Patent Description:
The present specification relates to systems and methods configured to close a left atrial appendage (LAA). More particularly, the present specification relates to devices having a pre-deployment shape and at least one post-deployment shape configured to exert pressure on an LAA wall to close the LAA.

A left atrial appendage (LAA), comprising a small sac in a wall of a left atrium, can be a source of both atrial arrhythmias as well as emboli which can cause strokes. Left atrial appendage occlusion and ligation devices are used to eliminate atrial arrhythmias and emboli from clots in the atrial appendage.

<FIG> shows first, second, third and fourth prior art devices used to close or occlude a left atrial appendage. The first device <NUM> (also referred to as the PLAATO (Percutaneous Left Atrial Appendage Transcatheter Occlusion) device) consists of a self-expanding Nitinol cage <NUM> covered with polytetrafluoroethylene. Rows of anchors <NUM> along a circumference secure the cage <NUM> within the LAA ostium. The second device <NUM> (also referred to as the Watchman® device) has a self-expanding Nitinol frame with fixation anchors <NUM> and a permeable polyester fabric cover <NUM>. The third device <NUM> (also referred to as the ACP (Amplatzer™ Cardiac Plug) device) is a self-expanding device composed of a Nitinol wire mesh and polyester patch and consists of a distal lobe <NUM> and a proximal disk <NUM> connected by a short central waist <NUM>. The fourth device <NUM> (also referred to as the WaveCrest® device) has an umbrella shaped polytetrafluoroethylene cap <NUM> and a plurality of anchors <NUM>.

Each of these prior art devices have shortcomings thereby suggesting that development is required for a more effective and widely acceptable LAA closure device. Most prior devices depend on a single post deployment shape and dimensions for adequate anchoring in the LAA, resulting in improper closure and premature dislodgement. Appropriate sizing is essential for adequate function of these devices. Also, all of these devices rely solely on the shape memory changes from the Nitinol cage for adequate sizing and fit and do not allow for an operator to adjust the shape or dimension or a pressure applied by the device on LAA wall post-deployment to adjust to individual LAA anatomy.

<CIT> discloses devices, methods and systems for occluding an opening within the tissue of a body, such as a left atrial appendage. In one embodiment, a medical device includes an occluder portion and an anchor portion. The occluder portion includes a hub that defines an axis, the occluder portion extending between a proximal end coupled to the hub and a distal end defining occluder eyelets adjacent thereto. The anchor portion extends between a first end and a second end, the first end coupled to an anchor hub and the second end defining anchor eyelets adjacent thereto and hingeably coupled to the occluder eyelets. With this arrangement, the anchor hub is moveable along the axis to move the anchor portion between a retracted position and a deployed position upon the occluder portion being in an expanded position.

<CIT> discloses a left atrial appendage plugging device which comprises a support skeleton and a choke membrane; the support skeleton is a hollow near-spherical body having elasticity; the choke membrane is cap-shaped and is arranged on the proximal periphery of the support skeleton; an anchor thorn is arranged on the distal circumference of the support thorn, and is used for grasping on the inner wall of a left atrial appendage. The invention further discloses a left atrial appendage plugging system which comprises a conveying device and the left atrial appendage plugging device mentioned in the technical scheme above; the conveying device comprises a conveying sheath and a push rod; the left atrial appendage plugging device is arranged in the conveying sheath; one end of the push rod is arranged in the conveying sheath, and is detachably connected with the fixed end of the left atrial appendage plugging device. According to the left atrial appendage plugging device and system, the damage to vascular access can be reduced so as to reduce the operation risk.

<CIT> discloses a device for containing emboli within a left atrial appendage of a patient which includes a frame that is expandable from a reduced cross section to an enlarged cross section and a slider assembly. There is provided in accordance with various embodiments of the present invention methods of preventing retention anchors from projecting outside of the native diameter of the frame, thus facilitating recapture of the device.

The present specification discloses a device according to claim <NUM>.

Optionally, the central member is rigid and includes a plurality of 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 plurality of extensions is 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 extensions comprises a plurality of barbs and each of the plurality of barbs has a sharp edge tapering in one direction.

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

The tissue ingrowth member has a flat disc shape when in the second post-deployment configuration.

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.

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

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

Optionally, the central member is rigid and includes a plurality of phalanges along its length, the plurality of phalanges configured to change from a first configuration, in which the plurality of phalanges is flush with the central member, to a second configuration, in which the plurality of phalanges extends 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 phalanges, once extended, is 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 phalanges is configured to be spring-loaded or magnetically actuated to change from the first configuration to the second configuration.

The present specification also discloses a device adapted to treat a left atrial appendage (LAA) of a patient, the device comprising: a tissue ingrowth member; a first connector and a second connector, wherein the second connector is positioned at a center of the tissue ingrowth member; a central member having distal and proximal ends, wherein the distal end of the central member is positioned proximate to 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 a 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 second strut having a distal end and a proximal end, wherein the proximal end of the at least one second strut is coupled to at least one second corresponding point along a 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 against a cardiac wall and when in the second post-deployment configuration, the device has at least one second dimension and applies a second pressure against the cardiac wall, wherein the at least one second dimension is greater than the at least one first dimension and the second pressure is greater than the first pressure.

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

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 wherein 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.

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

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 the second connector and the plurality of barbs is configured to engage and lock with the second connector to lock the device in the second post-deployment configuration.

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

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

For illustrative purposes, a method of using a device to close a left atrial appendage (LAA) in in a patient may comprise positioning the device in the LAA, wherein the device comprises a tissue ingrowth member, a connector, a central member having distal and proximal ends with the distal end of the central member positioned proximate a center of the tissue ingrowth member and the proximal end of the central member coupled to the connector, and a plurality of struts having distal and proximal ends with the distal ends of the plurality of struts coupled to a plurality of corresponding points along a circumference of the tissue ingrowth member and the proximal ends of the plurality of struts coupled 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 a second post-deployment configuration wherein, when in said first post-deployment configuration, the device has at least one first dimension and applies a first pressure against a cardiac wall and when in said second post-deployment configuration, said device has at least one second dimension and applies a second pressure against the cardiac wall, wherein said at least one second dimension is greater than said at least one first dimension and said second pressure is greater than said first pressure.

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

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

Optionally, the central member is rigid and includes a plurality of phalanges along its length, said plurality of phalanges configured to change from a first configuration, wherein the plurality of phalanges is flush with said central member, to a second configuration, wherein said plurality of phalanges extends outwardly from said central member, and wherein the central member is configured to pass through said center of said tissue ingrowth member and said plurality of phalanges, once extended, is configured to engage and lock with said center of said tissue ingrowth member to lock said device in said second post-deployment configuration.

