Patent Description:
Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia, affecting over <NUM> million people worldwide. Atrial fibrillation is the irregular, chaotic beating of the upper chambers of the heart. Electrical impulses discharge so rapidly that the atrial muscle quivers, or fibrillates. Episodes of atrial fibrillation may last a few minutes or several days. The most serious consequence of atrial fibrillation is ischemic stroke. It has been estimated that up to <NUM>% of all strokes are related to atrial fibrillation. Most atrial fibrillation patients, regardless of the severity of their symptoms or frequency of episodes, require treatment to reduce the risk of stroke. The left atrial appendage (LAA) is a small organ attached to the left atrium of the heart as a pouch-like extension. In patients suffering from atrial fibrillation, the left atrial appendage may not properly contract with the left atrium, causing stagnant blood to pool within its interior, which can lead to the undesirable formation of thrombi within the left atrial appendage. Thrombi forming in the left atrial appendage may break loose from this area and enter the blood stream. Thrombi that migrate through the blood vessels may eventually plug a smaller vessel downstream and thereby contribute to stroke or heart attack. Clinical studies have shown that the majority of blood clots in patients with atrial fibrillation are found in the left atrial appendage. As a treatment, medical devices have been developed which are positioned in the left atrial appendage and deployed to close off the ostium of the left atrial appendage. Over time, the exposed surface(s) spanning the ostium of the left atrial appendage becomes covered with tissue (a process called endothelization), effectively removing the left atrial appendage from the circulatory system and reducing or eliminating the amount of thrombi which may enter the blood stream from the left atrial appendage.

A continuing need exists for improved medical devices and methods to control thrombus formation within the left atrial appendage of patients suffering from atrial fibrillation.

The invention relates to a medical device according to claim <NUM>. Further aspects of the invention are defined by claims <NUM>-<NUM>.

The above drawings should not be understood as limiting to the scope of the invention. Various modification which fall within the scope of the appended claims, are possible.

The terms "upstream" and "downstream" refer to a position or location relative to the direction of blood flow through a particular element or location, such as a vessel (i.e., the aorta), a heart valve (i.e., the aortic valve), and the like.

The terms "proximal" and "distal" shall generally refer to the relative position, orientation, or direction of an element or action, from the perspective of a clinician using the medical device, relative to one another. While the terms are not meant to be limiting, "proximal" may generally be considered closer to the clinician or an exterior of a patient, and "distal" may generally be considered to be farther away from the clinician, along the length of the medical device.

The terms "monolithic" and "unitary" shall generally refer to an element or elements made from or consisting of a single structure or base unit/element. A monolithic and/or unitary element shall exclude structure and/or features made by assembling or otherwise joining multiple discrete elements together.

The term "about", in the context of numeric values, generally refers to a range of numbers that one of skill in the art would consider equivalent to the recited value (i.e., having the same function or result). Other uses of the term "about" (i.e., in a context other than numeric values) may be assumed to have their ordinary and customary definition(s), as understood from and consistent with the context of the specification, unless otherwise specified.

Weight percent, percent by weight, wt%, wt-%, % by weight, and the like are synonyms that refer to the concentration of a substance as the weight of that substance divided by the weight of the composition and multiplied by <NUM>.

The recitation of numerical ranges by endpoints includes all numbers within that range, including the endpoints (e.g. <NUM> to <NUM> includes <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, and <NUM>).

The following description should be read with reference to the drawings wherein like reference numerals indicate like elements throughout the several views. The detailed description and drawings are intended to illustrate but not limit the claimed invention. Those skilled in the art will recognize that the various elements described and/or shown may be arranged in various combinations and configurations without departing from the scope defined by the appended claims.

The various individual elements described below, even if not explicitly shown in a particular combination, are nevertheless contemplated as being combinable or arrangable with each other to form other additional embodiments or to complement and/or enrich the described embodiment(s), as would be understood by one of ordinary skill in the art.

The occurrence of thrombi in the left atrial appendage (LAA) during atrial fibrillation may be due to stagnancy of the blood pool in the LAA. The blood may still be pulled out of the left atrium by the left ventricle, however less effectively due to the irregular contraction of the left atrium caused by atrial fibrillation. Therefore, instead of an active support of the blood flow by a contracting left atrium and left atrial appendage, filling of the left ventricle may depend primarily or solely on the suction effect created by the left ventricle. Further, the contraction of the left atrial appendage may not be in sync with the cycle of the left ventricle. For example, contraction of the left atrial appendage may be out of phase up to <NUM> degrees with the left ventricle, which may create significant resistance to the desired flow of blood. Further still, most left atrial appendage geometries are complex and highly variable, with large irregular surface areas and a narrow ostium or opening compared to the depth of the left atrial appendage. These aspects as well as others, taken individually or in various combinations, may lead to high flow resistance of blood out of the left atrial appendage.

