Medical device frame components, systems and methods thereof - Patents.com

Abstract

Medical devices, systems, and methods are provided for occluding a left atrial appendage of a heart. In one embodiment, the medical device system includes a pusher catheter having a medical device coupled adjacent a distal end of the pusher catheter. The medical device includes a primary hub and a secondary hub with a framework extending therebetween, the primary hub including a groove defined therein. The framework is movable between a contracted position and an expanded position, and when the framework moves to the contracted position, the groove is configured to align with a portion of the framework as the secondary hub moves through the hole in the primary hub. In another embodiment, components of the framework may be configured to minimize resistance in the system as the medical device is delivered and moved between the contracted and expanded positions.

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, including, for example, the left atrial appendage. [Background technology]

[0002] Each of the upper chambers of the heart, the atria, is attached to an atrial appendage. For example, the left atrial appendage is a feature of all human hearts. The physiological function of such appendages is not fully understood, but they certainly act as filling chambers while the heart is beating normally. The appendages typically project from the atria and cover the outer portions of the atria. The appendages differ substantially from one another. For example, one appendage may be configured as a tapered protuberance, while another may be configured as an inwardly recessed sock-like hole. The inner surface of the 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, which appear to be inactive. In other words, while the heart is functioning normally, the atrial 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 arrhythmic, blood can pool inside the atrial appendages, causing thrombosis. This can lead to a risk of stroke, especially if this occurs in the left atrial appendage, because blood clots can be pumped out of the heart and into the cranial circulatory system when normal sinus rhythm is restored after an arrhythmic event.

[0004] Historically, surgical modifications have sometimes been made to the atrial appendage to reduce the risks posed by atrial fibrillation. In recent years, devices have been introduced that can be delivered percutaneously to the left atrial appendage. 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 reintegrate into the cardiac tissue. This process, coupled with the growth of endothelium over the face of the device, can leave the surface on which the appendage sits in a smooth, endothelialized state. Percutaneously implanted devices offer a less invasive means of addressing problems associated with the left atrial appendage compared to surgical procedures.

[0005] However, due to the large variability in size and volume of the ostium of the left atrial appendage, many of the current implantable devices include structures that cannot accommodate such variability, resulting in devices that are inappropriate for many left atrial appendage anatomies. One important aspect to minimize the effect of ostium size variability is the ability to disengage and re-anchor the medical device within the left atrial appendage if the physician believes a better position is achievable, so that the medical device has the ability to be disengaged from the tissue, manipulated, and then re-anchor to the tissue, repeating steps similar to those disclosed in commonly assigned U.S. Pat. No. 9,693,780 by Miles et al., which disclosure is incorporated herein by reference in its entirety, until the physician is satisfied with the location of the medical device in the ostium of the left atrial appendage. However, one problem with repeated fastening and disengagement of a medical device is that components of the medical device may become entangled due to the dynamic forces of the beating heart that are applied to the medical device while the physician is fastening the medical device to the heart, such as the left atrial appendage. Another problem often found in percutaneous delivery systems involves resistance between various components of the medical device and its delivery system. Such resistance may minimize the physician's tactile sensation while delivering the medical device.

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

[0007] Embodiments of the present invention are directed to various devices, systems, and methods for delivering a medical device. In one embodiment, a medical device for occluding a left atrial appendage of a heart is provided. The medical device includes a delivery catheter and a sheath, the delivery catheter including a medical device coupled adjacent to a delivery catheter distal end of the delivery catheter. The sheath extends with a wall between a distal end and a proximal end, a central lumen and a central axis are defined within the sheath along a longitudinal length of the sheath, such that the medical device and the delivery catheter are advanceable through the central lumen of the sheath. Additionally, the sheath defines concentric lumens therein to extend along the wall, the sheath is deflectable at a first deflectable portion to a first pivot position along a distal portion of the sheath, and the sheath is deflectable at a second deflectable portion to a second pivot position along the distal portion of the sheath. In this configuration, at least one of the first and second pivot positions of each of the first and second deflectable portions is adjustable along the longitudinal length of the distal portion of the sheath.

[0008] In another embodiment, a radius of at least one of the first and second pivot positions is adjusted as at least one of the first and second pivot positions is adjusted, hi a further embodiment, the radius increases as at least one of the first and second pivot positions is moved proximally along the length of the sheath and the radius decreases as at least one of the first and second pivot positions is moved distally along the length of the sheath.

[0009] In another embodiment, the sheath includes a slidable tubular member having a distal end, the slidable tubular member positioned within a concentric lumen defined in the sheath, the distal end of the slidable tubular member defining at least one of a first pivot position and a second pivot position of the sheath, In a further embodiment, the slidable tubular member is linearly slidable within the concentric lumen to change at least one of the first pivot position and the second pivot position of the sheath.

[0010] In another embodiment, the slidable tubular member includes an opening defined therein, the opening sized and configured to retain a control wire therein, the control wire extending distal to at least one of the first and second pivot locations to control deflection of at least one of the first and second deflectable portions, respectively. In another embodiment, the first and second deflectable portions are deflectable in a plurality of directions. In yet another embodiment, the sheath is separately and independently deflectable to the first and second pivot locations along the sheath.

[0011] In another embodiment, the first and second deflectable portions are deflectable by a control actuator integrated into a sheath handle of the sheath, the control actuator including at least one of a rack and pinion system, a pneumatic system, and a hydraulic system. In another embodiment, at least one of the first and second deflectable portions is deflectable by a plurality of wires extending through concentric lumens along a longitudinal length of the sheath, the plurality of wires having a first portion and a second portion and having a transition point between the first portion and the second portion, the first portion being distal to the second portion and more flexible than the second portion, and the transition point of the plurality of wires being movable along the longitudinal length to change a radius of at least one of the first and second deflectable portions.

