Device for occluding an auricle of the heart

Abstract

Aspects of the present disclosure relate to devices, methods, and systems related to occlusion. In particular examples, devices, methods, and systems can include devices for placement in vessels, auricles, and body openings. The devices can include a unitary frame having a face portion including a central frame portion and a plurality of elongate members.

Description

[0001] This application is a divisional application of application filed on January 9, 2018, with application number 201680040567.9, entitled "Device for Occluding the Auricle of the Heart".

[0002] Cross-references to related applications

[0003] This application claims priority to provisional application No. 62 / 161,742, filed on May 14, 2015, the entire contents of which are incorporated herein by reference. Technical Field

[0004] This application relates to implantable medical devices that can be used to close orifices, channels, spaces, organs and other structures within a patient's body. Background Technology

[0005] Heart structures such as the auricle of the heart can cause impaired blood flow to the heart, which is associated with a wide range of heart-related pathologies. For example, complications arising from impaired blood flow within the auricle of the heart and associated with atrial fibrillation can lead to embolic stroke. Summary of the Invention

[0006] Various aspects of this application provide implantable medical devices that can be used to occlude orifices, channels, spaces, organs, and other structures, including structures within the heart, in a patient's body. For example, this application provides an occlusion device that can be deployed into a patient's body. Deployment (unfolding) can occur using catheter techniques, but various deployment techniques are contemplated.

[0007] Devices consistent with aspects of this application can be deployed into a patient's atrial appendage. The heart has a left atrial appendage and a right atrial appendage. Aspects of this application relate to occlusion devices that provide enhanced conformability of the device frame (including the occlusion surface) relative to the atrial appendage wall under various physiological conditions. Furthermore, this application relates to occlusion devices that provide more complete and faster atrial appendage closure, including improved sealing of the atrial appendage around its orifice, enhanced clinical outcomes, patient safety, and overall efficiency, including reduced thrombus formation, reduced occlusion embolism, greater conformability, and enhanced clinical usability.

[0008] Various aspects of the present invention relate to devices, methods, and systems related to occlusion. In particular embodiments, devices for placement in blood vessels, atrial appendages, and internal openings may include a monolithic self-expanding frame having a proximal end, a distal end, and a longitudinal axis. In particular embodiments, the monolithic self-expanding frame may include a face portion and a body portion, the face portion having a preloaded flat configuration and (i) a central frame portion disposed at the proximal end and (ii) a plurality of elongated members extending from the central frame portion. In particular embodiments, the device may include a membrane attached to the monolithic self-expanding frame. In particular examples, the plurality of elongated members may be configured to bend or flex in a plane substantially orthogonal to the longitudinal axis and to mitigate longitudinal movement of the face portion in response to compressive forces applied to the body portion of the monolithic self-expanding frame.

[0009] In certain embodiments, a device with elongation and deployment configurations for placement in blood vessels, auricles, and internal openings may include a nitinol cutting tube frame having proximal and distal ends. In certain embodiments, the nitinol cutting tube frame may include a face portion and a body portion, the face portion having a central frame portion disposed at the proximal end and including a plurality of arc segments (arcs) arranged around the perimeter of the central frame portion, and a plurality of elongated members extending from the central frame portion. In certain examples, the device may also include a membrane attached to the entire nitinol cutting tube frame. Furthermore, and in certain examples, the central frame portion and the plurality of elongated members may form a substantially uniform surface, and the central frame portion may be configured to provide attachment points for a delivery system of the device.

[0010] In certain embodiments, methods for reducing thrombus formation when treating a patient's left atrial appendage may include positioning a transcatheter assembly through an opening in the left atrial appendage. In certain embodiments, the method may further include deploying a device from the transcatheter assembly, the device comprising: a monolithic self-expanding frame having a proximal end, a distal end, and a longitudinal axis; and a membrane, the monolithic self-expanding frame including a face portion and a body portion, the face portion having a central frame portion disposed proximally and a plurality of elongated members extending from the central frame portion, the body portion being substantially orthogonal to the face portion, and the membrane being attached to the monolithic self-expanding frame, wherein the face portion and the membrane define an occlusal surface of the device. Furthermore, in certain embodiments, the method may include absorbing one or more forces from the left atrial appendage by flexing the plurality of elongated members in a plane orthogonal to the longitudinal axis to mitigate longitudinal movement of the face portion in response to the forces.

[0011] Although several embodiments have been disclosed, other embodiments of this application will become apparent to those skilled in the art from the following detailed description of illustrative embodiments shown and described herein. Therefore, the accompanying drawings and detailed description are to be regarded as illustrative in nature and not restrictive. Attached Figure Description

[0012] Figure 1A It is a cross-sectional view of the human heart. According to various aspects of this application, the delivery system is positioned to prepare to deploy the occlusion device into the heart's LAA.

[0013] Figure 1B It shows Figure 1A The construction of the device, wherein, according to various aspects of this application, the blocking device is deployed from the delivery system and positioned within the LAA.

[0014] Figure 1C It shows Figure 1A The structure, according to various aspects of this application, involves the occlusion device being deployed from the delivery system and positioned within the blood vessel.

[0015] Figure 2 This is a perspective view of an exemplary frame for a blocking device according to various aspects of this application.

[0016] Figure 3 This is a schematic top view of an exemplary surface portion of a blocking device according to various aspects of this application.

[0017] Figure 4A This is a top view of an exemplary surface portion of a blocking device in a first configuration prior to the application of force, according to various aspects of this application.

[0018] Figure 4B Based on all aspects of this application Figure 4A The exemplary surface portion shown is in a schematic top view in response to an applied force in a second configuration.

[0019] Figure 5A This is a schematic side view of another exemplary frame of a blocking device according to various aspects of this application.

[0020] Figure 5B This is a side view of an exemplary frame of a blocking device with a curved portion in the surface portion according to various aspects of this application.

[0021] Figure 6A This is a schematic top view of a portion of an exemplary frame and a central frame portion that may be included in the occlusion device according to various aspects of this application.

[0022] Figure 6B This refers to the loading condition prior to flattening, similar to that in a delivery system, according to various aspects of this application. Figure 6A A perspective view of the exemplary frame and the central frame portion shown.

[0023] Figure 7 This is a perspective view of an exemplary blocking device according to various aspects of this application.

[0024] Figure 8 This is a perspective view of another exemplary frame for a blocking device according to various aspects of this application.

[0025] Figure 9A This is a perspective view of another exemplary frame in a fixed configuration for a blocking device according to various aspects of this application.

[0026] Figure 9B It is based on various aspects of this application before deformation to the final shape. Figure 9A The side view shows the support cut pattern of the frame shown.

[0027] Figure 10 This is an exemplary flat pattern of a frame that can be used to form a closure device from sheet material, according to various aspects of this application.

[0028] Figure 11 This is another exemplary flat pattern of a frame that can be used to form a closure device from sheet material, according to various aspects of this application.

[0029] Figure 12 This is a top view of an exemplary central frame portion that may be included in the blocking device according to various aspects of this application.

[0030] Figure 13 This is a perspective view of an alternative design of an exemplary frame for a blocking device according to various aspects of this application.

[0031] Figure 14 This is a perspective view of an alternative design of another exemplary frame for a blocking device according to various aspects of this application.

[0032] Figure 15 This is a perspective view of an alternative design of another exemplary frame for a blocking device according to various aspects of this application.

[0033] Figure 16 This is a perspective view of an alternative design of another exemplary frame for a blocking device according to various aspects of this application.

[0034] Figure 17 This is a perspective view of an alternative design of another exemplary frame for a blocking device according to various aspects of this application.

[0035] Figure 18 This is a perspective view of an alternative design of another exemplary frame for a blocking device according to various aspects of this application.

[0036] The following detailed description and the accompanying drawings illustrate specific embodiments by way of example, and this application can be modified in various ways and alternatives. However, it is not intended to limit this application to the specific embodiments described. Rather, this application is intended to cover all modifications, equivalents, and alternatives that fall within the scope of this application as defined by the appended claims. Detailed Implementation

[0037] Figure 1A -B is a cross-sectional view of a human heart 10, wherein, according to various aspects of this application, the delivery system 20 is positioned to prepare to deploy the occlusion device 30 into the atrial appendage 18 of the heart. Figure 1A -B shows a diagram including the right atrium 14, left atrium 16, right ventricle 32, and left ventricle 34 of the heart 10. As shown, the auricle 18 is located in the left atrium 16 of the heart 10, and therefore, the auricle 18 can be considered as the left auricle 18. Although the following discussion focuses on deploying the occlusion device 30 into the left auricle 18, the occlusion device 30 can be deployed into other auricles or openings of the human heart 10 or other locations in the human body.

[0038] The left atrial appendage 18 can be viewed as a muscular sac extending from the anterolateral wall 36 of the left atrium 16 of the heart 10, serving as a reservoir for the left atrium 16. During a normal cardiac cycle, the left atrial appendage 18 contracts rhythmically along with the rest of the left atrium 16 during the contraction of the heart 10. Thus, during a normal cardiac cycle, the left atrial appendage 18 contracts together with the left atrium 16, pumping blood that may have accumulated or collected within the left atrial appendage 18, allowing it to circulate from the left atrial appendage 18. However, during cardiac cycles characterized by arrhythmias (e.g., atrial fibrillation), the left atrial appendage 18 may not contract sufficiently with the left atrium 16, potentially causing blood to pool within it. This pooled blood within the atrial appendage 18 is prone to clot formation and thrombus formation, which can migrate from the atrial appendage 18 and ultimately lead to embolic stroke. The occlusion device 30 conforming to all aspects of this application may be delivered to the left atrial appendage 18 to help prevent and act against blood stasis within the left atrial appendage 18.

[0039] In a specific example, and such Figure 1AAs shown in –B, the occlusion device 30 can be delivered to the left atrial appendage 18 via a minimally invasive transcatheter procedure. More specifically, the delivery system 20 can be guided through the inferior vena cava 12, into the right atrium 14, through the atrial septum 15, and into the left atrium 16 to the atrial appendage 18. In some embodiments, the percutaneous access to the patient's vascular structures may be, for example, at the patient's femoral vein. It should be understood that this exemplary technique is merely one example, and many other access techniques can be performed to deploy the occlusion device provided herein. At this point in the deployment process, the occlusion device is contained within the lumen of the delivery system 20 and configured as a collapsed, low-profile delivery configuration. While a transcatheter system has been generally shown and described, other delivery systems (e.g., thoracoscopic systems) are also contemplated.

[0040] Figure 1B It shows Figure 1A The occlusion device 30 is constructed such that, according to various aspects of this application, it is deployed from the delivery system 20 and positioned within the left atrial appendage 18. As shown, a control catheter 22 may be releasably coupled to the occlusion device 30 and slidably disposed within the lumen of the delivery system 20. The control catheter 22 can be used by a clinical operator to deploy the occlusion device 30 from the delivery system 20. For example, after positioning the occlusion device 30 through the orifice 38 of the left atrial appendage 18, the clinical operator can retract the delivery system 20 relative to the control catheter 22 to expose and deploy the occlusion device 30. The orifice 38 can be considered as part of the anterolateral wall 36 of the left atrium 16, with a tapered portion beginning at the orifice 38 to form a sac-like structure of the left atrial appendage 18. The occlusion device 30 may include an occlusion surface 40 arranged adjacent to the orifice 38 of the left atrial appendage 18. As discussed in further detail below (e.g., refer to...), Figure 6A -B) The control conduit 22 can be releasably connected to the closure device 30 via a hub or central frame portion or plug (or the like), which is inserted into the central frame portion centrally arranged within the closure surface 40 of the closure device 300.

