Patent Publication Number: US-10758240-B2

Title: Medical device for modification of left atrial appendage and related systems and methods

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     The present application is a continuation of U.S. patent application Ser. No. 15/094,254, filed Apr. 8, 2016, which claims the benefit of U.S. Provisional No. 62/148,317, filed on Apr. 16, 2015. Further, U.S. patent application Ser. No. 15/094,254 also claims benefit to, and is a continuation-in-part of, U.S. patent application Ser. No. 14/308,695, filed Jun. 18, 2014, now issued as U.S. Pat. No. 9,649,115, which in turn claims benefit to U.S. Provisional Application No. 61/837,628, filed on Jun. 20, 2013. Further, U.S. patent application Ser. No. 14/308,695 claims benefit to, and is a continuation-in-part of, U.S. patent application Ser. No. 13/666,612, filed Nov. 1, 2012, now issued as U.S. Pat. No. 9,693,781, which in turn claims benefit to U.S. Provisional Application No. 61/553,948, filed on Nov. 1, 2011, and U.S. Provisional Application No. 61/661,799, filed on Jun. 19, 2012. Further, the above-listed U.S. patent application Ser. No. 13/666,612 claims benefit to, and is a continuation-in-part of, U.S. patent application Ser. No. 12/818,046, filed on Jun. 17, 2010, now issued as U.S. Pat. No. 8,636,764, which in turn claims benefit to the following U.S. Provisional Patent Applications: U.S. Provisional Application No. 61/345,514, filed on May 17, 2010; U.S. Provisional Application No. 61/325,230, filed on Apr. 16, 2010; U.S. Provisional Application No. 61/320,635, filed on Apr. 2, 2010; U.S. Provisional Application No. 61/294,058, filed on Jan. 11, 2010; and U.S. Provisional Application No. 61/218,018, filed on Jun. 17, 2009. The disclosures of each application listed above are incorporated by reference herein in their entireties. 
    
    
     TECHNICAL FIELD 
     The present invention relates generally to the occlusion or modification of tissue openings or appendages and, more specifically, to devices, systems and methods for occluding or otherwise structurally altering such openings and appendages including, for example, left atrial appendages. 
     BACKGROUND 
     The upper chambers of the heart, the atria, have appendages attached to each of them. For example, the left atrial appendage is a feature of all human hearts. The physiologic function of such appendages is not completely understood, but they do act as a filling reservoir during the normal pumping of the heart. The appendages typically protrude from the atria and cover an external portion of the atria. Atrial appendages differ substantially from one to another. For example, one atrial appendage may be configured as a tapered protrusion while another atrial appendage may be configured as a re-entrant, sock-like hole. The inner surface of an appendage is conventionally trabeculated with cords of muscular cardiac tissue traversing its surface with one or multiple lobes. 
     The atrial appendages appear to be inert while blood is being pumped through them during normal heart function. In other words, the appendages don&#39;t appear to have a noticeable effect on blood pumped through them during normal heart function. However, in cases of atrial fibrillation, when the atria go into arrhythmia, blood may pool and thrombose inside of the appendages. Among other things, this can pose a stroke risk when it occurs in the left appendage since the thrombus may be pumped out of the heart and into the cranial circulation once normal sinus rhythm is restored following arrhythmia events. 
     Historically, appendages have sometimes been modified surgically to reduce the risk imposed by atrial fibrillation. In recent years devices which may be delivered percutaneously into the left atrial appendage have been introduced. The basic function of these devices is to exclude the volume within the appendage with an implant which then allows blood within the appendage to safely thrombose and then to be gradually incorporated into cardiac tissue. This process, coupled with the growth of endothelium over the face of the device, can leave a smooth, endothelialized surface where the appendage is located. In comparison to surgical procedures, devices implanted percutaneously are a less invasive means for addressing the problems associated with the left atrial appendage. 
     However, due to the wide variability of the ostium size and volume of the left atrial appendage, current implantable devices conventionally include a structure that cannot meet such variability, resulting in inadequate devices for many left atrial appendage anatomies. Further, such implantable devices are substantially limited by the orientation by which they can successfully be deployed. As such, it would be advantageous to provide a percutaneous system, method and/or device that addresses, for example, the issues of implant orientation, the variability in sizes and shapes of the left atrial appendage, or all of these, in order to provide high success in left atrial appendage modification. It would also be desirable to provide a device, system and method that enables easy positioning and repositioning of the device relative to the structure being modified or occluded including the positioning (or repositioning) of an occluder portion independent of other components or features of the device. 
     A variety of features and advantages will be apparent to those of ordinary skill in the art upon reading the description of various embodiments set forth below. 
     BRIEF SUMMARY OF THE INVENTION 
     Embodiments of the present invention are directed to various devices, systems and methods of occluding an opening in the tissue of a body. For example, in one embodiment, a medical device for modifying a left atrial appendage of a heart, is provided. The medical device includes an anchor portion and an occluder portion. The anchor portion includes anchor frame segments, each anchor frame segment extending between a first end and a second end, the second end of each anchor frame segment coupled to an anchor hub. The occluder portion includes a hub that defines an axis. The occluder portion includes multiple occluder frame segments that extend between a proximal end and a distal end. The proximal end of the occluder frame segments is pivotably coupled to the hub. Further, the distal end of the occluder frame segments is pivotably coupled to the first end of the anchor frame segments. 
     In one embodiment, the anchor hub is moveable along the axis to move the anchor portion between a retracted position and a deployed position. In another embodiment, the anchor hub is moveable along the axis to move at least a portion of the anchor portion through the hub. 
     In another embodiment, the occluder portion includes a tissue growth member. Further, in still another embodiment, the occluder portion includes at least one of a foam material and ePTFE. In another embodiment, the occluder frame segments and the anchor frame segments include a super elastic material. In a further embodiment, the super elastic material includes a Nitinol material. 
     In accordance with another embodiment of the present invention, a medical device for modifying a left atrial appendage of a heart, is provided. The medical device including an occluder portion and an anchor portion. The occluder portion includes a hub defining an axis, the occluder portion including a framework extending between a proximal end and a distal end, the proximal end of the framework coupled to the hub. The anchor portion extends between a first end and a second end, the first end pivotably coupled to the distal end of the framework, the second end coupled to an anchor hub. With this arrangement, the anchor hub is moveable along the axis proximally to move the anchor portion to an anchor retracted position with a portion of the anchor portion moveable through the hub and the anchor hub is moveable along the axis distally to move the anchor portion to an anchor deployed position. 
     In one embodiment, upon the anchor portion moving to an anchor retracted position, the occluder portion maintains a deployed position. In another embodiment, the anchor portion includes extensions extending distally adjacent to tines of the anchor portion and continuously extending inward and then extending proximally to the anchor hub. 
     In another embodiment, the occluder portion includes a tissue growth member. In another embodiment, the occluder portion includes at least one of a foam material and ePTFE. In still another embodiment, the framework includes a super elastic material. In a further embodiment, the super elastic material includes a Nitinol material. 
     In accordance with another embodiment of the present invention, a medical device for modifying a left atrial appendage of a heart, is provided. The medical device includes a framework including a hub that defines an axis. The framework includes a tissue growth member extending over a proximal side of the framework, the framework including an anchor portion extending distal of the tissue growth member, the anchor portion including tines configured to attach to the left atrial appendage. Further, the framework includes extensions extending distally adjacent from the tines, the extensions continuously extending distally and inward and then extending proximally to a secondary hub. 
     In one embodiment, the secondary hub moves along the axis, wherein, upon the secondary hub moving along the axis, the framework moves between a non-deployed position and a deployed position. In another embodiment, the secondary hub moves proximally and distally along the axis, wherein, upon the secondary hub moving proximally, the framework moves to a non-deployed position and, wherein, upon the secondary hub moving distally, the framework moves to a deployed position. In another embodiment, the secondary hub is moveable along the axis relative to the hub. 
     In another embodiment, the tissue growth member includes at least one of a foam material and ePTFE. In another embodiment, the framework includes a super elastic material. In still another embodiment, the super elastic material includes a Nitinol material. 
     These various embodiments may include other components, features or acts as will be apparent from the detailed description set forth below. Additionally, other embodiments, configurations and processes are set forth below in the detailed description of the invention. 