[0012] According to another embodiment of the present invention, a medical device system for occluding a left atrial appendage of a heart with an implant is provided, the implant being positioned adjacent to a delivery catheter. The medical device includes a sheath such that the sheath extends with a wall between a distal end and a proximal end and has a central lumen and a central axis defined within the sheath along a longitudinal length of the sheath such that the implant and the delivery catheter are advanceable through the central lumen of the sheath. The sheath defines concentric lumens therein to extend along the wall, the sheath is deflectable at a first deflectable portion to a first pivot position along a distal portion of the sheath, and the sheath is deflectable at a second deflectable portion to a second pivot position along the distal portion of the sheath. In this configuration, at least one of the first and second pivot positions of the first and second deflectable portions, respectively, is adjustable along the longitudinal length of the distal portion of the sheath.

[0013] In another embodiment, a radius of at least one of the first and second pivot positions is adjusted as at least one of the first and second pivot positions is adjusted, hi a further embodiment, the radius increases as at least one of the first and second pivot positions is moved proximally along the length of the sheath and the radius decreases as at least one of the first and second pivot positions is moved distally along the length of the sheath.

[0014] In another embodiment, the sheath includes a slidable tubular member having a distal end, the slidable tubular member positioned within a concentric lumen defined within the sheath, the distal end of the slidable tubular member defining at least one of a first pivot position and a second pivot position of the sheath. In yet another embodiment, the slidable tubular member is linearly slidable within the concentric lumen to vary at least one of the first pivot position and the second pivot position of the sheath. In another embodiment, the slidable tubular member includes an opening defined therein, the opening sized and configured to retain a control wire therein, the control wire extending distal to at least one of the first pivot position and the second pivot position to control deflection of at least one of the first deflectable portion and the second deflectable portion, respectively.

[0015] In another embodiment, the first and second deflectable portions are deflectable in multiple directions. In yet another embodiment, the sheath is separately and independently deflectable along the sheath to a first and a second pivot position. In another embodiment, the first and second deflectable portions are deflectable by a control actuator integrated into a sheath handle of the sheath, the control actuator including at least one of a rack and pinion system, a pneumatic system, and a hydraulic system. In another embodiment, at least one of the first and second deflectable portions is deflectable by a plurality of wires extending through concentric lumens along a longitudinal length of the sheath, the plurality of wires having a first portion and a second portion and a transition point between the first portion and the second portion, the first portion being distal to the second portion and more flexible than the second portion, and the transition point of the plurality of wires being movable along the longitudinal length to change a radius of at least one of the first and second deflectable portions.

[0016] According to another embodiment of the invention, a method is provided for axially aligning a distal end of a medical device delivery system with an ostium of a left atrial appendage of a heart, the method steps including positioning a distal end of a sheath adjacent the left atrial appendage of the heart, the sheath extending with a wall between a distal end and a proximal end, a central lumen and a central axis defined within the sheath along a longitudinal length of the sheath such that an implant and a delivery catheter are advanceable through the central lumen of the sheath, the sheath defining concentric lumens therein extending along the wall, the sheath being deflectable at a first deflectable portion to a first pivot position along a distal portion of the sheath and the sheath being deflectable at a second deflectable portion to a second pivot position along the distal portion of the sheath, and adjusting at least one of the first and second pivot positions of each of the first and second deflectable portions along the longitudinal length of the distal portion of the sheath.

[0017] In another embodiment, the adjusting step includes adjusting a radius of at least one of the first and second deflectable portions. In yet another embodiment, the adjusting step includes increasing a radius of at least one of the first and second pivot positions by moving at least one of the first and second pivot positions proximally along a length of the sheath. In yet another embodiment, the adjusting step includes sliding a tubular member within the concentric lumen such that a distal end of the tubular member corresponds with at least one of the first and second pivot positions of the first and second deflectable portions, respectively. In another embodiment, the adjusting step includes moving one or more control wires proximally or distally to move at least one of the first and second pivot positions along a length of the sheath.

[0018] In accordance with another embodiment of the present invention, a medical device system is provided. The medical device system includes a sheath, a pusher catheter, and a medical device. The sheath extends longitudinally and defines a lumen and an axis along the length of the sheath. The pusher catheter extends longitudinally between a proximal end and a distal end, the proximal end being associated with a handle. The pusher catheter is sized and configured to be moved through the lumen of the sheath. The medical device is configured to be coupled adjacent to the distal end of the pusher catheter, the medical device including a framework movable between a contracted position and a deployed position. The framework extends to define an elongated structure having an eyelet structure extending adjacent one end, the elongated structure defining a line extending tangentially along the elongated structure adjacent one end, the eyelet structure extending from the elongated structure such that the eyelet structure extends along one side of the tangentially extending line. In this configuration, the eyelet structure located along one side of the tangentially extending line minimizes the resistance of the medical device against the inner surface of the sheath when the medical device is in the retracted position.

[0019] In another embodiment, the framework extends to define an occluder frame and an anchor frame, the occluder frame being hingeably coupled to the anchor frame using a hinge component positioned within the eyelet structure. In another embodiment, the anchor frame includes an anchor frame eyelet, the hinge component being disposed through both the anchor frame eyelet and the eyelet structure. In yet another embodiment, the eyelet structure includes a first eyelet and a second eyelet having a gap therebetween, the anchor frame eyelet being disposed within the gap such that the hinge component extends through each of the first eyelet and the second eyelet and the anchor frame eyelet.

[0020] In accordance with another embodiment of the present invention, a medical device system is provided that is configured to minimize resistance against an inner surface of a sheath. The medical device system includes a pusher catheter and a medical device. The pusher catheter extends longitudinally between a proximal end and a distal end, the proximal end being associated with a handle. The pusher catheter is sized and configured to be moved through a lumen of a sheath. The medical device is configured to be coupled adjacent to a distal end of the pusher catheter, the medical device including a framework movable between a retracted position and a deployed position. The framework extends to define an elongated structure having an eyelet structure disposed adjacent one end, the elongated structure defining a line extending tangentially along the elongated structure adjacent the one end. The eyelet structure extends from the elongated structure such that the eyelet structure extends along one side of the tangentially extending line. In this configuration, when the medical device is in the retracted position, the eyelet structure disposed along one side of the tangentially extending line minimizes resistance of the medical device against an inner surface of the sheath.

