Occlusive implant system

Abstract

A delivery system for an occlusive implant may include a delivery sheath having a delivery lumen extending proximal to the distal end of the delivery sheath, and a core wire slidably disposed within the delivery lumen. The core wire may be configured to engage releasably with the occlusive implant. The delivery sheath may include a circumferential ring monolithically formed with the delivery sheath at the distal end of the delivery sheath, and a plurality of elongated 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 placement configuration, and a delivery system for the occlusive implant. The occlusive implant may be positioned within the distal portion of the delivery lumen in the delivery configuration.

Description

Technical Field

[0001] The present disclosure generally relates to medical devices, and more specifically, to medical devices adapted for use in percutaneous medical procedures including implantation into the left atrial appendage (LAA) of the heart.

Background Art

[0002] The left atrial appendage is a small organ attached to the left atrium of the heart. During normal heart function, when the left atrium contracts to pump blood into the left ventricle, the left atrial appendage contracts to pump blood into the left atrium. The ability of the left atrial appendage to contract plays a role in maintaining cardiac output by helping to improve filling of the left ventricle. However, in patients with atrial fibrillation, the left atrial appendage may not be able to contract or eject properly, resulting in blood pooling inside the left atrial appendage and potentially leading to the formation of unwanted thrombi within the left atrial appendage.

[0003] Thrombi formed in the left atrial appendage may break free from this area and enter the bloodstream. Thrombi that move through the blood vessels can ultimately contribute to a stroke or heart attack by occluding smaller blood vessels downstream. Clinical studies have shown that the majority of thrombi in patients with atrial fibrillation originate within the left atrial appendage. As a treatment, medical devices have been developed for placement to close the left atrial appendage. Known medical devices and methods each have specific advantages and disadvantages. There is a continuing need to provide alternative medical devices and alternative methods for manufacturing and using medical devices.

Summary of the Invention

[0004] In one example, a delivery system for an occlusive implant comprises a delivery sheath having a delivery lumen extending proximal to the distal end of the delivery sheath, and a core wire slidably disposed within the delivery lumen, the core wire being configured to engage releasably with the occlusive implant. The delivery sheath may include a circumferential ring monolithically formed with the delivery sheath at the distal end of the delivery sheath, and a plurality of elongated slots located proximal to the circumferential ring.

[0005] In addition to or as an alternative to any examples disclosed herein, a plurality of elongated slots are arranged adjacent to the circumferential ring. In addition to or as an alternative to any examples disclosed herein, a plurality of elongated slots are partially extended in the thickness direction in the sidewall of the delivery sheath.

[0006] In addition to or as an alternative to any examples disclosed herein, multiple elongated slots extend completely through the side walls of the delivery sheath. In addition to or as an alternative to any examples disclosed herein, a second polymer material, different from the aforementioned polymer material, is placed in at least one of a plurality of elongated slots.

[0007] In addition to or in place of any examples disclosed herein, a plurality of elongated slots may include a plurality of first elongated slots having a first length and a plurality of second elongated slots having a second length different from the first length.

[0008] In addition to or as an alternative to any examples disclosed herein, a plurality of first elongated slots are alternated with a plurality of second elongated slots around the outer circumference of the delivery sheath.

[0009] In addition to or in place of any examples disclosed herein, the plurality of elongated slots include elongated slots in a first circumferential row and elongated slots in a second circumferential row located proximal to the elongated slots in the first circumferential row.

[0010] In addition to or as an alternative to any examples disclosed herein, adjacent elongated slots of a second circumferential row are spaced circumferentially at a greater distance than adjacent elongated slots of a first circumferential row.

[0011] In addition to or as an alternative to any examples disclosed herein, the elongated slots of a first circumferential row include a first quantity of elongated slots, and the elongated slots of a second circumferential row include a second quantity of elongated slots that is less than the first quantity of elongated slots.

[0012] In addition to, or as an alternative to, any example disclosed herein, each elongated slot of the second circumferential row is aligned in the axial direction with one elongated slot of the first circumferential row.

[0013] In addition to or as an alternative to any examples disclosed herein, the delivery sheath further includes a second circumferential ring formed monolithically with respect to the delivery sheath. The second circumferential ring may be positioned in the axial direction between the elongated slots of the first circumferential row and the elongated slots of the second circumferential row.

[0014] In addition to or as an alternative to any examples disclosed herein, at least one of the multiple elongated slots is wider at the distal end of at least one elongated slot than at the proximal end of at least one elongated slot.

[0015] In addition to or as an alternative to any examples disclosed herein, at least one elongated slot is tapered from proximal to distal. In addition to or as an alternative to any examples disclosed herein, an occlusive implant system may include an occlusive implant configured to transition between a delivery configuration and a placement configuration, and a delivery system for the occlusive implant. The delivery system includes a delivery sheath having a delivery lumen extending proximal to the distal end of the delivery sheath and 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 monolithically formed with the delivery sheath at its distal end, and a plurality of elongated slots disposed proximal to the circumferential ring. The occlusive implant may be placed within the distal portion of the delivery lumen in the delivery configuration.

[0016] In addition to or in place of any examples disclosed herein, an occlusive implant includes an expandable framework and an occlusive element fixed to the expandable framework.

[0017] In addition to or as an alternative to any examples disclosed herein, the distal end of the delivery sheath is configured to expand radially outward upon recapture of the occluded implant. In addition to or as an alternative to any example disclosed herein, the circumferential ring extends continuously around the delivery lumen.

[0018] In addition to or as an alternative to any examples disclosed herein, a delivery system for an occlusive implant comprises a delivery sheath having a delivery lumen extending proximal to the distal end of the delivery sheath and formed of a polymer material, and a core wire slidably disposed within the delivery lumen, the core wire being configured to engage releasably with an occlusive implant. The delivery sheath may include a circumferential ring monolithically formed with the delivery sheath at the distal end of the delivery sheath, and a plurality of elongated strips formed of a second polymer material different from the polymer material. The plurality of elongated strips may be embedded in the sidewall of the delivery sheath proximal to the circumferential ring.

[0019] In addition to or as an alternative to any examples disclosed herein, the second polymer material has a lower durometer than the polymer material. The above summary of some embodiments, aspects, and / or examples is not intended to describe any or all embodiments of the present disclosure. The following drawings and detailed description illustrate the above embodiments in more detail. [Brief explanation of the drawing]

[0020] This disclosure can be better understood by considering the following "Modes for Carrying Out the Invention" in relation to the attached drawings. [Figure 1] Figure 1 is a side view of a selected embodiment of the occlusion implant system. [Figure 2] Figure 2 is a side view of a selected embodiment of the occlusion implant system. [Figure 3] Figure 3 shows a selected configuration of the delivery system for the occlusive implant in the occlusive implant system of Figures 1-2. [Figure 4A] Figure 4A is a cross-sectional view showing a selected configuration of the delivery system shown in Figure 3. [Figure 4B] Figure 4B is a cross-sectional view showing a selected configuration of the delivery system shown in Figure 3. [Figure 5] FIG. 5 shows a selected aspect of a delivery system for an occlusion implant of the occlusion implant system of FIGS. 1-2. [Figure 6] FIG. 6 is a cross-sectional view showing a selected aspect of the configuration of the delivery system of FIG. 5. [Figure 7] FIG. 7 shows a selected aspect of a delivery system for an occlusion implant of the occlusion implant system of FIGS. 1-2. [Figure 8] FIG. 8 shows a selected aspect of a delivery system for an occlusion implant of the occlusion implant system of FIGS. 1-2. [Figure 9] FIG. 9 shows a selected aspect of a delivery system for an occlusion implant of the occlusion implant system of FIGS. 1-2. [Figure 10] FIG. 10 shows a selected aspect of a delivery system for an occlusion implant of the occlusion implant system of FIGS. 1-2. [Figure 11] FIG. 11 is a cross-sectional view showing a selected aspect of the configuration of the delivery system of FIG. 10. [Figure 12] FIG. 12 schematically shows a selected aspect of recapturing an occlusion implant using the delivery system according to the present disclosure. [Figure 13] FIG. 13 schematically shows a selected aspect of recapturing an occlusion implant using the delivery system according to the present disclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Aspects of the present disclosure can follow various modifications and alternative forms, and multiple examples are shown in the drawings and described herein. However, it should be understood that this is not intended to limit the present disclosure to the specific embodiments described. On the contrary, all modifications, equivalents, and alternative forms within the spirit and scope of the present disclosure are intended to be covered.

