Systems and methods for tricuspid valve treatment

Abstract

To address problems in: delivering a prosthesis to a desired location in a human body, for example, delivering a replacement heart valve to the tricuspid valve; delivering devices through tortuous vasculature, either percutaneously or via open or semi-open surgical procedure, in order to gain access to perform procedures in the heart or other anatomical locations; and an ability to control deployment of the prosthesis at the desired location.SOLUTION: A delivery system for an implant, the delivery system comprises an elongate shaft including an implant retention area for retaining the implant, and a distal end having a hemispherical or parabolic shape.SELECTED DRAWING: Figure 20C

Description

Technical Field

[0001] Certain embodiments disclosed herein generally relate to a prosthesis for implantation into a lumen or body cavity and a delivery system for the prosthesis. In particular, the prosthesis and delivery system relate to replacement heart valves, such as replacement tricuspid heart valves, in some embodiments.

Background Art

[0002] Human heart valves, including the four aortic, pulmonary, mitral, and tricuspid valves, basically function as one-way valves and operate in synchronization with the pumping heart. The valve allows blood to flow downstream but prevents blood from flowing upstream. Diseased heart valves exhibit disorders such as stenosis or regurgitation of the valve, which interfere with the function of the valve for controlling blood flow. Such disorders can reduce the blood pumping efficiency of the heart, weaken, and be life-threatening conditions. For example, valve insufficiency can lead to symptoms such as heart hypertrophy and ventricular dilation. Therefore, extensive efforts have been made to develop methods and devices for repairing or replacing malfunctioning heart valves.

[0003] There are prostheses for correcting problems associated with malfunctioning heart valves. For example, mechanical and tissue-based heart valve prostheses can be used to replace malfunctioning native heart valves. More recently, considerable effort has been dedicated to developing replacement heart valves, particularly tissue-based replacement heart valves that can be delivered with less trauma to the patient than via open heart surgery. The replacement valve is designed to be delivered through minimally invasive procedures and even through percutaneous procedures. Such replacement valves often include a tissue-based valve body connected to an expandable frame that is delivered to the annulus of the native valve.

Summary of the Invention

Problems to be Solved by the Invention

[0004] Although not limited thereto, the development of prosthetic implants, including replacement heart valves that can be compacted for delivery and then controllably expanded for controlled placement, has proven particularly difficult. Further challenges relate to the ability of such prostheses to be fixed in a non-damaging manner to intravascular tissue, such as tissue within any body cavity or cavity.

[0005] Delivering a prosthesis to a desired location within the human body, for example delivering a replacement heart valve to the tricuspid valve, can also be a challenge. Obtaining an access path for performing a procedure within the heart or other anatomical location may require delivery of a device through a tortuous vasculature via a percutaneous or open or semi-open surgical procedure. The ability to control the deployment of the prosthesis at the desired location can also be a challenge. **Means for Solving the Problems**

[0006] Embodiments of the present disclosure are directed to prostheses such as, but not limited to, replacement heart valves. Embodiments of the present disclosure may be directed to delivery systems, devices, and / or methods of use for delivering and / or controllably deploying prostheses such as replacement heart valves to desired locations within the body. In some embodiments, a replacement heart valve and a method for delivering the replacement heart valve to a native heart valve such as the tricuspid valve are provided.

[0007] In some embodiments, a delivery system and method are provided for delivering a replacement heart valve to the location of a native tricuspid valve. In some embodiments, components of the delivery system facilitate bending of the delivery system to maneuver a prosthesis within the right atrium to a location within the native tricuspid valve. In some embodiments, a capsule is provided for housing the prosthesis for delivery to the location of the native tricuspid valve. In other embodiments, the delivery system and method can be adapted for delivery of an implant to locations other than the native tricuspid valve.

[0008] The present disclosure includes, but is not limited to, the following embodiments.

[0009] A delivery system for an implant, the delivery system comprising an elongate shaft having a distal end, an implant holding region for holding the implant, a bending portion configured to deflect the distal end of the elongate shaft in a first direction, and a portion positioned proximal to the bending portion. A deflection mechanism is configured to deflect the portion positioned proximal to the bending portion to deflect the bending portion in a second direction opposite the first direction.

[0010] A delivery system for an implant, the delivery system comprising an elongate shaft having a distal end, an implant holding region for holding the implant, a bending portion configured to deflect the distal end of the elongate shaft into a first plane, and a portion positioned proximal to the bending portion. A deflection mechanism is configured to deflect the portion positioned proximal to the bending portion in one or more planes that are not perpendicular to the first plane.

[0011] A delivery system for an implant, the delivery system comprising an elongate shaft having a distal end, an implant holding region for holding the implant, a first bending portion configured to deflect the distal end of the elongate shaft in a first direction, a second bending portion positioned adjacent to the first bending portion and configured to deflect the distal end of the elongate shaft in a second direction, and a portion positioned proximal to the second bending portion. A deflection mechanism can be configured to deflect the first bending portion, the second bending portion, and the portion positioned proximal to the second bending portion.

[0012] A delivery system for an implant, the delivery system comprising an elongated shaft having an implant holding region for holding the implant and a capsule having a distal end and surrounding the implant holding region, the distal end of the capsule forming the distal tip of the elongated shaft.

[0013] A delivery system for an implant, the delivery system comprising an elongated shaft having an implant holding region for holding the implant and a distal tip comprising a flexible sheath extending distally and configured to bend around a portion of a guide wire.

[0014] A delivery system for an implant, the delivery system comprising an elongated shaft having an implant holding region for holding the implant and a distal tip having a hemispherical or parabolic shape.

[0015] A delivery system for an implant, the delivery system comprising an elongated shaft having a wall surrounding a passage through which the implant is to be passed for deployment of the implant, the wall being configured to have a bend that defines a bend in the passage during deployment of the implant.

[0016] A delivery system for an implant, the delivery system comprising an elongated shaft having an axial dimension and an implant holding region for holding the implant and a port through which the implant is to be deployed from the elongated shaft in a direction transverse to the axial dimension.

[0017] A delivery system for an implant, the delivery system comprising an elongated shaft having an implant holding region for holding the implant and configured to bend more than 180 degrees to form a loop.

[0018] A delivery system for an implant, the delivery system comprising an elongate shaft having a capsule surrounding an implant holding region for holding the implant, and a hinge coupling the capsule to a portion of the elongate shaft.

[0019] A delivery system for an implant, the delivery system comprising an elongate shaft extending along an axis and having an outer surface and an implant holding region for holding the implant. One or more supports may extend radially outwardly from the outer surface of the elongate shaft and be configured to contact the outer surface so as to resist deflection of the elongate shaft transverse to the axis.

[0020] The system comprises a prosthetic heart valve configured for implantation within a patient's annulus. The system comprises an anchor configured to be fixed within a portion of the patient's body. The system comprises a tether configured to couple the prosthetic heart valve to the anchor.

[0021] A prosthetic valve for replacement of a patient's native valve, the prosthetic valve being configured to be moored within the annulus of the patient's native valve and comprising a prosthetic heart valve body forming a prosthetic valve annulus. The system comprises a port coupled to the prosthetic heart valve body and configured to receive a diagnostic or therapeutic device.

[0022] A method for treating a patient's tricuspid valve, the method comprising passing a delivery device for an implant into the patient's right atrium. The method comprises deploying the implant to the patient's tricuspid valve.

[0023] A method for treating a patient's tricuspid valve, the method comprising deploying a prosthetic heart valve within the patient's tricuspid valve annulus. The method comprises deploying an anchor within a portion of the patient's body. The method comprises providing a tether coupling the prosthetic heart valve to the anchor.

[0024] The method includes passing a diagnostic or therapeutic device through a port positioned in a prosthetic heart valve body that forms a prosthetic annulus.

[0025] The method includes coupling a pacemaker pacing lead to a prosthetic heart valve body positioned within a patient's cardiac annulus to provide electrical energy through the pacemaker pacing lead and through the prosthetic heart valve body to pace the function of the patient's heart.

[0026] The method is a step of delivering a delivery device for an implant to a portion of a patient's heart, the delivery device comprising an elongate shaft extending along an axis and having an outer surface. The method includes expanding one or more supports radially outwardly from the outer surface of the elongate shaft. The method includes contacting one or more supports with an external surface of the delivery device to resist deflection of the elongate shaft transverse to the axis.

Brief Description of the Drawings

[0027]

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DETAILED DESCRIPTION OF THE INVENTION

[0028] This specification and the drawings provide aspects and features of the present disclosure in the context of multiple embodiments of a replacement heart valve, delivery system, and method configured to be used in a patient's vascular system, such as for replacement or repair of a patient's normal heart valve. These embodiments may be considered in relation to replacement of specific valves such as the patient's aortic valve, tricuspid valve, mitral valve, or pulmonary valve. However, it should be understood that the features and concepts discussed herein may be applicable to devices other than heart valve implants. For example, the delivery system, replacement heart valve, and method can be applied to medical implants such as other types of expandable prostheses for use in other locations within the body, such as within arteries, veins, or other body cavities or other locations. In addition, specific features such as those of the valve, delivery system, and method should not be construed as limitations, and the features of any one embodiment discussed herein can be combined with the features of other embodiments as desired and where appropriate. Certain of the embodiments described herein are described in relation to a transfemoral delivery approach, but these embodiments may be used for other delivery approaches such as, for example, a transapical, transatrial, or transjugular approach. Further, certain of the features described in relation to specific embodiments may be combined with other embodiments, including those described in relation to different delivery approaches.

[0029] FIG. 1 shows one embodiment of a delivery device, delivery assembly, or delivery system 10 according to one embodiment of the present disclosure. Delivery system 10 can be used to deploy a prosthesis, such as a replacement heart valve, within the body. In some embodiments, delivery system 10 can use a two-plane deflection approach to properly deliver the prosthesis. The replacement heart valve can be delivered to the annulus of the patient's tricuspid heart valve or other heart valve locations in a variety of ways, such as by open surgery, minimally invasive surgery, and percutaneous or transcatheter delivery through the patient's vasculature. The exemplary transfemoral approach can be found in U.S. Patent Application Publication No. 2015 / 0238315, filed Feb. 20, 2015, the entire patent application of which is hereby incorporated by reference in its entirety. Delivery system 10 is described in relation to a percutaneous delivery approach, and more specifically in relation to a transfemoral artery delivery approach, but it should be understood that the features of delivery system 10 can be applied to other delivery systems, including delivery systems for transapical, trans-right atrial, or transjugular delivery approaches.

[0030] Delivery system 10 may be used to deploy a prosthesis, such as a replacement heart valve, within the body as described elsewhere in this specification. Delivery system 10 can receive and / or cover a portion of a prosthesis, such as a first end 301 and a second end 303 of a prosthesis or implant 70, shown in FIG. 3A. For example, delivery system 10 may be used to deliver an expandable prosthesis or implant 70, which includes a first end 301 and a second end 303, where the second end 303 is configured to deploy or expand before the first end 301.

[0031] FIG. 2A further shows an example of an implant 70 that can be inserted into the delivery system 10, specifically into the implant retention region 16. In FIG. 2A, for clarity of understanding, the prosthesis is shown only as the exposed metal frame shown. The prosthesis or implant 70 can take any number of different forms. Although specific examples of frames for the prosthesis are shown in FIG. 3A, it is understood that other designs and frame configurations may be used, including those disclosed in this application. The implant 70 can include one or more sets of anchors, such as a distal (or ventricular) anchor 80 that extends proximally when the prosthesis frame is in an expanded configuration, and a proximal (or atrial) anchor 82 that extends distally when the prosthesis frame is in an expanded configuration. The prosthesis can further include a strut 72 that can be interrupted at a mushroom-shaped tab 74 at the first end 301. Further consideration can be found in U.S. Patent Application Publication No. 2015 / 0328000 (A1), issued Nov. 19, 2015, which is hereby incorporated by reference in its entirety.

[0032] In some embodiments, the delivery system 10 can be used in conjunction with a replacement aortic valve, as shown in FIG. 3B. In some embodiments, the delivery system 10 may be modified to support and deliver a replacement aortic valve. However, the procedures and structures discussed below can be used equally well for replacement mitral valves and replacement aortic valves.

[0033] Additional details and example designs of the prosthesis are described in U.S. Patent No. 8,403,983, U.S. Patent No. 8,414,644, U.S. Patent No. 8,652,203, U.S. Patent Application Publication No. 2011 / 0313515, U.S. Patent Application Publication No. 2012 / 0215303, U.S. Patent Application Publication No. 2014 / 0277390, U.S. Patent Application Publication No. 2014 / 0277422, U.S. Patent Application Publication No. 2014 / 0277427, U.S. Patent Application Publication No. 2018 / 0021129, and U.S. Patent Application Publication No. 2018 / 0055629, the entireties of which are hereby incorporated by reference and made a part of this specification. Further details and embodiments of the replacement heart valve and prosthesis, and methods therefor for implantation, are described in U.S. Patent Application Publication No. 2015 / 0328000 and U.S. Patent Application Publication No. 2016 / 0317301, the entireties of each of which are hereby incorporated by reference and made a part of this specification.

[0034] Delivery system 10 can be relatively flexible. In some embodiments, delivery system 10 is particularly suitable for delivering a replacement heart valve to the location of the mitral valve through a transseptal approach (e.g., via a transseptal puncture between the right atrium and the left atrium). However, delivery system 10 can be suitable for delivering a replacement heart valve to the location of the tricuspid valve, among other locations.

[0035] As shown in FIG. 1, the delivery system 10 can include a shaft assembly or elongate shaft 12 having a proximal end 11 and a distal end 13, with a handle 14 coupled to the proximal end of the elongate shaft 12. The elongate shaft 12 can be used to hold an implant for advancing the implant 70 to a treatment site through the vasculature. The delivery system 10 can further include a relatively rigid continuous (or one-piece) sheath 51 surrounding the elongate shaft 12 that can prevent unwanted movement of the elongate shaft 12. The continuous sheath 51 can be attached at the proximal end of the elongate shaft 12 proximal to the handle 14, for example, at a sheath hub. The elongate shaft 12 can include an implant holding region 16 (shown in FIGS. 2A-2B, where FIG. 2A shows the implant 70 and FIG. 2B shows the implant 70 removed) at its distal end that can be used for this purpose. In some embodiments, the elongate shaft 12 can hold an expandable prosthesis in a compressed state in the implant holding region 16 for advancing the implant 70 within the body. The elongate shaft 12 can then be used to allow controlled expansion of the implant 70 at the treatment site. In some embodiments, the elongate shaft 12 can be used to allow continuous controlled expansion of the implant 70, as will be discussed in detail below. The implant holding region 16 is shown at the distal end of the delivery system 10 in FIGS. 2A-2B, but can be in other locations. In some embodiments, the implant 70 can be rotated within the implant holding region 16, for example, through rotation of the inner shaft assembly 18 discussed herein.

[0036] As shown in the cross-sectional views of FIGS. 2A-2B, the distal end of the delivery system 10 can include one or more secondary assemblies such as an outer sheath assembly 22, an intermediate shaft assembly 21, a rail assembly 20, an inner shaft assembly 18, and a nose cone assembly 31 as described in more detail below. In some embodiments, the delivery system 10 may not have any of the assemblies disclosed herein. For example, in some embodiments, the complete intermediate shaft assembly may not be incorporated into the delivery system 10. In some embodiments, the assemblies disclosed below may be in a radial order different from that considered.

[0037] Specifically, embodiments of the disclosed delivery system 10 may utilize a longitudinal rail within the rail assembly 20 to manipulate the distal end of the delivery system 10, thereby enabling the implant to be properly positioned within the patient's body. As will be discussed in more detail below, the steerable rail can be, for example, a rail shaft that extends through the delivery system 10 from the handle 14 generally to the distal end. In some embodiments, the steerable rail has a distal end that terminates proximal to the implant holding region 16. The user can manipulate the bending action of the distal end of the rail, thereby bending the rail in a specific direction. In a preferred embodiment, the rail has two or more bends along its length, thereby providing multiple directions of bending. When the rail bends, it presses against other assemblies and causes them to bend as well, such that the other assemblies of the delivery system 10 are configured to move with the rail as a corresponding single unit, thus providing sufficient steerability of the distal end of the delivery system 10.

[0038] Once the rail is maneuvered to a specific location within the patient's body, the implant 70 can be advanced along or relative to the rail via movement of other sheaths / shafts relative to the rail and released into the body. For example, the rail can be bent to a desired location within the body, such as to direct the implant 70 towards the native mitral valve. Other assemblies (e.g., outer sheath assembly 22, intermediate shaft assembly 21, inner assembly 18, and nose cone assembly 31) can passively follow the bend in the rail. Further, while maintaining the implant 70 in a compressed position without releasing or expanding the implant 70 (e.g., within the implant retention region 16), other assemblies (e.g., outer sheath assembly 22, intermediate shaft assembly 21, inner assembly 18, and nose cone assembly 31) can be advanced together relative to the rail (e.g., relatively together, in sequence with one actuator, simultaneously, almost simultaneously, at once, exactly once). The other assemblies (e.g., outer sheath assembly 22, intermediate shaft assembly 21, inner assembly 18, and nose cone assembly 31) can be advanced distally or proximally relative to the rail. In some embodiments, only the outer sheath assembly 22, intermediate shaft assembly 21, and inner assembly 18 are advanced together over the rail. Thus, the nose cone assembly 31 may remain in the same position. To release the implant 70 from the implant retention region 16, the assemblies can be translated relative to the inner assembly 18, individually, sequentially, or simultaneously.

[0039] Figure 2C shows the sheath assembly and, more particularly, shows the outer sheath assembly 22 translating distally integrally along the rail assembly 20, the intermediate shaft assembly 21, the inner shaft assembly 18, and the nose cone assembly 31. Further details regarding the assembly are provided below. In some embodiments, the outer sheath assembly 22, the intermediate shaft assembly 21, the inner shaft assembly 18, and the nose cone assembly 31 translate together (e.g., relative to one another, in sequence with one actuator, simultaneously, almost simultaneously, at once, strictly at once). This distal translation may occur while the implant 70 remains in the compressed configuration within the implant retention region 16.

[0040] As shown in FIGS. 2A-2C and further shown in FIGS. 4-8, starting with the outermost assembly, the delivery system can include an outer sheath assembly 22 that forms a radially outer cover, or sheath, that surrounds the implant retention region 16 and prevents the implant from expanding radially. Specifically, the outer sheath assembly 22 can prevent the radial expansion of the distal end of the implant from expanding radially. Moving radially inward, the intermediate shaft assembly 21 can be composed of an intermediate shaft hypotenuse 43 whose distal end is attached to an outer retaining member or outer retaining ring 42 for radially holding a part of a prosthesis, such as the proximal end of the implant 70, in a compressed configuration. The intermediate shaft assembly 21 can be disposed within the lumen of the outer sheath assembly 22. Moving further inward, the rail assembly 20 can be configured for maneuverability as described above and further described below. The rail assembly 20 can be disposed within the lumen of the intermediate shaft assembly 21. Moving further inward, the inner shaft assembly 18 can be composed of an inner shaft whose distal end is attached to an inner retaining member or inner retaining ring 40 (such as a PEEK ring) for axially maintaining the proximal end of the prosthesis, for example, the prosthesis. The inner shaft assembly 18 can be disposed within the lumen of the rail assembly 20. Further, the innermost radially assembly can be a nose cone assembly 31 that includes a nose cone shaft 27 having its distal end connected to the nose cone 28. The nose cone 28 can have a tapered tip. The nose cone assembly 31 is preferably disposed within the lumen of the inner shaft assembly 18. The nose cone assembly 31 can include a lumen for a guide wire to pass through it.

[0041] The elongated shaft 12, and more particularly the nose cone assembly 31, the inner assembly 18, the rail assembly 20, the intermediate shaft assembly 21 and the outer sheath assembly 22 can be configured together to deliver the implant 70 positioned within the implant retention region 16 (shown in FIG. 2A) to the treatment site. One or more of the secondary assemblies can then be moved to enable the implant 70 to be released at the treatment site. For example, one or more of the secondary assemblies can be movable relative to one or more of the other secondary assemblies. The handle 14 can comprise various control mechanisms that can be used to control the movement of the various secondary assemblies, as will be described in more detail below. Thus, the implant 70 can be controllably loaded onto the delivery system 10 and then deployed within the body. Further, the handle 14 can provide steering with respect to the rail assembly 20 and enable flexion / bending / steering of the distal end of the delivery system 10.

[0042] As discussed below, the inner retaining member 40, the outer retaining ring 42, and the outer sheath assembly 22 can cooperate to hold the implant 70 in a compact configuration. The inner retaining member 40 is shown engaged with the strut 72 at the proximal end 301 of the implant 70 in FIG. 2A. For example, slots located between radially extending teeth on the inner retaining member 40 can receive and engage struts 72 that may terminate in mushroom-shaped tabs on the proximal end of the implant 70. The intermediate shaft assembly 21 can be positioned over the inner retaining member 40 such that the first end 301 of the implant 70 is captured between the inner retaining member 40 and the outer retaining ring 42, thereby securing it to the delivery system 10 between the intermediate shaft assembly 21 and the inner retaining member 40. The outer sheath assembly 22 can be positioned to cover the second end 303 of the implant 70.

[0043] The outer retaining member 42 may be attached to the distal end of an intermediate shaft hypodermic tube 43 that can be attached to the proximal tube 44 at its proximal end, and the proximal tube can be attached to the handle 14 at its proximal end. The outer retaining member 42, when in the compressed position, can provide additional stability to the implant 70. The proximal end of the implant 70 can be captured therebetween and the outer retaining member 42 can be positioned over the inner retaining member 40 to securely attach it to the delivery system 10. The outer retaining member 42 can surround a portion of the implant 70, specifically the first end 301, and thus can prevent the implant 70 from expanding. Further, the intermediate shaft assembly 21 can be translated proximally relative to the inner assembly 18 into the outer sheath assembly 22, and thus can expose the first end 301 of the implant 70 held within the outer retaining member 42. In this manner, the outer retaining member 42 can be used to assist in fixing the implant 70 or in releasing it from the delivery system 10. The outer retaining member 42 can have a cylindrical or elongated tubular shape and may be referred to as an outer retaining ring, but is not limited to a particular shape.

[0044] As shown in FIG. 2A, the distal anchor 80 can be positioned in the delivery configuration and generally points distally (as shown, axially away from the main body of the prosthesis frame and away from the handle of the delivery system). The distal anchor 80 can be restrained in this delivery configuration by the outer sheath assembly 22. Thus, when the outer sheath 22 is pulled proximally, the distal anchor 80 can reverse its position (e.g., bend approximately 180 degrees) to the deployed configuration (e.g., generally pointing proximally). FIG. 2A also shows a proximal anchor 82 extending distally in its delivery configuration within the outer sheath assembly 22. In other embodiments, the distal anchor 80 can be held to generally point proximally in the delivery configuration and can be pressed against the body of the prosthesis frame.

[0045] Delivery system 10 may be provided to the user with implant 70 pre-introduced. In other embodiments, implant 70 may be loaded into the delivery system by a physician or nurse, for example, immediately prior to use.

[0046] Figures 4-8 show further views of delivery system 10 in which different assemblies are translated proximally and described in detail.

[0047] Beginning with the outermost assembly shown in FIG. 4, outer sheath assembly 22 can include an outer proximal shaft 102 directly attached to handle 14 at its proximal end and an outer hypodermic tube 104 attached at its distal end. Capsule 106 can then be attached at approximately the distal end of outer hypodermic tube 104. In some embodiments, capsule 106 can be sized 28 French or less. These components of outer sheath assembly 22 can form a lumen for other secondary assemblies to pass through.

[0048] The capsule 106 can be disposed at the distal end of the outer proximal shaft 102. The capsule 106 can be a tube formed of a plastic or metallic material. In some embodiments, the capsule 106 is formed of ePTFE or PTFE. In some embodiments, this capsule 106 is relatively thick to prevent tearing and help maintain the self-expanding implant in a compact configuration. In some embodiments, the material of the capsule 106 is the same material as the coating on the outer hypotube 104. As shown, the capsule 106 can have a diameter larger than the outer hypotube 104, but in some embodiments, the capsule 106 may have a diameter similar to the hypotube 104. In some embodiments, the capsule 106 may include a distal portion of larger diameter and a proximal portion of smaller diameter. In some embodiments, there may be a step or taper between the two portions. The capsule 106 can be configured to hold the implant 70 in a compressed position within the capsule 106. Further details of the structure of the capsule 106 are discussed below.

[0049] The outer sheath assembly 22 is configured to be slidable relative to the other assemblies individually. Further, the outer sheath assembly 22 can slide distally and proximally relative to the rail assembly 20 together with the intermediate shaft assembly 21, the inner assembly 18, and the nose cone assembly 31.

[0050] Moving radially inward, the next assembly is the intermediate shaft assembly 21. FIG. 5 is a view similar to FIG. 4, but with the outer sheath assembly 22 removed, thereby exposing the intermediate shaft assembly 21.

[0051] The intermediate shaft assembly 21 is an intermediate shaft hypo tube 43 that is generally mounted on the intermediate shaft proximal tube 44 at its proximal end, and the intermediate shaft proximal tube 44 can be mounted on the handle 14 at its proximal end. The intermediate shaft hypo tube 43 and an outer retaining ring 42 disposed at the distal end of the intermediate shaft hypo tube 43 can be included. Thus, the outer retaining ring 42 can be generally mounted at the distal end of the intermediate shaft hypo tube 43. These components of the intermediate shaft assembly 21 can form a lumen for other secondary assemblies to pass through.

[0052] As discussed with respect to FIG. 2A, the outer retaining ring 42 can be configured as a prosthesis retaining mechanism for use in engaging the implant 70. For example, the outer retaining ring 42 can be a ring or cover configured to radially cover the struts 72 on the implant 70. The outer retaining ring 42 can also be considered a part of the implant retaining region 16 and can be at the proximal end of the implant retaining region 16. With the struts or other parts of the implant 70 engaged with the inner retaining member 40 as discussed below, the outer retaining ring 42 can cover both the implant 70 and the inner retaining member 40 to fix the implant 70 on the delivery system 10. Thus, the implant 70 can be sandwiched between the inner retaining member 40 of the inner shaft assembly 18 and the outer retaining ring 42 of the intermediate shaft assembly 21.

[0053] The intermediate shaft assembly 21 is arranged to be slidable individually relative to other assemblies. Further, the intermediate shaft assembly 21 can slide distally and proximally relative to the rail assembly 20 together with the outer sheath assembly 22, the inner assembly 18, and the nose cone assembly 31.

[0054] Next, the radially inner side of the intermediate shaft assembly 21 is the rail assembly 20. FIG. 6A shows approximately the same view as FIG. 5, but with the intermediate shaft assembly 21 removed, thereby exposing the rail assembly 20. FIG. 6B further shows a cross-sectional view of the rail assembly 20 to view the tension wire. The rail assembly 20 can include a rail shaft 132 (or rail) that is generally attached to the handle 14 at its proximal end. The rail shaft 132 can be composed of a rail proximal shaft 134 directly attached to the handle at the proximal end and a rail hypotenuse 136 attached to the distal end of the rail proximal shaft 134. The rail shaft 132 can include a proximal rail shaft portion 603 and a distal rail shaft portion 601. The rail hypotenuse 136 can further include a non-invasive rail tip at its distal end. Further, the distal end of the rail hypotenuse 136 can abut against the proximal end of the inner holding member 40 as shown in FIG. 6A. In some embodiments, the distal end of the rail hypotenuse 136 may be spaced apart from the inner holding member 40. These components of the rail shaft assembly 20 can form a lumen for other secondary components to pass through.

[0055] As shown in FIG. 6B, one or more tension wires that can be used to apply a force to the rail hypotenuse 136 and maneuver the rail assembly 20 are attached to the inner surface of the rail hypotenuse 136. The tension wire can extend distally from the knob of the handle 14 to the rail hypotenuse 136, which will be discussed below. In some embodiments, the tension wire can be attached at different longitudinal locations on the rail hypotenuse 136, thereby providing multiple bending locations within the rail hypotenuse 136 and enabling multi-dimensional maneuvering.

