Medical system for treating the left atrial appendage

Abstract

A medical system can include a left atrial appendage closure device including an expandable frame configured to transition between a collapsed delivery configuration and an expanded deployed configuration and a proximal hub disposed along a central longitudinal axis of the expandable frame; wherein the left atrial appendage closure device includes a sensor disposed at least partially within an interior of the expandable frame and axially movable relative to the proximal hub; wherein the proximal hub includes a first threaded connection structure; and a delivery catheter including a core wire extending axially within a lumen of the delivery catheter, the core wire having a second threaded connection structure at a distal end thereof, the second threaded connection structure configured to releasably engage with the first threaded connection structure in an unreleased configuration and the second threaded connection structure disengaged from the first threaded connection structure in a released configuration.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Provisional Application No. 63 / 137,387, filed January 14, 2021, 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, as the left atrium contracts and forces blood into the left ventricle, the left atrial appendage 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 accumulate inside, which can lead to the unwanted 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, migrating through blood vessels, can eventually block smaller downstream vessels, 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 method, medical devices for closing the left atrial appendage have been developed. Each of the known medical devices and methods has certain advantages and disadvantages. There is a continuing need for alternative medical devices and guides, as well as alternative methods for manufacturing and using them. Summary of the Invention

[0006] In one example, a medical system may include a left atrial appendage closure device comprising an expandable frame and a proximal hub disposed along a central longitudinal axis of the expandable frame, the expandable frame being configured to switch between a collapsed delivery configuration and an expanded deployment configuration; wherein the left atrial appendage closure device includes a sensor at least partially disposed within the expandable frame and axially movable relative to the proximal hub; wherein the proximal hub includes a first threaded connection structure; and a delivery catheter including a core wire extending axially within the lumen of the delivery catheter, the core wire having a second threaded connection structure at its distal end, the second threaded connection structure being configured to releasably engage with the first threaded connection structure in an unreleased configuration.

[0007] Apart from or as an alternative to any of the examples disclosed herein, the sensor is a pressure sensor configured to sense fluid pressure in the space facing the proximal end of the sensor when the left atrial appendage closure device is in the release configuration.

[0008] Except for or as an alternative to any example disclosed herein, when the second threaded connection structure engages with the first threaded connection structure, the distal end of the second threaded connection structure engages with the proximal end of the sensor.

[0009] Except for or as an alternative to any example disclosed herein, when the second threaded connection structure is disengaged from the first threaded connection structure, the sensor is at least partially disposed within the proximal hub.

[0010] Except for or as an alternative to any example disclosed herein, when the second threaded connection structure is disengaged from the first threaded connection structure, the proximal end of the sensor extends toward the proximal side of the proximal hub.

[0011] Except for or as an alternative to any of the examples disclosed herein, the left atrial appendage closure device includes at least one spring that engages with the proximal hub and the sensor.

[0012] Except for any examples disclosed herein or as an alternative, at least one spring is a helical spring arranged coaxially around the sensor.

[0013] In addition to or as an alternative to any example disclosed herein, at least one spring comprises a plurality of springs spaced circumferentially around the sensor.

[0014] Except for any examples disclosed herein or as an alternative, at least one spring is fixedly attached to the inner surface of the near-side hub.

[0015] In addition to or as an alternative to any of the examples disclosed herein, the sensor includes a third threaded connection structure configured to thread the sensor to the first threaded connection structure.

[0016] In addition to or as an alternative to any example disclosed herein, when the left atrial appendage closure device is not in the release configuration, rotation of the core wire relative to the proximal hub causes the sensor to rotate relative to the proximal hub.

[0017] In addition to or as an alternative to any of the examples disclosed herein, a medical system may include a left atrial appendage closure device comprising an expandable frame and a proximal hub disposed along a central longitudinal axis of the expandable frame, the expandable frame being configured to switch between a collapsed delivery configuration and an expanded deployment configuration; wherein the left atrial appendage closure device includes a sensor at least partially disposed within the expandable frame and axially movable relative to the proximal hub; wherein the proximal hub includes a first threaded connection structure; and a delivery catheter including a core wire extending axially within the lumen of the delivery catheter, the core wire having a second threaded connection structure at its distal end, the second threaded connection structure being configured to releasably engage with the first threaded connection structure in an unreleased configuration; wherein the sensor includes an annular flange extending radially outward from the outer surface of the sensor.

[0018] Except for or alternative to any of the examples disclosed herein, the annular flange is axially closer to the distal end of the proximal hub in the release configuration than in the non-release configuration.

[0019] Except for or as an alternative to any of the examples disclosed herein, the annular flange is configured to engage with the proximal hub when the left atrial appendage closure device is in the release configuration.

[0020] In addition to or as an alternative to any example disclosed herein, in the release configuration, the sensor occupies at least 70% of the volume defined by the first threaded connection structure.

[0021] In addition to or as an alternative to any of the examples disclosed herein, a medical system may include a left atrial appendage closure device comprising an expandable frame and a proximal hub disposed along a central longitudinal axis of the expandable frame, the expandable frame being configured to switch between a collapsed delivery configuration and an expanded deployment configuration; wherein the left atrial appendage closure device includes a sensor at least partially disposed within the expandable frame and axially movable relative to the proximal hub; wherein the proximal hub includes a first connecting structure; and a delivery catheter including a core wire extending axially within the lumen of the delivery catheter, the core wire having a second connecting structure at its distal end, the second connecting structure being configured to releasably engage with the first connecting structure in an unreleased configuration; wherein an occlusion element is disposed on at least a portion of the expandable frame.

[0022] In addition to or as an alternative to any of the examples disclosed herein, the expandable frame includes a plurality of interconnected struts joined together at the proximal hub.

[0023] Except for or alternative to any examples disclosed herein, the first connection structure is formed on the inner surface of the near-side hub, and the second connection structure is formed on the outer surface of the core wire.

[0024] Except for any examples disclosed herein or as an alternative, at least one spring is tensioned between the proximal hub and the sensor.

[0025] In addition to or as an alternative to any of the examples disclosed herein, at least one spring is compressedly disposed between the proximal hub and the sensor.

