery system 100 comprising a delivery sheath 140 having a delivery lumen 142 extending proximally from a distal end of the delivery sheath 140. In one example, the delivery lumen 142 extends from a proximal opening to a distal opening of the delivery sheath 140. The delivery system 100 may include a proximal hub 110. In some embodiments, the delivery system may include an intermediate hub 112. In some embodiments, the delivery system 100 may include an intermediate shaft 114 extending from the proximal hub 110 to the intermediate hub 112. In some embodiments, the delivery sheath 140 may extend distally from the intermediate hub 112. Other configurations are also contemplated. In some embodiments, the delivery system 100 may include a side port 116. In some embodiments, the side port 116 may communicate with the intermediate shaft 114. Other configurations are also contemplated. In some embodiments, the delivery system 100 and / or delivery lumen 142 may include a proximal segment (not shown) extending within and / or through the intermediate hub 112, intermediate shaft 114, and proximal hub 110. In some embodiments, the proximal segment may be in fluid communication with the delivery lumen 142 of the delivery sheath 140 and / or may be an extension of the delivery lumen. In some embodiments, a side port 116 may be in fluid communication with the proximal segment and / or delivery lumen 142.

[0055] The occlusive implant system and / or delivery system 100 may include a core wire 130 slidably and / or rotatably disposed within a delivery lumen 142 (and a proximal segment, if present). The occlusive implant system may include an occlusive implant 200 configured for implantation within the left atrial appendage, releasably engaging and / or releasably attaching to the distal end of the core wire 130. In at least some embodiments, the occlusive implant 200 may be a left atrial appendage closure device. In some embodiments, the proximal end of the core wire 130 may extend proximally to the proximal end of the delivery sheath 140 and / or proximal to the proximal opening of the delivery lumen 142 for manual manipulation by a clinician or practitioner. In at least some embodiments, the delivery sheath 140 may include a polymeric material and / or may be formed of a polymeric material. In some embodiments, the delivery sheath 140 may include multiple polymeric materials and / or may be formed of multiple polymeric materials. In some embodiments, the delivery sheath may comprise a combination of metallic and polymeric materials and / or may be formed of a combination of metallic and polymeric materials. In some embodiments, the delivery sheath 140 may include reinforcing elements, such as mesh, coils, braids, etc., formed therein, embedded therein, or attached thereto, along at least a portion of the length of the delivery sheath 140. Other configurations are also contemplated. Suitable but non-limiting examples of materials for occlusive implant systems, core wire 130, and / or delivery sheath 140, etc. (including, but not limited to, metallic materials, polymeric materials, etc.) are discussed below.

[0056] Occlusive implant 200 may include expandable frame 210 (e.g., Figure 2 The extensible framework is configured to deliver configurations (e.g., Figure 1 ) and expanded configuration (e.g., Figure 2 The delivery configuration can be switched between the two configurations, for example, when the occlusive implant 200 is positioned within the delivery lumen 142, near the distal opening, and / or within the distal portion of the delivery lumen 142, and when the deployment configuration is when the occlusive implant 200 is not constrained by the delivery sheath 140.

[0057] In some embodiments, the expandable frame 210 may include a plurality of interconnected struts. In some embodiments, the expandable frame 210 may be compliant or semi-compliant and in an expanded configuration may generally conform to the shape and / or geometry of the left atrial appendage and / or be configured to sealably engage with the shape and / or geometry of the left atrial appendage.

[0058] In some embodiments, the proximal end of the expandable frame 210 may be configured to be releasably attached, connected, coupled, engaged, or otherwise connected to the distal end of the core wire 130 (e.g., Figure 2In some embodiments, the proximal end of the expandable frame 210 may include a proximal hub coupled thereto and / or non-releasably attached thereto. In some embodiments, the proximal hub may be configured and / or adapted to be releasably coupled, connected, mated, or otherwise engaged with the distal end of the core wire 130. Other means of releasably coupling and / or engaging the expandable frame 210 to the distal end of the core wire 130 are also contemplated.

[0059] In some embodiments, the occlusive implant 200 may include an occlusive element 220 (e.g., a membrane, fabric, or tissue element) that is connected to, disposed on, disposed on, surrounding, or covers at least a portion of the expandable frame 210. In some embodiments, the occlusive element 220 may be connected to, disposed on, disposed on, surrounding, or covering at least a portion of the expandable frame 210, or cover at least a portion of the outer surface (or outward-facing surface) of the expandable frame 210.

[0060] In some embodiments, the occlusive element 220 may be permeable or impermeable to blood and / or other fluids (such as water). In some embodiments, the occlusive element 220 may comprise a polymer membrane, a metal or polymer mesh, a porous or semi-porous filter-like material, or other suitable construction. In some embodiments, the occlusive element 220 prevents thrombi (e.g., blood clots, etc.) from passing through the occlusive element 220 and exiting the left atrial appendage into the bloodstream. In some embodiments, the occlusive element 220 promotes endothelialization after implantation, thereby effectively isolating the target site (e.g., the left atrial appendage, etc.) from the patient's circulatory system. Some suitable, but non-limiting, examples of materials for the occlusive element 220 are discussed below.

[0061] In some embodiments, the expandable frame 210 and / or the plurality of interconnected pillars may be integrally formed and / or cut from a single member. In some embodiments, the expandable frame 210 and / or the plurality of interconnected pillars may be integrally formed and / or cut from a single tubular member, and subsequently formed and / or heat-set into a desired shape in an unfolded configuration. In some embodiments, the expandable frame 210 and / or the plurality of interconnected pillars may be integrally formed and / or cut from a single flat member or sheet, and then rolled or formed into a tubular structure, and subsequently formed and / or heat-set into a desired shape in an unfolded configuration. Some exemplary means and / or methods for fabricating and / or forming the expandable frame 210 include laser cutting, machining, punching, stamping, electrical discharge machining (EDM), chemical melting, etc. Other means and / or methods are also contemplated.

