Articulated shaft for conveying system

Abstract

The present disclosure generally relates to systems, devices, and methods for a delivery system including a deflectable elongate shaft. The delivery system may include a deflectable elongate shaft including a tension tether extending along the length of the elongate shaft, the tension tether having a distal portion, a proximal portion, and an intermediate portion, the distal portion of the tension tether coupled to a portion of the elongate shaft such that the intermediate portion of the tension tether may be variably moved toward a first set of bidirectional breaks or a second set of bidirectional breaks. The tension tether may be configured to be tensioned to deflect the hypotube.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application No. 62 / 962,026, filed January 16, 2020, which is incorporated herein by reference in its entirety.

[0002] The present disclosure describes systems, devices, and methods related to implant deployment in fluid systems and refractive mechanisms. [Background technology]

[0003] Various diseases can affect the human body. Such diseases can be of the human heart and can include diseases of the human heart valves, including the aortic valve, mitral valve, tricuspid valve, and pulmonary valve. Stenosis, for example, is a common and serious valve disease that can affect the operation of the heart valves and the overall health of a person.

[0004] Implants may be provided that may replace or repair portions of the heart. Artificial implants, such as prosthetic heart valves, may be provided to replace portions of the heart. Prosthetic aortic, mitral, tricuspid, and even pulmonary valves may be provided.

[0005] The implant may be minimally invasive and deployed percutaneously to the desired portion of the subject, or such deployment may occur via a catheter, where a catheter may be deployed through the human vasculature.

[0006] The path to the delivery site in the subject may be tortuous. As such, the elongate shaft for the delivery device is preferably bendable to allow the elongate shaft to bend to accommodate the path within the subject. Various problems can arise when the elongate shaft is bent, such as imprecise orientation within the subject and possible damage to the elongate shaft. Further control over the bending of the elongate shaft may also be desirable. Summary of the Invention [Problem to be solved by the invention]

[0007] The present systems and methods relate to delivery systems and may relate to deflectable elongate shafts for such delivery systems within subjects in various procedures, including (but not limited to) medical and training procedures. Such filtering may occur as part of a deployment system for an implant within a subject. Subjects include (but are not limited to) medical patients, veterinary patients, animal models, cadavers, and simulators of the cardiac and vasculature systems (e.g., anthropomorphic phantoms and explanted tissues). [Means for solving the problem]

[0008] Embodiments herein may provide a delivery system for an implant. The delivery system may include an elongate shaft having a length and an implant holding region for holding the implant. The hypotube may extend along the length of the elongate shaft, may have a proximal portion and a distal portion, and may include a first set of bidirectional cuts aligned longitudinally along a first side of the hypotube, a second set of bidirectional cuts aligned longitudinally along a second side of the hypotube opposite the first side, and two longitudinally extending spine-like members positioned on opposite sides of the hypotube between the first set of bidirectional cuts and the second set of bidirectional cuts.

[0009] The tension tether may extend along the length of the elongate shaft and may have a distal portion, a proximal portion, and an intermediate portion, the distal portion of the tension tether being coupled to a portion of the elongate shaft such that the intermediate portion of the tension tether may be variably moved toward the first set of bidirectional breaks or the second set of bidirectional breaks, and the tension tether is configured to be pulled to deflect the hypotube.

[0010]

[0010] Embodiments herein may provide a delivery system for an implant. The delivery system may include an elongate shaft having a length. The elongate shaft may have an implant holding region for holding the implant, a first hypotube extending along the length of the elongate shaft and including a proximal end and a distal end, and a plurality of slits configured to allow the first hypotube to deflect in a first direction.

[0011] The elongate shaft may include a second hypotube including a distal portion and a proximal portion, the distal portion extending over the first hypotube and including a plurality of slits configured to allow the second hypotube to bend in a second direction opposite the first direction, and the proximal portion positioned adjacent the distal end of the first hypotube and including a plurality of slits configured to allow the proximal portion to bend in both the first direction and the second direction.

[0012] In embodiments herein, a method may be provided. The method may include inserting an elongate shaft of a delivery device into the vasculature of a subject. The elongate shaft may have a length and may include an implant holding region for holding an implant, a hypotube extending along the length of the elongate shaft and including a first set of bidirectional cuts longitudinally aligned along a first side of the hypotube and a second set of bidirectional cuts longitudinally aligned along a second side of the hypotube opposite the first side, and two longitudinally extending spine-like members positioned on opposite sides of the hypotube between the first set of bidirectional cuts and the second set of bidirectional cuts. A tension tether may extend within at least a portion of the hypotube.

[0013] The method may include bending the tension tether within the hypotube toward either the first set of bidirectional breaks or the second set of bidirectional breaks.

[0014] The method may include passively deflecting the hypotube to deflect the tension tether within the hypotube toward either the first set of bidirectional breaks or the second set of bidirectional breaks.

[0015] The tension tether may be configured to bend in a first direction toward a first set of bidirectional breaks and may be configured to bend in a second direction toward a second set of bidirectional breaks, further including the step of pulling the tension tether proximally to bend the hypotube in either the first direction or the second direction.

[0016] The method may include pulling the tensioning tether to deflect the hypotube in a first direction when the tensioning tether is deflected in a first direction, or in a second direction when the tensioning tether is deflected in a second direction.

[0017] The tension tether may be aligned with at least one of the two longitudinally extending spine-like members before being bent within the hypotube toward either the first set of bidirectional cuts or the second set of bidirectional cuts.

[0018] In embodiments herein, a method may be provided. The method may include inserting an elongate shaft of a delivery device into the vasculature of a subject. The elongate shaft may have a length and may include an implant holding region for holding an implant. A first hypotube may extend along the length of the elongate shaft and include a proximal end and a distal end and a plurality of slits configured to allow the first hypotube to flex in a first direction.

[0019] The second hypotube may include a distal portion and a proximal portion, the distal portion extending over the first hypotube and including a plurality of slits configured to allow the second hypotube to bend in a second direction opposite the first direction, and the proximal portion positioned proximal to the distal end of the first hypotube and including a plurality of slits configured to allow the proximal portion to bend in both the first direction and the second direction.

