Systems and methods for tricuspid valve treatment

Abstract

Devices, systems, and methods are described herein for providing improved treatment of the tricuspid valve. Such treatment may include tricuspid valve replacement, which may include providing a prosthetic tricuspid valve within the tricuspid valve annulus. A delivery system for delivering the prosthetic tricuspid valve to the tricuspid valve annulus is disclosed herein. Treatment may also include tricuspid valve repair.

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, function essentially as one-way valves and operate in synchronization with the pumping heart. The valves allow blood to flow downstream but prevent blood from flowing upstream. Diseased heart valves exhibit disorders such as stenosis or regurgitation of the valve, which interfere with the valve's function of controlling blood flow. Such disorders can reduce the heart's blood pumping efficiency, weaken, and be life-threatening conditions. For example, valve insufficiency can lead to symptoms such as heart hypertrophy and ventricular dilation. Accordingly, 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 devoted 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. Replacement valves are 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] The development of prosthesis implants, including replacement heart valves, that can be made compact for delivery and then controllly expandable for controlled placement, has proven particularly challenging. A further challenge relates to the ability of such prostheses to be fixed in a non-invasive manner to intraluminal tissue, such as any intracavitary or cavity tissue.

[0005] Delivering a prosthesis to a desired location within the human body, such as delivering a replacement heart valve to a tricuspid valve, can also be a challenge. Securing access routes to perform procedures within the heart or other anatomical locations may require device delivery via percutaneous, open, or semi-open surgical procedures through the winding vascular system. The ability to control the deployment of the prosthesis at the desired location can also be a challenge. [Means for solving the problem]

[0006] Embodiments of this disclosure are directed to prostheses such as replacement heart valves, but are not limited thereto. Embodiments of this disclosure may also be directed to delivery systems, devices, and / or methods of use for delivering and / or controllingly deploying prostheses such as replacement heart valves to a desired location within the body, but are not limited thereto. In some embodiments, replacement heart valves and methods for delivering replacement heart valves to congenital heart valves such as tricuspid valves are provided.

[0007] In some embodiments, delivery systems and methods are provided for delivering a replacement heart valve to the site of the original tricuspid valve. In some embodiments, components of the delivery system facilitate bending of the delivery system to maneuver a prosthesis in the right atrium to its site in the original tricuspid valve. In some embodiments, a capsule is provided to house the prosthesis for delivery to the site of the original tricuspid valve. In other embodiments, the delivery systems and methods may be adapted for delivery of the implant to a site other than the original tricuspid valve.

[0008] This disclosure includes, but is not limited to, the following embodiments:

[0009] An implant delivery system, comprising an elongated shaft having a distal end, an implant-holding region for holding an implant, a bent portion configured to deflect the distal end of the elongated shaft in a first direction, and a portion positioned proximal to the bent portion. The deflection mechanism is configured to deflect the portion positioned proximal to the bent portion in order to deflect the bent portion in a second direction opposite to the first direction.

[0010] An implant delivery system, comprising an elongated shaft having a distal end, an implant-holding region for holding an implant, a bent portion configured to deflect the distal end of the elongated shaft toward a first plane, and a portion positioned proximal to the bent portion. A deflection mechanism is configured to deflect the portion positioned proximal to the bent portion toward one or more planes not perpendicular to the first plane.

[0011] An implant delivery system, comprising an elongated shaft having a distal end, an implant-holding region for holding an implant, a first bent portion configured to deflect the distal end of the elongated shaft in a first direction, a second bent portion positioned close to the first bent portion and configured to deflect the distal end of the elongated shaft in a second direction, and a portion positioned proximal to the second bent portion. A deflection mechanism may be configured to deflect the first bent portion, the second bent portion, and the portion positioned proximal to the second bent portion.

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

[0013] An implant delivery system comprising an elongated shaft having an implant-holding region for holding the implant and a distal end having a flexible sheath that extends distally and is configured to bend around a portion of a guidewire.

[0014] An implant 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, comprising an elongated shaft having walls surrounding a passage through which an implant is to be passed for implant deployment, the walls being configured to have bends that define the bends in the passage during implant deployment.

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

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

[0018] A delivery system for an implant, comprising an elongated shaft having a capsule surrounding an implant-retaining area for holding the implant, and a hinge connecting the capsule to a portion of the elongated shaft.

[0019] A delivery system for an implant comprises an elongated shaft extending along an axis and having an outer surface and an implant-retaining region for holding the implant. One or more supports may be configured to extend radially outward from the outer surface of the elongated shaft and to contact the outer surface to resist the deflection of the elongated shaft transverse to the axis.

[0020] The system comprises a prosthesis heart valve configured for implantation within the patient's valve annulus. The system comprises anchors configured to be fixed within a portion of the patient's body. The system comprises tethers configured to connect the prosthesis heart valve to the anchors.

[0021] A prosthesis valve for the replacement of a patient's natural valve, comprising a prosthesis valve body configured to be anchored within the annular band of the patient's natural valve, forming the prosthesis valve annular band. The system comprises a port coupled to the prosthesis valve body and configured to receive a diagnostic or therapeutic device.

[0022] A method for treating a patient's tricuspid valve, the method comprising the steps of passing a delivery device for an implant into the patient's right atrium; and deploying the implant into the patient's tricuspid valve.

[0023] A method for treating a patient's tricuspid valve, the method comprising the steps of deploying a prosthesis heart valve within the patient's tricuspid valve annular ligament; deploying an anchor within a portion of the patient's body; and providing a tether to connect the prosthesis 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 includes 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, and expanding one or more supports radially outwardly from the outer surface of the elongate shaft, and contacting one or more supports against an external surface of the delivery device to resist deflection of the elongate shaft transverse to the axis. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] [Figure 1] FIG. 1 is a view showing one embodiment of a delivery system. [Figure 2A] FIG. 2 is a partial cross-sectional view of a distal end of the delivery system of FIG. 1 loaded with the valve prosthesis of FIG. 3A. [Figure 2B] FIG. 3 is a partial cross-sectional view of a distal end of the delivery system of FIG. 1 without the valve prosthesis of FIG. 3A. [Figure 2C] FIG. 4 is a partial cross-sectional view of a distal end of the delivery system of FIG. 1 with a particular shaft assembly translated along a rail assembly. [Figure 3A] FIG. 5 is a side view of one embodiment of a valve prosthesis that can be delivered using the delivery system described herein. [Figure 3B] FIG. 6 is a side view of one embodiment of an aortic valve prosthesis that can be delivered using the delivery system described herein. [Figure 4] FIG. 7 is a perspective view of a distal end of the delivery system of FIG. 1. [Figure 5] This figure shows the components of the delivery system in Figure 4, with the outer sheath assembly moved proximal and out of the field of view. [Figure 6A] This figure shows the components of the delivery system in Figure 5, with the intermediate shaft assembly moved proximal and out of the field of view. [Figure 6B] This is a cross-sectional view of the rail assembly. [Figure 6C] This is a cross-sectional view of an embodiment of the rail assembly. [Figure 7] This is a diagram showing the components of a delivery system. [Figure 8] This figure shows the components of the delivery system in Figure 7, with the inner assembly moved proximal and out of the field of view. [Figure 9] This figure shows one embodiment of a rail assembly. [Figure 10] This figure shows one embodiment of a delivery system handle. [Figure 11] Figure 10 is a cross-sectional view of the delivery system handle. [Figure 12A] This is a side view of the distal end of a long, slender shaft. [Figure 12B] This is a side view of the distal end of a slender shaft deflected from the position shown in Figure 12A. [Figure 12C] This is a top view of the distal end of a slender shaft deflected from the position shown in Figure 12A. [Figure 13A] This is a side view of the distal end of a long, slender shaft. [Figure 13B] This is a side view of the distal end of an elongated shaft deflected from the position shown in Figure 13A. [Figure 13C] This is a top view of the distal end of a slender shaft deflected from the position shown in Figure 13A. [Figure 13D] This is a front view of the distal end of an elongated shaft deflected from the position shown in Figure 13A. [Figure 14A] This is a perspective view of a deflection mechanism positioned on a long, slender shaft. [Figure 14B] This is a side view of the distal end of a long, slender shaft. [Figure 14C] This is a side view of the distal end of a slender shaft deflected from the position shown in Figure 14B. [Figure 14D] This is a top view of the distal end of a slender shaft deflected from the position shown in Figure 14B. [Figure 15A] This is a side view of the distal end of a long, slender shaft. [Figure 15B] This is a side view of the distal end of an elongated shaft deflected from the position shown in Figure 15A. [Figure 15C] This is a top view of the distal end of a slender shaft deflected from the position shown in Figure 15A. [Figure 16A] This is a side view of the distal end of a long, slender shaft. [Figure 16B] This is a side view of the distal end of a slender shaft deflected from the position shown in Figure 16A. [Figure 16C] This is a top view of the distal end of a slender shaft deflected from the position shown in Figure 16A. [Figure 17] This is a perspective view of the rail assembly where the tensioning ropes are positioned. [Figure 18A] This is a perspective view of a rail assembly having a cut positioned on the pipe of the rail assembly. [Figure 18B] This is a cross-sectional view of the rail assembly where the stopping section is positioned. [Figure 19A] This is a side view of the distal end of a long, slender shaft. [Figure 19B] Figure 19A is a top view of the distal end of the elongated shaft shown. [Figure 20A] This is a diagram depicting the elongated shaft that enters the right atrium of a patient's heart. [Figure 20B] This is a diagram of the distal end of the elongated shaft shown in Figure 20A, deflected from the position shown in Figure 20A. [Figure 20C]This is a diagram of the distal end of the elongated shaft shown in Figure 20B, deflected from the position shown in Figure 20B. [Figure 21] This diagram depicts a slender shaft that enters the right atrium of a patient's heart from the superior vena cava. [Figure 22A] This is a perspective view of an implant extending from a long, slender shaft. [Figure 22B] This is a perspective view of an implant extending from a long, slender shaft. [Figure 22C] This is a perspective view of an implant extending from a long, slender shaft. [Figure 23] This is a diagram of the implant located in the designated position within the tricuspid valve annular region. [Figure 24] This is a diagram of an embodiment of the tip of a long, slender shaft. [Figure 25A] This is a diagram of an embodiment of the tip of a long, slender shaft. [Figure 25B] This is a diagram of a capsule positioned inside the right ventricle of a patient's heart. [Figure 26] This is a diagram of an embodiment of the tip of a long, slender shaft. [Figure 27] This is a diagram of an embodiment of the tip of a long, slender shaft. [Figure 28] This is a diagram of an embodiment of the tip of a long, slender shaft. [Figure 29] This is a diagram of a flexible implant positioned within a slender, curved shaft. [Figure 30] This is a diagram of an implant configured to unfold from a port on the side of a long, slender shaft. [Figure 31] This is a diagram of an elongated shaft with a loop. [Figure 32A] This is a diagram of a long, slender shaft with a hinge. [Figure 32B] This is a diagram of the elongated shaft shown in Figure 32A, from which the capsule is being rotated from the position shown in Figure 32A. [Figure 33A] This is a diagram of a long, slender shaft with a hinge. [Figure 33B] This is a diagram of the elongated shaft shown in Figure 33A, from which the capsule is being rotated from the position shown in Figure 33A. [Figure 34A] This is a diagram of the elongated shaft inside the patient's right atrium. [Figure 34B] This is a diagram of the elongated shaft shown in Figure 34A, which is being translated from the position shown in Figure 34A. [Figure 35] This is a diagram of an implant in the tricuspid valve annular junction in a patient whose anchor is positioned in the inferior vena cava. [Figure 36A] This is a diagram of an implant in the tricuspid valve annular ossema in a patient whose anchor is connected to the right ventricular regulatory band. [Figure 36B] This is a perspective view of the anchor for connecting to the adjustment band. [Figure 36C] This is a perspective view of the anchor for connecting to the adjustment band. [Figure 36D] This is a perspective view of the anchor for connecting to the adjustment band. [Figure 36E] This is a perspective view of the anchor for connecting to the adjustment band. [Figure 36F] This is a perspective view of the anchor for connecting to the adjustment band. [Figure 37] This is a diagram of an implant in the tricuspid valve annular region in a patient whose anchor is connected to the wall of the right ventricle. [Figure 38A] This is a diagram of an implant in the right atrium of a patient, with the anchor connected to the wall of the right ventricle. [Figure 38B] Figure 38A shows the implant inside the tricuspid valve annular region of the patient. [Figure 39A] This is a schematic lateral view of an implant with a port for receiving a diagnostic or therapeutic device. [Figure 39B] This is a schematic lateral view of an implant with a port for receiving a diagnostic or therapeutic device. [Figure 39C] This is a lateral view of an implant with a port for receiving a diagnostic or therapeutic device. [Figure 39D]This is a bottom view of an implant with a port for receiving a diagnostic or therapeutic device. [Figure 39E] This is a lateral view of a port for receiving a diagnostic or therapeutic device. [Figure 39F] This is a lateral view of a port for receiving a diagnostic or therapeutic device. [Figure 39G] This is a lateral view of a port for receiving a diagnostic or therapeutic device. [Figure 40A] This is a schematic lateral view of an implant with a port for receiving a diagnostic or therapeutic device. [Figure 40B] This is a lateral view of an implant with a port for receiving a diagnostic or therapeutic device. [Figure 41] This is a lateral view of an implant with a port for receiving a diagnostic or therapeutic device. [Figure 42] This is a diagram of an implant having a port for receiving a diagnostic or therapeutic device at a predetermined position within the tricuspid valve annulus. [Figure 43] This is a diagram of an implant having a port for receiving a diagnostic or therapeutic device at a predetermined position within the tricuspid valve annulus. [Figure 44] This is a diagram of an implant equipped with a port for connecting to a pacemaker pacing lead. [Figure 45] This is a perspective view of the delivery system. [Figure 46] Figure 45 is a schematic diagram of the handle of the delivery system shown. [Figure 47] This is a front plan view of one embodiment of the adapter. [Figure 48] This is a side perspective view of one embodiment of an adapter and drive rod. [Figure 49] Figure 45 is a perspective view of the handle shown. [Figure 50] Figure 45 is a perspective view of the proximal portion of the handle. [Figure 51]This is a side view of the insertion of the delivery system into the patient's body. [Figure 52] This is a perspective view of one embodiment of the distal end of an elongated sheath. [Figure 53] This is a perspective view of one embodiment of the distal end of an elongated sheath. [Figure 54] Figure 53 is a cross-sectional view of the elongated sheath capsule. [Figure 55] Figure 53 is a schematic side view of the elongated sheath used to deploy the implant into the tricuspid heart valve. [Figure 56] This is a diagram of a slender shaft approaching the tricuspid valve. [Figure 57] This is a diagram of the elongated shaft shown in Figure 56, which has been deflected at a predetermined position. [Figure 58] This is a diagram of an implant deployed in the tricuspid valve. [Figure 59] This is a perspective view of one embodiment of a control device and an output device. [Figure 60] This is a perspective view of one embodiment of a control device and an output device. [Figure 61] This is a cross-sectional view of one embodiment of a delivery system handle. [Figure 62A] This is a side view of the distal end of a long, slender shaft. [Figure 62B] This is a side view of the elongated shaft shown in Figure 62A, with the support structure deployed. [Figure 62C] This is a diagram of the elongated shaft shown in Figure 62A, which is close to the mitral valve. [Figure 62D] This is a diagram of the elongated shaft shown in Figure 62A, which is close to the mitral valve. [Figure 62E] Figure 62A shows a slender shaft with its support structure extended, approaching the mitral valve. [Figure 62F] This is a diagram of a slender shaft approaching a tricuspid valve, with a support structure extended. [Figure 63A] This is a diagram of a slender shaft approaching the mitral valve. [Figure 63B] Figure 63A shows a slender shaft with its support structure extended, approaching the mitral valve. [Figure 64A] This is a perspective view of the support structure. [Figure 64B] This is a diagram of a slender shaft approaching the mitral valve. [Figure 64C] Figure 64B shows a slender shaft with its support structure extended, approaching the mitral valve. [Modes for carrying out the invention]

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

[0029] Figure 1 shows one embodiment of a delivery device, delivery assembly, or delivery system 10 according to one embodiment of the present disclosure. The delivery system 10 can be used to deploy prostheses, such as replacement heart valves, within the body. In some embodiments, the delivery system 10 can use a two-plane deflection approach to properly deliver the prosthesis. Replacement heart valves can be delivered in various ways to the atlanto-lubrication of the patient's tricuspid heart valve or other heart valve locations, such as by open surgery, minimally invasive surgery, and percutaneous or transcatheter delivery through the patient's vascular system. An example transfemoral approach can be found in U.S. Patent Application Publication No. 2015 / 0238315, filed February 20, 2015, the entire patent application, in whole, is incorporated herein by reference. While the delivery system 10 is described in relation to a percutaneous delivery approach, and more specifically in relation to a transfemoral artery delivery approach, it should be understood that the features of the delivery system 10 may be applicable to other delivery systems, including delivery systems for transcardiapical, transright atrial, or transjugular vein delivery approaches.

[0030] The 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. The delivery system 10 may receive and / or cover a portion of a prosthesis, such as the first end 301 and the second end 303 of a prosthesis or implant 70, as shown in Figure 3A. For example, the delivery system 10 may be used to deliver an expandable prosthesis or implant 70, the implant 70 comprising a first end 301 and a second end 303, in which case the second end 303 is configured to deploy or expand in front of the first end 301.

[0031] Figure 2A further illustrates an example of an implant 70 that may be inserted into the delivery system 10, specifically into the implant retention area 16. In Figure 2A, for ease 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. A specific example of a frame for the prosthesis is shown in Figure 3A, but it is understood that other designs and frame configurations may be used, including those disclosed in this application. The implant 70 may 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 extended configuration, and a proximal (or atrial) anchor 82 that extends distally when the prosthesis frame is in an extended configuration. The prosthesis may further comprise a strut 72 that may be interrupted at a mushroom-shaped tab 74 at a first end 301. Further considerations can be found in U.S. Patent Application Publication No. 2015 / 0328000(A1), issued on November 19, 2015, which is incorporated by reference throughout this specification.

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

[0033] Additional details and example designs of prostheses are described in U.S. Patent Nos. 8,403,983, 8,414,644, 8,652,203, U.S. Patent Publication Nos. 2011 / 0313515, U.S. Patent Publication Nos. 2012 / 0215303, U.S. Patent Publication Nos. 2014 / 0277390, U.S. Patent Publication Nos. 2014 / 0277422, U.S. Patent Publication Nos. 2014 / 0277427, U.S. Patent Publication Nos. 2018 / 0021129, and U.S. Patent Publication Nos. 2018 / 0055629, the entirety of which these patents and patent publications are incorporated by reference herein and constitute part of this specification. Further details and embodiments of replacement heart valves and prostheses, and methods thereof for implantation, are described in U.S. Patent Application Publication No. 2015 / 0328000 and U.S. Patent Application Publication No. 2016 / 0317301, each of which in whole is incorporated by reference and constitutes part of this Spec.

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

[0035] As shown in Figure 1, the delivery system 10 may comprise a shaft assembly or an elongated shaft 12 having a proximal end 11 and a distal end 13, with a handle 14 coupled to the proximal end of the elongated shaft 12. The elongated shaft 12 may be used to hold the implant to advance the implant 70 to the treatment site via the vascular system. The delivery system 10 may further comprise a relatively rigid continuous (or one-piece) sheath 51 surrounding the elongated shaft 12, which can prevent undesirable movement of the elongated shaft 12. The continuous sheath 51 may be fitted at the proximal end of the elongated shaft 12 proximal to the handle 14, for example, at the sheath hub. The elongated shaft 12 may include an implant-holding area 16 (shown in Figures 2A and 2B, where Figure 2A shows the implant 70 and Figure 2B shows the implant 70 removed) at its distal end, which can be used for this purpose. In some embodiments, the elongated shaft 12 can hold the expandable prosthesis in a compressed state within the implant-retaining region 16 to advance the implant 70 within the body. The elongated shaft 12 may then be used to enable controlled expansion of the implant 70 at the treatment site. In some embodiments, the elongated shaft 12 may be used to enable continuous controlled expansion of the implant 70, as will be discussed in detail below. The implant-retaining region 16 is shown in Figures 2A-2B at the distal end of the delivery system 10, but may be located elsewhere. In some embodiments, the implant 70 may be rotated within the implant-retaining region 16 through rotation of the internal shaft assembly 18, for example, as discussed herein.

[0036] As shown in the cross-sectional views of Figures 2A and 2B, the distal end of the delivery system 10 may include one or more secondary assemblies, such as the outer sheath assembly 22, the intermediate shaft assembly 21, the rail assembly 20, the inner shaft assembly 18, and the 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 different radial order than that considered.

