Medical occlusion devices

Abstract

An occluding device (20) includes a compliant balloon (5), the compliant balloon (5) including an insufflation port (3) for filling a fluid into a balloon chamber (26) and emptying the fluid from the balloon chamber (26). A distal tip element (10) and a proximal base element (4) are respectively disposed at the distal and proximal sides (28B, 28A) of the balloon (5). An elongated actuating element (9) is longitudinally slidably disposed in a balloon cavity (6), the balloon cavity (6) forming a longitudinal channel (27) from the proximal side (28A) to the distal side (28B) of the balloon (5), the elongated actuating element (9) being connected to the distal tip element (10) and longitudinally movable relative to the proximal base element (4) to set a distance between the distal tip element (100) and the proximal base element (4). A locking mechanism (2) is configured to maintain the distance between the distal tip element (10) and the proximal base element (4) set using the elongated actuating element (9).

Description

[0001] Related Applications

[0002] This patent application is a partial continuation of International Patent Application No. PCT / EP2018 / 075716 filed on September 23, 2018, which claims priority to European Patent Application No. 17192792.4 filed on September 23, 2017. Both of the above applications are assigned to the assignee of the present application and are incorporated herein by reference. Technical Field

[0003] The present invention generally relates to an occlusive device for occluding a cardiovascular defect or a gap between a medical device and adjacent body tissue. Background Art

[0004] There are several types of unnecessary or even pathological channels in the body. If located in blood vessels or the heart, such channels can lead to highly undesirable alterations in blood flow or bypassing of blood flow around organs.

[0005] WO95 / 32018 describes a method and apparatus for occluding a body passage by inserting an expandable frame into the body passage and expanding the frame with an expandable balloon to partially embed the frame into the wall of the passage. The frame may be provided with a separate sealing membrane, or the balloon may be used as the sealing membrane. If the balloon is not used as a sealing membrane, it may be removed together with the inflation tube after the expansion step, or the balloon may be separated from the inflation tube and left in place, either as a sealing membrane or simply to lock the frame in place. The frame may be maintained in its expanded state by plastic deformation during the expansion step. The expandable frame has a generally cylindrical shape and is described as suitable, for example, for closing a patent ductus arteriosus, in which an unwanted passage or duct connects the aorta to the main pulmonary artery near the heart.

[0006] US 4,836,204 describes a device for closing a perforation in the cardiac septum. The device comprises a double-balloon septal defect occlusion catheter to be inserted so that two initially deflated balloons are located on opposite sides of the septum. When inflated, the balloons cling to their respective septal wall sections and thus prevent leakage through the perforation.

[0007] Paravalvular leaks are a common complication, occurring in up to 30% of patients undergoing surgery or transcatheter prosthesis implantation. The option of percutaneously treating these defects may offer a safer solution for high-risk patients without exposing them to the risks associated with open heart reoperation. However, the devices currently in use are suboptimal because they have not been specifically developed for this intended use. Today, closure of paravalvular leaks is often accomplished using devices that were originally designed to occlude congenital heart defects. They are typically implanted in low-flow settings such as patent foramen ovale or atrial septal defects and in simple geometries. In contrast, paravalvular leaks develop in settings of high pressure and flow, and they are characterized by complex geometries. These defects are typically crescent-shaped or elliptical, may include tubular cross-sections with multiple deformations, and are compliant at best.

[0008] The left atrial appendage (LAA) is a cavity located in the left atrium of the heart. In patients with AF, the passage and stagnation of blood within this cavity can lead to thrombosis, which increases the risk of stroke. Percutaneous LAA occlusion is a therapy to prevent stroke in patients with AF. LAA occlusion can be used as an alternative to or in addition to oral anticoagulation. LAA occlusion has good clinical outcomes, but commercially available devices are often self-expanding and poorly designed to fit the anatomy, which can sometimes lead to complications or suboptimal outcomes. In these settings, some of the currently available occlusion devices are limited by poor conformity of the device to the defect (lack of consistency) and by a lack of an intra-device seal (due to high-flow environments).

[0009] Nevertheless, there are some concepts and implementations of occlusion devices specifically designed for paravalvular leak occlusion or LAA occlusion.

[0010] US 2014 / 0277426 A1 describes various devices for occluding a gap between a medical device and adjacent body tissue. The device generally includes a compliant body having a hollow interior and a fluid port for providing a pressurized fluid to inflate the compliant body. Various shapes and configurations of the compliant body, delivery device, and fixation device are described.

[0011] US 7,628,805 generally describes various concepts for locating and repairing paravalvular leaks. The concepts include sealing stents, as well as multi-component and radiation-cured adhesive compounds.

[0012] US 2012 / 078295 describes an occluder device for closing a passage in a circulatory system. The device comprises an expandable fixing unit for fixing the occluder on the passage by switching between a compact form and an expanded form.

[0013] Nevertheless, there remains a need for an improved occlusive device which avoids the disadvantages of currently known devices. Summary of the invention

[0014] In some applications of the present invention, an occlusion device is provided for occluding a cardiovascular defect or a gap between a medical device and adjacent body tissue. The occlusion device is used together with a guide wire and a delivery system. The occlusion device includes:

[0015] a compliant balloon, the balloon defining a fluid-tight balloon chamber, (b) having a balloon cavity forming a longitudinal passage from a proximal side to a distal side of the balloon, and (c) including an insufflation port for filling a fluid into the balloon chamber and evacuating the fluid from the balloon chamber;

[0016] a distal tip element and a proximal base element, wherein the distal tip element is disposed at the distal side of the airbag, and the proximal base element is disposed at the proximal side of the airbag;

[0017] an elongated actuator member longitudinally slidably disposed within the balloon lumen, connected to the distal tip member, and longitudinally movable relative to the proximal base member to set a distance between the distal tip member and the proximal base member; generally, the elongated actuator member is selected from the group consisting of a tube, a wire, a long handle, a cable, a strand, and a fiber;

[0018] a locking mechanism for maintaining the distance between the distal tip member and the proximal base member set using the elongated actuating member; and

[0019] A proximal connection element is disposed on the proximal side of the balloon and is configured to releasably connect the occluding device to a correspondingly configured distal connection element of the delivery system.

[0020] According to another aspect, an occlusion system is provided, comprising an occlusion device as described above and a delivery system (including a catheter device) cooperating therewith. The catheter device comprises an implanted catheter connected to an operating handle. The implanted catheter comprises a longitudinal channel for a guide wire, a distal connecting element for releasably connecting the catheter device to a correspondingly configured proximal connecting element of the occlusion device; and a fluid transfer system releasably connected to a corresponding insufflation port of the occlusion device. The distal connecting element and the proximal connecting element are generally configured as mating components respectively disposed at the proximal end of the catheter device and the proximal end of the occlusion device. Examples of such mating components include mating threads, latches or snap connections.

[0021] Clinical indications include, but are not limited to, paravalvular leak (PVL), patent foramen ovale (PFO), atrial septal defect (ASD), ventricular septal defect (VSD), intravalvular leak (IVL), leaflet endoleak, leaflet perforation, type I intravascular leak after vascular graft implantation, left or right apex closure after transcardiac therapeutic access, and left atrial appendage occlusion.

[0022] The occluding device is designed to be delivered to the area to be treated in its longitudinally expanded form, either fully or partially compressed. After delivery, the occluding device is adapted to the anatomy of the anchoring area by inflating the balloon and subsequently shortening the longitudinal dimension of the frame formed between the proximal base element and the distal tip element. Under the influence of the internal pressure, the balloon will assume a certain volume, which, for a given longitudinal frame dimension, will result in a certain transverse or radial dimension, thereby providing a good seal between the balloon and adjacent anatomical structures or implanted medical devices. Changing the longitudinal frame dimension by selecting a different distance between the distal tip element and the proximal base element will result in a corresponding change in the radial or transverse expansion of the balloon. In other words, under other constant conditions, shortening the distance between the distal tip element and the proximal base element results in a corresponding increase in radial or transverse expansion, which improves the seal with adjacent tissues and / or medical devices and closes off unwanted blood passages. The lateral expansion of the balloon need not be symmetrical because the balloon is not necessarily symmetrical and / or because the anatomical structure targeted by the lateral expansion of the balloon may result in asymmetric balloon expansion. The radial or lateral expansion together includes within its scope one or more directions that are generally perpendicular to the longitudinal axis of the balloon. (Alternatively, the balloon is partially inflated (e.g., to air pressure) and the longitudinal dimension of the frame is shortened; the balloon can then be further inflated before release, e.g., to form a good seal between the balloon and adjacent anatomical structures or implanted medical devices, if desired.)

[0023] In the context of the present disclosure, the terms "distal" and "proximal" are used according to their standard meanings in the field of percutaneous cardiovascular devices. The term "proximal" refers to those parts of the device assembly that are closer to the end of a catheter that is configured to be manipulated by a user (e.g., a catheter handle manipulated by a physician) when following a delivery catheter during percutaneous delivery. The term "distal" is used to refer to those parts of the device assembly that are farther away from the end of the catheter and are configured to be manipulated by a user and / or for further insertion into a patient. Thus, in an occlusion device for a gap between a medical device and adjacent body tissue, such as a pericuspid leak, the proximal end may face the left atrium and the distal end may face the left ventricle when the occlusion device is positioned at the defect using a transseptal approach.

[0024] The term "compliant" in relation to an airbag or to a structural component should be understood to imply a deformability substantially in response to an applied force. Thus, a "compliant airbag" should be understood to be an airbag that gradually expands under the influence of an increase in radial pressure, as long as a certain bursting pressure is not exceeded.

[0025] The term "strut" is to be understood as an elongated structural element which may be formed, for example, as a thin metal wire, a rod, a thick-walled tube, none of which necessarily has a circular cross-section.

[0026] The compliant balloon of the occluding device is not necessarily pre-shaped, as the balloon, because it is compliant, will take on the shape of the defect once inflated within the defect. However, for some applications, the sidewall of the balloon has a different thickness in a particular area (e.g., in the center so that the balloon assumes a figure eight shape when inflated, or longitudinally forms a skeleton on one side, resulting in less inflation on that side of the balloon). Additionally, the pre-shaped balloon can be used to establish a predetermined, non-uniform localized elasticity to an applied radial pressure.

[0027] For some applications, the balloon includes silicone, polyurethane, polytetrafluoroethylene (PTFE), polymethyl methacrylate, polyetheretherketone (PEEK), polyvinyl chloride, polyethylene terephthalate, nylon, polyamide, polyamide, polyether block amide (PEBA) or other biocompatible materials. For some applications, the balloon includes a compliant, biodegradable material selected from polycaprolactone (PCL), polyglycolic acid (PGA), polylactic acid (PLA) and polydioxanone (PDO or PDS). Optionally, the balloon is externally treated with a hydrophilic coating, a hydrophobic coating, an anti-inflammatory coating, an anticoagulant coating or other coating to promote the growth of endothelial cells, for example by chemical methods or by changing the porosity of the outer surface of the balloon.

[0028] For some applications, the proximal base element and the distal tip element are connected by one or more struts. Depending on the specific application, various configurations of struts can be considered. According to one application, these struts include a single connecting strut arranged in the balloon cavity or outside the balloon. For other applications, the struts include several struts, for example, arranged in a dragon-like manner on the outside of the balloon. Applying internal pressure to the balloon will cause it to inflate against an elastic force of the compliant balloon material while resisting the structural constraints provided by the several external connecting struts. In particular, this configuration can provide the following advantages: an improved stability of the compliant balloon against unwanted local deformation. Generally, this will enable the occlusion device to better adapt to the geometry of the defect to be closed.

[0029] The locking mechanism for maintaining a predetermined distance between the distal tip element and the proximal base element may also be configured in various ways. For example, the locking mechanism may include a rotatable elongated actuating element (e.g., a wire) formed with a threaded portion for mating with a corresponding portion formed on the proximal base element. For some applications, the locking mechanism is configured as a ratchet mechanism, whereby the distance between the distal tip element and the proximal base element may be selected from a range of distances. This allows for an accurate and reliable definition of the radial extension of the occluding device and thus improves the reliability of the occluding device.

[0030] The elongated actuating element is longitudinally slidably arranged in the balloon cavity, connected to the distal tip element and longitudinally slidable relative to the proximal base element, thereby setting a distance between the distal tip element and the proximal base element. For this purpose, the elongated actuating element is generally formed as an elongated flexible member with a smooth surface. For some applications, the elongated actuating element is configured as an actuating wire. The use of actuating wires has been widely established in the field of cardiovascular intervention. In the present case, the use of a wire together with a suitable proximal counterpart allows a simple, precise and reproducible selection of the distance between the distal tip element and the proximal base element.

[0031] In the field of cardiovascular intervention, tools for filling and deflating balloons and other inflatable devices are also well known. For some applications, the balloon has an insufflation port configured as an automatic shutoff valve when not connected to a corresponding fluid transfer system of the delivery system. In particular, this allows the balloon to be filled via a longitudinal fluid line that can then be disconnected and retracted and only needs to be reinserted and reconnected when additional filling or deflating of the balloon is required.

[0032] The aforementioned elements as well as those claimed and described below and used in accordance with the present invention should generally be understood with their established meanings in the medical arts.