[0021] In another embodiment, the framework extends to define an occluder frame and an anchor frame, the occluder frame being hingeably coupled to the anchor frame using a hinge component positioned within the eyelet structure. In a further embodiment, the anchor frame includes an anchor frame eyelet, the hinge component being disposed through both the anchor frame eyelet and the eyelet structure. In another embodiment, the eyelet structure includes a first eyelet and a second eyelet having a gap therebetween, the anchor frame eyelet being disposed within the gap such that the hinge component extends through each of the first eyelet and the second eyelet and the anchor frame eyelet. [Brief description of the drawings]

[0022] The above 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 view of a medical device system depicting a medical device coupled to a delivery system, according to one embodiment of the present invention. [Figure 1A] 1A is a partial cross-sectional view of a medical device system taken along section line 1A-1A of FIG. 1 showing an anchor portion of the medical device in a deployed position according to another embodiment of the present invention. [Diagram 2] 13 is a perspective view of a medical device system showing an anchor portion of the medical device being retracted by an anchor actuator on a handle of a delivery system according to another embodiment of the present invention. FIG. [Figure 2A] 2A is a partial cross-sectional view of the medical device system taken along section line 2A-2A of FIG. 2, showing the anchor portion in a retracted position according to another embodiment of the present invention. [Diagram 3] 1 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] 2 is an exploded view of components of a medical device according to another embodiment of the present invention. [Diagram 5] 1 is a perspective view of an alignment portion of a medical device according to another embodiment of the present invention. [Figure 6] FIG. 13 is a front view of the alignment portion showing the components of the anchor portion in a retracted position with the secondary hub and anchor frame segments shown in phantom in accordance with another embodiment of the present invention. [Figure 7] FIG. 13 is an enlarged perspective view of a medical device with an alignment portion coupled to a hub according to another embodiment of the present invention, showing a secondary hub disengaged from the anchor actuator and aligned with and positioned adjacent to the primary hub of the medical device. [Figure 8] FIG. 13 is a side view of an occluder portion of a medical device according to another embodiment of the present invention. [Figure 8A] 8 is an enlarged view of the closure portion taken from area 8A of FIG. 8 showing an eyelet structure of the closure portion according to another embodiment of the present invention. [Figure 9]13 is a simplified cross-sectional view of an end portion of a delivery system showing the profile of the hinge eyelets relative to the inner surface of the sheath and relative to an extension of the occluder portion according to another embodiment of the present invention. FIG. [Figure 10] 13 is an enlarged front view of another embodiment of an eyelet structure of a closure portion showing the eyelet structure in a preformed state according to another embodiment of the present invention. FIG. [Figure 11] 2 is a perspective view of an eyelet structure according to another embodiment of the present invention, showing the eyelet structure in a formed state. [Figure 12] 13 is a perspective view of an eyelet structure coupled to an eyelet of an anchor frame having a hinge part according to another embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0023] 1, 1A, 2, 2A, and 7, a medical device 10 is provided that is removably coupled to a delivery system 12. The medical device 10 and delivery system 12 together may be referred to as a medical device delivery system 14 that may be used in an interventional procedure to percutaneously close and modify an opening or cavity, such as a left atrial appendage 5, in a heart (not shown). The delivery system 12 may include a pusher catheter 16 and a handle 18, with the pusher catheter 16 coupled to the medical device 10 adjacent a distal end 20 of the pusher catheter 16. The delivery system 12 may also include a sheath 22 that is sized and configured to facilitate advancing the medical device 10 through a lumen 24 of the sheath with the pusher catheter (see also FIG. 3). Additionally, the medical device 10 may include a framework 26 or frame structure that extends to define an occluder portion 28 and an anchor portion 30. Additionally, the medical device 10 may include a primary hub 32 and a secondary hub 34 such that the framework 26 may extend between the primary hub 32 and the secondary hub 34. The primary hub 32 may define a bore 36 and an axis 38 that may each extend through the primary hub 32 such that the axis 38 may extend axially relative to the bore 36 and structure of the primary hub 32. Such an axis 38 may also extend axially along the length of the medical device delivery system 14 and its components. In one embodiment, the primary hub 32 may include a groove 40 defined within a mating portion 41 of the primary hub 32 and adjacent the bore 36. Additionally, the secondary hub 34 may be movable along the axis 38 and through the primary hub 32 to move the framework 26 between a contracted position (FIG. 2A) and a deployed position (FIG. 1A). In this configuration, as the secondary hub 34 moves along the axis 38 and through the hole 36 in the primary hub 32, the grooves 40 can be sized and configured to align portions of the framework 26 such that entanglement of the framework 26 can be minimized as the framework 26 moves between the contracted and deployed positions.Furthermore, when the skeleton 26 is at least partially contracted within the sheath 22, the skeleton 26 can extend in a configuration that can minimize resistance with the inner surface 42 of the sheath 22, as further described herein (see FIG. 9).

[0024] 1, 1A, and 4, as previously described, the framework 26 may extend with an occluder portion 28 and an anchor portion 30. The anchor portion 30 may extend with an anchor frame 44 having anchor teeth 46 extending therefrom. The occluder portion 28 may include an occluder frame 48 having a tissue growth member 50 attached thereto. The tissue growth member 50 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, that is sized and configured to promote tissue ingrowth. Additionally, the tissue growth member 50 may be formed from one or more polymeric materials, such as ePTFE and / or polyurethane foam. Additionally, the tissue growth member 50 may extend in multiple layers having various thicknesses and sizes.

