Devices and methods for atrial appendage obstruction

Abstract

To provide devices and other equipment related to effective occlusion. [Solution] Various embodiments of this disclosure relate to devices, methods, and systems related to occlusion. In some embodiments, the devices, methods, and systems may include devices for placement in blood vessels, accessory organs, and openings within the body. The devices may include a single frame having a central frame portion and a planar portion comprising a plurality of elongated members.

Description

Technical Field

[0001] Cross - References Related to the Application This application claims priority to the provisional patent application No. 62 / 161,742, filed on May 14, 2015, the entire specification of which is incorporated herein by reference.

[0002] This disclosure relates to implantable medical devices that can be used to occlude openings, conduits, spaces, organs, and other structures within a patient, including structures within the heart.

Background Art

[0003] Structures of the heart, such as the atrial appendage, can contribute to disruptions in the blood flow of the heart associated with many heart - related pathologies. For example, complications arising from disruptions in blood flow within accessory organs and associated with atrial fibrillation can contribute to embolic strokes.

Summary of the Invention

Problems to be Solved by the Invention

[0004] Various forms of this disclosure provide implantable medical devices that can be used to occlude openings, conduits, spaces, organs, and other structures within a patient, including structures within the heart. For example, this disclosure provides an occlusion device that can be placed within a patient. Although various placement techniques are contemplated, placement can be performed using catheter - based techniques.

[0005] Devices consistent with the various forms of this disclosure can be placed in the patient's atrial appendage. The heart has a left atrial appendage and a right atrial appendage. The various forms of this disclosure concern occlusion devices that provide enhanced fit of the device frame (including the occlusion surface) compared to the atrial appendage wall under physiological conditions. Furthermore, this disclosure concerns occlusion devices that can provide enhanced clinical outcomes, including improved sealing of the appendages around their ostium, more complete and rapid closure of the appendages, reduced thrombus formation, reduced occluder embolus formation, greater fit, and enhanced clinical comfort, patient safety, and overall efficacy.

[0006] Various embodiments of this disclosure relate to devices, methods, and systems related to occlusion. In some embodiments, a device for placement in blood vessels, accessory organs, and openings within the body may include a single self-expanding frame having a proximal end, a distal end, and a longitudinal axis. In some embodiments, the single self-expanding frame may include a pre-assembled planar shape and a planar portion having (i) a center frame portion located at the proximal end and (ii) a plurality of elongated members extending from the center frame portion, and a body portion. In some embodiments, the device may include a membrane attached to the single self-expanding frame. In some embodiments, the plurality of elongated members may be configured to be substantially flex or bend in a plane perpendicular to the longitudinal axis and to reduce the longitudinal movement of the planar portion in response to a compressive force applied to the body portion of the single self-expanding frame.

[0007] In some embodiments, devices for placement in internal blood vessels, appendages, and openings having an elongated and positioned shape may include a cut tubular frame of nitinol having a proximal and distal end. In some embodiments, the cut tubular frame of nitinol may include a central frame portion positioned at the proximal end and a plurality of arcs positioned around the central frame portion, and a face portion including a plurality of elongated members extending from the central frame portion, and a body portion. In some embodiments, the device may also include a membrane attached to the cut tubular frame of nitinol. In further and some embodiments, 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 an attachment point for a delivery system for the device.

[0008] In one embodiment, a method for reducing thrombus formation in the treatment of a patient's left atrial appendage may include deploying a transcatheter assembly through a small opening in the left atrial appendage. In one embodiment, the method may also include deploying a device from the transcatheter assembly, the device comprising a single self-expanding frame having a proximal end, a distal end, and a longitudinal axis, the single self-expanding frame comprising a central frame portion located at the proximal end and a planar portion having a plurality of elongated members extending from the central frame portion, a body portion positioned substantially perpendicular to the planar portion, and a membrane attached to the single self-expanding frame, the planar portion and membrane defining the occlusion surface of the device. Further and in one embodiment, the method may include absorbing one or more forces from the left atrial appendage, thereby bending the plurality of elongated members in a plane perpendicular to the longitudinal axis and reducing the longitudinal movement of the planar portion in response.

[0009] While several embodiments are disclosed, other embodiments of this disclosure will be apparent to those skilled in the art from the following detailed description, which illustrates and describes the embodiments of this disclosure specifically described. Therefore, the figures and detailed description are deemed to be essentially and unrestricted in their specificity. [Brief explanation of the drawing]

[0010] [Figure 1A] Figure 1A is a cross-sectional view of a human heart in which a delivery system is positioned in preparation for the placement of an occluding device into the cardiac LAA, according to various forms of the present disclosure.

[0011] [Figure 1B] Figure 1B shows an embodiment of Figure 1A having an occlusion device that is positioned in the delivery system and located within the LAA, according to various embodiments of the present disclosure.

[0012] [Figure 1C] Figure 1C shows an embodiment of Figure 1A having an occlusion device that is positioned within a blood vessel and is located within a delivery system, according to various embodiments of the present disclosure.

[0013] [Figure 2] Figure 2 is a perspective view of exemplary frames for occlusion devices in various forms of the present disclosure.

[0014] [Figure 3] Figure 3 is a top view illustrating specific exemplary surface portions of an occlusion device in various forms of the present disclosure.

[0015] [Figure 4A] Figure 4A is a schematic top view of an exemplary surface portion of a first-form closure device before force is applied, according to various embodiments of the present disclosure.

[0016] [Figure 4B] Figure 4B is a top view illustrating a specific example of a surface portion shown in Figure 4A that takes on a second shape in response to an applied force, according to various embodiments of this disclosure.

[0017] [Figure 5A] Figure 5A is a side view illustrating another exemplary frame of an occlusion device in various forms of the present disclosure.

[0018] [Figure 5B] Figure 5B is a side view of an exemplary frame of an occlusion device having a curvature in a face portion, according to various forms of the present disclosure.

[0019] [Figure 6A] Figure 6A is a top view of a specific description of a portion of an exemplary frame and a center frame portion that can be included with an occlusion device, according to various forms of the present disclosure.

[0020] [Figure 6B] Figure 6B is a perspective view of the exemplary frame and center frame portion shown in Figure 6A, similar to the state before flattening and loaded in a delivery system, according to various forms of the present disclosure.

[0021] [Figure 7] Figure 7 is a perspective view of an exemplary occlusion device, according to various forms of the present disclosure.

[0022] [Figure 8] Figure 8 is a perspective view of another exemplary frame for an occlusion device, according to various forms of the present disclosure.

[0023] [Figure 9A] Figure 9A is a perspective view of another exemplary frame for an occlusion device in a shaped configuration, according to various forms of the present disclosure.

[0024] [Figure 9B] Figure 9B is a side view of the strut cut pattern of the frame shown in Figure 9A, before being deformed into a shaped configuration, according to various forms of the present disclosure.

[0025] [Figure 10] Figure 10 is an exemplary planar pattern that can be used to form a sheet material to make a frame of an occlusion device, according to various forms of the present disclosure.

[0026] [Figure 11] Figure 11 shows another exemplary planar pattern that can be used to form a sheet material and create a frame for an occlusion device, according to various embodiments of the present disclosure.

[0027] [Figure 12] Figure 12 is a top view of an exemplary center frame portion that may be included with an occlusion device in various forms of the present disclosure.

[0028] [Figure 13] Figure 13 is a perspective view of an exemplary alternative frame design for an occlusion device, according to various embodiments of this disclosure.

[0029] [Figure 14] Figure 14 is a perspective view of another exemplary frame alternative design for an occlusion device, according to various forms of this disclosure.

[0030] [Figure 15] Figure 15 is a perspective view of another exemplary alternative frame design for an occlusion device, according to various forms of this disclosure.

[0031] [Figure 16] Figure 16 is a perspective view of another exemplary alternative frame design for an occlusion device, according to various forms of this disclosure.

[0032] [Figure 17] Figure 17 is a perspective view of another exemplary alternative frame design for an occlusion device, according to various forms of this disclosure.

[0033] [Figure 18] Figure 18 is a perspective view of another exemplary alternative frame design for an occlusion device, according to various embodiments of this disclosure.

[0034] This disclosure is subject to various modifications and substitutions, although certain embodiments are described as examples in the figures and in detail below. However, the present invention is not limited to the specific embodiments described. Rather, this disclosure is intended to include all modifications, equivalents, and substitutions that fall within the scope of this disclosure as defined by the supplementary claims. [Modes for carrying out the invention]

[0035] Figures 1A–B are cross-sectional views of a human heart 10 in which the delivery system 20 is positioned for the placement of an occlusion device 30 into an accessory organ 18 of the heart, according to various forms of the present disclosure. Figures 1A–B show a depiction of the heart 10 including the right atrium 14, left atrium 16, right ventricle 32, and left ventricle 34. As shown in the figures, the accessory organ 18 is located in the left atrium 16 of the heart 10, and therefore this accessory organ 18 can be considered the left atrial appendage 18. The following description focuses on the placement of the occlusion device 30 into the left atrial appendage 18, but the occlusion device 30 can be placed in other accessory organs or openings within the human heart 10 or in other locations within the human body.

[0036] The left atrial appendage 18 can be thought of as a muscular sac extending from the anterolateral wall 36 of the left atrium 16 of the heart 10, and functions as a storage vessel for the left atrium 16. In a normal cardiac cycle, the left atrial appendage 18 can contract rhythmically 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 with the left atrium 16 and pumps out blood that can be collected or gathered into the left atrial appendage 18 for circulation. However, during cardiac cycles characterized by arrhythmias (e.g., atrial fibrillation), the left atrial appendage 18 may not be able to contract sufficiently with the left atrium 16, and blood may stagnate within the left atrial appendage 18. The blood stagnating in the atrial appendage 18 is prone to coagulation and thrombus formation, which can be removed from the atrial appendage 18 and ultimately lead to an embolic stroke. An occlusion device 30 consistent with various forms of this disclosure can be delivered to the left atrial appendage 18 and help prevent and act upon blood stasis within the left atrial appendage 18.

[0037] In one embodiment shown in the figures in Figures 1A-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 operated through the superior vena cava 12 into the right atrium 14, through the atrial septum 15, and into the left atrium 16 toward the accessory organ 18. In some embodiments, percutaneous access to the patient's blood vessels can be, for example, in the patient's femoral vein. Of course, this exemplary technique is just one example, and many other access techniques can also be performed to place the occlusion device provided herein. In this point of the placement process, the occlusion device is contained within the lumen of the delivery system 20 and consists of a flattened, inconspicuous delivery shape. While the transcatheter system is generally shown and described, other delivery systems (e.g., under thoracoscopy) can also be considered.

[0038] Figure 1B shows the arrangement of Figure 1A, in various forms of the present disclosure, having an occlusion device 30 positioned within the left atrial appendage 18 and deployed from a delivery system 20. As shown, a control catheter 22 can be releasably coupled to the occlusion device 30 and is slidably positioned within the lumen of the delivery system 20. The control catheter 22 can be used by a clinician operator to deploy the occlusion device 30 from the delivery system 20. For example, after positioning the occlusion device 30 through a small opening 38 in the left atrial appendage 18, the clinician operator can retract the delivery system 20 with respect to the control catheter 22 to withdraw the occlusion device 30 from its sheath and deploy it. The small opening 38 can be considered a portion of the anterolateral wall 36 of the left atrium 16, tapering therefrom to form the saccular structure of the left atrial appendage 18. The occlusion device 30 may include an occlusion surface 40 positioned near the small opening 38 in the left atrial appendage 18. As will be described in more detail below (see, for example, Figures 6A-B), the control catheter 22 may be releasably connected to the occlusion device 30 via a hub or center frame portion or a plug (or similar) inserted into the center frame portion located in the center of the occlusion surface 40 of the occlusion device 300.

