Patent ID: 12213677

DETAILED DESCRIPTION OF THE INVENTION

Referring first toFIGS.1and1A, a medical device20and a distal end portion of a delivery system22is provided. The medical device20and delivery system22may be employed in interventional procedures for percutaneously closing and modifying an opening or cavity such as, for example, a left atrial appendage (“LAA”) within a heart (not shown). The medical device20may include frame components of an occluder portion24and an anchor portion26, the occluder portion24also including a tissue growth member28attached thereto. Further, the anchor portion26may be hingably coupled to the occluder portion24such that the anchor portion26may be actuated, upon deployment of the occluder portion24, between a deployed position and a non-deployed position (not shown) via an actuation mechanism at a handle (not shown) of the delivery system22. With this arrangement, the medical device20and delivery system22may provide functionality of separating the steps of deploying the occluder portion24and the anchor portion26, thereby, providing additional and enhanced functionality to the physician to properly position and implant the medical device20in the LAA.

As set forth, the occluder portion24may include an occluder material or a tissue growth member28attached thereto. The tissue growth member28may be a porous material, or other cell attaching material or substrate, configured to promote endothelization and tissue growth thereover. The tissue growth member28may extend over a proximal side of the medical device20and, particularly, over the occluder portion24and may extend over a portion of the anchor portion26and hinges coupling the anchor portion26to the occluder portion24. As such, due to the shape of the frame components of the occluder portion24, the tissue growth member28may include a proximal face that is generally convex to form an outer surface40. The tissue growth member28may also include an inner surface42on its distal side that is generally concave shaped. In one embodiment, the tissue growth member28may extend primarily over an outside surface of frame components of the occluder portion24with a portion of the tissue growth member28extending on both the outside surface and the inside surface of the frame components of the occluder portion24. In another embodiment, the tissue growth member28may extend primarily over both the outside surface and the inside surface of the frame components of the occluder portion24of the medical device20. In another embodiment, the tissue growth member28may extend solely over the outside surface of the frame components of the occluder portion24.

With respect toFIGS.1A and1B, the tissue growth member28may include one or more types of materials and/or layers. In one embodiment, the tissue growth member28may include a first material layer30and a second material layer32. The first material layer30may primarily be an underside layer or base layer of the tissue growth member28. The first material layer30may include porous and conformable structural characteristics. For example, the first material layer30may include a foam type material, such as, a polyurethane foam or any other suitable polymeric material, such as a polymer fabric, woven or knitted. The second material layer32may include one or more layers of, for example, an expanded polytetrafluoroethylene (ePTFE) material. The second material layer32may be attached to an outer surface of the first material layer30with, for example, an adhesive. In one embodiment, the second material layer32may include a first layer32A, a second layer32B, and a third layer32C such that the first layer32A may be directly attached to the first material layer30and the third layer32C may be an outer-most layer covering the proximal side of the medial device20with the second layer32B extending therebetween. The various layers of the second material layer32may be bonded together by adhesives and/or by a thermal bonding heat process or other appropriate processes known in the art. In one particular example, the outer-most layers, such as the second and third layers32B,32C, may be formed of an ePTFE material having an internodal distance (sometimes referred to as pore size) of approximately 70 μm to approximately 90 μm. The first layer32A of the second material layer32, adjacent the first material layer30, may be formed of an ePTFE material having a reduced internodal distance relative to the second and third layers32B,32C. For example, the internodal distance of the first layer32A may be approximately 10 μm. This first layer32A may be bonded or adhered to the first material layer30using an adhesive material. Any other suitable sized layers of ePTFE may be employed, such as ePTFE having an internodal distance up to about 250 μm. Further, there may be one or more additional layers, similarly sized to the first layer32A, extending over a hub end34with flaps36(outlined with an “X” configuration) where the delivery system22interconnects with the medical device20(seeFIG.1).

The second material layer32made of ePTFE effectively prevents the passage of blood, due to the small internodal distance and pore size of the first layer32A, while the larger internodal distance of other layers (e.g.,32B and32C) enable tissue in-growth and endothelization to occur. Additionally, the first material layer30, being formed of a polyurethane foam, enables aggressive growth of tissue from the LAA wall into the tissue growth member28at the inside or concave side of the medical device20. Further, the first material layer30provides an exposed shelf38on the outer surface40around the periphery and distal end portion of the tissue growth member28, which promotes aggressive fibroblast and tissue growth to further initiate endothelization over the outer surface40of the second material layer32. It is noted that the use of appropriate adhesive materials between the first material layer30and the next adjacent layer32A may also serve to fill in the pores of the next adjacent layer32A and further inhibit possible flow of blood through the tissue growth member28. Additional layers of ePTFE may also be included to the second material layer32of the tissue growth member28.

With reference toFIGS.2and3, description of the medical device20and its frame components will now be provided.FIG.2depicts the frame components in an assembled and fully deployed state andFIG.3depicts the frame components as cut from a flat sheet. As previously set forth, the medical device20includes an occluder portion24and an anchor portion26. The occluder portion24may include multiple occluder frame segments that may be interconnected to form the occluder portion24. The occluder portion24may extend between a first end44and a second end46with face struts50and an occluder zig-zag portion52therebetween. Further, the occluder portion24includes base extensions48extending from the first end44. The base extensions48may be coupled to a hub54via rings56with notches defined at an inner diameter in the rings56. Each base extension48may extend from a proximal most portion of the occluder portion24or first end44, the first end44being one end of each base extension48and face strut50. Each base extension48may be sized and configured to be positioned around the hub54and held by one or more rings56. Each base extension48, at the first end44, may extend to one face strut50of the occluder portion24, the face strut50extending radially and distally from the first end44. Each face strut50may include an extension58on a back side thereof, the extension58having a hook configuration sized and configured to hold a portion of the tissue growth member (not shown). Further, each face strut50extends to a v-extension60of the occluder zig-zag portion52such that distal ends of each v-extension60may be coupled to distal ends of adjacent v-extensions60(side-by-side) to define the occluder zig-zag portion52. The occluder zig-zag portion52may enlarge radially and distally from the face struts50to a distal end or the second end46of the occluder portion24. At the second end46, the occluder portion24may include an occluder eyelet62sized configured to hingably couple to the anchor portion26.

The anchor portion26may include multiple anchor frame segments that may be interconnected to form the anchor portion26. The anchor portion26may extend between a first end64and a second end66with anchor actuator arms68and an anchor zig-zag portion70therebetween. The anchor actuator arms68may extend between the first end64and the anchor zig-zag portion70. Each anchor actuator arm68may be configured to couple to a collar arrangement or splined sleeve72at the first end64of the anchor portion26such that the anchor actuator arms68are coupled as a unit or together via the splined sleeve72. The splined sleeve72may be configured to actuate along an axis74of the medical device20to move the anchor portion26between the anchor deployed position and anchor non-deployed position (not shown), discussed in more detail hereafter.

With reference now toFIGS.2,3, and3A, the anchor actuator arms68may also include a flexure portion76. The flexure portion76defines a taper82and radius extending along the radial length of the flexure portion76toward the anchor zig-zag portion70and then widens again at the anchor zig-zag portion70. Such taper82along the radial length in the flexure portion76facilitates repetitious movement of the anchor portion26between the deployed position and the non-deployed position while also maintaining structural integrity of the anchor portion26, and minimizing the stress and strain in the flexure portion76while facilitating a tight radius or loop. In one embodiment, the anchor actuator arms68may each include a coil (not shown) that may be wound around a portion of the actuator arm and over the flexure portion76with the ends of the coil secured to the anchor actuator arm68. Such coil may substantially capture the anchor actuator arm68from extending in undesirable locations in the LAA should there be a facture or break in the anchor actuator arm68.

Each flexure portion76of the anchor actuator arms68may extend to anchor v-extensions78such that the proximal ends of each anchor v-extension78may be coupled to proximal ends of adjacent anchor v-extensions78(similar to the occluder zig-zag portion52) to form the anchor zig-zag portion70. At the interconnection of the proximal ends of the anchor v-extensions78or the second end66of the anchor portion26, such proximal ends define an anchor eyelet80. The anchor eyelet80may be sized and configured to hingably couple to a corresponding occluder eyelet62of the occluder portion24, as shown by dotted lines84(seeFIG.3).

With respect toFIG.3A, the anchor struts or anchor v-extensions78of the anchor zig-zag portion70may include one or more hooks86or barbs that may extend at an acute angle88from the anchor portion26or anchor v-extensions and remote from the occluder portion24. Such acute angle88may range between about forty-five degrees and about sixty degrees. Further, the hooks86may extend from the anchor v-extensions78with a predetermined height90so as to provide effective engagement with a tissue wall within the LAA, but not to the extent of piercing all the way through the tissue wall to cause effusions in the LAA. The hooks also include a thickness92(seeFIG.2). Such thickness92may be similar to the thickness of sheet material from which the fame components (i.e., occluder portion24and anchor portion26) of the medical device20are cut.