[0037] More specifically, embodiments of the disclosed delivery system 10 may utilize a longitudinal rail within a rail assembly 20 to steer the distal end of the delivery system 10, thereby enabling proper placement of the implant in the patient's body. As will be discussed in more detail below, the steerable rail may be, for example, a rail shaft extending through the delivery system 10 from a handle 14 to a generally distal end. In some embodiments, the steerable rail has a distal end that ends proximal to the implant holding area 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 strikes and presses against other assemblies, causing those assemblies to bend as well, so that the other assemblies of the delivery system 10 are configured to move together 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 the movement of other sheaths / shafts relative to the rail and released into the body. The rail can be bent to a desired position within the body, for example, to guide the implant 70 toward the natural mitral valve. Other assemblies (e.g., the outer sheath assembly 22, the intermediate shaft assembly 21, the inner assembly 18, and the nose cone assembly 31) can passively follow the bends in the rail. Furthermore, without releasing or expanding the implant 70 (e.g., within the implant retention area 16), the other assemblies (e.g., the outer sheath assembly 22, the intermediate shaft assembly 21, the inner assembly 18, and the nose cone assembly 31) can be advanced together relative to the rail (e.g., relatively together, sequentially with one actuator, simultaneously, almost simultaneously, one at a time, or exactly one at a time) while maintaining the implant 70 in a compressed position. Other assemblies (e.g., the outer sheath assembly 22, the intermediate shaft assembly 21, the inner assembly 18, and the nose cone assembly 31) can be advanced distally or proximal to the rail. In some embodiments, only the outer sheath assembly 22, the intermediate shaft assembly 21, and the inner assembly 18 are advanced together on the rail. Thus, the nose cone assembly 31 may remain in the same position. To free the implant 70 from the implant retention area 16, the assemblies can be translated individually, sequentially, or simultaneously relative to the inner assembly 18.

[0039] Figure 2C shows the sheath assembly, specifically the outer sheath assembly 22, intermediate shaft assembly 21, inner shaft assembly 18, and nose cone assembly 31, which are integrally translated distally along the rail assembly 20, and further details of the assembly are given below. In some embodiments, the outer sheath assembly 22, intermediate shaft assembly 21, inner shaft assembly 18, and nose cone assembly 31 translate together (e.g., together relatively, sequentially with one actuator, simultaneously, almost simultaneously, one at a time, exactly one at a time). This distal translation may occur while the implant 70 remains in a compressed configuration within the implant retention region 16.

[0040] As shown in Figures 2A–2C and further in Figures 4–8, starting with the outermost assembly, the delivery system may include an outer sheath assembly 22 that surrounds the implant retention area 16 and forms a radially outer cover or sheath to prevent the implant from expanding radially. Specifically, the outer sheath assembly 22 can prevent radial expansion of the distal end of the implant. Moving radially inward, the intermediate shaft assembly 21 may consist of an intermediate shaft hypotube 43 mounted on an outer retaining member or outer retaining ring 42 for radially holding a portion of the prosthesis, such as the proximal end of the implant 70, in a compression configuration. The intermediate shaft assembly 21 may be located within the lumen of the outer sheath assembly 22. Moving further inward, the rail assembly 20 may be configured for maneuverability as listed above and further described below. The rail assembly 20 may be located within the lumen of the intermediate shaft assembly 21. Moving further inward, the inner shaft assembly 18 may consist of an inner shaft whose distal end is mounted on an inner retaining member or inner retaining ring 40 (such as a PEEK ring) for axially maintaining the prosthesis, for example, the proximal end of the prosthesis. The inner shaft assembly 18 may be located within the lumen of the rail assembly 20. Furthermore, the most radially innermost assembly may be a nose cone assembly 31, which includes a nose cone shaft 27 having its distal end connected to a nose cone 28. The nose cone 28 may have a tapered tip. The nose cone assembly 31 may preferably be located within the lumen of the inner shaft assembly 18. The nose cone assembly 31 may include a lumen for a guidewire to pass through it.

[0041] The elongated shaft 12, more specifically the nose cone assembly 31, inner assembly 18, rail assembly 20, intermediate shaft assembly 21, and outer sheath assembly 22 may be collectively configured to deliver the implant 70, positioned within the implant holding area 16 (shown in Figure 2A), to the treatment site. One or more of the secondary assemblies may then be moved to allow the implant 70 to be released at the treatment site. For example, one or more of the secondary assemblies may be movable relative to one or more of the other secondary assemblies. The handle 14 may be equipped with various control mechanisms that can be used to control the movement of the various secondary assemblies, as will be described in more detail below. In this way, the implant 70 can be controllably loaded onto the delivery system 10 and subsequently deployed in the body. Furthermore, the handle 14 may provide steering relative to the rail assembly 20, allowing for bending / flexing / maneuvering 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 in Figure 2A engaged with the post 72 at the proximal end 301 of the implant 70. For example, a radially extending slot on the inner retaining member 40 located between teeth can receive and engage with the post 72, which may end with a mushroom-shaped tab on the proximal end of the implant 70. The intermediate shaft assembly 21 can be positioned on the inner retaining member 40 so that the first end 301 of the implant 70 is captured between the inner retaining member 40 and the outer retaining ring 42, thereby securely mounting 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 the intermediate shaft hypotube 43, which 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 can provide further stability to the implant 70 when in the compressed position. The outer retaining member 42 can be positioned on the inner retaining member 40 so that the proximal end of the implant 70 is caught between them and securely fitted into the delivery system 10. The outer retaining member 42 can surround a portion of the implant 70, specifically the first end 301, and thus prevent the implant 70 from expanding. Furthermore, the intermediate shaft assembly 21 can be translated proximal to the inner assembly 18 into the outer sheath assembly 22, and thus expose the first end 301 of the implant 70 that is held within the outer retaining member 42. In this way, the outer retaining member 42 can be used to help fix the implant 70 or to help release it from the delivery system 10. The outer retaining member 42 can have a cylindrical or elongated tubular shape and may sometimes be called an outer retaining ring, but is not limited to a specific shape.

[0044] As shown in Figure 2A, the distal anchor 80 can be positioned in a delivery configuration, pointing generally 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 withdrawn proximal, the distal anchor 80 can be reversed (e.g., bent approximately 180 degrees) to an unfolded configuration (e.g., pointing generally proximal). Figure 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 point generally proximal in the delivery configuration and pressed against the body of the prosthesis frame.

[0045] The delivery system 10 may be provided to the user with the implant 70 pre-installed. In other embodiments, the implant 70 may be loaded into the delivery system by a physician or nurse immediately before use.

[0046] Figures 4 to 8 show further diagrams of the delivery system 10, which is described in detail, with different assemblies translated in the proximal direction.

[0047] Beginning with the outermost assembly shown in Figure 4, the outer sheath assembly 22 may include an outer proximal shaft 102 directly attached to the handle 14 at its proximal end, and an outer hypotube 104 attached at its distal end. A capsule 106 can then be attached to the generally distal end of the outer hypotube 104. In some embodiments, the capsule 106 may be 28 French or smaller in size. These components of the outer sheath assembly 22 may form a lumen for other secondary assemblies to pass through.

[0048] The capsule 106 can be positioned at the distal end of the outer proximal shaft 102. The capsule 106 may 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, the capsule 106 is relatively thick to prevent tearing and help maintain the auto-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 may have a larger diameter than the outer hypotube 104, although in some embodiments, the capsule 106 may have a similar diameter to the hypotube 104. In some embodiments, the capsule 106 may include a distal portion with a larger diameter and a proximal portion with a smaller diameter. In some embodiments, a step or taper may exist between the two portions. The capsule 106 may be configured to hold the implant 70 in a compressed position within the capsule 106. Further structural details of the capsule 106 are discussed below.

[0049] The outer sheath assembly 22 is configured to slide independently relative to the other assemblies. Furthermore, the outer sheath assembly 22 can slide distally and proximal 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. Figure 5 is similar to Figure 4, but the outer sheath assembly 22 has been removed, thereby exposing the intermediate shaft assembly 21.

[0051] The intermediate shaft assembly 21 is an intermediate shaft hypotube 43 that is generally attached to the intermediate shaft proximal tube 44 at its proximal end, and the intermediate shaft proximal tube 44 may include the intermediate shaft hypotube 43, which can be attached to the handle 14 at its proximal end, and an outer retaining ring 42 located at the distal end of the intermediate shaft hypotube 43. Thus, the outer retaining ring 42 can be attached generally to the distal end of the intermediate shaft hypotube 43. These components of the intermediate shaft assembly 21 can form a lumen through which other secondary assemblies can pass.

[0052] The outer retaining ring 42 can be configured as a prosthesis retaining mechanism that can be used to engage with the implant 70, as considered with respect to Figure 2A. For example, the outer retaining ring 42 may be a ring or cover configured to radially cover the post 72 on the implant 70. The outer retaining ring 42 can also be considered as part of the implant retaining area 16, and may be located at the proximal end of the implant retaining area 16. With the post or other components 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, thereby securing 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 positioned to be independently slidable relative to the other assemblies. Furthermore, the intermediate shaft assembly 21 can slide distally and proximal to the rail assembly 20 together with the outer sheath assembly 22, the inner assembly 18, and the nose cone assembly 31.

[0054] Next, radially inside the intermediate shaft assembly 21 is the rail assembly 20. Figure 6A shows approximately the same diagram as Figure 5, but with the intermediate shaft assembly 21 removed, thereby exposing the rail assembly 20. Figure 6B further shows a cross-sectional view of the rail assembly 20 to see the tension wire. The rail assembly 20 may include a rail shaft 132 (or rail) that is roughly attached to the handle 14 at its proximal end. The rail shaft 132 may consist of a rail proximal shaft 134 that is directly attached to the handle at its proximal end, and a rail hypotube 136 attached to the distal end of the rail proximal shaft 134. The rail shaft 132 may comprise a proximal rail shaft portion 603 and a distal rail shaft portion 601. The rail hypotube 136 may further comprise a non-traumatic rail tip at its distal end. Furthermore, the distal end of the rail hypotube 136 may abut against the proximal end of the inner retaining member 40, as shown in Figure 6A. In some embodiments, the distal end of the rail hypotube 136 may be spaced away from the inner retaining member 40. These components of the rail shaft assembly 20 can form a lumen for the passage of other secondary elements.

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

[0056] In some embodiments, a distal tension wire 138 may extend to the distal region of the rail hypotube 136, and two proximal tension wires 140 may extend to the proximal region of the rail hypotube 136, but 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 the distal location, and a single tension wire may extend to the proximal location. In some embodiments, a ring-shaped structure mounted inside the rail hypotube 136 is known as a tension wire connector and can be used as mounting points for the tension wires, such as a proximal ring 137 and a distal ring 135. In some embodiments, the rail assembly 20 may include a distal tension wire connector 135 and a proximal tension wire connector 137. In some embodiments, the tension wires may be connected directly to the inner surface of the rail hypotube 136.

[0057] The distal tension wire 138 can be connected (either directly or via connector 135) approximately at the distal end of the rail hypotube 136. The proximal tension wire 140 can be connected (either directly or via connector 137) at approximately 1 / 4, 1 / 3, or 1 / 2 of the length from the proximal end to the rail hypotube 136. In some embodiments, the distal tension wire 138 can pass through a smaller diameter tension wire lumen 139 (e.g., a tube, hypotube, or cylinder) fitted inside the rail hypotube 136. This can prevent the wire 138 from pulling the rail hypotube 136 at a location proximal to the distal connection. Furthermore, the lumen 139 can act as a compression coil to reinforce the proximal portion of the rail hypotube 136 and prevent undesirable bending. Thus, in some embodiments, the lumen 139 is located only in the proximal half of the rail hypotube 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 may extend into the distal half of the rail hypotube 136. In some embodiments, the lumen 139 is fitted to the outer surface of the rail hypotube 136. In some embodiments, no lumen 139 is used.

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

[0059] Figure 6C shows an embodiment in which the position of the proximal tension wire 140 is shifted by 180° from the position shown in Figure 6B. The position of the proximal tension wire 140 shown in Figure 6C allows the proximal portion of the rail hypotube 136 to be bent in the opposite direction to the direction possible in Figure 6B. For example, in the embodiment of Figure 6B, when the distal portion of the rail hypotube 136 is deflected downward by the tension of the distal tension wire 138, the proximal portion of the rail hypotube 136 can be deflected to the left relative to the downward direction (when looking from the proximal end of the rail hypotube 136 towards the distal end of the rail hypotube 136). However, in the embodiment of Figure 6C, when the distal portion of the rail hypotube 136 is deflected downward by the tension of the distal tension wire 138, the proximal portion of the rail hypotube 136 can be deflected to the right relative to the downward direction (when viewing from the proximal end of the rail hypotube 136 toward the distal end of the rail hypotube 136). Such a change can deflect the proximal portion of the rail hypotube 136, and therefore the elongated shaft 12, in the opposite direction to the direction possible in the embodiment shown in Figure 6B. The thickness of the cut in the rail shaft 132 may also be changed to allow deflection in the opposite direction.

[0060] The rail assembly 20 is positioned to slide freely on 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 along or against the rail assembly 20, in proximal and distal directions, etc., 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 a compressed position when they slide along or against the rail assembly 20.

[0061] Moving radially inward, the next assembly is the inner shaft assembly 18. Figure 7 shows almost the same diagram as Figure 6A, but the rail assembly 20 has been removed, thereby exposing the inner shaft assembly 18.

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

[0063] The inner retaining member 40 may be configured as a prosthesis retaining mechanism that can be used to engage with the implant 70, as considered with respect to Figure 2A. For example, the inner retaining member 40 may be a ring and may include a number of slots configured to engage with the struts 72 on the implant 70. The inner retaining member 40 may also be configured as part of the implant retaining region 16, or it may be located 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, the outer retaining ring 42 can secure the prosthesis on the delivery system 10 by covering both the prosthesis and the inner retaining member 40. 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 positioned to slide independently relative to the other assemblies. Furthermore, the inner shaft assembly 18 can slide distally and proximal 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 Figure 8. This may be a nose cone shaft 27, and in some embodiments, it may have a nose cone 28 on its distal end. The nose cone 28 may be made of polyurethane for non-traumatic entry and to minimize damage to the venous vascular system. The nose cone 28 may also be radiopaque to provide visibility under fluoroscopy.

[0066] The nose cone shaft 27 may be sized and configured to slidably accommodate a guidewire, and may include a lumen that allows the delivery system 10 to advance through the vascular system over the guidewire. However, embodiments of the system 10 considered herein may not use a guidewire, and therefore the nose cone shaft 27 may be solid. The nose cone shaft 27 may be connected from the nose cone 28 to the handle, or may be formed from different parts such as other assemblies. Furthermore, the nose cone shaft 27 may be formed from 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 part of the nose cone shaft 27.

[0068] The nose cone assembly 31 is positioned to slide independently relative to the other assemblies. Furthermore, the nose cone assembly 31 can slide proximal and distal 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, a spacer sleeve may be concentrically positioned between the intermediate shaft assembly and the rail assembly 20, generally between the intermediate 43 and the rail hypotube 136. In some embodiments, a spacer sleeve can be substantially embedded within the hypotube 43 of the intermediate shaft assembly 21, such as on the inner surface of the intermediate shaft assembly 21. In some embodiments, a spacer sleeve may be concentrically positioned between the rail assembly 20 and the inner assembly 18, generally within the rail hypotube 136. In some embodiments, a spacer sleeve may be used between the outer sheath assembly 22 and the intermediate shaft assembly 21. In some embodiments, a 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. A spacer sleeve can be used in any of the above locations.

[0070] As discussed above, the outer sheath assembly 22, the intermediate shaft assembly 21, the inner assembly 18, and the rail assembly 20 can house the outer hypotube 104, the intermediate shaft hypotube, the distal section 126, and the rail hypotube 136, respectively. Each of these hypotubes / sections / shafts is laser-cut to include several slots, thereby forming a curved path for the delivery system to follow.

[0071] For example, Figure 9 shows one embodiment of the rail hypotube 136. The rail hypotube 136 can also include several circumferential slots. The rail hypotube 136 can be broadly divided into several different regions. At the most proximal end is an uncut (or unslotted) hypotube region 231. Moving distally, the next region is the proximal slotted hypotube region 233. This region contains several circumferential slots cut into the rail hypotube 136. Generally, two slots are cut around each circumferential location that forms approximately half of the circumference. Thus, two spine-like sections are formed between the slots that extend the entire length of the hypotube 136. This is the region that can be guided by the proximal tension wire 140. Moving further distally, there is a location 237 where the proximal tension wire 140 connects, thereby avoiding slots. This region is just distal to the proximal slotted region.

[0072] Following the proximal tension wire connection region distally, 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 out to a similar length. Thus, the distal slotted region 235 provides easier bending than the proximal slotted hypotube region 233. 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 of approximately 180 degrees within a range of 1 / 2 inch. Furthermore, as shown in Figure 9, the distal slotted hypotube region 235 is offset from the spine-like portion of the proximal slotted hypotube region 233. Therefore, the two regions will achieve different bending patterns, enabling three-dimensional maneuverability of the rail assembly 20. In some embodiments, the spine-like portion may have an offset of 30, 45, or 90 degrees, but the specific offset is not limiting. In some embodiments, the proximal slotted hypotube region 233 may include a compression coil. This allows the proximal slotted hypotube region 233 to retain rigidity due to the specific bending of the distal slotted region 235.

[0073] At the most distal end of the distal slotted hypotube section 235 is the distal tension wire connection section 241, which is also a section of the rail hypotube 136 that does not have slots.

[0074] The handle 14 is located at the proximal end of the delivery system 10. An embodiment of the handle 14 is shown in Figure 10. A cross-section of the handle 14 is shown in Figure 11. The handle 14 may comprise several actuators, such as rotatable knobs, that can operate different components of the delivery system 10. The operation of the handle 14 is described in relation to the delivery of a replacement valve prosthesis or implant 70, but the handle 14 and 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, with the rail housing 202 positioned around the delivery housing 204. The inner surface of the rail housing 202 may have a screwable 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 detailed later. The rail housing 202 generally surrounds the delivery housing 204 for half its length, and therefore the delivery housing 204 extends both proximal and distal to the outside of the rail housing 202.

[0076] The rail housing 202 can accommodate two rotatable knobs, namely a distal tensile wire knob 206 and a proximal tensile wire knob 208. However, the number of rotatable knobs in the rail housing 202 may vary depending on the number of tensile wires used. Rotation of the distal tensile wire knob 206 provides a proximal force, thereby providing axial tension to the distal tensile wire 138 and causing the distal slotted section of the rail hypotube 136 to bend. The distal tensile wire knob 206 can be rotated in either direction, allowing bending in either direction, thereby controlling the front-to-rear angle. Rotation of the proximal tensile wire knob 208 provides a proximal force, thereby providing axial tension to the proximal tensile wire 140 and causing the proximal slotted section 133 of the rail hypotube 136 to bend, thereby controlling the in-to-outer angle. The proximal tension wire knob 208 can be rotated in either direction and can be bent in either direction. Therefore, when both knobs are actuated, two bends are made in the rail hypo tube 136, thereby enabling three-dimensional maneuvering of the rail shaft 132 and, consequently, three-dimensional maneuvering of the distal end of the delivery system 10. Furthermore, the proximal end of the rail shaft 132 is connected to the inner surface of the rail housing 202.

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

[0078] Moving to the delivery housing 204, the proximal ends of the inner shaft assembly 18, outer sheath assembly 22, intermediate shaft assembly 21, and 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 relative to the rail assembly 20 and rail housing 202.

[0079] A rotatable outer sheath knob 210 can be positioned at the distal end of the delivery housing 204 and distal to the rail housing 202. Rotation of the outer sheath knob 210 pulls the outer sheath assembly 22 proximal 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 is translated independently of 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] A rotatable intermediate shaft knob 214 may be located in the delivery housing 204 proximal to the rotatable outer sheath knob 210 and distal to the rail housing 202 in some embodiments. Rotation of the intermediate shaft knob 214 pulls the intermediate shaft assembly 21 proximal in the axial direction, and thus pulls the outer retaining ring 42 away from the implant 70, dislodging the inner retaining member 40 and the cover of the proximal end 301 of the implant 70, thereby freeing the implant 70. Thus, the intermediate shaft assembly 21 is translated independently of the other shafts in the delivery system 10.

[0081] A rotatable depth knob 212 may be located at the proximal end of the delivery housing 204, and therefore proximal to the rail housing 202. When the depth knob 212 is rotated, the entire delivery housing 204 moves distally or proximal to the rail housing 202, which remains in the same position. 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) proximal or distal to the rail assembly 20, while the implant 70 remains in a compressed configuration. In some embodiments, the operation of the depth knob 212 can cause the inner shaft assembly 18, the outer sheath assembly 22, the intermediate shaft assembly 21, and the nose cone shaft assembly 31 to move continuously relative to the rail assembly 20. In some embodiments, the operation of the depth knob 212 allows the inner shaft assembly 18, the outer sheath assembly 22, and the intermediate shaft assembly 21 to move together relative to the rail assembly 20. Thus, the rail shaft 132 can be aligned in a particular direction, and the other assemblies can be moved distally or proximal to the rail shaft 132 to finally position the implant 70 without releasing it. The components can be advanced along the rail shaft 132 by approximately 1 cm, 2 cm, 3 cm, 5 cm, 6 cm, 7 cm, 8 cm, 9 cm, or 10 cm. The components can be advanced along the rail shaft 132 by approximately 1 cm, 2 cm, 3 cm, 5 cm, 6 cm, 7 cm, 8 cm, 9 cm, or 10 cm. An example of this is shown in Figure 2C. Thus, the capsule 106 and the outer retaining ring 42 can be individually retracted relative to the inner assembly 18, sequentially, in some embodiments as detailed earlier, to release the implant 70. Therefore, the assemblies other than the rail assembly 20 can be pulled back across the rail shaft 132 by rotating the depth knob 212 in the opposite direction.

