Left atrial appendage closure device and method

Abstract

A device for treating a patient's left atrial appendage (LAA) includes a tissue ingrowth member, at least one connector, a tines, and a plurality of struts connected to the tissue ingrowth member and the at least one connector. A plurality of anchors extend from the tissue ingrowth member to near the connection point between the struts and the tissue ingrowth member. The device is configured to change shape from a compressed pre-deployment configuration to at least one expanded post-deployment configuration so that the anchors pierce and become lodged in cardiac tissue, thereby occluding the left atrial appendage opening.

Description

[0001] Cross-references

[0002] This application relies on the priority of U.S. Patent Provisional Application No. 62 / 925,316, entitled “Left Atrial Appendage Closure Device and Method” and filed on October 24, 2019, which is incorporated herein by reference in its entirety. Technical Field

[0003] The present specification relates to systems and methods configured to close a left atrial appendage (LAA). More specifically, the present specification relates to a device having a pre-deployment shape and at least one post-deployment shape, the device being configured to apply pressure on a LAA wall to close the LAA. Background Art

[0004] The left atrial appendage (LAA) consists of small sacs in the wall of the left atrium that can be a source of atrial arrhythmias and emboli that can lead to stroke. Left atrial appendage occlusion and ligation devices are used to eliminate atrial arrhythmias and emboli caused by clots in the atrial appendage.

[0005] Figure 1 A first prior art device, a second prior art device, a third prior art device, and a fourth prior art device for closing or occluding the left atrial appendage are shown. The first device 105 (also referred to as a percutaneous left atrial appendage occlusion (PLAATO) device) consists of a self-expanding nitinol cage 107 covered with polytetrafluoroethylene. Multiple rows of anchors 108 along the circumference secure the cage 107 within the LAA ostium. The second device 110 (also referred to as Device) has a self-expanding nitinol frame with anchors 112 and a permeable polyester fabric cover 114. A third device 115 (also known as Amplatzer TM The ACP device is a self-expanding device made of a nitinol wire mesh and polyester patch and consists of distal leaves 117 and a proximal disk 118 connected by a short central waist 116. The fourth device 120 (also known as The device) has an umbrella-shaped polytetrafluoroethylene cap 122 and multiple anchors 124.

[0006] Each of these prior art devices has disadvantages, indicating a need to develop more effective and widely accepted LAA closure devices. Most existing devices rely on a single post-deployment shape and size to adequately anchor in the LAA, resulting in improper closure and premature dislocation.

[0007] Proper sizing is critical for adequate function of these devices. Furthermore, all of these devices rely solely on shape memory changes in the nitinol cage to achieve adequate sizing and fit and do not allow the operator to adjust the shape or size or the pressure exerted by the device on the LAA wall after deployment to accommodate individual LAA anatomy. Summary of the invention

[0008] The present specification discloses a device suitable for treating a patient's left atrial appendage (LAA), the device comprising: a tissue ingrowth member; a connector; a central member having a distal end and a proximal end, wherein the proximal end of the central member is positioned near the center of the tissue ingrowth member and the distal end of the central member is connected to the connector; and a plurality of struts having a distal end and a proximal end, wherein the distal ends of the plurality of struts are connected to a plurality of corresponding points along the surface of the tissue ingrowth member, and wherein the proximal ends of the plurality of struts are connected to the connector; wherein the device is capable of being configured between a pre-deployment structure, a first post-deployment structure, and a second post-deployment structure, further wherein when in the first post-deployment structure, the device has at least one first size and applies a first pressure to the heart wall, and when in the second post-deployment structure, the device has at least one second size and applies a second pressure to the heart wall, wherein the at least one second size is larger than the at least one first size and the second pressure is larger than the first pressure.

[0009] Optionally, the central member is rigid and includes multiple extensions along its length, the extensions being unidirectional, and wherein the central member is configured to pass through the center of the tissue ingrowth member and the multiple extensions are configured to engage and lock with the center of the tissue ingrowth member to lock the device in a second post-deployment configuration.

[0010] Optionally, the plurality of extensions comprise a plurality of barbs and each of the plurality of barbs has a sharp edge tapering in one direction.

[0011] Optionally, the central member is rigid and includes a threaded connection mechanism comprising a first portion and a second portion, wherein the second portion is configured to be telescopically received within the first portion via threads on an outer surface of the second portion and an inner surface of the first portion, and further wherein the threads are configured to engage to lock the device in a post-deployment configuration. The threaded connection can be adjusted to vary the post-deployment pressure for an ideal deployment.

[0012] Optionally, the tissue ingrowth member has a substantially flat disc shape in the second post-deployment configuration.

[0013] Optionally, portions of the distal ends of the plurality of struts extend beyond the surface of the tissue ingrowth member to form a plurality of anchors.

[0014] Optionally, the device is compressed into the pre-deployment configuration and configured to be positioned within and delivered by a catheter.

[0015] Optionally, the device further comprises a second connector attached at the center of the tissue ingrowth member and connected to the distal end of the central member, further wherein the central member comprises a shape memory alloy adapted to be foldable and configured to have a substantially linear shape when the device is in a pre-deployment configuration and to have a curved shape when the device is in a second post-deployment configuration.

[0016] Optionally, the central member is rigid and includes a plurality of fingers along its length, the plurality of fingers being configured to change from a first configuration in which the plurality of fingers are flush with the central member to a second configuration in which the plurality of fingers extend outwardly from the central member, and wherein the central member is configured to pass through the center of the tissue ingrowth member, and the plurality of fingers once extended are configured to engage and lock with the center of the tissue ingrowth member to lock the device in a second post-deployment configuration. Optionally, the plurality of fingers are configured to be spring loaded or magnetically actuated to change from the first configuration to the second configuration.

[0017] The present specification also discloses a device suitable for treating a patient's left atrial appendage (LAA), the device comprising: a tissue ingrowth member; a first connector and a second connector, wherein the second connector is positioned at the center of the tissue ingrowth member; a central member having a distal end and a proximal end, wherein the distal end of the central member is positioned near the second connector and the proximal end of the central member is coupled to the first connector; at least one first strut having a distal end and a proximal end, wherein the distal end of the at least one first strut is coupled to at least one first corresponding point along the surface of the tissue ingrowth member, and wherein the proximal end of the at least one first strut is coupled to the second connector; and at least one first strut having a distal end and a proximal end. a second strut at a distal end and a proximal end, wherein the proximal end of at least one of the second struts is coupled to at least one second corresponding point along the surface of the tissue ingrowth member, and wherein the distal end of the at least one second strut is coupled to the first connector; wherein the device is configurable between a pre-deployment configuration, a first post-deployment configuration, and a second post-deployment configuration, wherein when in the first post-deployment configuration, the device has at least one first dimension and applies a first pressure to the heart wall, and when in the second post-deployment configuration, the device has at least one second dimension and applies a second pressure to the heart wall, wherein the at least one second dimension is larger than the at least one first dimension and the second pressure is larger than the first pressure.

[0018] Optionally, the tissue ingrowth member has an umbrella shape in the second post-deployment configuration and extends only between the second plurality of struts.

[0019] Optionally, a portion of the distal end of the at least one first strut extends beyond the at least one first corresponding point to form a first at least one first anchor, and a portion of the proximal end of the at least one second strut extends beyond the at least one second corresponding point to form at least one second anchor.

[0020] Optionally, the device is adapted to be compressed into a pre-deployment configuration and adapted to be positioned within a catheter.

[0021] Optionally, the central member is rigid and includes a plurality of barbs along its length, the barbs being unidirectional, and wherein the central member is configured to pass through a second connector and the plurality of barbs are configured to engage and lock with the second connector to lock the device in a second post-deployment configuration.

[0022] Optionally, the distal end of the central member is attached to a second connector, and wherein the central member is comprised of a shape memory alloy, is foldable and has a substantially straight shape when the device is in a pre-deployment configuration, and has a curved shape when the device is in a second post-deployment configuration.

