Pivot delivery system for implantable medical device

Abstract

To provide favorable systems and the like.SOLUTION: Various aspects of the present disclosure are directed toward apparatuses, systems and methods that include steering an implantable medical device. The apparatuses, systems and methods may include: an actuation line; a pivot coupled to the implantable medical device; and a tether attached at one end to the actuation line and arranged through the pivot.SELECTED DRAWING: Figure 5

Description

Technical Field

[0001] The present invention relates to medical devices and methods for treating anatomical spaces of the body (e.g., blood vessels). More specifically, the present invention relates to methods, devices, and systems that include an implantable medical device prosthesis that enables accurate deployment within an anatomical space.

Background Art

[0002] Vascular diseases are becoming increasingly common. Vascular procedures can be difficult due to the tortuous nature and complexity of the vascular system. For example, aortic dissection generally begins at or near the aortic valve root, continues along the ascending aorta and aortic arch, and can also affect the upper part of the descending aorta. Medical devices implanted in diseased states may be used to treat aortic dissection, aneurysms, and other diseases of the body's vascular or other luminal systems, such as the biliary tract, gastrointestinal tract, or respiratory system.

[0003] There is still a desire to provide medical devices, systems, and methods for repairing diseases along the aorta and along branches extending therefrom.

Summary of the Invention

[0004] According to one example (Example 1), a system for maneuvering an implantable medical device includes an actuation line, a pivot coupled to the implantable medical device, and a tether attached at one end to the actuation line, disposed through the pivot, and configured to orient the implantable medical device in response to tension applied to the actuation line and to release from the pivot after the implantable medical device is oriented.

[0005] According to another example (Example 2), additionally to the system of Example 1, the pivot includes a loop attached to the outer surface of the implantable medical device.

[0006] According to another embodiment ( "Embodiment 3"), additionally to the system of Embodiment 2, the loop includes a layer of graft material that forms a lumen between the outer surface of the implantable medical device and the graft material.

[0007] According to another example ( "Embodiment 4"), additionally to the system of Embodiment 3, the actuation line includes an eyelet, and the tether is attached to the eyelet at one end and is disposed through the pivot and the eyelet.

[0008] According to another embodiment ( "Embodiment 5"), additionally to the system of Embodiment 4, the tether is disposed through the eyelet, through the loop, and then attached to the eyelet.

[0009] According to another example ( "Embodiment 6"), additionally to the system of any one of Embodiments 1 - 5, the pivot and the actuation line are configured to form a pulley for orienting the implantable medical device in response to the tension applied to the actuation line.

[0010] According to another example ( "Embodiment 7"), additionally to the system of any one of Embodiments 1 - 6, the system further includes an actuation line lumen, and the tether is pulled into the actuation line lumen in response to the tension applied to the actuation line.

[0011] According to another embodiment ( "Embodiment 8"), additionally to the system of Embodiment 7, the actuation line lumen is attached to the outer surface of the implantable medical device proximal to the pivot.

[0012] According to another embodiment ( "Embodiment 9"), additionally to the system of any one of Embodiments 7 - 8, the pivot and the actuation line lumen are configured to form a pulley for orienting the implantable medical device in response to the tension applied to the actuation line.

[0013] According to another example (Example 10), in addition to any one of the systems of Examples 1 to 9, it further includes a removable lock wire configured to maintain the connection of the tether to the implantable medical device.

[0014] According to another example (Example 11), in addition to the system of Example 10, the tether includes an eyelet, the removable lock wire is disposed through the eyelet, and the removable lock wire is connected to the tether.

[0015] According to another example (Example 12), in addition to the system of Example 11, the eyelet of the tether is at or near the proximal end of the tether, and the distal end of the tether is connected to the actuating line.

[0016] According to another example (Example 13), in addition to the system of Example 12, the removable lock wire is disposed through the fluid lumen of the implantable medical device, and the tether is disposed from the fluid lumen of the implantable medical device at the proximal end of the tether to the outer surface of the removable lock wire at the distal end of the tether.

[0017] According to another example (Example 14), in addition to the system of Example 13, the tether is configured to be released from the actuating line in response to the withdrawal of the removable lock wire from the eyelet of the tether.

[0018] According to another example (Example 15), in addition to the system of Example 10, the system also includes a catheter disposed through the lumen of the implantable medical device, the proximal end of the tether is releasably connected to the catheter, and the distal end of the tether is connected to the actuating line.

[0019] According to one example (Example 16), the delivery system includes a catheter, an implantable medical device disposed near the front end of the catheter and including a proximal end, a distal end, and a fluid lumen extending therebetween, a loop connected to the outer surface of the implantable medical device, a lumen connected to the outer surface of the implantable medical device proximal to the loop, an actuation line disposed through the lumen, and a tether connected to the actuation line, configured to steer the implantable medical device in response to tension applied to the actuation line and disposed through the loop.

[0020] According to another example (Example 17), additionally to the system of Example 16, the loop and the lumen are pivot points, forming a pulley between the tether and the actuation line, and are configured to steer the implantable medical device in response to tension applied to the actuation line.

[0021] According to another example (Example 18), additionally to the system of Example 16, the system also includes a removable lock wire configured to maintain the connection of the tether to the implantable medical device, and the tether is configured to be released from the actuation line in response to the withdrawal of the removable lock wire.

[0022] According to another example (Example 19), a method of steering an implantable medical device includes delivering the implantable medical device to a target location within a patient's vasculature and manipulating an actuation line connected to the implantable medical device by a tether disposed through a loop connected to the outer surface of the implantable medical device to steer the implantable medical device.