[0056] In some embodiments, the distal tension wire 138 can extend to the distal region of the rail hypo tube 136, and the two proximal tension wires 140 can extend to the proximal region of the rail hypo tube 136, although other numbers of tension wires may be used and the specific number of tension wires is not limiting. For example, two tension wires may extend to a distal location, and a single tension wire may extend to a proximal location. In some embodiments, the ring-shaped structure mounted inside the rail hypo tube 136 is known as a tension wire connector and can be used as a mounting location for the tension wires, such as the proximal ring 137 and the distal ring 135. In some embodiments, the rail assembly 20 includes the distal tension wire connector 135 and may include the proximal tension wire connector 137. In some embodiments, the tension wire may be directly connected to the inner surface of the rail hypo tube 136.

[0057] The distal tension wire 138 can be connected (either directly or via a connector 135) at the distal end of the rail hypotenuse 136. The proximal tension wire 140 can be connected (either directly or via a connector 137) at approximately 1 / 4, 1 / 3, or 1 / 2 of the length from the proximal end to the rail hypotenuse 136. In some embodiments, the distal tension wire 138 can pass through a small-diameter tension wire lumen 139 (e.g., a tube, hypotenuse, cylinder) mounted inside the rail hypotenuse 136. This can prevent the wire 138 from pulling on the rail hypotenuse 136 at a location proximal to the distal connection. Further, the lumen 139 can strengthen the proximal portion of the rail hypotenuse 136 and act as a compression coil to prevent unwanted bending. Thus, in some embodiments, the lumen 139 is disposed only in the proximal half portion of the rail hypotenuse 136. In some embodiments, multiple longitudinally spaced or longitudinally adjacent lumens 139 may be used for each distal wire 138. In some embodiments, a single lumen 139 is used for each distal wire 138. In some embodiments, the lumen 139 can extend into the distal half of the rail hypotenuse 136. In some embodiments, the lumen 139 is mounted on the outer surface of the rail hypotenuse 136. In some embodiments, the lumen 139 is not used.

[0058] With respect to the pair of proximal pull wires 140, the wires can be spaced approximately 180° from each other to enable steering in both directions. Similarly, when a pair of distal pull wires 138 is used, the wires can be spaced approximately 180° from each other to enable steering in both directions. In some embodiments, the pair of distal pull wires 138 and the pair of proximal pull wires 140 can be spaced approximately 90° from each other. In some embodiments, the pair of distal pull wires 138 and the pair of proximal pull wires 140 may be spaced approximately 0° from each other. However, other locations for the pull wires can be used as well, and the specific location of the pull wires is not limited. In some embodiments, the distal pull wire 138 can pass through a lumen 139 that is disposed within the lumen of the rail hypotenuse 136. This can prevent an axial force on the distal pull wire 138 from forming a bend within the proximal region of the rail hypotenuse 136.

[0059] FIG. 6C shows an embodiment in which the position of the proximal pull wire 140 has moved 180° from the position shown in FIG. 6B. The position of the proximal pull wire 140 shown in FIG. 6C can bend the proximal portion of the rail hypo tube 136 in a direction opposite to the direction possible in FIG. 6B. For example, in the embodiment of FIG. 6B, when the distal portion of the rail hypo tube 136 is deflected downward by the pull of the distal pull wire 138, the proximal portion of the rail hypo tube 136 can be deflected leftward with respect to the downward direction (when looking from the proximal end of the rail hypo tube 136 toward the distal end of the rail hypo tube 136). However, in the embodiment of FIG. 6C, when the distal portion of the rail hypo tube 136 is deflected downward by the pull of the distal pull wire 138, the proximal portion of the rail hypo tube 136 can be deflected rightward with respect to the downward direction (when looking from the proximal end of the rail hypo tube 136 toward the distal end of the rail hypo tube 136). Such a change can deflect the proximal portion of the rail hypo tube 136 and thus the elongate shaft 12 in a direction opposite to the direction possible in the embodiment shown in FIG. 6B. The thickness of the cut in the rail shaft 132 may also be varied to allow deflection in the opposite direction.

[0060] The rail assembly 20 is arranged to be slidable over the inner shaft assembly 18 and the nose cone assembly 31. In some embodiments, the outer sheath assembly 22, the intermediate shaft assembly 21, the inner shaft assembly 18, and the nose cone assembly 31 may be configured to slide together along or relative to the rail assembly 20, such as in the proximal and distal directions, with or without bending of the rail assembly 20. In some embodiments, the outer sheath assembly 22, the intermediate shaft assembly 21, the inner shaft assembly 18, and the nose cone assembly 31 may be configured to hold the implant 70 in the compressed position when they slide simultaneously along or relative to the rail assembly 20.

[0061] Moving radially inward, the next assembly is the inner shaft assembly 18. FIG. 7 shows a view almost identical to FIG. 6A, but with the rail assembly 20 removed, thereby exposing the inner shaft assembly 18.

[0062] The inner shaft assembly 18 can include an inner shaft 122 generally attached to the handle 14 at its proximal end and an inner retaining ring 40 located at the distal end of the inner shaft 122. The inner shaft 122 itself can be composed of an inner proximal shaft 129 directly attached to the handle 14 at its proximal end and a distal section 126 attached to the distal end of the inner proximal shaft 129. Thus, the inner retaining ring 40 can be generally attached to the distal end of the distal section 126. These components of the inner shaft assembly 18 can form a lumen for other secondary assemblies to pass through.

[0063] The inner retaining member 40 can be configured as a prosthesis retaining mechanism for use in engaging the implant 70, as discussed with respect to FIG. 2A. For example, the inner retaining member 40 can be a ring and can include a plurality of slots configured to engage struts 72 on the implant 70. The inner retaining member 40 may also be configured as part of the implant retaining region 16 and may be at the proximal end of the implant retaining region 16. With the struts or other portions of the implant 70 engaged with the inner retaining member 40, the outer retaining ring 42 can cover both the prosthesis and the inner retaining member 40 to secure the prosthesis on the delivery system 10. Thus, the implant 70 can be sandwiched between the inner retaining member 40 of the inner shaft assembly 18 and the outer retaining ring 42 of the intermediate shaft assembly 21.

[0064] The inner shaft assembly 18 is arranged to be slidable individually with respect to other assemblies. Further, the inner shaft assembly 18 can slide distally and proximally with respect to the rail assembly 20 together with the outer sheath assembly 22, the intermediate shaft assembly 21, and the nose cone assembly 31.

[0065] Moving further inward from the inner shaft assembly 18, there is a nose cone assembly 31, also seen in FIG. 8. This may be a nose cone shaft 27, and in some embodiments, may have a nose cone 28 on its distal end. The nose cone 28 can be made of polyurethane for non-traumatic entry and to minimize damage to the venous vasculature. The nose cone 28 can also be radiopaque to provide visibility under fluoroscopy.

[0066] The nose cone shaft 27 is sized to slidably receive a guide wire and may include a lumen configured such that the delivery system 10 can be advanced over the guide wire through the vasculature. However, embodiments of the system 10 contemplated herein may not use a guide wire, and thus the nose cone shaft 27 can be solid. The nose cone shaft 27 may be connected from the nose cone 28 to the handle or may be formed of different parts such as other assemblies. Further, the nose cone shaft 27 may be formed of different materials such as plastic or metal as described in detail above.

[0067] In some embodiments, the nose cone shaft 27 includes a guide wire shield 1200 located in a portion of the nose cone shaft 27.

[0068] The nose cone assembly 31 is slidably disposed individually relative to other assemblies. Further, the nose cone assembly 31 can slide proximally and distally relative to the rail assembly 20 together with the outer sheath assembly 22, the intermediate shaft assembly 21, and the inner assembly 18.

[0069] In some embodiments, one or more spacer sleeves (not shown) can be used between different assemblies of the delivery system 10. For example, the spacer sleeve can be concentrically disposed between the intermediate shaft assembly and the rail assembly 20, generally between the intermediate 43 and the rail hypotenuse 136. In some embodiments, the spacer sleeve can be generally embedded within the hypotenuse 43 of the intermediate shaft assembly 21, such as on the inner surface of the intermediate shaft assembly 21. In some embodiments, the spacer sleeve may be concentrically disposed between the rail assembly 20 and the inner assembly 18, generally within the rail hypotenuse 136. In some embodiments, the spacer sleeve may be used between the outer sheath assembly 22 and the intermediate shaft assembly 21. In some embodiments, the spacer sleeve may be used between the inner shaft assembly 18 and the nose cone assembly 31. In some embodiments, four, three, two, or one of the spacer sleeves listed above may be used. The spacer sleeve can be used in any of the above positions.

[0070] As discussed above, the outer sheath assembly 22, the intermediate shaft assembly 21, the inner assembly 18, and the rail assembly 20 can each accommodate the outer hypotenuse 104, the intermediate shaft hypotenuse, the distal region 126, and the rail hypotenuse 136, respectively. Each of these hypotenuses / regions / shafts is laser cut to include a number of slots, thereby forming a bending path for the delivery system to follow.

[0071] For example, FIG. 9 shows an embodiment of the rail hypochannel 136. The rail hypochannel 136 can also include several circumferential slots. The rail hypochannel 136 can be generally divided into several different regions. At the most proximal end, there is a hypochannel region 231 that is not cut (or slotted). Moving distally, the next region is the proximal slotted hypochannel region 233. This region includes several circumferential slots cut into the rail hypochannel 136. Generally, two slots are cut around each circumferential location that forms approximately half of the circumference. Thus, two backbone-like portions are formed between the slots that extend completely along the length of the hypochannel 136. This is the region that can be guided by the proximal pull wire 140. Moving further distally, it is the location 237 where the proximal pull wire 140 connects, whereby the slots can be avoided. This region is just distal to the region with slots in the proximal direction.

[0072] Following the proximal pull wire connection region in the distal direction, there is a distal slotted hypotube region 235. This region is similar to the proximal slotted hypotube region 233, but has significantly more slots cut to an equivalent length. Thus, the region 235 slotted in the distal direction provides easier flexion than the hypotube region 233 slotted in the proximal direction. The proximal slotted hypotube region 233 and the distal slotted region 235 may include the bent portion of the rail shaft. In some embodiments, the proximal slotted hypotube region 233 can be configured to undergo a bend of approximately 90 degrees with a radius of 1 / 2 inch, while the distal slotted region 235 can bend approximately 180 degrees within a range of 1 / 2 inch. Further, as shown in FIG. 9, the hypotube region 235 slotted in the distal direction is offset from the backbone portion of the hypotube region 233 slotted in the proximal direction. Thus, the two regions will achieve different bending patterns and enable three-dimensional manipulation of the rail assembly 20. In some embodiments, the backbone portion can be offset by 30 degrees, 45 degrees, or 90 degrees, but the specific offset is not limiting. In some embodiments, the proximal slotted hypotube region 233 can include a compression coil. This allows the proximal slotted hypotube region 233 to retain rigidity for the unique flexion of the distal slotted region 235.

[0073] At the most distal end of the distal slotted hypotube region 235, there is a distal pull wire connection region 241, which is also a region without slots in the rail hypotube 136.

[0074] The handle 14 is disposed at the proximal end of the delivery system 10. An embodiment of the handle 14 is shown in FIG. 10. A cross-section of the handle 14 is shown in FIG. 11. The handle 14 may include several actuators such as a rotatable knob that can manipulate different components of the delivery system 10. The operation of the handle 14 is described in relation to the delivery of the replacement valve prosthesis or implant 70, but the handle 14 and the delivery system 10 can also be used to deliver other devices.

[0075] The handle 14 generally consists of two housings, namely a rail housing 202 and a delivery housing 204, and the rail housing 202 is disposed around the periphery of the delivery housing 204. The inner surface of the rail housing 202 may comprise a screwing area configured to engage with the outer surface of the delivery housing 204. Thus, the delivery housing 204 is configured to slide (e.g., twist) within the rail housing 202, as will be described in more detail later. The rail housing 202 generally surrounds about half of the length of the delivery housing 204, and thus the delivery housing 204 extends both proximally and distally outside the rail housing 202.

[0076] The rail housing 202 can accommodate two rotatable knobs, namely, a distal pull wire knob 206 and a proximal pull wire knob 208. However, the number of rotatable knobs in the rail housing 202 may vary depending on the number of pull wires used. Rotation of the distal pull wire knob 206 provides a proximal force, thereby providing an axial tension to the distal pull wire 138 and enabling bending of the distal slotted region of the rail hypo tube 136. The distal pull wire knob 206 can be rotated in either direction, allowing bending in either direction, thereby controlling the anterior-posterior angle. Rotation of the proximal pull wire knob 208 provides a proximal force, thereby providing an axial tension to the proximal pull wire 140 and enabling bending of the proximal slotted region 133 of the rail hypo tube 136, thereby controlling the medial-lateral angle. The proximal pull wire knob 208 can be rotated in either direction and allows bending in either direction. Thus, when both knobs are actuated, two bends can be made in the rail hypo tube 136, thereby enabling three-dimensional maneuvering of the rail shaft 132 and, by extension, three-dimensional maneuvering of the distal end of the delivery system 10. Further, the proximal end of the rail shaft 132 is connected at the inner surface of the rail housing 202.

[0077] Bending of the rail shaft 132 can be used to position the system, specifically the distal end, at a desired location of the patient, such as in a native tricuspid valve. In some embodiments, rotation of the pull wire knobs 206 / 208 can assist in maneuvering the distal end of the delivery system 10 to a desired position proximal to the valve being treated, such as the tricuspid valve or the mitral valve.

[0078] Upon moving to the delivery housing 204, the proximal ends of the inner shaft assembly 18, the outer sheath assembly 22, the intermediate shaft assembly 21, and the nose cone shaft assembly 31 can be connected to the inner surface of the delivery housing 204 of the handle 14. Thus, they can move axially with respect to the rail assembly 20 and the rail housing 202.

[0079] The rotatable outer sheath knob 210 can be disposed at the distal end of the delivery housing 204 and is distal to the rail housing 202. Rotation of the outer sheath knob 210 pulls the outer sheath assembly 22 proximally in the axial direction, thereby pulling the capsule 106 away from the implant 70 and releasing the distal end 303 of the implant 70. Thus, the outer sheath assembly 22 can be translated individually relative to the other shafts in the delivery system 10. The distal end 303 of the implant 70 can be released first, while the proximal end 301 of the implant 70 can remain radially compressed between the inner retaining member 40 and the outer retaining member 42.

[0080] The rotatable intermediate shaft knob 214 can be disposed in the delivery housing 204 proximal to the rotatable outer sheath knob 210 in some embodiments and is distal to the rail housing 202. Rotation of the intermediate shaft knob 214 pulls the intermediate shaft assembly 21 proximally in the axial direction, thus pulling the outer retaining ring 42 away from the implant 70 and removing the cover of the inner retaining member 40 and the proximal end 301 of the implant 70, thereby releasing the implant 70. Thus, the intermediate shaft assembly 21 can be translated individually relative to the other shafts in the delivery system 10.

[0081] Disposed at the proximal end of the delivery housing 204 and thus proximal to the rail housing 202 can be a rotatable depth knob 212. When the depth knob 212 is rotated, the entire delivery housing 204 moves distally or proximally relative to the rail housing 202 which remains in the same place. Thus, the distal end of the delivery system 10, the inner shaft assembly 18, the outer sheath assembly 22, the intermediate shaft assembly 21, and the nose cone shaft assembly 31 move together (e.g., simultaneously) proximally or distally relative to the rail assembly 20, while the implant 70 remains in the compressed configuration. In some embodiments, actuation of the depth knob 212 can continuously move the inner shaft assembly 18, the outer sheath assembly 22, the intermediate shaft assembly 21, and the nose cone shaft assembly 31 relative to the rail assembly 20. In some embodiments, actuation of the depth knob 212 can move the inner shaft assembly 18, the outer sheath assembly 22, and the intermediate shaft assembly 21 together relative to the rail assembly 20. Thus, the rail shaft 132 can be aligned in a particular direction and the other assemblies can move distally or proximally relative to the rail shaft 132 to ultimately position without releasing the implant 70. The components can be advanced approximately 1 cm, 2 cm, 3 cm, 5 cm, 6 cm, 7 cm, 8 cm, 9 cm, or 10 cm along the rail shaft 132. The components can be advanced beyond approximately 1 cm, 2 cm, 3 cm, 5 cm, 6 cm, 7 cm, 8 cm, 9 cm, or 10 cm along the rail shaft 132. An example of this is shown in FIG. 2C. Thus, the capsule 106 and the outer retaining ring 42 can be individually retracted relative to the inner assembly 18, in some embodiments continuously, as detailed above, releasing the implant 70. Thus, assemblies other than the rail assembly 20 can be retracted to return across the rail shaft 132 by rotating the depth knob 212 in the opposite direction.

[0082] The handle 14 may further comprise a mechanism (knob, button, handle) 216 for moving the nose cone shaft 27 and, by extension, the nose cone 28. For example, the knob 216 may be a part of the nose cone assembly 31 extending from the proximal end of the handle 14. Thus, the user can pull or push the knob 216 to translate the nose cone shaft 27 distally or proximally relative to the other shafts. This can be advantageous for translating the nose cone 28 proximally into the outer sheath assembly 22 / capsule 106 and thus facilitating retraction of the delivery system 10 from the patient.

[0083] In some embodiments, the handle 14 can provide a locking portion 218, such as a spring latch, to prevent translation of the nose cone shaft 27 by the knob 216 detailed above. In some embodiments, the locking portion 218 can be always actuated, and thus the nose cone shaft 27 does not move unless the user disengages the locking portion 218. The locking portion can be, for example, a spring latch that is always engaged until a button 218 in the handle 14 is pressed, thereby releasing the spring latch and allowing the nose cone shaft 27 to be translated proximally / distally. In some embodiments, the spring latch 218 allows movement of the nose cone shaft 27 in one direction and prevents movement in the opposite direction with either proximal or distal movement.

[0084] The handle 14 may further include a communication flush port for flushing different lumens of the delivery system 10. In some embodiments, a single flush port in the handle 14 may provide fluid connection to multiple assemblies. In some embodiments, the flush port may provide fluid connection to the outer sheath assembly 22. In some embodiments, the flush port may provide fluid connection to the outer sheath assembly 22 and the intermediate shaft assembly 21. In some embodiments, the flush port may provide fluid connection to the outer sheath assembly 22, the intermediate shaft assembly 21, and the rail assembly 20. In some embodiments, the flush port may provide fluid connection to the outer sheath assembly 22, the intermediate shaft assembly 21, the rail assembly 20, and the inner assembly 18. Thus, in some embodiments, the rail shaft 132, the outer retaining ring 42, and the capsule 106 can all be flushed by a single flush port.

[0085] FIG. 12A is a side view of the distal portion of the elongate shaft 12 with the elongate shaft 12 in a straight configuration. The capsule 106 is shown positioned between the outer hypotube 104 and the nose cone 28.

[0086] The elongated shaft 12 can comprise one or more bending portions that can bend the elongated shaft 12 at the bending portions. In the embodiment shown in FIG. 12A, for example, the elongated shaft 12 comprises two bending portions 600, 602. The bending portion 600 can correspond to the distal rail portion 601 shown in FIGS. 6B and 6C, and the bending portion 602 can correspond to the proximal rail portion 603 shown in FIGS. 6B and 6C. Thereby, the bending portions 600, 602 can be configured to bend the elongated shaft 12 in planes that are not perpendicular to each other, the bending portion 600 can bend in a plane that can be called a vertical plane, and the bending portion 602 can bend in a plane that can be called a horizontal plane accordingly. The bending portions 600, 602 can be configured to bend to orient the capsule 106 at a desired position for deployment of the implant 70 housed in the capsule 106.

[0087] The capsule 106 (and the implant holding region 16 housed in the capsule 106) can be configured to slide relative to the bending portions 600, 602 in the manner disclosed herein. For example, the outer sheath assembly 22, the intermediate shaft assembly 21, the inner shaft assembly 18, and the nose cone assembly 31 can be configured to slide relative to the bending portions 600, 602 (as part of the rail assembly 20) to vary the distance or depth of the capsule 106 from the rail assembly 20. The outer sheath assembly 22 can be configured to slide relative to the rail assembly 20 to vary the distance of the implant holding region from the patient's tricuspid valve.

[0088] Referring to FIG. 12B, the bending portion 600 positioned proximally to the capsule 106 and positioned between the capsule 106 and the bending portion 602 is shown to deflect the distal end of the elongated shaft 12 in a certain direction (which may be referred to as the downward direction as shown in FIG. 12B). The bending portion 600 deflects the distal end of the elongated shaft 12 in a plane (which may be referred to as a vertical plane). The bending portion 600 accordingly changes the orientation of the capsule 106, the distal end of the elongated shaft 12, and the implant holding region 16 positioned within the capsule 106.

[0089] FIG. 12C shows a top view of the elongated shaft 12 shown in FIGS. 12A and 12B when the bending portion 602 is bent. In FIG. 12C, the bending portion 602 positioned proximally to the bending portion 600 is shown to deflect the distal end of the elongated shaft 12 in a certain direction (which may be referred to as the right direction as shown in FIG. 12C). The bending portion 602 deflects the distal end of the elongated shaft 12 in a plane (which may be referred to as a horizontal plane). The bending portion 602 accordingly changes the orientation of the capsule 106, the distal end of the elongated shaft 12, and the implant holding region 16 positioned within the capsule 106.

[0090] Accordingly, the bending portion 602 can deflect the bending portion 600 and the capsule 106 in a plane perpendicular to the plane in which the bending portion 600 can deflect the capsule 106. The orthogonal plane of deflection can enable three-dimensional manipulation of the capsule 106.

[0091] The bending portion 602 as shown in FIG. 12C can be configured to deflect the distal end of the elongated shaft 12 in the right direction. Such a direction of deflection can be provided by the configuration of the tension wire shown in FIG. 6C.

[0092] Addition or various movements of the elongate shaft 12 may be desirable. Such addition or various movements may be desirable for various reasons, including various patient anatomical structures that are navigated at the distal end of the elongate shaft 12 or various uses of the elongate shaft 12.

[0093] Figures 13A - 13D illustrate embodiments in which a deflection mechanism may be utilized to provide deflection of a portion of the elongate shaft 12. Referring to Figure 13A, the deflection mechanism may include a sheath 610 that extends over a portion 614 of the elongate shaft 12. The portion 614 of the elongate shaft 12 may include a portion positioned proximal to the bending portion 602 and the bending portion 600. However, in other embodiments, the sheath 610 may extend over another portion of the elongate shaft 12 and, preferably, extends towards the distal end of the elongate shaft 12.

[0094] The sheath 610 is shown in cross - section in Figure 13A and may be configured to deflect to provide deflection of the elongate shaft 12. The sheath may include a control device utilized to control the deflection of the sheath 610. The control device may include a pull - tether 612 as shown in Figure 13A, and the pull - tether 612 may include a pull - wire or other form of tether. In other embodiments, other forms of control devices, such as gears, rails, or other forms of control devices, may be utilized. The pull - tether 612 may be oriented in the elongate shaft 12 such that retraction of the pull - tether 612 can deflect the elongate shaft 12 in a direction towards the pull - tether 612.

[0095] Referring to FIG. 13B, the bending portion 600 deflects the distal end of the elongated shaft 12 in the direction 605 (which may be referred to as the downward direction as shown in FIG. 13B). However, the deflection mechanism deflects the portions 600 and 602 of the bending portions 600 and 602 in the direction 607, which is opposite to the direction 605 in which the bending portion 600 deflects the distal end of the elongated shaft 12, by deflecting a portion 614 of the elongated shaft 12 positioned proximal to the bending portion 600 and the bending portion 602. The deflection mechanism deflects the bending portion 602, the bending portion 600, the capsule 106, the implant holding region 16 housed in the capsule 106, and the nose cone 28 in the direction opposite to the direction in which the bending portion 600 deflects the distal end of the elongated shaft 12. Therefore, the deflection mechanism can be utilized to deflect the elongated shaft 12 to create a height or distance from the distal end of the elongated shaft 12 to a desired implantation site.

[0096] The deflection mechanism deflects a portion 614 of the elongated shaft 12 in the same plane (the same plane) in which the bending portion 600 deflects the distal end of the elongated shaft 12.

[0097] The deflection mechanism may be utilized to bend the respective distal portions of the elongated shaft 12 at the bending portions 600 and 602 in a manner similar to that shown in FIGS. 12A - 12C. Referring to FIG. 13C, for example, the deflection mechanism deflects the proximal portion 614 of the elongated shaft 12, while the bending portion 600 continues to deflect the distal end of the elongated shaft 12 in the direction shown in FIG. 13B, and the bending portion 602 deflects the bending portion 600 in the vertical direction as described with respect to FIG. 12C. The deflection mechanism in the form of the elongated sheath 610 continues to deflect a portion 614 of the elongated shaft 12 proximal to the bending portion 600 and the bending portion 602 to deflect the bending portions 600 and 602 in a direction away from the direction in which the bending portion 600 deflects the distal end of the elongated shaft 12.

[0098] The deflection mechanism can be configured to provide a plurality of deflection directions of a portion 614 of the elongated shaft 12 proximal to the bending portions 600 and 602. For example, the deflection mechanism in the form of the sheath 610 can be configured to rotate around a portion of the elongated shaft 12 where the sheath 610 extends upward. Such rotation can move the position of the tension tether 612 relative to the elongated shaft 12 in order to deflect the elongated shaft 12 towards various positions of the tension tether 612. Thereby, various deflection directions of the elongated shaft 12 can result. For example, FIG. 13D shows a front view of an elongated sheath indicating (via arrows) a plurality of directions opposite to the direction 605 towards which the bending portion 600 can be deflected.

[0099] FIG. 14A shows a perspective view of the sheath 610 extending over the elongated shaft 12. The sheath 610 can be used instead of, or in combination with, the sheath 51 shown in FIG. 1. The sheath 610 can have a distal end 616 and a proximal end 618. The proximal end 618 of the sheath 610 can be coupled to a rotation control housing 620 that can be used to control the rotation of the sheath 610 around the elongated shaft 12. A user, such as a surgeon or other operator, can grip the rotation control housing 620 to control the direction of deflection of the elongated shaft 12 caused by the sheath 610 by controlling the rotation of the sheath 610 around the elongated shaft 12. The proximal end 618 of the sheath 610 can be alternatively or additionally coupled to a deflection control housing 622 that can be used to pull the tension tether 612 proximally to deflect the sheath 610 and can also be used to release the tension tether 612 in the distal direction to straighten the sheath 610. The deflection control housing 622 can be configured such that a user, such as a surgeon or other operator, can grip and control the sheath 610.

[0100] The control housings 620, 622 may be integrated to form a single control housing as desired. In one embodiment, the control of the control housings 620, 622 may be integrated with the handle 14 as desired, or may remain separate from the handle 14.

[0101] Figures 14B - 14D show the deflection mechanism in the form of the sheath 610 rotated 90° about the elongated shaft 12 relative to the position shown in Figure 13A. The sheath 610 can be rotated as desired, either through the use of the rotation control housing 620 or through other means. The relative position of the tension tie cord 612 has rotated 90° as shown in Figure 14D. Referring to Figure 14D, the sheath 610 can deflect the elongated shaft 12 in a direction perpendicular to the direction in which the bend portion 600 deflects the distal end of the elongated shaft 12. The sheath 610 can deflect the elongated shaft 12 in the same plane in which the bend portion 602 deflects a portion of the elongated shaft 12 distal to the bend portion 602.

[0102] The deflection mechanism in the form of the sheath 610 can have various orientations with respect to the elongated shaft 12 at any angular position with respect to the elongated shaft 12 as desired. Thereby, the deflection mechanism in the form of the sheath 610 can be configured to deflect a portion 614 of the elongated shaft 12 in a plurality of directions that may or may not be perpendicular to the direction in which the bend portion 600 deflects the distal end of the elongated shaft 12. The deflection mechanism in the form of the sheath 610 can deflect a portion 614 of the elongated shaft 12 in various directions opposite to the direction in which the bend portion 600 deflects the distal end of the elongated shaft 12, and those various directions can be the direction directly opposite (180°) to the direction in which the bend portion 600 deflects the distal end of the elongated shaft 12, and various other directions (e.g., 135° among many) between the directly opposite (180°) and the perpendicular direction (90°).

[0103] The deflection mechanism in the form of the sheath 610 can be configured to provide such deflection when the sheath 610 is rotated to deflect a portion 614 of the elongate shaft 12 in a direction that is the direction in which the bent portion 600 deflects the distal end of the elongate shaft 12.