[0025] Additionally, the occluder frame 48 may be coupled to the primary hub 32 such that the occluder frame 48 may extend radially outward from the primary hub 32 and may extend distally to an occluder frame distal end 52. Adjacent the distal end 52 of the occluder frame 48, the occluder frame 48 may include a plurality of occluder frame eyelets 54 defined therein. The anchor frame 44 may extend between a first end 56 and a second end 58, the first end 56 being coupled to the occluder frame 48 and the second end 58 being coupled to the secondary hub 34. The anchor frame 44 may extend with a plurality of interconnected anchor frame segments 60 extending between the first end 56 and the second end 58 of the anchor frame 44. Adjacent the first end 56 of the anchor frame 44, the anchor frame 44 may include a plurality of anchor frame eyelets 62 along a plurality of the anchor frame segments 60 of the anchor frame 44. At the secondary hub 34, multiple of the anchor frame segments 60 or anchor frame extensions may be coupled to the secondary hub 34. Each of the occluder frame eyelets 54 may be coupled to a corresponding one of the anchor frame eyelets 62 with a hinge component 64. The hinge component 64 may extend through the occluder frame eyelets 54 and the anchor frame eyelets 62 to facilitate pivoting of the anchor frame 44 about the hinge component 64 to pivot or rotate relative to the occluder frame 48. In this configuration, the anchor frame 44 may be pivotally coupled (or hingeably coupled) to the occluder frame 48 such that the anchor frame 44 can move between a retracted position (FIG. 2A) and a deployed position (FIG. 1A). The retracted position of the anchor frame 44 may be an anchor restraining position or a pivoting position. Thus, pivoting of the anchor frame 44 between the retracted position and the deployed position may help the physician adjust the position of the medical device 10 after the anchor portion 30 has been secured to tissue, for example, in the left atrial appendage 5.

[0026] 1A, 4, and 7, in one embodiment, the alignment portion 41 may be axially disposed and aligned along the axis 38 to be coupled to a distal side 51 of a portion of the primary hub 32. Further, such a primary hub 32 may include a first portion 53 and a second portion 55, the first portion 53 being sized and configured such that a finger 57 interfaces with and is coupled to the second portion 55 through an occluder connection opening 59 defined in the occluder frame 48 adjacent a proximal end of the occluder frame 48. Such a finger 57 may be maintained within the occluder connection opening 59 with the finger 57 positioned against a backstop 61 of the first portion 53 of the primary hub 32. In this manner, the first portion 53 and the second portion 55 of the primary hub 32 may be coupled to the occluder frame 48 using the alignment portion 41 positioned on the distal side 51 of the portion of the primary hub 32, such as along the distal side 51 of the second portion 55 of the primary hub 32.

[0027] 1-3, as previously described, the medical device 10 may be delivered through the vasculature with a delivery system 12. The delivery system 12 may include a pusher catheter 16 and a handle 18, which is integrated with a proximal portion 66 of the pusher catheter 16. The handle 18 may include various functional components, such as an anchor actuator 68, for manipulating the anchor frame 44 between a deployed position (FIG. 1A) and a retracted position (FIG. 2A). The delivery system 12 may include and be employed with a sheath 22 for delivering the medical device 10 through the vasculature to the left atrial appendage 5 within the heart. The sheath 22 may be positioned within the vasculature using known interventional techniques with a sheath distal end 70 positioned adjacent the left atrial appendage 5 of the heart. Once the medical device 10 has been advanced through the lumen 24 of the sheath 22 to the sheath distal end 70 (the medical device 10 is in a retracted position shown partially in dashed lines adjacent the sheath distal end 70 (see FIG. 3 )), the medical device 10 may be at least partially deployed from the sheath 22. That is, the sheath 22 may then be manually moved proximally (and / or the pusher catheter 16 advanced distally) such that the occluder portion 28 of the medical device 10 may be deployed from the sheath distal end 70 (see FIG. 2 ). Such occluder portion 28 may self-expand as soon as the occluder portion 28 is exposed from the sheath distal end 70. At this stage, the medical device 10 may be in a partially deployed state, after which the medical device 10 may be moved to a fully deployed state by deploying the anchor portion 30 (see FIG. 1 ). For example, when the occluder portion 28 is initially deployed, the anchor portion 30 may be in a retracted position with the anchor actuator 68 of the handle 18 in a proximal position (as shown in FIG. 2). Once the physician determines that the occluder portion 28 is in the proper and desired position adjacent the left atrial appendage 5, the anchor portion 30 may be driven from the retracted position to the deployed position by moving the anchor actuator 68 to a distal position, as indicated by arrow 72 (see FIG. 1). Once the anchor portion 30 is moved to the deployed position, the teeth 46 of the anchor portion 30 (FIG. 1A) may engage tissue to secure the medical device 10 within the left atrial appendage 5.If the physician determines that the medical device 10 is not in an optimal anchored position within the left atrial appendage 5, the anchor portion 30 can be pivoted back to the retracted position by moving the anchor actuator 68 from a distal position to a proximal position, as indicated by arrow 74 (see FIG. 2 ). Thus, the anchor actuator 68 can be manually moved proximally and distally to move the anchor portion 30 between the retracted and deployed positions such that the anchor portion 30 pivots between the deployed and retracted positions. In this manner, the anchor portion 30 of the medical device 10 can be secured and disengaged from tissue in the left atrial appendage 5 as needed by the physician until the physician obtains an optimal position or is satisfied with the position before releasing the delivery system 12 from the medical device 10. A similar medical device delivery system 14 with its handle 18, pusher catheter 16, medical device 10, and delivery sheath 12 is disclosed in commonly assigned U.S. patent application Ser. No. 15 / 438,650, filed Feb. 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.

[0028] 2A and 5-7, the alignment portion 41 will now be further described. For example, as previously described, the alignment portion may be coupled to, integral with, or within the primary hub 32. The alignment portion 41 may be sized and configured to aid in the movement of the anchor frame 44 between the previously described deployed (FIG. 1A) and retracted (FIG. 2A) positions to minimize entanglement of the anchor frame segments 60 or the anchor extensions of the anchor frame 44. Additionally, as the secondary hub 34 moves through the holes 36 of the primary hub 32, the grooves 40 defined within the alignment portion 41 of the primary hub 32 may be sized and configured to maintain the anchor frame segments 60 spaced apart and aligned to minimize potential entanglement of the anchor frame segments 60 as the medical device moves between the retracted and deployed positions. For example, FIG. 6 illustrates a distal or front view of the alignment portion 41 with the anchor frame segments 60 and secondary hub 34 shown in dashed lines. 2A with the secondary hub 34 in its proximal-most position. Thus, each of the grooves 40 of the alignment portion 41 may be spaced to correspond to and align with the spacing and position of each of the anchor frame segments 60 relative to the attachment of their respective second ends 58 to the secondary hub 34. FIG. 7 shows a distal side perspective view of the alignment portion 41 integral with the primary hub 32 with the secondary hub 34 disengaged or released from the distal-most end of the anchor actuator 68 (FIG. 1).