[0023] According to another example (Example 20), additionally to the method of Example 19, the method also includes maintaining the connection of the tether to the implantable medical device by a removable lock wire and releasing the tether from the loop in response to the withdrawal of the removable lock wire.

[0024] The accompanying drawings are included to provide a further understanding of the present disclosure, are incorporated in the specification, form a part thereof, illustrate embodiments, and together with the description serve to explain the principles of the present disclosure.

Brief Description of the Drawings

[0025]

Figure 1

Figure 2

Figure 3A

Figure 3B

Figure 4A

Figure 4B

Figure 4C

Figure 4D

Figure 4E

Figure 5

Figure 6A

Figure 6B

Figure 7A-E

DETAILED DESCRIPTION OF THE INVENTION

[0026] Those skilled in the art will readily understand that various aspects of the present disclosure can be implemented by any number of methods and apparatuses configured to perform the intended functions. Also, the accompanying drawings referred to herein are not necessarily drawn to scale and may be exaggerated to show various aspects of the present disclosure, and in that regard, it should be noted that the drawings should not be construed as limiting.

[0027] Various aspects of the present disclosure are directed to devices, systems, and methods including implantable medical devices that can be used for the treatment of the vasculature. The implantable medical device is delivered to the vasculature using a delivery system. Further, the implantable medical device described herein may be substantially cylindrical, may include branches, or may be any combination of fenestrated. Further, the implantable medical device may be configured to conform to the vasculature in which it is implanted, may be low profile to enable its delivery using minimally invasive procedures (e.g., transcatheter), and may withstand the forces and other stresses that occur after implantation in the vasculature.

[0028] The delivery system may be configured to position and / or manipulate an implantable medical device for accurate placement within the vasculature. To position and / or manipulate the implantable medical device, the delivery system may include an actuation line (e.g., a wire, tether, or other member) that changes the position of the implantable medical device in response to a user applying force to the actuation line. The actuation line may be releasably coupled to the implantable medical device to avoid trauma to the vasculature after the implantable medical device has been delivered and positioned. As discussed in more detail below, a tether coupled to the actuation line may be used in combination with a pivot coupled to the implantable medical device to orient the implantable medical device in response to the tension applied to the actuation line. In certain examples, the actuation line, pivot, and tether may form a pulley arrangement that facilitates the orientation of the implantable medical device to the patient's tortuous anatomy.

[0029] FIG. 1 shows an implantable medical device 100 and an actuation line 102 according to various aspects of the present disclosure. The implantable medical device 100 is releasably coupled to a delivery system for delivery of the implantable medical device 100 to a target location within a patient's vasculature. The delivery system may include a catheter 104 that includes a front end 106 and a rear end (not shown in FIG. 1). The implantable medical device 100 may be disposed near the front end 106 of the catheter 104. The catheter 104 can extend through the lumen of the implantable medical device 100, toward and beyond the proximal end 108 of the implantable medical device 100. The catheter 104 may also include a tip (not shown) at the tip 106. As shown in FIG. 1, the implantable medical device 100 includes a stent component and a graft component.

[0030] The implantable medical device 100 includes a proximal end 108, a distal end 110, and a fluid lumen extending therebetween. The proximal end 108 of the implantable medical device 100 can be considered the end of the implantable medical device 100 that is closest to the target location within the patient's vasculature. The actuation line 102 may be coupled to the implantable medical device 100 at one or more locations. As shown in FIG. 1, the actuation line 102 is attached adjacent to or near the proximal end 108 of the implantable medical device 100 and is accessible to the user of the delivery system. The actuation line 102 can be attached to other portions of the implantable medical device 100.

[0031] As shown, the actuation line 102 is coupled to the implantable medical device 100 via at least one tether 112. The tether 112 can be disposed through a portion of the implantable medical device 100 and through the actuation line 102 to couple the line 102 to the implantable medical device 100. In a particular example, as shown in FIG. 1, at least one tether 112 is disposed through the implantable medical device 100 near or adjacent to the proximal end 108 of the implantable medical device 100. The at least one tether 112 may be a single tether, as shown in FIG. 1. In other examples, the implantable medical device 100 can include a loop 114 attached or coupled to the outer surface of the implantable medical device 100. The loop 114 can include a layer of graft material that forms a lumen between the outer surface of the implantable medical device 100 and the graft material. The tether 112 can be disposed through the loop 114 to couple the line 102 to the implantable medical device 100. In other examples, the loop 114 or pivot may be one or more holes through the graft material of the implantable medical device 100. In these examples, the tether 112 is disposed through one or more holes of the implantable medical device 100.

[0032] In certain examples, line 102 is an actuation line 102 configured to maneuver / orient the implantable medical device 100 during its delivery. The actuation line 102 can include a stiffness such that a user operating the delivery system can apply a force to the actuation line 102 and maneuver the implantable medical device 100 bidirectionally (e.g., proximally and distally with respect to a target location within a patient's vasculature). For example, the actuation line 102 can have a stiffness greater than the stiffness of the tether 112. The stiffness of the actuation line 102 and / or the location at which the actuation line 102 is coupled to the implantable medical device 100 can facilitate deploying and positioning the implantable medical device 100 with respect to a target location within a patient's vasculature. For example, the implantable medical device 100 can be configured to deploy in a tortuous blood vessel having a curvature with at least one inflection point. In certain examples, the actuation line 102 is configured to maintain the proximal end 108 of the implantable medical device 100 substantially perpendicular to an inflection point in the curvature of the tortuous blood vessel during delivery of the implantable medical device 100.

