Left atrial appendage occluder hook placement

Abstract

A left atrial appendage (“LAA”) occluder may include a leaflet having a proximal end, a distal end, and an intermediate portion therebetween, the proximal and distal ends defining a proximal and a distal surface of the leaflet, respectively, the leaflet having an expanded, unbiased state and a collapsed, delivery state. A plurality of stabilizing wires may be attached to the leaflet, each stabilizing wire having a hook at its distal end, each hook having an end positioned radially lateral to the leaflet in the expanded state and configured to frictionally engage tissue of the LAA. In the expanded state of the leaflet, each hook has a distal endpoint positioned at a spaced axial distance from the distal surface of the leaflet at a distance between approximately 0 mm and approximately 1.5 mm.

Description

Cross-references to related applications

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 569,321, filed March 25, 2024, the contents of which are incorporated herein by reference. Background Technology

[0002] An occluder is a medical device used to treat (e.g., block) tissue at a target site within the body, such as a malformation, blood vessel, organ, opening, chamber, passage, orifice, lumen, or tube. For example, an occluder can be used for left atrial appendage (“LAA”) closure. The LAA is a normal anatomical structure consisting of a sac within the muscular wall of the left atrium. When a patient experiences atrial fibrillation (“AFib”), a blood clot can form within the LAA, which may break off and enter the bloodstream. By occluding the LAA, the amount of blood clot released from the LAA can be significantly reduced, if not completely eliminated. Various techniques have been developed for LAA occlusion. For example, balloon-shaped devices configured for complete implantation within the cavity of the LAA have been developed, as well as surgical techniques that involve inverting the cavity of the LAA and closing it surgically. Summary of the Invention

[0003] According to one aspect of this disclosure, an occluder for occluding the left atrial appendage (“LAA”) may include a leaflet sized and shaped for positioning within the LAA, the leaflet having a proximal end defining a proximal surface of the leaflet, a distal end defining a distal surface of the leaflet, and an intermediate portion connecting and extending between the proximal and distal ends of the leaflet, wherein the leaflet has an expanded state without applied force and a collapsed state for delivery to the LAA. The occluder may include a plurality of stabilizing lines coupled to the leaflet, each of the plurality of stabilizing lines having a hook at its distal end, each hook having an end positioned radially lateral to the leaflet in the expanded state, and each hook being configured to frictionally engage tissue of the LAA. In the expanded state of the leaflet, each hook may have a distal end point, the distal end point of each hook being positioned at a spaced axial distance from the distal surface of the leaflet in the expanded state, the spaced axial distance being between about 0 mm and about 1.5 mm. The spaced axial distance may be about 1.0 mm. The transition between the intermediate portion and the distal end of the leaflet can be curved, and the curvature of the transition can have a profile length measured between (i) the point where the distal end of the intermediate portion connects to the proximal end of the curved transition and (ii) the point where the distal end of the curved transition connects to the distal surface of the leaflet. In the expanded state of the leaflet, the hook can cross from the interior to the exterior of the leaflet at the intersection point, which is located between approximately 25% and approximately 50% of the profile length. The radius of curvature of the transition can be between approximately 0.075 inches (1.905 mm) and approximately 0.125 inches (3.175 mm). The occluder can include a disc at the proximal end of the occluder, and a connecting member can connect the disc and the leaflet. In the compressed state of the leaflet, a valley can be formed within the intermediate portion of the leaflet, and in the compressed state, the hook can extend radially outward from the central longitudinal axis of the leaflet beyond any structure of the leaflet.

[0004] According to another aspect of this disclosure, an occluder for occluding the left atrial appendage (“LAA”) may include a leaflet sized and shaped for positioning within the LAA, the leaflet having a proximal end defining a proximal surface of the leaflet, a distal end defining a distal surface of the leaflet, and an intermediate portion connecting and extending between the proximal and distal ends of the leaflet, wherein the leaflet has an expanded state without applied force and a collapsed state for delivery to the LAA. A plurality of stabilizing lines may be coupled to the leaflet, each of the plurality of stabilizing lines having a hook at its distal end, each hook having an end positioned radially outward of the leaflet in the expanded state, and each hook being configured to frictionally engage tissue of the LAA. The transition between the intermediate portion and the distal end of the leaflet may be curved, the curvature of the transition having a profile length measured between (i) the point where the distal end of the intermediate portion connects to the proximal end of the curved transition and (ii) the point where the distal end of the curved transition connects to the distal surface of the leaflet. In the expanded state of the leaflet, the hooks can cross from the inside to the outside of the leaflet at an intersection point, which is located between approximately 25% and approximately 50% of the profile length. In the expanded state of the leaflet, the intersection point can be located between approximately 25% and approximately 40% of the profile length. In the expanded state of the leaflet, the intersection point can be located between approximately 30% and approximately 35% of the profile length. In the expanded state of the leaflet, each hook can have a distal end point, which is positioned at a spaced axial distance from the distal surface of the leaflet in the expanded state, the spaced axial distance being approximately 1 mm. The radius of curvature of the transition section can be between approximately 0.075 inches (1.905 mm) and approximately 0.125 inches (3.175 mm). The occluder may include a disc at the proximal end of the occluder, and a connecting member can connect the disc and the leaflet. Under compressed conditions, a valley can be formed within the middle portion of the leaflet, and under compressed conditions, the hook can extend radially outward from the central longitudinal axis of the leaflet further than any structure of the leaflet.

