Medical devices and systems for closing tissue openings and methods thereof

Abstract

Medical devices, systems, and methods are provided for occluding the left atrial appendage of the heart. In one embodiment, a medical device (10) includes an occluder portion (16) and an anchor portion (18) pivotally coupled to one another at a hinge component (26). The hinge components each include a base having an arm extending from the base, with the arm of each one of the hinge components extending through and capturing a first eyelet of the occluder portion and a second eyelet of the anchor portion to facilitate pivotally coupling the anchor portion to the occluder portion.

Description

[Technical Field]

[0001] The present invention relates generally to the occlusion of tissue openings or atrial appendages, and more particularly to devices, systems, and methods for occluding or otherwise structurally modifying such openings and atrial appendages, such as the left atrial appendage. [Background technology]

[0002] Each of the atria, the upper chambers of the heart, is attached to an atrial appendage. For example, the left atrial appendage is a common feature of all human hearts. While the physiological function of such appendages is not fully understood, they certainly function as filling chambers during normal heartbeats. Atrial appendages typically protrude from the atria and cover their outer portions. Atrial appendages vary substantially from one another. For example, one atrial appendage may be configured as a tapered protrusion, while another may be configured as a sock-like hole with an inward recess. The inner surface of the atrial appendage is conventionally trabeculated with cords of myocardial tissue that traverse its surface with one or more lobes.

[0003] While the heart is functioning normally, blood is pumped through the atrial appendages, but the appendages appear to be inactive. In other words, while the heart is functioning normally, the appendages do not appear to have a significant effect on the blood pumped through them. However, in the case of atrial fibrillation, when the atria become irregular, blood can pool inside the atrial appendages, potentially causing thrombosis. This can pose a risk of stroke, particularly if it occurs in the left atrial appendage, because blood clots can be ejected from the heart and enter the cranial circulatory system when normal sinus rhythm is restored after an arrhythmic event.

[0004] Historically, surgical modifications to the atrial appendage have sometimes been performed to reduce the risks associated with atrial fibrillation. In recent years, devices that can be delivered percutaneously to the left atrial appendage have been introduced. The basic function of these devices is to evacuate the volume within the appendage with an implant, allowing the blood within the appendage to safely clot and then gradually resorb into the cardiac tissue. This process, coupled with endothelial growth over the surface of the device, can leave the surface on which the appendage is located in a smooth, endothelialized state. Percutaneously implanted devices offer a less invasive approach to addressing issues associated with the left atrial appendage compared to surgical procedures. Summary of the Invention [Problem to be solved by the invention]

[0005] However, due to the wide variation in size and volume of the ostium of the left atrial appendage, many current implantable devices include structures that cannot accommodate such variations, resulting in devices that are unsuitable for many left atrial appendage anatomies. Furthermore, such implantable devices are typically limited in their functionality as they can be adjusted within the left atrial appendage after being anchored therein. Yet another problem with many current implantable devices is their ability, once the implant is secured to tissue within the left atrial appendage, to be visible using imaging techniques in a manner that allows a physician to easily recognize whether the implant should be adjusted to a more optimal position within the left atrial appendage. Therefore, to increase the success rate of left atrial appendage revisions, it would be advantageous to provide percutaneous systems, methods, and / or devices that address issues related to the adjustability and visibility of implantable devices within the left atrial appendage, for example.

[0006] Various features and advantages will become apparent to those skilled in the art upon reading the following description of the various embodiments. [Means for solving the problem]

[0007] Embodiments of the present invention are directed to various devices, systems, and methods for occluding the left atrial appendage of a heart. In one embodiment, a medical device for occluding the left atrial appendage of a heart is provided. The medical device includes an occluder portion, an anchor portion, and a hinge component. The occluder portion is coupled to a hub defining an axis, and the occluder portion has occluder frame segments extending radially outward from the hub to a distal end portion of the occluder portion, with a plurality of the occluder frame segments at the distal end portion defining a first eyelet. The anchor portion includes anchor frame segments extending between a first end and a second end. The second end of the anchor frame segments is coupled to the anchor hub, and the first end of the anchor frame segments defines a second eyelet adjacent thereto. Each of the hinge components includes a base having an arm, the arm extending from the base. Each one arm of the hinge component extends through and captures a first eyelet of one of the occluder frame segments and a second eyelet of one of the anchor frame segments to facilitate pivotally coupling the anchor portion to the occluder portion.

[0008] In another embodiment, the arms each define a catch surface sized and configured to maintain the hinge component in a corresponding one of the first and second eyelets. In a further embodiment, the base extends with an inner surface, with the first and second eyelets positioned between the inner surface and the catch surfaces of the arms. In another embodiment, the arms are each independently movable and extend from the base to a free end, with each arm extending with an outer surface adjacent the free end, the outer surface configured to engage with structure defining the first and second eyelets to move the arm inward. In yet another embodiment, the arms include at least two arms.

[0009] In another embodiment, the hinge components each include a radiopaque material, the radiopaque material of the hinge components configured to facilitate imaging of the proximal boundary, the proximal boundary being proximal to a tooth extending from the anchor portion. In yet another embodiment, the structure defining one of the first eyelet and the second eyelet includes a radiopaque material, the radiopaque material of the structure configured to facilitate imaging of the proximal boundary, the proximal boundary being proximal to a tooth extending from the anchor portion. In yet another embodiment, a portion of the anchor frame segment includes a radiopaque material, the radiopaque material of the portion of the anchor frame segment configured to facilitate imaging of a distal-most boundary of the anchor portion. In another embodiment, the hinge component and a portion of the anchor frame segment comprise radiopaque material, the radiopaque material of the hinge component defining a proximal boundary, the radiopaque material of the portion of the anchor frame segment defining a distal boundary, the proximal and distal boundaries defining a landing zone for the anchor portion, and the landing zone for the anchor portion including teeth extending from the anchor portion.

[0010] According to another embodiment of the present invention, a medical device for occluding a left atrial appendage of a heart is provided. The medical device includes a framework and a plurality of hinge components. The framework includes an occluder portion and an anchor portion, the occluder portion coupled at a hub, the occluder portion of the framework extending radially outward relative to the hub to a distal end portion of the occluder portion. The anchor portion extends between a first end portion and a second end portion, the second end portion coupled to a secondary hub. The plurality of hinge components each include a base having an arm extending from the base. Each arm of the hinge component extends through an eyelet defined in the distal end portion of the occluder portion and the first end portion of the anchor portion to facilitate pivotal coupling of the anchor portion to the occluder portion.