[0033] The actuation line 102 can be detached or released from the implantable medical device 100 and removed from the patient after the implantable medical device 100 is positioned and deployed within a target location in the patient's vasculature. The actuation line 102 can include an eyelet or opening at a leading end through which the tether 112 can be disposed. Further, the tether 112 can be attached to the actuation line 102 at the eyelet or at another location, as described in further detail below. In other examples, the tether 112 is configured to be removed or loosened to detach the actuation line 102 from the implantable medical device 100.

[0034] FIG. 2 shows another implantable medical device 100 and an actuation line 102 according to various aspects of the present disclosure. The implantable medical device 100 may be releasably coupled to a delivery system. The delivery system may include a catheter 104 having a proximal end 106 and a distal end (not shown in FIG. 2). The implantable medical device 100 may be disposed near the proximal end 106 of the catheter 104. The delivery system may be configured to deliver the implantable medical device 100 to a target location within a patient's vasculature. In certain examples, the implantable medical device 100 may be configured to deploy in a tortuous blood vessel having a curvature with at least one inflection point. To facilitate deployment of the implantable medical device 100, the delivery system may include an actuation line 102 configured to maintain the proximal end 108 (or distal end 110) of the implantable medical device 100 substantially perpendicular to an inflection point of the curvature of the tortuous blood vessel during delivery of the implantable medical device 100.

[0035] The actuation line 102 (accessible to a user of the delivery system) is configured, for example, to manipulate / orient the implantable medical device 100 during its delivery and is releasably coupled to the implantable medical device 100 via at least one tether 112. The tether 112 may be disposed through a portion of the implantable medical device 100 and through the actuation line 102 to couple the actuation line 102 to the implantable medical device 100. In certain examples, and as shown in FIG. 2, at least one tether 112 is disposed through the implantable medical device 100 near or in the vicinity of the proximal end 108 of the implantable medical device 100. In other examples, the implantable medical device 100 may include a loop 114 attached to or coupled to the outer surface of the implantable medical device 100. The loop 114 may include a layer of graft material that forms a lumen between the outer surface of the implantable medical device 100 and the graft material. The tether 112 may be disposed through the loop 114 to couple the line 102 to the implantable medical device 100. In other examples, the loop 114 or pivot may be one or more holes through the graft piece material of the implantable medical device 100. In these examples, the tether 112 is disposed through one or more holes of the implantable medical device 100.

[0036] Furthermore, the actuation line 102 may be disposed through a sleeve 214 attached outside the implantable medical device 100. The implantable medical device 100 may include a graft component and one or more stent components. The sleeve 214 may be formed of a material similar to or the same as the graft component of the implantable medical device 100. The sleeve 214 can include a lumen through which the actuation line 102 is disposed. In a particular example, the sleeve 214 is a sealed structure that forms a lumen, or the sleeve 214 is a layer of graft material that forms a lumen between the sleeve 214 and the implantable medical device 100. The sleeve 214 can facilitate the actuation line 102 for manipulating the implantable medical device 100. The sleeve 214 can prevent traumatic interactions between the actuation line 102 and the blood vessel wall. Further, the sleeve 214 can reinforce the connection between the actuation line 102 and the implantable medical device 100 when a user applies force or tension to the actuation line 102. As shown, the sleeve 214 has a length similar to the length of the implantable medical device 100. In other examples, the sleeve 214 can have a length shorter than or longer than the implantable medical device 100.

[0037] The actuation line 102 can include a stiffness such that a user operating the delivery system can apply force to the actuation line 102 and manipulate the implantable medical device 100 bidirectionally (e.g., proximally and distally relative to a target location within the patient's vasculature). For example, the actuation line 102 can have a stiffness greater than the stiffness of the tether 112. The stiffness of the actuation line 102 and / or the location where the actuation line 102 is coupled to the implantable medical device 100 can facilitate deploying and positioning the implantable medical device 100 relative to a target location within the patient's vasculature.

[0038] FIG. 3A shows an external view of an exemplary delivery system 300 in an unoperated configuration according to one embodiment. The delivery system 300 can be used for the manipulation of the implantable medical device 100 (e.g., as shown in FIGS. 1-2). The delivery system 300 may include an actuation line 102. As shown in FIGS. 3A-B, the actuation line 102 includes an eyelet 306. Further, the delivery system 300 also includes a pivot 114 and a tether 112. For ease of illustration, element 308 illustrates a hole of the implantable medical device 100. Since FIGS. 3A-B are external views of the implantable medical device 100, element 308 shows the path from the outer surface of the implantable medical device 100 to the interior (flow lumen) of the implantable medical device 100.

[0039] Consistent with the loops shown in FIGS. 1-2, the pivot 114 can be coupled to the implantable medical device 100. Further, as shown in FIGS. 1-2, the pivot 114 can also be attached to the outer surface of the implantable medical device 100. In certain examples, the pivot 114 may be one or more holes of the implantable medical device 100. In other examples, the pivot 114 is a loop that includes a layer of graft material that forms a lumen between the outer surface of the implantable medical device 100 and the graft material.