Optionally, the device includes electrically conductive members configured to contact the LAA or LA surface wherein an electric current is passed through the electrical conductive members to ablate an LAA or LA tissue. Any one or more of the struts, connectors, extensions, barbs, tissue ingrowth members, connection points, or anchors may be configured to receive and deliver an electrical current to the cardiac tissue. The current can be monopolar or bipolar, radiofrequency current or current to induce electroporation in the LAA or LA tissue. The ablative effect can be used to ablate arrhythmogenic tissue proximate an LAA. The ablative effect can also be used to create fibrosis and help with anchoring of the LAA occlusion device.

The aforementioned and other embodiments of the present invention shall be described in greater depth in the drawings and detailed description provided below.

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

"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.

"Duration" and variations thereof refer to the time course of a prescribed treatment, from initiation to conclusion, whether the treatment is concluded because the condition is resolved or the treatment is suspended for any reason. Over the duration of treatment, a plurality of treatment periods may be prescribed during which one or more prescribed stimuli are administered to the subject.

"Period" refers to the time over which a "dose" of stimulation is administered to a subject as part of the prescribed treatment plan.

In the description and claims of the application, each of the words "comprise" "include" and "have", and forms thereof, are not necessarily limited to members in a list with which the words may be associated. It should be noted herein that any feature or component described in association with a specific embodiment may be used and implemented with any other embodiment unless clearly indicated otherwise.

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

The term "controller" refers to an integrated hardware and software system defined by a plurality of processing elements, such as integrated circuits, application specific integrated circuits, and/or field programmable gate arrays, in data communication with memory elements, such as random access memory or read only memory where one or more processing elements are configured to execute programmatic instructions stored in one or more memory elements.

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

For any method disclosed herein that includes discrete steps, the steps may be conducted in any feasible order. And, as appropriate, any combination of two or more steps may be conducted simultaneously.

Also herein, the recitations of numerical ranges by endpoints include all numbers subsumed within that range (e.g., <NUM> to <NUM> includes <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, etc.). Unless otherwise indicated, all numbers expressing quantities of components, molecular weights, and so forth used in the specification and claims are to be understood as being modified in all instances by the term "about. " Accordingly, unless otherwise indicated to the contrary, the numerical parameters set forth in the specification and claims are approximations that may vary depending upon the desired properties sought to be obtained by the present specification. At the very least, and not as an attempt to limit the doctrine of equivalents to the scope of the claims, each numerical parameter should at least be construed in light of the number of reported significant digits and by applying ordinary rounding techniques.

Notwithstanding that 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.

It should be appreciated that the devices and embodiments described herein are implemented in concert with a controller that comprises a microprocessor executing control instructions. The controller can be in the form of any computing device, including desktop, laptop, and mobile device, and can communicate control signals to the devices in wired or wireless form.

The present invention is directed towards multiple embodiments. The following disclosure is provided in order to enable a person having ordinary skill in the art to practice the invention. Language used in this specification should not be interpreted as a general disavowal 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. Also, the terminology and phraseology used is for the purpose of describing exemplary embodiments and should not be considered limiting. Thus, the present invention is to be accorded the widest scope encompassing numerous alternatives, modifications and equivalents consistent with the principles and features disclosed. For purpose of clarity, details relating to technical material that is known in the technical fields related to the invention have not been described in detail so as not to unnecessarily obscure the present invention.

<FIG> illustrates a left atrium <NUM> depicting a left atrial appendage <NUM> in a wall <NUM> of the left atrium <NUM>. <FIG> illustrates a plurality of left atrial appendages <NUM>, <NUM>, <NUM>, <NUM> depicting a variety of shapes of the left atrial appendages <NUM>, <NUM>, <NUM>, <NUM>.

<FIG> and <FIG> show wire-frame side views, <FIG> shows a top view and <FIG> shows a bottom view of an LAA (Left Atrial Appendage) occlusion device <NUM> in a fully deployed configuration, in accordance with some embodiments of the present specification. Referring now to <FIG> simultaneously, the device <NUM> has a tissue ingrowth member <NUM> that assumes a shape of a substantially circular or flat disc when the device <NUM> is in a fully expanded state. In some embodiments, the tissue ingrowth member <NUM> is a mesh, cage or web of wires. In some embodiments, the tissue ingrowth member <NUM> is a fabric cover. In some embodiments, the tissue growth member <NUM> is coated with extracellular matrix (ECM) or another biological material to promote tissue ingrowth. A distal end of a rigid central member, or tine, <NUM> is movably positioned within a center <NUM> of the substantially circular or disc shaped tissue ingrowth member <NUM> while a proximal end of the tine <NUM> is coupled to a connector <NUM>. In some embodiments, the tine <NUM> includes a plurality of unidirectional extensions or barbs <NUM> along its length.

Distal ends of a plurality of struts <NUM> are connected, coupled or attached to a plurality of connection points <NUM> along the circumference of the substantially circular or disc shaped tissue ingrowth member <NUM> while proximal ends of the plurality of struts <NUM> are coupled to the connector <NUM>. Portions of the distal tips of the plurality of struts <NUM> extend beyond their respective connection points <NUM> of attachment to form a plurality of anchors <NUM>. In some embodiments, the distal tips forming the anchors <NUM> are angled or bent with respect to a substantially horizontal plane of the tissue ingrowth member <NUM>.

In some embodiments, the tine <NUM>, the barbs <NUM> and the plurality of struts <NUM> are wires of a shape memory material such as, for example, Nitinol. As the device <NUM> changes shape from its pre-deployment configuration to its first post-deployment configuration, the rigid tine <NUM> extends through the center <NUM>. The first pre-deployment shape applies a first pressure on the LAA wall and the optional anchors <NUM> pierce the LAA wall to a first depth. In the first post-deployment position the operator has ability to adjust or reposition the LAA occlusion device <NUM> proximate an LAA. Once the operator is satisfied with the position of the LAA occlusion device <NUM>, the operator applies a pull or tension on the tine <NUM> pulling it through the center <NUM>, engage the unidirectional barbs <NUM> with the center <NUM>. This pulls allows the LAA occlusion device <NUM> to assume its <NUM>nd post-deployment position applying a <NUM>nd pressure on the LAA wall and the optional anchors <NUM> pierce the LAA wall to a <NUM>nd depth. In the <NUM>nd post-deployment, the LAA occlusion device <NUM> is secured to the LAA wall in its final therapeutic position/configuration. The central tine <NUM> may have multiple unidirectional barbs <NUM>, allowing for multiple <NUM>nd post-deployment positions dependent an individual patient and individual LAA anatomy. In embodiments, once the LAA occlusion device <NUM> is deployed, the tissue ingrowth member <NUM> faces the left atrial chamber and the connector <NUM> and struts <NUM> sit in the LAA cavity.