In an effort to reduce the occurrence of thrombi formation within the left atrial appendage and prevent thrombi from entering the blood stream from within the left atrial appendage, a medical device has been developed that closes off the left atrial appendage from the heart and/or circulatory system, thereby lowering the risk of stroke due to thrombolytic material entering the blood stream from the left atrial appendage.

Turning to the drawings, <FIG> is a partial cross-sectional view of certain elements of a human heart <NUM> and some immediately adjacent blood vessels. A heart <NUM> may include a left ventricle <NUM>, a right ventricle <NUM>, a left atrium <NUM>, and a right atrium <NUM>. An aortic valve <NUM> is disposed between the left ventricle <NUM> and an aorta <NUM>. A pulmonary or semi-lunar valve <NUM> is disposed between the right ventricle <NUM> and a pulmonary artery <NUM>. A superior vena cava <NUM> and an inferior vena cava <NUM> return blood from the body to the right atrium <NUM>. A mitral valve <NUM> is disposed between the left atrium <NUM> and the left ventricle <NUM>. A tricuspid valve <NUM> is disposed between the right atrium <NUM> and the right ventricle <NUM>. Pulmonary veins <NUM> return blood from the lungs to the left atrium <NUM>. A left atrial appendage (LAA) <NUM> is attached to and in fluid communication with the left atrium <NUM>.

<FIG> is a partial cross-sectional view of an example left atrial appendage <NUM>. As discussed above, the left atrial appendage <NUM> may have a complex geometry and/or irregular surface area. Those skilled in the art will recognize that the illustrated LAA is merely one of many possible shapes and sizes for the LAA, which may vary from patient to patient. Those of skill in the art will also recognize that the medical devices and methods disclosed herein may be adapted for various sizes and shapes of the LAA, as necessary. A left atrial appendage <NUM> may include a generally longitudinal axis <NUM> arranged along a depth of a main body <NUM> of the left atrial appendage <NUM>. The main body <NUM> may include a lateral wall <NUM> and an ostium <NUM> forming a proximal mouth <NUM>. In some embodiments, a lateral extent of the ostium <NUM> and/or the lateral wall <NUM> may be smaller or less than a depth of the main body <NUM> along the longitudinal axis <NUM>, or a depth of the main body <NUM> may be greater than a lateral extent of the ostium <NUM> and/or the lateral wall <NUM>. In some embodiments, the left atrial appendage <NUM> may narrow quickly along the depth of the main body <NUM> or the left atrial appendage may maintain a generally constant lateral extent along a majority of depth of the main body <NUM>. In some embodiments, the left atrial appendage <NUM> may include a distalmost region formed or arranged as a tail-like element associated with a distal portion of the main body <NUM>. In some embodiments, the distalmost region may protrude radially or laterally away from the longitudinal axis <NUM>.

<FIG> and <FIG> generally illustrate an example prior art implant <NUM>, such as that disclosed in <CIT>.

The implant <NUM> may generally comprise a support frame <NUM> partially covered by a membrane <NUM>, and a distal cap <NUM>. The support frame <NUM> may include proximal collar <NUM> and a plurality of struts forming a lattice of generally diamond-shaped wire portions extending therefrom. The support frame <NUM> may include a first row <NUM> of generally diamond-shaped wire portions, a second row <NUM> of generally diamond-shaped wire portions, and a third row <NUM> of elongated generally diamond-shaped wire portions. The support frame <NUM> may terminate at its distal end in a plurality of limbs <NUM>. The distal cap <NUM> may attach to the terminating distal ends of the limbs <NUM>. The support frame <NUM> may include a plurality of barbs <NUM> extending radially outward from the support frame <NUM> to penetrate tissue and inhibit longitudinal movement of the deployed implant <NUM> in a proximal direction. The barbs <NUM> may be generally arranged in a single row about the circumference of the support frame <NUM> and extending distally from a distal end of the second row <NUM> of diamond-shaped wire portions. The barbs <NUM> may each be disposed immediately alongside one strut forming one side portion of one elongated generally diamond-shaped wire portion of the third row <NUM>.