[0011] In another embodiment, the arms each define a catch surface sized and configured to maintain the hinge component in the occluder portion and the anchor portion. In another embodiment, the arms are each independently movable and extend from a base to a free end, each extending with an outer surface adjacent the free end, the outer surface configured to engage with structure defining the eyelet to urge the arm inward.

[0012] In another embodiment, the hinge components each include a radiopaque material, the radiopaque material of the hinge components configured to facilitate imaging of the proximal boundary, the proximal boundary being proximal to the tines extending from the anchor portion. In another embodiment, the structure defining the eyelet includes a radiopaque material, the radiopaque material of the structure configured to facilitate imaging of the proximal boundary, the proximal boundary being proximal to the tines extending from the anchor portion. In yet another embodiment, when the anchor portion is in the anchor deployed position, the anchor portion extends distally with an anchor post toward a distal end of the anchor portion, the anchor post including a tine extending therefrom, the anchor post including a portion distal to the tines having radiopaque material, the radiopaque material of a portion of the anchor frame segment configured to facilitate imaging of the distal boundary, the proximal and distal boundaries defining a landing zone of the anchor portion.

[0013] In accordance with another embodiment of the present invention, a method of occluding a left atrial appendage of a heart is provided, the method including: advancing a medical device having a catheter through the vascular system to the left atrial appendage, the medical device having a framework extending between a primary hub and a secondary hub, the primary and secondary hubs having a common axis, the framework extending with hinge components between an occluder portion and an anchor portion of the framework, each hinge component including a base and an arm extending from the base; deploying the framework adjacent the left atrial appendage from a contracted position to a deployed position such that the secondary hub is movable relative to the primary hub along the axis and such that the anchor portions pivot about the hinge components with the arms of each hinge component positioned through corresponding ones of the anchor eyelets defined in the anchor portion and the arms of each hinge component positioned through corresponding ones of the occluder eyelets defined in the occluder portion; and releasing the medical device from the catheter with the medical device framework secured to tissue adjacent the left atrial appendage.

[0014] In another embodiment, following deploying the framework, pivoting the anchor portion by moving the secondary hub proximally to move the anchor portion to a retracted position so that the teeth of the anchor portion are retracted from the tissue. In another embodiment, the deploying step includes securing the framework to tissue adjacent the left atrial appendage with teeth extending from the anchor portion of the framework. In yet another embodiment, the method further includes maintaining the anchor portion coupled to the occluder portion of the framework such that a catch surface of each arm of the hinge component defines a structure in which the first eyelet and the second eyelet are positioned between the catch surface and a base of each of the hinge components. In yet another embodiment, the method further includes using imaging techniques to visualize markers integrated into the framework to determine a landing zone of the framework, at least partially defined by the markers, relative to the tissue adjacent the left atrial appendage.

[0015] According to another embodiment of the present invention, there is provided a method of assembling an occlusion device, the method including the steps of providing an occluder frame portion, an anchor frame portion, and a plurality of hinge components, the occluder frame portion extending between a proximal end portion and a distal end portion, the anchor frame portion extending between a first end portion and a second end portion, the hinge components each including a base with an arm extending from the base, coupling the proximal end portion of the occluder frame portion to a hub such that the occluder frame portion extends distally and radially outward to the distal end portion, the distal end portion defining a first eyelet therein, inserting one arm of the hinge components through the first eyelet of the distal end portion of the occluder frame portion, inserting one arm of the hinge components through a second eyelet defined in the first end portion of the anchor frame portion, and coupling the second end portion of the anchor frame portion to a secondary hub.

[0016] In another embodiment, the method further includes coupling the anchor portion to the occluder portion at the catch surfaces of the arms and the inner surface of the base of each of the hinge components. In another embodiment, the inserting step includes independently moving the arms inwardly on the outer surfaces of the arms, wherein the arms engage with structure defining the first eyelet or engage with structure defining the second eyelet such that the arms are insertable through the first eyelet and the second eyelet.

[0017] In another embodiment, the method further includes integrating a marker into one of the occluder portion and the anchor portion to at least partially assist in determining a landing zone of the anchor portion relative to tissue adjacent the left atrial appendage. In another embodiment, the integrating includes integrating a marker with radiopaque material into at least one of the hinge components and structures defining the first and second eyelets, such that the radiopaque material is configured to facilitate imaging of the proximal boundary, the proximal boundary being proximal to the tines extending from the anchor portion. In a further embodiment, the integrating step includes integrating a marker with radiopaque material in a portion of the anchor portion, such that the marker is positioned to define the distal boundary, the proximal and distal boundaries defining a landing zone therebetween. In another embodiment, the distal boundary of the landing zone extends through and / or along the tines of the anchor portion.

[0018] According to another embodiment of the present invention, a medical device for occluding a left atrial appendage of a heart is provided. In this embodiment, the medical device includes a framework extending to define an occluder portion and an anchor portion, the anchor portion including teeth sized and configured to anchor the framework to tissue of the left atrial appendage. The anchor portion is pivotally coupled to the occluder portion with a plurality of hinge components such that each one of the hinge components extends through and is captured within a first eyelet of the occluder portion and a second eyelet of the anchor portion to facilitate pivotal movement of the anchor portion relative to the occluder portion. The hinge components and a portion of the anchor portion adjacent the teeth include radiopaque material. In this arrangement, the radiopaque material of the hinge component defines a proximal boundary, and the radiopaque material of a portion of the radiopaque material adjacent the teeth defines a distal boundary, such that the proximal and distal boundaries are spaced apart from each other to define a landing zone therebetween.

[0019] In another embodiment, the anchor portion includes a plurality of wires, each of the plurality of wires fixedly coiled around a portion of the anchor portion, and the plurality of wires includes a radiopaque material to define a distal-most boundary of the framework. In yet another embodiment, each of the hinge components includes a base having arms extending from the base, each of the arms including a catch surface for maintaining the anchor portion on the occluder portion. In another embodiment, the arms are each independently movable and extend from the base to a free end, each of the arms extending with an outer surface adjacent the free end, the outer surface configured to engage with structure defining the first and second eyelets to move the arms inward.

