Patent Description:
The upper chambers of the heart, the atria, have appendages attached to each of them. For example, the left atrial appendage is a feature of all human hearts. The physiologic function of such appendages is not completely understood, but they do act as a filling reservoir during the normal pumping of the heart. The appendages typically protrude from the atria and cover an external portion of the atria. Atrial appendages differ substantially from one to another. For example, one atrial appendage may be configured as a tapered protrusion while another atrial appendage may be configured as a re-entrant, sock-like hole. The inner surface of an appendage is conventionally trabeculated with cords of muscular cardiac tissue traversing its surface with one or multiple lobes.

The atrial appendages appear to be inert while blood is being pumped through them during normal heart function. In other words, the appendages do not appear to have a noticeable effect on blood pumped through them during normal heart function. However, in cases of atrial fibrillation, when the atria go into arrhythmia, blood may pool and thrombose inside of the appendages. Among other things, this can pose a stroke risk when it occurs in the left appendage since the thrombus may be pumped out of the heart and into the cranial circulation once normal sinus rhythm is restored following arrhythmia events.

Historically, appendages have sometimes been modified surgically to reduce the risk imposed by atrial fibrillation. In recent years devices which may be delivered percutaneously into the left atrial appendage have been introduced. The basic function of these devices is to exclude the volume within the appendage with an implant which then allows blood within the appendage to safely thrombose and then to be gradually incorporated into cardiac tissue. This process, coupled with the growth of endothelium over the face of the device, can leave a smooth, endothelialized surface where the appendage is located. In comparison to surgical procedures, devices implanted percutaneously are a less invasive means for addressing the problems associated with the left atrial appendage.

However, due to the wide variability of the ostium size and volume of the left atrial appendage, most current implantable devices include structure that cannot meet such variability, resulting in inadequate devices for many left atrial appendage anatomies. Further, such implantable devices are typically limited in their functionality as being able to be adjusted in the left atrial appendage after being anchored thereto. Further, another problem with many current implantable devices is their ability to be viewable with imaging techniques in a manner that a physician can readily recognize if the implant should be adjusted to a more optimal position within the left atrial appendage once the implant is secured to tissue in the left atrial appendage. As such, it would be advantageous to provide a percutaneous system, method and/or device that addresses, for example, the issues relating to the adjustability and viewability of implantable devices within the left atrial appendage in order to provide high success in left atrial appendage modification.

A variety of features and advantages will be apparent to those of ordinary skill in the art upon reading the description of various embodiments set forth below. <CIT> provides a medical device that 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 an occluder eyelet 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 an anchor eyelet adjacent thereto and hingeably coupled to the occluder eyelet. 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.

The invention is defined by appended claim <NUM>. Embodiments of the present invention are directed to various devices for occluding a left atrial appendage of a heart. In one embodiment, a medical device for occluding a left atrial appendage of a heart is provided. The medical device includes an occluder portion, an anchor portion, and hinge components. The occluder portion is coupled to a hub defining an axis, the occluder portion having occluder frame segments extending radially outward from the hub to a distal end portion of the occluder portion, multiple ones of the occluder frame segments at the distal end portion define a first eyelet. The anchor portion includes anchor frame segments, the anchor frame segments extending between first and second ends. The second end of the anchor frame segments is coupled to an anchor hub and the first end of the anchor frame segments define a second eyelet adjacent thereto. Each of the hinge components include a base with arms extending from the base. The arms of each one of the hinge components extend through and capture the first eyelet and the second eyelet of one of the occluder frame segments and one of the
anchor frame segments, respectively, to facilitate pivotably coupling the anchor portion to the occluder portion.

In another embodiment, the arms each define a catch surface sized and configured to maintain the hinge components to the corresponding ones of the first and second eyelets. In a further embodiment, the base extends with an inner surface, such that the first and second eyelets are positioned between the inner surface and the catch surface of the arms. In another embodiment, the arms are each independently moveable and extend from the base to a free end, each of the arms extending with an outer surface adjacent the free end, the outer surface configured to engage structure defining the first and second eyelets to move the arms inward. In still another embodiment, the arms include at least two arms.

In another embodiment, the hinge components each include a radiopaque material, the radiopaque material of the hinge components configured to facilitate imaging of a proximal boundary, the proximal boundary being proximal of tines extending from the anchor portion. In still another embodiment, structure defining one of the first and second eyelets includes a radiopaque material, the radiopaque material of the structure configured to facilitate imaging of a proximal boundary, the proximal boundary being proximal of tines extending from the anchor portion. In yet another embodiment, portions of the anchor frame segments include a radiopaque material, the radiopaque material of the portions of the anchor frame segments configured to facilitate imaging of a distal most boundary of the anchor portion. In another embodiment, the hinge component and portions of the anchor frame segments include a radiopaque material, the radiopaque material of the hinge component defining a proximal boundary and the radiopaque material of the portions of the anchor frame segments defining a distal boundary, the proximal and distal boundaries defining a landing zone of the anchor portion, the landing zone of the anchor portion including tines extending from the anchor portion.