[0033] Thus, according to the present invention, an inventive concept 1 provides an apparatus for occluding a cardiovascular defect or a gap between a medical device and adjacent body tissue, the apparatus being used in conjunction with a guide wire and a delivery system, wherein the apparatus comprises:

[0034] An occluding device comprising:

[0035] A compliant balloon (a) defines a fluid-tight balloon chamber, (b) has a balloon cavity forming a longitudinal passage from a proximal side to a distal side of the balloon, and (c) includes an insufflation port for filling a fluid into the balloon chamber and emptying the fluid from the balloon chamber;

[0036] a distal tip element and a proximal base element, wherein the distal tip element is disposed at the distal side of the airbag, and the proximal base element is disposed at the proximal side of the airbag;

[0037] a locking mechanism; and

[0038] a proximal connection element disposed on the proximal side of the balloon and configured to releasably connect the occluding device to a correspondingly configured distal connection element of the delivery system; and

[0039] an elongated actuator member longitudinally slidably disposed within the balloon cavity, connected to the distal tip member, and longitudinally movable relative to the proximal base member to set a distance between the distal tip member and the proximal base member,

[0040] Wherein the locking mechanism is configured to maintain the distance between the distal tip member and the proximal base member set using the elongated actuation member.

[0041] Inventive concept 2: The device according to inventive concept 1, wherein the elongated actuating element is selected from the group consisting of a tube, a wire, a long handle, a cable, a strand, and a fiber.

[0042] Inventive concept 3: The device according to inventive concept 1, wherein the distal tip element and the proximal base element are shaped to define a corresponding plurality of guide wire openings, and the plurality of guide wire openings are substantially coaxial with the balloon cavity to slidably receive the guide wire therein.

[0043] Inventive concept 4: The device according to inventive concept 1, wherein the proximal base element and the distal tip element include a proximal disk and a distal disk, respectively.

[0044] Inventive concept 5: The device according to Inventive concept 1, wherein the locking mechanism is provided on the proximal side of the airbag.

[0045] Inventive concept 6: The device according to inventive concept 5, wherein the locking mechanism is connected or integrated to the proximal base element.

[0046] Inventive concept 7: According to the device of Inventive concept 1, the compliant airbag includes a compliant material, and the compliant material is selected from the group consisting of polycaprolactone (PCL), polyglycolic acid (PGA), polylactic acid (PLA), polydioxanone (PDO or PDS), silicone, polyurethane, polytetrafluoroethylene (PTFE), polymethyl methacrylate, polyetheretherketone (PEEK), polyvinyl chloride, polyethylene terephthalate, nylon, polyamide, polyamide and polyether block amide (PEBA).

[0047] Inventive concept 8: According to any one of the inventive concepts 1 to 7, the device further comprises at least one connecting strut, wherein the connecting strut is fixed to the distal tip element and the proximal base element.

[0048] Inventive concept 9: The device according to inventive concept 8, wherein the at least one connecting strut comprises a single connecting strut disposed inside or outside the airbag.

[0049] Inventive concept 10: The device according to inventive concept 8, wherein the at least one connecting strut comprises a plurality of connecting struts disposed inside or outside the airbag.

[0050] Inventive concept 11: According to the device of inventive concept 10, the plurality of connecting struts are arranged in a cage-like arrangement.

[0051] Inventive concept 12: The device according to inventive concept 10, wherein the plurality of connecting struts are arranged as a frame.

[0052] Inventive concept 13: The apparatus according to any one of inventive concepts 1 to 7, wherein the occluding device comprises the elongated actuating element, the elongated actuating element being fixedly connected to the distal tip element.

[0053] Inventive concept 14: The device according to inventive concept 13, wherein the elongated actuation element is longitudinally slidable relative to the proximal base element.

[0054] Inventive concept 15: The device according to Inventive concept 13, wherein the locking mechanism includes one or more claws, and the slender actuating element includes a plurality of teeth, thereby jointly providing a ratchet mechanism, so that the distance between the distal tip element and the proximal base element can be selected from a distance range by distally pulling the slender actuating element through the locking mechanism.

[0055] Inventive concept 16: The device according to inventive concept 13, wherein the elongated actuating element comprises the metal wire.

[0056] Inventive concept 17: According to the device of inventive concept 13,

[0057] wherein the elongated actuating element is shaped to define a thread,

[0058] wherein the locking mechanism comprises a threaded opening defined by the proximal base member, wherein the threads of the elongated actuating member are disposed within the threaded opening, and

[0059] The occluding device is configured such that rotation of the elongated actuating element relative to the proximal base element causes the elongated actuating element to move longitudinally relative to the proximal base element, thereby setting the distance between the distal tip element and the proximal base element and maintaining the set distance.

[0060] Inventive concept 18: The device according to any one of inventive concepts 1 to 7, wherein the elongated actuation element is releasably connected to the distal tip element.

[0061] Inventive concept 19: According to the device of inventive concept 18,

[0062] wherein the occluding device further comprises: a locking elongated member fixed to the distal tip member and longitudinally slidable relative to the proximal base member, and

[0063] Wherein the locking mechanism is configured to lock the locking elongate member relative to the proximal base member to maintain the distance set using the elongate actuation member.

[0064] Inventive concept 20: The device according to inventive concept 19, wherein the locking elongated element is selected from the group consisting of a tube, a wire, a long handle, a cable, a strand, and a fiber.

[0065] Inventive concept 21: The device according to inventive concept 20, wherein the locking elongated element is the metal wire.

[0066] Inventive concept 22: The device according to inventive concept 18, wherein the elongated actuation element is longitudinally slidable relative to the proximal base element.

[0067] Inventive concept 23: The device according to Inventive concept 22,

[0068] wherein a distal end portion of the elongated actuator element is shaped to define a thread, and

[0069] The distal tip element is shaped to define a threaded opening, and the threads of the distal end portion of the elongated actuating element are releasably threaded into the threaded opening, thereby releasably connecting the elongated actuating element to the distal tip element.

[0070] Inventive concept 24: The device according to inventive concept 18,

[0071] wherein the elongated actuating element is shaped to define a thread,

[0072] wherein the proximal base member is shaped to define a threaded opening, wherein the threads of the elongated actuating member are disposed within the threaded opening, and

[0073] The occluding device is configured such that rotation of the elongated actuating element relative to the proximal base element causes the elongated actuating element to move longitudinally relative to the proximal base element, thereby setting the distance between the distal tip element and the proximal base element and maintaining the set distance.

[0074] Inventive concept 25: The device according to inventive concept 24,

[0075] wherein a distal portion of the elongated actuator element comprises a first positive connection element,

[0076] wherein the distal tip element is shaped to define a second positive connection element, and

[0077] Wherein the first positive connection element is releasably connected to the second positive connection element, such that the elongated actuation element is releasably connected to the distal tip element.

[0078] Inventive concept 26: According to any one of inventive concepts 1 to 7, the insufflation port includes an automatic closing valve.

[0079] Inventive concept 27: The device according to inventive concept 26, wherein the insufflation port is releasably connected to the delivery system, and wherein the automatic shut-off valve is configured to close when the insufflation port is disconnected from the delivery system.

[0080] Inventive concept 28: According to any one of Inventive concepts 1 to 7, the airbag has an average wall thickness between 100 and 5000 microns.

[0081] 29: According to any one of the inventive concepts 1 to 28, the airbag has a thinnest wall thickness ranging from 20 to 500 microns at a thinnest portion of a side wall of the airbag.

[0082] Inventive concept 30: The apparatus according to any one of inventive concepts 1 to 29, wherein the occluding device further comprises: a proximal radiopaque marker fixed to the proximal base element and comprising a material that is more radiopaque than the proximal base element.

[0083] Inventive concept 31: The apparatus according to any one of inventive concepts 1 to 29, wherein the occluding device further comprises: a distal radiopaque marker fixed to the distal tip element and comprising a material that is more radiopaque than the distal tip element.

[0084] Inventive concept 32: According to the device described in any one of Inventive concepts 1 to 29,

[0085] wherein the occluding device further comprises: a proximal radiopaque marker secured to the proximal base member and comprising a material that is more radiopaque than the proximal base member, and

[0086] The occluding device further includes: a distal radiopaque marker secured to the distal tip element and comprising a material that is more radiopaque than the distal tip element.

[0087] Inventive concept 33: An occlusion system, comprising the device according to any one of the inventive concepts 1 to 32, the occlusion system also comprising an implantation catheter, the occlusion device being releasably disposed in a compressed form in the implantation catheter, wherein a maximum distance between the proximal base element and the distal tip element is between 8 and 80 mm.

[0088] Inventive concept 34: An occlusion system, comprising the device according to any one of the inventive concepts 1 to 33, the occlusion system also comprising the delivery system cooperating therewith, wherein the delivery system comprises: an implantation catheter connected to an operating handle, the implantation catheter comprising a longitudinal channel for the guide wire; a distal connecting element for releasably connecting the implantation catheter to a correspondingly configured proximal connecting element of the occlusion device; and an inflation tube channel releasably connected to a corresponding insufflation port of the occlusion device.

[0089] According to an inventive concept 35 of the present invention, there is also provided an apparatus for occluding a cardiovascular defect or a gap between a medical device and adjacent body tissue, the apparatus being used together with a guide wire and a delivery system, wherein the apparatus comprises an occluding device, the occluding device comprising:

[0090] a compliant bladder defining a fluid-tight bladder chamber and including an insufflation port for filling a fluid into the bladder chamber and evacuating the fluid from the bladder chamber;

[0091] a distal tip element and a proximal base element, wherein the distal tip element is disposed at a distal side of the airbag, and the proximal base element is disposed at a proximal side of the airbag;

[0092] an elongated member having a fixed length and fixed to the distal tip member and the proximal base member so as to set a fixed distance between the distal tip member and the proximal base member; and

[0093] A proximal connection element is disposed on the proximal side of the balloon and is configured to releasably connect the occluding device to a correspondingly configured distal connection element of the delivery system.

[0094] Inventive concept 36: The device according to inventive concept 35, wherein the elongated element is selected from the group consisting of a tube, a wire, a long handle, a cable, a strand, and a fiber.

[0095] Inventive concept 37: The device according to inventive concept 35, wherein the proximal base element and the distal tip element include a proximal disk and a distal disk, respectively.

[0096] Inventive concept 38: According to the device of inventive concept 35, the compliant airbag includes a compliant material, and the compliant material is selected from the group consisting of polycaprolactone (PCL), polyglycolic acid (PGA), polylactic acid (PLA), polydioxanone (PDO or PDS), silicone, polyurethane, polytetrafluoroethylene (PTFE), polymethyl methacrylate, polyetheretherketone (PEEK), polyvinyl chloride, polyethylene terephthalate, nylon, polyamide, polyamide and polyether block amide (PEBA).

[0097] Inventive concept 39: According to the device of any one of inventive concepts 35 to 38, the airbag has a balloon cavity forming a longitudinal channel from a proximal side to a distal side of the airbag.

[0098] Inventive concept 40: The device according to inventive concept 39, wherein the elongated element is disposed within the balloon cavity.

[0099] Inventive concept 41: The device according to inventive concept 39, wherein the distal tip element and the proximal base element are shaped to define a corresponding plurality of guide wire openings, and the plurality of guide wire openings are substantially coaxial with the balloon cavity to slidably receive the guide wire therein.

[0100] Inventive concept 42: The device according to any one of inventive concepts 35 to 38, wherein the device further comprises at least one connecting strut, wherein the connecting strut is fixed to the distal tip element and the proximal base element.

[0101] Inventive concept 43: The device according to inventive concept 42, wherein the at least one connecting strut comprises a single connecting strut disposed inside or outside the airbag.

[0102] Inventive concept 44: The device according to inventive concept 42, wherein the at least one connecting strut comprises a plurality of connecting struts disposed inside or outside the airbag.

[0103] Inventive concept 45: The device according to inventive concept 44, wherein the plurality of connecting struts are arranged in a cage-like arrangement.

[0104] Inventive concept 46: The device according to inventive concept 44, wherein the plurality of connecting struts are arranged as a frame.

[0105] Inventive concept 47: The device according to any one of inventive concepts 35 to 38, wherein the insufflation port includes an automatic closing valve.

[0106] Inventive concept 48: The device according to inventive concept 47, wherein the insufflation port is releasably connected to the delivery system, and wherein the automatic shut-off valve is configured to close when the insufflation port is disconnected from the delivery system.

[0107] Inventive concept 49: According to any one of inventive concepts 35 to 38, the airbag has an average wall thickness between 100 and 5000 microns.

[0108] Inventive concept 50: According to any one of inventive concepts 35 to 49, the airbag has a thinnest wall thickness ranging from 20 to 500 microns at a thinnest portion of a side wall of the airbag.

[0109] Inventive concept 51: The apparatus according to any one of inventive concepts 35 to 50, wherein the occluding device further comprises: a proximal radiopaque marker fixed to the proximal base element and comprising a material that is more radiopaque than the proximal base element.

[0110] Inventive concept 52: The apparatus according to any one of inventive concepts 35 to 50, wherein the occluding device further comprises: a distal radiopaque marker fixed to the distal tip element and comprising a material that is more radiopaque than the distal tip element.