[0020] In accordance with another embodiment of the present invention, a method of occluding a left atrial appendage of a heart is provided, the method including the steps of advancing a medical device having a catheter through a vascular system to the left atrial appendage, the medical device having a framework extending to define an occluder portion and an anchor portion, the anchor portion including teeth sized and configured to anchor the framework to tissue of the left atrial appendage, the anchor portion pivotally coupled to the occluder portion with a plurality of hinge components, each one of the hinge components extending through and captured within a first eyelet of the occluder portion and a second eyelet of the anchor portion, deploying the framework adjacent the left atrial appendage from a retracted position to a deployed position such that the anchor portion is pivotally movable relative to the occluder portion; and imaging the medical device in the deployed position within the heart to visualize proximal and distal boundaries, the proximal boundary defined by the hinge component and the distal boundary defined by portions adjacent the teeth of the anchor portion such that the proximal and distal boundaries are spaced apart from one another to define a landing zone therebetween.

[0021] In another embodiment, the imaging step includes positioning a landing zone adjacent tissue of the left atrial appendage for anchoring the medical device. In another embodiment, the method further includes pivoting the anchor portion to a retracted position while the occluder portion remains in the expanded position to reposition the medical device relative to tissue of the left atrial appendage. In another embodiment, the method further includes releasing the medical device from the catheter while the framework of the medical device remains secured to tissue adjacent the left atrial appendage. In another embodiment, the method further includes pivoting the anchor portion to the retracted position using hinged components, each having a catch surface extending from an arm of the hinged component, such that the anchor portion remains pivotally coupled to the occluder portion of the framework. [Brief explanation of the drawings]

[0022] These and other advantages of the present invention will become apparent upon reading the following detailed description and upon reference to the drawings. [Figure 1] FIG. 1 is a perspective rear view of a medical device system depicting a medical device coupled to a delivery system, according to one embodiment of the present invention. [Figure 2] FIG. 10 is a perspective rear view of a medical device system depicting an anchor portion of the medical device being retracted with an anchor actuator of a handle of a delivery system according to another embodiment of the present invention. [Figure 3] FIG. 10 is a perspective view of a medical device system depicting a medical device at least partially retracted within a sheath of the medical device system, according to another embodiment of the present invention. [Figure 4] FIG. 10 is a side view of a framework of a medical device (without occluder material attached to the framework), depicting a framework having an occluder frame and an anchor frame, according to another embodiment of the present invention. [Figure 4A] 5 is an enlarged view of a hinge of a medical device taken from detail A of FIG. 4 according to another embodiment of the present invention. [Figure 4B]5 is an enlarged view of a hinge of a medical device taken from detail B of FIG. 4 according to another embodiment of the present invention. [Figure 5] FIG. 10 is an exploded view of various components of a hinge of a medical device, depicting hinge components configured to couple together an occluder and an anchor frame, according to another embodiment of the present invention. [Figure 6] FIG. 1 is a perspective view of a hinge component according to the present invention. [Figure 7] FIG. 1 is a bottom perspective view of a hinge component according to the present invention. [Figure 8] FIG. 1 is a side view of a hinge component according to the present invention. [Figure 9] FIG. 1 is a top view of a hinge component according to the present invention. [Figure 10] FIG. 10 is a front view of an occluder and aligned eyelets of an anchor frame according to another embodiment of the present invention. [Figure 11] FIG. 10 is a side perspective view of a hinge depicting a gap between a joined occluder frame and anchor frame according to another embodiment of the present invention. [Figure 11A] 12 is a cross-sectional view of a hinge taken from line AA of FIG. 11 according to another embodiment of the present invention. [Figure 12] FIG. 10 is a perspective view of another embodiment of a hinge component according to the present invention. [Figure 13] FIG. 13 is a bottom perspective view of the hinge component of FIG. 12 in accordance with the present invention. [Figure 14] FIG. 10 is a perspective view of another embodiment of a hinge component according to the present invention. [Figure 15] FIG. 15 is a bottom perspective view of the hinge component of FIG. 14 in accordance with the present invention. [Figure 16] FIG. 15 is a side view of the hinge component of FIG. 14 in accordance with the present invention. [Figure 17] FIG. 15 is a front view of the hinge component of FIG. 14 in accordance with the present invention. [Figure 18] FIG. 15 is a top view of the hinge component of FIG. 14 in accordance with the present invention. [Figure 19]FIG. 5 is an enlarged perspective view of a portion of the occluder frame taken from detail C of FIG. 4 according to another embodiment of the present invention. [Figure 20] FIG. 5 is an enlarged perspective view of a portion of an anchor frame cut away from detail D of FIG. 4 according to another embodiment of the present invention. [Figure 21] FIG. 10 is a proximal side view of a medical device according to another embodiment of the present invention. [Figure 21A] 22 is an enlarged view of a tooth of a medical device taken from area A of FIG. 21 according to another embodiment of the present invention. [Figure 22] FIG. 10 is a side view of another embodiment of a hinge, depicting a hinge having a rivet and a washer between the anchor eyelet and the occluder eyelet, according to another embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0023] 1 and 4, a medical device 10 is provided that is removably coupled to a delivery system 12. The medical device 10 and delivery system 12 may be used, for example, in an interventional procedure for percutaneously closing and modifying an opening or cavity, such as the left atrial appendage, in a heart (not shown). The medical device 10 may include a frame structure extending to define an occluder portion 16 and an anchor portion 18, which have corresponding frame components in an occluder frame 20 and an anchor frame 22. The occluder portion 16 may include an occluder frame 20 having a tissue growth member 24 attached thereto. The tissue growth member 24 may be in the form of an occlusion member, but may also be in the form of a filter member, a mesh member, a membrane, or any other structure, or combination thereof, sized and configured to promote tissue ingrowth. Furthermore, the tissue growth member 24 may be formed from one or more polymeric materials, such as ePTFE and / or polyurethane foam. The anchor frame 22 may be pivotally coupled to the occluder frame 20 such that the anchor frame 22 may be movable between a retracted position and a deployed position to assist the physician in adjusting the position of the medical device 10 following fixation of the anchor portions 18 to tissue in the left atrial appendage. Such a pivotable coupling between the anchor frame 22 and the occluder frame 20 may be employed with a hinge component 26 that facilitates efficient assembly of the pivotable connection between the anchor portions 18 and the occluder portion 16. Additionally, various portions of the medical device 10, such as the hinge component 26, the occluder frame 20, and / or the anchor frame 22, or other components associated therewith, may include and exhibit markers formed from radiopaque materials that aid visibility via imaging techniques to assist the physician in understanding the details of the landing zone 28 of the medical device 10 relative to the anatomical structures adjacent to the left atrial appendage of the heart. In this manner, the medical device 10 incorporates structural components to assist the physician in optimally positioning the medical device 10 in the left atrial appendage.