[0022] The following description should be read with reference to the drawings, which are not necessarily to scale, but similar reference numbers indicate similar elements in several figures. The detailed description and drawings are intended to be illustrative and not limiting to the disclosure. Those skilled in the art will recognize that various elements described and / or illustrated can be arranged in various combinations and configurations without departing from the scope of the disclosure. The modes and drawings for carrying out the invention illustrate exemplary embodiments of the disclosure. However, for ease of clarity and understanding, not all features and / or elements may be shown in each drawing, but unless otherwise specified, features and / or elements should be understood to exist independently.

[0023] The following definitions of terms shall apply unless otherwise given in a claim or herein. All numerical values, whether explicitly stated or not, are assumed to be modified by the term “approximately.” In the context of numerical values, “approximately” generally refers to a range of numerical values ​​that a person skilled in the art would consider to be equal to the stated value (e.g., having the same function or result). In many examples, “approximately” includes multiple numerical values ​​rounded to the nearest significant figure. Any other use of the term “approximately” (e.g., in a non-numerical context) is assumed, unless explicitly stated, to have a general and customary definition that can be understood and is consistent with the context of this Specified Publication.

[0024] When specifying a numerical range with an endpoint, all numbers within that range, including the endpoint, are included (for example, 1-5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0025] While several preferred dimensions, ranges, and / or values ​​relating to various components, features, and / or specifications are disclosed, a person skilled in the art inspired by this disclosure will understand that desired dimensions, ranges, and / or values ​​may deviate from those expressly disclosed.

[0026] As used herein and in the appended claims, the singular forms “a,” “an,” and “the” include multiple references unless the content clearly indicates otherwise. When used herein and in the appended claims, the term “or” is generally used to include “and / or” unless the content clearly indicates otherwise. For ease of understanding, it should be noted that certain elements of this disclosure may be described in the singular form even if there are multiple instances of that element in the embodiments in which it is disclosed, or even if there are repetitions. Each example of a feature includes and / or may be encompassed by a singular disclosure unless the opposite is expressly stated. For the sake of brevity and clarity, not all elements of this disclosure are necessarily shown in each drawing or described in detail below. However, the following descriptions may apply equally to any one or more components and / or all components unless expressly refuted. In addition, not all examples of some elements or features are necessarily illustrated in each drawing for the sake of clarity.

[0027] Relative terms such as “proximal,” “distal,” “forward,” “backward,” and their variations may generally be considered in relation to the position, orientation, and / or movement of various elements of the apparatus with respect to the user / operator / manipulator. “Proximal” and “backward” indicate or refer to being closer to or toward the user, while “distal” and “forward” indicate or refer to being further away from or away from the user. In some examples, the terms “proximal” and “distal” are arbitrarily assigned for the purpose of facilitating understanding of this disclosure, and such examples will be readily understood by 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, a blood vessel, or within an apparatus. Yet other relative terms and / or their variations, such as “axial,” “circumferential,” “longitudinal,” “lateral,” and “radial,” generally refer to the direction and / or orientation with respect to the central longitudinal axis of the disclosed structure or apparatus.

[0028] The term “range” may be understood to mean the maximum measurement of a stated or specified dimension unless it is preceded by “minimum” or specifically identified as “minimum,” where “minimum” may be understood to mean the minimum measurement of the stated or identified dimension. For example, the term “outer range” may be understood to mean the outer dimension, the term “radial range” may be understood to mean the radial dimension, and the term “longitudinal range” may be understood to mean the longitudinal range. The examples of “range” are all different (e.g., axial, longitudinal, transverse, radial, circumferential, etc.) and can be understood from the context in which they are used by a person skilled in the art. In general, “range” may be considered to be the maximum possible dimension measured according to the intended use, while the term “minimum range” may be considered to be the minimum possible dimension measured according to the intended use. In some examples, “range” is measured orthogonally within a plane and / or cross-section, but may also be measured obliquely, radially, circumferentially (e.g., along an arc), etc., as is evident from the specific context.

[0029] The terms “monolithic” and “integrated” generally refer to one or more elements made from or consisting of a single structure or basic unit / element. Monolithic elements and / or integrated elements shall exclude structures and / or features made by assembling or otherwise joining together multiple separate elements.

[0030] Descriptions in the specification such as "embodiments," "several embodiments," or "another embodiment" mean that the described embodiments possess a particular element, structure, or characteristic, but not all embodiments necessarily possess that particular element, structure, or characteristic. Furthermore, such phrasing does not necessarily refer to the same embodiment. Moreover, when a particular feature, structure, or characteristic is described in relation to one embodiment, it is within the knowledge of those skilled in the art that, unless explicitly stated otherwise, that particular feature, structure, or characteristic will be affected in relation to other embodiments, whether or not it is explicitly stated. In other words, the various individual elements described later are assumed to be combinable or configurable with respect to each other to form other additional embodiments or to complement and / or enhance the described embodiments, as will be understood by those skilled in the art, even if they are not explicitly shown in a particular combination.

[0031] For clarity, certain numerical nomenclature (e.g., First, Second, Third, Fourth, etc.) may be used throughout the specification and / or claims to name and / or identify various described and / or claimed features. This numerical nomenclature should be understood to be illustrative and not restrictive. In some embodiments, for the sake of brevity and clarity, it may be modified or omitted from previously used numerical nomenclature. That is, a feature identified as the “First” element may later be referred to as the “Second” element, the “Third” element, etc., or may be omitted entirely, and / or a different feature may be referred to as the “First” element. The meaning and / or designation in each instance will be obvious to those skilled in the art.

[0032] The following figures illustrate selected components and / or placements of an implant for occluding the left atrial appendage, a system for occluding the left atrial appendage, and / or methods for using the implant and / or system. Note that in any given figure, some features may be omitted or illustrated schematically for simplification. Additional details regarding some of the components of the implant and / or system may be illustrated in more detail in other figures. Although described in the context of occluding the left atrial appendage, the implant and / or system may also be used for other interventions and / or percutaneous medical procedures in a patient. Similarly, the devices and methods described herein with respect to percutaneous placement may be used for other types of surgical procedures as needed. For example, in some examples, the devices may be used in non-percutaneous procedures. The devices and methods according to this disclosure may be adapted and configured for other uses in anatomical structures.

[0033] Figures 1 and 2 schematically illustrate selected components and / or arrangements of an occlusive implant system. Note that in any given figure, some features of the occlusive implant system may be omitted or schematically illustrated for simplification. Additional details regarding some components of the occlusive implant system may be illustrated in more detail in other figures. Occlusive implant systems can be used to deliver and / or position various medical implants (e.g., cardiovascular implants, occlusive implants, etc.) to one or more locations within anatomical structures, including but not limited to the heart and / or left atrial appendage, in some embodiments. For clarity, the following description refers to occlusive implants, but other medical implants may be used and / or considered in conjunction with occlusive implant systems.