[0104] The deflection mechanism in the form of the sheath 610 can not only be configured to change the direction of deflection of the portion 614 via rotation of the sheath 610, but in embodiments, may be configured with a plurality of tension tie cords or other control devices that allow various directions of deflection of the sheath 610 without rotation of the sheath 610. For example, if four equally spaced tension tie cords (spaced 90° from each other) are utilized with the sheath 610, a combination of movements of the tension tie cords can provide various directions of deflection of the sheath 610. Other configurations may be utilized to change the direction of deflection of the sheath 610. At least one tension tie cord may be utilized in embodiments.

[0105] The embodiments of FIGS. 13A - 14D show an elongate shaft 12 having two bent portions 600, 602 configured to bend in a vertical plane. However, the configuration and use of the bent portions 600, 602 may be varied in other embodiments as desired. For example, FIGS. 15A - 16C show an embodiment in which the bent portion 602 is eliminated and the sheath 610 controls the deflection of the elongate shaft 12 instead. Thus, the sheath 610 can be configured to deflect the elongate shaft 12 in a direction that is opposite to the direction in which the bent portion 600 deflects the distal end of the elongate shaft 12, which direction can be the direction that is exactly opposite (180°) to the direction in which the bent portion 600 deflects the distal end of the elongate shaft 12, and various other directions (e.g., 135° among many) that are between the exactly opposite (180°) and the perpendicular direction (90°). FIGS. 15A - 15C show the sheath 610 deflecting a portion of the elongate shaft 12 to deflect the bent portion 600 in a direction that is opposite to the direction in which the bent portion 600 deflects the distal end of the elongate shaft 12.

[0106] The sheath 610 can be rotated from the orientation shown in FIGS. 15A - 15C to change the direction of deflection of a portion 614. FIGS. 16A - 16C show the sheath 610 rotated 90° from the orientation shown in FIGS. 15A - 15C to deflect a portion 614 in a plane perpendicular to the plane of deflection of the bending portion 600. As detailed in connection with FIGS. 13A - 14D, in other embodiments, the sheath 610 may be configured with a plurality of tension tie cords or other control devices that allow for various deflection directions of the sheath 610 without rotation of the sheath 610.

[0107] Other forms of deflection mechanisms may be utilized. For example, FIG. 17 shows an embodiment of a deflection mechanism in the form of a tension tie cord 630. The tension tie cord 630 may have a distal end 632 coupled to a portion of an elongate shaft 12, such as a rail shaft 132. The rail shaft 132 may extend over the inner shaft as disclosed herein and may have an outer sheath extending over the rail shaft 132 as disclosed herein. The distal end 632 may be coupled to the rail proximal shaft 134 or to another portion of the rail shaft 132 proximal to the bending portions 634, 636 of the rail hypo tube 136 or the rail shaft 132. For example, as shown in FIG. 17, the distal end 632 may be coupled to a portion proximal to the hypo tube region 231 that is not cut (or slotted).

[0108] The tension connecting wire 630 can be configured to be retracted to deflect a portion 638 of the rail shaft 132 and thereby deflect the elongated shaft 12 proximal to the bending portions 634, 636. Thereby, the bending portion 634 can be configured to deflect the distal end of the elongated shaft 12 in a certain direction, and the tension connecting wire 630 can be configured to deflect the bending portions 634, 636 in a direction opposite to the direction in which the bending portion 634 deflects the distal end of the elongated shaft 12 by deflecting the elongated shaft 12. The tension connecting wire 630 can be coupled to the rail shaft 132 in an orientation at a predetermined position that is opposite to the direction in which the bending portion 634 deflects the distal end of the elongated shaft 12 when the tension connecting wire 630 is retracted.

[0109] Although a single tension connecting wire 630 is shown in FIG. 17, multiple tension connecting wires may be utilized in other embodiments as desired. For example, if four equally spaced tension connecting wires (spaced 90° from each other) are coupled to the rail shaft 132, a combination of the movement of the tension connecting wires can provide various deflection directions of the elongated shaft 12. Other configurations may be utilized to vary the direction of deflection of the elongated shaft 12. Thus, one or more tension connecting wires can be configured to deflect the elongated shaft 12 in a direction opposite to the direction in which the bending portion 634 deflects the distal end of the elongated shaft 12, and that direction can be the direction opposite (180°) to the direction in which the bending portion 634 deflects the distal end of the elongated shaft 12, and various other directions therebetween including the direction perpendicular (90°) to the opposite (180°) direction (e.g., 135° among others).

[0110] Figures 18A - 18B show an embodiment of a deflection mechanism comprising a cut 640 in a portion of the elongated shaft 12 and a tension shaft 642 that can be retracted to deflect the elongated shaft 12 at the location of the cut 640. Referring to FIG. 18A, the cut 640 can be positioned on the rail shaft 132 at a desired location. Such a location can be proximal to the rail hypo - tube 136 or the bent portions 634, 636 of the rail shaft 132. For example, as shown in FIG. 18A, the cut 640 can be proximal to the hypo - tube region 231 that is not cut (or not slotted).

[0111] The cut 640 can be configured to bias the rail shaft 132 such that at the cut 640, the bent portion 634 deflects in a direction away from the direction in which the distal end of the elongated shaft 12 is deflected.

[0112] Referring to FIG. 18B, a cross - sectional view of the rail shaft 132 is shown. The deflection mechanism may comprise an inner shaft or tension shaft 642 that can be positioned within the rail shaft 132. The tension shaft 642 can be positioned between the rail shaft 132 and an inner shaft such as the inner shaft assembly 18 or a nose cone assembly 31. In other embodiments, the inner shaft or tension shaft 642 may be provided in other locations.

[0113] The inner shaft or pull shaft 642 may comprise a stop 644 coupled thereto. A portion of the rail shaft 132, particularly the portion of the rail shaft 132 distal to the cut 640, may comprise a stop 646. The biasing mechanism may be configured such that when the pull shaft 642 is pulled proximally, the stop 644 contacts the stop 646, applying a proximal force to the rail shaft 132, particularly to the portion of the rail shaft 132 that includes the cut 640. The cut 640 that provides the biasing direction of deflection can deflect the rail shaft 132 and the elongate shaft 12 accordingly in a direction of deflection in which the bend 634 is in a direction opposite to the direction in which the bend 634 deflects the distal end of the elongate shaft 12. Thus, the pull shaft 642 can be moved distally to reduce the force between the stops 644, 646 and straighten the rail shaft 132. FIG. 18B shows the stops 644, 646 spaced apart from each other, but the inner shaft or pull shaft 642 can be pulled proximally such that the stops 644, 646 contact each other.

[0114] A single pull shaft 642 is shown in FIG. 18B, but multiple pull shafts may be utilized in other embodiments as desired. For example, if four equally spaced pull shafts (spaced 90° from each other) with corresponding stops are utilized, a combination of the movement of the pull shafts can provide various directions of deflection of the elongate shaft 12. The cut pattern can be provided such that various directions of deflection are possible. Other configurations may be utilized to vary the direction of deflection of the elongate shaft 12. Thus, one or more pull shafts can be configured to deflect the elongate shaft 12 such that the bend portions 634, 636 are deflected in a direction opposite to the direction in which the bend portion 634 deflects the distal end of the elongate shaft 12, which direction can be the direction opposite (180°) to the direction in which the bend portion 634 deflects the distal end of the elongate shaft 12, and various other directions (e.g., 135° among others) between that opposite (180°) and perpendicular (90°) directions.

[0115] Figures 19A - 19B show the external views of the embodiments of FIGS. 17A - 18B. The sheath 610 may or may not be utilized in the deflection mechanism shown in FIGS. 17 - 18B. Thereby, the outer sheath assembly 22 may comprise the outer surface of the elongated shaft 12 with the deflection mechanism housed within the outer sheath assembly 22.

[0116] As shown in FIG. 19A, the bending portion 600 can deflect the distal end of the elongated shaft 12 in a certain direction. The deflection mechanism can deflect the proximal portion 614 of the elongated shaft 12 to deflect the bending portion 600 in a direction opposite to the direction of the distal end of the elongated shaft 12. FIG. 19B shows that the bending portions 600, 602 can continue to operate to deflect the respective distal portions of the elongated shaft 12.

[0117] The deflection mechanism may be utilized to provide additional or various movements of the elongated shaft 12. Such additional or various movements may be desirable for various reasons, including various patient anatomical structures navigated at the distal end of the elongated shaft 12 or various uses of the elongated shaft 12.

[0118] The deflection mechanism can be utilized to move the elongated shaft 12 for the delivery of a replacement heart valve that may include a replacement tricuspid valve. Although many of the embodiments herein are discussed in relation to a replacement tricuspid valve, the deflection mechanism may be utilized for various other implantations, including the delivery of mitral replacement valves, aortic valves, pulmonary valves, or for valve repair procedures, including the repair of tricuspid valves, mitral valves, aortic valves, or pulmonary valves.

[0119] Figures 20A-21 illustrate the use of an elongate shaft 12 for treating a patient's tricuspid valve. The elongate shaft 12 can be passed into the patient's body by an intravascular approach, which may include percutaneous access to the patient's vasculature. For example, the elongate shaft 12 can be advanced into the ipsilateral femoral vein and directed towards the right atrium 1076. Other methods of advancement may be utilized in other embodiments, including a transjugular approach, or other approaches including a transapical approach.

[0120] As shown in Figure 20A, the elongate shaft 12 can be advanced through the inferior vena cava 1079 to approach or reach the right atrium 1076 of the patient's heart. Also shown are the right ventricle 1077, the tricuspid valve 1083 including the tricuspid valve leaflets 1087, the tricuspid valve annulus 1085, and the superior vena cava 1081.

[0121] The delivery system may include the use of a deflection mechanism as discussed herein. As shown in Figure 20A, a deflection mechanism in the form of a sheath 610 can be utilized, although it is understood that other forms of deflection mechanisms may be utilized, including the deflection mechanisms shown in Figures 17-19B.

[0122] The elongate shaft 12 is deflected at its distal end so that the capsule 106, and by extension the implant retention region 16, are oriented to deploy the implant contained within the capsule 106 to the tricuspid valve 1083 in a desired manner and advanced towards the right atrium 1076. As depicted in Figure 20A, the distal end of the elongate shaft 12 may require deflection in the direction towards the tricuspid valve 1083 to align the distal end of the elongate shaft 12 and the capsule 106 (and the deployment port at the distal end of the capsule for the implant to be deployed) with the central axis of the tricuspid valve 1083. For other methods of deployment, other directions of deflection may be desired.

[0123] The bending portions 600, 602 can be utilized to deflect the distal end of the elongated shaft 12 in a desired direction. The bending portions 600, 602 can be configured to deflect the distal end of the elongated shaft in perpendicular planes to provide two planes of deflection. The bending portions 600, 602 can be configured as shown in FIG. 6C, and the proximal bending portion 602 is configured to deflect the distal portion of the elongated shaft 12 in a rightward (or forward) direction relative to the downward (or ventricular) direction of deflection of the distal bending portion 600. Such a configuration can assume the position of the tricuspid valve 1083 relative to the inferior vena cava 1079 within a human heart.

[0124] However, additional movement may be provided by the deflection mechanism disclosed herein. The deflection mechanism in the form of the sheath 610 can be utilized to deflect the proximal portion of the elongated shaft 12 to deflect the bending portions 600, 602 in a direction opposite to the direction in which the bending portion 600 deflects the distal end of the elongated shaft 12. Such deflection can include deflecting the proximal portion of the elongated shaft 12 and the bending portions 600, 602 in an atrial direction (or providing height from the tricuspid valve 1083). The capsule 106 and the distal end of the elongated shaft 12 may be deflected in an atrial direction (or provide height from the tricuspid valve 1083).

[0125] The deflection mechanism may be utilized to assume the shape of the patient's biological structure, which may include the shape of the right atrium 1076, the size and relative position of the tricuspid valve 1083, and the shape of the inferior vena cava 1079. For example, as shown in FIG. 20A, the distance from the bending portion 600 to the distal end of the elongated shaft 12 depends on the shape of the patient's right atrium 1076, and if the bending radius of the distal elongated shaft 12 of the bending portion 600 is too large, it may not be possible to properly direct the distal end of the elongated shaft 12 towards the tricuspid valve 1083. Therefore, the deflection mechanism may be utilized to deflect the bending portion 600 in a direction opposite to the direction in which the bending portion 600 deflects the distal end of the elongated shaft 12.

[0126] Referring to FIG. 20B, the deflection mechanism in the form of the sheath 610 can deflect the proximal portion of the elongate shaft 12, as described herein. The deflection of the proximal portion of the elongate shaft 12 can occur wholly or partially (at least in part) within the patient's inferior vena cava 1079. The deflection can move the bending portions 600, 602 to create a height from the tricuspid valve 1083 in a direction away from the tricuspid valve. Thereby, the distal end of the elongate shaft 12 may have a greater clearance space as the bending portion 600 deflects the distal end of the elongate shaft 12 toward the tricuspid valve 1083. As shown in FIG. 20B, the deflection mechanism can form a curve in the proximal portion of the sheath, although other forms of deflection may result. The bending portion 600 initiates the deflection of the distal end of the elongate shaft 12 in FIG. 20B.

[0127] Referring to FIG. 20C, the bending portion 600 deflects the distal end of the elongate shaft 12 in direction 605. The direction can be aligned with the axis of the tricuspid valve 1083 or, otherwise, be oriented in a desired orientation. The deflection mechanism in the form of the sheath 610 deflects the proximal portion of the elongate shaft 12 to deflect the bending portion 600 in a direction 607 that is opposite direction 605. Thereby, the capsule 106 has an increased height from the tricuspid valve 1083, enabling deployment of the implant housed within the capsule 106.

[0128] The deflection mechanism in the form of the sheath 610 can provide various deflection directions of the proximal portion of the elongated shaft 12 and corresponding various deflection directions of the bending portions 600, 602, the capsule 106, and the distal end of the elongated shaft 12. As considered in relation to FIGS. 14A-14D, for example, the sheath 610 can provide various deflection directions, including a direction perpendicular to the deflection direction provided by the bending portion 600 and a direction toward the deflection direction provided by the bending portion 600. Such various deflection directions can enable additional maneuverability and orbital changes of the distal end of the elongated shaft 12 within the right atrium or within the inferior vena cava 1079 or other regions in which the elongated shaft 12 is positioned. The deflection mechanism in the form of the sheath 610 can provide deflection in both the atrial and ventricular directions and for various other directions.

[0129] The operation of the deflection mechanism shown in FIGS. 20A-20C is not limited to the sheath 610 shown in FIGS. 13A-14D and also includes the use of the deflection mechanism shown in FIGS. 15A-19B. For example, this portion may be eliminated while the sheath 610 provides deflection of the proximal bending portion 602 of the elongated shaft 12 as detailed in relation to FIGS. 15A-16C. Further, the deflection mechanism may be positioned within the outer sheath assembly 22 as considered in relation to the embodiments of FIGS. 17-19B. Various deflection directions in both the atrial and ventricular directions and various other directions can result.

[0130] The deflection mechanism may be utilized to deflect the proximal portion of the elongated shaft 12 in one or more planes that are not perpendicular to the plane in which the bending portion 600 deflects the distal end of the elongated shaft 12.

[0131] Figure 21 shows the use of the deflection mechanism in an approach from the superior vena cava 1081. The approach can be a transjugular approach or through other access locations to the patient's body. The bending portions 600, 602 can be configured as shown in FIG. 6B, and the proximal bending portion 602 is configured to deflect the distal portion of the elongate shaft 12 in a leftward (or rearward) direction relative to the downward (or ventricular) direction of deflection of the distal bending portion 600. Such a configuration can assume the position of the tricuspid valve 1083 relative to the superior vena cava 1081 within the human heart. The method can include passing a delivery device for the implant into the patient's right atrium.

[0132] The deflection mechanism can deflect the proximal portion of the elongate shaft 12 to deflect the bending portion 600 in a direction 607 that is opposite to the direction 605 in which the bending portion 600 deflects the distal end of the elongate shaft 12, as shown in FIGS. 20A-20C. Similarly, other forms of deflection mechanisms may be utilized and other directions of deflection may result, as considered in connection with FIGS. 13A-19B.

[0133] The implant 70 housed within the capsule 106 can be deployed to be positioned within the tricuspid annulus 1085 in order to replace the native tricuspid valve 1083. When the distal end of the elongate shaft 12 is oriented as desired relative to the native tricuspid valve 1083, a release mechanism can be utilized to deploy the implant 70 from the deployment port 611 at the distal end of the capsule 106. The height of the deployment port 611 relative to the valve may be varied by deflecting the delivery device within the inferior vena cava or the superior vena cava. FIGS. 22A-22C illustrate the release mechanism of the delivery system 10. During the initial insertion of the implant 70 and the delivery system 10 into the body, the implant 70 can be positioned within the system 10 as shown in FIG. 2A. The distal end 303 of the implant 70, and specifically the distal anchor 80, is restrained within the capsule 106 of the outer sheath assembly 22, thereby preventing expansion of the implant 70. A similar one is shown in FIG. 2A, and the distal anchor 80 can extend in the distal direction when positioned within the capsule. The proximal end 301 of the implant 70 is restrained within the capsule 106 and within a portion of the inner retaining member 40, and thus is generally constrained between the capsule 106 and the inner retaining member 40.

[0134] Once the implant 70 is loaded within the delivery system 10, the user can pass a guidewire through the patient to the desired location. The guidewire passes through the lumen of the nose cone assembly 31, and thus the delivery system 10 can be advanced through the patient's body along the guidewire. The delivery system 10 can be advanced by the user manually axially moving the handle 14. In some embodiments, the delivery system 10 can be positioned within a stand while operating the control of the handle 14.

[0135] Generally, once in the heart, the user can initiate the manipulation of the rail assembly 20. Specifically, the user can initiate the manipulation of the bending portions 600, 602 using the distal pull wire knob 206 and / or the proximal pull wire knob 208. By turning either knob, the user can provide bending / bowing of the rail assembly 20 (either at the distal or proximal end) to bend the distal end of the delivery system 10 at one, two, or more locations into a desired configuration. As previously discussed, the user can provide multiple bends to the rail assembly 20 to direct the delivery system 10 towards the tricuspid valve. Specifically, the bends of the rail assembly 20 can direct the distal end of the delivery system 10, and thus the capsule 106, along the central axis through the native tricuspid valve and towards the tricuspid valve. Thus, when the outer sheath assembly 22, the intermediate shaft assembly 21, the inner assembly 18, and the nose cone assembly 31 are advanced together over the compressed implant 70 and the rail assembly 20, the capsule 106 travels exactly in line with the axis for proper release of the implant 70.

[0136] The user can also utilize a deflection mechanism that can create a height from the native tricuspid valve or, alternatively, orient the distal end of the elongate shaft 12 as desired. The height of the bend portion of the elongate shaft 12 may be varied from the tricuspid valve.

[0137] The system 10 can be positioned to a specific location in the patient's body, such as the native tricuspid valve, through the use of the bend portions and deflection mechanisms discussed herein or other techniques.

[0138] The user can also rotate and / or move the handle 14 itself in the stand for further fine adjustment of the distal end of the delivery system 10. The user can move the handle 14 itself and continue to rotate the proximal pull wire knob 208 and / or the distal pull wire knob 206 to orient the delivery system 10 in the body for release of the implant 70. The user can also move other assemblies relative to the rail assembly 20, such as proximally or distally.

[0139] The user can utilize a control mechanism, such as a rotation control housing 620 or a deflection control housing 622 as shown in FIG. 14A, or other control mechanisms, to control the operation of the deflection mechanism.

[0140] Once the distal end of the elongate shaft 12 is oriented as desired, the user can rotate the depth knob 212. As contemplated, rotation of this knob 212 advances the inner shaft assembly 18, the intermediate shaft assembly 21, the outer sheath assembly 22, and the nose cone assembly 31 together over / through the rail assembly 20, while the implant 70 remains in a compressed configuration within the implant retention region 16. For example, due to the rigidity of any of the inner shaft assembly 18, the intermediate shaft assembly 21, and / or the outer sheath assembly 22, these assemblies move straight forward in a direction aligned by the rail assembly 20.

[0141] When in the release position, the user can rotate the outer sheath knob 210, which translates the outer sheath assembly 22 (and thus the capsule 106) individually in the proximal direction towards the handle 14, as shown in FIG. 22A, relative to the other assemblies, specifically relative to the inner assembly 18. By doing so, the distal end 303 of the implant 70 is uncovered within the body and can begin to expand. At this point, the distal anchor 80 can invert in the proximal direction and the distal end 303 begins to expand radially outward. For example, if the system 10 is delivered to the location of the native tricuspid valve, the distal anchor 80 expands radially outward within the right ventricle. The distal anchor 80 can be positioned above the papillae and below the tricuspid annulus and tricuspid leaflets.

[0142] In some embodiments, as the distal anchor 80 expands radially, it can contact and / or extend between the cords in the right ventricle and contact the leaflets. In some embodiments, the distal anchor 80 may contact the tendons and / or extend between the tendons or may not contact the valve leaflets. Depending on the position of the implant 70, the distal end of the distal anchor 80 may be at or below the location where the tendon attaches to the free edge of the native valve leaflet.

[0143] As shown in the illustrated embodiment, the distal end 303 of the implant 70 is expanded outwardly. Note that the proximal end 301 of the implant 70 can remain covered by the outer retaining ring during this step so that the proximal end 301 remains radially compact. At this time, the system 10 can be pulled proximally such that the distal anchor 80 grasps and engages the leaflet of the tricuspid valve, or can be moved proximally to reposition the implant 70. For example, the assembly can be moved proximally relative to the rail assembly 20. Further, the deflection mechanism may be utilized to pull the elongate shaft 12 proximally relative to the tricuspid valve. Further, the system 10 can be twisted, which can cause tension to be applied to a cable through which at least a portion of the distal anchor 80 can extend therebetween. However, in some embodiments, the distal anchor 80 may not apply tension to the cable. In some embodiments, the distal anchor 80 can capture the native valve leaflet and be positioned between the tendons without any further movement of the system 10 after the outer sheath assembly 22 is withdrawn.

[0144] During this step, the system 10 can be moved proximally or distally to properly grasp the native leaflet of the tricuspid valve with the distal or ventricular anchor 80. This can be done by moving the outer sheath assembly 22, the intermediate shaft assembly 21, the inner assembly 18, and the nose cone assembly 31 relative to the rail assembly 20. Specifically, the tip of the ventricular anchor 80 can be moved proximally to engage the ventricular side of the native annulus such that the native leaflet is positioned between the anchor 80 and the body of the implant 70. When the implant 70 is in its final position, the distal anchor 80 can be positioned between at least a portion of the cables, whether or not there is tension in the cables.

[0145] The proximal end 301 of the implant 70 will remain in the outer retention ring 42 after the retraction of the capsule 106. The capsule 106 can surround the implant retention area and can be retracted proximally to deploy the implant. As shown in FIG. 22B, when the distal end 303 of the implant 70 is fully expanded (or as fully expanded as possible at this position), the outer retention ring 42 can be individually retracted proximally relative to other assemblies, specifically, relative to the inner assembly 18, to start the expansion of the proximal end 301 of the implant 70 by exposing the inner retention member 40. For example, in a tricuspid valve replacement procedure, after the distal or ventricular anchor 80 is positioned between at least a portion of the chordae tendineae and / or after engaging the native tricuspid valve annulus, the proximal end 301 of the implant 70 can be expanded in the right atrium.

[0146] The outer retention ring 42 can be moved proximally so that the proximal end 310 of the implant 70 can expand radially to its fully expanded configuration as shown in FIG. 22C. The implant 70 can be deployed into the valve. After the expansion and release of the implant 70, the inner assembly 18, the nose cone assembly 31, the intermediate shaft assembly 21, and the outer sheath assembly 22 can be simultaneously retracted along the rail assembly 20 or relative to the rail assembly 20 so as to be returned to their original positions. In some embodiments, they are not retractable relative to the rail assembly 20 and remain in the extended position. Further, the nose cone 28 can be retracted into the outer sheath assembly 22 through the center of the expanded implant 70, such as by translating the knob 216 proximally. Thus, the system 10 can be removed from the patient.

[0147] In some embodiments, the implant 70 can be delivered under fluoroscopy so that the user can view certain reference points for proper positioning of the implant 70. Additionally, echocardiography can be used for proper positioning of the implant 70.

[0148] Reference is made to FIG. 23, which schematically depicts a portion of an embodiment of a replacement heart valve (implant 70) positioned within the native tricuspid valve of the heart 83. A portion of the native tricuspid valve is schematically shown, representing a typical biological structure including a right atrium 1076 positioned above an annulus 1085 and a right ventricle 1077 positioned below the annulus 1085. The right atrium 1076 and the right ventricle 1077 communicate with each other through the tricuspid annulus 1085. Also schematically shown in FIG. 23 is the native tricuspid valve leaflet 1087 having chordae tendineae 1089 connecting the downstream end of the tricuspid valve leaflet 1087 to the papillary muscles of the right ventricle 1077. A portion of the implant 70 disposed upstream (towards the right atrium 1076) of the annulus 1085 can be referred to as being positioned annularly above. Generally, a portion within the annulus 1085 can be referred to as being positioned annularly within. A portion downstream of the annulus 1085 can be referred to as being positioned annularly below (towards the right ventricle 1077).

[0149] As shown in FIG. 23, the replacement heart valve (e.g., implant 70) can be positioned such that the tricuspid annulus 1085 is disposed between a distal anchor 80 and a proximal anchor 82. In some situations, the implant 70 can be positioned such that, for example, as shown in FIG. 23, the end or tip of the distal anchor 80 contacts the annulus 1085. In some situations, the implant 70 can be positioned such that the end or tip of the distal anchor 80 does not contact the annulus 1085. In some situations, the implant 70 can be positioned such that the distal anchor 80 does not extend around the valve leaflet 1087.

[0150] As shown in FIG. 23, the replacement heart valve or implant 70 can be positioned such that the end or tip of the distal anchor 80 is on the ventricular side of the tricuspid annulus 1085 and the end or tip of the proximal anchor 82 is on the atrial side of the tricuspid annulus 1085. The distal anchor 80 can be positioned such that the end or tip of the distal anchor 80 is on the ventricular side of the native valve leaflet beyond where the chordae tendineae 1089 are attached to the free end of the native valve leaflet. The distal anchor 80 can extend between at least some of the chordae tendineae 1089 and in some situations, such as that shown in FIG. 23, can contact or engage the ventricular side of the annulus 1085. In some situations, the distal anchor 80 may not contact the annulus 1085, but it is also contemplated that the distal anchor 80 can still contact the native valve leaflet 1087. In some situations, the distal anchor 80 can contact the tissue of the right ventricle 1077 beyond the annulus 1085 and / or the ventricular side of the valve leaflet.

[0151] When the implant 70 is deployed as desired, the deflection mechanism disclosed with respect to FIGS. 13A - 19B can be utilized to deflect the elongate shaft 12 to enable removal of the elongate shaft 12 from the patient's heart.

[0152] FIG. 24 shows a perspective view from the side of the nose cone 28 that forms the tip of the elongate shaft 12. The nose cone 28 includes a tip body 700 that closes the end of the capsule 106 (shown in a partial cross - section) and is positioned distally of the capsule 106. The tip body 700 includes a proximal portion 702 and a distal portion 704 that tapers from the proximal portion 702 to the distal portion 704. An opening 706 is positioned in the distal portion 704 of the tip body 700 for the guidewire 708 to pass through. The distal portion 704 of the tip body 700 can include a stiffened protruding region 710 that is tapered. The tapered outer profile of the stiffened protruding region can allow for ease of entry into the patient's vasculature and can assist in passing the tip of the elongate shaft 12 into the patient's vasculature.

[0153] However, it should be noted that the hard protruding region 710 may interfere with a part of the patient's body upon contact with the hard protruding region 710, or may potentially damage a part of the patient's body. For example, when the nose cone 28 is passed into the right ventricle of the patient's heart, potentially, the hard protruding region 710 may affect the interior of the right ventricle and may potentially puncture or otherwise damage the interior of the right ventricle. It should be noted that there is also a possibility of entanglement with the guide wire 708 at the opening 706. The length of the hard protruding region 710 may also inhibit the maneuverability of the distal end of the elongated shaft 12.

