Tissue scaffold-type closure device

Abstract

According to some embodiments, a septum closure device includes a support structure including a first anchor portion and an opposing second anchor portion, with a lumen extending through a center of the first anchor portion and a center of the second anchor portion, the support structure being configured to contract and expand between a compressed tubular configuration for insertion through a patient's vasculature and an expanded configuration in which the first and second anchor portions extend radially outward from the lumen; and a membrane coupled to the first anchor portion, the membrane configured to occlude a majority of the lumen when the support structure is expanded, the membrane configured to promote tissue growth at least across the membrane.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS All applications to which foreign or domestic priority is claimed in an Application Data Sheet filed with this application are hereby incorporated by reference under 37 CFR 1.57.

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 493,965, filed April 3, 2023, and U.S. Provisional Patent Application No. 63 / 387,588, filed December 15, 2022, the entire contents of each of which are incorporated herein by reference in their entirety.

[0003] This application relates generally to medical devices and, more particularly, to devices, systems, and methods for closing holes / openings in the atrial septum in specific configurations. [Background technology]

[0004] In the heart, the atrial septum separates the right and left atria, and the ventricular septum separates the left and right ventricles. Septal defects (e.g., holes or openings) can occur congenitally or can be created by penetrating the septum with a medical device to access specific locations within the heart. Additionally, non-congenital defects, such as patent foramen ovale, can persist into adulthood and are common. Implantable medical devices exist to treat several heart-related diseases and conditions. For example, occlusion devices can be used to block (e.g., completely or partially) blood flow through defects in the ventricular or atrial septum.

[0005] The femoral vein is the access point for many experimental catheterization procedures, and a few procedures use arterial access. The atrial septum is a percutaneous access point, for example, for the treatment of atrial fibrillation, left atrial appendage closure, percutaneous mitral valve repair, and percutaneous mitral valve replacement. These and other procedures require devices to pass through the atrial septum, potentially leaving an opening in the atrial septum that cannot close or heal spontaneously. Summary of the Invention

[0006] The chronic and debilitating effects of septal defects affect millions of people worldwide. An estimated 4.2 million people are born with an atrial septal defect (ASD) each year, and an estimated 27% are born with a persistent patent foramen ovale (PFO). Research has shown that 40% to 60% of individuals with ASD develop atrial fibrillation (AF), and approximately 20% of individuals with ASD develop mitral regurgitation. Living with an ASD is burdensome, often resulting in shortness of breath, extreme fatigue, peripheral edema, palpitations, and an increased risk of stroke. ASD can cause dilation of the atria, resulting in atrial arrhythmias (AA). Research has shown that 40% of cryptogenic strokes are associated with PFOs. PFOs have serious consequences, including an increased risk of stroke and the need for migraine medication.

[0007] Current treatment of ASDs and PFOs with permanent septal closure devices is often a last resort and can lead to serious complications. Because implantation of a closure device limits access to the left atrium, some physicians recommend treating AF before closure. Currently, only symptomatic defects or those suspected of paradoxical embolism are closed. Current closure devices for treating septal defects also have several problems. For example, current devices often contain protruding, bulky mesh components, which can cause chronic inflammation, delay the healing response, and increase the risk of stroke. Current devices often contain stiff, dense braids, which can disrupt the conduction network, increase the risk of arrhythmias, and cause septal noncompliance and increase the risk of septal erosion. Current devices are inelastic and noncompliant once implanted. This is due in part to the use of PTFE, which can lead to acute thrombosis and intimal hyperplasia. Furthermore, patients often require long-term medication, including dual antiplatelet therapy (DAPT) and aspirin / clopidogrel, for periods ranging from 3–6 months to up to 5 years after device placement. Long-term medication can be burdensome and potentially result in complex side effects. Additionally, once implanted, these devices impede septal access, limiting or eliminating future treatment options. Maintaining access to the left atrium is crucial for all patients, but is particularly important for patients with congenital heart disease (CHD), who have a high incidence of cardiac complications. Approximately 50% of CHD patients develop atrial fibrillation by age 65, resulting in a significantly increased risk of stroke, heart failure, congenital heart disease, arrhythmias, and non-congenital heart disease.

[0008] Disclosed herein are various systems, methods, and devices for treating septal defects, including ostium secundum ASD, by providing septal closure (e.g., blocking blood flow between the right and left atria of the heart) while allowing future access to the septum and reducing the negative side effects of the closure procedure. The disclosed systems, methods, and devices each have several innovative aspects, no single one of which is solely responsible for the desirable attributes disclosed herein.

[0009] The closure devices described herein may include membranes of electrospun microfiber or nanofiber materials that exhibit significantly superior endothelial cell growth compared to existing ePTFE and woven PET. The electrospun PU nanofiber scaffold supports the formation of a stable endothelial cell monolayer similar to that of vascular endothelium and myocardium. The formation of a smooth endothelium reduces shear forces and may prevent thrombus formation. The elastic nanofiber material also significantly reduces inflammatory responses compared to non-compliant alternatives such as PTFE / PET. The closure devices described herein may conform to the complex anatomy of the heart through septal compliance and contractile force. Once implanted, the closure devices promote the growth of a biostable cell scaffold with rapid tissue regeneration, often resulting in a complete tissue layer within eight weeks.

[0010] The closure device described herein allows transseptal access for multiple treatment options after implantation, potentially reducing or eliminating the need for post-procedure DAPT. Upon implantation, the acellular porous structure provides immediate septal closure, while the elastic membrane mimics the compliance of the septum. The closure device may also include a lightweight frame that allows for compliant fixation while protecting surrounding tissue. Furthermore, a smooth left atrial membrane reduces the patient's risk of stroke after implantation.

[0011] The closure devices described herein may be constructed from extremely lightweight materials. Lightweight materials allow the septum to better maintain its compliance. Septal compliance is important from a hemodynamic perspective because it more closely mimics the natural movement of cardiac tissue. Furthermore, a more flexible and conformable device better protects the complex cardiac anatomy, both within the septum (e.g., conduction fibers) and near the septum (e.g., the aorta). Finally, lightweight devices are inherently desirable because the less material implanted in the body, the less immune response there is. The best devices are fewer devices. Furthermore, some patients are hypersensitive to nickel, and reducing the implanted mass of nitinol will reduce this sensitivity.

[0012] According to some embodiments, a septum closure device includes a support structure including a first anchor portion and an opposing second anchor portion, with a lumen extending through a center of the first anchor portion and a center of the second anchor portion, the support structure configured to contract and expand between a compressed tubular configuration for insertion through a patient's vasculature and an expanded configuration in which the first and second anchor portions extend radially outward from the lumen; and a membrane coupled to the first anchor portion, the membrane configured to occlude a majority of the lumen when the support structure is expanded, the membrane configured to promote tissue growth at least across the membrane.

[0013] According to some embodiments, a method includes inserting a delivery system into a patient's vasculature, the delivery system including a release member and a sheath, the sheath including a septal closure device in a compressed configuration, the septal closure device including a first anchor portion and an opposing second anchor portion, the second anchor portion coupled to the release member; advancing a distal end of the sheath at least partially through a septum of the patient's heart; advancing the septal closure device inside the sheath such that the first anchor portion expands at a first section on a first side of the septum; advancing the septal closure device outside the sheath such that the second anchor portion expands at a second section on a second side of the septum opposite the first side, the second anchor portion remaining coupled to the release member in the expanded configuration; and releasing the septal closure device from the delivery system.

[0014] According to some embodiments, a septal closure device configured to be implanted in a patient's heart includes a support structure including a lumen, and a membrane including a plurality of electrospun fibers, the membrane coupled to at least a portion of the support structure, the membrane configured to occlude a majority of the lumen when the septal closure device is implanted.

[0015] According to some embodiments, a septal closure device configured to be implanted in a patient's heart includes a support structure including a central structure, and a membrane configured to promote tissue growth across the central structure, the membrane coupled to at least a portion of the support structure, the membrane configured to close a majority of the central structure when the septal closure device is implanted.

[0016] According to some embodiments, a septum closure device includes a support structure including a central structure, a first anchor portion and an opposing second anchor portion, and a membrane coupled to the first anchor portion, the membrane configured to close a majority of the central structure when the support structure is expanded, the membrane configured to promote tissue growth at least across the membrane.

[0017] These and other features, aspects, and advantages of the present application will be described with reference to drawings of specific embodiments that are intended to illustrate, but not limit, the invention. It should be understood that these drawings are for the purpose of illustrating the various concepts disclosed herein and may not be to scale. [Brief explanation of the drawings]

[0018] [Figure 1] 1 shows a schematic cross-section of a heart with a defect or opening in the atrial and ventricular septum. [Figure 2A] 1 shows a perspective view of a closure device according to one embodiment. [Figure 2B1] 2B shows a left atrial lateral view of the closure device of FIG. 2A including an occlusion membrane with a slit. [Figure 2B2] FIG. 2B shows a left atrial lateral view of the closure device of FIG. 2A including an electrospun closure membrane. [Figure 2C] 2B shows a right atrial lateral view of the closure device of FIG. 2A. [Figure 2D] 2B shows a side view of the closure device of FIG. 2A. [Figure 2E] 2B1 shows a cross-sectional view of the occlusion device of FIG. 2A taken along line 2E-2E of FIG. 2B1. [Figure 3A] 1 shows a perspective view of a closure device frame according to one embodiment. [Figure 3B] 3B shows a left atrial lateral view of the closure device frame of FIG. 3A. [Figure 3C] 3B shows a right atrial lateral view of the closure device frame of FIG. 3A. [Figure 3D] 3B shows a side view of the closure device frame of FIG. 3A. [Figure 4A] 1 shows a schematic cross-sectional view of the cardiac septum in a preoperative state. [Figure 4B] 1 shows a schematic cross-sectional view of the cardiac septum in an intraoperative state. [Figure 4C] 1 shows a schematic cross-sectional view of the cardiac septum in a post-operative state. [Figure 5A] 1 illustrates a delivery system for a closure device according to one embodiment. [Figure 5B] 5B illustrates the device loading component of the delivery system of FIG. 5A. [Figure 5C] 5B illustrates the device loading component of the delivery system of FIG. 5A. [Figure 6A] FIG. 1 illustrates a side view of a gripping system according to one embodiment. [Figure 6B] FIG. 6B shows a perspective view of the gripping system of FIG. 6A. [Figure 7A] 6B shows the gripping system of FIG. 6A. [Figure 7B] 6B shows the gripping system of FIG. 6A. [Figure 7C] 6B shows the gripping system of FIG. 6A. [Figure 7D] 6B shows the gripping system of FIG. 6A. [Figure 8A] 10 illustrates an example deployment of a closure device according to one embodiment. [Figure 8B] 10 illustrates an example deployment of a closure device according to one embodiment. [Figure 8C] 10 illustrates an example deployment of a closure device according to one embodiment. [Figure 8D] 10 illustrates an example deployment of a closure device according to one embodiment. [Figure 8E] 10 illustrates an example deployment of a closure device according to one embodiment. [Figure 9A] 1 shows a perspective view of a closure device according to one embodiment. [Figure 9B] 9B shows a left atrial lateral view of the closure device of FIG. 9A. [Figure 9C] 9B shows a right atrial lateral view of the closure device of FIG. 9A. [Figure 9D] 9B shows a side view of the closure device of FIG. 9A. [Figure 9E]9B shows a cross-sectional view of the closure device of FIG. 9A. [Figure 10A] 1 shows a perspective view of a closure device frame according to one embodiment. [Figure 10B] 10B shows a left atrial lateral view of the closure device frame of FIG. 10A. [Figure 10C] 10B shows a right atrial lateral view of the closure device frame of FIG. 10A. [Figure 10D] 10B shows a side view of the closure device frame of FIG. 10A. [Figure 10E] 1 shows a side view of a closure device frame. [Figure 10F] 10F shows a detailed view of the attachment portion of the closure device frame of FIG. 10E. [Figure 10G] 10A and 10H show detailed views of a portion of the closure device frame of FIG. 10E coupled to a portion of the delivery system of FIG. 5A. [Figure 10H] 10G and 10G show detailed views of a portion of the closure device frame of FIG. 10E coupled to a portion of the delivery system of FIG. 5A. [Figure 11A] 1 shows a left atrial lateral view of the closure device. [Figure 11B] 11B shows a right atrial lateral view of the closure device of FIG. 11A. [Figure 11C] 11B shows a side view of the closure device of FIG. 11A implanted in the cardiac septum. [Figure 11D] 11B shows a side view of the frame of the closure device of FIG. 11A. [Figure 11E] FIG. 11B shows a side view of the closure device of FIG. 11A coupled to a delivery system in an expanded configuration. [Figure 11F] 11B shows a schematic side view of the central portion of the occlusion device of FIG. 11A. [Figure 12A] 1 shows a partial view of the distal end of the delivery system. [Figure 12B] 12B shows a cross-sectional view of the distal end of the delivery system of FIG. 12A. [Figure 12C] 12B shows a gripping system of the delivery system of FIG. 12A. [Figure 13A] 1 shows a side view of a closure device frame. [Figure 13B] 13B shows a detailed view of the mounting portion of the closure device frame of FIG. 13A. DETAILED DESCRIPTION OF THE INVENTION

[0019] Next, embodiments of the present disclosure will be described with reference to the accompanying drawings. The terms used in the description presented herein are not intended to be construed as limiting or restrictive, merely because they are used in conjunction with the detailed description of specific embodiments of the present disclosure. Furthermore, while embodiments of the present disclosure may include several novel features, no single one of these is solely responsible for its desirable attributes or is essential to practicing the embodiments of the present disclosure described herein. For purposes of this disclosure, certain aspects, advantages, and novel features of various embodiments will be described herein. It should be understood that not necessarily all such advantages will be achieved in accordance with a particular embodiment. Thus, for example, one skilled in the art will recognize that an embodiment may be practiced in a manner that achieves one advantage or group of advantages as taught herein, without necessarily achieving other advantages that may be taught or suggested herein.

[0020] Although the various embodiments disclosed herein have particular relevance to septal closure devices (e.g., for blocking blood flow between the right and left atria of the heart), the features, advantages, and other properties disclosed herein may have direct or indirect applicability to other uses, such as, for example, systems, methods, and devices for hernia repair, vascular closure, other types of medical equipment, other mechanical devices, and / or the like.

[0021] I. Overview

[0022] A septum is a thin wall that separates, for example, a cavity into two smaller cavities or chambers or compartments. As used herein, the term "septum" is intended to define both the wall of the heart that separates the two atria and the wall that separates the right or left atrium from the ventricles.

[0023] 1 shows a schematic cross-sectional view of a heart 103 having a defect or opening in the atrial and ventricular septum. In the heart 103, an atrial septum 100, which comprises a tissue wall, separates the right atrium 101 from the left atrium 102, and an interventricular septum 104, which also comprises a tissue wall, separates the right ventricle 105 from the left ventricle 106 of the heart 103.

[0024] The heart 103 may include one or more defects. As used herein, the term "defect" may refer to, for example, a congenital defect and / or a hole / opening in the atrial septum that occurs after a percutaneous intervention using a transseptal puncture technique (e.g., mitral valve repair, left atrial appendage closure, and / or the like). As shown, the heart 103 includes a defect 107 located in the atrial septum 100 and a defect 107 located in the ventricular septum 104. The one or more defects 107 may have been created by penetrating the atrial septum 100 or the ventricular septum 104 with a medical instrument to access a particular location within the heart.

[0025] The femoral vein is the access point for many experimental catheterization procedures, and a few procedures use arterial access. The atrial septum 100 is a percutaneous access point for, for example, treatment of atrial fibrillation, left atrial appendage closure, percutaneous mitral valve repair, and percutaneous mitral valve replacement. These and other procedures require devices to pass through the atrial septum 100, potentially leaving an opening in the atrial septum that cannot close or heal naturally. In some embodiments, a closure device, such as the devices shown in Figures 2A-2E, can be implanted into the defect 107 to partially or completely close the defect 107.

[0026] II. Closure Device a. Overview

[0027] 2A-2E show closure device 200 in an expanded configuration. Referring to FIG. 2A, closure device 200 includes support structure 201. Support structure 201 may include first anchor portion 202 and opposing second anchor portion 204. Support structure 201 is configured to expand and contract between a compressed tubular configuration for insertion through a patient's vasculature and an expanded or elongated configuration in which first and second anchor portions 202, 204 extend radially outward from central portion 206. Central portion 206 may define lumen 208, which extends through the center of first anchor portion 202 and the center of second anchor portion 204. As shown in FIGS. 4A-4C, first and second anchor portions 202, 204 can be used to compress a septum (e.g., septum 7 of FIG. 1) therebetween. For example, as described further herein, closure device 200 can be inserted into heart 103 to partially or completely close defect 107. For example, if defect 107 is present in atrial septum 100, closure device 200 may be positioned such that either first or second anchor portion 202 / 204 is positioned on one side of septum 7 in first compartment 9 (e.g., corresponding to right atrium 101) and the opposite anchor portion 202, 204 is positioned on the opposite side of septum 7 in second compartment 10 (e.g., corresponding to left atrium 102). Support structure 201 is further described with reference to Figures 3A-3D.

[0028] The closure device 200 may further include one or more diaphragms or membranes coupled to the support structure 201. For example, in some embodiments, including the illustrated embodiment, the closure device 200 comprises a frame covering membrane 210 and a closure membrane 212. One or both of the membranes 210 / 212 may be configured to close the lumen 208 when the closure device 200 is in the expanded configuration. The frame covering membrane 210 may be configured to cover all or a portion of the first anchor portion 202 and / or the second anchor portion 204. For example, the frame covering membrane 210 may extend across the central portion 206 between the first and second anchor portions 202, 204. The closure membrane 212 may be disposed over the frame covering membrane 210 and configured to close off blood flow. As used herein, the term "closure" may refer to minimizing or completely preventing blood flow through the membrane. For example, when the closure device 200 is positioned within the heart 103 as described above, the closure membrane 212 may close the lumen 4 corresponding to the defect 107 and prevent blood flow from the first compartment 9 to the second compartment 10, or vice versa.