[0034] An occlusive implant system may include a delivery system 100, which includes a delivery sheath 140 having a delivery lumen 142 extending proximal to distal from the distal end of the delivery sheath 140. In one example, the delivery lumen 142 extends from the proximal opening to the 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 possible. 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 possible. In some embodiments, the delivery system 100 and / or delivery lumen 142 may include an intermediate hub 112, an intermediate shaft 114, and a proximal segment (not shown) extending within and / or through the 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 an extension of the delivery lumen 142. In some embodiments, a side port 116 may be in fluid communication with the proximal segment and / or the delivery lumen 142.

[0035] The occlusion implant system and / or delivery system 100 may include a core wire 130 slidably and / or rotatably disposed within a delivery lumen 142 (and proximal segment, if present). The occlusion implant system includes an occlusion implant 200, which is configured to be implanted in the left atrial appendage and may be releasably engaged with and / or releasably attached to the distal end of the core wire 130. In at least some embodiments, the occlusion implant 200 may be a left atrial appendage closure device. In some embodiments, the proximal end of the core wire 130 may extend to the proximal end of a delivery sheath 140 and / or proximal to the proximal opening of the delivery lumen 142 for manual manipulation by a clinician or operator. In at least some embodiments, the delivery sheath 140 may contain and / or be formed from a polymer material. In some embodiments, the delivery sheath 140 may contain and / or be formed from a plurality of polymer materials. In some embodiments, the delivery sheath may include a combination of metal and polymer materials and / or be formed from such a combination. In some embodiments, the delivery sheath 140 may include reinforcing elements such as mesh, coils, braids, etc., formed within the delivery sheath 140, embedded within the delivery sheath 140, or attached to the delivery sheath 140, along at least a portion of the length of the delivery sheath 140. Other configurations are also conceivable. Applicable materials for the occlusion implant system, core wire 130, and / or delivery sheath 140, etc., include, but are not limited to, metal materials, polymer materials, etc., and specific examples thereof will be further described below.

[0036] The occlusive implant 200 may include an expandable framework 210 (e.g., Figure 2) configured to transition between a delivery configuration (e.g., Figure 1) in which the occlusive implant 200 is positioned in and / or within the delivery lumen 142, close to the distal opening, and a configuration (e.g., Figure 2) in which the occlusive implant 200 is not constrained by the delivery sheath 140.

[0037] In some embodiments, the expandable framework 210 may include a plurality of interconnected struts. In some embodiments, the expandable framework 210 may be compliant or semi-compliant and may generally be configured to conform to and / or engage tightly with the shape and / or geometry of the left atrial appendage in its configuration.

[0038] In some embodiments, the proximal end of the expandable framework 210 may be configured to releasably attach, join, connect, engage, or otherwise connect to the distal end of the core wire 130 (e.g., Figure 2). In some embodiments, the proximal end of the expandable framework 210 may include a proximal hub connected to and / or non-releasably attached to that proximal end. In some embodiments, the proximal hub may be configured and / or adapted to releasably connect, join, mesh, or otherwise engage with the distal end of the core wire 130. Other means for releasably connecting and / or engaging the expandable framework 210 to the distal end of the core wire 130 are also conceivable.

[0039] In some embodiments, the occlusion implant 200 may include an occlusion element 220 (e.g., a membrane, fabric, or tissue element, etc.) that is connected to, positioned on, covering, circumferentially, or covering at least a portion of the expandable framework 210. In some embodiments, the occlusion element 220 may be connected to, positioned on, covering, circumferentially, or covering at least a portion of the outer surface (or outward-facing surface) of the expandable framework 210.

[0040] In some embodiments, the occlusion element 220 may be permeable to or impermeable to blood and / or other fluids (e.g., water). In some embodiments, the occlusion element 220 may include a polymer membrane, a metal or polymer mesh, a porous or semi-porous filter-like material, or other suitable structure. In some embodiments, the occlusion element 220 prevents thrombi (e.g., blood clots) from passing through the occlusion element 220 and entering the bloodstream from the left atrial appendage. In some embodiments, the occlusion element 220 promotes post-implantation endothelialization, thereby effectively isolating the target site (e.g., the left atrial appendage) from the patient's circulatory system. Some preferred but non-limiting examples of materials for the occlusion element 220 are described below.

[0041] In some embodiments, the expandable framework 210 and / or the interconnected struts may be integrally formed and / or cut from a single member. In some embodiments, the expandable framework 210 and / or the interconnected struts may be integrally formed and / or cut from a single tubular member and then formed and / or heat-set to the desired shape in the arrangement configuration. In some embodiments, the expandable framework 210 and / or the interconnected struts 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 to the desired shape in the arrangement configuration. Some exemplary means and / or methods for fabricating and / or forming the expandable framework 210 include laser cutting, machining, punching, stamping, electro-discharge machining (EDM), chemical dissolution, etc. Other means and / or methods are also conceivable.

[0042] During use, the delivery sheath 140 can be advanced and / or navigated to the left atrial appendage to deliver the occlusion 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 and / or with the guidewire covering it. For example, the delivery sheath 140 can be advanced to a distal end positioned adjacent to the patient's left atrium and left atrial appendage, in which case the occlusion implant 200 is positioned within the delivery sheath 140. In some embodiments, the delivery sheath 140 may include steering capability. After the distal end of the delivery sheath 140 is adjacent to and / or positioned in the left atrial appendage, the core wire 130 can be advanced distally to the delivery sheath 140 to advance the occlusion implant 200 outside the delivery sheath 140, at which point the occlusion implant 200 can transition to a placement configuration.

[0043] Although not explicitly shown, in some embodiments the occlusion implant system may further include an access device. In some embodiments, the access device may be a bidirectionally maneuverable catheter and / or intravascular catheter. Examples of intravascular catheters include, but are not limited to, balloon catheters, atherectomy catheters, device delivery catheters, drug delivery catheters, diagnostic catheters, and guide catheters.

[0044] In some embodiments, the access device may be advanced and / or navigated to the left atrial appendage. In one example, the access device may be advanced and / or navigated to the left atrial appendage using and / or with the guidewire covered. For example, the access device may be advanced into the patient's left atrium, with its distal tip positioned adjacent to the left atrial appendage. In some embodiments, the access device may include maneuverability. In some embodiments, the delivery system 100 may be inserted through the access device. In some embodiments, the length of the delivery sheath 140 may be substantially equal to the length of the access device. In some embodiments, the length of the delivery sheath 140 may be slightly longer than the access device. When in use, the delivery sheath 140 can be advanced within the access device with the occlusive implant 200 positioned within the delivery sheath 140 in delivery configuration. After the distal end of the delivery sheath 140 is positioned adjacent to and / or at the distal end of the access device, the core wire 130 can be advanced distally to the delivery sheath 140 and / or the access device, thereby advancing the occlusion implant 200 outside the delivery sheath 140 and the access device, at which point the occlusion implant 200 can transition to a positional configuration.

