Systems and methods for deploying implants - Patents.com

Abstract

Devices, systems, and methods relate to implants, such as prosthetic valves, for replacing native heart valves. Also disclosed herein is a delivery system for delivering the implant to an implantation site. The prosthetic valve may include a valve body supporting a plurality of prosthetic leaflets and one or more adjustable anchors coupled to the valve body for anchoring the prosthetic valve to the leaflets of the native heart valve, at least one of the adjustable anchors being axially slidable relative to the valve body to conform to the native anatomy of the native heart valve.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Application No. 63 / 281,812, filed November 22, 2021, the entire contents of which are incorporated herein by reference.

[0002] Certain examples disclosed herein relate generally to implants for implantation inside the body, and to delivery systems for the implants. In particular, the implants and delivery systems relate in some examples to heart valve replacement, such as mitral valve replacement or tricuspid valve replacement. [Background technology]

[0003] Human heart valves, including the aortic, pulmonary, mitral, and tricuspid valves, essentially function as one-way valves that operate in sync with the heart's beat. The valves allow blood to flow downstream but prevent blood from flowing upstream. Diseased heart valves exhibit disorders such as valve stenosis or regurgitation, impeding the valve's ability to control blood flow. Such disorders reduce the heart's blood-pumping efficiency and can lead to debilitating and life-threatening conditions. For example, valve malfunction can result in symptoms such as cardiac hypertrophy and ventricular dilation. Thus, there have been considerable efforts to develop methods and devices for repairing or replacing malfunctioning heart valves.

[0004] Prosthetic valves exist to correct problems associated with dysfunctional heart valves. For example, mechanical tissue-based prosthetic heart valves can be used to replace dysfunctional native heart valves. Recently, there has been a great deal of effort in developing replacement heart valves, particularly tissue-based replacement heart valves that can be delivered less traumatically to the patient compared to open-heart surgery. Replacement valves are designed to be delivered by minimally invasive procedures, and even percutaneous procedures. Such replacement valves often include a tissue-based valve body that is connected to an expandable frame and then delivered to the native valve annulus.

[0005] The development of prosthetic valves, including but not limited to prosthetic heart valves that can be miniaturized for delivery and then controllably expanded for controlled deployment, has proven particularly challenging. Additional challenges relate to the ability to secure such prosthetic valves to endoluminal tissue, such as tissue within any lumen or cavity of the body, in an atraumatous manner. The ability to control the deployment of the prosthetic valve to a desired location can also be difficult. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] US Patent Application Publication No. 2011 / 0313515 [Patent Document 2] US Patent Application Publication No. 2012 / 0215303 [Patent Document 3] US Patent Application Publication No. 2014 / 0277390 [Patent Document 4] US Patent Application Publication No. 2014 / 0277422 [Patent Document 5] US Patent Application Publication No. 2014 / 0277427 [Patent Document 6] US Patent Application Publication No. 2015 / 0238315 [Patent Document 7] US Patent Application Publication No. 2015 / 0328000 [Patent Document 8] US Patent Application Publication No. 2016 / 0317301 [Patent Document 9] US Patent Application Publication No. 2018 / 0021129 [Patent Document 10] US Patent Application Publication No. 2018 / 0055629 [Patent Document 11] U.S. Patent No. 8,403,983 [Patent Document 12] U.S. Patent No. 8,414,644 [Patent Document 13] U.S. Patent No. 8,652,203 Summary of the Invention

[0007] Examples of the present disclosure may be directed to implants, such as, but not limited to, replacement heart valves, and may be directed to the deployment of such implants. Examples of the present disclosure may also be directed to delivery systems, devices, and / or methods of use for delivering and / or controllably deploying implants, such as, but not limited to, replacement heart valves, to desired locations within the body. In some examples, replacement heart valves and methods of delivering replacement heart valves to native heart valves, such as the mitral valve or tricuspid valve, are provided.

[0008] The present disclosure includes, but is not limited to, the following examples. Examples may include a delivery system for an implant. The delivery system may include an elongate shaft having a distal end, an implant holding region for holding an implant, a first bent portion configured to deflect the distal end in a first plane, a first extension portion disposed proximally from the first bent portion and extending along a first axis, a second bent portion disposed proximally from the first extension portion and configured to be rotationally driven in a first rotational sense in a second plane extending transversely to the first plane, a third bent portion disposed proximally from the second bent portion and configured to be rotationally driven in a second rotational sense opposite the first rotational sense in the second plane, and a second extension portion disposed proximally from the third bent portion and extending along a second axis. The delivery system may include a biasing mechanism configured to bias the second bent portion in a first rotational orientation in the second plane and to bias the third bent portion in a second rotational orientation in the second plane to offset the first axis from the second axis with the first axis extending parallel to the second axis.

[0009] An example may include a method including delivering a delivery device for an implant into a portion of a patient's body. The delivery device may include an elongate shaft having a distal end, an implant holding region for holding the implant, a first bent portion configured to deflect the distal end in a first plane, a first extension portion disposed proximally from the first bent portion and extending along a first axis, a second bent portion disposed proximally from the first extension portion and configured to be rotationally driven in a first rotational sense in a second plane extending transversely to the first plane, a third bent portion disposed proximally from the second bent portion and configured to be rotationally driven in a second rotational sense opposite the first rotational sense in the second plane, and a second extension portion disposed proximally from the third bent portion and extending along the second axis. The delivery device may include a biasing mechanism configured to bias the second bent portion in a first rotational orientation in the second plane and to bias the third bent portion in a second rotational orientation in the second plane, thereby offsetting the first axis from the second axis with the first axis extending parallel to the second axis.

[0010] An example may include a delivery system for an implant. The delivery system may include an elongate shaft having a retention body configured to retain the implant. The delivery system may include a proximally extending diaphragm configured to be actuated distally to allow the retention body to be released from the implant.

[0011] Examples may include a method that includes delivering a delivery device for an implant into a portion of a patient's body. The delivery device may include an elongate shaft that may include a retention body that retains the implant and a proximally extending diaphragm that is configured to be driven distally to allow the retention body to be released from the implant.

[0012] Examples may include a delivery system for the implant. The delivery system may include one or more suction ports configured to apply a suction force against the native heart valve leaflets of the native heart valve to draw the native heart valve leaflets radially inward. The delivery system may include an elongate shaft having an implant holding region configured to at least partially deploy the implant from the implant holding region against the native heart valve with the one or more suction ports applying a suction force against the native heart valve leaflets.

[0013] Examples may include a method comprising applying suction from one or more suction ports against the native heart valve leaflets of the native heart valve to draw the native heart valve leaflets radially inward. The method may include at least partially deploying an implant from an elongate shaft having an implant retention region against the native heart valve with the one or more suction ports applying suction against the native heart valve leaflets.

[0014] Examples may include a prosthetic valve configured to be deployed relative to a native valve. The prosthetic valve may include a plurality of prosthetic leaflets. The prosthetic valve may include a valve body supporting the plurality of prosthetic leaflets. The prosthetic valve may include a plurality of distal anchors, each having a distal tip, each configured to transition from a compressed configuration to a deployed configuration, where at least one of the distal tips in the compressed configuration is longitudinally offset from a position of another of the distal tips in the compressed configuration.

[0015] Examples may include a method that includes deploying a prosthetic valve relative to a native valve, the prosthetic valve may include a plurality of prosthetic leaflets, a valve body supporting the plurality of prosthetic leaflets, and a plurality of distal anchors, each having a distal tip, each configured to transition from a compressed configuration to a deployed configuration, where at least one of the distal tips in the compressed configuration is longitudinally offset from a position of another of the distal tips in the compressed configuration.

[0016] Examples may include a prosthetic valve configured to be deployed relative to a native valve. The prosthetic valve may include a plurality of prosthetic leaflets. The prosthetic valve may include a valve body supporting the plurality of prosthetic leaflets. The prosthetic valve may include a plurality of distal anchors, each having a distal tip, at least one of the distal tips configured to have a larger diameter than another of the distal tips.

[0017] Examples may include a method including deploying a prosthetic valve relative to a native valve. The prosthetic valve may include a plurality of prosthetic leaflets, a valve body supporting the plurality of prosthetic leaflets, and a plurality of distal anchors each having a distal tip, at least one of the distal tips configured to have a larger diameter than another of the distal tips.

[0018] An example may include a delivery system for an implant. The delivery system may include an elongate shaft including an implant retaining region for retaining the implant. The delivery system may include one or more sutures configured to couple to at least one of a plurality of distal anchors in the implant, the one or more sutures configured to apply a radially inward compressive force to at least one of the plurality of distal anchors.

[0019] Examples may include a method that includes deploying an implant relative to a portion of a patient's body using a delivery system that may include an elongate shaft including an implant retaining region for retaining the implant, and one or more sutures configured to couple to at least one of a plurality of distal anchors of the implant, the one or more sutures configured to apply a radially inward compressive force to at least one of the plurality of distal anchors.

[0020] Examples may include a delivery system for an implant. The delivery system may include an elongate shaft including an implant retaining region for retaining the implant. The delivery system may include one or more sutures configured to form a circumferentially extending loop around the implant and configured to apply a radially inward compressive force to the implant.

[0021] Examples may include a method that includes deploying an implant relative to a portion of a patient's body using a delivery system that may include an elongate shaft including an implant retaining region that retains the implant, and one or more sutures that form a circumferentially extending loop around the implant, the one or more sutures configured to apply a radially inward compressive force to the implant.

[0022] An example may include a delivery system for an implant. The delivery system may include an elongate shaft including an implant holding region for holding the implant and an inner shaft configured to pass through the implant. The delivery system may include one or more sutures including a first portion configured to couple to the implant, the first portion configured to apply a radially inward compressive force to the implant, and a second portion configured to couple to the inner shaft.

[0023] Examples may include a method that includes deploying an implant relative to a portion of a patient's body using a delivery system that may include an elongate shaft including an implant retaining region for retaining the implant and an inner shaft configured to pass through the implant, and one or more sutures including a first portion configured to couple to the implant, the first portion configured to apply a radially inward compressive force to the implant, and a second portion configured to couple to the inner shaft.

[0024] Examples may include a prosthetic valve configured to be deployed relative to a native valve. The prosthetic valve may include a plurality of prosthetic leaflets. The prosthetic valve may include a valve body supporting the plurality of prosthetic leaflets. The prosthetic valve may include one or more anchors, each configured to anchor the prosthetic valve relative to the native valve, each including a first arm and a second arm, and each configured to extend radially outward to a tip, the tip including a loop connecting the first arm to the second arm, and the first arm configured to be actuated relative to the second arm to change the distance between the first arm and the second arm.

[0025] Examples may include a method that includes deploying a prosthetic valve relative to a native valve, the prosthetic valve may include a plurality of prosthetic leaflets, a valve body supporting the plurality of prosthetic leaflets, and one or more anchors, each configured to anchor the prosthetic valve relative to the native valve, each including a first arm and a second arm, and each configured to extend radially outward to a tip, the tip including a loop connecting the first arm to the second arm, the first arm configured to be actuated relative to the second arm to change a distance between the first arm and the second arm.

[0026] Examples may include a prosthetic valve configured to be deployed relative to a native valve. The prosthetic valve may include a plurality of prosthetic leaflets. The prosthetic valve may include a valve body supporting the plurality of prosthetic leaflets. Each of the one or more anchors may be configured to anchor the prosthetic valve relative to the native valve and may be configured to be slidably driven relative to the valve body.

[0027] Examples may include a method that includes deploying a prosthetic valve relative to a native valve. The prosthetic valve may include a plurality of prosthetic leaflets, a valve body supporting the plurality of prosthetic leaflets, and one or more anchors, each configured to anchor the prosthetic valve to the native valve, each configured to be slidably driven relative to the valve body.

[0028] An example may include a delivery system for an implant, the delivery system may include an elongate shaft including an implant retaining region for retaining the implant, and a control mechanism configured to control deflection of at least one distal anchor of the implant independently from deflection of at least one other distal anchor of the implant.

[0029] Examples may include a method that includes deploying an implant to a portion of a patient's body using a delivery system that may include an elongate shaft including an implant holding region for holding the implant and a control mechanism configured to control deflection of at least one distal anchor of the implant independently from deflection of at least one other distal anchor of the implant.

[0030] Examples may include a prosthetic valve configured to be deployed relative to a native valve, the prosthetic valve may include a plurality of prosthetic leaflets, a valve body supporting the plurality of prosthetic leaflets, and one or more pacemaker leads configured to anchor the valve body in place at the native valve.

[0031] Examples may include a method that includes deploying a prosthetic valve relative to a native valve. The prosthetic valve may include a plurality of prosthetic leaflets, a valve body supporting the plurality of prosthetic leaflets, and one or more pacemaker leads configured to anchor the valve body in place at the native valve.

[0032] Examples may include a method that includes imaging a native heart valve and manufacturing at least a portion of a prosthetic heart valve based on the imaging of the native heart valve.