[0111] Inventive concept 53: According to the device described in any one of inventive concepts 35 to 50,

[0112] wherein the occluding device further comprises: a proximal radiopaque marker secured to the proximal base member and comprising a material that is more radiopaque than the proximal base member, and

[0113] The occluding device further includes: a distal radiopaque marker secured to the distal tip element and comprising a material that is more radiopaque than the distal tip element.

[0114] Inventive concept 54: An occlusion system, comprising a device according to any one of inventive concepts 35 to 53, wherein the occlusion system also includes an implantation catheter, the occlusion device being releasably disposed in a compressed form in the implantation catheter, wherein a maximum distance between the proximal base element and the distal tip element is between 8 and 80 mm.

[0115] Inventive concept 55: An occlusion system, comprising the device according to any one of inventive concepts 35 to 54, wherein the occlusion system also includes the delivery system cooperating therewith, wherein the delivery system includes: an implantation catheter connected to an operating handle, the implantation catheter including a longitudinal channel for the guide wire; a distal connecting element for releasably connecting the implantation catheter to a correspondingly configured proximal connecting element of the occlusion device; and an inflation tube channel releasably connected to a corresponding insufflation port of the occlusion device.

[0116] According to an inventive concept 56 of the present invention, there is further provided a method of occluding a cardiovascular defect or a gap between a medical device and adjacent body tissue of a patient, the method comprising:

[0117] advancing a guide wire into the patient using a delivery system;

[0118] Positioning a compliant balloon of an occlusion device in a longitudinally extending manner within the cardiovascular defect or space to be occluded using the delivery system by advancing the occlusion device over the guide wire;

[0119] Filling a fluid into a fluid-tight airbag chamber defined by the airbag through an insufflation port of the airbag to inflate the compliant airbag;

[0120] Expanding the balloon in a radial direction or a lateral direction by shortening a distance between a distal tip element and a proximal base element to a desired distance and locking the distance, the distal tip element being disposed at a locking distal side of the balloon, and the proximal base element being disposed at the proximal side of the balloon; and

[0121] The occluding device is released from the delivery system.

[0122] Inventive concept 57: According to the method of inventive concept 56,

[0123] The airbag has a balloon cavity, and a longitudinal channel is formed from a proximal side to a distal side of the airbag.

[0124] wherein the distal tip member and the proximal base member are shaped to define a corresponding plurality of guide wire openings, the plurality of guide wire openings being substantially coaxial with the balloon lumen to slidably receive the guide wires therein, and

[0125] Wherein advancing the occluding device on the guide wire includes sliding the guide wire through the plurality of guide wire openings.

[0126] Inventive concept 58: The method according to inventive concept 56, wherein positioning the compliant balloon in the longitudinal extension comprises positioning the compliant balloon within the cardiovascular defect in the longitudinal extension.

[0127] Inventive concept 59: The method according to inventive concept 56, wherein positioning the compliant balloon in the longitudinally extending manner includes positioning the compliant balloon in the gap between the medical device and the adjacent body tissue in the longitudinally extending manner.

[0128] Inventive concept 60: The method according to inventive concept 59, wherein the medical device is a prosthetic heart valve, and wherein the method treats a paravalvular leak between the prosthetic heart valve and adjacent heart tissue of the patient.

[0129] Inventive concept 61: According to the method of inventive concept 60,

[0130] Wherein positioning and inflating the compliant airbag comprises:

[0131] positioning the balloon within a ventricle of the patient;

[0132] Then, partially inflating the airbag;

[0133] Next, positioning the balloon approximately at a longitudinal center of the paravalvular leak; and

[0134] Next, the airbag is further inflated, and

[0135] Wherein expanding the airbag includes expanding the airbag after further inflating the airbag.

[0136] Inventive concept 62: The method according to inventive concept 61, wherein positioning the balloon approximately at the longitudinal center of the paravalvular leak comprises: proximally withdrawing the balloon until the balloon is approximately at the longitudinal center of the paravalvular leak.

[0137] Inventive concept 63: The method according to inventive concept 56, wherein the method further comprises: partially inflating the balloon before positioning the balloon in the longitudinally extending manner at the cardiovascular defect or the gap to be occluded.

[0138] Inventive concept 64: The method according to inventive concept 56, wherein the method further comprises: after positioning the balloon in the longitudinally extending manner at the cardiovascular defect or the gap to be occluded:

[0139] partially inflating the airbag; and

[0140] After partially inflating the balloon, the balloon is repositioned in the longitudinally extended manner within the cardiovascular defect or the space to be occluded.

[0141] Inventive concept 65: According to the method of inventive concept 56,

[0142] The positioning of the balloon comprises: when the balloon is placed in an implanted catheter of the delivery system, delivering the balloon to the cardiovascular defect or the gap to be occluded,

[0143] The method comprises: before inflating the balloon, exposing a portion of the balloon from the implant catheter,

[0144] wherein inflating comprises inflating the portion of the airbag,

[0145] wherein expanding comprises: expanding the portion of the balloon by shortening the distance between the distal tip element and the proximal base element by moving the distal tip element toward the proximal base element, and

[0146] The method further comprises, before releasing the occluding device from the delivery system:

[0147] exposing a remaining portion of the balloon from the implantation catheter;

[0148] inflating the remaining portion of the airbag; and

[0149] The remaining portion of the balloon is expanded by further shortening the distance between the distal tip member and the proximal base member.

[0150] Inventive concept 66: The method according to inventive concept 56, wherein the proximal base element and the distal tip element comprise a proximal disk and a distal disk, respectively.

[0151] Inventive concept 67: According to the method of inventive concept 56, the compliant airbag includes a compliant material, and the compliant material is selected from the group consisting of polycaprolactone (PCL), polyglycolic acid (PGA), polylactic acid (PLA), polydioxanone (PDO or PDS), silicone, polyurethane, polytetrafluoroethylene (PTFE), polymethyl methacrylate, polyetheretherketone (PEEK), polyvinyl chloride, polyethylene terephthalate, nylon, polyamide, polyamide and polyether block amide (PEBA).

[0152] Inventive concept 68: The method according to inventive concept 56, wherein the occlusive device further comprises at least one connecting strut, wherein the connecting strut is fixed to the distal tip element and the proximal base element.

[0153] Inventive concept 69: The method according to inventive concept 68, wherein the at least one connecting strut comprises a single connecting strut disposed inside or outside the airbag.

[0154] Inventive concept 70: The method according to inventive concept 68, wherein the at least one connecting strut comprises a plurality of connecting struts disposed inside or outside the airbag.

[0155] Inventive concept 71: According to the method of inventive concept 70, the plurality of connecting struts are arranged in a cage-like arrangement.

[0156] Inventive concept 72: The method according to inventive concept 70, wherein the plurality of connecting struts are arranged as a frame.

[0157] Inventive concept 73: According to the method of inventive concept 56,

[0158] The airbag has a balloon cavity, and a longitudinal channel is formed from a proximal side to a distal side of the airbag.

[0159] wherein shortening the distance between the distal tip element and the proximal base element to the desired distance comprises: distally moving an elongated actuating element, the elongated actuating element being longitudinally slidably disposed in the balloon cavity, connected to the distal tip element, and longitudinally movable relative to the proximal base element, and

[0160] Wherein locking the distance includes using a locking mechanism to maintain the distance between the distal tip element and the proximal base element set by using the elongated actuating element.

[0161] Inventive concept 74: The method according to inventive concept 73, wherein the elongated actuating element is selected from the group consisting of a tube, a wire, a long shaft, a cable, a strand, and a fiber.

[0162] Inventive concept 75: The method according to inventive concept 73, wherein the occluding device comprises the elongated actuating element, the elongated actuating element being fixedly connected to the distal tip element.

[0163] Inventive concept 76: According to the method of inventive concept 75,

[0164] wherein the elongate actuation member is longitudinally slidable relative to the proximal base member, and

[0165] Wherein distally moving the elongate actuation element comprises sliding the elongate actuation element past the proximal base element.

[0166] Inventive concept 77: According to the method of inventive concept 75,

[0167] wherein the locking mechanism comprises one or more jaws and the elongated actuating element comprises a plurality of teeth that together provide a ratchet mechanism such that the distance between the distal tip element and the proximal base element can be selected from a range of distances by distally pulling the elongated actuating element through the locking mechanism, and

[0168] Wherein shortening the distance comprises distally pulling the elongated actuating element past the locking mechanism.

[0169] Inventive concept 78: The method according to inventive concept 75, wherein the elongated actuating element comprises the metal wire.

[0170] Inventive concept 79: According to the method of inventive concept 75,

[0171] wherein the elongated actuating element is shaped to define a thread,

[0172] wherein the locking mechanism comprises a threaded opening defined by the proximal base member, wherein the threads of the elongated actuating member are disposed within the threaded opening, and

[0173] Wherein shortening the distance comprises: rotating the elongated actuating element relative to the proximal base element to longitudinally move the elongated actuating element relative to the proximal base element, thereby setting the distance between the distal tip element and the proximal base element, and maintaining the set distance.

[0174] Inventive concept 80: The method according to inventive concept 73, wherein the elongated actuation element is releasably connected to the distal tip element.

[0175] Inventive concept 81: According to the method of inventive concept 80,

[0176] wherein the occluding device further comprises: a locking elongated member fixed to the distal tip member and longitudinally slidable relative to the proximal base member, and

[0177] Wherein locking the distance comprises: using the locking mechanism to lock the locking elongated member relative to the proximal base member to maintain the distance set by using the elongated actuating member.

[0178] Inventive concept 82: The method according to inventive concept 81, wherein the locking elongated element is selected from the group consisting of a tube, a wire, a shank, a cable, a strand, and a fiber.

[0179] Inventive concept 83: The method according to inventive concept 82, wherein the locking elongated element is the metal wire.

[0180] Inventive concept 84: According to the method of inventive concept 80,

[0181] wherein the elongate actuation member is longitudinally slidable relative to the proximal base member, and

[0182] Wherein distally moving the elongated actuating element comprises sliding the elongated actuating element over the proximal base element.

[0183] Inventive concept 85: According to the method of inventive concept 84,

[0184] wherein a distal portion of the elongated actuator element is shaped to define a thread,

[0185] wherein the distal tip element is shaped to define a threaded opening, the threads of the distal end portion of the elongated actuating element being releasably threaded into the threaded opening, whereby the elongated actuating element is releasably connected to the distal tip element, and the elongated actuating element is releasably connected to the distal tip element, and

[0186] The method further includes, after distally moving the elongated actuation element, disconnecting the elongated actuation element from the distal tip element.

[0187] Inventive concept 86: According to the method of inventive concept 80,

[0188] wherein the elongated actuating element is shaped to define a thread,

[0189] wherein the proximal base member is shaped to define a threaded opening, wherein the threads of the elongated actuating member are disposed within the threaded opening, and

[0190] Wherein shortening the distance comprises: rotating the elongated actuating element relative to the proximal base element to longitudinally move the elongated actuating element relative to the proximal base element, thereby setting the distance between the distal tip element and the proximal base element, and maintaining the set distance.

[0191] Inventive concept 87: According to the method of inventive concept 86,

[0192] wherein a distal portion of the elongated actuator element comprises a first positive connection element,

[0193] wherein the distal tip element is shaped to define a second positive connection element,

[0194] wherein the first positive connection element is releasably connected to the second positive connection element, whereby the elongate actuation element is releasably connected to the distal tip element, and

[0195] The method further includes, after distally moving the elongated actuation element, disconnecting the elongated actuation element from the distal tip element.

[0196] Inventive concept 88: The method according to inventive concept 56, wherein the insufflation port comprises an automatic shut-off valve.

[0197] Inventive concept 89: The method according to inventive concept 88, wherein the insufflation port is releasably connected to the delivery system, and wherein the automatic shut-off valve is configured to close when the insufflation port is disconnected from the delivery system.

[0198] Inventive concept 90: The method according to inventive concept 56, wherein releasing the occluding device from the delivery system comprises: releasing a proximal connecting element of the occluding device from a correspondingly configured distal connecting element of the delivery system.

[0199] Inventive concept 91: According to the method of inventive concept 90,

[0200] wherein the delivery system comprises: an implant catheter connected to an operating handle, the implant catheter comprising a longitudinal channel for the guide wire; and an inflation tube channel releasably connected to a corresponding insufflation port of the occluding device, and

[0201] Inflating the compliant airbag includes: filling the fluid into the liquid-tight airbag chamber through the inflation tube and the insufflation port of the airbag.

[0202] According to an inventive concept 92 of the present invention, there is additionally provided a method of occluding a cardiovascular defect or a gap between a medical device and adjacent body tissue of a patient, the method comprising:

[0203] advancing a guide wire into the patient's body using a delivery system;

[0204] Using the delivery system, positioning a compliant balloon of an occluding device in a compressed form within the cardiovascular defect or space to be occluded by advancing the occluding device over the guide wire;

[0205] Filling a fluid into a fluid-tight balloon chamber defined by the balloon through an insufflation port of the balloon, inflating the compliant balloon so that an elongated element sets a fixed distance between a distal tip element and a proximal base element, the elongated element having a fixed length and being fixed to a distal tip element and a proximal base element, the distal tip element being disposed at a distal side of the balloon, and the proximal base element being disposed at a proximal side of the balloon; and

[0206] The occluding device is released from the delivery system.

