Medical implantable atrial septal defect closure device

Abstract

The present invention relates to a medical implantable atrial septal defect closure device for occluding congenital heart malformations such as atrial septal defects (ASDs) and patent foramen ovale (PFOs) that provide hemodynamic support between the two atria. The closure device comprises a distal disc and a proximal disc with expandable shape memory properties, and a pre-created sealed potential fenestration sealed with a biocompatible polymer patch and sutures to be perforated and used for any possible intervention.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of U.S. Provisional No. 62 / 960,989 (Attorney Docket No. 55631-704.101), filed January 14, 2020, which is incorporated herein by reference in its entirety. Background Art

[0003] technical field. The present invention relates to a medical implantable atrial septal defect closure device, comprising a distal disc and a proximal disc with expandable shape memory properties, and a braided mesh with a biocompatible polymer patch and sutures, for closure of congenital heart malformations that provide hemodynamic support between the two atria, such as an atrial septal defect (ASD) and a patent foramen ovale (PFO). More specifically, the device comprises pre-created potential fenestrations on the disc that are sealed with a biocompatible polymer patch and sutures, allowing for opening / perforation and preparation for any potential intervention.

[0004] Atrial septal defect (ASD) and patent foramen ovale (PFO) are types of congenital heart defects that result in abnormal blood flow between the two atria. Atrial septal defect (ASD) is one of the most common types of congenital heart defects that allows communication between the left and right sides of the heart. These interatrial connections include several different defects in the cardiac terminals of the systemic and pulmonary veins (sinus venosus and coronary sinus defects) and in the atrial septum (atrial septal defect). PFOs are normal connections during fetal life and are also common after birth. PFOs can be identified in a high percentage of people using echocardiography, but some people live their entire lives without any treatment. However, some of these people experience stroke or transient ischemic attack related to impaired atrial function. Transcatheter closure of PFOs reduces the risk of recurrent cryptogenic stroke compared to medical therapy. People with ASDs or PFOs may suffer from complications, including peripheral embolism, thrombosis, and arterial hypertension.

[0005] Device closure of congenital heart defects via transcatheter approaches is now widely accepted as a surgical option. Currently, a wide variety of closure devices are commercially available. While high success rates have been achieved with occluder devices for ASDs and PFOs, some issues, such as residual shunts, can occur depending on the device type and defect morphology. Complete closure depends on endothelial growth to cover the device and septum, a process known as endothelialization. Therefore, the geometric fit between the device and the defect is crucial for the endothelialization process.

[0006] As previously reported in numerous studies, thrombotic events pose a significant threat to patients with PFOs and ASDs, which can be effectively prevented through percutaneous closure. Percutaneous closure can also improve migraine symptoms. Studies have shown that PFOs have a higher rate of thrombosis due to their high residual shunt rate and slow interatrial blood flow.

[0007] In early 1974, King and Mills first reported transcatheter closure of an ASD using a double-umbrella device. Rashkind and Mullins developed the first commercially available device, the Rashkind device, in the early 1980s. Since then, numerous devices have been developed to design reliable and safe closure systems. Closure devices for ASDs can also be used to prevent paradoxical embolism during transcatheter closure of PFOs.

[0008] Currently, there are several types of occlusion devices for ASD and PFO. The occlusion devices available on the market have a metal frame composed of one or more wires, a polymer patch covering the metal frame, and sutures for fixing the patch. Most devices on the market have the same double-disc concept, such as the Amplatzer Cribriform occluder, the Amplatzer ASD occluder, the Amplatzer PFO occluder, the Occlutech occluder, the CARDIOFORM septal occluder, etc., but there are also different concepts, such as a spiral single-strand nitinol wire covered with an expandable polytetrafluoroethylene (PTFE) patch thin mesh (Helex septal occluder), or two self-expanding square umbrellas made of polyethylene terephthalate (PET) patch (CardioSEAL or CardioSEAL-STARFlex devices). The Amplatzer occluder is the most common occluder used for transcatheter closure of ASD and PFO defects, but Tang et al. reported that they have some disadvantages, such as thrombosis and minor complications. Tang et al. pointed out that the Occlutech occluder has some disadvantages such as residual shunt and limited published experience. The same group reported residual leakage and wire frame fracture as complications of the Helex septal occluder.