[0041] After being exposed from the constraint limits (constraint range) of the delivery system 20, the occlusion device 30 can be reconfigured to an expanded configuration. The occlusion device 30 can be expanded to conform to the contour of the space defined within the left atrial appendage 18. In a particular example, the positioning of the occlusion device 30 relative to the orifice 38 of the left atrial appendage 18 can be enhanced, ensuring that the occlusion device 30 prevents thrombus formation from the left atrial appendage 18. More specifically, the occlusion surface 40 can be arranged within the left atrial appendage 18 such that the occlusion surface 40 connects portions of the anterolateral wall 36 on opposite sides of the orifice 38 to form a substantially uniform surface. In certain examples, if the occlusion surface is non-uniform relative to the orifice 38 of the left atrial appendage 18 (e.g., the device has a hub that protrudes beyond other portions of the occlusion surface; the device has a concave, partially concave, or recessed occlusion surface; the device has a concave, partially concave, or recessed occlusion surface and an attached cover that may be wrinkled or creased due to the non-uniform surface) or the occlusion surface includes protrusions, blood may collect or stagnate along that surface of the device implanted therein. In these examples, thrombi may form along the surface of the occlusion device because the non-uniform surface may alter / interrupt blood flow within the left atrium 18. Therefore, if the occlusion device includes a non-uniform surface due to improper positioning or design of the device, the patient may still be susceptible to blood clotting and thrombus formation.

[0042] After proper positioning and delivery of the occlusion device 30, the control catheter 22 can be disengaged from the occlusion device 30, and the delivery system 20 and the control catheter 22 can be removed from the patient. When the occlusion device 30 is deployed as shown, the space defined within the left atrial appendage 18 is substantially separated from the left atrium 16 due to the physical barrier provided by the occlusion device 30. In this way, stagnant blood in the left atrial appendage 18, which is prone to coagulation and thrombus formation, can be prevented from entering the left atrium 16, thereby preventing potential embolic stroke. Furthermore, the positioning of the occlusion surface 40 of the occlusion device 30 relative to the orifice 38 of the left atrial appendage 18 helps to prevent blood collection or stagnation along that surface of the occlusion device 30.

[0043] As described above, the occlusion device provided herein can be used in many different areas of the body, and the deployment of the occlusion device 30 into the left atrial appendage 18 is merely one exemplary embodiment. More specifically, Figure 1C It shows Figure 1A The structure, according to various aspects of this application, includes an occlusion device 30 that is deployed from the delivery system and positioned within the blood vessel between the vessel walls 42.

[0044] Figure 2This is a perspective view of an exemplary frame 200 for a closing device. As shown, the frame 200 may include a proximal end 202 and a distal end 204, and may be integral and self-expanding. Furthermore, the frame 200 may include a plurality of elongated members 206 and a central frame portion 208 disposed at the proximal end 202 of the frame 200. The plurality of elongated members 206 may extend from the central frame portion 208. The combination of the plurality of elongated members 206 and the central frame portion 208 forms a surface portion 220. Additionally, the frame 200 may include a body portion 214. The frame 200 including the plurality of elongated members 206 and the central frame portion 208 is shown in a pre-loaded flat configuration. In a particular example and as per [reference to...] Figure 5A As discussed further in section B, the frame 200 may be slightly arched due to being loaded into and unfolded from the delivery system. In a pre-loaded flat configuration, and as shown, a plurality of elongated members 206 and a central frame portion 208 (face portion 200) form a substantially flat surface (e.g., an outward deflection measured from the transition portion 216 between 0 mm and 1 mm). In a particular example, the central frame portion 208 is a hole with an inner and outer perimeter, from which the plurality of elongated members 206 radiate outward from the outer perimeter of the central frame portion 208.

[0045] The face portion 220 may be formed by a central frame portion 208 and a plurality of elongated members 206. The boundary of the face portion 220 can be considered at the transition portion 216 of the frame 200. As shown, the transition portion 216 is arranged around the perimeter of the face portion 220. The transition portion 216 allows the frame 200 to transition between the plurality of elongated members 206, with the main body portion 214 outside the face portion 220. More specifically, the main body portion 214 of the frame 200 extends from the plurality of elongated members 206, and the transition portion 216 allows the plurality of elongated members 206 of the frame 200 to transition to the main body portion 214 of the frame 200. As discussed in more detail below and in certain embodiments, the transition portion 216 may be configured as an anchoring region that contacts the wall of the auricle or vascular cavity to which the frame 200 (as part of the occlusion device) is implanted. The transition portion 216 may enhance the conformability of the frame 200 relative to the wall of the auricle or vascular cavity.

[0046] The main body 214 may include any number of rows and units. The main body 214 may branch to form multiple units in a single row, or the main body 214 may extend directly to the distal end 204 of the frame. In certain embodiments, the main body 214 may include units composed of pentagons, hexagons, or other shapes, such as, but not limited to, polygons, squares, rectangles, parallelograms, rhombuses, trapezoids, rhombuses, herringbone shapes, octagons, triangles, etc. For example, in... Figure 13 -18 shows the different shapes and arrangements of the main body 214.

[0047] In certain examples, a plurality of elongated members 206 are configured to flex and mitigate longitudinal movement of the face portion 220 in response to compressive forces (relative to the longitudinal axis 212 of the frame 200) applied to the body portion 214 of the frame 200. In some embodiments, forces are applied to the transition portion 216. The plurality of elongated members 206 may enhance the fatigue resistance of the frame 200 by acting as stress-relieving features that absorb flexural and / or torque, etc., in response to one or more forces applied to the frame 200. In certain examples and as follows relative to Figure 5A -B discusses in more detail that a plurality of elongated members 206 are configured to mitigate the movement of the surface portion 220 generally outward from the plane, and the movement outward from the plane may include the outward deflection of the surface portion 220.

[0048] As shown, the face portion 220 is a substantially uniform (proximal) surface formed by a plurality of elongated members 206 and a central frame portion 208. The plurality of elongated members 206 and the central frame portion 208 may comprise equal and constant surfaces throughout the face portion 220. Furthermore, the plurality of elongated members 206 and the central frame portion 208 may be formed without any protrusions extending outward from the face portion 220. In a particular example, the plurality of elongated members 206 and the central frame portion 208 may comprise substantially equal thicknesses (about the longitudinal axis 212) on the face portion 220. As discussed in more detail below, the face portion 220 having a substantially uniform surface or a surface without any protrusions extending outward from it can enhance the performance of the occlusion device including the frame 200 by reducing the chance of thrombosis. In a particular example, the substantially uniform surface of the face portion 220 may be planar.

[0049] As described above, the plurality of elongated members 206 are configured to bend or flex in a plane substantially perpendicular to the longitudinal axis 212 (formed by the face portion 220) to mitigate longitudinal movement of the face portion 220 in response to a compressive force (relative to the longitudinal axis 212 of the frame 200) applied to the body portion 214 of the frame 200. This force can be considered as a compressive force, and this compressive force can be applied to one or more locations on the body portion 214 of the frame 200. In certain examples, the compressive force may be non-uniform relative to the frame 200, while in other examples, the force can be considered as a radial force, which can be defined as a force or component of a force pointing inward relative to the frame 200 from one or more locations. In all or any of these examples, the force applied to one or more locations on the body portion 214 points along the body portion 214 toward the plurality of elongated members 206. The plurality of elongated members 206 can absorb the applied force and balance and / or distribute the applied force throughout the frame 200. Thus, the plurality of elongated members 206 bend or flex in a plane substantially perpendicular to the longitudinal axis 212 to mitigate the movement of the surface portion 220 (the combination of the plurality of elongated members 206 and the central frame portion 208) relative to the longitudinal axis 212 in response to forces applied to the frame 200. Furthermore, and in certain examples, the plurality of elongated members 206 flex and mitigate the movement of the surface portion 220 regardless of the shape or arrangement of the main body portion 214 of the frame 200.

[0050] When implanted in a blood vessel or opening within the body, slowing the movement of the face portion 220 of the frame 200 can enhance the performance of the frame 200. More specifically, when the frame 200 (or an occlusion device including the frame 200) is positioned in a space defined, for example, within the left atrial appendage (e.g., Figure 1A - The left atrial appendage 18 shown in B or as... Figure 1CWhen the occlusion device is within the contour of the vessel shown, thrombosis can occur along the occlusion device if the uneven surface alters the blood flow across the device surface. Reducing the longitudinal movement of the face portion 220 decreases the chance of thrombosis by avoiding interruption of blood flow. Furthermore, face portion 220 with a substantially uniform surface or without outward protrusions similarly enhances performance by avoiding interruption of blood flow. Additionally, an occlusion device with an occlusion surface having recesses (e.g., inward curvature of at least a portion of the occlusion surface) may not only interrupt blood flow by allowing blood to pool along the occlusion surface, but blood may also collect in the recesses. Each of these situations can lead to thrombosis. In certain cases, such a device including recesses in the occlusion surface may utilize a membrane to attempt to provide a uniform surface. The membrane may sink into the recesses or wrinkle due to the uneven surface, thus interrupting blood flow on the occlusion surface. Therefore, the frame 200, which includes a uniform surface portion 220 and also reduces the surface portion 220 in response to forces applied to the frame 200, can enhance the performance of the occlusion device including the frame 200 by reducing the chance of thrombosis.

[0051] Furthermore, the multiple elongated members 206 configured to flex and mitigate longitudinal movement of the surface portion 220 relative to the longitudinal axis 212 enhance the conformability of the frame 200. More specifically, the multiple elongated members 206 can facilitate the ability of the frame 200, and more specifically the body portion 214, to conform to irregular and / or dynamically variable tissue morphologies. When the frame 200 is inserted into a variable tissue morphology, the force exerted by the tissue morphology can be directed at one or more locations on the body portion 214 and / or the transition portion 216. In a particular example, the force is directed along the length of the body portion 214 towards the multiple elongated members 206, and the multiple elongated members 206 absorb the applied force and balance and / or distribute the applied force throughout the frame 200. Thus, the portions of the frame 200 that come into contact with the variable tissue morphology can conform to that tissue morphology (rather than the frame forcing the variable tissue morphology to conform to the shape of the frame). Furthermore, when implanted, the transition portion 216 of the frame 200 can be conformed to the shape of the orifice. In a particular example, the frame 200 (which may include a membrane attached to the frame) can be positioned within the left atrial appendage to help prevent thrombus formation from the left atrial appendage (e.g., as described above). Figure 1B (As shown in the diagram). After implantation, the portions of the frame 200 that contact the left atrial appendage conform to the left atrial appendage, and the forces applied through the left atrial appendage are absorbed by the plurality of elongated members 206. In the physiological state of the heart, the plurality of elongated members 206 are configured to hold the face portion 220 on opposite sides of the opening of the left atrial appendage to form and maintain a substantially uniform surface, thereby closing the opening, while allowing the portions of the transition portion 216 and the main body portion 214 that contact the atrial appendage to be configured to conform to the shape of the atrial appendage.

[0052] This conformal characteristic can be beneficial in providing substantial occlusion (sealing) and durable occlusion. Conformity also enhances the fatigue resistance of the occlusion device. Furthermore, occlusion devices with greater conformity cause less trauma to the patient and tend to resist in situ migration better than occlusion devices with less conformity. In some embodiments of the occlusion device provided herein, certain portions of the device are designed to be more conformal (compliant) than other portions of the same device. That is, the conformity of a single occlusion device can be designed to be different in different areas of the device. Additionally, in some embodiments, the desired degree of conformity can be achieved using frame material selection, heat treatment, and other processes. In a particular example, the frame 200 may be formed of nitinol (NiTi). In a particular, more specific embodiment, the frame 200 may be formed from a single piece of nitinol.