[0062] In use, the delivery sheath 140 can be advanced and / or navigated to the left atrial appendage to deliver the occlusive implant 200 to the left atrial appendage. In one example, the delivery sheath 140 can be advanced and / or navigated to the left atrial appendage using a guidewire and / or on a guidewire. For example, the delivery sheath 140 can be advanced into the patient's left atrium, with its distal end positioned adjacent to the left atrial appendage, where the occlusive implant 200 is disposed in a delivery configuration. In some embodiments, the delivery sheath 140 may include maneuverability. After the distal end of the delivery sheath 140 is positioned adjacent to and / or located at the left atrial appendage, the core wire 130 can be advanced distally relative to the delivery sheath 140 to eject the occlusive implant 200 from the delivery sheath 140, wherein the occlusive implant 200 can be converted to an unfolded configuration.

[0063] Although not explicitly shown, in some embodiments, the occlusive implant system may further include a access device. In some embodiments, the access device may be a bidirectional maneuverable catheter and / or an intravascular catheter. Examples of intravascular catheters may include, but are not limited to, balloon catheters, atherosclerotic catheters, device delivery catheters, drug delivery catheters, diagnostic catheters, and guiding catheters.

[0064] In some embodiments, the access device can be advanced and / or navigated to the left atrial appendage. In one example, the access device can be advanced and / or navigated to the left atrial appendage using a guidewire and / or on a guidewire. For example, the access device can be advanced into the patient's left atrium, with the distal end positioned adjacent to the left atrial appendage. In some embodiments, the access device may include manipulability. In some embodiments, a delivery system 100 can be inserted through the access device. In some embodiments, the length of the delivery sheath 140 can be substantially equal to the length of the access device. In some embodiments, the length of the delivery sheath 140 can be slightly longer than the access device. During use, the delivery sheath 140 can be advanced within the access device, with the occlusive implant 200 disposed therein in a delivery configuration. After the distal end of the delivery sheath 140 is positioned adjacent to and / or located at the distal end of the access device, the core wire 130 can be advanced distally relative to the delivery sheath 140 and / or the access device to eject the occlusive implant 200 from the delivery sheath 140 and the access device, wherein the occlusive implant 200 can be converted to an unfolded configuration.

[0065] In some embodiments, the conveying system, the conveying sheath 140, and / or the proximity device may be sized according to their intended use. For example, the length of the conveying system, the conveying sheath 140, and / or the proximity device may range from about 10 to about 150 cm, about 25 to about 125 cm, about 50 to about 100 cm, about 25 cm to about 50 cm, about 50 to about 75 cm, about 75 to about 100 cm, etc. Other lengths are also contemplated, including but not limited to subsets of the ranges disclosed herein. It is further contemplated that the outer diameter of the conveying system, the conveying sheath 140, and / or the proximity device may vary based on the purpose or application. In some examples, the outer diameter of the conveying system, the conveying sheath 140, and / or the proximity device may be approximately 2 mm, approximately 3 mm (or 9 French), approximately 3.5 mm, approximately 4 mm (or 12 French), approximately 4.5 mm, approximately 5 mm (or 15 French), approximately 5.33 mm, approximately 5.5 mm, approximately 5.66 mm (or 17 French), approximately 6 mm, approximately 6.5 mm, approximately 7 mm (or 21 French), approximately 8 mm, or other suitable sizes. In some embodiments, the outer diameter of the conveying system, the conveying sheath 140, and / or the proximity device may be at most 5.66 mm (17 French), and preferably less than 5.66 mm (17 French). Other configurations are also contemplated. In some embodiments, it is desirable that the outer diameter of the conveying system, the conveying sheath 140, and / or the proximity device be as small as possible.

[0066] In some embodiments, it may be necessary to recapture the occlusive implant 200 during the procedure. For example, the initial placement of the occlusive implant 200 may be incorrect and / or insufficient. Therefore, the delivery sheath 140 and / or access device may be configured to allow recapture of the occlusive implant 200.

[0067] Figures 3-11 Selected aspects of the configuration of the delivery sheath 140 are shown, which may allow the delivery sheath 140 to recapture the occlusive implant 200 and / or may enhance the ability of the delivery sheath 140 to recapture the occlusive implant 200. The core wire 130 and the occlusive implant 200 are shown in some figures for reference and illustration purposes only. Additionally, some features are not shown in all figures, and some figures may identify features not explicitly described or discussed for reference in particular figures. While the delivery sheath 140 has been described with reference to it, it should be understood that the illustrated configuration may be used in place of or as a supplement to the delivery sheath 140 in a proximity device.

[0068] In some embodiments, the distal end and / or distal end region of the delivery sheath 140 may be configured to resiliently expand radially outward during recapture of the occlusive implant 200. By allowing the distal end and / or distal end region of the delivery sheath 140 to resiliently expand radially outward during recapture of the occlusive implant 200, damage to the occlusive implant 200 and / or the delivery sheath 140 can be avoided. Additionally, allowing the distal end and / or distal end region of the delivery sheath 140 to resiliently expand radially outward during recapture of the occlusive implant 200 can reduce the force required to recapture the occlusive implant 200.

[0069] In some embodiments, the distal end region may be without any reinforcing elements. In some embodiments, the delivery sheath 140 may include a circumferential ring 144 integrally formed therewith at the distal end of the delivery sheath 140. In some embodiments, the circumferential ring 144 may be located at the distal end of the delivery sheath 140 and / or may be the distal extent of the delivery sheath 140. In at least some embodiments, the circumferential ring 144 may extend continuously and / or uninterruptedly around the circumference of the delivery lumen 142 and / or the delivery sheath 140.