[0040] As shown in FIGS. 3A-B, the tether 112 can be disposed through the loop 114 to couple the actuation line 102 to the implantable medical device 100. Additionally, one end of the tether 112 may be attached to the actuation line 102. In certain examples, the tether 112 may be attached to the actuation line 102 at the eyelet 306. From the attachment at the eyelet 306 (or another distal end portion of the actuation line 102), the tether 112 is disposed through the pivot 114. Further, after being disposed through the pivot 114 (or loop), the tether 112 moves proximally (e.g., towards the user along the outer surface of the implantable medical device 100).

[0041] In certain examples, each of the tether 112 and the actuation line 102 can transition at element 308 between the outer surface of the implantable medical device 100 and the interior (fluid lumen) of the implantable medical device 100. At this point, the tether 112 and the actuation line 102 can enter a catheter (e.g., such as those shown in FIGS. 1-2) that can be positioned for delivery of the implantable medical device 100. The tether 112 and / or the actuation line 102 can move proximally toward a handle portion of the user or the delivery system 300. In this way, the user may apply tension to the tether 112 and / or the actuation line 102. FIG. 3B shows an example of the delivery system 300 in an operating configuration (e.g., when the user applies tension to the actuation line 102). As shown in FIG. 3B, the actuation line 102 is pulled proximally relative to its position in the non-operating configuration shown in FIG. 3A.

[0042] The tether 112, as an attachment or connection to the actuation line 102, is pulled proximally with or dragged along with the actuation line 102 when tension is applied to the actuation line 102. As a result of the tether 112 being disposed through the pivot 114, the tether 112 curves, orients, or actuates the implantable medical device 100. The pivot 114 connected to or attached to the implantable medical device 100 and the tether 112 disposed through the pivot 114 pull, curve, orient, or force a configuration change of the end of the implantable medical device 100 to which the pivot 114 is connected. As shown in FIG. 7A, the actuation line 102, the tether 112, and the pivot 114 are combined to angle or curve the tip of the device in a tortuous anatomical structure to orient the implantable medical device 100.

[0043] In certain examples, the pivot 114 and the actuation line 102 are configured to form a pulley that orients the implantable medical device 100 in response to tension applied to the actuation line 102. The tether 112 can loop around the pivot 114 to form a pulley when the actuation line 102 is tensioned or pulled in the proximal direction.

[0044] Figure 4A shows an external view of another exemplary delivery system 400 in an unoperated configuration, according to one embodiment. The delivery system 400 may be used to manipulate the implantable medical device 100 (e.g., as shown in FIGS. 1-2). The delivery 400 may include an actuation line 102 and an actuation line lumen 214 (or sleeve). The actuation line lumen 214 may be attached or coupled to the outer surface of the implantable medical device 100. Further, the actuation line lumen 214 can facilitate the actuation line 102 in manipulating the implantable medical device 100. The actuation line lumen 214 can prevent traumatic interactions between the actuation line 102 and the blood vessel wall (and, as will be discussed in more detail below, can form part of a pulley). Further, the actuation line lumen 214 can strengthen the connection between the actuation line 102 and the implantable medical device 100 when a user applies force or tension to the actuation line 102. The delivery system 400 may also include a pivot or loop 114 coupled to the implantable medical device. The loop 114 and the actuation line lumen 214 may each include a layer of graft material that forms a lumen between the outer surface of the implantable medical device 100 and the graft material. The tether 112 may be disposed external to the actuation line lumen 214 through the loop 114.

[0045] As shown in FIG. 4A, the actuation line 102 includes an eyelet 306. One end of the tether 112 may be attached to the actuation line 102. In a particular example, the tether 112 may be attached to the actuation line 102 at the eyelet 306. From the attachment at the eyelet 306 (or another distal end portion of the actuation line 102), the tether 112 is disposed through the loop 114. Further, after being disposed through the loop 114 (or pivot), the tether 112 moves proximally (e.g., toward the user along the outer surface of the implantable medical device 100). As shown in FIG. 4A, the tether 112 is disposed through the eyelet 306, through the loop 114, and then attached to the eyelet 306 (e.g., as the tether 112 approaches the front end or distal end of the implantable medical device 100).

[0046] In certain examples, each of the tether 112 and the actuation line 102 can transition at element 308 between the outer surface of the implantable medical device 100 and the interior (fluid lumen) of the implantable medical device 100. For ease of illustration, element 308 illustrates a hole in the implantable medical device 100. FIG. 4A is an external view of the implantable medical device 100, and FIG. 4B is an internal view of the implantable medical device 100 having element 308, where element 308 shows a path from the outer surface of the implantable medical device 100 to the interior (fluid lumen) of the implantable medical device 100.

[0047] As shown in FIG. 4B, the delivery system 400 may include a removable lock wire 420. The removable lock wire 420 is configured in certain examples to maintain the connection of the tether 112 to the implantable medical device 100. Additionally, the tether 112 is configured to release from the actuation line 102 in response to withdrawal of the removable lock wire 420, as shown in FIGS. 4D - E and described in further detail below. In certain examples, the removable lock wire 420 may be attached to the tether 112. In other examples, as shown in FIG. 4B, the removable lock wire 420 may be disposed through a portion of the tether 112. The tether 112 can include, for example, an eyelet 422 disposed at an end of the tether 112. When the tether 112 includes the eyelet 422, the removable lock wire 420 is disposed through the eyelet 422 of the tether 112 to connect the removable lock wire 420 to the tether 112.

[0048] The eyelet 422 of the tether 112 may be disposed at one end of the tether 112, and the other end of the tether 112 is attached to the eyelet 306 of the actuation line 102. In certain examples, the eyelet 422 of the tether 112 is proximal to or near the proximal end of the tether 112, and the distal end of the tether 112 is connected to the actuation line 102.