[0045] In some embodiments, the dimensions of the delivery system, delivery sheath 140, and / or access device may be set according to their intended use. For example, the delivery system, delivery sheath 140, and / or access device may have lengths in the ranges of about 10 to about 150 centimeters, about 25 to about 125 centimeters, about 50 to about 100 centimeters, about 25 to about 50 centimeters, about 50 to about 75 centimeters, about 75 to about 100 centimeters, etc. Other lengths, including but not limited to parts of several ranges disclosed herein, are also envisioned. It is further envisioned that the outer diameter of the delivery system, delivery sheath 140, and / or access device may be modified based on use or application. In some examples, the outer diameter of the delivery system, delivery sheath 140, and / or access device may be about 2 mm, about 3 mm (or 9 French), about 3.5 mm, about 4 mm (or 12 French), about 4.5 mm, about 5 mm (or 15 French), about 5.33 mm, about 5.5 mm, about 5.66 mm (or 17 French), about 6 mm, about 6.5 mm, about 7 mm (or 21 French), about 8 mm, or other preferred sizes. In some embodiments, the outer diameter of the delivery system, delivery sheath 140, and / or access device may be as large as 5.66 mm (17 French), and preferably smaller than 5.66 mm (17 French). Other configurations are also conceivable. In some embodiments, it is desirable that the outer diameter of the delivery system, delivery sheath 140, and / or access device be as small as possible.

[0046] 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 inaccurate and / or inappropriate. Therefore, the delivery sheath 140 and / or access device may be configured to allow recapture of the occlusive implant 200.

[0047] Figures 3–11 show selected configurations of the delivery sheath 140 that may enable the delivery sheath 140 to recapture the occluded implant 200 and / or enhance the ability of the delivery sheath 140 to recapture the occluded implant 200. For reference and illustrative purposes only, the core wire 130 and the occluded implant 200 are shown in some of the figures. Furthermore, not all features are shown in all figures, and some figures may show for reference some features that are not explicitly described or mentioned in relation to a particular figure. It should be understood that the configurations described with reference to the delivery sheath 140, but which are illustrated, may be applied to the access device instead of or in addition to the delivery sheath 140.

[0048] In some embodiments, the distal end and / or distal end region of the delivery sheath 140 may be configured to elastically expand radially outward when the occluded implant 200 is recaptured. By enabling the distal end and / or distal end region of the delivery sheath 140 to elastically expand radially outward when the occluded implant 200 is recaptured, damage to the occluded implant 200 and / or the delivery sheath 140 can be avoided. Furthermore, by enabling the distal end and / or distal end region of the delivery sheath 140 to elastically expand radially outward when the occluded implant 200 is recaptured, the force required to recapture the occluded implant 200 can be reduced.

[0049] In some embodiments, the distal end region may not have any one or more reinforcing elements. In some embodiments, the delivery sheath 140 may include a circumferential ring 144 formed monolithically with the distal end of the delivery sheath 140. In some embodiments, the circumferential ring 144 may be located at the most distal end of the delivery sheath 140 and / or constitute the most distal range of the delivery sheath 140. In at least some embodiments, the circumferential ring 144 may extend continuously and / or uninterruptedly around the outer circumference of the delivery lumen 142 and / or the delivery sheath 140.

[0050] In some embodiments, the delivery sheath 140 may include a plurality of longitudinal slots 150 arranged and / or formed in the sidewall 146 of the delivery sheath 140. The plurality of longitudinal slots 150 may be formed as a plurality of openings and / or apertures within the sidewall 146 of the delivery sheath 140. Thus, the plurality of longitudinal slots 150 can be understood as a plurality of voids formed in a plurality of parts of the sidewall 146, or a plurality of voids formed in a plurality of parts of the sidewall 146 where no material forming the sidewall 146 exists. 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 conceivable.

[0051] In some embodiments, the multiple elongated slots 150 may include 2 elongated slots, 3 elongated slots, 4 elongated slots, 5 elongated slots, 6 elongated slots, 7 elongated slots, 8 elongated slots, 9 elongated slots, 10 elongated slots, 11 elongated slots, 12 elongated slots, 13 elongated slots, 14 elongated slots, 15 elongated slots, 16 elongated slots, 17 elongated slots, 18 elongated slots, 19 elongated slots, 20 elongated slots, or another suitable or desired number of elongated slots.

[0052] In some embodiments, the multiple elongated slots 150 may have axial lengths ranging from approximately 0.127 mm (0.005 inches) to approximately 50.8 mm (2.0 inches). In some embodiments, the multiple elongated slots 150 may have axial lengths ranging from approximately 0.1905 mm (0.0075 inches) to approximately 38.1 mm (1.5 inches). In some embodiments, the multiple elongated slots 150 may have axial lengths ranging from approximately 0.254 mm (0.01 inches) to approximately 25.4 mm (1.0 inch). In some embodiments, the multiple elongated slots 150 may have axial lengths ranging from approximately 0.508 mm (0.02 inches) to approximately 19.05 mm (0.75 inches). Other axial lengths are also conceivable.

[0053] In some embodiments, the multiple elongated slots 150 may have a lateral and / or circumferential width of approximately 0.0127 mm (0.0005 inches) to approximately 12.7 mm (0.5 inches). In some embodiments, the multiple elongated slots 150 may have a lateral and / or circumferential width of approximately 0.01905 mm (0.00075 inches) to approximately 6.35 mm (0.25 inches). In some embodiments, the multiple elongated slots 150 may have a lateral and / or circumferential width of approximately 0.0254 mm (0.001 inches) to approximately 5.08 mm (0.2 inches). In some embodiments, the multiple elongated slots 150 may have a lateral and / or circumferential width of approximately 0.0508 mm (0.002 inches) to approximately 2.54 mm (0.1 inches). Other lateral and / or circumferential widths are also conceivable.

[0054] In some embodiments, the circumferential ring 144 may have an axial length of approximately 0.127 mm (0.005 inches) to approximately 50.8 mm (2.0 inches). In some embodiments, the circumferential ring 144 may have an axial length of approximately 0.1905 mm (0.0075 inches) to approximately 38.1 mm (1.5 inches). In some embodiments, the circumferential ring 144 may have an axial length of approximately 0.254 mm (0.01 inches) to approximately 25.4 mm (1.0 inch). In some embodiments, the circumferential ring 144 may have an axial length of approximately 0.508 mm (0.02 inches) to approximately 19.05 mm (0.75 inches). Other axial lengths are also conceivable.

[0055] In some embodiments, the elongated slots 150 may be located proximal to the circumferential ring 144. In some embodiments, the elongated slots 150 may be spaced apart from the distal end of the delivery sheath 140. In some embodiments, the elongated slots 150 may be located adjacent to the circumferential ring 144. In some embodiments, the elongated slots 150 may be located directly adjacent to the circumferential ring 144.

[0056] In some embodiments, the multiple elongated slots 150 may be arranged around and / or the central longitudinal axis of the delivery sheath 140. In some embodiments, the multiple elongated slots 150 may be arranged and / or provided as an array extending circumferentially around and / or the central longitudinal axis of the delivery sheath 140. The multiple elongated slots 150 may be spaced apart from each other in the circumferential direction.

[0057] In some embodiments, the elongated slots 150 may extend completely through the side wall 146 of the delivery sheath 140, as shown in Figure 4A. In some embodiments, the elongated slots 150 may extend from the outer surface of the delivery sheath 140 to the inner surface of the delivery sheath 140 and / or the delivery lumen 142. In some embodiments, the delivery lumen 142 may be in fluid communication with the outside of the delivery sheath 140 via the elongated slots 150.

[0058] In some embodiments, the multiple elongated slots 150 may partially extend in the thickness direction in the side wall 146 of the delivery sheath 140, as shown in Figure 4B. In some embodiments, the multiple elongated slots 150 may extend radially inward from the outer surface of the delivery sheath 140. In some alternative configurations, the multiple elongated slots 150 may extend radially outward from the inner surface of the delivery sheath 140. In some embodiments, the multiple elongated slots 150 may include multiple elongated slots extending radially inward from the outer surface of the delivery sheath 140 and multiple elongated slots extending radially outward from the inner surface of the delivery sheath 140. Several other configurations and / or combinations thereof are also conceivable.