[0207] Inventive concept 93: According to the method of inventive concept 92, the airbag has a balloon cavity forming a longitudinal channel from the proximal side to the distal side of the airbag.

[0208] Inventive concept 94: The method according to inventive concept 93, wherein the elongated element is disposed within the balloon lumen.

[0209] Inventive concept 95: According to the method of inventive concept 93,

[0210] wherein the distal tip element and the proximal base element are shaped to define a corresponding plurality of guide wire openings, the plurality of guide wire openings being substantially coaxial with the balloon lumen to slidably receive the guide wires therein; and

[0211] Wherein advancing the occluding device on the guide wire comprises: sliding the guide wire through the plurality of guide wire openings.

[0212] Inventive concept 96: The method according to inventive concept 92, wherein the elongated element is selected from the group consisting of a tube, a wire, a shank, a cable, a strand, and a fiber.

[0213] Inventive concept 97: The method according to inventive concept 92, wherein the proximal base element and the distal tip element comprise a proximal disk and a distal disk, respectively.

[0214] Inventive concept 98: According to the method of inventive concept 92, the compliant airbag includes a compliant material, and the compliant material is selected from the group consisting of polycaprolactone (PCL), polyglycolic acid (PGA), polylactic acid (PLA), polydioxanone (PDO or PDS), silicone, polyurethane, polytetrafluoroethylene (PTFE), polymethyl methacrylate, polyetheretherketone (PEEK), polyvinyl chloride, polyethylene terephthalate, nylon, polyamide, polyamide and polyether block amide (PEBA).

[0215] Inventive concept 99: The method according to inventive concept 92, wherein the occlusive device further comprises at least one connecting strut, wherein the connecting strut is fixed to the distal tip element and the proximal base element.

[0216] Inventive concept 100: The method according to inventive concept 99, wherein the at least one connecting strut comprises a single connecting strut disposed inside or outside the airbag.

[0217] Inventive concept 101: The method according to inventive concept 99, wherein the at least one connecting strut comprises a plurality of connecting struts disposed inside or outside the airbag.

[0218] Inventive concept 102: According to the method of inventive concept 101, the plurality of connecting struts are arranged in a cage-like arrangement.

[0219] Inventive concept 103: The method according to inventive concept 101, wherein the plurality of connecting struts are arranged into a frame.

[0220] Inventive concept 104: The method according to inventive concept 92, wherein the insufflation port comprises an automatic shut-off valve.

[0221] Inventive concept 105: The method according to inventive concept 104, wherein the insufflation port is releasably connected to the delivery system, and wherein the automatic shut-off valve is configured to close when the insufflation port is disconnected from the delivery system.

[0222] Inventive concept 106: The method according to inventive concept 92, wherein releasing the occluding device from the delivery system comprises: releasing a proximal connection element of the occluding device from a correspondingly configured distal connection element of the delivery system.

[0223] Inventive concept 107: According to the method of inventive concept 106,

[0224] The delivery system comprises: an implant catheter connected to an operating handle, the implant catheter comprising a longitudinal channel for the guide wire; and an inflation tube channel releasably connected to the corresponding insufflation port of the occluding device; and

[0225] Inflating the compliant airbag includes: filling the fluid into the liquid-tight airbag chamber through the inflation tube and the insufflation port of the airbag.

[0226] The above and other features and objects of the present invention and the manner in which they are achieved will become more apparent, and the present invention itself will be better understood, by referring to the following description of various embodiments of the present invention in conjunction with the accompanying drawings, in which:

[0227] The present invention can be more fully understood through the following detailed description of the embodiments in conjunction with the accompanying drawings.

[0228] In the attached figure: BRIEF DESCRIPTION OF THE DRAWINGS

[0229] Figure 1a A cross-sectional view showing an expanded occlusive device according to an application of the present invention;

[0230] Figure 1b and Figure 1c show Figure 1a A side elevation view of the occluding device shown, according to an application of the present invention;

[0231] Figure 2a A cross-sectional view showing an expanded occlusive device according to an application of the present invention;

[0232] Figure 2b and Figure 2c show Figure 2a A side elevation view of the occluding device shown, according to an application of the present invention;

[0233] Figure 3a A cross-sectional view showing an expanded occlusive device according to an application of the present invention;

[0234] Figure 3b and Figure 3c An application according to the present invention is shown in Figure 3a A side elevation view of the occluding device shown in ;

[0235] Figure 4a A cross-sectional view showing an expanded occlusive device according to an application of the present invention, according to an application of the present invention;

[0236] Figure 4b and Figure 4c An application according to the present invention is shown in Figure 4aA side elevation view of the occluding device shown in ;

[0237] Figure 5a An application according to the present invention is shown in Figure 4a A cross-sectional view of the occluding device shown in after actuation and longitudinal shortening of the ratchet assembly;

[0238] Figure 5b and Figure 5c An application according to the present invention is shown in Figure 5a A side elevation view of the occluding device shown in ;

[0239] Figure 6a A cross-sectional view showing an expanded occlusive device according to an application of the present invention, according to an application of the present invention;

[0240] Figure 6b An application according to the present invention is shown in Figure 6a A side elevation view of the occluding device shown;

[0241] Figure 6c A cross-sectional view showing an expanded occlusive device according to an application of the present invention, according to an application of the present invention;

[0242] Figure 6d An application according to the present invention is shown in Figure 6c A side elevation view of the occluding device shown;

[0243] Figure 6e A cross-sectional view showing an expanded occlusive device according to an application of the present invention, according to an application of the present invention;

[0244] Figure 6f An application according to the present invention is shown in Figure 6e A side elevation view of the occluding device shown;

[0245] Figure 7 A cross-sectional view showing an expanded occlusive device according to an application of the present invention, according to an application of the present invention;

[0246] Figure 8 A cross-sectional view showing an expanded occlusive device according to an application of the present invention, according to an application of the present invention;

[0247] Figure 9a A cross-sectional view showing an expanded occlusive device according to an application of the present invention, according to an application of the present invention;

[0248] Figure 9b An application according to the present invention is shown in Figure 9a A side elevation view of the occluding device shown;

[0249] Fig.10a An application according to the present invention is shown in Figure 2a A cross-sectional view of the occluding device shown in FIG. 1 in a compressed form within an implant catheter of a delivery system;

[0250] Fig.10b and Fig.10c The present invention is applied in Figure 2a A side view and a cross-sectional view of the occluding device shown in FIG. 1 when released from the implanted catheter but still connected to the implanted delivery system;

[0251] Fig.11a and Fig.11b An application according to the present invention is shown in Figure 2a A side view of the occluding device shown in FIG. 1 at different respective expansion stages within a congenital defect;

[0252] Fig.12a and Figure 12b The corresponding application according to the present invention is shown Figure 2a a side view of the occluding device as it is expanded within a cardiovascular defect that is a cavity or discontinuity in body tissue; and

[0253] Fig.13a and Fig.13b An application according to the present invention is shown Figure 2a A side view of the occluding device is shown in FIG. 1 , wherein the occluding device is expanded within a gap between a medical device and adjacent body tissue.

[0254] Fig.14a A cross-sectional view showing an expanded occlusive device according to an application of the present invention;

[0255] Fig.14b and Fig.14c An application according to the present invention is shown Fig.14a A side elevation view of the occluding device shown;

[0256] Fig.15a A cross-sectional view of an expanded occlusive device showing an application of the present invention;

[0257] Fig.15b and Fig.15c An application according to the present invention is shown in Fig.15a A side elevation view of the occluding device shown;

[0258] Fig.16 An arrangement of an application according to the present invention is shown Figure 2a The method of the occluding device as shown;

[0259] Fig.17aA cross-sectional view showing an expanded occlusive device according to an application of the present invention, according to an application of the present invention; and

[0260] Fig.17b An application according to the present invention is shown Fig.17a A side elevation view of the occluding device is shown.

[0261] It will be understood that the drawings are not necessarily drawn to scale and that in some cases relative dimensions may be significantly distorted for ease of visualization. DETAILED DESCRIPTION

[0262] Figure 1a A cross-sectional view of an expanded occlusive device 20 is shown in accordance with an application of the present invention. Figure 1b and Figure 1c An application according to the present invention is shown Figure 1a The occluding device 20 is shown in a side elevation view. The occluding device is used in conjunction with a guide wire 106 and a delivery system 107 (eg, Figures 10a to 10c As shown in the figure, the occlusion device 20 includes a compliant balloon 5, the compliant balloon 5 having a central balloon cavity 6, and a longitudinal passage 27 is formed through the interior of the balloon 5 from a proximal side 28A to a distal side 28B of the balloon 5. The balloon 5 defines a fluid-tight balloon chamber 26. The balloon 5 is generally compliant, as described above. Optionally, the balloon cavity 6 is foldable so that the balloon cavity 6 can be folded after the guide wire 106 ( Figures 10a to 10c After the occlusion device 20 is inserted into the sac (as shown), the balloon cavity 6 closes itself, thus not leaving an open channel in the occlusion device 20. For example, the foldability of the balloon cavity 6 can be provided by providing proximal and distal valves at the entrance of the balloon cavity 6, or by configuring the balloon cavity 6 to collapse and fold longitudinally.

[0263] The occluding device 20 further comprises a frame 22, comprising a proximal base element 4 and a distal tip element 10, which are respectively arranged at the proximal side 28A and the distal side 28B of the balloon 5 and connected by an elongated actuating element 9, which passes through the central cavity 6 of the balloon 5 and can slide longitudinally. The elongated actuating element 9 is longitudinally movable relative to the proximal base element 4, thereby setting a distance between the distal tip element 10 and the proximal base element 4. Generally, the elongated actuating element 9 is selected from the group consisting of a tube, a metal wire, a long handle, a cable, a strand and a fiber. The reduction of the distance may cause the distal tip element 10 to move toward the proximal base element 4, the proximal base element 4 to move toward the distal tip element 10, or both actions to occur.

[0264] For some applications, the proximal base member 4 and the distal tip member 10 include a proximal disk 30 and a distal disk 32, respectively. The frame 22 provides structural support for the balloon 5. The frame 22 can be formed of a cut structure so that each component of the frame 22 is integrally connected to each other. The elongated actuator element 9 can have a linear or non-linear cross-section and can have plastic or metal deformable properties.

[0265] The occluding device 20 also includes a locking mechanism 2 for maintaining the distance set by the elongated actuating element 9 between the distal tip element 10 and the proximal base element 4. For example, the locking mechanism 2 may include a crimping element, a threaded element, a locking element, an inflatable balloon, a locking wire, or a ratchet element. For some applications, the locking mechanism 2 is disposed at the proximal side 28A of the balloon 5, for example, connected to or integrated into the proximal base element 4.

[0266] The occluding device 20 is shaped to form a closed three-dimensional shape. The occluding device 20 includes a proximal connecting element 1, which is configured to attach the occluding device 20 to the delivery system 107 and release the occluding device 20 from the delivery system 107, such as from an implantation catheter 14 of the delivery system 107. It should be noted that after the occluding device 20 is released from the implantation catheter 14, the longitudinal channel 27 is still defined through the interior of the balloon 5. Generally, when the occluding device 20 is connected to the implantation catheter 14, no part of the implantation catheter 14 is disposed inside the balloon 5.

[0267] Typically, the proximal base member 4 and the distal tip member 10 (e.g., the proximal disk 30 and the distal disk 32) are shaped to define a plurality of corresponding guide wire openings 105a and 105b that are substantially coaxial with the balloon lumen 6 to slidably receive a guide wire 106 therein (e.g., Figures 10a to 10c As shown), to deliver the occluding device 20.

[0268] For some applications, the proximal base member 4 and the distal tip member 10 (e.g., the proximal disc 30 and the distal disc 32) are deformable to allow the members to automatically adjust their shapes when the balloon 5 is inflated. Alternatively, the proximal base member 4 and the distal tip member 10 (e.g., the proximal disc 30 and the distal disc 32) are non-deformable.

[0269] For some applications, the proximal base member 4 and the distal tip member 10 (eg, the proximal disk 30 and the distal disk 32 ) include a plastic or a metal, such as Nitinol.

[0270] Although the proximal disk 30 and the distal disk 32 are shown as circles, the disks may have other shapes, such as flowers, crosses, stars, ovals, or any other shapes necessary or suitable for proper cardiovascular defect occlusion and device stability. The proximal disk 30 and the distal disk 32 are generally radially symmetrical, but may also be asymmetrical.

[0271] The occluding device 20 also includes an insufflation port 3 that extends into the balloon 5 along a central axis of the balloon 5 or at other locations, such as near the central axis. The insufflation port 3 is releasably connected to an inflation tube channel of the implant catheter 14 and allows the balloon 5 to be inflated and deflated while connected before the occluding device 20 is released from the implant catheter 14. Within the central lumen 6 of the balloon 5, the balloon 5 can define a guide wire lumen 7 to allow the guide wire 106 (in the middle of the balloon 5) to be inserted into the balloon 5. Figures 10a to 10c ) is free to move axially through the occlusion device 20. Typically, in a configuration in which the proximal opening of the guidewire lumen 7 is centered around the central axis of the balloon 5, the insufflation port 3 is off-center, and vice versa.