[0009] In the prior art, the discs of the PFO device are stretched on both sides due to the waist design between the discs, wherein they have a convex or concave shape that produces residual shunts. The prior art device has a single point connection between the discs, which creates the risk of residual shunts due to the waist area allowing blood to flow after implantation and not completely blocking the defect area. In addition, the devices in the prior art have two cruciform nitinol anchors, one side of which is covered with a double layer of knitted PET fabric (Premere PFO occluder), or a shape memory metal skeleton, eight wires and two PET patches fixed by two wire frames (SolySafe spacer occluder). Residual shunts are a common complication associated with these occluders. In addition, in the prior art, some devices include a double umbrella made of polyvinyl alcohol (PVA) and a six-strand nitinol wire arm, and there is an additional foam plug (Intrasept) between the two umbrellas. Luermans et al. reported some complications associated with the Intrasept device, such as cryptogenic stroke, transient ischemic attack, peripheral embolism, etc. Another device also has a nitinol wire mesh and two left atrial anchors that are inserted directly into the PFO sac (SeptRx), but Tang et al noted that experience with this device is less.

[0010] Another novel, suture-based, "device-free" system, the NobleStitch EL system, is available. This system consists of two polypropylene sutures—one for the septum primum and one for the septum secundum—fastened together by a specialized delivery and sealing system. This system allows for the defect to be closed and repaired during surgery by simply applying sutures, and then removing the delivery device from the body. This approach can only be performed when the defect anatomy is suitable.

[0011] Transcatheter closure using closure devices offers many advantages, including safety, ease of use, minimal invasiveness, and few complications. However, existing technologies present a problem: occluders often fail to fully close the defect due to their geometry. Because defect geometry is not universal, closure devices cannot fully cover the defect geometry, particularly in patent foramen ovale defects, potentially leading to residual shunts. Another issue is that previous closure devices require a high level of precision and skill, are time-consuming, and carry the potential risk of inadequate defect closure. Furthermore, existing occluder devices in the prior art do not allow for physician intervention if the atrial septum needs to be crossed after implantation. Some physicians perforate the occluder during surgery when intervention is necessary, and they require different fenestration calibrations for different patients. Occluders with fenestrations cannot meet physician requirements when a specific fenestration diameter is required, as the fenestration may not be suitable for every procedure. Consequently, these issues can pose a high risk to both patients and the healthcare system.

[0012] In light of the problems in the prior art, there is a need in the art for an occlusion device with a geometry that better matches the heart defect, to avoid complications such as residual shunts associated with inadequate closure of congenital heart defects, and to allow access to both sides of the atrium during interventional transseptal procedures. Summary of the Invention

[0013] The present invention relates to a medical implantable atrial septal defect closure device comprising a distal disc and a proximal disc with expandable shape memory properties, as well as a woven mesh with a biocompatible polymer patch and sutures, for occluding congenital heart malformations such as atrial septal defects (ASDs) and patent foramen ovale (PFOs) that provide hemodynamic support between the two atria. More specifically, the device includes pre-created potential fenestrations on the disc that are sealed with a biocompatible polymer patch and sutures, allowing for opening / perforation and preparation for any potential intervention.

[0014] The present invention aims to develop an occlusion device with a geometry that better matches the geometry of the heart defect and eliminates complications caused by inadequate closure of congenital heart defects. The present invention includes a left atrial disc, a right atrial disc, a flattened connecting waist, and an angle between the two discs to provide a good fit to the congenital heart defect and minimize the risk of shunts caused by undersizing or oversizing that may result in the formation of non-occluded areas.

[0015] Another object of the present invention is to create fusion between the device surface and the tissue and septal wall of the atrial septal defect. In order to provide fusion and perfect attachment of the device to the tissue, the device includes electrodes connected to a surrounding metal braided mesh disk that contacts the tissue of the atrial septal defect to transmit energy such as radiofrequency (RF), heat, or the like, thereby creating fusion between the device surface and the tissue. The push rod cable used for the device also has a core with isolated conductive metal wires for delivering energy to the device after implantation.