The distal cap <NUM> includes a central hub <NUM> and a plurality of spokes <NUM> extending radially outward therefrom. The spokes <NUM> each have a first end <NUM> that attaches to a corresponding terminating distal end of one of the limbs <NUM>. The central hub <NUM> remains positioned proximal of the terminating distal ends of the limbs <NUM> at all operational positions of the implant <NUM>. Additionally, at no point during the operation of the implant <NUM> does any portion of the plurality of struts extend distally of the terminating distal ends of the limbs <NUM>. That is, the terminating distal ends of the limbs <NUM> are the distalmost element of the plurality of struts and/or the support frame <NUM>.

Turning to <FIG>, during delivery of the example prior art implant <NUM> into a left atrial appendage, the implant <NUM> may be disposed within a delivery catheter <NUM> to collectively form a medical device <NUM>. The medical device <NUM> may be percutaneously inserted into a patient to deliver the implant <NUM> to the left atrial appendage. Initially, the implant <NUM> may be disposed in a first, constrained position, such that the support frame <NUM> fits within the lumen of the delivery catheter <NUM>, as seen in <FIG>. Upon reaching the left atrial appendage, the delivery catheter <NUM> may be withdrawn proximally to expose the implant <NUM>. As the delivery catheter <NUM> is withdrawn, the terminating distal ends of the limbs <NUM> and the first ends <NUM> of the spokes <NUM> are exposed and expand radially outward. As seen in <FIG>, when the barbs <NUM> reach the distal end of the delivery catheter <NUM>, the terminating distal ends of the limbs <NUM> and the first ends <NUM> have extended radially outward to a second, flowering position. Continuing to withdrawn the delivery catheter <NUM>, the distal cap <NUM> fully deploys radially outward, pulling the terminating distal ends of the limbs <NUM> radially outward to a third, mid-deployment position, as seen in <FIG>. Next, the delivery catheter <NUM> is completely withdrawn from the implant <NUM> so that the implant <NUM> may assume a fourth, expanded position where the support frame <NUM> may extend radially outward from a central longitudinal axis farther than the terminating distal ends of the limbs <NUM> and/or the first ends <NUM> of the spokes <NUM>, as seen in <FIG>. The implant <NUM>, in the fourth expanded position, pushes outward to "drive" into the tissue such that the tissue conforms to the shape of the outer surface of the implant <NUM>. Lastly, the delivery catheter <NUM> and/or a delivery shaft (not shown) disposed therein may be disconnected from the proximal collar <NUM> and removed from the patient.

Applicants have found that recapture of the implant may be made easier by staggering the barbs into multiple rows such that less distally-directed force is required for the delivery catheter to remove any given row from the tissue of the left atrial appendage. Additionally, changes in geometry to certain aspects of the implant may permit the use of more-compliant struts that also facilitate easier recapture and repositioning of the implant while maintaining at least the same amount of radially outward force at each of the barbs/anchors, and providing improved conformability to and sealing with the geometry of the left atrial appendage. Further still, changes in geometry at the distal end of the implant may facilitate use in shorter left atrial appendages, as well as easier and cheaper manufacturing of the implant, for example, avoiding manual assembly of the spokes to the limbs and/or individual laser welds to each of these joints. Accordingly, an example implant is disclosed herein, which may incorporate some or all of these changes.

<FIG> illustrates a perspective view of a portion of an example implant <NUM>. The implant <NUM> may include a self-expanding monolithic support frame <NUM> extending from a proximal collar <NUM> to a distal collar <NUM>. In some embodiments, the support frame <NUM> may include a plurality of struts forming a lattice of generally diamond-shaped wire portions. In some embodiments, the support frame <NUM> may include, generally extending from proximally to distally, a first row <NUM> of generally diamond-shaped wire portions, a second row <NUM> of generally diamond-shaped wire portions adjacent the first row <NUM>, a third row <NUM> of generally diamond-shaped wire portions adjacent the second row <NUM>, a fourth row <NUM> of generally diamond-shaped wire portions adjacent the third row <NUM>, and a fifth row <NUM> of generally diamond-shaped wire portions adjacent the fourth row <NUM>. In some embodiments, a plurality of legs may extend from the proximalmost and/or distalmost row(s) of generally diamond-shaped wire portions to the proximal and/or distal collar(s), respectively. In some embodiments, the proximalmost and/or distalmost row(s) of generally diamond-shaped wire portions may be attached directly to the proximal and/or distal collar(s), respectively. As will be appreciated by the skilled artisan, additional or fewer rows of generally diamond-shaped wire portions may be included in the support frame <NUM>. Increasing the number of rows of generally diamond-shaped wire portions may permit a thinner strut thickness to be used, which may result in greater flexibility, compliance, and conformability of the plurality of struts and/or the support frame <NUM>. In other words, when deployed, the support frame <NUM> may substantially conform to an internal geometry and/or shape of the lateral wall of the left atrial appendage, rather than forcing the lateral wall to conform to the shape of the support frame.