[0005] According to another aspect of this disclosure, a method for occluding the left atrial appendage (“LAA”) may include positioning an occluder in a collapsed state within a delivery catheter. The occluder may include a leaflet having a proximal end defining a proximal surface of the leaflet, a distal end defining a distal surface of the leaflet, and an intermediate portion connecting and extending between the proximal and distal ends of the leaflet. The occluder may also include a plurality of stabilizing lines coupled to the leaflet, each of the plurality of stabilizing lines having a hook at its distal end. The method may further include advancing the occluder into or adjacent to the LAA as the occluder collapses within the delivery catheter. The method may further include converting the leaflet to a partially dilated state, wherein the distal end of the leaflet has exited the delivery catheter and has begun self-dilation, while the proximal end of the leaflet remains collapsed within the delivery catheter. When the leaflet is in the partially dilated state, the hook may contact the tissue of the LAA. After contacting the hook with the tissue of the LAA, the occluder can be fully deployed from the delivery catheter. Between the partial dilation of the leaflet and the full deployment of the occluder from the delivery catheter, the hook can maintain tissue contact with the LAA. After the occluder is fully deployed from the delivery catheter, compression of the leaflet by the tissue from the LAA can form a valley within the middle portion of the leaflet. The hook can maintain tissue contact with the LAA while the valley is formed within the middle portion of the leaflet. Full deployment of the occluder from the delivery catheter may include a disc that deploys from the delivery catheter, the disc being connected to the leaflet of the occluder via a connecting member. After deployment of the disc, the disc can at least partially cover the opening of the LAA. Attached Figure Description

[0006] Figure 1 illustrates a plugging device according to the prior art.

[0007] Figure 2 illustrates the flaps of the occluder of Figure 1 in an expanded, overcompressed state, with the disk of the occluder outside the view of Figure 2.

[0008] Figure 3 illustrates the occluder that unfolds in the middle of Figure 1.

[0009] Figure 4 This is a schematic diagram of the conveying system according to this disclosure.

[0010] Figure 5 and Figure 6 These are illustrations and pictures of side views of exemplary embodiments of a medical device including an arcuate leaflet according to the present disclosure.

[0011] Figure 7 The illustration shows a state of expansion and overcompression. Figures 5 to 6 The leaflets of the occluder, in which the disc of the occluder is located Figure 7 Outside of the view.

[0012] Figure 8 The diagram shows... Figures 5 to 6 The sealing device unfolds in the middle.

[0013] Figure 9 yes Figures 5 to 6 A magnified view of a portion of the valve leaflet of the occluder.

[0014] Figure 10 yes Figures 5 to 6 A standalone view of an example of the stabilization line of a plug.

[0015] Figure 11 Is using Figures 5 to 6 A flowchart illustrating an exemplary method for using medical devices to block a patient's LAA.

[0016] Figure 12 It is manufacturing Figures 5 to 6 A flowchart of an exemplary method for a medical device. Detailed Implementation

[0017] LAA closure procedures using transcatheter occluders typically require precise deployment of the occluder into highly variable anatomical features. LAA structures can vary considerably from patient to patient. For example, LAA structures can differ in diameter, length, orientation, number of leaflets, ellipticity, and bending angle. At least in part due to this variability, determining the appropriate size of a self-expanding transcatheter occluder device for LAA closure can be particularly difficult.

[0018] While the appropriate size of the occluder for a particular patient's laminar flow area (LAA) can be estimated, a true assessment of the occluder's fit in the LAA cannot be determined until the occluder is actually implanted. If an incorrect occluder size is selected, the occluder may not fit properly in the LAA, or it may not anchor correctly within the LAA. This could lead to occluder embolization or require retrieval and implantation of another occluder of a different size. Therefore, the expectation of occluder devices that function well across a wider range of anatomy reduces the importance of selecting the correct occluder size for a particular patient.

[0019] Additionally, when deploying a self-expanding transcatheter occluder from the delivery device, the stability of the occluder during deployment can be a significant factor in accurately placing the occluder within the LAA. Therefore, occluder devices capable of engaging with the LAA tissue relatively early during deployment are desirable to help stabilize the occluder in the desired position within the LAA before full deployment.

[0020] This disclosure generally relates to medical devices used in the human body. Specifically, this disclosure relates to an occlusion device having a hook placement and frame profile that allows for enhanced stability of the occluder during deployment, and the ability of a particular size occluder to operate within a wide range of anatomical structures.

[0021] The disclosed embodiments can lead to more consistent and improved patient outcomes. However, it is contemplated that the features and methods described in this disclosure as presented herein can be incorporated into any number of systems, as understood by those skilled in the art based on this disclosure.

[0022] Although exemplary embodiments of the medical device are described as treating target sites including LAAs, it should be understood that the use of the term "target site" is not intended to be limiting, as the medical device can be configured to treat any target site located anywhere in the body (e.g., malformations, blood vessels, organs, openings, cavities, passages, orifices, lumens, etc.). As used herein, the term "vascular system malformation" is not intended to be limiting, as the medical device can be configured to bridge or otherwise support various vascular system malformations. For example, a vascular system malformation can be any malformation that affects the shape of a natural lumen (e.g., atrial septal defect, lesion, vascular dissection, or tumor). Embodiments of the medical device can be used, for example, to occlude, patent foramen ovale ("PFO"), atrial septal defect ("ASD"), ventricular septal defect ("VSD"), or patent ductus arteriosus ("PDA"), as described above. Furthermore, the term "lumen" is not intended to be limiting, as vascular system malformations can reside in various locations within the vascular system (e.g., blood vessels, arteries, veins, passages, organs, lumens, etc.). As used herein, the term "proximal" refers to the portion of the medical device or delivery device that is closest to the operator when the medical device is being used as intended, and the term "distal" refers to the portion of the medical device or delivery device that is furthest from the operator at any given time while the medical device is being delivered by the delivery device. Furthermore, the terms "unfolding" and "implanting" are used interchangeably herein.