[0023] Optionally, the central member is rigid and includes a plurality of fingers along its length, the plurality of fingers being configured to change from a first configuration wherein the plurality of fingers are flush with the central member to a second configuration wherein the plurality of fingers extend outwardly from the central member, and wherein the central member is configured to pass through the center of the tissue ingrowth member, and the plurality of fingers once extended are configured to engage and lock with the center of the tissue ingrowth member to lock the device in the second post-deployment configuration. Optionally, the plurality of fingers are spring loaded or magnetically actuated to change from the first configuration to the second configuration.

[0024] The present specification also discloses a method of using a device to close a patient's left atrial appendage (LAA), the method comprising: positioning the device in the LAA, wherein the device comprises a tissue ingrowth member; a connector; a central member having a distal end and a proximal end, wherein the distal end of the central member is positioned near the center of the tissue ingrowth member and the proximal end of the central member is connected to the connector; and a plurality of struts having a distal end and a proximal end, wherein the distal ends of the plurality of struts are connected to a plurality of corresponding points along the circumference of the tissue ingrowth member and the proximal ends of the plurality of struts are connected to the connector, wherein the device is delivered in a pre-deployment configuration; and changing the device from the pre-deployment configuration to a first post-deployment configuration, and then to a second post-deployment configuration, wherein when in the first post-deployment configuration, the device has at least one first size and applies a first pressure to the heart wall, and when in the second post-deployment configuration, the device has at least one second size and applies a second pressure to the heart wall, wherein the at least one second size is larger than the at least one first size and the second pressure is larger than the first pressure.

[0025] Optionally, the central member is rigid and comprises a plurality of barbs along its length, the barbs being unidirectional, and wherein the central member is configured to pass through the center of the tissue ingrowth member and the plurality of barbs are configured to engage and lock with the center of the tissue ingrowth member to lock the device in the second post-deployment configuration.

[0026] Optionally, the device further comprises a second connector attached to the center of the tissue ingrowth member and connected to the distal end of the central member, wherein the central member is formed of a shape memory alloy, is foldable and has a substantially straight shape when the device is in the pre-deployment configuration, and has a curved shape when the device is in the second post-deployment configuration.

[0027] Optionally, the central member is rigid and includes a plurality of fingers along its length, the plurality of fingers being configured to change from a first configuration wherein the plurality of fingers are flush with the central member to a second configuration wherein the plurality of fingers extend outward from the central member, and wherein the central member is configured to pass through the center of the tissue ingrowth member, and the plurality of fingers, once extended, are configured to engage and lock with the center of the tissue ingrowth member to lock the device in the second post-deployment configuration.

[0028] Optionally, the device includes a conductive member configured to contact the surface of the LAA or LA, wherein an electric current is passed through the conductive member to ablate the LAA or LA tissue. Any one or more of the pillars, connectors, extensions, barbs, tissue ingrowth members, connection points, or anchors can be configured to receive an electric current and deliver the electric current to the cardiac tissue. The electric current can be a unipolar or bipolar, radiofrequency current, or an electric current that induces electroporation in the LAA or LA tissue. The ablation effect can be used to ablate arrhythmogenic tissue near the LAA. The ablation effect can also be used to produce fibrosis and help anchor the LAA occlusion device.

[0029] The above and other embodiments of the present invention will be described in more depth in the drawings and detailed description provided below. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] These and other features and advantages of the present invention will be further understood as they become better understood by reference to the detailed description when considered in conjunction with the accompanying drawings, wherein:

[0031] Figure 1 The LAA occlusion devices of the first prior art, the second prior art, the third prior art and the fourth prior art are shown;

[0032] Figure 2A The left atrium is shown depicting the left atrial appendage in the left atrium wall;

[0033] Figure 2B Multiple left atrial appendages are shown;

[0034] Figure 3A shows a first wireframe side view of a LAA occlusion device according to some embodiments of the present specification;

[0035] Figure 3B Some embodiments according to the present invention are shown. Figure 3A Top view of the LAA occlusion device;

[0036] Figure 3C Some embodiments according to the present invention are shown. Figure 3A Bottom view of the LAA occlusion device;

[0037] Figure 3D Some embodiments according to the present invention are shown. Figure 3A A second wireframe side view of the LAA occlusion device;

[0038] Figure 3E shows a wireframe side view of another LAA occlusion device according to some embodiments of the present specification;

[0039] Figure 3F Some embodiments according to the present invention are shown. Figure 3EPre-deployment and post-deployment shapes of the LAA occlusion device;

[0040] Figure 4A shows a wireframe side view of another LAA occlusion device according to some embodiments of the present specification;

[0041] Figure 4B shows a wireframe side view of yet another LAA occlusion device according to some embodiments of the present specification;

[0042] Figure 4C shows a wireframe side view of a LAA occlusion device with a magnet according to some embodiments of the present specification;

[0043] Figure 4D shows a wireframe side view of another LAA occlusion device with a magnet according to some embodiments of the present specification;

[0044] Figure 4E shows a wireframe side view of a LAA occlusion device including a thread mechanism for changing shape according to some embodiments of the present specification;

[0045] Figure 4F shows a wireframe side view of another LAA occlusion device including a thread mechanism for changing shape according to some embodiments of the present specification;

[0046] Figure 5 shows a wireframe side view of another LAA occlusion device in a pre-deployment shape and a post-deployment shape according to some embodiments of the present specification;

[0047] Fig. 6A shows a pre-deployment shape, a first post-deployment shape, and a second post-deployment shape of another LAA occlusion device according to some embodiments of the present specification;

[0048] Figure 6B Shown are some embodiments of the present specification for Fig. 6A A catheter system for deploying a LAA occlusion device into the left atrium of a patient's heart;

[0049] Figure 6C Some embodiments according to the present invention are shown. Fig. 6A A side cross-sectional view of a LAA occlusion device in a first deployed shape;

[0050] Fig.6D Some embodiments according to the present invention are shown. Fig. 6A A perspective view of a LAA occlusion device in a first deployed shape;

[0051] Fig. 6E Some embodiments according to the present invention are shown. Fig. 6AA view of a LAA occlusion device in a second deployed shape;

[0052] Fig. 6F Some embodiments according to the present invention are shown. Fig. 6A another view of the LAA occlusion device in a second deployed shape with an optional anchor;

[0053] Figure 6G shows a side view of another LAA occlusion device in a first deployed shape according to some embodiments of the present specification;

[0054] Figure 6H Some embodiments according to the present invention are shown. Fig. 6F A side view of the LAA occlusion device in a second deployed shape;

[0055] Fig.6I Some embodiments according to the present invention are shown. Fig. 6A Different views of the central ridge of the LAA occlusion device;

[0056] Figure 7 A catheter for deploying a LAA occlusion device into the left atrium of a patient's heart according to some embodiments of the present specification is shown;

[0057] Figure 8 is a cross-sectional view of a connector of a LAA occlusion device according to some embodiments of the present specification; and

[0058] Fig. 9 is a flow chart of several exemplary steps of a method of closing the LAA using an occlusion device according to some embodiments of the present specification. DETAILED DESCRIPTION

[0059] "Treat," "treatment," and variations thereof refer to any reduction in the extent, frequency, or severity of one or more symptoms or signs associated with a condition.

[0060] "Duration" and variations thereof refer to the time course of a prescribed treatment, from the start to the end, whether the treatment ends because the condition resolves or is suspended for any reason. Within the duration of treatment, multiple treatment sessions may be prescribed during which one or more prescribed stimuli are administered to the subject.

[0061] A "session" is the time during which a "dose" of stimulation is administered to a subject as part of a prescribed treatment plan.

[0062] The term "and / or" means one or all of the listed elements or a combination of any two or more of the listed elements.