In some embodiments, the support frame <NUM> may include a plurality of anchors <NUM> provided to secure the implant <NUM> to the lateral wall of the left atrial appendage after deployment and thereby inhibit proximal movement of the implant <NUM> relative to the left atrial appendage. In some embodiments, the plurality of anchors <NUM> may be arranged into a first row <NUM> of anchors and a second row <NUM> of anchors disposed proximally of the first row <NUM> of anchors, wherein the first row <NUM> of anchors and the second row <NUM> of anchors cooperate to form a staggered pattern about the circumference of the support frame <NUM>. Each of the plurality of anchors <NUM> may extend distally from a strut node junction <NUM>, such that a hook portion of each of the plurality of anchors <NUM> is positioned within an interior of one generally diamond-shaped wire portion, spaced apart from the adjacent struts. While not explicitly shown, additional rows or other alternate arrangements of the plurality of anchors <NUM> are also possible. In some embodiments, the plurality of anchors <NUM> may be equally spaced apart from each other. In some embodiments, the plurality of anchors <NUM> may be spaced an unequal intervals or distances from each other. In some embodiments, the staggered pattern may be uniform, such that angles and distances between adjacent anchors are the same. In some embodiments, the staggered pattern may be non-uniform, such that some or all angles and distances between adjacent anchors are different. The staggered pattern may provide improved fixation strength, improved apposition to adjacent tissue, a reduced profile in a first, constrained position, reduced force required to remove the plurality of anchors <NUM> from the tissue (compared to placing all of the anchors in a single row) since only a portion of the total anchors is removed at a time, and reduced force required to retrieve the implant <NUM> back into a delivery catheter for repositioning (compared to having all of the anchors in a single row). Transition of the implant <NUM> from the first, constrained position to a second, flowering position to a third, mid-deployment position to a fourth, unconstrained position will be described in more detail below.

<FIG> illustrates a cross-sectional view of a profile of the implant <NUM> and/or the support frame <NUM> in a fourth, unconstrained position. In the cross-sectional view, certain features of the profile can be described. In the fourth, unconstrained position, the profile extends distally from the proximal collar <NUM> and curves radially outward at a first bend <NUM> adjacent the proximal collar <NUM>. The first bend <NUM> forms a serpentine-like S-shape as the profile extends radially outward to a second bend <NUM>. At the second bend <NUM>, the profile turns distally and radially inward, such that a first segment <NUM> of the profile forms a first angle <NUM> with a reference plane tangent to the second bend <NUM> and parallel to a central longitudinal axis of the implant <NUM>. In some embodiments, the first angle <NUM> may be in a range from about <NUM> degrees to about <NUM> degrees, or about <NUM> degrees to about <NUM> degrees. In some embodiments, the second bend <NUM> may include a short generally straight segment (about <NUM>,<NUM> (<NUM>,<NUM> inches) to about <NUM>,<NUM> (<NUM>,<NUM> inches) long) extending distally along the reference plane and an intermediate bend turning radially inward, such that the first segment <NUM> extends distally and radially inward from the intermediate bend. The first segment <NUM> extends distally and radially inward from the second bend <NUM> (and/or the intermediate bend) to a third bend <NUM>, where the profile turns radially inward at a sharper angle while still extending distally, such that a second segment <NUM> of the profile forms a second angle <NUM> with the first segment <NUM> of the profile (and/or a reference plane tangent thereto). In some embodiments, the second angle <NUM> may be in a range from about <NUM> degrees to about <NUM> degrees, about <NUM> degrees to about <NUM> degrees, or about <NUM> degrees to about <NUM> degrees. The second segment <NUM> extends distally and radially inward from the third bend <NUM> to a fourth bend <NUM> adjacent the distal collar <NUM>. At the fourth bend <NUM>, the profile turns proximally and continues radially inward to the distal collar <NUM>, such that a third segment <NUM> of the profile (and/or a reference plane tangent thereto) forms a third angle <NUM> with the central longitudinal axis. In some embodiments, the third single <NUM> may be in a range from about <NUM> degrees to about <NUM> degrees, about <NUM> degrees to about <NUM> degrees, or about <NUM> degrees to about <NUM> degrees. The third segment <NUM> extends proximally and radially inward from the fourth bend <NUM> to the distal collar <NUM>. The first segment <NUM> may have a first length, the second segment <NUM> may have a second length, and the third segment <NUM> may have a third length. The length of the second segment <NUM> and the length of the third segment <NUM> may be compared as a ratio. In some embodiments, the ratio of the length of the second segment <NUM> to the length of the third segment <NUM> (i.e., second length divided by third length) may be about <NUM> to about <NUM>, about <NUM> to about <NUM>, or about <NUM> to about <NUM>. As may be seen from the profile illustrated in <FIG>, the distal ends of the plurality of struts of the support frame <NUM> (at the distal collar <NUM>) may be disposed proximal of a distalmost portion of the plurality of struts of the support frame <NUM> and/or the implant <NUM>. In some embodiments, an overall length of the implant <NUM> from a proximalmost portion to a distalmost portion, as measured along a line parallel to the central longitudinal axis, may be from about <NUM>, <NUM> (<NUM>,<NUM> inches) to about <NUM>,<NUM> (<NUM>,<NUM> inches), or about <NUM>,<NUM> (<NUM>,<NUM> inches), in the fourth, unconstrained position. In some embodiments, a center of a radius forming the third bend <NUM> may be located, as measured along a line parallel to the central longitudinal axis, about <NUM>,<NUM> (<NUM>,<NUM> inches) to about <NUM>,<NUM> (<NUM>,<NUM> inches), or about <NUM>,<NUM> (<NUM>,<NUM> inches) to about <NUM>,<NUM> (<NUM>,<NUM> inches) or about <NUM>,<NUM> (<NUM>,<NUM> inches) to about <NUM>,<NUM> (<NUM>,<NUM> inches) proximal of the distalmost portion, in the fourth, unconstrained position.