[0023] Some embodiments of this disclosure provide an improved percutaneous catheter-guided endovascular occlusion device for use within a patient's vascular system (e.g., blood vessels, channels, lumens, orifices or cavities through tissue, etc., such as ASD). Other physiological conditions exist within the human body in which occlusion of blood vessels or other channels is also necessary to prevent blood from flowing into or through them. These device embodiments can be used at any location within a vascular system whose anatomical conditions are suitable for its design.

[0024] Medical devices may include one or more layers of occlusive material, each layer of which may include any material configured to substantially block or occlude blood flow in order to promote blood clot formation. As used herein, “substantially block or occlude flow” should functionally mean that blood flow may occur for a short period of time, but the body’s clotting mechanisms or proteins or other bodily deposits on the occlusive material cause occlusion or cessation of flow after that initial period of time.

[0025] Some embodiments of this disclosure may be formed from a plurality of lines having a predetermined relative orientation with respect to each other. However, it should be understood that, according to other embodiments of this disclosure, the medical device may be formed from a tube etched or laser-cut, or the device may include a plurality of slices of sealing material or tubular members joined together to a scaffold structure.

[0026] The present disclosure will now be described more fully with reference to the accompanying drawings, in which some embodiments of the invention are shown, but not all embodiments. In fact, the present disclosure may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that the disclosure will satisfy applicable legal requirements. The same numerals throughout the text refer to the same elements.

[0027] In at least one known medical device for occlusion of deformities, such as the medical device 50 shown in FIG. 1, the medical device 50 includes a proximal end 52 and a distal end 54, having a disc 56 at the proximal end 52 and a leaflet 58 at the distal end 54. The leaflet 58 has a proximal edge 60 (also referred to as the proximal side), a distal edge 62 (also referred to as the distal side), and an intermediate or central portion 64 defining a cavity 66 (“intermediate portion” and “central portion” are used interchangeably herein). The medical device 50 also includes a stabilizing line 68 (which may be alternatively referred to herein as an anchor) fixed to a radially outer or circumferential surface of the intermediate portion 64. The stabilizing line 68 terminates in a hook 70 at its free end, thereby helping to hold the medical device 50 at the target site and preventing the medical device 50 from displaced from the target site upon deployment.

[0028] In this known medical device 50, a proximal edge 60 and a distal edge 62 are connected to an intermediate portion 64 at a first relatively sharp (e.g., non-arc) transition 72 and a second sharp transition 74, respectively. The first transition 72 connects the proximal edge 60 to the intermediate portion 64 at approximately a 90-degree angle. Similarly, the second transition 74 connects the distal edge 62 to the intermediate portion 64 at approximately a 90-degree angle. The first transition 72 and the second transition 74 partially define the generally rectangular cross-section of the leaflet 58, resulting in relatively sharp circumferential edges of the device and relatively high radial forces applied to the surrounding tissue. In other words, the first transition 72 and the second transition 74 may each have a small radius of curvature, for example, between about 0 mm and about 2 mm, including between about 0.5 mm and about 1 mm, including between about 0.6 mm and about 0.8 mm. In the example shown, a hook 70 is positioned proximal to the bend at the second transition 74.

[0029] A potential problem with the medical device 50 is shown in Figure 2. Figure 2 shows a 25mm version of the medical device 50 in an overcompressed state, where the leaflets 58 are visible, but the disc 56 is not in the view. In this example, 25mm refers to the diameter of the leaflets 58 in the unbiased state or without applied force. As used herein, the term overcompression can generally refer to a situation where the medical device 50 is deployed into a cavity or anatomical structure smaller than the indicated range of use of a particular medical device 50. For example, the 25mm version of the medical device 50 shown in Figure 2 could be intended for use in a left atrial appendage with a landing zone width between 19mm and 22mm. In this example, Figure 2 shows a 25mm version of the medical device 50 deployed into a cavity smaller than 19mm (e.g., about 17mm). In Figure 2, the leaflets 58 of the medical device 50 are positioned within a cylindrical tube T having a wall W. The outer contour C of the leaflets 58 (labeled on the right side of Figure 2) illustrates the contour C of the outer surface of the leaflets 58 relative to the wall W of the tube T. As shown in Figure 2, in this overcompression state, a valley V is formed at the middle or central portion 64 of the leaflet 58. The valley V is radially positioned inwardly from the wall W of the tube T, wherein the portions of the leaflet 58 proximal to the valley V and distal to the valley V contact the inner surface of the wall W of the tube T. For example, in the view of Figure 2, the portion of the leaflet 58 on the right side proximal to the valley V (e.g., the lower right of the figure) contacts the inner wall W of the tube T, but no hook 70 contacts the inner wall W of the tube T. It should be understood that the tube T represents implantation or deployment in a body cavity (e.g., LAA). It is noteworthy that the valley V forms where the hook 70 of the stabilization line 68 departs from the leaflet 58. In the overcompression state shown, the portion of the medical device 50 at the radially outermost position is not the hook 70, but rather the portion of the leaflet 58 proximal and / or distal to the valley V. Therefore, under this state of overcompression, although the leaflet 58 can contact the inner wall W of the tube T (meaning contact with the inner surface of the tissue defining the lumen (e.g., LAA), one or more hooks 70 of the stabilizing line 68 remain spaced from the inner wall W of the tube T and thus do not contact it (meaning a lack of contact between the hook 70 and the tissue of the treated lumen). This gap is indicated as gap G1 in Figure 2. Under the conditions shown in Figure 2, the hooks 70 of the stabilizing line 68 cannot engage with the tissue (or cannot fully engage). This phenomenon is at least partly due to the position of the stabilizing line 68 on the leaflet 58, and the fact that the leaflet 58 is generally cylindrical in shape and has a small radius of curvature at the first transition 72 and the second transition 74. It should be clear from the above description that this phenomenon may result in poor anchoring of the medical device 50 within the LAA (or within other anatomical structures treated by the medical device 50), which may increase the likelihood of displacement of the medical device 50.