[0063] In the description and claims of this application, each of the words "comprises," "includes," and "has," and forms thereof, are not necessarily limited to the members of the list associated with the word. The term "comprises" and its variations do not have a limiting meaning when these terms appear in the specification and claims. It should be noted herein that any feature or component described in connection with a particular embodiment can be used and implemented with any other embodiment unless explicitly indicated otherwise.

[0064] Unless otherwise specified, "a," "an," "the," "one or more," and "at least one" are used interchangeably and mean one or more than one.

[0065] The term "controller" refers to an integrated hardware and software system defined by multiple processing elements, such as integrated circuits, application specific integrated circuits, and / or field programmable gate arrays, which are in data communication with memory elements, such as random access memory or read-only memory, wherein the one or more processing elements are configured to execute program instructions stored in the one or more memory elements.

[0066] The term "cardiac tissue" refers to a portion of a pulmonary vein, the ostium of a pulmonary vein, the junction between the left atrium and a pulmonary vein, the atrium, the left atrial appendage, tissue adjacent thereto, or other parts of the heart and adjacent tissue.

[0067] For any method disclosed herein comprising discrete steps, the steps may be performed in any feasible order. Also, any combination of two or more steps may be performed simultaneously, if desired.

[0068] In addition, in this article, the description of the numerical range by endpoints includes all numbers contained in the range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, 5, etc.). Unless otherwise indicated, all numbers used in this specification and claims to represent the amount of components, molecular weight, etc. should be understood to be modified by the term "about" in all cases. Therefore, unless otherwise indicated, the numerical parameters set forth in this specification and claims are approximate values ​​that may vary depending on the desired properties attempted to be obtained by the present invention. At least, and without attempting to limit the doctrine of equivalents to the scope of the claims, each numerical parameter should be interpreted at least according to the number of reported significant figures and by applying ordinary rounding techniques.

[0069] Although the numerical ranges and parameters setting forth the broad scope of the specification are approximations, the numerical values ​​set forth in the specific examples are reported as precisely as possible. All numerical values, however, inherently contain a range necessarily resulting from the standard deviation found in their respective testing measurements.

[0070] It should be understood that the devices and embodiments described herein are implemented with a controller including a microprocessor that executes control instructions. The controller can be in the form of any computing device, including desktops, laptops, and mobile devices, and can transmit control signals to the device in wired or wireless form.

[0071] The present invention relates to multiple embodiments. The following disclosure is provided to enable a person of ordinary skill in the art to practice the present invention. The language used in this specification should not be interpreted as a general negation of any one specific embodiment or used to limit the claims beyond the meaning of the terms used therein. The general principles defined herein may be applied to other embodiments and applications without departing from the spirit or scope of the present invention. In addition, the terms and wordings used are for the purpose of describing exemplary embodiments and should not be considered restrictive. Therefore, the present invention will be given the widest scope, covering many alternatives, modifications and equivalents consistent with the disclosed principles and features. For clarity, details related to technical materials known in the technical field related to the present invention are not described in detail to avoid unnecessary confusion of the present invention.

[0072] Figure 2A The left atrium 201 is shown depicting a left atrial appendage 203 in a wall 205 of the left atrium 201 . Figure 2B A plurality of left atrial appendages 211 , 213 , 215 , 217 are shown, depicting various shapes of the left atrial appendages 211 , 213 , 215 , 217 .

[0073] First embodiment

[0074] Figure 3A and 3D A wireframe side view is shown. Figure 3B Shows a top view, Figure 3C A bottom view of a LAA (left atrial appendage) occlusion device 300 in a fully deployed configuration according to some embodiments of the present specification is shown. Figures 3A to 3D , the device 300 has a tissue ingrowth member 305, which is in the shape of a substantially circular or flat disc when the device 300 is in a fully expanded state. In some embodiments, the tissue ingrowth member 305 is a mesh, cage, or fabric of wire. In some embodiments, the tissue ingrowth member 305 is a fabric covering. In some embodiments, the tissue ingrowth member 305 is coated with an extracellular matrix (ECM) or another biomaterial to promote tissue ingrowth. The distal end of the rigid center member or tine 310 is movably positioned within the center 312 of the substantially circular or disc-shaped tissue ingrowth member 305, and the proximal end of the tine 310 is connected to the connector 315. In some embodiments, the tine 310 includes a plurality of unidirectional extensions or barbs 317 along its length.

[0075] The distal ends of the plurality of struts 320 are connected, coupled or attached to a plurality of connection points 322 along the circumference of the substantially circular or disc-shaped tissue ingrowth member 305, while the proximal ends of the plurality of struts 320 are coupled to the connector 315. Portions of the distal tips of the plurality of struts 320 extend beyond their respective attachment connection points 322 to form a plurality of anchors 325. In some embodiments, the distal tips forming the anchors 325 are angled or curved relative to the substantially horizontal plane of the tissue ingrowth member 305.

[0076] In some embodiments, the tines 310, the barbs 317, and the plurality of struts 320 are wires of a shape memory material such as, for example, nitinol. As the shape of the device 300 changes from its pre-deployment configuration to its first post-deployment configuration, the rigid tines 310 extend through the center 312. The first pre-deployment shape exerts a first pressure on the LAA wall and the optional anchor 325 pierces the LAA wall to a first depth. In the first post-deployment position, the operator has the ability to adjust or reposition the LAA occlusion device 300 near the LAA. Once the operator is satisfied with the position of the LAA occlusion device 300, the operator applies a pulling force or tension on the tines 310, pulling it through the center 312 so that the unidirectional barbs 317 engage with the center 312. This pulling force allows the LAA occlusion device 300 to assume its second post-deployment position, thereby exerting a second pressure on the LAA wall, and the optional anchor 325 pierces the LAA wall to a second depth. After the second deployment, the LAA occlusion device 300 is fixed to the LAA wall in its final treatment position / configuration. The central tine 310 can have multiple unidirectional barbs 317, allowing multiple second post-deployment positions, depending on the individual patient and individual LAA anatomy. In an embodiment, once the LAA occlusion device 300 is deployed, the tissue ingrowth member 305 faces the left atrium and the connector 315 and strut 320 are located in the LAA cavity.

[0077] Second embodiment

[0078] According to the embodiments of this specification, Figure 3E shows a wireframe side view, while Figure 3F Another LAA occlusion device 350 is shown in its pre-deployment and post-deployment shapes. Figure 3E and 3F The device 350 and Figures 3A-3D The device is similar to Figures 3A-3D The rigid central member or tine 310 of the device 300 is replaced by Figure 3E and 3FA collapsible central member or tine 360 ​​is provided in the device 350. The distal end of the collapsible tine 360 ​​is connected to the hub 312. The collapsible tine is made of SMA and changes over time from a relatively straight pre-deployment position to a relatively coiled post-deployment position, wherein the second post-deployment pressure slowly increases over time after deployment and the anchor 325 becomes more deeply embedded in the LAA wall over time after deployment.

[0079] Reference Figure 3E and 3F Prior to deployment, the tines 360 maintain a substantially straight configuration. However, after deployment, the tines 360 change their shape from a substantially straight configuration to a coiled or curved configuration 327, such as Figure 3E and 3F The shape of the tines 360 is adjusted from a substantially straight configuration to a coiled or curved configuration to pull the connector 315 toward the tissue ingrowth member 305, thereby expanding the plurality of struts 320 and embedding the plurality of anchors 325 into the endocardium / myocardium of the patient's heart. In an embodiment, Figure 3E and 3F The tines 360 do not include barbs.

[0080] Reference Figure 3F , the device 350 is configured into a pre-deployment shape 330, wherein the device 350 is compressed and positioned within a catheter, such as Figure 7 The device 350 is positioned within the catheter 705. The device 350 assumes a first post-deployment shape 333 such that the device 350 is partially expanded when released from the catheter. Finally, the device 350 transitions to a second post-deployment shape 335 in which the device 350 is fully expanded due to the shape of the tines 360 changing from a substantially straight configuration to a coiled or curved configuration.