[0029] The obturator membrane 212 may have a generally circular shape. However, in some embodiments, the obturator membrane 212 may have any suitable shape (e.g., square, rectangular, polygonal, and / or the like) that sufficiently covers a majority of the lumen 208 when the closure device 200 is in the expanded configuration. The obturator membrane 212 may be coupled to the covering membrane 210 and / or support structure 201 of the closure device 200 by any suitable means, including, for example, adhesive bonding, heat sealing, lamination, spraying, dipping, electrospinning, suturing, co-molding, crimping, interlocking, combinations of the foregoing, and / or the like. Similarly, the frame covering membrane 210 may be coupled to the support structure 201 by any suitable means, including, for example, adhesive bonding, heat sealing, suturing, co-molding, crimping, interlocking, combinations of the foregoing, and / or the like. In some examples, the support structure 201 is completely encapsulated / surrounded by the frame coating 210, such that no portion of either the first anchor portion 202 or the second anchor portion 204 is uncovered by either the frame coating 210 or another coating. In certain embodiments, at least 90% of the surface area of ​​the support structure 201 is encapsulated by the frame coating 210, and in certain embodiments, at least 80% of the surface area of ​​the support structure 201 is encapsulated by the frame coating. In certain embodiments, only the outer end of the support structure 201 is exposed (i.e., not encapsulated by the frame coating). For example, in some embodiments, a portion of the support structure 201 that extends beyond 90% of the inner diameter of the closure device 200 is exposed. As another example, in some embodiments, a portion of the support structure 201 that extends beyond 80% of the inner diameter of the closure device 200 is exposed. In some instances, completely encapsulating the closure device 200 with a membrane (e.g., the frame covering membrane 210 and / or the closure membrane 212) or encapsulating a majority of the closure device 200 with a membrane may provide certain advantages over non-encapsulated devices with exposed metal components, such as devices with metal braids.For example, devices with exposed metal can damage adjacent cardiac structures, such as the aorta, due to direct contact between the metal components and cardiac tissue and erosion of the metal over time. In some instances, the obturator membrane 212 may be bonded to the central portion 206 defining the lumen 208. In this example, a majority (e.g., 80%, 90%, etc.) or the entire support structure 201 may be encapsulated by one or both of the frame-covering membrane 210 and the obturator membrane 212. As described herein, the material of the membranes 210 and 212 provides a scaffold for tissue growth. If the entire closure device 200 is covered by the membranes 210 and 212, the closure device 200 does not contain exposed metal, which is desirable because contact of exposed metal with circulating blood can be harmful to the patient. Additionally, the obturator membrane 212 bonded to the central portion 206 functions as an occlusive element, allowing blood cells to quickly coat the closure device 200 and subsequently endothelialize on the closure device 200. In some embodiments, multiple or additional membranes with reduced surface area (e.g., at least 5% relative to the main frame covering membrane 210) can be placed on the support structure 201 or main frame covering membrane 210 relative to one or more features on the closure device 200, such as anchor portions 202, 204 or similar peripheral structures, to create softer regions within the frame covering membrane 210 and promote atraumatic membrane coverage. For example, certain portions of the support structure 201 may include additional membrane layers.

[0030] The frame covering membrane 210 may be constructed of any suitable material that can expand and contract with the closure device 200. Generally, the frame covering membrane 210 extends from the upper edge 222 of the first anchor portion 202 (e.g., FIG. 2E ), along the struts of the first anchor portion 202, across the central portion 206, along the struts of the second anchor portion 204, to the outer edge 220 of the second anchor portion 204 (e.g., FIG. 2D ). Therefore, a suitable material for the frame covering membrane 210 advantageously has sufficient flexibility to stretch along the support structure 201 while generally conforming to the shape of the support structure 201. For example, the frame covering membrane 210 may be constructed of a resilient material such as, for example, silicone or a medical elastomer, polyurethane, polyurethane blends, and / or the like. In another example, the frame covering 210 may be constructed of a mesh material such as, for example, polyethylene terephthalate (PET), expanded polytetrafluoroethylene (ePTFE), polytetrafluoroethylene (PTFE), polyvinyl alcohol (PVA), and / or the like. In some embodiments, the frame covering 210 may be constructed of a biodegradable or bioabsorbable material.

[0031] The obturator membrane 212 may be made of any suitable material capable of expanding and contracting with the closure device 200 and sufficiently occluding blood flow. For example, the obturator membrane 212 may be made of an elastic material such as, for example, silicone or a medical elastomer, polyurethane, a polyurethane blend, and / or the like. In another example, the obturator membrane 212 may be made of a mesh material such as, for example, polyethylene terephthalate (PET), expanded polytetrafluoroethylene (ePTFE), polytetrafluoroethylene (PTFE), polyvinyl alcohol (PVA), and / or the like. In some embodiments, the obturator membrane 212 may be made of a biodegradable or bioabsorbable material.

[0032] In some embodiments, including the embodiment shown in FIG. 2B2, the obturator membrane 212 and / or frame-coated membrane 210 comprise an electrospun membrane. Electrospun elastic materials are a subset of elastic materials. For example, the obturator membrane 212 and / or frame-coated membrane 210 may comprise continuous micro / nanopolymer fibers. By using an electrospun membrane, the membranes 210 and / or 212 may have high elasticity and / or be highly compliant. For example, when electrospun polymers are used for the membranes 210, 212, the membranes 210, 212 are less likely to break (e.g., tear) when stretched compared to their immersed / sprayed counterparts. Electrospun membranes may also promote the development and growth of a tissue layer over the obturator membrane 212 and / or closure device 200 when implanted. For example, the electrospun obturator membrane 212 and / or frame-coated membrane 210 may allow a thin layer of tissue to endothelialize (e.g., enable rapid endothelialization). For example, electrospun materials as used in the embodiments disclosed herein may be advantageously associated with better endothelialization (faster and less inflammation) than non-porous materials, which (without being bound or limited to a particular theory) may be the result of the nanofiber matrix better mimicking natural physiology and promoting healthy cell growth. As the tissue layer grows, the closure device 200 can completely close the lumen 4, reducing the risk of thrombus growth. In embodiments where tissue growth is promoted, the closure device 200 can serve as a scaffold for tissue growth and function as an artificial septum for the heart 103. Furthermore, due in part to the compliance of the electrospun membrane (e.g., closure membrane 212), there may be less inflammation in the septal tissue when the closure device 200 is implanted compared to other non-compliant materials such as PET or PTFE. As previously discussed, less inflammation may promote faster endothelialization. Electrospun nanofiber membranes support the formation of a stable endothelial cell monolayer similar to that of vascular endothelium and myocardium. In some embodiments, all or a portion of the frame covering 210 may be configured to minimize tissue growth on the frame covering 210 .For example, it may be desirable to have a minimal amount of tissue growing within the inner boundary of the central section 206 / lumen 208.

[0033] The use of elastic closure technologies, such as electrospun membranes, for the obturator membrane 212 and / or frame covering membrane 210 may provide several important advantages to the closure device 200, including improved septal compliance. For example, electrospun membranes can mimic the compliance of the septum. In one example, endothelialization of the closure device 200 may be improved, in part, due to the compliance of the obturator membrane 212 and / or frame covering membrane 210. Compliant materials, such as polyurethane and silicone, exhibit better healing and a lower inflammatory response compared to non-compliant, inelastic materials, such as PET, ePTFE, and PTFE. In another example, the use of compliant materials may improve a patient's hemodynamics. This is because a compliant neoseptum better mimics the native septum, allowing pressures within the heart to better mimic native physiology. In yet another example, the use of compliant materials may result in improved response from structures surrounding the implanted closure device 200 compared to non-compliant materials. For example, the use of stiff closure materials (i.e., non-compliant) often leads to persistent inflammation and poor healing. Continued inflammation can lead to a stiff septum, which can have serious consequences. For example, it can cause damage to the electrical conduction system throughout the cardiac septum (i.e., both the atrial and ventricular septum). Damage to the electrical conduction system increases a patient's risk of atrial arrhythmias, which is why closure devices are often associated with atrial arrhythmias.

[0034] In some embodiments, the closure device 200 may include one or more frame covering membranes 210. For example, the closure device 200 may include 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, etc. frame covering membranes 210. When multiple frame covering membranes 210 are present, the multiple membranes may be stacked on top of each other, and / or different frame covering membranes 210 may cover different portions of the support structure 201. For example, one or more frame covering membranes 210 may cover the support structure 201, while one or more frame covering membranes 210 may cover the second anchor portion 204. In some embodiments, the closure device 200 may include one or more closure membranes 212. For example, the closure device 200 may include 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, etc. closure membranes 212. When multiple closure membranes 212 are present, the multiple closure membranes may be stacked on top of each other.

[0035] 2B1 and 2B2 show left atrial lateral views of a closure device 200 including an obturator membrane 212 according to different embodiments. FIG. 2C shows a right atrial lateral view of the closure device 200. In some instances, it may be desirable to repass the septum 7 after the closure device 200 has been positioned within the heart 103. For example, in some instances, a subsequent medical procedure may require repassing the same lumen 4 corresponding to the now-closed defect 107 to access the first compartment 9 through the second compartment 10 (or vice versa). In some embodiments, including the embodiment shown in FIGS. 2B1 and 2B2, the closure device 200 may be configured to allow a medical instrument (e.g., a catheter) to pass through the obturator membrane 212 and lumen 208 to access the opposite compartment of the heart through the closure device 200. Generally, the closure device 200 may be repassed in a subsequent medical procedure months or years after the closure device 200 is initially implanted in the heart 103, although in some embodiments, the closure device 200 may be repassed immediately after implantation. In embodiments in which one or both of the frame covering membrane 210 and the obturator membrane 212 are configured to promote tissue in-growth, repassage of the closure device 200 may require puncturing both the tissue layer formed on the obturator membrane 212 (e.g., tissue layer 115 in FIG. 4C ) and the obturator membrane 212 to pass through the lumen 208. While the obturator membrane 212 is shown positioned near one side of the closure device 200, it will be appreciated that the obturator membrane 212 may be positioned anywhere within or on the closure device 200. For example, the obturator membrane 212 may be positioned at different locations along the neck defined by the central portion 206. In one example, the obturator membrane 212 is positioned primarily on the right atrial or left atrial side. In another example, the obturator membrane 212 may be centrally positioned within the neck defined by the central portion 206 between the right and left atrial sides. The location of the obturator membrane 212 on the closure device 200 and / or its relative location to the frame covering membrane 210 may affect the location of the final tissue layer 115 formed on the closure device 200.For example, if the closure membrane 212 is positioned within the central portion 206 , a tissue layer 115 may form within the closure device 200 and within the central portion 206 .

[0036] In some embodiments, including the embodiment shown in FIG. 2B1 , the obturator membrane 212 may include multiple cuts or slits 214 to facilitate passage of a medical instrument through the closure device 200. For example, the obturator membrane 212 may include 1, 2, 3, 4, 5, 10, 15, 20, 30, 50, etc. slits 214. The length L of each individual slit 214 may vary based on the location of the slit 214 on the obturator membrane 212. In some embodiments, when the obturator membrane 212 has a circular shape, each individual slit 214 may extend a certain percentage of the chord length. As used herein, the term “chord” refers to a line segment connecting any two points on the circumference of a circle. For example, each individual slit 214 may have a length that extends between 10% and 100% of the chord (e.g., 10% and 100%, 20% and 90%, 30% and 75%, 50% and 60%, any value in between, etc.). Generally, the slits 214 are generally parallel to one another. During operation, as a medical instrument passes through the obturator membrane 212, the medical instrument may pass through one of the slits 214, causing the obturator membrane 212 to elastically deform to allow the medical instrument to pass through the closure device 200. When the medical instrument is removed from the closure device 200 (e.g., pulled back through the patient's vasculature), the obturator membrane 212 may be configured to return to its original position and continue to close the lumen 4. In embodiments in which the closure device 200 includes multiple obturator membranes 212, the multiple membranes 212 may be stacked such that the slits 214 of a first membrane 212 are perpendicular to or at different angles to the slits 214 of a second membrane 214. For example, when the closure device 200 is positioned within the heart 103, the slits 214 of the first obturator membrane 212 may run substantially vertically, and the slits 214 of the second obturator membrane 212 may run substantially horizontally.

[0037] In some embodiments, the occlusion membrane 212 may include individual slits 214 extending across approximately the center of the occlusion membrane 212. The length L of the individual slits 214 may extend a percentage of the length of a chord line corresponding to the diameter of the occlusion membrane 212 when the occlusion membrane 212 has a circular shape. For example, the individual slits 214 may have a length that extends between 10% and 100% of the diameter chord line (e.g., 10% and 100%, 20% and 90%, 30% and 75%, 50% and 60%, values ​​in between, etc.).

[0038] In some embodiments, including the embodiment shown in FIG. 2B2, the closure membrane 212 comprises an electrospun membrane. In the embodiment of FIG. 2B2, the closure membrane 212 may not include slits 214. Instead, the closure membrane 212 may include a plurality of perforations, e.g., 1, 5, 10, 25, 50, 100, 500, 1000, 10,000, 100,000, etc. The electrospun closure membrane 212 may have elastic properties. For example, the closure membrane 212 may be deformable with an elongation of at least 100% to 1000% (e.g., 100% to 1000%, 200% to 800%, 400% to 600%, values ​​in between, etc.). As described above, the electrospun membrane may comprise a polyurethane or polyurethane blend, which may have an ultimate strain of at least 350% to 600% (e.g., 350% to 600%, 400% to 500%, any value therebetween). The electrospun fibers used in the electrospun membrane may comprise fibers having a diameter of at least 750 nanometers to 5 microns (e.g., 750 nanometers to 5 microns, 2 microns to 4 microns, 2.5 microns to 3.5 microns, any value therebetween). In this example, the obturator membrane 212 may function as a fragile tissue scaffold. Depending on the type and diameter of the fibers used, the obturator membrane 212 may preferably have a scaffold thickness of between 50 microns and 200 microns (e.g., 50 microns to 200 microns, 75 microns to 175 microns, 100 microns to 150 microns, 100 microns to 125 microns, any value therebetween). However, it is recognized that the thickness of the obturator membrane 212 varies based on several factors, and that in some embodiments, it may be desirable to have a thinner or thicker obturator membrane 212. Use of a thin obturator membrane 212 may provide the advantage of allowing the obturator membrane 212 to lie flat against the septum, flexing flexibly with the septum after implantation. Generally, the fiber structure of the obturator membrane 212 is random, non-aligned fibers, which causes the obturator membrane 212 to have similar properties in all directions. The obturator membrane 212, acting as a tissue scaffold, may promote the growth of a tissue layer across at least the outer surface of the obturator membrane 212 (e.g., in the direction facing the left atrial side 216).However, in some embodiments, the obturator membrane 212 may be configured to limit or prevent any tissue growth within the obturator membrane 212 (e.g., tissue scaffold) so that the obturator membrane 212 maintains similar elasticity whether or not a tissue layer is present. In some embodiments, the obturator membrane 212 may be semi-porous. For example, the obturator membrane 212 is permeable to gases but not liquids. In some embodiments, a semi-porous membrane is permeable to water but not blood. The use of an acellular porous structure may allow immediate septum closure upon implantation of the closure device 200, prior to tissue growth. In some embodiments, as a result of the electrospinning process, the obturator membrane 212 may be impermeable / non-porous to certain elements (e.g., endothelial cells) but may allow certain elements (e.g., fluids such as plasma) to pass through / diffuse through the membrane 212. As such, the electrospun obturator membrane 212 creates an excellent scaffold for cell growth. Once the closure device 200 is implanted, a medical instrument may pass directly through any tissue layer (e.g., tissue layer 115) and the obturator membrane 212 above the closure device 200, causing elastic deformation of the obturator membrane 212. Generally, it may be desirable to avoid plastically deforming the obturator membrane 212 during the procedure. Once the subsequent medical procedure is completed and the medical instrument is withdrawn, the obturator membrane 212 may return to approximately its original position (e.g., as a result of the elastic properties of the obturator membrane 212) and continue to close the lumen 4. Generally, even after the medical instrument has been passed, the closure device 200 may provide the same amount of closure of the lumen 4 as when the closure device 200 was initially implanted (e.g., before it was passed). For example, the medical instrument may cause minimal damage or plastic deformation to the obturator membrane 212. Furthermore, even after passing during a subsequent procedure (e.g., if a tissue layer has been perforated), the obturator membrane 212 continues to promote new tissue growth throughout the closure device 200, increasing the occlusion of the closure device 200 as the tissue layers grow.

[0039] 2B1 and 2B2 show left atrial lateral views of the closure device 200, and FIG. 2C shows a rear view of the closure device 200. As shown in FIGS. 2B1 / 2B2 and 2C, the anterior / left atrial side 216 of the closure device 200 can be a significant target for a medical instrument operator (e.g., a physician) to pass through. However, the passable portion / area of ​​the closure device 200, including the lumen 208, is smaller than the overall diameter of the left atrial side 216 of the closure device 200, as shown in FIG. 2C. In some embodiments, the anchor frame 201 supporting the membranes 210 and 212 can be constructed from a radiopaque material. In some instances, the radiopaque material used can be nitinol. The radiopaque support structure 201 provides the physician with clear visualization of the closure device 200 within the anatomy under fluoroscopy. This feature is important for accurate deployment and positioning during implantation of the closure device 200, as well as for repassage of the closure device 200 (either acutely or chronically), because it makes positioning the septal puncture much easier. In some embodiments, all or a portion of the obturator membrane 212 may be composed of a radiopaque material to assist the operator in passing the closure device 200. For example, a portion of the obturator membrane 212 may be dyed or otherwise treated with a radiopaque substance. For example, between 0% and 100% of the obturator membrane 212 (e.g., 0% and 100%, 10% and 90%, 25% and 75%, 50% and 60%, any value between the above, etc.) may be composed of a radiopaque material. In some embodiments, it may be preferable for less than 30% of the obturator membrane 212 to be composed of a radiopaque material. In some embodiments, the portion of the obturator membrane 212 composed of a radiopaque material may correspond to the lumen 208. For example, a central portion (e.g., a circle) of the obturator membrane 212, approximately the same size as the lumen 208, may be constructed of a radiopaque material. In some embodiments, the obturator membrane 212 may include only radiopaque targets, such as, for example, X-shaped targets, circular targets, and / or the like.When a medical procedure involves passing the closure device 200, the medical instrument operator can use fluoroscopic imaging to identify the radiopaque portion of the closure device 200, which the operator can use to safely pass the closure device 200 without contacting the support structure 201. In some embodiments, the radiopaque portion of the closure device 200 can allow the medical instrument operator to select a septal region to pass outside of the closure device 200.