With respect toFIG.3, the occluder portion24and the anchor portion26are depicted in a pre-formed state subsequent to being laser cut from a flat sheet or sheet material of, for example, super elastic material, such as Nitinol. As such, the occluder portion24and the anchor portion26, in the pre-formed state, may be substantially planar and flat, after which, the frame components of the occluder portion24and/or the anchor portion26may then be heat-set to a desired shape and configuration, as known to one of ordinary skill in the art, similar to the fully deployed configuration (seeFIG.2). Further, as known to one of ordinary skill in the art, other processes may be employed, such as chemical etching and electro-polishing of the frame components. The occluder portion24may include ten face struts50and ten base extensions48with ten occluder eyelets62extending from the occluder zig-zag portion52. Similarly, the anchor portion26may include ten anchor actuator arms68with ten anchor eyelets80extending from the anchor zig-zag portion70. It should be noted that the occluder portion24and anchor portion26may include more or less frame components, such as the respective face struts50and anchor actuator arms68, as known to one of ordinary skill in the art. As shown by dotted line84, occluder eyelets62may be configured to couple to corresponding anchor eyelets80with a hinge-like coupling arrangement. Such may be employed by directly interlocking the occluder eyelets62with the anchor eyelets80, as depicted inFIG.2.

In another embodiment, the fame components of the occluder portion24and the anchor portion26may be laser cut from tubular material, rather than a flat sheet. In this embodiment, the frame components may be laser cut, and then heat set to the desired configuration, similar to that shown inFIG.2. Various frame components of the occluder portion24and the anchor portion26may need to be modified as readily understood by one of ordinary skill in the art.

With reference toFIG.3B, in another embodiment, the occluder portion24and the anchor portion26may be hingably coupled together by aligning the occluder eyelets62with the anchor eyelets80and positioning an individual interlocking piece94(shown in outline) within and through each of the respective aligned eyelets62,80. Such an interlocking piece94may be a polymeric filament or the like. Ends96of the interlocking piece94may be heated to form a bulbous shape (not shown) at the ends96that, upon cooling, harden and maintain the bulbous shape so as to prevent the respective aligned eyelets from de-coupling. In this manner, the occluder and anchor eyelets62,80may be interlocked via the interlocking piece94to provide a hinged coupling arrangement for the anchor portion26to pivot relative to the occluder portion24and, more particularly, for the anchor portion26to pivot about the occluder eyelets62. In another embodiment, the interlocking piece94may be a metallic rivet press fitted through aligned eyelets to provide a hinged coupling arrangement.

Now with reference toFIG.4, a medical device delivery system100for delivering the medical device20to, for example, the LAA is provided. The medical device delivery system100may include the before-mentioned delivery system22, the medical device20, and a sheath102. The delivery system22may include a delivery catheter104coupled to a handle106with the medical device20operatively coupled to the handle106at a distal end of the delivery catheter104. The delivery catheter104may be sized and configured to be inserted through the sheath102such that the medical device20may be pushed through the sheath102to the distal end thereof. The medical device20may be partially exposed, at certain stages of delivery, as depicted. The functionality and detail of the various components of the medical device delivery system100will be described in detail hereafter.

With reference now toFIGS.5,5A, and5B, a distal portion of the delivery catheter104will now be described,FIG.5Abeing a cross-sectional view of the distal portion of the delivery catheter104along an axis106thereof depicted inFIG.5andFIG.5Bbeing an enlarged cross-sectional view of a portion of the same. The delivery catheter104may define a lumen108extending longitudinally therethrough between a proximal end (not shown) and a distal end110of the delivery catheter104. In one embodiment, the delivery catheter104may include a shaft (not shown), a spiral cut portion112, an inner distal tube114, and a collet116. Such distal portion of the delivery catheter104may include enhanced lateral flexibility along the region of the spiral cut portion112. That is, the distal portion of the delivery catheter104may be more flexible than portions of the delivery catheter104more proximal than the spiral cut portion112. The spiral cut portion112may be formed by spirally or helically cutting a slit into the peripheral structure of the distal portion of the delivery catheter104, as depicted. The inner distal tube114may be coupled to the delivery catheter104and within the lumen108of the distal portion of the delivery catheter104. The collet116may be positioned and thermally coupled to the distal end110of the delivery catheter104and within the inner distal tube114with collet fingers118extending distally therefrom. The collet fingers118may be sized and configured to latch to the hub of the medical device (not shown) with nubs120or protrusions extending from free ends of the collet fingers118. The collet fingers118are moveable outward, as indicated by arrows122, and are biased to an inward position as shown. The collet116and collet fingers118may be made from a metallic material, such as stainless steel or Nitinol, or any other suitable metallic material that can maintain a biasing force. Such inward biasing of the collet fingers118will be discussed in further detail hereafter. With respect to the enhanced flexibility of the delivery catheter104along the spiral cut portion112, such enhanced flexibility facilitates the medical device to self-center upon being deployed in the LAA. In other words, the radial strength of the medical device (not shown) may be greater than the lateral forces of the delivery catheter104along the spiral cut portion112to, thereby, allow the medical device to self-center in the LAA in instances where the axis106of delivery catheter cannot be made concentric to the ostium of the LAA during delivery and deployment of the medical device.

Now with reference toFIGS.6A,6B, and6C, description of steps that may be employed for loading the medical device20into the sheath102will now be provided. For example, the delivery catheter104may include a loader124sized and configured to facilitate loading the occluder portion24of the medical device20into the sheath102so that the delivery catheter104can push the occluder portion24through the sheath102to a distal portion thereof. With reference toFIG.6A, the loader124may include a tube portion126and a handle portion128. The loader124may be slideably positioned over the delivery catheter104such that the delivery catheter104extends through a bore defined through the loader124. The loader124may be moved over the distal end of the delivery catheter104and manually moved or forced over the occluder portion24of the medical device20so that occluder portion24moves to a constricted position enclosed within the tube portion126. However, prior to moving the loader124over the occluder portion24, the anchor portion should be in a non-deployed position such that an actuator knob and plunger shaft of the handle106should be moved to a proximal position, as depicted inFIGS.8and8A. Referring back toFIG.6A, once the loader124is moved completely over the occluder portion24, the medical device20may then be advanced through the sheath102. The sheath102, at this point, has already been advanced through the circulatory system to the heart with a distal portion of the sheath102positioned in the LAA (not shown), employing typical techniques known in the art.

As depicted inFIGS.6B and6C, the loader124may be inserted into the sheath102and, more particularly, a sheath hub130. The sheath hub130may be coupled at a proximal end of the sheath102. The components of the sheath hub130may include a valve132and a sheath fluid port134. The valve132may be a rotating hemostasis valve, such as a Touhy Borst valve or the like, configured to constrict or limit back-flow of blood from the sheath102upon rotation of the valve132. The sheath fluid port134may extend from the sheath hub130and may be sized and configured to flush or aspirate air from the sheath102that may become trapped upon loading the medical device20into the sheath102. In another embodiment, the loader124may also include a valve positioned around the delivery catheter104to maintain hemostasis while inserted into the sheath hub130.

As set forth, the loader124may be mated or inserted into the sheath hub130with a snap or click fit via nubs136at the distal end of the tube portion126and a rib (not shown) within a bore138defined in the sheath hub130. Once the loader124is positioned within the sheath hub130, the delivery catheter104may be advanced through a lumen defined longitudinally in the sheath102such that the distal end of the delivery catheter104moves to a distal portion of the sheath102to expose a distal tip of the occluder portion24of the medical device20from the distal end of the sheath102. With this arrangement, the distal tip of the occluder portion24may be exposed at the distal end of the sheath102and provides, due to the occluder material, a cushioned tip140, without any exposed metal frame members, facilitating an atraumatic entry into the LAA, thereby, reducing the potential of effusions in the LAA.

Referring toFIGS.7through11, deployment and detachment of the medical device20in an LAA5(shown in outline) relative to the delivery system22will now be described. With respect toFIGS.7and8, upon the physician positioning the distal portion of the sheath102in the LAA5with the medical device20positioned at the distal portion of the sheath102with the cushioned tip140of the occluder portion24exposed at the distal end of the sheath102, the physician may atraumatically position the distal portion of the sheath102to a desired location in the LAA5. Once the desired location is determined, the physician can deploy the occluder portion24of the medical device20. Such may be employed by simply withdrawing the sheath102or manually moving the sheath102in a proximal direction. As the sheath102is withdrawn, the occluder portion24self-expands to an occluder deployed position with the anchor portion26maintained in an anchor non-deployed position, as depicted inFIG.8.

With respect toFIG.8, a distal portion of the delivery catheter104coupled to the medical device20is shown. The delivery catheter104of this embodiment is coupled to the medical device20with an occluder hub nut142and collet116arrangement. For example, the distal portion of the delivery catheter104includes the inner distal tube114and an actuator shaft144. The actuator shaft144may include a layered coil, such as a speedometer cable, at a distal end portion thereof, which may be coupled to an inner distal connector146moveable within the collet116. As previously set forth, the collet116may include collet fingers118extending distally from the collet116. The inner distal connector146may include threads sized and configured to couple to the occluder hub nut142and, more particularly, to a threaded screw hole148defined in the occluder hub nut142. The occluder hub nut142, at a distal end thereof, may include the splined sleeve72. As previously set forth, the splined sleeve72may be sized and configured to couple end portions of each of the anchor actuator arms68. In another embodiment, the inner distal connector146and occluder hub nut142may be reversed such that the inner distal connector146includes a nut configuration and the occluder hub nut142includes a screw configuration. In either case, the medical device20may be threadably coupled to the delivery catheter104.