[0033] An example may include a prosthetic valve configured to be deployed relative to a native heart valve, the prosthetic valve may include a plurality of prosthetic leaflets and a valve body supporting the plurality of prosthetic leaflets, at least a portion of the prosthetic heart valve manufactured based on imaging of the native heart valve. [Brief description of the drawings]

[0034] [Figure 1] FIG. 1 illustrates an example of a delivery system. [Figure 2A] FIG. 2A illustrates a partial cross-sectional view of the distal end of the delivery system of FIG. 1 loaded with the implant of FIG. 3E. [Figure 2B] FIG. 2B illustrates a partial cross-sectional view of the distal end of the delivery system of FIG. 1 without the implant of FIG. 3E. [Figure 2C] FIG. 2C illustrates a partial cross-sectional view of the distal end of the delivery system of FIG. 1, where a particular shaft assembly is translated along a rail assembly. [Figure 3A] FIG. 3A illustrates a perspective view of an implant that may be delivered using the delivery systems described herein. [Figure 3B] FIG. 3B illustrates a bottom view of the implant shown in FIG. 3A. [Figure 3C] FIG. 3C illustrates a schematic cross-sectional view of the implant shown in FIG. 3A. [Figure 3D] FIG. 3D illustrates a side view of one example of an aortic valve prosthesis that may be delivered using the delivery systems described herein. [Figure 3E] FIG. 3E illustrates a side view of one example of a prosthetic valve that may be delivered using the delivery systems described herein. [Figure 4]FIG. 4 illustrates a perspective view of the distal end of the delivery system of FIG. [Diagram 5] FIG. 5 illustrates the components of the delivery system of FIG. 4 with the outer sheath assembly driven proximally to a position not visible in the illustration. [Figure 6A] FIG. 6A illustrates the components of the delivery system of FIG. 5 with the midshaft assembly driven proximally to a position not visible in the illustration. [Figure 6B] FIG. 6B illustrates a cross section of the rail assembly. [Figure 6C] FIG. 6C illustrates a cross section of an example rail assembly. [Figure 7] FIG. 7 illustrates the components in the delivery system. [Figure 8] FIG. 8 illustrates the components of the delivery system of FIG. 7 with the inner assembly driven proximally to a position not visible in the illustration. [Figure 9] FIG. 9 illustrates an example of a rail assembly. [Figure 10] FIG. 10 illustrates an example of a handle in a delivery system. [Figure 11] FIG. 11 illustrates a cross section of the handle of the delivery system in FIG. [Figure 12A] FIG. 12A illustrates a side view of the distal end of the elongate shaft. [Figure 12B] FIG. 12B illustrates a side view of the distal end of the elongate shaft deflected from the position shown in FIG. 12A. [Figure 12C] FIG. 12C illustrates a top view of the distal end of the elongate shaft deflected from the position shown in FIG. 12A into the atrium of the heart. [Figure 13A] FIG. 13A illustrates a side view of the distal end of the elongate shaft. [Figure 13B] FIG. 13B illustrates a side view of the distal end of the elongate shaft deflected from the position shown in FIG. 13A. [Figure 13C] FIG. 13C illustrates a top view of the distal end of the elongate shaft deflected from the position shown in FIG. 13A into the atrium of the heart. [Figure 13D] FIG. 13D illustrates a top view of the distal end of the elongate shaft deflected from the position shown in FIG. 13C into the atrium of the heart. [Figure 13E] FIG. 13E illustrates a cross-sectional view of the rail assembly. [Figure 13F] FIG. 13F illustrates a cross-sectional view of the rail assembly shown in FIG. 13E taken along line 13F-13F. [Figure 13G] FIG. 13G illustrates a cross-sectional view of the rail assembly shown in FIG. 13E taken along line 13G-13G. [Figure 13H] FIG. 13H illustrates a cross-sectional view of the rail assembly shown in FIG. 13E taken along line 13H-13H. [Figure 14] FIG. 14 illustrates a cross-sectional view of the rail assembly. [Figure 15A] FIG. 15A illustrates a perspective view of a rail assembly with a notch disposed on the tube of the rail assembly. [Figure 15B] FIG. 15B illustrates a cross-sectional view of a rail assembly having a stopper disposed on the upper surface. [Figure 16A] FIG. 16A illustrates a side view of the distal end of the elongate shaft. [Figure 16B] FIG. 16B illustrates a top view of the distal end of the elongate shaft shown in FIG. 16A. [Figure 17A] FIG. 17A illustrates the elongate shaft being introduced into the right atrium of a patient's heart. [Figure 17B] FIG. 17B illustrates the distal end of the elongate shaft shown in FIG. 17A deflected from the position shown in FIG. 17A. [Figure 17C]FIG. 17C illustrates the distal end of the elongate shaft shown in FIG. 17B deflected from the position shown in FIG. 17B. [Figure 18A] FIG. 18A illustrates the distal end of the elongate shaft aligned with the tricuspid valve. [Figure 18B] FIG. 18B illustrates the expansion body inflated within the inferior vena cava. [Figure 19] FIG. 19 illustrates the elongated shaft being introduced through the superior vena cava into the right atrium of the patient's heart. [Figure 20A] FIG. 20A illustrates a perspective view of an implant deployed from an elongate shaft. [Figure 20B] FIG. 20B illustrates a perspective view of the implant deployed from the elongate shaft. [Figure 20C] FIG. 20C illustrates a perspective view of the implant deployed from the elongate shaft. [Figure 21] FIG. 21 illustrates the implant in place within the annulus of the tricuspid valve. [Figure 22A] FIG. 22A illustrates a perspective view of a diaphragm on an elongate shaft. [Figure 22B] FIG. 22B illustrates a cross-sectional view of the diaphragm shown in FIG. 22A. [Figure 23A] FIG. 23A illustrates a perspective view of the diaphragm shown in FIG. 22A actuated from the position shown in FIG. 22A. [Figure 23B] FIG. 23B illustrates a cross-sectional view of the diaphragm shown in FIG. 23A. [Figure 24A] FIG. 24A illustrates the delivery system in proximity to the native valve. [Figure 24B] FIG. 24B illustrates the delivery system shown in FIG. 24A applying a suction force against the leaflets of a native heart valve. [Figure 24C] FIG. 24C illustrates the delivery system shown in FIG. 24A at least partially deploying the implant against the native valve. [Figure 24D] FIG. 24D illustrates the delivery system shown in FIG. 24A after the implant has been deployed against the native valve. [Figure 24E] FIG. 24E illustrates a cross-sectional view of a portion of the delivery system. [Diagram 25] FIG. 25 illustrates a partial cross-sectional view of the distal end of a delivery system loaded with a prosthetic valve. [Figure 26] FIG. 26 illustrates a top view of the distal tips of the anchors in the prosthetic valve. [Figure 27] FIG. 27 illustrates a top view of the distal tips of the anchors in the prosthetic valve. [Figure 28] FIG. 28 illustrates a cross-sectional view from above of the prosthetic valve. [Figure 29] FIG. 29 illustrates a cross-sectional view from above of the prosthetic valve. [Figure 30A] FIG. 30A illustrates a side view of a prosthetic valve deployed relative to a native valve, the prosthetic valve having an inflatable tip. [Figure 30B] FIG. 30B illustrates a side view of the prosthetic valve shown in FIG. 30A with the tip inflated. [Figure 31A] FIG. 31A illustrates a side view of a prosthetic valve deployed relative to a native valve, the prosthetic valve having an inflatable tip. [Figure 31B] FIG. 31B illustrates a perspective view of a tube coupled to an inflation conduit of a prosthetic valve. [Figure 31C] FIG. 31C illustrates a side view of the prosthetic valve shown in FIG. 31A with the tip inflated. [Diagram 32] FIG. 32 illustrates a cross-sectional view from above of the prosthetic valve. [Figure 33A] FIG. 33A illustrates a side cross-sectional view of an implant positioned within an elongate shaft of a delivery system. [Figure 33B] FIG. 33B illustrates a side cross-sectional view of the implant shown in FIG. 33A deployed relative to the native valve. [Figure 33C] FIG. 33C illustrates how the implant shown in FIG. 33A fails to capture the leaflets of the native valve. [Figure 33D] FIG. 33D illustrates the anchors of the implant being compressed radially inward by the delivery system. [Diagram 34] FIG. 34 illustrates a side cross-sectional view of the implant deployed against the native valve. [Figure 35A] FIG. 35A illustrates the implant being compressed radially inward by the delivery system. [Figure 35B] FIG. 35B illustrates a cross-sectional view from above of the implant compressed radially inward by the delivery system. [Figure 35C] FIG. 35C illustrates the implant being compressed radially inward by the delivery system. [Diagram 36] FIG. 36 illustrates the implant being compressed radially inward by the inner shaft of the delivery system. [Figure 37A] FIG. 37A illustrates the implant being compressed radially inward by the inner shaft of the delivery system. [Figure 37B] FIG. 37B illustrates the implant shown in FIG. 37A compressed radially inward by the inner shaft of a delivery system. [Figure 38A] FIG. 38A illustrates the implant being compressed radially inward by the inner shaft of the delivery system. [Figure 38B] FIG. 38B illustrates the implant shown in FIG. 38A compressed radially inwardly by the inner shaft of a delivery system. [Figure 39] FIG. 39 illustrates the implant being compressed radially inward by the inner shaft of the delivery system. [Figure 40A] FIG. 40A illustrates a side cross-sectional view of an implant held by a delivery system. [Figure 40B]FIG. 40B illustrates a side cross-sectional view of the implant shown in FIG. 40A deployed relative to the native valve. [Figure 40C] FIG. 40C illustrates a side cross-sectional view of the implant shown in FIG. 40A with the distal anchor released from the delivery system. [Figure 40D] FIG. 40D illustrates a cross-sectional side view of the implant shown in FIG. 40A in an deployed state. [Diagram 41] FIG. 41 illustrates a side cross-sectional view of the implant deployed against the native valve. [Diagram 42] FIG. 42 illustrates a side view of the tip of the implant. [Diagram 43] FIG. 43 illustrates a side view of the tip of the implant. [Diagram 44] FIG. 44 illustrates a top view of the tip of the implant shown in FIG. [Figure 45A] FIG. 45A illustrates a side cross-sectional view of an implant held by a delivery system. [Figure 45B] FIG. 45B illustrates a side cross-sectional view of the implant shown in FIG. 45A deployed relative to the native valve. [Figure 45C] FIG. 45C illustrates a side cross-sectional view of the implant shown in FIG. 45A in an deployed state. [Figure 46A] FIG. 46A illustrates a side cross-sectional view of an implant deployed by a delivery system. [Figure 46B] FIG. 46B illustrates a cross-sectional side view of the anchor of the implant during deployment. [Figure 46C] FIG. 46C illustrates a cross-sectional side view of an implant that has failed to capture the native leaflets. [Figure 46D] FIG. 46D illustrates a cross-sectional side view of the implant with the anchors retracted. [Figure 46E] FIG. 46E illustrates a cross-sectional side view of the implant with the anchors retracted. [Figure 46F] FIG. 46F illustrates a side cross-sectional view of the implant deployed relative to the native valve. [Figure 46G] FIG. 46G illustrates a cross-sectional view from above of the implant shown in FIG. 46F. [Fig. 46H] FIG. 46H illustrates a side view of the anchor shown in FIG. 46F. [Figure 47] FIG. 47 illustrates a cross-sectional view of the locking member of the anchor. [Figure 48] FIG. 48 illustrates a cross-sectional view of the locking member of the anchor. [Figure 49] FIG. 49 illustrates a cross-sectional view of the locking member of the anchor. [Figure 50] FIG. 50 illustrates a schematic cross-sectional side view of the control mechanism. [Figure 51A] FIG. 51A illustrates a schematic cross-sectional side view of the control mechanism. [Figure 51B] FIG. 51B illustrates a schematic cross-sectional side view of a deployed implant. [Figure 52A] FIG. 52A illustrates a schematic cross-sectional side view of an implant within a capsule. [Figure 52B] FIG. 52B illustrates a schematic cross-sectional side view of the implant during deployment. [Figure 52C] FIG. 52C illustrates a schematic cross-sectional side view of the implant during deployment. [Figure 53A] FIG. 53A illustrates a schematic cross-sectional side view of the implant during deployment. [Figure 53B] FIG. 53B illustrates a schematic cross-sectional side view of the implant during deployment. [Figure 53C] FIG. 53C illustrates a schematic cross-sectional side view of the implant during deployment. [Figure 54] FIG. 54 illustrates a schematic cross-sectional side view of a delivery system deploying an implant. [Figure 55] FIG. 55 illustrates a perspective cross-sectional view of a portion of the control mechanism shown in FIG. [Figure 56] FIG. 56 illustrates an assembly diagram for each component of the control mechanism shown in FIG. [Figure 57] FIG. 57 illustrates a side perspective view of the housing of the control mechanism shown in FIG. [Figure 58] FIG. 58 illustrates a schematic cross-sectional side view of the delivery system shown in FIG. 54 deploying an implant. [Figure 59] FIG. 59 illustrates a schematic cross-sectional side view of the delivery system shown in FIG. 54 deploying an implant. [Figure 60] FIG. 60 illustrates a side cross-sectional view of a portion of the control mechanism shown in FIG. [Figure 61] FIG. 61 illustrates a schematic cross-sectional side view of the delivery system shown in FIG. 54 adjusting a distal anchor of an implant. [Figure 62] FIG. 62 illustrates a side cross-sectional view of a portion of the control mechanism shown in FIG. [Figure 63] FIG. 63 illustrates a schematic cross-sectional side view of the delivery system shown in FIG. 54 adjusting a distal anchor of an implant. [Figure 64] FIG. 64 illustrates a schematic cross-sectional side view of an implant deployed relative to a portion of a heart. [Figure 65] FIG. 65 illustrates a schematic cross-sectional side view of the implant shown in FIG. 64 deployed relative to a portion of a heart. [Figure 66] FIG. 66 illustrates a side cross-sectional view of the locking member. [Figure 67] FIG. 67 illustrates a schematic cross-sectional side view of the implant shown in FIG. 64 deployed against a portion of a heart and coupled to a pacemaker. [Figure 68] FIG. 68 illustrates a schematic cross-sectional side view of an implant deployed relative to a portion of a heart. [Figure 69] FIG. 69 illustrates a schematic cross-sectional side view of the imaging procedure. [Figure 70] FIG. 70 illustrates a schematic diagram of a processing system. [Figure 71] FIG. 71 illustrates a side view of the manufacturing assembly. [Figure 72] FIG. 72 illustrates a cross-sectional view from above on the mandrel. [Figure 73] FIG. 73 illustrates a side view of the manufacturing assembly. [Figure 74] FIG. 74 illustrates a cross-sectional view from above of the valve body positioned on the mandrel. [Figure 75] FIG. 75 illustrates a cross-sectional view from above of a valve body having an inner valve body and an outer valve body. [Figure 76] FIG. 76 illustrates a side view of the manufacturing assembly. [Figure 77] FIG. 77 illustrates a perspective view of a prosthetic heart valve. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0035] The present specification and drawings provide aspects and features of the present disclosure in the context of several examples of implants, such as prosthetic valves, delivery systems, and methods configured for use within a patient's vasculature, such as for replacing or repairing the patient's native heart valve. The prosthetic valves may include replacement heart valves or other configured prosthetic valves. These examples may be described in the context of replacing a particular valve, such as aortic, tricuspid, mitral, or pulmonary valves, of a patient. However, it will be understood that the features and concepts described herein may be applied to devices other than implants for heart valves. For example, the implants, delivery systems, and methods may be applied to medical implants, such as other types of expandable prosthetic valves, for use at other locations in the body, such as in arteries, veins, or other body cavities or other locations. In addition, specific features of prosthetic valves, delivery systems, methods, etc. should not be taken as limiting, and features in any example described herein may be combined with features in other examples as desired and appropriate. Although certain examples described herein are described in connection with a transfemoral delivery approach, it will be understood that these examples may be used in connection with other delivery approaches, such as, for example, a transapical, transatrial, or transjugular approach. Moreover, it will be understood that certain features described in connection with certain examples may be incorporated with other examples, including features described in connection with different delivery approaches.