[0040] FIG. 2D shows a side view of the closure device 200, and FIG. 2E shows a cross-sectional view of the closure device 200 along line 2E-2E in FIG. 2B1. The left atrial side 216 of the closure device 200, including the closure membrane 212, may comprise a generally planar surface. In some embodiments, the outer edge 222 of the left atrial side 216 may curve away from the dorsal / right atrial side 218. As shown more clearly in FIG. 2E, the curvature of the outer edge 222 of the left atrial side 216 may only begin near the periphery of the left atrial side 216. For example, between 80% and 100% of the diameter of the left atrial side 216 (e.g., 80% to 100%, 82.5% to 97.5%, 85% to 95%, 87.5% to 92.5%, values ​​in between, etc.) may be generally planar. Generally, it may be preferable for the outer edge 222 to be as flush as possible with the septal tissue without causing trauma to the septal tissue. For example, the outer edge 222 may be flat (i.e., without curvature) or slightly curved inward (i.e., away from the septal tissue), as shown at least in FIG. 2E. Furthermore, a flat or minimally curved outer edge 222 can ensure close contact with the septal tissue, resulting in better fixation and rapid endothelialization. In some embodiments, a closure device 200 having a curved outer edge 222 may improve delivery of the closure device 200 because the closure device 200 is less likely to scratch or contact the lumen of the delivery sheath. The right atrial side 218 of the closure device 200 may also be generally planar and generally parallel to the left atrial side 216. For example, a medical instrument in the right atrium 101 can pass through the right atrial side 218 and enter the left atrium 102 across a first plane (e.g., corresponding to the right atrial side 218) and a second parallel plane (e.g., corresponding to the left atrial side 216). In some embodiments, the second anchor portion 204 can be configured to lie flat against the septal tissue when implanted, resulting in a flat radius of curvature for the support structure 201. In some instances, the closure device 200 can be configured such that there is minimal or no discontinuity in the two planes defined by the left atrial side 216 and the right atrial side 218. For example, one or both of the left atrial sides 216 and 218 can form a continuous surface.For example, a portion of the support structure 201 may minimally extend from the left atrial side 216 into the left atrium 102 and from the right atrial side 218 into the right atrium 101. For example, the minimal extension may be between 0 mm and 0.5 mm (e.g., 0 mm and 0.5 mm, 0.1 mm and 0.4 mm, 0.2 mm and 0.3 mm, values ​​therebetween, etc.). For further clarification, a discontinuity may refer to a portion of the closure device 200 that is out of the plane of the majority of the left atrial side 216 or out of the plane of the majority of the right atrial side 218 after the closure device 200 is implanted. For example, with respect to the left atrial side 216, the curved portions of the outer edges 220 and 222 may extend less than 0.5 mm, preferably less than 0.1 mm, into the left atrium 102 with respect to a plane defined by the left atrial 102 wall. With respect to the right atrial side 218, the outer petal tip 244 may extend less than 0.5 mm, preferably less than 0.1 mm, into the right atrium 101 relative to the plane defined by the right atrial 101 wall. Minimal extension of the closure device 200 may provide certain advantages, such as allowing the left atrial side 216 and the right atrial side 218 to have a flat shape against the septal wall. For example, a flat shape may improve the rate at which the closure device 200 becomes endothelialized, since tissue does not have to grow over the edges or only needs to grow over a small edge of the closure device 200. An additional advantage of eliminating / reducing discontinuities in the closure device 200 is that discontinuities are often sites of thrombus formation and infection.

[0041] Referring to Figure 2D, closure device 200 is generally bowl-shaped in side view. As shown in Figure 2E, first and second anchor portions 202, 204 define lumen 208, with first anchor portion 202 curving from central portion 206 toward left atrial side 216 and away from lumen 208, and second anchor portion 204 curving from central portion 206 toward right atrial side 218 and away from lumen 208. As first anchor portion 202 moves away from lumen 208, first anchor portion 202 forms first plane 216, as described above. As second anchor portion 204 moves away from lumen 208, the lower edge of second anchor portion 204 contacts second plane 218. The second anchor portion 204 continues to extend away from the lumen 208 toward the left atrial side 216 at an angle of between 5% and 85% (e.g., between 5% and 85%, 15% and 75%, 25% and 60%, 35% and 55%, or any value therebetween) relative to a second plane corresponding to the right atrial side 218. The second anchor portion 204 may extend in this direction until it reaches an outer edge 220 of the second anchor portion 204. In some embodiments, the outer edge 220 may have a different angle relative to the second plane of the right atrial side 218 than the majority of the second anchor portion 204. The frame covering 210 may conform to the shape of the support structure 201 in the expanded configuration, extending from at or near the outer edge 220 of the second anchor portion 204, along the curve of the second anchor portion 204, across the central portion 206, and to at or near the outer edge 222 of the first anchor portion 202. The bowl-shaped nature of the closure device 200 can reduce the presence of a protrusion into the left atrium 102 when the closure device 200 is implanted. This can be beneficial because a protrusion into the left atrium 102 can increase the risk of stroke. In some embodiments, it may be preferable to reduce the corresponding bulging of the right atrium 101 caused by the bowl-shaped closure device 200.

[0042] In some embodiments, the closure device 200 may include holes in the obturator membrane 212 such that the closure device 200 behaves as a compliant shunt. For example, the holes may be located near the center of the obturator membrane 212. Due to the compliance of the obturator membrane 212, an increase in pressure differential across the septum may cause the holes to expand, thereby allowing the closure device 200 to act like a dynamic pressure relief valve. One advantage of this embodiment may be improved performance for heart failure patients during exercise. b. Membrane properties

[0043] As mentioned above, the closure device 200 may include one or more membranes, such as the frame-covered membrane 210 and the closure membrane 212. While some properties of the membranes 210, 212 have been described above, for greater clarity, additional membrane behaviors and properties are described in this section. It is recognized that the properties described herein may apply to either or both the frame-covered membrane 210 and the closure membrane 212. This section describes the properties of the membranes 210, 212. It is further recognized that some embodiments of the closure device 200 may include all of the following and previously described properties, while other embodiments of the closure device 200 may include only some of the properties described herein.

[0044] The membranes 210, 212 may comprise electrospun membranes, such as continuous micro / nano polymer fibers. The electrospun fibers used in the electrospun membranes 110, 112 may include fibers having a diameter of at least 0.5 microns to 5 microns (e.g., 0.5 microns to 5 microns, 1 micron to 4.5 microns, 1.5 microns to 4 microns, 2 microns to 3 microns, values ​​therebetween, etc.). In some instances, it may be preferable for the diameter of the fibers in the electrospun membranes 110, 112 to be between 1 and 3 microns. As discussed above, the use of electrospun membranes can result in membranes 210, 212 that are highly elastic and / or compliant. Furthermore, the electrospun membranes 110, 112 can enable endothelialization of a thin layer of tissue over the closure device 200 upon implantation. Furthermore, the electrospun membranes 110, 112 may improve the compliance of the septum of the closure device 200. A compliant septum better mimics the natural septum and allows blood pressure within the heart to better mimic natural physiology.

[0045] The compliance of the closure device 200 can be attributed in part to the elastic properties of the electrospun membranes 110, 112. For example, the electrospun membranes 110, 112 can be deformable at an elongation of at least between 100% and 1000% (e.g., 100% to 1000%, 200% to 800%, 400% to 600%, values ​​in between, etc.). In some instances, the electrospun membranes 110, 112 may be preferably configured to elongate greater than 400% during routine procedures (e.g., puncture and passage with a medical device such as a catheter) without plastically deforming. An elongation in this range may enable the closure device 200 to adequately close the defect 107 while being punctured (e.g., because the fibers elongate to surround the medical device) and immediately after the medical device is removed (e.g., because the fibers can elastically elongate and return to their original configuration). The ultimate strain of the fibers of the electrospun membranes 110, 112 can be at least between 350% and 600% (eg, 350% and 600%, 400% and 550%, 450% and 500%, values ​​therebetween, etc.).

[0046] The stretchability of electrospun membranes 110, 112 allows electrospun membranes 110, 112 to flex during the cardiac cycle. During a normal cardiac cycle, the septum continually flexes in response to changes in pressure within the heart (e.g., toward the left atrium and in opposite directions toward the right atrium). Once implanted, closure device 200 desirably does not interfere with, or significantly interferes with, the normal flexing of the septum. Rather, it desirably promotes normal flexing of the septum. In some instances, once closure device 200 is implanted, it may move with the septum during a normal cardiac cycle. Additionally, electrospun membranes 110, 112 may flex further within the left and right atria depending on the phase of the cardiac cycle. In some instances, the electrospun membranes 110, 112 may elastically deflect (e.g., relative to the support structure 201) between at least 0.5 mm and 5 mm (e.g., 0.5 mm to 5 mm, 1 mm to 4.5 mm, 1.5 mm to 4 mm, 2 mm to 3.5 mm, 2.5 mm to 3 mm, values ​​in between, etc.). It is recognized that the amount of deflection varies from patient to patient and is dependent, in part, on the pressure within the patient's heart. In this manner, normal deflection of the septum is promoted, and strain on the septum is minimized by the closure device 200. This behavior may provide significant long-term benefits when compared to other rigid septal closure devices. Rigid closure devices may strain the septum and heart, resulting in a stiff septum that does not deflect normally during the cardiac cycle. This may impact the patient's hemodynamics and lead to long-term complications, such as increased risk of stroke, need for long-term care, erosion of adjacent cardiac structures, and atrial arrhythmias.

[0047] The ability of the closure device 200 to flex with the septum and promote normal cardiac behavior can be attributed in part to the weight of the closure device 200. Because the closure device 200 is lightweight, it can maintain septal compliance and protect the septum and surrounding cardiac structures. For example, a lighter closure device 200 can result in less fouling of the septum after implantation. In another example, a lightweight closure device 200 can move freely with the septum as it flexes. In some examples, the weight of the closure device 200 can be between 25 micrograms and 200 micrograms (e.g., 25 μg to 200 μg, 50 μg to 150 μg, 75 μg to 125 μg, values ​​therebetween, etc.). In some examples, it may be preferable for the closure device 200 to weigh less than 50 micrograms. It is recognized that the weight of the closure device 200 depends in part on the size of the closure device 200 and the size of the defect 107 to be closed using the closure device 200. For example, a closure device 200 used for a small defect in a pediatric patient may weigh less than a closure device 200 used for a large defect in an adult patient. The above ranges are for closure devices 200 for adults. In some cases, the closure device 200 may be 5 to 10 times lighter than currently available closure devices. The lightweight nature of the closure device 200 may be due in part to the use of electrospun fibers in the membranes 110, 112. Some commercially available closure materials use metal braids or structures to seal septal defects. The use of metal braids may increase the weight and / or stiffness of the closure device and / or may result in other negative consequences, as described herein. For example, a heavy / rigid closure device may compromise the septal conduction system. The lightweight nature of the closure device 200 may also be due in part to the design of the first anchor portion 202 and the second anchor portion 204, which can be gripped outside the support structure 201 during implantation. Support structure 201 is further described herein with reference to at least Figures 3A-3D.

[0048] The compliance of the closure device 200 may be due in part to the thickness T of the closure device 200 (see, e.g., FIG. 2D ). For example, it may be desirable to minimize the thickness T of the closure device 200 to reduce expansion of the closure device 200 into the left and right atria 102, 101. In the heart, the thickness of the septum may be approximately 1 mm to 5 mm (depending on the patient and the location of the defect) where the closure device 200 is implanted. In some instances, the thickness T of the closure device 200 may be between 1 mm and 5 mm, 2 mm to 5 mm (e.g., 1 mm to 5 mm, 2 mm to 5 mm, 2.5 mm to 4.5 mm, 3 mm to 4 mm, values ​​in between, etc.). In some instances, it may be desirable for the thickness of the closure device 200 to be 5 mm or less. The closure device 200 may be significantly thinner than commercially available closure devices, which may be 5 mm to 10 mm or thicker.

[0049] As shown in FIG. 4B , the implanted closure device 200 (prior to endothelialization) has a thickness similar to that of the septum 7. Furthermore, once implanted, the closure device 200 extends minimally into the right atrium 101 and left atrium 102, eliminating discontinuities that could become sites of thrombus formation and infection. Specifically, the closure device 200 is substantially flush with the left atrium 102. As used herein, substantially flush may mean that the closure device 200 extends less than 0.5 mm into the left atrium 102 relative to the edge of the septum 7. For example, in some instances, the closure device 200 may extend between 0.05 mm and 0.5 mm (e.g., 0.05 mm to 0.5 mm, 0.1 mm to 0.4 mm, 0.15 mm to 0.35 mm, 0.2 mm to 0.3 mm, values ​​therebetween, etc.). In some instances, it may be desirable to extend less than 0.1 mm into the left atrium 102. Minimizing the extension of the closure device 200 into the left atrium 102 may reduce or eliminate the need for long-term medication and associated morbidity traditionally associated with septal closure devices, in part because the closure device 200 significantly reduces the strain on the septum. Furthermore, once endothelialization of the closure device 200 occurs (see, e.g., FIG. 4C ), the septum of the left atrium 102 may be substantially flattened in shape because the closure device 200 is sufficiently embedded in the septum and covered with tissue. Similarly, the closure device 200 may also only minimally extend into the right atrium 101 after endothelialization, even before it is covered with tissue. For example, in some instances, the closure device 200 may extend between 0.1 mm and 2 mm (e.g., 0.1 mm to 2 mm, 0.25 mm to 1.75 mm, 0.5 mm to 1.5 mm, 0.75 mm to 1.25 mm, values ​​in between, etc.) into the right atrium 101 (relative to the septum 7). In comparison, commercially available closure devices may extend between 3 mm and 5 mm (or more) into each of the left and right atria 101, 102. A small overall thickness and minimal extension into the left and right atria 101, 102 is desirable for improved septal compliance and long-term patient health, while providing the added benefit of rapid endothelialization of the closure device 200.For example, closure device 200, at least in part due to its ultra-thin design and minimal atrial dilation, may endothelialize significantly faster than commercially available closure devices (which can take years to begin endothelializing). The smooth tissue interface correspondingly reduces the risk of stroke because the smooth endothelium reduces shear forces on the septum, helping to prevent thrombus formation.

[0050] To further clarify, currently available commercially available devices have several disadvantages compared to closure device 200 in terms of the rate of endothelialization and the consequences of delayed endothelialization. For example, when currently available commercially available closure devices are implanted in a patient, the patient often must receive antiplatelet medications and antibiotics for at least three to six months while the device and implantation site heal and the device begins to become endothelialized. For at least this period, and in some cases longer, current devices have exposed metal (e.g., braid) in the bloodstream, which can become a site for thrombus formation and / or infection. The long time it takes current devices to become endothelialized is likely due to at least three factors. First, current devices typically utilize metal (e.g., metal braid) and often unencapsulated metal, which results in slower endothelialization rates compared to compliant meshes. Second, current devices are thick, requiring tissue to grow over and along the sides of the device. Third, current devices have several discontinuities (i.e., portions of the device that extend / protrude directly into the bloodstream). Because of the discontinuities, the projections take longer to become covered by tissue, and in many cases, they never become covered by tissue. A further suggested reason for the improved endothelialization of the closure device 200 relates to the relative movement between adjacent portions of the device. In commercially available braided devices, the filaments move continuously relative to one another, which can slow down cell growth and increase inflammation and scarring. Conversely, the relative movement between adjacent portions of the closure device 200 is limited, which may contribute to the improved endothelialization.

[0051] In another example, the compliance of the closure device 200 may be due in part to the thickness T2 of the lumen 208 of the closure device 200 (see, e.g., FIG. 2E). In this example, thickness T2 may encompass not only the thickness of the obturator membrane 212 but also the tissue that eventually forms within the lumen 208 after the closure device 200 is implanted. Even if the lumen is open when the closure device 200 is initially implanted, over time, tissue may form and fill the lumen 208. Depending on the type and diameter of the fiber used, the obturator membrane 212 may preferably have a scaffold thickness between 20 microns and 100 microns (e.g., 20 microns to 100 microns, 30 microns to 90 microns, 40 microns to 80 microns, 50 microns to 70 microns, 50 microns to 60 microns, values ​​therebetween, etc.). It may be desirable to minimize thickness T2 of the lumen 208 to reduce expansion of the closure device 200 into the left and right atria 102, 101. As mentioned above, the thickness of the septum can be approximately 2 mm to 2.5 mm (varies depending on the patient) where the closure device 200 is implanted. In some cases, the thickness T2 of the lumen 208 can be between 1 mm and 5 mm, between 2 mm and 5 mm (e.g., between 1 mm and 5 mm, between 2 mm and 5 mm, between 2.5 mm and 4.5 mm, between 3 mm and 4 mm, values ​​therebetween, etc.). In some cases, it may be desirable for the thickness T2 of the lumen 208 to be 3 mm or less.

[0052] As described herein, the closure device 200, and particularly the membranes 210, 212, may be configured to promote rapid tissue growth across and / or around the closure device 200. Once implanted, the membranes 210, 212 may serve as a scaffold for cellular growth. For example, a complete tissue layer (e.g., covering at least a majority of the closure membrane 212) may form after a period of time, such as between 10 and 90 days (e.g., between 10 and 90 days, between 20 and 80 days, between 30 and 70 days, between 40 and 60 days, between 45 and 55 days, any value therebetween, etc.) after implantation of the closure device 200. In some embodiments, 90% tissue coverage may be achieved on the portion of the membrane 210, 212 over the first anchor portion 202 (i.e., the portion extending into the left atrium 102) within 10 days. In some embodiments, 80% tissue coverage of the portion of membrane 210, 212 on first anchor portion 202 may be achieved within 10 days. It is recognized that the duration of full tissue layer support may vary based on several factors, including the patient, defect size, size of closure device 200, and / or the like. Rapid tissue growth may be the result of one or more of the membrane properties / characteristics described above. In particular, rapid growth is believed to be a result of the use of electrospun membranes, which significantly accelerate the formation of a full endothelial monolayer compared to ePTFE membranes. In some instances, rapid tissue growth may be the result of membrane 210, 212 including one or more of the following characteristics: continuous micro / nano polymer fibers; fiber diameters ranging from 0.5 microns to 5 microns; fibers having an elongation of at least between 100% and 1000%; and fibers having an ultimate strain of between 350% and 600%. In certain embodiments, rapid tissue growth may be the result of the membranes 210, 212 having a combination of one or more of the following ranges: fiber diameters between 0.5 microns and 5 microns; fiber diameters between 1 micron and 3 microns; fibers deformable at elongations between 100% and 500%; fibers deformable at elongations between 200% and 400%; fibers with ultimate strains between 350% and 600%; and fibers with ultimate strains between 400% and 500%.Note that these ranges may include additional ranges as described above and may be used with combinations of other features herein (e.g., support structure 201 features, delivery system 500 features, other closure device 200 features, and / or other membrane 210, 212 features described herein). As a result of rapid tissue formation, interatrial blood flow between the left atrium 102 and the right atrium 101 through lumen 4 may be completely eliminated or may be further reduced compared to the intraoperative state (e.g., the state as described with reference to FIG. 4B). c. Closure device frame

[0053] 3A-3D show the frame or support structure 201 of the closure device 200 in an expanded configuration. FIG. 3A is a perspective view of the support structure 201, and FIG. 3B shows a left atrial lateral view of the support structure 201. As described above, the support structure 201 includes a first anchor portion 202 and a second anchor portion 204 extending radially outward from a central portion 206. In some embodiments, the first anchor portion 202 and the second anchor portion 204 may comprise separate components joined (e.g., welded, hinged) at the central portion 206, while in other embodiments, the first and second anchor portions 202, 204 comprise a single component molded to form the support structure 201. The central portion 206 may include multiple central connecting portions (e.g., 206A, 206B, 206C, etc.), which may define the boundaries of the lumen 208.