[0039] After emerging from the confinement of the delivery system 20, the occlusion device 30 can reconfigure its expanded shape. The occlusion device 30 can expand to conform to the contour of the space defined within the left atrial appendage 18. In one embodiment, the position of the occlusion device 30 relative to the opening 38 of the left atrial appendage 18 can be reinforced, and the occlusion device 30 can ensure that the thrombus is prevented from embolizing the left atrial appendage 18. More specifically, the occlusion surface 40 can be positioned within the left atrial appendage 18, and the occlusion surface 40 can be connected to a portion of the anterolateral wall 36 on the opposite side of the opening 38 to form a substantially uniform surface. In some embodiments, if the occlusion surface is non-uniform with respect to the opening 38 of the left atrial appendage 18 (e.g., a device having an occlusion surface that is concave, partially concave, or includes a depression, or a device having an occlusion surface that includes a recessed and covered area attached thereto, which may be folds or wrinkles as a result of the non-uniform surface), or if the occlusion surface includes a projection, blood may collect or stagnate along the surface of the device implanted therein. In these embodiments, since the non-uniform surface may alter / disrupt the blood flow in the left atrium 18, thrombi may form along the surface of the occlusion device. Therefore, if the occlusion device is improperly positioned or includes a non-uniform surface as a result of the device's design, the patient remains susceptible to blood coagulation and thrombus formation.

[0040] Following proper placement and delivery of the occlusion device 30, the control catheter 22 can be detached from the occlusion device 30, and the delivery system 20 and control catheter 22 can be removed from the patient. With the occlusion device 30 positioned as shown, the space defined in the left atrial appendage 18 is essentially separated from the left atrium 16 due to the physical obstruction provided by the occlusion device 30. In this way, blood stagnating in the LAA 18, which is prone to clotting and thrombus formation, can be prevented from entering the left atrium 16, thereby preventing the potential occurrence of an embolic stroke. Furthermore, positioning the occlusion surface 40 of the occlusion device 30 relative to the opening 38 of the left atrial appendage 18 can help prevent blood from accumulating or stagnating along the surface of the occlusion device 30.

[0041] As stated above, the occlusion devices provided herein can be used in many different areas of the body, and the placement of the occlusion device 30 in the left atrial appendage 18 is just one exemplary embodiment. More specifically, Figure 1C shows the arrangement of Figure 1A, in various forms of the present disclosure, having the occlusion device 30 positioned within a vascular space between the walls of the vascular space 42 and positioned from a delivery system.

[0042] Figure 2 is a perspective view of an exemplary frame 200 for an occlusion device. As shown, the frame 200 may include a proximal end 202 and a distal end 204, and may be single and self-expanding. Furthermore, the frame 200 may include a plurality of elongated members 206 and a center frame portion 208 positioned at the proximal end 202 of the frame 200. The plurality of elongated members 206 may extend from the center frame portion 208. Together, the combination of the plurality of elongated members 206 and the center frame portion 208 forms a surface portion 220. Furthermore, the frame 200 may include a body portion 214. The frame 200 including the plurality of elongated members 206 and the center frame portion 208 is shown in a pre-assembled planar shape. In one embodiment and as described in more detail in comparison with Figures 5A-B, the frame 200 may be slightly bent as a result of being loaded into and out of the delivery system. As shown in the pre-assembled planar shape, the multiple elongated members 206 and the center frame portion 208 (surface portion 220) form a substantial plane (e.g., eccentrically outward by 0 mm to 1 mm measured from the transition portion 216). In one embodiment, the center frame portion 208 is a hole having an inner circumference and an outer circumference, and the multiple elongated members 206 radiate outward from the outer circumference of the center frame portion 208.

[0043] The surface portion 220 may consist of a center frame portion 208 and a plurality of elongated members 206. The boundary of the surface portion 220 can be considered to be at the transition portion 216 of the frame 200. As shown, the transition portion 216 is positioned around the outer periphery of the surface portion 220. The transition portion 216 transitions the frame 200 between the plurality of elongated members 206, and the body portion 214 is outside the surface portion 220. More specifically, the body portion 214 of the frame 200 extends from the plurality of elongated members 206, and the transition portion 216 transitions the plurality of elongated members 206 of the frame 200 into the body portion 214 of the frame 200. As will be further described in further details below and in some embodiments, the transition portion 216 may be configured as a landing section that contacts the wall of an appendage or blood vessel, into which the frame 200 (as part of an occlusion device) is implanted. The transitional portion 216 can improve the conformity of the frame 200 to the wall of an accessory organ or blood vessel.

[0044] The body portion 214 can contain any number of rows and cells. The body portion 214 can be bifurcated to form multiple cells in rows, or the body portion 214 can extend directly to the distal end 204 of the frame. In one embodiment, the body portion 214 can contain cells made of five-sided shapes, six-sided shapes, or other shapes, including but not limited to polygons, squares, rectangles, parallelograms, rhombuses, trapezoids, diamond shapes, V-shapes, octagons, triangles, and similar shapes. Different shapes and arrangements of the body portion 214 are shown, for example, in Figures 13-18.

[0045] In some embodiments, the multiple elongated members 206 are configured to reduce bending and longitudinal movement of the face portion 220 (relative to the longitudinal axis 212 of the frame 200) in response to compressive forces applied to the body portion 214 of the frame 200. In some embodiments, the force is applied to the transition portion 216. The multiple elongated members 206 can increase the fatigue resistance of the frame 200 by functioning as stress-relieving properties that absorb bending and / or rotational forces and similar forces in response to one or more forces applied to the frame 200. In some embodiments and as further described below with respect to Figures 5A-B, the multiple elongated members 206 are configured to reduce movement of the face portion 220 substantially outward from the plane, and outward movement from the plane may include outward deformation of the face portion 220.

[0046] As shown, the surface portion 220 is a substantially uniform (proximal) surface formed by a plurality of elongated members 206 and a center frame portion 208. The plurality of elongated members 206 and the center frame portion 208 may include an equally constant surface across the surface portion 220. Furthermore, the plurality of elongated members 206 and the center frame portion 208 may be formed without outward projections from the surface portion 220. In one embodiment, the plurality of elongated members 206 and the center frame portion 208 may include substantially equal thickness (with respect to the longitudinal axis 212) across the surface portion 220. As will be described in more detail below, a surface portion 220 having a substantially uniform surface or a surface without outward projections from there can enhance the performance of the occlusion device including the frame 200 by reducing the opportunity for thrombus formation. In one embodiment, the substantially uniform surface of the surface portion 220 may be planar.

[0047] As described above, the multiple elongated members 206 are configured to substantially deflect or bend in a plane (formed by the surface portion 220) perpendicular to the longitudinal axis 212, thereby mitigating the longitudinal movement of the surface portion 220 (relative to the longitudinal axis 212 of the frame 200) in response to a compressive force applied to the body portion 214 of the frame 200. This force can be considered a compressive force, and it can be applied to one or more locations on the body portion 214 of the frame 200. In some embodiments, the compressive force can be non-uniform with respect to the frame 200, and in other embodiments, the force can be considered a radial force, which can be defined as a force directed inward from one or more locations on the frame 200, or as a component of this force. In all or any of these embodiments, the force applied to one or more locations on the body portion 214 is directed along the body portion 214 toward the multiple elongated members 206. Multiple elongated members 206 can absorb applied forces and balance and / or share forces applied at any point on the frame 200. As a result, the multiple elongated members 206 are configured to substantially deflect or bend in a plane perpendicular to the longitudinal axis 212, mitigating the movement of the surface portion 220 (combination of the multiple elongated members 206 and the center frame portion 208) relative to the longitudinal axis 212 in response to forces applied to the frame 200. In further and in some embodiments, the multiple elongated members 206 bend to mitigate the movement of the surface portion 220 independent of the shape or arrangement of the body portion 214 of the frame 200.

[0048] Reducing the movement of the surface portion 220 of the frame 200 can improve the performance of the frame 200 when implanted in a blood vessel or opening within the body. More specifically, when the frame 200 (or an occlusion device including the frame 200) is located, for example, in the contour of a space defined in the left atrial appendage (e.g., in a blood vessel as shown in the left atrial appendage 18 in Figures 1A-B or Figure 1C), thrombus formation can occur along the occlusion device in cases where an uneven surface alters blood flow across the surface of the device. Reducing the movement of the longitudinal surface portion 220 reduces the opportunity for thrombus formation by avoiding disturbance of blood flow. Furthermore, a surface portion 220 having a substantially uniform surface or a surface without outward projections similarly improves performance by avoiding disturbance of blood flow. Moreover, an occlusion device having an occlusion surface with depressions (e.g., curvature inward at least in part of the occlusion surface) can not only disturb blood flow by causing blood to accumulate along the occlusion surface, but blood can also collect in the depressions. Each of these examples may contribute to thrombus formation. In one embodiment, such a device, which includes a depression in the occlusion surface, can utilize a membrane to attempt to provide a uniform surface. The membrane may, as a result of the non-uniform surface, fall into the depression or wrinkle, thus disrupting blood flow across the occlusion surface. Therefore, a frame 200 that includes a uniform surface portion 220 and also reduces the movement of 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 opportunity for thrombus formation.

[0049] Furthermore, multiple elongated members 206 configured to reduce deflection and longitudinal movement of the surface portion 220 relative to the longitudinal axis 212 can enhance the conformability of the frame 200. More specifically, the multiple elongated members 206 can help the frame 200 and, more particularly, the body portion 214's ability to conform to irregular tissue topography and / or dynamically changing tissue topography. When the frame 200 is implanted during changing tissue topography, forces applied from the tissue topography can be directed to one or more locations on the body portion 214 and / or transition portion 216. In one embodiment, this force is directed along the length of the body portion 214 toward the multiple elongated members 206, and the multiple elongated members 206 absorb the applied force and balance and / or share the forces applied at any point on the frame 200. As a result, the portion of the frame 200 that is in contact with the changing tissue topography can conform there (as opposed to a frame that forces the changing tissue topography to conform to the shape of the frame). Furthermore, the transition portion 216 of the frame 200 can conform to the shape of the pore when implanted. In one embodiment, the frame 200 (which may include a membrane attached thereto) can be positioned in the left atrial appendage to help prevent a thrombus from embolizing through the left atrial appendage (for example, as shown at the top of Figure 1B). After implantation, the portion of the frame 200 that contacts and conforms to the left atrial appendage, and the forces applied through the left atrial appendage, can be absorbed by the multiple elongated members 206. Under the physiological conditions of the heart, the multiple elongated members 206 are configured such that the surface portion 220 on the opposite side of the pore in the left atrial appendage continues to form and maintain a substantially uniform surface that closes the pore, while the transition portion 216 and a portion of the body portion 214 that contacts the appendage conform to the shape of the appendage.

[0050] Such conforming properties can be advantageous in providing substantial sealing and durable occlusion. Conformity can also increase the fatigue resistance of the occlusion device. Furthermore, an occlusion device with substantial conformity may be less traumatic to the patient and more resistant to displacement from its original position than a less conforming occlusion device. In some embodiments of the occlusion devices provided herein, some parts of the device are designed to be more conforming than other parts of the same device. That is, the conformity of a single occlusion device can be designed to differ in different areas of the device. Furthermore, in some embodiments, the selection of frame material, heat treatment, and other treatments can be used to achieve a desired degree of conformity. In some embodiments, the frame 200 may be made of nitinol (NiTi). In certain embodiments, the frame 200 may be made of a single piece of nitinol.