[0020] These and other features, aspects, and advantages are described below with reference to the drawings that are intended to illustrate, but not limit, the disclosure, in which like reference numerals indicate corresponding features consistently throughout like embodiments. [Brief explanation of the drawings]

[0021] [Figure 1] FIG. [Figure 2] 2 is a perspective view of a handle of the transport device shown in FIG. 1. FIG. [Figure 3] FIG. 2 is a side exploded assembly view of the components of the transporter shown in FIG. 1. [Figure 4] FIG. 2 is a side exploded assembly view of the components of the transporter shown in FIG. 1. [Figure 5] FIG. 1 is a bottom view of a hypotube according to one embodiment of the present disclosure. [Figure 6] FIG. 1 is a bottom view of a hypotube according to one embodiment of the present disclosure. [Figure 7] FIG. 7 is a top view of the hypotube shown in FIG. 6. [Figure 8] FIG. 8 is a cross-sectional side view of the hypotube shown in FIGS. 6 and 7 positioned within the hypotube shown in FIG. 5. [Figure 9] FIG. 8 is a cross-sectional side view of the hypotube shown in FIGS. 6 and 7 positioned within the hypotube shown in FIG. 5. [Figure 10] FIG. 1 is a perspective view of an artificial valve. [Figure 11] 1 is a schematic side view of a delivery device approaching the aortic valve. [Figure 12] FIG. 1 is a schematic side view of a prosthetic aortic valve in place. [Figure 13] FIG. 1 is a top view of a hypotube according to one embodiment of the present disclosure. [Figure 14] FIG. 14 is a side view of the hypotube shown in FIG. 13. [Figure 15] FIG. 1 is a side view of a hypotube according to one embodiment of the present disclosure. [Figure 16] FIG. 16 is a top view of the hypotube shown in FIG. 15. [Figure 17] FIG. 16 is an end view of the hypotube shown in FIG. 15. [Figure 18] FIG. 1 is a side view of a hypotube according to one embodiment of the present disclosure. [Figure 19] FIG. 1 is a side view of a hypotube according to one embodiment of the present disclosure. [Figure 20] FIG. 20 is a top view of the hypotube shown in FIG. 19. [Figure 21] FIG. 1 is a side view of a hypotube according to one embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0022] The following description and examples illustrate in detail some exemplary embodiments of the disclosure. Those skilled in the art will recognize that there are many modifications and variations of the disclosure that fall within its scope. Therefore, the description of specific exemplary embodiments should not be considered to limit the scope of the present disclosure.

[0023] Figure 1 illustrates one embodiment of an implant delivery system 10 that may be similar to the implant 12 illustrated in Figure 10. The implant 12 may be an aortic implant with a prosthetic aortic valve. In embodiments, the implant may take forms other than those illustrated in Figure 10; for example, the implant may be a mitral, tricuspid, or pulmonary valve prosthesis, among other forms of prosthetic devices. The implant may comprise a stent, clip, or other form of implant that may be inserted into a portion of a subject, including the heart.

[0024] The implant 12 may be configured to expand to be placed in place within the native valve position, or may be an expandable implant as shown in FIG. 10 . The implant 12 may include a frame 14 including a plurality of supports 16 configured to be compressed for positioning within a delivery device 18 and configured to be expanded when desired. The frame 14 may support prosthetic valve leaflets 20 that act in place of the native valve leaflets. The frame 14 may include a coupler 22 for coupling to the delivery device 18 to hold the implant 12 on the delivery device 18 until deployment is desired. The coupler 22 may include an opening as shown in FIG. 10 or may take other shapes as desired. While the implant 12 is shown in FIG. 10 , the use of the delivery device 18 is not limited to the embodiment of the implant 12 shown in FIG. 10 and may extend to other shapes of implants as desired.

[0025] Referring again to FIG. 1 , the delivery system 10 may include a delivery device 18 that may include an elongated shaft 24 having a proximal end 26 and a distal end 28, the elongated shaft 24 having a length between the proximal end 26 and the distal end 28. A housing in the form of a handle 30 may be positioned at a proximal portion of the elongated shaft 24, including the proximal end 26 of the elongated shaft 24. The handle 30 may be configured to be grasped by an individual for use in manipulating the delivery device 18. The elongated shaft 24 may extend outward from the handle 30 and may be configured for insertion into a subject to be guided to a desired treatment site on the subject. The elongated shaft 24 may be configured for insertion into the subject's vasculature or may be inserted into the subject's vasculature. Such insertion may be percutaneous and minimally invasive, such as transfemoral entry. Other forms of entry, such as transapical, may also be utilized. The handle 30 remains external to the subject during insertion.

[0026] The elongate shaft 24, in embodiments disclosed herein, may include an implant holding region 32, which may be covered by a sheath to form a capsule. The implant holding region 32 may be configured to hold an implant. The implant may be held within the implant holding region 32 until a desired time for deployment of the implant. The elongate shaft 24 may be inserted into a subject and navigated to a desired deployment location to position the implant holding region 32 as desired. The delivery device 18 may then be manipulated to deploy the implant from the implant holding region 32.

[0027] The elongate shaft 24 may further include a nosecone 34 at the distal end 28 of the elongate shaft 24. The nosecone 34 may form the tip of the elongate shaft 24 and may be flexible to prevent injury to parts of the subject contacted by the tip of the elongate shaft 24.

[0028] FIG. 2 shows a perspective view of the handle 30 of the delivery device 18. The handle 30 may include an outer surface 36 for grasping and may include a proximal portion 38 and a distal portion 40. The outer surface 36 of the handle 30 may be ergonomically configured for grasping by a user. The handle 30 may be configured to be driven distally to move the elongate shaft 24 distally, or driven proximally to move the elongate shaft 24 proximally. The handle 30 may be configured to rotate about its longitudinal axis and the elongate shaft 24 to rotate and apply torque to the elongate shaft 24. Such rotation may be desirable to provide a desired orientation of the implant deployed from the implant holding region 32. The proximal portion 38 may include a flush port 42 for flushing fluids (including air) from the elongate shaft 24.

[0029] The handle 30 may further include a release mechanism positioned therein that may be configured to release the implant from the implant holding area 32. Components of the release mechanism may include a release actuator 44 that is operated to release the implant from the implant holding area 32. The release actuator 44 may be positioned on the proximal portion 38 of the handle 30. The release mechanism may further include a lock 46 on the proximal portion 38 to lock the release actuator 44 in place. The release mechanism may further include a motor or other drive device (such as a manually driven device) that may be positioned within the handle 30. The motor or other drive device may be configured to rotate a torque shaft 48, as shown in FIG. 3, to rotate to move an outer sheath 50 that may cover the implant holding area 32.