[0024] 1-3 , as described, a medical device 10 can be delivered through the vascular system with a delivery system 12. The delivery system 12 can include a pusher catheter 30 and a handle 32, which is integrated with a proximal portion of the catheter 30. The handle 32 can include various functional components, such as an anchor actuator 34, for manipulating the anchor frame 22 between a deployed position ( FIG. 1 ) and a retracted position ( FIG. 2 ). The delivery system 12 can include and be used with a delivery sheath 36 for delivering the medical device 10 to the left atrial appendage. The delivery sheath 36 can be positioned within the vascular system using known interventional techniques, with a deliverable sheath distal end 38 positioned adjacent the left atrial appendage of the heart. Once the medical device 10 has been advanced through the lumen of the delivery sheath 36 to the sheath distal end 38 (the medical device 10 is in a retracted position, partially shown in dashed lines adjacent the sheath distal end 38 (see FIG. 3 )), the medical device 10 may be at least partially deployed from the delivery sheath 36. That is, the delivery sheath 36 may then be manually moved proximally (and / or the pusher catheter 30 may be advanced distally) so that the occluder portion 16 of the medical device 10 may be deployed from the sheath distal end 38. Such an occluder portion 16 may self-expand immediately upon exposure from the sheath distal end 38. At this stage, the medical device 10 may be in a partially deployed state, after which the medical device may be moved to a fully deployed state by deploying the anchor portion 18. For example, when the occluder portion 16 is initially deployed, the anchor portion 18 may be in a retracted position with the anchor actuator 34 of the handle 32 in a proximal position (as depicted in FIG. 2 ). Once the physician determines that the occluder portion 16 is in the proper and desired position adjacent the left atrial appendage, the anchor portion 18 may be pivoted from the retracted position to the deployed position by moving the anchor actuator 34 to a distal position, as indicated by arrow 40 (see FIG. 1). Once the anchor portion 18 is moved to the deployed position, the teeth 145 (FIGS. 4 and 21A) of the anchor portion 18 may engage tissue to secure the medical device 10 within the left atrial appendage.If the physician determines that medical device 10 is not in an optimally secured position within the left atrial appendage, anchor portion 18 may be pivoted back to the retracted position by moving anchor actuator 34 from a distal position to a proximal position, as shown by arrow 42 (see FIG. 2 ). Thus, anchor actuator 34 may be manually moved proximally and distally to move anchor portion 18 between the retracted and deployed positions such that anchor portion 18 pivots between the deployed and retracted positions. In this manner, anchor portion 18 of medical device 10 may be secured and disengaged from tissue in the left atrial appendage as needed by the physician until the physician obtains an optimal position or is satisfied with the position before releasing delivery system 12 from medical device 10. A similar medical device delivery system 14 with its handle 32, pusher catheter 30, medical device 10, and delivery sheath 12 is disclosed in commonly assigned U.S. patent application Ser. No. 15 / 438,650, filed February 21, 2017, now issued as U.S. Patent No. 10,631,969, entitled "MEDICAL DEVICE FOR MODIFICATION OF LEFT ATRIAL APPENDAGE AND RELATED SYSTEMS AND METHODS," the disclosure of which is incorporated herein by reference in its entirety.

[0025] 4, 4A, 4B, and 5, the frame components or framework of the medical device 10 in a fully expanded position will now be described. As previously mentioned, the framework of the medical device 10 may include an occluder frame 20 and an anchor frame 22. The occluder frame 20 may be coupled to and extend from a primary hub 44, the primary hub 44 having a tubular characteristic that may define an axis 46 therethrough. The occluder frame 20 may extend between a proximal end 48 and a distal end 50 such that the proximal end 48 of the occluder frame 20 may be coupled to the primary hub 44. The occluder frame 20 may extend from the proximal end 48 with occluder frame segments 52 and / or occluder frame struts. For example, the occluder frame segments 52 may extend distally and radially from the primary hub 44 to the distal end 50 of the occluder frame 20 relative to the axis 46, such that adjacent the distal end 50, the occluder frame segments 52 may extend in a configuration having an occluder frame eyelet 54 defined therein. In one embodiment, every other occluder frame segment 52 adjacent the distal end 50 of the frame segment 52 may define a configuration having one of the occluder frame eyelets 54 defined therein. In another embodiment, the occluder frame segments 52 extending between those occluder frame segments having an occluder frame eyelet 54 defined therein may extend to a free end 56. In yet another embodiment, the occluder frame eyelets 54 may be referred to as first eyelets, and each of the occluder frame eyelets may be sized and configured to be coupled to the anchor frame 22. In yet another embodiment, each of the occluder frame eyelets 54 may be sized and configured to be coupled to one of the plurality of hinge components 26.

[0026] The anchor frame 22 may extend with a plurality of anchor frame segments 60 and / or anchor frame struts that may extend radially between a first end 62 and a second end 64. Adjacent to the first end 62, the anchor frame segment 60 may extend in a configuration that defines a plurality of anchor frame eyelets 66 therein. Each of the anchor frame eyelets 66 may correspond to one of the occluder frame eyelets 54. Such anchor frame eyelets 66 may be referred to as second eyelets and may be sized and configured to couple to the occluder frame 20 via the occluder frame eyelets 54. Furthermore, the anchor frame eyelets 66 may correspond to and be coupled to one of the plurality of hinge components 26. In this manner, the first end 62 or first end portion of the anchor frame 22 may be pivotally coupled to the occluder frame 20 via the hinge component 26. Furthermore, the second end 64 of the anchor frame segment 60 may extend to and be coupled to a secondary hub 68. The secondary hub 68 may be movable along the axis 46 such that the primary hub 44 and the secondary hub 68 are axially aligned so that they are positioned along the axis 46, or a common axis. In this arrangement, movement of the secondary hub 68 along the axis 46 via the anchor actuator 34 (FIGS. 1 and 2) results in pivoting the anchor portion 18 about the hinge component 26 such that the anchor frame 22 may move between a retracted position and a deployed position.

[0027] 6-9, one of the hinge components 26 will now be described. In one embodiment, each of the hinge components 26 may include a base 70 and an arm 72 extending from the base 70. The base 70 may extend in a cylindrical or any other suitable configuration, which may be larger than the occluder frame eyelet 54 or the anchor frame eyelet 66 (see FIG. 5), so that the base can act as a sealing structure. The base 70 may extend with a radial side 74 between opposing flat surfaces 76. One of the flat surfaces 76 may be a structure that can act as a sealing structure, as well as a surface from which the arm 72 may extend. The arms 72 may each be an elongated structure, with one end of the elongated structure being a free end 78. The hinge component 26 may define a hinge axis 80 extending centrally through the opposing planar faces 76 with the elongated configuration of the arms 72 extending longitudinally along the hinge axis 80 .