[0030] Another potential problem with medical device 50 (somewhat related to that shown and described in conjunction with Figure 2) is illustrated in Figure 3. Figure 3 shows the same 25mm version of medical device 50 in an intermediate stage of unfolding from catheter 104. As the tip or distal end 54 of leaflet 58 extends from catheter 104, it begins to self-expand to its set shape. As shown in Figure 3, in this intermediate unfolding stage, although the proximal end 52 of leaflet 58 remains in a collapsed state within catheter 104, the distal end 54 of medical device 50 extends radially outward from the central longitudinal axis of medical device 50, further than any hook 70 of any stabilizing line 68. This results in another gap G2 between the outermost point of the frame of medical device 50 and the outermost point of the hook 70 of medical device 50. Similar to gap G1, gap G2 can obstruct one or more of the hooks 70 from engaging the tissue of the lumen (e.g., LAA wall) during this intermediate stage of unfolding. This could result in some or none of the hooks 70 being able to engage the tissue during deployment until the proximal end 52 of the leaflet 58 is fully released from the catheter 104 (e.g., fully deployed). If one or more or all of the hooks 70 fail to anchor into the tissue when the leaflet 58 is deployed into the lumen, the medical device 50 may “jump” (e.g., move rapidly and / or reposition itself, at least in part, due to the force of self-expansion) when the leaflet 58 is fully deployed due to the lack of anchorage, which is undesirable. The concerns described in conjunction with Figure 3 can be applied to all delivery and deployment of the medical device 50, while the concerns described in conjunction with Figure 2 can be more isolated from the situation where the medical device 50 is overcompressed upon full deployment.

[0031] Figure 4 This is a schematic diagram of a delivery system 100. The delivery system 100 may include a delivery device 102, which includes a conduit 104 and a coupling member 106 configured to connect a distal end of a delivery cable 108 to a medical device 110 to facilitate deployment of the medical device 110 at a target site. The medical device 110 is deployed to treat the target site and, in an exemplary embodiment, is an occlusion device (“occluder”). It should be understood that the delivery system 100 may also be adapted for use with other medical devices, such as medical device 50.

[0032] Figures 5 to 6An exemplary embodiment of a medical device 110 is shown. The medical device 110 includes a proximal end 112 and a distal end 114. The proximal end 112 includes a disc 116, and the distal end 114 includes a leaflet 118, wherein the disc 116 and the leaflet 118 are connected by a connecting member 120. The leaflet 118 includes a proximal portion 122 defining a proximal surface 124 of the leaflet 118, a distal portion 126 defining a distal surface 128 of the leaflet 118, and an intermediate or central portion 130 connecting and extending between the proximal portion 122 and the distal portion 126. The central portion 130 has a circumferential or radially outer surface 131. The proximal surface 124 is connected to or abuts the intermediate portion 130 at a first transition T1, and the distal surface 128 is connected to or abuts the intermediate portion 130 at a second transition T2. The first transition portion T1 and the second transition portion T2 may each independently have a radius of curvature between about 0.001 inches (0.0254 mm) and about 0.150 inches (3.81 mm), more particularly between about 0.025 inches (0.635 mm) and about 0.150 inches (3.81 mm), and even more particularly between about 0.075 inches (1.905 mm) and about 0.125 inches (3.175 mm). The radius of curvature of the first transition portion T1 may be the same as that of the second transition portion T2. ​​Alternatively, the first transition portion T1 and the second transition portion T2 may have different radii of curvature. In an alternative embodiment, only one of the first transition portion T1 and the second transition portion T2 has a defined radius of curvature, and the other is a relatively sharp transition portion (e.g., about 90°). With this configuration, the leaflet 118 can be generally cylindrical, with rounded bends at its proximal and distal ends, although the bends can have different radii of curvature as described above.

[0033] The leaflet 118 may further include a plurality of stabilizing lines 132 connected to the leaflet 118 at a radially outer surface 131 (also referred to as a circumferential surface) of the intermediate portion 130. Each stabilizing line 132 may include a hook 134 at its terminal. The hook 134 may extend radially outward from the intermediate portion 130 of the leaflet 118.

[0034] Some embodiments of the medical device 110 disclosed herein may be formed of a woven fabric or mesh material comprising a plurality of strands having a predetermined relative orientation with respect to each other. However, it should be understood that, according to other embodiments of the present disclosure, the medical device 110 may be formed from a tube etched or laser-cut, or the device may include an occlusive material coupled to a stent structure or frame.

[0035] In one embodiment, the medical device 110 is formed of a shape memory material comprising a metal fabric. The metal fabric is deformed to generally conform to the surface of a mandrel. On the surface of the mandrel, the metal fabric is treated under heating conditions to allow for heat setting. The heat setting of the metal fabric ensures that once the metal fabric is removed from the surface of the mandrel, it will retain the basic shape of the mandrel. In an exemplary embodiment, the mandrel used for the heat setting treatment defines the radius of curvature of the metal fabric relative to the edges (specifically, the first transition T1 and the second transition T2) of the leaflets 118 of the medical device 110.

[0036] The radius of curvature selected and defined for each of the first transition section T1 and the second transition section T2 rounds or softens the circumferential edge of the medical device 110. This rounding or softening of the circumferential edge results in a reduction of the radial force applied to the surrounding tissue. Therefore, the medical device 110 is more conform to the anatomy of the target site in which it is deployed, particularly the LAA.