[0272] According to one application of the present invention, the compliant balloon 5 can be inflated by filling the balloon chamber 26 with any fluid, including but not limited to a buffer solution (optionally including a contrast agent), blood (e.g., autologous blood), foam, and glue (e.g., gel, a liquid polymer that can change its properties to become hard, or a hydrogel that remains gel or self-curing at human body temperature). For applications in which the fluid includes autologous blood, the autologous blood can be drawn from the patient during the deployment of the occluding device 20, for example, at a proximal position of the balloon 5 inside the patient's body, or drawn from outside the patient's body, and filled into the balloon chamber 26 by the deployment system. For applications in which the fluid includes blood, an anticoagulant can be mixed into the blood to delay the clotting time for a period of time in the event that the balloon 5 must be retrieved; the blood eventually coagulates.

[0273] The above-mentioned fluid provides long-term shape fixation, sealing and occlusive properties of the expanded occlusive device 20. The balloon 5 provides acute, i.e., immediate shape fixation, sealing and occlusive properties of the expanded occlusive device 20. Therefore, for applications in which the occlusive device 20 is radiopaque and implanted in a beating heart under echocardiographic, fluoroscopic and / or X-ray guidance, after the balloon 5 is inflated, the surgeon can immediately observe whether the defect has been occluded (by observing the cessation of blood flow through the defect). The immediate closure of the defect after the balloon 5 is inflated is in contrast to known closure devices including a braided metal wire mesh, which generally do not provide immediate closure of the defect, but only provide good closure after blood has sufficiently coagulated within the mesh several days or weeks later. Therefore, the effectiveness of these known closure devices can generally only be evaluated at least several days after implantation.

[0274] The implant catheter 14 and the insufflation port 3 may contain specific channels, valves and membranes designed to be compatible with the fluid used, including a filter membrane that is permeable to blood if blood is used as the filling fluid of the balloon chamber 26.

[0275] Furthermore, the frame 22 allows for longitudinal adjustment of the balloon 5 to enhance the stability of the occluding device 20 and to enhance occlusion of the defect.

[0276] In some applications, the frame 22 can be designed to have a limited conformability (e.g., due to the thickness of the frame 22 or the material properties of the frame 22), such as to create a tapered shape to provide asymmetric restriction to the balloon 5, such as tapering at the distal end so that the balloon 5 has a pear-shaped shape when constrained by anatomical structures or other constraints. The frame 22 can have a generally conical or frustoconical shape, a cylindrical shape, or any other necessary or appropriate shape. In some applications, the balloon 5 is configured to have limited conformability in certain portions of the balloon, such as to create a figure eight shape or a tapered shape, or an asymmetric shape when expanded under inflation.

[0277] In some applications, the frame 22 also includes a single support 21, which enters the interior of the airbag and gradually tapers the airbag 5 component. The support 21 may or may not be fixed to the inner surface of the airbag 5 or embedded in the airbag 5, as described below with reference to Figure 2a Optionally, the support column 21 passes through the central lumen 6 of the airbag 5 (configuration not shown).

[0278] Figures 2a to 9b Draw a picture that can be used with Figure 1a to Figure 1cThe occluding device 20 presented in the application of the present invention is combined with other optional features provided. In order to avoid repetition, only those features that are different from the above-mentioned occluding device will be proposed. The same reference numerals represent the same or corresponding features.

[0279] Figure 2a A cross-sectional view of an expanded occlusive device 120 according to an application of the present invention is shown. Figure 2b and Figure 2c An application according to the present invention is shown in Figure 2a The occluding device 120 is shown in a side elevation view. The occluding device 120 includes a frame 122, which may include the proximal base element 4 and the distal tip element 10 (e.g., the proximal disc 30 and the distal disc 32), connected by a plurality of struts 11, which may have any suitable form, passing through the inside (not shown) or outside (as shown) of the balloon 5 and gradually reducing the balloon 5 component. Such an application may allow the balloon 5 to be caged in its assembly to avoid unnecessary interference of the occluding device 20 with body tissue or implanted prosthesis, and provide anchoring support for the occluding device 20 at the defect, such as the cardiovascular defect. In this application, the frame 122 may include 2, 4, 6, 8, 10, 12 or any other suitable even or odd number of struts 11. The struts 11 may be arranged inside or outside the balloon. For some applications, the struts 11 are not fixed to any surface of the balloon. For other applications, the struts 11 are: (a) fixed to a (inner or outer) surface of the airbag 5, (b) embedded in the wall of the airbag 5 during the manufacturing process (e.g., by casting in the wall). Alternatively, the airbag 5 can be molded on the struts 11, and the struts 11 remain internally fixed to the airbag 5.

[0280] In some applications, the wall thickness and / or width of the struts 11 forming the frame 122 may vary along their entire length or a portion thereof. Thus, a strut 11 may have a first portion that is wider than a second portion. In other applications, an intermediate or distal end of a strut 11 may have a greater or lesser wall thickness and / or strut width. Varying the wall thickness and / or width of the struts 11 may determine the radial stability of the frame 122.

[0281] Figure 3a A cross-sectional view of an expanded occlusive device 220 according to an application of the present invention is shown. Figure 3b and Figure 3c An application according to the present invention is shown Figure 3aThe occlusion device 220 is shown in a side elevation view. The occlusion device 220 includes a frame 222, which may include the proximal base element 4 and the distal tip element 10 (e.g., the proximal disc 30 and the distal disc 32) connected by a support 12, which passes through the exterior and gradually narrows the balloon 5 component. As described above with reference to Figure 2a As mentioned above, the support column 12 may or may not be fixed to the inner surface (not shown) or the outer surface (as shown) of the airbag 5 or embedded in the airbag 5 .

[0282] Now refer to Figure 4a , which shows a cross-sectional view of an expanded occlusive device 320 according to an application of the present invention. Figure 4b and Figure 4c , which shows an application according to the present invention Figure 4a A side elevation view of the occluding device 320 is shown.

[0283] See also Figure 5a , which is an application of the present invention Figures 4a to 4c The occluding device 320 is shown in a cross-sectional view after the ratchet mechanism 13 described below has been actuated and longitudinally shortened. Figure 5b and Figure 5c , which shows an application according to the present invention Figure 5a A side elevation view of the occluding device 320 is shown.

[0284] like Figures 4a to 4c As shown, in this configuration, the elongated actuating element 9 includes an elongated actuating element 324 fixedly connected to the distal tip element 10. The elongated actuating element 324 includes a plurality of teeth 326, and the locking mechanism 2 includes one or more jaws. The elongated actuating element 324 and the jaws of the locking mechanism together provide a ratchet mechanism 13, so that the distance between the distal tip element 10 and the proximal base element 4 can be selected from a range of distances by pulling the elongated actuating element 324 distally through the locking mechanism 2. Figures 5a to 5c As shown, this ratchet mechanism 13 allows longitudinal adjustment of the occluding device 320 in one direction while inhibiting movement in another direction, so that the proximal base member 4 and the distal tip member 10 can only approach each other before the device 320 is released from the implant catheter 14. Optionally, any excess proximal portion of the elongated actuating element 324 extending through the proximal base member 4 to the outside of the occluding device 320 is cut off and removed from the body; to this end, the elongated actuating element 324 can be perforated or have a weaker (e.g., thinner) axial portion that is configured to break when a breaking force is applied.

[0285] Likewise Figures 4a to 4c and Figure 5a to Figure 5c As shown, the occluding device 320 is optionally configured to assume a figure eight shape when inflated. For example, the figure eight shape can be achieved by the thickness of an axial center portion of the strut 11, or by connecting a limiting band of the strut 11 at an axial position of the narrower center portion of the figure eight, or by the thickness of the airbag 5 causing the inflation of the narrower center portion of the figure eight to be reduced.

[0286] Now refer to Figure 6a , which shows a cross-sectional view of an expanded occlusive device 370 according to an application of the present invention. Figure 6b , which shows an application according to the present invention Figure 6a The occluding device 370 is a side elevation view of the occluding device 370 shown in FIG. Figures 4a to 4c and Figure 5a to Figure 5c The occluding device 320 described is the same.

[0287] like Figure 6a to Figure 6b As shown, in this configuration, the elongated actuating element 9 includes an elongated actuating element 374 fixedly connected to the distal tip element 10. The elongated actuating element 374 is shaped to define a thread 376, and the locking mechanism 2 includes a threaded opening defined by the proximal base element 4. The thread 376 of the elongated actuating element 374 is disposed within the threaded opening. The occluding device 370 is configured so that rotation of the elongated actuating element 374 relative to the proximal base element 4 causes the elongated actuating element 374 to move longitudinally relative to the proximal base element 4, thereby setting the distance between the distal tip element 10 and the proximal base element 4 and maintaining the set distance. If desired, this arrangement can both shorten the distance and then extend the distance. For some applications, the locking mechanism 2 is disposed at the proximal side 28A of the balloon 5, for example, connected to or integrated into the proximal base element 4. Optionally, any excess proximal portion of the elongate actuating element 374 extending through the proximal base member 4 to the exterior of the occluding device 370 is cut away and removed from the body.

[0288] Still refer to Figure 6a to Figure 6bAlternatively, the elongated actuating element 374 is not shaped to define the threads 376, and the locking mechanism 2 includes a non-threaded opening defined by the proximal base member 4. Pulling the elongated actuating element 374 proximally sets the distance between the distal tip member 10 and the proximal base member 4. Once the desired distance is set, the locking mechanism 2 is locked to secure the elongated actuating element 374 relative to the proximal base member 4. For some applications, the locking mechanism 2 is disposed at the proximal side 28A of the balloon 5, for example, connected to or integrated into the proximal base member 4.

[0289] Now refer to Figure 6c , which shows a cross-sectional view of an expanded occlusive device 380 according to an application of the present invention. Figure 6d , which shows an application according to the present invention Figure 6c The occluding device 380 is a side elevation view of the occluding device 380 shown in FIG. 3. Except as described below, the occluding device 380 is similar to the occluding device 380 described above with reference to FIG. Figure 6a to Figure 6b The occluding device 370 described is the same.

[0290] like Figure 6c to Figure 6d As shown, in this configuration, the elongated actuating element 9 includes an elongated actuating element 384 fixedly connected to the distal tip element 10. The locking mechanism 2 includes a spool assembly 382, ​​the spool assembly 382 including a spool and generally including a housing enclosing the spool. A proximal portion of the elongated actuating element 384 is wound around the spool. The occluding device 380 is configured so that rotation of the spool causes the elongated actuating element 384 to move longitudinally relative to the proximal base element 4, thereby setting the distance between the distal tip element 10 and the proximal base element 4 and maintaining the set distance. If necessary, this arrangement can both shorten the distance and then extend the distance. For some applications, the locking mechanism 2 is disposed at the proximal side 28A of the balloon 5, for example connected to or integrated into the proximal base element 4.

[0291] Now refer to Figure 6e , which shows a cross-sectional view of an expanded occlusive device 390 according to an application of the present invention. Figure 6f , which shows an application according to the present invention Figure 6e The occluding device 390 is similar to the occluding device 390 described above except as described below. Figure 6a to Figure 6b An occluding device 370 is described.

[0292] like Figure 6e to Figure 6fAs shown, in this configuration, the elongated actuating element 9 comprises an elongated actuating element 392, axially fixedly connected to a proximal base element 395. The elongated actuating element 392 is shaped to define a thread 396, and the locking mechanism 2 is disposed at the distal side 28B of the balloon 5, the locking mechanism 2 comprising a threaded opening defined by a distal tip element 398. The thread 396 of the elongated actuating element 392 is disposed in the threaded opening. The occluding device 390 is configured so that rotation of the elongated actuating element 392 relative to the distal tip element 398 causes the elongated actuating element 392 to move longitudinally relative to the distal tip element 398, thereby setting the distance between the distal tip element 398 and the proximal base element 395 and maintaining the set distance. This arrangement can both shorten the distance and then extend the distance if necessary. This configuration is suitable for implantation positions in which the excess distal portion of the elongated actuation element 392 that protrudes from the distal side 28B of the occlusion device 390 when the device is shortened does not interfere with anatomical structures, for example, in the LAA, as described below with reference to Figure 12a to Figure 12b described.

[0293] Optionally, the proximal base member and a proximal portion of the elongated actuating member 392 together include a rotatable ratchet mechanism 394 configured to allow the elongated actuating member 392 to rotate in only one rotational direction.

[0294] Now refer to Figure 7 , which shows a cross-sectional view of an expanded occluding device 420 according to an application of the present invention. The occluding device 420 includes a locking elongated element 8, which (a) passes through the locking mechanism 2 within the central lumen 6 and (b) is fixed to a distal tip element 410. The locking elongated element 8 is longitudinally slidable relative to the proximal base element 4. Generally, the locking elongated element 8 is selected from the group consisting of a tube, a wire, a long handle, a cable, a strand and a fiber.