[0081] In some embodiments, the second post-deployment shape 335 has a corresponding first compressed dimension 'd greater than the first post-deployment shape 333. pe 'at least one first expansion dimension'd e In some embodiments, the second post-deployment 335 shape has a corresponding second compressed dimension 'l that is smaller than the first post-deployment shape 333 pe 'at least one second expansion dimension'l e In some embodiments, the second post-deployment 335 shape has a corresponding second compressed dimension 'd greater than the first post-deployment shape 333. pe 'at least one second expansion dimension'd e'. The device 350 in the first post-deployment shape 333 exerts a first pressure on the LAA wall, and the device 350 in the second post-deployment shape 335 exerts a second pressure on the LAA wall. In some embodiments, the first pressure on the LAA wall is less than the second pressure on the LAA wall. The anchor 325 has a first position in the first post-deployment shape and a second position in the second post-deployment shape. In embodiments, the anchors 325 in the second position penetrate the LAA wall more deeply than they do in the first position.

[0082] Third to Eighth Embodiments

[0083] Figure 4A A wireframe side view of another LAA occlusion device 400 is shown, in accordance with some embodiments of the present description. Figure 4B A wireframe side view of another LAA occlusion device 450 according to some embodiments of the present specification is shown. Figure 4A and 4B , the device 400, 450 includes a tissue ingrowth member 405, which, when the device 400, 450 is in a fully expanded state, has an umbrella or inverted cap shape, such as Figure 4A and 4B In some embodiments, tissue ingrowth member 405 is a mesh, cage, or fabric of wire. In some embodiments, tissue ingrowth member 405 is a membrane or fabric covering. In some embodiments, tissue ingrowth member 405 is coated with an extracellular matrix (ECM) or another biomaterial to promote tissue ingrowth. Figure 4A , the distal end of the rigid center member or tine 410 is movably positioned within a first connector 413, which is positioned at the center 412 of the tissue ingrowth member 405, and the proximal end of the tine 410 is coupled to a second connector 415. The tine 410 includes a plurality of one-way extensions or barbs 417 along its length. In some embodiments, as the shape of the device 400 changes from its pre-deployment configuration to its post-deployment configuration, the rigid tine 410 extends through the first connector 413 and the barbs 417 engage with the first connector 413, thereby locking the device in the post-deployment configuration. In some embodiments, as the shape of the device 400 changes from its pre-deployment configuration to its post-deployment configuration, the rigid tine 410 extends through the first connector 413 and the center 412 and punctures the epicardium / myocardium of the patient's heart, thereby helping to secure the device in place.

[0084] refer to Figure 4B , the device 450 includes a foldable tine 460 instead of a rigid tine, and the distal end of the foldable tine 460 is connected to the second connector 413. Before deployment, the tine 460 is in a substantially straight configuration. After deployment, the shape of the tine 460 changes from a substantially straight configuration to a coiled or curved configuration 427, such as Figure 4B As shown. Figure 4A As with the device 400 depicted in FIG. 1 , the rigid tines 410 extend through the center 412 and the second connector 413, or with Figure 4B As with the device 450 depicted in the accompanying drawings, the shape of the tines 460 is adjusted from a substantially straight configuration to a coiled or curved configuration 427, pulling the first connector 413 and the second connector 415 toward each other, thereby expanding the first plurality of struts 420 and the second plurality of struts 440 and embedding the first plurality of anchors 425 and the second plurality of anchors 455 into the endocardium / myocardium of the patient's heart.

[0085] The distal ends of the first plurality of struts 420 are connected, coupled or attached to a first plurality of connection points 422 along the circumference of the umbrella-shaped or inverted bowl-shaped tissue ingrowth member 405, while the proximal ends of the first plurality of struts 420 are coupled to the second connector 415. Portions of the distal tips of the first plurality of struts 420 extend beyond their respective attachment connection points 422 to form a first plurality of anchors 425. In some embodiments, the distal tips forming the first plurality of anchors 425 are angled or curved relative to the substantially horizontal plane of the tissue ingrowth member 405.

[0086] The proximal ends of the second plurality of struts 440 are connected, coupled or attached to a second plurality of connection points 452 along the circumference of the umbrella-shaped or inverted bowl-shaped tissue ingrowth member 405, while the distal ends of the second plurality of struts 440 are coupled to the first connector 413. In embodiments, the tissue ingrowth member 405 is positioned on one side of the device 400, 400 having only the second plurality of struts 440. Portions of the proximal tips of the second plurality of struts 440 extend beyond their respective attachment connection points 452 to form a second plurality of anchors 455. In some embodiments, the proximal tips forming the second plurality of anchors 455 are angled or curved relative to the substantially horizontal plane of the tissue ingrowth member 405. In some embodiments, the positioning of the first plurality of connection points 422 coincides with the positioning of the second plurality of attachment connection points 452. In alternative embodiments, the positioning of the first plurality of connection points 422 does not coincide with the positioning of the second plurality of attachment connection points 452.

[0087] In some embodiments, the tines 410, 460, the barbs 417, and the first and second pluralities of struts 420, 440 are wires of a shape memory material such as, for example, Nitinol.

[0088] In an embodiment, the device 400, 450 is configured in a pre-deployment shape, wherein the device 400 is compressed and positioned within a catheter, such as Figure 7catheter 705. The device 400, 450 assumes a first post-deployment shape, such that the device 400, 450 is partially expanded when released from the catheter. Finally, the device 400, 450 transitions to a second post-deployment shape, in which the device 400, 450 is fully expanded. In some embodiments, when in the second post-deployment shape, the first connector 412 and the second connector 415 are positioned closer together than when in the first post-deployment shape, and the LAA occlusion device has a larger transverse dimension "d" in the second post-deployment shape than when in the first post-deployment shape, thereby applying greater pressure on at least 50% of the transverse circumference of the device.

[0089] In some embodiments, the second post-deployment shape has at least one dimension 'd' that is greater than the first post-deployment shape. In some embodiments, the second post-deployment shape has at least one dimension 'l' that is less than the first post-deployment shape. The device 400, 450 in the first post-deployment shape applies a first pressure on the LAA wall, while the device 400, 450 in the second post-deployment shape applies a second pressure on the LAA wall. In some embodiments, the first pressure on the LAA wall is less than the second pressure on the LAA wall. The first plurality of anchors 425 and the second plurality of anchors 455 have a first position in the first post-deployment shape and a second position in the second post-deployment shape. In an embodiment, the first plurality of anchors 425 and the second plurality of anchors 455 in the second position penetrate the LAA wall deeper than they do in the first position. In an embodiment, once implanted, the device 400, 450 is positioned so that the tissue ingrowth member 405 faces the left atrium, and the opposite side of the device 400, 450 including the first plurality of pillars 420 (without the tissue ingrowth member between the pillars 420) is positioned toward the patient's LAA and resides in the patient's LAA.

[0090] In other embodiments, Figure 4C and 4D As shown, the shape change from the first post-deployment shape to the second post-deployment shape is achieved using magnetic forces. In some embodiments, the first set of magnets 428, 438 is positioned at the proximal end 430p, 470p of the device 430, 470 and the second set of magnets 429, 439 is positioned at the distal end 430d, 470d of the device 430, 470. The magnetic force between the first set of magnets 428, 438 and the second set of magnets 429, 439 causes the proximal and distal ends of the device 430, 470 to be pulled together, compressing the dimension "l" of the device and increasing the dimension "d" of the device, which causes an increase in the post-deployment pressure / force on the LAA wall to hold the device in place. The final post-deployment pressure is determined by the attractive force between the 2 sets of magnets. In some embodiments, the pressure and attractive force between the magnets increase over time after deployment until the pressure reaches a final pressure, at which time the device is anchored in the LAA.