[0059] In some embodiments, the multiple elongated slots 150 may extend over a thickness of approximately 10% of the side wall 146 of the delivery sheath 140. In some embodiments, the multiple elongated slots 150 may extend over a thickness of approximately 20% of the side wall 146 of the delivery sheath 140. In some embodiments, the multiple elongated slots 150 may extend over a thickness of approximately 30% of the side wall 146 of the delivery sheath 140. In some embodiments, the multiple elongated slots 150 may extend over a thickness of approximately 40% of the side wall 146 of the delivery sheath 140. In some embodiments, the multiple elongated slots 150 may extend over a thickness of approximately 50% of the side wall 146 of the delivery sheath 140. In some embodiments, the multiple elongated slots 150 may extend over a thickness of approximately 60% of the side wall 146 of the delivery sheath 140. In some embodiments, the elongated slots 150 may extend over approximately 70% of the thickness of the side wall 146 of the delivery sheath 140. In some embodiments, the elongated slots 150 may extend over approximately 80% of the thickness of the side wall 146 of the delivery sheath 140. In some embodiments, the elongated slots 150 may extend over approximately 90% of the thickness of the side wall 146 of the delivery sheath 140. Other configurations are also conceivable.

[0060] In some embodiments, various combinations of elongated slots extending completely through the side wall 146 and elongated slots extending partially in the thickness direction in the side wall 146 are also envisioned. In some embodiments, such combinations of elongated slots extending completely through the side wall 146 and elongated slots extending partially in the thickness direction in the side wall 146 may include elongated slots extending to different degrees in the thickness direction in the side wall 146 (for example, some elongated slots extending completely through the side wall 146, some elongated slots extending over a first proportion of the thickness in the side wall 146, and some elongated slots extending over a second proportion of the thickness in the side wall 146).

[0061] As described herein, in some embodiments, the sidewalls 146 and / or the delivery sheath 140 may be formed from a polymer material. In some embodiments, as shown in Figures 5-6, a second polymer material 152, different from the aforementioned polymer material, may be placed in at least one of the multiple elongated slots 150. In some embodiments, the second polymer material 152 may be a softer material and / or a material with a lower durometer than the aforementioned polymer material. In some embodiments, the second polymer material 152 is more elastic than the aforementioned polymer material and / or can be stretched or elongated more than the aforementioned polymer material without breaking and / or fracturing. In some embodiments, the second polymer material 152 may be placed in each of the multiple elongated slots 150. In some embodiments, the second polymer material 152 may be placed in a portion of the multiple elongated slots 150, or in only some of the multiple elongated slots 150. In some embodiments, the second polymer material 152 may be placed in only one of the elongated slots 150.

[0062] In some embodiments, the second polymer material 152 may extend completely through the side wall 146 of the delivery sheath 140, as shown in Figure 6. In some embodiments, the second polymer material 152 may extend from the outer surface of the delivery sheath 140 to the inner surface of the delivery sheath 140 and / or the delivery lumen 142. In some embodiments, the delivery lumen 142 can be prevented from fluid communication with the outside of the delivery sheath 140 by the second polymer material 152.

[0063] In some embodiments, the second polymer material 152 may partially extend in the thickness direction along 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 positioned 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 positioned radially away from the inner surface of the delivery sheath 140, and / or the outward-facing surface of the second polymer material 152 may be positioned radially away from the outer surface of the delivery sheath 140. Several other configurations and / or combinations thereof are also conceivable.

[0064] In some embodiments, the second polymer material 152 may have a radial thickness of about 10% of the thickness of the sidewall 146 of the delivery sheath 140. In some embodiments, the second polymer material 152 may have a radial thickness of about 20% of the thickness of the sidewall 146 of the delivery sheath 140. In some embodiments, the second polymer material 152 may have a radial thickness of about 30% of the thickness of the sidewall 146 of the delivery sheath 140. In some embodiments, the second polymer material 152 may have a radial thickness of about 40% of the thickness of the sidewall 146 of the delivery sheath 140. In some embodiments, the second polymer material 152 may have a radial thickness of about 50% of the thickness of the sidewall 146 of the delivery sheath 140. In some embodiments, the second polymer material 152 may have a radial thickness of about 60% of the thickness of the sidewall 146 of the delivery sheath 140. In some embodiments, the second polymer material 152 may have a radial thickness of about 70% of the thickness of the sidewall 146 of the delivery sheath 140. In some embodiments, the second polymer material 152 may have a radial thickness of about 80% of the thickness of the sidewall 146 of the delivery sheath 140. In some embodiments, the second polymer material 152 may have a radial thickness of about 90% of the thickness of the sidewall 146 of the delivery sheath 140. Other configurations are also conceivable.

[0065] In some embodiments, the plurality of elongated slots 150 may comprise a plurality of first elongated slots 151 having a first length (e.g., a first longitudinal length or a first axial length) and a plurality of second elongated slots 153 having a second length different from the first length (e.g., a second longitudinal length or a second axial length). In at least some embodiments, the second length may be shorter than the first length. In some embodiments, the plurality of elongated slots 150 may comprise a plurality of additional elongated slots having a length different from the first and / or second length (e.g., a plurality of third elongated slots having a third length).

[0066] In some embodiments, the plurality of first elongated slots 151 may alternate with the plurality of second elongated slots 153 around the outer circumference of the delivery sheath 140. Other patterns and / or distributions of the plurality of first elongated slots 151 and / or the plurality of second elongated slots 153 around the outer circumference of the delivery sheath 140 are also conceivable. In one non-limiting example, the plurality of first elongated slots 151 may be arranged in pairs, with a single elongated slot of the plurality of second elongated slots 153 positioned between adjacent pairs of the plurality of first elongated slots 151 around the outer circumference of the delivery sheath 140 (e.g., a "2-1-2 (two-one-two)" arrangement). Other examples include, but are not limited to, a "3-1-3" arrangement, a "2-2-2" arrangement, a "1-3-1" arrangement, and so on.

[0067] In some embodiments, the multiple elongated slots 150 may comprise a first circumferential row of elongated slots 155 and a second circumferential row of elongated slots 157 located proximal to the first circumferential row of elongated slots 155, as shown in Figure 8. The first circumferential row of elongated slots 155 may be spaced axially and / or longitudinally from the second circumferential row of elongated slots 157. In some embodiments, the delivery sheath 140 may comprise a second circumferential ring 148 formed monolithically with the delivery sheath 140. In some embodiments, the second circumferential ring 148 may be located proximal to the circumferential ring 144 and / or the first circumferential row of elongated slots 155. In some embodiments, the second circumferential ring 148 may be located axially between the first circumferential row of elongated slots 155 and the second circumferential row of elongated slots 157. In at least some embodiments, the second circumferential ring 148 may extend continuously and / or without interruption around the outer circumference of the delivery lumen 142 and / or delivery sheath 140.

[0068] In some embodiments, the second circumferential ring 148 may have the same longitudinal dimension or longitudinal range as the circumferential ring 144. In some embodiments, the longitudinal dimension or longitudinal range of the second circumferential ring 148 may be equal to the longitudinal dimension or longitudinal range of the circumferential ring 144. In some embodiments, the longitudinal dimension or longitudinal range of the second circumferential ring 148 may be smaller than the longitudinal dimension or longitudinal range of the circumferential ring 144. In some embodiments, the longitudinal dimension or longitudinal range of the second circumferential ring 148 may be larger than the longitudinal dimension or longitudinal range of the circumferential ring 144.