<FIG> shows a wire-frame side views while <FIG> shows pre-deployment and post-deployment shapes of another LAA occlusion device <NUM>, in accordance with embodiments of the present specification. The device <NUM> of <FIG> and <FIG> is similar to that of <FIG>, with the difference of the rigid central member, or tine, <NUM> in the device <NUM> of <FIG> being replaced with a collapsible central member, or tine, <NUM> in the device <NUM> of <FIG> and <FIG>. The distal end of the collapsible tine <NUM> is connected to the center <NUM>. The collapsible tine is made of SMA and over time changes from a relatively straight pre-deployment position to relatively coiled post-deployment position wherein the <NUM>nd post-deployment pressure slowly increases over time post-deployment and the anchors <NUM> embed deeper into the LAA wall over time, post-deployment.

Referring to <FIG> and <FIG>, prior to deployment, the tine <NUM> maintains a substantially straight configuration. However, post deployment, the tine <NUM> changes its shape from a substantially straight to a coiled or curved configuration <NUM>, as shown in <FIG> and <FIG>. Modulation of the shape of the tine <NUM>, from the substantially straight configuration to the coiled or curved configuration, pulls the connector <NUM> toward the tissue ingrowth member <NUM>, thereby expanding the plurality of struts <NUM> and burying the plurality of anchors <NUM> into the endocardium/myocardium of a patient's heart. In embodiments, the tine <NUM> of <FIG> and <FIG> does not include barbs.

Referring to <FIG>, the device <NUM> is configured into a pre-deployment shape <NUM> wherein the device <NUM> is compressed and positioned within a catheter, such as the catheter <NUM> of <FIG>. The device <NUM> assumes a first post-deployment shape <NUM> such that the device <NUM> is partially expanded upon being released from the catheter. Finally, the device <NUM> transitions to a second post-deployment shape <NUM> wherein the device <NUM> is fully expanded due to the tine <NUM> shaping from the substantially straight configuration to the coiled or curved configuration.

In some embodiments, the second post-deployment shape <NUM> has at least one first expanded dimension 'de' that is greater than a corresponding first compressed dimension 'dpe' of the first post-deployment shape <NUM>. In some embodiments, the second post-deployment <NUM> shape has at least one second expanded dimension 'le' that is less than a corresponding second compressed dimension 'lpe' of the first post-deployment shape <NUM>. In some embodiments, the second post-deployment <NUM> shape has at least one second expanded dimension 'de' that is greater than a corresponding second compressed dimension 'dpe' of the first post-deployment shape <NUM>. In the first post-deployment shape <NUM>, the device <NUM> exerts a first pressure on the LAA wall while in the second post-deployment shape <NUM>, the device <NUM> 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 anchors <NUM> have a first position in the first post-deployment shape and a second position in the second post-deployment shape. In embodiments, in the second position, the anchors <NUM> pierce the LAA wall deeper than they do when in the first position.

<FIG> shows a wire-frame side view of another LAA occlusion device <NUM>, in accordance with some embodiments of the present specification. <FIG> shows a wire-frame side view of yet another LAA occlusion device <NUM>, in accordance with some embodiments of the present specification. Referring to <FIG> and <FIG> simultaneously, the devices <NUM>, <NUM> comprise a tissue ingrowth member <NUM> that assumes a shape of an umbrella or inverted cap when the devices <NUM>, <NUM> are in a fully expanded state, as depicted in <FIG> and <FIG>. In some embodiments, the tissue ingrowth member <NUM> is a mesh, cage or web of wires. In some embodiments, the tissue ingrowth member <NUM> is a membrane or a fabric cover. In some embodiments, the tissue ingrowth member <NUM> is coated with extracellular matrix (ECM) or another biological material to promote tissue ingrowth. Referring to <FIG>, a distal end of a rigid central member, or tine, <NUM> is movably positioned within a first connector <NUM> positioned at a center <NUM> of the tissue ingrowth member <NUM> while a proximal end of the tine <NUM> is coupled to a second connector <NUM>. The tine <NUM> includes a plurality of unidirectional extensions or barbs <NUM> along its length. In some embodiments, as the device <NUM> changes shape from its pre-deployment configuration to its post-deployment configuration, the rigid tine <NUM> extends through the first connector <NUM> and the barbs <NUM> engage with the first connector <NUM>, locking the device in the post-deployment configuration. In some embodiments, as the device <NUM> changes shape from its pre-deployment configuration to its post-deployment configuration, the rigid tine <NUM> extends through the first connector <NUM> and center <NUM> and punctures the epicardium/myocardium of the patient's heart, assisting in holding the device in place.

Referring to <FIG>, the device <NUM> comprises a collapsible tine <NUM> in place of a rigid tine and the distal end of the collapsible tine <NUM> is connected to the second connector <NUM>. Prior to deployment, the tine <NUM> is in a substantially straight configuration. Post deployment, the tine <NUM> changes its shape from substantially straight to a coiled or curved configuration <NUM>, as shown in <FIG>. Extension of the rigid tine <NUM> through said center <NUM> and said second connector <NUM>, as with the device <NUM> depicted in <FIG>, or modulation of the shape of the tine <NUM>, from a substantially straight configuration to the coiled or curved configuration <NUM>, as with the device <NUM> depicted in <FIG>, pulls the first and second connectors <NUM>, <NUM> toward each other thereby, expanding the first and second plurality of struts <NUM>, <NUM> and burying the first and second plurality of anchors <NUM>, <NUM> into the endocardium/myocardium of a patient's heart.

Distal ends of a first plurality of struts <NUM> are connected, coupled or attached to a first plurality of connection points <NUM> along a circumference of the umbrella or inverted bowl shaped tissue ingrowth member <NUM> while proximal ends of the first plurality of struts <NUM> are coupled to the second connector <NUM>. Portions of the distal tips of the first plurality of struts <NUM> extend beyond their respective connection points <NUM> of attachment to form a first plurality of anchors <NUM>. In some embodiments, the distal tips forming the first plurality of anchors <NUM> are angled or bent with respect to a substantially horizontal plane of the tissue ingrowth member <NUM>.

Proximal ends of a second plurality of struts <NUM> are connected, coupled or attached to a second plurality of connection points <NUM> along a circumference of the umbrella or inverted bowl shaped tissue ingrowth member <NUM> while distal ends of the second plurality of struts <NUM> are coupled to the first connector <NUM>. In embodiments, the tissue ingrowth member <NUM> is positioned on a side of the devices <NUM>, <NUM> having only the second plurality of struts <NUM>. Portions of the proximal tips of the second plurality of struts <NUM> extend beyond their respective connection points <NUM> of attachment to form a second plurality of anchors <NUM>. In some embodiments, the proximal tips forming the second plurality of anchors <NUM> are angled or bent with respect to the substantially horizontal plane of the tissue ingrowth member <NUM>. In some embodiments, the positioning of the first plurality of connection points <NUM> coincides with the positioning of the second plurality of connection points <NUM> of attachment. In alternate embodiments, the positioning of the first plurality of connection points <NUM> does not coincide with the positioning of the second plurality of connection points <NUM> of attachment.