[0016] Yet another object of the present invention is to allow the physician to access both sides of the atrium when an interventional transseptal procedure is required. The sealed fenestrations with biocompatible polymer patches and sutures located on the disc perfectly close the septal defect in the septum. In the present invention, there are no exact fenestrations in an open form, and there is a pre-created fenestration frame in the structure of the metal braided mesh so as to be perforated to enable access to the other ventricular side or blood perfusion to change or regulate the pressure gradient between the two atria in order to provide medical treatment to the patient acutely or chronically after the device is implanted. These fenestrations on the mesh structure are sealed or covered with patches so that they are in a closed or sealed form. And these sealed fenestrations act as potential fenestrations that can be perforated in the event that an interventional transseptal procedure is required later.

[0017] Another object of the present invention is to prevent the disc of the occluder from protruding and to provide a better seal. The connecting waist of the braided preformed metal structure of the present invention has a flat geometric design and a specific angle between the disc and the waist, which has a closing and sealing performance within the defect position independently of the closure of the disc to seal both sides of the defect. The design of the connecting waist in the present invention eliminates the effect of disc protrusion and closes the defect tunnel and prevents residual shunts. In contrast to the prior art, the present invention provides a flat connection between the discs, so that the defect area is completely closed by the connecting waist and the risk of residual shunts is eliminated.

[0018] The present invention overcomes the problems of the prior art of inadequate closure of the atrial septal defect, not having a geometry that matches the heart defect, not allowing post-implantation intervention to cross the atrial septum, and other attachment shortcomings by providing a device that has a geometry that better matches the heart defect to avoid complications such as residual shunts, has electrodes connected to the surrounding nitinol mesh disk to deliver energy to the device and tissue to fuse them for perfect attachment, and has pre-created sealed potential fenestrations to allow access to both sides of the atrium when an interventional transseptal procedure is required.

[0019] In a first aspect, the present invention includes a device for closing an atrial septal defect, such as a patent foramen ovale (PFO) or an atrial septal defect (ASD). The device includes an expandable frame structure formed of a nickel-titanium alloy or other shape memory metal mesh (105) and having a left atrial disc (101), a right atrial disc (106), and a waist (107, 112, 117) connecting the left atrial disc (101) and the right atrial disc (106). At least one fenestration (102) is located on the left atrial disc (101), and at least one fenestration (102) is located on the right atrial disc (106). A biocompatible polymer patch (111) is located on both the left atrial disc (101) to seal the at least one fenestration (102) and the right atrial disc (106) to seal the at least one fenestration (102), wherein the biocompatible polymer patch is configured to be perforated to allow access therethrough when needed.

[0020] In certain embodiments, the device may further include at least one radiopaque marker (108) located on the left and / or right biocompatible polymer patch (111) for indicating the location of one or more of the fenestrations (102). The device may further include a connecting hub (116) configured to be attached to a pushrod cable (109) containing electrodes (113) to deliver energy to the device surface and the septal tissue to achieve fusion.

[0021] In any such device, the waist (107, 112, 117) may be in a flat form between the left atrial disc (101) and the right atrial disc (106), or may be in a cylindrical form between the left atrial disc (101) and the right atrial disc (106).

[0022] In any such device, the biocompatible polymer patch (111) may comprise a material selected from the group consisting of polytetrafluoroethylene (PTFE), polyethylene terephthalate (PET), polyester Polyurethane (PU) or bioresorbable polymer material.

[0023] In some cases, the device may include a plurality of fenestrations (102) located on at least one of the left atrial disc (101) and the right atrial disc (106) of the metal braided mesh (105).

[0024] In some cases, at least some of the plurality of fenestrations (102) may have different sizes from one another, while in other cases, the sizes of some or all of the fenestrations will be the same.

[0025] The device of the present invention may include a layer of biocompatible polymer patch (111) located on the left atrial disc (101) and a separate layer of biocompatible polymer patch (111) located on the right atrial disc (106) to provide a hemostatic seal. For example, there may be three layers of biocompatible polymer patch (111) on the metal braided mesh (105), including a first layer located on the left atrial disc (101), a second layer located on the right atrial disc (106), and a third layer located in the waist to provide a hemostatic seal.