Additional constructional details may be found with the discussion directed to <FIG> and <FIG> below.

Turning to <FIG>, the implant <NUM> is illustrated in different stages of deployment. During delivery of the implant <NUM> to a left atrial appendage, the implant <NUM> may be disposed within a lumen of a delivery catheter <NUM> to collectively form a medical device <NUM>. The medical device <NUM> may be percutaneously inserted into a patient to deliver the implant <NUM> to the left atrial appendage. Initially, the implant <NUM> may be disposed in a first, constrained position, with the first bend <NUM>, the second bend <NUM>, and the third bend <NUM> substantially straightened into an elongated shape such that the support frame <NUM> fits within the lumen of the delivery catheter <NUM> with the second segment <NUM> and the third segment <NUM> generally parallel to each other, as seen in <FIG>. A delivery shaft (not shown) disposed within the lumen of the delivery catheter <NUM> may be removably connected to the implant <NUM> at the proximal collar <NUM>. Upon reaching the left atrial appendage, the delivery catheter <NUM> may be withdrawn proximally while the delivery shaft is held stationary, or the delivery shaft may be advanced distally while the delivery catheter <NUM> is held stationary (i.e., relative movement between the delivery catheter and the delivery shaft may be used), to expose the implant <NUM> within the left atrial appendage. As the delivery catheter <NUM> is withdrawn, the fourth bend <NUM> extends from a distal end of the delivery catheter <NUM> first with the distal collar <NUM> disposed proximal of the fourth bend <NUM>.

As the delivery catheter <NUM> is withdrawn, the support frame <NUM> is exposed and expands radially outward slightly at the fourth bend <NUM>. Next, as seen in <FIG>, as the third bend <NUM> exits the delivery catheter <NUM>, or about when the plurality of anchors <NUM> initially begins to exit the distal end of the delivery catheter <NUM>, the fourth bend <NUM> is opened compared to the first, constrained position, and the second segment <NUM> and the third bend <NUM> are translated radially outward compared to the first, constrained position, such that the second segment <NUM> angles distally and radially inward from the third bend <NUM> toward the fourth bend <NUM> to define a second, flowering position, wherein the exposed support frame <NUM> generally resembles a tulip. In the second, flowering position, the implant <NUM> is partially disposed within the lumen of the delivery catheter <NUM>, with a portion of the first segment <NUM> and the second bend <NUM> remaining positioned within the lumen of the delivery catheter <NUM>. In the second, flowering position, the first row <NUM> of anchors <NUM> may be disposed outside of the lumen of the delivery catheter <NUM> and the second row <NUM> of anchors <NUM> may be disposed inside of the lumen of the delivery catheter <NUM>. In the second, flowering position, the plurality of anchors <NUM> may be prevented from engaging surrounding tissue (i.e., the lateral wall) of the left atrial appendage. At this stage of deployment, positioning of the implant <NUM> within the left atrial appendage may be adjusted without having to remove anchors from tissue.