With reference toFIG.8A, one embodiment of the handle106is depicted. The handle106may include a handle housing150, an anchor actuator release button152, a plunger shaft154, and an actuator knob156. The handle housing150may be coupled to a proximal portion of the delivery catheter104. The plunger shaft154and actuator knob156is shown in a first position that correlates to the anchor portion26being in a non-deployed position (seeFIG.8). The plunger shaft154and actuator knob156may be moved bi-linearly between a first position and a second position while depressing the anchor actuator release button152. The functions and various components of the handle106will become apparent to one of ordinary skill in the art as discussed in further detail hereafter.

As depicted inFIGS.8and8A, the anchor portion26of the medical device20is in an anchor non-deployed position. The actuator knob156and plunger shaft154are moved to the first position, as indicated by arrow155that corresponds to the anchor non-deployed position prior to loading the medical device20into the loader124and then into the sheath102(seeFIGS.6A and6B). In the anchor non-deployed position, the inner distal connector146is threadably coupled to the occluder hub nut142and is positioned proximal the hub54with the anchor portion26in a first position or an anchors non-deployed position or, otherwise said, an anchors-in position with a portion of the anchor actuator arms68proximal the hub54and within a bore158defined in the hub54. Further, in the anchor non-deployed position, the plunger shaft154and knob156of the handle106may be in a proximal or first position as well. With this arrangement, a physician may determine the most favorable position of the medical device20within the LAA5with the occluder portion24in the deployed position prior to deploying the anchor portion26.

Now turning toFIGS.9and9A, the anchor portion26of the medical device20may be moved to an anchor deployed position or anchor-out or anchor second position once the physician determines the deployed occluder portion24is positioned in the LAA5as desired. Such anchor deployed position may be employed by manually moving the actuator knob156distally, as indicated by arrow160, while also depressing the release button152. In the anchor deployed position, the inner distal connector146and occluder hub nut142are also moved distally from the collet116and into the hub54or through the hub54. Such linear distal movement also moves the anchor actuator arms68, coupled to the splined sleeve72, from a distal portion of the delivery catheter104, through and out of the hub54to an everted, deployed position or an expanded position such that the anchor portion26unfolds and expands radially by pivoting or rotating at the hinged connection (i.e., at occluder and anchor eyelets62,80) between the occluder portion24and anchor portion26. At the anchor deployed position, hooks86or tines of the anchor portion26are sized and configured to grab tissue and prevent movement so as to effectively anchor the medical device20within the LAA5. Once the anchor portion26is deployed, the physician may view the medical device20through imaging techniques to ensure proper positioning of the medical device20in the LAA5while also performing stability tests by pulling proximally on the handle106to ensure the medical device20is effectively engaging the LAA5. Such imaging techniques may be enhanced by markers strategically located on the medical device20and delivery catheter104to provide imaging information to the physician. Such markers may be made from a radiopaque material, such as platinum, gold, tantalum, or alloys thereof, or any other suitable radiopaque materials that are biocompatible.

The hooks86of the anchor portion26may extend both distally and proximally so as to substantially prevent movement of the medical device20in both the proximal and distal directions relative to the LAA5. In one embodiment, the hooks86may include an acute angle88(FIG.3A) relative to the axis74of the medical device20or the struts of the anchor zig-zag portion70. The hooks86are configured to grab and may dig at the tissue of the LAA5. Such hooks86may be sized, oriented, and configured to prevent puncture or piercing of the hooks86all the way through the tissue of the LAA5, but provide effective and even aggressive engagement with the tissue to provide safe anchoring of the medical device20in the LAA5.

If the physician is dissatisfied with the location or engagement of the medical device in the LAA, the physician may readily disengage the anchor portion26from the tissue of the LAA by simply moving the actuator knob156in the proximal direction to the first position (FIG.8A), which simultaneously moves the actuator shaft144proximally and, thus, pivots the anchor portion26to a disengaged or anchor non-deployed position. The physician may then re-position the occluder portion24within the LAA5and, once satisfied with the location of the occluder portion24in the LAA5, the physician may readily move the actuator knob156forward or a distal direction to pivot and re-engage the anchor portion26with the tissue of the LAA5. The physician may then determine again through imaging and stability tests if the medical device20is positioned in the LAA5in an effective and safe manner that satisfies the physician. As can be readily understood, the steps of re-positioning the occluder portion24and re-engaging the anchor portion26of the medical device20can be repeated until the physician is satisfied.

Now referring toFIGS.10,10A, and10B, the functions of releasing the medical device20will now be described. The medical device20may be detached or released by unscrewing the inner distal connector146from the screw hole148defined in the occluder hub nut142. Such releasing may be employed by rotating the actuator knob156of the handle106counter-clockwise several turns, as indicated by arrow162, until the inner distal connector146unwinds from the screw hole148of the occluder hub nut142. The actuator knob156may then be pulled proximally back to the first position, as indicated by arrow164, while depressing the release button152, which facilitates movement of the inner distal connector146in the proximal direction. As the inner distal connector146is moved proximally through or into the collet116, the collet fingers118extending distally from the collet116collapse inward since the collet fingers118may be biased toward an inward position. In other words, prior to the inner distal connector146being unwound, the collet fingers118may be held in an outer position substantially concentric with the axis74of the medical device20, which maintains the delivery catheter104locked to the medical device20. The collet fingers118include outward extending nubs120that are held against an abutment166within the hub54(also shown inFIG.9). In this manner, once the inner distal connector146is unscrewed from the occluder hub nut142and moved to a proximal position away from the collet fingers118, the collet fingers118flexibly collapse with a bias to an inward position to move the nubs120away from the abutment166in the hub54, thereby, unlocking or unlatching the delivery catheter104from the medical device20. The delivery catheter104may then be removed from the medical device20with the collet fingers118collapsed and the nubs120moved proximally from the abutment166within the hub54as depicted inFIG.11.

With respect toFIGS.2and12, a moveable portion that may include a spring170is depicted. In one embodiment, the moveable portion may include a spring170with a polymeric covering in the form of polymeric flaps or occluder flaps36. Such moveable portion having the spring170may be sized and configured to close-off the bore158of the hub54once the delivery catheter104is released from the medical device20. The spring170may include a clover configuration or any other suitable configuration to effectively close-off the hub54. The spring170may move between a first biased position (or open first position) and a second relaxed position (or closed second position). The first biased position of the spring170(shown in outline form) is depicted inFIG.12, which is the position of the spring170with the delivery catheter104coupled to the hub54. In one embodiment, the position of the delivery catheter104attached to the hub54holds the spring170in the biased or open first position. Once the delivery catheter104is removed from the hub54, the spring170may automatically move to the closed, second relaxed position (seeFIG.2) with the occluder flaps36(see alsoFIG.1) substantially minimizing or eliminating any through hole on the proximal face and adjacent the hub54. In the second relaxed position of the spring170, the bore158defined in the hub54is substantially closed-off with occluder flaps36, leaving only a cross-like slit (as depicted by adjacently extending occluder flaps36inFIG.1) and substantially eliminating any metal exposed at the hub54. In this manner, the occluder flaps36, in the closed second position, advantageously provides a surface at the proximal face of the device without exposed metal at the hub54and, further, provides a contiguous surface with the polymeric material of the occluder portion that closes-off the hub54.

As previously set forth, the spring170may be embedded in the occluder material or tissue growth member28or attached to an inner occluder material surface such that the spring170may include various layers and/or folds of, for example, ePTFE, with one or more slits defining the flaps36that facilitates interconnection of the delivery catheter104to the hub54when the spring170is in the first biased position but then may substantially close-off the bore158defined in the hub54when in the second relaxed position. Such arrangement is advantageous to substantially prevent blood flow through the hub54or to substantially prevent the potential of migrating emboli or thrombus from the hub54itself once the medical device20is positioned in the LAA. In this manner, the spring170facilitates closing-off the through hole of the hub54and/or covers any exposed metal at the hub so that emboli or thrombus that may collect on the metal is prevented from escaping from the hub. In other words, the flaps36provide a substantially impassible barrier relative to otherwise potential migrating emboli or thrombus at the hub54.

Now referring toFIGS.13A and13B, actuation of the release button152of the handle106is depicted. The handle housing150defines a hole172that may extend along a longitudinal axis of the handle housing150and may be sized to hold the plunger shaft154to move bi-linearly therethrough. The handle housing150may also define a hollow portion174therein. The plunger shaft154may extend through the handle housing150and be coupled to components coupled to actuator shaft144and the inner distal connector146at the distal portion of the delivery catheter104(seeFIG.9). The handle106also may include a leaf spring176configured to bias against the release button152. The release button152may include a button post178. The leaf spring176may be coupled to the button post178to bias the release button152to a non-depressed position or first position. The plunger shaft154may also include two travel stops180fixed thereto. By depressing the release button152to a depressed position or second position, the button post178depresses the leaf spring176and moves within a cavity182. Once the button post178is moved within the cavity182, the travel stops180coupled to the plunger shaft154may then freely move distally (and then back proximally) past the button post178a predetermined distance gauged by the travel stops180within the hollow portion174defined by the handle housing150. In this manner, the plunger shaft154may move the predetermined distance which directly corresponds with the distance or length moved by the actuator shaft144and actuation of the anchor portion of the medical device20between the anchor non-deployed position and anchor deployed position (seeFIGS.8and9).