In accordance with another embodiment of the present invention, a medical device for occluding a left atrial appendage of a heart is provided. The medical device includes a framework and multiple hinge components. The framework includes an occluder portion and an anchor portion, the occluder portion coupled at a hub such that the occluder portion of the framework extends radially outward relative to the hub to a distal end portion of the occluder portion. The anchor portion extends between a first end portion and a second end portion, the second end portion coupled to a secondary hub. The multiple hinge components each include a base with arms extending from the base. The arms of each one of the hinge components extend through eyelets defined in the distal end portion and the first end portion of the occluder portion and the anchor portion, respectively, to facilitate pivotably coupling the anchor portion to the occluder portion.

In another embodiment, the arms each define a catch surface sized and configured to maintain the hinge components to the occluder portion and anchor portion. In another embodiment, the arms are each independently moveable and extend from the base to a free end, each of the arms extending with an outer surface adjacent the free end, the outer surface configured to engage structure defining the eyelets to move the arms inward.

In another embodiment, the hinge components each include a radiopaque material, the radiopaque material of the hinge components configured to facilitate imaging of a proximal boundary, the proximal boundary being proximal of tines extending from the anchor portion. In another embodiment, structure defining the eyelets include a radiopaque material, the radiopaque material of the structure configured to facilitate imaging of a proximal boundary, the proximal boundary being proximal of tines extending from the anchor portion. In still another embodiment, upon the anchor portion being in an anchor deployed position, the anchor portion extends distally with anchor struts from the hinge components toward a distal end of the anchor portion, the anchor struts including tines extending therefrom, the anchor struts including portions distal the tines with a radiopaque material, the radiopaque material of the portions of the anchor frame segments configured to facilitate imaging of a distal boundary, the proximal and distal boundaries defining a landing zone of the anchor portion.

In accordance with another embodiment of the present invention, a method of occluding a left atrial appendage of a heart is provided. The method includes the steps of: advancing a medical device with a catheter through a vasculature and to the left atrial appendage, the medical device having a framework extending between a primary hub and a secondary hub, the primary hub and the secondary hub having a common axis, the framework extending with hinge components between an occluder portion and an anchor portion of the framework such that each of the hinge components includes a base and arms extending from the base; deploying the framework adjacent the left atrial appendage from a constricted position to a deployed position such that the secondary hub is moveable along the axis relative to the primary hub and such that the anchor portion pivots about the hinge components with the arms of each of the hinge components positioned through corresponding ones of an anchor eyelet defined in the anchor portion and the arms of each of the hinge components positioned through corresponding ones of an occluder eyelet defined in the occluder portion; and releasing the medical device from the catheter with the framework of the medical device secured to tissue adjacent the left atrial appendage.

In another embodiment, wherein, subsequent to the deploying the framework, pivoting the anchor portion by moving the secondary hub proximally to move the anchor portion to a retracted position such that tines of the anchor portion are retracted from the tissue. In another embodiment, the deploying step includes securing the framework to the tissue adjacent the left atrial appendage with tines extending from the anchor portion of the framework. In still another embodiment, the method further includes maintaining the anchor portion coupled to the occluder portion of the framework with a catch surface of each of the arms of the hinge components such that the first and second eyelets define structure positioned between the catch surface and the base of each of the hinge components. In yet another embodiment, the method further includes viewing markers integrated with the framework with imaging techniques to determine a landing zone of the framework, at least partially defined by the markers, relative to the tissue adjacent the left atrial appendage.

In accordance with another embodiment of the present invention, a method of assembling an occlusion device is provided. The method includes the steps of: providing an occluder frame portion, an anchor frame portion and multiple hinge components, the occluder frame portion extending between a proximal end portion and a distal end portion, the anchor frame portion extending between first and second end portions, the hinge components each including a base with arms extending from the base; coupling the proximal end portion of the occluder frame portion to a hub such that the occluder frame portion extends distally and radially outward to the distal end portion, the distal end portion defining a first eyelet therein; inserting the arms of one of the hinge components through the first eyelet of the distal end portion of the occluder frame portion; inserting the arms of the one of the hinge components through a second eyelet defined in the first end portion of the anchor frame portion; and coupling the second end portion of the anchor frame portion to a secondary hub.

In another embodiment, the method further includes coupling the anchor portion to the occluder portion with a catch surface of the arms and an inner surface the base of each of the hinge components. In another embodiment, the inserting step includes independently moving the arms inwardly upon an outer surface of the arms engaging structure defining the first eyelet or engaging structure defining the second eyelet so that the arms are insertable through the first and second eyelets.

In another embodiment, the method further includes integrating markers into one of the occluder portion and the anchor portion to at least partially assist in determining a landing zone of the anchor portion relative to the tissue adjacent the left atrial appendage. In another embodiment, the integrating comprises integrating the markers in at least one of the hinge components and structure defining the first and second eyelets with a radiopaque material such that the radiopaque material is configured to facilitate imaging of a proximal boundary, the proximal boundary being proximal of tines extending from the anchor portion. In a further embodiment, the integrating step includes integrating the markers in portions of the anchor portion with a radiopaque material such that the markers are positioned to define a distal boundary, the proximal boundary and the distal boundary defining the landing zone therebetween. In another embodiment, the distal boundary of the landing zone extends through and/or along the tines of the anchor portion.