[0030] The release mechanism may include a control device for operating a motor or other drive device. As shown in FIG. 2, the control device may be in the form of control device buttons 52, 54 or other forms. One button 52 may be configured to retract the outer sheath 50 (moving the outer sheath 50 proximally), and another button 54 may be configured to advance the outer sheath 50 (moving the outer sheath distally). In this manner, the control device may be used to selectively control deployment of the implant from the implant-retaining region 32 by movement of the outer sheath 50 (e.g., exposing the implant for release or covering the implant for recapture).

[0031] The handle 30 may further include a flush valve 56 for allowing fluid to flow from the elongate shaft 24 .

[0032] The handle 30 may include a deflection mechanism 58 configured to deflect at least a portion of the elongate shaft 24. The deflection may be in a longitudinal plane extending outward from the longitudinal axis of the elongate shaft 24. Such deflection may be utilized to accommodate various bends within the subject's anatomy that need to be navigated to deliver the implant to a desired location. The deflection mechanism 58 may provide controllable deflection of the elongate shaft 24 to oppose passive deflection that may occur by simply passing a flexible shaft through a bend within the subject's anatomy. The deflection mechanism 58 is discussed in more detail with respect to FIG. 4.

[0033] 3 shows an exploded assembly view of the components of delivery device 18, including elongated shaft 24. The top component shown in FIG. 3 is generally the innermost component of elongated shaft 24, and the bottom component shown in FIG. 3 is generally the outermost component of elongated shaft 24.

[0034] 3, the elongate shaft 24 may comprise an assembly of components. The various components may comprise subassemblies of the elongate shaft 24. The elongate shaft 24 may include multiple layers or multiple sheaths extending over other layers or sheaths.

[0035] In the embodiment shown in FIG. 3 , the innermost component of the elongate shaft 24 may comprise an inner shaft or guidewire lumen 60. The guidewire lumen 60 may extend the length of the elongate shaft 24 and may have a proximal end that couples to the handle 30. The distal end of the guidewire lumen 60 may couple to the nosecone 34. A manifold 61 may be coupled to the guidewire lumen 60 and may hold a suture 63 to hold the implant in place within the implant holding region 32. Retainers 62, 64 may be coupled to the guidewire lumen 60 for coupling to a release pin 66. Upon movement of the release pin 66, the implant may be allowed to deploy from the implant holding region 32.

[0036] A torque shaft 48 may be provided with a sheath that extends over the guidewire lumen 60. The torque shaft 48 may have a proximal end that couples to a motor or other drive device in the handle 30 and may have a distal end 68 with a threaded portion for a threaded body 70 (such as a nut or other form of threaded body) to slide over. Washers 72, 74 may hold the torque shaft 48 in place.

[0037] The hypotube 76 may be positioned distal to the distal end of the torque shaft 48 or may be spaced apart from the distal end of the torque shaft 48, as shown in FIG. 3. The hypotube 76 may be configured to extend along the length of the elongate shaft 24 and may include a proximal end and a distal end. The hypotube 76 may include multiple slits, as shown in FIGS. 6 and 7, which may allow the hypotube 76 to flex in one direction. A catch 78 for the retainers 62, 64 may be positioned within the interior cavity of the hypotube 76 to prevent undesired proximal movement of the retainers 62, 64 within the hypotube 76. The hypotube 76 may include a sheath extending over the guidewire lumen 60.

[0038] The tension tether coupler 80 may be positioned within the hypotube 76. The tension tether coupler 80 may comprise a body configured to couple to a distal end of the tension tether 82 and retain the tension tether 82 in the hypotube 76. The tension tether 82 may have a distal end coupled to the tension tether coupler 80 and a proximal portion including a proximal end coupled to the articulation mechanism.

[0039] The flexible shaft 84 may comprise a sheath extending over the torque shaft 48, may have a proximal end coupled to the deflection mechanism, and may have a distal end coupled to the proximal end of the torque shaft channel 86. The flexible shaft 84 may comprise a substantial length of the elongate shaft 24 and, as noted in FIG. 1, forms the outer surface of the elongate shaft 24. The flexible shaft 84 may be configured to be flexible to accommodate the subject's anatomy as it enters.

[0040] The hypotube 88 may have a proximal portion that includes a torque shaft channel 86. The torque shaft channel 86 may include an opening that allows the threaded body 70 to transfer motion provided from the threaded portion of the torque shaft 48 to the outer sheath 50. The threaded body 70 may slide longitudinally along the threaded portion of the torque shaft 48, as the torque shaft channel 86 may prevent rotation of the threaded body 70. The threaded body 70 may extend outward through the torque shaft channel 86 to couple to the proximal portion 90 of the hypotube 92, thereby allowing the hypotube 92 to slide longitudinally along the threaded body 70. In this manner, the outer sheath 50 is coupled to and slidable over the hypotube 92.

[0041] The hypotube 88 may have a distal portion including a distal end 94 that connects to the distal end 96 of the hypotube 76. As such, the hypotube 88 may connect to the tension tether 82 and the hypotube 76 at the distal end 94 of the hypotube 88. The proximal portion 98 of the hypotube adjacent the torque shaft channel 86 does not cover the hypotube 76. The proximal portion 98 of the hypotube may include the proximal end of the hypotube.

[0042] The outer sheath of the elongate shaft 24 may include a number of components. Such components may include an outer sheath 50 extending over the implant holding region 32. The proximal end of the outer sheath 50 may be coupled to the hypotube 92, which may include a sheath 100 extending over the hypotube 92 and forming the outer surface of the elongate shaft 24, as shown in FIG. 1 . The proximal end of the hypotube 92 may be coupled to the threaded body 70, and such connection may be covered with the outer sheath 102, which forms the outer surface of the elongate shaft 24, as shown in FIG. 1 . Additionally, the proximal portion of the outer sheath may include a hypotube 105, which may prevent fluids (such as blood) from entering the torque shaft channel 86 when the outer sheath is slid distally. The hypotube 105 may be covered with outer sheaths 107, 108, which form the outer surface of the elongate shaft 24, as shown in FIG. 1 .

[0043] In operation, the release mechanism may be actuated to rotate the torque shaft 48, which causes the threaded body 70 to slide longitudinally along the torque shaft channel 86. This longitudinal movement is provided to the outer sheath 50, which exposes and deploys the implant from the elongate shaft 24.