[0070] In some embodiments, the delivery sheath 140 may include a plurality of longitudinal slots 150 disposed and / or formed in a sidewall 146 of the delivery sheath 140. The plurality of longitudinal slots 150 may be formed as openings and / or holes located within the sidewall 146 of the delivery sheath 140. Therefore, the plurality of longitudinal slots 150 can be understood as voids formed in portions of the sidewall 146 or voids formed in portions of the sidewall 146 not containing material forming the sidewall 146. In some embodiments, the plurality of longitudinal slots 150 may be formed by removing material from the sidewall 146 of the delivery sheath 140. Other configurations and / or methods for forming the plurality of longitudinal slots 150 are also contemplated.

[0071] In some embodiments, the plurality of longitudinal slots 150 may include two longitudinal slots, three longitudinal slots, four longitudinal slots, five longitudinal slots, six longitudinal slots, seven longitudinal slots, eight longitudinal slots, nine longitudinal slots, ten longitudinal slots, eleven longitudinal slots, twelve longitudinal slots, thirteen longitudinal slots, fourteen longitudinal slots, fifteen longitudinal slots, sixteen longitudinal slots, seventeen longitudinal slots, eighteen longitudinal slots, nineteen longitudinal slots, twenty longitudinal slots, or other suitable or desired number of longitudinal slots.

[0072] In some embodiments, the plurality of longitudinal slots 150 may have an axial length between approximately 0.127 mm (0.005 inch) and approximately 50.8 mm (2.0 inch). In some embodiments, the plurality of longitudinal slots 150 may have an axial length between approximately 0.1905 mm (0.0075 inch) and approximately 38.1 mm (1.5 inch). In some embodiments, the plurality of longitudinal slots 150 may have an axial length between approximately 0.254 mm (0.01 inch) and approximately 25.4 mm (1.0 inch). In some embodiments, the plurality of longitudinal slots 150 may have an axial length between approximately 0.508 mm (0.02 inch) and approximately 19.05 mm (0.75 inch). Other axial lengths are also contemplated.

[0073] In some embodiments, the plurality of longitudinal slots 150 may have a lateral width and / or circumferential width between approximately 0.0127 mm (0.0005 inches) and approximately 12.7 mm (0.5 inches). In some embodiments, the plurality of longitudinal slots 150 may have a lateral width and / or circumferential width between approximately 0.01905 mm (0.00075 inches) and approximately 6.35 mm (0.25 inches). In some embodiments, the plurality of longitudinal slots 150 may have a lateral width and / or circumferential width between approximately 0.0254 mm (0.001 inches) and approximately 5.08 mm (0.2 inches). In some embodiments, the plurality of longitudinal slots 150 may have a lateral width and / or circumferential width between approximately 0.0508 mm (0.002 inches) and approximately 2.54 mm (0.1 inches). Other lateral widths and / or circumferential widths are also contemplated.

[0074] In some embodiments, the circumferential ring 144 may have an axial length between approximately 0.127 mm (0.005 inches) and approximately 50.8 mm (2.0 inches). In some embodiments, the circumferential ring 144 may have an axial length between approximately 0.1905 mm (0.0075 inches) and approximately 38.1 mm (1.5 inches). In some embodiments, the circumferential ring 144 may have an axial length between approximately 0.254 mm (0.01 inches) and approximately 25.4 mm (1.0 inch). In some embodiments, the circumferential ring 144 may have an axial length between approximately 0.508 mm (0.02 inches) and approximately 19.05 mm (0.75 inches). Other axial lengths are also contemplated.

[0075] In some embodiments, a plurality of longitudinal slots 150 may be disposed proximal to the circumferential ring 144. In some embodiments, the plurality of longitudinal slots 150 may be spaced apart from the distal end of the delivery sheath 140. In some embodiments, the plurality of longitudinal slots 150 may be disposed adjacent to the circumferential ring 144. In some embodiments, the plurality of longitudinal slots 150 may be disposed immediately adjacent to the circumferential ring 144.

[0076] In some embodiments, a plurality of longitudinal slots 150 may be arranged around and / or around the central longitudinal axis of the delivery sheath 140. In some embodiments, the plurality of longitudinal slots 150 may be arranged in an array and / or arranged to extend circumferentially around and / or around the delivery sheath 140 and / or the central longitudinal axis of the delivery sheath 140. The plurality of longitudinal slots 150 may be circumferentially spaced apart from each other.

[0077] In some embodiments, the plurality of longitudinal slots 150 may extend completely through the sidewalls 146 of the delivery sheath 140, as in Figure 4AAs seen in the embodiments. In some embodiments, a plurality of longitudinal slots 150 may extend from the outer surface of the delivery sheath 140 to the delivery lumen 142 and / or the inner surface of the delivery sheath 140. In some embodiments, the delivery lumen 142 may be in fluid communication with the outside of the delivery sheath 140 through the plurality of longitudinal slots 150.

[0078] In some embodiments, a plurality of longitudinal slots 150 may extend partially through the sidewalls 146 of the delivery sheath 140, as in Figure 4B As seen in the diagram. In some embodiments, a plurality of longitudinal slots 150 may extend radially inward from the outer surface of the delivery sheath 140. In some alternative configurations, a plurality of longitudinal slots 150 may extend radially outward from the inner surface of the delivery sheath 140. In some embodiments, the plurality of longitudinal slots 150 may include longitudinal slots extending radially inward from the outer surface of the delivery sheath 140 and longitudinal slots extending radially outward from the inner surface of the delivery sheath 140. Other configurations and / or combinations thereof are also contemplated.

[0079] In some embodiments, the plurality of longitudinal slots 150 may extend through approximately 10% of the sidewall 146 of the delivery sheath 140. In some embodiments, the plurality of longitudinal slots 150 may extend through approximately 20% of the sidewall 146 of the delivery sheath 140. In some embodiments, the plurality of longitudinal slots 150 may extend through approximately 30% of the sidewall 146 of the delivery sheath 140. In some embodiments, the plurality of longitudinal slots 150 may extend through approximately 40% of the sidewall 146 of the delivery sheath 140. In some embodiments, the plurality of longitudinal slots 150 may extend through approximately 50% of the sidewall 146 of the delivery sheath 140. In some embodiments, the plurality of longitudinal slots 150 may extend through approximately 60% of the sidewall 146 of the delivery sheath 140. In some embodiments, the plurality of longitudinal slots 150 may extend through approximately 70% of the sidewall 146 of the delivery sheath 140. In some embodiments, the plurality of longitudinal slots 150 may extend through approximately 80% of the sidewall 146 of the delivery sheath 140. In some embodiments, the plurality of longitudinal slots 150 may extend through approximately 90% of the sidewall 146 of the delivery sheath 140. Other configurations are also envisioned.