[0036] FIG. 1 illustrates an example of a delivery device, delivery assembly, or delivery system 10. The delivery system 10 can be used to deploy an implant, such as a prosthetic valve, inside the body. In some examples, the delivery system 10 can use a dual-plane deflection approach to properly deliver the implant. An implant, such as a prosthetic heart valve, can be delivered to a patient's mitral valve, tricuspid heart valve annulus, or other heart valve locations, such as the aortic valve or pulmonary valve, in a variety of manners, such as open surgery, minimally invasive surgery, and percutaneous or transcatheter delivery through the patient's vasculature. An exemplary transfemoral approach can be found in U.S. Patent Application Publication No. 2015 / 0238315, filed February 20, 2015, the entirety of which is incorporated herein by reference in its entirety. Although delivery system 10 is described in connection with a percutaneous delivery approach, and more specifically, a transfemoral delivery approach, it will be understood that the features of delivery system 10 may be applied to other delivery systems, including delivery systems for a transapical, transatrial, or transjugular delivery approach.

[0037] Delivery system 10 may be used to deploy a prosthetic valve, such as a replacement heart valve as described elsewhere herein, within the body. Delivery system 10 may receive and / or cover a portion of a prosthetic valve, such as a first end 301 and a second end 303 of a prosthetic valve or implant 70 as illustrated in FIG. 3E, or corresponding first and second ends of an implant as illustrated in FIGS. 3A-3D. For example, delivery system 10 may be used to deliver an expandable prosthetic valve or implant 70, where implant 70 includes a first end 301 and a second end 303, and second end 303 is configured to be deployed or expanded prior to first end 301.

[0038] FIG. 2A further illustrates an example of an implant 70 (shown in FIG. 3E) that may be inserted into the delivery system 10, and specifically into the implant holding area 16. For ease of understanding, the implant is shown in FIG. 2A as having only a bare metal frame. The implant 70 may take any number of different forms. For example, the implants shown in FIGS. 3A-3E may be utilized, among other forms of implants. Although a particular example of a frame for an implant is shown in FIG. 3E, it will be understood that other designs and frame configurations, including those disclosed herein, may also be used. The implant 70 may include a set or sets of anchors, such as a distal (or ventricular) anchor 80 that extends proximally when the prosthetic frame is in an expanded configuration, and a proximal (or atrial) anchor 82 that extends distally when the prosthetic frame is in an expanded configuration. The prosthetic valve may further include struts 72, which may terminate at the first end 301 in mushroom-shaped tabs 74. Further discussion may be found in U.S. Patent Application Publication No. 2015 / 0328000, published November 19, 2015, which is incorporated herein by reference in its entirety.

[0039] In some examples, the delivery system 10 can be used with a replacement aortic valve, such as that shown in FIG 3D. In some examples, the delivery system 10 can be modified to support and deliver a replacement aortic valve. However, the procedures and structures described below can be used with replacement tricuspid and aortic valves alike.

[0040] 3A-3C illustrate one example of an implant 400 that may be utilized in accordance with examples herein. The implant 400 may include a proximal or first end 402 and a distal or second end 404. The implant 400 may include a valve body 406 having a proximal end 408 and a distal end 410.

[0041] 3C illustrates a schematic cross-sectional view of the implant 400. In an example, the valve body 406 may include an inner body 412 and an outer body 414. The inner body 412 may include a valve frame 416, which may be referred to as an inner valve frame 416. The inner valve frame 416 may include a number of struts separated by apertures. In an example, a seal skirt 418 may be provided on the inner valve frame 416, which may reduce fluid flow through the seal skirt 418.

[0042] The outer body 414 is disposed radially outward from the inner body 412 and may include a seal body, in an example. The outer body 414 may include a frame, which may be referred to as an outer frame 420, which may extend around a periphery of the inner valve frame 416. A seal skirt 422 (as can be seen in FIG. 3A) may be coupled to the outer frame 420. The seal skirt 422 may be configured to reduce the flow of fluid around the outer body 414, thereby reducing the likelihood of fluid leakage (e.g., paravalvular leakage) around the outer body 414. In an example, the outer body 414 may be configured to be flexible to allow the outer body 414 to conform to the shape of an implantation site, such as a valve annulus.

[0043] The valve body 406 may support a number of prosthetic leaflets 424 (shown in FIG. 3B). The prosthetic leaflets 424 may be positioned within a flow channel 426 of the implant 400 through which fluid may flow. The prosthetic leaflets 424 may be configured to open and close in a manner that mimics the action of a natural valve, in examples. The valve body 406 may encircle a central axis 428 that may pass through the flow channel 426.

[0044] One or more anchors 430 may be coupled to the valve body 406. In the example shown in FIGS. 3A-3C, the anchors 430 may include distal anchors and may extend from the distal end 410 of the valve body 406. The anchors 430 may be configured to extend radially outward from the valve body 406 and may have a hook shape. In an example, the distal anchors may be configured to hook onto the distal tips of the leaflets of the native valve with the distal tips of each of the distal anchors positioned radially outward of the leaflets. Other configurations may be utilized as desired. In an example, a proximal portion 432 of the distal anchor 430 may be coupled to a distal portion of the valve body 406, among other configurations.

[0045] Although the implant 400 is shown in an expanded configuration in FIGS. 3A-3C, it may also be in a compressed configuration. The compressed configuration of the implant 400 may be compressed for insertion and delivery to an implantation site. For example, the implant 400 may be compressed radially inward and the anchors 430 may be elongated and extend along a central axis 428. Such a configuration is shown in FIG. 2A with respect to the implant 70 of FIG. 3E. The implant shown in FIG. 3D may similarly be held in a compressed configuration and, in examples, expanded to an expanded configuration. In examples, the implant may include a self-expanding implant configured to transition from a compressed configuration to an expanded configuration.

[0046] Additional details and additional exemplary designs regarding prosthetic valves are described in U.S. Pat. Nos. 8,403,983, 8,414,644, 8,652,203, U.S. Patent Application Publication No. 2011 / 0313515, 2012 / 0215303, 2014 / 0277390, 2014 / 0277422, 2014 / 0277427, 2018 / 0021129, and 2018 / 0055629, the entireties of which are incorporated by reference herein and made a part of this specification. Further details and examples regarding replacement heart valves and regarding prosthetic valves and methods for implanting same are provided in U.S. Published Application Publication Nos. 2015 / 0328000 and 2016 / 0317301, the entireties of which are incorporated by reference herein and made a part of this specification.

[0047] The delivery system 10 can be relatively flexible. In some examples, the delivery system 10 is particularly suitable for delivering an implant in the form of a prosthetic valve to an implantation site, such as the mitral valve location, via a transseptal approach (e.g., between the right and left atria via a percutaneous puncture). However, the delivery system 10 may also be suitable for delivering a replacement heart valve to the tricuspid valve location, among other locations.

[0048] As shown in FIG. 1, the delivery system 10 can include a shaft assembly or elongate shaft 12 including a proximal end 11 and a distal end 13, with a handle 14 coupled to the proximal end of the elongate shaft 12. The elongate shaft 12 can be used to hold an implant 70 and drive the implant 70 forward through the vasculature to a treatment location. The delivery system 10 can further include a relatively rigid live-on (or one-piece) sheath 51 surrounding the elongate shaft 12 to prevent undesired movement of the elongate shaft 12. The live-on sheath 51 can be attached at the proximal end of the elongate shaft 12, for example at a sheath hub, near the handle 14. At the distal end, the elongate shaft 12 can include an implant holding region 16 (shown in FIGS. 2A-2B, with the implant 70 of FIG. 3E in FIG. 2A and with the implant 70 removed in FIG. 2B) that can be used for this purpose. In some examples, the elongate shaft 12 can hold the expandable implant in a compressed state at the implant holding region 16 to advance the implant within the body. The elongate shaft 12 can then be used to allow controlled expansion of the implant at the treatment location. In some examples, the elongate shaft 12 can be used to allow sequential controlled expansion of the implant, as described in more detail below. Although the implant holding region 16 is shown at the distal end of the delivery system 10 in FIGS. 2A-2B, it can be at other locations. In some examples, the implant can be rotationally driven within the implant holding region 16, such as by rotationally driving the inner shaft assembly 18 described herein.

[0049] As shown in the cross-sectional views of FIGS. 2A-2B, the distal end of the delivery system 10 can include one or more subassemblies, such as an outer sheath assembly 22, a mid-shaft assembly 21, a rail assembly 20, an inner shaft assembly 18, a nosecone assembly 31, etc., as described in more detail below. In some examples, the delivery system 10 need not have all of the assemblies disclosed herein. For example, in some examples, a complete mid-shaft assembly may not be incorporated within the delivery system 10. In some examples, the assemblies disclosed below may be located in a different radial order than the order described.

[0050] In particular, the disclosed examples of the delivery system 10 can utilize steerable rails in the rail assembly 20 to steer the distal end of the delivery system 10 so that the implant can be properly positioned within the patient's body. As described in more detail below, the steerable rail can be, for example, a rail shaft that extends generally through the delivery system 10 from the handle 14 to the distal end. In some examples, the steerable rail has a distal end that terminates near the implant holding area 16. A user can manipulate the bend in the distal end of the rail, thereby allowing the rail to bend in a particular direction. In a preferred example, the rail has two or more bends along its length, thereby providing multiple bending directions. When the rail is bent, it is pressed against the other assemblies, thereby bending the other assemblies, such that the other assemblies of the delivery system 10 can be configured to be steered together with the rail as a cooperating single unit, thus providing full steerability for the distal end of the delivery system.

[0051] After the rail is steered to a particular location within the patient's body, an implant, such as implant 70 shown in FIG. 3E, can be driven forward along or against the rail by driving the other sheath / shaft relative to the rail and released into the body. The rail can be bent to a desired location within the body, such as to guide the implant toward a native valve, such as a native mitral valve or native tricuspid valve. The other assemblies (e.g., outer sheath assembly 22, mid shaft assembly 21, inner shaft assembly 18, and nosecone assembly 31) can passively follow the rail bending. Furthermore, the other assemblies (e.g., outer sheath assembly 22, mid shaft assembly 21, inner shaft assembly 18, and nosecone assembly 31) can be driven forward together (e.g., relative to each other, sequentially, simultaneously, nearly simultaneously, exactly simultaneously) relative to the rail while maintaining the implant in a compressed position without releasing or expanding the implant (e.g., within the implant holding area 16). The other assemblies (e.g., outer sheath assembly 22, mid shaft assembly 21, inner shaft assembly 18, and nosecone assembly 31) can be driven forward together, either distally or proximally, relative to the rail. In some examples, only the outer sheath assembly 22, mid shaft assembly 21, and inner shaft assembly 18 are driven forward together on the rail; thus, the nosecone assembly 31 may remain in the same position. The assemblies can be driven translationally, individually, sequentially, or simultaneously, relative to the inner shaft assembly 18, which releases the implant from the implant retaining area 16.