In accordance with another embodiment of the present invention, a medical device for occluding a left atrial appendage of a heart is provided. In this embodiment, the medical device includes a framework extending to define an occluder portion and an anchor portion, the anchor portion including tines sized and configured to anchor the framework to tissue of the left atrial appendage. The anchor portion is pivotably coupled to the occluder portion with multiple hinge components such that each one of the hinge components extend through and are captured within a first eyelet of the occluder portion and a second eyelet of the anchor portion to facilitate pivotably moving the anchor portion relative to the occluder portion. The hinge components and portions adjacent the tines of the anchor portion include a radiopaque material. With this arrangement, the radiopaque material of the hinge components define a proximal boundary and the radiopaque material of the portions adjacent the tines define a distal boundary such that the proximal and distal boundaries are spaced relative to each other to define a landing zone therebetween.

In another embodiment, the anchor portion includes multiple wires, each of the multiple wires fixedly coiled around portions of the anchor portion, the multiple wires comprising the radiopaque material to define a distal most boundary of the framework. In still another embodiment, each of the hinge components include a base with arms extending from the base, each of the arms including a catch surface to maintain the anchor portion to the occluder portion. In another embodiment, the arms are each independently moveable and extend from the base to a free end, each of the arms extending with an outer surface adjacent the free end, the outer surface configured to engage structure defining the first and second eyelets to move the arms inward.

In accordance with another embodiment of the present invention, a method of occluding a left atrial appendage of a heart is provided. The method includes the steps of: advancing a medical device with a catheter through a vasculature and to the left atrial appendage, the medical device having a framework extending to define an occluder portion and an anchor portion, the anchor portion including tines sized and configured to anchor the framework to tissue of the left atrial appendage, the anchor portion pivotably coupled to the occluder portion with multiple hinge components such that each one of the hinge components extend through and are captured within a first eyelet of the occluder portion and a second eyelet of the anchor portion, the hinge components and portions adjacent the tines of the anchor portion comprise a radiopaque material; deploying the framework adjacent the left atrial appendage from a constricted position to a deployed position such that the anchor portion is pivotably moveable relative to the occluder portion; and imaging the medical device in the deployed position within the heart to visualize a proximal boundary defined by the hinge components and to visualize a distal boundary defined by the portions adjacent the tines of the anchor portion such that the proximal and distal boundaries are spaced relative to each other to define a landing zone therebetween.

In another embodiment, the imaging step includes the step of positioning the landing zone adjacent to tissue of the left atrial appendage for anchoring the medical device thereto. In another embodiment, the method further includes the step of pivoting the anchor portion to a retracted position with the occluder portion maintaining an expanded position to re-position the medical device relative to tissue of the left atrial appendage. In another embodiment, the method further includes the step of releasing the medical device from the catheter with the framework of the medical device secured to tissue adjacent the left atrial appendage. In another embodiment, the method further includes the step of pivoting the anchor portion to the retracted position with hinge components each having a catch surface extending from arms of the hinge components so that the anchor portion remains pivotably coupled to the occluder portion of the framework.

The foregoing and other advantages of the invention will become apparent upon reading the following detailed description and upon reference to the drawings in which:.

Referring to <FIG> and <FIG>, a medical device <NUM> removably coupled to a delivery system <NUM> is provided. The medical device <NUM> and delivery system <NUM> together may be referenced as a medical device delivery system <NUM>, which may be employed in interventional procedures for percutaneously closing and modifying an opening or cavity such as, for example, a left atrial appendage within a heart (not shown). The medical device <NUM> may include a frame structure extending to define an occluder portion <NUM> and an anchor portion <NUM>, the occluder portion <NUM> and anchor portion <NUM> with corresponding frame components of an occluder frame <NUM> and an anchor frame <NUM>. The occluder portion <NUM> may include the occluder frame <NUM> with a tissue growth member <NUM> attached to the occluder frame <NUM>. The tissue growth member <NUM> may be in the form of an occlusive member, but may also be in the form of a filter member, a mesh member, a membrane or any other structure, or combinations thereof, sized and configured to promote tissue in-growth. Further, the tissue growth member <NUM> may be formed from one or more polymeric materials, such as ePTFE and/or a polyurethane foam. The anchor frame <NUM> may be pivotably coupled to the occluder frame <NUM> such that the anchor frame <NUM> may be moveable between a retracted position and a deployed position to assist the physician in adjusting the position of the medical device <NUM> subsequent to the anchor portion <NUM> being secured to tissue in the left atrial appendage. Such pivotable coupling between the anchor frame <NUM> and occluder frame <NUM> may be employed with a hinge component <NUM>, the hinge component <NUM> facilitating efficient assembly of the pivotable connection between the anchor portion <NUM> and the occluder portion <NUM>. Further, various portions of the medical device <NUM>, such as the hinge component <NUM>, the occluder frame <NUM> and/or the anchor frame <NUM>, or other components associated therewith, may include and exhibit markers formed from radiopaque material to assist visibility via imaging techniques to assist the physician in understanding the detail of a landing zone <NUM> of the medical device <NUM> relative to the anatomy adjacent the left atrial appendage of the heart. In this manner, the medical device <NUM> incorporates structural components to assist the physician in optimally positioning the medical device <NUM> in the left atrial appendage.