Continuing to withdraw the delivery catheter <NUM>, a proximal end of the second segment <NUM> and the third bend <NUM> is translated radially outward and distally relative to the fourth bend <NUM> (and/or compared to the second, flowering position) to a third, mid-deployment position. In the third, mid-deployment position, the third bend <NUM> constitutes a portion of the support frame <NUM> that defines a lateralmost extent from the central longitudinal axis, as seen in <FIG>. Similarly, the fourth bend <NUM> widens or opens laterally as the third bend <NUM> translates distally. In the third, mid-deployment position, the first segment <NUM> extends distally and radially outward from the second bend <NUM> toward the third bend <NUM>. In the third, mid-deployment position, the second segment <NUM> extends less distally (i.e. extends a shorter longitudinal distance) and more radially inward (i.e., extends along a greater lateral or radial distance from the central longitudinal axis) from the second bend <NUM> toward the third bend <NUM> than in the second, flowering position. In the third, mid-deployment position, the first row <NUM> of anchors <NUM> may be disposed outside of the lumen of the delivery catheter <NUM> and the second row <NUM> of anchors <NUM> may be disposed outside of the lumen of the delivery catheter <NUM>. In the third, mid-deployment position, the first row <NUM> of anchors <NUM> may engage tissue (i.e., the lateral wall) of the left atrial appendage sufficiently to be effective, and the second row <NUM> of anchors <NUM> may or may not engage tissue of the left atrial appendage. At this stage of deployment, positioning of the implant <NUM> within the left atrial appendage may be adjusted by removing the first row <NUM> of anchors <NUM> from tissue prior to adjustment. For a given quantity of anchors, having more than one row of anchors requires less axially-directed force to remove each individual row of anchors from the tissue than having all of the anchors in a single row.

Next, the delivery catheter <NUM> is completely withdrawn from the implant <NUM> so that the implant <NUM> is disposed outside of the delivery catheter <NUM> and may assume a fourth, unconstrained position where the support frame <NUM> at the second bend <NUM> may extend laterally or radially outward from the central longitudinal axis farther than at the third bend <NUM>, as seen in <FIG> and <FIG>, to define a widest lateral extent of the implant <NUM>. In the fourth, unconstrained position, the implant <NUM> may assume the profile discussed above with respect to <FIG> and <FIG>. During use and implantation, the implant <NUM>, in some embodiments, may assume a deployed position wherein the implant <NUM> substantially conforms to the geometry of the left atrial appendage, as illustrated in <FIG>. Lastly, the delivery catheter <NUM> and/or a delivery shaft (not shown) slidably disposed therein may be disconnected from the proximal collar <NUM> and removed from the patient.

<FIG> illustrates the support frame <NUM> in an unrolled <NUM>-D flat-pattern view, as cut from a tubular member, such as a metallic hypotube, or other suitable starting substrate. In some embodiments, the monolithic support frame <NUM> may be laser cut from a single tubular member. The skilled artisan will recognize that other manufacturing methods known in the art may be used including, but not limited to, machining, chemical etching, water cutting, EDM, etc. In some embodiments, the proximal collar <NUM> may be integrally formed with the support frame <NUM> and/or the plurality of struts. In some embodiments, after cutting the support frame <NUM>, a plurality of free distal ends <NUM> may be fixedly attached to the distal collar <NUM>. In some embodiments, the distal collar <NUM> may be formed as an annular ring member having an outer diameter smaller than an outer diameter of the tubular member and/or the proximal collar <NUM>, for example, as seen in <FIG>. The plurality of free distal ends <NUM> may be inserted into an interior of the distal collar <NUM> and fixedly attached thereto, for example, by adhesive(s), welding or soldering, friction fit, or other mechanical means. In some embodiments, the plurality of free distal ends <NUM> may be formed and inserted into a distal end of the distal collar <NUM>, such that the plurality of struts extends distally from the distal collar <NUM>. In some embodiments, a portion of the plurality of free distal ends <NUM> may extend through and/or proximally of the distal collar <NUM>. In other words, the distal collar <NUM> may be disposed within an interior of the implant <NUM>. The smaller outer diameter of the distal collar <NUM> facilitates a reduced profile in the first, constrained position.