[0154] Figures 25A and 25B show an embodiment of the distal tip of an elongated shaft 12 comprising a flexible sheath 712 that extends distally and is configured to bend around a portion of the guide wire 708. The distal tip can comprise a tip body 714 having a proximal portion 716 and a distal portion 718, and the distal tip can have an outer surface 720 that tapers in a direction from the proximal portion 716 to the distal portion 718 of the tip body 714. The tip body 714 can be positioned distally of the capsule 106 and can be positioned at and near the distal end of the capsule 106. The tip body 714 can be movable relative to the capsule 106 for deploying the implant 70 enclosed by the capsule 106 from the capsule 106.

[0155] The outer surface 720 can taper from the proximal portion 716 of the tip body 714 to the proximal portion 722 of the flexible sheath 712. The flexible sheath 712 can extend from the proximal portion 722 of the flexible sheath 712 to the distal end 724 of the flexible sheath 712. The flexible sheath 712 can have a cylindrical shape from the proximal portion 722 of the flexible sheath 712 to the distal end 724 of the flexible sheath 712.

[0156] The flexible sheath 712 can have a length configured to extend over the curvature at the tip of the guide wire 708 for the guide wire 708 having a curved configuration 726 at the tip of the guide wire 708. Thus, the flexible sheath 712 can cover the curvature at the tip of the guide wire 708 to reduce the likelihood of injury due to contact between the guide wire and a portion of the patient's body. FIG. 25B shows, for example, the distal tip within the patient's right ventricle 1077. The flexible sheath 712 is bent around the guide wire 708 when the guide wire 708 is positioned within the right ventricle. The flexible sheath 712 covers a portion of the guide wire 708 that might otherwise contact the inner wall of the patient's right ventricle 1077. Further, the flexible sheath 712 is flexible to reduce the likelihood of puncture or other interference with the inner wall of the patient's right ventricle 1077. The curvature of the flexible sheath 712 along the guide wire 708 can additionally reduce the likelihood of entanglement of the guide wire 708.

[0157] FIGS. 26-28 show embodiments of the distal tip of the elongate shaft 12 that can reduce the outer profile of the distal portion of the elongate shaft 12. Such features can be utilized to more easily navigate or deflect the elongate shaft 12 in various vascular shapes. For example, in the methods shown in FIGS. 20A-21, the reduced outer profile of the distal portion of the elongate shaft 12 can enable better maneuverability of the elongate shaft 12 within and toward the right atrium 1076.

[0158] FIG. 26 shows an embodiment of the distal tip of an elongated shaft 12 having a hemispherical shape. The distal tip can include a tip body 730 having a proximal portion 732 and a distal portion 734, and can have an outer surface 736 that tapers in a direction from the proximal portion 732 to the distal portion 734. The tip body 730 can be positioned distally of the capsule 106 and can be positioned at and near the distal end of the capsule 106. The tip body 730 can be movable relative to the capsule 106 to deploy an implant 70 surrounded by the capsule 106 from the capsule 106. The hemispherical tip body can form a convex outer shape at the distal end 738 of the distal tip. The outer surface 736 can be convex from the proximal portion 732 of the tip body 730 to the distal end 738 of the tip body 730. The tip body 730 can include an opening 739 at its distal end 738 for the guide wire 708 to pass through.

[0159] FIG. 27 shows an embodiment of the distal tip of an elongated shaft 12 having a parabolic shape. The distal tip can include a tip body 740 having a proximal portion 742 and a distal portion 744, and can have an outer surface 746 that tapers in a direction from the proximal portion 742 to the distal portion 744. The tip body 740 can be positioned distally of the capsule 106 and can be positioned at and near the distal end of the capsule 106. The tip body 740 can be movable relative to the capsule 106 to deploy an implant 70 surrounded by the capsule 106 from the capsule 106. The parabolic tip body can form a convex outer shape at the distal end 748 of the distal tip. The outer surface 746 can be convex from the proximal portion 742 of the tip body 740 to the distal end 748 of the tip body 740. The tip body 740 can include an opening 749 at its distal end 748 for the guide wire 708 to pass through.

[0160] Figure 28 shows an embodiment in which the distal end 750 of the capsule 106 forms the distal tip of the elongated shaft 12. The distal end 750 of the capsule may extend over the distal end of the implant (or anchor 80) and may include a rounded portion 752 that can provide a smooth outer profile to the distal tip of the elongated shaft 12. Thus, the distal tip may comprise a non-traumatic rounded tip. The capsule may comprise a portion 754 having a planar outer profile at the leading edge of the capsule 106. That portion 754 may comprise an opening or port 756 through which the implant is deployed.

[0161] The capsule 106 can be configured to have an elastic distal end 705 and can conform to the shape of the implant 70 positioned within the capsule 106. A tie layer or the like may be added to the capsule 106 to provide elasticity of the capsule 106 with respect to the implant 70. The capsule 106 may comprise, for example, an ePTFE tip with an elastic tie layer of a small durometer. When the implant 70 is deployed, the implant can be advanced distally through the port 756 from the capsule 106 with the rounded portion 752 of the distal end 750 expanded to receive the distal movement of the implant 70. The port 756 or opening at the distal end 705 of the capsule 106 may be configured to allow the guidewire 708 to pass therethrough.

[0162] In the embodiment shown in Figure 28, a separate tip body need not be present at the distal tip of the elongated shaft 12, thus reducing the distal outer profile of the elongated shaft 12.

[0163] One or more features of the distal tip embodiments of Figures 25A - 28 may be utilized alone or in combination with any other embodiment of the delivery system, other system, or other method disclosed herein.

[0164] FIG. 29 shows an embodiment of an elongated shaft 800 composed of a wall 802 surrounding a passageway 804 through which an implant 806 is to be passed for its deployment. The wall 802 can be configured to have a bend 808 that defines a bend in the passageway 804 during the deployment of the implant 806.

[0165] The wall 802 can be configured to be maneuverable, and a control mechanism can be utilized to maneuver the wall 802. For example, a pull tether 810 or other form of control mechanism can be utilized to control the direction of the bend of the wall 802, and more specifically, to direct the opening or port 812 through which the implant 806 is to be passed into a desired orientation, so as to maneuver the wall 802.

[0166] In one embodiment, the wall 802 may not be maneuverable, but the wall can have a bend implemented in a desired orientation by the wall 802.

[0167] The passageway 804 can have a deployment passageway in which the implant 806 is to be deployed. The passageway 804 can be configured to hold the implant 806 and can include an implant holding region. The passageway 804 can be configured to hold the implant 806 in an approach and entry to the right atrium 1706, or other parts of the patient's heart or vascular system.

[0168] The implant 806 can be configured to be a flexible implant that is configured to bend in a direction transverse to the axial dimension 814 of the implant 806. Thereby, the implant 806 can be configured to bend within the passageway 804 in a direction transverse to the axial dimension 814 of the implant 806 for the deployment of the implant 806. A deployment device such as a push-in shaft 815 can be utilized to push the implant 806 from the port 812 for deployment. Other forms of deployment devices such as expandable balloons can be utilized as desired.

[0169] Implant 806 may be an expandable implant and may be self-expanding for deployment to a desired portion of a patient's body. Implant 806 may be configured similarly to implant 70, but may be configured to bend in a direction transverse to the axial dimension 814 of implant 806 as it passes through the bending deployment passageway. Such a configuration may be provided by a more slender frame of implant 70 to allow for greater flexibility in the transverse direction.

[0170] The components of elongate shaft 12 may be utilized with elongate shaft 800, including the use of an outer sheath assembly, an intermediate shaft assembly, a rail assembly, an inner shaft assembly, and a nose cone assembly. Any or all of the assemblies may be utilized to effect or assist in the deployment of implant 806. The deflection mechanisms disclosed herein may be utilized. One or more features of elongate shaft 800 may be utilized alone or in combination with any other embodiment of the delivery systems, other systems, or other methods disclosed herein.

[0171] The use of wall 802 having a bend 808 that defines the bend in passageway 804 during deployment of implant 806 can provide the benefit of including a reduced transverse outer profile of elongate shaft 800. For example, as shown in FIGS. 20A-21, capsule 106 of elongate shaft 12 can form a relatively large radius of rotation for elongate shaft 12 with respect to bend portion 600. The use of the bend in passageway 804 can allow for a reduced transverse outer profile of elongate shaft 800 with a relatively smaller radius of rotation. Thus, port 812 can be moved close to tricuspid valve 1083 for deployment of flexible implant 806 with elongate shaft 800 having a reduced transverse outer profile. The implant can be passed through the bending deployment passageway to deploy the implant (which may be a prosthetic tricuspid valve).

[0172] Figure 30 shows an embodiment of an elongated shaft 900 having an axial dimension 902 and having a port 904 for an implant 906 that is deployable in a direction transverse to the axial dimension 902. The elongated shaft 900 can comprise a sidewall 908, and the port 904 can be positioned in the sidewall 908.

[0173] The sidewall 908 can be configured to be maneuverable, and a control mechanism can be utilized to maneuver the sidewall 908. For example, a pull tether 909 or other form of control mechanism can be utilized to maneuver the sidewall 908 to orient the port 904 in a desired orientation.

[0174] The elongated shaft 900 can comprise an implant holding region 910 for holding the implant 906. The implant 906 can be configured to be deployed in the axial dimension of the implant 906 and exit through the port 904 in the axial dimension of the implant 906. The implant 906 can be configured to be compressed in the axial dimension of the implant 906 prior to deployment.

[0175] A deployment mechanism can be utilized to deploy the implant 906 from the port 904. The deployment mechanism can comprise an inflatable body 912 configured to push the implant 906 out of the port 904 as shown in Figure 30, or in other embodiments, other forms of deployment mechanisms can be utilized. The implant can be deployed through the port 904 in a direction transverse to the axial dimension of the elongated shaft.

[0176] The implant 906 can be an expandable implant and can be self-expanding for deployment to a desired portion of the patient's body. The implant 906 can be configured similarly to the implant 70, but can be configured to be compressed in the axial dimension of the implant 906.

[0177] The components of the elongated shaft 12 may be utilized with an elongated shaft 900, including the use of an outer sheath assembly, an intermediate shaft assembly, a rail assembly, an inner shaft assembly, and a nose cone assembly. Any or all of the assemblies may be utilized to perform or assist in the deployment of the implant 906. The deflection mechanisms disclosed herein may be utilized. One or more features of the elongated shaft 900 may be utilized alone or in conjunction with any other embodiments of the delivery systems, other systems, or other methods disclosed herein.

[0178] The use of an elongated shaft 900 having an axial dimension 902 and having a port 904 for an implant 906 that is deployed in a direction transverse to the axial dimension 902 can provide benefits including a reduced lateral profile of the elongated shaft 900. For example, as shown in FIGS. 20A - 21, the capsule 106 of the elongated shaft 12 can form a relatively large radius of rotation for the elongated shaft 12 with respect to the bend portion 600. The use of a port 904 for an implant 906 that is deployed in a direction transverse to the axial dimension 902 can enable a reduced lateral profile of the elongated shaft 900. Thus, the port 904 can be moved to be proximate to the tricuspid valve 1083 for deployment of the implant 906 while the elongated shaft 900 has a reduced lateral profile.

[0179] FIG. 31 shows an embodiment of an elongated shaft 1300 configured to bend more than 180 degrees to form a loop 1302. The shaft 1300 may be configured similarly to the elongated shaft 12, but may be configured to bend more than 180 degrees to form a loop 1302. Such a feature may be provided by a control mechanism that extends along the outer diameter of the shaft 1300 and is configured to provide bending beyond 180 degrees, such as a push shaft that applies a distal force to bend the shaft 1300 more than 180 degrees. Other mechanisms may be utilized as well. Thus, the elongated shaft 1300 can form a loop 1302 that can be positioned at a desired location within a patient's body.

[0180] For example, as shown in FIG. 31, the loop 1302 can be positioned within the right atrium 1076 in an embodiment where the implant 70 is to be deployed to the tricuspid valve 1083. The loop 1302 can be positioned within the right atrium 1076 to allow for a greater clearance of the distal end of the capsule 106 from the wall of the right atrium 1076. The loop 1302 can be oriented in the atrial direction so as to be away from the tricuspid valve 1083. The elongated shaft is configured to bend at the bent portion of the elongated shaft with the implant holding region positioned distally of the bent portion.

[0181] The elongated shaft is bent more than 180 degrees to at least partially form a loop within the patient's right atrium. The degree of bending of the elongated shaft 1300 can be varied as desired. For example, in one embodiment, the degree of bending may be more than 200 degrees, in one embodiment, more than 230 degrees, in one embodiment, more than 250 degrees, and in one embodiment, more than 270 degrees. Other degrees of bending can be utilized as desired. One or more features of the elongated shaft 1300 may be utilized alone or in combination with any other embodiment of the delivery system, other system, or other method disclosed herein.

[0182] The components of the elongated shaft 12 may be utilized with the elongated shaft 1300, including the use of an outer sheath assembly, an intermediate shaft assembly, a rail assembly, an inner shaft assembly, and a nose cone assembly. Any or all of the assemblies may be utilized to perform or assist in the deployment of the implant 70 held by the implant retention region. The deflection mechanism disclosed herein may be utilized.

[0183] Figures 32A - 33B show embodiments of an elongated shaft including a hinge that couples a capsule to a portion of the elongated shaft. Figure 32A shows, for example, an elongated shaft 1400 having a distal portion 1402 with a hinge 1404. The hinge 1404 is coupled to the proximal portion 1406 of the capsule 106. The capsule 106 is configured to rotate about the hinge 1404 to position the port 1408 of the capsule 106 in a desired orientation relative to the tricuspid valve 1083. Figure 32B shows, for example, the capsule 106 rotated about the hinge 1404 with the port 1408 oriented toward the tricuspid valve 1083.

[0184] Figure 33A shows an embodiment in which the hinge 1404 in the distal portion 1402 of the elongated shaft 1400 is coupled to the capsule 106 at the central portion 1407 of the capsule positioned between the proximal portion 1406 and the distal portion 1410 of the capsule 106. Thus, the capsule may be configured to pivot about the hinge 1404 to position the port 1408 of the capsule 106 in a desired orientation relative to the tricuspid valve 1083. Figure 33B shows, for example, the capsule 106 rotated about the hinge 1404 with the port 1408 oriented toward the tricuspid valve 1083.

[0185] The capsule 106 shown in FIGS. 32A - 33B can be rotated about the hinge 1404 through the use of a control mechanism, which may comprise a push shaft, a pull shaft, or other device configured to control the rotation of the capsule 106. The implant can be configured to be deployed from the capsule 106 by a deployment mechanism, which may comprise an inflatable body or the like for deploying the implant from the capsule 106.

[0186] The capsule 106 can be configured to rotate about the hinge 1404 to various angles, including between 0 degrees and 360 degrees or greater, as desired. The capsule 106 can be rotated, for example, to provide a desired orientation of the port 1408 of the capsule 106 in a desired orientation relative to the tricuspid valve 1083 or other delivery site.

[0187] The hinge 1404 can comprise a pin extending through an opening or can include other forms of hinges as desired.

[0188] The components of the elongate shaft 12 may be utilized with the elongate shaft 1400, including the use of an outer sheath assembly, an intermediate shaft assembly, a rail assembly, an inner shaft assembly, and a nose cone assembly. Any or all of the assemblies may be utilized to effect or assist in the deployment of the implant 70 held by the implant holding region. The deflection mechanisms disclosed herein may be utilized. One or more features of the elongate shaft 1400 may be utilized alone or in combination with any other embodiment of the delivery system, other system, or other method disclosed herein.

[0189] Figures 34A - 34B show a method that can be utilized for the deployment of an implant from an elongate shaft 12. Referring to Figure 34A, the method can include positioning a capsule 106 of the elongate shaft 12 within the right atrium 1076 of a patient's heart. Next, a bending portion 600 can be utilized to deflect the capsule 106 in a certain direction. The elongate shaft 12 can be translated proximally, for example, by retracting the elongate shaft 12 from the patient's heart, to position the capsule 106 in a desired orientation relative to the tricuspid valve 1083.

[0190] Figure 34B shows, for example, the elongate shaft 12 being retracted in the proximal direction to position the capsule 106 at a desired position relative to the tricuspid valve 1083. Next, the implant can be deployed from the capsule 106 for implantation to the tricuspid valve 1083 using the methods disclosed herein. The methods of Figures 34A - 34B can be utilized alone or in combination with any other embodiments of the delivery systems, other systems, or other methods disclosed herein.

[0191] Various other methods of deploying the implant or utilizing the systems and devices disclosed herein can be utilized.

[0192] Figures 62A - 64C show embodiments that utilize one or more supports configured to extend radially outward from an outer surface of the elongate shaft 12 and contact the outer surface so as to resist deflection of the elongate shaft transverse to an axis along which the elongate shaft extends. The embodiments can be utilized in combination with any other embodiments disclosed herein.

[0193] FIG. 62A shows an embodiment in which one or more supports 1450 in the form of an arm portion can be utilized. The support 1450 is shown in FIG. 62A in an undeployed configuration, an unexpanded configuration, or a straight configuration, and the support 1450 is crushed against the outer surface of the elongate shaft 12. The support 1450 may extend proximally from the distal tip 1452 of the support 1450 to the position of the handle 14 or to another position for access to the exterior of the patient's body.

[0194] The support 1450 may be held in the undeployed configuration, unexpanded configuration, or straight configuration shown in FIG. 62A by a sheath 1454 that extends along the outer surface of the elongate shaft 12 over the elongate shaft 12 and the support 1450. The sheath 1454 may be configured similar to the sheath 51 shown, for example, in FIG. 1 or shown as the sheath 610 in FIG. 13A by way of example. In an embodiment, the sheath 1454 may be configured to slide proximally and / or distally along the outer surface of the elongate shaft 12 to remove or cover the support 1450 as desired. The proximal portion of the sheath 1454 may be controlled, for example, to move the sheath 1454 proximally or distally.

[0195] The support 1450 can extend to the distal tip 1452 of the support 1450. Each support 1450 may have an intermediate portion 1456 between the distal tip 1452 and the proximal portion of the support 1450 that may be configured to extend radially outwardly from the outer surfaces of the sheath 1454 and the elongate shaft 12. Each support 1450 can be shaped to extend radially outwardly from the outer surface of the elongate shaft 12 and, in an embodiment, may be biased to extend radially outwardly from the outer surface of the elongate shaft 12. For example, the support 1450 may include a shape memory material that may be preformed to extend radially outwardly. The shape memory material may include nitinol or other forms of shape memory material. In an embodiment, the support 1450 may be made from other materials such as stainless steel or another material.

[0196] The supports 1450 can each be configured to contact an external surface. The external surface can include a portion of the patient's vascular system, including a portion of the patient's heart. For example, in an embodiment, the support 1450 can be configured to contact the atrial wall (which may include the atrial septum) or other portion of the patient's heart. The support 1450 can be configured to be non-invasive. Each of the intermediate portion 1456 and the distal tip 1452 can be rounded or smoothed, for example, to reduce the likelihood of damage to the heart wall.

[0197] Each support 1450 can be stiff enough to reduce deflection of the elongate shaft 12 in a direction transverse to the axis along which the elongate shaft 12 extends. However, the support 1450 can be flexible to extend radially outward from a non-expanded configuration (shown in FIG. 62A) to an expanded configuration (shown in FIG. 62B). The support 1450 can be deflected outwardly by the sheath 1454 being retracted proximally or by the support 1450 being advanced distally relative to the distal end 1458 of the sheath 1454.

[0198] FIG. 62B shows the support 1450 being advanced distally relative to, for example, the sheath 1454. The support 1450 extends radially outwardly in the expanded configuration shown in FIG. 62B. The intermediate portion 1456 of the support 1450 projects outwardly from the distal end 1458 of the sheath 1454 to the distal tip 1452 of the support 1450. The support 1450 is positioned to resist deflection of the elongate shaft 12 in a direction transverse to the axis 1460 along which the elongate shaft 12 extends.

[0199] In an embodiment, the support 1450 can be advanced distally and / or the sheath 1454 can be retracted proximally to expand the support 1450.

[0200] Figures 62C - 62E illustrate an exemplary method of using a delivery device that utilizes a support 1450. Figure 62C shows, for example, that the delivery device can be used to deliver an implant to the mitral valve 1461. The elongated shaft 12 of the delivery device can, for example, be passed transseptally through the atrial septum 1462 between the right atrium 1076 and the left atrium 1075. For example, the puncture to pass the elongated shaft 12 through the atrial septum 1462 may be performed at the atrial septum 1462. The support 1450 can remain in an unexpanded configuration covered by the sheath 1454 at this point. The delivery device is positioned within the left atrium 1075.

[0201] Figure 62D shows that the capsule 106 surrounding the implant holding region can be deflected, for example, in the ventricular direction, towards the left ventricle 1073, via the bending portion 600. One or more other bending portions, including the bending portion 602, can be used to align the capsule 106 as desired with respect to the mitral valve 1461. For example, the bending portion 602 can deflect the capsule in a plane extending transverse to the plane of the bend of the bending portion 600, according to the methods disclosed herein. Various directions of deflection may be utilized.

[0202] When the capsules 106 are arranged in a row at a predetermined position, the depth of the capsules 106 can be increased in the ventricular direction using the methods disclosed herein. However, an increase in depth in the ventricular direction can result in a force being applied to the elongated shaft 12 in the atrial direction 1463 (marked in FIG. 62D). Further, a decrease in depth in the atrial direction can result in a force being applied to the elongated shaft 12 in the ventricular direction 1464 (marked in FIG. 62D). Such forces can arise from the movement of the capsules 106 or from the contact of the capsules 106 with structures such as the chordae or leaflets of the mitral valve 1461. The forces in the elongated shaft 12 can provide stress to the puncture of the atrial septum 1462. In embodiments, the stress can increase the likelihood of an undesired size of the puncture of the atrial septum 1462, increase the time for the puncture to seal, or decrease the likelihood of the puncture sealing.

[0203] To reduce the deflection of the elongated shaft 12 and the stress accessible to the atrial septum 1462, the support 1450 can be expanded radially outwardly to contact the wall of the patient's heart. FIG. 62D shows, for example, the support 1450 expanded in a configuration such as that shown in FIG. 62B. The support 1450 moves from a non-expanded state to an expanded state. The distal tip 1452 and / or the intermediate portion 1456 of the support 1450 can contact the atrial wall to support the elongated shaft 12. The support 1450 can be positioned to resist the forces in the atrial direction 1463 and / or the ventricular direction 1464 as desired. In embodiments, other directions (e.g., transverse to the atrial direction 1463 and / or the ventricular direction 1464) can be utilized as desired. The atrial wall can comprise opposing portions of the atrial wall as shown in FIG. 62D or, in embodiments, the wall of the atrial septum.

[0204] The support 1450 can be positioned proximal to the bending portions 600, 602 or at other locations as desired. The support 1450 can remain in place during an increase in the depth of the capsule 106 or during other deployment procedures performed by the elongate shaft 12. FIG. 62E shows, for example, the support 1450 in place when the depth of the capsule 106 is increased in the ventricular direction.

[0205] When the implant is deployed, the support 1450 can be retracted to an undeployed configuration, an unexpanded configuration, or a straightened configuration as shown in FIG. 62A and pulled into the patient's body. The support 1450 can be pulled in with the elongate shaft 12.

[0206] In embodiments, the sheath 1454 may not be utilized and the support 1450 may be directly coupled to the elongate shaft 12 and extend radially outwardly from the elongate shaft 12. A separate control mechanism may be utilized to control the deployment of the support 1450 in such embodiments.

[0207] The support 1450 can beneficially reduce the deflection of the elongate shaft 12 and reduce the stress on the atrial septum 1462. Thereby, the accuracy of the modification and depth control of the capsule 106 can be improved due to a reduced likelihood of unwanted deflection of the elongate shaft 12. Further, the reduced stress on the atrial septum 1462 can reduce the likelihood of an unwanted increase in the size of the puncture of the atrial septum 1462. Such features can shorten the time for the puncture to seal or increase the likelihood of sealing of the puncture. A smaller puncture of the atrial septum can reduce the likelihood of requiring an occluder utilized to seal the puncture following deployment of the heart valve implant. Thereby, a reduction in the steps for the implant deployment procedure results.

[0208] The support 1450 may be further utilized for deployment to other locations within the patient's body. For example, FIG. 62F shows an embodiment in which the support 1450 is utilized for deployment to the tricuspid valve. The delivery device is positioned within the right atrium 1076. The support 1450 can extend radially outward from the elongate shaft 12 and can contact the right atrial wall. Other contact locations within the patient's vasculature, such as the inferior vena cava 1079 or the superior vena cava 1081, may be utilized as desired.

[0209] The form of the support may be varied in embodiments.

[0210] For example, FIGS. 63A - 63B show an embodiment in which the support 1466 comprises an inflatable body. The support 1466 may be configured to be inflated with a fluid or the like so as to move from an undeployed configuration, an unexpanded configuration, or a straight configuration, as shown in FIG. 63A, to an expanded or deployed configuration, as shown in FIG. 63B. FIG. 63A shows the support in an undeployed or undeflected configuration with the sheath 1454 extending over the support 1466. Next, the support 1466 can be inflated via a fill lumen or the like to an expanded or inflated configuration, as shown in FIG. 63B.

[0211] Referring to FIG. 63B, the support 1466 can contact the atrial wall to resist deflection of the elongate shaft 12 in a manner similar to that considered with respect to the support 1450 shown in FIGS. 62E or 62F. In embodiments, one or more inflatable bodies may be utilized. The inflatable body can have a rectangular or other shape (e.g., an ellipsoid of revolution), or can have other shapes such as a disk in embodiments. Further, the configuration of the inflatable body can comprise a membrane, can comprise a mesh body, or can have other forms in embodiments.

[0212] Figures 64A-64B show an embodiment in which the support 1468 comprises a mesh configured to extend radially outwardly from the elongate shaft 12. The mesh can be configured as a plurality of disks 1470, 1472 each extending radially outwardly from the elongate shaft 12. The disks 1470, 1472 can be configured to be positioned on either side of a puncture of the atrial septum, although other locations may be utilized in embodiments. In embodiments, a single disk may be utilized, or a greater number of disks (e.g., three disks, or four disks) may be utilized as desired.

[0213] The support 1468 can be configured as one or more occluders configured to seal a puncture of the atrial septum. Thereby, the support can reduce fluid flow between the atria and, in embodiments, support the elongate shaft 12 from deflection.

[0214] For example, FIG. 64B shows the support 1468 in an undeployed configuration, an unexpanded configuration, or a straightened configuration. The sheath 1454 extends over the support 1468. A tether 1474 can couple the support 1468 to the sheath 1454 or the elongate shaft 12. The support 1468 can be positioned at a desired location relative to the atrial septum and the puncture at the deployment site.

[0215] FIG. 64C shows the support 1468 deployed from the elongate shaft 12 and extending radially outwardly. The surface area of the disks 1470, 1472 relative to the atrial septum can reduce the likelihood of deflection of the elongate shaft 12. The disk 1470 can be positioned in the left atrium and the other disk 1472 can be positioned in the right atrium. The position and configuration of the disks may vary in embodiments. For example, the disks 1470, 1472 can be made from a mesh material configured to expand upon deployment. The material can include a shape memory material such as nitinol or other forms of shape memory material. In embodiments, the disks can comprise an inflatable body or other forms of occluders.

[0216] The support 1468 can either recede and be retracted during the deployment of the heart valve implant or remain in place during the puncture of the atrial septum. The support 1468 can remain in place as an occluder following deployment.

[0217] In embodiments, various other forms of mesh bodies and discs can be utilized as supports herein. The support may be used for deployment to the mitral or tricuspid valve or other valves as desired. One or more features of the support embodiments may be utilized with any other embodiment of the delivery systems, other systems, or other methods disclosed herein.

[0218] The implants disclosed herein can be utilized with anchors configured to be fixed within a portion of a patient's body. The anchors can serve to further secure the implant at a desired implantation location within the patient's heart. The implant can comprise a prosthetic heart valve, and in particular, can comprise a prosthetic heart valve configured for implantation within the patient's tricuspid annulus 1085. The implant can comprise a prosthetic tricuspid heart valve and can comprise the implants disclosed herein.