[0053] To deliver the frame 200 to various locations within the body, the frame 200 can be reconfigured into a low-profile (elongated) configuration for loading into a delivery catheter (such as) deployed via catheter deployment for occlusion devices. Figure 1B In the control conduit 22 shown. After being exposed from the constraint limits (constraint range) of the delivery system, the frame 200 is configured to self-expand and reconfigure. Figure 2 The construction shown is illustrated. For example, frame 200 can be expanded to conform to the contour of the space defined within the body (e.g., Figure 1A - The left atrial appendage 18 shown in B or as in Figure 1C (As shown in the diagram within the blood vessel). As described above, the central frame portion 208 can serve as a connection point to a control catheter for the transcatheter deployment of the occlusion device. Thus, the frame 200 (and the occlusion device including the frame 200) can have a hubless face portion 220 (e.g., without any additional structures or elements extending beyond the central frame portion 208, without any additional thickness beyond the central frame portion 208, without any flanges, or without any dimension exceeding the maximum thickness of the plurality of elongated members 206 and the central frame portion 208). The hubless face portion 220 (e.g., any apertures extending beyond the face portion 220) provides a generally uniform surface formed by the plurality of elongated members 206 and the central frame portion 208.

[0054] Figure 2 The illustrative components shown are not intended to indicate any limitation on the use or functional scope of embodiments of the disclosed subject matter. Nor should the illustrative components be construed as having any dependency or related requirement on any individual component or combination of components shown herein. Furthermore, in embodiments, in Figure 2 Any one or more of the components shown may be integrated with various other components (and / or components not shown) described herein, all of which are considered to be within the scope of the disclosed subject matter. For example, see references to... Figure 2The described framework 200 can be used with delivery system 20 ( Figure 1A Used together as shown in –B). More specifically, the frame 200 may form part of the occlusion device 30 (e.g., a plurality of elongated members 206 and a central frame portion 208 form part of the occlusion surface 40). Furthermore, the frame 200 may include a membrane attached thereto (e.g., as shown in reference). Figure 7 (As shown and discussed).

[0055] Figure 3 This is a schematic top view of an exemplary surface portion 300 of a blocking device according to various aspects of this application. The surface portion 300 includes a plurality of elongated members 302 and a central frame portion 304. As shown, the plurality of elongated members 302 may extend from the central frame portion 304 and include a common bend within the surface portion 300 that is substantially formed in a common plane (e.g., the x-y plane as shown). The common bend may be configured such that the plurality of elongated members 302 do not overlap within the surface portion 300. In a particular example, the plurality of elongated members 302 may have a zigzag pattern (e.g., as shown in the diagram). Figure 8 (as shown in the image).

[0056] The multiple elongated members 302 may include any number of bends or semi-bends. For example, in Figure 8 In section -11, other bending styles are shown. As illustrated, each elongated member 302 includes multiple bending segments. For illustrative purposes, in Figure 3 In the diagram, a curved section is highlighted in one of a plurality of elongated members 302. The plurality of elongated members 302 may include a first curved section 306, a second curved section 308, and a third curved section 310. In a particular example, the first curved section 306 and the third curved section 310 are curved along a first direction, while the second curved section 308 is curved along a second direction opposite to the first direction. Thus, the plurality of elongated members 302 may include a first inflection point 318 between the first curved section 306 and the second curved section 308, and a second inflection point 320 between the second curved section 308 and the third curved section 310. The first inflection point 318 and the second inflection point 320 alter the curvature of the plurality of elongated members 302.

[0057] Furthermore, each of the first bending segment 306, the second bending segment 308, and the third bending segment 310 is arranged in a common plane. Thus, the plurality of elongated members 302 and the bends formed by the first bending segment 306, the second bending segment 308, and the third bending segment 310 occur substantially within the x-y plane. More specifically, each of the first bending segment 306, the second bending segment 308, and the third bending segment 310 bends within the x-y plane. The central frame portion 304 may also be arranged within the x-y plane. When the blocking device includes a face portion 300, the plurality of elongated members 302 and the central frame portion 304 may be arranged in a common plane. Furthermore, and when the blocking device includes a face portion 300, the plurality of elongated members 302 are configured to flex and mitigate the longitudinal movement of the face portion 300 in response to a compressive force applied to another portion of the blocking device (orthogonal to the x-y plane) (e.g., as referenced above). Figure 2 (Detailed discussion follows). Multiple elongated members 302 are configured to flex or bend substantially in the x-y plane to mitigate longitudinal movement of the surface portion 300 (orthogonal to the x-y plane).

[0058] In a particular embodiment, each of the first curved segment 306, the second curved segment 308, and the third curved segment 310 may include an equal radius of curvature. In other examples, the first curved segment 306 and the third curved segment 310 may include a first radius of curvature, and the second curved segment 308 may include a second (and different) radius of curvature. The (first) radius of curvature of the first curved segment 306 and the third curved segment 310 may be greater than the (second) radius of curvature of the third curved segment 310. Furthermore, and in a particular example, the lengths of the first curved segment 306 and the third curved segment 310 may be substantially equal. The length of the second curved segment 308 may be equal to or greater than the lengths of the first curved segment 306 and the third curved segment 310. Additionally, the lengths of the first curved segment 306 and the third curved segment 310 may be greater than the length of the second curved segment 308. As shown, the length of the second curved segment 308 is greater than that of the first curved segment 306 and the third curved segment 310, which are substantially equal in length.

[0059] As described above, a plurality of elongated members 302 extend from the central frame portion 304. Thus, the starting points 312 of the plurality of elongated members 302 are arranged at the central frame portion 304, and the ending points 314 of the plurality of elongated members 302 are arranged at the perimeter of the surface portion 300. For illustrative purposes, in Figure 3In the diagram, a starting point 312 and an ending point 314 are shown for one of a plurality of elongated members 302. In a particular example, the starting point 312 and the ending point 314 may be arranged symmetrically with respect to the surface portion 300. More specifically, the tangent 316 formed between the starting point 312 and the ending point 314 may be substantially straight. The curvature of the plurality of elongated members 302 may be symmetrical, such that the plurality of elongated members 302 include a curvature (having one or more inflection points) extending from the starting point 312 in one direction and back in another direction to the ending point 314.

[0060] In the described embodiments, the surface portion 300 includes ten of a plurality of elongated members 302. In some embodiments, the surface portion 300 may include two, three, four, five, six, seven, eight, nine, eleven, twelve, thirteen, fourteen, fifteen, sixteen, or more than sixteen of the plurality of elongated members 302. Furthermore, a central frame portion 304 is shown including ten peaks 322 corresponding to each of the plurality of elongated members 302. The central frame portion 304 may include a number of peaks equal to the number of elongated members 302 included in the surface portion 300. In other examples, the central frame portion 304 may be generally circular.

[0061] Figure 3 The illustrative components shown are not intended to indicate any limitation on the use or functional scope of embodiments of the disclosed subject matter. Nor should the illustrative components be construed as having any dependency or related requirement on any individual component or combination of components shown herein. Face portion 300 may be integrated with various other blocking devices (and / or components not shown) described herein, all of which are considered to be within the scope of the disclosed subject matter. For example, face portion 300 may be integrated with… Figure 2 Used together with the frame 200 shown.

[0062] Figure 4A This is a top view schematic diagram of an exemplary surface portion 400 of a blocking device in a first configuration prior to the application of any aspect of this application. The surface portion 400 includes a plurality of elongated members 402a-j and a central frame portion 404. The plurality of elongated members 402a-j extend from the central frame portion 404. The central frame portion 404 and the plurality of elongated members 402a-j are arranged in an x-y plane. The plurality of elongated members 402a-j and the central frame portion 404 may be formed from a single piece of frame. The single piece of frame may be formed by laser cutting (e.g., of a tube or flat sheet), etching, wire cutting, or other processes.

[0063] Furthermore, the face portion 400 may be a substantially uniform surface or have a substantially uniform thickness. The plurality of elongated members 402a-j and the central frame portion 404 may include equal and constant surfaces over the entire face portion 400, such that the face portion 400 has no protrusions (e.g., relative to the z-axis). A face portion 400 having a substantially uniform surface or no outward protrusions therefrom can enhance the performance of the occlusion device including the frame 400 by reducing the chance of thrombosis by mitigating the interruption of blood flow over the entire face portion 400.

[0064] For illustrative purposes, the outer peripheral boundary 406 of the surface portion 400 is shown. In a particular example, the outer peripheral boundary 406 can be viewed as being composed of the end portions of a plurality of elongated members 402a-j (e.g., as shown in the figure). Figure 2 The non-solid boundary formed by the surface portion 220 around the transition portion 216 shown is illustrated. In other examples, the outer peripheral boundary 406 may be a solid boundary formed by the portions of the forming surface portion 400 of the frame. In the example and as follows relative to... Figure 7 As discussed in further detail, the surface portion 400 may include a membrane attached thereto. The membrane is attached to provide a barrier against thrombi forming emboli from the atrial appendage or blood vessels and to enhance sealing. Suitable membranes include occlusive or semi-occlusive materials. Embodiments with semi-occlusive materials may allow the passage of certain fluid / blood components while inhibiting the passage of thrombi. In these examples, the peripheral boundary 406 may be formed by the boundary of the membrane.

[0065] The blocking device may include a face portion 400 (e.g., as referenced above). Figure 2 The frame 200 shown and discussed. The occlusion device including the face portion 400 may include a portion parallel to... Figure 4A The longitudinal axis of the z-axis shown. Therefore, the blocking device including the surface portion 400 has a central frame portion 404 and a plurality of elongated members 402a-j arranged in a plane (x-y plane) perpendicular to the longitudinal axis of the blocking device. The surface portion 400 of such a blocking device (e.g., as...) Figure 2 The portion shown can be considered as the first part of the blocking device, wherein the main body of the blocking device is arranged substantially outside and / or orthogonally to the surface portion 400 and the x-y plane.

[0066] like Figure 4A As shown, a plurality of elongated members 402a-j and a central frame portion 404 are arranged in an initial configuration where no force is applied. In the first configuration, the plurality of elongated members 402a-j may not overlap and may include a common bend. Furthermore, apart from being arranged in the x-y plane, the plurality of elongated members 402a-j and the central frame portion 404 are uniform.

[0067] Figure 4B This is a schematic top view of the surface portion 400 in a second configuration according to various aspects of this application in response to an applied force. In response to the applied force (shown for illustrative purposes), a plurality of elongated members 402a-j are configured to flex and mitigate movement relative to the x-y plane. Furthermore, the plurality of elongated members 402a-j are configured to flex or bend substantially within the x-y plane to mitigate longitudinal movement of the surface portion 400 relative to the x-y plane. As described above, the blocking device may include the surface portion 400 (e.g., as shown in the above references). Figure 2 The framework shown and discussed (200). Figure 4B The applied force shown may be a compressive force applied to a portion of the occlusion device arranged outside the x-y plane. In various embodiments, the compressive force corresponds to the compressive force associated with parts of the device that conform to the body's anatomy (e.g., the heart) and include the anatomical structure. The compressive force may be non-uniformly distributed from one or more sides of the occlusion device toward the occlusion device. Furthermore, the compressive force may be angled relative to the z-axis from one or more sides of the occlusion device toward the occlusion device.