With reference to <FIG>, as set forth, the medical device <NUM> may be delivered through the vasculature with the delivery system <NUM>. The delivery system <NUM> may include a pusher catheter <NUM> and a handle <NUM>, the handle <NUM> integrated with a proximal portion of the catheter <NUM>. The handle <NUM> may include various functional components, such as an anchor actuator <NUM>, to manipulate the anchor frame <NUM> between the deployed position (<FIG>) and the retracted position (<FIG>). The delivery system <NUM> may include and be employed with a delivery sheath <NUM> for delivering the medical device <NUM> to the left atrial appendage. The delivery sheath <NUM> may be positioned within the vasculature using known interventional techniques with a sheath distal end <NUM> deliverable to be positioned adjacent the left atrial appendage of the heart. Upon the medical device <NUM> being advanced through a lumen of the delivery sheath <NUM> to the sheath distal end <NUM> (the medical device <NUM> being in the constricted position partially shown in dashed lines adjacent the sheath distal end <NUM> (see <FIG>)), the medical device <NUM> may at least partially be deployed from the delivery sheath <NUM>. That is, the delivery sheath <NUM> may then be manually moved proximally (and/or the pusher catheter <NUM> advanced distally) so that the occluder portion <NUM> of medical device <NUM> may be deployed from the sheath distal end <NUM>. Such occluder portion <NUM> may immediately self-expand as the occluder portion <NUM> is exposed from the sheath distal end <NUM>. At this stage, the medical device <NUM> may be in a partially deployed state, after which, the medical device may be moved to a fully deployed state by deploying the anchor portion <NUM>. For example, upon the occluder portion <NUM> initially being deployed, the anchor portion <NUM> may be in the retracted position with the anchor actuator <NUM> of the handle <NUM> in the proximal position (as depicted in <FIG>). Once a physician determines that the occluder portion <NUM> is in an appropriate and desired position adjacent the left atrial appendage, the anchor portion <NUM> may be pivoted from the retracted position to the deployed position by moving the anchor actuator <NUM> to the distal position, as shown by arrow <NUM> (see <FIG>). Once the anchor portion <NUM> is moved to the deployed position, the tines <NUM> (<FIG> and <FIG>) of the anchor portion <NUM> may engage tissue to secure the medical device <NUM> in the left atrial appendage. If the physician determines that the medical device <NUM> is not in an optimal secured position in the left atrial appendage, the anchor portion <NUM> may be pivoted back to the retracted position by moving the anchor actuator <NUM> from the distal position to the proximal position, as shown by arrow <NUM> (see <FIG>). As such, the anchor actuator <NUM> may be manually moved proximally and distally to move the anchor portion <NUM> between the retracted and deployed positions such that the anchor portion <NUM> pivots between the deployed and retraced positions. In this manner, the anchor portion <NUM> of the medical device <NUM> may be secured and disengaged from tissue in the left atrial appendage as needed by the physician until the physician obtains an optimal position or is satisfied with its position prior to releasing the delivery system <NUM> from the medical device <NUM>. A similar medical device delivery system <NUM> with its handle <NUM>, pusher catheter <NUM>, medical device <NUM> and delivery sheath <NUM> is disclosed in commonly assigned <CIT>, now issued as <CIT> entitled MEDICAL DEVICE FOR MODIFICATION OF LEFT ATRIAL APPENDAGE AND RELATED SYSTEMS AND METHODS.

With reference to <FIG> and <FIG>, frame components or a framework of the medical device <NUM>, in the fully expanded position, will now be described. As previously set forth, the framework of the medical device <NUM> may include the occluder frame <NUM> and the anchor frame <NUM>. The occluder frame <NUM> may be coupled to and extend from a primary hub <NUM>, the primary hub <NUM> having a tubular characteristic that may define an axis <NUM> therethrough. The occluder frame <NUM> may extend between a proximal end <NUM> and a distal end <NUM> such that the proximal end <NUM> of the occluder frame <NUM> may be coupled to the primary hub <NUM>. The occluder frame <NUM> may extend from the proximal end <NUM> with occluder frame segments <NUM> and/or occluder frame struts. For example, the occluder frame segments <NUM> may extend distally and radially from the primary hub <NUM> and relative to the axis <NUM> to the distal end <NUM> of the occluder frame <NUM> such that, adjacent the distal end <NUM>, the occluder frame segments <NUM> may extend with structure with occluder frame eyelets <NUM> defined therein. In one embodiment, every-other occluder frame segment <NUM> adjacent the distal end <NUM> of the frame segments <NUM> may define structure with one of the occluder frame eyelets <NUM> defined therein. In another embodiment, the occluder frame segments <NUM> extending between those occluder frame segments with the occluder frame eyelets <NUM> defined therein may extend to free ends <NUM>. In still another embodiment, the occluder frame eyelets <NUM> may be referenced as first eyelets, each of the occluder frame eyelets sized and configured to be coupled to the anchor frame <NUM>. In still another embodiment, each of the occluder frame eyelets <NUM> may be sized and configured to be coupled to one of the multiple hinge components <NUM>.