[0051] To deliver the frame 200 to a location within the body, the frame 200 can be reconfigured into an inconspicuous (elongated) shape for loading into a delivery catheter (such as the control catheter 22 shown in Figure 1-B) used for transcatheter placement of the occlusion device. After emerging from the confinement of the delivery system, the frame 200 is configured to self-expand and reconfigure into the shape shown in Figure 2. The frame 200 can, for example, expand to conform to the contour of a defined space within the body (e.g., in the left atrial appendage 18 shown in Figures 1A-B or in a blood vessel as shown in Figure 1C). As mentioned above, the central frame portion 208 can function as a linkage point to the control catheter for transcatheter placement of the occlusion device. As a result, the frame 200 (and the closure device including the frame 200) may have a hubless surface portion 220 (e.g., without any additional structure or elements beyond the center frame portion 208, without any additional thickness exceeding the thickness of the center frame portion 208, being edgeless, or having dimensions exceeding the maximum thickness of the multiple elongated members 206 and the center frame portion 208). The hubless surface portion 220 (e.g., any small holes (eyelets) extending beyond the surface portion 220) provides a substantially uniform surface formed by the multiple elongated members 206 and the center frame portion 208.

[0052] The components specifically described in Figure 2 are not intended to imply any limitations on the scope of use or functionality of the embodiments of the disclosed subject matter. The components specifically described are not to be understood as having any dependency or requirement relating to any one component or combination of components specifically described therein. Furthermore, any one or more components described in any of Figure 2 may, in embodiments, be integrated with various other components described therein (and / or components not specifically described), all of which are considered to be within the scope of the disclosed subject matter. For example, the frame 200 described with reference to Figure 2 can be used in conjunction with the delivery system 20 (shown in Figures 1A-B). More specifically, the frame 200 may form part of the closure device 30 (together with a plurality of elongated members 206 and a center frame portion 208 that form part of the closure surface 40, for example). Furthermore, the frame 200 may include a membrane attached thereto (as shown and described with reference to Figure 7, for example).

[0053] Figure 3 is a top view illustrating an exemplary planar portion 300 of an occlusion device according to various embodiments of the present disclosure. The planar portion 300 includes a plurality of elongated members 302 and a center frame portion 304. As shown, the plurality of elongated members 302 may extend from the center frame portion 304 and may include a common curvature within the planar portion 300, which is substantially formed in a common plane (e.g., the xy plane as shown). The common curvature may provide the plurality of elongated members 302 so as not to overlap within the planar portion 300. In some embodiments, the plurality of elongated members 302 may have a zigzag pattern (e.g., as shown in Figure 8).

[0054] The multiple elongated members 302 can include any number of curved or semi-curved patterns. Other curved patterns are shown, for example, in Figures 8-11. As shown, each of the multiple elongated members 302 includes multiple curved sections. For the purpose of specific explanation, the curved sections are highlighted in one of the multiple elongated members 302 in Figure 3. The multiple elongated members 302 can include a first curved section 306, a second curved section 308, and a third curved section 310. In one embodiment, the first curved section 306 and the third curved section 310 are curved in a first direction, and the second curved section 308 is curved in a second direction, which is the opposite direction to the first direction. As a result, the multiple elongated members 302 can 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 multiple elongated members 302.

[0055] Furthermore, each of the first curved section 306, the second curved section 308, and the third curved section 310 is located in a common plane. Thus, the curvature formed by the multiple elongated members 302 and the first curved section 306, the second curved section 308, and the third curved section 310 substantially occurs in the xy plane. More specifically, each of the first curved section 306, the second curved section 308, and the third curved section 310 is curved in the xy plane. The center frame section 304 may also be located in the xy plane. If the surface section 300 is included in the closure device, the multiple elongated members 302 and the center frame section 304 may be located in a common plane. Furthermore, if the surface section 300 is included in the closure device, the multiple elongated members 302 are configured to mitigate the longitudinal movement (perpendicular to the xy plane) of the surface section 300 in response to a compressive force applied to another part of the closure device (for example, as described above with reference to Figure 2). Multiple elongated members 302 are configured to bend or flex substantially in the xy-plane to mitigate the longitudinal movement (perpendicular to the xy-plane) of the surface portion 300.

[0056] In one embodiment, each of the first curved section 306, the second curved section 308, and the third curved section 310 may include an equal radius of curvature. In another embodiment, the first curved section 306 and the third curved section 310 may include a first radius of curvature, and the second curved section 308 may include a second (and different) radius of curvature. The (first) radius of curvature of the first curved section 306 and the third curved section 310 may be greater than the (second) radius of curvature of the third curved section 310. In further and in certain embodiments, the first curved section 306 and the third curved section 310 may include approximately equal lengths. The second curved section 308 may include a length that is greater than or equal to the first curved section 306 and the third curved section 310. Furthermore, the first curved section 306 and the third curved section 310 may include lengths greater than the length of the second curved section 308. As shown, the length of the second curved section 308 is greater than that of the first curved section 306 and the third curved section 310, which are substantially equal in length.

[0057] As described above, the multiple elongated members 302 extend from the center frame portion 304. Thus, the starting point 312 for the multiple elongated members 302 is located in the center frame portion 304, and the ending point 314 for the multiple elongated members 302 is located on the outer periphery of the surface portion 300. For the purpose of specific explanation, the starting point 312 and the ending point 314 are shown in one of the multiple elongated members 302 in Figure 3. In one embodiment, the starting point 312 and the ending point 314 may be located symmetrically with respect to the surface portion 300. More specifically, the tangent line 316 formed between the starting point 312 and the ending point 314 may be substantially straight. The curvature pattern of the multiple elongated members 302 may be symmetrical, and the multiple elongated members 302 may include curvatures (having one or more inflection points) that extend in one direction from the starting point 312 and return in another direction to the ending point 314.

[0058] In the embodiments described, the surface portion 300 includes a plurality of 10 elongated members 302. In some embodiments, the surface portion 300 may include a plurality of 2, 3, 4, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 16, or more than 16 elongated members 302. Furthermore, the center frame portion 304 is shown to include a plurality of 10 peaks 322 corresponding to each of the plurality of elongated members 302. The center frame portion 304 may include a number of peaks equal to the number of plurality of elongated members 302 included in the surface portion 300. In other embodiments, the center frame portion 304 may include a substantially circular shape.

[0059] The components specifically described in Figure 3 are not intended to imply any limitations on the scope of use or functionality of the embodiments of the disclosed subject matter. The components specifically described should not be understood as having any dependency or requirement relating to any one component or combination of components specifically described herein. The surface portion 300 can be integrated with various other occlusion devices (and / or components not specifically described) described herein, all of which are considered to be within the scope of the disclosed subject matter. For example, the surface portion 300 can be used in relation to the frame 200 shown in Figure 2.

[0060] Figure 4A is a schematic top view of an exemplary surface portion 400 of a first shape closure device before force is applied, according to various embodiments of the present disclosure. The surface portion 400 includes a plurality of elongated members 402a-j and a center frame portion 404. The plurality of elongated members 402a-j extend from the center frame portion 404. The center frame portion 404 and the plurality of elongated members 402a-j are arranged in the xy plane. The plurality of elongated members 402a-j and the center frame portion 404 may be made of a single frame. The single frame may be formed by laser cutting (e.g., tube or planar sheet), etching, wire forming, or other processes.

[0061] Furthermore, the surface portion 400 can have a substantially uniform surface or thickness. The multiple elongated members 402a-j and the center frame portion 404 may include equal and constant surfaces extending across the surface portion 400, such that the surface portion 400 is free of protrusions (e.g., with respect to the z-axis). A surface portion 400 having a substantially uniform surface or a surface free of outward protrusions can enhance the performance of the occlusion device including the frame 400 by reducing turbulence in blood flow across the surface portion 400, thereby reducing the opportunity for thrombus formation.

[0062] For the purpose of concrete illustration, the periphery 406 of the surface portion 400 is shown. In one embodiment, the periphery 406 can be considered a non-physical boundary formed by the terminal portions of a plurality of elongated members 402a-j (e.g., a surface portion 220 formed around a transition portion 216, as shown in Figure 2). In other embodiments, the periphery 406 can be a physical boundary formed by parts of the frame forming the surface portion 400. As described in detail below with reference to either embodiment and Figure 7, the surface portion 400 may include a membrane attached thereto. The membrane is attached to provide an obstruction to thrombuses embolizing accessory organs or blood vessels and to enhance sealing. Suitable membranes for use include occlusive or semi-occlusive materials. Embodiments having semi-occlusive materials can allow passage of some fluid / blood components while obstructing the passage of thrombus. In these embodiments, the periphery 406 can be formed by a membrane boundary.

[0063] The surface portion 400 can be incorporated together with the closure device (for example, via the frame 200 shown with reference to Figure 2 and described above). The closure device including the surface portion 400 may include a longitudinal axis parallel to the z-axis shown in Figure 4A. Thus, the closure device including the surface portion 400 has a center frame portion 404 and a plurality of elongated members 402a-j arranged in a plane (xy-plane) perpendicular to the longitudinal axis of the closure device. The surface portion 400 of such a closure device (for example, as shown in Figure 2) can be considered a first part of the closure device having substantially the external and / or body portion of the closure device arranged perpendicular to the surface portion 400 and the xy-plane.

[0064] As shown in Figure 4A, the multiple elongated members 402a-j and the center frame portion 404 are arranged in their initial shape, with no forces applied to them. The multiple elongated members 402a-j may not overlap in the first shape and may include a common curvature. Furthermore, the multiple elongated members 402a-j and the center frame portion 404 are uniform in addition to being arranged in the xy plane.

[0065] Figure 4B is a top view illustrating a specific description of a second shape of surface portion 400 in response to an applied force, according to various embodiments of the present disclosure. In response to an applied force (shown for illustrative purposes), a plurality of elongated members 402a-j are configured to bend and reduce the movement of the surface portion 400 with respect to the xy plane. Furthermore, the plurality of elongated members 402a-j are configured to bend or flex substantially within the xy plane to reduce the longitudinal movement of the surface portion 400 with respect to the xy plane. As described above, the surface portion 400 can be incorporated together with the occlusion device (e.g., via a frame 200 shown with reference to Figure 2 and described above). The applied force shown in Figure 4B may be a compressive force applied to a portion of the occlusion device located outside the xy plane. In various embodiments, the compressive force corresponds to a compressive force associated with the portion in which the device conforms to the tissue of the body (e.g., the heart), including the movement of the tissue. The compressive force may be directed non-uniformly from one or more sides of the occlusion device to the occlusion device. Furthermore, the compressive force can be directed toward the occlusion device from one or more sides of the occlusion device at an angle to the z-axis.

[0066] As shown in Figure 4B and in response to the applied force, one or more of the multiple elongated members 402a~j bend / deflate. In one embodiment, the multiple elongated members 402a~j are configured such that one or more of the multiple elongated members 402a~j closest to the compressive force deform to a greater degree than one or more of the multiple elongated members 402a~j further away. More specifically and as shown, the multiple elongated members 402b~e bend / deflate (in the xy plane), while the multiple elongated members 402a and 402f~j bend / deflate to a lesser degree (in the xy plane) or do not bend / deflate at all. The multiple elongated members 402a and 402f~j can share the applied force among themselves by transmitting the applied force along their length. As a result, the bending of the multiple elongated members 402a to j occurs substantially within the xy plane in order to mitigate the movement of the multiple elongated members 402a to j and the center frame portion 404 (in the z direction or in a direction perpendicular to the xy plane) that are outside the xy plane.