[0068] like Figure 4B As shown, and in response to an applied force, one or more of the elongated members 402a-j flex / bend. In a particular example, the elongated members 402a-j are configured such that one or more of the elongated members 402a-j located closest to the compressive force bend more than one or more of the elongated members 402a-j located further away from the compressive force. More specifically, and as shown, the elongated members 402b-e (in the x-y plane) flex / bend, while the elongated members 402a and 402f-j (in the x-y plane) flex / bend less or not at all. The elongated members 402a and 402f-j can transmit the applied force along their length to distribute the applied force among the elongated members 402a and 402f-j. As a result, the deflection of the multiple slender members 402a-j occurs primarily within the x-y plane, thereby mitigating the movement of the multiple slender members 402a-j and the central frame portion 404 outside the x-y plane (along the z direction or perpendicular to the x-y plane).

[0069] In a specific example, the occlusion device including the facet portion 400 can be implanted in a variable tissue morphology. Forces applied by the tissue morphology can be directed at one or more locations. The facet portion 400 can be formed as part of a frame of the occlusion device conformable to the variable tissue morphology. In a specific example, the occlusion device can be positioned within the left atrial appendage to help prevent thrombus formation and embolism from the left atrial appendage (e.g., as described above). Figure 1B(As shown in the diagram). After implantation, the force applied via the left atrial appendage can be absorbed by a plurality of elongated members 402a-j. In some embodiments, the plurality of elongated members 402a-j hold the face portion 400 in the x-y plane on opposite sides of the orifice of the left atrial appendage to form and maintain the uniformity of the face portion 400, thereby closing the orifice while allowing the remainder of the occlusion device to conform to the shape of the atrial appendage. In other embodiments, only the contact vessel or a portion of the main body of the occlusion device is configured to conform. The outer peripheral boundary 406 of the face portion 400 may conform to the shape of the orifice in response to the force applied via the left atrial appendage. For example, and as compared Figure 4A and Figure 4B As shown, the peripheral boundary 406 can change its shape in response to a force applied to the occlusion device. The peripheral boundary 406 maintains the closure of the orifice of the left atrial appendage, while multiple elongated members 402a-j slow down the movement of the surface portion 400 and maintain its uniformity to avoid thrombus formation.

[0070] In the first construction ( Figure 4A ) and second construction ( Figure 4B In each of the following configurations, the surface portion 400 remains a substantially uniform surface within the x-y plane. In a particular example, the surface portion 400 also remains a planar surface within the x-y plane. In the first configuration ( Figure 4A ) and second construction ( Figure 4B In each of the ), multiple slender members 402a-j may not overlap.

[0071] Figure 4A - The illustrative components shown in B are not intended to indicate any limitation on the use or functional scope of embodiments of the disclosed subject matter. Nor should the illustrative components be construed as having any dependency or related requirement on any individual component or combination of components shown herein. Face portion 400 may be integrated with various other blocking devices (and / or components not shown) described herein, all of which are considered to be within the scope of the disclosed subject matter. For example, face portion 400 may be integrated with... Figure 2 Used together with the frame 200 shown.

[0072] Figure 5A This is a schematic side view of another exemplary frame 500 of a blocking device according to various aspects of this application. Frame 500 may include face portions (502a and 502b) and a body portion 504. Although not shown, face portions (502a and 502b) may include a central frame portion and a plurality of elongated members. The central frame portion may be referenced... Figure 2 -4 or Figure 6A -B shows and describes aspects that are consistent with each other, and multiple elongated members can be formed with reference. Figure 2 -4 The aspects shown and described are consistent with each other.

[0073] A surface portion 502a is disposed at the proximal end 512 of the frame 500. Furthermore, the surface portion 502a may be disposed in a plane 518a perpendicular to or orthogonal to the longitudinal axis 516 of the frame 500. The plane 518a may include an upper boundary 520a and a lower boundary 522a. Additionally, the frame 500 may include a transition portion 506 disposed between the surface portion 502a (and a plurality of elongated members) and the main body portion 504. The transition portion 506 includes a bend to transition the frame 500 from the plane 518a to the main body portion 504. In a particular example, the surface portion 502a may be substantially planar (e.g., perpendicular to the longitudinal axis 516 of the frame 500). Furthermore, the surface portion 502a may include a uniform surface. More specifically, the surface portion 502a has a surface without any protrusions outside the surface of the surface portion 502a.

[0074] In a specific example, and such Figure 5B As shown, according to various aspects of this application, frame 500 may include a bend in face portion 502b. The bend may be formed as frame 500 is loaded or unloaded into a delivery system (e.g., as described above). Figure 1A - As shown and discussed in B). Figure 5A A frame 500 in a pre-loaded flat configuration is shown. Once loaded and unloaded, the peak 532 of the bend may be approximately 1 mm to 3 mm higher or lower than the transition portion 506. Figure 5A In the pre-loaded flat configuration shown, surface portion 502a is substantially flat or planar (e.g., the peak of the bend measured from transition portion 506 is less than 1 mm). For the substantially vertical surface portion 502b, surface portion 502b is arranged within plane 518b. In these examples, plane 518b may be parallel to the peak 532 of the bend of surface portion 502b. Plane 518b may include an upper boundary 520b and a lower boundary 522b. In certain examples, the bend of surface portion 502b may extend outward from frame 500 (as shown) or the bend of surface portion 502b may extend inward from frame. Similar to surface portion 502a, surface portion 502b may include a uniform surface. More specifically, surface portion 502b has a surface without protrusions outside the surface of surface portion 502b. More specifically, surface portion 502b may not have protrusions relative to the surface of surface portion 502b including the bend.

[0075] Both surface portion 502a and surface portion 502b include multiple elongated members. As discussed in detail above (for example, see reference...). Figure 2-4) A plurality of elongated members are configured to flex or bend substantially within the planes (518a and 518b) to mitigate the movement of face portions 502a and 502b relative to the longitudinal axis 516 in response to compressive forces applied to the body portion 504 of the frame 500. In a particular example, the plurality of elongated members are configured to flex or bend substantially within the planes (518a and 518b) to mitigate the movement of the face portions (502a or 502b) substantially outward from the planes (518a and 518b), and the outward movement from the planes (518a and 518b) includes a less than 15% outward deflection of the face portions (502a or 502b) in response to 25% compression of the body portion 504 (15% of the outer diameter of the body portion 214).

[0076] A 15% outward deflection is present by the upper boundaries (520a and 520b) of the planes (518a or 518b). More specifically, if the deflection is greater than the upper boundaries (520a and 520b), the surface portions (502a and 502b) deflect outward from the planes (518a or 518b). Thus, and in a particular example, multiple elongated members are configured to flex and mitigate the movement of the surface portions (502a and 502b) substantially outward from the planes (518a or 518b) in response to the compressive force applied to the body portion 504 of the frame 500, such that the surface portions (502a or 502b) remain between the upper boundaries (520a and 520b) and the lower boundaries (522a and 522b).

[0077] This force can be considered as a compressive force, and this compressive force can be applied to one or more locations on the main body portion 504 of the frame 500. In a particular example, the compressive force may be non-uniform relative to the frame 500, while in other examples, the force can be considered as a radial force, which can be defined as a force or component of a force pointing inward from one or more locations relative to the main body portion 504.

[0078] In a specific example, the frame 500 may be implanted into a patient. More specifically, when the frame 500 (or an occlusion device including the frame 500) is positioned in a space defined, for example, within the left atrial appendage (e.g., Figure 1AWhen the device is within the contour of the left atrial appendage 18 (as shown in Figure B), thrombi can form along the occlusion device if the blood flow on that surface is altered by a non-uniform surface (e.g., with protrusions). After implantation, the forces applied to the body portion 504 of the frame via the left atrial appendage can be absorbed by a plurality of elongated members 502a-j included in the face portions (502a or 502b). The plurality of elongated members are configured to mitigate longitudinal movement of the face portions (502a and 502b) relative to the longitudinal axis 516 on opposite sides of the orifice of the left atrial appendage to form and maintain a substantially protrusion-free surface that closes the orifice of the left atrial appendage, while allowing the remainder of the occlusion device (e.g., the body portion 504) to conform to the shape of the atrial appendage. By maintaining a substantially uniform surface over the entire orifice of the left atrial appendage, mitigating the longitudinal movement of the face portions (502a and 502b) reduces the chance of thrombus formation by mitigating the interruption of blood flow.

[0079] In a particular example, the main body portion 504 of the frame 500 may taper toward the distal end 514. In some examples, the main body portion 504 of the frame 500 may include a first tapered section 508 and a second tapered section 510. The perimeters of the first tapered section 508 and the second tapered section 510 may decrease at different rates. For example, and as... Figure 5A and 5B As shown, the rate of decrease of the first tapering segment 508 is less than the rate of decrease of the second tapering segment 510. The first tapering segment 508 can taper from the surface portions (502a and 502b) at an angle between 0 and 10 degrees, or 0 and 20 degrees, or 0 and 30 degrees. The second tapering segment 510 can taper at an angle between 40 and 75 degrees, or 30 and 80 degrees, or 30 and 85 degrees. Depending on the desired implantation of the occlusion device including the frame 500, the frame 500 may include a single tapering portion or multiple tapering segments (the first tapering segment 508 and the second tapering segment 510). The first tapering segment 508 and the second tapering segment 510 may be manufactured and sized for specific anatomical structures of the left atrial appendage.

[0080] Certain embodiments of the frame 500 resist wrinkling. For example, certain embodiments of the occlusion device provided herein generally exhibit greater resistance to wrinkling when the device is loaded or reloaded into a delivery catheter. Wrinkling is a type of deformation, such as folding, bending, kinking, or overlapping, of a portion of the occlusion device (e.g., the distal portion), which results in an uneven configuration of the device. Wrinkling can cause the occlusion device to experience structural tangles and / or damage, resistance to loading, poor sealing performance, etc. The “acorn” shape of the frame 500 enhances its resistance to wrinkling. It has been found that these embodiments may better prevent patient trauma, partly due to the acorn shape, the membrane that completely or more completely covers the frame, improved conformability and sealing, better fatigue resistance, and the ePTFE material used to reinforce the covering during growth.

[0081] Furthermore, the main body 504 of the frame 500 can be another shape, such as cylindrical, conical, truncated conical, hemispherical, spherical cap, pyramidal, truncated pyramidal, and combinations thereof. Any and all combinations of these different shapes and different figures are conceivable and within the scope of this application.

[0082] In certain examples, the face portions (502a or 502b), body portion 504, and transition portion 506 of frame 500 are formed from a single, self-expanding structure. In certain examples, frame 500 may be constructed from a single piece of material. Thus, it can be said that in some embodiments, frame 500 comprises a seamless structure. Furthermore, the material of frame 500 may have a single thickness and / or width throughout frame 500. In some embodiments, the material of frame 500 may vary in thickness and / or width to alter the radial force exerted by frame 500 in a particular region, increase or decrease the rigidity or toughness of frame 500 in a particular region, enhance resistance to migration, and / or control the process of loading (and / or reloading) frame 500 into a delivery conduit in preparation for deploying (and / or positioning or re-deploying) a closure device made of frame 500. However, in some embodiments, frame 500 may be constructed differently, such that frame 500 comprises two or more portions formed separately from each other.