[0069] The elongated slots 155 in the first circumferential row may be spaced apart from each other in the circumferential direction around the outer circumference of the delivery sheath 140. The elongated slots 157 in the second circumferential row may be spaced apart from each other in the circumferential direction around the outer circumference of the delivery sheath 140. In some embodiments, the elongated slots 157 in the second circumferential row may be spaced further apart from each other in the circumferential direction than the elongated slots 155 in the first circumferential row.

[0070] In some embodiments, the elongated slots 155 of the first circumferential row may comprise a first number of elongated slots, and the elongated slots 157 of the second circumferential row may comprise a second number of elongated slots that is less than the first number of elongated slots. For example, the elongated slots 155 of the first circumferential row may have more elongated slots than the elongated slots 157 of the second circumferential row that extend around the outer circumference of the delivery sheath 140. Generally, it may be advantageous for the delivery sheath 140 to have more "open spaces," notched areas, voids, or areas from which material has been removed around the side wall 146 at a position relatively close to the distal end of the delivery sheath 140. Therefore, under the additional condition or characteristic that the multiple elongated slots 155 of the first circumferential row are larger or wider in the circumferential direction than the multiple elongated slots 157 of the second circumferential row (for example, a larger portion of the side wall 146 remains between the multiple elongated slots of the second circumferential row 157 than between the multiple elongated slots of the first circumferential row 155), it is also conceivable that the number of elongated slots in the first circumferential row is less than the number of elongated slots in the second circumferential row.

[0071] In some embodiments, each elongated slot 157 of the second circumferential row may be aligned in the axial direction with one elongated slot 155 of the first circumferential row. In some embodiments, each elongated slot 157 of the second circumferential row may cooperate and / or combine with one elongated slot 155 of the first circumferential row to form a longer elongated slot interrupted by the second circumferential ring 148. In some embodiments, the longer elongated slot interrupted by the second circumferential ring 148 may alternate with shorter elongated slots (i.e., the remaining slots of the first circumferential row elongated slots 155 that are not included in or used to form a longer elongated slot interrupted by the second circumferential ring 148) around the outer circumference of the delivery sheath 140.

[0072] In some embodiments, at least one of the multiple elongated slots 150 may be wider at its distal end than at its proximal end. In some embodiments, at least one of the multiple elongated slots 150 may be stepped from the proximal end to the distal end and / or to the distal end. In some embodiments, at least one of the multiple elongated slots 150 may be tapered from the proximal end to the distal end and / or to the distal end, as shown in Figure 9. Other configurations are also conceivable.

[0073] In some alternative embodiments, the delivery sheath 140 may include a circumferential ring 144 formed monolithically with the distal end of the delivery sheath 140, and a plurality of longitudinal strips 160 formed from a second polymer material different from the polymer material forming the delivery sheath 140 and / or the sidewall 146 of the delivery sheath 140. The plurality of longitudinal strips 160 may be embedded in the sidewall 146 of the delivery sheath 140 proximal to the circumferential ring 144, as shown in Figures 10-11. The second polymer material forming the plurality of longitudinal strips 160 may be a softer material and / or a material with a lower durometer than the aforementioned polymer material. In some embodiments, the second polymer material may be more elastic than the aforementioned polymer material and / or can be stretched or elongated more than the aforementioned polymer material without breaking and / or fracturing.

[0074] In some embodiments, the plurality of elongated strips 160 may comprise a plurality of first elongated strips having a first length (e.g., a first longitudinal length or a first axial length) and a plurality of second elongated strips having a second length (e.g., a second longitudinal length or a second axial length) different from the first length, similar to the plurality of elongated slots 150 in Figure 7 above. In at least some embodiments, the second length may be shorter than the first length. In some embodiments, the plurality of elongated strips 160 may comprise a plurality of additional elongated slots having a length different from the first and / or second length (e.g., a plurality of third elongated slots having a third length).

[0075] In some embodiments, the plurality of first elongated strips may alternate with the plurality of second elongated strips around the outer periphery of the delivery sheath 140. Other patterns and / or distributions of the plurality of first elongated strips and / or the plurality of second elongated strips around the outer periphery of the delivery sheath 140 are also conceivable. In one non-limiting example, the plurality of first elongated strips may be arranged in pairs, with a single elongated slot of the plurality of second elongated strips positioned between adjacent pairs of the plurality of first elongated strips around the outer periphery of the delivery sheath 140 (e.g., a "2-1-2" configuration). Other examples include, but are not limited to, a "3-1-3" configuration, a "2-2-2" configuration, a "1-3-1" configuration, and so on.

[0076] In some embodiments, the multiple elongated strips 160 may comprise a first circumferential row of elongated strips and a second circumferential row of elongated strips positioned proximal to the first circumferential row of elongated strips, similar to the multiple elongated slots 150 in Figure 8 above. The first circumferential row of elongated strips may be spaced axially and / or longitudinally from the strips of the second circumferential row. In some embodiments, the delivery sheath 140 may be monolithically formed with the delivery sheath 140, similar to the second circumferential ring 148 above, and may comprise a circumferential ring 144 and / or a second circumferential ring positioned proximal to the first circumferential row of elongated strips. In some embodiments, the second circumferential ring may be positioned axially between the first circumferential row of elongated strips and the second circumferential row of elongated strips. In at least some embodiments, the second circumferential ring may extend continuously and / or without interruption around the outer circumference of the delivery lumen 142 and / or delivery sheath 140.

[0077] In some embodiments, the second circumferential ring may have the same longitudinal dimension or longitudinal range as the circumferential ring 144. In some embodiments, the longitudinal dimension or longitudinal range of the second circumferential ring may be equal to the longitudinal dimension or longitudinal range of the circumferential ring 144. In some embodiments, the longitudinal dimension or longitudinal range of the second circumferential ring may be smaller than the longitudinal dimension or longitudinal range of the circumferential ring 144. In some embodiments, the longitudinal dimension or longitudinal range of the second circumferential ring may be larger than the longitudinal dimension or longitudinal range of the circumferential ring 144.

[0078] Long strips adjacent to each other in the circumferential direction of the long strips in the first circumferential row may be spaced apart from each other in the circumferential direction around the outer circumference of the delivery sheath 140. Long strips adjacent to each other in the circumferential direction of the long strips in the second circumferential row may be spaced apart from each other in the circumferential direction around the outer circumference of the delivery sheath 140. In some embodiments, long strips adjacent to each other in the circumferential direction of the long slots in the second circumferential row may be spaced apart from each other by a greater distance in the circumferential direction than long strips adjacent to each other in the circumferential direction of the long strips in the first circumferential row.

[0079] In some embodiments, the elongated strips of the first circumferential row may comprise a first quantity of elongated strips, and the elongated strips of the second circumferential row may comprise a second quantity of elongated strips less than the first quantity of elongated strips. For example, the elongated strips of the first circumferential row may have more elongated strips than the elongated strips of the second circumferential row that extend around the outer circumference of the delivery sheath 140. Generally, it may be advantageous for the delivery sheath 140 to have a greater amount of the second polymer material relatively close to the distal end of the delivery sheath 140. Therefore, under the additional condition or characteristic that some of the elongated strips in the first circumferential row are larger or wider in the circumferential direction than some of the elongated strips in the second circumferential row (for example, a larger portion of the sidewall 146 remains between some of the elongated strips in the second circumferential row than between some of the elongated strips in the first circumferential row), it is also possible that the quantity of elongated strips in the first row is less than the quantity of elongated strips in the second row.