[0067] In one embodiment, an occlusion device including a surface portion 400 can be implanted during a changing tissue topography. Forces applied from the tissue topography can be directed to one or more locations. The surface portion 400 can be formed as part of the frame of the occlusion device and can conform to the changing tissue topography. In one embodiment, the occlusion device can be located in the left atrial appendage (e.g., as shown in Figure 1B) and help prevent embolization from the left atrial appendage. After implantation, forces applied through 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 can maintain the surface portion 400 in the xy plane opposite the opening in the left atrial appendage, forming and maintaining the uniformity of the surface portion 400 to close the opening, while the rest of the occlusion device can conform to the shape of the appendage. In other embodiments, only a portion of the body of the occlusion device that contacts the blood vessel or appendage is configured to conform. The periphery 406 of the surface portion 400 can conform to the shape of the pore in response to the force applied through the left atrial appendage. For example, as shown by comparing Figures 4A and 4B, the periphery 406 can change its shape in response to the force applied to the occlusion device. The periphery 406 maintains closure of the pore in the left atrial appendage, while the multiple elongated members 402a-j reduce the movement of the surface portion 400 and maintain its uniformity to avoid thrombus formation.

[0068] In each of the first shape (Figure 4A) and the second shape (Figure 4B), the surface portion 400 maintains a substantially uniform surface in the xy plane. In one embodiment, the surface portion 400 also maintains a plane in the xy plane. The multiple elongated members 402a~j may also not overlap with each of the first shape (Figure 4A) and the second shape (Figure 4B).

[0069] The components specifically described in Figures 4A and 4B are not intended to imply any limitations on the scope of use or functionality of the embodiments of the disclosed subject matter. The components specifically described should not be understood as having any dependency or requirement relating to any one component or combination of components specifically described herein. The surface portion 400 can be integrated with various other occlusion devices described herein (and / or components not specifically described herein), all of which are considered to be within the scope of the disclosed subject matter. For example, the surface portion 400 can be used in relation to the frame 200 shown in Figure 2.

[0070] Figure 5A is a side view providing a specific description of another exemplary frame 500 of the occlusion device according to various embodiments of the present disclosure. The frame 500 may include face portions (502a and 502b) and a body portion 504. Although not shown, the face portions (502a and 502b) may include a center frame portion and a plurality of elongated members. The center frame portion may be formed in accordance with the embodiments shown and described with reference to Figures 2-4 or Figures 6A-B, and the plurality of elongated members may be formed in accordance with the embodiments shown and described with reference to Figures 2-4.

[0071] The surface portion 502 may be positioned at the proximal end 512 of the frame 500. Furthermore, the surface portion 502a may be positioned in a plane 518a perpendicular or orthogonal to the longitudinal axis 516 of the frame 500. The plane 518a may include an upper limit 520a and a lower limit 522a. Furthermore, the frame 500 may also include a transition portion 506 positioned between the surface portion 502a (and a plurality of elongated members) and the body portion 504. The transition portion 506 includes a curve that transitions the frame 500 from the plane 518 to the body portion 504. In one embodiment, the surface portion 502a may be substantially planar (for example, 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 that does not protrude outward from the surface portion 502a.

[0072] In one embodiment and as shown in Figure 5B, the frame 500 may include curvature in the surface portion 502b in various forms of the present disclosure. The curvature may result from the frame 500 being loaded and unloaded into the delivery system (for example, as shown and described in Figures 1A-B). Figure 5A shows the frame 500 in a pre-assembled planar shape. Once loaded and unloaded, the peak of curvature 532 may be about 1 mm to 3 mm higher or lower than the transition portion 506. In the pre-assembled planar shape shown in Figure 5A, the surface portion 502a is substantially planar or flat (e.g., a peak of curvature less than 1 mm measured from the transition portion 506). For substantially orthogonal surface portions 502b, the surface portion 502b is located within a plane 518b. In these embodiments, the plane 518b may be parallel to the peak of curvature 532 of the surface portion 502b. The plane 518b may include an upper limit 520b and a lower limit 522b. In one embodiment, the curvature of the surface portion 502b may be outward from the frame 500 (as shown), or the curvature of the surface portion 502b may be inward. Similar to surface portion 502a, surface portion 502b may include a uniform surface. More specifically, surface portion 502b may have a surface without outward projections relative to surface portion 502b. More specifically, surface portion 502b may have no projections relative to the surface of surface portion 502b, including the curvature.

[0073] Both the surface portion 502a and surface portion 502b include a plurality of elongated members. As described in detail above (see, for example, Figures 2-4), the plurality of elongated members are configured to bend or deflect substantially within the plane (518a and 518b) to mitigate the movement of the surface portions 502a and 502b relative to the longitudinal axis 516 in response to the compressive force applied to the body portion 504 of the frame 500. In one embodiment, the elongated members are configured to bend or deflect substantially within a plane (518a and 518b), thereby mitigating the movement of the planar portion (502a or 502b) substantially outward from the plane (518a and 518b), and the outward movement from the plane (518a or 518b) includes an eccentricity of the planar portion (502a or 502b) less than 15% outward (15% of the outer diameter of the body portion 214) in response to a 25% compression of the body portion 504.

[0074] A 15% outward eccentricity is represented by the upper limits (520a and 520b) of the plane (518a or 518b). More specifically, if the eccentricity is greater than the upper limits (520a and 520b), the face portions (502a and 502b) are deflected outward from the plane (518a or 518b). As a result, and in some embodiments, the multiple elongated members are configured to mitigate the movement of the face portions (502a and 502b) substantially outward from the plane (518a or 518b) in response to bending and compressive forces applied to the body portion 504 of the frame 500, so that the face portions (502a or 502b) can be kept within the upper limits (520a and 520b) and lower limits (522a and 522b).

[0075] The force can be considered a compressive force, and the compressive force can be applied to one or more locations on the body portion 504 of the frame 500. In one embodiment, the compressive force can be non-uniform with respect to the frame 500, and in another embodiment, the force can be considered a radial force, which can be defined as a force directed inward from one or more locations on the body portion 504, or as a component of the force.

[0076] In one embodiment, the frame 500 can be implanted in a patient. More specifically, if the frame 500 (or an occlusion device including the frame 500) is located within the contour of a defined space in, for example, the left atrial appendage (e.g., the left atrial appendage 18 shown in Figures 1A-B), thrombosis may occur along the occlusion device in cases where an uneven surface (e.g., having protrusions) alters blood flow across the surface of the device. After implantation, forces applied to the body portion 504 of the frame via the left atrial appendage can be absorbed by multiple elongated members contained within the surface portion (502a or 502b). The multiple elongated members are configured to reduce the longitudinal movement of the surface portion (502a and 502b) relative to the longitudinal axis 516 on the opposite side of the opening in the left atrial appendage, forming and maintaining a substantially protrusion-free surface that closes the opening in the left atrial appendage, while conforming the rest of the occlusion device (e.g., the body portion 504) to the shape of the appendage. The longitudinal mitigating motion of the surface portions (502a and 502b) reduces the opportunity for thrombus formation by mitigating turbulence in blood flow through maintaining a substantially uniform surface across the foramen of the left atrial appendage.

[0077] In one embodiment, the body portion 504 of the frame 500 may taper toward the distal end 514. In some embodiments, the body portion 504 of the frame 500 may include a first tapered portion 508 and a second tapered portion 510. The first tapered portion 508 and the second tapered portion 510 may reduce in circumference at different rates. For example, as shown in Figures 5A and 5B, the first tapered portion 508 is reduced in circumference at a smaller rate than the second tapered portion 510. The first tapered portion 508 may taper at an angle of 0 to 10°, 0 to 20°, or 0 to 30° from the face portions (502a and 502b). The second tapered portion 510 can be tapered at an angle of 40–75°, 30–80°, or 30–85°. The frame 500 may include one or more tapered portions (first tapered portion 508 and second tapered portion 510) by the intended implant in the occlusion device including the frame 500. The first tapered portion 508 and the second tapered portion 510 may be manufactured to the size of the specific tissue of the left atrial appendage.

[0078] Several embodiments of the frame 500 are resistant to folds. For example, certain embodiments of the occlusion devices provided herein generally exhibit greater resistance to folds when the device is loaded or reloaded in a delivery catheter. A fold is a type of deformation, such as folding, bending, twisting, or overlapping of a portion of the occlusion device (e.g., the tip portion), which makes the constructed device uneven. Folds can cause the occlusion device to experience structural entanglement and / or damage, resistance to loading, inadequate sealing performance, and the like. The "acorn" shaped frame 500 enhances the frame 500's resistance to folds. These embodiments have been found to be better at preventing patient trauma thanks to the acorn shape, a membrane covering all or more of the frame, improved fit and sealing, better fatigue resistance, and partial ePTFE material covering that grows and enhances.

[0079] Furthermore, the body portion 504 of the frame 500 can be of other shapes, such as cylindrical, conical, frustoconical, hemispherical, spherical cap, pyramidal, pyramidal, and similar shapes, as well as combinations thereof. Any and all combinations and quasi-combinations of such various shapes and various geometric shapes are conceivable and within the scope of this disclosure.

[0080] In some embodiments, the face portions (502a or 502b), body portion 504, and transition portion 506 of the frame 500 are formed from a single, self-expanding structure. In some embodiments, the frame 500 may be made from a single piece of material. Thus, in some embodiments, the frame 500 may include a seamless structure. Furthermore, the material of the frame 500 may be one thickness and / or width throughout the entire frame 500. In some embodiments, the material of the frame 500 may vary in thickness and / or width to facilitate variations in the radial forces exerted by the frame 500 in those specific regions, increasing or decreasing the rigidity or flexibility of the frame 500 in certain regions, increasing the resistance to movement, and / or controlling the process of loading (and / or reloading) the frame 500 into a delivery catheter, which is provided for the placement (and / or repositioning and re-displacement) of an occlusion device made of the frame 500. However, in some embodiments, the frame 500 may be made differently and to include two or more parts formed separately from one another.

[0081] Furthermore, while NiTi can be used as the material for frame 500 (and any of the frames described herein), other materials such as stainless steel, L605 steel, polymers, MP35N steel, polymer materials, Pyhnox, Elgiloy, or any other suitable biocompatible material, and combinations thereof, can also be used as the material for frame 500. The superelastic properties and softness of NiTi can enhance the conformability of frame 500. In addition, NiTi can be shaped to a desired form; that is, NiTi can be shaped such that frame 500 tends to self-expand to a desired form when frame 500 is released, such as when frame 500 is placed out of a delivery system. More specifically, the frame 500 (made of NiTi) may have spring properties such that the frame 500 is elastically deformed or "crushed" (for example, as shown and described with reference to Figure 1A) into an inconspicuous delivery shape for loading in the delivery system, and then reformed into an expanded shape upon emerging from the delivery system, as shown in Figures 5A and 5B. The frame 500 may generally be conformable, fatigue-resistant, and elastic, so that it can conform to the topography of the surrounding tissue when the occlusion device is placed in a patient. In one embodiment, bioabsorbable or bioresorbable materials, such as bioabsorbable or bio-absorbable polymers, may be used in or as part of the frame 500.