[0054] The first anchor portion 202 may include a plurality of interconnected petals 228, with each petal 228 formed from struts 224. For example, the first petal 228A includes a first strut 224A and a second strut 224B. In some embodiments, the first anchor portion 202 may include 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, etc. petals 228. Each strut 224 may extend radially outward from the central portion 206 toward the left atrial side 216 before forming a plane corresponding to the left atrial side 216. Two struts 224 forming a petal 228 may be joined at a petal tip 230. The petal tip 230 may be comprised of a half-loop and may extend away from the lumen 208 and the right atrial side 218 at an angle relative to the left atrial side 216, as described above. For example, a first strut 224A and a second strut 224B are connected at one end by a first central connector 206A (e.g., forming the central portion 206) and at the other end by a first petal tip 230A. As the two struts 224 forming a petal 228 extend away from the central portion 206, the distance between the two struts 224 increases, reaching a maximum distance near the center of the petal 228. After reaching the maximum distance, the distance between the two struts 224 decreases until the petal tip 230 is reached. Each petal 228 may be connected to adjacent petals 228 on either side by petal connectors 226. Each petal 228 may be connected to adjacent petals 228 at or near the position where the two struts 224 forming the individual petal 228 are at their maximum distance from each other. For example, first petal 228A, consisting of first strut 224A and second strut 224B, is connected to second petal 228B, consisting of third strut 224C and fourth strut 224D, at first petal connector 226A. Similarly, first petal 228A is connected to third petal 228C, consisting of fifth strut 224E and sixth strut 224F, at second petal connector 226B. Figure 3B is a top view of support structure 201 of closure device 200, further illustrating the components described above.

[0055] 3C shows a right atrial lateral view of the support structure 201 of the closure device 200, and FIG. 3D shows a side view of the support structure 201. The second anchor portion 204 may include a plurality of interconnected inner and outer petals 232, 234, where each inner petal 232 is formed from struts 236 and each outer petal 234 is formed from struts 236. Furthermore, adjacent struts 236 of two adjacent inner petals 232 form an outer petal 234. For example, the first inner petal 232A includes a first strut 236A and a second strut 236B, the second inner petal 232B includes a third strut 236C and a fourth strut 236D, and the first outer petal 234A includes a second strut 236B and a third strut 236C. Generally, the second anchor portion 204 includes the same number of inner petals 232 as outer petals 234. In some embodiments, the second anchor portion 204 may include 2, 4, 6, 8, 10, 15, 20, 25, 30, etc. inner and outer petals 232, 234.

[0056] Each strut 236 forming the inner petal 232 may extend radially outward from the central portion 206 toward the right atrial side 218 and curve upward toward the left atrial side 216. The base of the curve of each strut 236 forming the inner petal 232 may contact a plane corresponding to the right atrial side 218. Two struts 236 forming the inner petal 232 may be joined at an inner petal tip 238. The multiple petal tips 238 may form the outer edge 220 of the second anchor portion 204, which may correspond to the outer edge of the frame covering 210. The inner petal tip 238 may constitute the portion of the second anchor portion 204 closest to the left atrial side 216 when the closure device 200 is in the expanded configuration. For example, a first strut 236A and a second strut 236B are connected at one end by a first central connector 206A and at the other end by a first inner petal tip 238A. As the two struts 236 extend away from the central portion 206, the distance between the two struts 236 increases, reaching a maximum distance near the center of the inner petal 232. After reaching the maximum distance, the distance between the two struts 236 decreases until the inner petal tip 238 is reached. Each inner petal 232 may be connected to adjacent inner petals 232 on either side by inner petal connectors 240. Each inner petal 232 may be connected to adjacent inner petals 232 at or near the location where the two struts 236 forming the individual inner petal 232 are at their maximum distance from each other. For example, the first inner petal 232A, including the first strut 236A and the second strut 236B, is connected to the second inner petal 232B, including the third strut 236C and the fourth strut 236D, at the first inner petal connector 240A. Similarly, the first inner petal 232A is connected to the third inner petal 232C, including the fifth strut 236E and the sixth strut 236F, at the second inner petal connector 240B.

[0057] The individual struts 236 forming the outer petal 234 may extend radially outward from the central portion 206 toward the right atrial side 218, reaching a bending point 242. At the bending point 242, the individual struts 236 forming the outer petal 234 may curve toward the central portion 206 and continue toward the right atrial side 218. The curvature of the outer petal 234 is most clearly shown in FIG. 3D . Two struts 236 forming the outer petal 234 may be joined at an outer petal tip 244. The outer petal tip 244 may include an open-ended loop structure. In some embodiments, portions of the two struts 236 forming the outer petal 242 may form the outer petal tip 244. As described further herein, the outer petal tip 244 may be used to connect the closure device 200 to a medical instrument for implanting the closure device 200. For example, the outer petal tip 244 can include or define an eyelet for connecting the closure device 200 to a delivery system. In some embodiments, the outer petal tip 244 can terminate at or near a second plane corresponding to the right atrial side 218. As described above, the outer petals 234 can include the struts 236 of the adjacent inner petals 232. For example, the first outer petal 234A can include the second strut 236B and the third strut 236C, and the second outer petal 234B can include the first strut 236A and the sixth strut 236F. As the two struts 236 (e.g., struts 236B and 236C) forming an outer petal 234 (e.g., outer petal 234A) extend away from an inner petal connector (e.g., first inner petal connector 240A), the distance between the two struts 236 increases, reaching a maximum distance at or near the inner petal tips 238 corresponding to the two inner petals 232 (e.g., first inner petal tip 238A and second inner petal tip 238B). After reaching the maximum distance, the distance between the two struts 236 decreases until it reaches the outer petal tip 244 (e.g., outer petal tip 244A).

[0058] In some embodiments, the first anchor portion 202 and the second anchor portion 204 may be aligned such that the petal tip 230 of the first anchor portion 202 is offset from the outer petal tip 244 of the second anchor portion 204. For example, the petal tip 230 of the first anchor portion 202 may be aligned generally axially with the inner petal tip 238 of the second anchor portion 204 relative to the lumen 208. Similarly, the outer petal tip 244 of the second anchor portion 204 may be aligned generally axially with the petal connector 226 of the first anchor portion 202 relative to the lumen 208. This configuration may improve the compressive force applied to the septum 7 when the closure device 200 is implanted.

[0059] As shown in FIG. 3B , the support structure 201 in the expanded configuration includes an inner diameter D1 and an outer diameter D2. The inner diameter D1 may be defined by the distance between two opposing central connectors 206 (e.g., central connector 206A and central connector 206D). The size of the inner diameter D1 may be slightly larger or smaller than the lumen 4 corresponding to the defect 107. The outer diameter D2 may be defined by the distance between two opposing petal tips 230 (e.g., petal tip 230A and petal tip 230D) of the first anchor portion 202. The number of petals 228 of the first anchor portion 202, the number of inner and outer petals 232 and 234 of the second anchor portion 204, the lengths of the struts 224 and 236, and the inner and outer diameters D1 and D2 of the support structure 201 can be varied as needed for a particular application of the closure device 200.

[0060] In some embodiments, the inner diameter D1 can be between 4 mm and 45 mm (e.g., 4 mm and 45 mm, 10 mm and 40 mm, 20 mm and 30 mm, values ​​therebetween, etc.). The inner diameter D1 of a particular closure device 200 may be selected based on the size of the target defect 107. In some embodiments, the outer diameter D2 can be between 10 mm and 60 mm (e.g., 10 mm and 60 mm, 15 mm and 50 mm, 20 mm and 45 mm, 25 mm and 35 mm, values ​​therebetween, etc.). Generally, the size of the outer diameter D2 can vary based on the desired size of the inner diameter D1, and the inner and outer diameters D1 and D2 may be selected based on the size of the target defect 107. The outer diameter D2 is generally larger than the target defect 107 so that there is enough tissue within the septum 7 for the support structure 201 to be compressed therebetween.

[0061] As described herein, the support structure 201 is configured to expand and contract between a compressed tubular configuration for insertion through a patient's vasculature and an expanded or elongated configuration in which the first and second anchor portions 202, 204 extend radially outward from the central portion 206. The support structure 201 may be composed of any suitable material that can conform to the compressed tubular configuration with minimal plastic deformation and allow it to expand to the expanded configuration for implantation. This material may enable the support structure 201 to be self-expandable. Generally, the support structure 201 may be composed of a non-toxic material such that the closure device 200 can be implanted in a human (e.g., the heart) without adverse effects due to corrosion of the support structure 201. Additionally, the support structure 201 may be configured to protect surrounding tissues once implanted. In some embodiments, the support structure 201 may comprise a metal, plastic, a bioabsorbable material, and / or the like. In some embodiments, the support structure 201 may comprise a metal, plastic, and / or the like. In some embodiments, the support structure 201 may comprise a shape memory material, such as, for example, Nitinol. The shape memory material may allow the support structure 201 to conform to a tubular form and self-expand upon release from the implantation device. In some embodiments, the support structure 201 may comprise a lightweight polymer coated with Nitinol.

[0062] III. Implantation of a Closure Device

[0063] 4A-4C illustrate cross-sections of the cardiac septum before, during, and after implantation of the closure device 200. FIG. 4A illustrates a cross-sectional view of the septum 7 of the heart 103 in a preoperative state (i.e., before implantation of the closure device 200). The septum 7 corresponds to the interatrial septum 100 and can separate the right atrium 101 from the left atrium 102. As illustrated, the septum 7 includes a defect 107 having a lumen 4 extending through the septum 7. Prior to implantation of the closure device 200, blood can flow freely through the lumen 4 from the right atrium to the left atrium, or vice versa.

[0064] FIG. 4B shows a cross-sectional view of the septum 7 of the heart 103 in an intraoperative state with the closure device 200 implanted. For example, the closure device 200 may be anchored in the fossa ovalis. During operation, as described further herein, the closure device 200 is positioned within the lumen 4 in a compressed configuration and expanded to an expanded configuration such that the first anchor portion 202 is positioned on the left atrium 102 side of the septum 7 and the second anchor portion 204 is positioned on the heart 103 side of the septum 7. In the implanted state, the tissue of the septum 7 is compressed between the first anchor portion 202 and the second anchor portion 204, and the lumen 4 is aligned with the lumen 208 of the closure device 200. Compressing the septum 7 can anchor the closure device 200 in the implanted state. In this configuration, the obturator membrane 212 closes the existing defect, closing the lumen 4 and significantly reducing or eliminating inter-atrial blood flow.

[0065] FIG. 4C shows a cross-sectional view of the septum 7 of the heart 103 in a postoperative state after a closure device 200 was implanted in the heart 103 during a previous procedure. As shown, a tissue layer 115 has grown over the closure device 200, particularly on the left atrial side 216 of the obturator membrane 212. In FIG. 4C, the cell scaffold corresponding to the closure device 200 has fully endothelialized. As a result of the tissue layer 115, interatrial blood flow between the left atrium 102 and the right atrium 101 through the lumen 4 may be completely eliminated or further reduced compared to the intraoperative state depicted in FIG. 4B. As discussed above, the use of electrospun materials for the obturator membrane 212 and / or frame covering membrane 210 may have facilitated the growth of the tissue layer 115. In some embodiments, a complete tissue layer (e.g., covering a majority of the obturator membrane 212) may form after a certain period of time, such as 1 day, 3 days, 5 days, 10 days, 15 days, 30 days, 45 days, 60 days, or 90 days, after implantation of the closure device 200. It is recognized that the period of time required to support a complete tissue layer may vary based on several factors, including the patient, the size of the defect, the size of the closure device 200, and / or the like. The formation of a complete endothelial monolayer may be significantly faster with an electrospun membrane compared to an ePTFE membrane. For example, an ePTFE membrane may remain largely uncovered by cellular tissue even several months after implantation. In the postoperative state with the tissue layer 115 intact, an operator can puncture the tissue layer 115 and the obturator membrane 212 and pass the lumen 208 through the closure device 200 to pass a medical instrument (e.g., from the left atrium 102 to the right atrium 101) through the closure device 200. Once the subsequent procedure is completed and the medical instrument is pulled back through the lumen 208, the obturator membrane 212 may continue to partially or completely occlude the lumen 4. After the second operation, the tissue layer 115 reforms over the closure device 200, completely occluding the lumen 4 again.

[0066] Any of the devices described herein (e.g., closure device 200, closure device 200′, closure device 300, devices including frame 201″ or frame 301′, and / or the like) may include one or more membranes that are identical to or include some or all of the properties of frame covering membrane 210 and / or obturator membrane 212 described herein. Additionally, the membranes described herein (e.g., frame covering membrane 210, obturator membrane 212, etc.) may be used with other medical devices and implants.

[0067] IV. Delivery Systems a. Overview of the delivery system

[0068] FIG. 5A illustrates an embodiment of a delivery system 500 that can be used to implant the closure device 200 in a patient's heart. For example, the delivery system 500 may include a catheter system. The delivery system 500 is an over-the-wire, single-use, transfemoral delivery system that facilitates the loading, delivery, and deployment of the closure device 200, for example, in the treatment of ostium secundum ASD. The delivery system 500 may include a handle 502, an implantable loader 504, a sheath 506 (e.g., 12FR), and a catheter 508. In some embodiments, the delivery system 500 may be used with one or more of a dilator, a guidewire (e.g., an ultra-stiff guidewire), heparinized saline, a Luer-lock flushing syringe, and / or similar auxiliary devices (not shown). The handle 502 may include one or more mechanical systems for controlling the positioning, deployment, and release of the closure device 200. 5A , the handle 502 includes a release button 501 and a rotation knob 503. The delivery system 500 may also include a gripping system 550, described further below. The release button 501 may be configured to move distally and proximally along the handle 502 to control disengagement of the closure device 200 from the gripping system 550. For example, when the release button 501 is in a proximal position, the gripping system 550 is locked, and moving the release button 501 to a distal position unlocks the gripping system 550, allowing removal of the closure device 200. The rotation knob 503 may be configured to rotate about an axis of the handle 502. The rotation knob 503 may control the distal and proximal movement of the sheath 506. For example, rotating the rotation knob 503 in a first direction (e.g., clockwise) can retract the sheath 506 proximally, and rotating the rotation knob 503 in a second direction (e.g., counterclockwise) can extend the sheath 506 distally. As described further herein, the sheath 506 can be retracted prior to deployment of the closure device 200.

[0069] As shown in FIG. 5A , one embodiment of closure device 200 is disposed in an expanded configuration near the end of sheath 506. During operation, closure device 200 may be housed within sheath 506 in a compressed configuration for delivery through the patient's vasculature toward the heart. In some embodiments, the working length WL of delivery system 500 may extend from the proximal end of sheath 506 to the distal end of catheter 508. The working length WL may be between 50 cm and 200 cm (e.g., 50 cm and 200 cm, 90 cm and 180 cm, 120 cm and 160 cm, values ​​therebetween, etc.). Delivery system 500 is one example of a delivery system, and it will be appreciated that any suitable delivery system may be used to implant closure device 200.

[0070] 5B and 5C illustrate one embodiment of an implant loader 504 of a delivery system 500. As shown, prior to implantation, a loader lure 510 is connected to the proximal end of a sheath 506. A grasping system 550 may be used to grasp the closure device 200 (e.g., by the outer petal tip 244) for delivery. The grasping system 550 is further described in FIGS. 6A-7D. During operation, the closure device 200 in a compressed form (e.g., FIG. 5C) is connected to the grasping system 550, and the grasping system 550 is pushed / advanced through the sheath 506 until the closure device 200 reaches its target destination within the patient's heart. While FIGS. 5A-5C, 6A-6B, and 7C-7D depict only the support structure 201 of the closure device 200, it will be appreciated that the support structure 201 is displayed for illustrative purposes and that, during operation, the complete closure device 200 is implanted in the patient. b. Release system

[0071] 6A and 6B show side and perspective views, respectively, of a grasping system 550. The grasping system 550 (also referred to herein as a release system / release member) may include multiple grasping tools 514 connected to a connector 512. Each individual grasping tool 514 is connected to the connector 512 at a proximal end and includes a flag 516 at a distal end. The flag 516 may be connected to the outer petal tip 244 of the closure device 200 for delivery and release of the closure device 200. The grasping tools 514 may include thin protrusions extending distally from the connector 512. Similar to the support structure 201, the grasping tools 514 may be configured to expand and contract between a compressed, tubular configuration for insertion through a patient's vasculature and an expanded or elongated configuration in which the flag 516 extends radially outward from a central portion (e.g., the central portion 206 of the closure device 200). The flag 516 may include a wider portion than the gripper 514, with a notch 518. The flag 516 and notch 518 may be configured to connect with the outer petal tip 244 of the support structure 201. For example, the flag 516 may extend through a loop of the outer petal tip 244 such that the loop of the outer petal tip 244 is positioned within the notch 518. In the expanded configuration shown in FIGS. 6A and 6B, the connection between the flag 516 and the outer petal tip 244 may be loose, allowing minimal or no movement of the gripper 514 to disengage the flag 516 from the outer petal tip 244 and release the closure device 200. To prevent unintentional release of the closure device 200, each gripper 514 may be covered with a locking tube 520, as shown in FIGS. 7A-7D.

[0072] In some embodiments, the grasping system 550 may include the same number of grasping tools 514 as the outer petal tips 244 of the closure device 200 used in operation. For example, each grasping tool 514 may have a corresponding outer petal tip 244 for connection. For example, the grasping system 550 may include 2, 4, 6, 8, 10, 15, 20, 25, 30, etc. grasping tools 514. In some embodiments, the grasping tools 514 may comprise metal, plastic, and / or the like. In some embodiments, the grasping tools 514 may comprise a shape memory material, such as nitinol. The shape memory material may allow the grasping tools 514 to conform to a tubular shape and self-expand when released from the dial end of the sheath 506.