[0082] The handle 14 may further include a mechanism (knob, button, handle) 216 for moving the nose cone shaft 27 and, consequently, the nose cone 28. For example, the knob 216 may be 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 proximal to the other shaft independently. This may be advantageous for translating the nose cone 28 proximal to the outer sheath assembly 22 / capsule 106, and thus facilitate the retraction of the delivery system 10 from the patient.

[0083] In some embodiments, the handle 14 may provide a locking mechanism 218, such as a spring locking mechanism, to prevent translation of the nose cone shaft 27 by the knob 216 described earlier. In some embodiments, the locking mechanism 218 may be always active, and therefore the nose cone shaft 27 will not move unless the user disengages the locking mechanism 218. The locking mechanism may be, for example, a spring locking mechanism that is always engaged until a button 218 on the handle 14 is pressed, thereby releasing the spring locking mechanism and allowing the nose cone shaft 27 to be translated proximal / distal. In some embodiments, the spring locking mechanism 218 allows movement of the nose cone shaft 27 in one direction, either proximal or distal, and prevents movement in the opposite direction.

[0084] The handle 14 may further include a communicating 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 connections to multiple assemblies. In some embodiments, the flush port may provide a fluid connection to the outer sheath assembly 22. In some embodiments, the flush port may provide fluid connections to the outer sheath assembly 22 and the intermediate shaft assembly 21. In some embodiments, the flush port may provide fluid connections 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 connections 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] Figure 12A is a side view of the distal portion of the elongated shaft 12 in a straight configuration. The capsule 106 is positioned and shown between the outer hypotube 104 and the nose cone 28.

[0086] The elongated shaft 12 may have one or more bends that allow the elongated shaft 12 to bend at the bend portion. In the embodiment shown in Figure 12A, for example, the elongated shaft 12 has two bends 600, 602. The bend 600 may correspond to the distal rail portion 601 shown in Figures 6B and 6C, and the bend 602 may correspond to the proximal rail portion 603 shown in Figures 6B and 6C. Thereafter, the bends 600, 602 can be configured to bend the elongated shaft 12 in a plane that is not perpendicular to each other, the bend 600 may bend in a plane that can be called a vertical plane, and the bend 602 may bend in a plane that can be called a horizontal plane. The bends 600, 602 may be configured to bend in order to orient the capsule 106 to a desired position for deployment of the implant 70 housed in the capsule 106.

[0087] The capsule 106 (and the implant-retaining area 16 housed within the capsule 106) may be configured to slide against the bent 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 may be configured to slide against the bent portions 600, 602 (as part of the rail assembly 20) to change the distance or depth of the capsule 106 from the rail assembly 20. The outer sheath assembly 22 may be configured to slide against the rail assembly 20 to change the distance of the implant-retaining area from the patient's tricuspid valve.

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

[0089] Figure 12C shows a top view of the elongated shaft 12 shown in Figures 12A and 12B, when the bent portion 602 is bent. In Figure 12C, the bent portion 602, positioned proximal to the bent 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 rightward direction, as shown in Figure 12C). The bent portion 602 deflects the distal end of the elongated shaft 12 in a plane (which may be referred to as the horizontal plane). The bent portion 602 changes the orientation of the capsule 106, the distal end of the elongated shaft 12, and the implant-retaining region 16 positioned within the capsule 106 accordingly.

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

[0091] A bent portion 602, as shown in Figure 12C, may be configured to deflect the distal end of the elongated shaft 12 to the right. Such a direction of deflection may be provided by the configuration of the tension wire shown in Figure 6C.

[0092] Additional or various modifications of the elongated shaft 12 may be desired. Such additions or modifications may be desired for various reasons, including different patient biomechanisms to be navigated by the distal end of the elongated shaft 12, or for various uses of the elongated shaft 12.

[0093] Figures 13A to 13D illustrate embodiments in which a deflection mechanism may be used to provide deflection of a portion of an elongated shaft 12. Referring to Figure 13A, the deflection mechanism may comprise a sheath 610 extending over a portion 614 of the elongated shaft 12. The portion 614 of the elongated shaft 12 may comprise portions positioned proximal to the bent portions 602 and 600. However, in other embodiments, the sheath 610 may extend over other portions of the elongated shaft 12, and as far as possible, to the distal end of the elongated shaft 12.

[0094] The sheath 610, shown in a cross-sectional view in Figure 13A, may be configured to deflect to provide deflection for the elongated shaft 12. The sheath may include a control device used to control the deflection of the sheath 610. The control device may include a tension tie 612, as shown in Figure 13A, which may be a tension wire or other form of tie. In other embodiments, other forms of the control device may be used, such as gears, rails, or other forms of the control device. The tension tie 612 may be oriented on the elongated shaft 12 such that the retraction of the tension tie 612 can deflect the elongated shaft 12 toward the tension tie 612.

[0095] Referring to Figure 13B, the bent portion 600 deflects the distal end of the elongated shaft 12 in direction 605 (which may also be called the downward direction, as shown in Figure 13B). However, the deflection mechanism deflects a portion 614 of the elongated shaft 12 located proximal to the bent portions 600 and 602 in direction 607, which is opposite to the direction 605 in which the bent portion 600 deflects the distal end of the elongated shaft 12. The deflection mechanism also deflects the bent portion 602, the bent portion 600, the capsule 106, the implant holding area 16 housed within the capsule 106, and the nose cone 28 in the direction opposite to the direction in which the bent portion 600 deflects the distal end of the elongated shaft 12. Therefore, the deflection mechanism can be used to deflect the elongated shaft 12 in order to create a height or distance from the distal end of the elongated shaft 12 to a desired planting location.

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

[0097] The deflection mechanism may be used to bend the distal portions of the elongated shaft 12 in the bent portions 600 and 602 in a manner similar to that shown in Figures 12A to 12C. Referring to Figure 13C, for example, the deflection mechanism deflects the proximal portion 614 of the elongated shaft 12, while the bent portion 600 continues to deflect the distal end of the elongated shaft 12 in the direction shown in Figure 13B, and the bent portion 602 deflects the bent portion 600 in the vertical direction as described with respect to Figure 12C. In the form of an elongated sheath 610, the deflection mechanism continues to deflect the portions 600 and 602 in a direction away from the direction in which the bent portion 600 deflects the distal end of the elongated shaft 12, by deflecting a portion 614 of the elongated shaft 12 proximal to the bent portions 600 and 602.

[0098] The deflection mechanism may be configured to provide multiple directions of deflection for a portion 614 of the elongated shaft 12 proximal to the bent portions 600 and 602. For example, in the form of a sheath 610, the deflection mechanism may be configured so that the sheath 610 rotates around a portion of the elongated shaft 12 extending upward. Such rotation can move the position of the tension rope 612 relative to the elongated shaft 12 in order to deflect the elongated shaft 12 toward various positions of the tension rope 612. This can result in various directions of deflection for the elongated shaft 12. For example, Figure 13D shows a front view of an elongated sheath, showing (through arrows) multiple directions opposite to the direction 605 toward which the bent portion 600 may be deflected.

[0099] Figure 14A shows a perspective view of a sheath 610 extending over an elongated shaft 12. The sheath 610 can be used in place of or in combination with the sheath 51 shown in Figure 1. The sheath 610 may have a distal end 616 and a proximal end 618. The proximal end 618 of the sheath 610 may be coupled to a rotation control housing 620 which can be used to control the rotation of the sheath 610 around the elongated shaft 12. A user, such as a surgeon or other user, can grasp the rotation control housing 620 to control the direction of the 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 coupled to, or in addition to, a deflection control housing 622, which can be used to pull the tension tie 612 proximal to deflect the sheath 610, and can also be used to release the tension tie 612 distally to straighten the sheath 610. The deflection control housing 622 may be configured to allow a user, such as a surgeon or other user, to grasp and control the sheath 610.

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

[0101] Figures 14B to 14D show the deflection mechanism in the form of a sheath 610 rotated 90° around 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 a rotation control housing 620 or by other means. The relative position of the tension tie rope 612 is 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 bent portion 600 deflects the distal end of the elongated shaft 12. The sheath 610 can deflect the elongated shaft 12 in the same plane as the bent portion 602 deflects a portion of the elongated shaft 12 distal to the bent portion 602.

[0102] The deflection mechanism in the form of the sheath 610 can have various orientations relative to the elongated shaft 12 at any angular position relative to the elongated shaft 12, as desired. Thus, the deflection mechanism in the form of the sheath 610 can be configured to deflect a portion 614 of the elongated shaft 12 in multiple directions, which may or may not be perpendicular to the direction in which the bent 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 bent portion 600 deflects the distal end of the elongated shaft 12, and these various directions may be the exact opposite direction (180°) and various other directions (e.g., 135°) between the exact opposite (180°) and the perpendicular direction (90°).

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

[0104] The deflection mechanism in the form of the sheath 610 may be configured to change the direction of deflection of a portion 614 via rotation of the sheath 610, and in embodiments, it may consist of multiple tethering ropes or other control devices that enable various directions of deflection of the sheath 610 without rotation of the sheath 610. For example, if four equally spaced tethering ropes (spaced 90° from each other) are used in the sheath 610, the combination of movement of the tethering ropes can provide various directions of deflection of the sheath 610. Other configurations may be used to change the direction of deflection of the sheath 610. At least one tethering rope may be used in embodiments.

[0105] Embodiments in Figures 13A to 14D show an elongated 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 modified in other embodiments as desired. For example, Figures 15A to 16C show an embodiment in which the bent portions 602 are eliminated, and the sheath 610 controls the deflection of the elongated shaft 12 instead of the bent portions 602. Thus, the sheath 610 can be configured to deflect the elongated shaft 12 in a direction opposite to the direction in which the bent portions 600 deflected the distal end of the elongated shaft 12, and that direction could be the exact opposite direction (180°) and various other directions (e.g., 135°) between the exact opposite (180°) and the perpendicular (90°). Figures 15A to 15C show a sheath 610 that deflects a portion of the elongated shaft 12 in order to deflect the bent portion 600 in a direction opposite to the direction in which the distal end of the elongated shaft 12 is deflected.

[0106] The sheath 610 may be rotated from the orientation shown in Figures 15A-15C to change the direction of deflection of a portion 614. Figures 16A-16C show the sheath 610 rotated 90° from the orientation shown in Figures 15A-15C to deflect a portion 614 in a plane perpendicular to the plane of deflection of the bent portion 600. As detailed in relation to Figures 13A-14D, the sheath 610 may, in other embodiments, consist of a plurality of tensioning ropes or other control devices that allow for various directions of deflection of the sheath 610 without rotation of the sheath 610.

[0107] Other forms of deflection mechanisms may be used. For example, Figure 17 shows an embodiment of a deflection mechanism in the form of a tension tie rope 630. The tension tie rope 630 may have a distal end 632 that is coupled to a portion of an elongated shaft 12, such as a rail shaft 132. The rail shaft 132 may extend over an inner shaft as disclosed herein, or it may have an outer sheath that extends 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 rail hypotube 136 or the bent portion 634, 636 of the rail shaft 132. For example, as shown in Figure 17, the distal end 632 may be coupled to a portion proximal to an uncut (or unslotted) hypotube section 231.

[0108] The tension tie rope 630 may be configured to be retracted in order to deflect a portion 638 of the rail shaft 132, and consequently, to deflect the elongated shaft 12 proximal to the bent portions 634 and 636. This allows the bent portion 634 to be configured to deflect the distal end of the elongated shaft 12 in a certain direction, and the tension tie rope 630 to be configured to deflect the elongated shaft 12 in a direction opposite to the direction in which the bent portion 634 deflected the distal end of the elongated shaft 12. At a given position, the tension tie rope 630 may be coupled to the rail shaft 132 in an orientation opposite to the direction in which the bent portion 634 deflected the distal end of the elongated shaft 12 when the tension tie rope 630 is retracted.

[0109] Although a single tension tie 630 is shown in Figure 17, multiple tension ties may be used in other embodiments as desired. For example, if four equally spaced tension ties (spaced 90° from each other) are coupled to the rail shaft 132, the combination of the movement of the tension ties can provide various directions of deflection for the elongated shaft 12. Other configurations may be used to change the direction of deflection for the elongated shaft 12. Thus, one or more tension ties can be configured to deflect the elongated shaft 12 in a direction opposite to the direction in which the bent portion 634 deflected the distal end of the elongated shaft 12, and that direction could be a direction directly opposite (180°) to the direction in which the bent portion 634 deflected the distal end of the elongated shaft 12, and a variety of other directions in between, including the direct opposite (180°) and the perpendicular (90°) direction (e.g., 135°).

[0110] Figures 18A and 18B show an embodiment of a deflection mechanism comprising a cut 640 in a portion of an 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 Figure 18A, the cut 640 can be positioned on the rail shaft 132 at a desired location. Such a location may be proximal to a bent portion 634, 636 of the rail hypotube 136 or the rail shaft 132. For example, as shown in Figure 18A, the cut 640 may be proximal to an uncut (or unslotted) hypotube section 231.

[0111] The cut 640 may have a configuration that biases the rail shaft 132 so that 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 Figure 18B, a cross-sectional view of the rail shaft 132 is shown. The deflection mechanism may include an inner shaft or tension shaft 642 that can be positioned within the rail shaft 132. The tension shaft 642 may be positioned between the rail shaft 132 and an inner shaft such as an inner shaft assembly 18 or a nose cone assembly 31. In other embodiments, the inner shaft or tension shaft 642 may be located elsewhere.

[0113] The inner shaft or tension shaft 642 may be provided with a stopper 644 coupled thereto. The rail shaft 132, in particular a portion of the rail shaft 132 distal to the cut 640, may be provided with a stopper 646. The deflection mechanism may be configured such that when the tension shaft 642 is pulled proximal, the stopper 644 contacts the stopper 646, applying a proximal force to the rail shaft 132, in particular a portion of the rail shaft 132 including the cut 640. The cut 640, which provides the biasing direction of the deflection, can deflect the rail shaft 132 and the elongated shaft 12 in a direction of this deflection, which may be in the opposite direction to the direction in which the bent portion 634 deflected the distal end of the elongated shaft 12. Thus, the tension shaft 642 may be moved distally to reduce the force between the stoppers 644, 646 and straighten the rail shaft 132. Figure 18B shows the stoppers 644 and 646 spaced apart from each other, but the inner shaft or tension shaft 642 may be pulled proximally so that the stoppers 644 and 646 come into contact with each other.

[0114] Although a single tension shaft 642 is shown in Figure 18B, multiple tension shafts may be used in other embodiments as desired. For example, if four equally spaced tension shafts (spaced 90° from each other) with corresponding stoppers are used, the combination of movement of the tension shafts can provide various deflection directions for the elongated shaft 12. Cut patterns may be provided to allow various deflection directions. Other configurations may be used to change the deflection direction of the elongated shaft 12. Therefore, one or more tension shafts can be configured to deflect the elongated shaft 12 so that the bent portions 634, 636 are deflected in a direction opposite to the direction in which the bent portion 634 deflects the distal end of the elongated shaft 12, and this direction can be a variety of other directions in between (e.g., 135°), including the direction directly opposite (180°) and the direction perpendicular (90°) to the direction in which the bent portion 634 deflects the distal end of the elongated shaft 12.

[0115] Figures 19A to 19B show external views of the embodiments shown in Figures 17A to 18B. The sheath 610 may or may not be used in the deflection mechanism shown in Figures 17 to 18B. Thereafter, the outer sheath assembly 22 may have an outer surface of the elongated shaft 12 with the deflection mechanism housed within the outer sheath assembly 22.

[0116] As shown in Figure 19A, the bent 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 in order to deflect the bent portion 600 in a direction opposite to the direction of the distal end of the elongated shaft 12. Figure 19B shows that the bent portions 600 and 602 can continue to operate to deflect their respective distal portions of the elongated shaft 12.

[0117] A deflection mechanism may be used to provide additional or varied movements of the elongated shaft 12. Such additional or varied movements may be desirable for various reasons, including different patient biomechanisms to be navigated at the distal end of the elongated shaft 12, or for various uses of the elongated shaft 12.

[0118] The deflection mechanism may be used to move the elongated shaft 12 toward the delivery of a replacement heart valve, which may include a replacement tricuspid valve. Although many of the embodiments described herein are considered in relation to replacement tricuspid valves, the deflection mechanism may be used for a variety of other implantations, including the delivery of mitral replacement valves, aortic valves, and 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 elongated shaft 12 for treating a patient's tricuspid valve. The elongated shaft 12 can be inserted into the patient's body using an intravascular technique, which may include a percutaneous access to the patient's vascular system. For example, the elongated shaft 12 may be inserted into the ipsilateral femoral vein and advanced toward the right atrium 1076. Other advancement methods may be used in other embodiments, including other approaches such as a transjugular vein approach or a transapical approach.

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

[0121] The delivery system may include the use of a deflection mechanism as described herein. While a deflection mechanism in the form of a sheath 610 may be used as shown in Figure 20A, it is understood that other forms of deflection mechanisms may be used, including the deflection mechanisms shown in Figures 17 to 19B.

[0122] The elongated shaft 12 can be advanced toward the right atrium 1076 at its distal end, which is deflected so that the capsule 106 and, consequently, the implant-holding region 16 are oriented to deploy the implant housed in the capsule 106 toward the tricuspid valve 1083 in a desired manner. As depicted in Figure 20A, the distal end of the elongated shaft 12 may require deflection toward the tricuspid valve 1083 in order to align the distal end of the elongated 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. Other directions of deflection may be desired for other deployment methods.

[0123] The bends 600 and 602 can be used to deflect the distal end of the elongated shaft 12 in a desired direction. The bends 600 and 602 can be configured to deflect the distal end of the elongated shaft in two perpendicular planes, providing two planes of deflection. The bends 600 and 602 can be configured as shown in Figure 6C, with the proximal bend 602 configured to deflect the distal portion of the elongated shaft 12 to the right (or anteriorly) relative to the downward (or ventricular) deflection of the distal bend 600. Such a configuration can take the place of the tricuspid valve 1083 relative to the inferior vena cava 1079 in a human heart.

[0124] However, additional movement may be provided by deflection mechanisms disclosed herein. A deflection mechanism in the form of a sheath 610 may be used to deflect the proximal portion of the elongated shaft 12 in such a way that the bent portion 600 deflects the bent portion 600, 602 in the opposite direction to the direction in which the distal end of the elongated shaft 12 is deflected. Such deflection may include deflecting the proximal portion of the elongated shaft 12 and the bent portions 600, 602 toward the atrium (or providing height from the tricuspid valve 1083). The capsule 106 and the distal end of the elongated shaft 12 may be deflected toward the atrium (or providing height from the tricuspid valve 1083).

[0125] The deflection mechanism may be used to accommodate the shape of the patient's biostructure, 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 Figure 20A, the distance from the bent portion 600 to the distal end of the elongated shaft 12 may be such that the bending radius of the elongated shaft 12 distal to the bent portion 600 is too large, and depending on the shape of the patient's right atrium 1076, it may not be possible to properly orient the distal end of the elongated shaft 12 toward the tricuspid valve 1083. Therefore, the deflection mechanism may be used to deflect the bent portion 600 in the opposite direction to the direction in which the bent portion 600 deflects the distal end of the elongated shaft 12.

[0126] Referring to Figure 20B, the deflection mechanism in the form of the sheath 610 can deflect the proximal portion of the elongated shaft 12, as described herein. The deflection of the proximal portion of the elongated shaft 12 may occur whole or partially (at least partially) within the patient's inferior vena cava 1079. The deflection may cause the bent portions 600, 602 to move to create height from the tricuspid valve 1083 in the direction away from the tricuspid valve. Thereafter, the distal end of the elongated shaft 12 may have a larger clearance space for the bent portion 600 to deflect the distal end of the elongated shaft 12 toward the tricuspid valve 1083. As shown in Figure 20B, the deflection mechanism can form a curve in the proximal portion of the sheath, but other forms of deflection may result. The bent portion 600 initiates the deflection of the distal end of the elongated shaft 12 in Figure 20B.

[0127] Referring to Figure 20C, the bent portion 600 deflects the distal end of the elongated shaft 12 in direction 605. This direction can be aligned with the axis of the tricuspid valve 1083, or otherwise directed in a desired orientation. The deflection mechanism in the form of the sheath 610 deflects the proximal portion of the elongated shaft 12 in direction 607, which is opposite to direction 605, to deflect the bent portion 600. This increases the height of the capsule 106 from the tricuspid valve 1083, allowing for the deployment of the implant housed in the capsule 106.