[0026] The above summary of some embodiments, aspects, and / or examples is not intended to describe every embodiment or every implementation of this disclosure. The accompanying drawings and detailed description below illustrate these embodiments in more detail. Attached Figure Description

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

[0028] Figure 1-2 This is a side view of an exemplary medical system;

[0029] Figure 3-4 The various aspects of the left atrial appendage closure mechanism are shown;

[0030] Figure 5 This is a partial cross-sectional view of an exemplary configuration of the left atrial appendage closure device in the release configuration;

[0031] Figure 6 It is in the unreleased structure Figure 5 A partial cross-sectional view of an exemplary construction of a left atrial appendage closure device;

[0032] Figure 7 This is a partial cross-sectional view of an exemplary configuration of the left atrial appendage closure device in the release configuration;

[0033] Figure 8 It is in the unreleased structure Figure 7 A partial cross-sectional view of an exemplary construction of a left atrial appendage closure device;

[0034] Figure 9 This is a partial cross-sectional view of an exemplary configuration of the left atrial appendage closure device in the release configuration;

[0035] Figure 10 It is in the unreleased structure Figure 9 A partial cross-sectional view of an exemplary construction of a left atrial appendage closure device;

[0036] Figure 11 This is a partial cross-sectional view of an exemplary configuration of the left atrial appendage closure device in the release configuration;

[0037] Figure 12 It is in the unreleased structure Figure 11 A partial cross-sectional view of an exemplary construction of a left atrial appendage closure device;

[0038] Figures 13A-13C It shows the relationship with Figure 11 Exemplary construction of the left atrial appendage closure device and its associated aspects of a medical system; and

[0039] Figure 14 A left atrial appendage closure device is shown, which is placed inside the opening of the left atrial appendage of a patient's heart.

[0040] While various modifications and alternatives may be made to aspects of this disclosure, its details have been illustrated by way of example in the accompanying drawings and will be described in detail. However, it should be understood that the purpose is not to limit aspects of this disclosure to the specific embodiments described. Rather, the invention encompasses all modifications, equivalents, and alternatives falling within the spirit and scope of this disclosure. 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 in multiple 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, its presence is to be understood unless otherwise specified.

[0042] The terms defined below shall apply unless otherwise defined in the claims or elsewhere in this specification.

[0043] Whether explicitly stated or not, this document assumes that all numerical values ​​are modified by the term "approximately". 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 values ​​by endpoints includes all values ​​within 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 appropriate dimensions, ranges and / or values ​​related to various components, features and / or specifications are disclosed, those skilled in the art inspired by this disclosure will understand 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 indicators unless expressly specified otherwise. As used in this specification and the appended claims, the term “or” is generally used to include “and / or” unless expressly specified 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 appear repeatedly in the disclosed examples. Each instance of a feature may include and / or be contained in a single disclosure unless expressly stated otherwise. For the purposes of brevity and clarity, not all elements of this disclosure need to be shown in every drawing or discussed in detail below. However, it should be understood that the discussion below can be equally applied to any and / or all components that have more than one component, unless expressly stated otherwise. Furthermore, for clarity, not all instances of certain elements or features are shown in every drawing.

[0047] For example, relative terms such as “proximal,” “distal,” “advancing,” “retreating,” and their variations are generally considered relative to the positioning, orientation, and / or operation of various elements relative to the user / operator / manipulator of the device, where “proximal” and “retreating” indicate or refer to being closer to or towards the user, while “distal” and “advancing” indicate or refer to being further away 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 these cases are clear to those skilled in the art. Other related terms, such as “upstream,” “downstream,” “inflow,” and “outflow,” refer to the direction of fluid flow within a lumen (such as a body cavity, blood vessel, or device). Other relative terms, such as “axial,” “circumferential,” “longitudinal,” “lateral,” “radial,” and / or their variations, 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 representing the largest measured value of the stated or identified dimension, unless the range or dimension in question is previously or identified as “minimum,” in which case it can be understood as representing the smallest measured value of the stated or identified dimension. For example, “outer range” can be understood as an outer dimension, “radial range” as a radial dimension, “longitudinal range” as a longitudinal dimension, and so on. Each instance of “range” can be different (e.g., axial, longitudinal, lateral, radial, circumferential, etc.) and will be clear to those skilled in the art from the context in which they are used. 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 typically be measured orthogonally in a plane and / or cross-section, but it is apparent from a particular context that it can be measured in different ways, such as, but not limited to, diagonally, radially, circumferentially (e.g., along an arc), etc.

[0049] The terms "integral" and "monolithic" generally refer to one or more elements made up of or composed of a single structural or basic unit / element. Integral elements and / or monolithic elements should exclude structures and / or features formed by assembling or otherwise joining together multiple separate structures or elements.

[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 the contrary is explicitly stated, those skilled in the art will, to the best of their knowledge, implement that specific feature, structure, or characteristic in conjunction with other embodiments, whether explicitly described or not. That is, the various individual elements described below, even if not explicitly shown in a specific combination, are still considered to be combinable or arranged together 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 the numerical designations are not restrictive but 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 a different feature may be referred to as a “first” element. The meaning and / or name in each case are clear to a skilled practitioner.

[0052] The following figures illustrate selected components and / or arrangements of implants for occluding the left atrial appendage, medical systems for occluding the left atrial appendage, and / or methods of using the implants and / or medical systems. It should be noted that in any given figure, some features may not be shown or may be shown schematically for the sake of brevity. Additional details regarding some components of the implants and / or systems may be shown in more detail in other figures. Although discussed in the context of occluding the left atrial appendage, the implants and / or systems can also be used for other interventions and / or percutaneous medical procedures within the patient's body. Similarly, the devices and methods described herein with respect to percutaneous deployment can be suitably used for other types of surgical procedures. For example, in some examples, the device can be used for non-percutaneous procedures. The devices and methods according to this disclosure can also be adapted and configured for other uses within anatomical structures.

[0053] Now turn to the attached image. Figure 1-2 A medical system 10 is shown, comprising a delivery catheter 40 having a lumen 42 extending from a proximal opening to a distal opening, a core wire 30 slidably disposed within the lumen 42 of the delivery catheter 40 and / or extending axially within the lumen of the delivery catheter, and a left atrial appendage closure device 100 having an expandable frame 110 configured to collapse the delivery configuration (e.g., Figure 1 ) and extended expansion construction (e.g., Figure 2The left atrial appendage closure device 100 is positioned within the lumen 42 near the distal opening in the collapsed delivery configuration. When the left atrial appendage closure device 100 is positioned distal to the distal opening of the lumen 42 and / or the delivery catheter 40, and / or when the left atrial appendage closure device 100 is not constrained by the delivery catheter 40, the left atrial appendage closure device 100 and / or the expandable frame 110 can be configured to switch between a collapsed delivery configuration and an expanded deployment configuration. The left atrial appendage closure device 100 may be positioned and / or releasably connected to the distal portion of the core wire 30. The core wire 30 may be slidably and / or rotatably positioned within the lumen 42 of the delivery catheter 40. In some embodiments, the proximal end of the core wire 30 may extend proximally to the proximal end of the delivery catheter 40 and / or the proximal opening of the lumen 42 for manual manipulation by a clinician or practitioner. In some embodiments, the exemplary left atrial appendage closure device 100 may be releasably engaged, removably attached, or otherwise releasably connected to the distal end of the core wire 30. Suitable, but non-limiting, examples of materials for the medical system 10, the core wire 30, the delivery catheter 40, and / or the left atrial appendage closure device 100, etc., will be discussed below. It is contemplated that any and / or all exemplary occlusion implants disclosed herein may be used in accordance with and / or associated with the exemplary medical system 10 described above.