[0026] In any such device, the left atrial disc (101) and the right atrial disc (106) may be formed as a full circle. Alternatively, the left atrial disc (101) and the right atrial disc (106) may be formed as a semicircle.

[0027] In any such device, the waist may be configured to allow an angle between the left atrial disc (101) and the right atrial disc (106) in the range of 15° to 90°.

[0028] In any such device, the radiopaque marker (108) is located only on the patch (111) of the right atrial disc (106).

[0029] In any such device, the metal braided mesh (105) may be made of a superelastic shape memory metal alloy, wherein the metal alloy comprises nickel titanium alloy

[0030] In any such device, the shape memory metal mesh may comprise a fully woven structure in whole or in part. Alternatively, the shape memory metal mesh may comprise a partially woven structure in whole or in part. Still further alternatively, the shape memory metal mesh may comprise a non-woven structure in whole or in part. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] Figure 1 Schematic diagram of a preferred embodiment of the closure device of the present invention for patent foramen ovale (PFO), with component details including sealing potential fenestration (102), metal braided mesh (105), connecting waist (107) of a conventional PFO occluder, and radiopaque marker (108) (A. front view of the closure device, B. side view of the closure device).

[0032] Figure 2 Schematic diagram of a preferred embodiment of the occlusion device of the present invention for atrial septal defect (ASD), with component details including sealing potential fenestration (102), metal braided mesh (105), connecting waist of the ASD occluder (112) and radiopaque marker (108) (A. front view of the occlusion device, B. side view of the occlusion device).

[0033] Figure 3 (Panels A-D) are schematic diagrams of a preferred embodiment of the occlusion device of the present invention, having component details including a left atrial disc (101), a largest sized sealing potential window (102), a second medium sized sealing potential window (103), a smallest sized third sealing potential window (104), a metal braided mesh (105), a right atrial disc (106), a connecting waist (107) of a conventional PFO occluder, a radiopaque marker (108), a connecting hub (116) attached to a push rod cable (109), a screw hub (110), an electrode (113), and patch (111) material (A. front view of the occlusion device, B. side view of the occlusion device, C. illustration showing two patch (111) layers on the metal braided mesh (105) and a cross-section of the device, one angle view AA, D. a cross-section of the device, another angle view BB).

[0034] Figure 4(Panels A-C) are schematic diagrams of a preferred embodiment of the occlusion device of the present invention, having component details including a left atrial disc (101), a largest sealing potential fenestration (102), a second medium sealing potential fenestration (103), a smallest third sealing potential fenestration (104), a metal braided mesh (105), a right atrial disc (106), a connecting waist (112) of the ASD occluder, a radiopaque marker (108), a connecting hub (116) attached to a push rod cable (109), a screw hub (110), an electrode (113), and patch (111) material (A. front view of the occlusion device, B. side view of the occlusion device, C. illustration showing three patch (111) layers on the metal braided mesh (105).

[0035] Figure 5 Schematic diagram of a preferred embodiment of the occlusion device of the present invention, referred to as a tunnel PFO occluder, with component details including a right disc diameter (114), a left disc diameter (115), a connecting hub (116), and a connecting waist (117) of the tunnel PFO occluder.

[0036] Figure 6 is a schematic diagram of a preferred embodiment of the occlusion device of the present invention, referred to as a tunnel PFO occluder, with component details including electrodes (113) and a connecting waist (117) of the tunnel PFO occluder.

[0037] Figure 7 Schematic diagram of a preferred embodiment of the occlusion device of the present invention, referred to as a tunnel PFO occluder, with component details including a semicircular atrial disc (118), electrodes (113), and a connecting waist (117) of the tunnel PFO occluder.

[0038] Figure 8 Schematic diagram of a preferred embodiment of the occlusion device of the present invention, referred to as a tunnel PFO occluder, with component details including a 90° straight anchoring component (119) for better device stability and reduced risk of device embolism and a connecting waist (117) of the tunnel PFO occluder.