[0128] The deflection mechanism in the form of the sheath 610 can provide various deflection directions for the proximal portion of the elongated shaft 12 and corresponding various deflection directions for the bent portions 600, 602, the capsule 106, and the distal end of the elongated shaft 12. As discussed in relation to Figures 14A to 14D, for example, the sheath 610 can provide various deflection directions, including directions perpendicular to the deflection direction provided by the bent portion 600 and directions toward the deflection direction provided by the bent portion 600. Such various deflection directions can allow for additional maneuverability and trajectory changes for 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 in various other directions.

[0129] The operation of the deflection mechanism shown in Figures 20A to 20C is not limited to the sheath 610 shown in Figures 13A to 14D, but also includes the use of the deflection mechanism shown in Figures 15A to 19B. For example, the sheath 610 may be excluded when it provides deflection of the proximal bent portion 602 of the elongated shaft 12, as detailed in relation to Figures 15A to 16C. Furthermore, the deflection mechanism may be positioned within the outer sheath assembly 22, as considered in relation to the embodiments in Figures 17 to 19B. Various directions of deflection in both the atrial and ventricular directions, as well as various other directions, may result.

[0130] The deflection mechanism may be used 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 bent portion 600 deflects the distal end of the elongated shaft 12.

[0131] Figure 21 illustrates the use of a deflection mechanism in an approach from the superior vena cava 1081. The approach may be a transjugular approach or via other entry points into the patient's body. The bends 600, 602 may be configured as shown in Figure 6B, with the proximal bend 602 configured to deflect the distal portion of the elongated shaft 12 to the left (or posteriorly) relative to the downward (or ventricular) deflection of the distal bend 600. Such a configuration can assume the position of the tricuspid valve 1083 relative to the superior vena cava 1081 in the human heart. The method may involve passing a delivery device for the implant into the patient's right atrium.

[0132] The deflection mechanism can deflect the proximal portion of the elongated shaft 12 in a direction 607 opposite to the direction 605 that deflected the distal end of the elongated shaft 12, as shown in Figures 20A to 20C. Similarly, other forms of deflection mechanisms may be used, as discussed in relation to Figures 13A to 19B, and other directions of deflection may result.

[0133] The implant 70, housed within the capsule 106, can be deployed to be positioned within the tricuspid valve annular ligament 1085 to replace the innate tricuspid valve 1083. Once the distal end of the elongated shaft 12 is oriented as desired relative to the innate tricuspid valve 1083, the release mechanism can be used to deploy the implant 70 through 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 or superior vena cava. Figures 22A–22C show 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 Figure 2A. The distal end 303 of the implant 70, and specifically the distal anchor 80, is confined within the capsule 106 of the outer sheath assembly 22, thereby preventing the expansion of the implant 70. A similar arrangement is shown in Figure 2A, where the distal anchor 80 can extend distally when positioned within the capsule. The proximal end 301 of the implant 70 is confined within the capsule 106 and part of the inner retaining member 40, and is thus largely restrained between the capsule 106 and the inner retaining member 40.

[0134] Once the implant 70 is loaded into the delivery system 10, the user can guide the guidewire into the patient to the desired location. The guidewire passes through the lumen of the nose cone assembly 31, thereby allowing the delivery system 10 to be advanced throughout the patient's body by following the guidewire. The delivery system 10 can be advanced by the user manually moving the handle 14 axially. In some embodiments, the delivery system 10 can be placed in a stand while the control of the handle 14 is operated.

[0135] Generally, once in the heart, the user can initiate maneuvering of the rail assembly 20, specifically, using the distal pull wire knob 206 and / or the proximal pull wire knob 208 to initiate maneuvering of the bent sections 600, 602. By turning either knob, the user can bend the distal end of the delivery system 10 to a desired configuration at one, two, or more locations by providing a bend / flex of the rail assembly 20 (at either the distal or proximal end). As previously discussed, the user can provide multiple bends to the rail assembly 20 to orient the delivery system 10 toward the tricuspid valve. Specifically, bends in the rail assembly 20 can orient the distal end of the delivery system 10, and consequently the capsule 106, toward the tricuspid valve along the central axis passing through the innate tricuspid valve. Therefore, as the outer sheath assembly 22, the intermediate shaft assembly 21, the inner assembly 18, and the nose cone assembly 31 are advanced together with the compressed implant 70 across the rail assembly 20, the capsule 106 moves in a straight line with the axis for proper release of the implant 70.

[0136] The user can also utilize a deflection mechanism, which can create height from the innate tricuspid valve, or otherwise orient the distal end of the elongated shaft 12 as desired. The height of the bent portion of the elongated shaft 12 may be altered from the tricuspid valve.

[0137] System 10 can be positioned to a specific location in the patient's body, such as the congenital tricuspid valve, through the use of bending portions and deflection mechanisms discussed herein, or other technologies.

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

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

[0140] Once the distal end of the elongated shaft 12 is oriented as desired, the user can rotate the depth knob 212. As considered, the 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 across / through the rail assembly 20, while the implant 70 remains in a compressed configuration within the implant retention area 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 advance straight forward in the 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) independently in the proximal direction toward the handle 14, as shown in Figure 22A, relative to other assemblies, specifically the inner assembly 18. By doing so, the distal end 303 of the implant 70 is de-covered in the body and can begin to expand. At this point, the distal anchor 80 can be reversed in the proximal direction, and the distal end 303 begins to expand radially outward. For example, if the system 10 is delivered to the site of the natural tricuspid valve, the distal anchor 80 expands radially outward within the right ventricle. The distal anchor 80 may be positioned above the papillary and below the tricuspid valve annulare and tricuspid leaflets.

[0142] In some embodiments, the distal anchor 80 may contact the ligaments in the right ventricle and / or extend between the ligaments as it expands radially, and may also contact the valve leaflets. In some embodiments, the distal anchor 80 may contact the tendons and / or extend between the tendons, or may not contact the valve. 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 tendons connect to the free edge of the innate valve.

[0143] As shown in the illustrated embodiment, the distal end 303 of the implant 70 is expanded outward. Note that the proximal end 301 of the implant 70 may remain covered by the outer retaining ring during this step so that the proximal end 301 remains radially compact. At this point, the system 10 can be pulled proximal so that the distal anchor 80 grasps and engages with the leaflets of the tricuspid valve, or it can be moved proximal to reposition the implant 70. For example, the assembly can be moved proximal to the rail assembly 20. Furthermore, a deflection mechanism may be used to pull the elongated shaft 12 proximal to the tricuspid valve. Furthermore, the system 10 may be twisted, which can cause the distal anchor 80 to exert tension on the cord through which at least a portion of the distal anchor may extend. However, in some embodiments, the distal anchor 80 may not exert tension on the cord. In some embodiments, the distal anchor 80 may be positioned between the tendons, capturing the innate valve without any further movement of the system 10 after the outer sheath assembly 22 has been withdrawn.

[0144] During this step, the system 10 may be moved proximal or distal to allow the distal or ventricular anchor 80 to properly grasp the leaflets of the innate tricuspid valve. This may 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 may be moved proximal to engage with the ventricular side of the innate entral zona so that the innate leaflets are 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 may be positioned between at least a portion of the tract, with or without tension in the tract.

[0145] The proximal end 301 of the implant 70 will remain in the lateral retaining ring 42 after the retraction of the capsule 106. The capsule 106 can surround the implant retaining area and can be retracted proximal to deploy the implant. As shown in Figure 22B, once the distal end 303 of the implant 70 is fully expanded (or expanded as completely as possible in this position), the lateral retaining ring 42 can be independently retracted proximal to the other assemblies, specifically to the inner assembly 18, to initiate expansion of the proximal end 301 of the implant 70 by exposing the inner retaining member 40. For example, in a tricuspid valve replacement procedure, after the distal or ventricular anchor 80 has been positioned between at least a portion of the chordae tendineae and / or engaged with the natural tricuspid valve annular ligament, the proximal end 301 of the implant 70 can be expanded in the right atrium.

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

[0147] In some embodiments, the implant 70 may be delivered under fluoroscopy so that the user can see specific reference points for proper positioning of the implant 70. Furthermore, echocardiography can be used for proper positioning of the implant 70.

[0148] Here, we refer to Figure 23, which shows a schematic depiction of a portion of an embodiment of a replacement heart valve (implant 70) positioned within the innate tricuspid valve of the heart 83. A portion of the innate tricuspid valve is schematicly shown, representing a typical biological structure, including the right atrium 1076 positioned above the atlantoluminal zone 1085 and the right ventricle 1077 positioned below the atlantoluminal zone 1085. The right atrium 1076 and the right ventricle 1077 communicate with each other through the tricuspid atlantoluminal zone 1085. Also schematicly shown in Figure 23 is the innate tricuspid leaflet 1087, which has chordae tendineae 1089 connecting the downstream end of the tricuspid leaflet 1087 to the papillary muscle of the right ventricle 1077. A portion of the implant 70 positioned upstream of the atlantoluminal zone 1085 (towards the right atrium 1076) can be said to be positioned annularly above. Generally, a portion within the atlantoluminal zone 1085 can be said to be positioned annularly within. A portion of the downstream zona 1085 can be described as being positioned annularly below (towards the right ventricle 1077).

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

[0150] As shown in Figure 23, the replacement heart valve or implant 70 may be positioned such that the end or tip of the distal anchor 80 is on the ventricular side of the tricuspid atlus 1085 and the end or tip of the proximal anchor 82 is on the atrial side of the tricuspid atlus 1085. The distal anchor 80 may be positioned such that the end or tip of the distal anchor 80 is on the ventricular side of the innate leaflet beyond where the chordae tendineae 1089 connect to the free end of the innate leaflet. The distal anchor 80 may extend between at least a portion of the chordae tendineae 1089 and may contact or engage with the ventricular side of the atlus 1085 in some situations, such as those shown in Figure 23. In some situations, the distal anchor 80 may not contact the atlus 1085, but it may still be able to contact the innate leaflet 1087. In some situations, the distal anchor 80 may come into contact with the tissue of the right ventricle 1077 beyond the entrinx 1085 and / or the ventricular side of the valve leaflet.

[0151] Once the implant 70 is deployed as desired, the deflection mechanism disclosed in relation to Figures 13A to 19B can be used to deflect the elongated shaft 12 so as to allow for its removal from the patient's heart.

[0152] Figure 24 shows a lateral perspective view of the nose cone 28, which forms the tip of the elongated shaft 12. The nose cone 28 comprises a tip body 700 that closes the end of the capsule 106 (shown in a partial cross-sectional view) and is positioned distal to the capsule 106. The tip body 700 comprises a proximal portion 702 and a distal portion 704, tapering 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 may include a tapered rigid projection 710. The tapered shape of the rigid projection can allow for easy entry into the patient's vascular system and can help pass the tip of the elongated shaft 12 into the patient's vascular system.

[0153] However, it should be noted that the rigid projection 710 may interfere with or potentially injure a portion of the patient's body in contact with it. For example, if the nose cone 28 is passed into the right ventricle of the patient's heart, the rigid projection 710 may potentially affect the interior of the right ventricle and potentially puncture or otherwise injure it. It should also be noted that it may become entangled with the guidewire 708 at the opening 706. The length of the rigid projection 710 may also impede the maneuverability of the distal end of the elongated shaft 12.

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

[0155] The outer surface 720 may 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 may extend from the proximal portion 722 to the distal end 724. The flexible sheath 712 may have a cylindrical shape from the proximal portion 722 to the distal end 724.

[0156] The flexible sheath 712 may have a length configured to extend over the leading curve of the guidewire 708 for the guidewire 708 which has a curved configuration 726 at its end. Thus, the flexible sheath 712 can cover the leading curve of the guidewire 708 to reduce the possibility of injury due to contact between the guidewire and a part of the patient's body. Figure 25B shows, for example, the distal tip in the patient's right ventricle 1077. The flexible sheath 712 is bent around the guidewire 708 when the guidewire 708 is positioned in the right ventricle. The flexible sheath 712 covers the portion of the guidewire 708 that could otherwise come into contact with the inner wall of the patient's right ventricle 1077. Furthermore, the flexible sheath 712 is flexible to reduce the possibility 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 possibility of entanglement of the guide wire 708.

[0157] Figures 26–28 show embodiments of the distal tip of the elongated shaft 12 in which the distal outline of the elongated shaft 12 can be reduced. Such features can be used to make it easier to navigate or deflect the elongated shaft 12 in various vascular shapes. For example, in the method shown in Figures 20A–21, the reduced distal outline of the elongated shaft 12 can enable better maneuverability of the elongated shaft 12 in and toward the right atrium 1076.

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

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

[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 have a rounded portion 752 that extends over the distal end (or anchor 80) of the implant and can provide a smooth outer shape to the distal tip of the elongated shaft 12. Thus, the distal tip may have a non-traumatic rounded tip. The capsule may have a portion 754 with a planar outer shape at the leading edge of the capsule 106. The portion 754 may have an opening or port 756 into which the implant is deployed.

[0161] The capsule 106 can be configured to have an elastic distal end 705 that can adapt to the shape of the implant 70 positioned within the capsule 106. Tie layers or the like may be added to the capsule 106 to provide elasticity to the implant 70. The capsule 106 may have, 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 from the capsule 106 through the port 756, with the rounded portion 752 of the distal end 750 expanding to accommodate 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 a guidewire 708 to pass through.

[0162] In the embodiment shown in Figure 28, the separate tip body does not necessarily have to be present at the distal end of the elongated shaft 12, and therefore the distal outer shape of the elongated shaft 12 is reduced.

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

[0164] Figure 29 shows an embodiment of an elongated shaft 800 comprising a wall 802 surrounding a passage 804 through which an implant 806 is to pass for its deployment. The wall 802 may be configured to have a bend 808 that defines a bend in the passage 804 during the deployment of the implant 806.

[0165] The wall 802 can be configured to be maneuverable, and a control mechanism can be used to maneuver the wall 802. For example, a tension tie 810 or other form of control mechanism can be used to maneuver the wall 802 to control the direction of bending of the wall 802, and more specifically, to orient the opening or port 812 through which the implant 806 passes to a desired orientation.

[0166] In one embodiment, the wall 802 does not have to be maneuverable, but the wall may have a bend that is carried out by the wall 802 in a desired orientation.

[0167] The passage 804 may have a deployment passage into which the implant 806 is deployed. The passage 804 may be configured to hold the implant 806 and may have an implant retention area. The passage 804 may be configured to hold the implant 806 in an approach and access to the right atrium 1706 or other part of the patient's heart or vascular system.

[0168] The implant 806 may be configured to be a flexible implant that bends in a direction transverse to the axial dimension 814 of the implant 806. Thereafter, the implant 806 may be configured to bend in the passage 804 in a direction transverse to the axial dimension 814 of the implant 806 for deployment. A deployment device such as a push shaft 815 may be used to push the implant 806 out of the port 812 for deployment. Other forms of deployment devices, such as an expandable balloon, may be used as desired.

[0169] The implant 806 may be an expandable implant and may self-expand for deployment to a desired part of the patient's body. The implant 806 may be configured similarly to the implant 70, but may be configured to bend in a direction transverse to the axial dimension 814 of the implant 806 when passing through a bending and deployment passage. Such a configuration may be provided by a thinner frame of the implant 70 to allow for greater lateral flexibility.

[0170] The components of the elongated shaft 12 may be used together with the elongated 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 used to carry out or assist in the deployment of the implant 806. The deflection mechanism disclosed herein may be used. One or more features of the elongated shaft 800 may be used alone or in combination with any other embodiment, other system, or other method of the delivery system disclosed herein.

[0171] The use of a wall 802 having a bend 808 that defines a bend in the passage 804 during the deployment of the implant 806 can provide benefits including a reduced lateral profile of the elongated shaft 800. For example, as shown in Figures 20A to 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 600. The use of a bend in the passage 804 can allow a reduced lateral profile of the elongated shaft 800 with a relatively smaller radius of rotation. Thus, the port 812 can be moved to approach the tricuspid valve 1083 for the deployment of the flexible implant 806 with the elongated shaft 800 having a reduced lateral profile. The implant can be passed through the bent deployment passage for the deployment of the implant (which may be a prosthesis tricuspid valve).

[0172] Figure 30 shows an embodiment of an elongated shaft 900 having an axial dimension 902 and a port 904 for an implant 906 that is extended in a direction transverse to the axial dimension 902. The elongated shaft 900 may have side walls 908, and the port 904 may be positioned on the side walls 908.

[0173] The side wall 908 can be configured to be maneuverable, and a control mechanism may be used to maneuver the side wall 908. For example, a tethering rope 909 or other form of control mechanism may be used to maneuver the side wall 908 to orient the port 904 to a desired orientation.

[0174] The elongated shaft 900 may have an implant-retaining region 910 for holding the implant 906. The implant 906 may be configured to unfold 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 may be configured to compress in the axial dimension of the implant 906 before unfolding.

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

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

[0177] The components of the elongated shaft 12 may be used together with the 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 used to carry out or assist in the deployment of the implant 906. The deflection mechanism disclosed herein may be used. One or more features of the elongated shaft 900 may be used alone or in combination with any other embodiment, other system, or other method of the delivery system disclosed herein.

[0178] The use of an elongated shaft 900 having an axial dimension 902 and a port 904 for an implant 906 that is deployed transverse to the axial dimension 902 can provide the benefit of a reduced lateral profile of the elongated shaft 900. For example, as shown in Figures 20A to 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 bent portion 600. The use of a port 904 for an implant 906 that is deployed 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 approach the tricuspid valve 1083 for deployment of the implant 906 while the elongated shaft 900 has a reduced lateral profile.

[0179] Figure 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 configured to result in bending beyond 180 degrees, such as a push shaft extending along the outer diameter of the shaft 1300 and applying distal force to bend the shaft 1300 beyond 180 degrees. Other mechanisms may be used similarly. Thus, the elongated shaft 1300 can form a loop 1302 that can be positioned at a desired location within the patient's body.

[0180] For example, as shown in Figure 31, the loop 1302 may be positioned within the right atrium 1076 in an embodiment in which the implant 70 will be deployed to the tricuspid valve 1083. The loop 1302 may be positioned within the right atrium 1076 to allow for greater clearance of the distal end of the capsule 106 from the wall of the right atrium 1076. The loop 1302 may be oriented in the atrial direction so as to move away from the tricuspid valve 1083. The elongated shaft is configured to bend at the bent portion of the elongated shaft, with the implant retention area positioned distal to the bent portion.

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

[0182] The components of the elongated shaft 12 may be used together 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 used to perform or assist in the deployment of the implant 70 held by the implant retention area. The deflection mechanism disclosed herein may be used.

[0183] Figures 32A to 33B show embodiments of an elongated shaft including a hinge that connects 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 connected to the proximal portion 1406 of the capsule 106. The capsule 106 is configured to rotate around 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 around the hinge 1404 with the port 1408 oriented toward the tricuspid valve 1083.

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

[0185] The capsule 106 shown in Figures 32A to 33B can be rotated around 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 may be configured to rotate around the hinge 1404 to a variety of angles, including between 0 degrees and 360 degrees or larger, as desired. The capsule 106 may be rotated to provide a desired orientation of the port 1408 of the capsule 106, for example, in a desired orientation toward the tricuspid valve 1083 or other delivery location.

[0187] The hinge 1404 may include a pin extending through the opening, or may include other forms of the hinge as desired.

[0188] The components of the elongated shaft 12 may be used in conjunction with the elongated 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 used to perform or assist in the deployment of the implant 70 held by the implant retention area. The deflection mechanism disclosed herein may be used. One or more features of the elongated shaft 1400 may be used alone or in conjunction with any other embodiment, other system, or other method of the delivery system disclosed herein.

[0189] Figures 34A and 34B illustrate methods that may be used for deploying the implant from the elongated shaft 12. Referring to Figure 34A, the method may include positioning the capsule 106 of the elongated shaft 12 within the right atrium 1076 of the patient's heart. The bent portion 600 may then be used to deflect the capsule 106 in a certain direction. The elongated shaft 12 may be translated proximally, for example, by retracting the elongated shaft 12 from the patient's heart, in order to position the capsule 106 in a desired orientation relative to the tricuspid valve 1083.

[0190] Figure 34B shows an elongated shaft 12 being retracted proximal to position the capsule 106 in a desired location relative to the tricuspid valve 1083. The implant can then be deployed from the capsule 106 to the tricuspid valve 1083 for implantation using the method disclosed herein. The methods of Figures 34A–34B may be used alone or in conjunction with any other embodiment, other system, or other method of the delivery system disclosed herein.

[0191] Various other methods of deploying implants or utilizing the systems and apparatus disclosed herein may be used.

[0192] Figures 62A to 64C illustrate embodiments utilizing one or more supports that extend radially outward from the outer surface of the elongated shaft 12 and are configured to contact the outer surface in order to resist the deflection of the elongated shaft 12 across the axis along which it extends. These embodiments may be used in conjunction with any other embodiments disclosed herein.

[0193] Figure 62A shows an embodiment in which one or more supports 1450 may be used, for example, in the form of an arm. In Figure 62A, the supports 1450 are shown in an unfolded, unextended, or straightened configuration, and the supports 1450 are compressed against the outer surface of an elongated shaft 12. The supports 1450 may extend proximal from the distal end 1452 of the supports 1450 to the position of the handle 14, or to another position for access to the outside of the patient's body.