[0054] Figure 3-4 An exemplary configuration of a left atrial appendage closure device 100 including an expandable frame 110 configured to switch between a collapse delivery configuration and an expansion deployment configuration is shown. In some embodiments, the left atrial appendage closure device 100 may include a proximal hub 130 disposed along the central longitudinal axis of the expandable frame 110. In some embodiments, the proximal hub 130 may be centered on the central longitudinal axis of the expandable frame 110. For example, the proximal hub 130 may be coaxial with the central longitudinal axis of the expandable frame 110. In some embodiments, the expandable frame 110 may include a plurality of interconnected struts joined together at the proximal hub 130. In some embodiments, the proximal hub 130 may be integrally formed and / or integrally formed with the expandable frame 110 and / or the plurality of interconnected struts. In some embodiments, the left atrial appendage closure device 100 may include a self-expanding frame, and / or the expandable frame 110 may be a self-expanding frame.

[0055] The expandable frame 110 may be compliant in its expansion configuration and substantially conforms to and / or seals the shape and / or geometry of the lateral walls and / or orifices of the left atrial appendage. In some embodiments, the left atrial appendage closure device 100 may expand to a size, extent, or shape less than or different from the maximum degree of unconstraint determined by the surrounding tissue and / or lateral walls of the left atrial appendage. In some embodiments, reducing the thickness of the various elements of the expandable frame 110 may increase the flexibility and compliance of the expandable frame 110 and / or the left atrial appendage closure device 100, thereby allowing the expandable frame 110 and / or the left atrial appendage closure device 100 to conform to the surrounding tissue, rather than forcing the tissue to conform to the expandable frame 110 and / or the left atrial appendage closure device 100.

[0056] In some embodiments, such as Figure 3 As shown, the left atrial appendage closure device 100 may optionally include an occlusion element 120 (e.g., mesh, fabric, membrane, and / or other surface treatment) disposed on, above, around, or covering at least a portion of the expandable frame 110. In some embodiments, the occlusion element 120 may be disposed on, above, around, or covering at least a portion of the outer (or outward-facing) surface of the expandable frame 110. In some embodiments, the occlusion element 120 may be fixed to and / or extend radially outward from the proximal hub 130. For reference, the occlusion element 120 has been... Figure 4 The left atrial appendage closure device 100 is removed from view to show a selected aspect of it, which would otherwise be hidden from view by the occlusion element 120.

[0057] In some embodiments, the expandable frame 110 may include a plurality of anchoring members 112 disposed around the outer periphery of the expandable frame 110 in an expanded deployment configuration. The plurality of anchoring members 112 may extend radially outward from the expandable frame 110. In some embodiments, at least some of the plurality of anchoring members 112 may each have and / or include a body portion, a tip portion, and a barb projecting circumferentially therefrom. In some embodiments, some and / or each of the plurality of anchoring members 112 has at least one barb projecting circumferentially therefrom. Some suitable, but non-limiting, examples of materials for the expandable frame 110, the plurality of anchoring members 112, etc., will be discussed below.

[0058] In some embodiments, the plurality of anchoring members 112 may provide an anchoring mechanism to help retain the left atrial appendage closure device 100 in the expandable configuration at a target site (e.g., the left atrial appendage) within the patient's anatomy. However, the barbs may be configured, positioned, and / or arranged such that engagement between the barbs and surrounding tissue at the target site is minimized or avoided. For example, in the expandable configuration, the barbs may not puncture, penetrate, and / or extend into the surrounding tissue. Furthermore, in some embodiments, the plurality of anchoring members 112 may provide an attachment mechanism for securing the occlusion element 120 to the expandable frame 110.

[0059] In some embodiments, the occlusion element 120 may extend distally through at least some of the plurality of anchoring members 112. In some embodiments, the occlusion element 120 may extend distally through each and / or all of the plurality of anchoring members 112. In at least some embodiments, at least a distal portion of the occlusion element 120 may be attached to the expandable frame 110. In some embodiments, at least some of the plurality of anchoring members 112 extend and / or protrude through the occlusion element 120. In some embodiments, for example, by passing some and / or each of the plurality of anchoring members 112 through the occlusion element 120, the occlusion element 120 may be attached to some and / or each of the plurality of anchoring members 112 at some and / or each of them.

[0060] In some embodiments, barbs and / or tip portions on at least some and / or each of the plurality of anchoring members 112 may be disposed radially outward and / or on the exterior of the occlusion element 120, while the base of the respective anchoring member is disposed radially inward and / or on the interior of the occlusion element 120. The barbs may be used to retain the occlusion element 120 on the expandable frame 110, thereby preventing the occlusion element 120 from detaching from and / or releasing from the expandable frame 110 during transitions between a collapse delivery configuration and an expansion deployment configuration. In some embodiments, the attachment of the distal portion of the occlusion element 120 to the expandable frame 110 does not require sutures and / or adhesives.

[0061] In some embodiments, the occlusion element 120 may be permeable, semi-permeable, or impermeable to blood and / or other fluids (such as water). In some embodiments, the occlusion element 120 may comprise a polymer membrane, a metal or polymer mesh, a porous filter-like material, or other suitable structure. In some embodiments, the occlusion element 120 may be configured to prevent thrombi (i.e., blood clots, etc.) from passing through the occlusion element 120 and / or leaving the left atrial appendage and entering the bloodstream when the left atrial appendage closure device 100 and / or the expandable frame 110 in an expandable configuration are disposed within the orifice of the left atrial appendage. In some embodiments, the occlusion element 120 may be configured to promote endothelialization at the orifice of the left atrial appendage after implantation of the left atrial appendage closure device 100, thereby effectively removing the left atrial appendage from the patient's circulatory system. Some suitable but non-limiting examples of materials for the occlusion element 120 are discussed below.

[0062] In some embodiments, the left atrial appendage closure device 100 may include a sensor 140 at least partially disposed within the expandable frame 110 and axially movable relative to the proximal hub 130 and / or the expandable frame 110. In some alternative embodiments, the left atrial appendage closure device 100 may include a plug and / or stop in place of the sensor 140, wherein the plug and / or stop is at least partially disposed within the expandable frame 110 and axially movable relative to the proximal hub 130 and / or the expandable frame 110. In some embodiments, the sensor 140, and / or the plug and / or stop positioned as described herein, may be used to reduce the exposed surface area of ​​the proximal hub 130 and / or reduce the risk of thrombosis.