[0028] The arms 72 may each extend from one of the planar surfaces 76 to extend in a common direction from the base 70. In one embodiment, the hinge component 26 may extend with four arms 72. Other embodiments of the hinge component 26 may include two arms or three arms. In another embodiment, one or more of the hinge components 26 may include at least two arms extending from the base 70. The arms 72 may each extend toward a free end 78 having a head structure 82 or a knob structure. The arms 72 may extend along their ends to define an outer end surface 84 and a lower catch surface 86, both of which may be surfaces of the head structure 82. The outer end surface 84 may be sized and configured to engage with structure defining portions of either the obturator eyelet 54 or the anchor frame eyelet 66. Furthermore, the lower catch surface 86 may be sized and configured to maintain coupling between the obturator frame 20 and the anchor frame 22. In another embodiment, the head structure 82 can define an outer end surface 84 and a catch surface 86. In another embodiment, each of the arms 72 can be independently movable relative to an adjacent arm 72. In another embodiment, each of the arms 72 can be independently movable relative to the base 70. The independent movement of the arms 72 can be such that when a force is applied to the outer end surfaces 84 of the arms 72, the arms 72 can each move independently to a biased state, moving in a flexed or biased manner. When the force is removed from the outer end surfaces 84 of the arms 72, the arms 72 can each be moved to a relaxed or semi-relaxed state, such that the arms 72 can be slightly contracted when within the respective occluder eyelet 54 and anchor eyelet 66.

[0029] In another embodiment, the hinge component 26 may include a key structure 88. In one embodiment, the key structure 88 may be integral with the arms 72 of the hinge component 26. In another embodiment, the key structure 88 may extend with four post structures 90, with one post structure 90 between each adjacently extending arm 72. In another embodiment, the arms 72 have an elongated length that is greater than the post structures 90. The key structure 88 may be sized and configured to engage with structure defining the occluder frame eyelet 54, such that the eyelet at least partially corresponds to the contour of the key structure 88.

[0030] 5, 10, 11, and 11A, assembly of the hinge component 26 with the occluder frame 20 and anchor frame 22 will now be described. For example, the occluder frame eyelet 54 may be positioned adjacent the hinge component 26 such that the hinge axis 80 of the hinge component 26 extends centrally or axially through the occluder frame eyelet 54. With this axially aligned orientation between the hinge component 26 and the occluder frame eyelet 54, the hinge component 26 may be moved toward the occluder frame eyelet 54 such that structure defining the occluder frame eyelet 54 may be pressed against the outer end surfaces 84 of the arms 72. The arms 72 may then be moved independently inward to allow the occluder frame eyelet 54 to move past the outer end surfaces 84 toward the base 70 as the arms 72 are moved through the eyelets 54. Similar to the occluder frame eyelet 54, the anchor frame eyelet 66 may be oriented to be axially aligned with the hinge axis 80 to move the structure defining the anchor frame eyelet 66 relative to the outer end surface 84 of the arm 72, thereby moving the arm 72 inwardly and then moving the anchor frame eyelet 66 to be positioned between the lower catch surface 86 of the arm 72 and the occluder frame 20 defining the occluder frame eyelet 54, as shown in FIG. 11A. Furthermore, in one embodiment, the structure defining the occluder frame eyelet 54 may include recesses 92 defined therein, as shown in FIGS. 5 and 10. Such recesses 92 may be sized and configured to correspond with the key structures 88 of the hinge component 26, such that each recess 92 may correspond with one of the post structures 90 positioned between adjacently extending arms 72. Furthermore, in another embodiment, the occluder frame eyelets 54 and the anchor frame eyelets 66 can be positioned and aligned together as depicted in FIG. 10, and then the arms 72 of the hinge component 26 are inserted through each of the aligned occluder frame eyelets 54 and anchor frame eyelets 66, as shown in FIG. 11.In another embodiment, when each of the occluder eyelets 54 and anchor eyelets 66 are coupled to the hinge component 26, the key structure 88 may provide a gap 94 between the occluder eyelet 54 and the anchor eyelet 66 because the anchor frame eyelet 66 does not correspond to the key structure 88. Thus, the key structure 88 may inherently provide the gap 94 so as to eliminate the need for a washer between the occluder eyelet 54 and the anchor frame eyelet 66. In this arrangement, the hinge component 26 may be advantageous in its efficiency in coupling the occluder frame 20 and the anchor frame 22 together.

[0031] 12 and 13 , in conjunction with several components depicted in FIG. 5 , another embodiment of a hinge component 102 is provided. This embodiment may be similar to the previous embodiments of the hinge component depicted in FIGS. 6-9 , except that this embodiment of the hinge component 102 does not exhibit keyed or post structures adjacent to the arms of the hinge component 102. Thus, the hinge component 102 of this embodiment may be used in the same manner as the previous embodiments and may include similar functionality as the hinge components of the previous embodiments. As in the previous embodiments, the hinge component 102 may include a base 104 having arms 106 extending therefrom. The arms 106 may include head structures 108 having outer end surfaces 110 that may assist the arms 106 in moving independently inward when a force is applied to the outer end surfaces 110 of either one of the arms 106. Additionally, the arms 106 may also include lower surfaces 112 sized and configured to act as catches to retain the occluder frame eyelets 54 and anchor frame eyelets 66 on this embodiment of the hinge component 102. In another embodiment, the hinge component 102 may be used with a washer (not shown) that may be positioned between the structure defining the occluder frame eyelets 54 and anchor frame eyelets 66 of the respective occluder frame 20 and anchor frame 22.

[0032] 14-18, another embodiment of a hinge component 120 is provided. Similar to the previous embodiment, the hinge component 120 may include a base 122 having arms 124 extending therefrom. In this embodiment, rather than four arms, the hinge component 120 may present two arms 124 extending from the base 122. The arms 124 may extend to a head structure 126 or knob structure having an outer end surface 128 sized and configured to engage with structure defining the occluder frame eyelet 54 and the anchor frame eyelet 66 to facilitate independent inward movement of the arms 124, similar to that described in the previous embodiment (see FIG. 5). 11 and 11A , the hinge component 120 may be assembled to the occluder frame 20 and the anchor frame 22 by axially aligning the occluder frame eyelets 54 and the anchor frame eyelets 66 with the hinge axis 132 of the hinge component 120. In another embodiment, the hinge component may include a base having three arms extending from the base.