The anchor frame <NUM> may extend with multiple anchor frame segments <NUM> and/or anchor frame struts that may extend radially between a first end <NUM> and a second end <NUM>. Adjacent the first end <NUM>, the anchor frame segments <NUM> may extend with structure so as to define multiple anchor frame eyelets <NUM> therein. Each of the anchor frame eyelets <NUM> may correspond with one of the occluder frame eyelets <NUM>. Such anchor frame eyelet <NUM> may be referenced as a second eyelet and may be sized and configured to couple to the occluder frame <NUM> via the occluder frame eyelets <NUM>. Further, the anchor frame eyelets <NUM> may correspond with, and be coupled to, one of the multiple hinge components <NUM>. In this manner, the first end <NUM> or first end portion of the anchor frame <NUM> may be pivotably coupled to the occluder frame <NUM> via the hinge components <NUM>. Further, the second end <NUM> of the anchor frame segments <NUM> may extend, and be coupled to, a secondary hub <NUM>. The secondary hub <NUM> may be moveable along the axis <NUM> such that the primary and secondary hubs <NUM>, <NUM> are axially aligned so as to be positioned along the axis <NUM>, or a common axis. With this arrangement, movement of the secondary hub <NUM> along the axis <NUM> via the anchor actuator <NUM> (<FIG>) results in pivoting the anchor portion <NUM> about the hinge components <NUM> so that the anchor frame <NUM> may move between the retracted and deployed positions.

Now with reference to <FIG>, one of the hinge components <NUM> will now be described. In one embodiment, each of the hinge components <NUM> may include a base <NUM> and arms <NUM> extending from the base <NUM>. The base <NUM> may extend with a cylindrical structure, or any other suitable structure that may be larger than the occluder or anchor frame eyelets <NUM>, <NUM> (see <FIG>) so that the base can act as a blocking structure. The base <NUM> may extend with a radial side surface <NUM> between opposing flat surfaces <NUM>. One of the flat surfaces <NUM> may be a structure that can act as the blocking structure as well as being the surface from which the arms <NUM> may extend from. The arms <NUM> may each be an elongated structure, one end of the elongated structure being a free end <NUM>. The hinge component <NUM> may define a hinge axis <NUM> extending centrally through the opposing flat surfaces <NUM> with the elongated structure of the arms <NUM> extending longitudinally along the hinge axis <NUM>.

The arms <NUM> may each extend from one of the flat surfaces <NUM> so as to extend in a common direction from the base <NUM>. In one embodiment, the hinge component <NUM> may extend with four arms <NUM>. Other embodiments of the hinge component <NUM> may include two arms or three arms. In another embodiment, one or more of the hinge components <NUM> may include at least two arms extending from the base <NUM>. The arms <NUM> may each extend toward the free end <NUM> with a head structure <NUM> or knob structure. The arms <NUM>, along an end thereof, may each extend to define an outer end surface <NUM> and an underside catch surface <NUM> both of which may be surfaces of the head structure <NUM>. The outer end surface <NUM> may be sized and configured to engage structure defining a portion of either the occluder or anchor frame eyelets <NUM>, <NUM>. Further, the underside catch surface <NUM> may be sized and configured to maintain the coupling between the occluder and anchor frames <NUM>, <NUM>. In another embodiment, the head structure <NUM> may define the outer end surface <NUM> and the catch surface <NUM>. In another embodiment, each of the arms <NUM> may be independently moveable relative to an adjacent arm <NUM>. In another embodiment, each of the arms <NUM> may be independently moveable relative to the base <NUM>. The independent moveability of the arms <NUM> may move in a flexing manner or biasing manner such that, upon a force being placed on the outer end surface <NUM> of the arms <NUM>, the arms <NUM> may each independently move to a biased state. Upon the force being removed from the outer end surface <NUM> of the arms <NUM>, the arms <NUM> may each moved to a relaxed state or semi-relaxed state as the arms <NUM> may be slightly constricted upon being within the respective occluder and anchor eyelets <NUM>, <NUM>.

In another embodiment, the hinge component <NUM> may include a key structure <NUM>. In one embodiment, the key structure <NUM> may be integrated with the arms <NUM> of the hinge component <NUM>. In another embodiment, the key structure <NUM> may extend with four post structures <NUM>, one post structure <NUM> between each adjacently extending arm <NUM>. In another embodiment, the arms <NUM> have a greater elongated length than the post structures <NUM>. The key structure <NUM> may be sized and configured to engage the structure defining the occluder frame eyelet <NUM> such that the eyelet corresponds at least partially with a profile of the key structure <NUM>.