[0080] In some embodiments, various combinations of longitudinal slots that extend completely through the sidewall 146 and longitudinal slots that extend partially through the sidewall 146 are also contemplated. In some embodiments, the combination of longitudinal slots that extend completely through the sidewall 146 and longitudinal slots that extend partially through the sidewall 146 may include different amounts of longitudinal slots extending through the sidewall 146 (e.g., some longitudinal slots extend completely through the sidewall 146, some longitudinal slots extend through a first percentage of the sidewall 146, some longitudinal slots extend through a second percentage of the sidewall 146, etc.).

[0081] As discussed herein, in some embodiments, the sidewall 146 and / or the delivery sheath 140 may be formed of a polymer material. In some embodiments, a second polymer material 152, different from the polymer material, may be disposed within at least one of the plurality of longitudinal slots 150, such as in Figures 5-6 As seen in the embodiments. In some embodiments, the second polymer material 152 may be a material that is softer and / or less hard than the polymer material. In some embodiments, the second polymer material 152 may be more elastic and / or able to stretch or elongate further than the polymer material without breaking and / or failing. In some embodiments, the second polymer material 152 may be disposed in each of the plurality of longitudinal slots 150. In some embodiments, the second polymer material 152 may be disposed in a subset of the plurality of longitudinal slots 150, or only in some of the plurality of longitudinal slots 150. In some embodiments, the second polymer material 152 may be disposed in only one of the plurality of longitudinal slots 150.

[0082] In some embodiments, the second polymer material 152 may extend completely through the sidewall 146 of the delivery sheath 140, as in Figure 6 As seen in the embodiments. In some embodiments, the second polymer material 152 may extend from the outer surface of the delivery sheath 140 to the delivery lumen 142 and / or the inner surface of the delivery sheath 140. In some embodiments, the second polymer material 152 may prevent the delivery lumen 142 from fluid communication with the outside of the delivery sheath 140.

[0083] In some embodiments, the second polymer material 152 may extend partially through the sidewall 146 of the delivery sheath 140. In some embodiments, the second polymer material 152 may extend radially inward from the outer surface of the delivery sheath 140. In some alternative configurations, the second polymer material 152 may extend radially outward from the inner surface of the delivery sheath 140. In some embodiments, the second polymer material 152 may be disposed between the inner surface and the outer surface of the delivery sheath 140. In some embodiments, the inward-facing surface of the second polymer material 152 may be radially spaced from the inner surface of the delivery sheath 140, and / or the outward-facing surface of the second polymer material 152 may be radially spaced from the outer surface of the delivery sheath 140. Other configurations and / or combinations thereof are also contemplated.

[0084] In some embodiments, the radial thickness of the second polymer material 152 may be approximately 10% of the thickness of the sidewall 146 of the delivery sheath 140. In some embodiments, the radial thickness of the second polymer material 152 may be approximately 20% of the thickness of the sidewall 146 of the delivery sheath 140. In some embodiments, the radial thickness of the second polymer material 152 may be approximately 30% of the thickness of the sidewall 146 of the delivery sheath 140. In some embodiments, the radial thickness of the second polymer material 152 may be approximately 40% of the thickness of the sidewall 146 of the delivery sheath 140. In some embodiments, the radial thickness of the second polymer material 152 may be approximately 50% of the thickness of the sidewall 146 of the delivery sheath 140. In some embodiments, the radial thickness of the second polymer material 152 may be approximately 60% of the thickness of the sidewall 146 of the delivery sheath 140. In some embodiments, the radial thickness of the second polymer material 152 may be approximately 70% of the thickness of the sidewall 146 of the delivery sheath 140. In some embodiments, the radial thickness of the second polymer material 152 may be approximately 80% of the thickness of the sidewall 146 of the delivery sheath 140. In some embodiments, the radial thickness of the second polymer material 152 may be approximately 90% of the thickness of the sidewall 146 of the delivery sheath 140. Other configurations are also contemplated.

[0085] In some embodiments, the plurality of longitudinal slots 150 may include a first plurality of longitudinal slots 151 having a first length (e.g., a first longitudinal length or a first axial length) and a second plurality of longitudinal slots 153 having a second length different from the first length (e.g., a second longitudinal length or a second axial length), as shown in Figure 7 As seen in the previous embodiments. In at least some embodiments, the second length may be less than the first length. In some embodiments, the plurality of longitudinal slots 150 may include additional plurality of longitudinal slots with lengths different from the first length and / or the second length (e.g., a third plurality of longitudinal slots with a third length, etc.).

[0086] In some embodiments, the first plurality of longitudinal slots 151 may be arranged alternately with the second plurality of longitudinal slots 153 around the circumference of the delivery sheath 140. Other patterns and / or distributions of the first plurality of longitudinal slots 151 and / or the second plurality of longitudinal slots 153 around the circumference of the delivery sheath 140 are also contemplated. In a non-limiting example, the first plurality of longitudinal slots 151 may be arranged in pairs, with individual longitudinal slots of the second plurality of longitudinal slots 153 positioned between adjacent pairs of the first plurality of longitudinal slots 151 around the circumference of the delivery sheath 140 (e.g., a "two-one-two" configuration). Other examples may include, but are not limited to, "three-one-three" configurations, "two-two-two" configurations, "one-three-one" configurations, etc.