Referring back toFIG.8, in another embodiment, the sheath102may include an imaging device190. The imaging device190may be sized and configured to be positioned at a distal end of the sheath102and may include one or more lines192extending from the imaging device190and proximally toward the sheath hub130(FIG.5C) for transferring imaging information from the imaging device190to a computer and a display (not shown), as known to one of ordinary skill in the art, and viewable by the physician in real-time. The sheath102, upon being withdrawn from the occluder portion24, being positioned substantially concentric or proximal of the medical device20, may be at a vantage point and location in the left atrium adjacent the LAA to provide detailed imaging information otherwise not readily available to the physician. The imaging device190may be an ultrasound imaging device or any other suitable imaging device known in the art. In another embodiment, an imaging device190amay be positioned proximal a distal end of the delivery catheter104in a similar manner to that described above. In still another embodiment, the distal end of the delivery catheter104and/or sheath102may include one or more sensor devices191. The sensor devices191may be configured to sense pressure, flow, and any other cardiac dynamics that may be useful to the physician. In this manner, the sensor devices191and/or imaging device190,190amay provide additional information to assist the physician to accurately position the medical device20in the LAA5.

Now with reference toFIGS.14A and14B, another embodiment of a medical device200coupled to a distal portion of a delivery catheter202, the medical device200(depicted in a simplistic profile view) in a partially deployed position and fully deployed position, respectively, is provided. As in previous embodiments, the medical device200may include an occluder portion204and an anchor portion206that may be separately deployed. For example, once a sheath208is positioned in the LAA (not shown) with the medical device200at a distal end portion thereof, the sheath208is withdrawn to deploy an occluder portion204of the medical device200or to partially deploy the medical device200. Once the occluder portion204is deployed, then the anchor portion206may be deployed, to fully deploy the medical device200.

In this embodiment, the occluder portion204is substantially similar to the previous embodiment, except the tissue growth member210is attached to an outer surface of the frame components of the occluder portion204. The tissue growth member210of this embodiment may include similar layering of one or more materials as set forth for the tissue growth member described in detail relative toFIG.1B. Further, although the anchor portion206may be hingably coupled to the occluder portion204with a hinge arrangement212and, in many respects functions similar to the previous embodiment, the anchor portion206of this embodiment includes multiple separate and distinct anchor frame segments214, best shown inFIG.15.

With reference toFIG.15, the frame components of the occluder portion204and the anchor portion206are depicted in, for example, a preformed state subsequent to being laser cut from a flat sheet of super elastic material, such as Nitinol. For simplicity purposes, there is only one anchor frame segment214shown, but in this embodiment, there may be five anchor frame segments214to correspond and couple to, for example, occluder frame apertures216of the occluder portion204. As shown, the frame components of the occluder portion204may be substantially similar to the frame components of the occluder portion204described in the previous embodiment relative toFIG.3.

With respect to the anchor frame segments214, each anchor frame segment214may extend between a first end218and second end220with two actuator arms222extending therebetween such that each anchor frame segment214may exhibit a “Y” or “V” configuration in the pre-formed state. Each actuator arm222may include an anchor hinge aperture224at the second end220and, at the first end218, the actuator arm222may be coupled to a collar arrangement226or splined sleeve, similar to that of the previous embodiment. With this arrangement, the actuator arms222, as depicted inFIGS.14A and14B, may pivot about the occluder portion204at the hinge arrangement212. Further, the actuator arms222may form a loop configuration or loop extension in the anchor deployed position with the first end218of the actuator arms222moveable or actuatable through the hub228of the medical device200.

Now with reference toFIGS.16A,16B, and17, another embodiment of a medical device250depicted in a partially deployed position (FIG.16A) and a fully deployed position (FIG.16B), similar to previous embodiments, is depicted. In this embodiment, the occluder portion252can be similar to the previous embodiments, but the anchor portion254may include an anchor zig-zag portion256and loop extensions258or actuator arms as separate anchor frame components. In this embodiment, the medical device250may include a dual hinge arrangement. For example, the occluder portion252may be hingably coupled to an anchor zig-zag portion256with a first hinge arrangement260and the anchor zig-zag portion256may be hingably coupled to the loop extensions258with a second hinge arrangement262. The profile and functionality of the medical device250may be similar to the previous embodiments, except the loop extensions258may take a more direct inward angle from the anchor zig-zag portion256due to the second hinge arrangement262therebetween. Similar to the embodiment ofFIG.15, this embodiment may include ten loop extensions258or actuator arms, though for simplicity purposes only two loop extensions258(as a single loop extension segment) are shown inFIG.17. It should be noted that the embodiments ofFIGS.14and16also provide the feature to facilitate a cushion tip (not shown) as depicted inFIG.7when constricted in the sheath264. Further, it should be noted the embodiments depicted and described relative toFIGS.1,14and16include similar features and structure and, therefore, the descriptions provided in one embodiment may also be applicable to the other described embodiments.

Now with reference toFIGS.18through20, another embodiment of a medical device300and a medical device delivery system302for modifying an LAA5of the heart that facilitates imaging of the LAA5with contrast fluid304and an imaging device (not shown) is provided. In this embodiment, the structural components and functionality of the medical device300and the medical device delivery system302may be substantially similar to any one of the embodiments previously described. For example, the medical device300may include an occluder portion306and an anchor portion308, similar to that described above.

In this embodiment, upon the medical device300being positioned within the LAA5with the anchor portion308deployed and engaged with tissue of the LAA5, the medical device delivery system302and the medical device300may include a common flow path310defined therethrough for injecting a contrast fluid304through a hub312of the medical device300and to a distal side of the medical device300and into the LAA5. One important aspect of this embodiment may be that the occluder portion306of the medical device includes a substantially non-permeable material of, for example, a polymeric material, such as foam and/or ePTFE, described in earlier embodiments herein as the tissue growth member. In one embodiment, the ePTFE may be the material that is non-permeable. In this manner, a physician can determine whether the contrast fluid304is being substantially maintained within the LAA5on the distal side of the medical device300to assess whether the medical device300is properly positioned within the LAA5. Also, the physician can determine whether there are gaps between an outer periphery314of the medical device300and the tissue of the LAA5by viewing the contrast fluid304dissipating from the distal side of the medical device300, as discussed in further detail below.

In one embodiment, the occluder portion306of the medical device300may include a polymeric material, such as the before-described foam and/or ePTFE. In another embodiment, the polymeric material may include a bio-agent coated over or impregnated within the polymeric material. Such bio-agent may be configured to enhance tissue growth and endothelization over the proximal side of the occluder portion306of the medical device300. In another embodiment, the polymeric material may include a coating thereon that may be an anti-thrombotic coating, such as Heprin. In still another embodiment, the occluder portion may include a biological tissue, in addition to or instead of the before-described polymeric material. Such biological tissue may be a biological sourced tissue, such as pericardial tissue and/or peritoneum tissue, or any suitable biological tissue that is biocompatible as known in the art. Further, the biological tissue may be non-permeable, strong, and thin so as to readily be moved with the occluder portion frame structure between collapsed and expanded configurations. Further, the non-permeable characteristics of the pericardial tissue may function to substantially maintain contrast fluid304in the LAA5upon the medical device being positioned in the LAA. In another embodiment, the biological tissue may be permeable or include portions with permeable characteristics and other portions with non-permeable characteristics.

With reference toFIGS.18,18A and18B, the medical device delivery system302includes a sheath316, a delivery catheter318coupled to a handle320, and the medical device300coupled to a distal end of the delivery catheter318, similar to that described and depicted relative toFIG.4herein (as well as other embodiments herein). The delivery catheter318extends between a proximal end and a distal end such that the proximal end is coupled to the handle320and the distal end of the delivery catheter318is coupled to the implantable medical device300. Further, the delivery catheter318defines a lumen322extending along a longitudinal length of the delivery catheter318. The handle320may include a fluid port324sized and configured to directly communicate with the lumen322of the delivery catheter318. Also, the delivery catheter318may include an actuator shaft326(coupled to the handle320and actuatable by the actuator knob321) extending therethrough for controlling actuation of the anchor portion308of the medical device300. With this arrangement, fluid, such as contrast fluid304, may be injected through the fluid port324of the handle320and directly through the lumen322of the delivery catheter318such that the contrast fluid304may advance toward the medical device300. The contrast fluid304may be a radio opaque fluid or dye (or any other suitable contrast fluid) that is viewable through imaging techniques, such as fluoroscopy or any other suitable imaging technique, as known to one of ordinary skill in the art.

As in previous embodiments, the delivery catheter318and the medical device300coupled at the distal end thereof may be sized and configured to be pushed through a sheath lumen317defined along a length of the sheath316. The sheath316may also include a sheath fluid port328sized and configured to inject fluid, such as contrast fluid304, through the sheath lumen317and to exit from the distal end of the sheath316. Such injection of contrast fluid304through the sheath lumen317via the sheath fluid port328may provide additional information to the physician relative to imaging a proximal side of the medical device300upon being positioned in the LAA, discussed further herein.

The fluid, such as contrast fluid304, may be injected through the fluid port324of the handle320, as well as the sheath fluid port328of the sheath316, with an injection device330. In one embodiment, the injection device330may be a syringe for manual injection through the fluid port324of the handle320or through the sheath fluid port328of the sheath316. In another embodiment, the injection device330may include an injection machine that controls the pressure, amount, and/or flow rate of fluid being injected through the fluid port324of the handle320(or through the sheath fluid port328of the sheath316), as known to one of ordinary skill in the art.