[0083] Furthermore, NiTi can be used as a material for frame 500 (and any frames discussed herein), but other materials can be used as materials for frame 500, such as stainless steel, L605 steel, polymers, MP35N steel, polymeric materials, Pyhnox, Elgiloy, or any other suitable biocompatible materials and combinations thereof. The hyperelastic properties and softness of NiTi enhance the conformability of frame 500. Furthermore, NiTi can be shaped to a desired form. That is, NiTi can be shaped such that when frame 500 is unconstrained, such as when frame 500 is extended from the delivery system, frame 500 tends to self-expand into the desired shape. More specifically, frame 500 (made of NiTi) can have an elastic nature that allows frame 500 to elastically collapse or “compress” into a low-profile delivery configuration for loading into the delivery system (e.g., see reference). Figure 1A (as shown and discussed), and then reconstructed as such when exposed from the delivery system. Figure 5A and 5BThe expanded configuration is shown. Frame 500 may be generally conformable, fatigue-resistant, and elastic, such that when the occlusion device is deployed in the patient's body, frame 500 may conform to the morphology of surrounding tissues. In certain embodiments, bioresorbable or bioabsorbable materials, including, for example, bioresorbable or bioabsorbable polymers, may be used as frame 500 or a portion thereof.

[0084] In some embodiments, portions or the entirety of frame 500 (and the frames of other devices provided herein) are coated (e.g., sputtered) with a radiation-impermeable coating to enhance the visibility of X-ray imaging. For example, in some such embodiments, portions or the entirety of frame 500 may be coated with a noble metal, such as, but not limited to, tantalum, platinum, etc. In some embodiments, frame 500 is formed of nitinol tubing or nitinol sheet.

[0085] In some embodiments, the frame 500 may be treated using various electropolishing techniques. In some embodiments, this electropolishing is performed while the frame 500 is in a cut-tube configuration (before diameter expansion). In some embodiments, this electropolishing is performed while the frame 500 is in a diameter expansion and shaping configuration. In some embodiments, the frame 500 may be treated using various heat treatment techniques. The use of such techniques can enhance certain desired performance characteristics of the occlusion device provided herein, such as, but not limited to, enhanced conformability, enhanced fatigue resistance, and reduced trauma to the patient from the device.

[0086] The frame 500 may also include one or more anchors 524, 526 disposed on the main body portion 504. For example... Figure 5A and Figure 5BAs shown, the frame includes a first set of anchors 524 and a second set of anchors 526. While individual anchors in each of the first and second sets of anchors 524 and 526 are highlighted, each anchor 524, 526 includes an anchoring portion 528 (accessible to a blood vessel or atrial appendage wall to hold the frame 500 and associated occlusion device in place) and an arm 530. In a particular example, the first set of anchors 524 and the second set of anchors 526 may be arranged at the same height relative to the distal end 514 around the perimeter of the frame 500. In other examples, the anchoring portion 528 of the first set of anchors 524 is arranged at a first height relative to the distal end 514, and the anchoring portion 528 of the second set of anchors 526 is arranged at a second height relative to the distal end 514, wherein the first height is greater than the second height. The height of the anchoring portions 528 of the first set of anchors 524 and the second set of anchors 526 can be varied by arranging the first set of anchors 524 and the second set of anchors 526 at different heights on the frame 500. In other examples, the height of the anchoring portions 528 of the first set of anchors 524 and the second set of anchors 526 can be varied by changing the length of the arm 530. More specifically, and as shown, the arm 530 of the first set of anchors 524 may be shorter than the arm 530 of the second set of anchors 526. The height difference between the first set of anchors 524 and the second set of anchors 526 may be the difference between the lengths of the arms 530 of the first set of anchors 524 and the arms 530 of the second set of anchors 526. In a particular example, the first set of anchors 524 and the second set of anchors 526, and the remainder of the frame 500, may be a single piece (one-piece). More specifically, the first set of anchors 524 and the second set of anchors 526 may also be formed from the same single piece of material as the remainder of the frame 500.

[0087] In a specific example, interleaving the first set of anchors 524 and the second set of anchors 526 reduces the amount of force required to switch the frame 500 between an unfolded configuration (as shown) and an elongated or delivery configuration via the delivery system. The frame can be positioned within the delivery system (e.g., as shown) by retracting the frame 500 into a portion of the delivery system (delivery sheath). Figure 1A (As shown in the diagram). During the retraction of frame 500 into the delivery system, the force required to position frame 500 within the delivery system increases upon contact with protrusions (such as anchors). Consequently, staggering the first set of anchors 524 and the second set of anchors 526 at different heights also causes the amount of force required to retract anchors 524 and 526 into the delivery system to be offset by approximately half relative to the multiple anchors located at the same height around the frame.

[0088] Figure 5A and Figure 5BThe illustrative components shown are not intended to indicate any limitation on the use or functional scope of embodiments of the disclosed subject matter. Nor should the illustrative components be construed as having any dependency or related requirement on any individual component or combination of components shown herein. Frame 500 may be integrated with various other occlusion devices (and / or components not shown) described herein, all of which are considered to be within the scope of the disclosed subject matter. For example, frame 500 may include a membrane attached thereto (e.g., as referenced). Figure 7 (As shown and discussed), or frame 500 may be used in place of frame 708 included in blocking device 700. In addition, face portions 220, 300, 400 may include alternative face portions (502a or 502b).

[0089] Figure 6A This is a schematic top view of an exemplary frame 600 and a portion of a central frame portion 602 that may be included in a clogging device according to various aspects of this application. In a particular example, the frame 600 may be formed of a nitinol material. Furthermore, the frame 600 may be a single, monolithic, and self-expanding piece. The central frame portion 602 may include a plurality of arc segments 604 arranged around the perimeter of the central frame portion 602. Consistent with various aspects of this application, the central frame portion 602 may be arranged as a central section of the frame 600 that can be used in a clogging device. The frame 600 may be formed of a single structure, such as a tube. The tube may be cut to form the frame 600, which includes the central frame portion 602 and the plurality of arc segments 604. The frame 600 also includes a plurality of elongated members 606 that may form the face portions and body portions of the frame 600.

[0090] The central frame portion 602 and the plurality of elongated members 606 are substantially planar. Forming the frame 600 from a cut tube allows the central frame portion 602 to be substantially flat. To arrange the central frame portion 602 and the plurality of elongated members 606 from the tube into a planar configuration, the cut tube must be constructed as follows: Figure 6B The manufacturing structure shown is flattened. As discussed in more detail below, such as Figure 6A As shown, multiple arc segments 604 can be configured to distribute strain around the central frame portion 602 during the transition from a fabricated configuration to a flattened configuration. Similarly, multiple arc segments 604 can be configured to distribute strain around the central frame portion 602 during the transition of the frame 600 from an elongated configuration (e.g., a frame 600 disposed within a delivery system) to an unfolded configuration. In the unfolded configuration, Figure 6A A portion of the frame 600 shown may be a surface portion (e.g., Figure 2 The central section of the face portions 220, 300, and 400 shown in Figure 4.

[0091] The central frame portion 602 can be configured to be attached to a delivery system (e.g., Figure 1A- The delivery system described in section B) is used to deliver the occlusion device, including frame 600, to a target location within the patient's body. Furthermore, frame 600 can be withdrawn from the delivery system via attachment to the central frame portion 602, i.e., from... Figure 6A The unfolding / flattening structure shown is transformed into an elongated structure located within the delivery system. The strain applied to the frame by transitioning between the various structures is distributed through multiple arc segments 604 surrounding the central frame portion 602.

[0092] Furthermore, the multiple elongated members 606 can be configured to bend and reduce the bending of the central frame portion 602 and the multiple elongated members 606 from Figure 6A The planar profile shown is essentially moving outwards. Although Figure 6A Only a portion of the plurality of elongated members 606 is shown, but the plurality of elongated members 606 may include bends to absorb forces that may be applied to the frame 600 in portions (not shown) outside the planar profile of the central frame portion 602 and the plurality of elongated members 606.

[0093] Figure 6B It is based on all aspects of this application prior to flattening Figure 6A The image shows a perspective view of the frame 600 and the central frame portion 602. The frame 600 is shown in a manufacturing configuration after the frame has been formed from, for example, a cut tube or flat sheet, including multiple arc segments 604. The multiple arc segments 604 reinforce the frame 600 when flattened. Figure 6A The planar profile shown is capable of providing flexibility during the transition of the tube to be flattened. Furthermore, the multiple arc segments 604 can transition around the central frame portion 602 and distribute the strain generated by flattening the frame 600 from the manufacturing process. Stress accumulation occurs at peaks or at the multiple arc segments 604 and / or at the transitions between the multiple arc segments 604 and the multiple elongated members 606, compared to the substantially circular or rectangular central region, with the bends of the multiple arc segments 604 providing an optimized area for stress distribution.

[0094] In a specific example, the curved portions (curvature) of multiple arc segments 604 can be... Figure 6A The bend (curvature) shown is reversed. Furthermore, the width of the plurality of arc segments 604 may be equal to the width of the plurality of elongated members 606. In other examples, the width of the plurality of arc segments 604 may be greater than the width of the plurality of elongated members 606 by between 101% and 160%.

[0095] Figure 6A - The illustrative components shown in B are not intended to indicate any limitation on the use or scope of functionality of embodiments of the disclosed subject matter. Nor should the illustrative components be construed as having any dependency or related requirement on any individual component or combination of components shown herein. Furthermore, in embodiments, in Figure 6A-B Any one or more of the components shown may be integrated with various other components (and / or components not shown) described herein, all of which are considered to be within the scope of the disclosed subject matter. For example, as Figure 1A As shown in -B, refer to Figure 6A - The frame 600 described in B can be used with the delivery system 20 and form part of the closure device 30 (e.g., a plurality of elongated members 606 and a central frame portion 602 form part of the closure surface 40). Furthermore, the frame 200 may include a membrane attached thereto (e.g., as referenced). Figure 7 (As shown and discussed).

[0096] Figure 7 This is a perspective view of an exemplary blocking device 700 according to various aspects of this application. The blocking device 700 may include a central frame portion 702, a plurality of elongated members 704 extending from the central frame portion 702, and a main body portion 706. The central frame portion 702, the plurality of elongated members 704, and the main body portion 706 together form a frame 708 of the blocking device. In a particular example, the frame 708 may be a single piece (e.g., formed from a single structure or a single material) and self-expanding. Furthermore, the central frame portion 702 and the plurality of elongated members 704 are arranged in a common plane orthogonal to the longitudinal axis 712 of the blocking device 700. The central frame portion 702 and the plurality of elongated members 704 may be in the x-y plane. However, the main body portion 706 of the frame 708 may be arranged outside the x-y plane. In a particular example, a plurality of elongated members 704 are bendable and mitigate longitudinal movement of the central frame portion 702 and the plurality of elongated members 704 relative to the x-y plane in response to a compressive force applied to the body portion 706. As shown, the plurality of elongated members 704 include a common bend extending from the central frame portion 702 of the frame 708 within the x-y plane.

[0097] The occlusion device 700 may further include a membrane disposed on the frame 708. The combination of the occlusion device 700, the central frame portion 702, and the plurality of elongated members 704 (face portions of the frame 708) collectively defines the occlusion surface of the occlusion device 700. Furthermore, the central frame portion 702 and the plurality of elongated members 704 being arranged in a common plane enhances the attachment of the membrane 710 to it. In a particular example, the central frame portion 702 and the plurality of elongated members may be planar. Furthermore, the central frame portion 702 and the plurality of elongated members 704 (face portions of the frame 708) may have generally uniform (proximal) surfaces. The central frame portion 702 and the plurality of elongated members 704 may include equal (smooth) and constant (consistent) surfaces. Furthermore, the central frame portion 702 and the plurality of elongated members 704 may be formed without any outward protrusions therefrom. In a particular example, the central frame portion 702 and the plurality of elongated members 704 may include substantially equal thicknesses (about the y-axis) across the surface portion 220. The central frame portion 702 and the plurality of elongated members 704 having substantially uniform surfaces or surfaces without outward protrusions therefrom can enhance the performance of the occlusion device 700 by reducing the chance of thrombosis.