[0037] The disc 116 of the medical device 110 is configured to abut adjacent to the adjacent wall surrounding the opening of the vascular defect to prevent movement of the medical device 110 and to help seal any abnormalities that may occur when the medical device 110 unfolds. Discs of various sizes and shapes are conceivable. In one embodiment, the diameter of the disc portion may be larger than the vascular abnormality to be sealed, in order to cover the abnormal opening.

[0038] The leaflet 118 of the medical device 110 is sized to engage with the lumen of the abnormality to be occluded. The medical device 110 can then be held at the target site by radial engagement between the leaflet 118 and the lumen of the abnormality. The hook 134 of the stabilizing line 132 also engages with surrounding tissue and improves the retention of the medical device 110 at the target site.

[0039] One particular shape memory material that can be used to form the medical device 110 (and particularly the leaflet 118) described herein is nitinol. Nitinol alloys exhibit high elasticity, described as “hyperelastic” or “pseudoelastic.” This elasticity allows the medical device 110 to be elastic and, after passing through the delivery catheter 104 in a tortuous form, return to a predetermined expansion configuration for deployment. Materials and methods of manufacturing medical devices with shape memory properties are provided in U.S. Publication No. 2007 / 0265656, filed June 21, 2007, entitled “Multi-layer Braided Structures for Occluding Vascular Defects,” which is incorporated herein by reference in its entirety.

[0040] It is also understood that the medical device 110 can be formed of various materials other than nitinol with elastic properties, such as stainless steel, alloys traded under the name Elgiloy®, or Hastalloy, Phynox®, MP35N, cobalt-chromium-molybdenum alloys, metals, polymers, or mixtures of metals and polymers. Suitable polymers may include PET (polyester), polyester, polypropylene, polyethylene, HDPE, Pebax, nylon, polyurethane, silicone, PTFE, polyolefins, and ePTFE. Additionally, the medical device is contemplated to include any material having the desired elastic properties to ensure that the device can be deployed and used as the occluder disclosed in this application.

[0041] Figure 7 A 25mm version of the medical device 110 is shown in an over-compressed state. Figure 7 In this configuration, the leaflet 118 of the medical device 110 is positioned within the same cylindrical tube T as shown and described in conjunction with Figure 2. The outer contour C of the leaflet 118 is marked on... Figure 7 On the upper left side, to better show the outline C of the outer surface of the leaflet 118 relative to the wall W of the tube T. (See image below.) Figure 7 As shown, under this overcompression state, a valley V is generated at the middle or central portion 130 of the leaflet 118. The valley V is radially positioned inwardly at a distance from the wall W of the tube T, wherein the portions of the leaflet 118 proximal to the valley V and distal to the valley V contact the inner surface of the wall W of the tube T. As illustrated in conjunction with Figure 2, it should be understood that the tube T represents implantation or deployment in a body cavity (e.g., LAA).

[0042] It is noteworthy that, unlike the configuration shown and described in conjunction with Figure 2, the valley V is formed at a proximal distance from the location of the hook 134 of the stabilizing line 132 away from the leaflet 118. Therefore, in the overcompression state shown, the portion of the medical device 110 at its radially outermost position is the hook 134, not the portion of the leaflet 118 proximal and / or distal to the valley V. In this overcompression state, while the leaflet 118 may contact the inner wall W of the tube T (this represents contact with the inner surface of the tissue defining the lumen (e.g., LAA), one or more hooks 134 of the stabilizing line 132 also contact the inner wall W of the tube T (this represents contact between the hook 134 and the tissue of the lumen being treated). For example, in Figure 7 In the view, although on the upper right side, the portions of the leaflet 118 proximal and distal to the valley V contact the inner wall W of the tube T, the hook 134 on the upper right side also contacts the inner wall W of the tube T. On the other hand, although on the upper left side, the portions of the leaflet 118 proximal and distal to the valley V do not contact the inner wall W of the tube T, the hook 134 on the upper left side contacts the inner wall W of the tube T. Therefore, although the configuration shown and described in conjunction with FIG2 includes gap G1, in Figure 7Such a gap does not exist in the configuration. In other words, in Figure 7 Under the conditions shown, the hook 134 of the stabilizing line 132 is still able to engage with the tissue, even though the leaflet 118 is in an overcompressed state. It should be clear from the above description that even in an overcompressed state, this phenomenon allows the medical device 110 to be properly anchored within the LAA (or within other anatomical structures treated by the medical device 110), which reduces the likelihood of displacement of the medical device 110 and increases the range of target sites (e.g., the LAA) that can be properly treated with a single size of the medical device 110.

[0043] Figure 8 It shows the relationship with Figure 7 The same 25mm version of the medical device 110, but in the intermediate stage of unfolding from the catheter 104. As the tip or distal end 126 of the leaflet 118 extends from the catheter 104, it begins to self-expand to its intended shape. Figure 8 As shown, during this intermediate unfolding phase, although the proximal end 122 of the leaflet 118 remains in a collapsed state within the catheter 104, the distal end 126 of the medical device 110 extends radially outward from the central longitudinal axis of the medical device 110 beyond most of the medical device 110 (except for the hook 134 of the stabilizing line 132). In other words, compared to the intermediate expanded state of the medical device 50 shown in FIG. 3 (in FIG. 3, the gap space G2 extends radially inward between the leaflet 58 and the hook 70), during intermediate unfolding, there is almost or no radial gap between the radially outermost contour of the leaflet 118 and the hook 134. In some cases, hook 134 may be positioned at approximately the same distance from the central longitudinal axis of medical device 110 as the radially outermost profile of leaflet 118, and in other embodiments, hook 134 may extend slightly further in the radial direction than the radially outermost profile of leaflet 118, or the radially outermost profile of leaflet 118 may extend only a very small distance in the radial direction compared to hook 134 (e.g., a very small gap G2 may be present, if any). In the absence of any gap similar to G2, hook 134 may readily contact, grasp, or otherwise abrasively engage tissue within the treatment site (e.g., tissue of LAA) as leaflet 118 begins to unfold from catheter 104 but before the proximal end 122 of leaflet 118 exits catheter 104. Because the hooks 134 of the leaflet 118 are able to engage tissue before the leaflet 118 is fully deployed from the catheter 104, the leaflet 118 is able to anchor to the target site during deployment, thus preventing significant movement of the medical device (including the “jumping” described above in conjunction with Figure 3) during the later stages of deployment (including when the medical device 110 is fully deployed from the catheter 104).