Now with reference to <FIG>, <FIG>, assembly of the hinge components <NUM> with the occluder and anchor frame <NUM>, <NUM> will now be described. For example, the occluder frame eyelet <NUM> may be positioned adjacent the hinge component <NUM> such that the hinge axis <NUM> of the hinge component <NUM> extends centrally or axially through the occluder frame eyelet <NUM>. With this axially aligned orientation between the hinge component <NUM> and the occluder frame eyelet <NUM>, the hinge component <NUM> may be moved toward the occluder frame eyelet <NUM> so that the structure defining the occluder frame eyelet <NUM> may be pushed against the outer end surface <NUM> of the arms <NUM>. The arms <NUM> may then independently move inward to allow the occluder frame eyelet <NUM> to move past the outward end surface <NUM> and toward the base <NUM> such that the arms <NUM> are moved through the eyelet <NUM>. Similar to the occluder frame eyelet <NUM>, the anchor frame eyelet <NUM> may be oriented to be axially aligned relative to the hinge axis <NUM> to move the structure defining the anchor frame eyelet <NUM> against the outer end surface <NUM> of the arms <NUM>, thereby moving the arms <NUM> inward, to then move the anchor frame eyelet <NUM> to sit between the underside catch surface <NUM> of the arms <NUM> and the occluder frame <NUM> defining the occluder frame eyelet <NUM>, as shown in <FIG>. Further, in one embodiment, the structure defining the occluder frame eyelet <NUM> may include recesses <NUM> defined therein, as shown in <FIG> and <FIG>. Such recesses <NUM> may be sized and configured to correspond with the key structure <NUM> of the hinge component <NUM> such that each recess <NUM> may correspond with one of the post structures <NUM> positioned between adjacently extending arms <NUM>. Further, in another embodiment, the occluder frame eyelet <NUM> and the anchor frame eyelet <NUM> may be positioned and aligned together, as depicted in <FIG>, to then insert the arms <NUM> of the hinge component <NUM> through each of the aligned occluder and anchor frame eyelets <NUM>, <NUM>, as shown in <FIG>. In another embodiment, upon coupling each of the occluder and anchor eyelets <NUM>, <NUM> to the hinge component <NUM>, the key structure <NUM> may provide a gap <NUM> between the occluder and anchor eyelets <NUM>, <NUM> since the anchor frame eyelet <NUM> does not correspond with the key structure <NUM>. As such, the key structure <NUM> may inherently provide the gap <NUM> so as to eliminate the need for a washer between the occluder and anchor frame eyelets <NUM>, <NUM>. With this arrangement, the hinge component <NUM> may be advantageous in the efficiency of coupling the occluder and anchor frames <NUM>, <NUM> together.

With reference to <FIG> in conjunction with some components depicted in <FIG>, another embodiment of a hinge component <NUM> is provided. This embodiment may be similar to the previous embodiment of the hinge component depicted in <FIG>, except this embodiment of the hinge component <NUM> does not exhibit a keyed structure or post structure adjacent arms of the hinge component <NUM>. As such, the hinge component <NUM> of this embodiment may be employed similar to the previous embodiment and may include similar functionality as the hinge component of the previous embodiment. As in the previous embodiment, the hinge component <NUM> may include a base <NUM> with arms <NUM> extending from the base <NUM>. The arms <NUM> may include a head structure <NUM> with an outer end surface <NUM> that may assist in the arms <NUM> independently moving inward upon a force being placed upon the outer end surface <NUM> of any one of the arms <NUM>. Further, the arms <NUM> may also include an underside surface <NUM> sized and configured to act as a catch for maintaining the occluder and anchor frame eyelets <NUM>, <NUM> to this embodiment of the hinge component <NUM>. In another embodiment, the hinge component <NUM> may be employed with a washer (not shown) that may be positioned between the structure defining the occluder and anchor frame eyelets <NUM>, <NUM> of the respective occluder and anchor frames <NUM>, <NUM>.

Now with reference to <FIG>, another embodiment of a hinge component <NUM> is provided. Similar to the previous embodiments, the hinge component <NUM> may include a base <NUM> with arms <NUM> extending from the base <NUM>. In this embodiment, rather than four arms, the hinge component <NUM> may exhibit two arms <NUM> extending from the base <NUM>. The arms <NUM> may extend to a head structure <NUM> or knob structure with an outer end surface <NUM> sized and configured to engage structure defining the occluder and anchor frame eyelets <NUM>, <NUM> to facilitate the arms <NUM> to independently move inward, similar to that described in previous embodiments (see <FIG>). Further, the arms <NUM> may extend to define an underside surface <NUM> sized and configured to catch or maintain the occluder and anchor frame eyelets <NUM>, <NUM> between the underside surface <NUM> and the base <NUM> of the hinge component <NUM>, similar to that depicted in <FIG>. Further, the hinge component <NUM> may be assembled to the occluder and anchor frames <NUM>, <NUM> by axially aligning the occluder and anchor frame eyelets <NUM>, <NUM> with a hinge axis <NUM> of the hinge component <NUM>, similar to that depicted in <FIG>. In another embodiment, hinge components may include a base with three arms extending from the base.