[0063] In at least some embodiments, in the release configuration of the medical system 10 and / or the left atrial appendage closure device 100, the sensor 140 and / or the plug and / or the stop may be at least partially disposed within the proximal hub 130, such as Figure 3 and Figure 4As shown. In the release configuration, the core wire 30 can detach and / or separate from the left atrial appendage closure device 100 and / or proximal hub 130, as described herein. In some embodiments, in the release configuration, the proximal end 142 of the sensor 140 and / or plug and / or stop can be configured to be substantially flush with the proximal extent of the proximal hub 130. In some embodiments, in the release configuration, the proximal end 142 of the sensor 140 and / or plug and / or stop can extend to the proximal side of the proximal extent of the proximal hub 130. For example, in some embodiments, in the release configuration, the proximal end 142 of the sensor 140 and / or plug and / or stop can extend to approximately 1 mm, approximately 2 mm, approximately 3 mm, approximately 4 mm, approximately 5 mm, approximately 6 mm, approximately 7 mm, approximately 8 mm, or approximately 10 mm proximal to the proximal side of the proximal extent of the proximal hub 130. In one example, in the release configuration, the proximal end 142 of the sensor 140 and / or the plug and / or the stop may extend approximately 4 mm to approximately 5 mm proximal to the nearest extent of the proximal hub 130. Other extents and / or dimensions are also contemplated. In some embodiments, the proximal end 142 of the sensor 140 and / or the plug and / or the stop may have a convex shape extending in the proximal direction. In some embodiments where the proximal end 142 of the sensor 140 and / or the plug and / or the stop has a convex shape, in the release configuration, the nearest extent of the sensor 140 and / or the plug and / or the stop may be substantially flush with the nearest extent of the proximal hub 130. In some embodiments where the proximal end 142 of the sensor 140 and / or the plug and / or the stop has a convex shape, in the release configuration, the nearest extent of the sensor 140 and / or the plug and / or the stop may extend proximal to the nearest extent of the proximal hub 130.

[0064] In some embodiments, in the release configuration, the proximal end 142 of the sensor 140 and / or the plug and / or the stop extending proximally to the proximal portion of the proximal hub 130 can allow endothelial growth on the orifice of the occlusion element 120 and / or the left atrial appendage without obstructing and / or clogging the proximal end 142 of the sensor 140 and / or the plug and / or the stop. In some embodiments, in the release configuration, the proximal end 142 of the sensor 140 and / or the plug and / or the stop can be positioned distally to the proximal portion of the proximal hub 130 and proximal to the distal end of the proximal hub 130, such that the proximal end 142 of the sensor 140 and / or the plug and / or the stop is recessed within the proximal hub 130 to allow and / or promote endothelial growth thereon. Those skilled in the art will recognize that the type, construction, and performance of the sensor 140 and / or the plug and / or the stop can be used to determine whether excessive endothelial growth should be allowed and / or promoted.

[0065] like Figure 4As shown, sensor 140, and / or plug and / or stop, may extend distally into the interior of left atrial appendage closure device 100 and / or expandable frame 110. In some embodiments, sensor 140, and / or plug and / or stop, may have a substantially cylindrical outer surface. In some embodiments, sensor 140, and / or plug and / or stop, may be hollow and / or may include an internal space configured to receive components of sensor 140, and / or plug and / or stop. The total length of sensor 140, and / or plug and / or stop, may vary depending on the configuration of sensor 140, and / or plug and / or stop, and / or components disposed within the internal space of sensor 140, and / or plug and / or stop.

[0066] In one exemplary configuration, sensor 140, and / or plug and / or stop, may include one or more internal components disposed within an internal space. In some embodiments, sensor 140, and / or plug and / or stop, may have no internal components. Therefore, in any particular example, any and / or all internal components may be considered optional. In some embodiments, sensor 140 may include a sensing element disposed within sensor 140, the sensing element communicating with a proximal end 142 of sensor 140. In some embodiments, sensor 140 may be a pressure sensor and / or may include a pressure sensing element. In some embodiments, the proximal end 142 of sensor 140 may include a diaphragm extending across the proximal end 142 of sensor 140, and pressure-transmitting fluid may be disposed within the proximal end 142 of sensor 140 between the diaphragm and the sensing element. When the expandable frame 110 in the delivery configuration and / or release configuration and / or the left atrial appendage closure device 100 are disposed within the orifice of the left atrial appendage, the sensor 140 may be configured to sense fluid pressure within the space (e.g., the left atrium) and / or adjacent to the proximal end 142 of the sensor 140. In some embodiments, the sensor 140 may be configured to sense and / or detect (and / or the sensor 140 may include sensing elements configured to sense and / or detect) temperature, flow rate, heart rate, electrical signals in the heart, heart rhythm, or other characteristics.

[0067] In some embodiments, sensor 140 may include an integrated circuit board for controlling sensor 140 and / or other internal components of sensor 140. In some embodiments, sensor 140 may include a communication coil disposed within the internal space of sensor 140. In some embodiments, the communication coil may be configured for bidirectional wireless communication and / or power transfer. In some embodiments, sensor 140 may optionally include a battery. In some embodiments, sensor 140 may be powered “on demand” via an inductive link. In some embodiments, the communication coil may be and / or may form part of the inductive link. In some embodiments, sensor 140 may include a capacitor disposed within the internal space, which is configured to serve as a temporary power source for sensor 140 and / or other internal components of sensor 140 (e.g., during “on demand” power transfer to sensor 140 and / or left atrial appendage closure device 100). In some embodiments, the communication coil may be wound around a battery. In some embodiments, the communication coil may be wound around a capacitor. In some embodiments, the communication coil may be a self-contained feature and / or may be wound around an inert and / or non-functional structure to maintain its shape and / or form. Other configurations are also contemplated.

[0068] In some battery-based embodiments, the battery may be rechargeable. While a direct connection can be used to charge the battery, this configuration can be quite invasive for the patient. Therefore, wireless (e.g., inductive) recharging capability may be more desirable and much less invasive for the patient. In some battery-based embodiments, the battery may be non-rechargeable. When using a non-rechargeable battery, it may be desirable to have a battery lifespan at least as long as the patient's expected remaining lifespan to avoid the need for battery replacement in the patient's later years, when surgery may be more challenging.

[0069] Figure 5-12 An exemplary configuration of the medical system 10 is shown. Figure 5 , Figure 7 , Figure 9 and Figure 11 A medical system 10 and / or a left atrial appendage closure device 100 in a release configuration is shown. In the release configuration, the core wire 30 (not shown) can be detached and / or separated from the left atrial appendage closure device 100 and / or the proximal hub 130. Figure 6 , Figure 8 , Figure 10 and Figure 12A medical system 10 and / or a left atrial appendage closure device 100 in an unreleased configuration is illustrated. In the unreleased configuration, the core wire 30 can be at least partially releasably engaged, attached, and / or connected to the left atrial appendage closure device 100 and / or the proximal hub 130. In at least some embodiments, a collapse delivery configuration and / or an expansion deployment configuration can be used and / or applied simultaneously and / or interchangeably with the unreleased configuration. For the purposes of this disclosure, any configuration in which the core wire 30 is at least partially engaged with the left atrial appendage closure device 100 and / or the proximal hub 130 can be considered an unreleased configuration.