    
    
     
       BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS 
       The foregoing and other advantages of the invention will become apparent upon reading the following detailed description and upon reference to the drawings in which: 
         FIG. 1  is a perspective view of a medical device and a distal portion of a delivery system, according to one embodiment of the present invention; 
         FIG. 1A  is a partial cross-sectional view of the medical device, taken along section line  1 A of  FIG. 1 , according to another embodiment of the present invention; 
         FIG. 1B  is an enlarged section view of an occluder portion, taken from detail  1 B of  FIG. 1A , according to another embodiment of the present invention; 
         FIG. 2  is a perspective view of the medical device of  FIG. 1 , depicting the frame without its tissue growth member, according to another embodiment of the present invention; 
         FIG. 3  is a top view of frame components of the occluder portion and the anchor portion of the medical device of  FIG. 2 , depicting frame components laser cut from a flat sheet prior to being assembled, according to another embodiment of the present invention; 
         FIG. 3A  is a partial enlarged view of the anchor portion depicted in  FIG. 3 , according to another embodiment of the present invention; 
         FIG. 3B  is an enlarged view of a hinged coupling between the occluder portion and the anchor portion of the medical device, according to another embodiment of the present invention; 
         FIG. 4  is a perspective views of a medical device delivery system, according to another embodiment of the present invention; 
         FIG. 5  is a side view of an end portion of a delivery catheter, according to another embodiment of the present invention; 
         FIG. 5A  is a cross-sectional view of the end portion of the delivery catheter, taken along a longitudinal axis of the delivery catheter of  FIG. 5 , according to another embodiment of the present invention; 
         FIG. 5B  is an enlarged view of the end portion of the delivery catheter, according to another embodiment of the present invention; 
         FIGS. 6A-6C  are perspective views of a loader, depicting the loader being pushed over an occluder portion of the medical device, the medical device inserted into a sheath, and pushed to a distal end of the sheath, respectively, according to another embodiment of the present invention; 
         FIG. 7  is a side view of a distal portion of the sheath, depicting a portion of the medical device exposed at a distal end of the sheath in the LAA, according to another embodiment of the present invention; 
         FIG. 8  is a cross-sectional side view of the distal portion of the delivery system and the medical device, depicting a sheath withdrawn to deploy the occluder portion of the medical device in the LAA and depicting the anchor portion in an anchor non-deployed position, according to another embodiment of the present invention; 
         FIG. 8A  is a side view of a handle, depicting the handle in a first position corresponding to the anchor non-deployed position, according to another embodiment of the present invention; 
         FIG. 9  is a cross-sectional side view of the distal portion of the delivery system and the medical device, depicting both the occluder portion and the anchor portion in an anchor deployed position in the LAA, according to another embodiment of the present invention; 
         FIG. 9A  is a side view of the handle, depicting the handle in a second position corresponding to the anchor deployed position, according to another embodiment of the present invention; 
         FIG. 10  is a cross-sectional side view of the distal portion of the delivery system and the medical device, depicting the delivery system in the process of being released from the medical device in the LAA, according to another embodiment of the present invention; 
         FIG. 10A  is a side view of the handle, depicting a portion of the handle being rotated for releasing the medical device, according to an embodiment of the present invention; 
         FIG. 10B  is a side view of the handle, depicting a portion of the handle actuated from the second position to the first position, according to an embodiment of the present invention; 
         FIG. 11  is a cross-sectional side view of the distal portion of the delivery system and the medical device, depicting the delivery catheter fully released from the medical device, according to another embodiment of the present invention; 
         FIG. 12  is a partial perspective view of the proximal side of the medical device coupled to the delivery system, according to another embodiment of the present invention; 
         FIGS. 13A and 13B  are cross-sectional side views of the handle, depicting a release button in a first and second position, respectively, to facilitate actuation of a plunger shaft, according to another embodiment of the present invention; 
         FIGS. 14A and 14B  are simplistic side profile views of another embodiment of a medical device, depicting the medical device in an anchor non-deployed position and an anchor deployed position, respectively, according to the present invention; 
         FIG. 15  is a top view of the occluder portion and the anchor portion of the medical device of  FIGS. 14A and 14B , depicting fame components cut from a flat sheet, according to another embodiment of the present invention; 
         FIGS. 16A and 16B  are simplistic side profile views of another embodiment of a medical device, depicting the medical device in an anchor non-deployed position and an anchor deployed position, respectively, according to the present invention; 
         FIG. 17  is a top view of the occluder portion and the anchor portion of the medical device of  FIGS. 15A and 15B , depicting frame components cut from a flat sheet, according to another embodiment of the present invention; 
         FIG. 18  is a perspective view of a medical device delivery system, depicting a medical device attached and deployed at a distal end of the delivery system, according to another embodiment of the present invention; 
         FIG. 18A  is a cross-sectional view of section  18 A of  FIG. 18 , depicting a lumen defined in a proximal portion of a catheter of the delivery system, according to another embodiment of the present invention; 
         FIG. 18B  is a cross-sectional view of section  18 B of  FIG. 18 , depicting a sheath lumen of a sheath with the catheter of the delivery system therein, according to another embodiment of the present invention; 
         FIG. 19  is a cross-sectional view of the medical device and the distal portion of the delivery system, depicting a contrast fluid flowing from a hub of the medical device and into the left atrial appendage, according to another embodiment of the present invention; 
         FIG. 20  is an enlarged cross-sectional view of the distal portion of the delivery system and the hub of the medical device (with the occluder portion removed for simplification purposes), depicting a flow path of the contrast fluid moving through the delivery system and hub of the medical device, according to another embodiment of the present invention; 
         FIG. 20A  is an enlarged cross-sectional view taken from region  20 A of  FIG. 20 , depicting the flow path for the contrast fluid at a distal portion of the delivery system, according to another embodiment of the present invention; 
         FIG. 20B  is an enlarged cross-sectional view taken from region  20 B of  FIG. 20 , depicting the flow path for the contrast fluid at the hub of the medical device, according to another embodiment of the present invention; 
         FIG. 21  is a side view of another embodiment of a medical device, according to the present invention; 
         FIG. 22  is an exploded view of the medical device of  FIG. 21 , according to another embodiment of the present invention; 
         FIG. 23  is a top view of an occluder frame of an occluder portion, depicting the occluder frame as cut from a flat sheet of material, according to another embodiment of the present invention; 
         FIG. 24  is a top view of an anchor portion, depicting the anchor frame as cut from a flat sheet of material, according to another embodiment of the present invention; 
         FIG. 25  is a front view of an occluder hub retainer, according to another embodiment of the present invention; 
         FIG. 25A  is a cross-sectional view taken along section A-A of  FIG. 25 , according to another embodiment of the present invention; 
         FIG. 26  is a front view of an occluder hub portion, according to another embodiment of the present invention; 
         FIG. 26A  is a cross-sectional view taken along section A-A of  FIG. 26 , according to another embodiment of the present invention; and 
         FIG. 27  is an enlarged perspective view of an occluder hub, depicting the occluder frame coupled to the occluder hub, according to another embodiment of the present invention. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     Referring first to  FIGS. 1 and 1A , a medical device  20  and a distal end portion of a delivery system  22  is provided. The medical device  20  and delivery system  22  may 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 device  20  may include frame components of an occluder portion  24  and an anchor portion  26 , the occluder portion  24  also including a tissue growth member  28  attached thereto. Further, the anchor portion  26  may be hingably coupled to the occluder portion  24  such that the anchor portion  26  may be actuated, upon deployment of the occluder portion  24 , between a deployed position and a non-deployed position (not shown) via an actuation mechanism at a handle (not shown) of the delivery system  22 . With this arrangement, the medical device  20  and delivery system  22  may provide functionality of separating the steps of deploying the occluder portion  24  and the anchor portion  26 , thereby, providing additional and enhanced functionality to the physician to properly position and implant the medical device  20  in the LAA. 
     As set forth, the occluder portion  24  may include an occluder material or a tissue growth member  28  attached thereto. The tissue growth member  28  may be a porous material, or other cell attaching material or substrate, configured to promote endothelization and tissue growth thereover. The tissue growth member  28  may extend over a proximal side of the medical device  20  and, particularly, over the occluder portion  24  and may extend over a portion of the anchor portion  26  and hinges coupling the anchor portion  26  to the occluder portion  24 . As such, due to the shape of the frame components of the occluder portion  24 , the tissue growth member  28  may include a proximal face that is generally convex to form an outer surface  40 . The tissue growth member  28  may also include an inner surface  42  on its distal side that is generally concave shaped. In one embodiment, the tissue growth member  28  may extend primarily over an outside surface of frame components of the occluder portion  24  with a portion of the tissue growth member  28  extending on both the outside surface and the inside surface of the frame components of the occluder portion  24 . In another embodiment, the tissue growth member  28  may extend primarily over both the outside surface and the inside surface of the frame components of the occluder portion  24  of the medical device  20 . In another embodiment, the tissue growth member  28  may extend solely over the outside surface of the frame components of the occluder portion  24 . 