Now with reference toFIGS.19and20, fluid, such as contrast fluid304, may flow through the lumen322of the delivery catheter318, as discussed above, and through the hub312(and components associated therewith) of the medical device300, the medial device300being positioned in the LAA5. As the contrast fluid304exits the hub312of the medical device300, as depicted by arrows332inFIG.19, the contrast fluid304mixes with the blood in the LAA5and is viewable via real-time imaging techniques, such as with a fluoroscopy or the like. Due to the occluder portion306having the substantially non-permeable material associated therewith, if the medical device300is properly positioned in the LAA5, the contrast fluid304may be substantially maintained within the LAA5, but for general seeping around the outer periphery314of the medical device300without an identifiable source or gap. In this manner, the physician can readily identify if the medical device is properly positioned within the LAA by viewing the contrast fluid304substantially maintained on a distal side of the medical device. The meaning of substantially maintaining contrast fluid304in the LAA means substantially containing, sustaining and/or retaining the contrast fluid in the LAA, except for general seeping along the outer periphery314.

If there is a gap between the outer periphery314of the medical device300and the tissue of the LAA5, the physician will readily ascertain and identify such gap due to the contrast fluid304moving through a localized portion from the LAA5such that contrast fluid is viewable in a concentrated flow or jet escaping the LAA5and moving proximally past the outer periphery314of the medical device300. If the physician determines there is a gap, the physician can readily retract the anchor portion308and re-position the medical device300in the LAA5and then deploy the anchor portion308to engage the tissue in the LAA5, as discussed in detail herein. The physician may then inject additional contrast fluid304through the hub312of the medical device300to determine if the medical device300is properly positioned. In addition, the physician may also inject contrast fluid304through the sheath316via the sheath fluid port328, as previously discussed, to view a proximal side of the medical device300in the LAA5, thereby, obtaining additional information relative to the position of the medical device300in the LAA5. Once the physician is satisfied with the position of the medical device300, the delivery catheter318may be de-coupled or detached from the medical device300, as previously set forth herein.

With respect toFIGS.20,20A, and20B, the flow path (depicted by arrows310inFIG.20) of the contrast fluid304flowing from the delivery catheter318and through the hub312will now be described. The flow path310extends through the lumen322of the delivery catheter318and surrounds and moves along a length of the actuator shaft326and the delivery catheter318. Section20C identified inFIG.20may be substantially similar to that described and depicted inFIG.18A, depicting the delivery catheter318defining the lumen322with the actuator shaft326positioned therethrough. The flow path310continues to advance along the collet336and then outward into a space334or channel defined between the collet fingers338(seeFIGS.20and20A). The flow path310continues advancing between an inner distal connector340and the delivery catheter318and then between the inner distal connector340and the medical device300(only the hub312is shown), as depicted inFIGS.20and20A. The hub312includes a guide ring342that may be embedded within the inner diameter or bore344defined in the hub312itself. Such guide ring342includes apertures346(seeFIG.20B) defined therein through which the flow path310extends. Such apertures346may include an annular space or partial annular configuration or space. In another embodiment, the inner diameter or bore may include an annular protrusion, instead of the guide ring342, such that the bore344between the annular protrusion and the inner distal connector340may define an annular space through which the flow path310extends (instead of the apertures346). Once the flow path310continues through the apertures346or annular space and past the guide ring342or annular protrusion in the bore344, the flow path310continues advancing through the bore344of the hub312and distally over the inner distal connector340. The inner distal connector340may include threads along an inner diameter thereof to couple to threads on a proximal end of the anchor hub350. The flow path310continues advancing through the hub312until exiting the hub312, as depicted with arrows332, so that contrast fluid304can enter the LAA5on the distal side of the medical device300, as shown inFIG.19. With this arrangement, each of the handle320, delivery catheter318and hub312of the medical device300includes a common, shared, or corresponding flow path310that facilitates contrast fluid304to exit a distal side of the medical device300. As such, a physician may view the medical device300positioned in the LAA5to determine if the contrast fluid304is being substantially maintained within the LAA (since the occluder portion includes a non-permeable material), but for minor general seeping along the outer periphery314of the medical device300contacting the LAA5. In this manner, the physician can obtain additional imaging information to ascertain whether the medical device300is properly positioned in the LAA5.

Now with reference toFIGS.21and22, another embodiment of a medical device360for positioning and securing within the ostium of a left atrial appendage, is provided. The medical device360of this embodiment may be employed with the previously described delivery systems herein, for example, the medical device delivery system302with its sheath316, delivery catheter318and handle320, described and depicted inFIG.18. Similar to previous embodiments, the medical device360may include an occluder portion362and an anchor portion364, the occluder portion362and anchor portion364including a frame structure or framework. Such frame structure may define an occluder frame366and an anchor frame368pivotably coupled to each other. In this embodiment, the occluder portion362with its frame structure may include different and additional structural features than previous embodiments. For example, the occluder portion362may include additional conformability with the anatomy as well as the occluder portion362may hold structural characteristics that enhance its ease for constricting within the sheath.

As set forth, the medical device360may include the anchor portion364. Similar to previous embodiments, the anchor portion364may include multiple anchor frame segments370extending between a first end372and a second end374. The first end372may be coupled to an anchor hub376or secondary hub. The second end374may include an anchor aperture378for pivotably coupling to the occluder portion362. Such pivotable coupling or connection may be a hingable coupling that may be formed with interlocking pieces371, similar to the interlocking pieces94described relative toFIG.3B.

In addition, the anchor frame segments370may include tines380at a distal position of the second end374of the anchor portion364. Further, the anchor frame segments370may extend distally from the second end374and then extend radially inward, and then extend proximally toward the first end372and the anchor hub376so that a distal most portion of the anchor portion364exhibits a loop type configuration or an arcuate component/configuration, similar to previous embodiments. Such distal most portion of the medical device360having the arcuate component or configuration so that the distal most portion of the medical device may be atraumatic to tissue within the left atrial appendage.

The occluder portion362may include a hub382or primary hub defining an axis384and may include occluder frame segments386and a tissue growth member388. The occluder frame segments386may extend from a proximal end390to a distal end392, the proximal end390coupled to the hub382and the distal end392configured to be coupled to the second end374of the anchor portion368. In one embodiment, the proximal end390may be pivotably coupled to the hub382, discussed in further detail herein. The occluder frame segments386may extend in a cup-like configuration defining an outer side surface or convex configuration and an inner side surface exhibiting a concave configuration. The outer side surface of the occluder frame segments386may be attached to the tissue growth member388also having the cup-like configuration.

The tissue growth member388may include one or more layers of tissue growth material layers. For example, the one or more layers may include one or more foam layers and/or one or more ePTFE layers. In one embodiment, the tissue growth member388may include a first layer394, a second layer396, and a third layer398. The first layer394may be a foam material, such as polyurethane foam or any other suitable polymeric material. The first layer394may be attached to the outer side surface of the occluder frame segments386by stitching or sewing the first layer394to the occluder frame segments386. In another embodiment, the first layer394may be adhesively attached and/or hooked to the occluder frame segments386. The second layer396may be smaller in size than the first layer394and may be disc shaped. The second layer396may be a foam material, similar to the first layer394, and may be adhesively attached to a proximal side and outer surface of the first layer394. The third layer398may be an ePTFE layer or other suitable polymeric material that induces tissue growth. The third layer398may include multiple ePTFE layers. The third layer398of the tissue growth member388may be adhesively attached to the outer surface of the first and second layers394,396or may be attached employing any other suitable affixing procedure. Further, the third layer398may be larger than both the first and second layers394,396such that the third layer398may extend more distal than the first layer394. In one embodiment, the third layer398may extend distal the first layer394and distal the occluder frame segments386.

With reference toFIG.23, the occluder frame366having occluder frame segments386are shown as cut from a flat sheet of material. In this depicted as-cut state, the occluder frame segments386may be a monolithic seamless structure exhibiting a star-like configuration with the occluder frame segments386extending from a central portion to an outer periphery of the star-like configuration. The proximal end390of each of the occluder frame segments386may be at the central portion and the distal end392of each of the occluder frame segments386may be at the outer periphery of the star-like configuration. The occluder frame segments386may include coupling frame segments400and intermediate frame segments402(or conforming or stabilizing frame segments), the intermediate frame segments402and coupling frame segments400extending to the outer periphery in an alternating manner such that the intermediate frame segments402extend between each of the coupling frame segments400. The coupling frame segments400may be thicker than the intermediate frame segments402. That is, the coupling frame segments400may include a greater width than the intermediate frame segments402. The intermediate frame segments402interconnect the coupling frame segments400with a v-configuration and may provide additional conformability of the occluder portion362with the anatomy of the left atrial appendage. The intermediate frame segments402provide additional support and points of contact to push and maintain the tissue growth member388(FIG.21) against the tissue so that the occluder portion362conforms and stabilizes the tissue growth member388against tissue in the left atrial appendage.

The coupling frame segments400, adjacent the proximal end390or central portion, may include a first opening404, a second opening406and a fixture holding piece408. The first opening404may be sized and configured to couple to retainer fingers430of the hub382(FIG.27), discussed in further detail herein. The second opening406may be sized and configured to stitch the first layer394of the tissue growth member388to the occluder frame segments386. The fixture holding piece408may be sized and configured to hold the occluder frame366through various frame preparation processes, such as electro-polishing. Once the preparation processes are complete the fixture holding piece408may be removed.

Further, adjacent the distal end392of each of coupling frame segments400, the coupling frame segments400may include an occluder aperture410and a third opening412. The occluder aperture410may be sized and configured to couple the occluder frame segments386to the anchor portion364in a pivotable or hinged manner. The third opening412may be utilized as another opening for stitching the first layer394of the tissue growth member388(FIG.22) to the occluder frame segments386.

