MXPA01004564A - Method and device for left atrial appendage occlusion - Google Patents

Abstract

This invention is an occlusion device (10) for use in a body lumen such as the left atrial appendage (31). The occlusion device includes an occlusion member (11), and may also include a stabilizing member (12). The stabilizing member inhibits compression of the left atrial appendage, facilitating tissue ingrowth onto the occlusion member. Themethod of making the device includes forming a plurality of slots in a tube, the slots creating radially outwardly biased longitudinal elements (228). A membrane barrier (15) is then attached to the elements.

Description

METHOD AND DEVICE FOR THE APPENDIX OCCLUSION LEFT ATRIAL The embolic attack is the third cause of national death of adults, and is a leading cause of disability. There are more than 700,000 attacks per year in the United States alone. Of these, approximately 100,000 are hemorrhagic and 600,000 are ischemic (due to narrowing of the vessels or to an embolism). The most common cause of the embolic attack emanating from the heart is the formation of thrombi, due to atrial fibrillation. Approximately 80,000 attacks per year are attributed to atrial fibrillation. This atrial fibrillation is an arrhythmia of the heart, which results in rapid and chaotic heartbeat, which produces less cardiac output and irregular and turbulent blood flow in the vascular system. There are more than five million people with atrial fibrillation in the world, with approximately four hundred thousand new cases reported every year. Atrial fibrillation is associated with a 500 percent increased risk of seizures due to this condition. A patient with atrial fibrillation typically has a significantly decreased quality of life due, in part, to fear of an attack, and the pharmaceutical regimen necessary to reduce the risk. For patients who develop a thrombus F atrial from atrial fibrillation, the clot occurs normally in the left atrial appendage ("LAA") of the heart. This LAA is a cavity that looks like a small finger, and that connects to a lateral wall of the left atrium, between the mitral valve and the root of the left pulmonary vein. The LAA contracts normally with the • 10 rest of the left atrium, during a normal heart cycle, thus preventing the blood from becoming stagnant, but often fails to contract with any force in patients experiencing atrial fibrillation, due to the discordant electrical signals associated with the AF. As a result, it is predisposed to the formation of a thrombus, to form in stagnant blood within the LAA. Blackshear and Odell have reported that of the 1288 patients with non-rheumatic atrial fibrillation, involved in their study, 221 (17%) had a thrombus detected in the left atrium of the heart. Blackshear JELL, Odell JA., In Appendage Obliration to Reduce Stroke in Cardiac Surgical Patients Wi th Atrial Fibrillation (Obliteration of the Appendix for Redur Attacks in Patients with Cardiac Surgery, with Atrial Fibrillation). Ann Thorac Surg. , 1996.61 (2): 755-9. Of patients with atrial thrombi, 201 (91%) had atrial thrombus located within the left atrial appendage. The above suggests that the elimination or containment of the thrombus formed within the L A • of patients with atrial fibrillation, would significantly reduce the incidence of attacks in those patients. Pharmacological therapies for the prevention of seizures, such as administration, oral or systemic, of warfarin or the like, have been inadequate because of • 10 serious side effects of the medications and lack of willingness of the patient to take the medication. Invasive or thoracic surgery techniques have been used to obliterate LAA, however, many patients are not suitable candidates for these surgical procedures, due to a compromised condition or who have undergone a cardiac surgery pre-viously. In addition, the perceived risks of even a thoracic surgical procedure often matter more than the potential benefits. See Blackshear and Odell, earlier. See also Lindsay BD., Obliteration of the Left Atrial Appendage: A Concept Worth Testing Ann Torac. Surg. , 1996.61 (2): 515. Despite various efforts in the prior art, there still remains a need for a minimally invasive method and associated devices to reduce the risk of thrombus formation in the left atrial appendage.

• Compendium of the Invention 5 A method for occluding an atrial appendage is provided, according to one aspect of the present invention. The method comprises the steps of inhibiting changes in the volume of the appendix, and occluding the opening of this appendix. The inhibition of changes in the stage of The volume preferably comprises introducing a bulky element into the appendix to resist compression of the appendix wall. Preferably, the volume element is an expandable element. In one embodiment, the introduction of an expandable volume element comprises deploying a bulky self-expanding element from a deployed catheter. The occlusion step comprises placing an occlusion element to enclose the volume element within the appendix. According to another aspect of this In accordance with the invention, a method for facilitating cell growth on an occlusion device of the atrial appendage is provided. The method comprises the steps of placing an occlusion device through the opening of the appendix, this occlusion device has a surface for bonding to the tissue thereon. The method further comprises the step of resisting the compression of the appendix at least during the time period of tissue attachment. The resistance stage preferably comprises the • placement of a volume structure within the appendix. In accordance with a further aspect of the present invention, an occlusion device is provided for implantation within the left atrial appendage. This occlusion device comprises an occlusion member, which can be enlarged from a reduced cross section • 10 to an enlarged cross section. This occlusion device may further comprise a stabilizing member, which may be enlarged from a reduced cross section to an enlarged cross section. This enlarged cross-section of the stabilizing member can be smaller than the enlarged cross section of the occlusion member. Any of the structures of the occlusion member and the stabilization member, described herein, may be provided as only one occlusion member, without the corresponding stabilizing member. The occlusion device further preferably comprises a hub between the occlusion member and the stabilizing member. The occlusion member comprises an expandable frame, which can be made of at least two spokes. Each radius or ray has a first end and a second end, and the first end is attached to the cube. The spokes can be moved between an axial orientation, to provide a low profile, such as for transluminal implantation, and a radially enlarged orientation, such • as during implantation, within the appendix, to 5 occlude this appendix. The stabilizing member comprises at least two elements, which can be moved from an axial orientation, when this stabilizing member is in the reduced cross section, to an inclined orientation when the B 10 stabilizing member is in the enlarged cross-section. In one embodiment, each element comprises a proximal section, a distal section and a fold in between the proximal and distal sections, when the stabilizing member is in the enlarged cross-section. Preferably, the occlusion device further comprises at least one tissue binding element, such as a hook, spike or barb. • In accordance with a further aspect of the present invention, an occlusion device is provided for occlude a tubular structure of the body. This occlusion device comprises a body, having a longitudinal axis. An expandable occlusion member is provided in a first position on the shaft, and a stabilizing member is provided in a second position on the shaft. The occlusion member comprises a plurality of spokes, which are hinged to the body and can move between an axial orientation and an inclined orientation. Typically, the occlusion member furthermore • It comprises a polymer membrane, carried by the rays. The stabilizing member 5 comprises at least three elements movable radially to the outside. In one embodiment, a hinge is provided in the body, between the occlusion member and the stabilizing member. A hinge construction comprises a helical spring.

• In accordance with a further aspect of the present invention, a method for obtaining an occlusion device is provided. This method comprises the steps of supplying a tube, having a first end, a second end and a longitudinal axis. A plurality of slots, that extend axially, are cut in a first position in the tube, to create a first plurality of longitudinal elements. A second plurality of grooves, extending axially, are cut in a second position in the tube, to create a second plurality of longitudinal elements. The method further comprises the steps of providing an orientation, directed radially to the exterior, in at least one of the first and second plurality of elements. A polymer membrane can be attached to At least one of the first and second plurality of elements. In one embodiment, a hinge is provided in the tube, between this first and second plurality of elements. According to one more aspect of this • invention, a method for occluding an atrial appendage is provided. The method comprises the steps of introducing a stabilizing member into the appendage, to resist compression of the appendix wall, and to prevent rotation and axial migration of the implant, and to place an occlusion member through the appendix. The introduction stage • 10 preferably comprises introducing a radially expandable stabilizing member, and radially expanding this member within the appendix. The placement step may comprise or place the occlusion member within the appendix or place the occlusion member through a opening of the appendix. In one embodiment, the introduction and placement are achieved by introducing a deployment catheter into the appendix and deploying the stabilization member • and the occlusion member from the catheter. Preferably, the method further comprises the step of facilitating the Cell growth on the occlusion member. Additional features and advantages of the present invention will become apparent to a person skilled in the art, in view of the detailed description of the preferred embodiments that follow, when considered in conjunction with the accompanying drawings and claims.