[0091] Reference Figure 4C , device 430 has a tissue ingrowth member 435 that is substantially circular or flat in shape when device 430 is in a fully expanded state. In some embodiments, tissue ingrowth member 435 is a mesh, cage, or fabric of wire. In some embodiments, tissue ingrowth member 435 is a fabric covering. In some embodiments, tissue ingrowth member 435 is coated with an extracellular matrix (ECM) or another biomaterial to promote tissue ingrowth.

[0092] The distal ends of the plurality of struts 431 are connected, coupled or attached to a plurality of connection points 432 along the circumference of the substantially circular or disc-shaped tissue ingrowth member 435, while the proximal ends of the plurality of struts 431 are coupled to the connector 433. Portions of the distal tips of the plurality of struts 431 extend beyond their respective attachment connection points 432 to form a plurality of anchors 434. In some embodiments, the distal tips forming the anchors 434 are angled or curved relative to the substantially horizontal plane of the tissue ingrowth member 435. In some embodiments, the first set of magnets 428 and the second set of magnets 429 comprise a plurality of magnets in the range of 1 to 20. In some embodiments, the first set of magnets 428 are positioned on the plurality of struts 431. In other embodiments, the first set of magnets 428 are positioned on the connector 433. In some embodiments, the second set of magnets 429 are positioned on the tissue ingrowth member 435.

[0093] In some embodiments, the plurality of struts 431 are wires of a shape memory material such as, for example, Nitinol. In embodiments, once the LAA occlusion device 430 is deployed, the tissue ingrowth member 435 faces the left atrium and the connector 433 and struts 431 are located in the LAA cavity.

[0094] Reference Figure 4D , the device 470 includes a tissue ingrowth member 475 that exhibits an umbrella or inverted cap shape when the device 470 is in a fully expanded state. In some embodiments, the tissue ingrowth member 475 is a mesh, cage, or fabric of wire. In some embodiments, the tissue ingrowth member 475 is a membrane or fabric covering. In some embodiments, the tissue ingrowth member 475 is coated with an extracellular matrix (ECM) or another biomaterial to promote tissue ingrowth. The distal ends of the first plurality of struts 471 are connected, coupled, or attached to a first plurality of connection points 472 along the circumference of the umbrella or inverted bowl-shaped tissue ingrowth member 475, and the proximal ends of the first plurality of struts 471 are coupled to a second connector 477. Portions of the distal tips of the first plurality of struts 471 extend beyond their respective attachment connection points 472 to form a first plurality of anchors 478. In some embodiments, the distal tips forming the first plurality of anchors 478 are angled or curved relative to the substantially horizontal plane of the tissue ingrowth member 475.

[0095] The proximal ends of the second plurality of struts 473 are connected, coupled or attached to a second plurality of connection points 474 along the circumference of the umbrella-shaped or inverted bowl-shaped tissue ingrowth member 475, while the distal ends of the second plurality of struts 473 are coupled to the first connector 476. In an embodiment, the tissue ingrowth member 475 is positioned on the side of the device 470 having only the second plurality of struts 473. Portions of the proximal tips of the second plurality of struts 473 extend beyond their respective attachment connection points 474 to form a second plurality of anchors 479. In some embodiments, the proximal tips forming the second plurality of anchors 479 are angled or curved relative to the substantially horizontal plane of the tissue ingrowth member 475. In some embodiments, the positioning of the first plurality of connection points 472 coincides with the positioning of the second plurality of attachment connection points 474. In an alternative embodiment, the positioning of the first plurality of connection points 472 does not coincide with the positioning of the second plurality of attachment connection points 474. In some embodiments, the first set of magnets 438 and the second set of magnets 439 comprise a plurality of magnets in the range of 1 to 20. In some embodiments, the first set of magnets 438 is positioned on the first plurality of struts 471. In other embodiments, the first set of magnets 438 are positioned on the second connector 477. In some embodiments, the second set of magnets 439 are positioned on the second plurality of struts 473. In other embodiments, the second plurality of magnets 439 are positioned on the first connector 476. In some embodiments, the first plurality of struts 471 and the second plurality of struts 473 are wires of a shape memory material such as, for example, Nitinol.

[0096] In other embodiments, Figure 4E and 4F As shown, the threaded connection mechanism 431 between the proximal end 480p, 490p of the device 480, 490 and the distal end 480d, 490d of the device 480, 490 is used to modify the length "l" and diameter "d" of the device 480, 490 to achieve the desired end pressure that is optimal for device stability and anchoring. In an embodiment, the threaded connection mechanism 461 is rigid and includes a first portion 462, which is configured to axially receive a second portion 463. The second portion 463 includes threads on its outer surface to securely connect with the inner threaded surface of the first portion 462. The second portion 463 can be telescopically pushed into and out of the first portion 462 by a rotational motion to change the length "l" of the device 480, 490. The threads on the outer surface of the second portion 463 are engaged with the threads on the inner surface of the first portion 461 at a specific depth of the second portion 463 in the first portion 461, locking the device 480, 490 at the desired length "l". The threaded connection mechanism 461 allows the user to titrate these parameters in a controlled manner to meet the individual LAA anatomy. Preoperative, intraoperative, and postoperative imaging can be used to determine the required size and fit.

[0097] Reference Figure 4E, device 480 has a tissue ingrowth member 485 that is substantially circular or flat disc shaped when device 480 is in a fully expanded state. In some embodiments, tissue ingrowth member 485 is a mesh, cage, or fabric of wire. In some embodiments, tissue ingrowth member 485 is a fabric covering. In some embodiments, tissue ingrowth member 485 is coated with an extracellular matrix (ECM) or another biomaterial to promote tissue ingrowth.

[0098] The distal ends of the plurality of struts 481 are connected, coupled or attached to a plurality of connection points 482 along the circumference of the substantially circular or disc-shaped tissue ingrowth member 485, while the proximal ends of the plurality of struts 481 are coupled to a connector 483. Portions of the distal tips of the plurality of struts 481 extend beyond their respective attachment connection points 482 to form a plurality of anchors 484. In some embodiments, the distal tips forming the anchors 484 are angled or curved relative to the substantially horizontal plane of the tissue ingrowth member 485. In some embodiments, the first end of the first portion 462 of the threaded connection mechanism 461 is attached to the tissue ingrowth member 485 at the connection point 488, and the second end of the first portion 462 of the threaded connection mechanism 461 receives the first end of the second portion 463 of the threaded connection mechanism 461. The second end of the second portion 463 of the threaded connection mechanism 461 is attached to the connector 483. In embodiments, the connector 483 and the second portion 463 of the threaded connection mechanism 461 can be rotated to push the second portion 463 into and out of the first portion 462 to change the length "l" of the device 480. In other embodiments, the connection point 488 of the threaded connection mechanism 461 and / or the first portion 462 can be rotated to push the second portion 463 in and out of the first portion 462 to change the length “l” of the device 480 .

[0099] In some embodiments, the plurality of struts 471 are wires of a shape memory material such as, for example, Nitinol.In embodiments, once the LAA occlusion device 480 is deployed, the tissue ingrowth member 485 will face the left atrium and the connector 483 and struts 481 are located in the LAA cavity.

[0100] Reference Figure 4F, the device 490 includes a tissue ingrowth member 495 that, when the device 490 is in a fully expanded state, presents an umbrella or inverted cap shape. In some embodiments, the tissue ingrowth member 495 is a mesh, cage, or fabric of wire. In some embodiments, the tissue ingrowth member 495 is a membrane or fabric covering. In some embodiments, the tissue ingrowth member 495 is coated with an extracellular matrix (ECM) or another biomaterial to promote tissue ingrowth. The distal ends of the first plurality of struts 491 are connected, coupled, or attached to a first plurality of connection points 492 along the circumference of the umbrella or inverted bowl-shaped tissue ingrowth member 495, and the proximal ends of the first plurality of struts 491 are coupled to a second connector 497. Portions of the distal tips of the first plurality of struts 491 extend beyond their respective attachment connection points 492 to form a first plurality of anchors 498. In some embodiments, the distal tips forming the first plurality of anchors 498 are angled or curved relative to the substantially horizontal plane of the tissue ingrowth member 495.