In some embodiments, the tines <NUM>, <NUM>, the barbs <NUM> and the first and second plurality of struts <NUM>, <NUM> are wires of a shape memory material such as, for example, Nitinol.

In embodiments, the devices <NUM>, <NUM> are configured into a pre-deployment shape wherein the device <NUM> is compressed and positioned within a catheter, such as the catheter <NUM> of <FIG>. The devices <NUM>, <NUM> assume a first post-deployment shape such that the devices <NUM>, <NUM> are partially expanded upon being released from the catheter. Finally, the devices <NUM>, <NUM> transition to a second post-deployment shape wherein the devices <NUM>, <NUM> are fully expanded. In some embodiments, when in the second post-deployment shape, the first connector <NUM> and second <NUM> connector are positioned closer together than when in the first post-deployment shape and a transverse dimension "d" of the LAA occlusion device when in the second post-deployment shape is greater than when in the first post-deployment shape, exerting a greater pressure across at least <NUM>% of a transverse circumference of the device.

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. In the first post-deployment shape the devices <NUM>, <NUM> exert a first pressure on the LAA wall while in the second post-deployment shape the devices <NUM>, <NUM> exert 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 and second plurality of anchors <NUM>, <NUM> have a first position in the first post-deployment shape and a second position in the second post-deployment shape. In embodiments, in the second position the first and second plurality of anchors <NUM>, <NUM> pierce the LAA wall deeper than they do when in the first position. In embodiments, once implanted, the devices <NUM>, <NUM> are positioned such that the tissue ingrowth member <NUM> faces the left atrium while an opposite side of the devices <NUM>, <NUM>, comprising the first plurality of struts <NUM>, with no tissue ingrowth member between said struts <NUM>, is positioned facing an LAA of the patient and resides within the LAA of the patient.

In other embodiments, as shown in <FIG> and <FIG>, the shape change from the first post-deployment shape to the second post-deployment shape is be achieved by using magnetic force. In some embodiments, a first set of magnets <NUM>, <NUM> is positioned at a proximal end 430p, 470p of the device <NUM>, <NUM> and a second set of magnets <NUM>, <NUM> is positioned at a distal end 430d, 470d of the device <NUM>, <NUM>. Magnetic forces between the first set of magnets <NUM>, <NUM> and the second set of magnets <NUM>, <NUM> results in drawing the proximal end and distal end of the device <NUM>, <NUM> together, compressing the dimension "I" of the device and increasing the dimension "d" of the device, which causes an increase in a post-deployment pressure/force on the LAA wall to keep the device in position. The final post-deployment pressure is determined by the attractive force between the <NUM> sets of magnets. In some embodiments, the pressure and the attractive force between the magnets increases post-deployment over time until the pressure reaches a final pressure at which time the device becomes anchored in an LAA.

Referring now to <FIG>, the device <NUM> has a tissue ingrowth member <NUM> that assumes a shape of a substantially circular or flat disc when the device <NUM> is in a fully expanded state. In some embodiments, the tissue ingrowth member <NUM> is a mesh, cage or web of wires. In some embodiments, the tissue ingrowth member <NUM> is a fabric cover. In some embodiments, the tissue growth member <NUM> is coated with extracellular matrix (ECM) or another biological material to promote tissue ingrowth.

Distal ends of a plurality of struts <NUM> are connected, coupled or attached to a plurality of connection points <NUM> along the circumference of the substantially circular or disc shaped tissue ingrowth member <NUM> while proximal ends of the plurality of struts <NUM> are coupled to a connector <NUM>. Portions of the distal tips of the plurality of struts <NUM> extend beyond their respective connection points <NUM> of attachment to form a plurality of anchors <NUM>. In some embodiments, the distal tips forming the anchors <NUM> are angled or bent with respect to a substantially horizontal plane of the tissue ingrowth member <NUM>. In some embodiments, the first set of magnets <NUM> and the second set of magnets <NUM> comprise a number of magnets in a range of <NUM> to <NUM>. In some embodiments, the first set of magnets <NUM> is positioned on the plurality of struts <NUM>. In other embodiments, the first set of magnets <NUM> is positioned on the connector <NUM>. In some embodiments, the second set of magnets <NUM> is positioned on the tissue ingrowth member <NUM>.

In some embodiments, the plurality of struts <NUM> are wires of a shape memory material such as, for example, Nitinol. In embodiments, once the LAA occlusion device <NUM> is deployed, the tissue ingrowth member <NUM> faces the left atrial chamber and the connector <NUM> and struts <NUM> sit in the LAA cavity.

Referring now to <FIG>, the devices <NUM> comprises a tissue ingrowth member <NUM> that assumes a shape of an umbrella or inverted cap when the device <NUM> is in a fully expanded state. In some embodiments, the tissue ingrowth member <NUM> is a mesh, cage or web of wires. In some embodiments, the tissue ingrowth member <NUM> is a membrane or a fabric cover. In some embodiments, the tissue ingrowth member <NUM> is coated with extracellular matrix (ECM) or another biological material to promote tissue ingrowth. Distal ends of a first plurality of struts <NUM> are connected, coupled or attached to a first plurality of connection points <NUM> along a circumference of the umbrella or inverted bowl shaped tissue ingrowth member <NUM> while proximal ends of the first plurality of struts <NUM> are coupled to a second connector <NUM>. Portions of the distal tips of the first plurality of struts <NUM> extend beyond their respective connection points <NUM> of attachment to form a first plurality of anchors <NUM>. In some embodiments, the distal tips forming the first plurality of anchors <NUM> are angled or bent with respect to a substantially horizontal plane of the tissue ingrowth member <NUM>.