[0044] The flexibility and deflection of the elongate shaft 24 will be discussed with respect to the deflection mechanism shown in FIG. 4 and other characteristics of the systems disclosed herein. With reference to FIG. 4, a deflection mechanism may be provided that operates to dynamically deflect at least a portion of the elongate shaft 24. The deflection mechanism may be positioned at the proximal end of the elongate shaft 24. The deflection mechanism may be positioned distal to the handle 30 and at the proximal end of the elongate shaft 24, although other locations may be utilized as desired.

[0045] The deflection mechanism may include a control device 104 that may be manipulated by an individual to control deflection of the elongate shaft. The control device 104 is shown in FIG. 4 as comprising a rotatable knob, although other forms of control devices may be utilized as desired. The control device 104 may include threads on an interior of the control device 104 that engage with a threaded body 106. The threaded body 106 may be configured to slide along rails 109 that prevent rotational movement of the threaded body 106, thus allowing the threaded body 106 to slide along its length. A proximal mount 110 and a sealing ring 112 may be configured to couple the proximal end of the deflection mechanism to the handle 30.

[0046] The distal portion of threaded body 106 may be coupled to spring 113 and coupler 114, which couples threaded body 106 to the proximal end of tensioning tether 82. Thus, longitudinal movement of threaded body 106 longitudinally moves tensioning tether 82. Distal mount 117 couples the deflection mechanism to the proximal end of flexible shaft 84.

[0047] In operation, control device 104 may be manipulated to move tensioning tether 82 proximally or distally to change the working length of tensioning tether 82. Moving tensioning tether 82 proximally may shorten the working length of tensioning tether 82, thus bending elongate shaft 24 in a portion of elongate shaft 24 proximal to the distal attachment point of tensioning tether 82 on elongate shaft 24.

[0048] FIG. 5 shows a bottom view of the proximal portion of the hypotube 88. The hypotube 88 may include a single vertebra 116 extending longitudinally along the length of the hypotube 88. The single vertebra 116 may be positioned on a side of the hypotube 88 that is not intended to bend. A cut 118 may extend through the surface of the hypotube 88, extending from the outer surface to the inner surface facing the central cavity of the hypotube 88. The cut may extend around the outer periphery of the hypotube 88, offset from the location of the single vertebra 116. FIG. 13 shows the cut pattern on the opposite side of the hypotube 88, designated by reference numeral 118. The cut 118 may include multiple teeth 120 configured to fit and engage with recesses 122 having corresponding shapes as the teeth 120. The central tooth 121 may be larger than the two side teeth 120. In this manner, the cuts 118 may provide a single direction of deflection for the hypotube 88, i.e., toward the central tooth 121 shown in Figure 13. Figure 14 shows a side view of the cuts 118 that the hypotube 88 may utilize along its length.

[0049] FIG. 6 shows a bottom view of the cut pattern of the inner hypotube 76. The inner hypotube 76 may include cuts 124 forming teeth 126 that engage correspondingly shaped indentations 128. The cuts 124 may be configured to allow the inner hypotube 76 to flex in a single direction. The size of the gap between the teeth 126 and the indentations 128 may be smaller than that of the hypotube 88, and therefore less flex may be available in the inner hypotube 76 than in the hypotube 88. FIG. 7 illustrates the opposite side of the hypotube 76, showing a single vertebra 130 extending longitudinally along the length of the hypotube 76.

[0050] The outer hypotube 88 may extend over the inner hypotube 76, as discussed with respect to FIG. 3. FIG. 8 shows an enlarged cross-sectional view of a proximal portion 98 of the outer hypotube 88 adjacent the torque shaft channel 86, as discussed with respect to FIG. 3. Certain components of the elongate shaft 24 have been omitted from the illustration for clarity. The hypotube 88 extends over the inner hypotube 76, specifically over the proximal end 132 of the hypotube 76. Thus, the portion 98 of the outer hypotube 88 is positioned between the proximal end 132 of the inner hypotube 76 and the torque shaft channel 86 that does not cover the inner hypotube 76. The portion 98 is positioned distal to the channel 86 and the portion of the elongate shaft that comprises the torque shaft 48, which may have greater stiffness than the proximal portion of the outer hypotube 88.

[0051] The distal portion of the hypotube 88 extends over the hypotube 76 and includes a plurality of slits configured to allow the hypotube 88 to bend in a direction opposite to the direction of bending of the hypotube 76. The vertebrae 116, 130 of each hypotube 88, 76 are positioned 180 degrees from one another. In this manner, the inner hypotube 76 may prevent bending of the outer hypotube 88 away from the central tine 121 of the outer hypotube 88. Such a feature may act to prevent kinks from forming in the outer hypotube 88 if the outer hypotube 88 is bent in the wrong direction, as discussed further with respect to FIG. 11 .

[0052] 9 shows an enlarged cross-sectional view of the distal end 96 of the inner hypotube 76 coupled to the distal end 94 of the outer hypotube 88. A coupler or the like may couple the distal end 96 of the inner hypotube 76 to the distal end 94 of the outer hypotube 88. The coupling between the distal ends 96, 94 transfers force from the tension tether 82 to the hypotube 88.

[0053] The deflection characteristics of the elongate shaft 24 will be discussed with respect to Figure 11, which shows a view of the elongate shaft 24 as it is delivered to the aortic valve 134 of the heart. In particular, the elongate shaft 24 has been deflected to conform to the geometry of the heart, particularly the aortic arch 136. The deflection mechanism is operated to pull the tension tether 82 proximally, deflecting the elongate shaft 24.

[0054] However, the configuration of the elongate shaft 24 can present difficulties if the direction of bending of the outer hypotube 88 is not properly oriented for insertion into the aortic arch or another portion of a subject's anatomy. For example, upon insertion of the elongate shaft 24 into the subject's anatomy, the elongate shaft may rotate about its longitudinal axis, thus causing the direction of bending of the outer hypotube 88 to be in a direction opposite to the desired bending, or in a direction of bending that is different than desired overall.