<FIG> shows a detailed view of a portion of the support frame <NUM> illustrated in <FIG>. In the portion shown, one can see how the first row <NUM> and the second row <NUM> of anchors <NUM> may be formed. In some embodiments, such as shown in <FIG>, the plurality of anchors <NUM> may be integrally formed with the plurality of struts of the support frame <NUM> from a single tubular member, such that the plurality of anchors <NUM> is unitary with the support frame <NUM>. In some embodiments, the plurality of anchors <NUM> may be manufactured separately and added at a later time, such as by adhesive(s), welding or soldering, or other known attachment means. Subsequent forming, bending, heat-treating, and/or other procedures may be performed on the support frame <NUM> in order to achieve a desired profile or shape, such as that shown in <FIG>.

In some embodiments, a method of manufacturing the implant <NUM> may include the steps of.

<FIG> illustrates the example implant <NUM> having a membrane <NUM> disposed over at least a portion of the support frame <NUM>. While not explicitly illustrated, the implant <NUM> shown in <FIG> may include the membrane <NUM>. In the interest of clarity, the membrane <NUM> was not shown in <FIG>. In some embodiments, at least some of the plurality of anchors <NUM> project through the membrane <NUM>. In some embodiments, the membrane <NUM> may be attached to the support frame <NUM> at each anchor <NUM>, for example, by passing each anchor <NUM> through the membrane <NUM>, such as through a pore or aperture. In some embodiments, the membrane <NUM> may be attached to the support frame <NUM> by other suitable attachment means, such as but not limited to, adhesive(s), sutures or thread(s), welding or soldering, or combinations thereof. In some embodiments, the membrane <NUM> may be permeable or impermeable to blood and/or other fluids, such as water. In some embodiments, the membrane <NUM> may include a polymeric membrane, a metallic or polymeric mesh, a porous filter-like material, or other suitable construction. In some embodiments, the membrane <NUM> prevents thrombi (i.e. blood clots, etc.) from passing through the membrane <NUM> and out of the left atrial appendage into the blood stream. In some embodiments, the membrane <NUM> promotes endothelization after implantation, thereby effectively removing the left atrial appendage from the patient's circulatory system.

<FIG> illustrates a partial cross-sectional view of the implant <NUM> disposed within an example left atrial appendage, such as that shown in <FIG>, in a deployed position. As can be seen in <FIG>, the support frame <NUM> may be compliant and substantially conform to and/or be in sealing engagement with the shape and/or geometry of the lateral wall of the left atrial appendage in the deployed position. At its largest size, extent, or shape, the implant <NUM> may expand to the fourth, unconstrained position in the deployed position. In some embodiments, the implant <NUM> may expand to a size, extent, or shape less than or different from the fourth, unconstrained position in the deployed position, which may be partially constrained, as determined by the surrounding tissue and/or lateral wall of the left atrial appendage. Reducing the thickness of the plurality of struts compared to the device shown in <FIG> increases the flexibility and compliance of the support frame <NUM> and/or the implant <NUM>, thereby permitting the implant <NUM> to conform to the tissue around it, rather than forcing the tissue to conform to the implant.

In some embodiments, the plurality of struts of the support frame <NUM> and/or the plurality of anchors <NUM> may be formed of or include a metallic material, a metallic alloy, a ceramic material, a rigid or high performance polymer, a metallic-polymer composite, combinations thereof, and the like. Some examples of some suitable materials may include metallic materials and/or alloys such as stainless steel (e.g., <NUM>, 304v, or <NUM> stainless steel), nickel-titanium alloy (e.g., nitinol, such as super elastic or linear elastic nitinol), nickel-chromium alloy, nickel-chromium-iron alloy, cobalt alloy, nickel, titanium, platinum, or alternatively, a polymer material, such as a high performance polymer, or other suitable materials, and the like. The word nitinol was coined by a group of researchers at the United States Naval Ordinance Laboratory (NOL) who were the first to observe the shape memory behavior of this material. The word nitinol is an acronym including the chemical symbol for nickel (Ni), the chemical symbol for titanium (Ti), and an acronym identifying the Naval Ordinance Laboratory (NOL).

In some embodiments, the plurality of struts of the support frame <NUM> and/or the plurality of anchors <NUM> may be mixed with, may be doped with, may be coated with, or may otherwise include a radiopaque material. Radiopaque materials are understood to be materials capable of producing a relatively bright image on a fluoroscopy screen or another imaging technique such as X-ray during a medical procedure. This relatively bright image aids the user of device in determining its location. Suitable radiopaque materials may include, but are not limited to, bismuth subcarbonate, iodine, gold, platinum, palladium, tantalum, tungsten or tungsten alloy, and the like.