• Brief Description of the Drawings Figure 1 shows a perspective view of an embodiment, having the characteristics of the invention, with an occlusion member and a retention member; • Figure 2 shows an end view of the apparatus of Figure 1, in partial section; Figure 3 shows a longitudinal cross-sectional view of the apparatus of Figures 1 and 2; Figure 3A shows a perspective view of an apparatus having the characteristics of the invention; Figure 3B shows an elevation view, in partial section, of the apparatus of Figure 3A; Figure 4 shows an elevation view of an apparatus having the characteristics of the invention in a deployed state within a body cavity; Figure 5 shows an elevation view of an apparatus having the features of the invention in a deployed state within a body cavity; Figure 6 shows a perspective view of an apparatus for sealing and separating a body cavity having the characteristics of the invention; Figure 7 shows an elevation view of a partial section of an apparatus for sealing and separating a body cavity, having the characteristics of the invention; Figure 8 shows a cross-sectional view of the apparatus of Figure 7, taken along lines 8-8; Figure 9 shows a schematic view of the heart of a patient with a transeptal catheter deployed through the septum and a delivery catheter and apparatus for sealing and separating a body cavity there disposed; Figure 10 shows a schematic view of the heart of a patient in partial section, with a delivery catheter disposed within the opening of the LAA; Figure 11 shows an enlarged view of the distal end of the delivery catheter and the LAA of a patient, according to Figure 10, with an apparatus for sealing and separating a body cavity, partially deployed within the LAA; Figure 12 shows the apparatus for sealing and separating a cavity from the body of Figure 11, deployed completely within the LAA; Figure 13 shows an elevation view of a device for occluding a body cavity, this device has the characteristics of the invention; Figure 14 shows a cross-sectional view of the device for occluding a body cavity, according to Figure 13, taken along lines 14-14; Figure 15 shows a device for occluding a body cavity, this device has the • 10 features of the invention, displayed within a LAA; Figure 16 shows a device for occluding a body cavity, this device has the characteristics of the invention, deployed within a LAA; Figure 17 shows a LAA that has been occluded by a method having the characteristics of the invention; Figure 18 shows an LAA occluded by the method having the characteristics of the invention; Figure 19 shows a LAA occluded by the method having the characteristics of the invention; Figure 20 is an elevation view of an apparatus for closing an interior cavity of a patient's body in a partial section, having the characteristics of the invention; Figure 21 is a schematic view of an apparatus for closing an interior cavity of a patient's body, in contact with the tissue of a LAA; • Figure 22 is a schematic view of a device for closing an interior cavity of a patient's body, in contact with the tissue of a LAA; Figure 23 shows a LAA, which has been closed by a method having the characteristics of the invention; Figure 24 is a perspective view of an occlusion device, according to the present invention; Figure 25 is a side elevational view of the occlusion device shown in Figure 24; Figure 26 is a perspective view of an alternate embodiment of the present invention; Figure 27 is a side elevation view of the embodiment shown in Figure 26; • Figure 28 is a perspective view of one more embodiment of the present invention; Figure 29 is a side elevational view of the embodiment of Figure 28; Figure 30 is a perspective view of a further occlusion device, in accordance with the present invention; Figure 30 (A) is a side view of the device shown in Figure 30; Figure 31 is an end view, taken at • along line 31-31 of Figure 30; Figure 32 is a schematic illustration of an inflatable balloon placed inside the occlusion device of Figure 30; Figure 33 is a schematic view of a deployment mode of a pull cord, of the • 10 occlusion device of Figure 30; Figures 34A and 34B are schematic representations in lateral elevation of the barrier layers, partial and complete, in the occlusion device of Figure 30; Figure 35 is a schematic side elevational view of an alternate occlusion device, in accordance with the present invention; Figure 36 is a schematic view of a boundary layer mesh for use in forming a composite barrier membrane, according to the present invention; Figure 37 is a cross-sectional view, with parts separated, of the components of a composite barrier membrane, according to the present invention; Figure 38 is a cross-sectional view, through a composite barrier, formed of the components illustrated in Figure 37; and • Figure 39 is a top plan view of the composite barrier illustrated in Figure 38.

Detailed Description of the Preferred Modality Figures 1 to 3 show a modality of an occlusion device 10, having the characteristics of • the invention, wherein an occlusion member 11 is secured to a retention member 12, which is arranged to fix the occlusion member in a desired position, within a body passage or cavity. The occlusion member 11 generally has a disk configuration with an outline external around the perimeter of a frame structure 14, which supports a barrier 15. The outer contour 13 can be circular or polygonal, or have any other • Configuration that is adequate to conform to the interior surface of the body cavity. A cube 16 may be located near the center of the occlusion member 11, which serves to connect the retention member 12 to the occlusion member, in addition to other functions. The outer contour 13 is typically made of a soft polymer material 17, which allows the flexibility of the contour and facilitates the sealing of this external contour against the inner surface of a cavity or passage of the body. The barrier 15 can be a mesh or thin film of material, which serves to block the passage of the material within a surrounded area by the external contour 5 13. This barrier 15 can be secured to the external contour 13 along its entire perimeter 18, in order to achieve a complete seal between them and can be molded in the external contour 13 or joined there by a suitable method, such as rubber, welding, sewing or other suitable method. • 10 This external contour 13 is supported, at least partially, by the frame structure 14, which connects the external contour and the hub. The frame structure 14 can be made of one or more elements of high strength material, such as stainless steel or MP35N, or it can be preferably made from a configuration memory or pseudo-elastic alloy, such as NiTi, or any of a variety of structural biodegradable materials • known (for example polyglycolic acid, polylactic acid, poly-L-lactic acid and its derivatives or copolymers, such as PLGA). Preferably, the frame structure 14 is made of a material that can be self-expanded from a constricted configuration, so that the occlusion device 10 can be delivered to the deployment site in a low profile or flexible configuration, which facilitates the percutaneous delivery.

Preferably, a radial ring 21 is contained within the soft polymer material 17 of the outer contour 13 and serves to maintain the annular configuration of the • external contour and facilitate radial expansion of the outer contour 5 from a constrained position or configuration. The radial ring 21 can be insulated within the soft polymer material 17 of the outer contour 13, or it can be connected to at least some of the elements 22 of the frame structure 14, in order to have a stronger mechanical joint, between the external contour and the frame structure. The radial ring 21 is shown in a substantially circular configuration, but may be polygonal or of another suitable configuration, and may have connections or joints spaced apart to facilitate Contrasting or bending the device for non-invasive delivery. In addition to connecting the retaining member 12 and the • occlusion member 11, the hub 16 can serve to accommodate a rotation coupling 23 which is connected to the end proximal 24 of a shaft 25 penetrating the tissue, inside the retaining member. The rotation coupling 23 allows the transfer of torsion to the tissue penetration axis 25, which preferably has an extension of helical configuration or distal end 26, which is configured to be screwed into the tissue to be mechanically fixed. The longitudinal movement of the axis 25 which penetrates the tissue in relation to the retaining member 12 and the hub 16, can be prevented by adjusting a lumen 27 of the • retention member, containing the tissue penetration axis, so that the extension 26, helically configured, at the distal end, is too large to pass through the lumen and the proximal end 24 of the tissue penetration axis it is prevented from passing through the lumen by the rotation coupling there united. East • 10 rotation coupling 23 can also be configured to be longitudinally captured by the hub 16, but will still be rotatably disposed there. Figures 3A and 3B illustrate an alternative embodiment of an occlusion device 10 having a occlusion member 11 and a retention member 12. This latching member 12 has an axis 28 and members 29, which extend radially from a proximal end of the shaft.