[0080] In some embodiments, each elongated strip of the second circumferential row elongated strips may be aligned in the axial direction with one elongated strip of the first circumferential row elongated strips. In some embodiments, each elongated strip of the second circumferential row elongated strips may cooperate and / or combine with one elongated strip of the first circumferential row elongated strips to form a longer elongated strip interrupted by the second circumferential ring. In some embodiments, the longer elongated strip interrupted by the second circumferential ring may alternate with shorter elongated strips (i.e., the remaining strips of the first circumferential row elongated strips 155 that are not included in or used to form a longer elongated strip interrupted by the second circumferential ring) around the outer circumference of the delivery sheath 140.

[0081] In some embodiments, at least one of the multiple elongated strips 160 may be wider at its distal end than at its proximal end. In some embodiments, at least one of the multiple elongated strips 160 may be stepped from the proximal end to the distal end and / or to the distal end. In some embodiments, at least one of the multiple elongated strips 160 may be tapered from the proximal end to the distal end and / or to the distal end. Other configurations are also conceivable.

[0082] Figures 12-13 show embodiments of the delivery sheath 140 during the recapture of the occlusive implant 200. As described herein, the access sheath is used in conjunction with the occlusive implant system and / or delivery system and may therefore include some and / or all of the multiple characteristics associated with the delivery sheath 140.

[0083] During use, after the occlusion implant 200 has been placed, imaging and / or other verification techniques may determine that the placement was improper or that the occlusion implant 200 needs to be repositioned and / or removed. In some embodiments, the delivery system may be used to recapture the occlusion implant 200 for removal and / or repositioning within the left atrial appendage. When the occlusion implant 200 is drawn into the delivery lumen 142 of the delivery sheath 140 and the expandable framework is transitioned from placement to delivery and / or delivery (for example, when the expandable framework is contracted (folded)), the distal end and / or distal end region of the delivery sheath 140 may be configured to elastically expand radially outward to prevent damage to the occlusion implant 200, the expandable framework 210 and / or occlusion element 220, and the delivery sheath 140.

[0084] Multiple elongated slots 150 may be configured to allow the distal end and / or distal end region of the delivery sheath 140 to expand radially outward. By providing multiple elongated slots 150 in the delivery sheath 140, the delivery sheath 140 may be more flexible and / or able to expand elastically by a larger amount and / or on a larger scale compared to when the multiple elongated slots 150 are not present. If the delivery sheath 140 is not allowed to expand radially outward by a sufficient amount, the delivery sheath 140 may break by cracking, tearing, and / or spreading due to the force applied during recapture, thereby potentially creating harmful features on the delivery sheath 140 within the patient's anatomical structure.

[0085] As shown in Figures 12-13, during recapture of the occluded implant 200, the circumferential ring 144, sidewalls 146, and / or multiple elongated slots 150 (which may include various configurations and / or arrangements as described herein) may stretch and / or expand radially outward and / or circumferentially. The distal end of the delivery sheath 140 and / or the circumferential ring 144 may be configured to expand by a greater amount and / or size than the rest of the delivery sheath 140. In some embodiments, the distal end and / or distal portion of the multiple elongated slots 150 may be configured to expand by a greater amount and / or size than the proximal end and / or proximal portion of the multiple elongated slots 150. In some embodiments, the delivery sheath 140 may be more rigid, less elastic, and / or less flexible on the proximal side. In some embodiments, the distal end of the delivery sheath 140 may be more elastic and / or more flexible and / or less rigid than the rest of the delivery sheath 140.

[0086] The various components of an occlusive implant system (and / or other components disclosed herein) and the materials that may be used for such various components disclosed herein may include those generally associated with medical devices and / or systems. For simplicity of explanation, the following description refers to systems. However, this is not intended to limit the devices and methods described herein, and this description may apply to other elements, members, components, or devices disclosed herein, such as, but not limited to, delivery systems, delivery sheaths, occlusive implants, core wires, expandable frameworks, occlusive elements, etc., and / or such elements or components.

[0087] In some embodiments, the system and / or its components may be made from metals, metal alloys, polymers (some examples of which are disclosed below), metal-polymer composites, ceramics, combinations thereof, or other suitable materials.

[0088] Some examples of suitable metals and metal alloys include stainless steel such as 304 and / or 316 stainless steel and its variations; mild steel; nickel-titanium alloys such as linear elastic and / or superelastic Nitinol; and nickel-chromium-molybdenum alloys (e.g., UNS:N06625 such as INCONEL® 625, UNS:N06022 such as HASTELLOY® C-22®, HASTELLOY® C276®, etc.). UNS:N10276, other HASTELLOY® alloys, etc., nickel-copper alloys (e.g., UNS:N04400, etc., such as MONEL® 400, NICKELVAC® 400, NICORROS® 400), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R44035, etc., such as MP35-N®), nickel-molybdenum alloys (e.g., HASTELLOY® ALLOY Other nickel alloys such as UNS:N10665 (e.g., 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, e.g., ELGILOY®, PHYNOX®); platinum-enriched stainless steel; titanium; combinations thereof, etc.; or any other suitable materials.

[0089] In at least some embodiments, some or all of the systems and / or other components disclosed herein may also be doped with, fabricated from, or include radiopaque materials. Radiopaque materials are understood to be materials that can produce relatively bright images on a fluoroscopy screen or by other imaging techniques (e.g., ultrasound, etc.) during medical procedures. These relatively bright images assist the user in determining the position and / or orientation of the systems and / or other components disclosed herein. Some examples of radiopaque materials include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, and polymer materials loaded with radiopaque fillers.

[0090] In some embodiments, a certain degree of magnetic resonance imaging (MRI) compatibility is imparted to the systems and / or other elements disclosed herein. For example, the systems and / or their components or parts may be made of materials that do not substantially distort the image and do not produce substantial artifacts (e.g., gaps in the image). For example, certain ferromagnetic materials may be unsuitable because they can produce artifacts in MRI images. The systems or parts thereof may also be made from materials that can be imaged by MRI equipment. Some materials exhibiting these properties include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS:R44003 such as ELGILOY® and PHYNOX®), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R44035 such as MP35-N®), nitinol, and others.

[0091] In some embodiments, the systems and / or other elements disclosed herein may be made from polymers or other suitable materials, or may include polymers or other suitable materials.Other examples of some suitable polymers include polytetrafluoroethylene (PTFE), ethylenetetrafluoroethylene (ETFE), fluoroethylene propylene (FEP), polyoxymethylene (POM, e.g., DELRIN®), polyether block esters, polyurethane, polypropylene (PP), polyvinyl chloride (PVC), polyether esters (e.g., ARNITEL®), ether or ester-based copolymers (e.g., butylene / poly(alkylene ether) phthalates and / or other polyester elastomers (HYTREL®, etc.)), polyamides (e.g., DURETHAN® or CRISTAMID®), elastomer polyamides, block polyamides / ethers, polyether block amides (PEBA, e.g., PEBAX®), ethylene vinyl acetate copolymer (EVA), silicone, polyethylene (PE), MARLEX® high-density polyethylene, MARLEX® low-density polyethylene, linear low-density polyethylene (e.g., REXELL®). Polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyether ether ketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly-p-phenylene terephthalamide (e.g., KEVLAR®), polysulfone, nylon, nylon-12 (GRILAMID®, etc.), perfluoro This may include (propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefins, polystyrene, epoxy, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS50A), polycarbonate, polyurethane silicone copolymer (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 can be mixed with a liquid crystal polymer (LCP). For example, the mixture may contain up to about 6% LCP.