[0194] The support 1450 can be held in an unextended, non-extended, or straightened configuration as shown in Figure 62A by a sheath 1454 extending along the outer surface of the elongated shaft 12 and over the support 1450. The sheath 1454 can be configured similarly to the sheath 51 shown, for example, in Figure 1, or as sheath 610 in Figure 13A. In embodiments, the sheath 1454 may be configured to slide proximal and / or distally along the outer surface of the elongated shaft 12 to uncover or cover the support 1450 as desired. The proximal portion of the sheath 1454 can be controlled, for example, to move the sheath 1454 proximal or distal.

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

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

[0197] Each support 1450 may be stiff enough to reduce the deflection of the elongated shaft 12 in a direction transverse to the axis along which the elongated shaft 12 extends. However, the support 1450 may be flexible in order to extend radially outward from an unextended configuration (shown in Figure 62A) to an extended configuration (shown in Figure 62B). The support 1450 can be deflected outward 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] Figure 62B shows, for example, a support 1450 being advanced distally relative to the sheath 1454. In the extended configuration shown in Figure 62B, the support 1450 extends radially outward. The middle portion 1456 of the support 1450 protrudes outward 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 the deflection of the elongated shaft 12 as it crosses the axis 1460 along which the elongated shaft 12 extends.

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

[0200] Figures 62C to 62E illustrate an exemplary method of using a delivery device utilizing 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 be passed transseptally through the atrial septum 1462 between the right atrium 1076 and the left atrium 1075. For example, a puncture to pass the elongated shaft 12 through the atrial septum 1462 may be performed in the atrial septum 1462. The support 1450 may 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 retention area can be deflected, for example, in the ventricular direction toward the left ventricle 1073 via the bent portion 600. One or more other bent portions, including the bent portion 602, may be used to align the capsule 106 as desired with respect to the mitral valve 1461. For example, the bent portion 602 can deflect the capsule in a plane extending across the plane of the bend of the bent portion 600, according to the method disclosed herein. Various directions of deflection may be utilized.

[0202] When the capsules 106 are aligned in a fixed 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 may result in a force being applied to the elongated shaft 12 in the atrial direction 1463 (indicated in Figure 62D). Furthermore, a decrease in depth in the atrial direction may result in a force being applied to the elongated shaft 12 in the ventricular direction 1464 (indicated in Figure 62D). Such forces may arise from the movement of the capsules 106 or from contact between the capsules 106 and structures such as the ligaments or leaflets of the mitral valve 1461. Forces on the elongated shaft 12 can provide stress to the puncture of the atrial septum 1462. In embodiments, stress may increase the magnitude of the potentially undesirable puncture of the atrial septum 1462, and may also increase the time it takes 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 on the atrial septum 1462 as much as possible, the support 1450 can be expanded radially outward to contact the wall of the patient's heart. Figure 62D shows the expanded support 1450 in a configuration such as that shown in Figure 62B. The support 1450 moves from an unexpanded state to an expanded state. The distal tip 1452 and / or middle 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 forces in the atrial direction 1463 and / or ventricular direction 1464 as desired. In embodiments, other directions (e.g., transverse to the atrial direction 1463 and / or ventricular direction 1464) may be utilized as desired. The atrial wall may consist of opposing portions of the atrial wall as shown in Figure 62D, or, in embodiments, the wall of the atrial septum.

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

[0205] Once the implant is deployed, the support 1450 can be retracted into an undeployed, unexpanded, or straightened configuration as shown in Figure 62A, and retracted from the patient's body. The support 1450 can be retracted together with the elongated shaft 12.

[0206] In this embodiment, the sheath 1454 may not be used, and the support 1450 may be directly coupled to the elongated shaft 12, or it may extend radially outward from the elongated shaft 12. A separate control mechanism may be used to control the deployment of the support 1450 in such an embodiment.

[0207] The support 1450 can beneficially reduce the deflection of the elongated shaft 12, thereby reducing stress in the atrial septum 1462. This improves the accuracy of capsule modification and depth control due to the reduced possibility of undesirable deflection of the elongated shaft 12. Furthermore, the reduced stress on the atrial septum 1462 can reduce the possibility of an undesirable increase in the size of the puncture in the atrial septum 1462. Such features can shorten the time it takes for the puncture to seal, or increase the likelihood of puncture sealing. A smaller puncture in the atrial septum may reduce the likelihood of needing an occluder used to seal the puncture following the deployment of the cardiac valve implant. This results in a reduction in the number of steps required for the implant deployment procedure.

[0208] The support 1450 may be further utilized for deployment to other locations within the patient's body. For example, Figure 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 elongated shaft 12 and can contact the right atrial wall. Other contact locations in the patient's vascular system may be utilized, such as the inferior vena cava 1079 or the superior vena cava 1081, as desired.

[0209] The form of the support may be varied depending on the embodiment.

[0210] For example, Figures 63A and 63B show embodiments 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 that it moves from an unexpanded, unextended, or straightened configuration as shown in Figure 63A to an expanded or unfolded configuration as shown in Figure 63B. Figure 63A shows the support in an unextended or undefended configuration, with the sheath 1454 extending over the support 1466. The support 1466 can then be inflated to an expanded or inflated configuration via a filled lumen or the like, as shown in Figure 63B.

[0211] Referring to Figure 63B, the support 1466 can come into contact with the atrial wall to resist the deflection of the elongated shaft 12 in a manner similar to that considered with respect to the support 1450 shown in Figure 62E or Figure 62F. In embodiments, one or more inflatable bodies may be used. The inflatable body may be rectangular or other shapes (e.g., ellipsoid), or other shapes such as a disc in embodiments. Furthermore, the configuration of the inflatable body may comprise a membrane, a mesh body, or other forms in embodiments.

[0212] Figures 64A and 64B show an embodiment in which the support 1468 comprises a mesh configured to extend radially outward from an elongated shaft 12. The mesh may consist of a plurality of discs 1470, 1472, each extending radially outward from the elongated shaft 12. The discs 1470, 1472 may be configured to be positioned on either side of the atrial septal puncture, but other locations may be utilized in the embodiment. In the embodiment, a single disc may be used, or a greater number of discs (e.g., three or four discs) may be used as desired.

[0213] The support 1468 may be configured as one or more occluding bodies configured to seal the atrial septal puncture. Thereafter, the support can reduce fluid flow between the atria and, in an embodiment, can support the elongated shaft 12 from deflection.

[0214] For example, Figure 64B shows the support 1468 in an unextended, unexpanded, or straightened configuration. The sheath 1454 extends over the support 1468. A tie cord 1474 can connect the support 1468 to the sheath 1454 or the elongated shaft 12. The support 1468 can be positioned in a desired location for puncture at the atrial septum and the deployment site.

[0215] Figure 64C shows a support 1468 extending radially outward from an elongated shaft 12. The surface areas of the discs 1470 and 1472 relative to the atrial septum can reduce the possibility of deflection of the elongated shaft 12. Disc 1470 may be positioned in the left atrium, and the other disc 1472 may be positioned in the right atrium. The position and configuration of the discs may be varied in embodiments. For example, the discs 1470 and 1472 may be made from a mesh material configured to expand upon deployment. The material may include shape memory materials such as nitinol or other forms of shape memory materials. In embodiments, the discs may comprise an inflatable body or other forms of occlusion.

[0216] The support 1468 may either retract and be retracted during the deployment of the heart valve implant, or it may remain in place during the puncture of the atrial septum. Following deployment, the support 1468 may remain in place as an occluder.

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

[0218] The implants disclosed herein may be used with anchors configured to be fixed within a portion of the patient's body. The anchors may be provided to further secure the implant at a desired implantation site within the patient's heart. The implant may comprise a prosthesis heart valve, and in particular, a prosthesis heart valve configured for implantation within the patient's tricuspid valve annular 1085. The implant may comprise a prosthesis tricuspid heart valve and may comprise the implants disclosed herein.

[0219] Figures 35 to 38B show embodiments of anchors that can be utilized in the implant disclosed in this specification. Figure 35, for example, shows an implant 70 at a predetermined position in 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 is configured to be fixed in the inferior vena cava 1079 of the patient's heart. The anchor 1800 may include a stent that is fixed within the inferior vena cava 1079. A connecting wire 1802 can be coupled from the anchor 1800 to the implant 70 to fix the implant at a predetermined position in the tricuspid annulus 1085. The connecting wire 1802 can be rigid to resist the force in the atrial direction applied to the implant 70. In one embodiment, the anchor 1800 may be positioned in the superior vena cava 1081 of the patient's heart as an alternative to, or in combination with, the anchor in the inferior vena cava 1079. An atrial ball anchor may be utilized in certain embodiments.

[0220] Figure 36A shows an embodiment in which an anchor 1900 is configured to be fixed to the moderator band 1902 of a patient's right ventricle 1077. The anchor 1900 can be coupled to one or more connecting wires 1904 that couple to the implant 70. The connecting wires 1904 can be configured to resist the force applied to the implant 70 in the atrial direction to fix the implant 70 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. An additional form 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 configured such that the anchor 2000 can be fixed to the wall of the patient's right ventricle 1077. For example, the anchor 2000 can include an expandable body that, in a compressed or undeployed state, is passed through a puncture in the wall and disposed on the outer surface of the wall of the right ventricle 1077. 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​​ Embodiments disclosed herein may be deployed within the tricuspid valve annular region of a patient, and the anchor may be deployed within a portion of the patient's body. A tether may be provided connecting the prosthesis valve to the anchor. The anchor may be connected to the prosthesis valve by the tether.

[0225] Figure 38A shows an embodiment in which an implant 70 (indicated by a cover present on the implant 70) is deployed in the patient's right atrium 1076 and then moved ventricularly to connect with the leaflets 1087 of the tricuspid valve 1083. The implant 70 may be deployed in the right atrium 1076 using methods disclosed herein, including deploying the implant 70 from the capsule 106 into the right atrium 1076. The implant 70 may be moved ventricularly in a variety of ways. In one embodiment, as shown in Figure 38A, the implant 70 may be connected to one or more tethering cords 2102. The tethering cords 2102 may be configured to be pulled away from the atrium 1076 in order to move the implant 70 ventricularly to connect with the leaflets 1087. The tethering cord 2102 can be connected to an anchor 2100 positioned on the wall of the right ventricle 1077 and may be configured to be retracted through the anchor 2100 to pull the tethering cord 2102 away from the atrium 1076. In other embodiments, other methods may be used to pull the tethering cord 2102 away from the atrium 1076. In one embodiment, a rail structure may be used to guide the implant 70 in the ventricular direction to connect to the valve leaflet 1087.

[0226] In one embodiment, the elongated shaft 12 may be used to push the implant 70 in the ventricular direction to connect with the valve leaflet 1087. In one embodiment, another pushing device (such as a device that can be passed through the superior vena cava 1081) may be used to push the implant 70 in the ventricular direction. A combination of methods may be used as desired. The implant 70 in a predetermined position in the tricuspid annular region is shown in Figure 38B.

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

[0228] The systems, apparatus, and methods disclosed in relation to Figures 13A to 38B and Figures 62A to 64C may be used in combination, substitution, or any other modification as desired, in conjunction with any embodiment disclosed in this application.

[0229] Implants used in accordance with the systems, apparatus, and methods disclosed herein may include ports that can be configured to accept diagnostic or therapeutic devices. Such diagnostic or therapeutic devices may include pacemaker pacing leads. Embodiments of such implants are shown in Figures 39A to 44.

[0230] Referring to Figure 39A, an embodiment of the implant 1500 in an extended configuration is shown. The implant 1500 may comprise 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 may comprise an inner frame body 1522 and an inner frame mooring feature 1524. The inner frame body 1522 may have an upper region 1522a, an intermediate region 1522b, and a lower region 1522c. As shown in the figure, the inner frame body 1522 may have a generally 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] Although the illustrated inner frame body 1522 is bulbous, it will be understood that the diameters of the upper region 1522a, the middle region 1522b, and / or lower region 1522c may be the same so that the inner frame body 1522 is generally cylindrical along one or more regions. Furthermore, all or part of the inner frame body 1522 may have a non-circular cross-section, such as a D-shaped, elliptical, or egg-shaped cross-section, but is not limited thereto.

[0233] Referring next to the outer frame 1540 shown in Figure 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 may be formed as a single unit or as a single piece.

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

[0235] The upper region 1542a of the outer frame body 1542 may comprise a first region 1546a and a second region 1546b. The size and / or shape of the first region 1546a may be determined to generally correspond to the size and / or shape of the inner frame 1520.

[0236] The intermediate region 1542b of the outer frame body 1542 may generally extend downward from the outward-extending region 1546b of 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, lower end, and / or the portion in between may differ. For example, all or part of the outer frame body 1542 may have a non-circular cross-section, such as, but not limited to, a D-shaped, elliptical, or otherwise egg-shaped cross-section.

[0238] The outer frame 1540, such as the outer frame body 1542, may be used to attach or fix the implant 1500 to a natural valve, such as a natural tricuspid valve. For example, the intermediate region 1542b and / or anchoring feature portion 1524 of the outer frame body 1542 may be positioned to contact or engage with the natural valve annular ligament, the tissue beyond the natural valve annular ligament, the natural 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.

[0239] Continuing to refer to the implant 1500 shown in Figure 39A, the valve body 1560 is mounted to the inner frame 1520 inside the inner frame body 1522. The valve body 1560 functions as a one-way valve to allow 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 multiple valve leaflets 1562, such as three valve leaflets 1562, which are joined at a joint. 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 is joined 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 may 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 can have the shape of an oppositely reversed funnel as shown in FIG. 39A. 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 annular band 1595 on which the valve leaflets 1562 are positioned, and port 1591 can be positioned outside the valve annular band 1595. This allows pacemaker leads passing through port 1591 to avoid interference with the movement of the valve leaflets 1562.

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

[0247] Figure 39B shows an alternative to the embodiment of Figure 39A with a modification to the design of the cover or skirt (or cloth) 1580 / 1590. As illustrated, the skirt 1580 / 1590 can be in contact with 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 bottom outside 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 hematopoietic formation / embolus.

[0248] Therefore, port 1591 can pass through both the upper and lower portions of the skirt 1580, as shown in Figure 39B.

[0249] Figures 39C to 39D show illustrations of embodiments of implant 1600 in an extended configuration, respectively. Implant 1600 may have a structure similar to implant 1500 described earlier. Implant 1600 may comprise 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 port 1591 is shown extending from the top surface of implant 1600.

[0250] Referring first to the outer frame 1640 shown in Figures 39C to 39D, the outer frame 1640 can be attached to the inner frame 1620 using any known fasteners and / or techniques. Although the outer frame 1640 is shown as a separate component from the inner frame 1620, it should be understood that frames 1620 and 1640 can be unified or formed from a single object.

[0251] As shown in the illustrated embodiment, the outer frame 1640 may comprise an outer frame body 1642. The outer frame body 1642 may 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 may be sized and / or molded to substantially match 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 may have a shape similar to that of the outer frame body 1542 described earlier in relation to Figure 39A. However, it is understood that all or part of the outer frame body 1642 may have a non-circular cross-section, such as a D-shaped, elliptical, or otherwise egg-shaped cross-section, but not limited to these.

[0253] Continuing to refer to the implant 1600 shown in Figure 39C, the outer frame body 1642 may comprise a plurality of supports, at least some of which form cells 1646a to 1646c.

[0254] The upper row of cells 1646a may have an irregular octagonal shape, such as a “heart” shape. Such additional space may be beneficial as it allows the outer frame 1640 to maintain a smaller outline when pleated. Cells 1646a can be formed via a combination of struts. As shown in the illustrated embodiment, the upper row of cells 1646a can be formed from a set of circumferentially extendable struts 1648a having a zigzag or wavy shape that forms a repeating “V” shape.

[0255] The middle portion of cell 1646a may be formed from a set of supports 1648b extending downward from each of the "V" shaped bottom ends.

[0256] The lower portion of cell 1646a may be formed from a set of circumferentially expandable supports 1648c having a zigzag or undulating shape that forms a repeating "V" shape.

[0257] The intermediate and / or lower columns of cells 1646b and 1646c may have a different shape from the first column 1646a. The intermediate column of cell 1646b and the lower column of cell 1646c may have a diamond shape or a roughly diamond shape. The diamond shape or roughly diamond shape may be formed through a combination of pillars.

[0258] The upper portion of cell 1646a may be formed from a set of circumferentially extendable struts 1648c such that cell 1646b shares struts with cell 1646a. The lower portion of cell 1646b may be formed from a set of circumferentially extendable struts 1648d. As shown in the illustrated embodiment, one or more of the circumferentially extendable struts 1648d may extend substantially downward, substantially 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 extendable struts 1648d such that cell 1646c shares struts with cell 1646b. The lower portion of cell 1646c can be formed from a set of circumferentially extendable struts 1648e. The circumferentially extendable struts 1648e can generally extend downward.

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

[0261] The outer frame 1640 may include a set of locking tabs 1652 extending from or adjacent to the upper end of the upper region 1642a. As shown, the locking tabs 1652 may extend upward from a set of eyelets 1650. The outer frame 1640 may include 12 locking tabs 1652, but it should be understood that more or fewer locking tabs may be used. The locking tabs 1652 may include a longitudinally extending post 1652a. At the upper end of the post, the locking tab 1652 may have an enlarged head 1652b. As shown, the enlarged head 1652b may have a semicircular or semi-elliptical shape that forms a “mushroom” shape with the longitudinal post 1652a. The locking tabs 1652 may include eyelets 1652c that can be positioned through the enlarged head 1652b. It is understood that the lock tab 1652 may have grommets in other locations, or may have two or more grommets.

[0262] The lock tab 1652 can be advantageously used with several types of delivery systems. For example, the strut shape and 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 earlier. The eyelets 1652c and / or eyelets 1650 can be used to secure the outer frame 1640 to a “mooring” 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 the re-engaging and repositioning of 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 natural valve, such as a natural tricuspid valve. For example, the intermediate region 1642b and / or anchoring feature portion 1624 of the outer frame body 1642 may be positioned to contact or engage with the natural valve annular ligament, the tissue beyond the natural valve annular ligament, the natural 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 may be sized and positioned relative to the inner frame anchor mechanism 1624 so that the implant 1600 can be further secured to tissue by engaging with or sandwiching tissue in a body cavity positioned between the outer frame body 1642 and the inner frame anchor mechanism 1624, such as the natural valve membrane and / or natural valve annular ligament. As shown, the inner frame anchoring 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 joints with respect to the valve body 1660.

[0264] The valve body 1660 may comprise multiple valve leaflets 1662, such as three valve leaflets 1662 joined at a joint. The valve body 1660 may include one or more intermediate components 1664.

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

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

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

[0268] Figure 39D shows a bottom view of implant 1600, indicating the location of the exit opening 1593.

[0269] Referring to Figures 39E to 39G, the port can have various forms. The port is shown isolated from the implant. Referring to Figure 39E, the tubular body of port 1591 may be made of a braided or woven material that exhibits a biasing force to constrict the central lumen 1594. The constriction of the central lumen 1594 can form a seal with the diagnostic or therapeutic device when a diagnostic or therapeutic device, which may include a pacemaker pacing lead, is inserted through port 1591, in order to prevent backflow of blood through port 1591. The braided material may be made of wire such as woven and heat-set nitinol wire. Other materials may be used as desired.

[0270] Port 1591 may be equipped with position markers such as a radiopaque marker 1597 that identify the location of port 1591, in particular the location of the aperture 1592 of port 1591 in imaging.

[0271] Figure 39F shows an embodiment of a port 2200 comprising 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, which may include a pacemaker pacing lead, passes. The body 2206 may be made of a polymer such as a fluoroelastomer or an elastomer material such as 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 the pacemaker pacing lead when inserted through the port 2200 to prevent backflow of blood through the port 2200. Other materials may be used as desired.

[0272] Port 2200 may include position markers such as radiopaque markers 2210 that identify the location of port 2200, particularly the location of the aperture 2202 of port 2200 in imaging.

[0273] Figure 39G shows an embodiment of a port 2300 comprising 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 comprise a valve 2310 positioned therein, which can form a seal with a diagnostic or therapeutic device when a diagnostic or therapeutic device, which may contain a pacemaker pacing lead, is inserted through the port 2300, in order to prevent backflow of blood through the port 2300. The valve 2310 may comprise a duckbill valve or other forms of valve.

[0274] Port 2300 may include position markers such as radiopaque markers 2312 that specify the location of port 2300, in particular the location of the aperture 2302 of port 2300 in imaging. The body 2306 may be made of polymer, elastomer, silicone, or braided material. Other materials may be used as desired.

[0275] Any embodiment of the port disclosed herein may have a drug coating implanted on either the outer or inner surface, or both, for release into the patient's body. Furthermore, the coating may be provided on either the outer or inner surface, or both, to provide a surface that is hydrophilic, hydrophobic, or antithrombotic.