[0029] In one embodiment, the alignment portion 41 may be a ring structure 76 having a groove 40 defined therein that may be coupled to a distal side of the primary hub 32. In another embodiment, the alignment portion 41 may be integrally formed with the primary hub 32. In another embodiment, the alignment portion 41 may extend with an inner surface 78 and an outer surface 80 defined between a first side 82 and a second side 84, respectively. The ring structure 76 may extend to define an outer diameter 86, the outer diameter 86 extending to define the outer surface 80 of the ring structure 76. The ring structure 76 may also define an inner diameter 88, the inner diameter 88 extending to define the inner surface 78 of the ring structure 76. The first side 82 and the second side 84 may be spaced apart from one another to define a depth 90 of the ring structure 76. In another embodiment, the inner surface 78 and the outer surface 80 may extend with a depth 90 such that the depth 90 is a common dimension between the inner surface 78 and the outer surface 80. In another embodiment, the inner surface 78 may define a first depth and the outer surface 80 may define a second depth, the second depth being greater than the first depth. In another embodiment, the first depth of the inner surface 78 may be greater than the second depth of the outer surface 80. In yet another embodiment, the inner surface 78 may define a generally circular shape, except for the groove 40 defined therein. In another embodiment, the outer surface 80 may extend to define a circular shape.

[0030] As previously mentioned, the inner surface 78 may define a groove 40 therein. The groove 40 may also be referred to as a slot, a notch, or a channel. The groove 40 may be sized and configured to facilitate movement of the anchor frame segment 60 adjacent to the secondary hub 34 along the groove 40 as the secondary hub 34 moves along the axis 38. In another embodiment, the grooves 40 may be evenly spaced along the inner surface 78 of the ring structure 76 such that each groove 40 corresponds with one of the anchor frame segments 60 extending from the secondary hub 34. In another embodiment, the grooves 40 may be defined radially spaced apart on the inner surface 78 of the ring structure 76. In another embodiment, each groove 40 may be defined by two oppositely positioned walls 96 and one sidewall 98 extending between the oppositely positioned walls 96. In one embodiment, each of the oppositely positioned walls 96 may extend generally parallel. As such, each groove 40 may define a gap 92 between two oppositely disposed walls 96 and a height 94 defined from an outer wall 98 and the inner surface 78 of the ring structure 76. Additionally, the anchor frame segments 60 or anchor extensions may extend to define a generally square or rectangular cross-section that may be sized smaller than the corresponding dimensions of the above-mentioned gap 92 and height 94 that define each of the grooves 40. Additionally, the inner diameter 88 of the ring structure 76 may be sized to be larger than the diameter or width of the secondary hub 34 such that the secondary hub 34 can easily move along the axis 38 into and / or through the bore 36 of the primary hub 32. In this configuration, as the secondary hub 34 moves through the hole 36 in the primary hub 32, the grooves 40 in the alignment portion 41 of the primary hub 32 can control the spacing and alignment between adjacent extending anchor frame segments 60 to minimize entanglement of the various components of the anchor frame as the medical device 10 is adjusted to various positions, for example, within or adjacent the tissue of the left atrial appendage 5.

[0031] 8, 8A, and 9, there is shown another embodiment of an occluder frame 100 that may be implemented with the medical device delivery system 14 (FIG. 3) described herein. When the occluder frame 100 is at least partially fastened within the sheath 22, the occluder frame 100 may extend in a configuration that may minimize resistance with the inner surface 102 of the sheath 22, as previously described. For example, the occluder frame 100 may extend with a plurality of occluder frame segments 106, each of which may extend radially outward from a proximal end 108 toward a distal end 110 of the occluder frame 100. Some of the occluder frame segments 104 may define a configuration adjacent the distal end that may define the occluder frame eyelets 106 of the occluder frame 100. Such structure defining each of the closure frame eyelets 106 may be formed to extend along one side of a tangent 112 that connects to a corresponding one of the closure frame eyelets 106 and may be defined to extend along the outside 114 of a portion of an adjacent closure frame segment 104.

[0032] In one embodiment, the occluder frame 100 may be formed from a flat sheet of Nitinol material and laser cut to form a plurality of occluder frame segments 104. The occluder frame segments 104 of the occluder frame 100 may be heat set into a predetermined shape and configuration such that each of the occluder frame segments 104 extends radially outwardly relative to an axis 116 and may be interconnected to the primary hub 32 (see FIG. 1A ) toward a distal end 110 of the occluder frame 100. In one embodiment, alternating ones of the occluder frame segments 104 may each extend with an elongated portion 118, a neck portion 120, and an occluder frame eyelet 106, each of which is initially formed in or along a commonly defined plane when each is cut as a one-piece, seamless, unitary structure from the flat sheet material. The elongated portion 118 may extend distally to a cross portion 122. Each occluder frame segment 104 may extend with a pair of elongated portions 118. For those occluder frame segments 104 having an occluder frame eyelet 106, a neck portion 120 may extend from the intersection portion 122 and continue to extend distally to the occluder frame eyelet 106. The neck portion 120 may be narrower than the configuration of the occluder frame eyelet 106. Additionally, the neck portion 120 may extend with a twisted configuration 124. Such twisted configuration 124 defined within the neck portion 120 may be formed via heat setting as a result of twisting the flat configuration of the occluder frame eyelet 106 to extend approximately 90 degrees relative to the flat configuration of the remainder of the occluder frame segment 104. In one embodiment, the closure frame eyelet 106 may be formed such that when the closure frame eyelet 106 is twisted 90 degrees, the structure of the closure frame eyelet 106 may extend along one side of a tangent 112 defined along the outer side 114 of the closure frame segment 104, the tangent 112 extending along the closure frame segment 104 adjacent to the neck portion 120 or intersection portion 122 of the closure frame segment 104.In this configuration, when the occluder frame 100 is clamped within the sheath 22 (similar to the embodiments previously described and illustrated herein, in which the anchor frame segments 60 are pivotally coupled to the occluder frame segments 104 via the hinge components 64), the occluder frame eyelets 106 may extend along or slightly beyond the tangent line to substantially prevent point contact, thereby minimizing resistance of the occluder frame 100 against the inner surface 102 of the sheath 22 or the tissue growth member 50. As shown in FIG. 9, for simplicity, the tissue growth member 50 is shown with minimized dashed lines and only two occluder frame segments 104 and their associated anchor frame segments 60 are shown in their constrained configuration within the sheath 20. In this manner, because the structure defining the occluder frame eyelet 106 is formed on one side of the tangent line 112, the structure of the occluder frame segment 104 minimizes drag or pressure against the inner surface 102 of the sheath 22, thereby minimizing resistance against the inner surface 102 of the sheath 22 as the pusher catheter 16 advances the medical device through the sheath 22, as described herein.