[0082] In some embodiments, some or all of the frame 500 (and the frames of other devices provided herein) is coated with a radiopaque coating (e.g., sputter coating) for enhanced visibility on radiographs. For example, in some such embodiments, some or all of the frame 500 may be coated with a precious metal such as tantalum, platinum, and its like, but not limited to these. In some embodiments, the frame 500 is made of nitinol tubing or sheets of nitinol.

[0083] In some embodiments, the frame 500 may be processed using various electropolishing techniques. In some embodiments, such electropolishing is performed while the frame 500 is in a cut tubular shape (before diameter expansion). In some embodiments, such electropolishing is performed while the frame 500 is in a diameter expanded and shaped form. In some embodiments, the frame 500 may be processed using various heat treatment techniques. The use of such techniques can enhance some desirable performance characteristics of the occlusion devices provided herein, including but not limited to increased fit, increased fatigue resistance, and reduced trauma from the device to the patient.

[0084] The frame 500 may also include one or more anchors 524, 526 positioned on the torso portion 504. As shown in Figures 5A and 5B, the frame includes a first group of anchors 524 and a second group of anchors 526. Although only one of each of the first group of anchors 524 and the second group of anchors is highlighted, each anchor 524, 526 includes an anchor portion 528 (which can contact the wall of a blood vessel or appendage to hold the frame 500 and the associated occlusion device in place) and an arm 530. In one embodiment, the first group of anchors 524 and the second group of anchors 526 may be positioned at the same height around the frame 500 with respect to the distal end 514. In other embodiments, the anchor portion 528 of the first group anchor 524 is positioned at a first height relative to the distal end 514, and the anchor portion 528 of the second group anchor 526 is positioned at a second height relative to the distal end 514, with the first height being higher than the second height. The heights of the anchor portions 528 of the first group anchor 524 and the second group anchor 526 can be varied by positioning the first group anchor 524 and the second group anchor 526 at different heights on the frame 500. In other embodiments, the heights of the anchor portions 528 of the first group anchor 524 and the second group anchor 526 can be varied by changing the length of the arm 530. More specifically and as shown, the arm 530 of the first group anchor 524 may be shorter than the arm 530 of the second group anchor 526. The difference in height between the anchors 524 of the first group and the anchors 526 of the second group can be the difference in length between the arms 530 of the anchors 524 of the first group and the arms 530 of the anchors 526 of the second group. In one embodiment, the anchors 524 of the first group, the anchors 526 of the second group and the rest of the frame 500 can be a single piece. More specifically, the anchors 524 of the first group and the anchors 526 of the second group can also be formed from the same single piece of material as the rest of the frame 500.

[0085] In one embodiment, alternating the arrangement of anchors 524 of the first group and anchors 526 of the second group reduces the amount of force required to move the frame 500 between its positioned shape and its elongated or delivery shape through the delivery system (as shown). The frame can be positioned within the delivery system (e.g., as shown in Figure 1A) by confining the frame 500 within a portion of the delivery system (a delivery sheath). If the frame 500 comes into contact with protrusions (such as anchors) during the process of confining it within the delivery system, the force required to position the frame 500 within the delivery system increases. Thus, alternating the arrangement of anchors 524 of the first group and anchors 526 of the second group at different heights also alternates the amount of force required to confine the anchors 524 and 526 within the delivery system, which is approximately half the amount compared to multiple anchors positioned at the same height around the frame.

[0086] The components specifically described in Figures 5A and 5B are not intended to imply any limitations on the scope of use or functionality of the embodiments of the disclosed subject matter. The components specifically described are not to be understood as having any dependency or requirement relating to any one component or combination of components specifically described herein. Frame 500 can be integrated with various other occlusion devices described herein (and / or components not specifically 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 (as shown and described with reference to, for example, Figure 7), or frame 500 may be used in place of frame 708 included with occlusion device 700. Furthermore, face portions 220, 300, and 400 may be incorporated in place of face portions (502a or 502b).

[0087] Figure 6A is a top view illustrating a specific portion of an exemplary frame 600 and a center frame portion 602 that may be included with an occlusion device in various forms of the present disclosure. The frame 600 may, in one embodiment, be made of a nitinol material. Furthermore, the frame 600 may be single and self-expanding. The center frame portion 602 may include a plurality of arcs 604 arranged around the center frame portion 602. The center frame portion 602 may be positioned as the central portion of the frame 600 that can be used with an occlusion device, consistent with various forms of the present disclosure. The frame 600 may be made of a single structure such as a tube. The tube may be cut to form the frame 600 and may include the center frame portion 602 and the plurality of arcs 604. The frame 600 may also include a plurality of elongated members 606, which may form face portions and body portions of the frame 600.

[0088] The center frame portion 602 and the multiple elongated members 606 are substantially planar. Forming the frame 600 from a cut tube makes the center frame portion 602 substantially planar. In order to arrange the center frame portion 602 and the multiple elongated members 606 from the tube in a planar shape, the cut tube must be flattened from its manufactured shape as shown in Figure 6B. As will be described in more detail below, the multiple arcs 604 may be configured to distribute strain around the center frame portion 602 when transitioning from the manufactured shape to the flattened shape as shown in Figure 6A. The multiple arcs 604 may similarly be configured to distribute strain around the center frame portion 602 when transitioning from an elongated shape (e.g., the frame 600 arranged in a delivery system) and an arranged shape to the frame 600. In the arranged shape, the portion of the frame 600 shown in Figure 6A may be the central portion of a surface portion (e.g., surface portions 220, 300, 400 shown in Figures 2-4).

[0089] The center frame portion 602 may be configured to attach a delivery system (e.g., the delivery system shown in Figures 1A-B) for delivering an occlusion device including the frame 600 to a target location in the patient. Furthermore, the frame 600 can be confined within the delivery system by attachments to the center frame portion 602, transitioning from the positioned / flattened shape shown in Figure 6A to the elongated shape within the delivery system. The strain placed on the frame through the transition between shapes is distributed by multiple arcs 604 around the center frame portion 602.

[0090] Furthermore, the multiple elongated members 606 may be configured to mitigate deflection and movement of the center frame portion 602 and the multiple elongated members 606 substantially outward from the planar profile shown in Figure 6A. Although only a portion of the multiple elongated members 606 is shown in Figure 6A, the multiple elongated members 606 may include curvatures that absorb forces that may be applied to the portion of the frame 600 (not shown) outside the planar profile of the center frame portion 602 and the multiple elongated members 606.

[0091] Figure 6B is a perspective view of the frame 600 and center frame portion 602 shown in Figure 6A before flattening, according to various embodiments of the present disclosure. The frame 600 is shown in its manufactured shape after the frame is formed, for example, from cut tubes or planar sheets and includes a plurality of arcs 604. The plurality of arcs 604 enhance the ability of the frame 600 to flatten into the planar profile shown in Figure 6A. The plurality of arcs 604 can provide flexibility during the transition from tube to flatten. Furthermore, the plurality of arcs 604 can transfer and distribute the strain resulting from flattening the frame 600 from its manufactured shape around the center frame portion 602. Stress accumulates at peaks or in the plurality of arcs 604 and / or in the transition between the plurality of arcs 604 and the plurality of elongated members 606. The curvature of the plurality of arcs 604 provides an optimized area for stress distribution compared to a substantially circular or rectangular central region.

[0092] In one embodiment, the curvature of the multiple arcs 604 can be reversed from the curvature shown in Figure 6A. Furthermore, the width of the multiple arcs 604 can be equal to the width of the multiple elongated members 606. In another embodiment, the width of the multiple arcs 604 can be 101% to 160% greater than the width of the multiple elongated members 606.

[0093] The components specifically described in Figures 6A-B are not intended to imply any limitations on the scope of use or functionality of the embodiments of the disclosed subject matter. The components specifically described are not to be understood as having any dependency or requirement on any one component or combination of components specifically described therein. Furthermore, any one or more components described in any of Figures 6A-B may, in embodiments, be integrated with various other components described therein (and / or components not specifically described), all of which are considered to be within the scope of the disclosed subject matter. For example, the frame 600 described with reference to Figures 6A-B may be used in connection with the delivery system 20 and form part of the closure device 30 shown in Figures 1A-B (e.g., a plurality of elongated members 606 and a center frame portion 602 form part of the closure surface 40). Furthermore, the frame 200 may include a membrane attached thereto (e.g., as shown and described with reference to Figure 7).

[0094] Figure 7 is a perspective view of an exemplary closure device 700 in various forms of the present disclosure. The closure device 700 may include a center frame portion 702, a plurality of elongated members 704 extending from the center frame portion 702, and a body portion 706. The center frame portion 702, the plurality of elongated members 704, and the body portion 706 together form a frame 708 of the closure device. In some embodiments, the frame 708 may be single (e.g., made of one structure or one piece of material) and self-extending. Furthermore, the center frame portion 702 and the plurality of elongated members 704 are arranged in a common plane perpendicular to the longitudinal axis 712 of the closure device 700. The center frame portion 702 and the plurality of elongated members 704 may be located in the xy plane. However, the body portion 706 of the frame 708 may be located outside the xy plane. In one embodiment, the multiple elongated members 704 can mitigate the movement of the center frame portion 702 and the multiple elongated members 704 in the longitudinal direction with respect to x and y in response to deflection and compressive forces applied to the body portion 706. As shown, the multiple elongated members 704 include a common curvature extending from the center frame portion 702 of the frame 708 in the xy plane.

[0095] The closure device 700 may also include a membrane positioned on the frame 708. The closure device 700, combined with the center frame portion 702 and the plurality of elongated members 704 (the surface portion of the frame 708), can define the closure surface of the closure device 700 together. Furthermore, the center frame portion 702 and the plurality of elongated members 704 positioned in a common plane can enhance the attachment of the membrane 710 thereto. In some embodiments, the center frame portion 702 and the plurality of elongated members can be planar. Furthermore, the center frame portion 702 and the plurality of elongated members 704 (the surface portion of the frame 708) can have substantially uniform (closely adjacent) surfaces. The center frame portion 702 and the plurality of elongated members 704 can include equal and constant surfaces. Furthermore, the center frame portion 702 and the plurality of elongated members 704 can be formed without outward projections therefrom. In some embodiments, the center frame portion 702 and the plurality of elongated members 704 can include substantially equal thickness (with respect to the y-axis) across the surface portion 220. The center frame portion 702 and the multiple elongated members 704, having a substantially uniform surface or a surface without outward protrusions, can enhance the performance of the occlusion device 700 by reducing the opportunity for thrombus formation.

[0096] As shown, the membrane 710 can cover the center frame portion 702. The center frame portion 702 can be an opening in the frame 708 (for example, as shown in Figures 2-4 and 6A). The membrane 710 can cover or partially cover the center frame portion 702, closing off the surface portion of the frame 708. The membrane 710 can partially extend into the center frame portion 702 to provide sealing. Furthermore, the membrane 710 can be attached to the outer portion of the frame 700 to cover the entire frame 700 (for example, so that the frame 700, which may be made of nitinol, is not exposed to blood or tissue in a living organism).