[0055] 11 , damage to the elongate shaft 24 can occur if the elongate shaft 24 is advanced through the aortic arch or other portion of a subject in the wrong direction, in the direction of bending of the outer hypotube 88. For example, the elongate shaft 24 may be inserted into the aortic arch 136 and contact the wall of the aortic arch 136. Such contact may cause the elongate shaft 24 to bend in a direction opposite to the direction of bending of the outer hypotube 88. While the presence of the inner hypotube 76 along the distal portion of the outer hypotube 88 prevents kinking in these portions, the portion 98 of the outer hypotube 88 shown in FIG. 8 may bend due to the lack of the inner hypotube 76 in that portion 98.

[0056] 13 and 14 illustrate variations on the outer hypotube 88, where the hypotube 138 shown includes the hypotube 88 cut pattern along a distal portion 145 of the hypotube 138, but changes the cut pattern at a proximal portion 139 of the hypotube 138 where the inner hypotube 76 is not present (corresponding to the discussed portion 98). The hypotube 138 may include a distal portion 145 and a proximal portion 139, where the distal portion 145 is configured to extend over the hypotube 76 and includes the hypotube 88 cut pattern that allows the hypotube 138 to bend in a direction (e.g., a second direction) opposite to the direction of bending of the inner hypotube 76 (e.g., a first direction). The distal portion 145 may include a single spine 116 positioned between the multiple cuts 118 in the hypotube 138. The spine 116 may be in a position that is 180 degrees from the spine 130 of the inner hypotube 76 .

[0057] The proximal portion 139 may be positioned proximal to the distal end of the inner hypotube 76 and may include a plurality of cuts 140, 142 configured to allow the proximal portion 139 to bend in both the second direction of the distal portion 145 and the first direction of the inner hypotube 76. FIGS. 13 and 14 illustrate that the cuts in the proximal portion 139 of the outer hypotube 138 may be provided as first and second sets of bidirectional cuts (comprising a first set of cuts 140 and a second set of cuts 142). The bidirectional cuts 140, 142 are bidirectional because they allow bending in two directions in the same plane. The cuts 140, 142 may be longitudinally aligned as shown in FIG. 13, or as shown in FIG. 14, two vertebrae 141 (a mirror image of FIG. 14 is provided on the other side of FIG. 14) separate the sets of longitudinally aligned cuts 140, 142. The first set of cuts 140 may be positioned on one side of the hypotube 138, and the second set of cuts 142 may be positioned on the opposite side of the hypotube 138. The first set of cuts 140 may be aligned longitudinally along a first side of the hypotube 138, and the second set of cuts 142 may be aligned longitudinally along a second side of the hypotube 138 opposite the first side. The vertebrae 141 may be rotatably positioned perpendicular to the cuts 140, 142 or may extend parallel to one another. The vertebrae 141 may extend longitudinally and be positioned on opposite sides of the hypotube 138 between the first set of cuts 140 and the second set of cuts 142. The vertebrae 141 may be rotatably offset from the vertebrae 116 of the distal cut 118 of the hypotube 138 by 90 degrees. In this manner, the dual spine 141 configuration and uniformly shaped breaks 140 on opposite sides of the hypotube 138 may allow for bidirectional bending of the proximal portion of the hypotube 138.

[0058] Additionally, each of the cuts 140, 142 may have a curved cut so that the entire interior area of ​​the cuts 140, 142 are in contact simultaneously. For example, the cuts may have a rounded oval shape as desired.

[0059] 11 , once the elongate shaft 24 is inserted into a subject's vasculature, if the elongate shaft 24 is misoriented, the breaks 140, 142 allow the proximal portion 139 of the hypotube 138 to bend in an opposite direction to the distal portion 145, thus reducing the possibility of damage (including kinking) to the elongate shaft 24. The breaks in the hypotube 138 allow the proximal portion of the hypotube 138 to bend in the direction of and opposite the bending of the inner hypotube 76.

[0060] The inner hypotube 76 may further be configured to prevent the distal portion 145 of the outer hypotube 138 from bending in the direction of the bend of the inner hypotube 76. The inner hypotube 76 may remain coupled to a tensioning tether 82 configured to be pulled proximally to cause the outer hypotube 138 to bend.

[0061] The plurality of cuts 140 , 142 in the proximal portion 139 of the outer hypotube 138 may be positioned distal to the torque shaft 48 configured to move the sheath 50 to cover the implant holding area 32 .

[0062] 15 and 16 show a variation of one embodiment of the outer hypotube 88, in which the pattern of cuts 140, 142 in the proximal portion 139 of the hypotube 138 shown in FIGS. 13 and 14 extends along the entire length of the hypotube 144. The hypotube 144 may be configured to bend in two directions within a single plane. The hypotube 144 may extend along the length of the elongate shaft 24 and may have a proximal portion and a distal portion.

[0063] 15 , the inner hypotube 76 may be eliminated from assembly with the elongate shaft 24. As such, the tensioning tether 82 may be coupled to the distal portion of the hypotube 144 and the distal portion of the elongate shaft 24. Additionally, the implant holding region 32 may be positioned distal to the distal portion of the hypotube 144.

[0064] The hypotube 144 may include a first set of bidirectional cuts 140 aligned longitudinally along a first side of the hypotube 144 and a second set of bidirectional cuts 142 aligned longitudinally along a second side of the hypotube 144 opposite the first side. Two longitudinally extending vertebrae (vertebrae 141 is depicted in FIG. 15 , with the opposing vertebrae on the opposite side from that depicted in FIG. 15 ) may be positioned on opposite sides of the hypotube 144 between the first set of bidirectional cuts 140 and the second set of bidirectional cuts 142, respectively.

[0065] The tensioning tether 82 (marked by alternating tensioning tether positions 82a, 82b shown in FIG. 15 ) extends along the length of the elongate shaft 24 and may have a distal portion, a proximal portion, and an intermediate portion. The proximal portion of the tensioning tether 82 may be coupled to a deflection mechanism, such as deflection mechanism 58 shown in FIG. 4 , configured to tension the tensioning tether 82 to deflect the hypotube 144.

[0066] A distal portion of tension tether 82 may be coupled to a portion of elongate shaft 24 such that an intermediate portion of tension tether 82 is aligned with at least one of the longitudinally extending vertebrae 141. As shown in FIG. 15 , a distal portion 147 of hypotube 144 may include a coupling point, which may include a coupler 146, at the distal end of hypotube 144. The distal portion of tension tether 82 may be coupled to a coupling point (in the form of a coupler 146) that may be longitudinally aligned with one of two longitudinally extending vertebrae 141 (the opposite vertebrae being on the opposite side from that shown in FIG. 15 ).