[0033] 10-12, another embodiment of the occluder frame 130 may include a pair of occluder frame eyelets 132 for a given occluder frame segment 134. Similar to the previous embodiment, the occluder frame 130 may include a plurality of occluder frame segments 134 extending radially outward from the proximal end toward the distal end. Additionally, alternating ones of the occluder frame segments 134 of the occluder frame 130 may include a pair of occluder frame eyelets 132 adjacent the distal end of the occluder frame 130. In this embodiment, each of the pairs of occluder frame eyelets 132 of the occluder frame 130 may be sized and configured to receive one of the anchor frame eyelets 62 between the pair of occluder frame eyelets 132. Further, similar to that shown and described in the previous embodiment, each of the closure frame eyelets 132 may be formed along one side of a tangent 138 defined along the outer side 139 of the closure frame segment 134 adjacent the neck portion 140 of the closure frame segment 134.

[0034] Each of the occluder frame segments 134 having occluder frame eyelets 132 may include a pair of elongated portions 142 that may extend distally to a crossover portion 144. The crossover portion 144 may extend to a neck portion 140. The neck portion 140 may extend to a pair of occluder eyelets 132, such as a first occluder frame eyelet 146 and a second occluder frame eyelet 148. Such an occluder frame 130 may be laser cut from a Nitinol sheet material such that the first occluder frame eyelet 146 and the second occluder frame eyelet 148 extend in the same plane as the remainder of the occluder frame 130. Through one or more heat curing processes known to those skilled in the art, the occluder frame 130 may be molded such that the occluder frame 130 extends radially outward and distally from a proximal side to a distal side of the occluder frame 130, similar to that depicted in FIG. Additionally, in one or more heat treatment processes, the first and second closure frame eyelets 146, 148 may be twisted in opposite rotational directions, for example, such that the planar configurations of the first and second eyelets 146, 148 extend substantially perpendicular to the planar configuration of the corresponding neck portion 140 of the closure frame 130. Thus, the first and second closure frame eyelets 146, 148 may be heat treated to a twisted position that may be twisted approximately 90 degrees from their original laser cut position. In this configuration, the first and second closure frame eyelets 146, 148 may extend to define a gap 150 therebetween. The gap 150 may be sized and configured to receive a corresponding one of the anchor frame segments 60 that define the anchor frame eyelets 62. Thus, the anchor frame segment 60 having the anchor frame eyelet 62 adjacent the end of the anchor frame segment 60 may be positioned in alignment with the first closure frame eyelet 146 and the second closure frame eyelet 148 such that the anchor frame segment 60 may be connected to the closure frame segment 134 by the hinge component 152.That is, the structure defining the anchor frame eyelet 62 may be disposed within the gap 150 between the first closure frame eyelet 146 and the second closure frame eyelet 148 such that the anchor frame eyelet 62 may be aligned with the first closure frame eyelet 146 and the second closure frame eyelet 148 such that the hinge component 152 can extend through each eyelet, as shown in FIG. 12 .

[0035] With the anchor frame segment 60 hingeably coupled between the opposing first and second occluder frame eyelets 146, 148 within the gap 150, the anchor frame segment 60 may pivot about the hinge component 152. Additionally, because the anchor frame segment 60 may be sandwiched between the structure defining the first and second occluder frame eyelets 146, 148, the anchor frame segment 60 may pivot with greater control by limiting lateral movement or rocking of the anchor frame segment 60 relative to the occluder frame segment 134. In this manner, the anchor frame segment 60 may pivot about the hinge component 152 in a more controlled manner. This controlled pivoting facilitates minimal lateral movement as the anchor frame segments 60 are sandwiched between the corresponding first and second occluder frame eyelets 146, 148, which may further minimize potential entanglement of the anchor frame segments 60 as the secondary hub 34 moves through the primary hub 32 to move the anchor frame 44 between the retracted and deployed positions, as previously described herein (see FIGS. 1, 1A, 2, and 2A). Additionally, as previously described, each of the first and second occluder frame eyelets 146, 148 may extend along one side of a tangent that may be defined along the neck portion 140 corresponding to the first and second occluder frame eyelets 146, 148. Thus, when the occluder frame 130 is retracted within the sheath 22, resistance of the occluder frame segments 134 against the inner surface of the sheath 22 may be minimized in a manner similar to that described in the previous embodiment.

[0036] 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 described in detail herein. It should be understood, however, that the invention is not intended to be limited to the particular forms disclosed. On the contrary, the invention includes combining any part of one embodiment with another embodiment, all modifications, equivalents, and alternatives falling within the spirit and scope of the invention.

[0037] [Embodiment] (1) A medical device system for occluding a left atrial appendage of a heart, comprising: a pusher catheter extending between a distal end and a proximal end, the proximal end being associated with a handle; 11. A medical device system comprising: a medical device configured to be coupled adjacent to the distal end of the pusher catheter, the medical device having a primary hub and a secondary hub, a framework extending between the primary hub and the secondary hub, the primary hub defining a bore and an axis extending respectively through the primary hub, the primary hub including a groove defined in the hub adjacent the bore, the framework configured to be movable between a contracted position and an expanded position, the secondary hub moves through the bore of the primary hub along the axis as the framework moves between the contracted position and the expanded position, the groove being sized and configured to align with a portion of the framework as the secondary hub moves through the bore of the primary hub. (2) The medical device system of embodiment 1, wherein each of the portions of the framework extends in a wire-like structure. (3) The medical device system of embodiment 1, wherein the grooves are disposed along a distal side of the primary hub so as to be radially spaced and disposed radially relative to the axis of the primary hub. (4) The medical device system of embodiment 1, wherein the portion of the framework is configured to slide through the groove. (5) The medical device system of embodiment 1, wherein the ring structure is coupled to a distal side of the primary hub such that the groove is defined on the inside of the ring structure and the groove is positioned to surround the axis defined in the primary hub.