[0219] Figures 35 - 38B illustrate embodiments of an anchor that can be utilized with the implant disclosed herein. Figure 35, for example, shows an implant 70 at a predetermined position within the tricuspid annulus 1085 of a patient's heart. The implant 70 includes a prosthetic valve flap for replacing a native valve flap. An anchor 1800 is utilized and configured to be secured within the inferior vena cava 1079 of the patient's heart. The anchor 1800 may include a stent that is secured within the inferior vena cava 1079. A tie cord 1802 can be coupled from the anchor 1800 to the implant 70 to secure the implant at a predetermined position within the tricuspid annulus 1085. The tie cord 1802 can be rigid to resist forces in the atrial direction applied to the implant 70. In one embodiment, the anchor 1800 may be positioned within the superior vena cava 1081 of the patient's heart as an alternative to, or in combination with, the anchor within the inferior vena cava 1079. An atrial ball anchor may be utilized in certain embodiments.

[0220] Figure 36A illustrates an embodiment in which an anchor 1900 is configured to be secured to the moderator band 1902 of a patient's right ventricle 1077. The anchor 1900 can be coupled to one or more tie cords 1904 that couple to the implant 70. The tie cords 1904 can be configured to resist forces applied to the implant 70 in the atrial direction to secure the implant within the tricuspid annulus 1085.

[0221] The anchor 1900 can have various forms. The anchor 1900 may include a hook as shown in FIGS. 36A and 36B. In one embodiment, the anchor 1900 can have the form of a loop 1906 as shown in FIG. 36D, or a plurality of loops 1908 (one or more loops) as shown in FIG. 36E. In one embodiment, the anchor 1900 can have the form of a cover 1910 for covering a portion of the adjustment band 1902 as shown in FIG. 36C. The cover 1910 can have a V-shaped configuration as shown in FIG. 36C, or a U-shaped configuration as shown by cover 1912 in FIG. 36F.

[0222] The anchor can be deployed on the adjustment band 1902 during the process of implanting the implant 70, or in another process where the connecting wire 1904 is coupled between the anchor and the implant 70. Additional forms of the anchor can include a return or expandable body that extends across a portion of the adjustment band 1902 to secure the anchor to the adjustment band 1902.

[0223] FIG. 37 shows an embodiment in which the anchor 2000 is configured to be fixed to the wall of a patient's right ventricle 1077. For example, the anchor 2000 can include an expandable body that is passed through a puncture in the wall and disposed on the outer surface of the wall of the right ventricle 1077 in a compressed or undeployed state. The expandable body can be expanded to have a dimension larger than the size of the puncture to prevent the anchor 2000 from passing back through the puncture. One or more connecting wires 2002 can be coupled from the anchor 2000 to the implant 70 to fix the implant at a predetermined position within the tricuspid annulus 1085. The anchor 2000 in other embodiments can have other forms, including a return or hook for coupling to the wall of the right ventricle 1077. The anchor 2000 can be deployed and fixed to the wall of the right ventricle 1077 during the process of implanting the implant 70, or in another process where the connecting wire 2002 is coupled between the anchor 2000 and the implant 70.

[0224] The embodiments disclosed herein may be deployed within the tricuspid annulus of a patient, and the anchor may be deployed within a portion of the patient's body. The tether may be provided to couple the prosthetic heart valve to the anchor. The anchor may be coupled to the prosthetic heart valve with the tether.

[0225] FIG. 38A shows an embodiment in which an implant 70 (shown with a cover present on the implant 70) is deployed within the right atrium 1076 of a patient and then moved in a ventricular direction to couple the implant 70 to the leaflet 1087 of the tricuspid valve 1083. The implant 70 may be deployed within the right atrium 1076 using the methods disclosed herein, including deploying the implant 70 from a capsule 106 into the right atrium 1076. The implant 70 may be moved in a ventricular direction in various ways. In one embodiment, as shown in FIG. 38A, the implant 70 may be coupled to one or more tethers 2102. The tethers 2102 may be configured to be pulled away from the atrium 1076 to move the implant 70 in a ventricular direction for coupling to the leaflet 1087. The tethers 2102 may be coupled to an anchor 2100 positioned on the wall of the right ventricle 1077 and may be configured to be drawn through the anchor 2100 to pull the tethers 2102 away from the atrium 1076. In other embodiments, other methods may be utilized to pull the tethers 2102 away from the atrium 1076. In one embodiment, a rail structure may be utilized to guide the implant 70 in a ventricular direction for coupling to the leaflet 1087.

[0226] In one embodiment, an elongate shaft 12 may be utilized to push the implant 70 in a ventricular direction for coupling to the leaflet 1087. In one embodiment, another pushing device (such as a device that may be passed through the superior vena cava 1081) may be utilized to push the implant 70 in a ventricular direction. Combinations of methods may be utilized as desired. The implant 70 in a predetermined position within the tricuspid annulus is shown in FIG. 38B.

[0227] In embodiments, the implant may, as desired, extend over the heart valve flap or cusp 1087 and include a distal anchor for anchoring to the heart valve flap or cusp 1087. The implant 70 may be anchored to the heart valve flap or cusp 1087. In embodiments, such a distal anchor may be excluded.

[0228] The systems, devices, and methods disclosed with respect to FIGS. 13A - 38B and FIGS. 62A - 64C can be utilized with any of the embodiments disclosed in this application in any desired combination, substitution, or any other variation.

[0229] Implants utilized in accordance with the systems, devices, and methods disclosed herein can include ports configured to receive diagnostic or therapeutic devices. Such diagnostic or therapeutic devices can include a pacemaker pacing lead. Embodiments of such implants are shown in FIGS. 39A - 44.

[0230] Referring to FIG. 39A, an embodiment of the implant 1500 in an expanded configuration is shown. The implant 1500 can include an inner frame 1520, an outer frame 1540, a valve body 1560, and one or more skirts such as an outer skirt 1580 and an inner skirt 1590.

[0231] Referring first to the inner frame 1520, the inner frame 1520 can include an inner frame body 1522 and an inner frame anchoring feature 1524. The inner frame body 1522 can have an upper region 1522a, an intermediate region 1522b, and a lower region 1522c. As shown, the inner frame body 1522 can generally have a bulbous shape such that the diameters of the upper region 1522a and the lower region 1522c are smaller than the diameter of the intermediate region 1522b.

[0232] The illustrated inner frame body 1522 is bulbous, although it is understood that the diameters of the upper region 1522a, the middle region 1522b, and / or the lower region 1522c may be the same such that the inner frame body 1522 is generally cylindrical along one or more regions. Further, all or part of the inner frame body 1522 may have a non-circular cross-section, such as, but not limited to, a D-shaped, elliptical, or oval cross-section.

[0233] Referring next to the outer frame 1540 shown in FIG. 39A, the outer frame 1540 can be attached to the inner frame 1520 using any suitable fasteners and / or other techniques. Although the outer frame 1540 is shown as a separate component from the inner frame 1520, it is understood that the frames 1520, 1540 can be formed as a single or integral unit.

[0234] As shown in the illustrated embodiment, the outer frame 1540 can include an outer frame body 1542. The outer frame body 1542 can have an upper region 1542a, a middle region 1542b, and a lower region 1542c.

[0235] The upper region 1542a of the outer frame body 1542 can include a first section 1546a and a second section 1546b. The first section 1546a can be sized and / or shaped to generally conform to the size and / or shape of the inner frame 1520.

[0236] The middle region 1542b of the outer frame body 1542 can extend generally downwardly from the section 1546b that extends outwardly from the upper region 1542a.

[0237] Although the intermediate region 1542b and the lower region 1542c are described as cylindrical, it is understood that the diameters of the upper end, the lower end, and / or portions therebetween may be different. For example, all or part of the outer frame body 1542 may have a non-circular cross-section, such as a D-shaped, elliptical, or otherwise oval cross-section, without limitation.

[0238] The outer frame 1540, such as the outer frame body 1542, may be used to attach or fix the implant 1500 to a native valve such as a native tricuspid valve. For example, the intermediate region 1542b and / or the anchoring feature 1524 of the outer frame body 1542 may be positioned to contact or engage a native valve annulus, tissue distal to the native valve annulus, a native valve leaflet, and / or other tissue at or around the implantation site during one or more phases of the cardiac cycle, such as systole and / or diastole.

[0239] Continuing to refer to the implant 1500 shown in FIG. 39A, the valve body 1560 is attached to the inner frame 1520 within the interior of the inner frame body 1522. The valve body 1560 functions as a one-way valve to permit blood flow in a first direction through the valve body 1560 and to block blood flow in a second direction through the valve body 1560.

[0240] The valve body 1560 may comprise a plurality of valve leaflets 1562, such as three valve leaflets 1562, that are joined at the seams. The valve body 1560 may comprise one or more intermediate components 1564. The intermediate component 1564 may be positioned between a portion or all of the valve leaflets 1562 and the inner frame 1520 such that at least a portion of the valve leaflets 1562 are coupled to the frame 1520 via the intermediate component 1564.

[0241] Next, referring to the outer skirt 1580 shown in FIG. 39A, a cover in the form of the outer skirt 1580 can be attached to the inner frame 1520 and / or the outer frame 1540. As shown, the outer skirt 1580 can be positioned and fixed around a portion or the entire exterior of the outer frame 1540.

[0242] Next, referring to the inner skirt 1590 shown in FIG. 39A, a cover in the form of the inner skirt 1590 can be attached to the valve body 1560 and the outer skirt 1580.

[0243] The implant 1500 has been described as including the inner frame 1520, the outer frame 1540, the valve body 1560, and the skirts 1580, 1590, but it is understood that the implant 1500 need not include all of the components.

[0244] The implant 1500 can include a port 1591 that is coupled to the valve body 1560 and configured to receive a diagnostic or therapeutic device that can include a pacemaker lead. The port 1591, as shown in FIG. 39A, can include a tube that extends along the height of the implant 1500 to guide a pacemaker lead through the implant 1500. The tube of the port 1591 can include an inlet opening 1592 and an outlet opening 1593, with a central lumen 1594 extending between the inlet opening 1592 and the outlet opening 1593. The tube can have a cylindrical shape or, as shown in FIG. 39A, can have the shape of an oppositely reversed funnel. The tube can be configured to have a pacemaker lead passed therethrough from the inlet opening 1592 along the central lumen 1594 to the outlet opening 1593.

[0245] Port 1591 can be positioned on the outer frame 1540 of the valve body 1560. The valve body 1560 can form a valve annulus 1595 where the valve tip 1562 is positioned, and the port 1591 can be positioned outside the valve annulus 1595. Thereby, the pacemaker lead passing through the port 1591 can avoid interference with the movement of the valve tip 1562.

[0246] Port 1591 can be configured to pass through the outer skirt 1580 of the implant 1500 and can pass through the opening of the outer frame 1540 and between the struts of the outer frame 1540. Ports 1591 in other locations may be utilized in other embodiments.

[0247] FIG. 39B shows an alternative of the embodiment of FIG. 39A with changes to the design of the cover or skirt (or cloth) 1580 / 1590. As shown, the skirt 1580 / 1590 can contact both the inner frame 1520 and the outer frame 1540. The skirt 1580 / 1590 can start from the inside of the outer frame 1540, transition to the outside of the outer frame 1540, then adhere to the outer bottom of the inner frame 1520, and then proceed upward along the outside of the inner frame 1520. By closing the skirt 1580 / 1590, this can avoid / reduce thrombus formation / embolism.

[0248] Thus, the port 1591 can pass through both the upper part and the lower part of the skirt 1580 as shown in FIG. 39B.

[0249] FIGS. 39C - 39D respectively show diagrams of embodiments of the implant 1600 in an expanded configuration. The implant 1600 can have a structure similar to the previously described implant 1500. The implant 1600 can include an inner frame 1620, an outer frame 1640, a valve body 1660, and one or more skirts such as an outer skirt 1680 and an inner skirt 1690. A perspective view of the port 1591 is shown extending from the top surface of the implant 1600.

[0250] Referring initially to the outer frame 1640 shown in FIGS. 39C - 39D, the outer frame 1640 can be attached to the inner frame 1620 using any known fasteners and / or techniques. The outer frame 1640 is shown as a separate component from the inner frame 1620, but it should be understood that the frames 1620, 1640 can be unified or formed as one piece.

[0251] As shown in the illustrated embodiment, the outer frame 1640 can include an outer frame body 1642. The outer frame body 1642 can have an upper region 1642a, an intermediate region 1642b, and a lower region 1642c. At least a portion of the upper region 1642a of the outer frame body 1642 can be sized and / or shaped to generally conform to the size and / or shape of the upper region 1622a of the inner frame 1620.

[0252] When in an extended configuration, such as a fully extended configuration, the outer frame body 1642 can have a shape similar to that of the outer frame body 1542 previously described in connection with FIG. 39A. However, it is understood that all or part of the outer frame body 1642 can have a non - circular cross - section, such as, but not limited to, a D - shaped, oval, or otherwise egg - shaped cross - section.

[0253] Continuing to refer to the implant 1600 shown in FIG. 39C, the outer frame body 1642 can include a plurality of struts with at least a portion of the struts forming cells 1646a - 1646c.

[0254] The upper row of cell 1646a can have an irregular octagonal shape such as a "heart" shape. Such additional space can be beneficial in allowing the outer frame 1640 to maintain a smaller outer profile when the pleats are formed. Cell 1646a can be formed via a combination of struts. As shown in the illustrated embodiment, the upper row of cell 1646a can be formed from a set of circumferentially extensible struts 1648a having a zigzag or wavy shape forming a repeating "V" shape.

[0255] The middle portion of cell 1646a can be formed from a set of struts 1648b extending downward from each bottom end of the "V" shape.

[0256] The lower portion of cell 1646a can be formed from a set of circumferentially extensible struts 1648c having a zigzag or undulating shape forming a repeating "V" shape.

[0257] The middle and / or lower rows of cells 1646b, 1646c can have a different shape than the first row 1646a. The middle row of cell 1646b and the lower row of cell 1646c can have a diamond shape or generally a diamond shape. The diamond shape or generally a diamond shape can be formed via a combination of struts.

[0258] The upper portion of cell 1646a can be formed from a set of circumferentially extensible struts 1648c such that cell 1646b shares struts with cell 1646a. The lower portion of cell 1646b can be formed from a set of circumferentially extensible struts 1648d. As shown in the illustrated embodiment, one or more of the circumferentially extensible struts 1648d can extend generally downward and generally parallel to the longitudinal axis of the outer frame 1640.

[0259] The upper portion of cell 1646c can be formed from a set of circumferentially extensible struts 1648d such that cell 1646c shares a strut with cell 1646b. The lower portion of cell 1646c can be formed from a set of circumferentially extensible struts 1648e. The circumferentially extensible struts 1648e can generally extend downwardly.

[0260] As shown in the illustrated embodiment, implant 1600 can include a set of tabs 1650. The upper set of tabs 1650 can extend from the upper region 1642a of the outer frame body 1642. As shown, the upper set of tabs 1650 can extend from the upper portion of cell 1646a, such as the upper apex of cell 1646A. The upper set of tabs 1650 can be used to attach the outer frame 1640 to the inner frame 1620.

[0261] The outer frame 1640 can include a set of locking tabs 1652 that extend therefrom at or near the upper end of the upper region 1642a. As shown, the locking tabs 1652 can extend upwardly from the set of tabs 1650. The outer frame 1640 can include 12 locking tabs 1652, but it should be understood that a greater or fewer number of locking tabs may be used. The locking tabs 1652 can include longitudinally extending struts 1652a. At the upper end of the strut, the locking tab 1652 can include an enlarged head 1652b. As shown, the enlarged head 1652b can have a semi-circular or semi-elliptical shape that forms a "mushroom" shape with the longitudinally extending strut 1652a. The locking tabs 1652 can include tabs 1652c that can be positioned through the enlarged head 1652b. It is understood that the locking tabs 1652 may include tabs in other locations or may include two or more tabs.

[0262] The lock tab 1652 can be advantageously used with a plurality of types of delivery systems. For example, the shape of the strut and the enlarged head 1652b can be used to secure the outer frame 1640 to a "slot" based on a delivery system, such as the inner retaining member 40 described above. The stop 1652c and / or the stop 1650 can be used to secure the outer frame 1640 to a "tethering" based delivery system, such as one that utilizes sutures, wires or fingers to control the delivery of the outer frame 1640 and the implant 1600. This can advantageously facilitate re-catching and re-positioning the outer frame 1640 and the implant 1600 in their original positions.

[0263] The outer frame 1640, such as the outer frame body 1642, may be used to attach or secure the implant 1600 to a native valve, such as a native tricuspid valve. For example, the intermediate region 1642b and / or the tethering feature 1624 of the outer frame body 1642 may be positioned to contact or engage a native valve annulus, tissue distal to the native valve annulus, native valve leaflets, and / or other tissue at or around the implantation site during one or more phases of the cardiac cycle, such as systole and / or diastole. As another example, the outer frame body 1642 can be sized and positioned relative to the inner frame anchor mechanism 1624 such that it engages or sandwiches tissue of a body cavity positioned between the outer frame body 1642 and the inner frame anchor mechanism 1624, such as a native valve membrane and / or a native valve annulus, to further secure the implant 1600 to the tissue. As shown, the inner frame anchor mechanism 1624 includes nine anchors, but it should be understood that fewer or more anchors may be used. In some embodiments, the number of individual anchors can be selected as a multiple of the number of seams with respect to the valve body 1660.

[0264] The valve body 1660 may include a plurality of valve tips 1662, such as, for example, three valve tips 1662 that are joined at the seam. The valve body 1660 can include one or more intermediate components 1664.

[0265] Next, referring to the outer skirt 1680 shown in FIG. 39C, a cover or outer skirt 1680 can be attached to the inner frame 1620 and / or the outer frame 1640. The outer skirt 1680 is positioned to surround a portion, or all, of the outside of the outer frame 1640 and can be fixed thereto. The inner skirt 1690 can be attached to the valve body 1660 and the outer skirt 1680.

[0266] The implant 1600 has been described as including the inner frame 1620, the outer frame 1640, the valve body 1660, and the skirts 1680, 1690, but it should be understood that the implant 1600 need not include all of the components. For example, in some embodiments, the implant 1600 includes the inner frame 1620, the outer frame 1640, and the valve body 1660, but the skirt 1680 may be omitted. Further, although the components of the implant 1600 have been described and illustrated as separate components, it should be understood that one or more of the components of the implant 1600 may be formed integrally or as one piece. For example, in some embodiments, the inner frame 1620 and the outer frame 1640 may be formed integrally or as one piece as a single component.

[0267] Referring to FIG. 39C, the upper end of the port 1591 is shown extending from the upper surface of the skirt 1680 and the outer frame 1640. The opening 1592 can be lifted above the upper surface of the skirt 1680 and the outer frame 1640 so that a user can pass through to a diagnostic or therapeutic device that may include a pacemaker pacing lead passing through the opening 1592.

[0268] FIG. 39D shows a bottom view of the implant 1600 and shows the location of the outlet opening 1593.

[0269] Referring to FIGS. 39E - 39G, the port can have various forms. The port is shown isolated from the implant. Referring to FIG. 39E, the body of the tube of port 1591 can be made of a braided or woven material that exhibits a bias to constrict the central lumen 1594. The constriction of the central lumen 1594 can form a seal with a diagnostic or therapeutic device that may include a pacemaker pacing lead when the diagnostic or therapeutic device is inserted through port 1591 to prevent backflow of blood through port 1591. The braided material can be made of wires such as nitinol wires that are woven and heat - set. Other materials may be utilized as desired.

[0270] Port 1591 can include a position marker such as a radiopaque marker 1597 that identifies the location of port 1591, particularly the location of the opening 1592 of port 1591 in imaging.

[0271] FIG. 39F shows an embodiment of a port 2200 that includes a tube having an inlet opening 2202, an outlet opening 2204, and a body 2206 positioned between the inlet opening 2202 and the outlet opening 2204. The body 2206 can surround a central lumen 2208 through which a diagnostic or therapeutic device that may include a pacemaker pacing lead can pass. The body 2206 can be made of a polymer such as an elastomeric material like fluoroelastomer or silicone configured to be biased toward the central lumen 2208. The bias of the body 2206 toward the central lumen 2208 can form a seal with a pacemaker pacing lead when inserted through port 2200 to prevent backflow of blood through port 2200. Other materials may be utilized as desired.

[0272] Port 2200 may include a position marker, such as a radiopaque marker 2210, that identifies the position of port 2200, particularly the position of the opening 2202 of port 2200 in imaging.

[0273] FIG. 39G shows an embodiment of port 2300 that includes a tube having an inlet opening 2302, an outlet opening 2304, and a body 2306 positioned between the inlet opening 2302 and the outlet opening 2304. The body 2306 may surround a central lumen 2308 through which a pacemaker pacing lead passes. The central lumen 2308 may include a valve 2310 positioned therein, and the valve 2310 may form a seal with a diagnostic or therapeutic device that includes a pacemaker pacing lead when the diagnostic or therapeutic device is inserted through port 2300 to prevent backflow of blood through port 2300. The valve 2310 may include a duckbill valve or other form of valve.

[0274] Port 2300 may include a position marker, such as a radiopaque marker 2312, that identifies the position of port 2300, particularly the position of the opening 2302 of port 2300 in imaging. The body 2306 may be made from a polymer, elastomer, silicone, or braided material. Other materials may be utilized as desired.

[0275] Any embodiment of the ports disclosed herein may be implanted on either the outer or inner surface, or both, of the drug coating for release to the patient's body. Additionally, the coating may be provided on either the outer or inner surface, or both, to provide a surface with hydrophilic, hydrophobic, or antithrombotic properties.

[0276] Figures 40A - 40B illustrate an embodiment of a port 2400 having an opening in a valve body 1560 of an implant 1500. The port 2400 can extend through a cover or skirt of the implant 1500 that can include an outer skirt 1580 as shown in Figure 40A. The opening can be made of a material biased toward the center of the opening so that when a pacemaker pacing lead is passed through the opening, the material can form a seal with the pacemaker pacing lead to prevent backflow of blood through the port 2400. For example, an elastic material can form a seal with the pacing lead. As shown in Figure 40B, the opening can be positioned between struts of an outer frame to provide a passage for the lead to pass through. The opening can be surrounded by a position marker, such as a radiopaque marker that identifies the location of the opening of the port 2400, particularly in imaging, at the location of the port 2400.

[0277] Figure 41 illustrates an embodiment where a port 2500 includes a tearable portion of a valve body 1660. The tearable portion can be a tearable portion of an outer skirt 1680 as shown in Figure 41. The tearable portion can allow a diagnostic or therapeutic device to pass through. The tearable portion can be configured to be penetrated by a puncture device or a pacemaker pacing lead to pass through the tearable portion. The material surrounding the resulting opening in the skirt 1680 can be configured to be biased toward the opening to prevent backflow of blood through the port 2500. The tearable portion forms a flap that presses against the pacing lead to seal with the pacing lead because backflow is applied to the flap that contacts the lead. An elastic material can be used to form a seal against the lead. As shown in Figure 41, the opening can be positioned between struts of an outer frame to allow a passage for the pacing lead. The opening can be surrounded by a position marker, such as a radiopaque marker that identifies the location of the opening of the port 2500, particularly in imaging, at the location of the port 2500.

[0278] In one embodiment, the port can be positioned outside the outer valve body for positioning between the outer valve body and the annulus of the heart valve. The port can include a loop for materials through which a diagnostic or therapeutic device can pass.

[0279] FIG. 42 shows the use of port 1591 as shown in FIG. 39C. A diagnostic or therapeutic device that can include a pacemaker pacing lead 2600 can pass through port 1591. The tip 2602 of pacemaker pacing lead 2600 can be positioned within the right ventricle.

[0280] FIG. 43 shows the use of port 2400 as shown in FIG. 40B. A diagnostic or therapeutic device that can include a pacemaker pacing lead 2600 can pass through port 2400. The tip 2602 of pacemaker pacing lead 2600 can be positioned within the right ventricle.

[0281] The method can include passing a diagnostic or therapeutic device through a port positioned in a prosthetic heart valve body. The prosthetic heart valve body can form a prosthetic heart valve annulus. The port can include a tube for a diagnostic or therapeutic device to pass through.

[0282] FIG. 44 shows an embodiment configured such that port 2700 is coupled to pacemaker pacing lead 2600 to form an electrical connection between implant 1600 and pacemaker pacing lead 2600. The tip 2702 of pacemaker pacing lead 2600 can be coupled to port 2700 and configured to provide electrical energy to implant 1600. The frame of implant 1600 can provide electrical energy to pace the function of the patient's heart. Pacemaker pacing lead 2600 can be directly coupled to the implant frame, as shown in FIG. 44. The implant frame can be made of nitinol or another conductive material. The implant may include one or more electrical terminals 2703 in contact with the patient's body and configured to provide electrical energy to the patient's body to pace the function of the patient's heart. For example, the terminals can be on the outside of the implant body or positioned on the valve tip anchor or other part of the implant in contact with a portion of the patient's heart.

[0283] In the embodiments disclosed herein, the prosthetic valve body can be deployed to the patient's cardiac valve annulus using the methods disclosed herein. The valve body can be expanded within the cardiac valve annulus and tethered to the cardiac valve flap or the valve tip of the cardiac valve. The valve body can be brought into contact with the patient's cardiac valve.

[0284] The method may include coupling a pacemaker pacing lead to a prosthetic heart valve body positioned within the patient's cardiac annulus to provide electrical energy through the pacemaker pacing lead and through the prosthetic heart valve body so as to pace the function of the patient's heart. The method may include providing electrical energy through a frame. The prosthetic valve body may comprise one or more electrical terminals in contact with a portion of the patient's heart. Electrical energy may be provided through the pacemaker pacing lead and through the prosthetic heart valve body to pace the function of the patient's heart.

[0285] If a conduction disorder is detected at the time of implant, or if chronic conduction problems develop over time, any embodiment of the port for the pacemaker pacing lead may be utilized emergently.

[0286] Diagnostic or therapeutic devices may comprise not only a pacemaker pacing lead, but also other forms of devices such as catheters or other medical devices passed through an implant.

[0287] The implant embodiments disclosed herein may be utilized alone or across embodiments as desired. Such embodiments may be utilized in the tricuspid valve, mitral valve, or other valves as desired. The features of the implant embodiments may be combined across embodiments as desired.

[0288] Any and all of the embodiments disclosed herein may be utilized with a powered implant delivery system. Further, in any and all embodiments, the delivery system may utilize a processor for control of at least one motor for operating the delivery device. Further, in any and all embodiments, the delivery system may comprise a sensor as disclosed herein. The delivery system may comprise a sensor configured to sense one or more of the state of the patient's body or the state of the delivery device. The processor may process signals provided by the sensor, and the signals may include a feedback signal to the processor.

[0289] Features of such systems are disclosed in U.S. Provisional Patent Application No. 62 / 837,641, filed Apr. 23, 2019, the entire contents of which are incorporated herein by reference. Features of such systems are also disclosed in PCT Application PCT / US2020 / 029138, filed Apr. 21, 2020, the entire contents of which are incorporated herein by reference (along with the U.S. national stage application for PCT Application PCT / US2020 / 029138).

[0290] Referring to FIG. 45, an elongated shaft 12 and a housing in the form of a handle 15 can form a delivery device configured to deliver an implant 70 to a location within a patient's body. The delivery device can include the use of a sheath 610 as shown in FIG. 45 and can include a deflection mechanism disclosed herein. The delivery system 10 can include at least one motor configured to operate at least a portion of the delivery device. The operation of at least a portion of the delivery device can include deflection of a portion of the delivery device (including the elongated shaft) or other movement of the delivery device and can include actuation of the operation of the delivery device. The operation can include, among other operations of the delivery device, deployment (complete or partial) of the implant 70 to that location in the body. The motor can include a motor 500 as shown in FIG. 46 or, among other forms of motors, can include a plurality of motors 502 as shown in FIG. 61 (i.e., can include at least one motor).

[0291] As shown in FIG. 45, a housing in the form of a handle 15 can be positioned at the proximal end 11 of the elongated shaft 12. The proximal end 11 of the elongated shaft 12 can be coupled to the handle 15. The handle 15 can include a control device 504 configured to control at least one motor. A control device 504 as shown in FIG. 45 can include a plurality of buttons, although in other embodiments, other forms of control devices can be utilized. The control device 504 can be positioned on the handle 15 as shown in FIG. 45 or can be located remotely.