[0049] As shown in FIG. 4B, the removable lock wire 420 is disposed through the flow lumen of the implantable medical device 100, and the tether 112 is disposed from the fluid lumen (e.g., the internal portion) of the implantable medical device 100 at the proximal end of the tether 112 to the outer surface of the removable lock wire 420 at the distal end of the tether.

[0050] As also shown in FIG. 4B, the delivery system 400 may include a catheter 104 with the implantable medical device 100 disposed near the front end of the catheter 104 (as shown in more detail in FIGS. 1-2). The catheter 104 can extend through the lumen of the implantable medical device 100, toward and beyond the front end of the implantable medical device 100. The catheter 104 may also include a tip (not shown) at its distal end. The removable lock wire 420 can be disposed through the lumen of the catheter 104 and, as shown in FIG. 4D, can be retracted into the lumen of the catheter 104 to release the tether 112.

[0051] FIG. 4C shows an external view of the delivery system 400 shown in FIGS. 4A-B in an actuated configuration according to one embodiment. The tether 112 is pulled proximally or dragged with the actuating line 102 when tension is applied to the actuating line 102 as an attachment or connection to the actuating line 102. As a result of the tether 112 being disposed through the loop 114, the tether 112 curves, orients, or actuates the implantable medical device 100. The loop 114 connected or attached to the implantable medical device 100 and the tether 112 disposed through the loop 114 pull, curve, orient, or force a configuration change at the end of the implantable medical device 100 to which the loop 114 is connected. As shown in FIG. 7A, the actuating line 102, the tether 112, and the loop 114 are combined to angle or curve the tip of the device in a tortuous anatomical structure to orient the implantable medical device 100.

[0052] Furthermore, the tether 112 is pulled into the actuation line lumen 214 in response to the tension applied to the actuation line 102. In a particular example, as shown in FIG. 4C, the tether 112 can follow a path starting from the attachment of the tether 112 at the eyelet 306 of the actuation line 102, the tether 112 returning to the actuation line lumen 214 through the loop 114 and being able to return from the actuation line lumen 214 through the eyelet 306 of the actuation line 102. The tether 112 (and the actuation line 102) can then enter the implantable medical device 100 at the element 308. At this point, the actuation line 102 can enter the catheter 104 and move proximally towards the handle portion of the user or the delivery system 400. In this way, the user can apply tension to the actuation line 102.

[0053] As shown in FIG. 4C, the actuation line lumen 214 is attached to the outer surface of the implantable medical device 100 proximal to the loop 114 (or pivot). In a particular example, the path shown in FIG. 4C forms a pulley arrangement for orienting the implantable medical device 100. For example, the loop 114 and the actuation line lumen 214 are configured to form a pulley for orienting the implantable medical device 100 in response to the tension applied to the actuation line 102. The loop 114 and the actuation line lumen 214 are pivot points within the pulley and are configured to form a pulley between the tether 112 and the actuation line 102 for maneuvering the implantable medical device 100 in response to the tension applied to the actuation line 102.

[0054] FIG. 4D shows an internal view of the delivery system 400 in a configuration for removing the tether 112. The tether 112 is configured to be released from the actuation line 102 in response to the withdrawal of the removable lock wire 420 from the eyelet 422 of the tether 112. As shown in FIG. 4D, the removable lock wire 420 can be drawn into the catheter 104. The removable lock wire 420 can be removed after the implantable medical device 100 has been oriented in the desired configuration at the target location within the patient's body.

[0055] FIG. 4E shows an external view of the delivery system 400 in a configuration for removal of the tether in one embodiment. The tether 112 is configured to be released from the actuation line 102 in response to the withdrawal of the removable lock wire 420. The continuous tension applied to the actuation line 102 after the release or removal of the removable lock wire 420 pulls the tether 112 through an element 308 (e.g., a hole in the implantable medical device 100). At this point, the tether 112 and the actuation line 102 are detached from the medical device 100. In addition, the user can continue to apply tension or pull out the actuation line 102 to remove the actuation line 102 and the tether 112 attached to the actuation line 102 from the patient.

[0056] FIG. 5 shows an internal view of the implantable device 100 having an exemplary lock wire 420 arrangement according to one embodiment. The catheter 104 is also shown in FIG. 5 and the catheter 104 is disposed through the flow lumen of the implantable medical device 100. At the distal end of the catheter 104 there is an olive 524. The olive 524 may be a non-traumatic tip of the catheter 104 and the delivery system.

[0057] In certain examples, as discussed in more detail above with reference to FIGS. 4A-E, the lock wire 420 may be embedded in a portion of the olive 524. The olive 524 can include a notch portion 526 as shown in FIG. 5. In certain examples, the lock wire 420 is embedded in the notch portion 526 of the olive 524 during delivery and steering / orientation of the implantable medical device 100. The lock wire 420 may be disposed through an eyelet 422 of the tether 112 for steering / orientation of the implantable medical device 100 as discussed in detail above. The end of the tether 112 including the eyelet 422 is coupled to the catheter 104 by the lock wire 420 and the other end of the tether 112 is external to the implantable medical device 100 for attachment or connection to an actuation line 102 (not shown). As shown in FIG. 5, the tether 112 migrates from the inside to the outside of the implantable medical device 100 by being disposed through an element 308 (e.g., a hole in the implantable medical device 100).