[0101] The proximal ends of the second plurality of struts 493 are connected, coupled or attached to a second plurality of connection points 494 along the circumference of the umbrella-shaped or inverted bowl-shaped tissue ingrowth member 495, while the distal ends of the second plurality of struts 493 are coupled to the first connector 496. In an embodiment, the tissue ingrowth member 495 is positioned on the side of the device 490 having only the second plurality of struts 493. Portions of the proximal tips of the second plurality of struts 493 extend beyond their respective attachment connection points 494 to form a second plurality of anchors 499. In some embodiments, the proximal tips forming the second plurality of anchors 499 are angled or curved relative to the substantially horizontal plane of the tissue ingrowth member 495. In some embodiments, the positioning of the first plurality of connection points 492 coincides with the positioning of the second plurality of attachment connection points 494. In alternative embodiments, the positioning of the first plurality of connection points 492 does not coincide with the positioning of the second plurality of attachment connection points 494. In some embodiments, a first end of a first portion 462 of a threaded connection mechanism 461 is attached to a first connector 496, and a second end of the first portion 462 of the threaded connection mechanism 461 receives a first end of a second portion 463 of the threaded connection mechanism 461. A second end of the second portion 463 of the threaded connection mechanism 461 is attached to a second connector 497. In embodiments, the second connector 497 and the second portion 463 of the threaded connection mechanism 461 can be rotated to push the second portion 463 into and out of the first portion 462 to change the length "l" of the device 490. In other embodiments, the first connector 496 and the first portion 462 of the threaded connection mechanism 461 can be rotated to push the second portion 463 into and out of the first portion 462 to change the length "l" of the device 490. In some embodiments, the first plurality of struts 471 and the second plurality of struts 473 are wires of a shape memory material such as, for example, Nitinol.

[0102] Ninth embodiment

[0103] Figure 5 A wireframe side view of a LAA occlusion device 500 in a pre-deployment shape 502 and a post-deployment shape 504 according to some embodiments of the present specification is shown. The device 500 has a tissue ingrowth member 505 that is umbrella-shaped or inverted bowl-shaped when the device 500 is in a fully expanded state. In some embodiments, the tissue ingrowth member 505 is a mesh, cage, or fabric of wire. In some embodiments, the tissue ingrowth member 505 is a membrane or fabric covering. The proximal end of the tine 510 is connected, coupled, or attached to a connector 513 at the center 512 of the tissue ingrowth member 505. A stopper 515 is connected near the distal end of the tine 510. A portion 517 of the distal end of the tine 510 extends distally and beyond the stopper 515 to puncture and anchor / cage into the epicardium / myocardium of the patient's heart and in particular the LAA. The stopper 515 is used to control the length of the portion 517. In one embodiment, the tine 510 and portion 517 are made of SMA, which changes from a relatively straight position to a relatively coiled position. In some embodiments, the tine 510 includes a plurality of unidirectional extensions or barbs along its length on the portion 517 away from the stop 515.

[0104] The distal ends of the plurality of struts 520 are connected, coupled or attached to a plurality of connection points 522 along the circumference of the umbrella-shaped or inverted bowl-shaped surface 505, while the proximal ends of the plurality of struts 520 are coupled to the connector 513. Portions of the distal tips of the plurality of struts 520 extend beyond their respective attachment connection points 522 to form a plurality of anchors 525. In some embodiments, the distal tips forming the anchors 525 are angled or curved relative to the substantially horizontal plane of the tissue ingrowth member 505.

[0105] In some embodiments, the tines 510, barbs, and plurality of struts 520 are wires of a shape memory material such as, for example, Nitinol.

[0106] Prior to deployment, the tines 510 and the portion 517 maintain a substantially straight configuration 526. However, after deployment, the shape of the tines 510 and the portion 517 changes from their respective substantially straight configurations 526 to a coiled or curved configuration 527. During deployment, the portion 517 is used to puncture the epicardium / myocardium in the LAA. After deployment, the portion 517 is coiled up and anchored or snapped into the epicardium / myocardium of the LAA. Subsequently, the shape of the tines 510 and the snapped portion 517 is adjusted from the substantially straight configuration 526 to the coiled or curved configuration 527, and the device 500 is pulled into the LAA, thereby further expanding or opening the plurality of struts 520 and embedding or pressing the plurality of anchors 525 into the epicardium / myocardium of the LAA.

[0107] In an embodiment, the device 500 is configured into a pre-deployment shape 502, wherein the device 500 is compressed and positioned within a catheter, such as Figure 7 The device 500 assumes a first post-deployment shape such that the device 500 is partially expanded when released from the catheter. Finally, the device 500 transforms into a second post-deployment shape 504, wherein the device 500 is fully expanded due to the shape of the tines 510 and the gripping portion 517 changing from a substantially straight configuration to a coiled or curved configuration.

[0108] In some embodiments, the second post-deployment shape 504 has at least one dimension that is greater than the first post-deployment shape 502. In some embodiments, the second post-deployment shape 504 has at least one dimension that is less than the first post-deployment shape 502. The device 500 in the first post-deployment shape 502 exerts a first pressure on the LAA wall, while the device 500 in the second post-deployment shape 504 exerts a second pressure on the LAA wall. In some embodiments, the first pressure on the LAA wall is less than the second pressure on the LAA wall. The anchor 525 has a first position in the first post-deployment shape 502 and a second position in the second post-deployment shape 504. In an embodiment, the anchors 525 in the second position penetrate the LAA wall more deeply than they do in the first position.

[0109] Tenth embodiment

[0110] According to some embodiments of this specification, Fig. 6A A pre-deployment shape 601, a first post-deployment shape 602, and a second post-deployment shape 603 are shown, and Fig.6I Different views of the rigid central member or spine 610 of the LAA occlusion device 600 are shown. Fig. 6A and 6B, the device 600 has a wire mesh 605, and when the device 600 is in the second post-deployment shape 603, the wire mesh presents an umbrella shape. In some embodiments, the wire mesh 605 is a cage, a frame or a fabric woven using a plurality of wires 607. The proximal surface of the device 600 is covered with a tissue ingrowth membrane for endothelialization of the proximal surface. The ingrowth membrane is made of any biocompatible material known in the art. In one embodiment, the membrane can be covered with or made of an extracellular matrix. The proximal ends of a plurality of wires 607 of the wire mesh 605 are connected to a first connector 613, and the first connector is positioned at the center 612 of the proximal surface of the wire mesh 605, and the distal ends of a plurality of wires 607 of the wire mesh 605 are connected to a second connector 615. The second connector 615 is positioned at the distal end of the ridge 610. The distal end of the second connector 615 includes an anti-damage tip 616. In some embodiments, the tip 616 includes a substantially cylindrical bolt or a press-fit connector. The proximal end of the spine 610 has one or more fingers 630 having a first position (unexpanded) and a second position (expanded) in a first post-deployment shape 602 of the device 600 and a second post-deployment shape 603. In the first position or configuration, the plurality of fingers are flush with the spine. In the second position or configuration, the plurality of fingers extend outwardly from the spine. The second connector 615 is reversibly connected to the Figure 6B The internal pusher catheter 668 is used for deployment and retrieval of the device 600 and deployment of the fingers 630. In various embodiments, the fingers 630 are spring loaded or magnetically actuated to enable deployment of the fingers 630 when the LAA occlusion device 600 changes from the first post-deployment shape 602 to the second post-deployment shape 603. In various embodiments, the ridges 610 and fingers 630 are constructed of a biocompatible material such as stainless steel, titanium, or polyetheretherketone (PEEK).