[0070] In some embodiments, the proximal hub 130 of the expandable frame 110 may be configured to releasably attach, connect, engage, engage, or otherwise connect to the distal end of the core wire 30. In some embodiments, the proximal hub 130 may include a first threaded connection structure 170 configured and / or adapted to releasably connect, engage, engage, or otherwise engage with a second threaded connection structure 180 at the distal end of the core wire 30 in an unreleased configuration of the medical system 10 and / or the left atrial appendage closure device 100, such as... Figure 6 , Figure 8 , Figure 10 and Figure 12 As shown. In some embodiments, a first threaded connection structure 170 may be formed on the inner surface of the proximal hub 130. In some embodiments, a second threaded connection structure 180 may be formed on the outer surface of the core wire 30. Furthermore, in some embodiments, the first connection structure and / or the second connection structure does not need to be threaded. Other configurations are also considered, including but not limited to snap-fit ​​engagements, engagement clips, spring features, mating protrusions and recesses, etc.

[0071] In some embodiments, when the second threaded connection structure 180 is disengaged from the first threaded connection structure 170, and / or when the left atrial appendage closure device 100 and / or the medical system 10 are in a release configuration, the sensor 140 is at least partially disposed within the proximal hub 130. Figure 5-12 As shown, sensor 140, and / or plug and / or stop, can be axially movable relative to proximal hub 130 and / or expandable frame 110. In some embodiments, when the second threaded connection structure 180 disengages from the first threaded connection structure 170, and / or when the left atrial appendage closure device 100 and / or medical system 10 is in a release configuration, in which the proximal end 142 of sensor 140 and / or plug and / or stop can be substantially flush with the proximal extent of proximal hub 130, such as Figure 5 , Figure 7 , Figure 9 and Figure 11As shown. In some embodiments, when the second threaded connection structure 180 is disengaged from the first threaded connection structure 170, and / or when the left atrial appendage closure device 100 and / or medical system 10 are in a release configuration, in which the proximal end 142 of the sensor 140 and / or the plug and / or the stop can extend to the proximal side of the proximal range of the proximal hub 130, as shown. Figure 5 , Figure 7 , Figure 9 and Figure 11 As indicated by the dashed line 143 in the attached diagram. When the second threaded connection structure 180 engages with the first threaded connection structure 170, and / or when the left atrial appendage closure device 100 and / or the medical system 10 are in the unreleased configuration, the distal end of the second threaded connection structure 180 and / or the distal end of the core wire 30 can engage the proximal end 142 of the sensor 140 and / or the plug and / or the stop, as shown in the attached diagram. Figure 6 , Figure 8 , Figure 10 and Figure 12 As shown.

[0072] In some embodiments, the distal end of the second threaded connection structure 180 and / or the distal end of the core wire 30 may have a concave shape extending proximally. When the second threaded connection structure 180 engages with the first threaded connection structure 170, and / or when the left atrial appendage closure device 100 and / or the medical system 10 is in an unreleased configuration, the concave shape may be configured to engage, abut, and / or mate with the convex shape of the proximal end 142 of the sensor 140 and / or the plug and / or the stop. In some embodiments, when the second threaded connection structure 180 engages with the first threaded connection structure 170, and / or when the left atrial appendage closure device 100 and / or the medical system 10 is in an unreleased configuration, the distal end of the second threaded connection structure 180 and / or the distal end of the core wire 30 may directly contact the proximal end 142 of the sensor 140 and / or the plug and / or the stop.

[0073] In some embodiments, when the second threaded connection structure 180 is disengaged from the first threaded connection structure 170, and / or when the left atrial appendage closure device 100 and / or medical system 10 are in a release configuration, the sensor 140, and / or the plug and / or the stop may occupy at least 50% of the volume defined by the first threaded connection structure 170. In some embodiments, when the second threaded connection structure 180 is disengaged from the first threaded connection structure 170, and / or when the left atrial appendage closure device 100 and / or medical system 10 are in a release configuration, the sensor 140, and / or the plug and / or the stop may occupy at least 60% of the volume defined by the first threaded connection structure 170. In some embodiments, when the second threaded connection structure 180 is disengaged from the first threaded connection structure 170, and / or when the left atrial appendage closure device 100 and / or medical system 10 are in a release configuration, the sensor 140, and / or the plug and / or the stop may occupy at least 70% of the volume defined by the first threaded connection structure 170. In some embodiments, when the second threaded connection structure 180 is disengaged from the first threaded connection structure 170, and / or when the left atrial appendage closure device 100 and / or the medical system 10 are in the release configuration, the sensor 140, and / or the plug and / or the stop may occupy at least 80% of the volume defined by the first threaded connection structure 170. In some embodiments, when the second threaded connection structure 180 is disengaged from the first threaded connection structure 170, and / or when the left atrial appendage closure device 100 and / or the medical system 10 are in the release configuration, the sensor 140, and / or the plug and / or the stop may occupy at least 90% of the volume defined by the first threaded connection structure 170.

[0074] In some embodiments, the sensor 140, and / or the plug and / or the stop, may include an annular flange 144 extending radially outward from the outer surface of the sensor 140, and / or the plug and / or the stop. In some embodiments, the annular flange 144 may be oriented substantially perpendicular to the central longitudinal axis and / or the outer surface of the sensor 140, and / or the plug and / or the stop. In at least some embodiments, the outer surface of the sensor 140, and / or the plug and / or the stop may be generally cylindrical in shape. The annular flange 144 may extend circumferentially around and / or around the outer surface of the sensor 140, and / or the plug and / or the stop. The annular flange 144 may be disposed between and axially spaced from the proximal end 142 of the sensor 140, and / or the plug and / or the stop. In some embodiments, the annular flange 144 may be axially closer to the distal end and / or furthest extent of the proximal hub 130 in the release configuration than in the non-release configuration. In some embodiments, the annular flange 144 may be configured to engage and / or abut against the side hub 130 when the left atrial appendage closure device 100 and / or medical system 10 is in the release configuration. In some embodiments, the annular flange 144 may be configured to engage and / or abut against the distal end of the side hub 130 when the left atrial appendage closure device 100 and / or medical system 10 is in the release configuration. In some embodiments, the annular flange 144 may discontinuously surround and / or encircle the outer surface of the sensor 140, and / or the plug and / or the stop. For example, in some embodiments, the annular flange 144 may include a plurality of separate flanges circumferentially spaced around and / or surrounding the outer surface of the sensor 140, and / or the plug and / or the stop at a common axial location between the proximal end 142 of the sensor 140, and / or the plug and / or the stop and the distal end of the sensor 140, and / or the stop. In some embodiments, the annular flange 144 may include a proximal cone, a distal cone, or both to facilitate axial movement of the sensor 140, and / or the plug and / or the stop relative to the proximal hub 130, and / or to facilitate alignment of the sensor 140, and / or the plug and / or the stop 40 with the first threaded connection structure 170 and / or the volume defined by the first threaded connection structure 170. In some embodiments, the annular flange 144 may include a proximal cone, a distal cone, or both, to facilitate coaxial alignment of the sensor 140, and / or the plug and / or the stop with the central longitudinal axis of the left atrial appendage closure device 100 and / or the expandable frame 110.