[0097] As described above, the multiple elongated members 704 may be configured to reduce the movement of the center frame portion 702 and the multiple elongated members 704 longitudinally in response to deflection and compressive forces applied to the body portion 706. When the occlusion device 700 is implanted in a patient, the multiple elongated members 704 can help the frame 708's ability to adapt and conform to irregular tissue topography and / or dynamically changing tissue topography. Forces may be applied from the tissue topography and directed to one or more locations on the body portion 706. In one embodiment, this force is directed along the length of the body portion 706 toward the multiple elongated members 704, and the multiple elongated members 704 deform and absorb the applied force and balance and / or share the applied force at any point in the frame 708. In one embodiment, the occlusion device 700 can be positioned within the left atrial appendage (for example, as shown at the top of Figure 1B) to help prevent a thrombus from embolizing the left atrial appendage. After implantation, the occlusion device 700 fits into the left atrial appendage, and any forces applied through the left atrial appendage can be absorbed by the multiple elongated members 704. The multiple elongated members 704 maintain a planar occlusion surface in a common plane opposite the opening of the left atrial appendage. In response to forces applied to the body portion 706, the deflection of the multiple elongated members 704 maintains a substantially uniform surface (substantially planar and / or without protrusions) and closes the opening, helping to prevent a thrombus from embolizing the left atrial appendage without disturbing blood flow along the occlusion surface.

[0098] The bending or deflection maintained within a common plane (e.g., a plane) perpendicular to the positioned center frame portion 702 and the multiple elongated members 704 and the longitudinal axis 712 can provide structural stability for the membrane 710 when the occlusion device 700 is implanted. As mentioned above, thrombi can form along the surface of the occlusion device 700 due to heterogeneous surfaces that alter blood flow. As mentioned above, the center frame portion 702 and the multiple elongated members 704 can be uniform and free of protrusions. The absence of protrusions can also help reduce thrombus formation by not altering blood flow. Therefore, if the occlusion device does not maintain a planar and / or uniform surface, the patient may remain susceptible to blood coagulation and thrombus formation. If the frame supporting the membrane does not include a planar and / or uniform surface, the membrane may conform to a non-planar and / or heterogeneous surface, and provide a device with a heterogeneous surface or facet containing protrusions, which may alter blood flow across. As a result, the center frame portion 702 and the multiple elongated members 704 can enhance the structural stability of the membrane 710 and maintain a planar and / or uniform closure surface for the closure device 700.

[0099] In some embodiments, biocompatible materials are used for the membrane. In some embodiments, the membrane 710 may include fluoropolymers such as polytetrafluoroethylene (PTFE) polymer or stretched polytetrafluoroethylene (ePTFE) polymer. In some embodiments, the membrane 710 may be made of polyester, silicone, urethane, polyethylene terephthalate, or another biocompatible polymer, or a combination thereof. In some embodiments, bioabsorbable or bio-absorbable materials, such as bioabsorbable or bio-absorbable polymers, may be used. In some embodiments, the membrane 710 may include fluoropolymers such as those described in one or more of U.S. Patent No. 7,049,380, U.S. Patent No. 7,462,675, and U.S. Patent No. 8,048,440 (the contents of which are incorporated herein by reference). In some embodiments, the membrane 710 may include Dacron, polyolefin, carboxymethylcellulose cloth, polyurethane, or other woven or film elastomers. In some embodiments, the membrane 710 may include knitted fabrics or fibers. For example, in various embodiments including wire, the film 710 can be woven or nonwoven. In some embodiments, the film 710 can be a copolymer of fluoropolymers or a blend thereof.

[0100] In some embodiments, the membrane 710 is configured to be in, filter, regulate, or regulate a passage for fluids and / or materials (such as blood and / or thrombi) through the membrane 710. In some embodiments, the membrane 710 is configured to cause rapid tissue endothelial growth therein. In some embodiments, the membrane 710 provides a blood or body fluid impermeable membrane that blocks the flow of blood or body fluids through the membrane but promotes endothelial growth and endothelialization. The membrane 710 may have a microporous structure that provides a scaffold for tissue endothelial growth for durable occlusion and auxiliary anchoring strength of the occlusion device 700. In some embodiments, the membrane 710 is a porous membrane. The pores of the membrane 710 may be sized such that they help to obstruct the passage of blood, other body fluids, and embolus, substantially or, in some examples, completely. In some embodiments, the membrane 710 obstructs or substantially obstructs the passage of blood, other body fluids, thrombi, embolus, or other body material through the membrane 710.

[0101] In some embodiments, the membrane 710 is configured such that desired regulation of the passage of fluids and / or blood components through the membrane 710 is immediately and without thrombosis. 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 can be applied to the membrane 710 to improve its wetting and acoustic impermeability. In some embodiments, the membrane 710 may be modified with a chemical part that promotes one or more of the endothelial cell adhesion, endothelial cell migration, endothelial cell proliferation, and resistance to thrombus formation. In some embodiments, the membrane 710 may be modified with covalently bound heparin or impregnated with one or more drug substances that are released in vivo 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.

[0102] In some embodiments, the membrane 710 is pre-perforated to regulate flow rate through the membrane 710, generate filtration properties, and / or influence the tendency of internal tissue growth into the membrane 710. In some embodiments, part or all of the membrane 710 is treated to make the 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 the membrane 710. In some embodiments, the membrane 710 is treated to stiffen the membrane 710 or to add a surface texture. For example, in some embodiments, the membrane 710 is treated with fluorinated ethylene propylene (FEP) to provide a stiff membrane 710 or a textured surface on the membrane 710. Other membrane 710 material treatment techniques can also be used to provide beneficial mechanical properties and textures that respond to interactions. Such materials and techniques can be used in any of the occlusion devices provided herein.

[0103] In one embodiment, the membrane 710 conforms 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 between them (like a drum skin).

[0104] In some embodiments, the membrane 710 is attached to a selected area of ​​the frame 708 and not to other areas of the frame 708. This technique can, in some embodiments, facilitate enhanced fit of the occlusion device 700 to patient tissue topography and / or enhanced catheter loading at the implant site. In other embodiments, the membrane 710 is attached to all parts of the frame 708. In some embodiments, the membrane 710 can include folds, folds, curls, openings, corrugations, and the like. In other embodiments, folds, folds, or the like on the membrane 710 are avoided on the center frame portion 702 and the multiple elongated members 704, minimizing turbulence of blood flow across them as a result of their uniform surface. In some embodiments, the membrane 710 is an elastic member that can elastically expand and retract to adapt to the expandability and mounting of the frame 708. Such features and techniques can also be incorporated together with other embodiments of the occlusion device provided herein.

[0105] In some embodiments, the film 710 can be attached to the frame 708 using an adhesive. In some embodiments, FEP is used as the adhesive to attach the film 710 to the frame 708 or a portion thereof. For example, the FEP coating can be applied to some or all of the frame 708, and the FEP acts as a binding agent to bond the film 710 to the frame 708.

[0106] The components specifically described in Figure 7 are not intended to imply any limitations on the scope of use or functionality of the embodiments of the disclosed subject matter. The components specifically described are not to be understood as having any dependency or requirement related to any one component or combination of components specifically described therein. Furthermore, any one or more components described in any of Figure 7 may, in embodiments, be integrated with various other components described therein (and / or components not specifically described), all of which are considered to be within the scope of the disclosed subject matter. For example, the occlusion device 700 described with reference to Figure 7 may be used in conjunction with the delivery system 20 (shown in Figures 1A-B) instead of the occlusion device 30. Furthermore, the center frame portion 702 and the multiple elongated members 704 may be replaced with the center frame portion and multiple elongated members described with reference to Figures 2-4. Furthermore, the occlusion device 700 may include anchors (as shown, for example, in Figures 5A-B). Also, the center frame portion 702 may be replaced with the center frame portion 602 as shown in Figures 6A-B.

[0107] Figure 8 is a perspective view of another exemplary frame 800 for an occlusion device according to various embodiments of the present disclosure. The frame 800 may include a center frame portion 802 and a plurality of elongated members 804. The center frame portion 802 and the plurality of elongated members 804 are arranged in a common plane perpendicular to the longitudinal axis (not specifically described) of the frame 800.

[0108] The frame 800 also includes a portion 806 that is non-planar with respect to the center frame portion 802 and the plurality of elongated members 804. The plurality of elongated members 804 may include a common structure. As shown, the plurality of elongated members 804 include a zigzag pattern that acts as a spring element and absorbs and distributes forces applied to the frame 800. In response to forces applied to the frame 800, the plurality of elongated members 804 can increase the fatigue resistance of the frame 800 by functioning as stress-relieving properties that absorb transposition, bending and / or rotational forces and similar. The plurality of elongated members 804 are configured to deflect in a common plane and, in response to forces applied to the frame 800, mitigate the movement of the center frame portion 802 and the plurality of elongated members 804 in the longitudinal plane.

[0109] Figure 9A is a perspective view of another exemplary frame 900 for a shaped closure device according to various embodiments of the present disclosure. The frame 900 may include a center frame portion 902 and a plurality of elongated members 904. The center frame portion 902 and the plurality of elongated members 904 are arranged in a common plane perpendicular to the longitudinal axis (not specifically described) of the frame 900. As shown in Figure 9A, adjacent elongated members 904 of the plurality of elongated members 904 overlap. Each of the plurality of elongated members 904 includes a curve, and the plurality of elongated members 904 are arranged to provide an overlapping pattern shown, forming a common curve. The center frame portion 902 and the plurality of elongated members 904 can be considered to be arranged in a common plane, the common plane being bounded by the thickness of the center frame portion 902, and the plurality of elongated members 904 forming a surface of the frame 900.

[0110] The frame 900 also includes a body portion 906 that is non-planar with respect to the center 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 can function as spring elements and absorb forces applied to the frame 900. In response to forces applied to the frame 900, the plurality of elongated members 904 can increase the fatigue resistance of the frame 900 by functioning as stress-relieving properties that absorb transposition, bending and / or rotational forces and similar. The plurality of elongated members 904 are configured to deflect in a common plane and mitigate the longitudinal movement of the center frame portion 902 and the plurality of elongated members 904 in response to forces applied to the frame 900.

[0111] Figure 9B is a side view of the strut cut pattern 908 of the frame 900 shown in Figure 9A before it is deformed into a set shape, according to various embodiments of the present disclosure. Before forming the frame 900 into the set shape shown in Figure 9A, the strut cut pattern 908 can be formed by laser cutting a tube. As shown in Figure 9B, the strut cut pattern 908 includes a center frame portion 902, a plurality of elongated members 904, and a body portion 906. When forming the strut cut pattern 908 into the shape shown in Figure 9A, the body portion 906 can be arranged in an acorn shape, and adjacent pairs of the plurality of elongated members 904 can overlap each other as specifically illustrated by the arrows in Figure 9B.

[0112] Figure 10 shows an exemplary planar pattern 1000 that can be used to form a sheet material to create a frame for an occlusion device, according to various embodiments of the present disclosure. Nitinol sheet material can be used. The pattern 1000 forms an occlusion device frame without protrusions from the outer surface of the frame relative to the center frame portion 1004. The planar pattern 1000 can also be used to form a plurality of elongated members having curved portions corresponding to the material portion 1002 of the pattern 1000. The boundary 1006 shown in Figure 10 can correspond to the boundary of the surface portion of the frame for the occlusion device.

[0113] The planar pattern 1000 in Figure 10 can be used to form multiple elongated members corresponding to material portions 1002 of the pattern 1000, including, for example, curved portions (and other nonlinear shapes). Such curved portions can be directed to increase fatigue resistance by providing elements such as, but not limited to, stress relaxation properties, portions designed to absorb transposition, bending and / or rotational forces and the like, and combinations of such features. The planar pattern 1000 can also be used to form occlusion device frames. Thus, by cutting sheet material using the planar pattern and by using the techniques described above, a wide range of occlusion device frame design features can be achieved.