[0033] 4 and 21 , in another embodiment, various portions of the framework of medical device 10 may include radiopaque material to define markers, which are configured to be visible using imaging techniques, such as fluoroscopic imaging, as known to those skilled in the art. The markers may be integrated with and arranged with the framework to define proximal and distal boundaries 140, 141, such that the space between the proximal and distal boundaries 140, 141 may define the landing zone 28 of medical device 10. Additionally, the markers may define the distal-most boundary 142 of medical device 10, such that the distal-most boundary 142 may indicate the distal end 50 of medical device 10 to a physician. The proximal and distal boundaries 140, 141 of the landing zone 28 (as well as the distal-most end of the medical device) are indicated by dashed lines, which generally extend through or adjacent to and alongside the markers integrated with the framework of medical device 10.

[0034] For example, with reference to FIGS. 4, 21, and 21A, the distal boundary 141 of the landing zone 28 may extend through a tooth marker 168 positioned adjacent a tooth 145 of the anchor frame 22. The tooth 145 may extend at discrete locations and along discrete anchor posts using a dual tooth configuration 170. The tooth 145 may extend with the dual tooth configuration 170 at discrete, spaced apart locations along the outer radial periphery of the anchor frame 22, the outer radial periphery extending in a generally circular outline (as depicted in FIG. 21). In one embodiment, the tooth marker 168 or one of the markers adjacent the tooth 145 may be positioned within an opening 172 defined beneath or within a structure extending to define the dual tooth configuration 170. Such a tooth marker 168 may be cylindrical, as depicted by the dashed line in FIG. 21A, sized and configured to be positioned within the opening 172 associated with the dual tooth configuration 170. In another embodiment, the tooth marker 168 may be positioned in or adjacent to each of the dual tooth configurations 170 of the anchor frame 22. In another embodiment, the tooth marker 168 may be positioned in alternating ones of the dual tooth configurations 170, or stated another way, in every other one of the dual tooth configurations 170 positioned along the outer radial periphery of the anchor frame 22. In another embodiment, the tooth marker 168 may be positioned in some of the multiple dual tooth configurations 170. In this arrangement, the tooth marker 168 positioned along the outer radial periphery adjacent the tooth 145 defines the distal boundary 141 of the landing zone 28 such that the distal boundary 141 of the landing zone 28 may extend along the outer radial periphery such that the distal boundary extends in a generally circular configuration, as shown by the dashed line of the distal boundary 141 in FIG. 21 .

[0035] 4 and 21 , as previously described, the proximal boundary 140 of the landing zone 28 may be defined by a hinge marker 144, such as a marker integrated with or adjacent to the hinge component 26 or along another portion of the framework of the medical device 10. Like the distal boundary 141, the proximal boundary 140 of the landing zone 28 may extend in a generally circular outline. The hinge marker 144 defining the proximal boundary 140 may be located proximal to the tooth marker 170 defining the distal boundary 141. The landing zone 28 of the medical device 10, defined between the proximal boundary 140 and the distal boundary 141, may generally be the radially most portion of the anchor frame 22, including the teeth 145 extending from the anchor frame 22 of the medical device 10. Thus, the hinge marker 144 and tooth marker 168 that define the landing zone 28 of the medical device 10 may assist a physician through imaging techniques in viewing the proximal boundary 140 and distal boundary 141 to determine the landing zone 28 of the medical device 10 relative to the tissue anatomy so that the physician can manipulate the position of the medical device 10 and obtain proper anchoring via the teeth 145 of the medical device 10 in the tissue adjacent the left atrial appendage.

[0036] 4, 4A, and 4B, the hinge components 26 described above may be formed of a radiopaque material to define a hinge marker 144. Because each of the hinge components 26 is formed of a radiopaque material, a physician may approximately determine the proximal boundary 140 with the imaging techniques described above. In one embodiment, the proximal boundary 140 may be collectively defined by each of the hinge components 26. In another embodiment, the proximal boundary 140 may be defined by a plurality of occluder crimp rings 146 formed of a radiopaque material. Such occluder crimp rings 146 may be attached to the occluder frame 20 such that each one of the crimp rings 146 may be positioned adjacent to a corresponding one of the hinge components 26. Similarly, in another embodiment, the proximal boundary 140 may be defined by a plurality of anchor crimp rings 148 made of a radiopaque material. The anchor crimp rings 148 may be attached to the anchor frame 22 such that each one of the anchor crimp rings 148 may be positioned adjacent to a hinge component 26. In another embodiment, multiple anchor crimp rings 148 may be positioned adjacent to each one of the hinge components 26. In yet another embodiment, the proximal boundary 140 may be defined by at least one of an occluder insertion marker 150 and an anchor insertion marker 152. Such an occluder insertion marker 150 and an anchor insertion marker 152 may be positioned in an opening defined in at least one of the occluder frame 20 or the anchor frame 22 such that one or more insertion markers 150, 152 may be positioned adjacent to each one of the hinge components 26. In this manner, the hinge components 26 and / or structures adjacent the hinge components may be formed from or have radiopaque material integrated therewith to define the proximal boundary 140 of the landing zone 28. In another embodiment, the hinge component 26 and / or structures adjacent to the hinge component 26 may be doped to form a radiopaque material or coated with a radiopaque material to define the proximal boundary 140 of the landing zone 28.

[0037] 4 and 19 , in another embodiment, the proximal boundary 140 may be defined by a marker integrated with a portion of the occluder frame 20, such as, for example, a structure adjacent the free end 56 of the occluder frame 20. Additionally, such portion adjacent the free end 56 of the occluder frame segment 52 may be integrated with a crimp ring 154 formed from a radiopaque material. In another embodiment, the portion adjacent the free end 56 of the occluder frame segment 52 may undergo a doping process to form a radiopaque material therein. In another embodiment, the portion adjacent the free end 56 of the occluder frame segment 52 may receive a coating layer 155 of a radiopaque material.