[0075] In some embodiments, the left atrial appendage closure device 100 may include at least one spring 150 engaged with the proximal hub 130 and sensor 140, and / or plug and / or stop. In some embodiments, at least one spring 150 may be coupled to the proximal hub 130 and / or sensor 140, and / or plug and / or stop. In some embodiments, at least one spring 150 may be fixedly attached to the inner surface of the proximal hub 130. In some embodiments, at least one spring may be fixedly attached to the sensor 140, and / or plug and / or stop, and / or annular flange 144. In some embodiments, at least one spring 150 may include a plurality of springs circumferentially spaced around and / or surrounding the outer surface of the sensor 140, and / or plug and / or stop, and / or sensor 140. In some embodiments, at least one spring 150 may respectively include and / or be formed as a helical spring, a mesh network having spring function, or other suitable structures capable of providing similar spring function. In some embodiments, at least one spring 150 may include a helical spring arranged coaxially around the sensor 140, and / or the plug and / or the stop, such as Figure 9 and Figure 10 As shown. In some embodiments, as Figure 5 and Figure 6 As shown, at least one spring 150 can be tensioned between the proximal hub 130 and the sensor 140, and / or the plug and / or the stop. In some embodiments, at least one spring 150 can be tensioned between the proximal hub 130 and the annular flange 144 of the sensor 140, and / or the plug and / or the stop. In some embodiments, as Figure 7-10 As shown, at least one spring 150 can be compressibly disposed between the proximal hub 130 and the sensor 140, and / or the plug and / or the stop. In some embodiments, at least one spring 150 can be compressibly disposed between the proximal hub 130 and the annular flange 144 of the sensor 140, and / or the plug and / or the stop. In some embodiments, at least one spring 150 can be disposed between the proximal hub 130 and the proximal flange 146, the proximal flange being disposed at the proximal end 142 of the sensor 140, and / or the plug and / or the stop, as shown. Figure 9 and Figure 10 As shown. The proximal flange 146 may extend radially outward from the outer surface of the sensor 140, and / or the plug and / or the stop in a manner similar to the annular flange 144. In some embodiments, the proximal flange 146 may extend substantially perpendicular to the central longitudinal axis and / or the outer surface of the sensor 140, and / or the plug and / or the stop.

[0076] In some embodiments, the sensor 140, and / or the plug and / or the stop may include a third threaded connection structure 148 formed on the outer surface of the sensor 140, and / or the plug and / or the stop, near the proximal end 142, and configured to thread the sensor 140, and / or the plug and / or the stop to the first threaded connection structure 170, such as... Figure 11 As shown. In some embodiments, when the left atrial appendage closure device 100 is not in the release configuration, rotation of the core wire 30 relative to the proximal hub 130 can rotate the sensor 140, and / or the plug and / or the stop relative to the proximal hub 130, to axially move the sensor 140, and / or the plug and / or the stop relative to the proximal hub 130 and / or the expandable frame 110, such as... Figure 12 As shown. In some embodiments, the first threaded connection structure 170 and the second threaded connection structure 180 can be configured such that when the left atrial appendage closure device 100 is not in the release configuration, clockwise rotation of the core wire 30 relative to the proximal hub 130 can advance the second threaded connection structure 180 distally within the proximal hub 130 and the first threaded connection structure 170, and distally, relative to the proximal hub 130 and the first threaded connection structure 170, and counterclockwise rotation of the core wire 30 relative to the proximal hub 130 can retract the second threaded connection structure 180 proximally within the proximal hub 130 and the first threaded connection structure 170, and proximally. In another configuration, the first threaded connection structure 170 and the second threaded connection structure 180 can be configured such that when the left atrial appendage closure device 100 is not in the release configuration, counterclockwise rotation of the core wire 30 relative to the proximal hub 130 can advance the second threaded connection structure 180 distally within the proximal hub 130 and the first threaded connection structure 170 relative to the proximal hub and the first threaded connection structure, and clockwise rotation of the core wire 30 relative to the proximal hub 130 can retract the second threaded connection structure 180 proximally within the proximal hub 130 and the first threaded connection structure 170 relative to the proximal hub and the first threaded connection structure.

[0077] In some embodiments, the distal end of the core wire 30 and / or the second threaded connection structure 180 may include a first locking element 190 formed thereon, such as Figures 13A-13C As shown. In at least some embodiments, the first locking element 190 may extend distally from the second threaded connection structure 180. In some embodiments, the proximal end 142 of the sensor 140, and / or the plug and / or the stop may include a second locking element 192 formed thereon. In some embodiments, the second locking element 192 may extend distally into the proximal end 142 of the sensor 140, and / or the plug and / or the stop, and / or the second locking element 192 may be recessed into the proximal end 142 of the sensor 140, and / or the plug and / or the stop.

[0078] exist Figure 13A In one exemplary configuration shown, the first locking element 190 may be a protruding key extending axially parallel to the central longitudinal axis. This protruding key may be disposed along the outer periphery of the second threaded connection structure 180. The second locking element 192 may be a notch formed in the proximal end 142 of the sensor 140, and / or the plug and / or the stop, near the outer surface of the sensor 140, and / or the plug and / or the stop. The protruding key and the notch may be complementary shapes, configured such that the protruding key can engage with and nest within the notch while preventing relative rotation between them. The protruding key and the notch may each include a flat side configured to transmit rotational force therebetween, such that rotational force applied to the core wire 30 is transmitted through the protruding key and the notch to the sensor 140, and / or the plug and / or the stop. Therefore, when the left atrial appendage closure device 100 is not in the release configuration, the rotation applied to the core wire 30 causes the sensor 140, and / or the plug and / or the stop to rotate and move axially relative to the proximal hub 130.