[0295] In this configuration, the elongated actuating element 9 comprises an elongated actuating element 424 disposed within the central lumen 6, releasably connected to the distal tip element 410, and longitudinally slidable relative to the proximal base element 4. Typically, the elongated actuating element 424 is selected from the group consisting of a tube, a wire, a long handle, a cable, a strand, and a fiber. After longitudinally adjusting the length of the occluding device 20 by adjusting the distance between the proximal base element 4 and the distal tip element 410 by pulling and / or pushing the elongated actuating element 424, the locking mechanism 2 is activated, thereby fixing the locking elongated element 8 within the locking mechanism 2 in the proximal base element 4 through which the locking wire 24 passes, to keep the distance between the proximal base element 4 and the distal tip element 410 set using the elongated actuating element 424 fixed. For some applications, the locking mechanism 2 is disposed at the proximal side 28A of the balloon 5 , for example, connected to the proximal base member 4 or integrated into the proximal base member 4 .

[0296] The user may directly pull and / or push the elongated actuating element 424, in which case the axial movement of the elongated actuating element 424 pulls or pushes the distal tip element 410 in the direction of the proximal base element 4. Typically, due to the sufficient axial rigidity of the locking elongated element 8, pulling or pushing the elongated actuating element 424 also causes a corresponding movement of the locking elongated element 8 through the proximal base element 4.

[0297] After the desired distance is set and the locking mechanism 2 has locked the locking elongated element 8, the elongated actuating element 424 is released from the distal tip element 410 and removed from the occlusion device 420 and the patient's body. For example, a distal portion 426 of the elongated actuating element 424 may be shaped to define a thread 428, and the distal tip element 410 may be shaped to define a threaded opening, and the thread 428 of the distal portion 426 of the elongated actuating element 424 is releasably screwed into the threaded opening, so that the elongated actuating element 424 is releasably connected to the distal tip element 410. The elongated actuating element 424 is released from the distal tip element 410 by rotating the elongated actuating element 424, thereby loosening it from the distal tip element 410. Alternatively, for example, the elongated actuating element 424 is releasably connected to the distal tip element 410 using first and second positive connection elements, such as described below with reference to Figure 8 described.

[0298] It is noted that in this configuration, as well as in other configurations in which the elongated actuating element 9 is releasably connected to the distal tip element 410, the elongated actuating element 9 is not an element of the occluding device 20 and is indeed disconnected from the occluding device 20 and removed from the body during the implantation process.

[0299] Optionally, any excess proximal portion of the locking elongate member 8 extending through the proximal base member 4 to the exterior of the occluding device 420 is cut off and removed from the body.

[0300] Now refer to Figure 8 , which shows a cross-sectional view of an expanded occluding device 520 according to an application of the present invention. Except as described below, the occluding device 520 is similar to the occluding device 520 described above with reference to Figure 7 The occluding device 420 described is the same.

[0301] In this configuration, the elongated actuating element 9 comprises an elongated actuating element 524 which is similar to that described above with reference to Figure 7 The elongated actuating element 424 is described. The actuating element 524 is shaped to define a thread 526. The proximal base member 4 is shaped to define a threaded opening, and the thread 526 of the elongated actuating element 524 is disposed within the threaded opening. Typically, the elongated actuating element 524 is selected from the group consisting of a tube, a wire (e.g., a plurality of wires braided together), a long handle, a cable, a strand, and a fiber.

[0302] The slender actuating element 524 can be rotated by a user, in which case the slender actuating element 524 engages the threaded opening, so that the rotation of the slender actuating element 524 pulls a distal tip element 510 in the direction of the proximal base element 4 and causes the occlusion device 20 to shorten, thereby setting the distance between the distal tip element 510 and the proximal base element 4 and maintaining the distance.

[0303] For some applications, the locking mechanism 2 is disposed at the proximal side 28A of the airbag 5 , for example, connected to or integrated into the proximal base member 4 .

[0304] After the desired distance has been set and the locking mechanism 2 has locked the locking elongated element 8, the elongated actuating element 524 is released from the distal tip element 510 and removed from the occlusion device 520 and the patient's body. For example, a distal portion 530 of the elongated actuating element 524 may include a first positive connection element, and the distal tip element 510 may be shaped to define a second positive connection element. The first positive connection element is releasably connected to the second positive connection element, so that the elongated actuating element 524 is releasably connected to the distal tip element 510. The elongated actuating element 524 is released from the distal tip element 510 by separating the first positive connection element from the second positive connection element, for example, by removing a fixing wire from a corresponding channel of the positive connection element as is known in the prior art.

[0305] Now refer to Figure 9a , which shows a cross-sectional view of an expanded occluding device 540 according to an application of the present invention. Figure 9b , which shows an application according to the present invention Figure 9a A side elevation view of the occluding device 540 is shown in FIG. 380. Except as described below, the occluding device 380 is similar to the occluding device 540 described above with reference to FIG. Figure 6a to Figure 6b The occluding device 370 described is the same.

[0306] like Figure 9a to Figure 9b As shown, in this configuration, the elongated actuating element 9 is connected to the distal tip element 10 by passing through a distal pulley system 544, so that the first part 542A and the second part 542B of the elongated actuating element 9 extend distally through the proximal base element. Pulling one or both of the parts 542A and 542B proximally sets the distance between the distal tip element 10 and the proximal base element 4. The locking mechanism 2 includes a locking mechanism 546, for example, the locking mechanism 546 uses compression and / or friction to hold the elongated actuating element 9, for example, in a smaller channel of the locking mechanism 546. Optionally, the locking mechanism 546 can be released after locking, in order to readjust the distance between the distal tip element 10 and the proximal base element 4, and then locked again. Locking the locking mechanism 546 maintains the set distance between the distal tip element 10 and the proximal base element 4. If necessary, this arrangement can both shorten the distance and then extend the distance. The locking mechanism 546 is typically disposed at the proximal side 28A of the airbag 5 , for example connected to or integrated into the proximal base element 4 .

[0307] Now refer to Fig.10a , which shows an example of an application according to the present invention Figure 2a107. Referring also to FIG. 108 , there is shown a cross-sectional view of the occluding device 120 in a compressed form within the catheter 14 of the delivery system 107. Fig.10b and Fig.10c , which respectively show Figure 2a A perspective view and a cross-sectional view of the occluding device 120 and its major components are shown when released from the implant catheter 14 but still connected to the delivery system 107, according to one application of the present invention. Figures 10a to 10c The occluding device 120 is shown by way of example; the delivery system 107 may also be used mutatis mutandis to deliver the other occluding devices described herein.

[0308] The implant catheter 14 allows the occlusion device 120 to be introduced into a defect in a cardiovascular device through the cardiovascular system to deploy the occlusion device 120 to seal the defect and maintain occlusion, or allows the occlusion device 120 to be introduced into another location in the patient's body. Typically, the delivery system 107 also includes a multi-knob delivery system handle 18.

[0309] The implant catheter 14 is connected to the occlusion device 120 via a proximal connection element 1. The implant catheter 14 contains the occlusion device 120 in its compressed form, i.e., in its vented rather than expanded configuration. For some applications, when the occlusion device 120 is disposed in the implant catheter 14 in a compressed form, a maximum distance D between the proximal base element 4 and the distal tip element 10 is between 8 and 80 mm, such as between 10 and 60 mm. (The "maximum distance" is the distance between the proximal base element 4 and the respective points of the distal tip element 10 that are farthest from each other.) As described above, Fig.10a The occluding device 120 is shown by way of example; the delivery system 107 may also be used, mutatis mutandis, to deliver other occluding devices described herein, in which case these other occluding devices may optionally have the maximum distance D described immediately above.

[0310] The delivery system 107 includes all components and channels to allow the controllable occlusion device 120 to be exposed, inflated, deflated, longitudinally adjusted, retrievable and released at the end of implantation. As known in the catheter field, the implant catheter 14 is usually adjustable in direction. In another configuration, the implant catheter 14 is flexible but not adjustable in direction.

[0311] Exposure of the occluding device 120 is controlled by an implant knob 16 in the delivery system handle 18. For example, advancement of the occluding device 120 can be achieved by exposing and retracting a connecting hypotube that is connected to the proximal base member 4. Retraction can be achieved by pulling a fixation wire that is placed within the hypotube, thereby maintaining the fixation wire in a positively connected position. Proximal withdrawal of the fixation wire releases the positive connection, thereby releasing the occluding device 120. For some applications, the handle 18 includes a disc actuation knob 17 that is configured to move the elongated actuating element to change the distance between the distal tip member 10 and the proximal base member 4, such as by rotating and / or pulling / pushing the elongated actuating element, depending on the specific configuration of the elongated actuating element, as described above.

[0312] The conveying system 107 allows the route of the guide wire 106 and the route of the slender actuator element to be within the structure of the occlusion device and within the central inner cavity 6 of the occlusion device 120. The guide wire 106 is used to guide the occlusion device 120 to the target defect, and the slender actuator element is used to adjust the length of the occlusion device 120.

[0313] Typically, the delivery system 107 includes a mechanism for inflating and deflation of the balloon 5 through an insufflation port 19 in the handle 18 .

[0314] The delivery system 107 is configured to provide a steering function to achieve good positioning of the occluding device 120 in the target defect, for example, controlled by a steering knob 15, including a steering limiter, within the delivery system handle 18. For cardiac applications, the steering function can achieve an antegrade procedure from the venous groin to the inferior vena cava, to the right atrium, to the left atrium, or a retrograde procedure from the arterial groin to the left ventricle, and allows the occluding device 120 to be implanted using any technique known in the art.

[0315] Reference Figure 1c to Figure 9b. For some applications, the frame 22, 122 or 222, including the proximal base element 4 and the distal tip element 10 (e.g., the proximal disk 30 and the distal disk 32) and the elongated actuator element 9, the plurality of struts 11 or struts 12, respectively, have plastic or metal deformable properties and may include any suitable biocompatible material, including stainless steel, titanium, nitinol, tantalum, gold, platinum iridium, tungsten, alloys of any of the above metals, including platinum iridium alloys, cobalt chromium alloys, nickel titanium alloys, and nickel titanium platinum alloys. Alternatively, the frame 22, 122 or 222 may include a polymer, including a polyester fiber or a polycarbonate copolymer, or any metal or polymer or polymer and metal combination capable of providing soft plastic deformation. Suitable materials include biodegradable materials that are also biocompatible, in order to undergo decomposition or degradation into non-essential compounds as part of a normal biological process. Suitable biodegradable materials include polylactic acid, polyglycolic acid (PGA), collagen or other connective proteins or natural substances, polycaprolactone, hyaluronic acid, adhesive proteins, copolymers and composites of these materials and combinations thereof, as well as combinations of other biodegradable polymers.

[0316] Still refer to Figure 1c to Figure 9b According to some applications of the present invention, the frame 22, 122 or 222 and the balloon 5 of the occluding device 20, 120 or 220 can be manufactured in different sizes, as necessary or suitable for cardiovascular defects of different sizes or other suitable areas of the body.

[0317] Reference Figures 10a to 10c , Figure 11a to Figure 11b , which shows Figure 2a 1 and 2. Side views of the occlusion device 120 in different corresponding dilation stages in a congenital defect (eg, patent foramen ovale (PFO)), according to an application of the present invention. Figure 11a to Figure 11b The occluding device 120 is shown by way of example; these techniques may also be used mutatis mutandis with the other occluding devices described herein.

[0318] In some applications of the present invention, a method of occluding a cardiovascular defect in a patient is provided. Alternatively, the method can be used to seal a gap between a medical device and adjacent body tissue of a patient; for example, the medical device can be a prosthetic heart valve, and the method can treat a paravalvular leak between the prosthetic heart valve and adjacent cardiac tissue of the patient.

[0319] The guide wire 106 is advanced into the patient's body using a delivery system 107. Fig.10aAs shown. Using the delivery system 107, the compliant balloon 5 of the occluding device 120 is positioned (partially or completely compressed) in a longitudinally extended manner within the cardiovascular defect by advancing the occluding device 120 on the guide wire 106. Optionally, the balloon 5 is partially inflated before being positioned in the longitudinally extended manner within the cardiovascular defect or the space to be occluded. Alternatively, optionally, after the balloon 5 is positioned in the longitudinally extended manner within the cardiovascular defect or the space to be occluded, the balloon 5 is partially inflated and then, repositioned in the longitudinally extended manner within the cardiovascular defect or the space to be occluded.

[0320] The compliant airbag 5 is inflated by filling a fluid into the liquid-tight airbag chamber 26 defined by the airbag 5 through the insufflation port 3 of the airbag 5 . Fig.11a The occluding device 20 is shown after the airbag 5 has been inflated. Fig.11a The figure eight shape shown is because the defect restricts the balloon 5 from having this shape and / or because the balloon 5 is configured to assume this shape even in the absence of anatomical structure.

[0321] Then, the balloon 5 is radially or laterally expanded by shortening the distance between the distal tip element 10 and the proximal base element 4 to a desired distance, and the distance is locked. The radial or laterally expansion provides a good seal between the balloon and the adjacent anatomical structure. Fig.11b The occluding device 20 is shown after the balloon 5 has been radially or laterally expanded.