[0073] 7A shows an embodiment of a grasping tool 514 and connector 512 of a grasping system 550 disposed in a guidewire lumen 522. The grasping system 550, connected to a closure device 200, can be moved along the guidewire lumen 522 within a sheath 506 within a patient's vasculature prior to implantation.

[0074] FIG. 7B illustrates an embodiment of a grasping system 550 further including multiple locking tubes 520. In some embodiments, the locking tubes 520 may be connected to release lumens 524, as described further below. The locking tubes 520 may comprise hollow tubes extending distally from the connectors 512. As shown in FIG. 7C, the grasping tools 514 extend through the locking tubes 520. In some embodiments, including the illustrated embodiment, the locking tubes 520 may include skives 526 near their proximal ends to allow the locking tubes 520 to be threaded onto (i.e., individually attached to) the grasping tools 514. In this configuration, the locking tubes 520 can be longer than the grasping tools 514, thereby enabling effective actuation. During operation, prior to deployment of the closure device 200, the locking tubes 520 extend over the flags 516 and outer petal tips 244, preventing premature release of the closure device 200. Similar to the graspers 514, the locking tubes 520 may be configured to expand and contract between a compressed, tubular configuration for insertion through a patient's vasculature and an expanded configuration in which the distal ends of the locking tubes 520 extend radially outward from a central portion (e.g., central portion 206 of closure device 200). In the compressed configuration, the locking tubes 520 contact each other and help secure the closure device 200 to the grasping system 550. In the expanded configuration, the locking tubes 520 extend with the graspers 514 until the closure device 200 reaches a fully or nearly fully expanded position.

[0075] The locking tube 520 may be constructed of any suitable material that allows the locking tube 520 to be compressed for delivery and easily expandable for deployment of the closure device 200. In some embodiments, the locking tube 520 may be made of plastic, polymer, metal, and / or the like. In some instances, the locking tube 520 may compromise composite materials, such as, for example, polymer-coated coils.

[0076] 7D shows the locking tube 520 and grasper 514 system with the locking tube 520 retracted, exposing the flag 516 of the grasper 514. The release lumen 524 is retracted toward the proximal end of the delivery system 500, which may also retract the locking tube 520 proximally, exposing the flag 516. In some embodiments, the handle 502 may include an actuator (e.g., release button 501) that controls the release lumen 524. For example, the release button 501 may be configured to move from a locked position, in which the locking tube 520 covers the flag 516 of the grasper 514, to a released position, in which the release lumen 524 and locking tube 520 are retracted proximally, exposing the flag 516. Once the locking tube 520 is retracted, the closure device 200 is released from the delivery system 500, either automatically or by slightly moving the closure device 200 relative to where it was deployed, e.g., the septum 7.

[0077] The combination of the grasper 514, the locking tube 520, and the outer petal tips 244 of the closure device 200 allows the closure device 200 to be in a fully or nearly fully expanded configuration prior to actual deployment of the closure device 200. This system allows the operator (e.g., a physician) of the delivery system 500 to optimize the position of the closure device 200 within the patient's heart before releasing the device. Additionally, the system may allow the operator to fully retract the expanded closure device 200 within the delivery system 500. For example, if the closure device 200 is deployed in a suboptimal position or if a problem occurs during operation, the system allows the operator to retract the fully expanded closure device 200 within the delivery system 500 and remove it from the patient if necessary. Once the operator is confident that the closure device 200 is secured in place (e.g., within the lumen 4 of the heart 103), the operator can retract the locking tube 520, releasing the closure device 200 from the delivery system 500.

[0078] V. Deployment Examples

[0079] 8A-8E illustrate an example deployment of one embodiment of the closure device 200. FIGS. 8A-8E show the closure device 200 expanded outward from the handle 502 of the delivery system 500. However, it will be appreciated that in operation, the closure device 200 is attached to the delivery system 500 and moved over a wire through the sheath 506 to the target location. The sheath 506 is pre-positioned across the atrial septal defect (target location) from the right atrium to the left atrium. As described herein, the delivery system 500 allows for repositioning and retrieval of the closure device 200, if necessary, before final release.

[0080] Generally, the closure device 200 can be advanced to the heart using conventional transcatheter techniques via a transfemoral approach. For example, a dilator (e.g., 12 Fr) and delivery sheath 506 can be inserted into the femoral vein, advanced along the inferior vena cava, and inserted into the right atrium. Once the distal end of the delivery sheath 506 has crossed the ASD, the dilator can be removed. The closure device 200 attached to the delivery system 500 can be delivered through the delivery sheath 506 over a guidewire (not shown) under fluoroscopic guidance. For example, after deflation of the lumen of the delivery system 500 and the implanted loader 504, the closure device 200 can be housed within the implanted loader 504. The implanted loader 504 may be attached to a pre-placed delivery sheath 506 so that the closure device 200 can be advanced through the delivery sheath 506. The handle 502 engages with the implanted loader 504, allowing for stepwise deployment of the closure device 200, as described below. The handle 502 can be used to control the predictable placement, deployment, and release of the closure device 200 across the ASD using a variety of mechanisms. In one example, a physician can rotate the rotation knob 503 to retract the sheath 506, deploying the closure device 200, and rotate the release button 501 to release the closure device 200. For example, with the distal end of the sheath 506 across the ASD, the physician can rotate the rotation knob 503 a first amount in a first direction to partially retract the sheath 506 and deploy the first anchor portion 202 within the left atrium 102. Once successful deployment of the first anchor portion 202 is confirmed, the physician can retract the delivery system 500 proximally until the first anchor portion 202 contacts the septum (e.g., septum 7). While maintaining the position of the delivery system 500, the physician can then continue to rotate the rotation knob 503 a second amount in the first direction to fully retract the sheath 506 and deploy the second anchor portion 204 into the right atrium 101. At this point, the physician can verify that the closure device 200 has been properly deployed and / or positioned.If the closure device 200 is not correctly deployed or positioned, the physician can partially or fully rotate the rotation knob 503 in a second direction to retract the closure device 200 again and store it in the sheath 506. At this point, the delivery system 500 can be repositioned for a new deployment attempt. Once successful deployment is confirmed, the physician can actuate the release button 501 (e.g., move the release button 501 proximally) to retract the locking tube 520 and permit disengagement of the closure device 200 from the grasping system 550. In some embodiments, the handle 502 may include one or more visual indicators that indicate when the rotation knob 503 has been rotated a first amount to deploy the first anchor portion 202 and when the rotation knob 503 has been rotated a second amount to deploy the second anchor portion 204.

[0081] 8A shows the closure device 200 in a collapsed configuration within a delivery system 500. As shown, a guidewire lumen 522 extends distally from the delivery system 500.

[0082] 8B shows closure device 200 beginning to exit delivery system 500. Closure device 200 is positioned such that first anchor portion 202 exits delivery system 500 before second anchor portion 204. As shown, as closure device 200 exits delivery system 500, first anchor portion 202 immediately begins to expand to its expanded configuration. In operation, delivery system 500 is positioned such that first anchor portion 202 expands on one side of septum 7, such as into left atrium 102 of heart 103.

[0083] 8C shows closure device 200 with first anchor portion 202 fully out of delivery system 500. In the illustrated configuration, outer diameter D2 of closure device 200 is generally larger than target lumen 4 of heart 103, so first anchor portion 202 must be retracted into delivery system 500 and out of lumen 4.

[0084] 8D shows closure device 200 with both first anchor portion 202 and second anchor portion 204 fully exiting delivery system 500. As shown, second anchor portion 204 is not fully expanded and is still connected to flag 516 of grasper 514 within locking tube 520. In some embodiments, second anchor portion 204 may not fully expand until first anchor portion 202 is pulled back to contact septum 7 of heart 103. For example, once first anchor portion 202 is expanded within left atrium 102, first anchor portion 202 may be pulled back so that petal 228 contacts atrial septum 100. When atrial septum 100 applies a force to petals 228, first anchor portion 202 may partially evert (e.g., as shown in FIG. 8E ), causing second anchor portion 204 to expand to a fully expanded position and compressing the septum between first anchor portion 202 and second anchor portion 204. In some embodiments, first anchor portion 202 may be released from delivery system 500 in a fully operable state and may not need to be pulled back against the septum to be everted.

[0085] Continuing to refer to FIG. 8E , once the second anchor portion 204 is fully expanded, the septum 7 is compressed between the first anchor portion 202 and the second anchor portion 204 during the procedure. At this point, the closure device 200 is still connected to the delivery system 500. Once the operator is confident that the closure device 200 is in the correct position (e.g., with the septum 7 compressed between the first and second anchor portions 202, 204 and the lumen 208 positioned inside the lumen 4), the operator can pull back the release lumen 524, exposing the flag 516 and outer petal tip 244 of the second anchor portion 204 to the locking tube 520. This action may release the closure device 200, or the operator may need to gently move the closure device 200 until the outer petal tip 244 clears the flag 516. At this point, the delivery system 500 is withdrawn from the patient, and the procedure is complete.

[0086] VI. Closure Device

[0087] 9A-9E show closure device 200′ in an expanded configuration. FIG. 9A shows a perspective view of closure device 200′, FIG. 9B shows a left atrial lateral view of closure device 200′, FIG. 9C shows a right atrial lateral view of closure device 200′, FIG. 9D shows a side view of closure device 200′, and FIG. 9E shows a cross-sectional view of closure device 200′. Closure device 200′ may include all of the same components as closure device 200 and may function in a similar or identical manner to closure device 200. Components of closure device 200′ that share the same function and characteristics as closure device 200 are designated with the same reference numerals with a prime added (e.g., support structure 201′).

[0088] Figures 10A-10D show the frame / support structure 201' of the closure device 200'. Figure 10A shows a perspective view of the frame 201', Figure 10B shows a left atrial lateral view of the frame 201', Figure 10C shows a right atrial lateral view of the frame 201', and Figure 10D shows a side view of the frame 201'.

[0089] As seen most clearly in FIGS. 9E and 10D , one difference between the support structure 201′ of the closure device 200′ and the support structure 201 of the closure device 200 is that the support structure 201′ is shaped to further eliminate discontinuities in the closure device 200′ after implantation. For example, the outer edge 220′ of the second anchor portion 204′ does not include a curved portion (see, e.g., outer edge 222 in FIG. 2E ). Instead, when the obturator membrane 212′ is coupled to the first anchor portion 202′ (i.e., in contrast to the example where the obturator membrane 212′ is coupled to the central portion 206′), the outer edge 220′ is generally parallel to the obturator membrane 212′. As a result, the outer edge 220′ of the first anchor portion 202′ and left atrial side 216′ of the closure device 200′ is substantially flat on the left atrium 102 side of the septum after the closure device 200′ is implanted.

[0090] Similarly, as seen most clearly in FIGS. 10C and 10D , the outer petals 234′ of the second anchor portion 204′ may be shaped differently from the outer petals 234 of the second anchor portion 204 of the closure device 200. For example, the struts 236′ of the outer petals 234′ may extend outward from the inner petal tip 238′, similar to the struts 236 of the outer petals 234 of the second anchor portion 204 of the closure device 200. However, in the second anchor portion 204′, the struts 236′ of the outer petals 234′ extend to the outer petal edge 239′ at the outer petal's 234′'s radially outermost position. At the outer petal edge 239′, the struts 236′ bend back toward the outer petal tip 244′, downward toward the right atrial side 218′, and inward toward the central portion 206′ of the support structure 201′. As a result of this bending, the outer petal tip 244' is positioned within the outer petal 234', and the outer petal edge 239' represents the outer edge of the outer petal 234. Furthermore, the struts 236' between the outer petal edge 239' and the outer petal tip 244' are at a similar angle to the horizontal as the struts 236' between the inner petal connector 240' and the inner petal tip 238'. Therefore, when the closure device 200' is implanted, the outer petal tip 244' and the second anchor portion 204' collectively lie substantially flat on the right atrium 102 side of the septum.

[0091] 10E and 10F show an embodiment of an additional frame / support structure 201″ that can be used as part of closure device 200 or closure device 200′. FIG. 10E shows a side view of frame 201″, and FIG. 10F shows a detailed view of a portion of frame 201″. Frame 201″ may include all of the same components as frame 201 of closure device 200 and frame 201′ of closure device 200′ and may function in a similar or identical manner to the frames of closure devices 200, 200′. Components of frame 201″ that share the same function and characteristics as frames 201, 201′ are designated with the same reference number with a double prime (e.g., support structure 201″).

[0092] The frame 201" differs from the frames 201, 201' primarily in the structure of the petal tips of the frame 201". For example, one or more of the petal tips 230" of the first anchor portion 202" can include a marker tip 231". The marker tip 231" may extend from the petal tip 230". In the illustrated example, the marker tip 231" extends inward toward the lumen 208". In some examples, the marker tip 231" can be radiopaque, allowing a physician to identify the outer boundary of the implanted frame 201". The marker tip 231" can be designed as an atraumatic tip to minimize trauma to the patient during implantation. For example, the marker tip 231" can be generally circular. In some embodiments, each petal tip 230" can include a marker tip 231". In other embodiments, alternating petal tips 230" can include a marker tip 231".

[0093] The outer petal tip 244" of the frame 201" may include a shoulder stop 246". The shoulder stop 246" may be located inside the eyelet of the outer petal tip 244" and may be a portion of the outer petal tip 244" that has a width greater than the width of the eyelet. The shoulder stop 246" can be used to prevent or limit movement of the locking tube 520 relative to the rest of the frame 201". For example, when coupled to the delivery system 500, the outer petal tip 244" can be connected to the flag 516 of the grasper 514 via the eyelet of the outer petal tip 244". The locking tube 520 can extend beyond the eyelets and flags 516 to ensure that the frame 201'' is locked to the delivery system 500, and the shoulder stop 246'' can limit the locking tube 520 from extending beyond the outer petal tip 244''. Additionally, as shown in FIG. 10E, the strut 236'' extending toward the outer petal tip 244'' can be folded in the same plane as the second anchor portion 204 and bent outward to improve attachment to the delivery system 500.

[0094] 10G and 10H show detailed views of the outer petal tip 244" of the support structure 201" engaged with the gripper 514 of the delivery system 500. As shown in FIGS. 10G and 10H, the flags 516 may each include an extension tab 528 to ensure a secure disconnect after removing the locking tube 520. The extension tab 528 may be a section of material extending from the flag 516 that is greater than the length of the eyelet in the outer petal tip 244. The extension tab 528 may prevent the flag 516 from protruding past the outer petal tip 244. For example, the inclusion of the extension tab 528 prevents the flag 516 from extending through the eyelet at the outer petal tip 244". Additionally, in some instances, the portion of the flag 516 adjacent the notch 518 may be thicker than the length / diameter of the eyelet at the outer petal tip 244, thereby preventing this portion of the notch 518 from extending through the notch. This arrangement can prevent the flag 516 and the remainder of the gripper 514 from extending completely through the petal tip eyelet 244.

[0095] VII. Closure Devices

[0096] 11A-11E show various views of closure device 300. Closure device 300 may include at least some or all of the structure and functionality as closure device 200 shown and described in connection with FIGS. 2A-4C, with the differences noted below. Accordingly, the reference numerals used to designate various features or components of closure device 200 are the same as those used to identify corresponding features of components of closure device 300, differing only in that the numeric identifiers for closure device 300 include a "3" instead of a "2."

[0097] 11A and 11B show left atrial and right atrial lateral views, respectively, of closure device 300. Closure device 300 differs from closure device 200 primarily in the configuration of support structure 301 and central portion 306. In some embodiments, closure device 300 may offer particular advantages when implemented to close a PFO defect. However, closure device 300 may also be used to treat other defects (e.g., ASD). Support structure 301 may include a first anchor portion 302 and a second anchor portion 304. In some embodiments, first anchor portion 302 may be identical to second anchor portion 304. Anchor portions 302, 304 may include a plurality of struts 350 extending radially outward from central portion 306. The plurality of struts 350 may extend toward outer petal 334. Outer petal 334 may include an outer petal tip 344. The outer petal tip 344 can be configured to connect / couple with the grasper 514 of the delivery system 500 (e.g., via a flag 516). For example, the outer petal tip 344 can be or include an eyelet. In some embodiments, all or a portion of the outer petal 334 can be radiopaque.

[0098] The support structure 301 can be covered with a membrane. The first anchor portion 302 can be covered with a first membrane 312A, and the second anchor portion 304 can be covered with a second membrane 312B. In some embodiments, a single membrane 312 can cover both the first anchor portion 302 and the second anchor portion 304. The membranes 312A and 312B can have the same or matching structure and characteristics as the frame covering membrane 210 and the closure membrane 212 of the closure device 200. The closure device 300 can include a smaller central portion 306 and lumen 308 compared to the closure device 200. The membranes 312A and 312B can extend over the lumen 308 on both sides of the closure device 300 (e.g., over the first anchor portion 202 and the second anchor portion 204). Like the closure device 200, the closure device 300 can be repassable once implanted. The physician can repass the closure device 300 through the lumen 308 and / or between the pair of struts 350. In some embodiments, the covering of the membranes 312A, 312B may only partially extend outward at either the left atrial disc 301 or the right atrial disc 302, or both. In some implementations, the closure device 300 can be used as a shunt. For example, the closure device 300 can include one or more permanent openings (e.g., holes, slits, and / or the like) extending therethrough that can be used to exchange fluids across the closure device 300.

[0099] FIG. 11C shows a side view of the closure device 300 implanted in the septum 7 of the heart. As shown, the implanted closure device 300 (pre-endothelialized) has a thickness similar to that of the septum 7. As discussed herein, in the heart, the septum thickness can be approximately 1 mm to 5 mm (depending on the patient and the location of the defect) in which the closure device 300 is implanted. As such, it may be desirable to minimize the thickness T3 of the closure device 300 to reduce expansion of the closure device 200 into the left and right atria 102, 101. The compliance of the closure device 300 may be due in part to the thickness T3 of the closure device 300. In some instances, the thickness T3 of the closure device 300 may be between 1 mm and 5 mm, 2 mm and 5 mm (e.g., 1 mm and 5 mm, 2 mm and 5 mm, 2.5 mm and 4.5 mm, 3 mm and 4 mm, values ​​in between, etc.). In some instances, it may be desirable for the thickness of the closure device 300 to be 5 mm or less. The closure device 300 may be significantly thinner than commercially available closure devices, which may be 5 mm to 10 mm or thicker. In some embodiments, the closure device 300 includes an expandable and contractible central connector, as described with reference to FIG. 11E, to provide the closure device 300 with a variable thickness.