     With respect to  FIGS. 1A and 1B , the tissue growth member  28  may include one or more types of materials and/or layers. In one embodiment, the tissue growth member  28  may include a first material layer  30  and a second material layer  32 . The first material layer  30  may primarily be an underside layer or base layer of the tissue growth member  28 . The first material layer  30  may include porous and conformable structural characteristics. For example, the first material layer  30  may 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 layer  32  may include one or more layers of, for example, an expanded polytetrafluoroethylene (ePTFE) material. The second material layer  32  may be attached to an outer surface of the first material layer  30  with, for example, an adhesive. In one embodiment, the second material layer  32  may include a first layer  32 A, a second layer  32 B, and a third layer  32 C such that the first layer  32 A may be directly attached to the first material layer  30  and the third layer  32 C may be an outer-most layer covering the proximal side of the medial device  20  with the second layer  32 B extending therebetween. The various layers of the second material layer  32  may 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 layers  32 B,  32 C, 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 layer  32 A of the second material layer  32 , adjacent the first material layer  30 , may be formed of an ePTFE material having a reduced internodal distance relative to the second and third layers  32 B,  32 C. For example, the internodal distance of the first layer  32 A may be approximately 10 μm. This first layer  32 A may be bonded or adhered to the first material layer  30  using 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 layer  32 A, extending over a hub end  34  with flaps  36  (outlined with an “X” configuration) where the delivery system  22  interconnects with the medical device  20  (see  FIG. 1 ). 
     The second material layer  32  made of ePTFE effectively prevents the passage of blood, due to the small internodal distance and pore size of the first layer  32 A, while the larger internodal distance of other layers (e.g.,  32 B and  32 C) enable tissue in-growth and endothelization to occur. Additionally, the first material layer  30 , being formed of a polyurethane foam, enables aggressive growth of tissue from the LAA wall into the tissue growth member  28  at the inside or concave side of the medical device  20 . Further, the first material layer  30  provides an exposed shelf  38  on the outer surface  40  around the periphery and distal end portion of the tissue growth member  28 , which promotes aggressive fibroblast and tissue growth to further initiate endothelization over the outer surface  40  of the second material layer  32 . It is noted that the use of appropriate adhesive materials between the first material layer  30  and the next adjacent layer  32 A may also serve to fill in the pores of the next adjacent layer  32 A and further inhibit possible flow of blood through the tissue growth member  28 . Additional layers of ePTFE may also be included to the second material layer  32  of the tissue growth member  28 . 
     With reference to  FIGS. 2 and 3 , description of the medical device  20  and its frame components will now be provided.  FIG. 2  depicts the frame components in an assembled and fully deployed state and  FIG. 3  depicts the frame components as cut from a flat sheet. As previously set forth, the medical device  20  includes an occluder portion  24  and an anchor portion  26 . The occluder portion  24  may include multiple occluder frame segments that may be interconnected to form the occluder portion  24 . The occluder portion  24  may extend between a first end  44  and a second end  46  with face struts  50  and an occluder zig-zag portion  52  therebetween. Further, the occluder portion  24  includes base extensions  48  extending from the first end  44 . The base extensions  48  may be coupled to a hub  54  via rings  56  with notches defined at an inner diameter in the rings  56 . Each base extension  48  may extend from a proximal most portion of the occluder portion  24  or first end  44 , the first end  44  being one end of each base extension  48  and face strut  50 . Each base extension  48  may be sized and configured to be positioned around the hub  54  and held by one or more rings  56 . Each base extension  48 , at the first end  44 , may extend to one face strut  50  of the occluder portion  54 , the face strut  50  extending radially and distally from the first end  44 . Each face strut  50  may include an extension  58  on a back side thereof, the extension  58  having a hook configuration sized and configured to hold a portion of the tissue growth member (not shown). Further, each face strut  50  extends to a v-extension  60  of the occluder zig-zag portion  52  such that distal ends of each v-extension  60  may be coupled to distal ends of adjacent v-extensions  60  (side-by-side) to define the occluder zig-zag portion  52 . The occluder zig-zag portion  52  may enlarge radially and distally from the face struts  50  to a distal end or the second end  46  of the occluder portion  24 . At the second end  46 , the occluder portion  24  may include an occluder eyelet  62  sized configured to hingably couple to the anchor portion  26 . 
     The anchor portion  26  may include multiple anchor frame segments that may be interconnected to form the anchor portion  26 . The anchor portion  26  may extend between a first end  64  and a second end  66  with anchor actuator arms  68  and an anchor zig-zag portion  70  therebetween. The anchor actuator arms  68  may extend between the first end  64  and the anchor zig-zag portion  70 . Each anchor actuator arm  68  may be configured to couple to a collar arrangement or splined sleeve  72  at the first end  64  of the anchor portion  26  such that the anchor actuator arms  68  are coupled as a unit or together via the splined sleeve  72 . The splined sleeve  72  may be configured to actuate along an axis  74  of the medical device  20  to move the anchor portion  26  between the anchor deployed position and anchor non-deployed position (not shown), discussed in more detail hereafter. 
     With reference now to  FIGS. 2, 3, and 3A , the anchor actuator arms  68  may also include a flexure portion  76 . The flexure portion  76  defines a taper  82  and radius extending along the radial length of the flexure portion  76  toward the anchor zig-zag portion  70  and then widens again at the anchor zig-zag portion  70 . Such taper  82  along the radial length in the flexure portion  76  facilitates repetitious movement of the anchor portion  26  between the deployed position and the non-deployed position while also maintaining structural integrity of the anchor portion  26 , and minimizing the stress and strain in the flexure portion  76  while facilitating a tight radius or loop. In one embodiment, the anchor actuator arms  68  may each include a coil (not shown) that may be wound around a portion of the actuator arm and over the flexure portion  76  with the ends of the coil secured to the anchor actuator arm  68 . Such coil may substantially capture the anchor actuator arm  68  from extending in undesirable locations in the LAA should there be a facture or break in the anchor actuator arm  68 . 
     Each flexure portion  76  of the anchor actuator arms  68  may extend to anchor v-extensions  78  such that the proximal ends of each anchor v-extension  78  may be coupled to proximal ends of adjacent anchor v-extensions  78  (similar to the occluder zig-zag portion  52 ) to form the anchor zig-zag portion  70 . At the interconnection of the proximal ends of the anchor v-extensions  78  or the second end  66  of the anchor portion  26 , such proximal ends define an anchor eyelet  80 . The anchor eyelet  80  may be sized and configured to hingably couple to a corresponding occluder eyelet  62  of the occluder portion  24 , as shown by dotted lines  84  (see  FIG. 3 ). 
     With respect to  FIG. 3A , the anchor struts or anchor v-extensions  78  of the anchor zig-zag portion  70  may include one or more hooks  86  or barbs that may extend at an acute angle  88  from the anchor portion  26  or anchor v-extensions and remote from the occluder portion  24 . Such acute angle  88  may range between about forty-five degrees and about sixty degrees. Further, the hooks  86  may extend from the anchor v-extensions  78  with a predetermined height  90  so 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 thickness  92  (see  FIG. 2 ). Such thickness  92  may be similar to the thickness of sheet material from which the fame components (i.e., occluder portion  24  and anchor portion  26 ) of the medical device  20  are cut. 
     With respect to  FIG. 3 , the occluder portion  24  and the anchor portion  26  are 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 portion  24  and the anchor portion  26 , in the pre-formed state, may be substantially planar and flat, after which, the frame components of the occluder portion  24  and/or the anchor portion  26  may 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 (see  FIG. 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 portion  24  may include ten face struts  50  and ten base extensions  48  with ten occluder eyelets  62  extending from the occluder zig-zag portion  52 . Similarly, the anchor portion  26  may include ten anchor actuator arms  68  with ten anchor eyelets  80  extending from the anchor zig-zag portion  70 . It should be noted that the occluder portion  24  and anchor portion  26  may include more or less frame components, such as the respective face struts  50  and anchor actuator arms  68 , as known to one of ordinary skill in the art. As shown by dotted line  84 , occluder eyelets  62  may be configured to couple to corresponding anchor eyelets  80  with a hinge-like coupling arrangement. Such may be employed by directly interlocking the occluder eyelets  62  with the anchor eyelets  80 , as depicted in  FIG. 2 . 
     In another embodiment, the fame components of the occluder portion  24  and the anchor portion  26  may 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 in  FIG. 2 . Various frame components of the occluder portion  24  and the anchor portion  26  may need to be modified as readily understood by one of ordinary skill in the art. 