[0087] In some embodiments, the plurality of longitudinal slots 150 may include longitudinal slots 155 in a first circumferential row and longitudinal slots 157 in a second circumferential row disposed near the longitudinal slots 155 in the first circumferential row, as shown in Figure 8 As seen in the diagram. The longitudinal slots 155 of the first circumferential row may be axially and / or longitudinally spaced from the longitudinal slots 157 of the second circumferential row. In some embodiments, the delivery sheath 140 may include a second circumferential ring 148 integrally formed with the delivery sheath 140. In some embodiments, the second circumferential ring 148 may be disposed proximal to the circumferential ring 144 and / or the longitudinal slots 155 of the first circumferential row. In some embodiments, the second circumferential ring 148 may be axially disposed between the longitudinal slots 155 of the first circumferential row and the longitudinal slots 157 of the second circumferential row. In at least some embodiments, the second circumferential ring 148 may extend continuously and / or uninterruptedly around the circumference of the delivery lumen 142 and / or the delivery sheath 140.

[0088] In some embodiments, the second circumferential ring 148 may have a longitudinal dimension or longitudinal range similar to that of the circumferential ring 144. In some embodiments, the longitudinal dimension or longitudinal range of the second circumferential ring 148 may be equal to that of the circumferential ring 144. In some embodiments, the longitudinal dimension or longitudinal range of the second circumferential ring 148 may be smaller than that of the circumferential ring 144. In some embodiments, the longitudinal dimension or longitudinal range of the second circumferential ring 148 may be larger than that of the circumferential ring 144.

[0089] Circumferentially adjacent longitudinal slots in the longitudinal slots 155 of the first circumferential row may be circumferentially spaced apart from each other around the circumference of the delivery sheath 140. Circumferentially adjacent longitudinal slots in the longitudinal slots 157 of the second circumferential row may be circumferentially spaced apart from each other around the circumference of the delivery sheath 140. In some embodiments, the circumferentially adjacent longitudinal slots in the longitudinal slots 157 of the second circumferential row may be circumferentially spaced apart by a greater distance than the circumferentially adjacent longitudinal slots in the longitudinal slots 155 of the first circumferential row.

[0090] In some embodiments, the longitudinal slots 155 of the first circumferential row may include a first number of longitudinal slots, while the longitudinal slots 157 of the second circumferential row may include a second number of longitudinal slots, fewer than the first number. For example, the longitudinal slots 155 of the first circumferential row may have more longitudinal slots extending circumferentially around the delivery sheath 140 than the longitudinal slots 157 of the second circumferential row. Generally, for the delivery sheath 140, it may be advantageous to have more “open spaces,” cut-out areas, gaps, or material removed from the sidewalls in the sidewalls 146 around its circumference at locations closer to the distal end of the delivery sheath 140. Therefore, it is also envisioned that the first number of longitudinal slots may be fewer than the second number of longitudinal slots, with the additional condition or feature that the longitudinal slots in the first circumferential row of longitudinal slots 155 are larger or wider in the circumferential direction than the longitudinal slots in the second circumferential row of longitudinal slots 157 (e.g., more sidewalls 146 are retained between the longitudinal slots in the second circumferential row of longitudinal slots 157, rather than between the longitudinal slots in the first circumferential row of longitudinal slots 155).

[0091] In some embodiments, each longitudinal slot in the longitudinal slots 157 of the second circumferential row may be axially aligned with one longitudinal slot in the longitudinal slots 155 of the first circumferential row. In some embodiments, each longitudinal slot in the longitudinal slots 157 of the second circumferential row may engage and / or combine with one longitudinal slot in the longitudinal slots 155 of the first circumferential row to form an elongated longitudinal slot interrupted by the second circumferential ring 148. In some embodiments, the elongated longitudinal slot interrupted by the second circumferential ring 148 may alternate with shorter longitudinal slots formed by the remaining slots in the longitudinal slots 155 of the first circumferential row around the circumference of the delivery sheath 140, wherein the remaining slots in the longitudinal slots of the first circumferential row are not included in or are not used to form the elongated longitudinal slot interrupted by the second circumferential ring 148.

[0092] In some embodiments, at least one of the plurality of longitudinal slots 150 is wider at its distal end than at its proximal end. In some embodiments, at least one of the plurality of longitudinal slots 150 may be stepped from its proximal end toward its distal end and / or toward its distal end. In some embodiments, at least one of the plurality of longitudinal slots 150 may taper from its proximal end toward its distal end and / or toward its distal end, as in... Figure 9 As seen in the image. Other configurations have also been envisioned.

[0093] In some alternative embodiments, the delivery sheath 140 may include a circumferential ring 144 integrally formed therewith at the distal end of the delivery sheath 140 and a plurality of longitudinal strips 160 formed of a second polymer material different from the polymer material forming the delivery sheath 140 and / or the sidewalls 146 of the delivery sheath 140. (As in...) Figures 10-11 As seen, multiple longitudinal strips 160 can be embedded within the sidewalls 146 of the delivery sheath 140, located proximal to the circumferential ring 144. The second polymer material forming the multiple longitudinal strips 160 can be a softer and / or less rigid material than the polymer material. In some embodiments, the second polymer material can be more elastic and / or able to stretch or elongate further than the polymer material without breaking and / or failing.

[0094] In some embodiments, the plurality of longitudinal strips 160 may include a first plurality of longitudinal strips having a first length (e.g., a first longitudinal length or a first axial length) and a second plurality of longitudinal strips having a second length (e.g., a second longitudinal length or a second axial length) different from the first length, similar to the above. Figure 7 The plurality of longitudinal slots 150. In at least some embodiments, the second length may be less than the first length. In some embodiments, the plurality of longitudinal strips 160 may include additional plurality of longitudinal slots with lengths different from the first length and / or the second length (e.g., a third plurality of longitudinal slots with a third length, etc.).