[0052] 2C illustrates the sheath assemblies, specifically the outer sheath assembly 22, the mid shaft assembly 21, the inner shaft assembly 18, and the nosecone assembly 31, translated distally together along the rail assembly 20, with further details regarding the assemblies described below. In some examples, the outer sheath assembly 22, the mid shaft assembly 21, the inner shaft assembly 18, and the nosecone assembly 31 are translated together (e.g., relatively together, sequentially, simultaneously, near simultaneously, simultaneously, exactly simultaneously) by a single actuator. This distal translation can occur while the implant remains in a compressed configuration within the implant retaining region 16.

[0053] As shown in FIGS. 2A-2C and further shown in FIGS. 4-8, beginning with the outermost assembly, the delivery system can include an outer sheath assembly 22 forming a radially outer covering or sheath surrounding the implant retaining area 16 to prevent radial expansion of the implant. Specifically, the outer sheath assembly 22 can prevent radial expansion of the distal end of the implant. Continuing radially inward, the midshaft assembly 21 can be comprised of a midshaft hypotube 43, the distal end of which is attached to an outer retaining member or ring 42 for radially retaining a portion of the prosthetic valve, such as the proximal end of the implant, in a compact configuration. The midshaft assembly 21 can be disposed within the lumen of the outer sheath assembly 22. Continuing further inward, the rail assembly 20 can be configured for steerability as described above and below. The rail assembly 20 can be disposed within the lumen of the midshaft assembly 21. Continuing inward, the inner shaft assembly 18 can be comprised of an inner shaft, the distal end of which is attached to an inner retaining member or inner retaining ring 40 (such as a PEEK ring) for axially retaining the implant, such as the proximal end of the implant. The inner shaft assembly 18 can be disposed within the lumen of the rail assembly 20. Further, the radially innermost assembly is the nosecone assembly 31, which includes a nosecone shaft 27, the distal end of which is connected to a nosecone 28. The nosecone 28 can have a tapered tip. The nosecone assembly 31 is preferably disposed within the lumen of the inner shaft assembly 18. The nosecone assembly 31 can include a lumen for passing a guidewire therethrough.

[0054] The elongate shaft 12, and more specifically the nosecone assembly 31, inner shaft assembly 18, rail assembly 20, mid shaft assembly 21, and outer sheath assembly 22, can be collectively configured to deliver an implant positioned within the implant holding area 16 (shown in FIG. 2A) to a treatment location. The implant can then be released at the treatment location by actuating one or more subassemblies. For example, one or more subassemblies may be movable relative to one or more other subassemblies. The handle 14 can include various control mechanisms that can be used to control the movement of the various subassemblies, as described in more detail below. In this manner, an implant can be controllably loaded onto the delivery system 10 and then deployed within the body. Additionally, the handle 14 can provide maneuverability for the rail assembly 20 to provide bending / flexing / steering of the distal end of the delivery system 10.

[0055] As described below, the inner retaining member 40, the outer retaining ring 42, and the outer sheath assembly 22 cooperate to hold the implant in a compact configuration. The inner retaining member 40 is shown in FIG. 2A as engaging with posts 72 at the proximal end 301 of the implant 70. For example, slots located between radially extending teeth on the inner retaining member 40 can receive and engage with posts 72 that can terminate in mushroom-shaped tabs 74 on the proximal end of the implant 70. The midshaft assembly 21 can be positioned over the inner retaining member 40 such that the first end 301 of the implant 70 is captured between the inner retaining member 40 and the outer retaining ring 42, thereby securely attaching the implant 70 to the delivery system 10 between the midshaft assembly 21 and the inner retaining member 40. The outer sheath assembly 22 can be positioned over the second end 303 of the implant 70.

[0056] The outer retention member 42 may be attached to a distal end of the midshaft hypotube 43, which may be attached at its proximal end to the proximal tube 44, which may be attached at its proximal end to the handle 14. The outer retention member 42 may provide additional stability to the implant when in a compressed position. The outer retention member 42 may be positioned over the inner retention member 40 such that the proximal end of the implant 70 is captured between the inner retention member 40 and the outer retention member 42, thereby securely attaching the implant 70 to the delivery system 10. The outer retention member 42 may surround a portion of the implant, particularly the first end 301 of the implant, such as the first end of the implant shown in FIGS. 3A-3D or the first end of the implant 70 shown in FIG. 3E, thereby preventing expansion of the implant 70. Additionally, the intermediate shaft assembly 21 may be translated proximally relative to the inner shaft assembly 18 and into the outer sheath assembly 22 to expose the first end 301 of the implant 70 retained within the outer retention member 42. In this manner, the outer retention member 42 may be used to assist in securing the implant to the delivery system 10 or releasing the implant from the delivery system 10. The outer retention member 42 may have a cylindrical or elongated tubular shape and may be referred to as an outer retention ring, but is not limited to any particular shape.

[0057] As shown in FIG. 2A, the distal anchor of the implant can be located in a delivery configuration in which the distal anchor (such as distal anchor 80 shown in FIG. 3E) faces generally distally (axially away from the body of the prosthetic valve frame and away from the handle of the delivery system as shown). The distal anchor can be constrained in this delivery configuration by the outer sheath assembly 22. Thus, when the outer sheath 22 is retracted proximally, the distal anchor can flip position (e.g., bend through about 180 degrees) to the deployed configuration (e.g., facing generally proximally) as shown in FIGS. 3A-3C and 3E. FIG. 2A also shows that the proximal anchor 82 in the example of FIG. 3E extends distally in the delivery configuration within the outer sheath assembly 22. In other examples, the distal anchor 80 can be held generally proximally oriented in the delivery configuration and compressed against the body of the prosthetic valve frame.

[0058] The delivery system 10 may be provided to a user with the implant preloaded, or, in other instances, the implant can be loaded into the delivery system immediately prior to use, such as by a doctor or nurse.

[0059] 4-8 illustrate further views of the delivery system 10 with the different assemblies translated proximally, which will now be described in detail.

[0060] Beginning with the outermost assembly shown in Figure 4, the outer sheath assembly 22 can include an outer proximal shaft 102 attached directly to the handle 14 at its proximal end and an outer hypotube 104 attached at its distal end. A capsule 106 can be attached entirely to the distal end of the outer hypotube 104. In some examples, the capsule 106 can be 28 French or smaller in size. These components of the outer sheath assembly 22 can form a lumen for passage of other subassemblies therethrough.

[0061] A capsule 106 can be disposed at the distal end of the outer proximal shaft 102. The capsule 106 can be a tube formed from a plastic or metal material. In some examples, the capsule 106 is formed from ePTFE or PTFE. In some examples, the capsule 106 is relatively thick to prevent tearing and to help maintain the self-expanding implant in a compact configuration. In some examples, the material of the capsule 106 is the same material as the coating on the outer hypotube 104. As shown, the capsule 106 can have a larger diameter than the outer hypotube 104, but in some examples, the capsule 106 can have a similar diameter as the hypotube 104. In some examples, the capsule 106 can include a distal portion having a larger diameter and a proximal portion having a smaller diameter. In some examples, a step or taper can be provided between the two portions. The capsule 106 can be configured to hold the implant in a compressed position within the capsule 106. Further constructional details regarding capsule 106 are provided below.

[0062] The outer sheath assembly 22 is configured to be independently slidable relative to the other assemblies, and furthermore, the outer sheath assembly 22, together with the mid shaft assembly 21, the inner shaft assembly 18, and the nosecone assembly 31, can slide both distally and proximally relative to the rail assembly 20.

[0063] Continuing radially inward, the next assembly is the mid-shaft assembly 21. Figure 5 shows a view similar to Figure 4, but with the outer sheath assembly 22 removed, thus exposing the mid-shaft assembly 21.

[0064] The midshaft assembly 21 can include a midshaft hypotube 43 generally attached at its proximal end to a midshaft proximal tube 44, which can be attached at its proximal end to the handle 14, and an outer retaining ring 42 disposed at the distal end of the midshaft hypotube 43. Thus, the outer retaining ring 42 can be generally attached at the distal end of the midshaft hypotube 43. These components of the midshaft assembly 21 can form a lumen through which other subassemblies pass.

[0065] The outer retaining ring 42 can be configured as a prosthetic valve retention mechanism that can be used to engage an implant, as described with respect to FIG. 2A. For example, the outer retaining ring 42 can be a ring or cover configured to radially cover struts on an implant. The outer retaining ring 42 can also be considered part of the implant retaining area 16 and can be located at a proximal end of the implant retaining area 16. With the struts or other portions of the implant engaged with the inner retaining member 40, the outer retaining ring 42 can cover both the implant and the inner retaining member 40, as described below, to secure the implant on the delivery system 10. Thus, the implant can be sandwiched between the inner retaining member 40 of the inner shaft assembly 18 and the outer retaining ring 42 of the midshaft assembly 21.

[0066] The mid-shaft assembly 21 is arranged to be independently slidable relative to the other assemblies, and further, the mid-shaft assembly 21, together with the outer sheath assembly 22, the inner shaft assembly 18, and the nosecone assembly 31, can slide both distally and proximally relative to the rail assembly 20.

[0067] Next, the rail assembly 20 is located radially inward of the midshaft assembly 21. FIG. 6A shows a view similar to FIG. 5, but with the midshaft assembly 21 removed, thus exposing the rail assembly 20. FIG. 6B further shows a cross section of the rail assembly 20, where the tension tether in the form of a tension wire is visible. The rail assembly 20 may include a rail shaft 132 (or rail) generally attached to the handle 14 at its proximal end. The rail shaft 132 may be comprised of a rail proximal shaft 134 attached directly 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 include a proximal rail shaft portion 603 and a distal rail shaft portion 601. The rail hypotube 136 may further include an atraumatic rail tip at its distal end. Additionally, the distal end of the rail hypotube 136 can abut against the proximal end of the inner retaining member 40, as shown in FIG 6A. In some examples, the distal end of the rail hypotube 136 can be spaced apart from the inner retaining member 40. These components of the rail shaft assembly 20 can form a lumen through which other subassemblies can pass.

[0068] 6B, attached to the inner surface of the rail hypotube 136 are one or more tension tethers in the form of pull wires that can be used to apply force to the rail hypotube 136 to steer the rail assembly 20. The pull wires can extend distally from a knob in the handle 14 to the rail hypotube 136, as described below. In some examples, the pull wires can be attached at different longitudinal locations on the rail hypotube 136, thereby providing multiple bend positions within the rail hypotube 136 to allow for multi-dimensional steering.

[0069] In some examples, a distal pull wire 138 can extend to the distal section of the rail hypotube 136 and two proximal pull wires 140 can extend to the proximal section of the rail hypotube 136, although other numbers of pull wires can be used and the particular number of pull wires is not limiting. For example, two pull wires can extend to the distal location and a single pull wire can extend to the proximal location. In some examples, ring-like structures provided inside the rail hypotube 136, known as pull wire connectors, can be used as attachment locations for the pull wires, such as the proximal ring 137 and the distal ring 135. In some examples, the rail assembly 20 can include a distal pull wire connector 135 and a proximal pull wire connector 137. In some examples, the pull wires can be directly connected to the inner surface of the rail hypotube 136.

[0070] The distal pull wire 138 can be connected (either by itself or via a connector 135) entirely at the distal end of the rail hypotube 136. The proximal pull wire 140 can be connected (either by itself or via a connector 137) approximately one-quarter, one-third, or one-half of the length of the rail hypotube 136 from the proximal end. In some examples, the distal pull wire 138 can be passed through a small diameter pull wire lumen 139 (e.g., tube, hypotube, cylinder) disposed within the rail hypotube 136. This can prevent the wire 138 from pulling on the rail hypotube 136 in close proximity to the distal connection point. Additionally, the lumen 139 can act as a compression coil to reinforce the proximal portion of the rail hypotube 136 and prevent unwanted bending. Thus, in some examples, the lumen 139 is located only proximal to the middle of the rail hypotube 136. In some examples, multiple lumens 139, such as multiple longitudinally spaced lumens or multiple adjacently spaced lumens, can be used per distal wire 138. In some examples, a single lumen 139 is used per distal wire 138. In some examples, the lumen 139 can extend distally into the rail hypotube 136 beyond the center. In some examples, the lumen 139 is provided on the exterior surface of the rail hypotube 136. In some examples, no lumen 139 is used.