[0038] 4 and 20 , as previously described, the distal-most boundary 142 of the medical device 10 can be defined by a structure adjacent the distal end 50 of the anchor frame 22 of the medical device 10. For example, the structure can be a coil 156 formed or wrapped around the anchor frame 20, where the coil 156 is formed from a wire material. The coil 156 can be formed of a radiopaque material. Such a coil 156 can also undergo a doping process to form the coil 156 with a radiopaque material, or the coil 156 can be coated with a radiopaque material. In another embodiment, the distal-most boundary 142 can be defined by, for example, a distal insertion marker 158 integrated into an opening defined in the anchor frame 22 adjacent the coil 156. In another embodiment, the distal-most boundary 142 can be defined by a distal crimp ring 159 wrapped around the anchor frame 22 adjacent the coil 156. Such a distal-most boundary 142 may assist the physician in visually recognizing the boundaries and limits of the medical device via imaging techniques, providing a frame of reference for the landing zone 28 and other radiopaque markers described herein to better assist the physician in determining the landing zone 28 of the medical device 10 relative to the anatomical structure of the left atrial appendage.

[0039] Referring to FIG. 22 in conjunction with some of the components of FIG. 4 , in another embodiment, the proximal boundary 140 can be defined with a hinge component 160 or with a structure positioned therein. For example, the hinge component 160 can include a washer 162 positioned between the structure of the occluder eyelet 54 and the anchor eyelet 66 defined by the respective occluder frame 20 and anchor frame 22. In this embodiment, the washer 162 can be formed from a radiopaque material. Such a washer 162 can be integrated with the various hinge components described herein. In one embodiment, the hinge component 160 can be a polymer filament positioned within the occluder and anchor eyelets with opposing ends formed into bulbous structures 164 via heating the opposing ends of the hinge component 160. The various radiopaque markers described herein can be formed from radiopaque materials such as platinum, gold, tantalum, or alloys thereof, or any other suitable radiopaque material that is biocompatible, as known to those skilled in the art.

[0040] 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 are herein described in detail. It should be understood, however, that the invention is not intended to be limited to the particular forms disclosed. Rather, the invention includes combining any part of one embodiment with other embodiments, all modifications, equivalents, and alternatives falling within the spirit and scope of the invention.

[0041] [Embodiment] (1) A medical device for occluding the left atrial appendage of the heart, comprising: an occluder portion coupled to a hub defining an axis, the occluder portion having occluder frame segments extending radially outward from the hub to a distal end portion of the occluder portion, a plurality of the occluder frame segments at the distal end portion defining a first eyelet; an anchor portion having an anchor frame segment extending between a first end and a second end, the second end of the anchor frame segment coupled to an anchor hub, and the first end of the anchor frame segment defining a second eyelet adjacent thereto; a plurality of hinge components, each of the hinge components including a base having an arm extending from the base, the arm of each one of the hinge components extending through and capturing the first eyelet of one of the occluder frame segments and the second eyelet of one of the anchor frame segments, respectively, to facilitate pivotally coupling the anchor portion to the occluder portion. (2) A medical device as described in embodiment 1, wherein each of the arms defines a catch surface sized and configured to maintain the hinge component in a corresponding one of the first eyelet and the second eyelet. (3) The medical device of embodiment 2, wherein the base extends with an inner surface, and the first eyelet and the second eyelet are positioned between the inner surface and the catch surface. (4) A medical device as described in embodiment 1, wherein the arms are each independently movable and extend from the base to a free end, each of the arms extending with an outer surface adjacent the free end, the outer surface configured to engage with structures defining the first eyelet and the second eyelet to move the arms inward. (5) A medical device as described in embodiment 1, wherein the arm includes at least two arms.

[0042] (6) The medical device of embodiment 1, wherein each of the hinge components includes a radiopaque material, the radiopaque material of the hinge components being configured to facilitate imaging of a proximal boundary, the proximal boundary being proximal to a tooth extending from the anchor portion. (7) A medical device as described in embodiment 1, wherein a structure defining one of the first eyelet and the second eyelet includes a radiopaque material, the radiopaque material of the structure being configured to facilitate imaging of a proximal boundary, the proximal boundary being proximal to a tooth extending from the anchor portion. (8) A medical device as described in embodiment 1, wherein a portion of the anchor frame segment includes a radiopaque material, and the radiopaque material of the portion of the anchor frame segment is configured to facilitate imaging of the distal-most boundary of the anchor portion. (9) The medical device of embodiment 1, wherein the hinge component and a portion of the anchor frame segment comprise radiopaque material, the radiopaque material of the hinge component defines a proximal boundary, the radiopaque material of the portion of the anchor frame segment defines a distal boundary, the proximal and distal boundaries define a landing zone of the anchor portion, and the landing zone of the anchor portion includes teeth extending from the anchor portion. (10) A medical device for occluding the left atrial appendage of the heart, comprising: a framework having an occluder portion and an anchor portion, the occluder portion coupled at a hub, the occluder portion of the framework extending radially outward relative to the hub to a distal end portion of the occluder portion, the anchor portion extending between a first end portion and a second end portion, the second end portion coupled to a secondary hub; a plurality of hinge components, each of the hinge components including a base having an arm extending from the base, the arm of each one of the hinge components extending through an eyelet defined in the distal end portion of the occluder portion and the first end portion of the anchor portion, respectively, to facilitate pivotally coupling the anchor portion to the occluder portion.

[0043] (11) The medical device of embodiment 10, wherein the arms each define a catch surface sized and configured to retain the hinge component in the occluder portion and the anchor portion. (12) The medical device of embodiment 10, wherein the arms are each independently movable and extend from the base to a free end, each of the arms extending with an outer surface adjacent the free end, the outer surface configured to engage with a structure defining the eyelet to move the arm inward. (13) The medical device of embodiment 10, wherein each of the hinge components includes a radiopaque material, the radiopaque material of the hinge components configured to facilitate imaging of a proximal boundary, the proximal boundary being proximal to a tooth extending from the anchor portion. (14) The medical device of embodiment 10, wherein the structure defining the eyelet includes a radiopaque material, the radiopaque material of the structure configured to facilitate imaging of a proximal boundary, the proximal boundary being proximal to a tooth extending from the anchor portion. (15) The medical device of embodiment 14, wherein when the anchor portion is in the anchor deployed position, the anchor portion extends distally with an anchor post from the hinge component toward a distal end of the anchor portion, the anchor post including a tooth extending therefrom, the anchor post including a portion distal to the tooth having radiopaque material, the radiopaque material of the portion of the anchor frame segment configured to facilitate imaging of a distal boundary, and the proximal boundary and the distal boundary define a landing zone for the anchor portion.