[0100] FIG. 11D shows a side view of the support structure 301 of the closure device 300 (e.g., with the single membrane(s) 312 removed). FIG. 11E shows a side view of the closure device 300 in an expanded but unimplanted state coupled to the gripping system 550 of the delivery system 500. The closure device 300 can include a central portion 306 extending between the first anchor portion 302 and the second anchor portion 304. The central portion 306 can be used to couple the first anchor portion 302 to the second anchor portion 304. In some embodiments, the central portion 306 can be or can include a resilient member. For example, the central portion 306 can be an expandable connection between the first anchor portion 302 and the second anchor portion 304. In one example, the central portion 306 can be a spring. The elastic central portion 306 can allow the first anchor portion 302 and the second anchor portion 304 to apply a compressive force to the septum 7 when the closure device 300 is implanted in the heart. Because the central portion 306 is expandable, the closure device 300 can accommodate various tunnel lengths through the septum. For example, septal thicknesses vary, resulting in various defect (e.g., tunnel) lengths. Because the central portion 306 is expandable, the same closure device 300 can be used for various defect tunnel lengths while still providing similar compression to the septum and closing the defect. In some embodiments, the central portion 306 can be a triple-start spring configured to extend at low force. In a non-limiting example, the central portion 306 can have a deflection of approximately 2 to 10 mm at 4.5 N. The central portion 306 can also be configured to bend. In this case, the first anchor portion 302 and the second anchor portion 304 may not be in parallel planes when implanted. Bendable central portion 306 may provide the advantage that, once implanted, first anchor portion 302 and second anchor portion 304 may be placed in a non-parallel position to better conform to the unique shape of an individual patient's heart. Although central portion 306 is shown exposed in FIG. 11C, in some embodiments, central portion 306 may be covered by a membrane similar to membranes 312A, 312B.Additionally, spring 306 can be designed with variable-width helical coils to achieve a consistent force across its extension range. In one such example, spring 306 can be manufactured by cutting helical cuts into a tube. The thickness of the cut pattern can be adjusted to achieve a consistent force. In another example, the helical cuts can be shaped inward (i.e., hourglass-shaped) or outward (i.e., barrel-shaped) to achieve the desired spring performance. Additionally, certain limiting elements can be included between the coils of spring 306 to prevent overextension. For example, spring 306 can be coated with an elastic polymer. In another example, a sliding element can be introduced into the helical structure. The sliding element allows free movement but limits the helical extension beyond a set point.

[0101] FIG. 11F shows a schematic side view of an exemplary central portion 306 formed as a spring that may be included in the closure device 300. As shown, the central portion 306 may be formed from helical coils 360. Gaps 362 may exist between the helical coils 360. In some examples, the helical coils 360 may include one or more sliding elements 364 and one or more stop elements 366. The sliding elements 364 may be portions of the helical coils 360 that extend into the gaps 362 and may move within the gaps 362 as the spring 306 expands and contracts. For example, as shown in FIG. 11F, when the spring 306 expands, the sliding element 364 moves from left to right as shown, and when the spring 306 compresses, the sliding element 364 moves from right to left as shown. Stop element 366 can be a portion of helical coil 360 that extends into gap 362 that includes sliding element 364 and is configured to limit extension of helical coil 360 beyond a set point. For example, extension of helical coil 360 can continue until sliding element 364 contacts stop element 366, which prevents further movement of sliding element 364 in that direction and prevents further extension of helical coil 360.

[0102] 12A-12C illustrate additional and / or alternative features and components that may be implemented in delivery system 500. Delivery system 500 can be used to deploy closure device 300 (or closure device 200, or closure device 200′) by converting rotational motion of handle 502 (e.g., using a release knob) into linear motion to retract locking tube 520. For example, a physician can rotate the release knob on handle 502 to deploy closure device 200, 200′, 300 without causing a corresponding rotation of closure device 200, 200′, 300.

[0103] FIG. 12A shows a partial view of the distal end of the delivery system 500, including a gripping system 550. FIG. 12B shows a cross-sectional view of the distal end of the delivery system 500. The gripping system 550 can include a locking tube holder 530. The locking tube holder 530 can include a connecting portion 532 and a shaft portion 534. The connecting portion 532 can be coupled to the shaft portion 534. The connecting portion 532 is configured to hold the locking tube 520 in a fixed position relative to each other. The connecting portion 532 can allow the gripper 514 to extend through the locking tube 520 and the connecting portion 532. The shaft portion 534 can extend proximally from the connecting portion 532. The shaft portion 534 can include threads on at least a portion of its outer surface. The connecting portion 532 can be located distal to the lordal lure 510, and the shaft portion 534 can extend at least partially within the lordal lure 510. In some embodiments, including the one shown, the connecting portion 532 and the shaft portion 534 may be hollow, allowing the locking tube holder 530 to move over the guidewire lumen 522. The threaded shaft portion 534 may engage with the internally threaded cylinder 526 of the release lumen 524. The internally threaded cylinder 526 may be coupled to the distal end of the release lumen 524 and disposed within the connector 512. The internally threaded cylinder 526 may be configured to rotate within the connector 512 while remaining in an axially fixed position such that the internally threaded cylinder 526 cannot move distally or proximally. As such, rotation of the release lumen 524 (e.g., via a release knob) results in a corresponding rotation of the internally threaded cylinder 526. As the internally threaded cylinder 526 rotates, the threads of the internally threaded cylinder 526 engage the threads of the shaft portion 534, moving the locking tube holder 530 proximally or distally, depending on the direction of rotation.

[0104] 12C shows a side view of the grasping system 550 in the locked and unlocked positions. In one example, rotating the release knob counterclockwise moves the locking tube holder 530 proximally. The connector 512 can be fixed relative to the loader lure 510. As a result, moving the locking tube holder 530 proximally retracts the locking tube 520, exposing the flag 516 of the grasping tool 514. With the flag 516 exposed, the outer petal tip 344 of the closure device 300 is also released from the locking tube 520, allowing the closure device 300 to be deployed.

[0105] 13A and 13B show an embodiment of an additional frame / support structure 301′ that can be used as part of closure device 300. FIG. 13A shows a side view of frame 301′, and FIG. 13B shows a detailed view of a portion of frame 301′. Frame 301′ may include all of the same components as frame 301 of closure device 300 and may function in a similar or identical manner as the frame of closure device 300. Components of frame 301′ that share the same function and characteristics as frame 301 are designated with the same reference numerals with a prime added (e.g., support structure 201″).

[0106] The frame 301′ differs from the frame 301′ primarily in the structure of the petal tips. For example, one or more of the outer petal tips 344′ of the first anchor portion 302′ or the second anchor portion 304′ can include a marker tip 331′. The marker tip 331′ may extend from the outer petal tip 344′. In the illustrated example, the marker tip 331′ extends inward toward the central portion 306′. In some examples, the marker tip 331′ can be radiopaque, allowing a physician to identify the outer boundary of the implanted frame 301′. The marker tip 331′ can be designed as an atraumatic tip to minimize trauma to the patient during implantation. For example, the marker tip 331′ can be generally circular. In some embodiments, each outer petal 334′ of one or both of the first or second anchor portions 302′, 304′ can include a marker tip 331′. In other embodiments, alternating outer petals 334' on one or both of the first or second anchor portions 302', 304' may include marker tips 331'.

[0107] In some examples, the outer petal tip 344' of the frame 301' may include a shoulder stop 346'. The outer petal tip 344' with the shoulder stop 346' may be on one of the first anchor portion 302' and the second anchor portion 304', and the outer petal tip 344' with the marker tip 331' may be on the opposite anchor portion 302', 304'. The shoulder stop 346' may be located inside the eyelet of the outer petal tip 344' and may be a portion of the outer petal tip 344' that has a width greater than the width of the eyelet. The shoulder stop 346' can be used to prevent or limit movement of the locking tube 520 relative to the rest of the frame 301'. For example, when coupled to the delivery system 500, the outer petal tip 344' may be connected to the flag 516 of the grasping tool 514 via the eyelet of the outer petal tip 344'. The locking tube 520 can extend beyond the eyelets and flags 516 to ensure that the frame 301' is locked to the delivery system 500, and the shoulder stop 346' can limit the locking tube 520 from extending beyond the outer petal tip 344'. Additionally, as shown in FIG. 13B, the struts of the outer petal 334' that extend toward the outer petal tip 344' can be folded in the same plane as the second anchor portion 304 and bent outward to improve attachment to the delivery system 500.

[0108] Returning to FIG. 13A , the struts 350′ of the frame 301′ may include one or more joints 348′. The joints 348′ can be portions of the frame 301′ where a pair of struts 350′ meet. The joints 348′ can form one or more additional petals in the anchor portions 302, 304. For example, each joint 348′ can define the intersection of an outer petal 334′ and an inner petal 332′. Including the joints 348′ in the frame 301′ can increase the axial clamping force provided by the implanted closure device 300.

[0109] VIII. Additional Embodiments

[0110] In the foregoing specification, the system and process have been described with reference to specific embodiments thereof. It will, however, be apparent that various modifications and changes can be made therein without departing from the broader spirit and scope of the present disclosure as set forth in the claims. The specification and drawings are, therefore, to be regarded in an illustrative rather than a restrictive sense.

[0111] Indeed, while the systems and processes have been disclosed in the context of particular embodiments and examples, those skilled in the art will recognize that various embodiments of the systems and processes extend beyond the specifically disclosed embodiments to other alternative embodiments and / or uses of the systems and processes, as well as obvious modifications and equivalents thereof. Moreover, while several variations of the system and process embodiments have been shown and described in detail, other modifications that are within the scope of this disclosure will be readily apparent to those skilled in the art based on this disclosure. It is also contemplated that various combinations or subcombinations of specific features and aspects of the embodiments may be made and still fall within the scope of the disclosure. It should be understood that various features and aspects of the disclosed embodiments can be combined with or substituted for one another to form various aspects of the disclosed system and process embodiments. Any methods disclosed herein need not be performed in the order described. Therefore, it is not intended that the scope of the systems and processes disclosed herein be limited by the specific embodiments described above.

[0112] It will be understood that the systems and methods of the present disclosure each have several innovative aspects, no single one of which is solely responsible for or required to achieve the desirable attributes disclosed herein. The various features and processes described above may be used independently of one another or may be combined in various ways. All possible combinations and subcombinations are intended to be within the scope of the present disclosure.

[0113] Certain features described herein in the context of separate embodiments may also be implemented in combination in a single embodiment. Conversely, various features described in the context of a single embodiment may also be implemented in multiple embodiments separately or in any suitable subcombination. Furthermore, even if features are described above as acting in a particular combination and originally claimed as such, one or more features from the claimed combination may, in some cases, be deleted from the combination, and the claimed combination may be directed to a subcombination or a variation of the subcombination. No single feature or group of features is essential or essential to each embodiment.

[0114] It will be understood that conditional language used herein (e.g., "can," "could," "might," "may," "for example," etc.) is generally intended to convey that certain embodiments include certain features, elements, and / or states, and other embodiments do not, unless otherwise specified or the context of use dictates otherwise. Thus, such conditional language is not generally intended to imply that features, elements, and / or steps are in any way required by one or more embodiments, or that one or more embodiments necessarily include logic for determining whether those features, elements, and / or steps are included in or performed in any particular embodiment, with or without user input or prompting. The terms "comprising," "including," "having," etc. are synonymous and are used inclusively and open-endedly, and do not exclude additional elements, features, acts, operations, etc. Additionally, the term "or" is used in an inclusive (as opposed to exclusive) sense, so that, for example, when used to recite a list of elements, the term "or" refers to one, some, or all of the elements in the list. Furthermore, the articles "a," "an," and "the," as used in this application and the appended claims, shall be construed to mean "one or more" or "at least one" unless otherwise specified. Similarly, while operations may be depicted in the figures in a particular order, it should be recognized that such operations need not be performed in the particular order or sequential order depicted, and that not all depicted operations need be performed, to achieve desirable results. Furthermore, the figures may generally depict one or more exemplary processes in flowchart form. However, other operations not depicted may be incorporated into the generally depicted exemplary methods and processes. For example, one or more additional operations may be performed before, after, simultaneously with, or between depicted operations. Furthermore, operations may be rearranged or reordered in other embodiments.In some situations, multitasking and parallel processing may be advantageous. Furthermore, the separation of various system components in the above-described embodiments should not be understood as requiring such separation in all embodiments, and it will be understood that the described program components and systems may generally be integrated into a single software product or packaged into multiple software products. Furthermore, other embodiments are within the scope of the following claims. In some cases, the actions recited in the claims may be performed in a different order to achieve desirable results.

[0115] Furthermore, while the methods and devices described herein are susceptible to various modifications and alternative forms, specific examples thereof have been shown in the drawings and are described in detail herein. However, it should be understood that the embodiments are not limited to the particular forms or methods disclosed; rather, the embodiments are intended to cover all modifications, equivalents, and alternatives within the spirit and scope of the various described implementations and the appended claims. Furthermore, the disclosure herein of particular features, aspects, methods, properties, attributes, properties, elements, etc., associated with an embodiment can be used with all other embodiments described herein. Any method disclosed herein need not be performed in the order described. Although the methods disclosed herein may include specific actions performed by a practitioner, the method may include, explicitly or implicitly, any third-party direction of those actions. Ranges disclosed herein encompass all overlapping, combined ranges, and combinations thereof. Words such as "up to," "at least," "greater than," "less than," and "between" are inclusive of the recited numbers. Numbers preceded by terms such as "about" or "approximately" are inclusive of the stated number and should be interpreted in the context (e.g., as precisely as reasonably possible given the circumstances, e.g., ±5%, ±10%, ±15%, etc.). For example, "about 3.5 mm" includes "3.5 mm". Words preceded by terms such as "substantially" are inclusive of the stated number and should be interpreted in the context (e.g., as precisely as reasonably possible given the circumstances). For example, "substantially constant" includes "constant". Unless otherwise noted, all measurements are made at standard conditions, including temperature and pressure.

[0116] As used herein, a phrase referring to "at least one" of a list of items refers to any combination of those items, including single members. For example, "at least one of A, B, or C" is intended to cover A, B, C, A and B, A and C, B and C, and A, B, and C. Connecting words such as "at least one of X, Y, and Z" are generally understood from the context to be used to convey that an item, term, etc. can be at least one of X, Y, or Z, unless otherwise indicated. Thus, such connectives generally do not imply that a particular embodiment requires that at least one of X, at least one of Y, and at least one of Z, respectively, be present. The headings provided herein are for convenience only and do not necessarily affect the scope or meaning of the devices and methods disclosed herein.

[0117] Thus, the scope of the claims is not intended to be limited to the embodiments shown herein but is to be accorded the widest scope consistent with the present disclosure and the principles and novel features disclosed herein.

[0118] IX. Illustrative Provisions

[0119] Examples of embodiments of the present disclosure can be described in light of the following exemplary clauses. Features described in the following exemplary embodiments can be combined with additional features disclosed herein. Additionally, inventive combinations of additional features are disclosed herein that are not specifically described in the following exemplary embodiments and do not include the same features as the following specific embodiments. For the sake of brevity, the following exemplary embodiments do not identify every inventive aspect of the present disclosure. The following exemplary embodiments are not intended to identify key features or essential features of the subject matter described herein. Any of the following exemplary clauses, or features of any of the exemplary clauses, can be combined with one or more other exemplary clauses, features of other exemplary clauses, or other features of the present disclosure.

[0120] Section 1 1. A septum closure device comprising: a support structure including a first anchor portion and an opposing second anchor portion, a lumen extending through a center of the first anchor portion and a center of the second anchor portion, the support structure configured to contract and expand between a compressed tubular configuration for insertion through a patient's vasculature and an expanded configuration in which the first and second anchor portions extend radially outward from the lumen; and a membrane coupled to the first anchor portion, the membrane configured to occlude a majority of the lumen when the support structure is expanded, the membrane configured to promote tissue growth at least across the membrane.

[0121] Section 2 10. The septal closure device of claim 1, wherein the membrane comprises an elastic material.

[0122] Section 3 3. The septal closure device of paragraph 1 or 2, wherein the membrane comprises a plurality of perforations.

[0123] Section 4 The septal closure device of any one of paragraphs 1 to 3, wherein the membrane comprises a radiopaque material.

[0124] Section 5 A septal closure device as described in any one of paragraphs 1 to 4, further comprising a second membrane that extends over the first anchor portion and the second anchor portion without closing the lumen when the support structure is expanded.

[0125] Section 6 6. The septal closure device of any one of paragraphs 1 to 5, wherein the first and second anchor portions include a plurality of interconnected struts.

[0126] Section 7 7. The septal closure device of any one of paragraphs 1 to 6, wherein the first and second anchor portions comprise a shape memory material.

[0127] Section 8 The septal closure device of any one of paragraphs 1 to 7, wherein the second anchor portion includes a plurality of loops, the plurality of loops configured to releasably couple the septal closure device to a delivery device.

[0128] Section 9 9. The septal closure device of any one of paragraphs 1 to 8, wherein the first anchor portion and the second anchor portion are configured to compress the cardiac septum therebetween.

[0129] Section 10 10. The septal closure device of clause 9, wherein the lumen is configured to align with an opening in the septum.

[0130] Section 11 11. The septal closure device of claim 9 or 10, wherein the membrane is configured to allow a medical instrument inserted into a first compartment of the heart to pass through the membrane and a tissue layer formed on the membrane and through the lumen to a second compartment of the heart, and the septum divides the first and second compartments of the heart.

[0131] Section 12 12. The septum closure device of any one of claims 1 to 11, wherein the membrane forms a continuous surface.

[0132] Section 13 13. The septal closure device of any one of claims 5 to 12, wherein the second membrane prevents the support structure from coming into direct contact with the patient's blood when the septal closure device is implanted in the patient.

[0133] Section 14 1. A method of inserting a delivery system into a patient's vasculature, the delivery system including a release member and a sheath, the sheath including a septal closure device in a compressed configuration, the septal closure device including a first anchor portion and an opposing second anchor portion, the second anchor portion coupled to the release member; advancing a distal end of the sheath at least partially through a septum of the patient's heart; advancing the septal closure device inside the sheath so that the first anchor portion expands at a first section on a first side of the septum; advancing the septal closure device outside the sheath so that the second anchor portion expands at a second section on a second side of the septum opposite the first side, the second anchor portion remaining coupled to the release member in the expanded configuration; and releasing the septal closure device from the delivery system.