[0095] In some embodiments, the first plurality of longitudinal strips may be arranged alternately with the second plurality of longitudinal strips around the circumference of the delivery sheath 140. Other patterns and / or distributions of the first plurality of longitudinal strips and / or the second plurality of longitudinal strips around the circumference of the delivery sheath 140 are also contemplated. In a non-limiting example, the first plurality of longitudinal strips may be arranged in pairs, with individual longitudinal slots in the second plurality of longitudinal strips positioned between adjacent pairs of the first plurality of longitudinal strips around the circumference of the delivery sheath 140 (e.g., a "two-one-two" configuration). Other examples may include, but are not limited to, "three-one-three" configurations, "two-two-two" configurations, "one-three-one" configurations, etc.

[0096] In some embodiments, the plurality of longitudinal strips 160 may include longitudinal strips of a first circumferential row and longitudinal strips of a second circumferential row disposed proximal to the longitudinal strips of the first circumferential row, similar to the above. Figure 8Multiple longitudinal slots 150. The longitudinal strips of the first circumferential row may be axially and / or longitudinally spaced from the strips of the second circumferential row. In some embodiments, the delivery sheath 140 may include a second circumferential ring (similar to the second circumferential ring 148 above), which is integrally formed with the delivery sheath 140 and disposed proximal to the circumferential ring 144 and / or the longitudinal strips of the first circumferential row. In some embodiments, the second circumferential ring may be axially disposed between the longitudinal strips of the first circumferential row and the longitudinal strips of the second circumferential row. In at least some embodiments, the second circumferential ring may extend continuously and / or uninterruptedly around the circumference of the delivery lumen 142 and / or the delivery sheath 140.

[0097] In some embodiments, the second circumferential ring may have a longitudinal dimension or longitudinal range similar to that of the circumferential ring 144. In some embodiments, the longitudinal dimension or longitudinal range of the second circumferential ring may be equal to that of the circumferential ring 144. In some embodiments, the longitudinal dimension or longitudinal range of the second circumferential ring may be smaller than that of the circumferential ring 144. In some embodiments, the longitudinal dimension or longitudinal range of the second circumferential ring may be larger than that of the circumferential ring 144.

[0098] Circumferentially adjacent longitudinal slots in the longitudinal strips of the first circumferential row may be circumferentially spaced apart from each other around the circumference of the conveying sheath 140. Circumferentially adjacent longitudinal slots in the longitudinal strips of the second circumferential row may be circumferentially spaced apart from each other around the circumference of the conveying sheath 140. In some embodiments, the circumferentially adjacent longitudinal slots in the longitudinal strips of the second circumferential row may be circumferentially spaced apart by a greater distance than the circumferentially adjacent longitudinal slots in the longitudinal strips of the first circumferential row.

[0099] In some embodiments, the longitudinal strips of the first circumferential row may include a first number of longitudinal strips, while the longitudinal strips of the second circumferential row may include a second number of longitudinal strips, fewer than the first number. For example, the longitudinal strips of the first circumferential row may have more longitudinal strips extending circumferentially around the delivery sheath 140 than the longitudinal strips of the second circumferential row. Generally, it may be advantageous for the delivery sheath 140 to have more of the second polymer material located closer to the distal end of the delivery sheath 140. Thus, it is also contemplated that the first number of longitudinal strips may be fewer than the second number of longitudinal strips, with the additional condition or characteristic that the longitudinal slots of the longitudinal strips of the first circumferential row are larger or wider in the circumferential direction than the longitudinal strips in the longitudinal strips of the second circumferential row (e.g., more sidewalls 146 are retained between the longitudinal strips in the second circumferential row than between the longitudinal strips in the first circumferential row).

[0100] In some embodiments, each longitudinal strip in the second circumferential row may be axially aligned with one longitudinal strip in the first circumferential row. In some embodiments, each longitudinal strip in the second circumferential row may engage and / or combine with one longitudinal strip in the first circumferential row to form an elongated longitudinal strip interrupted by a second circumferential ring. In some embodiments, the elongated longitudinal slot interrupted by the second circumferential ring may alternate with shorter longitudinal strips formed by the remaining strips in the first circumferential row around the circumference of the delivery sheath 140, wherein the remaining strips in the first circumferential row are not included in or are not used to form the elongated longitudinal strip interrupted by the second circumferential ring.

[0101] In some embodiments, at least one of the plurality of longitudinal strips 160 is wider at its distal end than at its proximal end. In some embodiments, at least one of the plurality of longitudinal strips 160 may be stepped from its proximal end toward its distal end and / or toward its distal end. In some embodiments, at least one of the plurality of longitudinal strips 160 may taper from its proximal end toward its distal end and / or toward its distal end. Other configurations are also contemplated.

[0102] Figures 12-13 Various aspects of the delivery sheath 140 during recapture of the occlusive implant 200 are illustrated. As discussed herein, the access sheath can be used in conjunction with the occlusive implant system and / or delivery system, and therefore can include some and / or all of the features associated with the delivery sheath 140.

[0103] In use, after the occlusive implant 200 is deployed, imaging and / or other verification techniques can determine that placement is inadequate or that the occlusive implant 200 needs to be repositioned and / or removed. In some embodiments, the delivery system can be used to recapture the occlusive implant 200 for removal and / or repositioning within the left atrial appendage. When the occlusive implant 200 is pulled into the delivery lumen 142 of the delivery sheath 140 and the expandable frame is switched from a deployed configuration to a delivery configuration and / or to a delivery configuration (e.g., when the expandable frame is collapsed), the distal end and / or distal end region of the delivery sheath 140 can be configured to resiliently expand radially outward to prevent damage to the occlusive implant 200, the expandable frame 210 and / or the occlusive element 220, and the delivery sheath 140.