[0039] Figure 9 Schematic diagram of a preferred embodiment of the occlusion device of the present invention with component details including a 45° angled anchoring component (120) for better device stability and reduced risk of device embolism and a connecting waist (117) of the tunnel PFO occluder.

[0040] Figure 10(Panels A-C) are schematic diagrams of a preferred embodiment of the occlusion device of the present invention having a sealed potential fenestration (102), with component details including a left atrial disc (101), a right atrial disc (106), a connecting waist (107) of a conventional PFO occluder, a connecting hub (116), and patch (111) material (A. α refers to the angle between the connecting waist (107) of the conventional PFO occluder and the left atrial disc (101) and the right atrial disc (106), L refers to the length between the left atrial disc (101) and the right atrial disc (106) or the length of the connecting waist (107) of the conventional PFO occluder, BW refers to the width of the connecting waist (107) of the conventional PFO occluder, C. Detailed illustrations showing different shapes of fenestrations in the form of X, Y and Z).

[0041] Figure 11 (Panels A and B) are schematic diagrams of a preferred embodiment of the occluding device of the present invention having two sealed potential fenestrations (102), with component details including a connecting hub (116) and patch (111) material (A. Detailed illustration showing fenestrations of different shapes in the form of X, Y and Z, B. Detailed illustration of patch (111) material).

[0042] Figure 12 is a schematic diagram of a preferred embodiment of the occlusion device of the present invention having three sealing potential fenestrations (102) of possible different shapes as X, Y and Z forms, and having component details including a connecting hub (116) and patch (111) material.

[0043] Figure 13 is a schematic diagram of a preferred embodiment of the occlusion device of the present invention having four sealing potential fenestrations (102) of possible different shapes as X, Y and Z forms, and having component details including connecting hub (116) and patch (111) material.

[0044] Description of Reference Signs

[0045] 101. Left atrial disc

[0046] 102. Seal potential fenestration

[0047] 103.Second sealed potential window

[0048] 104. Third seal potential window

[0049] 105. Metal woven mesh

[0050] 106.Right atrial disc

[0051] 107.Connection waist of conventional PFO occluder

[0052] 108. Radiopaque markers

[0053] 109.Putter Cable

[0054] 110.Screw hub

[0055] 111. Patch

[0056] 112.Connection waist of ASD occluder

[0057] 113. Electrodes

[0058] 114.Right disk diameter

[0059] 115. Left disk diameter

[0060] 116.Connecting hub

[0061] 117.Connection waist of tunnel PFO occluder

[0062] 118. Semicircular heart chamber plate

[0063] 119.90° anchoring components

[0064] 120.45° anchoring components

[0065] AA: Section of the installation, one angle view

[0066] BB: Section of the installation, another angle view

[0067] α: Angle between the connecting waist (107) of the conventional PFO occluder and the left atrial disc (101) and the right atrial disc (106)

[0068] L: Length between the left atrial disc (101) and the right atrial disc (106)

[0069] W: Width of the connecting waist (107) of a conventional PFO occluder

[0070] X, Y and Z: refer to different forms of the shape of the potential window (102) to be sealed DETAILED DESCRIPTION

[0071] The present invention discloses a medical implantable atrial septal defect occlusion device for percutaneously closing atrial septal defects, such as atrial septal defects (ASDs) and patent foramen ovale (PFOs), by providing closure at the defect area. There are three embodiments of the present invention. One embodiment provides an atrial septal occluder for an ASD. Another embodiment provides a conventional atrial septal occluder for a PFO, and yet another embodiment provides another atrial septal occluder for a PFO, referred to as a tunnel PFO occluder device.