[0044] (16) A method for occluding a left atrial appendage of a heart, the method comprising: advancing a medical device having a catheter through the vascular system to the left atrial appendage, the medical device having a framework extending between a primary hub and a secondary hub, the primary hub and the secondary hub having a common axis, the framework extending with hinge components between an occluder portion and an anchor portion of the framework, each hinge component including a base and an arm extending from the base; deploying the framework adjacent the left atrial appendage from a contracted position to a deployed position such that the secondary hub is movable relative to the primary hub along the axis and such that the anchor portions pivot about the hinge components with the arms of each of the hinge components positioned through corresponding ones of the anchor eyelets defined in the anchor portion and with the arms of each of the hinge components positioned through corresponding ones of the occluder eyelets defined in the occluder portion; and releasing the medical device from the catheter while the framework of the medical device remains secured to tissue adjacent the left atrial appendage. (17) The method of claim 16, wherein following the deploying of the framework, the anchor portion is pivoted by moving the secondary hub proximally to move the anchor portion to a retracted position such that the teeth of the anchor portion are retracted from the tissue. (18) The method of embodiment 16, wherein the deploying step includes securing the framework to the tissue adjacent to the left atrial appendage with teeth extending from the anchor portion of the framework. (19) The method of embodiment 16, further comprising maintaining the anchor portion coupled to the occluder portion of the framework such that the catch surface of each of the arms of the hinge component defines a structure in which the first eyelet and the second eyelet are positioned between the catch surface and the base of each of the hinge components. (20) The method of embodiment 16, further comprising using imaging technology to visualize markers integrated into the framework to determine a landing zone of the framework, at least partially defined by the markers, relative to the tissue adjacent the left atrial appendage.

[0045] (21) A medical device for occluding the left atrial appendage of the heart, comprising: a framework extending to define an occluder portion and an anchor portion, the anchor portion including teeth sized and configured to anchor the framework to tissue of the left atrial appendage, the anchor portion pivotally coupled to the occluder portion with a plurality of hinge components, each one of the hinge components extending through and being captured within a first eyelet of the occluder portion and a second eyelet of the anchor portion to facilitate pivotal movement of the anchor portion relative to the occluder portion; the hinge component and a portion of the anchor portion adjacent the tooth comprise radiopaque material, the radiopaque material of the hinge component defining a proximal boundary and the radiopaque material of the portion adjacent the tooth defining a distal boundary, the proximal and distal boundaries being spaced apart from one another to define a landing zone therebetween.

Claims

1. 1. A medical device for occluding the left atrial appendage of a heart, comprising: an occluder portion coupled to a hub defining an axis, the occluder portion having occluder frame segments extending radially outward from the hub to a distal end portion of the occluder portion, a plurality of the occluder frame segments at the distal end portion defining a first eyelet; an anchor portion having an anchor frame segment extending between a first end and a second end, the second end of the anchor frame segment coupled to an anchor hub, and the first end of the anchor frame segment defining a second eyelet adjacent thereto; a plurality of hinge components, each of the hinge components including a base having an arm extending from the base, the arm of each one of the hinge components extending through and capturing the first eyelet of one of the occluder frame segments and the second eyelet of one of the anchor frame segments, respectively, to facilitate pivotally coupling the anchor portion to the occluder portion.

2. The medical device of claim 1 , wherein the arms each define a catch surface sized and configured to retain the hinge component in a corresponding one of the first eyelet and the second eyelet.

3. The medical device of claim 2 , wherein the base extends with an inner surface, the first eyelet and the second eyelet being positioned between the inner surface and the catch surface.

4. 2. The medical device of claim 1, wherein the arms are each independently movable and extend from the base to a free end, each of the arms extending with an outer surface adjacent the free end, the outer surface configured to engage with structure defining the first eyelet and the second eyelet to move the arms inward.

5. The medical device of claim 1 , wherein the arm includes at least two arms.

6. 2. The medical device of claim 1, wherein the hinge components each include a radiopaque material, the radiopaque material of the hinge components configured to facilitate imaging of a proximal boundary, the proximal boundary being proximal to a tooth extending from the anchor portion.

7. 2. The medical device of claim 1, wherein a structure defining one of the first eyelet and the second eyelet comprises a radiopaque material, the radiopaque material of the structure configured to facilitate imaging of a proximal boundary, the proximal boundary being proximal to a tooth extending from the anchor portion.

8. 10. The medical device of claim 1, wherein a portion of the anchor frame segment includes a radiopaque material, the radiopaque material of the portion of the anchor frame segment configured to facilitate imaging of a distal-most boundary of the anchor portion.

9. 2. The medical device of claim 1, wherein the hinge component and a portion of the anchor frame segment comprise radiopaque material, the radiopaque material of the hinge component defining a proximal boundary, the radiopaque material of the portion of the anchor frame segment defining a distal boundary, the proximal and distal boundaries defining a landing zone of the anchor portion, and the landing zone of the anchor portion including teeth extending from the anchor portion.

10. 1. A medical device for occluding the left atrial appendage of a heart, comprising: a framework having an occluder portion and an anchor portion, the occluder portion coupled at a hub, the occluder portion of the framework extending radially outward relative to the hub to a distal end portion of the occluder portion, the anchor portion extending between a first end portion and a second end portion, the second end portion coupled to a secondary hub; a plurality of hinge components, each of the hinge components including a base having an arm extending from the base, the arm of each one of the hinge components extending through an eyelet defined in the distal end portion of the occluder portion and the first end portion of the anchor portion, respectively, to facilitate pivotally coupling the anchor portion to the occluder portion.

11. The medical device of claim 10 , wherein the arms each define a catch surface sized and configured to retain the hinge component in the occluder portion and the anchor portion.

12. 11. The medical device of claim 10, wherein the arms are each independently movable and extend from the base to a free end, each of the arms extending with an outer surface adjacent the free end, the outer surface configured to engage with structure defining the eyelet to cause the arm to move inward.

13. 11. The medical device of claim 10, wherein the hinge components each include a radiopaque material, the radiopaque material of the hinge components configured to facilitate imaging of a proximal boundary, the proximal boundary being proximal to a tooth extending from the anchor portion.

14. 11. The medical device of claim 10, wherein the structure defining the eyelet comprises a radiopaque material, the radiopaque material of the structure configured to facilitate imaging of a proximal boundary, the proximal boundary being proximal to a tooth extending from the anchor portion.

15. 15. The medical device of claim 14, wherein when the anchor portion is in the anchor deployed position, the anchor portion extends distally with an anchor post from the hinge component toward a distal end of the anchor portion, the anchor post including a tine extending therefrom, the anchor post including a portion distal to the tine having radiopaque material, the radiopaque material of the portion of the anchor post configured to facilitate imaging of a distal boundary, and the proximal and distal boundaries define a landing zone for the anchor portion.

Images