[0104] Multiple longitudinal slots 150 can be configured to allow radial outward expansion of the distal end and / or distal end region of the delivery sheath 140. By adding multiple longitudinal slots 150 to the delivery sheath 140, the delivery sheath 140 can be more flexible and / or allowed to expand elastically by a greater amount and / or a greater amplitude compared to the absence of multiple longitudinal slots 150. If the delivery sheath 140 is not allowed to expand radially outward sufficiently, the delivery sheath 140 may fail under the forces applied during recapture, such as rupture, splitting, and / or opening, thus creating a potentially dangerous feature on the delivery sheath 140 located within the patient's anatomy.

[0105] During the recapture of the occlusive implant 200, as in Figures 12-13 As seen herein, the circumferential ring 144, sidewall 146, and / or multiple longitudinal slots 150 (which may include different configurations and / or arrangements as described herein) can be stretched and / or expanded radially outward and / or circumferentially. The distal end of the delivery sheath 140 and / or the circumferential ring 144 can be configured to expand by a greater amount and / or a greater magnitude than the remainder of the delivery sheath 140. In some embodiments, the distal ends and / or distal portions of the multiple longitudinal slots 150 can be configured to expand by a greater amount and / or a greater magnitude than the proximal ends and / or proximal portions of the multiple longitudinal slots 150. In some embodiments, the delivery sheath 140 can be stiffer, less elastic, and / or less flexible in the proximal direction. In some embodiments, the distal end of the delivery sheath 140 can be more elastic and / or more flexible and / or less rigid than the remainder of the delivery sheath 140.

[0106] The materials that can be used in various components (and / or other elements disclosed herein) of occlusive implant systems and of such components may include materials commonly associated with medical devices and / or systems. For simplicity, the following discussion refers to systems. However, this is not intended to limit the devices and methods described herein, as the discussion can be applied to other elements, components, parts, or devices disclosed herein, such as, but not limited to, delivery systems, delivery sheaths, occlusive implants, cored wires, expandable frames, occlusive elements, etc., and / or their elements or parts.

[0107] In some embodiments, the system and / or its components may be made of metal, metal alloy, polymer (some examples of which are disclosed below), metal-polymer composites, ceramics, combinations thereof, or other suitable materials.

[0108] Some examples of suitable metals and metal alloys include: stainless steels, such as 304 and / or 316 stainless steel and / or variants thereof; low-carbon steels; nickel-titanium alloys, such as linearly elastic and / or hyperelastic nickel-titanium alloys; 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, NICK). ELVAC®400, NICORROS®400, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R44035, such as MP35-N®, etc.), nickel-molybdenum alloys (e.g., UNS: N10665, such as HASTELLOY®ALLOYB2®), 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 steel; titanium; combinations thereof; and similar materials; or any other suitable material.

[0109] In at least some embodiments, some or all of the systems and / or other elements disclosed herein may also be doped with, made of, or otherwise comprise a radiopaque material. A radiopaque material is understood to be a material capable of producing a relatively bright image on a fluorescent examination screen or another imaging technique (e.g., ultrasound) during a medical procedure. This relatively bright image helps the user determine the location and / or orientation of the systems and / or other elements 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.

[0110] In some embodiments, a degree of magnetic resonance imaging (MRI) compatibility is imparted to the systems and / or other components disclosed herein. For example, the system and / or its components or portions may be made of materials that substantially do not distort the image or produce significant artifacts (i.e., gaps in the image). For example, certain ferromagnetic materials may be unsuitable because they may produce artifacts in MRI images. The system or portions thereof may also be made of materials that can be imaged by an MRI machine. Some materials exhibiting these properties include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS: R44003, such as ELGILOY®, PHYNOX®, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R44035, such as MP35-N®, etc.), nitinol, and similar materials, among others.

[0111] In some embodiments, the systems and / or other elements disclosed herein may be made of, or comprise polymers or other suitable materials. Some examples of suitable polymers may include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., DELRIN®), polyether block copolymers, polyurethane, polypropylene (PP), polyvinyl chloride (PVC), polyether esters (e.g., ARNITEL®), ether or ester copolymers (e.g., butene / poly(alkylene ether) phthalate and / or other polyester elastomers, such as HYTREL®), polyamides (e.g., DURETHAN® or CRISTAMID®), elastic polyamides, block polyamides / ethers, polyether block amides (PEBA, e.g., PEBAX®), ethylene vinyl acetate copolymers (EVA), silicone, polyethylene (PE), MARLEX® high-density polyethylene, MAR LEX® low-density polyethylene, linear low-density polyethylene (e.g., REXELL®), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polypropylene 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., GRILAMID®), perfluoropropyl vinyl ether (PFA), ethylene-vinyl alcohol, polyolefins, polystyrene, epoxy resins, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS) 50A), polycarbonate, polyurethane-silicone copolymers (e.g., Elast-Eon® or ChronoSil®), ionomers, 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 6 percent LCP.

[0112] In some embodiments, the systems and / or other elements disclosed herein may include fabric materials disposed on or within a structure. The fabric material may consist of biocompatible materials (such as polymeric or biomaterials) suitable for promoting inward tissue growth. In some embodiments, the fabric material may include bioabsorbable materials. Some examples of suitable fabric materials include, but are not limited to, polyethylene glycol (PEG), nylon, polytetrafluoroethylene (PTFE, ePTFE), polyolefin materials such as polyethylene, polypropylene, polyester, polyurethane, and / or blends or combinations thereof.

[0113] In some embodiments, the systems and / or other elements disclosed herein may include textile materials and / or be formed from textile materials. Some examples of suitable textile materials may include synthetic yarns, which may be flat, shaped, twisted, textured, pre-shrinked, or unshrinked. Suitable synthetic biocompatible yarns for use in this disclosure include, but are not limited to, polyesters, including polyethylene terephthalate (PET) polyesters, polypropylene, polyethylene, polyurethane, polyolefins, polyethylene, polyacetate, polyamide, naphthalene dicarboxylene derivatives, natural silk, and polytetrafluoroethylene. Furthermore, at least one of the synthetic yarns may be a metallic yarn or a glass or ceramic yarn or fiber. Useful metallic yarns include yarns made of or containing stainless steel, platinum, gold, titanium, tantalum, or nickel-cobalt-chromium based alloys. The yarn may further include carbon, glass, or ceramic fibers. Ideally, the yarn is made of a thermoplastic material, including but not limited to polyester, polypropylene, polyethylene, polyurethane, polynaphthalene, polytetrafluoroethylene, etc. The yarn may be multifilament, monofilament, or spun yarn. The type and denier of the selected yarn can be chosen to form biocompatible and implantable prostheses, or more specifically, to form vascular structures with ideal characteristics.