With reference to <FIG> and <FIG>, in another embodiment, various portions of the framework of the medical device <NUM> may include radiopaque material to define markers, the radiopaque material configured to be viewable with imaging techniques, such as fluoroscopy type imaging, as known to one of ordinary skill in the art. The markers may be integrated and arranged with the framework to define a proximal boundary <NUM> and a distal boundary <NUM> such that a space between the proximal and distal boundaries <NUM>, <NUM> may define the landing zone <NUM> of the medical device <NUM>. Further, markers may define a distal most boundary <NUM> of the medical device <NUM> such that the distal most boundary <NUM> may indicate to the physician the distal end <NUM> of the medical device <NUM>. The proximal and distal boundaries <NUM>, <NUM> of the landing zone <NUM> (as well as the distal most end of the medical device) are shown with dashed lines, the dashed lines generally extending through or adjacently alongside the markers integrated with the framework of the medical device <NUM>.

For example, with respect to <FIG>, <FIG>, the distal boundary <NUM> of the landing zone <NUM> may extend through tine markers <NUM> positioned adjacent the tines <NUM> of the anchor frame <NUM>. The tines <NUM> may extend at separate locations and along separate anchor struts with a dual tine configuration <NUM>. The tines <NUM> may extend with the dual tine configuration <NUM> at separate and spaced locations along an outer radial periphery of the anchor frame <NUM>, the outer radial periphery extending with a generally circular profile (as depicted in <FIG>). In one embodiment, one of the tine markers <NUM> or markers adjacent the tines <NUM> may be positioned within an aperture <NUM> defined below or within the structure extending to define the dual tine configuration <NUM>. Such tine markers <NUM> may be cylindrical, as depicted with dashed lines in <FIG>, so as to be sized and configured to be positioned within the aperture <NUM> associated with the dual tine configuration <NUM>. In another embodiment, the tine markers <NUM> may be positioned within or adjacent to each of the dual tine configurations <NUM> of the anchor frame <NUM>. In another embodiment, the tine markers <NUM> may be positioned within alternating ones of the dual tine configurations <NUM> or, otherwise said, every other one of the dual tine configurations <NUM> positioned along the outer radial periphery of the anchor frame <NUM>. In another embodiment, the tine markers <NUM> may be positioned in some of the multiple dual tine configurations <NUM>. With this arrangement, the tine markers <NUM> positioned along the outer radial periphery adjacent the tines <NUM> define the distal boundary <NUM> of the landing zone <NUM> such that the distal boundary <NUM> of the landing zone <NUM> may extend along the outer radial periphery so that the distal boundary extends in a generally circular configuration, as shown with the dashed lines of the distal boundary <NUM> of <FIG>.

Further, with reference to <FIG> and <FIG>, as previously set forth, the proximal boundary <NUM> of the landing zone <NUM> may be defined by hinge markers <NUM>, such as markers integrated with, or adjacent to, the hinge components <NUM>, or along other portions of the framework of the medical device <NUM>. Similar to the distal boundary <NUM>, the proximal boundary <NUM> of the landing zone <NUM> may extend with a generally circular profile. The hinge markers <NUM> defining the proximal boundary <NUM> may be proximally located relative to the tine markers <NUM> defining the distal boundary <NUM>. The landing zone <NUM> of the medical device <NUM>, defined between the proximal boundary <NUM> and the distal boundary <NUM>, may generally be the most radial portion of the anchor frame <NUM> that includes the tines <NUM> extending from the anchor frame <NUM> of the medical device <NUM>. As such, the hinge markers <NUM> and the tine markers <NUM> defining the landing zone <NUM> of the medical device <NUM> may assist the physician through imaging techniques in viewing the proximal and distal boundaries <NUM>, <NUM> to determine the landing zone <NUM> of the medical device <NUM> relative to the tissue anatomy so that a physician can manipulate the position of the medical device <NUM> and obtain appropriate anchoring via the tines <NUM> of the medical device <NUM> in the tissue adjacent the left atrial appendage.