[0292] FIG. 46 shows a cross-sectional view of a handle 15 that includes a motor 500 and an actuator mechanism 506 that can be utilized to operate at least a portion of a delivery device. In various embodiments, the motor and actuator mechanism may be used to operate a pull wire while advancing through the vasculature. The motor and actuator mechanism may be used to operate a shaft / sheath to deploy and release an implant at a treatment site. The body of the handle 15 may include a plurality of components including a distal portion 508 and a proximal portion 510. The distal portion 508 as shown in FIG. 46 may be configured to hold the actuator mechanism 506, and the proximal portion 510 may be configured to hold the motor 500. In other embodiments, other components may be positioned within their respective distal portion 508 and proximal portion 510, and in certain embodiments, the handle 15 may include a single body. In the embodiment shown in FIG. 46, the distal portion 508 and the proximal portion 510 may be configured to couple together via couplers 512, 514 (to be labeled in FIGS. 49 and 50) and may be separable from each other in certain embodiments.

[0293] The actuating mechanism 506 may take the form as shown in FIG. 46 and may include a plurality of adapters 516a - g configured to engage a plurality of drive rods 518a - g (drive rods 518f - g are marked in FIG. 48). Each adapter 516a - g may comprise a plate or other body including a plurality of openings. FIG. 47 shows a front plan view of the adapter 516a. The adapter 516a shown in FIG. 47 may include openings 520a - g and 522. Each of the openings 520a - g may be configured to allow the respective drive rods 518a - g to pass therethrough (as represented in FIG. 48). The openings 520b - g may each be configured to be smooth seating surfaces that do not engage the respective drive rods 518b - g. However, the opening 520a may be configured to have a threaded or other surface that engages the drive rod 518a. For example, the drive rod 518a may include a gear thread, and the opening 520a may include a thread that matches the gear thread. Such a configuration allows the drive rod 518a to actuate the adapter 516a in two directions (distal and proximal) based on the direction in which the drive rod 518a rotates. Other forms of engagement may be utilized in other embodiments.

[0294] The central opening 522 may allow other components of the actuating mechanism 506, such as an assembly connector, to pass through the central opening and couple to the remaining respective adapters 516a - g.

[0295] FIG. 48 shows a perspective view of the adapter 516a with representative drive rods 518a - g extending through the openings 520a - g.

[0296] The other adapters 516b - g may be configured similarly to adapter 516a, but each of the respective adapters 516b - g may have an opening configured to engage with its respective drive rod 518b - g with the remaining opening having a smooth seating surface. For example, with respect to adapter 516b, an opening equivalent to opening 520b may be configured to engage drive rod 518b, while the remaining equivalent openings for openings 520a, 520c - g may have a smooth seating surface. Adapters 516c - g each have respective similar openings configured to engage with their respective drive rods 518c - g. In this way, a single drive rod 518a - g may be configured to actuate each respective dedicated adapter 516a - g. The remaining drive rods may pass through the remaining adapters without engaging the adapters.

[0297] Referring to FIG. 46, adapters 516a - g may be configured to slide within the internal cavity of the housing that includes handle 15. The outer surfaces of adapters 516a - g may be positioned, for example, on a track within handle 15 or otherwise configured to slide or move within handle 15.

[0298] Drive rods 518a - g may extend longitudinally along the interior of handle 15 and may be configured to engage with their respective adapters 516a - g. For example, FIG. 46 shows adapter 516a engaged by drive rod 518a and adapter 516g engaged by drive rod 518e (adapter 516g may utilize other configurations where, for example, adapter 516g is engaged by drive rod 518g in a configuration where it is configured to be engaged by drive rod 518e). The proximal ends of drive rods 518a - g may engage motor 500 and may be configured to be actuated by motor 500.

[0299] The adapters 516a - g may be coupled to an assembly connector that couples to respective portions of an assembly (outer sheath assembly 22, intermediate shaft assembly 21, rail assembly 20, inner assembly 18, and nose cone assembly 31), including the tension wire assemblies 138, 140. In certain embodiments, the adapters 516a - g may couple to specific components that each comprise the assembly. For example, in a particular embodiment, adapter 516a may directly couple to nose cone shaft 27. The coupling of the adapters 516a - g to the assembly connector may be such that adapter 516a couples to assembly connector 521 for the outer sheath assembly 22. Adapter 516b may couple to assembly connector 523 for the intermediate shaft assembly 21. Adapter 516c may couple to assembly connector 524 for the rail assembly 20. Adapter 516d may couple to an assembly connector for the distal tension wire 138, or may directly couple to the distal tension wire 138. Adapter 516e may couple to an assembly connector for the proximal tension wire 140, or may directly couple to the proximal tension wire 140. Adapter 516f may couple to assembly connector 526 for the inner assembly 18. Adapter 516g may couple to assembly connector 528 for the nose cone assembly 31. The assembly connectors 521, 523, 524, 526, 528 may comprise sheaths that extend concentrically over one another, or may comprise rods, wires, or other forms of connectors. The assembly connectors 521, 523, 524, 526, 528 may be configured to pass through a central opening (e.g., opening 522 shown in FIG. 47) of each respective adapter 516a - g.

[0300] The assembly connectors 521, 523, 524, 526, 528 may each have a proximal portion coupled to respective adapters 516a, b, c, f, g for actuating the respective assemblies, and a distal portion coupled to a part of the respective assembly. For example, the assembly connector 521 may be coupled to the outer sheath assembly 22 such that movement of the assembly connector 521 moves the outer cover, i.e., the sheath of the outer sheath assembly 22, to expose the implant 70 within the capsule 106. The assembly connector 523 may be coupled to the intermediate shaft assembly 21 such that movement of the assembly connector 523 moves the outer retaining member 42. The assembly connector 524 may be coupled to the rail assembly 20 such that movement of the assembly connector 524 moves the rail assembly 20. Movement of the adapters 516d and 516e may move the respective tension wires 138, 140. The assembly connector 526 may be coupled to the inner assembly 18 such that movement of the assembly connector 526 moves the inner retaining member 40. The assembly connector 528 may be coupled to the nose cone assembly 31 such that movement of the assembly connector 528 moves the nose cone 28. Each drive rod 518a - g may be actuated by the motor 500 to selectively move the respective adapters 516a - g, and accordingly, the respective parts of the assemblies (outer sheath assembly 22, intermediate shaft assembly 21, rail assembly 20, inner assembly 18 and nose cone assembly 31).

[0301] The movement of the assembly (outer sheath assembly 22, intermediate shaft assembly 21, rail assembly 20, inner assembly 18, and nose cone assembly 31) may be the translation of each assembly, which may include tension wires 138, 140, to produce a desired movement (e.g., deflection) or operation (e.g., deployment of the implant). For example, the motor 500 may be configured to translate the rail shaft of the rail assembly 20 relative to the inner sheath of the inner assembly 18 and the outer sheath of the outer sheath assembly 22. In certain embodiments, the motor 500 may be configured to translate the outer sheath of the outer sheath assembly 22 relative to the inner sheath of the inner assembly 18. The motor 500 may be configured to translate any of the assemblies relative to each other to produce a desired result. The motor 500 may be configured to manipulate the rail assembly 20, for example, by actuating the tension wires 138, 140. Other movements may include actuating the depth of the elongate shaft 12 and actuating the movement of the elongate shaft 12, such as the full or partial deployment of the implant 70. The movement may be that of the deflection mechanism disclosed herein.

[0302] In other embodiments, the actuation of the delivery device by the motor 500 may occur in a manner different from that shown in FIG. 46. In one embodiment, the configuration of the actuation mechanism 506 may be different from the configuration shown in FIG. 46.

[0303] The delivery system 10 may include a controller 530 configured to control the operation of the motor 500 and thereby control the actuation of a portion of the delivery device. The controller 530, as shown in FIG. 46, may include an input device and an output device (labeled as item 532). The controller 530 may include a memory 534 and a processor 536. The controller may include a power supply 538.

[0304] The input device and output device 532 may have multiple configurations, including electrical ports or terminals configured to transmit electrical signals. The input device may be configured to receive signals from the motor 500 and from sensors positioned on the delivery system 10. The output device may be configured to transmit signals receivable from the processor 536 or other components of the system 10 to the motor 500 or other components of the system 10. In certain embodiments, the input device and output device 532 may comprise a wireless transmission device, such as a Wi-Fi or Bluetooth® device or other device configured for wireless communication. In one embodiment where the controller 530 is positioned remotely from the delivery device, the input device and output device 532 may be configured to transmit and receive information via the Internet or other forms of communication media. In other embodiments, other forms of input and output devices may be utilized.

[0305] Memory 534 may be configured to store programs for operation by processor 536, as well as other data desired to be stored in controller 530. Memory 534 may be configured to store and log data regarding the patient and the operation of motor 500 and the delivery device during treatment, thereby enabling the system to learn from past events. The mode of learning may be based on an algorithm capable of identifying treatments that have produced positive results in the past, thereby enabling the system to continuously improve the treatment and increase the probability of success. Preferably, the data can be pooled from different patients, different clinicians, and / or different hospitals. Editing of the data can be used to increase accuracy and improve results in future treatments. This can be achieved, for example, by comparing the characteristics of a new patient with those of patients treated in the past. Data from treatments on past patients with similar anatomical structures and / or other parameters such as patient gender, age, and health are particularly useful. Other parameters such as the clinician's skill level and amount of experience and / or the equipment available at the hospital may also be incorporated into the algorithm. The data may be used in machine learning algorithms that utilize data from past implantation procedures or from patient characteristics.

[0306] Memory 534 may comprise various forms of memory, including a hard disk, solid state memory, various forms of RAM or ROM, or other forms of memory. In one embodiment, memory 534 may be configured to be removable from controller 530 for storage and / or data analysis. A separate memory 534 may be installed in controller 530, or may be exchanged within controller 530 or removed from controller 530 as desired for a particular form of operation.

[0307] Processor 536 may be configured to execute the processes disclosed herein, for example, to provide signals to components of system 10, such as motor 500, to execute a desired process. Processor 536 may be configured to operate motor 500 or at least one motor 500 to activate at least a portion of the delivery device. Processor 536 may be configured to operate at least one motor 500 to move (e.g., deflect or control the depth of elongate shaft 12) at least a portion of the delivery device, or to perform an operation of the delivery device, which operation may include deploying implant 70 from the delivery device. Processor 536 may be configured to implement a process stored in memory 534. Processor 536 may be configured to receive signals from components of system 10, such as a control device (e.g., control device 504) or a sensor of system 10. Processor 536 may be configured to process based on such signals and perform operations. Processor 536 may comprise a microprocessor or other form of processor as desired. In one embodiment, processor 536 may comprise multiple processors and may be distributed, in one embodiment, in a cloud computing environment or the like.

[0308] Power source 538 may be configured to provide power to components of controller 530, or may be configured to provide power to motor 500 or other components of system 10. Power source 538 may comprise one or more batteries according to a particular embodiment, which may be rechargeable from controller 530 or other components of system 10 as desired and may be detachable. In one embodiment, power source 538 may comprise a power plug, such as an AC plug, and may include a power regulator for converting AC power to power usable by system 10. Other forms of power source 538 (e.g., among others, supercapacitors, solar cells) may be used in other embodiments as desired.

[0309] The components of the controller 530 may be positioned together as shown in FIG. 46, or may be distributed as desired. The components of the controller 530 may be positioned within a separate housing or control box and may be coupled to the delivery device using a cable or the like. FIG. 46 shows a cable connection of the controller 530 to the delivery device. In other embodiments, wireless communication may be possible between one or more components of the controller 530 and the delivery device. In other embodiments, the components of the controller 530 may be positioned within the housing of the delivery device, for example, in the configuration shown in FIG. 61.

[0310] A power and signal connector 540 may extend between the controller 530 and the delivery device. For example, the signal connector 540 is shown extending along a portion of the handle 15 and may be coupled between the distal portion 508 and the proximal portion 510 of the handle 15 at the electrical coupler 542. The power connector 540 may extend from the power supply 538 of the controller 530 to the motor 500.

[0311] FIG. 49 shows a perspective view of the distal portion 508 of the handle 15. The distal portion 508 of the handle 15 may be configured to separate from the proximal portion 510 (shown in FIG. 50). Such a configuration may allow a particular portion of the handle 15 of the delivery device to be utilized in the delivery of the implant and then separated from another portion (e.g., the proximal portion 510) of the handle 15 so that the distal portion 508 can be sterilized or discarded. This process may separate the electrical components of the system 10, which may include the motor 500 positioned within the proximal portion 510 or may include the controller 530, from components that are inserted into or contact a part of the patient's body. This may increase the reusability of the system 10 and reduce the overall complexity associated with sterilizing the system 10. As shown in FIG. 49, the proximal portions of the drive rods 518a-g may extend proximally from the distal portion 508 of the handle 15 for coupling to respective openings 544a-g within the proximal portion 510 of the handle 15. By coupling the proximal portions of the drive rods 518a-g to the respective openings 544a-g, the motor 500 may be enabled to engage the drive rods 518a-g. The electrical coupler 542 and the coupler 512 are also shown protruding from the distal portion 508 of the handle 15.

[0312] FIG. 50 shows a perspective view of the proximal portion 510 of the handle 15. The proximal portion 510 may include the cable 546, or other connector that couples the proximal portion 510 to the controller 530, which may be housed in a control box or the like.

[0313] Referring again to FIG. 49, control device 504 is shown on distal portion 508 of handle 15 to include a plurality of buttons. Control device 504 may be configured to receive input from a user and operate motor 500, thereby operating a portion of the delivery device. Control device 504 may be configured to transmit a signal directly to motor 500 or may be transmitted to processor 536 of controller 530 for processing. Control device 504 may be configured to control deflection and movement of the delivery device. Control device 504 may be configured to control operation of the delivery device, such as deployment of implant 70. Control device 504 may have various forms and may have portions designated to control specific movement or operation of the delivery device as shown in FIG. 49.

[0314] The control device 504 of FIG. 49 may include a button 548 for controlling the rail assembly 20 and, in particular, for controlling the direction of deflection of the rail assembly 20, where the direction of deflection may be in at least two planes. The button 548 may be configured to control the maneuvering of the rail assembly 20. The user may press the desired button 548 to activate the delivery device to deflect the motor in the desired direction. The control device 504 of FIG. 49 may include a button 550 for controlling the depth of the elongate shaft 12 by sliding an assembly including, for example, the outer sheath assembly 22, the intermediate shaft assembly 21, the inner assembly 18, and the nose cone assembly 31 relative to the rail assembly 20. The button 550 may enable the user to increase or decrease the depth. The control device 504 of FIG. 49 may include a button 552 for activating the deployment of the implant 70. For example, the button 552 may activate the delivery device to the motor to retract the outer sheath assembly 22 and the intermediate shaft assembly 21 to deploy the implant 70. The control device 504 of FIG. 49 may include a button 554 for activating the movement of the nose cone assembly 31 to advance or retract the nose cone 28. Various configurations of control may be utilized to deflect the delivery device or to execute the operation of the delivery device. The control signal from the control device 504 may be sent directly to the motor 500 for operation, or may be sent to the processor 536 for processing in order to operate the motor 500 to activate at least a portion of the delivery device. The configuration of the control device 504 may be changed in other embodiments. The control signal may be utilized to operate the deflection mechanism disclosed herein.

[0315] Other embodiments of the control device that may be utilized include, among other forms of control devices, buttons, joysticks, touch pads, touch screens, knobs, or motion sensing devices.

[0316] System 10 may include an output device that may have various forms. The output device may be configured to provide the user with an output that may indicate the state of the delivery device or the state of the patient. The output device may be configured to provide an indicator of the state of the delivery device or the state of the patient. The output device may include a light source that may illuminate to indicate the state of the delivery device or the state of the patient. The light source may illuminate to indicate that it is in contact with or close to the surface of the patient's body (state of the delivery device), or may illuminate to indicate a particular state of the patient's body, such as accurate or inaccurate pressure sensed within the patient's body. Other forms of the output device may be utilized, including a tactile device such as a vibration actuator, which may indicate the state of the delivery device or the state of the patient. The output device may include a display screen of a touch screen. The output device may include a display screen 584 as shown in FIG. 59. The output device may include one or more of a display screen, a light source, a speaker, or a tactile device among other forms of the output device. Various forms of the output device may be utilized as desired. The indicator generated on the output device may include one or more of an image, data, audio, light, or tactile signal. The output device may be configured to provide an indicator based on the output provided by the processor 536.

[0317] The operation of the delivery device by at least one motor may include the translation of the elongate shaft 12 and may include the translation of the housing at the proximal end of the elongate shaft 12. Axial translation of the delivery device may be provided. FIG. 51 shows, for example, a side perspective view of a delivery device including an elongate shaft 572 and a housing 574. The delivery device is being passed in a transfemoral manner into the patient's body 576. The elongate shaft 572 may be configured similarly to the elongate shaft 12. The housing 574 may be configured similarly to the housing forming the handle 15, although the housing 574 may not include a handle for gripping by the user. Rather, the housing 574 may include a motor or may be configured to move along a motor-driven rail 577 or other assembly that actuates the axial movement of the delivery device into the patient's body. The axial movement of the delivery device may be controlled by a control device, which may be positioned proximate to the housing 574 or may be disposed remotely from the housing 574.

[0318] The motor 500 may be configured to operate the delivery device by selectively moving one or more of the outer sheath assembly 22, the intermediate shaft assembly 21, the inner assembly 18, the rail assembly 20, the assembly including the distal pull wire 138, the assembly including the proximal pull wire 140, and the nose cone assembly 31. The motor may be configured to implement any other method or may be utilized in any of the embodiments disclosed herein, including the embodiments of FIGS. 13A - 44 and FIGS. 62A - 64C.

[0319] In certain embodiments, the processor 536 may be utilized to automatically move the assembly or other portions of the elongate shaft 12 to perform the operation of the delivery device. For example, if a request is made to increase the depth of the elongate shaft 12 or deploy the implant 70, the processor 536 may then be configured to operate a program (which may be stored in the memory 534) to control the motor 500 to move the corresponding assembly or other portion of the elongate shaft 12. If a request is made that requires compensation for movement, the processor 536 may then be configured to operate a program (which may be stored in the memory 534) to control the motor 500 to move the corresponding assembly or other portion of the elongate shaft 12 to automatically perform such compensation. The processor 536 may be configured to operate the motor to move one of the assemblies to compensate for the movement of another of the assemblies. Particular movements or combinations of movements of the assembly or other portions of the elongate shaft 12 may be programmed in the memory 534 and operated by the processor 536. As discussed above, the programmed movements may be “learned” from previous procedures, specifically, based on data learned from previous procedures performed on patients having similar anatomical structures and / or other characteristics. The movements may be based on machine learning algorithms that utilize data from past implantation procedures or from patient characteristics. Thus, the steps of procedures successfully performed on patients having similar anatomical structures can be repeated, thereby increasing the likelihood of success of the procedure for the current patient. The processor 536 may be configured to automatically operate the motor 500 to actuate a part of the delivery device in a desired manner.

[0320] The system 10 may include sensors configured to sense the state of the delivery device and may include sensors configured to sense the state of the patient.

[0321] In certain embodiments, sensors may be utilized to sense the state of the delivery device. The sensors may comprise position sensors that may be utilized to identify the movement and / or position of one or more of the assemblies. For example, the position sensors may be configured to sense the amount by which the motor 500 has moved an assembly to track the position and movement of the assembly. The motor 500 may be wired to track the movement of various assemblies based on signals from the position sensors and to perform desired movements (e.g., simultaneous movement of assemblies, or movement for compensation of one or more assemblies). In one embodiment, signals from the position sensors may be provided to the processor 536 for the processor 536 to perform desired movements. The signals from the position sensors may be feedback signals to the processor 536. For example, the position sensors may sense that a portion of the elongate shaft 12 is moving in response to movement of another portion of the elongate shaft 12, and the processor 536 may operate the motor 500 to produce a movement for compensation based on this signal. An indicator indicative of the position of the delivery device may be provided to an output device as discussed herein. The indicator may be provided based on the position sensed by the position sensors.

[0322] The sensors may be utilized to sense the state of the delivery device in the form of a motor torque sensor. The sensors may be utilized to identify the amount of torque exerted by the motor 500. The motor torque sensor may be, for example, a current draw sensor capable of sensing the amount of current drawn by the motor 500. When the amount of torque exceeds a specific amount, the motor 500 may be configured to automatically stop its operation, or reverse, or reduce the torque. In one embodiment, the signal from the motor torque sensor may be provided to the processor 536 for the processor 536 to perform the desired movement. The signal from the motor torque sensor may be a feedback signal to the processor 536. For example, based on this signal, the processor 536 may operate the motor 500 to automatically stop its operation, or reverse, or reduce the torque. An indicator indicating the torque of the motor of the delivery device may be provided to the output device as discussed herein. The indicator may be provided based on the torque sensed by the motor torque sensor.

[0323] Referring to FIG. 52, sensors configured to sense the patient's condition may be utilized. Such sensors may be positioned as desired on the delivery device. Sensors configured to sense the patient's condition may include a peripheral pressure sensor 578. Such a pressure sensor 578 may be configured to sense pressures such as fluid pressure within the patient's body. The pressure sensor 578 may be utilized during and after delivery of the implant 70 to determine whether the deployed implant 70 is operating as desired after implantation, or to monitor the patient's condition generally before and after implantation. In the embodiment shown in FIG. 52, the pressure sensor 578 may be positioned on the nose cone 28 and, among other locations, may be positioned on the capsule 106. In this particular configuration of the pressure sensor 578, one pressure sensor may be positioned in the right ventricle during implantation of the implant 70 and one pressure sensor may be positioned in the right atrium during implantation. Thus, after implantation, the pressure gradient across the mitral valve can be determined. Signals from the pressure sensor 578 may be provided to an output device (such as output devices 568, 570 or other output devices) for indication to the user. In one embodiment, the pressure sensed by the pressure sensor 578 may be utilized as feedback to the system 10, such as the processor 536, to operate the delivery device. For example, if an inaccurate pressure is read, the processor 536 may operate the delivery device to redeploy the implant or perform another operation. In other embodiments, other positions of the pressure sensor 578 and other pressure readings may be provided.

[0324] In one embodiment, the sensor configured to sense the state of the delivery device may include a sensor configured to sense the spatial relationship between the delivery device and the surface of the patient's body. Such a sensor may be positioned on the delivery device. Such a sensor may include a contact sensor 580. The contact sensor 580 may comprise a force transducer or load cell, or other forms of contact sensor 580 configured to sense the force applied to the delivery device. As shown, the contact sensor 580 may be positioned at various locations on the elongated shaft 12, including on the nose cone 28 or other locations (such as on the outer surface of the generally elongated shaft 12). The contact sensor 580 may be configured to provide a signal when the elongated shaft 12 contacts a part of the patient's body. Such a signal may indicate the likelihood of damage to the patient's body by the elongated shaft 12. The signal from the contact sensor 580 may be provided to an output device (such as output devices 568, 570 or other output devices) for indication to the user. In one embodiment, the contact sensed by the contact sensor 580 may be utilized as feedback to the system 10, such as the processor 536, to operate the delivery device. For example, if contact with the surface is sensed, the processor 536 may then operate the delivery device to move away from that surface or stop the operation of the motor 500. In other embodiments, other positions of the contact sensor 580 and other contact sensors may be provided.

[0325] In one embodiment, the sensor configured to sense the state of the delivery device may include a proximity sensor 582. The proximity sensor 582 may be configured to sense the spatial relationship between the delivery device and the surface of the patient's body. Such a sensor may be positioned on the delivery device. The proximity sensor 582 may include a device for sensing the distance to a part of the patient's body, including the use of ultrasonic or echo signals or visual identification. As shown, the proximity sensor 582 may be positioned at various locations on the elongated shaft 12, including the nose cone 28 or other locations (such as on the generally outer surface of the elongated shaft 12). The proximity sensor 582 may be configured to provide a signal when the elongated shaft 12 approaches a part of the patient's body, and such a signal may be provided to an output device (such as output devices 568, 570 or other output devices) for the purpose of instructing the user. In one embodiment, the proximity sensed by the proximity sensor 582 may be utilized as feedback to the system 10, such as the processor 536, to operate the delivery device. For example, if proximity to a particular surface (such as the inner wall of a blood vessel) is sensed, the processor 536 may operate the delivery device to move away from that surface or stop the operation of the motor 500. Thus, the delivery device can be advanced through the patient's vasculature without damaging the inner wall of the blood vessel. This "smart catheter" technology can provide a significant improvement over current "blind catheters". For example, this technology can reduce or eliminate the possibility of vascular incision, which is an important and life-threatening risk associated with current delivery systems. Although embodiments have been described for purposes of illustration, it should be understood that other positions of the proximity sensor 582 and other proximity readings may be provided.

[0326] Figures 53 to 55 show an embodiment of a sensor configured to sense a patient's condition. The sensor includes a flow sensor that can sense a fluid flow (e.g., blood flow) within the patient's body. A plurality of sensors 583a - l (marked in FIG. 54) may be positioned on the delivery device to form a spaced - apart arrangement of the sensors 583a - l. The sensors 583a - l may be configured to sense a local fluid flow, and thus, the sensors 583a - l may sense a fluid flow within a local region of the body that is different from the fluid flow sensed by other sensors 583a - l. FIG. 53 shows a perspective view of the distal end of the elongated shaft 12 from which the sensors 583a - c can be seen on the capsule 106. FIG. 54 shows a cross - sectional view of the capsule 106 showing the spaced - apart arrangement of the sensors 583a - l. The sensors 583a - l may be positioned on the delivery device to sense fluid flow at a specific location proximate to the deployment site for the implant 70. Such a specific location may include the capsule 106 or another part of the delivery device.

[0327] FIG. 55 shows an exemplary operation of sensors 583a - l. The implant 70 may be deployed in the tricuspid valve with one distal anchor 80a capturing the valve leaflet 1108 and another distal anchor 80b not capturing the valve leaflet 1108. Sensors 583k, 583l may sense the blood flow due to the missed - captured valve leaflet 1108 and provide signals accordingly. Sensors 583a - l may be configured to sense the differential flow rates between sensors 583f, 583g proximate to the captured valve leaflet 1108 and sensors 583k, 583l proximate to the missed - captured valve leaflet 1108. The flow sensors 583a - l may be configured to provide a signal when flow is sensed and provide such a signal to an output device (such as output devices 568, 570 or other output devices) for user indication. In one embodiment, the flow rate sensed by the flow sensors 583a - l may be utilized as feedback to the system 10, such as the processor 536, to operate the delivery device. For example, if a flow rate indicating that the valve leaflet has been missed - captured is sensed, then the processor 536 may operate the delivery device to redeploy the implant 70 or perform another operation. In other embodiments, other positions of the flow sensors 583a - l and other flow readings may be provided.

[0328] Sensors configured to sense the state of the delivery device and sensors configured to sense the state of the patient may be coupled to the delivery device. However, in certain embodiments, sensors configured to sense the state of the delivery device and sensors configured to sense the state of the patient may not be coupled to the delivery device and may be outside the patient's body.

[0329] Signals from sensors configured to sense the state of the delivery device and sensors configured to sense the state of the patient may be utilized in a variety of ways. In one embodiment, the signals may be provided to an output device (such as output devices 568, 570 or other output devices) for instructions to the user. For example, the state of the delivery device may be indicated to the user in a variety of forms. For example, the output device may include one or more of a display screen, a light source, a speaker, or a tactile device, among other forms of the output device. The indicators generated on the output device may include one or more of an image, data, sound, light, or tactile signal. The user may be able to act in accordance with this based on this indicator. For example, if the indicator indicates that the delivery device has come into contact with a part of the patient's body, the user may then act accordingly to move the delivery device away from the body. Similarly, the state of the patient's body may be indicated to the user in a variety of forms.

[0330] In an embodiment, signals from sensors configured to sense the state of the delivery device and sensors configured to sense the state of the patient may be provided to processor 536. Processor 536 may provide a variety of outputs based on one or more of the state of the patient's body or the state of the delivery device sensed by one or more sensors. One such form of the output includes a log of data regarding an implantation procedure involving the delivery device. Such a log of data may be stored in memory 534. The data may be stored for subsequent retrieval by the user for analysis or may record a log of actions taken by the delivery device. For example, among other forms of sensor signals, position sensor signals may be logged to record the movement of the delivery device.