     With reference to  FIG. 3B , in another embodiment, the occluder portion  24  and the anchor portion  26  may be hingably coupled together by aligning the occluder eyelets  62  with the anchor eyelets  80  and positioning an individual interlocking piece  94  (shown in outline) within and through each of the respective aligned eyelets  62 ,  80 . Such an interlocking piece  94  may be a polymeric filament or the like. Ends  96  of the interlocking piece  94  may be heated to form a bulbous shape (not shown) at the ends  96  that, 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 eyelets  62 ,  80  may be interlocked via the interlocking piece  94  to provide a hinged coupling arrangement for the anchor portion  26  to pivot relative to the occluder portion  24  and, more particularly, for the anchor portion  26  to pivot about the occluder eyelets  62 . In another embodiment, the interlocking piece  94  may be a metallic rivet press fitted through aligned eyelets to provide a hinged coupling arrangement. 
     Now with reference to  FIG. 4 , a medical device delivery system  100  for delivering the medical device  20  to, for example, the LAA is provided. The medical device delivery system  100  may include the before-mentioned delivery system  22 , the medical device  20 , and a sheath  102 . The delivery system  22  may include a delivery catheter  104  coupled to a handle  106  with the medical device  20  operatively coupled to the handle  106  at a distal end of the delivery catheter  104 . The delivery catheter  104  may be sized and configured to be inserted through the sheath  102  such that the medical device  20  may be pushed through the sheath  102  to the distal end thereof. The medical device  20  may be partially exposed, at certain stages of delivery, as depicted. The functionality and detail of the various components of the medical device delivery system  100  will be described in detail hereafter. 
     With reference now to  FIGS. 5, 5A, and 5B , a distal portion of the delivery catheter  104  will now be described,  FIG. 5A  being a cross-sectional view of the distal portion of the delivery catheter  104  along an axis  106  thereof depicted in  FIG. 5  and  FIG. 5B  being an enlarged cross-sectional view of a portion of the same. The delivery catheter  104  may define a lumen  108  extending longitudinally therethrough between a proximal end (not shown) and a distal end  110  of the delivery catheter  104 . In one embodiment, the delivery catheter  104  may include a shaft (not shown), a spiral cut portion  112 , an inner distal tube  114 , and a collet  116 . Such distal portion of the delivery catheter  104  may include enhanced lateral flexiblity along the region of the spiral cut portion  112 . That is, the distal portion of the delivery catheter  104  may be more flexible than portions of the delivery catheter  104  more proximal than the spiral cut portion  112 . The spiral cut portion  112  may be formed by spirally or helically cutting a slit into the peripheral structure of the distal portion of the delivery catheter  104 , as depicted. The inner distal tube  114  may be coupled to the delivery catheter  104  and within the lumen  108  of the distal portion of the delivery catheter  104 . The collet  116  may be positioned and thermally coupled to the distal end  110  of the delivery catheter  104  and within the inner distal tube  114  with collet fingers  118  extending distally therefrom. The collet fingers  118  may be sized and configured to latch to the hub of the medical device (not shown) with nubs  120  or protrusions extending from free ends of the collet fingers  118 . The collet fingers  118  are moveable outward, as indicated by arrows  122 , and are biased to an inward position as shown. The collet  116  and collet fingers  118  may 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 fingers  118  will be discussed in further detail hereafter. With respect to the enhanced flexibility of the delivery catheter  104  along the spiral cut portion  112 , 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 catheter  104  along the spiral cut portion  112  to, thereby, allow the medical device to self-center in the LAA in instances where the axis  106  of delivery catheter cannot be made concentric to the ostium of the LAA during delivery and deployment of the medical device. 
     Now with reference to  FIGS. 6A, 6B, and 6C , description of steps that may be employed for loading the medical device  20  into the sheath  102  will now be provided. For example, the delivery catheter  104  may include a loader  124  sized and configured to facilitate loading the occluder portion  24  of the medical device  20  into the sheath  102  so that the delivery catheter  104  can push the occluder portion  24  through the sheath  102  to a distal portion thereof. With reference to  FIG. 6A , the loader  124  may include a tube portion  126  and a handle portion  128 . The loader  124  may be slideably positioned over the delivery catheter  104  such that the delivery catheter  104  extends through a bore defined through the loader  124 . The loader  124  may be moved over the distal end of the delivery catheter  104  and manually moved or forced over the occluder portion  24  of the medical device  20  so that occluder portion  24  moves to a constricted position enclosed within the tube portion  126 . However, prior to moving the loader  124  over the occluder portion  24 , the anchor portion should be in a non-deployed position such that an actuator knob and plunger shaft of the handle  106  should be moved to a proximal position, as depicted in  FIGS. 8 and 8A . Referring back to  FIG. 6A , once the loader  124  is moved completely over the occluder portion  24 , the medical device  20  may then be advanced through the sheath  102 . The sheath  102 , at this point, has already been advanced through the circulatory system to the heart with a distal portion of the sheath  102  positioned in the LAA (not shown), employing typical techniques known in the art. 
     As depicted in  FIGS. 6B and 6C , the loader  124  may be inserted into the sheath  102  and, more particularly, a sheath hub  130 . The sheath hub  130  may be coupled at a proximal end of the sheath  102 . The components of the sheath hub  130  may include a valve  132  and a sheath fluid port  134 . The valve  132  may 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 sheath  102  upon rotation of the valve  132 . The sheath fluid port  134  may extend from the sheath hub  130  and may be sized and configured to flush or aspirate air from the sheath  102  that may become trapped upon loading the medical device  20  into the sheath  102 . In another embodiment, the loader  124  may also include a valve positioned around the delivery catheter  104  to maintain hemostasis while inserted into the sheath hub  130 . 
     As set forth, the loader  124  may be mated or inserted into the sheath hub  130  with a snap or click fit via nubs  136  at the distal end of the tube portion  126  and a rib (not shown) within a bore  138  defined in the sheath hub  130 . Once the loader  124  is positioned within the sheath hub  130 , the delivery catheter  104  may be advanced through a lumen defined longitudinally in the sheath  102  such that the distal end of the delivery catheter  104  moves to a distal portion of the sheath  102  to expose a distal tip of the occluder portion  24  of the medical device  20  from the distal end of the sheath  102 . With this arrangement, the distal tip of the occluder portion  24  may be exposed at the distal end of the sheath  102  and provides, due to the occluder material, a cushioned tip  140 , without any exposed metal frame members, facilitating an atraumatic entry into the LAA, thereby, reducing the potential of effusions in the LAA. 
     Referring to  FIGS. 7 through 11 , deployment and detachment of the medical device  20  in an LAA  5  (shown in outline) relative to the delivery system  22  will now be described. With respect to  FIGS. 7 and 8 , upon the physician positioning the distal portion of the sheath  102  in the LAA  5  with the medical device  20  positioned at the distal portion of the sheath  102  with the cushioned tip  140  of the occluder portion  24  exposed at the distal end of the sheath  102 , the physician may atraumatically position the distal portion of the sheath  102  to a desired location in the LAA  5 . Once the desired location is determined, the physician can deploy the occluder portion  24  of the medical device  20 . Such may be employed by simply withdrawing the sheath  102  or manually moving the sheath  102  in a proximal direction. As the sheath  102  is withdrawn, the occluder portion  24  self-expands to an occluder deployed position with the anchor portion  26  maintained in an anchor non-deployed position, as depicted in  FIG. 8 . 
     With respect to  FIG. 8 , a distal portion of the delivery catheter  104  coupled to the medical device  20  is shown. The delivery catheter  104  of this embodiment is coupled to the medical device  20  with an occluder hub nut  142  and collet  116  arrangement. For example, the distal portion of the delivery catheter  104  includes the inner distal tube  114  and an actuator shaft  144 . The actuator shaft  144  may include a layered coil, such as a speedometer cable, at a distal end portion thereof, which may be coupled to an inner distal connector  146  moveable within the collet  116 . As previously set forth, the collet  116  may include collet fingers  118  extending distally from the collet  116 . The inner distal connector  146  may include threads sized and configured to couple to the occluder hub nut  142  and, more particularly, to a threaded screw hole  148  defined in the occluder hub nut  142 . The occluder hub nut  142 , at a distal end thereof, may include the splined sleeve  72 . As previously set forth, the splined sleeve  72  may be sized and configured to couple end portions of each of the anchor actuator arms  68 . In another embodiment, the inner distal connector  146  and occluder hub nut  142  may be reversed such that the inner distal connector  146  includes a nut configuration and the occluder hub nut  142  includes a screw configuration. In either case, the medical device  20  may be threadably coupled to the delivery catheter  104 . 