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

[0277] Figure 41 shows an embodiment in which port 2500 comprises a tearable portion of valve body 1660. The tearable portion may be a tearable portion of the outer skirt 1680 as shown in Figure 41. The tearable portion allows a diagnostic or therapeutic device to pass through. The tearable portion may be configured to be penetrated by a puncture device or pacemaker pacing lead to pass through the tearable portion. The material surrounding the resulting opening in the skirt 1680 may be configured to be biased toward the opening to prevent backflow of blood through port 2500. The tearable portion forms a flap that presses against the pacing lead to seal with it, as backflow is applied to the flap that contacts the lead. An elastic material may be used to form the seal that contacts the lead. As shown in Figure 41, the opening may be positioned between the struts of the outer frame to allow a passage for the pacing lead. The aperture may be surrounded by positional markers, such as radiopaque markers, that identify the location of the port 2500 aperture in imaging.

[0278] In one embodiment, the port may be positioned outside the outer valve body for positioning between the outer valve body and the annular band of the heart valve. The port may include a loop of material, such as a material through which a diagnostic or therapeutic device is passed.

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

[0280] Figure 43 illustrates the use of port 2400 as shown in Figure 40B. A diagnostic or therapeutic device that may be equipped with a pacemaker pacing lead 2600 can be passed through port 2400. The tip 2602 of the pacemaker pacing lead 2600 may be positioned inside the right ventricle.

[0281] The method may include passing a diagnostic or therapeutic device through a port located on the prosthesis heart valve body. The prosthesis heart valve body may form a prosthesis heart valve annulus. The port may comprise a tube through which the diagnostic or therapeutic device is passed.

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

[0283] In embodiments disclosed herein, the prosthesis valve body can be deployed into the patient's heart valve annulus using the method disclosed herein. The valve body can be expanded within the heart valve annulus and anchored to the heart valve flap or the leaflet of the heart valve. The valve body can be brought into contact with the patient's heart valve.

[0284] The method may include coupling a pacemaker pacing lead to a prosthesis heart valve body positioned within the patient's heart valve annulus to provide electrical energy through the pacemaker pacing lead and through the prosthesis heart valve body to pace the patient's cardiac function. The method may include providing electrical energy through a frame. The prosthesis valve body may have 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 prosthesis heart valve body to pace the patient's cardiac function.

[0285] If conduction disturbances are detected at the time of implantation, or if chronic conduction problems develop over time, any embodiment of a port for a pacemaker pacing lead may be used in an emergency.

[0286] Diagnostic or therapeutic devices may include not only pacemaker pacing leads, but also other forms of devices, such as catheters or other medical devices that are inserted into implants.

[0287] The implant embodiments disclosed herein may be used individually or across embodiments as desired. Such embodiments may be used with tricuspid valves, mitral valves, or other valves as desired. Features of the implant embodiments may be combined across embodiments as desired.

[0288] Any and all of the embodiments disclosed herein may be used in conjunction with a powered implant delivery system. Furthermore, in any and all embodiments, the delivery system may utilize a processor for controlling at least one motor for operating the delivery device. Furthermore, in any and all embodiments, the delivery system may include sensors such as those disclosed herein. The delivery system may include sensors configured to sense one or more of the patient's physical condition or the condition of the delivery device. The processor may process signals provided by the sensors, which may include feedback signals to the processor.

[0289] The features of such a system are disclosed in U.S. Provisional Patent Application No. 62 / 837,641, filed on 23 April 2019, and the entire content thereof is incorporated herein by reference. The features of such a system are also disclosed in PCT Application PCT / US2020 / 029138, filed on 21 April 2020, and the entire content thereof is incorporated herein by reference (along with the U.S. domestic application for PCT Application PCT / US2020 / 029138).

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

[0291] As shown in Figure 45, the housing in the form of a handle 15 may be positioned at the proximal end 11 of an elongated shaft 12. The proximal end 11 of the elongated shaft 12 may be coupled to the handle 15. The handle 15 may include a control device 504 configured to control at least one motor. The control device 504, as shown in Figure 45, may include a plurality of buttons, but in other embodiments, other forms of control devices may be used. The control device 504 may be positioned on the handle 15 as shown in Figure 45, or it may be located at a separate location.

[0292] Figure 46 shows a cross-sectional view of a handle 15 including a motor 500 and an actuation mechanism 506, which may be used to actuate at least part of the delivery device. In various embodiments, the motor and actuation mechanism may be used to actuate a pull wire as it advances through the vascular system. The motor and actuation mechanism may be used to actuate a shaft / sheath to deploy and release the implant at the treatment site. The body of the handle 15 may include multiple parts, including a distal portion 508 and a proximal portion 510. The distal portion 508, as shown in Figure 46, may be configured to hold the actuation mechanism 506, and the proximal portion 510 may be configured to hold the motor 500. In other embodiments, other components may be positioned within the respective distal portion 508 and proximal portion 510, and in certain embodiments, the handle 15 may consist of a single body. In the embodiment shown in Figure 46, the distal portion 508 and the proximal portion 510 may be configured to be joined together via couplers 512, 514 (marked in Figures 49 and 50), and in certain embodiments they may be separable from one another.

[0293] The operating mechanism 506 may take the form shown in Figure 46 and may include a plurality of adapters 516a to g configured to engage with a plurality of drive rods 518a to g (drive rods 518f to g are marked in Figure 48). Each adapter 516a to g may comprise a plate or other body containing a plurality of openings. Figure 47 shows a front plan view of adapter 516a. The adapter 516a shown in Figure 47 may include openings 520a to g and 522. Each of the openings 520a to g may be configured to allow each drive rod 518a to g to pass through it (as shown in Figure 48). Each of the openings 520b to g may be configured to be a smooth seating surface which does not engage with each drive rod 518b to g. However, opening 520a may be configured to have a threaded surface or other surface that engages with 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. In other embodiments, other forms of engagement may be utilized.

[0294] The central opening 522 may allow other components of the operating mechanism 506, such as assembly connectors, to pass through the central opening and connect to the remaining adapters 516a to g.

[0295] Figure 48 shows a perspective view of adapter 516a in which typical drive rods 518a to 520a extend through openings 520a to 520g.

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

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

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

[0299] Adapters 516a to 516g may be coupled to assembly connectors that connect to each part of the 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 and 140. In certain embodiments, adapters 516a to 516g may be coupled to specific components comprising each of the assemblies, for example, adapter 516a may be directly coupled to the nose cone shaft 27 in certain embodiments. The coupling of adapters 516a to 516g to the assembly connectors may be such that adapter 516a is coupled to the assembly connector 521 for the outer sheath assembly 22. Adapter 516b may be coupled to the assembly connector 523 for the intermediate shaft assembly 21. Adapter 516c may be coupled to the assembly connector 524 for the rail assembly 20. Adapter 516d may be coupled to the assembly connector for the distal tension wire 138, or it may be directly coupled to the distal tension wire 138. Adapter 516e may be coupled to an assembly connector for the proximal tensile wire 140, or it may be coupled directly to the proximal tensile wire 140. Adapter 516f may be coupled to an assembly connector 526 for the inner assembly 18. Adapter 516g may be coupled to an assembly connector 528 for the nose cone assembly 31. The assembly connectors 521, 523, 524, 526, and 528 may have sheaths extending concentrically over each other, or they may have rods, wires, or other forms of connectors. The assembly connectors 521, 523, 524, 526, and 528 may be configured to pass through the central opening of their respective adapters 516a to g (e.g., opening 522 shown in Figure 47).

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

[0301] The movement of the assemblies (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 pull wires 138, 140 to produce a desired movement (e.g., deflection) or action (e.g., implant deployment). For example, motor 500 may be configured to translate the rail shaft of rail assembly 20 relative to the inner sheath of inner assembly 18 and the outer sheath of outer sheath assembly 22. In certain embodiments, motor 500 may be configured to translate the outer sheath of outer sheath assembly 22 relative to the inner sheath of inner assembly 18. Motor 500 may be configured to translate any of the assemblies relative to each other to produce a desired result. Motor 500 may be configured to steer rail assembly 20 by, for example, acting on pull wires 138, 140. Other movements may include acting on the depth of the elongated shaft 12 and acting on the movement of the elongated shaft 12, such as the full or partial deployment of the implant 70. The movements may be those of the deflection mechanisms disclosed herein.

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

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

[0304] The input and output devices 532 may have multiple configurations, including electrical ports or terminals configured to transmit electrical signals. The input devices may be configured to receive signals from the motor 500 and from sensors positioned on the delivery system 10. The output devices may be configured to transmit signals that can be received 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 and output devices 532 may include wireless transmission devices, such as Wi-Fi or Bluetooth® devices or other devices configured for wireless communication. In one embodiment, where the controller 530 is located away from the delivery device, the input and output devices 532 may be configured to send and receive information via the Internet or other forms of communication media. In other embodiments, other forms of input and output devices may be used.

[0305] Memory 534 may be configured to store a program for operation by the processor 536, as well as other data that is to be stored in the controller 530. Memory 534 may be configured to store and log data about the patient and about the operation of the motor 500 and delivery device during the procedure, thereby enabling the system to learn from past events. The learning process may be based on an algorithm capable of identifying procedures that have produced positive results in the past, thereby enabling the system to continuously improve the procedure and increase the probability of success. Preferably, the data can be pooled from different patients, different clinicians, and / or different hospitals. The data can be edited to improve accuracy and outcomes in future procedures. This can be achieved, for example, by comparing the characteristics of a new patient with those of a patient treated in the past. Data from procedures on past patients with similar anatomical structures and / or other parameters such as the patient's sex, age, and health are particularly useful. Other parameters such as the clinician's skill level and 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 hard disks, 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 replaced within or out of controller 530 as desired for a particular form of operation.

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

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

[0309] The components of the controller 530 may be positioned together as shown in Figure 46, or they may be distributed as desired. The components of the controller 530 may be positioned in separate housings or control boxes and may be coupled to the delivery device using cables or the like. Figure 46 shows the 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 Figure 61.

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

[0311] Figure 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 Figure 50). Such a configuration may allow a particular portion of the handle 15 of the delivery device to be separated from another portion of the handle 15 (e.g., the proximal portion 510) so that it can be used in the delivery of the implant and then the distal portion 508 can be sterilized or disposed of. This process may separate electrical components of the system 10, which may include a motor 500 or a controller 530 positioned within the proximal portion 510, from components that are inserted into or come into contact with 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 Figure 49, the proximal portions of the drive rods 518a-g may extend proximal from the distal portion 508 of the handle 15 to connect to their respective openings 544a-g within the proximal portion 510 of the handle 15. The proximal portions of the drive rods 518a to g are coupled to their respective openings 544a to g, which allows the motor 500 to engage with the drive rods 518a to g. Electrical couplers 542 and 512 are also shown protruding from the distal portion 508 of the handle 15.

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

[0313] Referring again to Figure 49, the control device 504 is shown on the distal portion 508 of the handle 15, including a number of buttons. The control device 504 may be configured to receive input from the user and operate the motor 500, thereby operating a part of the delivery device. The control device 504 may be configured to send signals directly to the motor 500, or to send them to the processor 536 of the controller 530 for processing. The control device 504 may be configured to control the deflection and movement of the delivery device. The control device 504 may be configured to control the operation of the delivery device, such as the deployment of the implant 70. The control device 504 may have various forms and may have parts designated to control specific movements or operations of the delivery device, as shown in Figure 49.

[0314] The control device 504 in Figure 49 may include a button 548 that controls the rail assembly 20 and, in particular, the direction of deflection of the rail assembly 20, the direction of deflection may be in at least two planes. The button 548 may be configured to control the steering of the rail assembly 20. The user may press the desired button 548 to activate the delivery device to the motor to deflect in the desired direction. The control device 504 in Figure 49 may include a button 550 that controls the depth of the elongated shaft 12 by sliding an assembly, for example, an outer sheath assembly 22, an intermediate shaft assembly 21, an inner assembly 18, and a nose cone assembly 31, relative to the rail assembly 20. The button 550 may allow the user to increase or decrease the depth. The control device 504 in Figure 49 may include a button 552 that activates 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 in order to deploy the implant 70. The control device 504 in Figure 49 may include a button 554 that activates the movement of the nose cone assembly 31 to advance or retract the nose cone 28. Various configurations of the control may be used to deflect the delivery device or to perform the operation of the delivery device. Control signals from the control device 504 may be transmitted directly to the motor 500 for operation, or to the processor 536 for processing to activate the motor 500 to actuate at least a portion of the delivery device. The configuration of the control device 504 may be modified in other embodiments. Control signals may be used to operate the deflection mechanism disclosed herein.

[0315] Other possible embodiments of control devices include buttons, joysticks, touchpads, touchscreens, knobs, or motion sensing devices, among the many forms of control devices.

[0316] System 10 may include output devices, which may take various forms. The output devices may be configured to provide the user with an output that can indicate the status of the delivery device or the patient's condition. The output devices may be configured to provide an indicator of the status of the delivery device or the patient's condition. The output devices may include a light source that can illuminate to indicate the status of the delivery device or the patient's condition. The light source may illuminate to indicate contact with or proximity to the patient's body surface (status of the delivery device), or to indicate a specific state of the patient's body, such as accurate or inaccurate pressure being sensed within the patient's body. Other forms of output devices may be used, including tactile devices such as vibration actuators, which may indicate the status of the delivery device or the patient's condition. The output devices may include a touchscreen display screen. The output devices may include a display screen 584 as shown in Figure 59. Among other forms of output devices, the output devices may include one or more of the display screen, light source, speaker, or tactile device. Various forms of output devices may be used as desired. Indicators generated on the output devices may include one or more of the following: images, data, sound, light, or tactile signals. The output device may be configured to provide an index based on the output provided by the processor 536.

[0317] The operation of the delivery device by at least one motor may include translation of the elongated shaft 12, and may include translation of the housing at the proximal end of the elongated shaft 12. Axial translation of the delivery device may be provided. Figure 51 shows a side perspective view of the delivery device, for example, including an elongated shaft 572 and a housing 574. The delivery device is inserted transfemorally into the patient's body 576. The elongated shaft 572 may be configured similarly to the elongated shaft 12. The housing 574 may be configured similarly to the housing forming the handle 15, although the housing 574 may not have a handle for user gripping. Rather, the housing 574 may include a motor, or may be configured to move along a motor-driven rail 577, or other assembly that acts as an actuator for 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 close to the housing 574 or away from the housing 574.

[0318] The motor 500 may be configured to actuate 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 carry out any other method or may be used in any embodiment disclosed herein, including the embodiments shown in Figures 13A–44 and 62A–64C.

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

[0320] System 10 may include sensors configured to sense the status of the delivery device, and may include sensors configured to sense the status of the patient.

[0321] In certain embodiments, sensors may be used to sense the state of the delivery device. The sensors may include position sensors that can be used to determine the movement and / or position of one or more of the assemblies. For example, the position sensor may be configured to sense the amount by which the motor 500 has moved the 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 sensor 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 sensor may be provided to the processor 536 for the processor 536 to perform the desired movement. The signals from the position sensor may be feedback signals to the processor 536. For example, the position sensor may sense that a portion of the elongated shaft 12 is moving in response to the movement of another portion of the elongated shaft 12, and the processor 536 may operate the motor 500 to produce a movement for compensation based on this signal. An indicator of the position of the delivery device may be provided to an output device, as considered herein. The index may be provided based on the position detected by a position sensor.

[0322] The sensor may be used to sense the state of the delivery device in the form of a motor torque sensor. The sensor may be used to determine 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. If the amount of torque exceeds a certain amount, the motor 500 may be configured to automatically stop, reverse, or reduce its operation. In one embodiment, a signal from the motor torque sensor may be provided to the processor 536 for the processor 536 to perform a 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, reverse, or reduce its operation. An index indicating the torque of the motor of the delivery device may be provided to the output device, as considered herein. The index may be provided based on the torque sensed by the motor torque sensor.

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

[0324] In one embodiment, a 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 a 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 elsewhere (generally on the outer surface of the elongated shaft 12). The contact sensor 580 may be configured to provide a signal when the elongated shaft 12 comes into contact with a part of the patient's body. Such a signal may indicate the possibility of injury 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 instructions to the user. In one embodiment, contact detected by the contact sensor 580 may be used as feedback to a system 10, such as a processor 536, to activate the delivery device. For example, if contact with a surface is detected, the processor 536 may then activate the delivery device to move away from the surface or to 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, a 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 ultrasound 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 instructions to the user. In one embodiment, the proximity sensed by the proximity sensor 582 may be used as feedback to a system 10, such as a processor 536, to operate the delivery device. For example, if proximity to a specific surface (e.g., the inner wall of a blood vessel) is detected, the processor 536 may act to move the delivery device away from that surface, or stop the motor 500 from operating. Thus, the delivery device can be advanced through the patient's vascular system without damaging the inner wall of the blood vessel. This “smart catheter” technology can offer a significant improvement over current “blind catheters.” For example, this technology can reduce or eliminate the possibility of angiotomy, which is a significant and life-threatening risk associated with current delivery systems. While embodiments have been described for illustrative purposes, it should be understood that other positions and proximity readings of the proximity sensor 582 may be provided.

[0326] Figures 53–55 show one embodiment of a sensor configured to sense the patient's condition. The sensor comprises a flow sensor capable of sensing fluid flow (e.g., blood flow) within the patient's body. Multiple sensors 583a–l (marked in Figure 54) may be positioned on the delivery device to form a spaced-out array of sensors 583a–l. Sensors 583a–l may be configured to sense local fluid flow, so that sensors 583a–l may sense fluid flow in a localized area within the body that is different from the fluid flow sensed by other sensors 583a–l. Figure 53 shows a perspective view of the distal end of an elongated shaft 12, where sensors 583a–c can be seen on the capsule 106. Figure 54 shows a cross-sectional view of the capsule 106, showing the spaced-out array of sensors 583a–l. Sensors 583a–l may be positioned on the delivery device to sense fluid flow at specific locations close to the deployment site for the implant 70. Such specific locations may include capsule 106 or another part of the delivery device.

[0327] Figure 55 shows an illustrative operation of sensors 583a-l. The implant 70 may be deployed on the tricuspid valve with one distal anchor 80a engaging the valve 1108 and the other distal anchor 80b not engaging the valve 1108. Sensors 583k and 583l may sense the blood flow from the unengaged valve 1108 and provide a signal accordingly. Sensors 583a-l may be configured to sense the difference in flow rates between sensors 583f and 583g close to the engaged valve 1108 and sensors 583k and 583l close to the unengaged valve 1108. Flow sensors 583a-l may be configured to provide a signal when flow is sensed, and such a signal may be provided to an output device (such as output devices 568, 570, or other output devices) for user instruction. In one embodiment, the flow rates sensed by the flow sensors 583a-l may be used as feedback to a system 10, such as a processor 536, to activate the delivery device. For example, if a flow rate indicating a failure to capture the valve is detected, the processor 536 may then activate the delivery device to redeploy the implant 70 or perform another action. In other embodiments, other positions and other flow rate readings of the flow sensors 583a-l may be provided.

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

[0329] Signals from sensors configured to sense the status of the delivery device and sensors configured to sense the patient's status may be utilized in a variety of ways. In one embodiment, 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 status of the delivery device may be shown to the user in a variety of ways, and the output device may include one or more of the following, among other forms of output devices: a display screen, a light source, a speaker, or a haptic device. Indicators generated on the output device may include one or more of the following: images, data, sound, light, or haptic signals. The user may be able to act on and in accordance with these indicators. For example, if an 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. The patient's physical status may also be shown to the user in a variety of ways.

[0330] In the 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 the processor 536. The processor 536 may provide a variety of outputs based on one or more of the patient's physical state or the state of the delivery device sensed by one or more sensors. One such form of output may include a log of data relating to 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 it may log actions taken by the delivery device. For example, among other forms of sensor signals, a position sensor signal may be logged to record the movement of the delivery device.

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

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

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

[0334] In one embodiment, the method may include the step of extending a delivery device within a part of the patient's body to deliver an implant to a specific location in the body. The delivery system 10 is positioned in the ipsilateral femoral vein and can be advanced toward the right atrium. Therefore, it may be advantageous for the user to be able to maneuver the delivery system 10 through a complex area of ​​the heart in order to position the replacement tricuspid valve to match the original 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. The motor 500 can then be operated to activate the rail assembly 20 or deflection mechanism to direct the distal end of the delivery system 10 to target an appropriate area. The motor 500 may be driven 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 elongated shaft 12 in various ways in order to position the implant in the desired location for implantation.

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

[0336] Furthermore, sensors considered herein may be used in specific 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 physical condition or the state of the delivery device. The processor 536 may be configured to provide outputs based on one or more of the patient's physical condition or the state of the delivery device sensed by one or more sensors. For example, based on the state of the delivery device, the processor may cause at least a portion of the delivery device to avoid the surface of the patient's body or to retract from the surface of the patient's body.

[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 carry out any other method or may be utilized in any embodiment disclosed herein, including the embodiments shown in Figures 13A to 44 and Figures 62A to 64C.