[0331] Processor 536 may provide an output to an output device based on the state of the patient's body or the state of the delivery device sensed by one or more sensors. The output may result in an indicator on the output device (such as output devices 568, 570 or other output devices) for an instruction to the user. For example, the state of the delivery device may be shown to the user in various forms. For example, the output device may include one or more of a display screen, a light source, a speaker, or a tactile device, among other forms of the output device. Processor 536 may process the signals to generate a desired indicator for the user. For example, sensors 583a-l may sense blood flow during deployment of the implant 70, and processor 536 may process these signals to provide an indicator to the user that a valve leaflet has been captured and missed.

[0332] Processor 536 may provide an output that includes control of motor 500 based on the state of the patient's body or the state of the delivery device sensed by one or more sensors. Processor 536 may be configured to operate motor 500 to activate the delivery device based on signals from the sensors. The signals from the sensors may include feedback signals input to processor 536 for the processor to control the operation of motor 500. For example, signals from contact sensor 580 or proximity sensor 582 may be provided to processor 536 as feedback that the delivery device has contacted or is in proximity to the surface of the patient's body. Processor 536 may accordingly provide an output to operate motor 500 to avoid or retreat from the surface of the patient's body. Signals from flow sensors 583a - l may cause processor 536 to provide an output to motor 500 to redeploy implant 70 or move a portion of the delivery device to re - capture valve leaflet 1108. Signals from a position sensor may provide feedback to processor 536 regarding whether the delivery device is performing the correct movement, and processor 536 may operate motor 500 to perform a corrective movement (e.g., deflect elongate shaft 12 if necessary). Processor 536 may be programmed to automatically respond and generate an output based on the state of the patient's body or the state of the delivery device sensed by one or more sensors. The programming of processor 536 may be stored in memory 534 and operated by processor 536.

[0333] The delivery system can be used in a method for percutaneous delivery of a replacement tricuspid valve for treating patients troubled by moderate to severe tricuspid valve regurgitation. However, it should be understood that the delivery system described herein can also be used as part of other methods, such as for delivery of an implant for valve repair, as well as for delivery of implants to other heart valves and delivery of other implants.

[0334] In one embodiment, the method may include extending a delivery device within a portion of a patient's body to deliver an implant to a particular body location. The delivery system 10 may be positioned within the ipsilateral femoral vein and advanced toward the right atrium. Thus, it may be advantageous for a user to be able to maneuver the delivery system 10 through the complex regions of the heart to position the replacement tricuspid valve to coincide with the native tricuspid valve. This operation can be performed with or without the use of a guidewire. The distal end of the delivery system can be advanced toward or into the left atrium. Next, the motor 500 can be operated to actuate the rail assembly 20 or the deflection mechanism to target an appropriate region at the distal end of the delivery system 10. The motor 500 may be operated by a processor 536 as discussed herein. The motor 500 can be operated to create various bends in the rail assembly 20 and to deflect the elongate shaft 12 in various ways to position the implant at a desired location for implantation.

[0335] The operation of the motor 500 may be operated by a processor 536. A user may provide an input to the processor 536 using a control device 504.

[0336] Sensors further discussed herein may be utilized in certain embodiments. The delivery device may include one or more sensors coupled to the delivery device and configured to sense one or more of the patient's body condition or the condition of the delivery device. The processor 536 may be configured to provide an output based on one or more of the patient's body condition or the condition of the delivery device sensed by the one or more sensors. For example, the processor may cause at least a portion of the delivery device to avoid or retreat from the surface of the patient's body based on the condition of the delivery device.

[0337] The use of a processor, one or more sensors, and / or one or more motors with a delivery system, as disclosed herein, may be configured to implement any other method or may be utilized in any of the embodiments disclosed herein, including the embodiments of FIGS. 13A - 44 and FIGS. 62A - 64C.

[0338] In an embodiment, the delivery system 10 can be used in a method for percutaneous delivery of a replacement tricuspid valve to treat patients afflicted with moderate to severe tricuspid regurgitation. Such a method may utilize any of the systems or devices disclosed herein. Referring to FIG. 56, for example, the delivery device may be extended within a portion of the patient's body to deliver an implant to a particular body location. The portion of the patient's body may be the right atrium 1076, and the body location for delivering the implant may be the native tricuspid heart valve 1083. The delivery device may be extended within a portion of the patient's body in a manner similar to that disclosed herein, and the delivery device may be disposed within the ipsilateral femoral vein 1074 and advanced toward the right atrium 1076. Other access methods may be utilized as desired.

[0339] The delivery device may be extended into the right atrium 1076 within the inferior vena cava 1079. One or more motors may be operated by a processor 536 as contemplated herein and may be utilized to extend the delivery device into the right atrium 1076.

[0340] The delivery device may be maneuvered through the complex regions of the heart to position the replacement tricuspid valve to match the native tricuspid valve. The motor 500 may be operated to actuate the rail assembly 20 so that the distal end of the delivery device targets the appropriate region. For example, the motor 500 may be utilized to maneuver the rail assembly 20 into a desired orientation relative to the tricuspid heart valve 1083. The motor 500 may be operated by the processor 536 as discussed herein. The rail assembly 20 may form one or more bends so that the distal end of the delivery device is coaxially oriented with the native tricuspid heart valve 1083.

[0341] FIG. 57 shows, for example, the delivery device being deflected within the right atrium 1076 toward the native tricuspid heart valve 1083. One or more bends may be formed within the right atrium 1076 and / or the inferior vena cava 1079. Once the implant 70 is coaxially positioned with the native tricuspid heart valve 1083, the outer sheath assembly 22, the intermediate shaft assembly 21, the inner assembly 18, and the nose cone assembly 31 may be advanced together (e.g., using the motor 500) distally relative to the rail assembly 20 toward the right ventricle 1077. The depth of the elongate shaft 12 may be altered by the operation of the motor 500 disclosed herein, and the motor may be operated by the processor 536. Ventricular-atrial movement is enabled by proximal / distal translation of the other assemblies on the rail assembly 20. Additionally, a deflection mechanism as disclosed herein may be utilized. Other features from other embodiments disclosed herein may be utilized as desired.

[0342] The depth of the elongated shaft 12 may be changed until the capsule 106 is positioned at a desired location relative to the native tricuspid heart valve 1083. The distal end 303 of the implant 70, specifically the distal anchor 80, may be restrained within the capsule 106 of the outer sheath assembly 22, thus preventing expansion of the implant 70. Similar to that shown in FIG. 2A, the distal anchor 80 may extend in the distal direction when positioned within the capsule. The proximal end 301 of the implant 70 is restrained within the capsule 106 and within a portion of the inner retaining member 40, and thus is generally constrained between the capsule 106 and the inner retaining member 40. The implant 70 may then be deployed to the native tricuspid heart valve 1082. FIG. 58 shows, for example, the implant 70 deployed to the native tricuspid heart valve 1082. The distal anchor of the implant 70 extends over the valve leaflet 1087 of the tricuspid heart valve 1083. The delivery device may then be withdrawn from the patient's right atrium 1076.

[0343] The method may utilize the systems and devices disclosed herein. For example, the motor 500 may deflect a portion of the delivery device or deploy the implant to a part of the body. The motor may operate the deflection mechanisms disclosed herein, including controlling the operation of the embodiments of FIGS. 13A - 44 and FIGS. 62A - 64C, or other features of the embodiments disclosed herein. The operation of the motor 500 may be actuated by a processor 536. The user may provide an input to the processor 536 using the control device 504. The system 10 may be positioned through the use of the steering mechanisms or other techniques discussed herein. The delivery system 10 may be advanced by the user manually axially moving the handle 15. In some embodiments, the delivery system 10 may be disposed within a stand while operating the control of the handle 15.

[0344] The delivery device may be utilized in the form shown in FIG. 1, or other forms of delivery devices may be utilized, for example, a delivery device configured to deliver an implant to a native tricuspid valve.

[0345] In other embodiments, other methods of delivering the implant to the native tricuspid heart valve may be utilized, for example, transapical, transseptal, or other methods may be utilized.

[0346] Other locations for the valve implant may include the aortic or pulmonary valve and other valves in the patient's body. Other forms of implants may be delivered to other locations in the body as desired.

[0347] In some embodiments, the implant 70 can be delivered under fluoroscopy so that the user can view specific reference points to properly position the implant 70. Additionally, an echocardiogram may be used to properly position the implant 70.

[0348] In one embodiment, the proximity sensor 582 may be configured to provide a model of the spatial relationship of the elongated shaft 12 within the patient's body and from the surface of the patient's body. Such a model may be provided on output devices 584, 586 shown as display screens in FIGS. 59 and 60 (on a monitor and on a virtual reality or augmented reality display). Such a model may also be provided by other sensors positioned outside the patient's body, if desired. Such a model may be a two-dimensional or three-dimensional map of the patient's body for use by the processor 536 as feedback for the user to view and navigate through the patient's body to deliver the implant 70 to the desired location.

[0349] FIG. 59 shows one embodiment in which the operation of the delivery device can be performed at a location remote from the user. The user may utilize a control device 588, such as a joystick or other form of control device, to control the movement of the delivery device and the elongated shaft 12. The control device 588 may be configured to sense the movement of the delivery device and control the delivery device. The user may view the position of the elongated shaft 12 on the output device 584 in the form of a display screen. The position may be provided in a variety of ways, including external sensing of the position via a sensor using fluoroscopy or echocardiography. The position may also be provided via an image generated by a signal from a proximity sensor of the elongated shaft 12. The proximity sensor may be configured to generate an image of the spatial relationship between the elongated shaft 12 and the surface of the patient's body. A configuration including a motor for axial movement of the elongated shaft 12, as shown in FIG. 54, may be utilized similarly for remote control of the procedure.

[0350] FIG. 60 shows one embodiment in which the output device 586 is in the form of a display screen on a virtual reality or augmented reality display. The display may include a helmet (or other headset that enables enhanced visualization) for the user to wear, in which case the user can move their head to change the field of view provided by the display screen. Similar to the embodiment discussed with respect to FIG. 59, the position of the elongated shaft 12 and the position of the patient's heart as seen on the output device 586 may be provided in a variety of ways, including external sensing of the position via fluoroscopy or echocardiography. The position may also be provided via an image generated by a signal from a proximity sensor of the elongated shaft 12. The proximity sensor may be configured to generate an image of the spatial relationship between the elongated shaft 12 and the surface of the patient's body. A configuration including a motor for axial movement of the elongated shaft 12, as shown in FIG. 51, may be utilized similarly for remote control of the procedure.

[0351] In an exemplary method, a user (e.g., a clinician) may provide an input that can be assisted by use of the components disclosed herein (e.g., among a number of components, a processor, a motor, and one or more sensors). In embodiments, however, the implantation procedure may be performed autonomously (i.e., adapted to the intraoperative environment). The processor may perform autonomous control of the delivery device to perform the implantation procedure. The user may provide some inputs during the procedure, and thus the procedure may be performed semi-autonomously. Accordingly, the method may be performed autonomously or semi-autonomously (or at least semi-autonomously). Other autonomous procedures may include autonomously performing the methods disclosed with respect to the embodiments of FIGS. 13A-44 and FIGS. 62A-64C.

[0352] The method may include extending a delivery device within a portion of a patient's body to deliver an implant to a particular body location. The delivery device may be configured similar to any of the delivery device embodiments disclosed herein. The delivery device may be extended within a portion of the patient's body as disclosed herein. The implant may be configured similar to any of the implants disclosed herein, and the body location may include any of the locations disclosed herein.

[0353] The delivery device may be extended within a portion of the patient's body via advancement of the delivery device by a motor, such as an elongate shaft of the delivery device within the patient's body. The motor may be controlled by the processor 536. For example, a motor drive rail 577, or other assembly that actuates the axial movement of the delivery device into the patient's body may be utilized. In other embodiments, other methods may be utilized to extend the delivery device within a portion of the patient's body.

[0354] Processor 536 may run a program to operate the delivery device. Processor 536 may be programmed with a series of movements to move the delivery device to a desired location and for a desired deployment operation. For example, processor 536 may be configured to identify a desired delivery location, as well as a path and orientation to follow to reach the desired delivery location, based on external sensing of the location via fluoroscopy or echocardiography and / or based on a signal from a proximity sensor of the elongate shaft 12. The programmed series of movements may be provided based on the geometry of the path to the desired implantation location and the orientation of the desired implantation location. The movement and deployment of the delivery device may be pre-programmed in processor 536 and individualized based on a specific path to a desired location within the patient's body to follow. In certain embodiments, a machine learning algorithm may be utilized by processor 536 to control the operation of the delivery device. For example, the path and orientation may also be supplemented by data from previous treatments on patients with similar characteristics. Processor 536 and the programming may be utilized to extend the delivery device within a part of the patient's body as disclosed.

[0355] Processor 536 may continue to follow the program and may receive signals from one or more sensors. Processor 536 may receive feedback from the sensors (as discussed herein) that causes an output to be generated in processor 536 at step 846. Signals from the sensors may be utilized by processor 536 in a manner similar to that disclosed herein. For example, processor 536 may be configured to generate a log 848 of data. Processor 536 may be configured to generate an indicator 850. The indicator may be provided to determine whether the user should intervene in the treatment. For example, if the user (e.g., a clinician) receives an indicator that an autonomously operated delivery device has contacted a particular surface or that an implant has been deployed inappropriately, then the user may intervene to attempt to correct such operation.

[0356] Processor 536 may be configured to generate the operation of the delivery device. The operation may be provided for the processor 536 to modify the path and operation with minimal or no human interference using feedback from sensors as contemplated herein to complete the procedure. For example, if a position sensor indicates that the delivery device has deviated from the intended path, the processor 536 may automatically adjust the path. If a proximity sensor indicates that the delivery device is approaching a particular surface, the processor 536 may then automatically adjust the path. The processor 536 may be used to navigate to any desired location for implant delivery. Any of the sensors disclosed herein, and the feedback action from such sensors, may be utilized in such a manner. In certain embodiments, the user may provide some input during the procedure to modify the procedure, or alternatively may provide input to control the procedure.

[0357] The operation generated by the processor 536 may be based on a machine learning algorithm that utilizes data from past implantation procedures or from patient characteristics. The operation may be based on data “learned” from previous procedures and in particular from previous procedures performed on patients having similar anatomical structures and / or other characteristics. Thus, the steps of a procedure successfully performed on a patient having a similar anatomical structure can be repeated, thereby increasing the likelihood of success of the procedure for the current patient. The machine learning algorithm may be utilized by the processor 536 to control the operation of the delivery device.

[0358] The processor 536 may be configured to operate the motor 500 to produce the desired operation of the delivery device. The processor 536 may be configured to automatically operate the motor to deflect the delivery device to a desired body location. The processor 536 may be configured to automatically operate the motor to deflect the delivery device in at least two planes. The processor 536 may be configured to automatically deploy the implant 70 to a desired location and complete the delivery procedure. The processor 536 may be configured to complete the delivery device in certain embodiments without user control or intervention. The processor 536 may be configured to provide such confirmation of implantation as an indicator on an output device, such that the user is informed that the implant has been implanted.

[0359] The method may be utilized for replacement or repair of a heart valve within a patient's body. The heart valve may include one or more of an aortic heart valve, a mitral heart valve, a tricuspid heart valve, or a pulmonary heart valve. Other valves or body locations for implantation may be treated in other embodiments.

[0360] FIG. 61 shows an embodiment of a delivery device configured similarly to the device shown in FIG. 46, although a plurality of motors 502 may be utilized to control the operation of the delivery device. The plurality of motors 502 may each be configured to engage respective adapters 590, 592, 594 configured to operate a portion of the delivery device. The motors 502 may be configured to perform a linear movement of the adapters 590, 592, 594 to cause the operation of the delivery device. Further in the embodiment of FIG. 61, the processor, memory, and input and output devices of FIG. 46 may be provided on a printed circuit board 596 positioned within the handle. A power source 598, such as a battery pack or other form of power, may also be utilized within the handle. The embodiment of FIG. 61 may comprise a self - contained handle unit including a processor for performing a delivery procedure, receiving feedback from sensors, and, if desired, performing logging of data.

[0361] The motors disclosed in this specification may include, among other things, motors in various forms including electromagnetic, stepper, hydraulic, and piezoelectric. The methods, systems, and devices disclosed in this specification with respect to FIGS. 45-61 can be utilized in any of the embodiments disclosed in this specification. For example, the operation and control of any of the systems, devices, or methods of the embodiments of FIGS. 13A-44 or FIGS. 62A-64C can be carried out under the operation of the systems, devices, or methods of the embodiments of FIGS. 45-61.

[0362] Many of the systems and methods disclosed in this specification have been considered with respect to the implantation of prosthetic tricuspid valve implants, but it is understood that the systems and methods can be utilized to deliver various implants, including implants for the repair of heart valves. For example, among other types of implants, other types of heart valve implants shown in this specification (e.g., aortic valve implants and other repair implants) can be utilized.

[0363] The methods and systems disclosed in this specification are not limited to the delivery of implants in certain embodiments, but may be extended to any medical intervention or insertion into a patient's body, which may include performing a medical procedure inside the body. The methods and systems disclosed in this specification may be utilized as desired in the general use of catheters. For example, the handle shown in FIG. 61 and the components disclosed therein may include a general catheter handle in certain embodiments. Further, the configuration of the delivery device may be modified in other embodiments. For example, with respect to an aortic valve delivery device, the configuration of the implant holding region and other features of the delivery device may be modified.

[0364] While many of the embodiments herein have been discussed in relation to prosthetic tricuspid valves, the deflection mechanism and other embodiments disclosed herein may be utilized for a variety of other implantations, including delivery of mitral prosthetic valves, aortic valves, pulmonary valves, or for valve repair procedures, including repair of the tricuspid valve, mitral valve, aortic valve, or pulmonary valve.

[0365] From the foregoing description, it will be appreciated that advanced products and approaches for implant delivery systems are disclosed. Although some components, techniques, and aspects have been described with a certain scope of uniqueness, it is obvious that many changes can be made in the particular design, structure, and methodology without departing from the spirit and scope of the present disclosure.

[0366] The specific features described in the context of separate implementations of the present disclosure can also be implemented in combination in a single implementation. Conversely, the various features described in the context of a single implementation can also be implemented separately in multiple implementations or in any suitable sub-combination. Further, while features may be described above as functioning in a particular combination, one or more features from the claimed combination may in some cases be deleted from the combination, and this combination may be claimed as any sub-combination or as a variant of any sub-combination.

[0367] Furthermore, the methods may be depicted in the drawings or described in the specification in a particular order, but such methods need not be performed in the particular order shown or in a sequential order, nor is it necessary to perform all the methods to achieve the desired result. Other methods not depicted or described can be incorporated into the example methods and processes. For example, one or more additional methods can be performed after, concurrently with, or between any of the methods described. Further, the methods may be reconfigured or reordered in other implementations. Also, the separation of various system components in the implementations described above should not be understood as requiring such separation in all implementations, and the components and systems described can generally be integrated together into a single product or packaged into multiple products. Additionally, other implementations are within the scope of the present disclosure.

[0368] Hypothetical language such as "can," "could," "might," or "may" is generally intended to convey that a particular embodiment includes or does not include a particular feature, element, and / or step, unless specifically stated otherwise or understood otherwise in the context in which it is used. Thus, such hypothetical language is generally not intended to suggest that a feature, element, and / or step is required in any one or more embodiments.

[0369] Conjunctive language such as "at least one of X, Y, and Z" is generally used in contexts such as to convey that an item, term, etc. can be any of X, Y, or Z, unless specifically specified otherwise. Thus, such conjunctive language is generally not intended to suggest that a particular embodiment requires the presence of at least one of each of X, at least one of Y, and at least one of Z.

[0370] As used herein, words such as "about," "approximately," "generally," and "substantially," to the extent used herein, represent a particular value, amount, or characteristic that is still close to the specified value, amount, or characteristic that performs the desired function or achieves the desired result. For example, the terms "about," "approximately," "generally," and "substantially" may refer to a particular amount that is within 10% or less, 5% or less, 1% or less, 0.1% or less, and 0.01% or less of the specified amount. When the specified amount is 0 (e.g., none, having none at all), the ranges listed above may be a specific range and not within a specific percentage of that value. For example, it is within 10 wt. / vol.% or less, 5 wt. / vol.% or less, 1 wt. / vol.% or less, 0.1 wt. / vol.% or less, and 0.01 wt. / vol.% or less of the specified amount.

[0371] Some embodiments have been described in relation to the accompanying drawings. The drawings are drawn to scale, but such scale is not limiting, and dimensions and ratios other than those shown are contemplated and within the scope of the disclosed invention. Distances, angles, etc. are merely illustrative and do not necessarily bear an exact relationship to the actual dimensions and layout of the device shown. Components can be added, removed, and / or rearranged. Further, the disclosure herein of any particular feature, aspect, method, characteristic, feature, quality, attribute, element, etc. related to various embodiments can be used in all other embodiments described herein. Additionally, it will be understood that any method described herein can be implemented using any device suitable for performing the recited steps.