     With reference to  FIG. 8A , one embodiment of the handle  106  is depicted. The handle  106  may include a handle housing  150 , an anchor actuator release button  152 , a plunger shaft  154 , and an actuator knob  156 . The handle housing  150  may be coupled to a proximal portion of the delivery catheter  104 . The plunger shaft  154  and actuator knob  156  is shown in a first position that correlates to the anchor portion  26  being in a non-deployed position (see  FIG. 8 ). The plunger shaft  154  and actuator knob  156  may be moved bi-linearly between a first position and a second position while depressing the anchor actuator release button  152 . The functions and various components of the handle  106  will become apparent to one of ordinary skill in the art as discussed in further detail hereafter. 
     As depicted in  FIGS. 8 and 8A , the anchor portion  26  of the medical device  20  is in an anchor non-deployed position. The actuator knob  156  and plunger shaft  154  are moved to the first position, as indicated by arrow  155  that corresponds to the anchor non-deployed position prior to loading the medical device  20  into the loader  124  and then into the sheath  102  (see  FIGS. 6A and 6B ). In the anchor non-deployed position, the inner distal connector  146  is threadably coupled to the occluder hub nut  142  and is positioned proximal the hub  54  with the anchor portion  26  in a first position or an anchors non-deployed position or, otherwise said, an anchors-in position with a portion of the anchor actuator arms  68  proximal the hub  54  and within a bore  158  defined in the hub  54 . Further, in the anchor non-deployed position, the plunger shaft  154  and knob  156  of the handle  106  may be in a proximal or first position as well. With this arrangement, a physician may determine the most favorable position of the medical device  20  within the LAA  5  with the occluder portion  24  in the deployed position prior to deploying the anchor portion  26 . 
     Now turning to  FIGS. 9 and 9A , the anchor portion  26  of the medical device  20  may be moved to an anchor deployed position or anchor-out or anchor second position once the physician determines the deployed occluder portion  24  is positioned in the LAA  5  as desired. Such anchor deployed position may be employed by manually moving the actuator knob  156  distally, as indicated by arrow  160 , while also depressing the release button  152 . In the anchor deployed position, the inner distal connector  146  and occluder hub nut  142  are also moved distally from the collet  116  and into the hub  54  or through the hub  54 . Such linear distal movement also moves the anchor actuator arms  68 , coupled to the splined sleeve  72 , from a distal portion of the delivery catheter  104 , through and out of the hub  54  to an everted, deployed position or an expanded position such that the anchor portion  26  unfolds and expands radially by pivoting or rotating at the hinged connection (i.e., at occluder and anchor eyelets  62 ,  80 ) between the occluder portion  24  and anchor portion  26 . At the anchor deployed position, hooks  86  or tines of the anchor portion  26  are sized and configured to grab tissue and prevent movement so as to effectively anchor the medical device  20  within the LAA  5 . Once the anchor portion  26  is deployed, the physician may view the medical device  20  through imaging techniques to ensure proper positioning of the medical device  20  in the LAA  5  while also performing stability tests by pulling proximally on the handle  106  to ensure the medical device  20  is effectively engaging the LAA  5 . Such imaging techniques may be enhanced by markers strategically located on the medical device  20  and delivery catheter  104  to 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 hooks  86  of the anchor portion  26  may extend both distally and proximally so as to substantially prevent movement of the medical device  20  in both the proximal and distal directions relative to the LAA  5 . In one embodiment, the hooks  86  may include an acute angle  88  ( FIG. 3A ) relative to the axis  74  of the medical device  20  or the struts of the anchor zig-zag portion  70 . The hooks  86  are configured to grab and may dig at the tissue of the LAA  5 . Such hooks  86  may be sized, oriented, and configured to prevent puncture or piercing of the hooks  86  all the way through the tissue of the LAA  5 , but provide effective and even aggressive engagement with the tissue to provide safe anchoring of the medical device  20  in the LAA  5 . 
     If the physician is dissatisfied with the location or engagement of the medical device in the LAA, the physician may readily disengage the anchor portion  26  from the tissue of the LAA by simply moving the actuator knob  156  in the proximal direction to the first position ( FIG. 8A ), which simultaneously moves the actuator shaft  144  proximally and, thus, pivots the anchor portion  26  to a disengaged or anchor non-deployed position. The physician may then re-position the occluder portion  24  within the LAA  5  and, once satisfied with the location of the occluder portion  24  in the LAA  5 , the physician may readily move the actuator knob  156  forward or a distal direction to pivot and re-engage the anchor portion  26  with the tissue of the LAA  5 . The physician may then determine again through imaging and stability tests if the medical device  20  is positioned in the LAA  5  in an effective and safe manner that satisfies the physician. As can be readily understood, the steps of re-positioning the occluder portion  24  and re-engaging the anchor portion  26  of the medical device  20  can be repeated until the physician is satisfied. 
     Now referring to  FIGS. 10, 10A, and 10B , the functions of releasing the medical device  20  will now be described. The medical device  20  may be detached or released by unscrewing the inner distal connector  146  from the screw hole  148  defined in the occluder hub nut  142 . Such releasing may be employed by rotating the actuator knob  156  of the handle  106  counter-clockwise several turns, as indicated by arrow  162 , until the inner distal connector  146  unwinds from the screw hole  148  of the occluder hub nut  142 . The actuator knob  156  may then be pulled proximally back to the first position, as indicated by arrow  164 , while depressing the release button  152 , which facilitates movement of the inner distal connector  146  in the proximal direction. As the inner distal connector  146  is moved proximally through or into the collet  116 , the collet fingers  118  extending distally from the collet  116  collapse inward since the collet fingers  118  may be biased toward an inward position. In other words, prior to the inner distal connector  146  being unwound, the collet fingers  118  may be held in an outer position substantially concentric with the axis  74  of the medical device  20 , which maintains the delivery catheter  104  locked to the medical device  20 . The collet fingers  118  include outward extending nubs  120  that are held against an abutment  166  within the hub  54  (also shown in  FIG. 9 ). In this manner, once the inner distal connector  146  is unscrewed from the occluder hub nut  142  and moved to a proximal position away from the collet fingers  118 , the collet fingers  118  flexibly collapse with a bias to an inward position to move the nubs  120  away from the abutment  166  in the hub  54 , thereby, unlocking or unlatching the delivery catheter  104  from the medical device  20 . The delivery catheter  104  may then be removed from the medical device  20  with the collet fingers  118  collapsed and the nubs  120  moved proximally from the abutment  166  within the hub  54  as depicted in  FIG. 11 . 
     With respect to  FIGS. 2 and 12 , a moveable portion that may include a spring  170  is depicted. In one embodiment, the moveable portion may include a spring  170  with a polymeric covering in the form of polymeric flaps or occluder flaps  36 . Such moveable portion having the spring  170  may be sized and configured to close-off the bore  158  of the hub  54  once the delivery catheter  104  is released from the medical device  20 . The spring  170  may include a clover configuration or any other suitable configuration to effectively close-off the hub  54 . The spring  170  may 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 spring  170  (shown in outline form) is depicted in  FIG. 12 , which is the position of the spring  170  with the delivery catheter  104  coupled to the hub  54 . In one embodiment, the position of the delivery catheter  104  attached to the hub  54  holds the spring  170  in the biased or open first position. Once the delivery catheter  104  is removed from the hub  54 , the spring  170  may automatically move to the closed, second relaxed position (see  FIG. 2 ) with the occluder flaps  36  (see also  FIG. 1 ) substantially minimizing or eliminating any through hole on the proximal face and adjacent the hub  54 . In the second relaxed position of the spring  170 , the bore  158  defined in the hub  54  is substantially closed-off with occluder flaps  36 , leaving only a cross-like slit (as depicted by adjacently extending occluder flaps  36  in  FIG. 1 ) and substantially eliminating any metal exposed at the hub  54 . In this manner, the occluder flaps  36 , in the closed second position, advantageously provides a surface at the proximal face of the device without exposed metal at the hub  54  and, further, provides a contiguous surface with the polymeric material of the occluder portion that closes-off the hub  54 . 
     As previously set forth, the spring  170  may be embedded in the occluder material or tissue growth member  28  or attached to an inner occluder material surface such that the spring  170  may include various layers and/or folds of, for example, ePTFE, with one or more slits defining the flaps  36  that facilitates interconnection of the delivery catheter  104  to the hub  54  when the spring  170  is in the first biased position but then may substantially close-off the bore  158  defined in the hub  54  when in the second relaxed position. Such arrangement is advantageous to substantially prevent blood flow through the hub  54  or to substantially prevent the potential of migrating emboli or thrombus from the hub  54  itself once the medical device  20  is positioned in the LAA. In this manner, the spring  170  facilitates closing-off the through hole of the hub  54  and/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 flaps  36  provide a substantially impassible barrier relative to otherwise potential migrating emboli or thrombus at the hub  54 . 