With reference to <FIG>, the previously described hinge components <NUM> may be formed with radiopaque material to define the hinge markers <NUM>. With each of the hinge components <NUM> being formed of a radiopaque material, the physician will be able to approximately determine the proximal boundary <NUM> with the above-described imaging techniques. In one embodiment, the proximal boundary <NUM> may be defined collectively by each of the hinge components <NUM>. In another embodiment, the proximal boundary <NUM> may be defined by multiple occluder crimp rings <NUM> formed from radiopaque material. Such occluder crimp rings <NUM> may be attached to the occluder frame <NUM> so that each one of the crimp rings <NUM> may be positioned adjacent to a corresponding one of the hinge components <NUM>. Similarly, in another embodiment, the proximal boundary <NUM> may be defined by multiple anchor crimp rings <NUM> made of radiopaque material. The anchor crimp rings <NUM> may be attached to the anchor frame <NUM> such that each one anchor crimp rings <NUM> may be positioned adjacent the hinge component <NUM>. In another embodiment, multiple anchor crimp rings <NUM> may be positioned adjacent to each one of the hinge components <NUM>. In still another embodiment, the proximal boundary <NUM> may be defined by at least one of occluder insert markers <NUM> and anchor insert markers <NUM>. Such occluder and anchor insert markers <NUM>, <NUM> may be positioned in apertures defined in at least one of the occluder frame <NUM> or anchor frame <NUM> such that one or more insert markers <NUM>, <NUM> may be positioned adjacent each one of the hinge components <NUM>. In this manner, the hinge components <NUM> and/or structure adjacent the hinge components may be formed of radiopaque material, or have radiopaque material integrated therewith, so as to define the proximal boundary <NUM> of the landing zone <NUM>. In another embodiment, the hinge components <NUM> and/or structure adjacent the hinge components <NUM> may be doped to form radiopaque material or coated with a radiopaque material so as to define the proximal boundary <NUM> of the landing zone <NUM>.

With reference to <FIG> and <FIG>, in another embodiment, the proximal boundary <NUM> may be defined by markers integrated with, for example, portions of the occluder frame <NUM>, such as the structure adjacent the free ends <NUM> of the occluder frame <NUM>. Further, such portions adjacent the free ends <NUM> of the occluder frame segments <NUM> may be integrated with crimp rings <NUM> that are formed from a radiopaque material. In another embodiment, the portions adjacent the free ends <NUM> of the occluder frame segments <NUM> may undergo a doping process to form radiopaque material therein. In another embodiment, the portions adjacent the free ends <NUM> of the occluder frame segments <NUM> may receive a coating layer <NUM> of radiopaque material.

Now with reference to <FIG> and <FIG>, as previously set forth, the distal most boundary <NUM> of the medical device <NUM> may be defined by structure adjacent the distal end <NUM> of the anchor frame <NUM> of the medical device <NUM>. For example, the structure may be a coil <NUM> formed or wound about the anchor frame <NUM>, the coil <NUM> being formed from a wire material. The coil <NUM> may be made of a radiopaque material. Such coil <NUM> may also undergo a doping process to form the coil <NUM> with radiopaque material or the coil <NUM> may be coated with radiopaque material. In another embodiment, the distal most boundary <NUM> may be defined by distal insert markers <NUM> integrated into apertures defined, for example, in the anchor frame <NUM> adjacent the coil <NUM>. In another embodiment, the distal most boundary <NUM> may be defined by distal crimp rings <NUM> wrapped around the anchor frame <NUM> adjacent the coil <NUM>. Such distal most boundary <NUM> may assist the physician to visually recognize the boundaries and limits of the medical device, via imaging techniques, so as to provide a frame of reference relative to the landing zone <NUM> and the other radiopaque markers discussed herein to better assist the physician in determining the landing zone <NUM> of the medical device <NUM> relative to the anatomy of the left atrial appendage.

With reference to <FIG> in conjunction to some of the components of <FIG>, in another embodiment, the proximal boundary <NUM> may be defined with structure positioned with or within a hinge component <NUM>. For example, the hinge component <NUM> may include a washer <NUM> positioned between the structure of the occluder and anchor eyelets <NUM>, <NUM> defined by the respective occluder and anchor frames <NUM>, <NUM>. In this embodiment, the washer <NUM> may be formed from a radiopaque material. Such washer <NUM> may be integrated with the various hinge components set forth herein. In one embodiment (not claimed), the hinge component <NUM> may be a polymeric filament positioned within the occluder and anchor eyelets with opposing ends being formed into a bulbous structure <NUM> via heating the opposing ends of the hinge component <NUM>. The various radiopaque markers described herein may be formed from radiopaque material, such as platinum, gold, tantalum or
alloys thereof, or any other suitable radiopaque materials that are biocompatible, as known to one of ordinary skill in the art.

Claim 1:
A medical device (<NUM>) for occluding a left atrial appendage of a heart, comprising:
an occluder portion (<NUM>) coupled to a hub (<NUM>) defining an axis (<NUM>), the occluder portion having occluder frame segments (<NUM>) extending radially outward from the hub to a distal end portion of the occluder portion, multiple ones of the occluder frame segments at the distal end portion each defining an eyelet (<NUM>) of a first plurality of eyelets;
an anchor portion (<NUM>) having anchor frame segments (<NUM>), the anchor frame segments extending between first and second ends (<NUM>, <NUM>), the second end of the anchor frame segments coupled to an anchor hub (<NUM>) and the first end of each of the anchor frame segments defining an eyelet (<NUM>) of a second plurality of eyelets adjacent thereto; and
multiple hinge components (<NUM>), characterised by each of the hinge components including a base (<NUM>) with arms (<NUM>) extending from the base such that the arms of each one of the hinge components extend through and capture an eyelet of the first plurality of eyelets and an eyelet of the second plurality of eyelets of one of the occluder frame segments and one of the anchor frame segments, respectively, to facilitate pivotably coupling the anchor portion to the occluder portion.