[0372] Although several embodiments and variations thereof have been described in detail, other modifications and methods of using the same will be apparent to those skilled in the art. Accordingly, it is to be understood that various applications, modifications, materials, and substitutes can be made equivalently without departing from the scope of the unique and inventive disclosure or claims of this specification. Further aspects of the present invention are provided by the subject matter of the following clauses. [Clause 1] A delivery system for an implant, An elongated shaft, A distal end, An implant holding region for holding the implant, A bending portion configured to deflect the distal end of the elongated shaft in a first direction, and A portion positioned proximal to the bending portion An elongated shaft having, A deflection mechanism configured to deflect the portion positioned proximal to the bending portion to deflect the bending portion in a second direction opposite to the first direction A delivery system comprising. [Clause 2] The delivery system according to clause 1, wherein the distal end comprises a nose cone. [Clause 3] The delivery system according to clause 1 or 2, wherein the implant holding region is positioned between the distal end and the bending portion. [Clause 4] The delivery system according to any one of clauses 1 to 3, wherein the bending portion is configured to deflect the implant holding region in the first direction. [Clause 5] The delivery system according to any one of clauses 1 to 4, wherein the second direction is in the same plane as the first direction. [Clause 6] The delivery system according to any one of clauses 1 to 5, wherein the deflection mechanism comprises a sheath extending over a portion of the elongated shaft. [Clause 7] The delivery system according to claim 6, wherein the deflection mechanism comprises at least one tension tie rod configured to deflect the sheath. [Claim 8] The delivery system according to claim 6 or 7, wherein the sheath is configured to rotate about the portion of the elongated shaft where the sheath extends upward. [Claim 9] The elongated shaft includes an inner shaft, a rail shaft extending over the inner shaft, and an outer sheath extending over the rail shaft and is provided with, The delivery system according to any one of claims 1 to 5, wherein the deflection mechanism comprises a tension tie rod coupled to the rail shaft. [Claim 10] The delivery system according to claim 9, wherein the rail shaft comprises the bent portion. [Claim 11] The delivery system according to claim 10, wherein the rail shaft comprises a second bent portion configured to deflect the distal end of the elongated shaft in a direction perpendicular to the first direction. [Claim 12] The elongated shaft includes an inner shaft, a rail shaft extending over the inner shaft and having one or more cuts, and an outer sheath extending over the rail shaft and is provided with, The delivery system according to any one of claims 1 to 5, wherein the deflection mechanism comprises a stop portion on the rail shaft and a stop portion on the inner shaft configured to apply a force to the stop portion on the rail shaft to cause deflection of the rail shaft at the one or more cuts. [Claim 13] The delivery system according to claim 12, wherein the inner shaft is configured to be pulled proximally in order to apply the force to the stop portion on the rail shaft at the stop portion on the inner shaft. [Claim 14] The delivery system according to any one of claims 1 to 13, wherein the biasing mechanism is configured to bias the portion positioned proximal to the bent portion in a plurality of directions. [Claim 15] The delivery system according to claim 14, wherein at least one of the plurality of directions includes a direction toward the first direction. [Claim 16] The delivery system according to claim 14 or 15, wherein at least one of the plurality of directions includes a direction perpendicular to the first direction. [Claim 17] The delivery system according to any one of claims 1 to 16, wherein the bent portion is a first bent portion, and the elongated shaft includes a second bent portion configured to deflect the distal end of the elongated shaft in a direction perpendicular to the first direction. [Claim 18] The delivery system according to claim 17, wherein the second bent portion is positioned between the first bent portion and the portion positioned proximal to the bent portion, and the biasing mechanism is configured to bias the first bent portion and the second bent portion in the second direction. [Claim 19] The delivery system according to any one of claims 1 to 18, further comprising a capsule surrounding the implant holding region. [Claim 20] The delivery system according to claim 19, wherein the capsule is configured to be retracted to deploy the implant. [Claim 21] A delivery system for an implant, an elongated shaft, a distal end, an implant holding region for holding the implant, A bending portion configured to deflect the distal end of the elongated shaft in a first plane, and A portion positioned proximal to the bending portion An elongated shaft having A deflection mechanism configured to deflect the portion positioned proximal to the bending portion in one or more planes not perpendicular to the first plane A delivery system comprising [Item 22] The delivery system according to item 21, wherein the deflection mechanism comprises a sheath extending over at least a portion of the elongated shaft, and the sheath is configured to rotate around the portion of the elongated shaft over which it extends. [Item 23] The delivery system according to item 22, further comprising a tension tie rod coupled to the sheath and configured to deflect the sheath in one or more planes not perpendicular to the first plane. [Item 24] The delivery system according to item 23, wherein the tension tie rod is configured to rotate around the portion of the elongated shaft over which the sheath extends to change the plane in which the portion positioned proximal to the bending portion is deflected. [Item 25] The elongated shaft An inner shaft, A rail shaft extending over the inner shaft, An outer sheath extending over the rail shaft And comprising The delivery system according to item 21, wherein the deflection mechanism comprises a tension tie rod coupled to the rail shaft. [Item 26] The delivery system according to item 25, wherein the rail shaft comprises the bending portion. [Item 27] The bending portion is a first bending portion, and the rail shaft includes a second bending portion configured to deflect the distal end of the elongated shaft in a direction perpendicular to the first plane. The delivery system according to claim 25 or 26. [Claim 28] The elongated shaft includes an inner shaft, a rail shaft extending over the inner shaft and having one or more cuts, and an outer sheath extending over the rail shaft and is provided with The deflection mechanism includes a stop portion on the rail shaft and a stop portion on the inner shaft configured to apply a force to the stop portion on the rail shaft to cause deflection of the rail shaft at the one or more cuts. The delivery system according to claim 21. [Claim 29] The inner shaft is configured to be pulled proximally to cause the force to be applied to the stop portion on the rail shaft at the stop portion on the inner shaft. The delivery system according to claim 28. [Claim 30] The deflection mechanism is configured to deflect the portion positioned proximal to the bending portion in a plurality of directions. The delivery system according to any one of claims 21 to 29. [Claim 31] A delivery system for an implant, an elongated shaft, a distal end, an implant holding region for holding the implant, a first bending portion configured to deflect the distal end of the elongated shaft in a first direction, a second bending portion positioned proximal to the first bending portion and configured to deflect the distal end of the elongated shaft in a second direction, and a portion positioned proximal to the second bending portion and an elongated shaft having A deflection mechanism configured to deflect the first bending portion, the second bending portion, and the portion positioned proximal to the second bending portion A delivery system comprising the same. [Item 32] The delivery system according to Item 31, wherein the deflection mechanism includes a sheath extending over a portion of the elongated shaft. [Item 33] The delivery system according to Item 32, wherein the deflection mechanism includes at least one tension tie configured to deflect the sheath. [Item 34] The delivery system according to Item 33, wherein the at least one tension tie is configured to rotate around the portion of the elongated shaft over which the sheath extends, in order to change the plane in which the first bending portion, the second bending portion, and the portion positioned proximal to the second bending portion are deflected. [Item 35] The elongated shaft includes an inner shaft, a rail shaft extending over the inner shaft and including the first bending portion and the second bending portion, and an outer sheath extending over the rail shaft and the deflection mechanism includes a tension tie coupled to the rail shaft. The delivery system according to Item 31, wherein the deflection mechanism includes a tension tie coupled to the rail shaft. [Item 36] The elongated shaft includes an inner shaft, a rail shaft extending over the inner shaft and including the first bending portion and the second bending portion and having one or more cuts, and an outer sheath extending over the rail shaft and the delivery system includes the same. The deflection mechanism comprises a stop portion on the rail shaft and a stop portion on the inner shaft configured to apply a force to the stop portion on the rail shaft in order to cause deflection of the rail shaft in the one or more cuts, the delivery system according to claim 31. [Claim 37] The inner shaft is configured to be pulled proximally to cause the stop portion on the inner shaft to apply the force to the stop portion on the rail shaft, the delivery system according to claim 36. [Claim 38] The second direction is perpendicular to the first direction, the delivery system according to any one of claims 31 to 37. [Claim 39] The deflection mechanism is configured to deflect the first bent portion, the second bent portion, and the portion positioned proximal to the second bent portion in a direction opposite to the first direction, the delivery system according to any one of claims 31 to 38. [Claim 40] The deflection mechanism is configured to deflect the portion positioned proximal to the bent portion in a plurality of directions, the delivery system according to any one of claims 31 to 39. [Claim 41] A delivery system for an implant, the delivery system comprising an implant holding region for holding the implant, a capsule having a distal end and surrounding the implant holding region and an elongate shaft, the distal end of the capsule forming the distal tip of the elongate shaft, the delivery system. [Claim 42] The distal end of the capsule has a planar outer shape, the delivery system according to claim 41. [Claim 43] At least a portion of the distal end of the capsule is rounded, the delivery system according to claim 41 or 42. [Claim 44] The distal end of the capsule is configured to surround the distal portion of the implant when the implant is positioned in the implant holding region, the delivery system according to any one of paragraphs 41 to 43. [Paragraph 45] The distal end of the capsule is elastic, the delivery system according to any one of paragraphs 41 to 44. [Paragraph 46] The distal end of the capsule forms an opening for the implant to pass through, the delivery system according to any one of paragraphs 41 to 45. [Paragraph 47] The distal end of the capsule is configured to conform to the implant when the implant is positioned in the implant holding region, the delivery system according to any one of paragraphs 41 to 46. [Paragraph 48] A delivery system for an implant, an implant holding region for holding the implant, a distal tip comprising a flexible sheath extending distally and configured to bend around a portion of a guide wire and an elongated shaft having the same. [Paragraph 49] The distal tip comprises a proximal portion and a distal portion, and the distal tip tapers in a direction from the proximal portion to the distal portion, the delivery system according to paragraph 48. [Paragraph 50] The elongated shaft comprises a capsule extending over the implant holding region, a tip body forming the distal tip, and the tip body is movable relative to the capsule, the delivery system according to paragraph 48 or 49. [Paragraph 51] The tip body is positioned at the distal end of the capsule, the delivery system according to paragraph 50. [Paragraph 52] The outer surface of the tip body tapers from the proximal portion of the tip body to the proximal portion of the flexible sheath, the delivery system according to paragraph 51. [Paragraph 53] The delivery system according to item 52, wherein the flexible sheath has a cylindrical shape from the proximal portion of the flexible sheath to the distal end of the flexible sheath. [Item 54] The delivery system according to any one of items 50 to 53, wherein the capsule is configured to retract proximally to deploy the implant from the implant holding region. [Item 55] A delivery system for an implant, an implant holding region for holding the implant, a distal tip having a hemispherical or parabolic shape, and a delivery system comprising an elongate shaft having the same. [Item 56] The delivery system according to item 55, wherein the distal end of the distal tip has a convex outer shape. [Item 57] The delivery system according to item 55 or 56, wherein the elongate shaft comprises a capsule extending over the implant holding region, a tip body forming the distal tip, and the tip body is movable relative to the capsule. [Item 58] The delivery system according to item 57, wherein the tip body is positioned at the distal end of the capsule. [Item 59] The delivery system according to item 57 or 58, wherein the outer surface of the tip body is convex from the proximal portion of the tip body to the distal end of the tip body. [Item 60] The delivery system according to any one of items 57 to 59, wherein the capsule is configured to retract proximally to deploy the implant from the implant holding region. [Item 61] The delivery system according to any one of items 55 to 60, wherein the distal tip is configured to allow a guide wire to pass therethrough. [Item 62] A delivery system for an implant, A delivery system comprising an elongate shaft having a wall surrounding a passage through which the implant is to be passed for deployment of the implant, the wall configured to have a bend that defines a bend in the passage during deployment of the implant. [Item 63] The delivery system according to item 62, wherein the passage comprises an implant holding region for holding the implant. [Item 64] The delivery system according to item 62 or 63, wherein the wall is operable and the system further comprises a control mechanism for operating the wall. [Item 65] The delivery system according to item 64, wherein the control mechanism is configured to control the direction of the bend of the wall. [Item 66] The delivery system according to any one of items 62 to 65, wherein a port is positioned at a distal end of the passage through which the implant is to be passed for deployment of the implant. [Item 67] The delivery system according to any one of items 62 to 66, further comprising a flexible implant configured to bend across the axial dimension of the flexible implant within the passage. [Item 68] The delivery system according to item 67, wherein a distal end of the passage has an opening through which the flexible implant is to be passed in the axial dimension for deployment of the flexible implant. [Item 69] A delivery system for an implant, having an axial dimension, an implant holding region for holding the implant, and a port for deploying the implant from the elongate shaft in a direction transverse to the axial dimension, the delivery system comprising the elongate shaft having the same. [Item 70] The delivery system according to claim 69, wherein the port is positioned on a side wall of the elongated shaft. [Claim 71] The delivery system according to claim 69 or 70, wherein the port is adjacent to the implant holding region. [Claim 72] The delivery system according to any one of claims 69 to 71, further comprising a deployment mechanism for deploying the implant through the port. [Claim 73] The delivery system according to claim 72, wherein the deployment mechanism comprises an inflatable body. [Claim 74] The delivery system according to any one of claims 69 to 73, wherein the implant holding region is configured to hold the implant in an axial dimension of the implant that extends transverse to the axial dimension of the elongated shaft. [Claim 75] The delivery system according to claim 74, further comprising an implant positioned within the implant holding region in an axial dimension of the implant that extends transverse to the axial dimension of the elongated shaft. [Claim 76] A delivery system for an implant, comprising an implant holding region for holding the implant and an elongated shaft configured to bend more than 180 degrees to form a loop. [Claim 77] The delivery system according to claim 76, wherein the elongated shaft is configured to bend more than 200 degrees to form the loop. [Claim 78] The delivery system according to claim 76, wherein the elongated shaft is configured to bend more than 230 degrees to form the loop. [Claim 79] The delivery system according to claim 76, wherein the elongated shaft is configured to bend more than 250 degrees to form the loop. [Claim 80] The delivery system according to claim 76, wherein the elongated shaft is configured to bend more than 270 degrees to form the loop. [Claim 81] The delivery system according to claim 76, wherein the elongated shaft is configured to bend more than 180 degrees at a bent portion of the elongated shaft, and the implant holding region is positioned distal to the bent portion. [Claim 82] The delivery system according to any one of claims 76 to 81, wherein the elongated shaft comprises a port positioned distal to the implant holding region for deployment of the implant. [Claim 83] A delivery system for an implant, a capsule surrounding an implant holding region for holding the implant, and a hinge coupling the capsule to a portion of an elongated shaft wherein the elongated shaft comprises a delivery system. [Claim 84] The delivery system according to claim 83, wherein the capsule comprises a proximal portion and a distal portion, and the proximal portion of the capsule is coupled to the hinge. [Claim 85] The delivery system according to claim 83 or 84, wherein the capsule comprises a proximal portion, a distal portion, and a central portion positioned between the proximal portion and the distal portion, and the central portion of the capsule is coupled to the hinge. [Claim 86] The delivery system according to any one of claims 83 to 85, wherein the capsule is configured to rotate to a rotational position about the hinge, and the capsule is configured such that the implant is deployed from the capsule when the capsule is in the rotational position. [Claim 87] The delivery system according to any one of claims 83 to 86, wherein the capsule comprises a port for deployment of the implant when the capsule is in the rotational position. [Claim 88] The delivery system according to item 86 or 87, further comprising a deployment mechanism for deploying the implant from the capsule when the capsule is in the rotational position. [Item 89] The delivery system according to any one of items 83 to 88, further comprising a control mechanism for controlling the rotation of the capsule around the hinge. [Item 90] A delivery system for an implant, An elongated shaft extending along an axis and having an outer surface and an implant holding region for holding the implant, One or more supports extending radially outward from the outer surface of the elongated shaft and configured to contact an external surface so as to resist deflection of the elongated shaft transverse to the axis A delivery system comprising. [Item 91] The delivery system according to item 90, further comprising a sheath extending over the outer surface of the elongated shaft, wherein the one or more supports are configured to extend radially outward from the sheath. [Item 92] The elongated shaft comprises a bent portion configured to deflect the implant holding region in a first direction, and the one or more supports are configured to extend radially outward from the outer surface proximal to the bent portion. The delivery system according to item 90 or 91. [Item 93] The bent portion is a first bent portion, the elongated shaft is positioned proximal to the first bent portion, and the implant holding region is provided with a second bent portion configured to deflect in a second direction transverse to the first direction. The delivery system according to item 92, wherein the one or more supports are configured to extend radially outward from the outer surface proximal to the second bent portion. [Item 94] The delivery system according to any one of items 90 to 93, wherein the one or more supports are configured to move from a non-expanded state to an expanded state. [Item 95] The delivery system according to any one of Items 90 to 94, wherein the one or more supports comprise one or more inflatable bodies. [Item 96] The delivery system according to any one of Items 90 to 95, wherein the one or more supports comprise one or more mesh bodies. [Item 97] The delivery system according to any one of Items 90 to 96, wherein the one or more supports comprise one or more disks. [Item 98] The delivery system according to any one of Items 90 to 97, wherein the one or more supports comprise one or more occluding bodies. [Item 99] The delivery system according to any one of Items 90 to 94, wherein the one or more supports comprise one or more arms. [Item 100] At least one motor configured to operate at least a portion of the delivery system, A processor configured to operate the at least one motor to operate at least the portion of the delivery system The delivery system according to any one of Items 1 to 99, further comprising. [Item 101] The delivery system according to Item 100, further comprising one or more sensors configured to sense one or more of a state of the patient's body or a state of the delivery system, wherein the processor is configured to operate the at least one motor to operate at least the portion of the delivery system based on signals from the one or more sensors. [Item 102] The delivery system according to Item 101, wherein the processor is configured to provide an output based on the one or more of the state of the patient's body or the state of the delivery system sensed by the one or more sensors. [Item 103] A prosthetic heart valve configured for implantation within a patient's annulus band, An anchor configured to be secured within a portion of the patient's body, A tether configured to couple the prosthetic heart valve to the anchor A system comprising the same. [Item 104] The system according to item 103, wherein the prosthetic heart valve comprises a prosthetic valve flap. [Item 105] The system according to item 103 or 104, wherein the prosthetic heart valve comprises a plurality of anchors configured to extend over the heart valve flap. [Item 106] The system according to any one of items 103 to 105, wherein the anchor comprises a stent. [Item 107] The system according to item 106, wherein the stent is configured to be secured to one or more of the inferior vena cava or the superior vena cava. [Item 108] The system according to any one of items 103 to 105, wherein the anchor is configured to be secured to the wall of the patient's right ventricle. [Item 109] The system according to any one of items 103 to 105, wherein the anchor is configured to be secured to the moderator band of the patient's right ventricle. [Item 110] The system according to item 109, wherein the anchor comprises one or more of a hook, a loop, a cover, a loop, or an expandable body. [Item 111] The system according to any one of items 103 to 110, wherein the prosthetic heart valve comprises a prosthetic tricuspid heart valve. [Item 112] A prosthetic valve for replacement of a patient's native valve, A prosthetic heart valve body configured to be anchored within the annulus of the patient's native valve and forming a prosthetic valve annulus, A port coupled to the prosthetic heart valve body and configured to receive a diagnostic or therapeutic device A prosthetic valve comprising the same. [Item 113] The prosthetic valve according to Item 112, wherein the port comprises a tube through which the diagnostic or therapeutic device is allowed to pass. [Item 114] The prosthetic valve according to Item 113, wherein the tube is made of a fabric, a knitted material, or a polymer. [Item 115] The prosthetic valve according to Item 113 or 114, wherein the tube comprises a valve through which the diagnostic or therapeutic device is allowed to pass. [Item 116] The prosthetic valve according to any one of Items 112 to 115, wherein the prosthetic heart valve body comprises an outer frame body and an inner frame body, and the port is positioned on the outer frame body. [Item 117] The prosthetic valve according to Item 116, wherein the port is positioned on a cover extending over the outer frame of the outer frame body. [Item 118] The prosthetic valve according to Item 116 or 117, wherein the port comprises a tearable portion of the prosthetic heart valve body. [Item 119] The prosthetic valve according to any one of Items 112 to 118, wherein the port is configured to form a seal with the diagnostic or therapeutic device. [Item 120] The prosthetic valve according to any one of Items 112 to 119, wherein the port is positioned outside the prosthetic valve annulus. [Item 121] The prosthetic valve according to any one of Items 112 to 120, wherein an imaging marker identifies the location of the port. [Item 122] The prosthetic valve according to any one of Items 112 to 121, wherein the diagnostic or therapeutic device comprises a pacemaker pacing lead. [Item 123] A method for treating a patient's tricuspid valve, comprising: passing a delivery device for an implant into the right atrium of the patient; deploying the implant to the patient's tricuspid valve; and a method comprising. [Item 124] The method according to item 123, wherein the delivery device comprises an elongated shaft having an implant holding region for holding the implant. [Item 125] The delivery device comprises a deployment port for deploying the implant, and the method further comprises deflecting the delivery device in the inferior vena cava or the superior vena cava to change the height of the deployment port from the patient's tricuspid valve. The method according to item 124. [Item 126] The method according to item 124 or 125, wherein the elongated shaft comprises a bending portion configured to direct a distal portion of the elongated shaft toward the patient's tricuspid valve. [Item 127] The method according to item 126, further comprising changing the height of the bending portion from the patient's tricuspid valve. [Item 128] The method according to item 126 or 127, further comprising deflecting the bending portion and a portion of the elongated shaft proximal to the bending portion away from the patient's tricuspid valve. [Item 129] A sheath is positioned over the elongated shaft, and the method further comprises deflecting a portion of the elongated shaft using the sheath. The method according to any one of items 124 to 128. [Item 130] The method according to item 129, further comprising rotating the sheath to change the direction of deflection of the elongated shaft. [Item 131] The elongated shaft comprises an outer sheath extending over the rail shaft, the outer sheath being configured to slide relative to the rail shaft to vary the distance of the implant holding region from the patient's tricuspid valve, the method according to claim 124. [Claim 132] The elongated shaft has a distal end and comprises a capsule surrounding the implant holding region, the distal end of the capsule forming the distal tip of the elongated shaft, the method according to any one of claims 124 to 131. [Claim 133] The elongated shaft has a distal tip comprising a flexible sheath extending distally and configured to bend around a portion of a guide wire, the method according to any one of claims 124 to 131. [Claim 134] The method according to claim 133, further comprising the step of bending the flexible sheath around the portion of the guide wire when the guide wire is positioned in the patient's right ventricle. [Claim 135] The elongated shaft comprises a distal tip having a hemispherical or parabolic shape, the method according to any one of claims 124 to 132. [Claim 136] The implant is a prosthetic tricuspid valve, the method according to any one of claims 124 to 135, further comprising the step of passing the prosthetic tricuspid valve through a bending deployment passage of the elongated shaft to deploy the prosthetic tricuspid valve. [Claim 137] The prosthetic tricuspid valve has an axial dimension, and the prosthetic tricuspid valve bends across the axial dimension when passing through the bending deployment passage, the method according to claim 136. [Claim 138] The elongated shaft has an axial dimension, the method according to any one of claims 124 to 137, further comprising the step of deploying the implant through a port of the elongated shaft in a direction transverse to the axial dimension. [Claim 139] The method according to any one of claims 124 to 138, further comprising the step of bending the elongated shaft beyond 180 degrees to form a loop. [Claim 140] The method according to claim 139, wherein the loop is at least partially positioned within the right atrium of the patient. [Claim 141] The method according to any one of claims 124 to 140, wherein the elongated shaft comprises a capsule surrounding an implant holding region for holding the implant, and a hinge coupling the capsule to a portion of the elongated shaft. [Claim 142] The method according to claim 141, further comprising the step of pivoting the capsule around the hinge. [Claim 143] The method according to any one of claims 123 to 142, wherein at least a portion of the delivery device is actuated by at least one motor operated by a processor. [Claim 144] The method according to any one of claims 123 to 143, wherein the delivery device comprises one or more sensors coupled to the delivery device and configured to sense one or more of the state of the patient's body or the state of the delivery device. [Claim 145] A method for treating a tricuspid valve of a patient, comprising: deploying a prosthetic heart valve within the tricuspid annulus of the patient; deploying an anchor into a portion of the patient's body; providing a suture connecting the prosthetic heart valve to the anchor; and including. [Claim 146] The method according to claim 145, further comprising the step of connecting the anchor to the prosthetic heart valve with the suture. [Claim 147] The method according to claim 145 or 146, wherein the anchor comprises a stent. [Claim 148] The method according to item 147, further comprising the step of fixing the stent in the inferior vena cava or superior vena cava of the patient. [Item 149] The method according to item 145 or 146, further comprising the step of fixing the anchor to the moderator band of the right ventricle of the patient. [Item 150] The method according to item 149, wherein the anchor comprises one or more of a hook, a loop, a cover, a loop, or an expandable body. [Item 151] The method according to item 145 or 146, wherein the anchor is configured to be fixed to the wall of the right ventricle of the patient. [Item 152] The method according to any one of items 145 to 151, further comprising the step of tethering the prosthetic heart valve to the heart valve flap of the heart valve of the patient. [Item 153] A method comprising the step of passing a diagnostic or therapeutic device through a port positioned in a prosthetic heart valve body forming a prosthetic annulus. [Item 154] The method according to item 153, wherein the prosthetic heart valve body is positioned in the tricuspid heart valve annulus of the patient, and the diagnostic or therapeutic device is passed through the port into the right ventricle of the patient. [Item 155] The method according to item 153 or 154, wherein the port comprises a tube through which the diagnostic or therapeutic device is passed. [Item 156] The method according to item 155, wherein the tube is made of a fabric, a knitted material, or a polymer. [Item 157] The method according to item 155, wherein the tube comprises a valve through which the diagnostic or therapeutic device is passed. [Item 158] The method according to item 153, wherein the port comprises a tearable portion of the prosthetic heart valve body. [Item 159] The prosthetic heart valve body includes an outer frame body and an inner frame body, and the port is positioned on the outer frame body. The method according to any one of claims 153 to 158. [Claim 160] The port is positioned on a cover extending over the outer frame of the outer frame body. The method according to claim 159. [Claim 161] The port forms a seal with the diagnostic or therapeutic device. The method according to any one of claims 153 to 160. [Claim 162] The port is positioned outside the prosthetic valve annulus. The method according to any one of claims 153 to 161. [Claim 163] The method according to any one of claims 153 to 162 further includes imaging an imaging marker in the prosthetic heart valve body to identify the location of the port. [Claim 164] The diagnostic or therapeutic device includes a pacemaker pacing lead. The method according to any one of claims 153 to 163. [Claim 165] A method including coupling a pacemaker pacing lead to a prosthetic heart valve body positioned within a patient's cardiac valve annulus to provide electrical energy through the pacemaker pacing lead and through the prosthetic heart valve body to pace the function of the patient's heart. [Claim 166] The prosthetic heart valve body includes a frame, and the method according to claim 165 includes providing electrical energy through the frame. [Claim 167] The frame is in contact with the patient's heart valve. The method according to claim 166. [Claim 168] The prosthetic heart valve body includes one or more electrical terminals in contact with a portion of the patient's heart. The method according to any one of claims 165 to 167. [Claim 169] The method according to any one of claims 165 to 168, further comprising the step of providing said electrical energy through said pacemaker pacing lead and through said prosthetic heart valve body to pace the function of the heart of said patient. [Claim 170] The method according to any one of claims 165 to 169, further comprising the step of deploying said prosthetic heart valve body onto the heart valve annulus of said patient. [Claim 171] The method according to any one of claims 165 to 170, further comprising the step of expanding said prosthetic heart valve body within the heart valve annulus of said patient. [Claim 172] The method according to any one of claims 165 to 171, further comprising the step of anchoring said prosthetic heart valve body to the heart valve flaps of the heart valve of said patient. [Claim 173] The method according to any one of claims 165 to 172, further comprising the step of contacting said prosthetic heart valve body with the heart valve of said patient. [Claim 174] The method according to any one of claims 165 to 173, wherein said prosthetic heart valve body is positioned within the tricuspid heart valve annulus or the mitral heart valve annulus. [Claim 175] Delivering a delivery device for implantation to a portion of a patient's heart, said delivery device comprising an elongate shaft extending along an axis and having an outer surface, and Expanding one or more supports radially outwardly from said outer surface of said elongate shaft, and Contacting said one or more supports with a surface external to said delivery device to resist deflection of said elongate shaft transverse to said axis comprising a method. [Claim 176] The method according to claim 175, wherein said surface is an atrial wall. [Claim 177] The method according to claim 175 or 176, wherein said surface is a wall of the atrial septum. [Item 178] The delivery device is positioned within the atrium of the patient's heart, the method according to any one of Items 175 to 177. [Item 179] The method according to any one of Items 175 to 178, further comprising the step of deploying the implant to the mitral valve or tricuspid valve of the patient's heart. [Item 180] The delivery device includes an implant holding region and a bending portion, and the method includes expanding the one or more supports proximal to the bending portion and deflecting the implant holding region at the bending portion in a first direction, the method according to any one of Items 175 to 179. [Item 181] The bending portion is a first bending portion, and the method according to Item 180 further includes deflecting the implant holding region at a second bending portion positioned proximal to the first bending portion in a second direction transverse to the first direction. [Item 182] The one or more supports include one or more inflatable bodies, the method according to any one of Items 175 to 181. [Item 183] The one or more supports include one or more mesh bodies, the method according to any one of Items 175 to 182. [Item 184] The one or more supports include one or more arms, the method according to any one of Items 175 to 181.

Explanation of Reference Numerals

[0373] 10 Delivery system 11 Proximal end 12 Elongated shaft 14 Handle 15 Handle 16 Implant holding region 18 Inner shaft assembly, inner assembly 20 Rail assembly, rail shaft assembly 21 Intermediate shaft assembly 22 Outer sheath assembly, outer sheath 27 Nose cone shaft 28 Nose cone 31 Nose cone assembly 40 Inner retaining ring, inner retaining member 42 Outer retaining member, outer retaining ring 43 Intermediate shaft hypodermic tube, hypodermic tube 44 Proximal tube, intermediate shaft proximal tube 51 Sheath, continuous sheath 70 Implant 72 Strut 80 Distal anchor 80a, 80b Distal anchor 82 Proximal anchor 83 Heart 102 Outer proximal shaft 104 Outer hypodermic tube 106 Capsule 122 Inner shaft 126 Distal region 129 Inner proximal shaft, inner proximal region 132 Rail shaft 134 Rail proximal shaft 135 Distal ring, distal tension wire connector 136 Rail hypodermic tube 137 Proximal ring, proximal tension wire connector 138 Distal tension wire, tension wire assembly 139 Lumen 140 Proximal tension wire, tension wire assembly 231 Non-cut hypodermic tube region, non-slotted hypodermic tube region 233 Proximal slotted hypodermic tube region 235 Distal slotted hypodermic tube region 237 Location where slot is avoided 241 Distal traction wire connection area 301 First end, proximal end of the implant 70 303 Second end, distal end of the implant 70 500, 502 Motors 504 Control device 506 Actuating mechanism 508 Distal portion of the handle 510 Proximal portion of the handle 512, 514 Couplers 516a - g Adapters 518a - g Drive rods 520a - g Openings 521, 523, 524, 526, 528 Assembly connectors 522 Opening, central opening 530 Controller 532 Input device and output device 534 Memory 536 Processor 538 Power supply 540 Power connector, signal connector 542 Electrical coupler 544a - g Openings 546 Cable 548, 550, 552, 554 Buttons 568 Output device 570 Output device 572 Elongated shaft 574 Housing 576 Patient's body 577 Motor - driven rail 578 Peripheral pressure sensor, pressure sensor 580 Contact sensor 582 Proximity sensor 583a - l Sensors, flow sensors 584 Output device, display screen 586 Output device 588 Control device 590, 592, 594 Adapters 596 Printed circuit board 598 Power supply 848 Data log 850 Indicator, output 1074 Ipsilateral femoral vein 1076 Right atrium 1077 Right ventricle 1079 Inferior vena cava 1082 Tricuspid heart valve 1083 Tricuspid heart valve 1087 Valve membrane 1108 Valve membrane 1200 Guide wire shield 1600 Implant 1620 Inner frame 1622a Upper region 1624 Inner frame anchor mechanism 1640 Outer frame 1642 Outer frame body 1642a Upper region 1646a - c Cells 1648a, 1648d, 1648e Struts 1650 Notch 1652 Lock tab 1652a Strut 1652b Enlarged head 1652c Notch 1660 Valve body 1664 Intermediate component 1680 Outer skirt 1690 Inner skirt

Claims

1. 1. A delivery system for an implant, comprising: an implant holding area for holding the implant; a distal tip having a hemispherical or parabolic shape; A delivery system comprising an elongate shaft having a

2. The delivery system of claim 1 , wherein a distal end of the distal tip has a convex profile.

3. 3. The delivery system of claim 1 or 2, wherein the elongate shaft comprises a capsule extending over the implant holding region, a tip body forming the distal tip, the tip body being movable relative to the capsule.

4. The delivery system of claim 3 , wherein the tip body is positioned at a distal end of the capsule.

5. 5. The delivery system of claim 3 or 4, wherein the outer surface of the tip body is convex from a proximal portion of the tip body to a distal end of the tip body.

6. 6. The delivery system of claim 3, wherein the capsule is configured to retract proximally to deploy the implant from the implant holding area.

7. 7. The delivery system of claim 1, wherein the distal tip is configured for passage of a guidewire.

8. 8. The delivery system of claim 7, wherein a tip body forms the distal tip, the tip body including an opening at a distal end thereof for passage of the guidewire therethrough.

9. The elongated shaft comprises: a bending portion configured to deflect the distal tip of the elongate shaft in a first direction; and A portion located proximally of the bent portion. Equipped with 9. The delivery system of claim 1, further comprising a deflection mechanism configured to deflect the portion positioned proximal to the bending portion to deflect the bending portion in a second direction opposite to the first direction.

10. 10. The delivery system of claim 9, wherein the implant holding area is positioned between the distal tip and the bent portion.

11. 11. The delivery system of claim 9 or 10, wherein the second direction is coplanar with the first direction.

12. The elongated shaft comprises: An inner shaft; a rail shaft extending over the inner shaft; an outer sheath extending over the rail shaft; 12. A delivery system according to any one of claims 9 to 11, comprising:

13. The delivery system of claim 12 , wherein the rail shaft comprises the bent portion.

14. 14. The delivery system of claim 13, wherein the bent portion is a first bent portion and the rail shaft includes a second bent portion configured to deflect the distal tip in a third direction perpendicular to the first direction.

15. 15. The delivery system of claim 14, wherein the portion positioned proximal to the bent portion is a third bent portion, and the second bent portion is disposed between the first bent portion and the third bent portion.

16. 16. The delivery system of claim 14 or 15, wherein the rail shaft includes one or more cuts corresponding to the first bent portion and includes one or more cuts corresponding to the second bent portion.

17. 17. The delivery system of claim 14, wherein the deflection mechanism is configured to deflect the second bent portion in the second direction.

18. 18. The delivery system of claim 12, wherein the deflection mechanism comprises a tension tether coupled to the rail shaft.

19. 19. The delivery system of claim 9, wherein the deflection mechanism is configured to deflect the distal tip in the second direction.

20. 20. The delivery system of claim 1, further comprising the implant, the implant being a prosthetic heart valve.

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