[0338] In embodiments, the delivery system 10 can be used in a manner for percutaneous delivery of a replacement tricuspid valve to treat patients suffering from moderate to severe tricuspid regurgitation. Such a method may utilize any of the systems or devices disclosed herein. Referring to Figure 56, for example, the delivery device may be extended within a part of the patient's body to deliver the implant to a specific body location. The part of the patient's body may be the right atrium 1076, and the body location for implant delivery may be the original tricuspid heart valve 1083. The delivery device may be extended within a part of the patient's body in a manner similar to, for example, those disclosed herein, and the delivery device may be positioned within the ipsilateral femoral vein 1074 and advanced toward the right atrium 1076. Other access methods may be used 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 the processor 536, as considered herein, and may be used to extend the delivery device into the right atrium 1076.

[0340] The delivery device may be maneuvered to traverse complex regions of the heart in order to position the replacement tricuspid valve in alignment with the innate tricuspid valve. A 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 used to maneuver the rail assembly 20 to a desired orientation relative to the tricuspid heart valve 1083. The motor 500 may be operated by a processor 536 as discussed herein. The rail assembly 20 may have one or more bends so that the distal end of the delivery device is coaxially oriented with the innate tricuspid heart valve 1083.

[0341] Figure 57 shows, for example, the delivery device deflected in the right atrium 1076 toward the innate tricuspid valve 1083. One or more bends may be formed in the right atrium 1076 and / or inferior vena cava 1079. Once the implant 70 is positioned coaxially with the innate tricuspid valve 1083, the outer sheath assembly 22, the intermediate shaft assembly 21, the inner assembly 18, and the nose cone assembly 31 can be advanced together distally relative to the rail assembly 20 toward the right ventricle 1077 (for example, using the motor 500). The depth of the elongated shaft 12 may be changed by the operation of the motor 500 disclosed herein, which may be driven by the processor 536. Proximal / distal translation of the other assemblies on the rail assembly 20 enables ventricular-atrial movement. Furthermore, deflection mechanisms such as those 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 altered until the capsule 106 is positioned in the desired location relative to the innate tricuspid heart valve 1083. The distal end 303 of the implant 70, specifically the distal anchor 80, may be confined within the capsule 106 of the outer sheath assembly 22, thereby preventing expansion of the implant 70. As shown in Figure 2A, the distal anchor 80 can extend distally when positioned within the capsule. The proximal end 301 of the implant 70 is confined within the capsule 106 and part of the inner retaining member 40, thereby being largely restrained between the capsule 106 and the inner retaining member 40. The implant 70 may then be deployed onto the innate tricuspid heart valve 1082. Figure 58 shows, for example, the implant 70 deployed onto the innate tricuspid heart valve 1082. The distal anchor of the implant 70 extends over the valve 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 an implant to a portion of the body. The motor may operate the deflection mechanism disclosed herein, or other features of the embodiments disclosed herein, including controlling the operation of the embodiments in Figures 13A–44 and 62A–64C. The operation of the motor 500 may be driven by the processor 536. The user may provide input to the processor 536 using the control device 504. The system 10 can be positioned through the use of steering mechanisms or other techniques considered herein. The delivery system 10 can be advanced by the user manually moving the handle 15 axially. In some embodiments, the delivery system 10 can be placed in a stand while operating the control of the handle 15.

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

[0345] In other embodiments, other methods may be used to deliver the implant to the natural tricuspid heart valve, for example, transapical, transseptal, or other methods.

[0346] Other locations for valve implants may include the aortic valve 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 may be delivered under fluoroscopy so that the user can see specific reference points to properly position the implant 70. Furthermore, echocardiography 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 relationships of the elongated shaft 12 from inside the patient's body and from the surface of the patient's body. Such a model may be provided on output devices 584, 586 (on a monitor and on a virtual reality or augmented reality display) shown as display screens in Figures 59 and 60. 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 the user to view and for use by the processor 536 as feedback for navigating through the patient's body and delivering the implant 70 to a desired location.

[0349] Figure 59 shows one embodiment in which the operation of the delivery device may be performed remotely by a 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 can view the position of the elongated shaft 12 on an 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. Configurations including a motor for axial movement of the elongated shaft 12, as shown in Figure 54, may similarly be used for remote control of the procedure.

[0350] Figure 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 wear by the user, in which case the user can move their head to change the field of view provided by the display screen. Similar to the embodiments considered with respect to Figure 59, the position of the elongated shaft 12 and the position of the patient's heart as seen in 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. Configurations including a motor for axial movement of the elongated shaft 12, as shown in Figure 51, may similarly be used for remote control of the procedure.

[0351] In the exemplary method, a user (e.g., a clinician) may provide inputs that can be assisted by the use of components disclosed herein (e.g., among several 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 surgical 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, so that the procedure may be performed semi-autonomously. Thus, the method may be performed autonomously or semi-autonomously (or at least semi-autonomously). Other autonomous procedures may include autonomously performing the method disclosed with respect to embodiments in Figures 13A–44 and 62A–64C.

[0352] The method may include the step of extending a delivery device within a part of the patient's body to deliver an implant to a specific body location. The delivery device may be configured similarly to any embodiment of the delivery devices disclosed herein. The delivery device may be extended within a part of the patient's body as disclosed herein. The implant may be configured similarly to any implant disclosed herein, and the body location may include any location disclosed herein.

[0353] The delivery device may be extended within a part of the patient's body via a motor advancing the delivery device, such as an elongated shaft of the delivery device within the patient's body. The motor may be controlled by a processor 536. For example, a motor-driven rail 577 or other assembly that acts as an actuator for the axial movement of the delivery device into the patient's body may be used. In other embodiments, other methods may be used to extend the delivery device within a part of the patient's body.

[0354] The processor 536 may run a program to operate the delivery device. The processor 536 may be programmed with a series of movements to operate the delivery device to a desired location and for a desired deployment operation. For example, the processor 536 may be configured to identify a desired delivery location, as well as the 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 location identified via a proximity sensor on the elongated shaft 12. The programmed series of movements may be provided based on the geometry of the path to the desired implantation site and the orientation of the desired implantation site. The movement and deployment of the delivery device may be pre-programmed to the processor 536 and may be 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 the processor 536 to control the operation of the delivery device. For example, the path and orientation may also be complemented by data from previous procedures on patients with similar characteristics. The processor 536 and programming may be used to extend the delivery device within a part of the patient's body, as disclosed.

[0355] The processor 536 may continue according to the program and receive signals from one or more sensors. The processor 536 may receive feedback from sensors (as considered herein) which causes the processor 536 to generate an output in step 846. Signals from sensors may be utilized by the processor 536 in a manner similar to that disclosed herein. For example, the processor 536 may be configured to generate a data log 848. The processor 536 may be configured to generate an indicator 850. The indicator may be provided to help the user decide whether to intervene in a procedure. For example, if the user (e.g., a clinician) receives an indicator that an autonomously operated delivery device has come into contact with a particular surface or has improperly deployed an implant, the user may intervene to attempt to correct such operation.

[0356] The processor 536 may be configured to generate the action of the delivery device. The action may be provided so that the processor 536 can complete the procedure by correcting the path and movement with minimal or no human interference, using feedback from sensors such as those considered herein. For example, if a position sensor indicates that the delivery device is deviating from its 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 correct the procedure, or to control the procedure otherwise.

[0357] The actions performed by the processor 536 may be based on machine learning algorithms that utilize data from past implantation procedures or from patient characteristics. The actions may be based on data "learned" from previous procedures, and in particular from previous procedures performed on patients with similar anatomical structures and / or other characteristics. Thus, steps of a procedure that was successfully performed on patients with similar anatomical structures can be repeated, thereby increasing the likelihood of success in the current procedure on the patient. Machine learning algorithms may be used by the processor 536 to control the actions 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 location in the body. 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 the desired location and complete the delivery procedure. The processor 536 may be configured to complete the delivery device in a particular embodiment without user control or intervention. The processor 536 may be configured to provide such confirmation of implantation as an indicator on the output device, thereby informing the user that the implant has been implanted.

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

[0360] Figure 61 shows an embodiment of a delivery device configured similarly to the device shown in Figure 46, but multiple motors 502 may be used to control the operation of the delivery device. Each of the multiple motors 502 may be configured to engage with, for example, adapters 590, 592, and 594, which are configured to operate parts of the delivery device. The motors 502 may be configured to perform linear movement of adapters 590, 592, and 594 to produce operation of the delivery device. Furthermore, in the embodiment of Figure 61, the processor, memory, and input and output devices of Figure 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 supply, may also be used within the handle. The embodiment of Figure 61 may include a self-contained handle unit that includes a processor for performing delivery procedures, receiving feedback from sensors, and optionally logging data.

[0361] The motors disclosed herein may include, in particular, a variety of forms of motors, including electromagnetic, stepper, hydraulic, and piezoelectric motors. The methods, systems, and apparatus disclosed herein with respect to Figures 45 to 61 may be used in any embodiment disclosed herein. For example, the operation and control of any system, apparatus, or method in any embodiment of Figures 13A to 44 or Figures 62A to 64C may be carried out under the operation of the system, apparatus, or method in the embodiment of Figures 45 to 61.

[0362] While many of the systems and methods disclosed herein are considered in relation to the implantation of prosthetic tricuspid valve implants, it is understood that the systems and methods may be used to deliver a variety of implants, including implants for the repair of heart valves. For example, other types of implants, such as other types of heart valve implants shown herein (e.g., aortic valve implants and other restorative implants), may be used.

[0363] The methods and systems disclosed herein, in particular embodiments, are not limited to the delivery of implants but may be extended to any medical intervention or insertion into a patient's body, which may include performing medical procedures within the body. The methods and systems disclosed herein may be used as desired in the general use of catheters. For example, the handle shown in Figure 61 and the components disclosed therein may comprise a general catheter handle in particular embodiments. Furthermore, 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 retention area and other feature parts of the delivery device may be modified.

[0364] Although many of the embodiments described herein are considered in relation to replacement tricuspid valves, deflection mechanisms and other embodiments disclosed herein may be used for a variety of other implantations, including the delivery of mitral replacement valves, aortic valves, and pulmonary valves, or for valve repair procedures, including the repair of tricuspid valves, mitral valves, aortic valves, or pulmonary valves.

[0365] From the above description, it will be understood that progressive products and approaches for implant delivery systems are disclosed. While some components, techniques, and aspects have been described to a certain extent of uniqueness, it is evident that many modifications can be made to specific designs, structures, and methodologies without deviating from the spirit and scope of this disclosure.

[0366] Certain features described in this disclosure in the context of separate implementations may also be implemented in combination in a single implementation. Conversely, various features described in the context of a single implementation may also be implemented separately in multiple implementations or in any preferred secondary combination. Furthermore, features may be described above to function in a particular combination, but one or more features from a claimed combination may be removed from the combination in some cases, and this combination may be claimed as any secondary combination or as a variation of any secondary combination.

[0367] Furthermore, while methods may be depicted in drawings or described in the specification in a specific order, such methods do not need to be performed in a specific or sequential order shown, nor do they need to be performed in all ways 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 may be performed after, simultaneously with, or in between any of the described methods. Furthermore, methods may be reconfigured or re-ordered 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 in a single product or packaged in multiple products. In addition, other implementations are within the scope of this disclosure.

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

[0369] Conjunctional phrases such as "at least one of X, Y, and Z" are generally understood in contexts where they are used to convey that an item, term, etc., could be any of X, Y, or Z, unless it is specifically stated that it is not. Thus, such conjunctional phrases are not generally intended to suggest that a particular embodiment requires the presence of at least one of X, at least one of Y, and at least one of Z.

[0370] As used herein, terms such as “approximately,” “about,” “generally,” and “substantially” refer to specific values, quantities, or characteristics that are close to a specified value, quantity, or characteristic that still perform the desired function or achieve the desired result. For example, the terms “approximately,” “about,” “generally,” and “substantially” may refer to specific quantities that are within the range of 10% or less, 5% or less, 1% or less, 0.1% or less, and 0.01% or less of the specified quantity. If the specified quantity is 0 (e.g., none, none at all), the ranges listed above may be specific ranges and not within a specific percentage range of that value. For example, within the range of 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 quantity.

[0371] Several embodiments have been described in reference to the accompanying drawings. While the drawings are drawn to scale, such scale is not limiting, and dimensions and proportions other than those shown are intended and within the scope of the disclosed invention. Distances, angles, etc., are illustrative only and do not necessarily imply precise relationships to the actual dimensions and layout of the devices shown. Components can be added, removed, and / or rearranged. Furthermore, any particular features, aspects, methods, characteristics, features, qualities, attributes, elements, etc., disclosed herein in relation to various embodiments can be used in all other embodiments described herein. Additionally, it will be understood that any methods described herein can be carried out using any device suitable for performing the enumerated steps.

[0372] While several embodiments and variations thereof have been described in detail, other modifications and methods using the same will be obvious to those skilled in the art. Therefore, it should be understood that various uses, modifications, materials, and substitutes can be made from equivalents without departing from the scope of the unique and inventive disclosure or claims of this specification. [Explanation of Symbols]

[0373] 10 Delivery Systems 11 Proximal end 12 Long, slender shaft 14 handles 15 Handle 16. Implant retention area 18 Inner shaft assembly, inner assembly 20 Rail assemblies, rail shaft assemblies 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 hypo tube, hypo tube 44. Proximal tube, intermediate shaft proximal tube 51 Sheath, continuous sheath 70 Implants 72 Pillar 80 Distal anchor 80a, 80b distal anchors 82 Proximal anchor 83 Heart 102 Lateral proximal shaft 104 Outer hypotube 106 capsules 122 Inner shaft 126 Distal segment 129 Medial proximal shaft, medial proximal segment 132 Rail shaft 134 Rail proximal shaft 135 Distal ring, distal tension wire connector 136 Rail Hypo Tube 137 Proximal ring, proximal pull wire connector 138 Distal tension wire, tension wire assembly 139 Lumen 140 Proximal tensile wire, tensile wire assembly 231 Hypotube areas that cannot be cut, hypotube areas where slots cannot be added 233 Proximal slotted hypotube area 235 Distal slotted hypotube area 237 Locations where slots are avoided 241 Distal tensile wire connection area 301 First end, proximal end of implant 70 303 Second end, distal end of implant 70 500, 502 motors 504 Control Devices 506 Operating mechanism 508 Distal part of the handle 510 Proximal part of the handle 512, 514 Coupler 516a~g Adapter 518a~g Drive Rod 520a~g opening 521, 523, 524, 526, 528 Assembly Connectors 522 Opening, central opening 530 Controller 532 Input and Output Devices 534 memory 536 processors 538 Power supply 540 Power Connectors, Signal Connectors 542 Electrical coupler 544a~g opening 546 Cable Buttons 548, 550, 552, and 554 568 Output Devices 570 Output Devices 572 Long and slender shaft 574 Housing 576 The 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 devices, display screens 586 Output Devices 588 Control Devices 590, 592, 594 adapters 596 Printed circuit board 598 Power supply 848 Data Log 850 indicators, 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 1108 Valve 1200 Guidewire Shield 1600 implants 1620 Inner Frame 1622a upper region 1624 Internal frame anchor mechanism 1640 Outer frame 1642 Outer frame body 1642a upper region Cells 1646a~c 1648a, 1648d, 1648e posts 1650 eyelets 1652 Lock Tab 1652a Post 1652b Enlarged head 1652c Hatome 1660 Valve body 1664 Intermediate components 1680 Outer skirt 1690 Inner skirt

Claims

1. 1. A delivery system for an implant, comprising: An elongated shaft, Distal end, an implant holding area 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 proximally of the bent portion an elongated shaft having a deflection mechanism configured to deflect the portion positioned proximal to the bending portion to deflect the bending portion toward a second direction opposite the first direction; A delivery system comprising:

2. The delivery system of claim 1 , wherein the distal end comprises a nosecone.

3. 3. The delivery system of claim 1 or 2, wherein the implant holding area is positioned between the distal end and the bent portion.

4. 4. The delivery system of claim 1, wherein the bending portion is configured to bias the implant holding area in the first direction.

5. 5. The delivery system of claim 1, wherein the second direction is coplanar with the first direction.

6. 6. The delivery system of claim 1, wherein the deflection mechanism comprises a sheath extending over a portion of the elongate shaft.

7. 7. The delivery system of claim 6, wherein the deflection mechanism comprises at least one tension tether configured to deflect the sheath.

8. 8. The delivery system of claim 6 or 7, wherein the sheath is configured to rotate about the portion of the elongate shaft over which the sheath extends.

9. The elongated shaft An inner shaft; a rail shaft extending over the inner shaft; an outer sheath extending over the rail shaft; Equipped with 6. The delivery system of claim 1, wherein the deflection mechanism comprises a tension tether coupled to the rail shaft.

10. 10. The delivery system of claim 9, wherein the rail shaft comprises the bent portion.

11. 11. The delivery system of claim 10, wherein the rail shaft comprises a second bend portion configured to deflect the distal end of the elongate shaft toward a direction that is perpendicular to the first direction.

12. The elongated shaft An inner shaft; a rail shaft extending over the inner shaft and having one or more cuts; an outer sheath extending over the rail shaft; Equipped with 6. The delivery system of claim 1, wherein the deflection mechanism comprises a stop on the rail shaft and a stop on the inner shaft configured to apply a force to the stop on the rail shaft to cause deflection of the rail shaft at the one or more cuts.

13. 13. The delivery system of claim 12, wherein the inner shaft is configured to be pulled proximally to cause the stop on the inner shaft to apply the force to the stop on the rail shaft.

14. 14. The delivery system of claim 1, wherein the deflection mechanism is configured to deflect the portion positioned proximal to the bending portion in multiple directions.

15. 15. The delivery system of claim 14, wherein at least one of the plurality of directions includes a direction toward the first direction.

16. 16. The delivery system of claim 14 or 15, wherein at least one of the plurality of directions includes a direction that is perpendicular to the first direction.

17. 17. The delivery system of claim 1, wherein the bending portion is a first bending portion and the elongate shaft comprises a second bending portion configured to deflect the distal end of the elongate shaft toward a direction that is perpendicular to the first direction.

18. 18. The delivery system of claim 17, wherein the second bending portion is positioned between the first bending portion and the portion positioned proximal to the first bending portion, and the deflection mechanism is configured to deflect the first bending portion and the second bending portion toward the second direction.

19. 19. The delivery system of any one of claims 1 to 18, further comprising a capsule surrounding the implant holding area.

20. 20. The delivery system of claim 19, wherein the capsule is configured to be retracted to deploy the implant.

21. 1. A delivery system for an implant, comprising: An elongated shaft, Distal end, an implant holding area for holding the implant; a bending portion configured to deflect the distal end of the elongate shaft in a first plane; and a portion positioned proximally of the bent portion an elongated shaft having a deflection mechanism configured to deflect the portion positioned proximal to the bending portion in one or more planes that are not perpendicular to the first plane; A delivery system comprising:

22. 22. The delivery system of claim 21, wherein the deflection mechanism comprises a sheath extending over at least a portion of the elongate shaft and configured to rotate about the portion of the elongate shaft over which the sheath extends.

23. 23. The delivery system of claim 22, further comprising a tension tether coupled to the sheath and configured to deflect the sheath in one or more planes that are not perpendicular to the first plane.

24. 24. The delivery system of claim 23, wherein the tension tether is configured to rotate about the portion of the elongate shaft over which the sheath extends to change the plane in which the portion positioned proximally of the bent portion is deflected.

25. The elongated shaft An inner shaft; a rail shaft extending over the inner shaft; an outer sheath extending over the rail shaft; Equipped with 22. The delivery system of claim 21, wherein the deflection mechanism comprises a tension tether coupled to the rail shaft.

26. 26. The delivery system of claim 25, wherein the rail shaft comprises the bent portion.

27. 27. The delivery system of claim 25 or 26, wherein the bent portion is a first bent portion and the rail shaft comprises a second bent portion configured to deflect the distal end of the elongate shaft toward a direction that is perpendicular to the first plane.

28. The elongated shaft An inner shaft; a rail shaft extending over the inner shaft and having one or more cuts; an outer sheath extending over the rail shaft; Equipped with 22. The delivery system of claim 21, wherein the deflection mechanism comprises a stop on the rail shaft and a stop on the inner shaft configured to apply a force to the stop on the rail shaft to cause deflection of the rail shaft at the one or more cuts.

29. 29. The delivery system of claim 28, wherein the inner shaft is configured to be pulled proximally to cause the stop on the inner shaft to apply the force to the stop on the rail shaft.

30. 30. The delivery system of any one of claims 21 to 29, wherein the deflection mechanism is configured to deflect the portion positioned proximal to the bending portion in multiple directions.

31. 1. A delivery system for an implant, comprising: An elongated shaft, Distal end, an implant holding area for holding the implant; a first bending portion configured to deflect the distal end of the elongate shaft in a first direction; a second bent portion positioned proximal to the first bent portion and configured to deflect the distal end of the elongate shaft in a second direction; and a portion positioned proximally of the second bent portion; 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:

32. 32. The delivery system of claim 31, wherein the deflection mechanism comprises a sheath extending over a portion of the elongate shaft.

33. 33. The delivery system of claim 32, wherein the deflection mechanism comprises at least one tension tether configured to deflect the sheath.

34. 34. The delivery system of claim 33, wherein the at least one tension tether is configured to rotate about the portion of the elongate shaft over which the sheath extends to change a plane in which the first bent portion, the second bent portion, and the portion positioned proximal to the second bent portion are deflected.