Now with reference toFIG.24, the anchor frame368is depicted as-cut from sheet material, similar to previous embodiments, having a monolithic seamless structure. As in the previous embodiments, the anchor frame segments370of the anchor frame368may extend between the first end372and the second end374. The first end372or first end portion may define the anchor aperture378and the second end374or second end portion may include a hub coupling portion414. The anchor aperture378may be sized and configured to couple to the occluder aperture410defined in the occluder frame segments386to facilitate a pivotable or hinge connection. The hub coupling portion414may be coupled to the anchor hub376(FIG.22).

The anchor frame368may include an anchor tine portion416and extensions418extending between the first and second ends372,374to define the multiple anchor frame segments386. The extensions418may include a flexure portion420adjacently extending from the anchor tine portion416, the extensions418continuing to the hub coupling portion414and first end372of the anchor frame368. The anchor tine portion416may exhibit a zig-zag arrangement or strut segments422having multiple v-configurations coupled together. The anchor tine portion416may extend between the anchor apertures378and ends of the extensions418. Further, the anchor tine portion416may include one or more tines380extending from the strut segments422. In one embodiment, the strut segments422may include tines380extending proximally and distally. In another embodiment, some of the strut segments422may include tines380extending both proximally and distally with other ones of the strut segments422having tines380that only extend proximally toward the anchor aperture378.

With respect toFIGS.23and24, in one embodiment, the anchor frame368and occluder frame366may be laser cut from a flat sheet of super elastic material, such as Nitinol. The anchor frame368and occluder frame366may then be positioned with fixtures and heat-set in, for example, a sand bath to set and form the anchor frame368and occluder frame366in the shape as depicted inFIG.22. Upon the anchor frame368and occluder frame366being heat-set, the hub382may be secured to the proximal end390of the occluder frame segments386.

With respect toFIGS.25,25A,26, and26A, the hub382or primary hub is provided. The hub382may include a hub retainer424and a hub portion434. The hub retainer424, as depicted inFIGS.25and25A, may include a cylindrical portion426defining a retainer bore428extending therethrough. The cylindrical portion426may include retainer fingers430extending from one end thereof and extending and spaced evenly about a periphery of the one end of the cylindrical portion426. The retainer fingers430may extend radially from the one end to a free end432. Such retainer fingers430may be sized and configured to extend through the first opening404adjacent the proximal end390of the occluder frame segments386.

With respect toFIGS.26and26A, the hub portion434may include a somewhat cylindrical outer surface436and back-stop438in the form of a head portion, the hub portion434defining a hub bore440extending therethrough. The hub bore440may define the axis384of the medical device360(see alsoFIG.21). Further, the hub bore440may define structure sized and configured to interact with the delivery catheter, such as a circumferential recess442defined in the hub bore440.

With respect toFIGS.25A,26A and27, the hub382may be assembled and coupled to the occluder frame segments386. For example, the retainer fingers430may be inserted through the first opening404of the occluder frame segments386. The cylindrical outer surface436of the hub portion434may then be inserted and positioned within the retainer bore428so that the free end432of the retainer fingers430abut the back-stop438of the hub portion434, as depicted inFIG.27, so that the occluder frame segments386may be secured to the retainer fingers430. The hub retainer424and the hub portion434may be secured together via a weld or adhesive or any other suitable method, such as by welding a seam between the hub retainer424and the hub portion434. As previously set forth, the retainer fingers430of the hub retainer424may extend through corresponding first openings404of the occluder frame segments386such that the occluder frame segments386may be moveable, to an extent, over the retainer fingers430so that the occluder frame segments386may pivot at the proximal end390thereof over the retainer fingers430. With this arrangement, the occluder frame segments386may be pivotably coupled to the hub382at the proximal end390of the occluder frame segments386. Further, in this manner, the occluder portion362may readily constrict and pivot to an occluder constricted state within the sheath316of the delivery system302and, upon the occluder portion362being moved out of the sheath316, the occluder frame segments386may pivot so that the occluder portion362self-expands to a radially expanded position or occluder deployed position (seeFIG.18).

Now with reference toFIGS.28-35, various embodiments of an anchor portion, depicting various tine geometries, sized and configured to be coupled (or operatively coupled) to any one of the occluder portion embodiments set forth herein are provided. As such, any one of the anchor portion embodiments may be employed as the anchor portion to form a medical device, such as depicted inFIGS.1and21, sized and configured to implant within the left atrial appendage as described herein. Several considerations are made relative to tine geometries for a given anchor portion. The different structural characteristics of the various tine geometries depicted in the anchor portion embodiments herein may have preferable tine geometries dependent upon several factors relating to, for example, the structural characteristics and dimensions with a particular anchor portion and/or occluder portion of the medical device.

One consideration and aspect of tine geometry relates to a tine height of a given tine or tines of a given anchor portion. For example, increasing the tine height may provide increased anchoring effectiveness but may also increase the amount of potential tissue damage that may occur when the device is pulled upon with enough force to drag the tines through the tissue. Likewise, a decrease in tine height may lower the anchoring effectiveness and may decrease potential tissue damage upon pulling the device before it is detached from the delivery catheter. It has been found that a preferable tine height may be dependent upon several factors, such as tine angle and spacing between adjacent tines. In one embodiment, a preferable height of a tine may be about 0.032 inches and range between about 0.020 inches and about 0.050 inches. In addition, tines on struts that may be somewhat bowed may cause the tines to be more prominent than surrounding features of the device and, thus, may engage the tissue more reliably. Such prominence in the tines may increase the effective height of the tines and thus increase anchoring effectiveness, but may also create inconsistency in situations where the tines contact tissue at a rear wall of the left atrial appendage. In some embodiments and for consistency purposes, it may be preferable to limit bowing of the struts.

Another consideration of tine geometry relates to an angle that a given tine extends from a strut of the anchor portion. For example, minimizing an angle of the tines may improve the “grab” of the tines, but may also tend to hinder releasing the tissue upon retracting the anchor portion if re-positioning the device is desired. It has been found that an angle of the tine, relative to the strut it extends from, between about 25 degrees and about 60 degrees may be optimal for engaging tissue as well as releasing from the tissue. The tine height and spacing between adjacent tines may be factors for determining a preferred angle of the tines.

Another factor for tine geometry may include the alignment of the tines relative to the struts or axis of the device. For example, tines may be configured to align with the axis of the device. That is, tines may be formed to be non-aligned with the struts of the zig-zag pattern of an anchor portion such that the tines are substantially aligned with the axis of the medical device or such that a given tine may extend substantially within a plane defined by a given tine and the axis. The tines that may be aligned with the axis of the medical device may engage the tissue more securely, but also may cause more damage to the tissue when the device is pulled upon by the delivery catheter. On the other hand, tines aligned with struts that extend in the before-discussed zig-zag pattern, as depicted inFIGS.2and22herein, may not be aligned with the axis of the device such that a plane including the strut and the tines extending from the strut is transverse to the axis of the device. It has been found that tines aligned with the struts of the zig-zag pattern may provide sufficient grab for engaging tissue as well as provide better releasing of tissue so as to minimize any potential damage to the tissue.

Another consideration for tine geometries may include spacing and quantity of tines on a given strut of an anchor portion. For example, tines on a given strut that may be too close to another tine may lose engagement effectiveness due to load sharing. In other words, tines that are too close to another strut may result in a “bed of nails” effect. As such, adding additional tines in some cases or spacing between tines being too close may not result in higher retention forces. It is therefore desirable to have at least a pre-determined distance for the spacing between adjacent tines along a given strut for the tines to effectively engage the tissue in the LAA. Dependent upon several factors, such as tine angle and tine height, a preferred spacing between adjacent tines may be in the range of between about 0.060 inches and about 0.150 inches or the range between about 0.060 inches and about 0.120 inches.

Further, the sharpness of the tine tips may be another consideration relating to tine geometry. For example, sharper tine tips may yield better tissue engagement with a lower radial force. Another consideration for tine geometries may include tine flexibility, however, due to the height of the tines being minimal, the flexibility of the tines and the struts on which they extend from does not appear to be significant relative to the compliance of the tissue. In regard to the radial force of the anchor portion against the tissue, it has been found that increased radial force provided by the anchor portion and/or the occluder portion leads to increased retention against pull-out forces. Such increased radial force relative to increased retention appears to be a somewhat linear relationship.

As can be appreciated, there are several factors that may be considered relating to tine geometry. It is desirable for the tines of the anchor portion be reliable to effectively engage the tissue without extending completely through the tissue to potentially cause perfusions as well as tine geometries that readily release from the tissue upon retracting the anchor portion from the tissue in the LAA. Various embodiments of tine geometries associated with an anchor portion will now be described.