[0067] A distal portion of tensioning tether 82 may be coupled to a portion of elongate shaft 24 such that an intermediate portion of tensioning tether 82 may be variably moved toward a first set of bidirectional breaks 140 (denoted by tensioning tether 82a) or a second set of bidirectional breaks 142 (denoted by tensioning tether 82b), and the tensioning tether may be configured to be pulled to deflect hypotube 144. For example, distal portion 83 of tensioning tether 82 (denoted by variable positions of distal portions 83a,b in FIG. 15 ) may be coupled to a portion of elongate shaft 24, and the attachment point may be configured such that an intermediate portion of the tensioning tether may be variably moved toward first set of bidirectional breaks 140 or second set of bidirectional breaks 142. Such an attachment point is shown intermediate first set of breaks 140 and second set of breaks 142, longitudinally aligned with vertebral member 141. Such attachment points may be on the sidewalls of the hypotube 88, as shown in Figures 15 and 17. Thus, the tensioning tether 82 may initially be aligned with one of the two longitudinally extending spine-like members 141, with a distal portion of the tensioning tether 82 attached to a portion of the elongate shaft 24 such that an intermediate portion of the tensioning tether may be variably moved toward either the first set of bidirectional cuts 140 or the second set of bidirectional cuts 142.

[0068] In operation, as the elongate shaft 24 is inserted into and advanced through the subject's vasculature, the elongate shaft 24 may bend due to various properties, such as contact with a portion of the subject or bending over a guidewire. Such bending may cause the hypotube 144 to bend in that direction. The bending may be passive bending caused by contact with the surface of the subject or another property. The tension tether 82 may therefore bend within the hypotube 144 in the direction of bending and bend in that direction toward either the first set of breaks 140 or the second set of breaks 142. This property is depicted by the dashed lines in FIGS. 15 and 17 as the tension tether variably moves toward either break 140 (denoted as tension tether 82a at distal portion 83a) or break 142 (denoted as tension tether 82b at distal portion 83b). In this manner, the hypotube 144 may be passively deflected by the vasculature or another property to deflect the tension tether 82 within the hypotube 144 toward either the first set of breaks 140 or the second set of breaks 142.

[0069] As the tensioning tether moves in a direction toward these breaks 140, 142, it may be retracted proximally to continue movement in that direction. The tensioning tether may thus be pulled proximally to deflect the hypotube 144 in either a first direction (toward break 140) or a second direction (toward break 142). The tensioning tether may deflect the hypotube 144 in a direction toward break 140 if the tensioning tether is initially deflected toward break 140 and in the first direction. Furthermore, the tensioning tether may deflect the hypotube 144 in a direction toward break 142 if the tensioning tether is initially deflected toward break 142 and in the second direction. The tension tether may be aligned with at least one of the longitudinally extending spine-like members (such as spine-like member 141 and the opposing spine-like member on the side opposite the side shown in FIG. 15) before being bent within the hypotube 144 towards either the first set of cuts 140 or the second set of cuts 142.

[0070] 11 , as elongate shaft 24 is advanced and passively deflected in a direction toward aortic valve 134, the tensioning tether may be able to move toward breaks 140 or 142 in the inner diameter of elongate shaft 24, thus providing dynamic deflection in that direction. In this manner, because two directions of deflection in a single plane are possible with the configuration shown in FIG. 15 , the likelihood of elongate shaft 24 being rotated incorrectly is greatly reduced.

[0071] Figure 16 shows a top view of the configuration shown in Figure 15. Figure 17 shows an end view of the hypotube 144, shown with two possible positions for the tension tether as reference numerals 82a and 82b.

[0072] FIG. 18 shows a diagram of a hypotube 148 with a cut pattern 150 configured similarly to that shown in FIGS. 15 and 16, further including cuts having different sizes. A set of cuts may be configured to vary the cut thickness. The different thickness may allow for larger or smaller bend angles depending on the cut size (smaller cuts have smaller bend angles, larger cuts have larger bend angles). Thus, in embodiments, either of the cuts in the first and second sets of bidirectional cuts 140, 142 may vary the cut thickness as desired.

[0073] The cuts 140, 142 may each have a curved cut so that the entire interior area of ​​the cuts 140, 142 are simultaneously in contact, as disclosed. For example, the cuts may have a rounded oval shape as desired.

[0074] FIG. 19 illustrates an embodiment of a hypotube 152 that includes the cut pattern shown in FIGS. 15 and 16 (labeled cut pattern 155) at the distal portion of the hypotube 152 and further includes a cut pattern 153 with a greater number of bending directions within the proximal portion of the hypotube 152. The cut pattern 153 may be positioned proximate to the first and second sets of bidirectional cuts 140, 142. The cut pattern 153 may be positioned proximate to cut pattern 155. The cut pattern 153 may include multiple longitudinally alternating cuts that form a repeating pattern. The cuts 154, 156 in longitudinally adjacent lines of cuts may be offset from each other by 60 degrees as shown in FIG. 19 or by different amounts as desired. Equally sized cuts and a repeating pattern of cuts may allow for equal flexibility in all radial planes of direction. The cut pattern 153 may form an omnidirectional cut pattern. In other embodiments, flexibility may be provided in at least three directions of bending.

[0075] Score pattern 153 may provide improved transmission of rotational torque from handle 30 to the distal portion of elongate shaft 24. Score pattern 153 may be configured to transmit torque about the longitudinal axis of hypotube 152. Additionally, score pattern 153 may be stiffer than score pattern 155 in at least two bending directions provided by score pattern 155. In this manner, flexibility of elongate shaft 24 may be increased toward the distal portion of elongate shaft 24, which may be desirable for a particular subject anatomy.

[0076] FIG. 20 shows a top view of the hypotube 152 shown in FIG.

[0077] FIG. 21 shows a hypotube 160 that includes a combination of the cut pattern 153 shown in FIGS. 19 and 20 and the variable size cut pattern 150 shown in FIG.

[0078] The elongate shaft 24 may be configured to be dynamically deflected into position utilizing any of the hypotube configurations disclosed herein. The implant 12 may be deployed into position as shown in FIG.