• The members 29, which extend radially, serve to anchor the axis 28 and the occlusion member 11, by the contact with the tissue surrounding the occlusion device. Preferably, the members, which extend radially, self-expand from a constricted state and are made of a pseudo-elastic alloy cut such as NiTi, or a high strength material, such as stainless steel. Although it is preferable that the radially extending members 29 be self-expanding from a constricted state, they can also be expanded by the use of configuration memory properties or a radial force to the outside, • as it would be provided by a balloon that can be inflated or similar. The shaft 28 can be a single element or made of multiple elements, and can be made of the same materials as the radially extending members or of different materials, such as polymers or polymer compounds. Members 29, which extend radially, • 10 have a proximally oriented orientation at their radial ends 29A, so that the members bend and move easily in the distal direction during insertion of the occlusion device 10, but spring afuerei and dynamically attach to the surrounding tissue at move in the proximal direction. This configuration of the radially extending members, 29, allow for easy insertion into a body cavity, but prevents • exit device 10 to the inside and outside or the proximal direction. Figure 4 illustrates an occlusion device 30, similar to that of Figures 1 to 3, deployed within the left atrial appendage of a patient. An outer contour or periphery 32 of the occlusion device 30 is disposed adjacent the opening 33 of the atrial appendage. left in a position that allows a substantial seal of the outer contour against the inner surface 34 of the LAA. A distal extremity 35, helically configured, of a shaft 36 penetrating the tissue has been screwed into the LAA wall fabric and mechanically secured therein. A retaining member 38 maintains the position of an occlusion member 41 in an orientation substantially perpendicular to the longitudinal axis of the LAA 42. Figure 5 illustrates an occlusion device, • 10 similar to that illustrated in Figures 1 to 4, deployed within a LAA 51 of a patient, similar to that shown in Figure 4. The structure of an occlusion member 52 of the embodiment shown in Figure 5, differs from that shown in Figure 5. shown in Figure 4, in which a barrier structure 53 and frame 54 of the embodiment of Figure 5 is projected proximally from a plane defined by an external contour 55. This configuration may be useful for certain • LAA morphologies of patients. An object of the invention is to create a smooth surface outside the passage, or body cavity, in order to prevent the turbulent or swirling flow of blood or other body fluid within the cavity or passage. The alternative configuration of the occlusion device 50, shown in Figure 5, can be used in this aspect.

Figure 6 shows an alternative embodiment of an occlusion device 60 having an occlusion member 61, a frame structure 62, a barrier 63 and a retaining member in the form of an expandable member 65 having linked elements 66 that they are preferably expandable from a constrained configuration. The expandable member 65 is of generally cylindrical configuration and may have a series of linked elements 66 circumferentially driven by the links 68. Although Figure 8 illustrates the expandable member 65 as a series of linked elements 66., those skilled in the art will note that a similar effect can be achieved with a single wire in helical configuration or a plurality of wires in a mesh or braid configuration, or any other suitable configuration that can self-expand from a restricted configuration or expand with the application of heat or another form of energy or force. For example, expandable member 65 can be configured to be deployed by a radially outward force, delivered from within the expandable member. A balloon that can be inflated or similar,. it can be used to exert such force. The expandable member is preferably secured to an outer contour 71 of the occlusion member 61, but can also be secured to the frame structure 62, directly or indirectly, the expandable member 65 can be self-expanding from a constricted configuration as the member can. of occlusion 61 and the frame structure and its external contour 71. The frame structure 62, the • External contour 71 and barrier 63 may have a construction similar to that described above with respect to similar elements of the embodiments illustrated in Figures 1 to 5. Referring to Figure 7, expandable member 65, as shown in Figure 6, you can also have a wrapping 72 arranged around it, so as to act as a cover between the expandable member and an internal surface of a cavity or passage of the patient's body. The wrapper may facilitate the sealing function of the occlusion member 61, but is intended primarily to prevent damage to any tissue on the inner surface of the cavidaid of the body or to linked elements 66 of the expandable member. The wrapper 72 can roll all or part of the • expandable member 65 and can be made from a variety of suitable biocompatible materials, such as Dacron®, Nylon, TFE, PTFE or ePTFE. The wrap 72 can be a fabric, braid, film or have any other suitable configuration. The expandable member 65 can also be coated by immersion, spraying or other suitable process, with a material that reduces friction, such as Teflon®, or with an active compound, such as heparin.