     Now referring to  FIGS. 13A and 13B , actuation of the release button  152  of the handle  106  is depicted. The handle housing  150  defines a hole  172  that may extend along a longitudinal axis of the handle housing  150  and may be sized to hold the plunger shaft  154  to move bi-linearly therethrough. The handle housing  150  may also define a hollow portion  174  therein. The plunger shaft  154  may extend through the handle housing  150  and be coupled to components coupled to actuator shaft  144  and the inner distal connector  146  at the distal portion of the delivery catheter  104  (see  FIG. 9 ). The handle  106  also may include a leaf spring  176  configured to bias against the release button  152 . The release button  152  may include a button post  178 . The leaf spring  176  may be coupled to the button post  178  to bias the release button  152  to a non-depressed position or first position. The plunger shaft  154  may also include two travel stops  180  fixed thereto. By depressing the release button  152  to a depressed position or second position, the button post  178  depresses the leaf spring  176  and moves within a cavity  182 . Once the button post  178  is moved within the cavity  182 , the travel stops  180  coupled to the plunger shaft  154  may then freely move distally (and then back proximally) past the button post  178  a predetermined distance gauged by the travel stops  180  within the hollow portion  174  defined by the handle housing  150 . In this manner, the plunger shaft  154  may move the predetermined distance which directly corresponds with the distance or length moved by the actuator shaft  144  and actuation of the anchor portion of the medical device  20  between the anchor non-deployed position and anchor deployed position (see  FIGS. 8 and 9 ). 
     Referring back to  FIG. 8 , in another embodiment, the sheath  102  may include an imaging device  190 . The imaging device  190  may be sized and configured to be positioned at a distal end of the sheath  102  and may include one or more lines  192  extending from the imaging device  190  and proximally toward the sheath hub  130  ( FIG. 5C ) for transferring imaging information from the imaging device  190  to 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 sheath  102 , upon being withdrawn from the occluder portion  24 , being positioned substantially concentric or proximal of the medical device  20 , 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 device  190  may be an ultrasound imaging device or any other suitable imaging device known in the art. In another embodiment, an imaging device  190   a  may be positioned proximal a distal end of the delivery catheter  104  in a similar manner to that described above. In still another embodiment, the distal end of the delivery catheter  104  and/or sheath  102  may include one or more sensor devices  191 . The sensor devices  191  may be configured to sense pressure, flow, and any other cardiac dynamics that may be useful to the physician. In this manner, the sensor devices  191  and/or imaging device  190 ,  190   a  may provide additional information to assist the physician to accurately position the medical device  20  in the LAA  5 . 
     Now with reference to  FIGS. 14A and 14B , another embodiment of a medical device  200  coupled to a distal portion of a delivery catheter  202 , the medical device  200  (depicted in a simplistic profile view) in a partially deployed position and fully deployed position, respectively, is provided. As in previous embodiments, the medical device  200  may include an occluder portion  204  and an anchor portion  206  that may be separately deployed. For example, once a sheath  208  is positioned in the LAA (not shown) with the medical device  200  at a distal end portion thereof, the sheath  208  is withdrawn to deploy an occluder portion  204  of the medical device  200  or to partially deploy the medical device  200 . Once the occluder portion  204  is deployed, then the anchor portion  206  may be deployed, to fully deploy the medical device  200 . 
     In this embodiment, the occluder portion  204  is substantially similar to the previous embodiment, except the tissue growth member  210  is attached to an outer surface of the frame components of the occluder portion  204 . The tissue growth member  210  of this embodiment may include similar layering of one or more materials as set forth for the tissue growth member described in detail relative to  FIG. 1B . Further, although the anchor portion  206  may be hingably coupled to the occluder portion  204  with a hinge arrangement  212  and, in many respects functions similar to the previous embodiment, the anchor portion  206  of this embodiment includes multiple separate and distinct anchor frame segments  214 , best shown in  FIG. 15 . 
     With reference to  FIG. 15 , the frame components of the occluder portion  204  and the anchor portion  206  are 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 segment  214  shown, but in this embodiment, there may be five anchor frame segments  214  to correspond and couple to, for example, occluder frame apertures  216  of the occluder portion  204 . As shown, the frame components of the occluder portion  204  may be substantially similar to the frame components of the occluder portion  204  described in the previous embodiment relative to  FIG. 3 . 
     With respect to the anchor frame segments  214 , each anchor frame segment  214  may extend between a first end  218  and second end  220  with two actuator arms  222  extending therebetween such that each anchor frame segment  214  may exhibit a “Y” or “V” configuration in the pre-formed state. Each actuator arm  222  may include an anchor hinge aperture  224  at the second end  220  and, at the first end  218 , the actuator arm  222  may be coupled to a collar arrangement  226  or splined sleeve, similar to that of the previous embodiment. With this arrangement, the actuator arms  222 , as depicted in  FIGS. 14A and 14B , may pivot about the occluder portion  204  at the hinge arrangement  212 . Further, the actuator arms  222  may form a loop configuration or loop extension in the anchor deployed position with the first end  218  of the actuator arms  222  moveable or actuatable through the hub  228  of the medical device  200 . 
     Now with reference to  FIGS. 16A, 16B, and 17 , another embodiment of a medical device  250  depicted 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 portion  252  can be similar to the previous embodiments, but the anchor portion  254  may include an anchor zig-zag portion  256  and loop extensions  258  or actuator arms as separate anchor frame components. In this embodiment, the medical device  250  may include a dual hinge arrangement. For example, the occluder portion  252  may be hingably coupled to an anchor zig-zag portion  256  with a first hinge arrangement  260  and the anchor zig-zag portion  256  may be hingably coupled to the loop extensions  258  with a second hinge arrangement  262 . The profile and functionality of the medical device  250  may be similar to the previous embodiments, except the loop extensions  258  may take a more direct inward angle from the anchor zig-zag portion  256  due to the second hinge arrangement  262  therebetween. Similar to the embodiment of  FIG. 15 , this embodiment may include ten loop extensions  258  or actuator arms, though for simplicity purposes only two loop extensions  258  (as a single loop extension segment) are shown in  FIG. 17 . It should be noted that the embodiments of  FIGS. 14 and 16  also provide the feature to facilitate a cushion tip (not shown) as depicted in  FIG. 7  when constricted in the sheath  264 . Further, it should be noted the embodiments depicted and described relative to  FIGS. 1, 14 and 16  include similar features and structure and, therefore, the descriptions provided in one embodiment may also be applicable to the other described embodiments. 
     Now with reference to  FIGS. 18 through 20 , another embodiment of a medical device  300  and a medical device delivery system  302  for modifying an LAA  5  of the heart that facilitates imaging of the LAA  5  with contrast fluid  304  and an imaging device (not shown) is provided. In this embodiment, the structural components and functionality of the medical device  300  and the medical device delivery system  302  may be substantially similar to any one of the embodiments previously described. For example, the medical device  300  may include an occluder portion  306  and an anchor portion  308 , similar to that described above. 
     In this embodiment, upon the medical device  300  being positioned within the LAA  5  with the anchor portion  308  deployed and engaged with tissue of the LAA  5 , the medical device delivery system  302  and the medical device  300  may include a common flow path  310  defined therethrough for injecting a contrast fluid  304  through a hub  312  of the medical device  300  and to a distal side of the medical device  300  and into the LAA  5 . One important aspect of this embodiment may be that the occluder portion  306  of 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 fluid  304  is being substantially maintained within the LAA  5  on the distal side of the medical device  300  to assess whether the medical device  300  is properly positioned within the LAA  5 . Also, the physician can determine whether there are gaps between an outer periphery  314  of the medical device  300  and the tissue of the LAA  5  by viewing the contrast fluid  304  dissipating from the distal side of the medical device  300 , as discussed in further detail below. 