[0071] In the case of a pair of proximal pull wires 140, the wires can be spaced apart by approximately 180° to allow for steering in both directions. Similarly, if a pair of distal pull wires 138 is used, the wires can be spaced apart by approximately 180° to allow for steering in both directions. In some examples, the pair of distal pull wires 138 and the pair of proximal pull wires 140 can be spaced apart by approximately 90° from each other. In some examples, the pair of distal pull wires 138 and the pair of proximal pull wires 140 can be spaced apart by approximately 0° from each other. However, the particular locations for the pull wires are not limiting, as other locations for the pull wires may be used as well. In some examples, the distal pull wires 138 can pass through a lumen 139 disposed within the lumen of the rail hypotube 136. This prevents axial forces on the distal puller wire 138 from creating a bend in the proximal section of the rail hypotube 136.

[0072] Figure 6C illustrates an example where the position of the proximal tension tether or proximal pull wire 140 has been moved by 180° from the position shown in Figure 6B. The position of the proximal pull wire 140 shown in Figure 6C may allow the proximal portion of the rail hypotube 136 to bend in the opposite direction compared to the direction possible in Figure 6B. For example, in the example of Figure 6B, when the distal portion of the rail hypotube 136 is deflected downward by pulling the distal pull wire 138, the proximal portion of the rail hypotube 136 may be deflected to the left relative to the downward direction (when looking from the proximal end of the rail hypotube 136 toward the distal end of the rail hypotube 136). However, in the example of Figure 6C, when the distal portion of the rail hypotube 136 is deflected downward by pulling the distal pull wire 138, the proximal portion of the rail hypotube 136 may be deflected to the right relative to the downward direction (as viewed from the proximal end of the rail hypotube 136 toward the distal end of the rail hypotube 136). Such a variation may allow the proximal portion of the rail hypotube 136, and thus the elongate shaft 12, to be deflected in the opposite direction compared to what is possible in the example shown in Figure 6B. The thickness of the cut on the rail shaft 132 may also be varied to allow for the opposite deflection.

[0073] The rail assembly 20 is positioned to be slidable on the inner shaft assembly 18 and on the nosecone assembly 31. In some examples, the outer sheath assembly 22, the mid shaft assembly 21, the inner shaft assembly 18, and the nosecone assembly 31 can be configured to be slidably driven together, such as in a proximal-distal direction, along or relative to the rail assembly 20, with or without bending of the rail assembly 20. In some examples, the outer sheath assembly 22, the mid shaft assembly 21, the inner shaft assembly 18, and the nosecone assembly 31 can be configured to hold the implant 70 in a compressed position when they simultaneously slide along or relative to the rail assembly 20.

[0074] Continuing radially inward, the next assembly is the inner shaft assembly 18. Figure 7 shows a similar view to Figure 6A, but with the rail assembly 20 removed, thus exposing the inner shaft assembly 18.

[0075] The inner shaft assembly 18 may include an inner shaft 122 generally attached at its proximal end to the handle 14, and an inner retaining ring 40 disposed at the distal end of the inner shaft 122. The inner shaft 122 itself may be comprised of an inner proximal shaft 129 attached directly to the handle 14 at its proximal end, and a distal section 126 attached to the distal end of the inner proximal shaft 129. Thus, the inner retaining ring 40 may be generally attached at the distal end of the distal section 126. These components of the inner shaft assembly 18 may form a lumen through which other subassemblies may pass.

[0076] The inner retention member 40 can be configured as a prosthetic valve retention mechanism that can be used to engage an implant, as described with respect to FIG. 2A. For example, the inner retention member 40 can be a ring and can include a number of slots configured to engage with posts 72 on an implant 70, for example, as shown in FIG. 3E. The inner retention member 40 can also be considered part of the implant retention area 16 and can be located at a proximal end of the implant retention area 16. With the posts or other portions of the implant engaged with the inner retention member 40, the outer retention ring 42 can cover both the implant and the inner retention member 40 to secure the implant to the delivery system 10. Thus, the implant can be sandwiched between the inner retention member 40 of the inner shaft assembly 18 and the outer retention ring 42 of the midshaft assembly 21.

[0077] The inner shaft assembly 18 is arranged to be individually slidable relative to the other assemblies, and further, the inner shaft assembly 18, together with the outer sheath assembly 22, the mid shaft assembly 21, and the nosecone assembly 31, can slide both distally and proximally relative to the rail assembly 20.

[0078] Continuing inward from the inner shaft assembly 18 is the nosecone assembly 31, also seen in FIG. 8. This may be a nosecone shaft 27, which in some instances may have a nosecone 28 on its distal end. The nosecone 28 may be made from polyurethane for atraumatic introduction and to minimize damage to the venous vasculature. The nosecone 28 may also be radiopaque to provide visualization with fluoroscopy.

[0079] The nosecone shaft 27 may include an internal lumen sized and configured to slidably receive a guidewire to drive the delivery system 10 forward over the guidewire and through the vasculature. However, examples of the system 10 described herein may not use a guidewire, and therefore the nosecone shaft 27 may be solid. The nosecone shaft 27 may be connected from the nosecone 28 to a handle, or may be formed from different segments, such as other assemblies. Additionally, the nosecone shaft 27 may be formed from other materials, such as plastic or metal, similar to those described in detail above.

[0080] In some examples, the nosecone shaft 27 includes a guidewire shield 1200 disposed over a portion of the nosecone shaft 27 .

[0081] The nosecone assembly 31 is arranged to be independently slidable relative to the other assemblies, and further, the nosecone assembly 31, together with the outer sheath assembly 22, the mid shaft assembly 21, and the inner shaft assembly 18, can slide both distally and proximally relative to the rail assembly 20.

[0082] In some examples, one or more spacer sleeves (not shown) may be used between different assemblies of the delivery system 10. For example, a spacer sleeve may be concentrically positioned between the mid shaft assembly and the rail assembly 20, generally between the mid hypotube 43 and the rail hypotube 136. In some examples, a spacer sleeve may be embedded generally into the hypotube 43 of the mid shaft assembly 21, such as on the inner surface of the mid shaft assembly 21. In some examples, a spacer sleeve may be concentrically positioned between the rail assembly 20 and the inner shaft assembly 18, generally within the rail hypotube 136. In some examples, a spacer sleeve may be used between the outer sheath assembly 22 and the mid shaft assembly 21. In some examples, a spacer sleeve may be used between the inner shaft assembly 18 and the nosecone assembly 31. In some examples, four, three, two, or one of the spacer sleeves described above may be used. A spacer sleeve may be used in any of the locations described above.

[0083] As mentioned above, the outer sheath assembly 22, mid shaft assembly 21, inner shaft assembly 18, and rail assembly 20 can each contain an outer hypotube 104, a midshaft hypotube, a distal section 126, and a rail hypotube 136. Each of these hypotubes / sections / shafts can be laser machined to include multiple slots, which can create a tortuous path for the delivery system to follow.

[0084] For example, FIG. 9 shows an example of a rail hypotube 136. The rail hypotube 136 can also contain multiple circumferential slots. The rail hypotube 136 can generally be divided into several different sections. At the most proximal end is the uncut hypotube section 231. Continuing distally, the next section is the proximal slotted hypotube section 233. This section contains multiple circumferential slots cut into the rail hypotube 136. Generally, two slots are cut at each circumferential location, forming approximately half of the circumference. Thus, two backbones are formed between the slots that run the length of the hypotube 136. This is the section that can be guided by the proximal pull wire 140. Continuing distally, the proximal pull wires 140 connect at location 237, thus avoiding slots. This section may be immediately distal to the proximal slotted section.

[0085] Distal to the proximal pull wire connection region is the distal slotted hypotube section 235. This section is similar to the proximal slotted hypotube section 233, but has a greater number of slots cut therein at a comparable length. Thus, the distal slotted hypotube section 235 is intended to bend more easily than the proximal slotted hypotube section 233. The proximal slotted hypotube section 233 and the distal slotted hypotube section 235 may include rail shaft bends. In some examples, the proximal slotted section 233 may be configured to experience approximately a 90 degree bend at a half inch radius, while the distal slotted hypotube section 235 may bend approximately 180 degrees within a half inch radius. Additionally, as shown in FIG. 9, the backbone of the distal slotted hypotube section 235 is offset from the backbone of the proximal slotted hypotube section 233. Thus, the two sections achieve different bending patterns, which allows for three-dimensional steering of the rail assembly 20. In some examples, the backbone can be offset by 30 degrees, 45 degrees, or 90 degrees, although the particular offset is not limited. In some examples, the proximal slotted hypotube section 233 can include a compression coil, which allows the proximal slotted hypotube section 233 to remain rigid with respect to a particular bend in the distal slotted hypotube section 235.

[0086] At the distal most end of the distal slotted hypotube section 235 is a distal tension tether connection region 241 , which in this case is also a non-slotted section of the rail hypotube 136 .

[0087] A handle 14 is disposed at the proximal end of the delivery system 10. An example of the handle 14 is shown in FIG. 10. A cross-section of the handle 14 is shown in FIG. 11. The handle 14 can include a number of actuators, such as rotatable knobs, that can manipulate various components of the delivery system 10. Although operation of the handle 14 will be described with reference to delivering a replacement prosthetic valve or implant, such as that shown in FIGS. 3A-3E, the handle 14 and delivery system 10 can be used to deliver other devices as well.

[0088] The handle 14 is generally comprised of two housings, a rail housing 202 and a delivery housing 204, where the rail housing 202 is circumferentially disposed about the delivery housing 204. An inner surface of the rail housing 202 may include a threadable portion configured to engage an outer surface of the delivery housing 204. Thus, the delivery housing 204 is configured to slide (e.g., be threaded) within the rail housing 202, as described in more detail below. The rail housing 202 generally surrounds approximately half the length of the delivery housing 204, such that the delivery housing 204 extends outwardly beyond the rail housing 202, both proximally and distally.

[0089] The rail housing 202 can contain two rotatable knobs, a distal pull wire knob 206 and a proximal pull wire knob 208. However, the number of rotatable knobs on the rail housing 202 can vary depending on the number of pull wires being used. Rotational actuation of the distal pull wire knob 206 can provide a proximal force, which provides axial tension to the distal pull wire 138, causing bending of the distal slotted section of the rail hypotube 136. The distal pull wire knob 206 can be rotationally actuated in either direction, causing bending in either direction, which can control the anterior-posterior angle. Rotational actuation of the proximal pull wire knob 208 can provide a proximal force, which provides axial tension to the proximal pull wire 140, causing bending of the proximal slotted section 233 of the rail hypotube 136, which can control the medial-lateral angle. The proximal pull wire knob 208 can be rotationally actuated in either direction, thereby inducing a bend in either direction. Thus, when both knobs are actuated, there can be two bends in the rail hypotube 136, allowing three-dimensional steering with respect to the rail shaft 132, and thus the distal end of the delivery system 10. Additionally, the proximal end of the rail shaft 132 is connected on the inside surface of the rail housing 202.

[0090] The bending of the rail shaft 132 can be used to position the system, particularly the distal end, to a desired location in the patient, such as at the native tricuspid valve. In some examples, the rotational actuation of the pull wire knobs 206 / 208 can help steer the distal end of the delivery system 10 to a desired location near the valve to be treated, such as the tricuspid or mitral valve.

[0091] Continuing with the delivery housing 204, the proximal end of the inner shaft assembly 18, the proximal end of the outer sheath assembly 22, the proximal end of the mid shaft assembly 21, and the proximal end of the nosecone shaft assembly 31 may be connected to an inner surface of the delivery housing 204 of the handle 14 such that they can be driven axially relative to the rail assembly 20 and relative to the rail housing 202.

[0092] A rotatable outer sheath knob 210 can be disposed on the distal end of the delivery housing 204, such as at the distal end of the rail housing 202. Rotational actuation of the outer sheath knob 210 pulls the outer sheath assembly 22 axially proximally, thereby pulling the capsule 106 away from the implant it covers, thereby releasing the distal end of the implant. Thus, the outer sheath assembly 22 is translated independently relative to the other shafts in the delivery system 10. The distal end of the implant can be released first, while the proximal end of the implant can remain radially compressed between the inner and outer retention members 40 and 42.

[0093] The rotatable mid-shaft knob 214 can be disposed on the delivery housing 204, and in some instances can be disposed proximal to the rotatable outer sheath knob 210 and distal to the rail housing 202. Rotational actuation of the mid-shaft knob 214 pulls the mid-shaft assembly 21 axially proximally, which pulls the outer retaining ring 42 away from the implant, exposing the inner retaining member 40 and the proximal end of the implant, which releases the implant. Thus, the mid-shaft assembly 21 is translated independently relative to the other shafts in the delivery system 10.