[0058] The catheter 104 shown in FIG. 5 is provided as an example of various features of the catheter 104, and combinations of these illustrated features are clearly within the scope of the present invention. However, the examples and illustrations thereof are not intended to suggest that the concepts of the present invention provided herein are limited to one or more of those features shown in FIG. 5 from fewer features, additional features, or alternative features. For example, in various embodiments, the arrangement of the catheter 104 and / or the lock wire 420 shown in FIG. 5 may be included in the delivery system described with reference to FIGS. 1-4. The delivery system may include, for example, the olive 524, or the lock wire 420 may be fixed to the olive 524. It should be understood that the reverse is also true. For example, the tether 112 and the lock wire 420 shown in FIG. 5 may be employed in relation to the actuation line 102 shown in FIGS. 4A-E.

[0059] FIG. 6A shows an external view of another exemplary delivery system 600 according to one embodiment. The delivery system 600 may be used (e.g., as shown in FIGS. 1-2) to manipulate an implantable medical device. The delivery system 600 may include an actuation line 102 and a lumen 214 (or sleeve). The lumen 214 may be attached or connected to the outer surface of the implantable medical device 100.

[0060] Delivery system 600 may also include a pivot or loop 114 coupled to implantable medical device 100. Loop 114 and lumen 214 may each include a layer of graft material that forms a lumen between the outer surface of implantable medical device 100 and the graft material. Tether 112 may be disposed external to lumen 214 through loop 114. As shown in FIG. 6A, actuation line 102 includes an eyelet 306 and tether 112 is advanced through eyelet 306. Further, as shown in FIG. 6A, tether 112 includes two portions 626, 628 as a result of looping through eyelet 306 of actuation line 102. Portions 626, 628 of tether 112 are disposed through lumen 214 and are fed into the interior of implantable medical device 100 through a hole in implantable medical device 100 illustrated by element 308.

[0061] FIG. 6B shows an internal view of delivery system 600 shown in FIG. 6A, according to one embodiment. One of portions 626 of tether 112 may be attached to a catheter, as shown by element 630. Further, the other of portions 628 may be coupled to a part of delivery handle 632 available to a user. The user can apply tension to remove a portion of delivery handle 632 to apply tension to tether 112. Tether 112 can then be released from attachment point 630 on the catheter, thereby decoupling from eyelet 306 of actuation line 102. This decouples actuation line 102 from implantable medical device 100 after the orientation has been achieved.

[0062] FIGS. 7A-E show side views of the angle of a deployable device with respect to target positions 700a-e, according to various aspects of the present disclosure. Each of FIGS. 7A-E shows a side profile of the tip (or proximal) end 700a-e of a deployable device and is consistent with various sides of the present disclosure. In a particular example, target positions 700a-e may be in a tortuous blood vessel of a patient. The target positions 700a-e where the deployable device is implanted may have an angle (e.g., a curve having at least one inflection point 704a-e). Target positions 700a-e may be an abdominal aortic aneurysm (AAA) having an angle.

[0063] In certain examples, one of the ends 702a - e of the deployable device may be deployed perpendicular to an inflection point in the curvature of the tortuous vessel during delivery of the deployable device. Non - perpendicularity can adversely affect the ability of the deployable device to seal the target locations 700a - e. FIG. 7A shows the tip (or proximal) end 702a deployed perpendicular to the inflection point 704a. In certain examples, the perpendicularity of the deployable device may be a function of the flatness, angle, and rotational alignment of the device. FIG. 7B shows the tip (or proximal) end 702b of the deployable device angled with respect to the inflection point 704b of the target location 700b. FIG. 7C shows the tip (or proximal) end 702c of the deployable device rotated with respect to the inflection point 704c of the target location 700c. FIG. 7D shows the tip (or proximal) end 702d of the deployable device deformed with respect to the inflection point 704b of the target position 700d. FIG. 7E shows the tip (or proximal) end 702e of the expandable device deformed or flattened, rotated, and angled with respect to the inflection point 704e of the target position 700e.

[0064] The deployment and performance of the device can be improved by maneuvering the device into the appropriate position while maintaining one of the ends of the expandable device perpendicular to the target location 700a - for example, the curvature of a vessel having at least one inflection point 704a - e) during and after deployment. The actuation lines and their arrangement discussed herein facilitate maintaining the expandable device perpendicular during and after deployment (as shown in FIG. 7A) and reducing non - perpendicular, angled, or flat deployments (as shown in FIGS. 7B - E).

[0065] The lines discussed herein can be formed from metals such as stainless steel, cobalt - chromium alloys, and nitinol, polymers, or natural materials. Further, the actuation lines can also be formed from high - strength polymer fibers such as ultra - high - molecular - weight polyethylene fibers (e.g., SpectraTM, Dyneema PurityTM, etc.) or aramid fibers (e.g., TechnoraTM, etc.). In certain examples, the actuation line may have a column strength greater than that of a tether.

[0066] The graft component may be made from any material that is suitable for use as a graft in a selected body lumen and is resistant to expansion as discussed herein. The graft component may be composed of the same or different materials. Further, the graft component may include multiple layers of materials that may be the same or different materials. In one embodiment, the materials are used in combination and assembled together to form a graft. The graft material used for a stent graft can be formed from extrusion, coating, or wrap film, or a combination thereof. Polymers, biodegradable materials, and natural materials can be used for specific applications.