[0072] The subject of the occlusion device comprises two discs made of a metal braided mesh (105). The metal braided mesh (105) may be made of a metal alloy exhibiting shape memory and superelastic properties. The metal alloy may be Nitinol or other metal alloys exhibiting shape memory and superelastic properties. Figure 3 and Figure 4 In the invention, the device comprises two discs, namely the left atrial disc (101) and the right atrial disc (106). There is at least one sealed potential fenestration (102) located on the metal braided mesh (105) disc. Figure 3 、 Figure 4 、 Figure 10 、 Figure 11 、 Figure 12 and Figure 13 As can be seen, there can be more than one sealing potential fenestration (102). In one embodiment of the present invention, there are three sealing potential fenestrations (102) as the first, second and third sealing potential fenestrations. The advantage of having more than one fenestration is that the sealing potential fenestration (102) has the largest size compared to the other fenestrations, the second sealing potential fenestration (103) has a medium size compared to the other fenestrations, and the third sealing potential fenestration (104) has the smallest size compared to the other fenestrations. The advantage of having more than one fenestration is that it meets the doctor's requirements when the doctor needs a fenestration for electrophysiological examination and / or intervention of structural heart disease and a fenestration for atrial flow regulation at the same time. For each intervention, the doctor needs a different fenestration calibration. If atrial flow regulation requires a specific fenestration diameter, the doctor will select the appropriate size from the sealing potential fenestrations of different sizes to create a perforation. When an interventional transseptal surgery is required to open the right atrial disc (106) on the right side of the atrial septum, the sealing potential fenestrations (102, 103, 104) on the surface of the metal braided mesh (105) provide a path to enter the two sides of the atrium later.

[0073] There is a connection hub (116) on the right atrial disc (106) of the device, which is attached to a push rod cable (109) containing electrodes (113) to transmit energy such as radiofrequency (RF), heat or the like to create fusion between the device surface and tissue. The electrodes (113) are extensions of the energy cable within the push rod cable (109), and the connection hub (116) is mounted on the surface of the metal braided mesh (105) using a screw hub (110).

[0074] The subject of the device has a metal braided mesh (105) plate (101, 106) between the connecting waist Figure 10The angle is shown as α in FIG. This angle can be between 15° and 90° (degrees). In most cases, the anatomical PFO opening or tunnel has an angle of about 45 degrees. Therefore, the angle between the disc (101, 106) and the connecting waist (107) of a conventional PFO occluder will create a better fit with the PFO defect, thereby better closing and reducing the risk of residual shunt.

[0075] The potential fenestration (102) is sealed using a biocompatible polymer patch (111) made of a material such as polytetrafluoroethylene (PTFE), polyethylene terephthalate (PET), synthetic polyester Dacron, polyurethane (PU) or a bioabsorbable polymer material to provide a seal by forming a layer immediately between the two sides of the atrium and to provide a surface for better endothelialization. There is at least one layer of patch (111) on the metal braided mesh (105). The metal braided mesh (105) is the frame of the device and is a uniform structure. After the metal braided mesh (105) is produced, one or more layers of patch (111) are sutured to the metal braided mesh (105). One patch (111) layer can be sutured to the top of the disc and one patch can be sutured to the bottom of the disc. The suturing process is completed by sutures and needles made of PET or similar materials. After the suturing is completed, the sutures are sealed by welding to secure the sutures. In one embodiment of the present invention for an ASD, the occlusion device comprises a three-layer patch (111) on a metal braided mesh (105), one layer of which is located on the left atrial disc (101), another layer of which is located on the right atrial disc (106), and another layer of which is located in the connecting waist (112) of the ASD occluder to prevent flow between the atria. In another embodiment of the present invention for a PFO, two layers of patch (111) are located in the PFO occluder device as the left and right disc layers to provide a hemostatic seal. Figures 1-4 as well as Figure 10-13 The sealed potential fenestration (102) and / or patch (111) on the metal braided mesh (105) are shown. Since the sealed potential fenestration (102) is sealed with the patch (111), and these two features overlap in structure, the reference numerals in the drawings also overlap. Therefore, in some drawings, these overlapping features are shown with the reference numerals 102 or 111.

[0076] In the present invention, there is at least one radiopaque marker (108) to indicate the location of the sealed potential fenestration (102, 103, 104) because the potential fenestration is sealed by the patch (111), and without these markers, the doctor will not be able to determine the location of the potential fenestration. Using these radiopaque markers (108) on the patch (111) located on the right atrial disc (106), the doctor can visualize these pre-created sealed potential fenestrations (102, 103, 104) and, if intervention is required, enter the left atrial side and perforate the patch (111) on the sealed potential fenestration (102, 103, 104). The radiopaque markers (108) can be visualized under fluoroscopy.