[0094] A rotatable depth knob 212 can be located on the proximal end of the delivery housing 204, and thus proximal to the rail housing 202. When the depth knob 212 is rotationally driven, the entire delivery housing 204 is driven distally or proximally relative to the rail housing 202, which remains in the same position. Thus, at the distal end of the delivery system 10, the inner shaft assembly 18, the outer sheath assembly 22, the mid shaft assembly 21, and the nosecone shaft assembly 31 are driven together (e.g., simultaneously) proximally or distally relative to the rail assembly 20, while the implant 70 remains in the compressed configuration. In some examples, driving the depth knob 212 can sequentially drive the inner shaft assembly 18, the outer sheath assembly 22, the mid shaft assembly 21, and the nosecone shaft assembly 31 relative to the rail assembly 20. In some examples, actuation of the depth knob 212 can drive the inner shaft assembly 18, the outer sheath assembly 22, and the mid shaft assembly 21 together relative to the rail assembly 20. Thus, the rail shaft 132 can be aligned in a particular direction and the other assemblies can be driven distally or proximally relative to the rail shaft 132 for final alignment without releasing the implant. The components can be driven forward approximately 1 cm, 2 cm, 3 cm, 5 cm, 6 cm, 7 cm, 8 cm, 9 cm, or 10 cm along the rail shaft 132. The components can be driven forward approximately greater than 1 cm, greater than 2 cm, greater than 3 cm, greater than 5 cm, greater than 6 cm, greater than 7 cm, greater than 8 cm, greater than 9 cm, or greater than 10 cm along the rail shaft 132. An example of this is shown in Figure 2C.The capsule 106 and outer retaining ring 42 can then be individually, and in some instances sequentially, withdrawn from the inner shaft assembly 18 as described above, thereby releasing the implant. The assemblies other than the rail assembly 20 can then be withdrawn back onto the rail shaft 132 by rotating the depth knob 212 in the reverse direction.

[0095] The handle 14 may further include a mechanism (knob, button, handle) 216 for driving the nosecone shaft 27, and thus the nosecone 28. For example, the knob 216 may be part of the nosecone assembly 31 that extends from the proximal end of the handle 14. Thus, by pulling or pushing the knob 216, a user may drive the nosecone shaft 27 in a distal or proximal translational direction, independently of the other shafts. This may be advantageous in driving the nosecone 28 in a proximal translational direction into the outer sheath assembly 22 / capsule 106, thus facilitating withdrawal of the delivery system 10 from the patient.

[0096] In some examples, the handle 14 can provide a locking member 218, such as a spring lock member, to prevent translational movement of the nosecone shaft 27 by the knob 216 as described above. In some examples, the locking member 218 can be always active, so that the nosecone shaft 27 will not move unless the user releases the locking member 218. The locking member can be, for example, a spring lock member that is always active until a button 218 on the handle 14 is pressed to release the spring lock member and allow the nosecone shaft 27 to translate proximally / distally. In some examples, the spring lock member 218 allows movement of the nosecone shaft 27 in one direction, such as either proximal or distal movement, and prevents movement in the opposite direction.

[0097] The handle 14 can further include communicable flushing ports for flushing various lumens in the delivery system 10. In some examples, a single flushing port on the handle 14 can provide a fluid connection to multiple assemblies. In some examples, the flushing port can provide a fluid connection to the outer sheath assembly 22. In some examples, the flushing port can provide a fluid connection to the outer sheath assembly 22 and the mid shaft assembly 21. In some examples, the flushing port can provide a fluid connection to the outer sheath assembly 22, the mid shaft assembly 21, and the rail assembly 20. In some examples, the flushing port can provide a fluid connection to the outer sheath assembly 22, the mid shaft assembly 21, the rail assembly 20, and the inner shaft assembly 18. Thus, in some examples, the rail shaft 132, the outer retaining ring 42, and the capsule 106 can all be flushed by a single flushing port.

[0098] 12A illustrates a side view of the distal portion of the elongate shaft 12 in a straight configuration. The capsule 106 is positioned between the outer hypotube 104 and the nosecone 28.

[0099] The elongate shaft 12 may include one or more bends, which may allow the elongate shaft 12 to bend at the bends. In the example shown in FIG. 12A, for example, the elongate shaft 12 includes two bends 600, 602. The bends 600 may correspond to the distal rail portion 601 shown in FIGS. 6B and 6C, and the bends 602 may correspond to the proximal rail portion 603 shown in FIGS. 6B and 6C. In this manner, the bends 600, 602 may be configured to bend the elongate shaft 12 in mutually orthogonal planes, where the bends 600 may bend in a plane that may be referred to as a vertical plane, and the bends 602 may bend in a plane that may be referred to as a horizontal plane. The bends 600, 602 may be configured to bend to orient the capsule 106 to a desired position for deployment of an implant contained therein.

[0100] The capsule 106 (and the implant retaining region 16 contained therein) may be configured to be slidably actuated relative to the bent portions 600, 602 in the manner disclosed herein. For example, the outer sheath assembly 22, the mid shaft assembly 21, the inner shaft assembly 18, and the nosecone assembly 31 may be configured (as part of the rail assembly 20) to be slidably actuated relative to the bent portions 600, 602 to vary the distance or depth of the capsule 106 from the rail assembly 20. The outer sheath assembly 22 may be configured to be slidably actuated relative to the rail assembly 20 to vary the distance of the implant retaining region from a native valve, such as the patient's mitral or tricuspid valve, for which the implant is to be deployed.

[0101] 12B, bend portion 600, located proximal to capsule 106 and disposed between capsule 106 and bend portion 602, is shown as deflecting the distal end of elongate shaft 12 in a direction that may be referred to as downward as shown in FIG. 12B. Bend portion 600 deflects the distal end of elongate shaft 12 in a plane 607, shown in FIG. 12C, which may be referred to as a vertical plane. Thus, bend portion 600 has changed the orientation of capsule 106, the distal end of elongate shaft 12, and the implant retaining region 16 positioned within capsule 106.

[0102] FIG. 12C illustrates a plan view of the elongate shaft 12 shown in FIGS. 12A and 12B, where the bent portion 602 has been bent. In FIG. 12C, the elongate shaft 12 is shown as being positioned within the right atrium of the heart and above the tricuspid heart valve, including the anterior portion 1001, the posterior portion 1003, and the septal portion 1005. In FIG. 12C, the bent portion 602, located proximal to the bent portion 600, is shown as deflecting the distal end of the elongate shaft 12 in a direction that may be referred to as a rightward direction as shown in FIG. 12C. The bent portion 602 deflects the distal end of the elongate shaft 12 in a plane 609 shown in FIG. 12B, which may be referred to as a horizontal plane. Thus, the bent portion 602 has changed the orientation of the capsule 106, the distal end of the elongate shaft 12, and the implant retaining region 16 positioned within the capsule 106.

[0103] Flexing portion 602 may deflect flexing portion 600 and capsule 106 in a plane perpendicular to the plane in which flexing portion 600 may deflect capsule 106. Orthogonal deflection planes may allow for three-dimensional steering for capsule 106.

[0104] A bend 602, as shown in Figure 12C, may be configured to deflect the distal end of the elongate shaft 12 to the right. Such a deflection direction may be provided by the tension tether configuration shown in Figure 6C.

[0105] Control of the elongate shaft 12 can be complicated due to visualization of the elongate shaft 12 during the procedure. For example, the bend portion 600 can be deflected in a vertical plane and the bend portion 602 can be deflected in a horizontal plane, which may require understanding the geometry of the elongate shaft 12 and the movement of the bend portions 600, 602 to determine how to position the capsule in a desired position relative to the native valve. For example, to drive the capsule 106 to a specific position relative to the anterior portion 1001, the posterior portion 1003, and the septal portion 1005, the user must determine the movement of both the bend portion 602 and the bend portion 600, where the bend portion 602 moves in an arc that affects the position of the bend portion 600. Controlling such an arc can be technically challenging and laborious to manufacture. The deflection of the bend portion 602 affects the direction of the deflection of the bend portion 600. There is a need for improved ease of use with elongate shafts in delivery systems.

[0106] 13A illustrates one example of an elongate shaft 650 that may be utilized with a delivery system. The delivery system may be configured similarly to the examples of delivery systems disclosed herein, or may have a different configuration, as desired in the examples.

[0107] The elongate shaft 650 may include a distal end that may include an implant holding area that may be configured similarly to the implant holding area 16 shown in Figures 2A and 2B, for example. The implant holding area may include a capsule 106 that may cover the implant holding area and that may be driven back to deploy an implant held by the capsule 106. The distal end of the elongate shaft 650 may include a nosecone 28 that may be positioned distal to the capsule 106 and to the implant holding area.

[0108] The elongate shaft 650 may include a distal or first bent portion 652, which may be configured similarly to the bent portion 600 described with respect to Figures 12A-12C. The distal bent portion 652 may be configured to deflect the distal end in a plane, which may be referred to as a vertical plane, such as, for example, the plane 607 shown in Figure 12C. The distal bent portion 652 may be configured to deflect the distal end downward (as shown in Figure 13B) and return to align the distal end to be coaxial with the proximal portion of the elongate shaft 650 (as shown in Figure 13A). An implant retaining region within the capsule 106 may be located distal to the distal bent portion 652.

[0109] The elongate shaft 650 may include an intermediate or second bent portion 654 that may be located more proximally than the distal bent portion 652. The intermediate bent portion 654 may be configured to be rotationally driven in a rotational orientation within a plane 653 that may extend transversely to the plane 607. The plane 653 may be horizontal in examples and may extend perpendicular to the plane 607 in which the distal bent portion 652 rotates. FIG. 13C, for example, illustrates the rotation of the intermediate bent portion 654 in a rotational orientation (indicated by arrow 656). The intermediate bent portion 654 may be configured to deflect the distal bent portion 652 and to deflect the distal end of the elongate shaft 650.

[0110] The elongate shaft 650 may include a proximal or third bent portion 658 that may be located more proximally than the intermediate bent portion 654. The proximal bent portion 658 may be configured to be rotationally driven in a rotational sense within the plane 653 in which the intermediate bent portion 654 rotates. The proximal bent portion 658 may be configured to be rotationally driven in a rotational sense (indicated by arrow 657) that may be an opposite rotational sense to the rotational sense of the intermediate bent portion 654 within the plane 653. For example, in FIG. 13C, the intermediate bent portion 654 is shown as rotating in a counterclockwise rotational sense and the proximal bent portion 658 is shown as rotating in a clockwise rotational sense. In an example, such a configuration may be reversed (with the intermediate bent portion 654 rotating in a clockwise rotational sense and the proximal bent portion 658 rotating in a counterclockwise rotational sense). The proximal bend portion 658 may be configured to deflect the intermediate bend portion 654 and to deflect the distal bend portion 652 , as well as to deflect the distal end of the elongate shaft 650 .

[0111] The elongate shaft 650 may include a distal or first extension 660 that may be located proximally relative to the distal bend 652 and distal to the intermediate bend 654. The distal extension 660 may include a connecting portion joining the distal bend 652 and the intermediate bend 654 and may have a relatively short or long length, as desired. The distal extension 660 may include, for example, a divider between the rotational orientations of the distal bend 652 relative to the intermediate bend 654. The distal extension 660 may extend along an axis 663 (e.g., as shown in FIG. 13C).

[0112] The elongate shaft 650 may include a proximal or second extension 664 that may be located proximally relative to the proximal bend 658. The proximal extension 664 may connect the proximal bend 658 to the handle 14 and may have a relatively short or long length, as desired. The proximal extension 664 may extend along an axis 666 (shown, for example, in FIG. 13C).

[0113] The elongate shaft 650 may include an intermediate or third extension portion 668 that may be disposed between the proximal bend portion 658 and the intermediate bend portion 654. The intermediate extension portion 668 may be disposed distal to the proximal bend portion 658 and proximal to the intermediate bend portion 654. The intermediate extension portion 668 may include a connecting portion joining the intermediate bend portion 654 and the proximal bend portion 658 and may have a relatively short or long length, as desired. The intermediate extension portion 668 may include, for example, a divider between the rotational orientations of the intermediate bend portion 654 relative to the proximal bend portion 658. The intermediate extension portion 668 may extend along an axis 670 (e.g., as shown in FIG. 13C ) and may be configured to extend transversely relative to the axis 663 of the distal extension portion 660 and relative to the axis 666 of the proximal extension portion 664.

[0114] The bent portions 652, 654, 658 and the extension portions 660, 664, 668 may be configured to be coaxial with one another, for example, as shown in Figure 13A. The axis 663 along which the distal extension portion 660 extends, as shown in Figure 13C, may be coaxial with the axis 666 along which the proximal extension portion 664 extends, for example. The bent portions 652, 654, 658 may each be straight.

[0115] A deflection mechanism may be utilized to orient a portion of the elongate shaft 650 in a desired direction by deflecting the bends 652, 654, 658. The deflection mechanism may be configured to deflect the distal bend 652 to deflect the distal end of the elongate shaft 650 in a plane (such as the plane 607 shown in FIG. 12C). FIG. 13B illustrates the distal bend 652 deflecting the distal end of the elongate shaft 650 downward. The distal bend 652 extends transversely to the axis 663 of the distal extension 660 by deflecting the distal end of the elongate shaft 650. The distal bend 652 may extend perpendicularly to the axis 663 of the distal extension 660 by deflecting the distal end of the elongate shaft 650.

[0116] The deflection mechanism may be configured to deflect the intermediate bending portion 654 in a rotational direction (indicated by arrow 656) in the plane 653 and may be configured to deflect the proximal bending portion 658 in a rotational direction (indicated by arrow 657) in the plane 653, offsetting the axis 663 from the axis 666 with the axis 663 extending parallel to the axis 666. FIG. 13C illustrates such deflection, for example, for the intermediate bending portion 654 and the proximal bending portion 658. In FIG. 13C, the distal end and capsule 106 are deflected downward in a plane (such as the plane 607 shown in FIG. 12C). The intermediate bending portion 654 rotates in a rotational direction indicated by arrow 656. The proximal bending portion 658 rotates in a rotational direction indicated by arrow 657. Rotation of the intermediate bend portion 654 and the proximal bend portion 658 results in an offset of the axis 663 from the axis 666. The intermediate extension portion 668 and the axis 670 extend transversely to the axes 663, 666. The intermediate extension portion 668 extends obliquely relative to the proximal extension portion 664 and relative to the distal extension portion 660.