     In one embodiment, the occluder portion  306  of the medical device  300  may 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 portion  306  of the medical device  300 . 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 fluid  304  in the LAA  5  upon 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 to  FIGS. 18, 18A and 18B , the medical device delivery system  302  includes a sheath  316 , a delivery catheter  318  coupled to a handle  320 , and the medical device  300  coupled to a distal end of the delivery catheter  318 , similar to that described and depicted relative to  FIG. 4  herein (as well as other embodiments herein). The delivery catheter  318  extends between a proximal end and a distal end such that the proximal end is coupled to the handle  320  and the distal end of the delivery catheter  318  is coupled to the implantable medical device  300 . Further, the delivery catheter  318  defines a lumen  322  extending along a longitudinal length of the delivery catheter  318 . The handle  320  may include a fluid port  324  sized and configured to directly communicate with the lumen  322  of the delivery catheter  318 . Also, the delivery catheter  318  may include an actuator shaft  326  (coupled to the handle  320  and actuatable by the actuator knob  321 ) extending therethrough for controlling actuation of the anchor portion  308  of the medical device  300 . With this arrangement, fluid, such as contrast fluid  304 , may be injected through the fluid port  324  of the handle  320  and directly through the lumen  322  of the delivery catheter  318  such that the contrast fluid  304  may advance toward the medical device  300 . The contrast fluid  304  may 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 catheter  318  and the medical device  300  coupled at the distal end thereof may be sized and configured to be pushed through a sheath lumen  317  defined along a length of the sheath  316 . The sheath  316  may also include a sheath fluid port  328  sized and configured to inject fluid, such as contrast fluid  304 , through the sheath lumen  317  and to exit from the distal end of the sheath  316 . Such injection of contrast fluid  304  through the sheath lumen  317  via the sheath fluid port  328  may provide additional information to the physician relative to imaging a proximal side of the medical device  300  upon being positioned in the LAA, discussed further herein. 
     The fluid, such as contrast fluid  304 , may be injected through the fluid port  324  of the handle  320 , as well as the sheath fluid port  328  of the sheath  316 , with an injection device  330 . In one embodiment, the injection device  330  may be a syringe for manual injection through the fluid port  324  of the handle  320  or through the sheath fluid port  328  of the sheath  316 . In another embodiment, the injection device  330  may include an injection machine that controls the pressure, amount, and/or flow rate of fluid being injected through the fluid port  324  of the handle  320  (or through the sheath fluid port  328  of the sheath  316 ), as known to one of ordinary skill in the art. 
     Now with reference to  FIGS. 19 and 20 , fluid, such as contrast fluid  304 , may flow through the lumen  322  of the delivery catheter  318 , as discussed above, and through the hub  312  (and components associated therewith) of the medical device  300 , the medial device  300  being positioned in the LAA  5 . As the contrast fluid  304  exits the hub  312  of the medical device  300 , as depicted by arrows  332  in  FIG. 19 , the contrast fluid  304  mixes with the blood in the LAA  5  and is viewable via real-time imaging techniques, such as with a fluoroscopy or the like. Due to the occluder portion  306  having the substantially non-permeable material associated therewith, if the medical device  300  is properly positioned in the LAA  5 , the contrast fluid  304  may be substantially maintained within the LAA  5 , but for general seeping around the outer periphery  314  of the medical device  300  without 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 fluid  304  substantially maintained on a distal side of the medical device. The meaning of substantially maintaining contrast fluid  304  in the LAA means substantially containing, sustaining and/or retaining the contrast fluid in the LAA, except for general seeping along the outer periphery  314 . 
     If there is a gap between the outer periphery  314  of the medical device  300  and the tissue of the LAA  5 , the physician will readily ascertain and identify such gap due to the contrast fluid  304  moving through a localized portion from the LAA  5  such that contrast fluid is viewable in a concentrated flow or jet escaping the LAA  5  and moving proximally past the outer periphery  314  of the medical device  300 . If the physician determines there is a gap, the physician can readily retract the anchor portion  308  and re-position the medical device  300  in the LAA  5  and then deploy the anchor portion  308  to engage the tissue in the LAA  5 , as discussed in detail herein. The physician may then inject additional contrast fluid  304  through the hub  312  of the medical device  300  to determine if the medical device  300  is properly positioned. In addition, the physician may also inject contrast fluid  304  through the sheath  316  via the sheath fluid port  328 , as previously discussed, to view a proximal side of the medical device  300  in the LAA  5 , thereby, obtaining additional information relative to the position of the medical device  300  in the LAA  5 . Once the physician is satisfied with the position of the medical device  300 , the delivery catheter  318  may be de-coupled or detached from the medical device  300 , as previously set forth herein. 
     With respect to  FIGS. 20, 20A, and 20B , the flow path (depicted by arrows  310  in  FIG. 20 ) of the contrast fluid  304  flowing from the delivery catheter  318  and through the hub  312  will now be described. The flow path  310  extends through the lumen  322  of the delivery catheter  318  and surrounds and moves along a length of the actuator shaft  326  and the delivery catheter  318 . Section  20 C identified in  FIG. 20  may be substantially similar to that described and depicted in  FIG. 18A , depicting the delivery catheter  318  defining the lumen  322  with the actuator shaft  326  positioned therethrough. The flow path  310  continues to advance along the collet  336  and then outward into a space  334  or channel defined between the collet fingers  338  (see  FIGS. 20 and 20A ). The flow path  310  continues advancing between an inner distal connector  340  and the delivery catheter  318  and then between the inner distal connector  340  and the medical device  300  (only the hub  312  is shown), as depicted in  FIGS. 20 and 20A . The hub  312  includes a guide ring  342  that may be embedded within the inner diameter or bore  344  defined in the hub  312  itself. Such guide ring  342  includes apertures  346  (see  FIG. 20B ) defined therein through which the flow path  310  extends. Such apertures  346  may 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 ring  342 , such that the bore  344  between the annular protrusion and the inner distal connector  340  may define an annular space through which the flow path  310  extends (instead of the apertures  346 ). Once the flow path  310  continues through the apertures  346  or annular space and past the guide ring  342  or annular protrusion in the bore  344 , the flow path  310  continues advancing through the bore  344  of the hub  312  and distally over the inner distal connector  340 . The inner distal connector  340  may include threads along an inner diameter thereof to couple to threads on a proximal end of the anchor hub  350 . The flow path  310  continues advancing through the hub  312  until exiting the hub  312 , as depicted with arrows  332 , so that contrast fluid  304  can enter the LAA  5  on the distal side of the medical device  300 , as shown in  FIG. 19 . With this arrangement, each of the handle  320 , delivery catheter  318  and hub  312  of the medical device  300  includes a common, shared, or corresponding flow path  310  that facilitates contrast fluid  304  to exit a distal side of the medical device  300 . As such, a physician may view the medical device  300  positioned in the LAA  5  to determine if the contrast fluid  304  is being substantially maintained within the LAA (since the occluder portion includes a non-permeable material), but for minor general seeping along the outer periphery  314  of the medical device  300  contacting the LAA  5 . In this manner, the physician can obtain additional imaging information to ascertain whether the medical device  300  is properly positioned in the LAA  5 . 
     Now with reference to  FIGS. 21 and 22 , another embodiment of a medical device  360  for positioning and securing within the ostium of a left atrial appendage, is provided. The medical device  360  of this embodiment may be employed with the previously described delivery systems herein, for example, the medical device delivery system  302  with its sheath  316 , delivery catheter  318  and handle  320 , described and depicted in  FIG. 18 . Similar to previous embodiments, the medical device  360  may include an occluder portion  362  and an anchor portion  364 , the occluder portion  362  and anchor portion  364  including a frame structure or framework. Such frame structure may define an occluder frame  366  and an anchor frame  368  pivotably coupled to each other. In this embodiment, the occluder portion  362  with its frame structure may include different and additional structural features than previous embodiments. For example, the occluder portion  362  may include additional conformability with the anatomy as well as the occluder portion  362  may hold structural characteristics that enhance its ease for constricting within the sheath. 
     As set forth, the medical device  360  may include the anchor portion  364 . Similar to previous embodiments, the anchor portion  364  may include multiple anchor frame segments  370  extending between a first end  372  and a second end  374 . The first end  372  may be coupled to an anchor hub  376  or secondary hub. The second end  374  may include an anchor aperture  378  for pivotably coupling to the occluder portion  362 . Such pivotable coupling or connection may be a hingable coupling that may be formed with interlocking pieces  371 , similar to the interlocking pieces  94  described relative to  FIG. 3B . 
     In addition, the anchor frame segments  370  may include tines  380  at a distal position of the second end  374  of the anchor portion  364 . Further, the anchor frame segments  370  may extend distally from the second end  374  and then extend radially inward, and then extend proximally toward the first end  372  and the anchor hub  376  so that a distal most portion of the anchor portion  364  exhibits a loop type configuration or an arcuate component/configuration, similar to previous embodiments. Such distal most portion of the medical device  360  having 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 portion  362  may include a hub  382  or primary hub defining an axis  384  and may include occluder frame segments  386  and a tissue growth member  388 . The occluder frame segments  386  may extend from a proximal end  390  to a distal end  392 , the proximal end  390  coupled to the hub  382  and the distal end  392  configured to be coupled to the second end  374  of the anchor portion  368 . In one embodiment, the proximal end  390  may be pivotably coupled to the hub  382 , discussed in further detail herein. The occluder frame segments  386  may 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 segments  386  may be attached to the tissue growth member  388  also having the cup-like configuration. 