[0079] exist Figure 13B In another exemplary configuration shown, the first locking element 190 may be a hexagonal key extending axially parallel to the central longitudinal axis. This hexagonal key may be coaxially disposed with the second threaded connection structure 180 and / or the core wire 30. The second locking element 192 may be a hexagonal recess formed in the proximal end 142 of the sensor 140, and / or the plug and / or the stop, coaxial with the sensor 140, and / or the plug and / or the stop. The hexagonal key and the hexagonal recess may be complementary shapes configured such that the hexagonal key can engage with and nest within the hexagonal recess while preventing relative rotation between them. The hexagonal key and the hexagonal recess may each include a straight side (e.g., parallel to the central longitudinal axis) configured to transmit rotational force therebetween, such that rotational force applied to the core wire 30 is transmitted through the hexagonal key and the hexagonal recess to the sensor 140, and / or the plug and / or the stop. Therefore, when the left atrial appendage closure device 100 is not in the release configuration, the rotation applied to the core wire 30 causes the sensor 140, and / or the plug and / or the stop to rotate and move axially relative to the proximal hub 130.

[0080] exist Figure 13CIn another exemplary configuration shown, the first locking element 190 may be a wave-shaped key extending axially parallel to the central longitudinal axis. This wave-shaped key may be coaxially disposed with the second threaded connection structure 180 and / or the core wire 30. The second locking element 192 may be a wave-shaped groove formed in the proximal end 142 of the sensor 140, and / or the plug and / or the stop, coaxial with the sensor 140, and / or the plug and / or the stop. The wave-shaped key and the wave-shaped groove may be complementary shapes, configured such that the wave-shaped key can engage with and nest within the wave-shaped groove while preventing relative rotation between them. The wave-shaped key and the wave-shaped groove may each include a straight side (e.g., parallel to the central longitudinal axis) configured to transmit rotational force therebetween, such that rotational force applied to the core wire 30 is transmitted through the wave-shaped key and the wave-shaped groove to the sensor 140, and / or the plug and / or the stop. Therefore, when the left atrial appendage closure device 100 is not in the release configuration, the rotation applied to the core wire 30 causes the sensor 140, and / or the plug and / or the stop to rotate and move axially relative to the proximal hub 130.

[0081] Figures 13A-13C The configurations shown are merely examples and are not intended to be limiting. Other constructions and / or complementary shapes may also be envisioned for use as the first locking element 190 and the second locking element 192, including but not limited to stars, squares or rectangles, triangles, polygons with multiple sides not mentioned herein, ellipses, irregular shapes, and / or other shapes that can prevent relative rotation between the first locking element 190 and the second locking element 192.

[0082] In addition to or as an alternative to any of the configurations described herein, the core wire 30 may include at least one hole extending through the sidewall of the core wire into a hollow portion extending to the distal end of the core wire 30. In the unreleased configuration, at least one hole may be located proximal to the sensor 140, and / or the plug and / or the stop. This at least one hole may allow fluid communication between the exterior of the core wire 30 and the proximal end 142 of the sensor 140, and / or the plug and / or the stop. This may be useful when a practitioner wishes to detect and / or measure left atrial pressure and / or other characteristics with the sensor 140 prior to releasing the left atrial appendage closure device 100.

[0083] Figure 14This is a partial cross-sectional view of an exemplary left atrial appendage 50, which may be attached to and in fluid communication with the left atrium 60 of a patient's heart. In some patients, the left atrial appendage 50 may have complex geometry and / or irregular surface areas. Those skilled in the art will recognize that the left atrial appendage shown is merely one of many possible shapes and sizes of the left atrial appendage 50, which may vary from patient to patient. Those skilled in the art will also recognize that the medical devices, systems, and methods disclosed herein can be adapted to left atrial appendages 50 of various sizes and shapes, if necessary. The left atrial appendage 50 may include a generally longitudinal axis arranged along the depth of a body 52 of the left atrial appendage 50. The body 52 may include a wall 54 and an orifice 56 forming a proximal mouth 58. In some embodiments, the lateral extent of the orifice 56 and / or the wall 54 may be less than or less than the depth of the body 52 along the longitudinal axis, or the depth of the body 52 may be greater than the lateral extent of the orifice 56 and / or the wall 54. In some embodiments, the left atrial appendage 50 may include a tail-like element associated with the distal portion of the body 52, which may project radially or laterally away from the body 52.

[0084] like Figure 14 As shown, the left atrial appendage closure device 100 can be implanted within the orifice 56 of the left atrial appendage 50 to close the proximal mouth 58 and substantially and / or completely seal the left atrial appendage 50 from the left atrium 60 and / or the patient's circulatory system. As described herein, the sensor 140, and / or plug and / or stop may face the left atrium 60. In at least some embodiments, the sensor 140 may be a pressure sensor configured to sense fluid pressure within the left atrium 60 when the left atrial appendage closure device 100 is disposed within the orifice 56 of the left atrial appendage 50 in a release configuration.

[0085] The materials used in the various components of the medical system 10 and / or the left atrial appendage closure device 100, and the various elements disclosed herein, may include materials generally associated with medical devices. For the sake of brevity, the following discussion refers to medical 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, the core wire 30, the delivery catheter 40, the left atrial appendage closure device 100, the expandable frame 110, the occlusion element 120, the proximal hub 130, the sensor 140, and / or their elements or parts.

[0086] In some embodiments, the medical 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.

[0087] Some examples of suitable polymers may include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), and polyoxymethylene (POM, for example, available from DuPont). Polyether block esters, polyurethanes (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), and polyether esters (e.g., available from DSM EngineeringPlastics) ), ether or ester copolymers (e.g., butene / poly(alkylene ether) phthalates and / or other polyester elastomers, such as those available from DuPont) ), polyamide (e.g., available from Bayer) Or available from Elf Atochem ), elastic polyamide, block polyamide / ether, polyether block amide (PEBA, for example, can be marketed under the trademark name) (Originally obtained from ethylene vinyl acetate copolymer (EVA), silicone, polyethylene (PE)). High-density polyethylene, Low-density polyethylene, linear low-density polyethylene (e.g., 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., Polysulfone, nylon, nylon-12 (e.g., available from EMS American Grilon) 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., from Aortech Biomaterials) Or from AdvantSource Biomaterials Biocompatible polymers, other suitable materials, or mixtures, compositions, copolymers, polymer / metal composites, etc., are permitted. In some embodiments, the sheath may be blended with a liquid crystal polymer (LCP). For example, the blend may contain up to about 6% LCP.

[0088] Some examples of suitable metals and metal alloys include stainless steels such as 304V, 304L, and 316LV stainless steels; low-carbon steels; nickel-titanium alloys such as linearly elastic and / or hyperelastic nickel-titanium alloys; and other nickel alloys such as nickel-chromium-molybdenum alloys (e.g., UNS: N06625, for example...). 625, UNS: N06022, for example UNS: N10276, for example other Alloys, etc.), nickel-copper alloys (e.g., UNS: N04400, for example). 400, 400, 400, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035, for example). (etc.), nickel-molybdenum alloys (e.g., UNS: N10665, for example) ALLOY 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: R30003, for example). (etc.); platinum-rich stainless steel, titanium, platinum, palladium, gold, combinations thereof, or any other suitable material.