[0322] Thereafter, the occluding device 120 is released from the delivery system 107 .

[0323] For some applications, the proximal base element 4 and the distal tip element 10 are both shaped to define the above-mentioned several corresponding guide wire openings 105a and 105b, which are substantially coaxial with the balloon cavity 6 to slidably receive the guide wire 106 therein, and advancing the occlusion device 120 on the guide wire 106 includes sliding the guide wire 106 through the several guide wire openings 105a and 105b mentioned above.

[0324] For some applications, the balloon 5 has the above-mentioned balloon cavity 6, which forms the above-mentioned longitudinal channel 27 from the proximal side 28A to the distal side 28B of the balloon 5. The distance between the distal tip element 10 and the proximal base element 4 is shortened to the desired distance by pulling the elongated actuating element 9 which is longitudinally slidably disposed in the balloon cavity 6, connected to the distal tip element 10 and longitudinally movable relative to the proximal base element 4. The distance is locked using a locking mechanism 2, which is used to maintain the distance between the distal tip element 10 and the proximal base element 4 set using the elongated actuating element 9.

[0325] For some applications, the occluding device 120 is released from the delivery system 107 by releasing the proximal connection element 1 of the occluding device 120 from the correspondingly configured distal connection element of the delivery system 107 .

[0326] Optionally, the balloon 5 is partially exposed in its compressed form from the implantation catheter 14 of the delivery system 107 to the area to be treated (e.g., exposing half of the length of the balloon 5), and only the exposed portion of the balloon 5 is inflated. Then, for better occlusion targeting, the balloon 5 is repositioned, then fully exposed from the delivery system 107, and the remaining portion of the balloon 5 is inflated. Subsequently, the longitudinal distance is shortened.

[0327] Optionally, a portion of the balloon 5, in its compressed form, is exposed from the implantation catheter 14 of the delivery system 107 into the area to be treated (e.g., half of the length of the balloon 5 is exposed), and only the exposed portion of the balloon 5 is inflated. The exposed portion of the balloon 5 is expanded by shortening the distance between the distal tip element 10 and the proximal base element 4 by moving the distal tip element 10 toward the proximal base element 4. Before the occluding device 120 is released from the delivery system 107, the remaining portion of the balloon 5 is exposed, inflated, and expanded from the implantation catheter by further shortening the distance between the distal tip element 10 and the proximal base element 4.

[0328] For some applications, wherein the method is used to treat a paravalvular leak between an artificial heart valve and adjacent cardiac tissue of a patient, positioning and inflating the compliant balloon includes: positioning the balloon 5 within a ventricle of the patient; then, partially inflating the balloon 5; then, positioning the balloon 5 approximately at a longitudinal center of the paravalvular leak; and then, further inflating the balloon 5. The balloon 5 is expanded after further inflation. For some applications, positioning the balloon 5 approximately at the longitudinal center of the paravalvular leak is performed by proximally withdrawing the balloon 5 until the balloon 5 is approximately at the longitudinal center of the paravalvular leak.

[0329] Figure 12a to Figure 12b The corresponding application of the present invention is shown Figure 2a The occlusive device 120 is shown in a side view expanded within a cavity or discontinuity in the body tissue. For example, the cavity or discontinuity may be a cardiovascular defect, such as a left atrial appendage (LAA). Figure 12a to Figure 12b The occluding device 120 is shown by way of example; these techniques may also be used mutatis mutandis with other occluding devices described herein. Figures 10a to 10c and Figure 11a to Figure 11b The arrangement described can be used mutatis mutandis to achieve Figure 12a to Figure 12b Implantation shown.

[0330] For some applications, the airbag 5 is configured to have an eight-shaped shape (eg Fig.12a As shown), a pear-shaped shape (as Figure 12b Or a multi-petal shape.

[0331] Figure 13a to Figure 13b An application according to the present invention is shown in Figure 2a A side view of the occlusive device 120 is shown when the occlusive device 120 is expanded within a gap between the medical device and the surrounding body tissue. For example, the medical device may include a stent, such as a stent for a prosthetic valve. Figure 13a to Figure 13b The occluding device 120 is shown by way of example; these techniques may also be used mutatis mutandis with other occluding devices described herein. Figures 10a to 10c and Figure 11a to Figure 11b The arrangement described can be used mutatis mutandis to achieve Figure 13a to Figure 13b Implantation shown.

[0332] exist Fig.13bIn the illustrated configuration, the framework 122 of the occluder device 120 includes a skeleton strut 111 that connects the proximal base member 4 and the distal tip member 10 and is thicker than other struts 11 (if provided). The skeleton strut 111 is configured to reduce the relative inflation of the side of the balloon 5 compared to the inflation of the balloon elsewhere, thereby providing a balloon shape that is adapted to the anatomical structure of the gap to be filled. Alternatively or additionally, the wall of the balloon 5 on one side may be thicker on one side, thereby creating a skeleton that causes the balloon to be less inflated on that side.

[0333] Now refer to Fig.14a , which shows a cross-sectional view of an expanded occluding device 720 according to an application of the present invention. Fig.14b and Fig.14c , which shows an application according to the present invention Fig.14a 7 is a side elevation view of the occluding device 720. Except as described below, the occluding device 720 can implement any of the features of the other occluding devices described above (including but not limited to occluding devices 20, 120, 220, 320, 370, 380, 390, 420, 520 and 540) or below (including but not limited to occluding device 620).

[0334] like Figures 14a to 14c As shown, in this configuration, the occluding device 720 includes a frame 722, and the frame 722 includes a plurality of struts 711, which can have any suitable form, through the inside (not shown) or outside (as shown) and gradually reduce the balloon 5 component. Such an application can allow the balloon 5 to be caged in its assembly to avoid unnecessary interference of the occluding device 70 by the body tissue or implanted prosthesis, and provide anchoring support of the occluding device 720 at the defect, such as the cardiovascular defect. In this application, the frame 722 can include 2, 4, 6, 8, 10, 12 or any suitable even or odd number of struts 711. The struts 711 can be arranged inside or outside the balloon 5. For some applications, the struts 711 are not fixed to any surface of the balloon 5. For other applications, the struts 711 are (a) fixed to a surface (inside or outside) of the balloon 5, (b) embedded in the wall of the balloon 5 during manufacturing (e.g., by casting on the wall). Alternatively, the airbag 5 may be molded onto the struts 711 , with the struts 711 still internally fixed to the airbag 5 .

[0335] In this configuration, the struts 711 are not arranged parallel to a central longitudinal axis 713 of the occluding device 720. For example, as shown, the struts 711 may be arranged in a generally spiral configuration around the balloon 5.

[0336] Now refer to Fig.15a , which shows a cross-sectional view of an expanded occlusive device 820 according to an application of the present invention. Fig.15b and Fig.15c , showing an application according to the present invention Fig.15a The side elevation view of the occluding device 820 shown in FIG. Figures 14a to 14c The described occlusive device 720 is identical and may implement any of its features or any of the features of other occlusive plug devices described above (including but not limited to occlusive devices 20, 120, 220, 320, 370, 380, 390, 420, 520 and 540) or below (including but not limited to occlusive device 620).

[0337] like Figures 15a to 15c As shown, in this configuration, the occluding device 820 includes a frame 822, and the frame 822 includes a plurality of pillars 811, and the pillars have the above reference Figures 14a to 14c Any features of the frame 722 and / or the support 711 described.

[0338] In this configuration, the struts 811 are not aligned parallel to a central longitudinal axis 813 of the occluding device 820. For example, the struts 811 may be arranged around the balloon 5 in a zigzag (Z-shaped) manner, optionally including partial helical portions, as shown.

[0339] Now refer to Fig.16 , which shows a method of arranging the occluding device 120, according to an application of the present invention. Fig.16 The occluding device 120 is shown by way of example; these techniques may also be used mutatis mutandis with the other occluding devices described herein. Fig.16 The first frame shows the delivery system 107 approaching the left atrial appendage defect. The second frame shows half of the occluding device 120 exposed and pre-inflated. The third frame shows half of the occluding device 120 adjusted. The fourth frame shows half of the occluding device 120 exposed and pre-inflated. The fifth frame shows the complete inflation of the entire occluding device 120 and further adjustment, shortening the distance between the proximal base element 4 and the distal tip element 10. The sixth (final) frame shows the release of the occluding device 120 at the target location.

[0340] Now refer to Fig.17a , which shows a cross-sectional view of an expanded occluding device 620 according to an application of the present invention. Fig.17b , which shows an application according to the present invention Fig.17a620. Except as described below, the occluder 620 may implement any of the features of the other occluder devices described herein, with the necessary modifications, including but not limited to the materials of the support of the frame and the components of the occluder described herein. Like reference numerals refer to like parts.

[0341] The blocking device 620 comprises:

[0342] The compliant airbag 5 defines the fluid-tight airbag chamber 26 and includes the insufflation port 3 for filling a fluid into the airbag chamber 26 and draining the fluid from the airbag chamber 26;

[0343] The distal tip element 10 is disposed at the distal side 28B of the balloon 5, and a proximal base element 604 is disposed at the proximal side 28A of the balloon 5;

[0344] an elongated element 608 having a fixed length and fixed to the distal tip element 10 and the proximal base element 604 to set a fixed distance between the distal tip element 10 and the proximal base element 604; typically, the elongated element 608 is selected from the group consisting of a tube, a wire, a long handle, a cable, a strand, and a fiber; and

[0345] The proximal connection element 1 is disposed on the proximal side 28A of the balloon 5 and is configured to releasably connect the occluding device 620 to a correspondingly configured distal connection element of the delivery system 107 .

[0346] Typically, the balloon 5 has the balloon cavity 6 forming the longitudinal passage 27 from the proximal side 28A to the distal side 28B of the balloon 5. For some applications, the elongated member 608 is disposed in the balloon cavity 6. Typically, the proximal base member 604 and the distal tip member 10 are shaped to define respective plurality of guide wire openings 605a and 605b that are substantially coaxial with the balloon cavity 6, respectively, to slidably receive the guide wire 106 therein.

[0347] For some applications, the proximal base member 604 and the distal tip member 10 include a proximal disk 630 and a distal disk 32, respectively.

[0348] For some applications, the occluder device 620 further includes at least one connecting strut secured to the distal tip element and to the proximal base element, such as described above with reference to Figure 1a to Figure 1c The single connecting strut 21 is described above with reference to Figure 3a to Figure 3c The single connecting strut 12 described above, or the Figure 2a to Figure 2c Several struts 11 are described. The strut or struts may be arranged inside and / or outside the airbag 5 and arranged as described above.

[0349] In one application of the present invention, a method is provided for occluding a cardiovascular defect or a gap between a medical device and adjacent body tissue of a patient. The method comprises:

[0350] Using a delivery system to advance the guide wire 106 into the patient's body;

[0351] Positioning the compliant balloon 5 of the occluding device 5 in a compressed form within the cardiovascular defect or the gap to be occluded by advancing the occluding device 620 over the guide wire 106;

[0352] The compliant balloon 5 is inflated by filling a fluid into the liquid-tight balloon chamber 26 defined by the balloon 5 through the insufflation port 3 of the balloon 5, so that the elongated element 608 sets a fixed distance between the distal tip element 10 and the proximal base element 604, the elongated element 608 has a fixed length and is fixed to the distal tip element 10 and the proximal base element 604, the distal tip element 10 is disposed at the distal side 28B of the balloon 5, and the proximal base element 604 is disposed at the proximal side 28A of the balloon 5; and

[0353] The occluding device 620 is released from the delivery system.

[0354] In some applications of the present invention, two or more occlusive devices are implanted to occlude a defect, in series and / or side-by-side. For some applications, the frames of two or more occlusive devices are configured to connect the two or more occlusive devices together, typically in situ during an implantation procedure. For some applications, a portion of the surface of one of the balloons is free of any frame, so that the frame of another balloon contacts the exposed portion of the other balloon, for example to prevent leakage of the aligned balloons.

[0355] In some applications of the present invention, the occlusive devices described herein are packaged in sterile packaging.

[0356] In any configuration described herein, the airbag 5 may optionally have an average wall thickness between 100 and 5000 microns, such as between 200 and 1000 microns. Alternatively, the airbag 5 does not have such an average wall thickness.

[0357] In any configuration described herein, the airbag 5 optionally has a thinnest wall thickness between 20 and 500 microns, such as between 40 and 100 microns, at a thinnest portion of a side wall of the airbag 5. Alternatively, the airbag 5 does not have such a thinnest wall thickness.

[0358] In any configuration described herein, the occluding device may include a proximal radiopaque marker 23 affixed to the proximal base element and comprising a material that is more radiopaque than the proximal base element. Alternatively or additionally, in any configuration described herein, the occluding device may include a distal radiopaque marker 25 affixed to the distal tip element and comprising a material that is more radiopaque than the distal tip element. These radiopaque markers may allow for accurate echocardiographic, fluoroscopic, and / or X-ray guidance of the occluding device.