[0044] Therefore, the shape of the leaflet 118 and the position of the stabilizing line 132 and hook 134 relative to the leaflet 118 offer at least two advantages, including (i) the ability to treat a wider range of anatomical structures using a single-sized medical device 110, even during overcompression, due to anchoring; and (ii) the ability to deploy the medical device 110 with greater stability due to early engagement of the anchoring element with the tissue at the target site. Although the figures show two distinct deployment phases of the medical device 110, with the hook 134 being the radially outermost feature of the medical device 110, it should be understood that this relationship can exist in all phases of deployment once the hook 134 has left the catheter 104.

[0045] Figure 9 An enlarged view of a portion of the medical device 110 is shown, with focus on the stabilizing sutures 132 and hooks 134. In some examples, each stabilizing suture 132 may have a backing portion or a generally “U”-shaped proximal end 132a positioned radially outward of the outer surface 131 when coupled to the leaflet 118. The backing portion 132a may be positioned immediately adjacent to the lateral surface 124. A substantial portion of the length of each stabilizing suture 132 between the backing portion 132a and the hook 134 (also referred to as the engagement portion) at the distal end may lie radially inward of the outer surface 131. This may include a loop or eyelet 132b that may receive sutures or other fasteners to secure the eyelet 132b to the outer surface 131 of the leaflet 118, which, as described above, may be a braided or mesh configuration. Options for the construction of the stabilizing sutures 132 are described in more detail in U.S. Patent Application Publication No. 2022 / 0280166, the disclosure of which is incorporated herein by reference. Figure 10 An example of the shape of the stabilization line 132, which is used to stabilize and isolate the medical device 110 from other components, is illustrated.

[0046] Refer again Figure 9In some examples, hook 134 may be formed with a generally "C"-shaped or hook-shaped profile segment that begins at the distal end of orifice 132b and terminates at a radially outward position on outer surface 131. In the illustrated example, hook 134 may have a distal portion positioned between orifice 132b and the end of hook 134 such that hook 134 extends proximally from the distal portion to the end of hook 134. This distal portion may be positioned radially outward on outer surface 131 in an unbiased or set shape of medical device 110. In some examples, the distance D1 between the distal end of hook 134 and the distal surface 128 of leaflet 118 may be at most about 2 mm, including at most about 1.5 mm, including between about 0 mm and about 1.0 mm. In some examples, this distance D1 (e.g., it could be 1.0 mm) can even remain constant across different sizes of the medical device 110 (the different sizes corresponding to different diameters of the leaflets 118 of the device, for example, in a no-bias state or without applied force). For example, if the medical device 110 is provided in 20 mm size (corresponding to leaflets 118 with a diameter of 20 mm), 22 mm size (corresponding to leaflets 118 with a diameter of 22 mm), and 25 mm size (corresponding to leaflets 118 with a diameter of 25 mm), each different size can still have a distance D1 between about 0 mm and about 1.5 mm, including about 0 mm and about 1.0 mm. This relationship can at least partially explain Figures 7 to 8 The described function.

[0047] In some examples, the second transition portion T2 may have a profile length between the distal end of the substantially straight outer surface 131 and the starting point of the substantially straight distal surface 128, and the hook 134 may intersect from the interior to the exterior of the outer surface 131 with a length less than about half (50%) of the profile length (measured from the substantially straight outer surface 131 toward the distal surface 128). In some examples, the intersection point of the hook 134 may be between about 25% and about 40% of the profile length starting from the substantially straight outer surface 131 in the direction toward the distal surface 128, including about 30% or about 35%. In some examples, the hook 134 may intersect from the interior to the exterior of the outer surface 131 at any portion along the second transition portion T2.

[0048] Now go to Figure 11A flowchart depicts an exemplary method 700 for occluding a patient's LAA using a medical device 110. In an exemplary embodiment, method 700 includes providing a medical device 702. As described herein, the medical device includes a proximal end and a distal end, wherein the proximal end includes a disc and the distal end includes a leaflet, wherein the leaflet includes a proximal portion defining a proximal surface of the leaflet, a distal portion defining a distal surface of the leaflet, and an intermediate portion connecting and extending between the proximal and distal portions, wherein a first transition between the proximal and intermediate portions is curved, and a second transition between the intermediate and distal portions is curved, wherein the leaflet has an expanding configuration when deployed at a target site and a contracting configuration for delivery to the target site, wherein the disc and the leaflet are connected by a connecting member, and the leaflet also includes a plurality of stabilizing lines coupled to the leaflet at a radially outer surface of the intermediate portion, each stabilizing line including a hook portion extending radially outward from at least one leaflet.

[0049] Method 700 also includes advancing a medical device 704 to the LAA using a delivery system including a catheter and a delivery cable, positioning the medical device relative to the LAA 706 to block blood flow to and out of the LAA, and disconnecting the medical device from the delivery cable 708 to deploy the medical device.