[0114] Figure 11 shows another exemplary planar pattern 1100 that can be used to form a sheet material to create a frame for an occlusion device, according to various embodiments of the present disclosure. The pattern 1100 results in an occlusion device frame without protrusions from the outer surface of the frame with respect to the center frame portion 1104. The planar pattern 1100 can also be used to form elongated branch members having curved portions corresponding to the material portion 1102 of the pattern 1100. The boundary 1106 shown in Figure 10 can correspond to the boundary of the surface portion of the frame for the occlusion device.

[0115] For example, the planar pattern 1100 in Figure 11 can be used to form multiple elongated members corresponding to parts of the pattern 1100 that include wavy portions (and other nonlinear shapes). Such wavy portions can be directed to increase fatigue resistance by providing elements such as, but not limited to, stress relaxation properties, portions designed to absorb transposition, bending and / or rotational forces and the like, and combinations of such features. Thus, by cutting sheet material using planar patterns and by using the techniques described above, a wide range of features for closed device frame designs can be achieved.

[0116] Figure 12 is a top view of an exemplary center frame portion 1202 that may be included with an occlusion device in various forms of the present disclosure. The center frame portion 1202 does not protrude from the outer surface defined by the frame 1200. Rather, the frame material defining the center frame portion 1202 is coplanar with the outer surface defined by the frame 1200. In one embodiment and as shown, the center frame portion 1202 is a hole having an inner and outer circumference, and a plurality of elongated members 1204 extend radially outward from the outer circumference of the center frame portion 1202. Thus, the frame 1200 includes the center frame portion 1202, while not initiating or contributing to turbulence of bio-flow and / or potential for thrombus formation.

[0117] In some embodiments, the center frame portion 1202 provides attachment sites where delivery and / or recovery devices (e.g., catheters and similar) can be used to releasably connect to the frame 1200. In some embodiments, the center frame portion 1202 defines a circular through hole (as shown). In some embodiments, the center frame portion 1202 defines structural features having different shapes, including but not limited to oval, square, rectangular, triangular, keyhole, kidney, and similar, and combinations thereof. In some embodiments, the center frame portion 1202 may include or define threads, one or more keyholes, tabs, deformable elements, and similar, and combinations thereof.

[0118] In some embodiments, additional structures on the interior side of the frame 1200 may be added in areas of the center frame portion 1202 that can be used for releasable adhesion to the delivery and / or recovery device. For example, a collar (or other physical member, e.g., a coiled member, socket, screw-in, etc.) extending from the center frame portion 1202 to the tip may be included in or will be inside the frame 1200, while maintaining a uniform external surface of the frame 1200. Such a collar may have a variety of physical shapes and features as desired to facilitate releasable adhesion to the delivery and / or recovery device. In some embodiments, the absence of through holes is included as part of the occlusion device frame 1200. Such features and techniques are also incorporated together with other embodiments of the occlusion device provided herein.

[0119] The components specifically described in Figures 13–18 are not intended to imply any limitations on the scope of use or functionality of the embodiments of the disclosed subject matter. Figures 13–18 describe and show alternative body portions that may be arranged with one or more of the above-described face portions (e.g., face portions 220, 300, 400, 502a, 502b). The components specifically described should not be understood as having any dependency or requirement related to any one component or combination of components specifically described herein. Furthermore, any one or more of the components described in Figures 13–18 may, in embodiments, be integrated with various other components described therein (and / or components not specifically described), all of which are considered to be within the scope of the disclosed subject matter.

[0120] Figure 13 is a perspective view of alternative designs for an exemplary frame 1300 for an occlusion device according to various embodiments of the present disclosure. The frame 1300 includes a first set of cells 1302 and a second set of cells 1304. The first set of cells 1302 and the second set of cells 1304 may be substantially diamond-shaped. As further shown, the first set of cells 1302 and the second set of cells 1304 may overlap each other longitudinally to form the frame 1300. The first set of cells 1302 and the second set of cells 1304 may contain equal areas, or one of the first set of cells 1302 and the second set of cells 1304 may have a larger area than the other of the first set of cells 1302 and the second set of cells 1304.

[0121] The frame 1300 may also include a surface portion 1306. The surface portion 1306 may include a center frame portion 1308 and a plurality of elongated members 1310. As described above with reference in detail to Figures 2-5, the plurality of elongated members 1310 can increase the fatigue resistance of the frame 1300 by functioning as stress-relieving properties that absorb transposition, bending and / or rotational forces, and similar forces, in response to forces applied to the first set of cells 1302 and / or the second set of cells 1304. Thus, the plurality of elongated members 1310 may be configured to bend or deflect substantially in a plane, and the plurality of elongated members 1310 and the center frame portion 1308 are arranged 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 cells 1302 and / or the second set of cells 1304.

[0122] The components specifically described in Figure 13 are not intended to imply any limitations on the scope of use or functionality of the embodiments of the disclosed subject matter. Nor should the specifically described components be understood as having any dependency or requirement relating to any one component or combination of components specifically described herein. In some embodiments, for example, surface portions 220, 300, 400, 502a, or 502b may be incorporated instead of surface portion 1306.

[0123] Figure 14 is a perspective view of another exemplary alternative design for a frame 1400 for an occlusion device, according to various embodiments of the present disclosure. The frame 1400 may include a body portion 1408 and a face portion 1406 used to close off a target site within which a body portion 1408 is implanted. As shown, the body portion 1408 may be made of multiple struts or wires braided together.

[0124] The surface portion 1406 may include a center frame portion 1404 and a plurality of elongated members 1402. As described in detail with reference to Figures 2-5, the plurality of elongated members 1402 can increase the fatigue resistance of the frame 1400 by functioning as stress-relieving properties that absorb transposition, bending and / or rotational forces and similar forces in response to forces applied to the body portion 1408. Thus, the plurality of elongated members 1402 may be configured to bend or deflect substantially in a plane, and the plurality of elongated members 1402 and the center frame portion 1404 may be arranged to mitigate the longitudinal movement of the surface portion 1406 substantially outward from the plane in response to forces applied to one or more portions of the body portion 1408.

[0125] The components specifically described in Figure 14 are not intended to imply any limitations on the scope of use or functionality of the embodiments of the disclosed subject matter. Nor should the specifically described components be understood as having any dependency or requirement relating to any one component or combination of components specifically described herein. In some embodiments, for example, surface portions 220, 300, 400, 502a, or 502b may be incorporated instead of surface portion 1406.

[0126] Figure 15 is a perspective view of another exemplary alternative design for a frame 1500 for an occlusion device, according to various embodiments of the present disclosure. The frame 1500 may include a body portion 1508 and a face portion 1506 used to close off a target site within which a body portion 1508 is implanted. As shown, the body portion 1508 may be in a cylindrical shape formed by a plurality of struts or wires having diamond-shaped cells containing substantially equal areas.

[0127] The surface portion 1506 may include a center frame portion 1504 and a plurality of elongated members 1502. As described in detail above with reference to Figures 2-5, the plurality of elongated members 1502 can increase the fatigue resistance of the frame 1500 by functioning as stress-relieving properties that absorb transposition, bending and / or rotational forces and similar forces in response to forces applied to the body portion 1508. Thus, the plurality of elongated members 1502 may be configured to bend or deflect substantially in a plane, and the plurality of elongated members 1502 and the center frame portion 1504 are arranged to mitigate the longitudinal movement of the surface portion 1506 substantially outward from the plane in response to forces applied to one or more portions of the body portion 1508.

[0128] The components specifically described in Figure 15 are not intended to imply any limitations on the scope of use or functionality of the embodiments of the disclosed subject matter. Nor should the specifically described components be understood as having any dependency or requirement relating to any one component or combination of components specifically described herein. In some embodiments, for example, surface portions 220, 300, 400, 502a, or 502b may be incorporated instead of surface portion 1506.

[0129] Figure 16 is a perspective view of an alternative design for another exemplary frame 1600 for an occlusion device, according to various embodiments of the present disclosure. The frame 1600 may include a body portion 1608 and a face portion 1606 used to close off a target site in which a body portion 1608 is implanted. As shown, the body portion 1608 may be formed by a cylindrical shape formed by a plurality of struts or wires having a plurality of rows having a zigzag formation around the body portion 1608.

[0130] The surface portion 1606 may include a center frame portion 1604 and a plurality of elongated members 1602. As described in detail above with reference to Figures 2-5, the plurality of elongated members 1602 can increase the fatigue resistance of the frame 1600 by functioning as stress-relieving properties that absorb transposition, bending and / or rotational forces and similar forces in response to forces applied to the body portion 1608. Thus, the plurality of elongated members 1602 may be configured to bend or deflect substantially in a plane, and the plurality of elongated members 1602 and the center frame portion 1604 may be arranged to mitigate the longitudinal movement of the surface portion 1606 substantially outward from the plane in response to forces applied to one or more portions of the body portion 1608.

[0131] The components specifically described in Figure 16 are not intended to imply any limitations on the scope of use or functionality of the embodiments of the disclosed subject matter. Nor should the specifically described components be understood as having any dependency or requirement relating to any one component or combination of components specifically described herein. In some embodiments, for example, surface portions 220, 300, 400, 502a, or 502b may be incorporated instead of surface portion 1606.

[0132] Figure 17 is a perspective view of an alternative design for another exemplary frame 1700 for an occlusion device, according to various embodiments of the present disclosure. The frame 1700 may include a body portion 1708 and a face portion 1706 used to close off a target site in which a body portion 1708 is implanted. As shown, the body portion 1708 may be in a cylindrical shape formed by a plurality of struts or wires having substantially diamond-shaped cells containing substantially different regions in each row.

[0133] The surface portion 1706 may include a center frame portion 1704 and a plurality of elongated members 1702. As described in detail above with reference to Figures 2-5, the plurality of elongated members 1702 can increase the fatigue resistance of the frame 1700 by functioning as stress-relieving properties that absorb transposition, bending and / or rotational forces and similar forces in response to forces applied to the body portion 1708. Thus, the plurality of elongated members 1702 may be configured to bend or deflect substantially in a plane, and the plurality of elongated members 1702 and the center frame portion 1704 are arranged 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 body portion 1708.

[0134] The components specifically described in Figure 17 are not intended to imply any limitations on the scope of use or functionality of the embodiments of the disclosed subject matter. Nor should the components specifically described be understood as having any dependency or requirement relating to any one component or combination of components specifically described herein. In some embodiments, for example, surface portions 220, 300, 400, 502a, or 502b may be incorporated instead of surface portion 1706.

[0135] Figure 18 is a perspective view of another exemplary alternative design for a frame 1800 for an occlusion device, according to various embodiments of the present disclosure. The frame 1800 may include a body portion 1808 and a face portion 1806 used to close off a target site within which a body portion 1808 is implanted. As shown, the body portion 1808 may be formed by a plurality of struts or wires forming a diamond-shaped row.

[0136] The surface portion 1806 may include a center frame portion 1804 and a plurality of elongated members 1802. As described in detail above with reference to Figures 2-5, the plurality of elongated members 1802 can increase the fatigue resistance of the frame 1800 by functioning as stress-relieving properties that absorb transposition, bending and / or rotational forces and similar forces in response to forces applied to the body portion 1808. Thus, the plurality of elongated members 1802 may be configured to bend or deflect substantially in a plane, and the plurality of elongated members 1802 and the center frame portion 1804 may be arranged to mitigate the longitudinal movement of the surface portion 1806 substantially outward from the plane in response to forces applied to one or more portions of the body portion 1808.