[0098] As shown, membrane 710 may cover the central frame portion 702. The central frame portion 702 may be a hole in the frame 708 (e.g., as shown in the diagram). Figure 2 (As shown in –4 and 6A). Membrane 710 may cover or partially cover the central frame portion 702 to seal the face portion of frame 708. Membrane 710 may extend partially within the central frame portion 702 to provide a seal. Furthermore, membrane 710 may be attached to the exterior of frame 700 to completely cover frame 700 (e.g., so that frame 700, which may be composed of nitinol, is not exposed to in-situ (here) blood or tissue).

[0099] As described above, the plurality of elongated members 704 may be configured to bend and mitigate longitudinal movement of the central frame portion 702 and the plurality of elongated members 704 in response to compressive forces applied to the body portion 706. When the occlusion device 700 is implanted in a patient, the plurality of elongated members 704 may facilitate the ability of the frame 708 to adapt to and conform to irregular and / or dynamically variable tissue morphologies. Forces may be applied by the tissue morphology and may be directed at one or more locations on the body portion 706. In a particular example, the force is directed along the length of the body portion 706 towards the plurality of elongated members 704, and the plurality of elongated members 704 deform and absorb the applied force, balancing and / or distributing the applied force across the entire frame 708. In a particular example, the occlusion device 700 may be positioned within the left atrial appendage to help prevent thrombus formation from the left atrial appendage (e.g., as described above). Figure 1B(As shown in the diagram). After implantation, the occlusion device 700 conforms to the left atrial appendage, and forces applied via the left atrial appendage are absorbed by a plurality of elongated members 704. The plurality of elongated members 704 maintain planar occlusion surfaces in a common plane on opposite sides of the orifice of the left atrial appendage. The plurality of elongated members 704 bend in response to forces applied to the body portion 706 to maintain substantially uniform surfaces (substantially planar and / or without protrusions) and close the orifice to help prevent thrombus formation from the left atrial appendage without interrupting blood flow along the occlusion surface.

[0100] The arrangement of the central frame portion 702 and the plurality of elongated members 704, maintaining flexure or bending within a common plane (e.g., planar) orthogonal to the longitudinal axis 712, can provide structural stability to the membrane 710 when the occlusion device 700 is implanted. As mentioned above, thrombi may form along the face of the occlusion device 700 due to the alteration of blood flow by the non-uniform surface. As mentioned above, the central frame portion 702 and the plurality of elongated members 704 can be uniform without protrusions. The absence of protrusions can also enhance the mitigation of thrombosis by not altering blood flow. Therefore, if the occlusion device does not maintain a planar and / or uniform surface, the patient may still be prone to blood clotting and thrombus formation. If the frame supporting the membrane does not include a planar and / or uniform surface, the membrane can be conformable to a non-planar and / or non-uniform surface, providing a device with a non-uniform surface or a surface including protrusions, thereby altering blood flow through it. Thus, the central frame portion 702 and the plurality of elongated members 704 can enhance the structural stability of the membrane 710 and maintain the planar and / or uniform closure surface of the closure device 700.

[0101] In embodiments, biocompatible materials are used for the membrane. In certain embodiments, membrane 710 may comprise a fluoropolymer, such as a polytetrafluoroethylene (PTFE) polymer or an expanded polytetrafluoroethylene (ePTFE) polymer. In some embodiments, membrane 710 may be formed of a polyester, silicone resin, polyurethane, polyethylene terephthalate, or another biocompatible material or a combination thereof. In some embodiments, bioresorbable or bioabsorbable materials, such as bioresorbable or bioabsorbable polymers, may be used. In some embodiments, membrane 710 may comprise a fluoropolymer, such as that described in one or more of U.S. Patents 7,049,380, 7,462,675, and 8,048,440, the contents of which are incorporated herein by reference. In some embodiments, membrane 710 may comprise Dacron, polyolefins, carboxymethyl cellulose fabrics, polyurethane, or other woven or film elastomers. In some embodiments, membrane 710 may comprise a knitted or woven fabric. In various embodiments, the membrane 710 may be woven or nonwoven, for example comprising threads. In some embodiments, the membrane 710 may be formed from a copolymer of a fluoropolymer or a mixture thereof.

[0102] In some embodiments, membrane 710 is configured to inhibit, filter, regulate, or substantially regulate the passage of fluids and / or materials (such as blood and / or thrombi) through membrane 710. In some embodiments, membrane 710 is configured to induce rapid tissue growth within the membrane. In embodiments, membrane 710 provides a blood or body fluid impermeable membrane that occludes blood or body fluid flow through the membrane but still promotes inward growth and endothelialization. Membrane 710 may have a microporous structure that provides a framework for tissue inward growth to provide durable occlusion and supplemental anchoring strength for the occlusion device 700. In some embodiments, membrane 710 is a porous component. The size of the (small)pores of membrane 710 is designed to substantially, or in some examples entirely, contribute to blocking the passage of blood, other body fluids, and emboli. In some embodiments, membrane 710 blocks or substantially blocks the passage of blood, other body fluids, thrombi, emboli, or other body material through membrane 710.

[0103] In some embodiments, the membrane 710 is constructed such that desired modulation of fluids and / or blood components passing through the membrane 710 is immediate and independent of the thrombosis process. In some embodiments, the membrane 710 may be modified by one or more chemical or physical processes that enhance certain physical properties of the membrane 710. For example, a hydrophilic coating may be applied to the membrane 710 to improve its wettability and echogenicity. In some embodiments, the membrane 710 may be modified by chemical components that promote one or more of endothelial cell attachment, endothelial cell migration, endothelial cell proliferation, and inhibition of thrombosis. In some embodiments, the membrane 710 may be modified with covalently attached heparin or impregnated with one or more drugs released in situ to promote wound healing or reduce tissue inflammation. In some embodiments, the drug may be a corticosteroid, human growth factor, antimitotic agent, antithrombotic agent, or dexamethasone sodium phosphate.

[0104] In some embodiments, membrane 710 is pre-perforated to regulate fluid flow through membrane 710, create filtration properties, and / or influence the tendency of tissue to grow inward onto membrane 710. In some embodiments, part or all of membrane 710 is treated to make membrane 710 elastic. For example, in some embodiments, the membrane is treated with silicone or an elastic fluoropolymer to provide elasticity to part or all of membrane 710. In some embodiments, membrane 710 is treated to make membrane 710 more rigid or to add surface texture. For example, in some embodiments, membrane 710 is treated with fluorinated ethylene propylene (FEP) to provide a hardened membrane 710 or a rough surface on membrane 710. Other material treatment techniques for membrane 710 may also be employed to provide beneficial mechanical properties and tissue-responsive interactions. These materials and techniques can be used in any occlusion device provided herein.

[0105] In certain embodiments, the membrane 710 is conformable to the contour of the frame 708. In some embodiments, the membrane 710 may be attached to the outer periphery of the frame 708 and suspended therebetween (like a drumhead).

[0106] In some embodiments, the membrane 710 is attached to a selected region of the frame 708, but not to other regions of the frame 708. This technique can facilitate a more conformable occlusion device 700 to the patient's anatomy at the implantation site, and / or in some embodiments, facilitate enhanced catheter loading. In other embodiments, the membrane 710 is attached to all portions of the frame 708. In some embodiments, the membrane 710 may include folds, pleats, rolls, openings, corrugations, etc. In other embodiments, due to the uniform surface of the membrane 710, folds, pleats, etc., on the membrane 710 are avoided on the central frame portion 702 and the plurality of elongated members 704, thereby minimizing blood flow interruptions through it. In some embodiments, the membrane 710 is an elastic member that can be elastically stretched and contracted to accommodate the expandability and loadability of the frame 708. These features and techniques can also be incorporated into other embodiments of the occlusion devices provided herein.

[0107] In some embodiments, the membrane 710 is attached to the frame 708 using an adhesive. In some embodiments, FEP is used as an adhesive to attach the membrane 710 to the frame 708 or a portion thereof. For example, an FEP coating may be applied to some or all portions of the frame 708, and FEP may be used as an adhesive to adhere the membrane 710 to the frame 708.

[0108] Figure 7 The illustrative components shown are not intended to indicate any limitation on the use or functional scope of embodiments of the disclosed subject matter. Nor should the illustrative components be construed as having any dependency or related requirement on any individual component or combination of components shown herein. Furthermore, in embodiments, in Figure 7 Any one or more of the components shown may be integrated with various other components (and / or components not shown) described herein, all of which are considered to be within the scope of the disclosed subject matter. For example, see references to... Figure 7 The described blocking device 700 can be used with the delivery system 20 ( Figure 1A (As shown in –B) used together to replace the blocking device 30. Furthermore, as referenced... Figure 2 As described in section -4, the central frame portion 702 and the plurality of elongated members 704 may replace the central frame portion and the plurality of elongated members. Furthermore, the closure device 700 may include anchors (e.g., such as...). Figure 5A (As shown in –B). Furthermore, the central frame portion 702 can be as follows: Figure 6A The central frame portion 602 shown in -B is replaced.

[0109] Figure 8 This is a perspective view of another exemplary frame 800 for a blocking device according to various aspects of this application. The frame 800 may include a central frame portion 802 and a plurality of elongated members 804. The central frame portion 802 and the plurality of elongated members 804 are arranged in a common plane perpendicular to the longitudinal axis (not shown) of the frame 800.

[0110] The frame 800 also includes a non-planar portion 806 relative to the central frame portion 802 and the plurality of elongated members 804. The plurality of elongated members 804 may include a common configuration. As shown, the plurality of elongated members 804 include a zigzag pattern, which acts as an elastic element and absorbs and distributes forces applied to the frame 800. The plurality of elongated members 804 can enhance the fatigue resistance of the frame 800 by acting as stress-relieving (releasing) features that absorb displacement, deflection, and / or torque in response to forces applied to the frame 800. The plurality of elongated members 804 are configured to bend in a common plane to mitigate the movement of the central frame portion 802 and the plurality of elongated members 804 in the longitudinal plane in response to forces applied to the frame 800.

[0111] Figure 9A This is a perspective view of another exemplary frame 900 in a fixed configuration for a blocking device according to various aspects of this application. The frame 900 may include a central frame portion 902 and a plurality of elongated members 904. The central frame portion 902 and the plurality of elongated members 904 are arranged in a common plane perpendicular to a longitudinal axis (not shown) of the frame 900. Figure 9A As shown, adjacent elongated members 904 of a plurality of elongated members 904 overlap. Each of the plurality of elongated members 904 includes a bend, such that the plurality of elongated members 904 form a common bend to provide the overlapping pattern shown. The central frame portion 902 and the plurality of elongated members 904 can be viewed as being arranged in a common plane, and the common plane is defined by the thickness of the central frame portion 902 and the plurality of elongated members 904 forming the surface of the frame 900.