In some embodiments, the membrane <NUM> may be formed of or include a polymeric material, a metallic or metallic alloy material, a metallic-polymer composite, combinations thereof, and the like. In some embodiments, the membrane <NUM> is preferably formed of polyethylene terephthalate (PET) such as DACRON®, or expanded polytetrafluoroethylene (ePTFE). Other examples of suitable polymers may include polyurethane, a polyether-ester such as ARNTTEL® available from DSM Engineering Plastics, a polyester such as HYTREL® available from DuPont, a linear low density polyethylene such as REXELL®, a polyamide such as DURETHAN® available from Bayer or CRISTAMID® available from Elf Atochem, an elastomeric polyamide, a block polyamide/ether, a polyether block amide such as PEBA available under the trade name PEBAX®, silicones, polyethylene, Marlex high-density polyethylene, polytetrafluoroethylene (PTFE), polyetheretherketone (PEEK), polyimide (PI), and polyetherimide (PEI), a liquid crystal polymer (LCP) alone or blended with other materials.

In some embodiments, the delivery catheter <NUM> and/or the implant <NUM> may be made from, may be mixed with, may be coated with, or may otherwise include a material that provides a smooth, slick outer surface. In some embodiments, the delivery catheter <NUM> and/or the implant <NUM> may include or be coated with a lubricious coating, a hydrophilic coating, a hydrophobic coating, a drug-eluting material, an anti-thrombus coating, or other suitable coating depending on the intended use or application.

It should be understood that although the above discussion was focused on a medical device and methods of use within the vascular system of a patient, other embodiments of medical devices or methods in accordance with the disclosure can be adapted and configured for use in other parts of the anatomy of a patient. For example, devices and methods in accordance with the disclosure can be adapted for use in the digestive or gastrointestinal tract, such as in the mouth, throat, small and large intestine, colon, rectum, and the like. For another example, devices and methods can be adapted and configured for use within the respiratory tract, such as in the mouth, nose, throat, bronchial passages, nasal passages, lungs, and the like. Similarly, the apparatus and/or medical devices described herein with respect to percutaneous deployment may be used in other types of surgical procedures as appropriate. For example, in some embodiments, the medical devices may be deployed in a non-percutaneous procedure, such as an open heart procedure. Devices and methods in accordance with the invention can also be adapted and configured for other uses within the anatomy.

Claim 1:
A medical device (<NUM>) for left atrial appendage (<NUM>) closure, comprising:
a delivery catheter (<NUM>) having a lumen extending therethrough;
a left atrial appendage closure implant (<NUM>) comprising a proximal collar (<NUM>), a distal collar (<NUM>), and a monolithic support frame (<NUM>) extending therebetween; and
a delivery shaft slidably disposed within the lumen of the delivery catheter (<NUM>), the delivery shaft having a distal end removably connected to the left atrial appendage closure implant (<NUM>) at the proximal collar (<NUM>);
wherein the support frame (<NUM>) includes:
a first bend (<NUM>) extending from the proximal collar (<NUM>) to a second bend (<NUM>);
a first segment (<NUM>) extending from the second bend (<NUM>) to a third bend (<NUM>);
a second segment (<NUM>) extending from the third bend (<NUM>) to a fourth bend (<NUM>); and
a third segment (<NUM>) extending from the fourth bend (<NUM>) to the distal collar (<NUM>), the third segment extending proximally and radially inward, wherein the distal collar (<NUM>) is disposed proximal of the fourth bend (<NUM>);
wherein the support frame (<NUM>) is actuatable from a first constrained position to a second flowering position to a third mid-deployment position to a fourth unconstrained position;
wherein in the first constrained position, the left atrial appendage closure implant (<NUM>) is disposed within the lumen of the delivery catheter (<NUM>) with the first bend (<NUM>), the second bend (<NUM>), and the third bend (<NUM>) substantially straightened into an elongated shape, and the fourth bend (<NUM>) bent such that the second segment (<NUM>) and the third segment (<NUM>) are generally parallel to each other;
wherein in the second flowering position, the left atrial appendage closure implant (<NUM>) is partially disposed within the lumen of the delivery catheter (<NUM>) such that the fourth bend (<NUM>) is opened compared to the first constrained position, and the second segment (<NUM>) is translated radially outward compared to the first constrained position;
wherein, in the fourth unconstrained position, the left atrial appendage closure implant is disposed outside of the delivery catheter, wherein the support frame (<NUM>) at the second bend (<NUM>) extends radially outward farther than at the third bend (<NUM>) to define a widest lateral extent of the left atrial appendage closure implant (<NUM>).