[0111] The proximal ends of the first plurality of struts 620 of the wire mesh 605 are connected, coupled or attached to a first plurality of points along the perimeter of the first connector 613, while the distal ends of the first plurality of struts 620 are coupled to the second connector 615. Portions of the proximal tips of the first plurality of struts 620 extend beyond their respective attachment points to form a first plurality of anchors 625 (also at Figure 6C In some embodiments, the proximal tips forming the first plurality of anchors 625 are angled or curved relative to a substantially horizontal plane.

[0112] The proximal ends of the second plurality of struts 650 are connected, coupled or attached to a second plurality of points along the perimeter of the tissue ingrowth member 605, while the distal ends of the second plurality of struts 650 are coupled to the second connector 615. Portions of the proximal tips of the second plurality of struts 650 extend beyond their respective attachment points to form a second plurality of anchors 655. In some embodiments, the proximal tips forming the second plurality of anchors 655 are angled or curved relative to a substantially horizontal plane. In some embodiments, the first plurality of points coincide with the second plurality of attachment points. In alternative embodiments, the first plurality of points do not coincide with the second plurality of attachment points.

[0113] In some embodiments, the plurality of wires 607 along with the first plurality of struts 620 and the second plurality of struts 650 are of a shape memory material such as, for example, Nitinol. In some embodiments, the first plurality of anchors 625 and / or the second plurality of anchors 655 are optional.

[0114] like Fig.6I As shown, the distal end of the second connector 615 includes an atraumatic tip 616 of a substantially cylindrical bolt or press-fit connector. The internal passageway of the tip 616 includes a plurality of threads 617 that enable the tip 616 to pass through a plurality of threads 618 formed on the outer diameter of the distal end of the spine 610. The tip 616 enables the distal ends of the first plurality of struts 620 to be tightened.

[0115] As the shape of the device 600 changes from its pre-deployment shape 601 to its first post-deployment shape 602 and second post-deployment shape 603 , the rigid ridge 610 extends through the first connector 613 and the fingers 630 engage the first connector 613 to maintain the device 600 in its second post-deployment position.

[0116] In an embodiment, the device 600 is configured into a pre-deployment shape 601, wherein the device 600 is compressed and positioned within a catheter, such as Figure 6B The device 600 assumes a first post-deployment shape 602 such that the device 600 is partially expanded when released from the catheter. Finally, the device 600 transforms into a second post-deployment shape 603 in which the device 600 is fully expanded.

[0117] Figure 6B A catheter system 660 is shown for deploying a LAA occlusion device 600 into the left atrium of a patient's heart according to some embodiments of the present specification. The catheter system 660 includes an outer catheter 662 having a longitudinal cylindrical shaft having a central channel or lumen 664. Figure 6BAs shown, the LAA occlusion device 600 is compressed into a pre-deployment shape 601 and positioned within a lumen 664 such that the atraumatic tip 616 and the second connector 615 are located at a distal end 665, and the tissue ingrowth member 605 and the first connector 613 are toward a proximal end 666 of the outer catheter 662. In an embodiment, the first connector 613 has a central channel or lumen 667 to enable an inner catheter 668 to be axially inserted through the channel 667 and engaged with the second connector 615.

[0118] Reference Figure 6B , 6C 6D, the distal end of the inner catheter 668 has a plurality of threads 669 that engage or lock with a corresponding plurality of threads 670 formed on the inner surface of the proximal end of the second connector 615. The proximal end of the second connector 615 includes fingers 630. Once engaged or locked, the inner catheter 668 is used to push the compression device 600 through the distal end 665 near the LAA wall.

[0119] like Fig.6D As shown, once released from the outer catheter 662, the device 600 assumes the first post-deployment shape 602. The inner catheter 668 is now pulled proximally, thereby pulling the second connector 615 along so that the second connector 615 is located within the channel or lumen 667 of the first connector 613 and the expanded fingers 630 protrude out of the channel 667 and engage the proximal end of the first connector 613. The fingers 630 can be spring loaded and can be mechanically compressed and expanded. In one embodiment, magnetic actuation is used to expand and compress the fingers. Fig. 6E As shown, when the second connector 615 is pulled toward the first connector 613, the device 600 assumes the second post-deployment shape 603, and the expansion fingers 630 positioned at the proximal end of the first connector 613 maintain the device 600 in its second post-deployment shape 603. Once the device has been adjusted to the second post-deployment shape 603, the inner catheter 668 is disengaged from the second connector 615, releasing the catheter from the device and deploying it in its final second post-deployment position in the LAA.

[0120] In some embodiments, the second post-deployment shape 603 has at least one dimension that is greater than the first post-deployment shape 602. In some embodiments, the second post-deployment shape 603 has at least one dimension that is less than the first post-deployment shape 602. The device 600 in the first post-deployment shape 602 exerts a first pressure on the LAA wall, and the device 600 in the second post-deployment shape 603 exerts a second pressure on the LAA wall. In some embodiments, the first pressure on the LAA wall is less than the second pressure on the LAA wall. The first plurality of anchors 625 and the second plurality of anchors 655 have a first position in the first post-deployment shape 602 and a second position in the second post-deployment shape 603. Figure 6CA first plurality of anchors 625 are shown in a first position, and Fig. 6F The first plurality of anchors 625 and the second plurality of anchors 655 are shown in a second position. In an embodiment, the first plurality of anchors 625 and the second plurality of anchors 655 in the second position penetrate the LAA wall more deeply than they do in the first position. In other words, the first plurality of anchors 625 and the second plurality of anchors 655 in the second position protrude more than in the first position, thereby engaging the LAA wall more in the second post-deployment shape 603 than in the first post-deployment shape 602.

[0121] Eleventh Embodiment

[0122] Figure 6G and 6H Shown are a first post-deployment shape 677 and a second post-deployment shape 679 of another LAA occlusion device 675 in accordance with an embodiment of the present specification. Figure 6G and 6H The device 675 is similar to Figures 6A to 6F The difference between the device and 61 is that Figures 6A to 6F Compared with the umbrella member 605 in the device 600, Figure 6G and 6H The tissue ingrowth member 685 in the device 675 has a substantially spherical shape.

[0123] In an embodiment, Figure 6B The catheter system 660 is used to deploy the LAA occlusion device 675 to the left atrium of the patient's heart near the LAA. Therefore, the device 600 is replaced by the device 675 in a compressed shape within the catheter system 660 for deployment.

[0124] like Figure 6G As shown, once released from the outer catheter 662, the device 675 assumes a first post-deployment shape 677, while the inner catheter 668 is still engaged or locked with the second connector 615. The inner catheter 668 is then pulled proximally, thereby also pulling the second connector 615 along so that the second connector 615 is located within the channel or lumen 667 of the first connector 613, and the expanded fingers 630 protrude out of the channel 667 and engage the proximal end of the first connector 613. Figure 6HAs shown, as the second connector 615 is pulled toward the first connector 613, the device 675 assumes the second post-deployment shape 679, while the expansion fingers 630 engaged with the proximal end of the first connector 613 maintain the device 675 in its second post-deployment shape 679. Once the device 675 has been adjusted to the second post-deployment shape 679, the inner catheter 668 is disengaged from the second connector 615. In all deployments, the outer catheter 662 maintains the position of the LAA occlusion device (300, 400, 500, 600, 675) relative to the LAA, while the inner catheter 668 is used to pull the distal second connector 615 through the proximal first connector 613 to deploy the fingers 630 and secure the device in its second post-deployment position.