Figure 8 shows a cross-sectional view of the embodiment of Figure 7, taken on lines 8-8. Frame structure 62 has a shaft or hub • 73, arranged approximately in the center of the frame structure 5, which serves to connect the various radial elements 74 of the frame structure. This hub 73 may have an independent structure that links the various elements 74 of the frame structure 62, or may merely be the term of the various elements of the frame structure. • 10 frame structure and have a solid composition. In any structure, the hub 73 preferably allows a constricted configuration of the occlusion member 61 to facilitate percutaneous delivery of the occlusion device 60. The hub 73 may also have a lumen disposed therein, to allow the passage of a guide wire of another guide member. Preferably, the lumen will have a self-sealing valve or packing, which prevents passage of the • fluid or embolic material, once the guide wire or guide member is removed from the lumen. With reference to Figure 9, a schematic view of the heart 80 of the patient, in partial section, shows the trans-septal catheter 81 having a proximal end 82 and a distal end 83. The distal end 83 of the trans-septal catheter 81 is available within the heart 80 of patient with the distal end 84 of a delivery catheter 85, extending from the distal end 83 of the trans-septal catheter. This distal end 83 of the trans-septal catheter 81 has branched septum 86 of the heart 80 • of the patient and is disposed adjacent to the opening of the LAA 88 5 of the patient. At the proximal end 82 of the trans-septal catheter 81 there is a Luer connector 91, coupled to a hemostasis valve 92, which prevents the egress of blood from the lumen 93 of the trans-septal catheter 81. The proximal end 94 of the delivery catheter 85 extends proximally from the valve 92 for hemostasis and has a Luer 95 connector attached to its proximal end. The proximal end 96 of a plunger 97 extends from the Luer connector 95 of the delivery catheter. The proximal end 94 of the delivery catheter is arranged to allow rotational and axial movement of the plunger 97, while preventing blood or other body fluids from escaping between the delivery catheter 85 and the plunger 97. • Referring to FIG. 10, the heart 80 of a patient is shown in partial section, with the end distal 84 of a delivery catheter 85 disposed within the aperture 87 of the LAA. Figure 11 is an enlarged view of the LAA 88 shown in Figure 10 and the distal end of the delivery catheter 84, shown in partial section, contains a plunger 97, which is slidably disposed centrally. of an internal lumen 98 of the delivery catheter 85 and serves to apply the axial force in a distal direction 102 in the crushed occlusion member 101 disposed within the delivery catheter, thereby forcing the device 102 of • occlusion from the delivery catheter and deploy it. An occlusion device 102, having an expandable member 103 and an occlusion member 101 secured, is partially deployed and extends from the distal end of the delivery catheter 84 into the LAA 88 of the patient. The occlusion device 102 can also be guided inside • 10 of LAA 88 of the patient by the use of an appropriate wire or guide member. Figure 12 shows the occlusion device 102 of Figure 11, in a deployed state within the LAA 88 of the patient. An external contour 104 of the member of Occlusion 101 is in a substantial sealing contact with the inner surface 105 of the LAA 88. The expandable member 103 has expanded to thereby make contact with the inner surface f of the LAA and secure the occlusion device 102 therein and maintain the limb member. occlusion in a orientation substantially perpendicular to the longitudinal axis 106 of the LAA 88. A barrier 107 is disposed within an area limited by the external contour 104 and positioned to prevent the passage of the embolic material or other material to and from the LAA 88. The distal end 108 of the The plunger 97 extends from the distal end of the delivery catheter 84 after the occlusion device 102 has been pushed from the delivery catheter. Referring to Figure 13, an occlusion device 110 is shown, which has the features of the invention. This occlusion device 110 has a delivery catheter 111, with a distal end 112, a release mechanism 113, disposed at the distal end of the delivery catheter and an occlusive body or inflating member 114, secured in a peelable manner to the delivery catheter. detachment mechanism. The inflatable member 114 has a proximal end 115 and a distal end 116 with the proximal end being attached to the release mechanism 113 and the distal end terminating in an end cap 117. The inflatable member 114 has an outer surface 118 which may contain a fibrosis-inducing material, such as Dacron® or other similar materials. The inflatable member 114 can be made of a fluid-tight film of polymer material, which may or may not be elastic. Preferably, the inflatable member 114 is made of silicone, however, any suitable material, such as polyethylene, polyurethane or PET can be used. The detachment mechanism 113 may be activated by mechanical force or by delivering thermal or optical energy through a suitable conduit. Alternatively, the inflatable member can be pushed into the LAA from the delivery catheter 111 by an elongate push member, without the use of a release mechanism. The member Inflatable # 114 may be filled with a gas, fluid or gel, which is injected under pressure through the delivery catheter 114 and into the inflatable member. Suitable fluids for injection include saline or silicone. The inflatable member 114 may also be filled with a polymer material that may be hardened. Although the • Fluid, such as blood, or collagen, can also be used. A fluid, gel or polymer used to fill the inflatable member may contain contrast agents, such as gold, tantalum, bismuth, barium sulfate or the like, in order to improve visualization under fluoroscopy. or the X-ray image. Figure 14 is a cross-sectional view of the occlusion device 110 of Figure 13, taken at # long lines 14-14. An optional internal shaft 121 is shown disposed within the inflatable member 114, preferably in a concentric arrangement. The internal shaft 121 supplies the longitudinal axial support to the inflatable member 114, so as to maintain a longitudinal dimension of the inflatable member 114, when inflated and deployed. The inner shaft 121 can be solid or contain one or more lumens that may or may not be in fluid communication with an inner lumen of the inflatable member 114, and may be used for the passage of a wire or guide member. Figure 15 illustrates an alternative modality of • an occlusion device 110, consisting of an inflatable member 114 similar to the inflatable member of Figure 13, shown substantially deployed within a LAA 123 of a patient. The inflatable member 114 has been filled, at least partially, with a fluid, gas or gel, into the LAA 123 of a patient, so that the outer surface of the inflatable member 118 is in contact with at least part of inner surface 1243 of LAA. The inflatable member 114 may have rib members 125 which can interlock mechanically with the projections 126 on the inner surface of the LAA 124 or other surface irregularities of the internal surface of the cavity or passage of the patient's body. The rib members 125 form a complete circumference of the inflatable member 114, but • can also form a partial circle, spiral configuration or consist of projections randomly on the surface of the inflatable member 118. The rib members 125 extend radially for about 1 to 4 mm from the nominal surface of the inflatable member 114, and are preferably spaced by about 3 to 8 mm apart from one another. These members 125 of The rib may be made of any suitable polymer material, but are preferably made of the same material as the inflatable member, and are integrally molded there, or bonded with a suitable heat bond or adhesive bond. • to join medical polymers flexibly. The inflatable member 114 is illustrated with the distal end of the delivery catheter 112 and the attached release mechanism 113. As an alternative, or in addition to the polymer rib members 125, shown in Figure 15, tines or hooks can be secured to the outer surface of the inflatable member 114, which are configured to engage the inner surface of LAA 124 of the patient. Preferably, the tines or hooks, arranged on the outer surface of the inflatable member, and configured to be aicolated to the fabric of the inner surface of a LAA. 124 of the patient, will have a proximally directed orientation of the inflatable member 114, but will spring outward and will dynamically engage the tissue of the patient. • cavideid of the body in the movement in the proximal direction of the inflatable member. Figure 16 illustrates an occlusion device 10 consisting of an inflatable member 114 shown deployed within the LAA 123 of the patient. The embodiment of the inflatable member 114, shown in Figure 16, has an optional retention member 127 with an axis 128 of tissue penetration having a proximal end 131 and a distal end 132. A rotation coupling 133 is disposed at the proximal end 131 of the tissue penetration axis 128 and a helically configured end 134 is disposed at the distal end of the tissue. shaft 132. The distal end 134, helically configured, is shown deployed within and mechanically coupled to the wall tissue 135 of the LAA, so as to secure the inflatable member 114 and maintain its position within the LAA 123 of the patient. Figure 17 shows an alternative embodiment of an occlusion member 140, consisting of a polymer mass 141 that has been injected or delivered to the LAA 142 of the patient. The distal end 143 of delivery catheter 144 has a lumen 145 extending to a proximal end of the delivery catheter, which is in fluid communication with a source of pressurized polymeric material. A source of the pressurized polymeric material 146 can be any type of pump or device capable of forcing a polymer fluid or gel into the proximal end of the delivery catheter with sufficient pressure to force the polymeric fluid or gel out of the distal end 143 of the catheter. 144 of delivery and within the cavity or passage of the patient's body. This delivery catheter 144 can be placed by the techniques discussed above, for example, the trans-septal approach of Mullins, or any other suitable method. Once the distal end of the delivery catheter 143 is disposed within the desired portion of the LAA 142 of the patient, the polymer mass 141 can be injected to fill the cavity to the desired level. The LAA 142 can be filled completely or partially within the mass 141 of the polymer, which can be formulated to harden over time, with heat or remain in the fluid or gel state. The distal end of the delivery catheter may optionally include an expandable member that is used to substantially seal the delivery catheter against the internal surface of the cavity opening of the patient's body, during delivery of the polymer material. The expandable member may be an inflatable balloon or the like, which is well known in the art. Optionally, a retention member 127, having a tissue penetration axis 128 or the like, as shown in Figure 16, with respect to the inflatable member 114, may be deployed within the LAA 142 prior to injection of the mass 141 of the polymer and captured there to ensure the mass of the polymer within the LAA. Alternatively, the mass of the polymer can be used to fill the LAA of the patient and surround and secure a deployed device, as shown in Figures 4 or 5 in the LAA 142 of the patient.

Once the desired amount of the polymer mass 141 has been injected into the LAA 142, as advised for example by TE Echo Imaging, the delivery catheter 144 can be removed and the procedure terminated. Preferably, all of the LAA 142 of the patient is filled with the mass 141 of the polymer, as shown in Figure 18 and hardens or gels to maintain its configuration. It may be desired to have the mass 141 of the polymer held in a soft compressible form, after adjusting or hardening, so that it is at least partially elastic, with the heart restricting pumping action and resistant to fatigue as a result thereof. A material used to form the mass 141 of the polymer can contain contrast agents such as gold, platinum, tantalum, bismuth or the like, in order to better visualize the unfolding of the polymer mass under fluoroscopic examination or lightning imaging. . Another alternative embodiment of an occlusion member 140 can be found in Figure 19, which shows an occlusion coil 147, which has been deployed within a LAA 142. The occlusion coil 147, as shown, has assumed a random configuration , which mechanically occludes the LAA 142 and which has induced a clot and / or the formation of fibrosis 148 that also facilitates the occlusion of the LAA 142.