[0050] Method 700 may include additional, alternative, and / or fewer steps, including those described herein. For example, in some embodiments, positioning the medical device relative to the LAA 706 includes placing the leaflets of the medical device within the body of the LAA, and a disc outside the LAA abutting against an adjacent wall surrounding the opening of the LAA to prevent the medical device from moving toward the body of the LAA and to help seal any abnormalities.

[0051] In some examples of method 700, when the medical device is deployed from catheter 104, once hook 134 has been released from catheter 104, hook 134 is the most radially outwardly positioned structure of leaflet 118 at all points until and including when leaflet 118 is fully deployed into LAA. Further, in some examples of method 700, due to excessive compression of leaflet 118 by the tissue of LAA, a valley V is formed within the central portion 130 of leaflet 118, and despite the formation of the valley V, hook 134 remains in contact with the tissue of LAA for frictional engagement of LAA.

[0052] Now go to Figure 12A flowchart depicts an exemplary method 800 for manufacturing a medical device (e.g., medical device 110). As described herein, the medical device includes a proximal end and a distal end, wherein the proximal end includes a disc and the distal end includes a leaflet, wherein the leaflet includes a proximal portion defining a proximal surface of the leaflet, a distal portion defining a distal surface of the leaflet, and an intermediate portion connecting and extending between the proximal and distal portions, wherein a first transition between the proximal and intermediate portions is curved, and a second transition between the intermediate and distal portions is curved, wherein the leaflet has an expanded configuration when deployed at a target site and a contracted configuration for delivery to the target site, wherein the disc and the leaflet are connected by a connecting member, and the leaflet also includes a plurality of stabilizing lines at the radially outer surface of the intermediate portion and coupled to the leaflet, each stabilizing line including a hook portion extending radially outward from at least one leaflet. In an exemplary embodiment, method 800 includes providing 802 a shape memory material.

[0053] Method 800 may further include positioning shape memory material 804 on a mandrel having a desired shape, size, and radius of curvature for a first transition portion and a radius of curvature for a second transition portion, heat-setting the shape memory material 806 to define an expanded preset configuration having radii of curvature for the first transition portion and radii of curvature for the second transition portion, and removing the shape memory material from the mandrel 808 to obtain a medical device in the expanded preset configuration.

[0054] Method 800 may include additional, alternative, and / or fewer steps, including those described herein. For example, in some embodiments, removing the shape memory material 808 from the mandrel includes cooling the shape memory material to room temperature.

[0055] In some examples, method 800 further includes attaching one or more stabilizing sutures 132 to the leaflet 118 of the medical device 110. For example, a U-shaped backing portion 132a may be positioned radially lateral to the leaflet 118 adjacent to the proximal surface 124, wherein two legs of the stabilizing suture 132 extend through a "cell" or opening in the braid to the distal side of the U-shaped backing portion 132a, such that a majority of the stabilizing suture 132 is positioned within the leaflet 118. The backing portion 132a may be attached to the braid, for example, by one or more sutures. Eyelets 132b of the stabilizing suture 132 may remain within the leaflet 118 or be sutured to the braid of the leaflet 118 to secure the eyelets 132b to the leaflet 118. A portion of each hook 134 may extend through a cell or opening in the braid, such that at least a portion of the hook 134 protrudes beyond the leaflet 118. The positioning can be configured such that the farthest end of the hook 134 is about 1.5 mm from the distal surface 128 of the leaflet 118, including about 1.0 mm.

[0056] While embodiments of this disclosure have been described, it should be understood that various changes, adaptations, and modifications may be made therein without departing from the spirit of this disclosure and the scope of the appended claims. Furthermore, all directional references (e.g., up, down, upward, downward, left, right, leftward, rightward, top, bottom, above, below, vertical, horizontal, clockwise, and counterclockwise) are used for identification purposes only to aid the reader's understanding of this disclosure and do not create limitations, particularly regarding the location, orientation, or use of this disclosure. All content contained in the foregoing description or shown in the accompanying drawings should be construed as illustrative rather than restrictive. Changes in detail or structure may be made without departing from the spirit of this disclosure as defined in the appended claims.

[0057] Many modifications and other embodiments of the invention detailed herein will arise to those skilled in the art to which these disclosed embodiments pertain, based on the teachings presented in the foregoing description and the associated drawings. Therefore, it should be understood that this disclosure is not limited to the specific embodiments disclosed, and that modifications and other embodiments are intended to be included within the scope of the appended claims. Although specific terminology is used herein, it is used in a general and descriptive sense only and is not intended to be limiting.

[0058] Any patent, publication, or other disclosure that is allegedly incorporated herein in whole or in part by reference will be incorporated only to the extent that the incorporated material does not conflict with any existing definitions, statements, or other disclosures set forth herein. Therefore, and to the extent necessary, any conflicting material incorporated herein by reference will be superseded by the disclosure expressly set forth herein. Any material, or part thereof, that is allegedly incorporated herein by reference but conflicts with any existing definitions, statements, or other disclosures set forth herein will be incorporated only to the extent that such incorporated material does not conflict with any existing disclosures.

[0059] While the invention has been described with respect to specific embodiments, it should be understood that these embodiments are merely exemplary illustrations of the principles and applications of the invention. Therefore, it should be understood that many modifications can be made to the exemplary embodiments, and other arrangements can be designed, without departing from the spirit and scope of the invention as defined by the appended claims.