[0125] In some embodiments, the second post-deployment shape 679 has at least one dimension that is greater than the first post-deployment shape 677. In some embodiments, the second post-deployment shape 679 has at least one dimension that is less than the first post-deployment shape 677. The device 675 in the first post-deployment shape 677 exerts a first pressure on the LAA wall, while the device 675 in the second post-deployment shape 679 exerts a second pressure on the LAA wall. In some embodiments, the first pressure on the LAA wall is less than the second pressure on the LAA wall. The first plurality of anchors 625 and the second plurality of anchors 655 have a first position in the first post-deployment shape 677 and a second position in the second post-deployment shape 679. In embodiments, the first plurality of anchors 625 and the second plurality of anchors 655 in the second position pierce the LAA wall more deeply than they do in the first position. In other words, the first plurality of anchors 625 and the second plurality of anchors 655 in the second position protrude more than in the first position, thereby engaging the LAA wall more in the second post-deployment shape 679 than in the first post-deployment shape 677.

[0126] Figure 7 A catheter 705 for deploying a LAA occlusion device 700 near the left atrium LAA of a patient's heart according to some embodiments of the present specification is shown. The catheter 705 includes a longitudinal cylindrical outer catheter 710 having a central channel or lumen 715. As shown, the LAA occlusion device 700 is compressed into a pre-deployment shape and positioned near the distal end 720 of the catheter 705 within the lumen 715. In some embodiments, a first handle 725a, a second handle 725b, and a third handle 725c are included at the proximal end 722 of the catheter 705. While the first handle 725a and the second handle 725b enable a user to effectively hold and manipulate the outer catheter 710, the third handle 725c enables a user to use a plunger or an inner catheter 730 to push the device 700 out of the lumen 715 for release near the left atrium LAA.

[0127] In various embodiments, the device 700 is any of the LAA occlusion devices 300 , 350 , 400 , 450 , 500 , and 600 of the present specification.

[0128] Figure 8 800 is a cross-sectional view of a connector 800 of a LAA occlusion device according to some embodiments of the present specification. In various embodiments, the connector 800 is used in the LAA occlusion device of the present specification. As shown, the connector 800 includes a cylindrical element 805 having a plurality of threads 807 formed on an outer surface. According to some embodiments of the present specification, the cylindrical element 805 has a central channel or lumen 810 to allow rigid tines or ridges to pass through. In some embodiments, the channel or lumen 810 has an inner diameter of 1 mm. The proximal end of the cylindrical element 805 is fixed by a bolt 815, and the distal end of the cylindrical element 805 has a nut or screw 817 that can be operated via the thread 807. In some embodiments, the bolt 815 and the nut / screw 817 have an outer diameter of 2 mm.

[0129] Bolt 815 buckles the first end of multiple struts 820. In some embodiments, each of the multiple struts 820 is a nitinol wire with a diameter ranging from 0.4mm to 0.6mm. In some embodiments, each of the multiple struts 820 has a length ranging from 25mm to 30mm. The second ends of the multiple struts 820 form multiple coupling rings 825 to connect to multiple corresponding attachment points on the circumference or periphery of the tissue ingrowth member of the LAA occlusion device. In some embodiments, each of the multiple coupling rings 825 has a diameter of 1mm. Portions of the second ends of the multiple struts 820 extend beyond the multiple corresponding attachment points with the multiple anchors 830. In some embodiments, each of the multiple anchors 830 has a length of 2mm. A cross-sectional top view 835 of the connector 800 depicts multiple channels or chambers 837 within the wall of the connector 800. The channel 837 is configured to receive and hold the first ends of the multiple struts 820 in place once the nut / screw 817 is tightened onto the bolt 815.

[0130] In all embodiments of the present specification, multiple conductive elements can be constructed to contact the LAA and LA walls. Electric current can be passed through these conductive elements to electrically stimulate or ablate cardiac tissue. For example, any one or more of a support, a connector, an extension, a barb, a tissue ingrowth member, a connection point, or an anchor can be configured to receive an electric current and deliver the electric current to the cardiac tissue. Electrical parameters well known in the art can be used to stimulate or ablate cardiac tissue. The electric current can be a unipolar or bipolar, a radiofrequency current, or an electric current that induces electroporation in the LAA or LA tissue. The ablation effect can be used to ablate arrhythmogenic tissue near the LAA. The ablation effect can also be used to produce fibrosis and help anchor the LAA occlusion device. Radiofrequency (RF) energy and pulsed electrical stimulation or electroporation can be used to ablate cardiac tissue through the device. Ablation energy is used to ablate abnormal arrhythmogenic cardiac tissue or induce fibrosis to better anchor / fix the device.

[0131] Fig. 9 is a flowchart of a plurality of exemplary steps of a method of closing the LAA using an occlusion device according to some embodiments of the present specification. In various embodiments, the occlusion device is any of the LAA occlusion devices of the present specification.

[0132] At step 905, the device is positioned in a catheter in a pre-deployment shape, wherein the device is in a compressed state. At step 910, the device is released near the LAA wall using the catheter, causing the device to partially expand into a first post-deployment shape and apply a first pressure to the LAA wall. At step 915, the device is fully expanded into a second post-deployment shape and applies a second pressure to the LAA wall, thereby closing the LAA. In some embodiments, the second pressure is greater than the first pressure.

[0133] In various embodiments, the second post-deployment shape has at least one dimension that is larger than the first post-deployment shape. In some embodiments, the second post-deployment shape has at least one dimension that is smaller than the first post-deployment shape.

[0134] In some embodiments, the first pressure is less than the second pressure on the LAA wall. In some embodiments, the second post-deployment shape has at least one dimension greater than the first post-deployment shape. In some embodiments, the second post-deployment shape has at least one dimension less than the first post-deployment shape.

[0135] In some embodiments, the device in the first post-deployment position is repositioned in the LAAA or recaptured into the catheter for repositioning. In various embodiments, the device in the second post-deployment position is locked in its final position in the LAA, thereby occluding the LAA.

[0136] The above examples are merely illustrative of many applications of the system of the present invention. Although only a few embodiments of the present invention are described herein, it should be understood that the present invention may be implemented in many other specific forms without departing from the spirit or scope of the present invention. Therefore, the present examples and embodiments are to be considered illustrative rather than restrictive, and the present invention may be modified within the scope of the appended claims.

Claims

1. A device adapted to treat a left atrial appendage (LAA) of a patient, the device comprising: Tissue ingrowth components; Connectors; a central member having a first end and a second end, wherein the first end of the central member is positioned proximate a center of the tissue ingrowth member and the second end of the central member is coupled to the connector; and a plurality of struts having first ends and second ends, wherein the first ends of the plurality of struts are coupled to a plurality of corresponding points along a surface of the tissue ingrowth member, and wherein the second ends of the plurality of struts are coupled to the connector; The device is capable of being configured between a pre-deployment structure, a first post-deployment structure, and a second post-deployment structure, and further, wherein when in the first post-deployment structure, the device has at least one first dimension and applies a first pressure to the heart wall, and when in the second post-deployment structure, the tissue ingrowth member has a substantially flat disc shape, so that the entire device is suitable for physical contact with the heart wall, and the device has at least one second dimension and applies a second pressure to the heart wall, wherein the at least one second dimension is larger than the at least one first dimension and the second pressure is larger than the first pressure.

2. A device according to claim 1, wherein the central member is rigid and includes multiple extensions along its length, and wherein the central member is configured to pass through the center of the tissue ingrowth member and the multiple extensions are configured to engage and lock with the center of the tissue ingrowth member to lock the device in the second post-deployment structure.

3. The device of claim 2, wherein the plurality of extensions comprises a plurality of barbs and wherein each of the plurality of barbs has a sharp edge that tapers in one direction. The device of claim 2 , wherein the plurality of extensions are unidirectional.

5. The device of claim 1, wherein portions of the plurality of struts at the distal first ends extend beyond the surface of the tissue ingrowth member to form a plurality of anchors.

6. The device of claim 1, wherein the device is compressed into the pre-deployment configuration and is configured to be positioned within and delivered by a catheter.

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