[0359] The proximal radiopaque marker 23 and the distal radiopaque marker 25 are shown in the form of examples. Figure 1b and Figure 1c ; These markers may also be provided in other occluding devices described herein. Alternatively, the occluding device described herein does not include the proximal radiopaque marker 23 or the distal radiopaque marker 25. For example, each of the proximal radiopaque marker 23 and / or the distal radiopaque marker 25 may be shaped as a ring, such as Figure 1b and Figure 1c As shown; alternatively, the markers may have other shapes and / or different shapes or sizes from each other.

[0360] For example, the material of the proximal radiopaque marker 23 and / or the distal radiopaque marker 25 may include Au, PtIr or Ta.

[0361] For example, the proximal radiopaque marker 23 and / or the distal radiopaque marker 25 may be fixed to the proximal base element and the distal tip element, respectively, by gluing, soldering, crimping or welding.

[0362] In any configuration described herein, when the occluding device is in a compressed, uninflated form, a maximum distance between the proximal base element 4 and the distal tip element 10 is between 8 and 80 mm, for example, between 10 and 60 mm. (The "maximum distance" is the distance between the respective points of the proximal base element 4 and the distal tip element 10, which are the farthest from each other.) Optionally, when the proximal connecting element 1 is attached to the delivery system 107 and the occluding device is not disposed in the implant catheter 14, the occluding device is in the compressed, uninflated form described above.

[0363] Those skilled in the art will appreciate that the present invention is not limited to what has been specifically shown and described above. Rather, the scope of the present invention includes combinations and sub-combinations of the various features described above, as well as changes and modifications that those skilled in the art will recognize after reading the foregoing description that are not present in the prior art.

Claims

1. An apparatus for occluding a cardiovascular defect or a gap between a medical device and adjacent body tissue, said apparatus being used in conjunction with a guide wire and a delivery system, characterized in that: The apparatus comprises an occluding device, the occluding device comprising: a compliant bladder defining a fluid-tight bladder chamber and including an insufflation port for filling a fluid into the bladder chamber and evacuating the fluid from the bladder chamber; a distal tip element and a proximal base element, wherein the distal tip element is disposed at a distal side of the airbag, and the proximal base element is disposed at a proximal side of the airbag; an elongated element having a fixed length and fixed to the distal tip element and the proximal base element so as to set a fixed distance between the distal tip element and the proximal base element, the elongated element being a wire or a cable; and a proximal connection element disposed on the proximal side of the balloon and configured to releasably connect the occluding device to a correspondingly configured distal connection element of the delivery system, The airbag has a balloon cavity, forming a longitudinal channel from a proximal side to a distal side of the airbag, and The elongated element is disposed in the balloon cavity.

2. The device according to claim 1, characterized in that: The proximal base element and the distal tip element include a proximal disk and a distal disk, respectively.

3. The device according to claim 1, characterized in that: The compliant airbag includes a compliant material, and the compliant material is selected from the group consisting of polycaprolactone (PCL), polyglycolic acid (PGA), polylactic acid (PLA), polydioxanone, silicone, polyurethane, polytetrafluoroethylene (PTFE), polymethyl methacrylate, polyetheretherketone (PEEK), polyvinyl chloride, polyethylene terephthalate, polyamide and polyether block amide (PEBA).

4. The device according to any one of claims 1 to 3, characterized in that: The distal tip member and the proximal base member are shaped to define a corresponding plurality of guide wire openings that are substantially coaxial with the balloon lumen to slidably receive the guide wires therein.

5. The device according to any one of claims 1 to 3, characterized in that: The device also includes at least one connecting strut secured to the distal tip member and the proximal base member.

6. The device according to claim 5, characterized in that: The at least one connecting strut includes a single connecting strut disposed inside or outside the airbag.

7. The device according to claim 5, characterized in that: The at least one connecting strut includes a plurality of connecting struts, which are arranged inside or outside the airbag.

8. The device according to claim 7, characterized in that: The plurality of connecting struts are arranged in a cage-like manner.

9. The device according to claim 7, characterized in that: The plurality of connecting struts are arranged to form a frame.

10. The device according to any one of claims 1 to 3, characterized in that: The insufflation port includes an automatic shutoff valve.

11. The device according to claim 10, characterized in that: The insufflation port is releasably connected to the delivery system, and wherein the automatic shut-off valve is configured to close when the insufflation port is disconnected from the delivery system.

12. The device according to any one of claims 1 to 3, characterized in that: The airbag has an average wall thickness between 100 and 5000 microns.

13. The device according to any one of claims 1 to 3, characterized in that: A portion of a side wall of the airbag has a wall thickness of 20 to 500 microns.

14. The device according to any one of claims 1 to 3, characterized in that: The occlusive device also includes a proximal radiopaque marker secured to the proximal base member and comprising a material that is more radiopaque than the proximal base member.

15. The device according to any one of claims 1 to 3, characterized in that: The occluding device also includes a distal radiopaque marker secured to the distal tip element and comprising a material that is more radiopaque than the distal tip element.

16. The device according to any one of claims 1 to 3, characterized in that: The occlusive device further includes: a proximal radiopaque marker secured to the proximal base member and comprising a material that is more radiopaque than the proximal base member, and The occluding device further includes: a distal radiopaque marker secured to the distal tip element and comprising a material that is more radiopaque than the distal tip element.

17. An occlusion system, comprising the device according to any one of claims 1 to 3, characterized in that: The occlusion system also includes the delivery system that cooperates with the device, wherein the delivery system includes: an implant catheter connected to an operating handle, the implant catheter including a longitudinal channel for the guide wire; a distal connecting element for releasably connecting the implant catheter to a correspondingly configured proximal connecting element of the occlusion device; and an inflation tube channel releasably connected to a corresponding insufflation port of the occlusion device.

18. An apparatus for occluding a cardiovascular defect or a gap between a medical device and adjacent body tissue, said apparatus being used in conjunction with a guide wire and a delivery system, characterized in that: The device comprises: An occluding device comprising: A compliant balloon (a) defines a fluid-tight balloon chamber, (b) has a balloon cavity forming a longitudinal passage from a proximal side to a distal side of the balloon, and (c) includes an insufflation port for filling a fluid into the balloon chamber and emptying the fluid from the balloon chamber; a distal tip element and a proximal base element, wherein the distal tip element is disposed at the distal side of the airbag, and the proximal base element is disposed at the proximal side of the airbag; a locking mechanism; and a proximal connection element disposed on the proximal side of the balloon and configured to releasably connect the occluding device to a correspondingly configured distal connection element of the delivery system; and an elongated actuator member longitudinally slidably disposed within the balloon cavity, connected to the distal tip member, and longitudinally movable relative to the proximal base member to set a distance between the distal tip member and the proximal base member, Wherein the locking mechanism is configured to maintain the distance between the distal tip member and the proximal base member set using the elongated actuation member.

19. The device according to claim 18, characterized in that: The elongated actuating element is selected from the group consisting of a tube and a strand.

20. The device according to claim 18, characterized in that: The distal tip member and the proximal base member are shaped to define a corresponding plurality of guide wire openings that are substantially coaxial with the balloon lumen to slidably receive the guide wires therein.

21. The device according to claim 18, characterized in that: The proximal base element and the distal tip element include a proximal disk and a distal disk, respectively.

22. The device according to claim 18, characterized in that: The locking mechanism is disposed on the proximal side of the airbag.

23. The device according to claim 22, characterized in that: The locking mechanism is connected or integrated to the proximal base member.

24. The device according to claim 18, characterized in that: The compliant airbag includes a compliant material, and the compliant material is selected from the group consisting of polycaprolactone (PCL), polyglycolic acid (PGA), polylactic acid (PLA), polydioxanone, silicone, polyurethane, polytetrafluoroethylene (PTFE), polymethyl methacrylate, polyetheretherketone (PEEK), polyvinyl chloride, polyethylene terephthalate, polyamide and polyether block amide (PEBA).

25. The device according to any one of claims 18 to 24, characterized in that: The device also includes at least one connecting strut secured to the distal tip member and the proximal base member.

26. The device according to claim 25, characterized in that: The at least one connecting strut includes a single connecting strut disposed inside or outside the airbag.

27. The device according to claim 25, characterized in that: The at least one connecting strut includes a plurality of connecting struts, which are arranged inside or outside the airbag.

28. The device according to claim 27, characterized in that: The plurality of connecting struts are arranged in a cage-like manner.

29. The device according to claim 27, characterized in that: The plurality of connecting struts are arranged to form a frame.

30. The device according to any one of claims 18 to 24, characterized in that: The occluding device includes the elongated actuating element fixedly connected to the distal tip element.

31. The device according to claim 30, characterized in that: The elongated actuation member is longitudinally slidable relative to the proximal base member.

32. The device according to claim 30, characterized in that: The locking mechanism includes one or more jaws and the elongated actuating element includes a plurality of teeth that together provide a ratchet mechanism so that the distance between the distal tip element and the proximal base element can be selected from a range of distances by distally pulling the elongated actuating element through the locking mechanism.

33. The device according to claim 30, characterized in that: The elongated actuating element comprises a metal wire.

34. The device according to claim 30, characterized in that: The elongated actuating element is shaped to define a thread, wherein the locking mechanism comprises a threaded opening defined by the proximal base member, wherein the threads of the elongated actuating member are disposed within the threaded opening, and The occluding device is configured such that rotation of the elongated actuating element relative to the proximal base element causes the elongated actuating element to move longitudinally relative to the proximal base element, thereby setting the distance between the distal tip element and the proximal base element and maintaining the set distance.

35. Apparatus according to any one of claims 18 to 24, characterised in that: The elongate actuation element is releasably connected to the distal tip element.

36. The device according to claim 35, characterized in that: The occluding device further comprises: a locking elongated member fixed to the distal tip member and longitudinally slidable relative to the proximal base member, and Wherein the locking mechanism is configured to lock the locking elongate member relative to the proximal base member to maintain the distance set using the elongate actuation member.

37. The device according to claim 36, characterized in that: The locking elongate member is selected from the group consisting of a tube and a strand.

38. The device according to claim 37, characterized in that: The locking elongated element is a metal wire.

39. The device according to claim 35, characterized in that: The elongated actuation member is longitudinally slidable relative to the proximal base member.

40. The device according to claim 39, characterized in that: A distal portion of the elongated actuator element is shaped to define a thread, and The distal tip element is shaped to define a threaded opening, and the threads of the distal end portion of the elongated actuating element are releasably threaded into the threaded opening, thereby releasably connecting the elongated actuating element to the distal tip element.

41. The apparatus according to claim 35, characterized in that: The elongated actuating element is shaped to define a thread, wherein the proximal base member is shaped to define a threaded opening, wherein the threads of the elongated actuating member are disposed within the threaded opening, and The occluding device is configured such that rotation of the elongated actuating element relative to the proximal base element causes the elongated actuating element to move longitudinally relative to the proximal base element, thereby setting the distance between the distal tip element and the proximal base element and maintaining the set distance.

42. The device according to claim 41, characterized in that: A distal portion of the elongated actuator member includes a first positive connection member, wherein the distal tip element is shaped to define a second positive connection element, and Wherein the first positive connection element is releasably connected to the second positive connection element, such that the elongated actuation element is releasably connected to the distal tip element.

43. Apparatus according to any one of claims 18 to 24, characterised in that: The insufflation port includes an automatic shutoff valve.

44. The device according to claim 43, characterized in that: The insufflation port is releasably connected to the delivery system, and wherein the automatic shut-off valve is configured to close when the insufflation port is disconnected from the delivery system.

45. Apparatus according to any one of claims 18 to 24, characterised in that: The airbag has an average wall thickness between 100 and 5000 microns.

46. ​​Apparatus according to any one of claims 18 to 24, characterised in that: A portion of a side wall of the airbag has a wall thickness of 20 to 500 microns.

47. Apparatus according to any one of claims 18 to 24, characterised in that: The occlusive device also includes a proximal radiopaque marker secured to the proximal base member and comprising a material that is more radiopaque than the proximal base member.

48. Apparatus according to any one of claims 18 to 24, characterised in that: The occluding device also includes a distal radiopaque marker secured to the distal tip element and comprising a material that is more radiopaque than the distal tip element.

49. Apparatus according to any one of claims 18 to 24, characterised in that: The occlusive device further includes: a proximal radiopaque marker secured to the proximal base member and comprising a material that is more radiopaque than the proximal base member, and The occluding device further includes: a distal radiopaque marker secured to the distal tip element and comprising a material that is more radiopaque than the distal tip element.

50. A blocking system, characterized in that: The occlusion system comprises an apparatus according to any one of claims 18 to 24, further comprising an implantation catheter, wherein the occlusion device is releasably arranged in a compressed form in the implantation catheter, wherein a distance between the proximal base element and the distal tip element is 8 to 80 mm.

51. A blocking system, characterized in that: The occlusion system includes an apparatus according to any one of claims 18 to 24, and the occlusion system also includes the delivery system cooperating therewith, wherein the delivery system includes: an implantation catheter connected to an operating handle, the implantation catheter including a longitudinal channel for the guide wire; a distal connecting element for releasably connecting the implantation catheter to a correspondingly configured proximal connecting element of the occlusion device; and an inflation tube channel releasably connected to a corresponding insufflation port of the occlusion device.

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