[0077] In an embodiment of the present invention involving a tunnel PFO occluder, the device comprises a left atrial disc (101) and a right atrial disc (106) in the form of a full-circular atrial disc, such as Figure 5 and Figure 6 or in the form of a semicircular atrial disc (118) on both sides, used only to anchor the system in the atrial septum, as shown in Figure 7 In the tunnel PFO occluder embodiment, the PFO defect is closed by the internal connecting waist (117) of the tunnel PFO occluder. The present invention provides a flat connection within the atrial defect by connecting waists (107, 117) that are present in both PFO occluder embodiments as Figure 1 、 Figure 3 and Figure 10 The connecting waist (107) of the conventional PFO occluder shown in FIG; and Figure 5 、 Figure 6 、 Figure 7 、 Figure 8 、 Figure 9 The connecting waist (117) of the tunnel PFO occluder is shown in FIG. The connecting waist (117) of the tunnel PFO occluder divides the PFO tunnel into two separate parts, where the left and right connections are blocked, as shown in FIG. Figure 5 、 Figure 6 、 Figure 7 Even if there is residual shunt after disc closure, the connecting waist (117) of the tunnel PFO can be used to block blood flow from right to left or from left to right. The PFO occluder (conventional PFO occluder type and tunnel PFO occluder type) of the present invention has a flat connecting waist (107 and 117). In the embodiment of the present invention involving the ASD occluder, the connecting waist (112) of the ASD occluder is Figure 4 The waist of the cylindrical form of the ASD occluder.

[0078] In an embodiment of the tunnel PFO occluder, there is a 90° anchoring component (119) or a 45° anchoring component (120). The anchoring component (119 or 120) is not attached to the spacer. It is used to generate a clamping force for both sides of the structure. It can be transformed from a mesh or realized as a mesh alone. It is made of a metal braided mesh (105) as an occluder device. Figure 8 In the preferred embodiment of the tunnel PFO occluder, a 90° straight anchoring component (119) is included to achieve better device stability and reduce the risk of device embolism. Figure 9 In the present invention, a preferred embodiment of the tunnel PFO occluder includes a 45° angled anchoring component (120) for achieving better device stability and reducing the risk of device embolism.

[0079] The introducer system used in the occlusion procedure is placed into the femoral vein and a 0.035" guidewire is advanced through the body's venous access site from the inferior vena cava through the right atrium through the atrial septum to the left atrium. A delivery (Mullin) sheath is advanced over the guidewire until the tip of the catheter is placed in the desired position in the left atrium to provide sufficient support to deliver the device to the defect site. The disclosed device is loaded into the loader and flushed with saline solution to eliminate the risk of residual bubbles that may cause air embolism. The loader is connected to the delivery sheath via a male-female Luer lock mechanism. The main body of the occlusion device is connected to the push rod cable (109) via a screw hub (110) system to install and release the device at the desired location and time. The device is pushed through the delivery system with the help of the push rod cable (109) and the left atrial disc (101) of the device is opened in the left atrium and sometimes in the pulmonary vein to provide the left atrial disc (101) and gently pulled back to the defect site and open the connecting waist (107, 112 or 117).

[0080] By gently pulling the push rod cable (109), the doctor tests the stability of the device at the implantation position and, after confirmation, unscrews the push rod cable (109) to release the occlusion device. All intervention steps are performed under the guidance of fluoroscopy and / or transesophageal echocardiography (TEE) (2D or 3D). After the device is implanted in the desired position, the doctor checks the stability of the device and the possibility of controlling residual shunt or any other silent ASD, PFO by contrast agent flushing or TEE color imaging. Remove the delivery sheath, push rod cable (109) and all systems from the patient's femoral vein access point and seal the access point.