Proximal ends of a second plurality of struts <NUM> are connected, coupled or attached to a second plurality of connection points <NUM> along a circumference of the umbrella or inverted bowl shaped tissue ingrowth member <NUM> while distal ends of the second plurality of struts <NUM> are coupled to a first connector <NUM>. In embodiments, the tissue ingrowth member <NUM> is positioned on a side of the device <NUM> having only the second plurality of struts <NUM>. Portions of the proximal tips of the second plurality of struts <NUM> extend beyond their respective connection points <NUM> of attachment to form a second plurality of anchors <NUM>. In some embodiments, the proximal tips forming the second plurality of anchors <NUM> are angled or bent with respect to the substantially horizontal plane of the tissue ingrowth member <NUM>. In some embodiments, the positioning of the first plurality of connection points <NUM> coincides with the positioning of the second plurality of connection points <NUM> of attachment. In alternate embodiments, the positioning of the first plurality of connection points <NUM> does not coincide with the positioning of the second plurality of connection points <NUM> of attachment. In some embodiments, the first set of magnets <NUM> and the second set of magnets <NUM> comprise a number of magnets in a range of <NUM> to <NUM>. In some embodiments, the first set of magnets <NUM> is positioned on the first plurality of struts <NUM>. In other embodiments, the first set of magnets <NUM> is positioned on the second connector <NUM>. In some embodiments, the second set of magnets <NUM> is positioned on the second plurality of struts <NUM>. In other embodiments, the second plurality of magnets <NUM> is positioned on the first connector <NUM>. In some embodiments, the first and second plurality of struts <NUM>, <NUM> are wires of a shape memory material such as, for example, Nitinol.

In other embodiments, as shown in <FIG> and <FIG>, a screw connection mechanism <NUM> between a proximal end 480p, 490p of the device <NUM>, <NUM> and a distal end 480d, 490d of the device <NUM>, <NUM> is used to modify a length "l" and a diameter "d" of the device <NUM>, <NUM> to attain a desirable end pressure optimal for device stabilization and anchoring. In embodiments, the screw connection mechanism <NUM> is rigid and comprises a first portion <NUM> configured to axially receive a second portion <NUM>. The second portion <NUM> includes screw threads on its outer surface to securely connect with an inner threaded surface of the first portion <NUM>. The second portion <NUM> may be telescopically advanced into and out of the first portion <NUM> via a turning motion to change the length "I" of the device <NUM>, <NUM>. Engaging the screw threads of the outer surface of the second portion <NUM> with the screw threads of the inner surface of the first portion <NUM> at a certain depth of the second portion <NUM> within the first portion <NUM> locks the device <NUM>, <NUM> at a desired length "l". The screw connection mechanism <NUM> allows a user to titrate these parameters in a controllable fashion to meet individualized LAA anatomy. Pre, intra and post-procedure imaging can be used to ascertain the required dimension and fit.

Distal ends of a plurality of struts <NUM> are connected, coupled or attached to a plurality of connection points <NUM> along the circumference of the substantially circular or disc shaped tissue ingrowth member <NUM> while proximal ends of the plurality of struts <NUM> are coupled to a connector <NUM>. Portions of the distal tips of the plurality of struts <NUM> extend beyond their respective connection points <NUM> of attachment to form a plurality of anchors <NUM>. In some embodiments, the distal tips forming the anchors <NUM> are angled or bent with respect to a substantially horizontal plane of the tissue ingrowth member <NUM>. In some embodiments, a first end of the first portion <NUM> of the screw connection mechanism <NUM> is attached to the tissue ingrowth member <NUM> at a connection point <NUM> and a second end of the first portion <NUM> of the screw connection mechanism <NUM> receives a first end of the second portion <NUM> of the screw connection mechanism <NUM>. A second end of the second portion <NUM> of the screw connection mechanism <NUM> is attached to the connector <NUM>. In embodiments, the connector <NUM> and second portion <NUM> of the screw connection mechanism <NUM> may be rotated to advance the second portion <NUM> into and out of the first portion <NUM> to change the length "l" of the device <NUM>. In other embodiments, connection point <NUM> and/or the first portion <NUM> of the screw connection mechanism <NUM> may be rotated to advance the second portion <NUM> into and out of the first portion <NUM> to change the length "I" of the device <NUM>.

Proximal ends of a second plurality of struts <NUM> are connected, coupled or attached to a second plurality of connection points <NUM> along a circumference of the umbrella or inverted bowl shaped tissue ingrowth member <NUM> while distal ends of the second plurality of struts <NUM> are coupled to a first connector <NUM>. In embodiments, the tissue ingrowth member <NUM> is positioned on a side of the device <NUM> having only the second plurality of struts <NUM>. Portions of the proximal tips of the second plurality of struts <NUM> extend beyond their respective connection points <NUM> of attachment to form a second plurality of anchors <NUM>. In some embodiments, the proximal tips forming the second plurality of anchors <NUM> are angled or bent with respect to the substantially horizontal plane of the tissue ingrowth member <NUM>. In some embodiments, the positioning of the first plurality of connection points <NUM> coincides with the positioning of the second plurality of connection points <NUM> of attachment. In alternate embodiments, the positioning of the first plurality of connection points <NUM> does not coincide with the positioning of the second plurality of connection points <NUM> of attachment. In some embodiments, a first end of the first portion <NUM> of the screw connection mechanism <NUM> is attached to the first connector <NUM> and a second end of the first portion <NUM> of the screw connection mechanism <NUM> receives a first end of the second portion <NUM> of the screw connection mechanism <NUM>. A second end of the second portion <NUM> of the screw connection mechanism <NUM> is attached to the second connector <NUM>. In embodiments, the second connector <NUM> and second portion <NUM> of the screw connection mechanism <NUM> may be rotated to advance the second portion <NUM> into and out of the first portion <NUM> to change the length "l" of the device <NUM>. In other embodiments, first connector <NUM> and the first portion <NUM> of the screw connection mechanism <NUM> may be rotated to advance the second portion <NUM> into and out of the first portion <NUM> to change the length "I" of the device <NUM>. In some embodiments, the first and second plurality of struts <NUM>, <NUM> are wires of a shape memory material such as, for example, Nitinol.

<FIG> shows wire-frame side views of an LAA occlusion device <NUM> in pre-deployment and post-deployment shapes <NUM>, <NUM>.

The device <NUM> has a tissue ingrowth member <NUM> that assumes a shape of an umbrella or an inverted bowl when the device <NUM> is in a fully expanded state. In some embodiments, the tissue ingrowth member <NUM> is a mesh, cage or web of wires. In some embodiments, the tissue ingrowth member <NUM> is a membrane or a fabric cover. A proximal end of a tine <NUM> is connected, coupled or attached to a connector <NUM> at a center <NUM> of the tissue ingrowth member <NUM>. A stopper <NUM> is connected proximate a distal end of the tine <NUM>. A portion <NUM> of the distal end of the tine <NUM> extends distally and beyond the stopper <NUM> to puncture and anchor/lodge into the epicardium/myocardium of a patient's heart and specifically an LAA. The stopper <NUM> is used to control a length of the portion <NUM>. In one embodiment the tine <NUM> and the portion <NUM> is made of an SMA which changes from a relatively straight position to a relatively coiled position. In some embodiments, the tine <NUM> includes a plurality of unidirectional extensions or barbs along its length on the portion <NUM> distal to the stopper <NUM>.