     The tissue growth member  388  may 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 member  388  may include a first layer  394 , a second layer  396 , and a third layer  398 . The first layer  394  may be a foam material, such as polyurethane foam or any other suitable polymeric material. The first layer  394  may be attached to the outer side surface of the occluder frame segments  386  by stitching or sewing the first layer  394  to the occluder frame segments  386 . In another embodiment, the first layer  394  may be adhesively attached and/or hooked to the occluder frame segments  386 . The second layer  396  may be smaller in size than the first layer  394  and may be disc shaped. The second layer  396  may be a foam material, similar to the first layer  394 , and may be adhesively attached to a proximal side and outer surface of the first layer  394 . The third layer  398  may be an ePTFE layer or other suitable polymeric material that induces tissue growth. The third layer  398  may include multiple ePTFE layers. The third layer  398  of the tissue growth member  388  may be adhesively attached to the outer surface of the first and second layers  394 ,  396  or may be attached employing any other suitable affixing procedure. Further, the third layer  398  may be larger than both the first and second layers  394 ,  396  such that the third layer  398  may extend more distal than the first layer  394 . In one embodiment, the third layer  398  may extend distal the first layer  394  and distal the occluder frame segments  386 . 
     With reference to  FIG. 23 , the occluder frame  366  having occluder frame segments  386  are shown as cut from a flat sheet of material. In this depicted as-cut state, the occluder frame segments  386  may be a monolithic seamless structure exhibiting a star-like configuration with the occluder frame segments  386  extending from a central portion to an outer periphery of the star-like configuration. The proximal end  390  of each of the occluder frame segments  386  may be at the central portion and the distal end  392  of each of the occluder frame segments  386  may be at the outer periphery of the star-like configuration. The occluder frame segments  386  may include coupling frame segments  400  and intermediate frame segments  402  (or conforming or stabilizing frame segments), the intermediate frame segments  402  and coupling frame segments  400  extending to the outer periphery in an alternating manner such that the intermediate frame segments  402  extend between each of the coupling frame segments  400 . The coupling frame segments  400  may be thicker than the intermediate frame segments  402 . That is, the coupling frame segments  400  may include a greater width than the intermediate frame segments  402 . The intermediate frame segments  402  interconnect the coupling frame segments  400  with a v-configuration and may provide additional conformability of the occluder portion  362  with the anatomy of the left atrial appendage. The intermediate frame segments  402  provide additional support and points of contact to push and maintain the tissue growth member  388  ( FIG. 21 ) against the tissue so that the occluder portion  362  conforms and stabilizes the tissue growth member  388  against tissue in the left atrial appendage. 
     The coupling frame segments  400 , adjacent the proximal end  390  or central portion, may include a first opening  404 , a second opening  406  and a fixture holding piece  408 . The first opening  404  may be sized and configured to couple to retainer fingers  430  of the hub  382  ( FIG. 27 ), discussed in further detail herein. The second opening  406  may be sized and configured to stitch the first layer  394  of the tissue growth member  388  to the occluder frame segments  386 . The fixture holding piece  408  may be sized and configured to hold the occluder frame  366  through various frame preparation processes, such as electro-polishing. Once the preparation processes are complete the fixture holding piece  408  may be removed. 
     Further, adjacent the distal end  392  of each of coupling frame segments  400 , the coupling frame segments  400  may include an occluder aperture  410  and a third opening  412 . The occluder aperture  410  may be sized and configured to couple the occluder frame segments  386  to the anchor portion  364  in a pivotable or hinged manner. The third opening  412  may be utilized as another opening for stitching the first layer  394  of the tissue growth member  388  ( FIG. 22 ) to the occluder frame segments  386 . 
     Now with reference to  FIG. 24 , the anchor frame  368  is depicted as-cut from sheet material, similar to previous embodiments, having a monolithic seamless structure. As in the previous embodiments, the anchor frame segments  370  of the anchor frame  368  may extend between the first end  372  and the second end  374 . The first end  372  or first end portion may define the anchor aperture  378  and the second end  374  or second end portion may include a hub coupling portion  414 . The anchor aperture  378  may be sized and configured to couple to the occluder aperture  410  defined in the occluder frame segments  386  to facilitate a pivotable or hinge connection. The hub coupling portion  414  may be coupled to the anchor hub  376  ( FIG. 22 ). 
     The anchor frame  368  may include an anchor tine portion  416  and extensions  418  extending between the first and second ends  372 ,  374  to define the multiple anchor frame segments  386 . The extensions  418  may include a flexure portion  420  adjacently extending from the anchor tine portion  416 , the extensions  418  continuing to the hub coupling portion  414  and first end  372  of the anchor frame  368 . The anchor tine portion  416  may exhibit a zig-zag arrangement or strut segments  422  having multiple v-configurations coupled together. The anchor tine portion  416  may extend between the anchor apertures  378  and ends of the extensions  418 . Further, the anchor tine portion  416  may include one or more tines  380  extending from the strut segments  422 . In one embodiment, the strut segments  422  may include tines  380  extending proximally and distally. In another embodiment, some of the strut segments  422  may include tines  380  extending both proximally and distally with other ones of the strut segments  422  having tines  380  that only extend proximally toward the anchor aperture  378 . 
     With respect to  FIGS. 23 and 24 , in one embodiment, the anchor frame  368  and occluder frame  366  may be laser cut from a flat sheet of super elastic material, such as Nitinol. The anchor frame  368  and occluder frame  366  may then be positioned with fixtures and heat-set in, for example, a sand bath to set and form the anchor frame  368  and occluder frame  366  in the shape as depicted in  FIG. 22 . Upon the anchor frame  368  and occluder frame  366  being heat-set, the hub  382  may be secured to the proximal end  390  of the occluder frame segments  386 . 
     With respect to  FIGS. 25, 25A, 26, and 26A , the hub  382  or primary hub is provided. The hub  382  may include a hub retainer  424  and a hub portion  434 . The hub retainer  424 , as depicted in  FIGS. 25 and 25A , may include a cylindrical portion  426  defining a retainer bore  428  extending therethrough. The cylindrical portion  426  may include retainer fingers  430  extending from one end thereof and extending and spaced evenly about a periphery of the one end of the cylindrical portion  426 . The retainer fingers  430  may extend radially from the one end to a free end  432 . Such retainer fingers  430  may be sized and configured to extend through the first opening  404  adjacent the proximal end  390  of the occluder frame segments  386 . 
     With respect to  FIGS. 26 and 26A , the hub portion  434  may include a somewhat cylindrical outer surface  436  and back-stop  438  in the form of a head portion, the hub portion  434  defining a hub bore  440  extending therethrough. The hub bore  440  may define the axis  384  of the medical device  360  (see also  FIG. 21 ). Further, the hub bore  440  may define structure sized and configured to interact with the delivery catheter, such as a circumferential recess  442  defined in the hub bore  440 . 
     With respect to  FIGS. 25A, 26A and 27 , the hub  382  may be assembled and coupled to the occluder frame segments  386 . For example, the retainer fingers  430  may be inserted through the first opening  404  of the occluder frame segments  386 . The cylindrical outer surface  436  of the hub portion  434  may then be inserted and positioned within the retainer bore  428  so that the free end  432  of the retainer fingers  430  abut the back-stop  438  of the hub portion  434 , as depicted in  FIG. 27 , so that the occluder frame segments  386  may be secured to the retainer fingers  430 . The hub retainer  424  and the hub portion  434  may be secured together via a weld or adhesive or any other suitable method, such as by welding a seam between the hub retainer  424  and the hub portion  434 . As previously set forth, the retainer fingers  430  of the hub retainer  424  may extend through corresponding first openings  404  of the occluder frame segments  386  such that the occluder frame segments  386  may be moveable, to an extent, over the retainer fingers  430  so that the occluder frame segments  386  may pivot at the proximal end  390  thereof over the retainer fingers  430 . With this arrangement, the occluder frame segments  386  may be pivotably coupled to the hub  382  at the proximal end  390  of the occluder frame segments  386 . Further, in this manner, the occluder portion  362  may readily constrict and pivot to an occluder constricted state within the sheath  316  of the delivery system  302  and, upon the occluder portion  362  being moved out of the sheath  316 , the occluder frame segments  386  may pivot so that the occluder portion  362  self-expands to a radially expanded position or occluder deployed position (see  FIG. 18 ). 
     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 employing 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.