With respect toFIGS.28and28A, an anchor portion450may be formed from a flat sheet of metal, such as Nitinol, by for example, laser cutting, similar to that described in previous embodiments herein. Similar to previous embodiments, this embodiment of the anchor portion450may extend between a first end452and a second end454such that the first end452may couple to an anchor hub376(FIG.22) and the second end454may couple to a distal end or end portion of an occluder portion366(FIG.22). Further, similar to previous embodiments, the anchor portion450may include structure defining anchor struts456and anchor actuator arms458. The anchor struts456may extend to form multiple anchor v-extensions460to define an anchor zig-zag portion462. The anchor actuator arms458may extend from ends of the anchor v-extensions460to the first end452of the anchor portion450. Further, the anchor actuator arms458may define a flexure portion464that may extend with a radius from the anchor v-extensions460and may taper along such radius. The flexure portion464may include structural characteristics to facilitate actuating the anchor portion450between a retracted position and the deployed position, as set forth in previous embodiments. Further, the anchor portion450may define one or more apertures466formed in at least some of the anchor struts456of the anchor v-extensions460. For example, at the second end of the anchor portion or end of the v-extension, one of the apertures may be employed as a coupling aperture468or an anchor eyelet sized and configured to couple to the occluder portion similar to that depicted inFIG.3B. Further, for example, the one or more apertures466may be positioned along a portion or mid-portion of one of the anchor struts456so as to be sized and configured to receive a marker (not shown). The one or more apertures466sized to receive a marker may be included along every other anchor strut along the anchor zig-zag portion462of the anchor portion450.

In this embodiment, the anchor portion450may include anchor hooks470or tines extending along the anchor struts456of a given anchor v-extension460. For example, in a given anchor v-extension460of the anchor struts456, the anchor v-extension460may extend with a first strut472and a second strut474. Along the first strut472, the first strut may define one of the apertures466and the second strut474may extend continuously without an aperture. The first strut472may define multiple anchor hooks470or otherwise referenced as tines. Some of the anchor hooks470of the first strut472may be oriented to extend proximally and some of the anchor hooks470may be oriented to extend distally. The second strut474may also define multiple anchor hooks470. Such anchor hooks470of the second strut474may be oriented to extend proximally such that no anchor hooks extend distally along the second strut474.

In one embodiment, the anchor hooks470may extend relative to the anchor strut456at a first acute angle476and a second acute angle478. For example, the anchor hooks470may extend from a base480to a mid portion to define the first acute angle476. At the mid portion or mid-height of the anchor hooks470, the anchor hooks470may transition to the second acute angle478to further extend toward a tip482or end of the anchor hooks470, the first acute angle476being greater than the second acute angle478. In this manner, the anchor hooks470may be oriented to extend proximally and/or distally and then be further oriented to extend more proximally and/or more distally so as to exhibit a dual angled hook. In one embodiment, the first acute angle476may be about 70 degrees or within the range of about 45 degrees to about 75 degrees. The second acute angle478may be about 25 degrees or within the range to about 20 degrees to about 60 degrees.

In one embodiment, in a given anchor v-extension460, the first strut472may include three anchor hooks470that extend proximally and two anchor hooks470that extend distally. The second strut474may include four anchor hooks470that extend proximally. The aperture466sized for receiving a marker (not shown), as set forth above, may include one anchor hook470extending proximally at one side of the structure defining the aperture466and another anchor hook470extending distally at another side of the structure defining the aperture466such that the aperture466defines a transition between anchor hooks470extending proximally and distally. From this transition, the anchor hooks470extending proximally may be substantially evenly spaced relative to each other along the first strut472. The anchor hooks470extending distally may include a similar spacing or include a larger spacing as the anchor hooks470that extend proximally. Along the second strut474, the anchor hooks470that extend proximally may be substantially evenly spaced relative to each other. The spacing between anchor hooks470may be sized and configured such that each anchor hook470may effectively engage tissue without interfering with adjacently positioned anchor hooks470. As previously set forth, spacing of adjacent hooks on a given strut that are too close may result in load sharing and may lose their individual engagement or anchoring effectiveness. For example, spacing486between adjacently extending hooks may be about 0.065 inches or may be in the range of about 0.06 inches to about 0.12 inches.

The anchor hooks470that extend proximally and distally may include a common height484relative to the first or second strut472,474, the height484defined from the base480to the tip482. Such height484may be a predetermined height sized to facilitate engagement, or even aggressive engagement, of the tissue in the LAA, but a height sized to not puncture all the way through the tissue at or adjacent the ostium of the LAA. For example, the height484may be about 0.032 inches or within the range of about 0.020 inches and about 0.050 inches. Further, the depth or thickness92(FIG.2) of each anchor hook470may be defined by the thickness of the flat sheet from which the anchor portion450is cut. As such, the tip482of the anchor hooks470may define an edge, the edge defined by the thickness of the sheet material. In one embodiment, the sheet material employed may be sized such that the tip of the anchor hooks defines a point. In this manner, the thickness of the sheet material employed for cutting the anchor portion470may directly correlate with whether the tip defines an edge or resembles more a point. Other factors that may be effective to reduce an edge to a point may include the manufacturing processes of abrasive blasting and/or electropolishing.

With respect toFIG.29, another embodiment of an anchor portion490with anchor hooks492extending from anchor struts494of the anchor portion490is provided. This embodiment may be similar to the previous embodiment, except in this embodiment first and second struts496,498of the anchor v-extension500may define less anchor hooks492than the previous embodiment. For example, the first strut496may define multiple anchor hooks492, such as two anchor hooks that extend proximally and one anchor hook that extends distally. Further, the second strut498may include three anchor hooks492that extend proximally. The anchor hooks492of the second strut498may be evenly spaced relative to each other so as to define a spacing508. The spacing508of the anchor hooks492that extend proximally of both the first and second struts496,498may include a substantially common spacing508between the anchor hooks492. For example, the spacing508of adjacently extending anchor hooks492of this embodiment may be about 0.100 inches or range between about 0.060 inches and about 0.120 inches. In addition, the anchor hooks492may include a height509, the height509being about 0.032 inches and include similar ranges as set forth in the previous embodiment. Further, similar to the previous embodiment, each of the anchor hooks492may extend proximally or distally with a first acute angle502and a second acute angle504to exhibit a dual angled hook such that the first acute angle502may be greater than the second acute angle504. Such first and second acute angles502,504may include similar angle ranges as set forth in the previous embodiment. As in the previous embodiment, at the aperture506sized for a marker defined in the first strut496, only one anchor may extend from the structure defining such aperture506, rather than two anchor hooks as set forth in the previous embodiment.

With respect toFIG.30, another embodiment of an anchor portion510with anchor hooks512extending from anchor struts514of the anchor portion510is provided. In this embodiment, the anchor hooks512may extend along a first strut516and a second strut518of a given anchor v-extension520. Along the first strut516, the anchor hooks512may extend both proximally and distally. For example, the first strut516may include two anchor hooks512extending proximally and two anchor hooks512that extend distally. The two anchor hooks512extending proximally may include a spacing526which may be common or substantially similar to the spacing between the two anchor hooks512that extend distally. Such spacing526may be about 0.100 inches and may range between about 0.060 inches and about 0.120 inches. Further, the first strut516includes structure defining an aperture522such that one anchor hook extends proximally from the structure that defines the aperture522and another anchor hook extends distally from the structure that defines the aperture522. The second strut518may include three anchor hooks512extending proximally such that each of the three anchor hooks512include a substantially common spacing relative to adjacently extending anchor hooks512. Similar to other embodiments set forth herein, each of the anchor hooks512may define a single acute angle524relative to and extending from the anchor strut from which the anchor hook512extends from. Such single acute angle524of a given anchor hook512may be about 30 degrees and may extend in the range of about 25 degrees to about 60 degrees. Further, a height528of the anchor hooks512may be about 0.032 inches and may range between about 0.020 inches and about 0.050 inches.

In another embodiment, as depicted inFIG.31and similar to the previous embodiment ofFIG.30, an anchor portion530with first and second struts532,534may include additional anchor hooks536along each of the first and second struts532,534of anchor v-extensions538of the anchor portion, the anchor hooks536having a similar angle and height with similar ranges as the previous embodiment. For example, the first strut532may include three anchor hooks536extending proximally and two anchor hooks536extending distally. The second strut534may include four anchor hooks536extending proximally without any anchor hooks that extend distally. Further, a spacing539between proximally extending anchor hooks536may be common or substantially similar with the spacing between distally extending anchor hooks536. For example, the spacing539between adjacent anchor hooks536that extend in common directions may be about 0.073 inches or range between about 0.060 inches and about 0.120 inches.

Further, in another embodiment, as depicted inFIG.32and similar to the embodiment ofFIG.30, an anchor portion540with first and second struts542,544may include less anchor hooks546extending from anchor v-extensions548of the anchor portion540. For example, the first strut542may include three anchor hooks546, two anchor hooks extending proximally and one anchor hook extending distally. The second strut544may include two anchor hooks546extending proximally without any anchor hooks extending distally. Further, the anchor hooks546may define a height and angle similar to the previous embodiment with similar ranges, but a spacing549defined between the anchor hooks546may be different than the previous embodiments. For example, the spacing549between proximally extending anchor hooks546may be about 0.120 inches or between about 0.100 inches and about 0.150 inches.

In still another embodiment, as depicted inFIG.33, an anchor portion550with anchor hooks552extending from first and second struts554,556of anchor v-extensions558of the anchor portion550may be smaller in height than that depicted in previous anchor hook embodiments. For example, the anchor hooks552may define a height559of about 0.020 inches and a range of about 0.015 inches to about 0.030 inches. Further, a spacing557between commonly extending adjacent anchor hooks552may be about 0.073 inches and range between about 0.060 inches and about 0.120 inches. The anchor hooks, similar to previous embodiments, may define an acute angle of about 30 degrees or be in the range of about 25 degrees and about 60 degrees.