Distal ends of a plurality of struts <NUM> are connected, coupled or attached to a plurality of connection points <NUM> along a circumference of the umbrella or inverted bowl shaped surface <NUM> while proximal ends of the plurality of struts <NUM> are coupled to the connector <NUM>. Portions of the distal tips of the plurality of struts <NUM> extend beyond their respective connection points <NUM> of attachment to form a plurality of anchors <NUM>. In some embodiments, the distal tips forming the anchors <NUM> are angled or bent with respect to a substantially horizontal plane of the tissue ingrowth member <NUM>.

In some embodiments, the tine <NUM>, barbs, and the plurality of struts <NUM> are wires of a shape memory material such as, for example, Nitinol.

Prior to deployment, the tine <NUM> and the portion <NUM> remain in a substantially straight configuration <NUM>. However, post deployment, the tine <NUM> and the portion <NUM> change shapes from their respective substantially straight configurations <NUM> to coiled or curved configurations <NUM>. During deployment, the portion <NUM> is used to puncture the epicardium/myocardium in an LAA. Post-deployment, the portion <NUM> coils up and anchors or lodges into the epicardium/myocardium of the LAA. Subsequently, modulation of the shape of the tine <NUM> and the lodged portion <NUM>, from the substantially straight configuration <NUM> to the coiled or curved configuration <NUM>, pulls the device <NUM> into the LAA thereby further expanding or opening the plurality of struts <NUM> and burying or pressing the plurality of anchors <NUM> into the epicardium/myocardium of the LAA.

In embodiments, the device <NUM> is configured into a pre-deployment shape <NUM> wherein the device <NUM> is compressed and positioned within a catheter, such as the catheter <NUM> of <FIG>. The device <NUM> assumes a first post-deployment shape such that the device <NUM> is partially expanded upon being released from the catheter. Finally, the device <NUM> transitions to a second post-deployment shape <NUM> wherein the device <NUM> is fully expanded due to the tine <NUM> and the lodged portion <NUM> shaping from the substantially straight configurations to the coiled or curved configurations.

In some embodiments, the second post-deployment shape <NUM> has at least one dimension that is greater than the first post-deployment shape <NUM>. In some embodiments, the second post-deployment shape <NUM> has at least one dimension that is lesser than the first post-deployment shape <NUM>. In the first post-deployment shape <NUM> the device <NUM> exerts a first pressure on the LAA wall while in the second post-deployment shape <NUM> the device <NUM> 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 anchors <NUM> have a first position in the first post-deployment shape <NUM> and a second position in the second post-deployment shape <NUM>. In embodiments, in the second position the anchors <NUM> pierce the LAA wall deeper than they do when in the first position.

<FIG> shows pre-deployment, first post-deployment and second post-deployment shapes <NUM>, <NUM>, <NUM> while <FIG> shows different views of a rigid central member or spine <NUM> of an LAA occlusion device <NUM>, in accordance with some embodiments of the present specification. Referring now to <FIG> and <FIG> simultaneously, the device <NUM> has a wire mesh <NUM> that assumes a shape of an umbrella when the device <NUM> is in the second post-deployment shape <NUM>. In some embodiments, the wire mesh <NUM> is a cage, frame, or web woven using a plurality of wires <NUM>. The proximal surface of the device <NUM> is covered by 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 could be covered with or made of extracellular matrix. Proximal ends of the plurality of wires <NUM> of the wire mesh <NUM> are coupled to a first connector <NUM> positioned at a center <NUM> of the proximal surface of wire mesh <NUM> while distal ends of the plurality of wires <NUM> of the wire mesh <NUM> are coupled to a second connector <NUM>. The second connector <NUM> is positioned at a distal end of the spine <NUM>. A distal end of the second connector <NUM> comprises an atraumatic tip <NUM>. In some embodiments, the tip <NUM> includes a substantially cylindrical bolt or crimp. A proximal end of the spine <NUM> has one or more phalanges <NUM> that have a first position (non-expanded) in the first post-deployment shape <NUM> and a second position (expanded) in the second post-deployment shape <NUM> of the device <NUM>. In the first position or configuration, the plurality of phalanges is flush with the spine. In the second position or configuration, the plurality of phalanges extends outwardly from the spine. The <NUM>nd connector <NUM> is reversible connected to the inner pusher catheter <NUM> of <FIG> for deployment and retrieval of the device <NUM> and also for deployment of the phalanges <NUM>. In various embodiments, the phalanges <NUM> are spring-loaded or magnetically actuated to enable deployment of the phalanges <NUM> as the LAA occlusion device <NUM> changes from the first post-deployment shape <NUM> to the second post-deployment shape <NUM>. In various embodiments, the spine <NUM> and phalanges <NUM> are composed of a biocompatible material, such as stainless steel, titanium, or polyether ether ketone (PEEK).

Proximal ends of a first plurality of struts <NUM> of the wire mesh <NUM> are connected, coupled or attached to a first plurality of points along a perimeter of first connector <NUM> while distal ends of the first plurality of struts <NUM> are coupled to the second connector <NUM>. Portions of the proximal tips of the first plurality of struts <NUM> extend beyond their respective points of attachment to form a first plurality of anchors <NUM> (also shown in <FIG>). In some embodiments, the proximal tips forming the first plurality of anchors <NUM> are angled or bent with respect to a substantially horizontal plane.

Proximal ends of a second plurality of struts <NUM> are connected, coupled or attached to a second plurality of points along a perimeter of the tissue ingrowth member <NUM> while distal ends of the second plurality of struts <NUM> are coupled to the second connector <NUM>. Portions of the proximal tips of the second plurality of struts <NUM> extend beyond their respective points of attachment to form a second plurality of anchors <NUM>. In some embodiments, the proximal tips forming the second plurality of anchors <NUM> are angled or bent with respect to a substantially horizontal plane. In some embodiments, the first plurality of points coincide with the second plurality of points of attachment. In alternate embodiments, the first plurality of points do not coincide with the second plurality of points of attachment.

In some embodiments, the plurality of wires <NUM> along with the first and second plurality of struts <NUM>, <NUM> are of a shape memory material such as, for example, Nitinol. In some embodiments, the first and/or second plurality of anchors <NUM>, <NUM> are optional.

As shown in <FIG>, the distal end of the second connector <NUM> comprises the atraumatic tip <NUM> of a substantially cylindrical bolt or crimp. An internal channel of the tip <NUM> includes a plurality of threads <NUM> that enable the tip <NUM> to thread over a plurality of threads <NUM> formed on an outer diameter of the distal end of the spine <NUM>. The tip <NUM> enables fastening of the distal ends of the first plurality of struts <NUM>.