[0079] The cut patterns of any or all of the hypotubes 92, 94 shown in Figure 3 may be matched to the cut patterns of the hypotube embodiments shown in Figures 13-21. In this manner, matching cut profiles may be provided for the hypotubes 92, 94. The hypotubes 92, 94 may be considered outer hypotubes, and the hypotubes shown in Figures 13-21 may be considered middle hypotubes.

[0080] The configuration of the hypotubes and system components disclosed herein may be varied in other embodiments, and properties may be combined, varied, or substituted across embodiments as desired.

[0081] The use of the hypotubes and other components disclosed herein is not limited to use in delivery systems or delivery devices, but may extend to use in any medical device that is inserted into or withdrawn from a subject, for example, use may extend to a general medical cannula for insertion into a portion of a subject.

[0082] Hypotubes may be utilized in a variety of subjects and procedures. Subjects include, but are not limited to, medical patients, veterinary patients, animal models, cadavers, and simulators of the cardiac and vasculature systems (e.g., anthropomorphic phantoms and explanted tissues). Procedures include, but are not limited to, medical and training procedures.

[0083] The delivery devices and systems disclosed herein may be used in transcatheter aortic valve implantation (TAVI). The delivery devices and systems disclosed herein may be utilized for transarterial access, including transfemoral access, to the heart. In embodiments, various types of implants may be delivered by the delivery devices utilized in the systems herein, such as stents or filters, or diagnostic devices, among others.

[0084] The delivery devices, and systems and components disclosed herein may be utilized in percutaneous catheter procedures, including transarterial procedures, which may be transaortic or transjugular, and in particular transapical procedures.

[0085] Features of the embodiments may be changed, substituted, eliminated, or combined.

[0086] Additionally, the methods herein are not limited to the methods specifically described, but may include methods utilizing the systems and devices disclosed herein.

[0087] Method steps may be altered, eliminated, or added in the systems, apparatus, and methods disclosed herein.

[0088] Features of the embodiments disclosed herein may be implemented independently of the delivery device or independently of other components disclosed herein. Various devices of the system may be implemented independently.

[0089] In closing, while aspects of the present specification have been emphasized by reference to particular embodiments, those skilled in the art will readily appreciate that these disclosed embodiments are merely illustrative of the principles of the subject matter disclosed herein. It should therefore be understood that the disclosed subject matter is not limited to the particular methodology, protocols, and / or reagents, etc., described herein. Thus, various modifications or variations of the disclosed subject matter or alternative configurations may be made in accordance with the teachings herein without departing from the spirit of the present specification. Finally, the terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the scope of the systems, devices, and methods as disclosed herein, which are defined solely by the claims. Therefore, the systems, devices, and methods should not be limited to those precisely as shown and described.

[0090] Certain embodiments of the systems, apparatus, and methods are described herein, including the best mode known to the inventors for carrying out the same. Of course, variations on these described embodiments will become apparent to those of ordinary skill in the art upon reading the foregoing description. The inventors expect those of ordinary skill in the art to employ such variations as appropriate, and the inventors intend that the systems, apparatus, and methods may be practiced other than as specifically described herein. Accordingly, the systems, apparatus, and methods include all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Furthermore, any combination of the above-described embodiments in all possible variations thereof is encompassed by the systems, apparatus, and methods unless otherwise indicated herein or clearly contradicted by content.

[0091] Groupings of alternative embodiments, elements, or steps of systems, devices, and methods are not to be construed as limitations. Each group member may be referred to and claimed individually or in any combination with other group members disclosed herein. It is anticipated that one or more members of a group may be included in, or deleted from, a group for reasons of convenience and / or patentability. When any such inclusion or deletion occurs, the specification is considered to include the group as modified, and therefore fulfills the recitation of all Markush groups used in the appended claims.

[0092] Unless otherwise indicated, all numbers indicating features, items, quantities, parameters, properties, terms, etc. used in the specification and claims are to be understood as being modified in all instances by the term "about." As used herein, the term "about" means that the feature, item, quantity, parameter, property, or term so identified includes approximations that may vary, but are capable of performing the desired operation or process discussed herein.

[0093] The terms "a," "an," "the," and similar referents when used in the context of describing systems, devices, and methods (particularly in the context of the claims that follow) should be construed to include both the singular and the plural, unless otherwise indicated herein or clearly contradicted by the context. All methods described herein can be performed in any suitable order, unless otherwise indicated herein or clearly contradicted by the context. The use of any and all examples or exemplary language (e.g., "etc.") provided herein is intended merely to better clarify the systems, devices, and methods and does not otherwise impose limitations on the scope of the claimed systems, devices, and methods. No language in the specification should be construed as indicating any non-claimed element that is essential to the practice of the systems, devices, and methods.

[0094] All patents, patent publications, and other publications mentioned and identified in this specification are individually and expressly incorporated herein by reference in their entirety for the purpose of describing and disclosing the compositions and methodologies described in such publications that may be used, for example, in connection with the systems, apparatus, and methods. These publications are provided solely for their disclosure prior to the filing date of the present application. Nothing in this regard should be construed as an admission that the inventors are not entitled to antedate such disclosure by virtue of prior invention or for any other reason. All statements as to the date or representation as to the contents of these documents are based on the information available to the applicant and do not constitute any admission as to the accuracy of the dates or contents of these documents. Further aspects of the present invention are provided by the subject matter of the following sections. [Section 1] having a length an implant holding area for holding an implant; a first hypotube extending along the length of the elongate shaft and including a proximal end and a distal end and a plurality of slits configured to allow the first hypotube to deflect in a first direction; 1. A delivery system for an implant, comprising: an elongate shaft having a second hypotube including a distal portion and a proximal portion, the distal portion extending over the first hypotube and including a plurality of slits configured to allow the second hypotube to bend in a second direction opposite the first direction, the proximal portion positioned adjacent the distal end of the first hypotube and including a plurality of slits configured to allow the proximal portion to bend in both the first direction and the second direction. [Section 2] Item 10. The delivery system of item 1, wherein the first hypotube is configured to prevent the distal portion of the second hypotube from bending in the first direction. [Section 3] 3. The delivery system of claim 1 or 2, wherein the first hypotube is coupled to a tension tether configured to be pulled closely together to deflect the second hypotube. [Section 4] Item 4. The delivery system of item 3, wherein the distal end of the first hypotube is coupled to the distal end of the second hypotube. [Section 5] 5. The delivery system of any one of paragraphs 1 to 4, wherein the plurality of cuts in the proximal portion of the second hypotube include a first set of bidirectional cuts aligned longitudinally along a first side of the second hypotube and a second set of bidirectional cuts aligned longitudinally along a second side of the second hypotube opposite the first side, and two longitudinally extending spine-like members are positioned on opposite sides of the second hypotube between the first set of bidirectional cuts and the second set of bidirectional cuts, respectively. [Section 6] Item 6. The delivery system of item 5, wherein the plurality of breaks in the proximal portion of the second hypotube are positioned distal to a portion of the elongate shaft having greater stiffness than the proximal portion of the second hypotube. [Section 7] Item 7. The delivery system of item 6, wherein the plurality of cuts in the proximal portion of the second hypotube are positioned distal to a torque shaft configured to move a sheath to cover the implant holding area. [Section 8] Item 8. The conveying system of item 7, further comprising a release mechanism configured to rotate the torque shaft. [Section 9] Item 9. The delivery system of any one of items 1 to 8, wherein the plurality of cuts in the distal portion of the second hypotube include a plurality of teeth configured to fit into recesses. [Section 10] 10. The delivery system of any one of claims 1 to 9, wherein the first hypotube includes a single spine-like member positioned between the multiple gaps in the first hypotube, and the distal portion of the second hypotube includes a single spine-like member positioned between the multiple gaps in the second hypotube at a position that is 180 degrees from the single spine-like member of the first hypotube. [Explanation of symbols]