[0067] Examples of synthetic polymers include, but are not limited to, nylon, polyacrylamide, polycarbonate, polyformaldehyde, polymethyl methacrylate, polytetrafluoroethylene, polychlorotrifluoroethylene, polyvinyl chloride, polyurethane, elastomeric organosilicon polymers, polyethylene, polypropylene, polyurethane, polyglycolic acid, polyester, polyamide, mixtures, blends and copolymers thereof, which are suitable as graft materials. In one embodiment, the graft is made of a polyester such as polyethylene terephthalate including DACRON® and MYLAR®, and a polyaramid such as KEVLAR®, a polyfluorocarbon such as polytetrafluoroethylene (PTFE) with or without a hexafluoropropylene copolymer (TEFLON® or GORE-TEX®), and porous or non-porous polyurethane. In another embodiment, the graft comprises a stretched fluorocarbon polymer (especially PTFE) material. Preferred classes of fluoropolymers include polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), a copolymer of tetrafluoroethylene (TFE) and perfluoro(propyl vinyl ether) (PFA), a homopolymer of polychlorotrifluoroethylene (PCTFE) and its copolymer with TFE, ethylene-chlorotrifluoroethylene (ECTFE), a copolymer of ethylene-tetrafluoroethylene (ETFE), polyvinylidene fluoride (PVDF), and polyvinyl fluoride (PVF). Particularly preferred is ePTFE for its extensive use in vascular prostheses. In another embodiment, the graft comprises a combination of the materials listed above. In another embodiment, the graft is substantially impermeable to body fluids. The substantially impermeable graft can be made of a material that is substantially impermeable to fluids or can be composed of a permeable material that is treated or manufactured to be substantially impermeable to fluids (e.g., by laminating different types of materials as described above or known in the art). In another embodiment, the outermost tube comprises ePTFE.In another embodiment, the innermost tube comprises ePTFE. In another embodiment, the innermost tube and the outermost tube comprise an ePTFE film wrapped around the tube. In another embodiment, the secondary stent is covered with any of the materials disclosed herein or known in the art. In another embodiment, the second stent cover comprises ePTFE.

[0068] As further examples of graft materials, vinylidene fluoride / hexafluoropropylene hexafluoropropylene (HFP), tetrafluoroethylene (TFE), vinylidene fluoride, 1 - hydroperfluoropropylene, perfluoro(methyl vinyl ether), chlorotrifluoroethylene (CTFE), pentafluoropropene, trifluoroethylene, hexafluoroacetone, hexafluoroisobutylene, fluorinated poly(ethylene - propylene copolymer) (FPEP), poly(hexafluoropropene) (PHFP), poly(chlorotrifluoroethylene) (PCTFE), poly(vinylidene fluoride) (PVDF), poly(vinylidene fluoride - tetrafluoroethylene copolymer) (PVDF - TFE), poly(vinylidene fluoride - hexafluoropropene copolymer) (PVDF - HFP), poly(tetrafluoroethylene - hexafluoropropene copolymer) (PTFE - HFP), poly(tetrafluoroethylene - vinyl alcohol copolymer) (PTFE - VAL), poly(tetrafluoroethylene - vinyl acetate copolymer) (PTFE - VAC), poly(tetrafluoroethylene - propene copolymer) (PTFEP), poly(hexafluoropropene - vinyl alcohol copolymer) (PHFP - VAL), poly(ethylene - tetrafluoroethylene copolymer) (PETFE), poly(ethylene - hexafluoropropene copolymer) (PEHFP), poly(vinylidene fluoride - chlorotrifluoroethylene copolymer) (PVDF - CTFE), and combinations thereof, and additional polymers and copolymers described in U.S. Patent Application Publication No. 2004 / 0063805, which is hereby incorporated by reference in its entirety for all purposes, are included, but not limited thereto. Additional polyfluorocopolymers include tetrafluoroethylene (TFE) / perfluoroalkyl vinyl ether (PAVE). PAVE can be perfluoromethyl vinyl ether (PMVE), perfluoroethyl vinyl ether (PEVE), or perfluoropropyl vinyl ether (PPVE), as described in U.S. Patent Application Publication No. 2006 / 0198866 and U.S. Patent No. 7,049,380, which are hereby incorporated by reference in their entirety for all purposes.Other polymers and copolymers include polylactide, polycaprolactone-glycolide, polyorthoesters, polyanhydrides; polyamino acids; polysaccharides; polyphosphazenes; poly(ether-ester) copolymers such as PEO-PLLA, or blends thereof, polydimethyl-siloxane; poly(ethylene-vinyl acetate); acrylate-based polymers or copolymers such as poly(hydroxyethyl methyl methacrylate, polyvinylpyrrolidone); fluorinated polymers such as polytetrafluoroethylene; cellulose esters, and any polymers and copolymers described in U.S. Patent Application Publication No. 2004 / 0063805.

[0069] The graft component can be attached to the self-expanding stent element by using a connecting member that is a generally flat ribbon or tape having at least one generally flat surface, as discussed herein. In certain examples, the tape member is made from expanded PTFE (ePTFE) coated with an adhesive. The adhesive may be a thermoplastic adhesive. In certain examples, the thermoplastic adhesive may be fluorinated ethylene propylene (FEP). More specifically, the FEP-coated side of the ePTFE faces and contacts the outer surfaces of the self-expanding stent and the graft component, and thus the self-expanding stent can be attached to the graft component.