[0092] In some embodiments, the systems and / or other elements disclosed herein may include textile materials arranged structurally or within a structure. The textile materials may consist of biocompatible materials such as polymeric materials or biomaterials adapted to promote tissue internal growth. In some embodiments, the textile materials may include bioabsorbable materials. Some examples of suitable textile materials include, but are not limited to, polyethylene glycol (PEG), nylon, polytetrafluoroethylene (PTFE, ePTFE), polyethylene, polypropylene, polyester, polyurethane, and / or blends or combinations thereof.

[0093] In some embodiments, the systems and / or other elements disclosed herein may include and / or be formed from textile materials. Some examples of suitable textile materials include synthetic yarns that may be flat, moldable, twisted, textured, pre-shrunk, or unshrunk. Suitable synthetic biocompatible yarns for use in this disclosure include, but are not limited to, polyesters including polyethylene terephthalate (PET) polyester, polypropylene, polyethylene, polyurethane, polyolefin, polyvinyl, polymethylacetates, polyamides, naphthalenedicarboxylic acid derivatives, natural silk, and polytetrafluoroethylene. Furthermore, at least one of the synthetic yarns may be a metallic yarn, a glass or ceramic yarn, or a fiber. Useful metallic yarns include yarns made from stainless steel, platinum, gold, titanium, tantalum, or Ni-Co-Cr alloys, or yarns containing stainless steel, platinum, gold, titanium, tantalum, or Ni-Co-Cr alloys. The yarns may further include carbon fibers, glass fibers, or ceramic fibers. Preferably, the thread is made from a thermoplastic material including, but not limited to, polyester, polypropylene, polyethylene, polyurethane, polynaphthalene, and polytetrafluoroethylene. The thread may be multifilament, monofilament, or spun. The type and denier of the thread selected may be chosen to form a biocompatible and implantable prosthesis, more specifically, a vascular structure with desirable properties.

[0094] In some embodiments, the systems and / or other elements disclosed herein may include and / or be treated with a suitable therapeutic agent. Some examples of appropriate therapeutic agents include: antithrombotic agents (heparin, heparin derivatives, urokinase, and PPack (dextrophenylalanine proline arginine chloromethyl ketone), etc.); proliferation inhibitors (enoxaparin, angiopeptin, monoclonal antibodies capable of blocking smooth muscle cell proliferation, hirudin, and acetylsalicylic acid, etc.); anti-inflammatory agents (dexamethasone, prednisolone, corticosterone, budesonide, estrogen, sulfasalazine, and mesalamine, etc.); antitumor / antiproliferative / antimitotic agents (paclitaxel, 5-fluorouracil, cisplatin, vinblastine, vincristine, epotilon, endostatin, angiostatin, and thymidine kinase inhibitors, etc.); anesthetics (lidocaine, bupivacaine, and ropivacaine, etc.); anticoagulants (D-Phe-Pro-Arg chloromethyl ketone, RGD peptide-containing compounds, heparin) Examples of drugs include antithrombin compounds, platelet receptor antagonists, antithrombin antibodies, antiplatelet receptor antibodies, aspirin, prostaglandin inhibitors, platelet inhibitors, and mite antiplatelet peptides; vasodilators (growth factor inhibitors, growth factor receptor antagonists, transcription activators, and translation accelerators); vasodilators (growth factor inhibitors, growth factor receptor antagonists, transcription inhibitors, translation inhibitors, replication inhibitors, inhibitory antibodies, antibodies against growth factors, bifunctional molecules consisting of growth factors and cytotoxins, bifunctional molecules consisting of antibodies and cytotoxins); immunosuppressants ("Olimus" family drugs, rapamycin analogs, macrolide antibiotics, biolimus, everolimus, zotarolimus, temsirolimus, picrolimus, novolimus, myolimus, tacrolimus, sirolimus, pimecrolimus, etc.); cholesterol-lowering agents; vasodilators; and drugs that interfere with intrinsic vasoactive mechanisms.

[0095] It should be understood that this disclosure is illustrative in many respects. Modifications can be made in detail, particularly with respect to shape, size, and process configuration, without exceeding the scope of this disclosure. This may include, to a reasonable extent, using any feature of one exemplary embodiment in other embodiments. The scope of this disclosure is, of course, defined by the language expressed in the appended claims.

Claims

1. A delivery system for occlusive implants, A delivery sheath having a delivery lumen extending from the distal end to the proximal end of the delivery sheath, and the delivery sheath being formed from a polymer material, A core wire slidably disposed within the delivery lumen, configured to be releasably engaged with the occluding implant, A delivery system comprising a delivery sheath, a circumferential ring monolithically formed with the delivery sheath at the distal end of the delivery sheath, and a plurality of elongated slots disposed proximal to the circumferential ring.

2. The delivery system according to claim 1, wherein the plurality of elongated slots partially extend in the thickness direction in the side wall of the delivery sheath.

3. The delivery system according to claim 1, wherein the plurality of elongated slots extend completely through the side wall of the delivery sheath.

4. The delivery system according to claim 3, wherein a second polymer material different from the aforementioned polymer material is disposed in at least one of the plurality of elongated slots.

5. The delivery system according to any one of claims 1 to 4, wherein the plurality of elongated slots include a plurality of first elongated slots having a first length and a plurality of second elongated slots having a second length different from the first length.

6. The delivery system according to claim 5, wherein the plurality of first elongated slots are alternately arranged with the plurality of second elongated slots around the outer circumference of the delivery sheath.

7. The plurality of elongated slots include elongated slots in a first circumferential row and elongated slots in a second circumferential row located proximal to the elongated slots in the first circumferential row. The delivery sheath further includes the delivery sheath and a second circumferential ring formed monolithically, The delivery system according to any one of claims 1 to 6, wherein the second circumferential ring is positioned in the axial direction between the elongated slots of the first circumferential row and the elongated slots of the second circumferential row.

8. The delivery system according to claim 7, wherein adjacent elongated slots in the second circumferential row are spaced circumferentially at a greater distance than adjacent elongated slots in the first circumferential row.

9. The delivery system according to any one of claims 7 to 8, wherein the elongated slots of the first circumferential row include a first number of elongated slots, and the elongated slots of the second circumferential row include a second number of elongated slots that is less than the first number of elongated slots.

10. The delivery system according to any one of claims 7 to 9, wherein each elongated slot of the second circumferential row is aligned in the axial direction with one elongated slot of the first circumferential row.

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

12. The delivery system according to claim 11, wherein the at least one elongated slot is tapered from the proximal end to the distal end.

13. A delivery system for occlusive implants, A delivery sheath having a delivery lumen extending from the distal end to the proximal end of the delivery sheath, and the delivery sheath being formed from a polymer material, A core wire slidably disposed within the delivery lumen, configured to be releasably engaged with the occluding implant, The delivery sheath includes a circumferential ring monolithically formed with the delivery sheath at the distal end of the delivery sheath, and a plurality of elongated strips formed from a second polymer material different from the polymer material. A delivery system in which the plurality of elongated strips are embedded in the side wall of the delivery sheath located proximal to the circumferential ring.

14. An occlusive implant system, An occlusion implant comprising an expandable framework and an occlusion element fixed to the expandable framework, wherein the occlusion implant is configured to transition between a delivery configuration and a placement configuration, A delivery system according to any one of claims 1 to 13, comprising: An occlusion implant system wherein the occlusion implant is positioned within the distal portion of the delivery lumen in the delivery configuration.

15. The occlusion implant system according to claim 14, wherein the distal end of the delivery sheath is configured to expand radially outward when the occlusion implant is recaptured.

Images