[0095] 10. Conveying System 12 Implants 14 frames 16 Support 18 Transporting Device 20 Artificial valve leaflets 22 Coupler 24 Long and thin shaft 26 Near end 28 Distal end 30 Handle 32 Implant Retention Area 34 Nosecone 36 Outer surface 38 Proximal 40 Distal 42 Flush Port 44 Release Actuator 46 Rock 48 Torque shaft 50 outer sheath 52 buttons 54 Buttons 56 Flush valve 58 Refraction mechanism 60 Guidewire lumen 62 Retainer 64 Retainer 66 Release pin 68 Distal 70 Threaded body 72 Washer 74 Washer 76 Hypotube 78 Fasteners 80 Tension Tether Coupler 82 Tensile Tether 82a Tension tether position 82b Tension tether position 84 Flexible Shaft 86 Torque shaft channel 88 Hypotube 90 Proximal 92 Hypotube 94 Distal end 96 Distal end 98 Proximal 100 sheath 102 outer sheath 104 Control Device 105 Hypotube 106 Threaded Body 107 Outer sheath 108 Outer sheath 109 Rail 110 Proximity Platform 112 Sealing ring 113 Spring 114 Coupler 116 Vertebral Member 117 Distal table 118 Break 120 teeth 121 central tooth 124 Break 126 teeth 128 depression 130 Vertebral Member 132 Near End 134 Aortic Valve 136 Aortic Arch 138 Hypotube 139 Proximal 140 cuts 141 Vertebral Member 142 Break 144 Hypotube 145 Distal 146 Coupler 147 Distal 148 Hypotube 150 Cutting Patterns 152 Hypotube 153 Break Pattern 155 Break Pattern 160 Hypotube

Claims

1. having a length an implant holding area for holding an implant; a hypotube extending along the length of the elongate shaft, having a proximal portion and a distal portion, the hypotube including a first set of bidirectional cuts aligned longitudinally along a first side of the hypotube and a second set of bidirectional cuts aligned longitudinally along a second side of the hypotube opposite the first side, and two longitudinally extending spine-like members positioned on opposite sides of the hypotube between the first set of bidirectional cuts and the second set of bidirectional cuts, respectively; a pair of tension tethers having a distal portion, a proximal portion, and an intermediate portion extending along a length of the elongate shaft, the distal portions of the tension tethers being coupled to a portion of the elongate shaft such that the intermediate portions of the tension tethers can move toward the first set of bidirectional breaks or the second set of bidirectional breaks, the tension tethers being configured to be pulled to deflect the hypotube; an elongated shaft having A delivery system for an implant, wherein the distal portion of the hypotube has a connection point in the form of a coupler at the distal end of the hypotube, the distal portion of the tension tether is connected to the connection point longitudinally aligned with one of the two longitudinally extending vertebral members, and the pair of tension tethers cross each other at the connection point.

2. 2. The delivery system of claim 1, wherein the distal portion of the tensioning tether is coupled to the portion of the elongate shaft such that the intermediate portion of the tensioning tether is aligned with at least one of the two longitudinally extending spine-like members.

3. 3. The delivery system of claim 1 or claim 2, wherein the distal portion of the tensioning tether is coupled to a point on the distal portion of the hypotube that is longitudinally aligned with one of the two longitudinally extending spine-like members.

4. The delivery system of claim 3 , wherein the point is on a sidewall of the hypotube.

5. 5. The delivery system of claim 1, wherein the hypotube is configured to bend in two directions within a single plane.

6. 6. The delivery system of claim 1, wherein the hypotube includes a cut pattern providing at least three deflection directions positioned proximate the first set of bidirectional cuts and the second set of bidirectional cuts.

7. 7. The conveying system of claim 6, wherein the cut pattern providing at least three deflection directions includes a plurality of longitudinally alternating cuts.

8. 8. The delivery system of claim 6 or claim 7, wherein the cut pattern providing at least three directions of deflection is configured to provide equal flexibility of the hypotube in all radial planes of deflection.

9. 10. The delivery system of claim 8, wherein the cut pattern providing at least three deflection directions is configured to transmit torque about a longitudinal axis of the hypotube.

10. 10. The conveying system of claim 1, wherein the first set of bidirectional cuts and the second set of bidirectional cuts are each configured to vary cut thickness.

11. 11. The conveying system of claim 1, wherein the first set of bidirectional cuts and the second set of bidirectional cuts are each configured to have curved cuts such that all interior areas of the cuts are in contact simultaneously.

12. 12. The delivery system of claim 1, wherein the implant holding region is positioned distal to the distal portion of the hypotube.

13. 13. The delivery system of claim 1, wherein the proximal portion of the tensioning tether is coupled to a bending mechanism configured to tension the tensioning tether and cause the hypotube to bend.

14. 14. The delivery system of claim 13, further comprising a handle coupled to a proximal portion of the elongate shaft.

15. 15. The delivery system of any one of claims 1 to 14, further comprising a release mechanism configured to release the implant from the implant holding area.

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