[0112] The frame 900 also includes a body portion 906 that is non-planar relative to the central frame portion 902 and the plurality of elongated members 904. The body portion 906 may extend from the plurality of elongated members 904. The plurality of elongated members 904 may act as elastic elements and absorb forces applied to the frame 900. The plurality of elongated members 904 may enhance the fatigue resistance of the frame 900 by acting as stress-relieving (releasing) features that absorb displacement, deflection, and / or torque in response to forces applied to the frame 900. The plurality of elongated members 904 are configured to bend in a common plane to mitigate longitudinal movement of the central frame portion 902 and the plurality of elongated members 904 in response to forces applied to the frame 900.

[0113] Figure 9BIt is based on various aspects of this application before deformation to the final shape. Figure 9A The side view of the support column cut pattern 908 of the frame 900 shown. In shaping the frame 900 into... Figure 9A Before the shaping structure shown, the pillar cutting pattern 908 can be formed by laser cutting the tube. For example... Figure 9B As shown, the pillar cut pattern 908 includes a central frame portion 902, multiple elongated members 904, and a main body portion 906. The pillar cut pattern 908 is formed into... Figure 9A In the configuration shown, the main body 906 can be arranged in an acorn shape, and multiple adjacent sets of elongated members 904 overlap each other to form the shape, as shown. Figure 9B As shown by the arrow in the image.

[0114] Figure 10 This is an exemplary flat design 1000 of a frame for a closure device that can be formed from sheet material according to various aspects of this application. Nitinol sheet material can be used. Design 1000 results in a closure device frame without any protrusion from the outer surface of the frame involving the central frame portion 1004. Flat design 1000 can also be used to form a plurality of elongated members, the curved portions of which correspond to the material portion 1002 of design 1000. Figure 10 The boundary 1006 shown may correspond to the boundary of the face portion of the frame of the blocking device.

[0115] Figure 10 The flat pattern 1000 can be used, for example, to form multiple elongated members corresponding to material portions 1002 of pattern 1000 that include curved portions (and other non-linear shapes). These curved portions can be directed to enhance fatigue resistance by providing elements such as, but not limited to, stress-relieving features, portions designed to absorb displacement, deflection, and / or torque, and combinations of these features. The flat pattern 1000 can also be used to form a choke frame. Thus, it can be understood that a wide variety of choke frame design features can be obtained by cutting sheet material using a flat pattern and by using the techniques described above.

[0116] Figure 11 This is another exemplary flat design 1100 of a frame for producing a closure device according to various aspects of this application, which can be used to form a sheet material. Design 1100 results in a closure device frame without any protrusion from the outer surface of the frame involving the central frame portion 1104. Flat design 1100 can also be used to form branched elongated members, the curved portions of which correspond to the material portion 1102 of design 1100. Figure 10 The boundary 1106 shown may correspond to the boundary of the face portion of the frame of the blocking device.

[0117] Figure 11The flat pattern 1100 can be used, for example, to form multiple elongated members corresponding to portions of pattern 1100 that include wavy sections (and other non-linear shapes). These wavy sections can be directed to enhance fatigue resistance by providing elements such as, but not limited to, stress-relieving features, sections designed to absorb displacement, deflection, and / or torque, and combinations of these features. Thus, it can be understood that a wide variety of occlusion device frame design features can be obtained by using flat pattern cutting of sheet material and by using the techniques described above.

[0118] Figure 12 This is a top view of an exemplary central frame portion 1202 that may be included in an occlusion device according to various aspects of this application. The central frame portion 1202 does not protrude from the outer surface defined by the frame 1200. Instead, the frame material defining the central frame portion 1202 is flush with the outer surface defined by the frame 1200. In a particular example and as shown, the central frame portion 1202 is a hole having an inner and outer perimeter, with a plurality of elongated members 1204 radiating outward from the outer perimeter of the central frame portion 1202. Thus, the frame 1200 includes the central frame portion 1202 without initiating or contributing to the possibility of in-situ flow interruption and / or thrombus formation.

[0119] In some embodiments, the central frame portion 1202 provides an attachment location where a delivery and / or retrieval device (e.g., a conduit, etc.) can be releasably coupled to the frame 1200. In some embodiments, the central frame portion 1202 defines a circular through-hole (as shown). In some embodiments, the central frame portion 1202 defines structural features of different shapes, such as, but not limited to, oval, square, rectangular, triangular, keyhole-shaped, kidney-shaped, etc., and combinations thereof. In some embodiments, the central frame portion 1202 may include or define threads, one or more keyways, tabs, deformable elements, etc., and combinations thereof.

[0120] In some embodiments, additional structures on the inner side of frame 1200 may be added to a region of the central frame portion 1202 for releasable attachment to a delivery and / or retrieval device. For example, a collar (or other physical component, such as a winding member, socket, threaded fitting) may be included extending distally from the central frame portion 1202 into a portion that has become or will become the interior of frame 1200, while maintaining a uniform outer surface of frame 1200. Such a collar may have various physical shapes and features as desired to facilitate releasable attachment to a delivery and / or retrieval device. In some embodiments, through-holes are not included as part of the closure device frame 1200. These features and techniques may also be incorporated into other embodiments of the closure devices provided herein.

[0121] Figure 13 The illustrative components shown in -18 are not intended to indicate any limitation on the use or scope of functionality of embodiments of the disclosed subject matter. Figure 13 -18 describes and illustrates alternative body portions that may be arranged in one or more of the aforementioned surface portions (e.g., surface portions 220, 300, 400, 502a, 502b). Nor should illustrative components be construed as having any dependency or related requirement on any individual component or combination of components shown herein. Furthermore, in embodiments, in Figure 13 Any one or more of the components shown in any of the following 18 may be integrated with various other components (and / or components not shown) described herein, all of which are considered to be within the scope of the disclosed subject matter.

[0122] Figure 13 This is a perspective view of an alternative design of an exemplary frame 1300 for a blocking device according to various aspects of this application. The frame 1300 includes a first set of units 1302 and a second set of units 1304. The first set of units 1302 and the second set of units 1304 may be substantially rhomboid. Furthermore, as shown, the first set of units 1302 and the second set of units 1304 may longitudinally overlap each other to form the frame 1300. The first set of units 1302 and the second set of units 1304 may include equal areas, or the area of ​​one set of units 1302 and the second set of units 1304 may be larger than the other set.

[0123] The frame 1300 may also include a surface portion 1306. The surface portion 1306 may include a central frame portion 1308 and a plurality of elongated members 1310. (See above reference.) Figure 2 As discussed in detail in section -5, the plurality of elongated members 1310 can enhance the fatigue resistance of the frame 1300 by acting as stress-relief (release) features that absorb displacement, flexure, and / or torque in response to forces applied to the first set of units 1302 and / or the second set of units 1304. Thus, the plurality of elongated members 1310 can be configured to flex or bend in the plane in which the plurality of elongated members 1310 and the central frame portion 1308 are arranged substantially to mitigate the longitudinal movement of the surface portion 1306 substantially outward from the plane in response to forces applied to the first set of units 1302 and / or the second set of units 1304.

[0124] Figure 13The illustrative components shown are not intended to indicate any limitation on the use or scope of functionality of embodiments of the disclosed subject matter. Nor should the illustrative components be construed as having any dependency or related requirement on any individual component or combination of components shown herein. In certain examples, for instance, face portions 220, 300, 400, 502a, or 502b may comprise alternative face portion 1306.

[0125] Figure 14 This is a perspective view of an alternative design of another exemplary frame 1400 for a occlusion device according to various aspects of this application. Frame 1400 may include a main body portion 1408 and a face portion 1406 for occluding a target location where the main body portion 1408 is implanted. As shown, the main body portion 1408 may be formed of a plurality of struts (support rods) or wires woven together with each other.

[0126] The surface portion 1406 may include a central frame portion 1404 and a plurality of elongated members 1402. (See above reference.) Figure 2 As discussed in detail in section -5, the plurality of elongated members 1402 can enhance the fatigue resistance of the frame 1400 by absorbing stress relief features such as displacement, deflection, and / or torque in response to forces applied to the main body portion 1408. Thus, the plurality of elongated members 1402 can be configured to flex or bend in the plane in which the plurality of elongated members 1402 and the central frame portion 1404 are arranged substantially to mitigate longitudinal movement of the surface portion 1406 substantially outward from the plane in response to forces applied to one or more portions of the main body portion 1408.

[0127] Figure 14 The illustrative components shown are not intended to indicate any limitation on the use or scope of functionality of embodiments of the disclosed subject matter. Nor should the illustrative components be construed as having any dependency or related requirement on any individual component or combination of components shown herein. In certain examples, for instance, face portions 220, 300, 400, 502a, or 502b may comprise alternative face portion 1406.

[0128] Figure 15 This is a perspective view of an alternative design of another exemplary frame 1500 for a blocking device according to various aspects of this application. Frame 1500 may include a main body portion 1508 and a face portion 1508 for blocking a target location into which the main body portion 1506 is implanted. As shown, the main body portion 1508 may be a cylinder consisting of a plurality of struts (support rods) or wires, with rhomboid units comprising substantially equal areas.

[0129] The surface portion 1506 may include a central frame portion 1504 and a plurality of elongated members 1502. (See above reference.) Figure 2As discussed in detail in section -5, the plurality of elongated members 1502 can enhance the fatigue resistance of the frame 1500 by acting as stress-relief (release) features that absorb displacement, deflection, and / or torque in response to forces applied to the main body portion 1508. Thus, the plurality of elongated members 1502 can be configured to flex or bend in the plane in which the plurality of elongated members 1502 and the central frame portion 1504 are arranged substantially to mitigate longitudinal movement of the surface portion 1506 substantially outward from the plane in response to forces applied to one or more portions of the main body portion 1508.

[0130] Figure 15 The illustrative components shown are not intended to indicate any limitation on the use or scope of functionality of embodiments of the disclosed subject matter. Nor should the illustrative components be construed as having any dependency or related requirement on any individual component or combination of components shown herein. In certain examples, for instance, face portions 220, 300, 400, 502a, or 502b may include alternative face portion 1506.

[0131] Figure 16 This is a perspective view of an alternative design of another exemplary frame 1600 for a blocking device according to various aspects of this application. Frame 1600 may include a main body portion 1608 and a face portion 1606 for blocking a target location where the main body portion 1608 is implanted. As shown, the main body portion 1608 may be a cylinder composed of multiple struts or wires, having multiple rows (or columns) of zigzag configuration around the perimeter of the main body portion 1608.

[0132] The surface portion 1606 may include a central frame portion 1604 and a plurality of elongated members 1602. (See above reference.) Figure 2 As discussed in detail in section -5, the plurality of elongated members 1602 can enhance the fatigue resistance of the frame 1600 by absorbing stress relief features such as displacement, deflection, and / or torque in response to forces applied to the main body portion 1608. Thus, the plurality of elongated members 1602 can be configured to flex or bend in the plane in which the plurality of elongated members 1602 and the central frame portion 1604 are arranged substantially to mitigate longitudinal movement of the surface portion 1606 substantially outward from the plane in response to forces applied to one or more portions of the main body portion 1608.

[0133] Figure 16 The illustrative components shown are not intended to indicate any limitation on the use or scope of functionality of embodiments of the disclosed subject matter. Nor should the illustrative components be construed as having any dependency or related requirement on any individual component or combination of components shown herein. In certain examples, for instance, face portions 220, 300, 400, 502a, or 502b may include alternative face portion 1606.

[0134] Figure 17 This is a perspective view of an alternative design of another exemplary frame 1700 for a blocking device according to various aspects of this application. Frame 1700 may include a main body portion 1708 and a face portion 1706 for blocking a target location into which the main body portion 1708 is implanted. As shown, the main body portion 1708 may be a cylinder consisting of a plurality of struts (support rods) or wires, having generally rhomboid units comprising generally different areas in each row (row).