[0089] In some embodiments, the linear elastic and / or non-hyperelastic nickel-titanium alloy may range from about 50 to about 60 wt% nickel, with the remainder being substantially titanium. In some embodiments, the nickel in the composition ranges from about 54 wt% to about 57 wt%. An example of a suitable nickel-titanium alloy is the FHP-NT alloy, which is available from Furukawa Techno Material Co., Ltd. in Kanagawa, Japan. Other suitable materials may include ULTANIUM. TM (Available from Neo-Metrics) and GUM METAL TM (Available from Toyota). In some other embodiments, the desired properties can be achieved using a superelastic alloy (e.g., superelastic nitinol).

[0090] In at least some embodiments, part or all of the medical system and / or its components may also be doped with, made of, or otherwise include a radiopaque material. A radiopaque material is understood to be a material capable of producing a relatively bright image on a fluorescent screen or other imaging technique during medical procedures. This relatively bright image helps the user of the medical system determine their location. Some examples of radiopaque materials may include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymer materials loaded with radiopaque fillers, etc. Additionally, other radiopaque marking strips and / or coils may be incorporated into the design of the medical system to achieve the same result.

[0091] In some embodiments, a degree of magnetic resonance imaging (MRI) compatibility is endowed to the medical system and / or other components disclosed herein. For example, the medical 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 can produce artifacts in MRI images. The medical system or portions thereof may also be made of materials that an MRI machine can image. Some materials exhibiting these properties include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS: R30003, etc.). (etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035, for example) (etc.), nickel-titanium, and other materials.

[0092] In some embodiments, the medical system and / or other components disclosed herein may include a fabric material disposed on or within the structure. The fabric material may consist of a biocompatible material suitable for promoting tissue inward growth, such as a polymeric material or a biomaterial. In some embodiments, the fabric material may include a bioabsorbable material. 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 compositions thereof.

[0093] In some embodiments, the medical system 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 this disclosure include, but are not limited to, polyesters, including polyethylene terephthalate (PET) polyesters, polypropylene, polyethylene, polyurethane, polyolefins, ethylene polymers, polyacetate, polyamide, polyethylene naphthalate derivatives, natural silk, and polytetrafluoroethylene. Furthermore, at least one synthetic yarn 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 thermoplastic materials, including but not limited to polyester, polypropylene, polyethylene, polyurethane, polynaphthalene, polytetrafluoroethylene, etc. The yarn can be multifilament, monofilament, or staple fiber. The type and denier of the selected yarn can be chosen to form a biocompatible and implantable prosthesis, more specifically, to form a vascular structure with the desired properties.

[0094] In some embodiments, the medical system and / or other components may include and / or be treated with suitable therapeutic agents. Some 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 alkaloids, epoch-forming alkaloids, endostatin, angiostatin, and thymidine kinase inhibitors); anesthetics (such as lidocaine, bupivacaine, and ropivacaine); and anticoagulants (such as D-Phe-Pro-A). RG chloromethyl ketone, compounds containing RGD peptides, heparin, antithrombin compounds, platelet receptor antagonists, antithrombin antibodies, antiplatelet receptor antibodies, aspirin, prostaglandin inhibitors, platelet inhibitors, and tick antiplatelet peptides; angiogenesis promoters (such as growth factor inhibitors, growth factor receptor antagonists, transcription activators, and translation promoters); angiogenesis inhibitors (such as growth factor inhibitors, growth factor receptor antagonists, transcription 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); cholesterol lowering agents; vasodilators; and agents that interfere with endogenous vasoactive mechanisms.

[0095] It should be understood that this disclosure is illustrative in many respects. Changes in details, particularly in shape, size, and arrangement of steps, may be made without departing from the scope of this disclosure. To the appropriate extent, this may include the use of any feature of an exemplary embodiment used in other embodiments. Of course, the scope of this disclosure is defined by the language of the appended claims.

Claims

1. A medical system comprising: A left atrial appendage closure device comprising an expandable frame and a proximal hub disposed along the central longitudinal axis of the expandable frame, the expandable frame being configured to switch between a collapse delivery configuration and an expansion deployment configuration; The left atrial appendage closure device includes a sensor, which is at least partially disposed inside the expandable frame and is axially movable relative to the proximal hub. The proximal hub includes a first threaded connection structure; and A delivery catheter includes a core wire extending axially within the lumen of the delivery catheter, the core wire having a second threaded connection structure at its distal end, the second threaded connection structure being configured to releasably engage a first threaded connection structure in an unreleased configuration, and to disengage from the first threaded connection structure in a release configuration. Wherein, when the second threaded connection structure is disengaged from the first threaded connection structure, the sensor is at least partially disposed within the proximal hub.

2. The medical system according to claim 1, wherein, The sensor is a pressure sensor configured to sense fluid pressure in the space facing the proximal end of the sensor when the left atrial appendage closure device is in the release configuration.

3. The medical system according to claim 1, wherein, When the second threaded connection structure engages with the first threaded connection structure, the distal end of the second threaded connection structure engages with the proximal end of the sensor.

4. The medical system according to claim 1, wherein, When the second threaded connection structure disengages from the first threaded connection structure, the proximal end of the sensor extends to the proximal side of the proximal hub.

5. The medical system according to claim 1, wherein, The left atrial appendage closure device includes at least one spring that engages with the proximal hub and the sensor.

6. The medical system according to claim 5, wherein, The at least one spring is a helical spring arranged coaxially around the sensor.

7. The medical system according to claim 5, wherein, The at least one spring includes a plurality of springs spaced circumferentially around the sensor.

8. The medical system according to claim 5, wherein, The at least one spring is fixedly attached to the inner surface of the proximal hub.

9. The medical system according to claim 1, wherein, The sensor includes a third threaded connection structure configured to thread the sensor to the first threaded connection structure.

10. The medical system according to claim 9, wherein, When the left atrial appendage closure device is not in the release configuration, the rotation of the core wire relative to the proximal hub causes the sensor to rotate relative to the proximal hub.

11. The medical system according to claim 1, wherein, The sensor includes an annular flange that extends radially outward from the outer surface of the sensor.

12. The medical system according to claim 11, wherein, The annular flange is axially closer to the distal end of the proximal hub in the released configuration than in the unreleased configuration.

13. The medical system according to claim 11, wherein, The annular flange is configured to engage with the proximal hub when the left atrial appendage closure device is in the release configuration.

14. The medical system according to claim 1, wherein, In the release configuration, the sensor occupies at least 70% of the volume defined by the first threaded connection structure.

Images