[0081] In an embodiment of the present invention, the diameter of the fenestration may be 3, 4, 5, 6, 8, 10 or 12 mm. The sealing potential fenestration (102) may have any geometry and any diameter, such as from Figure 10 、 Figure 11 、 Figure 12 and Figure 13 As can be seen in the example of the X, Y and Z forms shown in FIG. In the present invention, the right disc diameter (114) and the left disc diameter (115) may be different depending on the implementation. Figure 10 In an embodiment of the present invention, the angle (α) of the connecting waist (107) of the conventional PFO occluder can be between 15° and 90° (degrees); the length (L) between the left atrial disc (101) and the right atrial disc (106) can be between 2 and 16 mm, and the width (W) of the connecting waist (107) of the conventional PFO occluder can be between 3 and 16 mm.

Claims

1. A device for occluding an atrial septal defect, the device comprising: An expandable frame structure formed of a shape memory metal braided mesh (105) and having a left atrial disc (101), a right atrial disc (106), and waist portions (107, 112, 117) connecting the left atrial disc (101) and the right atrial disc (106); at least one fenestration (102) located in the left atrial disc (101); at least one fenestration (102) located on the right atrial disc (106); wherein the fenestration is sealed with a biocompatible polymer patch (111), the biocompatible polymer patch (111) being on the left atrial disc (101) to seal the at least one fenestration (102) and on the right atrial disc (106) to seal the at least one fenestration (102), Characterized in that: the biocompatible polymer patch (111) is configured to be perforated to allow access therethrough when needed, and wherein the fenestrations (102) are pre-created fenestration frames in the structure of the shape memory metal braided mesh (105), and the device also includes at least one radiopaque marker (108) located on the left and / or right biocompatible polymer patch (111) to indicate the location of one or more of the fenestrations (102).

2. The device of claim 1, further comprising a connection hub (116) configured to attach to a push rod cable (109) containing electrodes (113) to deliver energy to the device surface and spaced tissue for fusion.

3. The device according to claim 1 or 2, wherein the waist (107, 112, 117) is in a flattened form between the left atrial disc (101) and the right atrial disc (106).

4. The device according to any one of claims 1 to 3, wherein the waist (107, 112, 117) is cylindrical between the left atrial disc (101) and the right atrial disc (106).

5. The device according to any one of claims 1 to 4, wherein the biocompatible polymer patch (111) comprises a material selected from the group consisting of polytetrafluoroethylene (PTFE), polyethylene terephthalate (PET), polyester or polyurethane (PU).

6. The device according to any one of claims 1 to 5, comprising a plurality of fenestrations (102) located on at least one of the left atrial disc (101) and the right atrial disc (106) of the shape memory metal braided mesh (105).

7. The apparatus of claim 6, wherein at least some of the plurality of fenestrations (102) have different sizes from one another.

8. The device according to any one of claims 1 to 7, comprising a first layer of biocompatible polymer patch (111) on the left atrial disc (101) and a second separate layer of biocompatible polymer patch (111) on the right atrial disc (106) to provide a hemostatic seal.

9. The device according to claim 8 comprises a three-layer biocompatible polymer patch (111) on the shape memory metal braided mesh (105), wherein the first layer is located on the left atrial disc (101), the second separate layer is located on the right atrial disc (106), and the third layer is located in the waist to provide a hemostatic seal.

10. The device according to any one of claims 1 to 9, wherein the left atrial disc (101) and the right atrial disc (106) are formed as a full circle or a semicircle.

11. The device according to any one of claims 1 to 10, wherein the waist is configured to allow an angle between the left atrial disc (101) and the right atrial disc (106) in the range of 15° to 90°.

12. The device of claim 1, wherein the radiopaque marker (108) is located only on a patch (111) of the right atrial disc (106).

13. The device according to any one of claims 1 to 12, wherein the shape memory metal braided mesh (105) is made of a superelastic shape memory metal alloy.

14. The device of claim 13, wherein the metal alloy comprises nickel titanium alloy.

15. The device according to any one of claims 1 to 13, wherein the shape memory metal braided mesh comprises a fully braided structure, a partially braided structure, or a non-braided structure.

16. The device according to any one of claims 1 to 4, wherein the biocompatible polymer patch (111) comprises a bioabsorbable polymer material.

Images