[0135] The surface portion 1706 may include a central frame portion 1704 and a plurality of elongated members 1702. (See above reference.) Figure 2 As discussed in detail in section -5, the plurality of elongated members 1702 can enhance the fatigue resistance of the frame 1700 by acting as a stress-relief (release) feature that absorbs displacement, deflection, and / or torque in response to forces applied to the main body portion 1708. Thus, the plurality of elongated members 1702 can be configured to flex or bend in the plane in which the plurality of elongated members 1702 and the central frame portion 1704 are arranged substantially to mitigate the longitudinal movement of the surface portion 1706 substantially outward from the plane in response to forces applied to one or more portions of the main body portion 1708.

[0136] Figure 17 The illustrative components shown are not intended to indicate any limitation on the use or scope of functionality of embodiments of the disclosed subject matter. Nor should the illustrative components be construed as having any dependency or related requirement on any individual component or combination of components shown herein. In certain examples, for instance, face portions 220, 300, 400, 502a, or 502b may comprise alternative face portion 1706.

[0137] Figure 18 This is a perspective view of an alternative design of another exemplary frame 1800 for a occlusion device according to various aspects of this application. Frame 1800 may include a main body portion 1808 and a face portion 1806 for occluding a target location into which the main body portion 1808 is implanted. As shown, the main body portion 1808 may be formed of a plurality of struts (support rods) or wires forming a rhomboid pattern.

[0138] The surface portion 1806 may include a central frame portion 1804 and a plurality of elongated members 1802. (See above reference.) Figure 2As discussed in detail in section -5, the plurality of elongated members 1802 can enhance the fatigue resistance of the frame 1800 by acting as stress-relief (release) features that absorb displacement, deflection, and / or torque in response to forces applied to the main body portion 1808. Thus, the plurality of elongated members 1802 can be configured to flex or bend in the plane in which the plurality of elongated members 1802 and the central frame portion 1804 are arranged substantially to mitigate longitudinal movement of the surface portion 1806 substantially outward from the plane in response to forces applied to one or more portions of the main body portion 1808.

[0139] Figure 18 The illustrative components shown are not intended to indicate any limitation on the use or scope of functionality of embodiments of the disclosed subject matter. Nor should the illustrative components be construed as having any dependency or related requirement on any individual component or combination of components shown herein. In certain examples, for instance, face portions 220, 300, 400, 502a, or 502b may include alternative face portion 1806.

[0140] Overall, it can be observed that certain embodiments of the occlusion devices provided herein are more conformable (less rigid) than commercially available occlusion devices. This enhanced conformability provides better sealing (more consistent contact between the occlusion device and surrounding tissue), improved fatigue resistance, less trauma to the patient, and more stable positioning, offering certain exemplary benefits. It should also be stated that the embodiments of the occlusion devices provided herein do not involve “driving” tissue to conform to the occlusion device. Rather, the occlusion device is generally intended to conform itself to the natural morphology of the surrounding tissue.

[0141] It has been found that certain embodiments of the occlusion device provided herein are more conducive to being recaptured and reloaded into the delivery sheath without causing damage to surrounding tissue. For example, in some embodiments, the anchoring member of the occlusion device is more conducive to deflection during recapture and reloading. Furthermore, in certain embodiments, the anchoring member allows the occlusion device to be fully reloaded into the delivery system without damaging the occlusion device and the delivery system. Thus, embodiments of the occlusion device provided herein can be removed from tissue substantially non-invasively.

[0142] The anchors of the occlusion device described herein enable non-invasive deflection during recapture and reloading, while providing stable in-situ positioning. Certain geometric features of the anchors are important for anti-migration performance. These factors include: the width and thickness of slender anchors, the apex angle (end angle), the number of anchors on the occlusion device, and the end length.

[0143] LAA closure effectiveness can be evaluated via contrast injection and color Doppler ultrasound during transesophageal echocardiography (TEE). Contrast injection is routinely used to initially assess the position of the occlusive device relative to surrounding tissues and can also be used to characterize LAA closure. Fluoroscopy measurements can be performed with contrast through the occlusive to quantify the size of the leak; however, it is difficult to assess the maximum diameter of the leak using this method. Color Doppler ultrasound is the preferred method for measuring the amount of leakage through the LAA occlusive. The TEE probe position is varied until the maximum leakage is observed. This image is captured, and the leakage is measured on the TEE workstation. In the TEE context, "substantially occluded" and "substantially closed" mean that no discernible flow passes through or around the occlusive device.

[0144] This application claims priority to Provisional Application No. 62 / 161,742, filed May 14, 2015, the entire contents of which are incorporated herein by reference. More specifically, Figures 1-29 of Provisional Application No. 62 / 161,742 relate to exemplary blocking devices and aspects thereof, and their teachings and related structural aspects are specifically incorporated herein.

[0145] As used herein with respect to measurement ranges (such as those just disclosed above), “about” and “approximately” are used interchangeably to refer to a measurement that includes the stated measurement as well as any measurement that reasonably approximates the stated measurement, but the latter may be distinguished by a reasonable amount that would be understood and readily recognized by a person of ordinary skill in the art as attributable to measurement error, differences in measurement and / or measurement equipment calibration, human error in reading and / or setting the measurement, adjustments made to optimize performance and / or structural parameters taking into account measurement differences associated with other components, specific implementation scenarios, imprecise adjustments and / or manipulations of the object by personnel or machines, etc.

[0146] Several embodiments of implantable occlusion devices and frames have been described herein. It should be understood that one or more features described in the context of a specific device may be combined with one or more features of any other device or multiple devices described herein. That is, features of the occlusion devices and frames described herein may be mixed and matched to provide embodiments of hybrid occlusion devices and device frames, and such embodiments of hybrid occlusion devices and device frames are within the scope of this application. In some examples, one or more features described for a specific device or frame may replace or substitute for one or more features of another device or frame. In some examples, one or more features described for a specific device or frame may be incorporated into or included in another device or frame. Furthermore, various combinations or sub-combinations of any features described herein may be used substantially with any device or frame described herein. It should be understood that the sizes of the occlusion devices and occlusion device frames provided herein may be varied to a wide range of dimensions, allowing the occlusion devices to be used in a variety of different anatomy, implantation sites, and implementation types.

[0147] Several features and advantages have been set forth in the foregoing description, including details of the structure and function of various alternatives and the apparatus and / or method. The description herein is intended to be exemplary only and not exhaustive. It will be apparent to those skilled in the art that various modifications can be made within the full scope indicated by the broad superordinate meaning of the terms expressed in the appended claims, particularly in terms of structure, materials, elements, components, shapes, dimensions, and arrangements of components, including combinations of these aspects within the scope of the principles described herein. Such various modifications are intended to be included herein without departing from the spirit and scope of the appended claims. All references, disclosures, and patents cited herein, including their included illustrations and figures, are incorporated herein by reference in their entirety.

Claims

1. A device for placement in a blood vessel, auricle, or internal opening, the device comprising: A self-expanding frame having a proximal end, a distal end, and a main body portion arranged therebetween about a longitudinal axis, the self-expanding frame defining a proximal lateral portion at the proximal end, including a hub centrally disposed within the proximal lateral portion, and a plurality of curved elongated members extending from the hub to the main body portion and to the distal end, the proximal lateral portion defining a bend: and A membrane is attached to the self-expanding frame, wherein the membrane is arranged along at least a portion of the proximal side portion, and wherein the membrane forms a substantially uniform surface along the proximal side portion, wherein the plurality of elongated members are configured to bend or flex in a common plane substantially orthogonal to the longitudinal axis, thereby mitigating longitudinal movement of the proximal side portion in response to compressive forces applied to the body portion, enhancing the structural stability of the membrane, and maintaining a uniform occlusion surface.

2. The apparatus as claimed in claim 1, characterized in that, The hub defines a hole having an inner perimeter and an outer perimeter, wherein the plurality of elongated members radiate outward from the outer perimeter of the hub, and wherein the self-expanding frame is integral.

3. The apparatus as described in claim 2, characterized in that, The main body also includes a plurality of arc segments arranged around the inner periphery of the hub.

4. The apparatus as claimed in claim 1, characterized in that, The thickness of the plurality of elongated members relative to the longitudinal axis is approximately equal to the thickness of the hub relative to the longitudinal axis.

5. The apparatus as claimed in claim 1, characterized in that, The hub and the plurality of elongated members are arranged in a first plane substantially orthogonal to the longitudinal axis.

6. The apparatus as claimed in claim 1, characterized in that, The proximal portion has a curved portion extending outward from the self-expanding frame.

7. The apparatus as claimed in claim 1, characterized in that, The proximal portion has a curved section extending inward toward the self-expanding frame.

8. The apparatus as claimed in claim 1, characterized in that, The membrane includes a semi-occlusive material configured to partially allow fluid to pass through while simultaneously inhibiting the passage of thrombi.

9. The apparatus as claimed in claim 8, characterized in that, The semi-occluded material includes expanded polytetrafluoroethylene (ePTFE).

10. The apparatus as claimed in claim 1, characterized in that, The self-expanding frame further includes a transition portion disposed between the plurality of elongated members and the main body portion, wherein the transition portion includes a bend to transition the plurality of elongated members toward the main body portion.

11. The apparatus as claimed in claim 1, characterized in that, The self-expanding frame is formed by cutting a tube, and the hub is formed by flattening the cutting tube.

12. The apparatus as claimed in claim 1, characterized in that, The self-expanding frame is formed from a flat sheet.

13. The apparatus as claimed in claim 1, characterized in that, The plurality of elongated members include a first curved section, a second curved section and a third curved section, a first inflection point between the first curved section and the second curved section, and a second inflection point between the second curved section and the third curved section.

14. The apparatus as claimed in claim 13, characterized in that, The first bending section and the third bending section include a bending portion along a first direction, the second bending section includes a bending portion along a second direction, and the first direction is opposite to the second direction.

15. The apparatus as claimed in claim 1, characterized in that, The surface portion and the body portion include a first configuration in the absence of the compressive force and a second configuration in response to the compressive force applied to the body portion, and the surface portion includes a substantially uniform surface in each of the first and second configurations.

16. The apparatus as claimed in claim 1, characterized in that, The surface portion includes a surface without any protrusions extending outward from the surface portion relative to the proximal end.

17. The apparatus as claimed in claim 1, characterized in that, The hub is configured to provide attachment points for delivering the device.

18. The apparatus as claimed in claim 1, characterized in that, The main body includes a first tapering section and a second tapering section. The perimeter of the first tapering section decreases at a first rate, and the perimeter of the second tapering section decreases at a second rate, wherein the first rate is less than the second rate.

19. The apparatus as claimed in claim 1, characterized in that, The main body also includes a plurality of anchors, wherein the plurality of anchors are staggered along the perimeter, and each anchor includes an anchoring portion and an arm.

20. The apparatus as claimed in claim 19, characterized in that, The plurality of anchors includes a first group of anchors and a second group of anchors, wherein the arm of the first group of anchors has a first length, the arm of the second group of anchors has a second length, and the second length is greater than the first length. The anchoring portion of the first set of anchors is arranged at a first height relative to the distal end, and the anchoring portion of the second set of anchors is arranged at a second height relative to the distal end, wherein the first height is greater than the second height.

21. The apparatus as claimed in claim 1, characterized in that, The hub is positioned in a common plane orthogonal to the longitudinal axis.

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