An apparatus for closing and separating a cavity or passage 150 from the body is shown in Figure 20, which has the features of the present invention. The device 150 • has an elongated shaft 151, with an internal lumen 152 and a proximal end 153 and a distal end 154. Disposed slidably within the internal lumen 152 of the elongated shaft 151, there are at least two elongated members 155, having proximal ends 156 and distal ends 157 and have tissue joining members 158 disposed in the distal ends. An optional distal anchor member 161 is also slidably disposed within the inner lumen 152 of the elongated shaft 151 and preferably has a distal end 162 terminating with a helical member 163. The proximal end 153 of the elongated shaft 151 has a proximal control module 164 which seals the inner lumen 152 of the elongated shaft 151 and allows rotation and translation of the proximal ends 156 of the elongated members 155 and the distal anchor member 161, while maintaining the seal between the members, to prevent the escape of fluids of the body thereof. The proximal control module 164 may, optionally, be configured to control the advancement and retraction of the elongate members 155 and the control activation of the tissue bonding members 158.

Figure 21 shows the apparatus for closing and separating a cavity 150 of the body, according to Figure 20, with the distal ends of the elongated members 157 and the tissue joining members 158, extending distally from the distal end of the elongated shaft 154. The distal ends of the elongated members 157 are angled or offset from a longitudinal axis 165 of the elongated shaft 151, so as to be connected to the tissue 166 of the opening 167 of the LAA 168, as shown. The elongate members 155 can be deflected by a stop or angulation contained in the distal end of the elongated shaft 154, but are preferably pre-configured in an angled configuration that manifests when the distal ends are free of the lumen restriction 152 of the elongated shaft user , which allows you to assume your relaxed condition of previous configuration. The helical member 163 at the distal end 162 of the distal anchor member 161 engages the wall tissue 171 of the LAA 168, thereby providing an optional anchor that can be used to move the elongated shaft 151 relative to the distal anchor member. 161 and give the greatest control of longitudinal axial movement of the elongated shaft relative to the opening 167 of LAA. The tissue joining members 158 are shown attached to an annular edge 172 of the opening 167 of LAA. Once the tissue binding members 158 join, a retaining member or retaining ring 173 can be advanced distally by applying an axial force on the elongated push shaft 174, which stretches the tissue binding members 158 and the tissue there closer together, as shown in the Figure 22. As the closure member 173 is advanced further distally, the annular edge of the LAA 172 is urged to close and finally the annular edge of the LAA will be closed completely in a closed state with the closure member 173 surrounding and compressing the tissue of the LAA. annular bode, as shown in Figure 23. Once a closed state of the LAA is achieved, the tissue binding members 158 can be detached and the apparatus for closing and separating the cavity 150 from the body is removed. An alternative method may have the tissue joining members 158 driven together by their proximal retraction at the distal end 154 of the elongated shaft 151, as opposed to the distal advancement of the closure member 173 with the elongated push shaft 174. In this manner, the annular edge of the LAA 172 can be urged into a closed state within the distal end 154 of the elongated shaft 151, at this point, the annular edge can be fixed in the closed state by a variety of methods, including the suture, tissue welding, the application of a suitable biocompatible adhesive, surgical staples or the like.

Referring to Figures 24 and 25, an alternative embodiment of the occlusion device 10 is illustrated, in accordance with the present invention. This occlusion device 10 comprises an occlusion member 11, comprising a frame 14 and a barrier 15. In the illustrated embodiment, the frame 14 comprises a plurality of rays 17, which extend radially outward, each having a length within them. of the range of about 0.5 to 2 cm, from a cube 16. In one embodiment, the rays have an axial length of about 1.5 cm. Depending on the desired insertion cross-sectional profile of the squashed occlusion device 10, as well as the requirements of the structural strength in the deployed device, any within the range of about 3 to 40 beams can be used. In some embodiments, approximately 12 to 24 beams are used and, in a preferred embodiment, 18 beams are used. The rays can advance from an orientation, which generally extends axially, such as to fit within a tubular introduction catheter, to a radially inclined orientation, as illustrated in Figures 24 and 25, following the deployment of the catheter . In a self-expanding mode, the rays are oriented radially outward, so that the occlusion member expands to its enlarged transverse section of implantation, under its own orientation, immediately following the deployment of the catheter. Alternatively, the occlusion member can be enlarged using any of a variety of enlarging structures, such as a balloon that can be inflated. Preferably, the rays comprise a metal, such as stainless steel, Nitinol, Elgiloy or other alloys, which can be determined through routine experimentation by those skilled in the art. The wires having a circular or rectangular cross section can be used, depending on the manufacturing techniques. In one embodiment, the rays with rectangular cross-section are cut, for example by known laser cutting techniques, from a tube material, a portion of which forms the hub 16. The barrier 16 may comprise any of a variety of materials that facilitate cell internal growth, such as ePTFE. The stability of the alternate materials for the barrier 15 can be determined through routine experimentation by those skilled in the art. This barrier 15 can be provided on either or both sides of the occlusion member. In one embodiment, the barrier 15 comprises two layers, with a layer on each side of the frame 14. The two layers can be joined together around the rays 17 in any of a variety of ways, such as by heat bonding, with or without an intermediate tie layer, cut such as polyethylene or FEP, adhesives, sutures and other techniques, which will be apparent to those skilled in the art, in view of the present disclosure. The bar 15 preferably has a thickness no greater than about 76 microns and a porosity within the approximate range of 5 to 60 microns. The barrier 15 in one embodiment is preferably secured to the frame 14 and retains sufficient porosity to facilitate internal cell growth and / or binding. A method of fabricating a suitable composite membrane barrier 15 is illustrated in Figures 36 to 39. As schematically illustrated in Figure 36, the tie layer 254 preferably comprises a mesh or other porous structure, having a surface area open within the range of approximately 10 to 90%. Preferably, the open surface area of the mesh is within the approximate range of 30 to 50%. The opening or pore size of the bending ACPA 254 is preferably within the approximate range of 127 to 1270 microns, and, in one embodiment, is about 408 microns. The thickness of the bonding layer 254 can vary widely and, in general, it is within the approximate range of 12.7 to 127 microns. In a preferred embodiment, the tie layer 254 has a thickness of about 25.4 to 50.8 microns. A suitable polyethylene bond mesh is available from Smith and Nephew, with code SN9. Referring to Figure 37, the tie layer 254 is preferably placed adjacent one or both sides of a beam or other frame element 14. The tie layer 254 and frame layers 14 are then placed between the first membrane 250 and a second membrane 252, for supplying a membrane composite material. This first • Membrane 250 and second 252 can comprise any of a variety of materials and thicknesses, depending on the desired functional result. In general, the membrane has a thickness in the range of 12.7 to 254 microns. In one embodiment, the membranes 250 and 252 have a thickness of approximate order of 25.4 microns to 50.8 microns, and comprise the porous ePTFE, which has a porosity within the approximate range of 10 to 100 microns. • The composite material is heated to a temperature of approximately 200 to 300 ° C, around about 1 to 5 minutes, to supply a composite membrane assembly with an embedded frame 14, as schematically illustrated in Figure 38. The composite final membrane has a thickness in the approximate range of 25.4 to 254 microns and preferably around 50.8 to 76.2 microns. However, the above thickness and process parameters can vary considerably, depending on the materials of the tie layer 254, the first layer 250 and the second layer 252. As illustrated in the top plan view in Figure 39, the The resulting finished composite membrane has a plurality of windows or "no limit" areas, suitable for cell attachment and / or internal growth. The adjoining areas 256 are limited by the posts of the frame 14, and the shaded pattern formed by the tie layer 254. In the illustrated embodiment, the filaments of the tie layer 254 are oriented in a non-parallel relationship with the frame posts. 14 and, in particular, at an angle within the approximate range of 15 to 85 °, from the longitudinal axis of the post. Preferably, a pattern of a regular window 256 is produced. The above procedure allows the bonding mesh to flow within the first and second membranes 250 and 252 and to provide a composite membrane 15 of higher strength (both tension and tear resistance). ) than the components without this binding mesh. The composite allows uniform bonding while maintaining the porosity of the membrane 15, to facilitate tissue attachment. By the flow of the thermoplastic bond layer in the pores of the outer mesh layers, 250 and 252, the flexibility of the composite is preserved and the overall thickness of the composite layer can be minimized. The occlusion device 10 may further be provided with a volume or stabilizer element 194. 5 This stabilizer 194 may be spaced along an axis of the occlusion member 11. In the illustrated embodiment, a distal end 190 and a proximal end 192 are identified for reference. The designation of proximal or distal is not intended to indicate any • 10 particular anatomical orientation or deployment orientation, within the deployment catheter. As shown in Figures 24 and 25, the stabilizer 194 is spaced distally from the occlusion member 11. For use in the LAA, the occlusion member 11 has an expanded diameter within the range of about 1 to 5 cm and, in one embodiment, of about 3 cm. The axial length of the member 11 of • occlusion in an expanded, unstressed orientation from the distal end 192 to the proximal hub 16 is of the order of about 1 cm. The overall length of the occlusion device 10 from the distal end 192 to the proximal end 190 is within the range of about 1.5 to 4 cm, in one embodiment, of about 2 cm. The axial length of the stabilizer 194 between the distal hub 191 and the hub proximal 16 is within the approximate range of 0.5 to 2 cm, and, in one embodiment, of about 1 cm. The expanded diameter of the stabilizer 194 is within the approximate range of 0.5 to 2.5 cm, and in one embodiment, of about 1.4 cm. The external diameter of the distal hub 191 and the proximal hub 16 is about 2.5 mm. Preferably, the occlusion device 10 is provided with one or more retaining structures, to retain the device in the left atrial appendage or other lumen of the body. In an illustrated embodiment, a plurality of tines or other anchors 195 is provided, to join the adjacent tissue and retain the occlusion device 10 in its implanted position and limit relative movement between the tissue and the occlusion device. Illustrated anchors are provided in one or more of the spokes 17, or other portion of the frame 14. Preferably, each ray, each second ray or each third ray is provided with one or two anchors each. The illustrated anchor is in the form of an uni pike, to extend within the tissue at or near the opening of the LAA. One or more anchors 195 may also be provided in stabilizer 194, such that they not only assist in orienting the occlusion device 10 and resist compression of the AA, but also in retaining the occlusion device 10 within the LAA. Any of a wide variety of structures can be used for the anchor 195, or in the occlusion member 11 or the stabilizer 194 or both, such as hooks, spikes, pins, sutures, adhesives and others that will be apparent to those skilled in the art. matter . During use, the occlusion device 10 is preferably positioned within a tubular anatomical structure to be occluded, such as the left atrial appendage, so that the occlusion member 11 is placed through or near the opening to the LAA. and the stabilizer 194 is placed inside the LAA. The stabilizer 194 assists in the proper placement and orientation of the occlusion member 11, as well as resists compression of the LAA behind the occlusion member 11. The present inventors have determined that the following deployment of an occlusion member 11 without a stabilizer 194 or other bulky structure to resist LAA compression, normal operation of the heart may cause compression and result in changes in volume in the LAA, forcing so that the fluid passes the occlusion member 11 and inhibits or prevents a complete seal. The provision of a dimensional stabilizer 194 to prevent crushing or pumping of the LAA thus minimizes leakage and the provision of barbs facilitates endothelilization or other cell growth through the occlusion member 11.