35. The elongated shaft An inner shaft; a rail shaft extending over the inner shaft and including the first bent portion and the second bent portion; an outer sheath extending over the rail shaft; Equipped with 32. The delivery system of claim 31 , wherein the deflection mechanism comprises a tension tether coupled to the rail shaft.

36. The elongated shaft An inner shaft; a rail shaft extending over the inner shaft, the rail shaft including the first bent portion and the second bent portion, and the rail shaft having one or more cuts; an outer sheath extending over the rail shaft; Equipped with 32. The delivery system of claim 31 , wherein the deflection mechanism comprises a stop on the rail shaft and a stop on the inner shaft configured to apply a force to the stop on the rail shaft to cause deflection of the rail shaft at the one or more cuts.

37. 37. The delivery system of claim 36, wherein the inner shaft is configured to be pulled proximally to cause the stop on the inner shaft to apply the force to the stop on the rail shaft.

38. 38. A delivery system according to any one of claims 31 to 37, wherein the second direction is perpendicular to the first direction.

39. 39. The delivery system of any one of claims 31 to 38, wherein the deflection mechanism is configured to deflect the first bending portion, the second bending portion, and the portion positioned proximal to the second bending portion toward a direction opposite to the first direction.

40. 40. The delivery system of any one of claims 31 to 39, wherein the deflection mechanism is configured to deflect the portion positioned proximal to the bending portion in multiple directions.

41. 1. A delivery system for an implant, the delivery system comprising: an implant holding area for holding the implant; a capsule having a distal end and surrounding the implant holding area; wherein the distal end of the capsule forms a distal tip of the elongate shaft.

42. 42. The delivery system of claim 41, wherein the distal end of the capsule has a planar profile.

43. 43. The delivery system of claim 41 or 42, wherein at least a portion of the distal end of the capsule is rounded.

44. 44. The delivery system of any one of claims 41 to 43, wherein the distal end of the capsule is configured to surround a distal portion of the implant when the implant is positioned in the implant holding area.

45. 45. A delivery system according to any one of claims 41 to 44, wherein the distal end of the capsule is elastic.

46. 46. ​​The delivery system of any one of claims 41 to 45, wherein the distal end of the capsule forms an opening through which the implant is passed.

47. 47. The delivery system of any one of claims 41 to 46, wherein the distal end of the capsule is configured to conform to the implant when the implant is positioned in the implant holding area.

48. 1. A delivery system for an implant, comprising: an implant holding area for holding the implant; a distal tip including a flexible sheath extending distally and configured to bend around a portion of the guidewire; A delivery system comprising an elongate shaft having a

49. 49. The delivery system of claim 48, wherein the distal tip comprises a proximal portion and a distal portion, the distal tip tapering in a direction from the proximal portion to the distal portion.

50. 50. The delivery system of claim 48 or 49, 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.

51. 51. The delivery system of claim 50, wherein the tip body is positioned at a distal end of the capsule.

52. 52. The delivery system of claim 51, wherein the outer surface of the tip body tapers from a proximal portion of the tip body to a proximal portion of the flexible sheath.

53. 53. The delivery system of claim 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.

54. 54. The delivery system of any one of claims 50 to 53, wherein the capsule is configured to retract proximally to deploy the implant from the implant holding region.

55. 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

56. 56. The delivery system of claim 55, wherein the distal end of the distal tip has a convex profile.

57. 57. The delivery system of claim 55 or 56, 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.

58. 58. The delivery system of claim 57, wherein the tip body is positioned at a distal end of the capsule.

59. 59. The delivery system of claim 57 or 58, 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.

60. 60. The delivery system of any one of claims 57 to 59, wherein the capsule is configured to retract proximally to deploy the implant from the implant holding region.

61. 61. The delivery system of any one of claims 55 to 60, wherein the distal tip is configured for passage of a guidewire.

62. 1. A delivery system for an implant, comprising: A delivery system comprising an elongate shaft having walls surrounding a passageway through which the implant is passed for deployment of the implant, the walls being configured with a bend that defines a bend in the passageway during deployment of the implant.

63. 63. The delivery system of claim 62, wherein the passage comprises an implant holding area for holding the implant.

64. 64. A delivery system according to claim 62 or 63, wherein the wall is steerable, the system further comprising a control mechanism for steering the wall.

65. 65. The delivery system of claim 64, wherein the control mechanism is configured to control the direction of the bending of the wall.

66. 66. The delivery system of any one of claims 62 to 65, wherein a port is positioned at the distal end of the passageway through which the implant is passed for deployment of the implant.

67. 67. The delivery system of any one of claims 62 to 66, further comprising a flexible implant configured to bend within the passageway transverse to an axial dimension of the flexible implant.

68. 68. The delivery system of claim 67, wherein a distal end of the passage has an opening through which the flexible implant is passed in the axial dimension for deployment of the flexible implant.

69. 1. A delivery system for an implant, comprising: It has an axial dimension, an implant holding area for holding the implant; a port through which the implant can be deployed from the elongate shaft in a direction transverse to the axial dimension; A delivery system comprising the elongate shaft having

70. 70. The delivery system of claim 69, wherein the port is positioned in a sidewall of the elongate shaft.

71. 71. The delivery system of claim 69 or 70, wherein the port is adjacent to the implant holding area.

72. 72. The delivery system of any one of Claims 69 to 71, further comprising a deployment mechanism for deploying the implant through the port.

73. 73. The delivery system of claim 72, wherein the deployment mechanism comprises an inflatable body.

74. 74. The delivery system of any one of claims 69 to 73, wherein the implant holding region is configured to hold the implant with an axial dimension of the implant extending transversely to the axial dimension of the elongate shaft.

75. 75. The delivery system of claim 74, further comprising an implant positioned within the implant holding area, with the axial dimension of the implant extending transversely to the axial dimension of the elongate shaft.

76. 1. A delivery system for an implant, comprising: A delivery system comprising an elongate shaft having an implant holding region for holding the implant and configured to bend greater than 180 degrees to form a loop.

77. 77. The delivery system of claim 76, wherein the elongate shaft is configured to bend greater than 200 degrees to form the loop.

78. 77. The delivery system of claim 76, wherein the elongate shaft is configured to bend greater than 230 degrees to form the loop.

79. 77. The delivery system of claim 76, wherein the elongate shaft is configured to bend greater than 250 degrees to form the loop.

80. 77. The delivery system of claim 76, wherein the elongate shaft is configured to bend greater than 270 degrees to form the loop.

81. 77. The delivery system of claim 76, wherein the elongate shaft is configured to bend greater than 180 degrees at a bend in the elongate shaft, and the implant holding area is positioned distal to the bend.

82. 82. The delivery system of any one of claims 76 to 81, wherein the elongate shaft comprises a port positioned distal to the implant holding region through which the implant can be deployed.

83. 1. A delivery system for an implant, comprising: a capsule surrounding an implant holding area for holding the implant; a hinge connecting the capsule to a portion of the elongate shaft; A delivery system comprising the elongate shaft having

84. 84. The delivery system of claim 83, wherein the capsule comprises a proximal portion and a distal portion, the proximal portion of the capsule being coupled to the hinge.

85. 85. The delivery system of 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, the central portion of the capsule being coupled to the hinge.

86. 86. The delivery system of any one of claims 83 to 85, wherein the capsule is configured to rotate about the hinge to a rotated position, and the capsule is configured such that the implant deploys from the capsule when the capsule is in the rotated position.

87. 87. The delivery system of any one of claims 83 to 86, wherein the capsule comprises a port through which the implant is deployed when the capsule is in a rotated position.

88. 88. The delivery system of claim 86 or 87, further comprising a deployment mechanism for deploying the implant from the capsule when the capsule is in the rotated position.

89. 89. A delivery system according to any one of claims 83 to 88, further comprising a control mechanism for controlling rotation of the capsule about the hinge.

90. 1. A delivery system for an implant, comprising: an elongate shaft extending along an axis and having an outer surface and an implant holding area for holding the implant; one or more supports extending radially outward from the outer surface of the elongate shaft and configured to contact the outer surface to resist deflection of the elongate shaft transverse to the axis; A delivery system comprising:

91. 91. The delivery system of claim 90, further comprising a sheath extending over the outer surface of the elongate shaft, the one or more supports configured to extend radially outward from the sheath.

92. 92. The delivery system of claim 90 or 91, wherein the elongate 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.

93. 93. The delivery system of claim 92, wherein the bent portion is a first bent portion, the elongate shaft comprises a second bent portion positioned proximal to the first bent portion and configured to deflect the implant holding area in a second direction transverse to the first direction, and the one or more supports are configured to extend radially outward from the outer surface proximal to the second bent portion.

94. 94. The delivery system of any one of claims 90 to 93, wherein the one or more supports are configured to move from an unexpanded state to an expanded state.

95. 95. A delivery system according to any one of claims 90 to 94, wherein the one or more supports comprise one or more expandable bodies.

96. 96. A delivery system according to any one of claims 90 to 95, wherein the one or more supports comprise one or more mesh bodies.

97. 97. A delivery system according to any one of claims 90 to 96, wherein the one or more supports comprise one or more discs.

98. 98. A delivery system according to any one of claims 90 to 97, wherein the one or more supports comprise one or more occlusions.

99. 95. A delivery system according to any one of claims 90 to 94, wherein the one or more supports comprise one or more arms.

100. at least one motor configured to actuate at least a portion of the delivery system; a processor configured to operate the at least one motor to actuate at least the portion of the delivery system; 100. The delivery system of any one of claims 1 to 99, further comprising:

101. 101. The delivery system of claim 100, further comprising one or more sensors configured to sense one or more of a patient's physical condition or a condition of the delivery system, and wherein the processor is configured to operate the at least one motor to actuate at least the portion of the delivery system based on signals from the one or more sensors.

102. 102. The delivery system of claim 101, wherein the processor is configured to provide an output based on the one or more of the condition of the patient's body or the condition of the delivery system sensed by the one or more sensors.

103. a prosthetic heart valve configured for implantation within a valve annulus of a patient; an anchor configured to be secured within a portion of a patient's body; a tether configured to couple the prosthetic heart valve to the anchor; A system comprising:

104. 104. The system of claim 103, wherein the prosthetic heart valve comprises a prosthetic valve flap.

105. 105. The system of claim 103 or 104, wherein the prosthetic heart valve comprises a plurality of anchors configured to extend over heart valve flaps.

106. 106. The system of any one of claims 103 to 105, wherein the anchor comprises a stent.

107. 107. The system of claim 106, wherein the stent is configured to be anchored in one or more of the inferior vena cava or the superior vena cava.

108. 106. The system of any one of claims 103 to 105, wherein the anchor is configured to be secured to a wall of the patient's right ventricle.

109. 106. The system of any one of claims 103 to 105, wherein the anchor is configured to be secured to a regulating band of a right ventricle of a patient.

110. 110. The system of claim 109, wherein the anchor comprises one or more of a hook, a barb, a cover, a loop, or an expandable body.

111. 111. The system of any one of claims 103 to 110, wherein the prosthetic heart valve comprises a prosthetic tricuspid heart valve.

112. 1. A prosthetic valve for replacement of a patient's native valve, comprising: 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:

113. 113. The prosthetic valve of claim 112, wherein the port comprises a tube through which the diagnostic or therapeutic device is passed.

114. 114. The prosthetic valve of claim 113, wherein the tube is made from a woven material, a braided material, or a polymer.

115. 115. The prosthetic valve of claim 113 or 114, wherein the tube comprises a valve through which the diagnostic or therapeutic device is passed.

116. 116. The prosthetic valve of any one of claims 112 to 115, wherein the prosthetic heart valve body comprises an outer frame body and an inner frame body, and the port is positioned in the outer frame body.

117. 117. The prosthetic valve of claim 116, wherein the port is positioned in a cover extending over the outer frame of the outer frame body.

118. 118. The prosthetic valve of claim 116 or 117, wherein the port comprises a tearable portion of the prosthetic heart valve body.

119. 119. The prosthetic valve of any one of claims 112 to 118, wherein the port is configured to form a seal with the diagnostic or therapeutic device.

120. 120. The prosthetic valve of any one of claims 112 to 119, wherein the port is positioned outside the prosthetic valve annulus.

121. 121. The prosthetic valve of any one of claims 112 to 120, wherein an imaging marker identifies the location of the port.

122. 122. The prosthetic valve of any one of claims 112 to 121, wherein the diagnostic or therapeutic device comprises a pacemaker pacing lead.

123. 1. A method for treating a tricuspid valve in a patient, comprising: passing a delivery device for the implant into the right atrium of the patient; deploying the implant into the patient's tricuspid valve; A method comprising:

124. 124. The method of claim 123, wherein the delivery device comprises an elongate shaft having an implant holding region for holding the implant.

125. 125. The method of claim 124, wherein the delivery device includes a deployment port through which the implant is deployed, the method further comprising deflecting the delivery device within the inferior vena cava or superior vena cava to vary the height of the deployment port from the patient's tricuspid valve.

126. 126. The method of claim 124 or 125, wherein the elongate shaft comprises a bent portion configured to direct a distal portion of the elongate shaft toward the patient's tricuspid valve.

127. 127. The method of claim 126, further comprising the step of varying the height of the bent portion from the patient's tricuspid valve.

128. 128. The method of claim 126 or 127, further comprising deflecting the bent portion and a portion of the elongate shaft proximal to the bent portion in a direction away from the patient's tricuspid valve.

129. 129. The method of any one of claims 124 to 128, wherein a sheath is positioned over the elongate shaft, the method further comprising deflecting a portion of the elongate shaft using the sheath.

130. 130. The method of claim 129, further comprising rotating the sheath to change the direction of deflection of the elongate shaft.

131. 125. The method of claim 124, wherein the elongate shaft comprises an outer sheath extending over a rail shaft, the outer sheath configured to slide relative to the rail shaft to vary the distance of the implant holding region from the patient's tricuspid valve.

132. 132. The method of any one of claims 124 to 131, wherein the elongate shaft has a distal end and comprises a capsule surrounding the implant holding area, the distal end of the capsule forming the distal tip of the elongate shaft.

133. 132. The method of any one of claims 124 to 131, wherein the elongate shaft extends distally and comprises a distal tip comprising a flexible sheath configured to bend around a portion of a guidewire.

134. 134. The method of claim 133, further comprising bending the flexible sheath around the portion of the guidewire when the guidewire is positioned in the patient's right ventricle.

135. 133. The method of any one of claims 124 to 132, wherein the elongate shaft comprises a distal tip having a hemispherical or parabolic shape.

136. 136. The method of any one of claims 124 to 135, wherein the implant is a prosthetic tricuspid valve, the method further comprising passing the prosthetic tricuspid valve through a bending deployment passage of the elongate shaft to deploy the prosthetic tricuspid valve.

137. 137. The method of claim 136, wherein the prosthetic tricuspid valve has an axial dimension, and the prosthetic tricuspid valve bends transversely to the axial dimension as it passes through the bending deployment passage.

138. 138. The method of any one of claims 124 to 137, wherein the elongate shaft has an axial dimension, and the method further comprises deploying the implant through a port in the elongate shaft in a direction transverse to the axial dimension.

139. 139. The method of any one of claims 124 to 138, further comprising bending the elongate shaft beyond 180 degrees to form a loop.

140. 140. The method of claim 139, wherein the loop is positioned at least partially within the patient's right atrium.

141. 141. The method of any one of claims 124 to 140, wherein the elongate shaft comprises a capsule surrounding an implant holding area to hold the implant, and a hinge connecting the capsule to a portion of the elongate shaft.

142. 142. The method of claim 141, further comprising pivoting the capsule about the hinge.

143. 143. The method of 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.

144. 144. The method of 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 a patient's physical condition or a condition of the delivery device.

145. 1. A method for treating a tricuspid valve in a patient, comprising: deploying a prosthetic heart valve within the patient's tricuspid annulus; deploying the anchor in a portion of the patient's body; providing a tether connecting the prosthetic heart valve to the anchor; A method comprising:

146. 146. The method of claim 145, further comprising coupling the anchor to the prosthetic heart valve with the tether.

147. 147. The method of claim 145 or 146, wherein the anchor comprises a stent.

148. 148. The method of claim 147, further comprising the step of anchoring the stent in the patient's inferior or superior vena cava.

149. 147. The method of claim 145 or 146, further comprising the step of securing the anchor to a regulating band in the patient's right ventricle.

150. 150. The method of claim 149, wherein the anchor comprises one or more of a hook, a barb, a cover, a loop, or an expandable body.

151. 147. The method of claim 145 or 146, wherein the anchor is configured to be secured to the wall of the patient's right ventricle.

152. 152. The method of any one of claims 145 to 151, further comprising anchoring the prosthetic heart valve to a heart valve flap of the patient's heart valve.

153. A method comprising passing a diagnostic or therapeutic device through a port positioned in a prosthetic heart valve body forming a prosthetic valve annulus.

154. 154. The method of claim 153, wherein the prosthetic heart valve body is positioned in the patient's tricuspid heart valve annulus and the diagnostic or therapeutic device is passed through the port into the patient's right ventricle.

155. 155. The method of claim 153 or 154, wherein the port comprises a tube through which the diagnostic or therapeutic device is passed.

156. 156. The method of claim 155, wherein the tube is made from a woven material, a braided material, or a polymer.

157. 156. The method of claim 155, wherein the tube comprises a valve through which the diagnostic or therapeutic device can be passed.

158. 154. The method of claim 153, wherein the port comprises a tearable portion of the prosthetic heart valve body.

159. 159. The method of any one of claims 153 to 158, wherein the prosthetic heart valve body comprises an outer frame body and an inner frame body, and the port is positioned in the outer frame body.

160. 160. The method of claim 159, wherein the port is positioned in a cover extending over the outer frame of the outer frame body.

161. 161. The method of any one of claims 153 to 160, wherein the port forms a seal with the diagnostic or therapeutic device.

162. 162. The method of any one of claims 153 to 161, wherein the port is positioned outside the prosthetic valve annulus.

163. 163. The method of any one of claims 153 to 162, further comprising imaging an imaging marker on the prosthetic heart valve body to identify the location of the port.

164. 164. The method of any one of claims 153 to 163, wherein the diagnostic or therapeutic device comprises a pacemaker pacing lead.

165. 1. A method comprising: coupling a pacemaker pacing lead to a prosthetic heart valve body positioned within a patient's heart valve annulus to provide electrical energy through the pacemaker pacing lead and through the prosthetic heart valve body to pace a function of the patient's heart.

166. 166. The method of claim 165, wherein the prosthetic heart valve body comprises a frame, the method including providing electrical energy through the frame.

167. 167. The method of claim 166, wherein the frame is in contact with the patient's heart valve.

168. 168. The method of any one of claims 165 to 167, wherein the prosthetic heart valve body comprises one or more electrical terminals in contact with a portion of the patient's heart.

169. 169. The method of any one of claims 165 to 168, further comprising providing the electrical energy through the pacemaker pacing lead and through the prosthetic heart valve body to pace a function of the patient's heart.

170. 170. The method of any one of claims 165 to 169, further comprising the step of deploying the prosthetic heart valve body into the patient's heart valve annulus.

171. 171. The method of any one of claims 165 to 170, further comprising expanding the prosthetic heart valve body within the patient's heart valve annulus.

172. 172. The method of any one of claims 165 to 171, further comprising anchoring the prosthetic heart valve body to a heart valve flap of the patient's heart valve.

173. 173. The method of any one of claims 165 to 172, further comprising contacting the prosthetic heart valve body with the patient's heart valve.

174. 174. The method of any one of claims 165 to 173, wherein the prosthetic heart valve body is positioned within the tricuspid or mitral heart valve annulus.

175. delivering a delivery device for the implant into a portion of the patient's heart, the delivery device comprising an elongate shaft extending along an axis and having an outer surface; extending one or more supports radially outward from the outer surface of the elongate shaft; contacting the one or more supports with an exterior surface of the delivery device to resist deflection of the elongate shaft transverse to the axis; A method comprising:

176. 176. The method of claim 175, wherein the surface is an atrial wall.

177. 177. The method of claim 175 or 176, wherein the surface is the wall of the atrial septum.

178. 178. The method of any one of claims 175 to 177, wherein the delivery device is positioned within an atrium of the patient's heart.

179. 179. The method of any one of claims 175 to 178, further comprising deploying the implant in a mitral or tricuspid valve of the patient's heart.

180. 180. The method of any one of claims 175 to 179, wherein the delivery device comprises an implant holding region and a bent portion, and the method includes expanding the one or more supports proximal to the bent portion and deflecting the implant holding region at the bent portion in a first direction.

181. 181. The method of claim 180, wherein the bent portion is a first bent portion, and the method further comprises deflecting the implant holding area at a second bent portion positioned proximal to the first bent portion in a second direction transverse to the first direction.

182. 182. A method according to any one of claims 175 to 181, wherein the one or more supports comprise one or more expandable bodies.

183. 183. The method of any one of claims 175 to 182, wherein the one or more supports comprise one or more mesh bodies.

184. 182. The method of any one of claims 175 to 181, wherein the one or more supports comprise one or more arms.

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