[0070] The stent components discussed herein can be manufactured from a variety of biocompatible materials. These materials can include other cobalt alloys such as 316L stainless steel, cobalt-chromium-nickel-molybdenum-iron alloy (“cobalt-chromium”), L605, tantalum, nitinol, or other biocompatible metals. In certain examples, as discussed in detail above, the stent (and graft) may be self-expanding. In other examples, the prosthesis may be balloon-expandable.

[0071] The stent components discussed herein can be composed of a material with a moderately high strength, i.e., a material that resists plastic deformation when stressed. In one embodiment, the stent component comprises a wire spirally wound around a mandrel with pins disposed thereon such that a helical coil and undulations can be simultaneously formed. Other configurations can also be used. In a specific example, the stent component is made from a superelastic alloy. There are various disclosures of the use of superelastic alloys such as Nitinol in stents. See, for example, U.S. Patent Nos. 4,503,569 (Dotter); 4,512,338 (Balko et al.); 4,990,155 (Wilkoff); 5,037,427 (Harada et al.); 5,147,370 (MacNamara et al.); 5,211,658 (Clouse); and 5,221,261 (Termin et al.).

[0072] A variety of materials of various metallic superelastic alloys such as Nitinol are suitable for use in the stent component. The main requirement for the materials is that they be suitably elastic even when made into very thin sheets or small-diameter wires. Various stainless steels treated physically, chemically, and by other methods to produce high elasticity are suitable, as are other metal alloys such as cobalt-chromium alloys (e.g., ELGILOY®), platinum / tungsten alloys, and in particular nickel-titanium alloys commonly known as "Nitinol".

[0073] The invention of the present application has been described generally and with respect to specific embodiments. It will be apparent to those skilled in the art that various modifications and variations can be made to the embodiments without departing from the scope of the present disclosure. Accordingly, the embodiments are intended to embrace modifications and variations of the present invention as long as they fall within the technical scope of the appended claims and the technical scope of their equivalents.

Claims

1. A system for manipulating an implantable medical device, comprising: an actuation line, a pivot coupled to the implantable medical device, and a tether attached at one end to the actuation line, disposed through the pivot, configured to orient the implantable medical device in response to tension applied to the actuation line, and to release from the pivot after the implantable medical device is oriented. The system further comprises: a system.

2. The system of claim 1, wherein the pivot comprises a loop attached to an outer surface of the implantable medical device.

3. The system of claim 2, wherein the loop comprises a layer of graft material that forms a lumen between the outer surface of the implantable medical device and the graft material.

4. The system of claim 3, wherein the actuation line includes an eyelet, and the tether is attached at one end to the eyelet and disposed through the pivot and the eyelet.

5. The system of claim 4, wherein the tether is disposed through the eyelet, through the loop, and then attached to the eyelet.

6. The system according to any one of claims 1 to 5, wherein the pivot and the actuation line are configured to form a pulley for orienting the implantable medical device in response to tension applied to the actuation line.

7. The system according to any one of claims 1 to 6, further comprising an actuation line lumen, wherein the tether is pulled into the actuation line lumen in response to tension applied to the actuation line.

8. The system of claim 7, wherein the actuation line lumen is attached to an outer surface of the implantable medical device proximal to the pivot.

9. The system according to any one of claims 7 to 8, wherein the pivot and the actuation line lumen are configured to form the pulley for orienting the implantable medical device in response to tension applied to the actuation line.

10. The system according to any one of claims 1 to 9, further comprising a removable lock wire configured to maintain the connection of the tether to the implantable medical device.

11. The system of claim 10, wherein the tether includes an eyelet, and the removable lock wire is disposed through the eyelet and connected to the tether.

12. The eyelet of the tether is at or near the proximal end of the tether, and the distal end of the tether is coupled to the actuation line, the system of claim 11.

13. The removable lock wire is disposed through a fluid lumen of the implantable medical device, and the tether is disposed from the fluid lumen of the implantable medical device at the proximal end of the tether to the outer surface of the removable lock wire at the distal end of the tether, the system of claim 12.

14. The tether is configured to release from the actuation line in response to withdrawal of the removable lock wire from the eyelet of the tether, the system of claim 13.

15. Further comprising a catheter disposed through a lumen of the implantable medical device, the proximal end of the tether being releasably coupled to the catheter, and the distal end of the tether being coupled to the actuation line, the system of claim 10.

16. Catheter, An implantable medical device disposed near a tip of the catheter and including a proximal end, a distal end, and a fluid lumen extending therebetween, A loop coupled to an outer surface of the implantable medical device, A lumen coupled to the outer surface of the implantable medical device proximal to the loop, An actuation line disposed through the lumen, and A tether coupled to the actuation line, disposed through the loop, and configured to maneuver the implantable medical device in response to tension applied to the actuation line, A delivery system comprising.

17. The loop and the lumen are pivot points and are configured to form a pulley between the tether and the actuation line to maneuver the implantable medical device in response to tension applied to the actuation line, the delivery system of claim 16.

18. Further comprising a removable lock wire configured to maintain the connection of the tether to the implantable medical device, the tether being configured to release from the actuation line in response to withdrawal of the removable lock wire, the delivery system of claim 16.

19. A method of maneuvering an implantable medical device, comprising: Delivering the implantable medical device to a target location within a patient's vasculature, and Operating an actuating line coupled to the implantable medical device by a tether disposed through a loop coupled to an outer surface of the implantable medical device to maneuver the implantable medical device. A method comprising. [

20. ] The method of claim 19, further comprising maintaining the connection of the tether to the implantable medical device by a removable lock wire, and releasing the tether from the loop in response to withdrawal of the removable lock wire.

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