[0134] Section 15 15. The method of clause 14, wherein a lumen extends through a center of the first anchor portion and a center of the second anchor portion, the lumen defining an opening in the septum.

[0135] Section 16 16. The method of clause 15, wherein the septal closure device further comprises a membrane coupled to the first anchor portion, the membrane configured to occlude a majority of the lumen.

[0136] Section 17 17. The method of claim 15 or 16, further comprising a second membrane that extends over the first anchor portion and the second anchor portion without blocking the lumen when the septal closure device is expanded.

[0137] Section 18 18. The method of claim 16 or 17, wherein the membrane comprises an elastic material.

[0138] Section 19 19. The method of any one of paragraphs 16 to 18, wherein the membrane comprises a plurality of perforations.

[0139] Section 20 20. The method of any one of clauses 16 to 19, further comprising leaving a septum closure device in the patient's heart for a period of time, the membrane configured to promote tissue growth at least across the membrane.

[0140] Section 21 21. The method of clause 20, further comprising inserting a medical device into the patient's vascular system, advancing the medical device into the first compartment, and advancing the medical device through a tissue layer on the membrane and through the membrane, wherein the medical device crosses the lumen and enters the second compartment.

[0141] Section 22 22. The method of any one of paragraphs 16 to 21, wherein the membrane comprises a radiopaque material that identifies the lumen that defines the passable area of ​​the septal closure device.

[0142] Section 23 1. A septal closure device configured to be implanted in a patient's heart, the septal closure device comprising: a support structure including a lumen; and a membrane including a plurality of electrospun fibers, the membrane coupled to at least a portion of the support structure, the membrane configured to close a majority of the lumen when the septal closure device is implanted.

[0143] Section 24 24. The septal closure device of claim 23, wherein the support structure further includes a first anchor portion and an opposing second anchor portion, and the lumen extends through a center of the first anchor portion and a center of the second anchor portion.

[0144] Section 25 25. The septal closure device of paragraph 23 or 24, wherein the plurality of electrospun fibers have a diameter between 0.5 microns and 5 microns.

[0145] Section 26 26. The septal closure device of any one of paragraphs 23 to 25, wherein the plurality of electrospun fibers are configured to deform at an elongation of at least 400%.

[0146] Section 27 27. The septal closure device of any one of paragraphs 23 to 26, wherein the plurality of electrospun fibers have an ultimate strain of between 350% and 600%.

[0147] Section 28 28. The septal closure device of any one of paragraphs 23 to 27, wherein the septal closure device has an overall thickness of less than 5 mm.

[0148] Section 29 29. The septal closure device of any one of paragraphs 23 to 28, wherein the septal closure device extends less than 0.1 mm into the left atrium of the heart when implanted.

[0149] Section 30 30. The septal closure device of any one of paragraphs 23 to 29, wherein the septal closure device extends less than 1 mm into the right atrium of the heart when implanted.

[0150] Section 31 31. The septal closure device of any one of paragraphs 23 to 30, wherein the septal closure device weighs less than 100 micrograms.

[0151] Section 32 32. The septal closure device of any one of paragraphs 23 to 31, wherein the plurality of electrospun fibers are configured to promote tissue growth across at least the membrane.

[0152] Section 33 33. The septal closure device of any one of paragraphs 24 to 32, wherein the support structure is configured to contract and expand between a compressed tubular configuration for insertion through a patient's vascular system and an expanded configuration in which the first and second anchor portions extend radially outward from the lumen.

[0153] Section 34 34. The septal closure device of any one of paragraphs 23 to 33, wherein the membrane is less than 100 microns thick.

[0154] Section 35 35. The septal closure device of any one of paragraphs 23 to 34, wherein the discontinuous surface of the septal closure device extends less than 0.1 mm into the heart when implanted.

[0155] Section 36 36. The septal closure device of any one of paragraphs 23 to 35, wherein the support structure is encapsulated within a second membrane.

[0156] Section 37 1. A septal closure device configured to be implanted in a patient's heart, the septal closure device comprising: a support structure including a central structure; and a membrane configured to promote tissue growth across the central structure, the membrane coupled to at least a portion of the support structure, the membrane configured to close a majority of the central structure when the septal closure device is implanted.

[0157] Section 38 38. The septal closure device of claim 37, wherein the support structure further includes a first anchor portion and an opposing second anchor portion, and the central structure extends through a center of the first anchor portion and a center of the second anchor portion.

[0158] Section 39 39. The septal closure device of paragraph 37 or paragraph 38, wherein the membrane comprises a plurality of electrospun fibers.

[0159] Section 40 40. The septal closure device of clause 39, wherein the plurality of electrospun fibers have a diameter between 0.5 microns and 5 microns.

[0160] Section 41 41. The septal closure device of any one of paragraphs 39 or 40, wherein the plurality of electrospun fibers are configured to deform at an elongation of at least 400%.

[0161] Section 42 42. The septal closure device of any one of paragraphs 39 to 41, wherein the plurality of electrospun fibers have an ultimate strain of between 350% and 600%.

[0162] Section 43 43. The septal closure device of any one of paragraphs 37 to 42, wherein the septal closure device has an overall thickness of less than 4 mm.

[0163] Section 44 44. The septal closure device of any one of paragraphs 37 to 43, wherein the septal closure device extends less than 0.1 mm into the left atrium of the heart when implanted.

[0164] Section 45 45. The septal closure device of any one of paragraphs 37 to 44, wherein the septal closure device extends less than 1 mm into the right atrium of the heart when implanted.

[0165] Section 46 46. ​​The septal closure device of any one of paragraphs 37 to 45, wherein the septal closure device weighs less than 100 micrograms.

[0166] Section 47 47. The septum closure device of any one of paragraphs 39 to 46, wherein the plurality of electrospun fibers are configured to promote tissue growth across at least the membrane.

[0167] Section 48 48. The septal closure device of any one of paragraphs 38 to 47, wherein the support structure is configured to contract and expand between a compressed tubular configuration for insertion through a patient's vascular system and an expanded configuration in which the first and second anchor portions extend radially outward from the central structure.

[0168] Section 49 49. The septal closure device of any one of paragraphs 37 to 48, wherein the membrane is less than 100 microns thick.

[0169] Section 50 50. The septal closure device of any one of paragraphs 37 to 49, wherein the support structure is encapsulated within a second membrane.

[0170] Section 51 1. A septum closure device comprising: a support structure including a central structure, a first anchor portion and an opposing second anchor portion; and a membrane coupled to the first anchor portion, the membrane configured to close a majority of the central structure when the support structure is expanded, the membrane configured to promote tissue growth at least across the membrane.

[0171] Section 52 A septal closure device comprising: a support structure including a first anchor portion, a second anchor portion opposite the first anchor portion, an expandable central structure coupled to the first anchor portion and the second anchor portion, a first membrane coupled to the first anchor portion, and a second membrane coupled to the second anchor portion.

[0172] Section 53 53. The septal closure device of clause 52, wherein the expandable central structure comprises an elastic member.

[0173] Section 54 54. The septal closure device of claim 52 or 53, wherein the expandable central structure includes a spring configured to bias the first anchor portion toward the second anchor portion.

[0174] Section 55 55. The septal closure device of any one of paragraphs 52 to 54, wherein the first membrane and the second membrane comprise an elastic material.

[0175] Section 56 56. The septal closure device of any one of paragraphs 52 to 55, wherein the first membrane and the second membrane include a plurality of perforations.

[0176] Section 57 57. The septal closure device of any one of paragraphs 52 to 56, wherein the first membrane and the second membrane comprise a radiopaque material.

[0177] Section 58 58. The septal closure device of any one of paragraphs 52 to 57, wherein the support structure is configured to contract and expand between a compressed tubular configuration for insertion through a patient's vascular system and an expanded configuration in which the first and second anchor portions extend radially outward from the expandable central structure.

[0178] Section 59 59. The septal closure device of any one of paragraphs 52 to 58, wherein the first and second anchor portions comprise a shape memory material.

[0179] Section 60 59. The septal closure device of any one of claims 52 to 59, wherein at least one of the first anchor portion and the second anchor portion includes a plurality of loops, the plurality of loops being configured to releasably couple the septal closure device to a delivery device.

[0180] Section 61 61. The septal closure device of any one of paragraphs 52 to 60, wherein the first anchor portion and the second anchor portion are configured to compress the cardiac septum therebetween.

[0181] Section 62 62. The septal closure device of claim 61, wherein the first and second membranes are configured to allow a medical instrument inserted into a first compartment of the heart to pass through the first and second membranes and a tissue layer formed on the first and second membranes to enter a second compartment of the heart, and the septum divides the first and second compartments of the heart.

[0182] Section 63 63. The septal closure device of any one of paragraphs 52 to 62, wherein the first membrane forms a continuous surface and the second membrane forms a continuous surface.

[0183] Section 64 64. The septal closure device of any one of paragraphs 52 to 63, wherein the first and second membranes prevent the support structure from coming into direct contact with the patient's blood when the septal closure device is implanted in the patient.

[0184] Section 65 Item 62. The septal closure device of item 61, wherein a lumen extends through the center of the first anchor portion, the center of the second anchor portion, and the center of the expandable central structure, the lumen defining an opening in the septum.

[0185] Section 66 66. The septal closure device of any one of paragraphs 52 to 65, wherein the first and second membranes comprise a plurality of electrospun fibers.

[0186] Section 67 Item 67. The septal closure device of item 66, wherein the plurality of electrospun fibers have a diameter between 0.5 microns and 5 microns.

[0187] Section 68 68. The septal closure device of paragraph 66 or 67, wherein the plurality of electrospun fibers are configured to deform at an elongation of at least 400%.

[0188] Section 69 69. The septal closure device of any one of paragraphs 66 to 68, wherein the plurality of electrospun fibers have an ultimate strain of between 350% and 600%.

[0189] Section 70 Item 66. The septum closure device of any one of items 66 to 69, wherein the plurality of electrospun fibers are configured to promote tissue growth across at least the first membrane and the second membrane.

[0190] Section 71 The septal closure device of any one of paragraphs 52 to 70, wherein the septal closure device has an overall thickness of less than 5 mm.

[0191] Section 72 72. The septal closure device of any one of paragraphs 52 to 71, wherein the septal closure device extends less than 1 mm into the right atrium of the heart when implanted.

[0192] Section 73 73. The septal closure device of any one of paragraphs 52 to 72, wherein the septal closure device extends less than 1 mm into the left atrium of the heart when implanted.

[0193] Section 74 74. The septal closure device of any one of paragraphs 52 to 73, wherein the septal closure device weighs less than 100 micrograms.

[0194] Section 75 75. The septum closure device of any one of paragraphs 52 to 74, wherein the first membrane and the second membrane are less than 100 microns thick.

[0195] Section 76 76. The septal closure device of any one of paragraphs 52 to 75, wherein the discontinuity of the septal closure device extends less than 0.1 mm into the heart when implanted.

[0196] Section 77 A delivery system for an implantable device, the delivery system including: a handle; a sheath including a first end and a second end distal to the first end; and a channel extending between the first end and the second end, the sheath extending from the handle; a lumen including a third end and a fourth end distal to the third end, the lumen configured to travel within the channel; a delivery apparatus including a connector body coupled to the lumen near the fourth end; and a plurality of implantable gripping arms, each including a distal arm tip, the plurality of implantable gripping arms extending distally relative to the connector body, the plurality of implantable gripping arms configured to releasably connect with a pre-implantable device at the distal arm tips. and a locking tube assembly including an implantable gripping arm, a plurality of locking tubes, and a locking tube holder, the plurality of locking tubes extending distally from the locking tube holder, the locking tube holder coupled to the fourth end, wherein each implantable gripping arm extends through a respective locking tube of the plurality of locking tubes, the plurality of locking tubes configured to transition between a locked configuration and an unlocked configuration, wherein in the locked configuration, the plurality of locking tubes extend over distal arm tips, and in the unlocked configuration, the plurality of locking tubes move proximally to expose the distal arm tips, and wherein in the unlocked configuration, the implantable device is releasable from the delivery system.

[0197] Section 78 78. The delivery system of clause 77, wherein the handle includes an actuator configured to transition the plurality of locking tubes between the locked configuration and the unlocked configuration.

[0198] Section 79 79. The delivery system of clause 78, wherein axial movement of the actuator causes axial movement of the plurality of locking tubes.

[0199] Section 80 79. The delivery system of clause 78, wherein rotational movement of the actuator causes axial movement of the plurality of locking tubes.

[0200] Section 81 81. The delivery system of any one of paragraphs 77 to 80, further comprising a guidewire, the guidewire extending through a second channel in the lumen.

[0201] Section 82 82. The delivery system of any one of paragraphs 77 to 81, wherein the implantable device transitions from a compressed tubular configuration for movement through the sheath to an expanded configuration upon exiting the second end of the sheath.

[0202] Section 83 83. The delivery system of any one of paragraphs 77 to 82, wherein each distal arm tip includes a flag having a notch, a portion of the implantable device is received in the notch prior to release of the implantable device, and the plurality of locking tubes extend over the flag in the locked configuration.

[0203] Section 84 84. The delivery system of any one of paragraphs 77 to 83, wherein the distal end of the lumen includes a female threaded cylinder, the locking tube holder includes a threaded shaft, the female threaded cylinder is disposed within the connector body and is axially fixed relative to the connector body, the threaded shaft is threadedly engaged with the female threaded cylinder, and rotation of the lumen causes axial movement of the locking tube holder.

[0204] Section 85 85. The delivery system of any one of paragraphs 77 to 84, wherein the plurality of embedded gripping arms are configured to transition between a compressed configuration for movement within the sheath and an expanded configuration in which the distal arm tips move outward from each other.

[0205] Section 86 86. The delivery system of any one of paragraphs 77 to 85, wherein the implantable device comprises a septal closure device described in any one of paragraphs 1 to 13 or 23 to 76.

[0206] Section 87 1. A method for implanting a closure device within a cardiac septal opening, the method comprising: coupling a distal end of a delivery apparatus to an outer tip of a first anchor portion of the closure device, the closure device being in a compressed configuration and the outer tip being radially outward from a center of the closure device in an expanded configuration; advancing the closure device and the delivery apparatus through a sheath positioned across the septal opening; advancing the closure device and the delivery apparatus until a second anchor portion of the closure device protrudes beyond the sheath and extends radially outward to a second side of the septal opening; retracting the sheath to a first side of the septal opening; advancing the closure device and the delivery apparatus until the first anchor portion protrudes beyond the sheath and extends radially outward to the first side of the septal opening; retracting the multiple locking tubes of the delivery apparatus to expose the outer tip of the first anchor portion; and releasing the closure device from the delivery apparatus.

[0207] Section 88 88. The method of clause 87, further comprising retracting the delivery apparatus and the closure device into the sheath, wherein retracting the delivery apparatus transitions the closure device from the expanded configuration to the compressed configuration.

[0208] Section 89 89. The method of clause 88, further comprising: repositioning the sheath across the septal opening; advancing the closure device and the delivery apparatus until the second anchor portion of the closure device protrudes beyond the sheath and extends radially outward to the second side of the septal opening; retracting the sheath to the first side of the septal opening; and advancing the closure device and the delivery apparatus until the first anchor portion protrudes beyond the sheath and extends radially outward to the first side of the septal opening.

[0209] Section 90 89. The method of any one of claims 87 to 89, wherein the delivery device is coupled to a lumen, the lumen configured to move the delivery device and the closure device proximally and distally within the sheath.

[0210] Section 91 91. The method of clause 90, wherein the delivery device includes a connector body coupled to the lumen near the distal end of the lumen, and a plurality of embedding gripping arms, each including a distal arm tip, the embedding gripping arms extending distally relative to the connector body, the embedding gripping arms configured to releasably connect with an outer tip of the first anchor portion at the distal arm tip.

[0211] Section 92 92. The method of clause 91, wherein the delivery apparatus further comprises a locking tube holder, the plurality of locking tubes extending distally from the locking tube holder, the locking tube holder coupled to the distal end of the lumen, each embedded gripping arm extending through a respective locking tube of the plurality of locking tubes, the plurality of locking tubes configured to transition between a locked configuration and an unlocked configuration, wherein in the locked configuration, the plurality of locking tubes extend over distal arm tips and, in the unlocked configuration, the plurality of locking tubes move proximally to expose the distal arm tips, and wherein in the unlocked configuration, the closure device is releasable from the delivery apparatus.

[0212] Section 93 Item 93. The method of item 92, wherein each distal arm tip includes a flag having a notch, the outer tip of the first anchor portion is received in the notch before release of the closure device, and the plurality of locking tubes extend over the flag in the locked configuration.

[0213] Section 94 Item 94. The method of item 93, wherein the distal end of the lumen includes a female threaded cylinder, the locking tube holder includes a threaded shaft, the female threaded cylinder is disposed within the connector body and is axially fixed relative to the connector body, the threaded shaft is threadedly engaged with the female threaded cylinder, and rotation of the lumen causes axial movement of the locking tube holder.

[0214] Section 95 95. The method of any one of paragraphs 91 to 94, wherein the plurality of embedded grasping arms are configured to transition between a compressed configuration for movement within the sheath and an expanded configuration in which the distal arm tips move outward from each other.

[0215] Section 96 96. The method of any one of clauses 87 to 95, wherein the sheath extends from a handle, the handle including an actuator configured to transition the plurality of locking tubes between the locked configuration and the unlocked configuration.

[0216] Section 97 97. The method of clause 96, wherein axial movement of the actuator causes axial movement of the plurality of locking tubes.

[0217] Section 98 97. The method of clause 96, wherein rotational movement of the actuator causes axial movement of the plurality of locking tubes.

[0218] Section 99 99. The method of any one of paragraphs 90 to 98, wherein the lumen is advanced over a guidewire, the guidewire extending through the lumen, the closure device, and the delivery apparatus.

[0219] Section 100 99. The method of any one of paragraphs 87 to 99, wherein the closure device comprises a septal closure device described in any one of paragraphs 1 to 13 or 23 to 76.