[0038] (6) The medical device system of embodiment 1, wherein the framework extends to define an occluder portion and an anchor portion, and the anchor portion is pivotally coupled to the occluder portion such that the anchor portion pivots when the secondary hub moves along the axis. (7) The medical device system of embodiment 1, wherein the framework includes a tissue growth member disposed adjacent to the proximal side of the framework. (8) A medical device for occluding a left atrial appendage of a heart, comprising: 1. A medical device comprising: a framework extending between a primary hub and a secondary hub, the primary hub defining a hole and an axis each extending through the primary hub, the primary hub including a groove defined in the hub adjacent the hole, the framework configured to be movable between a contracted position and an expanded position, the secondary hub moves along the axis through the hole in the primary hub as the framework moves between the contracted position and the expanded position, the groove being sized and configured to align with a portion of the framework as the secondary hub moves through the hole in the primary hub. (9) The medical device of embodiment 8, wherein each of the portions of the framework extends in a wire-like structure. (10) The medical device of embodiment 8, wherein the grooves are disposed along a distal side of the primary hub so as to be radially spaced and disposed radially relative to the axis of the primary hub.

[0039] (11) The medical device of embodiment 8, wherein the portion of the framework is configured for sliding movement through the groove. (12) The medical device of embodiment 8, wherein the ring structure is coupled to a distal side of the primary hub such that the groove is defined on an inner side of the ring structure and the groove is disposed to surround the axis defined in the primary hub. (13) The medical device of embodiment 8, wherein the framework extends to define an occluder portion and an anchor portion, the anchor portion being pivotally coupled to the occluder portion such that the anchor portion pivots when the secondary hub moves along the axis. (14) The medical device of embodiment 8, wherein the framework includes a tissue growth member disposed adjacent to a proximal side of the framework. (15) A method for occluding a left atrial appendage of a heart, comprising: providing a medical device having a framework extending between a primary hub and a secondary hub, the primary hub defining a bore and a shaft each extending through the primary hub, the secondary hub movable along the shaft to move the framework between a contracted position and an expanded position, the primary hub including a groove defined therein adjacent the bore of the primary hub; advancing the medical device through the vasculature toward the left atrial appendage with a pusher catheter such that the medical device is coupled adjacent a distal end of the pusher catheter; and moving the medical device between the contracted position and the expanded position such that the secondary hub moves through the hole in the primary hub while a portion of the framework is maintained within the groove to maintain alignment of the portion with the framework.

[0040] (16) The method of claim 15, wherein the moving includes moving the portion through the groove disposed along a distal side of the primary hub so as to be radially spaced and disposed radially relative to the axis of the primary hub. 17. The method of claim 15, wherein the moving comprises sliding the portion of the framework through and along the groove. (18) The method of claim 15, wherein the providing step includes providing a ring structure having the groove defined therein such that the ring structure is coupled to a distal side of the primary hub such that the groove is disposed to circumscribe the axis defined in the primary hub. 19. The method of claim 15, wherein the moving includes moving the portion through the groove such that the portion extends in a wire-like configuration. (20) The method of embodiment 15, wherein the providing step includes providing a tissue growth member disposed adjacent to a proximal side of the framework.

[0041] (21) A medical device system, comprising: a longitudinally extending sheath defining a lumen and an axis along a length of the sheath; a pusher catheter extending longitudinally between a proximal end and a distal end, the proximal end associated with a handle, the pusher catheter sized and configured to move through the lumen of the sheath; a medical device configured to be coupled adjacent the distal end of the pusher catheter, the medical device including a framework movable between a contracted position and a deployed position, the framework extending to define an elongated structure having an eyelet disposed adjacent one end, the elongated structure defining a line extending tangentially along the elongated structure adjacent the one end, the eyelet extending from the elongated structure such that the eyelet extends along one side of the tangentially extending line; A medical device system, wherein the eyelets located along the one side of the tangentially extending line minimize resistance of the medical device against an inner surface of the sheath when the medical device is in the retracted position. (22) The medical device system of embodiment 21, wherein the framework extends to define an occluder frame and an anchor frame, the occluder frame being hingeably coupled to the anchor frame by a hinge component disposed within the eyelet structure. (23) The medical device system of embodiment 22, wherein the anchor frame includes an anchor frame eyelet, and the hinge component is disposed through both the anchor frame eyelet and the eyelet structure. (24) The medical device system of embodiment 23, wherein the eyelet structure comprises a first eyelet and a second eyelet having a gap therebetween, and the anchor frame eyelet is positioned within the gap such that the hinge component extends through each of the first and second eyelets and the anchor frame eyelet. (25) A medical device system configured to minimize resistance against an inner surface of a sheath, the medical device system comprising: a pusher catheter extending longitudinally between a proximal end and a distal end, the proximal end associated with a handle, the pusher catheter sized and configured to move through the lumen of the sheath; a medical device configured to be coupled adjacent the distal end of the pusher catheter, the medical device including a framework movable between a contracted position and a deployed position, the framework extending to define an elongated structure having an eyelet structure disposed adjacent one end, the elongated structure defining a line extending tangentially along the elongated structure adjacent the one end, the eyelet structure extending from the elongated structure such that the eyelet structure extends along one side of the tangentially extending line; A medical device system, wherein the eyelets are positioned along one side of the tangentially extending line to minimize resistance of the medical device against the inner surface of the sheath when the medical device is in the retracted position.

[0042] (26) The medical device system of embodiment 25, wherein the framework extends to define an occluder frame and an anchor frame, the occluder frame being hingeably coupled to the anchor frame by a hinge component disposed within the eyelet structure. (27) The medical device system of embodiment 26, wherein the anchor frame includes an anchor frame eyelet, and the hinge component is disposed through both the anchor frame eyelet and the eyelet structure. (28) The medical device system of embodiment 27, wherein the eyelet structure comprises a first eyelet and a second eyelet having a gap therebetween, and the anchor frame eyelet is positioned within the gap such that the hinge component extends through each of the first and second eyelets and the anchor frame eyelet.