[0137] The components specifically described in Figure 18 are not intended to imply any limitations on the scope of use or functionality of the embodiments of the disclosed subject matter. Nor should the specifically described components be understood as having any dependency or requirement relating to any one component or combination of components specifically described herein. In some embodiments, for example, surface portions 220, 300, 400, 502a, or 502b may be incorporated instead of surface portion 1806.

[0138] In general, some embodiments of occlusion devices provided herein have been observed to be more conforming (less rigid) than commercially available occlusion devices. Such enhanced conformability can provide several exemplary benefits, including better sealing (more consistent contact between the occlusion device and the surrounding tissue), improved fatigue resistance, less trauma to the patient, and a more stable position. It can also be said that the embodiments of occlusion devices provided herein are not designed to "force" tissue to conform to the occlusion device. Rather, occlusion devices are generally intended to conform themselves to the natural topography of the surrounding tissue.

[0139] We have found that certain embodiments of the occlusion devices provided herein are more likely to be recaptured and reloaded into the delivery sheath without damaging the surrounding tissue. For example, in some embodiments, the anchor member of the occlusion device can be more eccentric during recapture and reloading. Furthermore, in some embodiments, the anchor 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 devices provided herein can be removed from the tissue essentially without trauma.

[0140] The anchors of the occlusion devices provided herein provide a stable in vivo position while being able to eccentrically shift without trauma during recapture and reloading. Several geometric parameters of the anchors are significant with respect to resistance to movement. Such factors include the angle and number of the anchor tips on the occlusion device, and the length, width, and thickness of the tips of the longitudinal anchor members.

[0141] The effectiveness of LAA occlusion can be assessed by contrast injection and color flow Doppler during transesophageal echocardiography (TEE). Contrast injection is procedurally used primarily to assess the location of the occlusion device relative to surrounding tissue, but is also used to indicate signs of LAA occlusion. Fluoroscopy is performed to quantify the size of the leak as the contrast agent passes through the occluder; however, the maximum diameter of the leak may be difficult to assess using this method. Color flow Doppler is the preferred method for measuring the leak passing through the LAA occluder. The TEE probe position is changed until the maximum leak is observed. Images are captured, and the leak measurement is performed on a TEE workstation. "Substantial occlusion" and "substantial occlusion" in light of TEE mean that there is no distinguishable flow through or around the occlusion device.

[0142] This application claims priority to Provisional Patent Application No. 62 / 161,742, filed on 14 May 2015 (which is incorporated herein in its entirety by reference). More specifically, Figures 1–29 of Provisional Patent Application No. 62 / 161,742 are specifically incorporated herein for illustrative purposes of occlusion devices and their embodiments, and for teaching and related structural embodiments thereof.

[0143] With respect to the scope of measurement (such as that disclosed immediately above), the terms used herein may be used interchangeably with respect to measurements that include the stated measurements and any measurements that are reasonably close to the stated measurements, but which may differ by a reasonably small amount, such as due to measurement errors, differences in measurements and / or calibration of manufacturing equipment, human error in reading and / or setting of measurements, adjustments made to optimize performance and / or structural parameters in consideration of differences in measurements related to other components, special implementation scenarios, improper adjustment and / or handling of the object by person or machine, and / or similar, and which would be understood by an individual with the usual skills in the relevant art and easily verifiable.

[0144] Several implantable occlusion device and frame configurations are described herein. Naturally, one or more features described in reference to a particular device can be combined with one or more features of any other device or multiple devices described herein. In other words, the occlusion device and frame configurations described herein can be mixed and combined to provide configurations of hybrid occlusion devices and device frames, and such configurations of hybrid occlusion devices and device frames are within the scope of this disclosure. In some examples, one or more features described in reference to a particular device or frame can replace or substitute one or more features of another device or frame. In some examples, one or more features described in reference to a particular device or frame can be added to or included with another device or frame. Furthermore, various combinations or quasi-combinations of any of the features described herein can generally be used with any of the devices or frames described herein. Naturally, the occlusion devices and occlusion device frames provided herein are scalable to a wide range of sizes, and the occlusion devices can be used in various different biostructures, implant sites, and in various implementations.

[0145] Several characteristic features and advantages, including various alternatives, along with details of the structure and function of the device and / or method, are described above. The disclosure is intended to be specific and not exhaustive. It will be apparent to those skilled in the art that various modifications can be made, particularly with respect to the structure, materials, elements, components, shape, size, and arrangement of parts, including combinations within the principles described herein, up to the full extent indicated by the broad, general meaning of the terms as expressed in the accompanying claims. These various modifications are intended to be encompassed therein, to the extent that they take the spirit and scope of the accompanying claims as their starting point. All references, publications, and patents described herein, including figures and accompanying drawings, are incorporated by reference to all of them.

Claims

1. A device for placement in blood vessels, accessory organs, and openings within the body, The device described above, A single self-extending frame having a proximal terminal, a distal terminal, and a longitudinal axis, A membrane attached to the single self-expanding frame, Includes, The single self-extending frame includes a face portion and a body portion, The surface portion has a pre-assembled planar shape, (i) a center frame portion located at the proximal end, and (ii) a plurality of elongated members extending from the center frame portion. A device wherein the plurality of elongated members are configured to bend or flex substantially in a plane perpendicular to the longitudinal axis, and to reduce the longitudinal movement of the surface portion in response to a compressive force applied to the body portion of the single self-extending frame.

2. The device according to claim 1, wherein the center frame portion is a hole having an inner circumference and an outer circumference, and the plurality of elongated members extend radially outward from the outer circumference of the center frame portion.

3. The device according to claim 2, wherein the center frame portion further includes a plurality of arcs arranged around the inner circumference of the center frame portion.

4. The device according to any one of claims 1 to 3, wherein the thickness of the plurality of elongated members with respect to the vertical axis is substantially equal to the thickness of the center frame portion with respect to the vertical axis.

5. The device according to any one of claims 1 to 4, wherein the center frame portion and the plurality of elongated members are arranged in a first plane substantially perpendicular to the vertical axis.

6. The device according to any one of claims 1 to 5, comprising an occlusive material configured such that the membrane obstructs the passage of fluid and the passage of blood clots therein.

7. The device according to claim 6, wherein the film is attached to the frame using an adhesive.

8. The device according to any one of claims 1 to 5, comprising a semi-occluding material configured such that the membrane obstructs the passage of a thrombus while partially allowing a fluid passage through it.

9. The device according to claim 8, wherein the semi-occluding material includes stretched polytetrafluoroethylene (ePTFE).

10. The device according to any one of claims 1 to 9, wherein the single self-extending frame further includes a transition portion disposed between the plurality of elongated members and the body portion, and the transition portion includes a curve that moves the plurality of elongated members toward the body portion.

11. The device according to any one of claims 1 to 10, wherein the single self-expanding frame is made of a cut tube, and the center frame portion is flattened from the cut tube.

12. The device according to any one of claims 1 to 10, wherein the single self-extending frame is made of a flat sheet.

13. The device according to any one of claims 1 to 12, wherein the plurality of elongated members include a first curved portion, a second curved portion, a third curved portion, a first inflection point between the first curved portion and the second curved portion, and a second inflection point between the second curved portion and the third curved portion.

14. The device according to claim 13, wherein the first curved portion and the third curved portion include curvature in a first direction, the second curved portion includes curvature in a second direction, and the first direction is opposite to the second direction.

15. The device according to any one of claims 1 to 14, wherein the surface portion and the body portion include a first shape without compressive force and a second shape 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 shapes.

16. The device according to any one of claims 1 to 15, wherein the surface portion includes a surface that does not have any outward projections from the surface portion relative to the proximal end.

17. The device according to any one of claims 1 to 16, wherein the center frame portion is configured to provide an attachment point for delivery of the device.

18. The device according to any one of claims 1 to 17, wherein the body portion includes a first tapered portion and a second tapered portion, the circumference of the first tapered portion decreases by a first proportion, the circumference of the second tapered portion decreases by a second proportion, and the first proportion is smaller than the second proportion.

19. The device according to any one of claims 1 to 18, wherein the body portion further includes a plurality of anchors, and each of the plurality of anchors includes an anchor portion and an arm.

20. The plurality of anchors include a first group of anchors and a second group of anchors, the arms of the first group of anchors include a first length, the arms of the second group of anchors include a second length, and the second length is greater than the first length, and The device according to claim 19, wherein the anchor portions of the first group of anchors are positioned at a first height relative to the distal end, the anchor portions of the second group of anchors are positioned at a second height relative to the distal end, and the first height is greater than the second height.

21. A device for placement in internal blood vessels, accessory organs, and openings having an elongated shape and an arranged shape, The device described above, A cut tube frame of nitinol having a proximal end and a distal end, The membrane attached to the cut tube frame of Nitinol, Includes, The cut tube frame of Nitinol includes a face portion and a body portion, The surface portion comprises a center frame portion including a plurality of arcs arranged at the proximal end and around the center frame portion, and a plurality of elongated members extending from the center frame portion. A device in which the center frame portion and the plurality of elongated members form a substantially uniform surface, and the center frame portion is configured to provide an attachment point for a delivery system for the device.

22. The device according to claim 21, wherein the center frame portion has a thickness substantially equal to the thickness of the plurality of elongated members.

23. The device according to claim 21 or 22, wherein the surface portion includes a surface without protrusions to the outside of the surface portion.

24. The device according to any one of claims 21 to 23, wherein the cut tube frame of nitinol includes a hubless surface portion.

25. The device according to any one of claims 21 to 24, wherein the body portion further includes a plurality of anchors, and each of the plurality of anchors includes an anchor portion and an arm.

26. The device according to any one of claims 21 to 25, wherein the cut tube frame of nitinol includes a longitudinal axis, and the plurality of elongated members are configured to substantially flex or bend in a plane perpendicular to the longitudinal axis, and in response to a compressive force applied to the body portion of the cut tube frame of nitinol, the longitudinal movement of the face portion is reduced.

27. The device according to any one of claims 21 to 26, wherein the plurality of elongated members include a first curved portion, a second curved portion, a third curved portion, a first inflection point between the first curved portion and the second curved portion, and a second inflection point between the second curved portion and the third curved portion.

28. The device according to any one of claims 21 to 27, wherein the plurality of arcs are arranged around the center frame portion, configured to distribute strain around the center frame portion when transitioning between the elongated shape and the arranged shape.

29. A method to reduce thrombus formation in the treatment of a patient's left atrial appendage, The transcatheter assembly is positioned through the small opening in the left atrial appendage, The device is to be placed from the transcatheter assembly, wherein the device is A single self-extending frame having a proximal terminal, a distal terminal, and a longitudinal axis, A membrane attached to the single self-expanding frame, Includes, The single self-extending frame includes a center frame portion located at the proximal end and a surface portion having a plurality of elongated members extending from the center frame portion, and a body portion positioned substantially perpendicular to the surface portion, wherein the surface portion and the membrane define the closing surface of the device, and are arranged accordingly. By absorbing one or more forces from the left atrial appendage, the plurality of elongated members in a plane perpendicular to the vertical axis are bent, thereby reducing and absorbing the vertical movement of the surface portion in response. Methods that include...

30. The method according to claim 29, comprising absorbing one or more forces from the left atrial appendage to reduce thrombus formation by substantially maintaining a planar occlusion surface.

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