With respect toFIG.34, in another embodiment, an anchor portion560may include first and second struts562,564with minimal anchor hooks566extending from anchor v-extensions568of the anchor portion560. For example, the first strut562may include a single anchor hook566extending proximally and a single anchor hook566extending distally. The second strut564may include a single anchor hook566extending proximally therefrom. Further, the anchor hooks566may extend with an acute angle570. The acute angle570may be about 45 degrees or in the range of about 25 degrees to about 60 degrees. The anchor hooks566may extend to a point572or an edge at a free end thereof to define a height574relative to the corresponding first strut562or the second strut564. For example, the height574of the anchor hooks566may be about 0.050 inches. In comparison to previous embodiments, the height574and angle570of the anchor hooks566may be more prominent to anchor hooks of previous embodiments, but may also include a fewer number of anchor hooks566. In another embodiment, the height may be about 0.032 inches and range between about 0.020 inches and about 0.060 inches.

With respect toFIG.35, another embodiment of an anchor portion580is provided. In this embodiment, the anchor portion580may be cut from a flat sheet of, for example, Nitinol in a radial arrangement or radial pattern, similar to the occluder portion366depicted inFIG.23. The anchor portion being cut in the radial arrangement may be heat-set to a formed shape similar to the anchor portions of previous embodiments, depicted for example inFIGS.2and22. Upon being heat-set and formed as desired, the anchor portion580may extend between a first end582and a second end584. The first end582may couple to an anchor hub376(FIG.22) and the second end584may couple to a distal end or end portion of an occluder portion366(FIG.22), similar to previous embodiments. The anchor portion580may define anchor actuator arms586extending from ends of anchor v-extensions588, the anchor v-extensions588continuously extending to define an anchor zig-zag portion590. Each of the anchor v-extensions588may define a first strut592and a second strut594extending to exhibit a v-configuration. As in previous embodiments, the first and second struts592,594may include anchor hooks596or tines extending therefrom. In this embodiment, the first strut592may include two anchor hooks596and the second strut594may include one anchor hook596, similar to the previous embodiment depicted inFIG.34. Such first and second struts592,594may include additional anchor hooks596or less or any one of the anchor hook variations and structural characteristics of the tine geometries as set forth in any one of the anchor portion embodiments described herein. In other words, any one of the anchor portion embodiments described herein may be cut from a flat sheet in a radial arrangement or radial pattern, similar to that set forth inFIG.35.

Now with reference toFIGS.36and37, another embodiment of a medical device600, similar to that described and depicted relative toFIGS.21and22, except in this embodiment the occluder portion may include alternate occluder materials. As in previous embodiments, the medical device600of this embodiment may include an anchor portion602and an occluder portion604. The anchor portion602may be formed from any one of the anchor portion embodiments cut from, for example, a flat sheet as set forth herein to a radially extending position, as depicted inFIG.36, through a heat-setting process as known to one of ordinary skill in the art. Further, as in previous embodiments, a first end606of the anchor portion602may be coupled to an anchor hub610and a second end608of the anchor portion602may be hingeably or pivotably coupled to a distal end612of the occluder portion604with a proximal end614of the occluder portion604being coupled to a hub616with a first part618and a second part620. With this arrangement, the anchor portion602may be movable between retracted and deployed positions with the anchor hub610being moveable along an axis622between respective proximal and distal positions while the occluder portion is in an expanded position, as described herein.

In this embodiment, the occluder portion604may include an occluder frame portion624and a tissue growth member626. The tissue growth member626may also be referenced as an occluder material portion or a polymeric material portion. The occluder frame portion624may also be formed from any one of the occluder frame embodiments cut from a flat sheet of, for example, Nitinol, as set forth herein to a radially extending position, as depicted inFIG.36, through a heat-setting process. In another embodiment, the occluder frame portion and/or the anchor portion may be cut from tubular stock, rather than from a flat sheet, and then may be formed into the radially extending positions, as depicted inFIG.36.

With reference toFIGS.36and37A, in one embodiment, the tissue growth member626may include multiple layers and portions. For example, the tissue growth member626may include an inner portion628and an outer portion630with a middle portion632positioned therebetween. Such tissue growth member626may include similar structural characteristics to that described relative toFIG.22, such as, being impermeable or impervious so as to not allow blood to flow through the tissue growth member. In one embodiment, the inner portion628may be positioned so that an inner surface634of the inner portion628extends over and directly contacts an outer surface636of the occluder frame portion624with at least one layer of a polymeric material, such as a woven or non-woven material. With this arrangement, the inner portion628may be adhesively attached and/or stitched with filaments to the outer surface636of struts638of the occluder frame portion624. Further, in this embodiment, the inner portion628may be formed with one or more layers of a polymeric material. The polymeric material may include one or more filaments that may be a knitted, weaved, or braided fabric or combinations thereof so as to provide a regular or substantially consistent pattern to form, for example, a mesh material. In another embodiment, the polymeric material may include one or more filaments formed in a random or arbitrary pattern. In another embodiment, the polymeric material may be made from any suitable medical grade polymeric material, such as polyester, polypropylene, or polyethylene, or any other medical grade polymeric material, or the like.

In another embodiment, the inner portion628may be a non-woven fabric. The non-woven fabric may be formed of polymeric filaments. For example, the non-woven fabric may be formed with random fibers that may be adhered together with various processes, such as heat pressing or with solvents as known by one of ordinary skill in the art, or any other suitable process for forming a non-woven fabric.

The middle portion632may be sized and configured to be positioned symmetrically along the axis622and over a central portion of the inner portion628and adjacent the hub616of the occluder frame portion624. The middle portion632of the tissue growth member626may serve as a reinforcement layer. Such middle portion632may be desirable due to the increased stresses and tension resulting from pulling and constricting the medical device600within the sheath102of the medical device delivery system100(FIG.4), the stresses over the medical device600being optimal adjacent the hub61of the occluder portion604. The middle portion632may be disc shaped and may extend with less surface area than the inner and outer portions628,630of the tissue growth member626. The middle portion632may be a polymeric material, such as a woven or non-woven fabric material described herein or any other suitable polymeric material that may serve as a reinforcement layer. As such, the middle portion632may be formed of a similar or the same material as the inner portion628. Further, the middle portion632may be adhesively attached to an outer surface of the inner portion628or stitched thereto with filaments.

The outer portion630of the tissue growth member626may be positioned over the outer surface or proximal side of the middle portion632and inner portion628. The outer portion630may be formed with successive layering of polymeric materials each of which may be adhesively attached over the other. As in previous embodiments, the outer portion630of the tissue growth member626may be formed of multiple polymeric layers, such as ePTFE, defining, for example, a first layer640, a second layer642, and a third layer644. In another embodiment, additional or less successive layering may be employed to form the outer portion630. It should be noted that the tensile strength of some polymeric materials, such as ePTFE, may be strongest in a first direction and weakest in a direction ninety degrees out-of-phase or orthogonal relative to the first direction. As such, the successive layering of adjacent layers of the outer portion630may be transverse or out-of-phase to each other relative to their respective strongest direction of tensile strength. In this manner, the multiple layers of the outer portion630may be successively or consecutively attached to each other and formed to bolster the strength of the outer portion630.

With respect toFIG.37A, in another embodiment, the tissue growth member626may include a hydrophilic coating652, represented by a dashed line. The hydrophilic coating652may be sized and configured to promote wettability of the tissue growth member626for purposes of imaging the device as well as act as a lubricant to minimize friction between the tissue growth member and the inner surface of the sheath102(seeFIG.4) as the device is delivered and advanced through the sheath102, as described herein. Such hydrophilic coating652may be coated over the exposed portions of the tissue growth member626or may be coated over the outer surface of the outer portion630of the tissue growth member626. The hydrophilic coating652may sprayed over portions of the tissue growth member626or the tissue growth member626may be dipped into a hydrophilic solution such that the hydrophilic solution may be integrated within the crevices of the tissue growth member626as well as cover the outer surfaces of the tissue growth member626. The hydrophilic coating652of the tissue growth member may be any suitable medical grade hydrophilic coating material, as known to one of ordinary skill in the art.

With respect toFIGS.36and37, the outer portion630may define a distal end portion646that extends further distally then a distal end648of the inner portion628of the tissue growth member626. As such, the distal end portion646of the outer portion630may extend radially in the form of a ring without contacting the inner portion628of the tissue growth member626. In another embodiment, the outer portion630and the inner portion628may extend distally a substantially equal amount. In still another embodiment, the inner portion628may define a distal end portion that extends further distally beyond a distal end of the outer portion, similar to that depicted inFIG.1A.

Upon the medical device600being implanted in the LAA, the inner portion628of the tissue growth member626may face and be exposed to the LAA and the outer portion630of the tissue growth member626may face and be exposed to the left atrium of the heart. As set forth, the inner portion628may be formed of a polymeric material, such as a woven or non-woven fabric or the like. The woven or non-woven fabric may include structural characteristics configured to aggressively promote and enhance tissue growth within and over the polymeric layer. The outer portion630, also being formed of a polymeric material such as ePTFE, may include structural characteristics to promote the formation of a smooth endothelization layer over the proximal side or outer surface of the tissue growth member626. In this manner, the medical device600may be implanted to permanently occlude the LAA.

While the invention may be susceptible to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and have been described in detail herein. However, it should be understood that the invention is not intended to be limited to the particular forms disclosed. Rather, the invention includes incorporating any portion of one embodiment with another embodiment, all modifications, equivalents, and alternatives falling within the spirit and scope of the invention as defined by the following appended claims.