As the device <NUM> changes shape from its pre-deployment shape <NUM> to its first and second post-deployment shapes <NUM>, <NUM>, the rigid spine <NUM> extends through the first connector <NUM> and the phalanges <NUM> engage with the first connector <NUM> to maintain the device <NUM> in its second post-deployment position.

In embodiments, the device <NUM> is configured into a pre-deployment shape <NUM> wherein the device <NUM> is compressed and positioned within a catheter, such as the catheter <NUM> of <FIG>. The device <NUM> assumes a first post-deployment shape <NUM> such that the device <NUM> is partially expanded upon being released from the catheter. Finally, the device <NUM> transitions to a second post-deployment shape <NUM> wherein the device <NUM> is fully expanded.

<FIG> shows a catheter system <NUM> for deploying the LAA occlusion device <NUM> into a left atrium of a patient's heart, in accordance with some embodiments of the present specification. The catheter system <NUM> includes an outer catheter <NUM> comprising a longitudinal cylindrical shaft having a central channel or lumen <NUM>. As shown in <FIG>, the LAA occlusion device <NUM> is compressed to be in the pre-deployment shape <NUM> and positioned within the lumen <NUM> such that the atraumatic tip <NUM> and the second connector <NUM> lie at a distal end <NUM> while the tissue ingrowth member <NUM> and the first connector <NUM> lie towards a proximal end <NUM> of the outer catheter <NUM>. In embodiments, the first connector <NUM> has a central channel or lumen <NUM> to enable an inner catheter <NUM> to be inserted axially through the channel <NUM> and engage with the second connector <NUM>.

Referring now to <FIG>, <FIG> and <FIG>, a distal end of the inner catheter <NUM> has a plurality of screw threads <NUM> that engage or lock with a corresponding plurality of threads <NUM> formed on an internal surface of a proximal end of the second connector <NUM>. The proximal end of the second connector <NUM> includes the phalanges <NUM>. Once engaged or locked, the inner catheter <NUM> is used to push the compressed device <NUM> through the distal end <NUM> proximate a LAA wall.

As shown in <FIG>, once released from the outer catheter <NUM>, the device <NUM> assumes the first post-deployment shape <NUM>. The inner catheter <NUM> is now pulled proximally thereby pulling the second connector <NUM> along so that the second connector <NUM> lies within the channel or lumen <NUM> of the first connector <NUM> and the expanded phalanges <NUM> protrude outside the channel <NUM> and engage a proximal end of the first connector <NUM>. The phalanges <NUM> could be spring loaded and can be mechanically compressed and expanded. In one embodiment magnetic actuation is used to expand and compress the phalanges. As shown in <FIG>, as the second connector <NUM> is pulled toward the first connector <NUM>, the device <NUM> assumes the second post-deployment shape <NUM> while the expanded phalanges <NUM>, positioned at the proximal end of the first connector <NUM>, maintain the device <NUM> in its second post-deployment shape <NUM>. Once the device has been modulated to be in the second post-deployment shape <NUM>, the inner catheter <NUM> is disengaged from the second connector <NUM>, releasing the catheter from the device and deploying it in the LAA in its final, <NUM>nd post-deployment, position.

In some embodiments, the second post-deployment shape <NUM> has at least one dimension that is greater than the first post-deployment shape <NUM>. In some embodiments, the second post-deployment shape <NUM> has at least one dimension that is lesser than the first post-deployment shape <NUM>. In the first post-deployment shape <NUM> the device <NUM> exerts a first pressure on the LAA wall while in the second post-deployment shape <NUM> the device <NUM> 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 and second plurality of anchors <NUM>, <NUM> have a first position in the first post-deployment shape <NUM> and a second position in the second post-deployment shape <NUM>. <FIG> shows the first plurality of anchors <NUM> in the first position while <FIG> shows the first and second plurality of anchors <NUM>, <NUM> in the second position. In embodiments, in the second position the first and second plurality of anchors <NUM>, <NUM> pierce the LAA wall deeper than they do when in the first position. In other words, in the second position the first and second plurality of anchors <NUM>, <NUM> protrude more than in the first position so as to engage the LAA wall more in the second post-deployment shape <NUM> than in the first post-deployment shape <NUM>.

<FIG> and <FIG> show first post-deployment and second post-deployment shapes <NUM>, <NUM> of another LAA occlusion device <NUM>, in accordance with embodiments of the present specification. The device <NUM> of <FIG> and <FIG> is similar to that of <FIG> and <FIG>, with the difference of the tissue ingrowth member <NUM> that assumes a substantially spherical shape in the device <NUM> of <FIG> and <FIG> compared to the umbrella shaped member <NUM> in the device <NUM> of <FIG>.

In embodiments, the catheter system <NUM> of <FIG> is used for deploying the LAA occlusion device <NUM> into a left atrium of a patient's heart proximate an LAA. Accordingly, the device <NUM> is replaced with the device <NUM>, in compressed shape, within the catheter system <NUM> for deployment.

As shown in <FIG>, once released from the outer catheter <NUM>, the device <NUM> assumes the first post-deployment shape <NUM> while the inner catheter <NUM> is still engaged or locked with the second connector <NUM>. The inner catheter <NUM> is subsequently pulled proximally thereby also pulling the second connector <NUM> along so that the second connector <NUM> lies within the channel or lumen <NUM> of the first connector <NUM> and the expanded phalanges <NUM> protrude outside the channel <NUM> and engage a proximal end of the first connector <NUM>. As shown in <FIG>, as the second connector <NUM> is pulled towards the first connector <NUM>, the device <NUM> assumes the second post-deployment shape <NUM> while the expanded phalanges <NUM>, engaged with the proximal end of the first connector <NUM>, maintain the device <NUM> in its second post-deployment shape <NUM>. Once the device <NUM> has been modulated to be in the second post-deployment shape <NUM>, the inner catheter <NUM> is disengaged from the second connector <NUM>. In all deployments, the outer catheter <NUM> maintain the position the LAA occlusion device (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>) relative to the LAA while the inner catheter <NUM> is used to pull the distal <NUM>nd connector <NUM> through the proximal 1st connector <NUM> to deploy the phalanges <NUM> and secure the device in its <NUM>nd post-deployment position.