Claims

1. An occluder for occluding the left atrial appendage ("LAA"), the occluder comprising: A leaflet, the leaflet being sized and shaped for positioning within a LAA, the leaflet having a proximal end, a distal end, and a middle portion, the proximal end defining a proximal surface of the leaflet, the distal end defining a distal surface of the leaflet, the middle portion connecting and extending between the proximal end and the distal end, wherein the leaflet has an expanded state without applied force and a collapsed state for delivery to the LAA; as well as Multiple stabilizing lines are connected to the leaflet, each of the multiple stabilizing lines having a hook at its distal end, each hook having an end positioned radially outward of the leaflet in the expanded state of the leaflet, and each hook being configured to frictionally engage the tissue of the LAA. In the expanded state of the leaflet, each hook has a farthest point, and the farthest point of each hook is positioned at a spaced axial distance from the distal surface of the leaflet in the expanded state, the spaced axial distance being between about 0 mm and about 1.5 mm.

2. The occluder according to claim 1, wherein, The axial distance between the intervals is approximately 1.0 mm.

3. The occluder according to claim 1, wherein, The transition between the intermediate portion and the distal end of the leaflet is curved, and the curvature of the transition has a profile length measured between (i) the point where the distal end of the intermediate portion connects to the proximal end of the curved transition and (ii) the point where the distal end of the curved transition connects to the distal surface of the leaflet.

4. The occluder according to claim 3, wherein, In the expanded state of the leaflet, the hook crosses from the inside of the leaflet to the outside of the leaflet at the intersection point, which is located between about 25% and about 50% of the profile length.

5. The occluder according to claim 4, wherein, The transition section has a radius of curvature between approximately 0.075 inches (1.905 mm) and approximately 0.125 inches (3.175 mm).

6. The occluder according to claim 1, wherein, The occluder includes a disc located at the proximal end of the occluder, and a connecting member connects the disc and the leaflet.

7. The occluder according to claim 1, wherein, In the compressed state of the leaflet, a valley is formed within the middle portion of the leaflet, and in the compressed state, the hook extends radially outward from the central longitudinal axis of the leaflet further than any structure of the leaflet.

8. An occluder for occluding the left atrial appendage ("LAA"), the occluder comprising: A leaflet, the leaflet being sized and shaped for positioning within a LAA, the leaflet having a proximal end, a distal end, and a middle portion, the proximal end defining a proximal surface of the leaflet, the distal end defining a distal surface of the leaflet, the middle portion connecting and extending between the proximal end and the distal end, wherein the leaflet has an expanded state without applied force and a collapsed state for delivery to the LAA; as well as Multiple stabilizing lines are connected to the leaflet, each of the multiple stabilizing lines having a hook at its distal end, each hook having an end positioned radially outward of the leaflet in the expanded state of the leaflet, and each hook being configured to frictionally engage the tissue of the LAA. Wherein, the transition between the intermediate portion and the distal end of the leaflet is curved, and the curvature of the transition has a profile length measured between (i) the point where the distal end of the intermediate portion connects to the proximal end of the curved transition and (ii) the point where the distal end of the curved transition connects to the distal surface of the leaflet. In the expanded state of the leaflet, the hook crosses from the inside of the leaflet to the outside of the leaflet at the intersection point, which is located between about 25% and about 50% of the profile length.

9. The occluder according to claim 8, wherein, In the expanded state of the leaflet, the intersection point is located between approximately 25% and approximately 40% of the profile length.

10. The occluder according to claim 9, wherein, In the expanded state of the leaflet, the intersection point is located between approximately 30% and approximately 35% of the profile length.

11. The occluder according to claim 8, wherein, In the expanded state of the leaflet, each hook has a farthest point, and the farthest point of each hook is positioned at a spaced axial distance from the distal surface of the leaflet in the expanded state, the spaced axial distance being approximately 1 mm.

12. The occluder according to claim 8, wherein, The transition section has a radius of curvature between approximately 0.075 inches (1.905 mm) and approximately 0.125 inches (3.175 mm).

13. The occluder according to claim 8, wherein, The occluder includes a disc located at the proximal end of the occluder, and a connecting member connects the disc and the leaflet.

14. The occluder according to claim 8, wherein, In the compressed state of the leaflet, a valley is formed within the middle portion of the leaflet, and in the compressed state, the hook extends radially outward from the central longitudinal axis of the leaflet further than any structure of the leaflet.

15. A method for occluding the left atrial appendage ("LAA"), the method comprising: The occluder, which is in a collapsed state, is positioned within the delivery conduit. The occluder comprises: A leaflet having a proximal end, a distal end, and a middle portion, the proximal end defining a proximal surface of the leaflet, the distal end defining a distal surface of the leaflet, and the middle portion connecting and extending between the proximal end and the distal end; and Multiple stabilizing lines are connected to the leaflet, and each of the multiple stabilizing lines has a hook at its distal end; When the occluder collapses within the delivery conduit, the occluder is advanced into or adjacent to the LAA; The leaflet is converted into a partially dilated state, in which the distal end of the leaflet has left the delivery conduit and has begun to self-dilate, while the proximal end of the leaflet remains collapsed within the delivery conduit. When the leaflet is in the partially expanded state, the hook contacts the tissue of the LAA; and After the hook is brought into contact with the tissue of the LAA, the occluder is fully deployed from the delivery catheter.

16. The method according to claim 15, wherein, Between the partially dilated state of the leaflet and the complete deployment of the occluder from the delivery catheter, the hook remains in contact with the tissue of the LAA.

17. The method according to claim 15, wherein, After the occluder is fully deployed from the delivery catheter, the compression of tissue from the LAA on the leaflet forms a valley within the middle portion of the leaflet.

18. The method according to claim 17, wherein, As the valley forms within the middle portion of the leaflet, the hook remains in contact with the tissue of the LAA.

19. The method according to claim 15, wherein, Full deployment of the occluder from the delivery conduit includes deploying a disc of the occluder from the delivery conduit, the disc of the occluder being connected to the leaflet of the occluder via a connecting member.

20. The method according to claim 19, wherein, After the disk of the occluder is deployed, the disk at least partially covers the opening of the LAA.

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