[0117] The offset of axis 663 from axis 666 results in a lateral displacement of the position of the distal end of elongate shaft 650 and capsule 106, and retraction of the distal end of elongate shaft 650 and capsule 106. Rotation of the capsule 106 and the distal end of elongate shaft 650 is reduced or eliminated with rotation of intermediate bend portion 654 and proximal bend portion 658. As a result, lateral movement of the distal end of elongate shaft 650 and of the capsule 106 may be relative to the proximal extension portion 664, which may extend into the handle 14 of the delivery system. The parallel configuration of axes 666, 663 may reduce or eliminate rotation of the capsule and the distal end of elongate shaft 650.

[0118] The intermediate bend portion 654 may be configured to be deflected in a rotational direction (indicated by arrow 656) by a deflection mechanism by an amount equal to the deflection of the proximal bend portion 658 in the rotational direction (indicated by arrow 657). For example, the intermediate bend portion 654 and the proximal bend portion 658 may each rotate by the same amount or angle, albeit in opposite directions, to allow the axis 663 to remain parallel to the axis 666 upon lateral displacement of the distal end of the elongate shaft 650 and the capsule 106. In an example, the deflection of the intermediate bend portion 654 may be simultaneous and equal in amount to the deflection of the proximal bend portion 658. The deflection mechanism may be configured to produce such simultaneous deflection of the intermediate bend portion 654 and the proximal bend portion 658 and equal deflection of the intermediate bend portion 654 and the proximal bend portion 658. Although in opposite directions, the same amount of deflection of the intermediate bend portion 654 and the proximal bend portion 658 may be induced throughout the range of deflection of the intermediate bend portion 654 and the proximal bend portion 658. This may result in an "S" shaped configuration of the elongate shaft 650.

[0119] The intermediate and proximal bends 654, 658 may be deflected a desired amount and may be deflected such that the axis 670 of the intermediate extension 668 extends perpendicular to the axes 663, 666 of the corresponding distal and proximal extensions 660, 664, respectively, and may continue to be deflected beyond such position, if desired, until the intermediate extension 654 contacts the proximal extension 664. FIG. 13D illustrates deflection of the intermediate and proximal bends 654, 658 to such an extent that the axis 670 extends perpendicular to the axes 663, 666. Lateral displacement of the end of the elongate shaft 650 and the capsule 106 has been caused to a greater extent than shown in FIG. 13C. The end of the elongate shaft 650 and the capsule 106 have been driven back to a greater extent than shown in FIG. 13C.

[0120] In examples, the bent portions 652, 654, 658 may be returned to their original, un-bent positions to withdraw the elongate shaft 650 from the deployment site.

[0121] The deflection of the intermediate bend portion 654 and the proximal bend portion 658 may reduce the complexity of the movement of the position of the distal end of the elongate shaft 650 and the position of the capsule 106, as compared to the example shown in FIG. 12C. For example, the user may determine that an angular deflection of the capsule 106 with respect to the axis of the heart valve may be caused via the distal bend portion 652, and a lateral displacement of the capsule 106 may be caused via the deflection of the intermediate bend portion 654 and the proximal bend portion 658. Improved positioning of the distal end of the elongate shaft 650 and the capsule 106 may be provided during the deployment procedure. In the example shown in FIG. 12C, the deflection of the bend portion 602 changes the direction in which the bend portion 600 is deflected, although the direction in which the distal bend portion 652 is deflected may also be the same upon deflection of the intermediate bend portion 654 and the proximal bend portion 656. Deflection may be utilized to center the location within the left or right atrium relative to an implantation site such as the tricuspid or mitral valve.

[0122] 13E illustrates a cross-sectional view of the elongate shaft 650 showing components of a deflection mechanism that may be utilized to deflect the bent portions 652, 654, 658. The deflection mechanism may include, for example, a shaft 671 that may be disposed within an outer sheath 672 of the elongate shaft 650. The shaft 671 may include a distal portion 674, an intermediate portion 676, and a proximal portion 678. The location of the distal portion 674 may correspond to the distal bent portion 652, the location of the intermediate portion 676 may correspond to the intermediate bent portion 654, and the location of the proximal portion 678 may correspond to the proximal bent portion 658.

[0123] The deflection mechanism may include a first tensioning tether 680 or pull wire that may be configured to deflect the distal bend portion 652. The first tensioning tether 680 may have a distal end 682 that may be coupled, for example, to a connection point on the shaft 671. The connection point may be positioned on a distal connector body 684, such as a distal connector ring or other structure of the shaft 671. The first tensioning tether 680 may extend proximally through an intermediate connector body 686 and through a proximal connector body 688 of the shaft 671. For example, the first tensioning tether 680 may pass through a tether lumen 690 that may pass through the intermediate connector body 686 and the proximal connector body 688. The proximal end 692 of the first tensioning tether 680 may be coupled to a tensioning body 694, where the tensioning body 694 may be configured to be actuated to create tension in the first tensioning tether 680 to drive the first tensioning tether 680 backward, and to be configured to release the tension to allow the first tensioning tether 680 to be driven forward in a distal direction.

[0124] The deflection mechanism may include a second tensioning tether 696 or pull wire that may be configured to deflect the intermediate bending portion 654. The second tensioning tether 696 may have a distal end 698 that may be coupled, for example, to a connection point on the shaft 671. The connection point may be positioned on an intermediate connector body 686, such as an intermediate connector ring or other structure of the shaft 671. The second tensioning tether 696 may extend proximally through the proximal connector body 688 of the shaft 671. For example, the second tensioning tether 696 may pass through a tether lumen 700 that may pass through the proximal connector body 688. The proximal end 702 of the second tensioning tether 696 may be coupled to a tensioning body 704, where the tensioning body 704 may be configured to be actuated to create tension in the second tensioning tether 696 to drive the second tensioning tether 696 backward, and to be configured to release the tension to allow the second tensioning tether 696 to be driven forward in a distal direction.

[0125] The position of the second tensioning tether 696 relative to the first tensioning tether 680 may be offset circumferentially to create a desired orientation of deflection for the distal bend portion 652 relative to the intermediate bend portion 654. The circumferential offset of the second tensioning tether 696 relative to the first tensioning tether 680 may be 90 degrees, or another amount, as desired. FIG. 13F illustrates a cross-sectional view of the elongate shaft 650, for example, taken across the central axis of the elongate shaft 650 (along line 13F-13F in FIG. 13E). The circumferential position of the first tensioning tether 680 is shown. FIG. 13G illustrates a cross-sectional view of the elongate shaft 650 taken along line 13G-13G in FIG. The circumferential position of the second tensioning tether 696 relative to the first tensioning tether 680 is shown.

[0126] The deflection mechanism may include a third tension tether 706 or tension wire that may be configured to deflect the proximal bend portion 658. The third tension tether 706 may have a distal end 708 that may be coupled to a connection point on the shaft 671, for example. The connection point may be positioned on a proximal connector body 688, such as a proximal connector ring or other structure of the shaft 671. The tension tether 706 may extend proximally to a proximal end 710 of the tension tether 706 that may be coupled to a tension body 704, which may be configured to be actuated to create tension in the tension tether 706 to drive the tension tether 706 backward and to release the tension to allow the tension tether 706 to be driven forward distally. The proximal connector body 688 may correspond to the location of the intermediate extension portion 668, which may correspond to the location of the distal extension portion 660.

[0127] The location of the third tensioning tether 706 relative to the first tensioning tether 680 and the second tensioning tether 696 may be circumferentially offset to create a desired orientation of deflection for the proximal bend portion 658 relative to the distal bend portion 652 and the intermediate bend portion 654. The circumferential offset of the third tensioning tether 706 relative to the first tensioning tether 680 may be 90 degrees, or another amount as desired. FIG. 13H, for example, illustrates a cross-sectional view of the elongate shaft 650 across the central axis of the elongate shaft 650 (along line 13H-13H in FIG. 13E). The circumferential location of the third tensioning tether 706 is shown relative to the first tensioning tether 680 and the second tensioning tether 696.

[0128] The third tension tether 706 may extend parallel to the second tension tether 696 at a location on the elongate shaft 671 opposite the location of the second tension tether 696. The third tension tether 706 may be coupled to the proximal connector body 688 at a location, and the second tension tether 696 may be coupled to the intermediate connector body 686 at a location opposite the location of the connection between the third tension tether 706 and the proximal connector body 688. In this manner, pulling on the second tension tether 696 may result in opposite rotation of the corresponding intermediate and proximal bend portions 654 and 658, respectively, although they may be coplanar relative to the pulling on the third tension tether 706. The rotation of the intermediate and proximal bend portions 654 and 658 may be in a plane transverse to the plane of rotation of the distal bend portion 652.

[0129] The proximal ends 702, 710 of the corresponding second and third tensioning tethers 696, 706 may be coupled to the tensioning body 704 to allow the tensioning body 704 to drive both tensioning tethers 696, 706 back simultaneously. Driving the tensioning body 704 back may drive the second and third tensioning tethers 696, 706 back by the same amount, which will cause the bends 654, 658 to rotate by the same amount, as shown, for example, in FIGS. 13C and 13D. Driving the tensioning body 704 forward distally may reduce deflection of the intermediate and proximal bends 654, 658, and may straighten the intermediate and proximal bends 654, 658, if desired. In this manner, deflection of both the intermediate and proximal bends 654, 658 may be controlled simultaneously by controlling the tensioning body 704. The distal bending portion 652 may be independently controlled via control of the tension body 694.

[0130] In an example, the shaft 671 may include one or more flexibility notches to allow deflection of the bending portions 652, 654, 658 in a desired manner. For example, the distal bending portion 652 may include one or more flexibility notches 712 configured to allow the bending portion 652 to deflect. The flexibility notches 712 may be disposed on the shaft 671 and may extend in a circumferential direction. The flexibility notches 712 may have an arc-like shape and may be spaced apart from one another in an axial direction. The flexibility notches 712 may be disposed on a side of the shaft 671 along which the tensioning tether 680 may extend.

[0131] The intermediate bending portion 654 may include one or more flexibility notches 714 configured to allow the intermediate bending portion 654 to deflect, and the proximal bending portion 658 may include one or more flexibility notches 716 configured to allow the proximal bending portion 658 to deflect. The flexibility notches 714 of the intermediate bending portion 654 may be disposed on a portion of the shaft 671 opposite the location of the flexibility notches 716 of the proximal bending portion 658. The second tensioning tether 696 may extend along the flexibility notches 714, and the third tensioning tether 706 may extend along the flexibility notches 716. The flexibility notches 714, 716 may be configured to allow the desired deflection of the bending portions 654, 658.

[0132] In examples, the tether lumens 690, 700 may include a compression body or compression coil that may apply distal compression to reduce the likelihood of undesired deflection of the bend portions 654, 658 when tension is created in one of the tensioning tethers 680, 696, 706. For example, when tension is created in the first tensioning tether 680, the compression force applied to the tether lumen 690 may reduce the likelihood of undesired deflection of the intermediate bend portion 654.

[0133] In an example, the outer sheath 672 may extend to the capsule 106 and may be utilized to drive the capsule 106 back during deployment of the implant. In an example, the outer sheath 672 may include the outer sheath assembly 22 described herein. In an example, the shaft 671 may include the rail assembly 20 described herein and may be utilized in a manner similar to the rail assembly 20. For example, one or more other assemblies may be configured to be driven forward and backward relative to the shaft 671 to vary the depth during the deployment of the implant. The shaft 671 may be utilized with one or more other assemblies disclosed herein, including the outer sheath assembly 22, the inner shaft assembly 18, the nosecone assembly 31, and / or the midshaft assembly 21 as disclosed herein.

[0134] In examples, tensioning bodies 694, 704 may be disposed within a handle of a delivery system, such as handle 14 described with respect to Figures 10 and 11. Tensioning body 694 may be configured to be manipulated, for example, by distal knob 206, and tensioning body 704 may be configured to be manipulated by proximal knob 208, among other forms of manipulation. Tensioning body 704 may be configured to be driven back into the handle to simultaneously drive tensioning tethers 696, 706 back.

[0135] In examples, other configurations of deflection mechanisms may be utilized as desired. FIG. 14 illustrates an example where the use of the third tensioning tether 706 may be omitted and the second tensioning tether 696 may be utilized to deflect both the intermediate bending portion 654 and the proximal bending portion 658. The second tensioning tether 696 may extend along the intermediate bending portion 654 and the proximal bending portion 658, for example, and tension in the second tensioning tether 696 creates a deflection of both the intermediate bending portion 654 and the proximal bending portion 658. The flexible notches 714, 716 may be configured to create the desired opposing rotational orientations of the corresponding intermediate bending portion 654 and the proximal bending portion 658, respectively. In examples, at least one tensioning tether may be configured to deflect the intermediate bending portion 654 and the proximal bending portion 658. In examples, at least one tensioning tether may be configured to deflect the distal bending portion 652. In examples, the number of tension tethers utilized for each bend portion 652, 654, 658 may be varied as desired. For example, two tension tethers or three tension tethers may be utilized as desired for each bend portion 652, 654, 658. Various other modifications to the delivery system may be utilized as desired.