In some embodiments, the second post-deployment shape <NUM> has at least one dimension that is greater than the first post-deployment shape <NUM>. In some embodiments, the second post-deployment shape <NUM> has at least one dimension that is lesser than the first post-deployment shape <NUM>. In the first post-deployment shape <NUM> the device <NUM> exerts a first pressure on the LAA wall while in the second post-deployment shape <NUM> the device <NUM> 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 and second plurality of anchors <NUM>, <NUM> have a first position in the first post-deployment shape <NUM> and a second position in the second post-deployment shape <NUM>. In embodiments, in the second position the first and second plurality of anchors <NUM>, <NUM> pierce the LAA wall deeper than they do when in the first position. In other words, in the second position the first and second plurality of anchors <NUM>, <NUM> protrude more than in the first position so as to engage the LAA wall more in the second post-deployment shape <NUM> than in the first post-deployment shape <NUM>.

<FIG> shows a catheter <NUM> for deploying an LAA occlusion device <NUM> into a left atrium of a patient's heart proximate an LAA, in accordance with some embodiments of the present specification. The catheter <NUM> comprises a longitudinal cylindrical outer catheter <NUM> having a central channel or lumen <NUM>. As shown, the LAA occlusion device <NUM> is compressed to be in a pre-deployment shape and positioned within the lumen <NUM> proximate a distal end <NUM> of the catheter <NUM>. In some embodiments, first, second and third handles 725a, 725b, 725c are included at a proximal end <NUM> of the catheter <NUM>. While the first and second handles 725a, 725b enable a user to effectively hold and manipulate the outer catheter <NUM>, the third handle 725c enables the user to push the device <NUM> out of the lumen <NUM>, using a plunger or inner catheter <NUM>, for release into the left atrium proximate an LAA.

In various embodiments, the device <NUM> is any of the LAA occlusion devices <NUM>, <NUM>, <NUM>, <NUM>, <NUM> and <NUM> of the present specification.

<FIG> is a cross-sectional view of a connector <NUM> of an LAA occlusion device, in accordance with some embodiments of the present specification. In various embodiments, the connector <NUM> is used in the LAA occlusion devices of the present specification. As shown, the connector <NUM> comprises a cylindrical element <NUM> having a plurality of threads <NUM> formed on an outer surface. The cylindrical element <NUM> has a central channel or lumen <NUM> to allow for passage of a rigid tine or spine in accordance with some embodiments of the present specification. In some embodiments, the channel or lumen <NUM> has an internal diameter of <NUM>. A proximal end of the cylindrical element <NUM> is secured by a bolt <NUM> while a distal end of the cylindrical element <NUM> has a nut or screw <NUM> that can be manipulated over the threads <NUM>. In some embodiments, the bolt <NUM> and the nut/screw <NUM> have an outer diameter of <NUM>.

The bolt <NUM> clasps first ends of a plurality of struts <NUM>. In some embodiments, each of the plurality of struts <NUM> is a Nitinol wire having a diameter ranging from <NUM> to <NUM>. In some embodiments, each of the plurality of struts <NUM> has a length ranging from <NUM> to <NUM>. Second ends of the plurality of struts <NUM> form a plurality of coupling loops <NUM> to connect to a plurality of corresponding points of attachment on a circumference or perimeter of a tissue ingrowth member of the LAA occlusion device. In some embodiments, each of the plurality of coupling loops <NUM> has a diameter of <NUM>. Portions of the second ends of the plurality of struts <NUM> extend beyond the plurality of corresponding points of attachment to a plurality of anchors <NUM>. In some embodiments, each of the plurality of anchors <NUM> has a length of <NUM>. A cross-sectional, top-down view <NUM> of the connector <NUM> depicts a plurality of channels or chambers <NUM> within a wall of the connector <NUM>. The channels <NUM> are configured to receive and hold the first ends of the plurality of struts <NUM> in place once the nut/screw <NUM> is tightened onto the bolt <NUM>.

In all of the embodiments of the present specification, a plurality of electrically conductive elements may be configured to make contact with the LAA and LA wall. Electrical current can be passed through these electrically conductive elements to electrically stimulate or ablate cardiac tissue. For example, any one or more of the struts, connectors, extensions, barbs, tissue ingrowth members, connection points, or anchors may be configured to receive and deliver an electrical current to the cardiac tissue. Well known electrical parameters in the art can be used to stimulate or ablate cardiac tissue. The current can be monopolar or bipolar, radiofrequency current or current to induce electroporation in the LAA or LA tissue. The ablative effect can be used to ablate arrhythmogenic tissue proximate an LAA. The ablative effect can also be used to create fibrosis and help with anchoring of the LAA occlusion device. Radiofrequency (RF) energy and pulsed electric stimulation or electroporation can be used to ablate cardiac tissue through the device. The ablative energy is used to either ablate abnormal arrhythmogenic cardiac tissue or induce fibrosis to better anchor/secure the device.

<FIG> is a flowchart of a plurality of exemplary steps of a method of using an occlusion device to close an LAA.

In various embodiments, the occlusion device is any of the LAA occlusion devices of the present specification.

At step <NUM>, the device is positioned in a catheter in a pre-deployment shape wherein the device is in a compressed state. At step <NUM>, using the catheter, the device is released proximate an LAA wall causing the device to partially expand into a first post-deployment shape and exert a first pressure on the LAA wall. At step <NUM>, the device fully expands into a second post-deployment shape and exerts a second pressure on the LAA wall thereby closing the LAA. In some embodiments, the second pressure is greater than the first pressure.

In various embodiments, the second post-deployment shape has at least one dimension that is greater than the first post-deployment shape. In some embodiments, the second post-deployment shape has at least one dimension that is lesser than the first post-deployment shape.

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 that is greater than the first post-deployment shape. In some embodiments, the second post-deployment shape has at least one dimension that is lesser than the first post-deployment shape.

In some embodiment, in the <NUM>st post-deployment position, the device can be repositioned in the LAAA or recaptured into the catheter for repositioning. In various embodiments, in the <NUM>nd post-deployment position, the device is locked in its final position in the LAA occluding the LAA.

Claim 1:
A device (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>) adapted to treat a left atrial appendage (LAA) of a patient, the device comprising:
a tissue ingrowth member (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>);
a connector (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>);
a central member (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>) having distal and proximal ends, wherein the distal end of the central member is positioned proximate a center of the tissue ingrowth member and the proximal end of the central member is coupled to the connector; and
a plurality of struts (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>) having distal and proximal ends, wherein the distal 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 proximal ends of the plurality of struts are coupled to the connector;
wherein said device is configurable between a pre-deployment configuration, a first post-deployment configuration, and a second post-deployment configuration, further wherein, when in said first post-deployment configuration, the device has at least one first dimension and applies a first pressure against a cardiac wall and when in said second post-deployment configuration, the device has at least one second dimension and applies a second pressure against the cardiac wall, wherein said at least one second dimension is greater than said at least one first dimension and said second pressure is greater than said first pressure,
characterized in that when in said second post-deployment configuration, said tissue ingrowth member has a flat disc shape.