[0114] In some embodiments, the systems and / or other elements disclosed herein may include suitable therapeutic agents and / or be treated with suitable therapeutic agents. Examples of suitable therapeutic agents may include: antithrombotic agents (such as heparin, heparin derivatives, urokinase, and PPack (d-phenylalanine-proline-arginine-chloromethyl ketone)); antiproliferative agents (such as enoxaparin, angiopeptidase, 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 agents, endostatin, angiostatin, and thymidine kinase inhibitors); anesthetics (such as lidocaine, bupivacaine, and ropivacaine); anticoagulants (such as D-Phe-Pro-Arg chloromethyl ketone, compounds containing RGD peptides, heparin, antithrombin compounds, platelet receptor antagonists, antithrombin antibodies, and anti-inflammatory agents). Platelet 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 inhibitors, translation inhibitors, replication inhibitors, inhibitory antibodies, antibodies against growth factors, bifunctional molecules composed of growth factors and cytotoxins, and bifunctional molecules composed of antibodies and cytotoxins); immunosuppressants (such as "olimus" series drugs, rapamycin analogs, macrolide antibiotics, biomus, everolimus, zotamolimus, tesimolimus, pimecrolimus, novimus, mycolimus, tacrolimus, sirolimus, pimecrolimus, etc.); cholesterol lowering agents; vasodilators; and agents that interfere with endogenous vasoactivity mechanisms.

[0115] It should be understood that this disclosure is illustrative in many respects only. Changes may be made in details, particularly in shape, size, and arrangement of steps, without departing from the scope of this disclosure. To the appropriate extent, this may include any feature used in one example embodiment (which may be used in other embodiments). Of course, the scope of this disclosure is defined in the language of the appended claims.

Claims

1. A delivery system for occlusive implants, the delivery system comprising: A delivery sheath having a delivery lumen extending from a distal end of the delivery sheath to a proximal end, the delivery sheath being formed of a polymer material; and A core wire, which is slidably disposed within the delivery lumen, is configured to releasably engage the occlusive implant; The delivery sheath includes a circumferential ring integrally formed therewith at the distal end of the delivery sheath and a plurality of longitudinal slots disposed on the proximal side of the circumferential ring.

2. The conveying system according to claim 1, wherein, The plurality of longitudinal slots extend partially through the sidewalls of the delivery sheath.

3. The conveying system according to claim 1, wherein, The plurality of longitudinal slots extend completely through the sidewalls of the delivery sheath.

4. The conveying system according to claim 3, wherein, A second polymer material, different from the polymer material, is disposed in at least one of the plurality of longitudinal slots.

5. The conveying system according to any one of claims 1-4, wherein, The plurality of longitudinal slots includes a first plurality of longitudinal slots having a first length and a second plurality of longitudinal slots having a second length different from the first length.

6. The conveying system according to claim 5, wherein, The first plurality of longitudinal slots and the second plurality of longitudinal slots are arranged alternately around the circumference of the delivery sheath.

7. The conveying system according to any one of claims 1-6, wherein, The plurality of longitudinal slots includes longitudinal slots in a first circumferential row and longitudinal slots in a second circumferential row disposed near the longitudinal slots in the first circumferential row. The delivery sheath further includes a second circumferential ring integrally formed with the delivery sheath; The second circumferential ring is axially disposed between the longitudinal slots of the first circumferential row and the longitudinal slots of the second circumferential row.

8. The conveying system according to claim 7, wherein, The adjacent longitudinal slots in the second circumferential row are circumferentially spaced further apart than the adjacent longitudinal slots in the first circumferential row.

9. The conveying system according to any one of claims 7-8, wherein, The longitudinal slots of the first circumferential row include a first number of longitudinal slots, while the longitudinal slots of the second circumferential row include a second number of longitudinal slots that is less than the first number of longitudinal slots.

10. The conveying system according to any one of claims 7-9, wherein, Each longitudinal slot in the second circumferential row is axially aligned with one longitudinal slot in the first circumferential row.

11. The conveying system according to any one of claims 1-6, wherein, At least one of the plurality of longitudinal slots is wider at the distal end of the at least one longitudinal slot than at the proximal end of the at least one longitudinal slot.

12. The conveying system according to claim 11, wherein, The at least one longitudinal slot tapers from the proximal end to the distal end.

13. A delivery system for an occlusive implant, the delivery system comprising: A delivery sheath having a delivery lumen extending from a distal end of the delivery sheath to a proximal end, the delivery sheath being formed of a polymer material; and A core wire, which is slidably disposed within the delivery lumen, is configured to releasably engage the occlusive implant; The delivery sheath includes a circumferential ring integrally formed therewith at the distal end of the delivery sheath and a plurality of longitudinal strips formed of a second polymer material different from the polymer material; The plurality of longitudinal strips are embedded in the sidewall of the delivery sheath, located near the circumferential ring.

14. An occlusive implant system, comprising: An occlusive implant comprising an expandable frame and an occlusive element fixed to the expandable frame, wherein the occlusive implant is configured to switch between a delivery configuration and a deployment configuration; and The conveying system according to any one of claims 1-13; In the delivery configuration, the occlusive implant is disposed in the distal portion of the delivery lumen.

15. The occlusive implant system according to claim 14, wherein, The distal end of the delivery sheath is configured to expand radially outward during recapture of the occlusive implant.

Images