Claims

1. 1. A medical device system for occluding a left atrial appendage of a heart, comprising: a pusher catheter extending between a distal end and a proximal end, the proximal end being associated with a handle; 11. A medical device system comprising: a medical device configured to be coupled adjacent to the distal end of the pusher catheter, the medical device having a primary hub and a secondary hub, a framework extending between the primary hub and the secondary hub, the primary hub defining a bore and an axis extending respectively through the primary hub, the primary hub including a groove defined in the hub adjacent the bore, the framework configured to be movable between a contracted position and an expanded position, the secondary hub moves through the bore of the primary hub along the axis as the framework moves between the contracted position and the expanded position, the groove being sized and configured to align with a portion of the framework as the secondary hub moves through the bore of the primary hub.

2. The medical device system of claim 1 , wherein each of the portions of the framework extends in a wire-like configuration.

3. The medical device system of claim 1 , wherein the grooves are disposed along a distal side of the primary hub so as to be radially spaced and disposed radially relative to the axis of the primary hub.

4. The medical device system of claim 1 , wherein the portion of the framework is configured for sliding movement through the groove.

5. 2. The medical device system of claim 1, wherein the ring structure is coupled to a distal side of the primary hub such that the groove is defined inside the ring structure and the groove is positioned to surround the axis defined in the primary hub.

6. 2. The medical device system of claim 1, wherein the framework extends to define an occluder portion and an anchor portion, the anchor portion pivotally coupled to the occluder portion such that the anchor portion pivots when the secondary hub moves along the axis.

7. The medical device system of claim 1 , wherein the framework includes a tissue growth member disposed proximally adjacent the framework.

8. 1. A medical device for occluding a left atrial appendage of a heart, comprising:

1. A medical device comprising: a framework extending between a primary hub and a secondary hub, the primary hub defining a hole and an axis each extending through the primary hub, the primary hub including a groove defined in the hub adjacent the hole, the framework configured to be movable between a contracted position and an expanded position, the secondary hub moves along the axis through the hole in the primary hub as the framework moves between the contracted position and the expanded position, the groove being sized and configured to align with a portion of the framework as the secondary hub moves through the hole in the primary hub.

9. The medical device of claim 8 , wherein each of the portions of the framework extends in a wire-like configuration.

10. The medical device of claim 8 , wherein the grooves are disposed along a distal side of the primary hub so as to be radially spaced and disposed radially relative to the axis of the primary hub.

11. The medical device of claim 8 , wherein the portion of the framework is configured for sliding movement through the groove.

12. 9. The medical device of claim 8, wherein the groove is defined on an interior side of a ring structure, the ring structure being coupled to a distal side of the primary hub such that the groove is disposed around the axis defined in the primary hub.

13. 9. The medical device of claim 8, wherein the framework extends to define an occluder portion and an anchor portion, the anchor portion pivotally coupled to the occluder portion such that the anchor portion pivots when the secondary hub moves along the axis.

14. The medical device of claim 8 , wherein the framework includes a tissue growth member disposed proximally adjacent the framework.

15. 1. A medical device system, comprising: a longitudinally extending sheath defining a lumen and an axis along a length of the sheath; a pusher catheter extending longitudinally between a proximal end and a distal end, the proximal end associated with a handle, the pusher catheter sized and configured to move through the lumen of the sheath; a medical device configured to be coupled adjacent the distal end of the pusher catheter, the medical device including a framework movable between a contracted position and a deployed position, the framework extending to define an elongated structure having an eyelet disposed adjacent one end, the elongated structure defining a line extending tangentially along the elongated structure adjacent the one end, the eyelet extending from the elongated structure such that the eyelet extends along one side of the tangentially extending line; A medical device system, wherein the eyelets located along the one side of the tangentially extending line minimize resistance of the medical device against an inner surface of the sheath when the medical device is in the retracted position.

16. 16. The medical device system of claim 15, wherein the framework extends to define an occluder frame and an anchor frame, the occluder frame being hingeably coupled to the anchor frame by a hinge component disposed within the eyelet structure.

17. The medical device system of claim 16 , wherein the anchor frame comprises an anchor frame eyelet, and the hinge component is disposed through both the anchor frame eyelet and the eyelet structure.

18. 18. The medical device system of claim 17, wherein the eyelet structure comprises a first eyelet and a second eyelet having a gap therebetween, the anchor frame eyelet being positioned within the gap such that the hinge component extends through each of the first and second eyelets and the anchor frame eyelet.

19. 1. A medical device system configured to minimize resistance against an inner surface of a sheath, the medical device system comprising: a pusher catheter extending longitudinally between a proximal end and a distal end, the proximal end associated with a handle, the pusher catheter sized and configured to move through the lumen of the sheath; a medical device configured to be coupled adjacent the distal end of the pusher catheter, the medical device including a framework movable between a contracted position and a deployed position, the framework extending to define an elongated structure having an eyelet structure disposed adjacent one end, the elongated structure defining a line extending tangentially along the elongated structure adjacent the one end, the eyelet structure extending from the elongated structure such that the eyelet structure extends along one side of the tangentially extending line; A medical device system, wherein the eyelets are positioned along one side of the tangentially extending line to minimize resistance of the medical device against the inner surface of the sheath when the medical device is in the retracted position.

20. 20. The medical device system of claim 19, wherein the framework extends to define an occluder frame and an anchor frame, the occluder frame being hingeably coupled to the anchor frame by a hinge component disposed within the eyelet structure.

21. 21. The medical device system of claim 20, wherein the anchor frame comprises an anchor frame eyelet, and the hinge component is disposed through both the anchor frame eyelet and the eyelet structure.

22. 22. The medical device system of claim 21, wherein the eyelet structure comprises a first eyelet and a second eyelet having a gap therebetween, the anchor frame eyelet being positioned within the gap such that the hinge component extends through each of the first and second eyelets and the anchor frame eyelet.

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