For this purpose, the stabilizer 194 is preferably movable between a reduced cross section profile for transluminal advancement within the left atrial appendage, and an enlarged orientation in cross section, as illustrated, to fill or substantially fill a cross section through the THE A. The stabilizing member can be enlarged to a cross section larger than the anatomical cavity, to ensure a tight fit and minimize the likelihood of compression. A convenient construction includes a plurality of elements 196, which can expand radially outward in response to axial compression of a distal hub 191, towards a proximal hub 16. The elements 196 each comprise a distal segment 198 and a proximal segment 202 connected by a fold 200. The elements 196 may be provided with an orientation in the direction of the radially enlarged orientation, as illustrated in Figure 225, or they may expand radially by applying an expansion force, such as an axially compressive force, between the distal hub 191 and the proximal hub 16 or a radial expansion force, as could be applied by a balloon that can be inflated. The elements 196 can be conveniently formed by laser cutting the same tube material as that used to construct a distal hub 191, a proximal hub 16 and the frame 14, as will be apparent to those skilled in the art in view of the present disclosure. Alternatively, the various components of the occlusion device 10 can be manufactured separately or manufactured in sub-assemblies and secured together during manufacture. As a subsequent implantation step for any of the occlusion devices described herein, a radiation-opaque dye or other visualizable medium can be introduced into one side or the other of the occlusion device, to allow visualization of any escaped blood or other fluid that comes out of the occlusion device. For example, in the context of an application in the left atrial appendage, the occlusion device may be provided with a tube or capillary opening, which allows the introduction of a visualizable dye from the deployed catheter through the occlusion device and into the occlusion device. of space trapped in the distal side of the occlusion device. Alternatively the dye may be introduced into the trapped space distal to the occlusion device, such as by advancing a small gauge needle from the deployed catheter through the barrier 15 into the occlusion device, to introduce the dye. A further embodiment of the occlusion device 10 is illustrated in Figures 26 and 27. This occlusion device 10 comprises an occlusion member 11 and a stabilizing member 194, as in the previous embodiment. In the present embodiment, however, each of the distal segments 198 tilt radially outwards in the proximal direction and end at a proximal end 204. This proximal end 204 may be provided with a traumatic configuration, to be pressed against, but not penetrate, the wall of the left atrial appendage or other tubular body structure. Three or more distal segments l | ^ 10 198 are preferably provided and, in general, any within the approximate range of 6 to 20 distal segments 198 may be used. In one embodiment, 9 distal segments are supplied. In this embodiment, 3 of the distal segments 198 have an axial length of about 5 mm and 6 of the distal segments 198 have an axial length of about 1 cm. The staggering of the lengths of the proximal segments 198 can axially lengthen the area in the left atrial appendage, against which the proximal ends 204 provide an anchorage support. for the occlusion device. This occlusion device 10, illustrated in Figures 26 and 27, is additionally provided with a hinge 206, to allow the longitudinal axis of the occlusion member 11 to be angularly oriented with respect to the axis. of the stabilizing member 194. In the illustrated embodiment, the hinge 206 is a helical coil, although any of a variety of hinge structures may be used. The illustrated embodiment can be conveniently formed by laser cutting a helical groove through a section of the tube, from which the main structural components of the occlusion device 10 are formed. At the distal end of the hinge 205, an annular band 208 connects the hinge 206 to a plurality of axially extending posts 210. In the embodiment (10 illustrated), three axial posts 210 are provided, equilaterally spaced around the circumference of the body, The axial posts 210 can be formed from a portion of the wall of the original material of the tube, this portion being left in its orientation original axial, followed by the formation of the distal segments 198, such as by laser cutting from the tubular wall.The occlusion member 11 is provided with an area < l proximal 212 in each of the rays 17. This proximal zone 212 has an increased degree of flexibility to accommodate the fit between the occlusion member 11 and the left atrial appendage wall. The proximal section 212 can be formed by reducing the cross-sectional area of each of the rays 17 or by increasing the length of each ray, making a wave pattern, as illustrated.