Claims

1. a support structure including a first anchor portion and an opposing second anchor portion, a lumen extending through a center of the first anchor portion and a center of the second anchor portion, the support structure configured to contract and expand between a compressed tubular configuration for insertion through a patient's vasculature and an expanded configuration in which the first and second anchor portions extend radially outward from the lumen; a membrane coupled to the first anchor portion, the membrane configured to occlude a majority of the lumen when the support structure is expanded, the membrane configured to promote tissue growth at least across the membrane; septal closure devices, including:

2. The septal closure device of claim 1 , wherein the membrane comprises an elastic material.

3. The septal closure device of claim 1 or 2, wherein the membrane includes a plurality of perforations.

4. The septal closure device of claim 1 , wherein the membrane comprises a radiopaque material.

5. 5. The septal closure device of claim 1, further comprising a second membrane that extends over the first anchor portion and the second anchor portion without closing the lumen when the support structure is expanded.

6. The septal closure device of claim 1 , wherein the first and second anchor portions include a plurality of interconnected struts.

7. The septal closure device of claim 1 , wherein the first and second anchor portions comprise a shape memory material.

8. The septal closure device of claim 1 , wherein the second anchor portion includes a plurality of loops, the plurality of loops configured to releasably couple the septal closure device to a delivery device.

9. The septal closure device of claim 1 , wherein the first anchor portion and the second anchor portion are configured to compress the cardiac septum therebetween.

10. The septal closure device of claim 9 , wherein the lumen is configured to align with an opening in the septum.

11. 11. The septal closure device of claim 9 or 10, wherein the membrane is configured to allow a medical instrument inserted into a first compartment of the heart to pass through the membrane and a tissue layer formed on the membrane and through the lumen to a second compartment of the heart, and the septum divides the first and second compartments of the heart.

12. The septal closure device of claim 1 , wherein the membrane forms a continuous surface.

13. 13. The septal closure device of claims 5 to 12, wherein the second membrane prevents the support structure from directly contacting the patient's blood when the septal closure device is implanted in the patient.

14. inserting a delivery system into a patient's vasculature, the delivery system including a release member and a sheath, the sheath including a septal closure device in a compressed configuration, the septal closure device including a first anchor portion and an opposing second anchor portion, the second anchor portion coupled to the release member; advancing the distal end of the sheath at least partially through the septum of the patient's heart; advancing the septal closure device inside the sheath such that the first anchor portion expands at a first section on a first side of the septum; advancing the septal closure device outside the sheath so that the second anchor portion expands at a second section on a second side of the septum opposite the first side, the second anchor portion remaining coupled to the release member in an expanded configuration; and Releasing the septal closure device from the delivery system. A method comprising:

15. The method of claim 14 , wherein a lumen extends through a center of the first anchor portion and a center of the second anchor portion, the lumen defining an opening in the septum.

16. The method of claim 15 , wherein the septal closure device further comprises a membrane coupled to the first anchor portion, the membrane configured to occlude a majority of the lumen.

17. 17. The method of claim 15 or 16, further comprising a second membrane that extends over the first anchor portion and the second anchor portion without closing the lumen when the septal closure device is expanded.

18. 18. The method of claim 16 or 17, wherein the membrane comprises an elastic material.

19. 19. The method of any one of claims 16 to 18, wherein the membrane comprises a plurality of perforations.

20. and further comprising placing a septum closure device within the patient's heart for a period of time, the membrane being configured to promote tissue growth at least across the membrane.

20. The method of any one of claims 16 to 19.

21. inserting a medical device into the vascular system of the patient; advancing the medical device into the first compartment; and advancing the medical device through the tissue layer on the membrane and through the membrane, the medical device passing across the lumen and into the second compartment; 21. The method of claim 20, further comprising:

22. 22. The method of any one of claims 16 to 21, wherein the membrane comprises a radiopaque material that identifies the lumen that defines the passable area of ​​the septal closure device.

23. 1. A septal closure device configured to be implanted in a patient's heart, comprising: a support structure including a lumen; a membrane comprising a plurality of electrospun fibers, the membrane being coupled to at least a portion of the support structure, the membrane being configured to occlude a majority of the lumen when the septal closure device is implanted; and septal closure devices, including:

24. 24. The septal closure device of claim 23, wherein the support structure further includes a first anchor portion and an opposing second anchor portion, the lumen extending through a center of the first anchor portion and a center of the second anchor portion.

25. 25. The septal closure device of claim 23 or 24, wherein the plurality of electrospun fibers have a diameter between 0.5 microns and 5 microns.

26. 26. The septal closure device of any one of claims 23 to 25, wherein the plurality of electrospun fibers are configured to deform at an elongation of at least 400%.

27. 27. The septal closure device of any one of claims 23 to 26, wherein the plurality of electrospun fibers have an ultimate strain of between 350% and 600%.

28. 28. The septal closure device of any one of claims 23 to 27, wherein the septal closure device has an overall thickness of less than 5 mm.

29. 29. The septal closure device of any one of claims 23 to 28, wherein the septal closure device extends less than 0.1 mm into the left atrium of the heart when implanted.

30. 30. The septal closure device of any one of claims 23 to 29, wherein the septal closure device extends less than 1 mm into the right atrium of the heart when implanted.

31. 31. The septal closure device of any one of claims 23 to 30, wherein the septal closure device weighs less than 100 micrograms.

32. 32. The septal closure device of any one of claims 23 to 31, wherein the plurality of electrospun fibers are configured to promote tissue growth across at least the membrane.

33. 33. The septal closure device of any one of claims 24 to 32, wherein the support structure is configured to contract and expand between a compressed tubular configuration for insertion through a patient's vasculature and an expanded configuration in which the first and second anchor portions extend radially outward from the lumen.

34. 34. The septal closure device of any one of claims 23 to 33, wherein the membrane is less than 100 microns thick.

35. 35. The septal closure device of any one of claims 23 to 34, wherein the discontinuity of the septal closure device extends less than 0.1 mm into the heart when implanted.

36. The septal closure device of any one of claims 23 to 3534, wherein the support structure is encapsulated within a second membrane.

37. 1. A septal closure device configured to be implanted in a patient's heart, comprising: a support structure including a central structure; a membrane configured to promote tissue growth across the central structure, the membrane being coupled to at least a portion of the support structure, the membrane being configured to close a majority of the central structure when the septal closure device is implanted; and septal closure devices, including:

38. The septal closure device of claim 3736, wherein the support structure further includes a first anchor portion and an opposing second anchor portion, and the central structure extends through a center of the first anchor portion and a center of the second anchor portion.

39. 39. The septal closure device of claim 37 or 38, wherein the membrane comprises a plurality of electrospun fibers.

40. 40. The septal closure device of claim 39, wherein the plurality of electrospun fibers have a diameter between 0.5 microns and 5 microns.

41. 41. The septal closure device of claim 39 or 40, wherein the plurality of electrospun fibers are configured to deform at an elongation of at least 400%.

42. 42. The septal closure device of any one of claims 39-41, wherein the plurality of electrospun fibers have an ultimate strain of between 350% and 600%.

43. 43. The septal closure device of any one of claims 37 to 42, wherein the septal closure device has an overall thickness of less than 4 mm.

44. 44. The septal closure device of any one of claims 37 to 43, wherein the septal closure device extends less than 0.1 mm into the left atrium of the heart when implanted.

45. 45. The septal closure device of any one of claims 37 to 44, wherein the septal closure device extends less than 1 mm into the right atrium of the heart when implanted.

46. 46. ​​The septal closure device of any one of claims 37 to 45, wherein the septal closure device weighs less than 100 micrograms.

47. 47. The septal closure device of any one of claims 39 to 46, wherein the plurality of electrospun fibers are configured to promote tissue growth across at least the membrane.

48. 48. The septal closure device of any one of claims 38 to 47, wherein the support structure is configured to contract and expand between a compressed tubular configuration for insertion through a patient's vasculature and an expanded configuration in which the first and second anchor portions extend radially outward from the central structure.

49. The septal closure device of any one of claims 3736 to 48, wherein the membrane is less than 100 microns thick.

50. 50. The septal closure device of any one of claims 37 to 49, wherein the support structure is encapsulated within a second membrane.

51. a support structure including a central structure, a first anchor portion, and an opposing second anchor portion; a membrane coupled to the first anchor portion, the membrane configured to close a majority of the central structure when the support structure is expanded, the membrane configured to promote tissue growth at least across the membrane; septal closure devices, including:

52. a first anchor portion; a second anchor portion opposite the first anchor portion; and a support structure including an expandable central structure coupled to the first anchor portion and the second anchor portion; a first membrane coupled to the first anchor portion; a second membrane attached to the second anchor portion; septal closure devices, including:

53. 53. The septal closure device of claim 52, wherein the expandable central structure comprises an elastic member.

54. 54. The septal closure device of claim 52 or 53, wherein the expandable central structure includes a spring configured to bias the first anchor portion toward the second anchor portion.

55. 55. The septal closure device of any one of claims 52 to 54, wherein the first membrane and the second membrane comprise an elastic material.

56. 56. The septal closure device of any one of claims 52 to 55, wherein the first membrane and the second membrane include a plurality of perforations.

57. 57. The septal closure device of any one of claims 52 to 56, wherein the first membrane and the second membrane comprise a radiopaque material.

58. 58. The septal closure device of any one of claims 52 to 57, wherein the support structure is configured to contract and expand between a compressed tubular configuration for insertion through a patient's vasculature and an expanded configuration in which the first and second anchor portions extend radially outward from the expandable central structure.

59. 59. The septal closure device of any one of claims 52 to 58, wherein the first and second anchor portions comprise a shape memory material.

60. 60. The septal closure device of any one of claims 52 to 59, wherein at least one of the first anchor portion and the second anchor portion includes a plurality of loops, the plurality of loops configured to releasably couple the septal closure device to a delivery device.

61. 61. The septal closure device of any one of claims 52 to 60, wherein the first anchor portion and the second anchor portion are configured to compress the cardiac septum therebetween.

62. 62. The septal closure device of claim 61, wherein the first and second membranes are configured to allow a medical instrument inserted into a first compartment of the heart to pass through the first and second membranes and tissue layers formed on the first and second membranes to enter a second compartment of the heart, and the septum divides the first and second compartments of the heart.

63. 63. The septal closure device of any one of claims 52 to 62, wherein the first membrane forms a continuous surface and the second membrane forms a continuous surface.

64. 64. The septal closure device of any one of claims 52 to 63, wherein the first and second membranes prevent the support structure from directly contacting the patient's blood when the septal closure device is implanted in the patient.

65. 62. The septal closure device of claim 61, wherein a lumen extends through a center of the first anchor portion, a center of the second anchor portion, and a center of the expandable central structure, the lumen defining an opening in the septum.

66. 66. The septal closure device of any one of claims 52 to 65, wherein the first and second membranes comprise a plurality of electrospun fibers.

67. 67. The septal closure device of claim 66, wherein the plurality of electrospun fibers have a diameter between 0.5 microns and 5 microns.

68. 68. The septal closure device of claim 66 or 67, wherein the plurality of electrospun fibers are configured to deform at an elongation of at least 400%.

69. 69. The septal closure device of any one of claims 66 to 68, wherein the plurality of electrospun fibers have an ultimate strain of between 350% and 600%.

70. 69. The septal closure device of any one of claims 66 to 68, wherein the plurality of electrospun fibers are configured to promote tissue growth across at least the first membrane and the second membrane.

71. 71. The septal closure device of any one of claims 52 to 70, wherein the septal closure device has an overall thickness of less than 5 mm.

72. 72. The septal closure device of any one of claims 52 to 71, wherein the septal closure device extends less than 1 mm into the right atrium of the heart when implanted.

73. 73. The septal closure device of any one of claims 52 to 72, wherein the septal closure device extends less than 1 mm into the left atrium of the heart when implanted.

74. 74. The septal closure device of any one of claims 52 to 73, wherein the septal closure device weighs less than 100 micrograms.

75. 75. The septal closure device of any one of claims 52 to 74, wherein the first membrane and the second membrane are less than 100 microns thick.

76. 76. The septal closure device of any one of claims 52 to 75, wherein the discontinuity in the septal closure device extends less than 0.1 mm into the heart when implanted.

77. 1. A delivery system for an implantable device, comprising: The handle and A sheath, a first end; a second end distal to the first end; and a sheath including a channel extending between the first end and the second end, the sheath extending from the handle; Lumens, a third end; and a fourth end distal to the third end, the lumen configured to travel within the channel; and a delivery device including a connector body coupled to the lumen near the fourth end; a plurality of implantable gripping arms, each including a distal arm tip, the plurality of implantable gripping arms extending distally relative to the connector body, the plurality of implantable gripping arms configured to releasably connect with a pre-implantable device at the distal arm tip; A plurality of lock tubes; a locking tube holder, the plurality of locking tubes extending distally from the locking tube holder, the locking tube holder coupled to the fourth end; a lock tube assembly including: Including, Each implantable gripping arm extends through a respective one of the plurality of locking tubes, the plurality of locking tubes configured to transition between a locked configuration and an unlocked configuration, wherein in the locked configuration the plurality of locking tubes extend over distal arm tips, and in the unlocked configuration the plurality of locking tubes move proximally to expose the distal arm tips, and wherein in the unlocked configuration the implantable device is releasable from the delivery system. Delivery system.

78. 78. The delivery system of claim 77, wherein the handle includes an actuator configured to transition the plurality of locking tubes between the locked and unlocked configurations.

79. 79. The delivery system of claim 78, wherein axial movement of the actuator causes axial movement of the plurality of locking tubes.

80. 79. The delivery system of claim 78, wherein rotational movement of the actuator causes axial movement of the plurality of locking tubes.

81. 81. The delivery system of any one of claims 77 to 80, further comprising a guidewire, the guidewire extending through a second channel of the lumen.

82. 82. The delivery system of any one of claims 77 to 81, wherein the implantable device transitions from a compressed tubular configuration for movement through the sheath to an expanded configuration upon exiting the second end of the sheath.

83. 83. The delivery system of any one of claims 77 to 82, wherein each distal arm tip includes a flag having a notch, a portion of the implantable device is received in the notch prior to release of the implantable device, and the plurality of locking tubes extend over the flag in the locked configuration.

84. 84. The delivery system of any one of claims 77 to 83, wherein the distal end of the lumen includes an internally threaded cylinder, the locking tube holder includes a threaded shaft, the internally threaded cylinder is disposed within the connector body and is axially fixed relative to the connector body, the threaded shaft is threadedly engaged with the internally threaded cylinder, and rotation of the lumen causes axial movement of the locking tube holder.

85. 85. The delivery system of any one of claims 77 to 84, wherein the plurality of embedded grasping arms are configured to transition between a compressed configuration for movement within the sheath and an expanded configuration in which the distal arm tips move outwardly from each other.

86. 86. The delivery system of any one of claims 77 to 85, wherein the implantable device comprises a septal closure device described in any one of paragraphs 1 to 13 or 23 to 76.

87. 1. A method of implanting a closure device within a septal opening in a heart, comprising: coupling a distal end of a delivery device to an outer tip of a first anchor portion of the closure device, the closure device being in a compressed configuration and the outer tip being radially outward from a center of the closure device in an expanded configuration; advancing the closure device and the delivery apparatus through a sheath positioned across the septal opening; advancing the closure device and the delivery apparatus until a second anchor portion of the closure device protrudes beyond the sheath and extends radially outward to a second side of the septal opening; retracting the sheath to a first side of the septal opening; advancing the closure device and the delivery apparatus until the first anchor portion protrudes beyond the sheath and extends radially outward to the first side of the septal opening; retracting the locking tubes of the delivery device to expose outer tips of the first anchor portions; and Releasing the closure device from the delivery device. A method comprising:

88. 88. The method of claim 87, further comprising retracting the delivery apparatus and the closure device into the sheath, wherein retracting the delivery apparatus transitions the closure device from the expanded configuration to the compressed configuration.

89. repositioning the sheath across the septal opening; advancing the closure device and the delivery apparatus until the second anchor portion of the closure device protrudes beyond the sheath and extends radially outwardly to the second side of the septal opening; retracting the sheath to the first side of the septal opening; advancing the closure device and the delivery apparatus until the first anchor portion protrudes beyond the sheath and extends radially outward to the first side of the septal opening; 89. The method of claim 88, further comprising:

90. 90. The method of any one of claims 87 to 89, wherein the delivery device is coupled to a lumen configured to move the delivery device and the closure device proximally and distally within the sheath.

91. the delivery device comprising: a connector body coupled to the lumen near the distal end of the lumen; a plurality of embedded gripping arms, each including a distal arm tip, the plurality of embedded gripping arms extending distally relative to the connector body, the plurality of embedded gripping arms configured to releasably connect with an outer tip of the first anchor portion at the distal arm tip; 91. The method of claim 90, comprising:

92. the delivery device comprising: a locking tube holder, the plurality of locking tubes extending distally from the locking tube holder, the locking tube holder coupled to the distal end of the lumen; a locking tube holder, wherein each recessed gripping arm extends through a respective one of the plurality of locking tubes, the plurality of locking tubes configured to transition between a locked configuration and an unlocked configuration, wherein in the locked configuration the plurality of locking tubes extend over distal arm tips, and in the unlocked configuration the plurality of locking tubes move proximally to expose the distal arm tips, and wherein in the unlocked configuration the closure device is releasable from the delivery apparatus; 92. The method of claim 91, comprising:

93. 93. The method of claim 92, wherein each distal arm tip includes a flag having a notch, an outer tip of the first anchor portion is received in the notch prior to release of the closure device, and the plurality of locking tubes extend over the flag in the locked configuration.

94. 94. The method of claim 93, wherein the distal end of the lumen includes an internally threaded cylinder, the locking tube holder includes a threaded shaft, the internally threaded cylinder is disposed within the connector body and is axially fixed relative to the connector body, the threaded shaft threadably engages with the internally threaded cylinder, and rotation of the lumen causes axial translation of the locking tube holder.

95. 95. The method of any one of claims 91 to 94, wherein the plurality of embedded grasping arms are configured to transition between a compressed configuration for movement within the sheath and an expanded configuration in which the distal arm tips move outwardly from each other.

96. 96. The method of any one of claims 87-95, wherein the sheath extends from a handle, the handle including an actuator configured to transition the plurality of locking tubes between the locked and unlocked configurations.

97. 97. The method of claim 96, wherein axial movement of the actuator causes axial movement of the plurality of locking tubes.

98. 97. The method of claim 96, wherein rotational movement of the actuator causes axial movement of the plurality of locking tubes.

99. 99. The method of any one of claims 90 to 98, wherein the lumen is advanced over a guidewire, the guidewire extending through the lumen, the closure device, and the delivery apparatus.

100. The method of any one of claims 7787 to 99, wherein the closure device comprises a septal closure device described in any one of claims 1 to 13 or claims 23 to 76.

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