Each of the rays 17 terminates at a proximal point 214. This proximal point 214 may be contained within the layers of the barrier 15 or may extend through or beyond the barrier 15, such as to attach to the adjacent tissue and assist in retaining the occlusion device 10 at the deployment site. Referring to Figures 28 and 29, a further version of the occlusion device 10, illustrated in Figures 2 and 25, is provided. The occlusion device 10 is provided with a proximal face 216 in the occlusion member 11, instead of the open and concave face proximally in the embodiment of Figures 24 and 25. This proximal face 216 is formed by the provision of a ray proximal 218 connecting an apex 220 to each distal ray 17. Proximal rays 218 each attach to a hub 222 at the proximal end of the occlusion device 10. The barrier 15 may surround each proximal face or face both or both of the occlusion member 11. In general, provision of the proximal ray 218 connected at an apex 220 to a distal ray 17 provides a greater radial force than a distal ray 17 alone. , which will provide increased resistance to compression if the occlusion member 11 is positioned with the LAA. Referring to Figures 30 to 35, an alternative embodiment of the occlusion device, in accordance with the present invention, is illustrated. In general, the occlusion device 10 comprises an occlusion member, but does not include a distinctive stabilizing member, as illustrated in connection with the previous embodiments. Any of the modalities previously described herein can also be constructed using only the occlusion member and omitting the stabilizing member, as will be apparent to those skilled in the art in view of the present disclosure. The occlusion device 10 comprises a proximal end 192, a distal end 190 and a longitudinal axis extending therebetween. A plurality of supports 228 extend between a proximal hub 222 and a distal hub 191. At least two or three supports 228 are provided and preferably at least about six. In one embodiment, eight supports 228 are provided. However, the precise number of supports 228 can be modified, depending on the desired physical properties of the occlusion device 10, as will be apparent to those skilled in the art,. in view of the present disclosure, without departing from the present invention. Each support 228 comprises a portion 218 of proximal ray, a portion 217 of distal ray and an apex 220, as already discussed. However, each of the proximal rays 218, distal rays 17 and apex may be in a region on an integral support 228, such as a continuous rib or frame member, extending in a generally curved configuration, as illustrated with a concavity facing the longitudinal axis of the occlusion device 10. Thus, no distinct point or hinge at the apex 220 is necessarily provided, as revealed in the previous embodiments, which include a hinge connection between the proximal ray 218 and the distal ray 17. At least some of the supports 228 and, preferably, , each support 228, is provided with one or two or more prongs 195. In the illustrated configuration, the occlusion device 10 is in its enlarged orientation, cut away as to occlude a left atrial appendage or other cavity or lumen of the body. In this orientation, each of the prongs 195 projects generally radially outwardly from the longitudinal axis, and inclines in the proximal direction. In one embodiment, where the tines 195 and the corresponding support 228 are cut from a single strip, sheet or tube material, the tine 195 will tilt radially outward in approximately one tangent to the curve formed by the support 228. The device 10 The occlusion, illustrated in Figure 30, can be constructed from any of a variety of ways, as will be apparent to those skilled in the art in view of the present disclosure. In a preferred method, the occlusion device 10 is constructed by laser cutting a piece of a tube material, to supply a plurality of axially extending slots between adjacent supports 228. Similarly, each barb 195 can be cut by laser from the corresponding support 228 or space between the adjacent supports 228. The grooves, which extend axially in general, separate adjacent supports 228 and by a sufficient distance from each proximal end 192, and the distal end 190, to leave a bucket proximal 222 and a distal hub 191 to which each of the supports 228 is joined. In this way, an integral cage structure can be formed. Alternatively, each of the components in the cage structure can be formed separately and joined together as by welding, heat bonded, adhesives and other fastening techniques, which are known in the art. A further method of manufacturing the occlusion device 10 is to laser cut a slot pattern in a flat sheet of appropriate material, such as a flexible metal or polymer, as discussed in connection with the previous embodiments. The flat leaflet can then be wound around an axis and the opposite edges joined together to form a tubular structure. The apex portion 220 carried by the pin 195 can be advanced from a low profile orientation, in which each of the supports 228 extends generally parallel to the longitudinal axis, to an implanted orientation, as illustrated, in which the apex 220 and barb 195 are positioned radially outwardly from the longitudinal axis. The support 228 may be oriented toward the enlarged orientation or may be advanced to the enlarged orientation at once to be placed within the tubular anatomical structure, in any of a variety of ways. For example, referring to Figure 32, a balloon 230 that can be inflated, is placed inside the occlusion device 10. This inflatable balloon 230 is connected by a removable coupling shape 232 to an inflation catheter 234 234. This catheter of inflation 234 is provided with an inflation lumen to provide communication between a source 236 of the inflation medium, outside of the patient, and balloon 230. Following placement within the lumen of the target body, balloon 230 is inflated , thereby making the pins 195 with the surrounding tissue. The inflation catheter 234 is thus removed, decoupling the removable coupling 232 and the inflation catheter 234 is then removed. In the alternative embodiment, the supports 228 are radially enlarged, such as through the use of a deploying catheter 238. This deployed catheter 238 comprises a lumen for receiving, in mobile form, an unfolding line 240. This unfolding line 240 extends in a loop 244 formed by a sliding knot 242. As will be evident from Figure 33, the proximal retraction in the line • 240 of unfolding, will cause the distal hub 191 to be urged toward the proximal pad 222, thereby radially enlarging the cross-sectional area of the occlusion device 10. Depending on the material used by the occlusion device 10, the supports 228 will retain the orientation radially enlarged by the deformation | 10 is elastic, or can be retained in the enlarged orientation such as by securing the sliding knot 242 immobile to the line 240 deployed in the radially enlarged orientation in full. This can be accompanied in any of a variety of ways, using additional knots, fasteners, adhesives or other techniques known in the art. Referring to Figures 34A and 34B, the occlusion device 10 may be provided with a barrier 15, such as a mesh or cloth, as previously discussed. This barrier 15 can be provided in only one hemisphere, such as the proximal layer, or it can be carried by the complete occlusion device 10, from the proximal end 192 to the distal end 190. The barrier can be secured to the radially facing surface inside 25 of supports 228, as illustrated in Figure 334B, or can be provided on the radially outwardly facing surface of supports 228, or both. One more mode of the occlusion device is • illustrates in Figure 35, in which the apex 220 is elongated in an axial direction to provide an additional contact area between the occlusion device 10 and the wall of the tubular structure. In this embodiment, one or two or three or more anchors 195 may be provided on each support 228, depending on the desired clinical performance. He • Occlusion device 10, illustrated in Figure 35, may also be provided with any of a variety of other features discussed herein, such as a partial or complete barrier cover 15. In addition, the occlusion device, illustrated in the Figure 35, can be enlarged using any of the techniques disclosed herein above. While particular forms of the invention have been described, it will be evident that various modifications can be made without departing from the spirit and scope of the invention. invention. Accordingly, the invention is not intended to be limited, except as indicated in the appended claims.

Claims (60)

1. CLAIMS 1. An occlusion device, for implantation within a tubular structure in the body, • this device comprises: an occlusion member, which can be enlarged from a reduced cross section to an enlarged cross section; and a stabilizing member, which can be enlarged from a reduced cross section to a section • 10 enlarged cross section.
2. 2. An occlusion device according to claim 1, wherein the enlarged cross-section of the stabilizing member is smaller than the enlarged cross-section of the occlusion member.
3. 3. An occlusion device according to claim 1, further comprising a hub, between the occlusion member and the stabilizing member.
4. 4. An occlusion device according to claim 1, wherein the occlusion member comprises a 20 expandable framework.
5. 5. An occlusion device according to claim 4, wherein the frame comprises at least two rays.
6. 6. An occlusion device according to claim 5, wherein at least one beam has a first end and a second end, and this first end is joined • to the cube.
7. 7. An occlusion device according to claim 1, wherein the stabilizing member comprises at least two elements, which can move from an axial orientation, when the stabilizing member is in the reduced cross section, to an orientation • 10 inclined, when the stabilizing element is in the enlarged cross section.
8. 8. An occlusion device according to claim 7, wherein each element comprises a proximal section, a distal section, and a fold between the 15 proximal and distal sections, when the stabilizing member is in the enlarged cross-section.
9. 9. An occlusion device according to claim 7, wherein the elements comprise wire.
10. 10. An occlusion device, according to claim 7, wherein the elements are cut from a tube.
11. 11. An occlusion device according to claim 1, further comprising at least one tissue binding member, the occlusion member or the stabilizing member, or both.
12. 12. An occlusion device, according to the • claim 11, in which the tissue binding structure 5 comprises an element that perforates the fabric.
13. 13. A method FOR obtaining an occlusion device, this method comprises the steps of: supplying a tube, having a first end, a second end and a longitudinal axis; • forming a plurality of grooves, extending axially, in a first position on the tube, to create a first plurality of longitudinal elements; and forming a second plurality of grooves, extending axially, in a second position, on the tube, to create a second plurality of longitudinal elements.
14. 14. A method according to claim 13, further comprising the step of providing an orientation, directed radially outward, on at least one of the 20 primerei and second plurality of elements.
15. 15. A method according to claim 13, further comprising the step of attaching a membrane or mesh to at least one of the first and second plurality of elements.
16. 16. A method according to claim 13, further comprising the step of providing a hinge on the tube, between the first and second plurality of elements.
17. 17. A method according to claim 16, wherein the provision of the hinge stage comprises supplying a spiral cut in the tube.
18. 18. A method according to claim 13, wherein the forming step comprises cutting with a laser or a chemical treatment.
19. 19. An occlusion device, to occlude a structure of a hollow body, this device comprises: a proximal end, a distal end and a longitudinal axis, extending through them; at least three supports, which extend between the proximal end and the distal end; each support comprises a flexible, elongated element, which can be moved from a first orientation, in which the element extends substantially parallel to the axis, by no more than the first distance from the axis, to a second orientation, in which less a portion of the element is inclined with respect to the axis and is separated by at least a second distance from the axis, which is greater than the first distance.
20. 20. An occlusion device according to claim 19, which comprises at least five supports.
21. 21. An occlusion device, according to claim 19, further comprising a proximal hub at the proximal end, and a distal hub, at the distal end.
22. 22. An occlusion device according to claim 21, in which the supports and the proximal hub and the distal hub are formed from a tube. • An occlusion device according to claim 21, in which the supports and the proximal hub and the distal hub are formed from a leaf. 24. An occlusion device according to claim 19, further comprising at least one barb in 15 each support. 25. An occlusion device, according to the # claim 20, further comprising at least one prong in each of at least two supports. 26. An occlusion device, according to claim 19, further comprising a berrera layer, carried by the supports. 27. An occlusion device, for implantation with a tubular structure in the body, this device comprises: an occlusion member, comprising at least 5 rays, which can be moved from a reduced cross section to an enlarged cross section, these rays can be moved from an axial orientation, when the occlusion member is in the reduced cross section, to an inclined orientation, when the member of • 10 occlusion is in the enlarged cross section. 28. An occlusion device according to claim 27, further comprising at least one hub in the occlusion member, for retaining the rays. 29. An occlusion device according to claim 27, wherein the occlusion member comprises at least eight rays. • 30. An occlusion device according to claim 28, wherein at least one beam has a first end and a second end, and this first end is 20 attach, cubed. 31. An occlusion device according to claim 27, wherein each ray comprises a proximal section, a distal section and a bend between the proximal and distal sections, when the occlusion member is in the enlarged cross-section. 32. An occlusion device, according to the • claim 27, in which the rays comprise wire. 33. An occlusion device according to claim 27, in which the rays are cut from a tube. 34. An occlusion device according to claim 27, further comprising at least one element. { tissue binding flfc on this occlusion member. 35. An occlusion device according to claim 34, wherein the tissue binding structure comprises a tissue piercing element. 36. An occlusion device according to claim 35, comprising at least one prong in each ray. áfc 37. An apparatus for preventing the passage of embolic material, from a left atrial appendage of a patient, this apparatus comprises: (a) an occlusion member, having an outer periphery, which is arranged around the occlusion member, and which is configured for contact with the surface of the patient's left atrial appendage; and (b) an element for securing the outer periphery of the occlusion member to the surface of the left atrial appendage. • 38. The apparatus of claim 37, wherein the element for securing the outer periphery of the occlusion member to the surface of the left atrial appendage of the patient, comprises a connecting element, which is in contact with the outer periphery and at least a portion of the surface of the left atrial appendage. • 39. The apparatus of claim 37, wherein the element for securing the outer periphery of the occlusion member to the surface of the left atrial appendage of the patient, comprises a retaining member secured to the occlusion member. 15 40. An apparatus for preventing the passage of embolic material from a body cavity or passage, and this apparatus comprises: (a) an occlusion member; Y (b) a retaining member, secured to the occlusion member 20 and configured to contact an interior surface of the body cavity or passage. 41. The apparatus of claim 40, wherein the retaining member is an expandable member, configured for contact with the inner surface of the body cavity, when in the expanded state. 42. The apparatus of claim 41, wherein the retainer member is configured for contact with the 5 inner surface of the left atrial appendix of the patient. 43. The apparatus of claim 42, wherein the expandable member is comprised of an expandable wire structure, cylindrically shaped. 44. The apparatus of claim 43, wherein the expandable member is comprised of linked metallic elements, capable of expansion from a constricted state. 45. The apparatus of claim 44, wherein the expandable member is self-expanding from a constricted state. 46. The apparatus of claim 44, wherein the linked metal elements are comprised of a pseudo-elastic alloy. 47. The apparatus of claim 46, wherein the pseudo-elastic alloy is NiTi. 48. The apparatus of claim 43, wherein the retaining member further comprises an outer envelope, disposed about and secured to the expandable member. 49. The apparatus of claim 48, wherein the outer shell is comprised of a polymer mesh. 50. The apparatus of claim 48, wherein the outer shell is comprised of PTFE. 51. The apparatus of claim 40, wherein the occlusion member has a transverse dimension of about 1 to 3 cm. 52. The apparatus of claim 40, wherein the retention member has a length of about 1 to 5 cm. 53. The apparatus of claim 40, further comprising an outer periphery, disposed around the occlusion member, configured for the sealing contact with the inner surface of the patient's left atrial appendage. 54. The apparatus of claim 53, wherein the outer periphery has a substantially annular configuration in a relaxed state. 55. The apparatus of claim 53, wherein the outer periphery is comprised of a soft polymer. 56. The apparatus of claim 40, wherein the occlusion member is configured for contact with the inner surface of the left atrial appendage of the patient, and the retaining member comprises an axis, having at least one member, extending radially, from and configured for contact with the inner surface of the patient's left atrial appendage, to limit axial movement of the occlusion member therein secured. 57. The apparatus of claim 56, wherein at least one of the members, which extend radially, is comprised of a pseudo-elastic NiTi alloy. 58. The apparatus of claim 56, wherein the occlusion member comprises a covered frame structure, with a polymer mesh, configured to prevent passage of the embolic material. 59. A device for occluding a cavity of a patient's body, comprising an occlusion body configured to fill, at least partially, the left atrial appendage of a patient. 60. The device of claim 59, wherein the occlusion body comprises a member that can be inflated.