[0136] The features in the examples of Figures 13A-14 may be used alone or in combination with any other examples disclosed herein.

[0137] 15A-15B illustrate one example of a deflection mechanism including a notch 640 in a portion of the elongate shaft 12 and a tension shaft 642 that can be driven back to deflect the elongate shaft 12 at the location of the notch 640. Referring to FIG. 15A, the notch 640 may be located on the rail shaft 132 at a desired location. Such a location may be proximal to the rail hypotube 136 or proximal to the bent portions 634, 636 of the rail shaft 132. For example, as shown in FIG. 15A, the notch 640 may be proximal to the non-notched (i.e., non-slotted) hypotube section 231. The bent portion 634 may correspond to bent portion 600 or 652, and the bent portion 636 may correspond to bent portion 602 or 654.

[0138] The notch 640 may have a configuration that biases the rail shaft 132 to deflect at the notch 640 away from the orientation in which the bent portion 634 deflected the distal end of the elongate shaft 12 .

[0139] 15B, a cross-sectional view of the rail shaft 132 is shown. The deflection mechanism may include an inner shaft or tension shaft 642, which may be disposed inside the rail shaft 132. The tension shaft 642 may be disposed between the rail shaft 132 and an inner shaft, such as the inner shaft assembly 18 or the nosecone assembly 31. In other examples, the inner shaft or tension shaft 642 may be provided in other locations.

[0140] The inner or tensioning shaft 642 may include a stop 644 coupled thereto. The rail shaft 132, particularly the portion of the rail shaft 132 distal to the notch 640, may include a stop 646. The deflection mechanism may be configured such that when the tensioning shaft 642 is pulled proximally, the stop 644 abuts against the stop 646, thereby applying a proximal force to the rail shaft 132, particularly the portion of the rail shaft 132 that includes the notch 640. With the notch 640 providing a biased deflection direction, the rail shaft 132, and thus the elongate shaft 12, may be deflected in this direction of deflection that is opposite to the direction in which the bent portion 634 deflected the distal end of the elongate shaft 12. The tensioning shaft 642 may then be driven distally to reduce the force between the stops 644, 646, thereby straightening the rail shaft 132. Although FIG. 15B shows the stops 644, 646 as spaced apart from one another, pulling the inner or pulling shaft 642 proximally can cause the stops 644, 646 to contact one another.

[0141] 15B shows a single tension shaft 642, in other examples, multiple tension shafts may be utilized as desired. For example, if four equally spaced tension shafts (spaced 90° apart from one another) with corresponding stops are utilized, the combination of tension shaft actuation may provide various deflection orientations for the elongate shaft 12. The cut patterns may be provided such that various deflection orientations are possible. Other configurations may be utilized to change the deflection orientation of the elongate shaft 12. Thus, the tension shaft or shafts may be configured to deflect the elongate shaft 12 to cause the bent portion 634, 636 to deflect in a direction opposite to the direction in which the bent portion 634 deflected the distal end of the elongate shaft 12, which may include a direction opposite (180°) to the direction in which the bent portion 634 deflected the distal end of the elongate shaft 12, and various other orientations (e.g., 135°, among others) that are located between and include the opposite (180°) and perpendicular (90°) orientations.

[0142] 16A-16B illustrate external views of the example of FIGS. 15A-15B. As shown in FIG. 16A, the bent portion 600 may deflect the distal end of the elongate shaft 12 in one direction. The deflection mechanism shown in FIGS. 15A-15B may deflect the bent portion 600 in a direction opposite to that of the distal end of the elongate shaft 12 by deflecting the proximal portion 614 of the elongate shaft 12. FIG. 16B illustrates that the bent portions 600, 602 may continue to operate to deflect the respective distal portions of the elongate shaft 12, with the distal bent portion 600 configured to deflect in a vertical plane and the proximal bent portion 602 configured to deflect in a horizontal plane.

[0143] In an example, an advantage of the configuration including the tension shaft 642 and the stop 646 on the rail shaft 132 is that when the depth knob 212, shown in FIGS. 10 and 11, is rotationally driven to decrease the depth of the tension shaft 642, the proximal portion 614 of the elongate shaft will deflect as shown in FIG. 16A. Thus, for example, a user attempting to decrease the depth of the capsule 106 relative to the implantation site may deflect the capsule 106 away from the implantation site as they attempt to decrease the depth of the capsule 106. This may be beneficial during an implantation procedure because the user may prefer to continue to deflect the capsule 106 away from the implantation site when using the depth knob 212 because the user was already attempting to drive the capsule 106 back from the implantation site.

[0144] Deflection mechanisms may be utilized to provide additional or different travel of the elongate shaft 12. Such additional or different travel may be desired for a variety of reasons, including because different patient anatomies are navigated by the distal end of the elongate shaft 12 and because different patient anatomies are navigated by different uses of the elongate shaft 12.

[0145] The deflection mechanism may be utilized to actuate the elongate shaft 12 to deliver a replacement heart valve, which may include a replacement tricuspid valve. Although many of the examples herein are described with respect to a replacement tricuspid valve, the deflection mechanism may be utilized in a variety of other implementations, including delivering a replacement mitral valve, aortic valve, or pulmonary valve, or including valve repair procedures including tricuspid valve repair, mitral valve repair, aortic valve repair, or pulmonary valve repair.

[0146] 17A-19 illustrate the use of the elongate shaft 12 to treat a patient's tricuspid valve. The elongate shaft 12 may be threaded into the patient's body in an intravascular manner, which may include percutaneous introduction into the patient's vascular system. For example, the elongate shaft 12 may be introduced into the ipsilateral femoral vein and driven forward toward the right atrium 1076. In other examples, other introduction techniques may be utilized, including a transjugular approach, or other approaches, including a transapical approach.

[0147] 17A, the elongate shaft 12 may be driven forward through the inferior vena cava 1079 to access or reach the right atrium 1076 of the patient's heart. The right ventricle 1077, the tricuspid valve 1083, including its leaflets 1087, the tricuspid annulus 1085, and the superior vena cava 1081 are also shown.

[0148] The delivery system may include the use of a deflection mechanism as described herein. The elongate shaft 12 may be driven forward toward the right atrium 1076, whereupon the distal end of the elongate shaft 12 is deflected to orient the capsule 106, and thus the implant holding area 16, so that the implant contained therein is deployed in a desired manner relative to the tricuspid valve 1083. As depicted in FIG. 17A, the distal end of the elongate shaft 12 may need to be deflected toward the tricuspid valve 1083 to align the distal end of the elongate shaft 12 and the capsule 106 (and a deployment port located at the distal end of the capsule for deployment of the implant therefrom) with the central axis of the tricuspid valve 1083. Other deflection orientations may be desirable for other deployment techniques.

[0149] Bends 600, 602 may be utilized to deflect the distal end of the elongate shaft 12 in a desired orientation. Bends 600, 602 may be configured to deflect the distal end of the elongate shaft in a vertical plane, thereby providing two planes of deflection. Bends 600, 602 may be configured similar to that shown in FIG. 6C, where the proximal bend 602 is configured to deflect the distal portion of the elongate shaft 12 to the right (or forward) relative to the downward (or toward the ventricle) deflection of the distal bend 600. Such a configuration may take into account the location of the tricuspid valve 1083 relative to the inferior vena cava 1079 in the human heart.

[0150] However, additional movement may be provided by the deflection mechanisms disclosed herein. Such deflection may include deflecting the proximal and bent portions 600, 602 of the elongate shaft 12 toward the atrium (or provide height from the tricuspid valve 1083). The capsule 106 and distal end of the elongate shaft 12 may also be deflected toward the atrium (or provide height from the tricuspid valve 1083).

[0151] The deflection mechanism may be utilized to take into account the patient's anatomy, which may include the geometry of the right atrium 1076, the size and relative location of the tricuspid valve 1083, and the geometry of the inferior vena cava 1079. For example, as shown in FIG. 17A, depending on the geometry of the patient's right atrium 1076, the distance of the bend portion 600 relative to the distal end of the elongate shaft 12 may be such that the bend radius of the elongate shaft 12 distal to the bend portion 600 is too large to adequately deflect the distal end of the elongate shaft 12 toward the tricuspid valve 1083. Thus, the deflection mechanism may be utilized to deflect the bend portion 600 in a direction opposite to the direction in which the bend portion 600 deflects the distal end of the elongate shaft 12.

[0152] 17B, ​​the height of the capsule 106 may be increased by deflecting the proximal portion of the elongate shaft 12 by utilizing a deflection mechanism as described with respect to FIGS. 15A and 15B. The deflection of the proximal portion of the elongate shaft 12 may be caused wholly or partially (at least partially) within the inferior vena cava 1079 of the patient. The deflection may create a height away from the tricuspid valve 1083 by driving the bends 600, 602. In this manner, the distal end of the elongate shaft 12 may have a larger clearance space for the bend 600 to deflect the distal end of the elongate shaft 12 toward the tricuspid valve 1083. As shown in FIG. 17B, the deflection mechanism may create a curvature in the proximal portion of the sheath, although other configurations of deflection may be provided. The bend 600 begins to deflect the distal end of the elongate shaft 12 in FIG. 17B.

[0153] 17C, the bent portion 600 biases the distal end of the elongate shaft 12 in a direction 605, which may be aligned with the axis of the tricuspid valve 1083, or may be otherwise oriented in a desired direction. The biasing mechanism biases the proximal portion of the elongate shaft 12, thereby biasing the bent portion 600 in a direction 611 opposite the direction 605. In this manner, the capsule 106 is increased in height above the tricuspid valve 1083, thereby allowing for the deployment of an implant contained therein.

[0154] A deflection mechanism may be utilized to deflect the proximal portion of elongate shaft 12 in one or more planes that are not perpendicular to the plane in which bend 600 deflects the distal end of elongate shaft 12.

[0155] In an example, the configuration of the delivery system as shown in Figures 13A-14 may be used to orient the elongate shaft in a desired orientation relative to the implantation site. For example, a deflection mechanism as described with respect to Figures 13A-14 may be used to center or align the distal end of the capsule 106 and elongate shaft 12 relative to the implantation site, such as the annulus of a heart valve (e.g., the tricuspid or mitral annulus). Features of the delivery system as shown in Figures 13A-14 may be combined with features shown in Figures 15A-16B as desired.

[0156] In examples, an expandable body 613 may be provided that may extend radially outward from the elongate shaft. Referring to FIG. 18A, the expandable body 613 may be disposed on a sheath 610 that may extend onto the elongate shaft, although in examples, the expandable body 613 may be integral to the elongate shaft. The sheath 610 may be slidable relative to the elongate shaft 12 in examples.

[0157] The expandable body 613 may be configured to expand radially outward from the elongate shaft 12 upon expansion. When expanded, the expandable body 613 may press against an inner surface of the patient's vasculature to help secure the elongate shaft 12 in a desired position during the deployment procedure. FIG. 18A illustrates the expandable body 613 in a deflated state within the patient's vasculature, such as the inferior vena cava 1079 and right atrium 1076. The elongate shaft 12 is shown in position for deployment of the implant relative to the tricuspid valve 1083.

[0158] The expandable body 613 may expand to an increased diameter, for example as shown in Figure 18B. The expandable body 613 may be pressed against the interior surfaces of the vasculature, such as the interior surface of the vena cava 1079 and the interior surface of the right atrium 1076. When the implant is deployed, the elongate shaft 12 may be secured against such surfaces to prevent undesired deflection due to pressure of the expandable body 613 against such surfaces.

[0159] At a desired time, the expandable body 613 may be deflated and withdrawn from the patient's vasculature. For example, after deployment of the implant, the expandable body 613 may be deflated and withdrawn. The features in Figures 18A-18B may be utilized with delivery systems such as those shown in Figures 13A-14.

[0160] In an example, the expandable body 613 may include channels to allow localized fluid flow therethrough. For example, the channels may allow the patient's blood to flow through the expandable body 613 and through the patient's vascular system during an implantation procedure.

[0161] Each feature in each example of FIGS. 18A-18B may be used alone or in combination with any other example disclosed herein.

[0162] In examples, other approaches to the deployment position may be utilized. FIG. 19 illustrates the use of a deflection mechanism, for example, in an approach from the superior vena cava 1081. The approach may be a transcervical approach or through another entry point into the patient's body. The bends 600, 602 may be configured similar to that shown in FIG. 6B, where the proximal bend 602 is configured to deflect the distal portion of the elongate shaft 12 leftward (or backward) relative to the downward (or ventricular) deflection of the distal bend 600. Such a configuration may take into account the location of the tricuspid valve 1083 relative to the superior vena cava 1081 in the human heart. The method may include passing a delivery device for the implant into the right atrium of the patient.

[0163] A deflection mechanism similar to that shown in Figures 17A-17C may deflect a proximal portion of the elongated shaft 12 to deflect a bent portion 600 in a direction 611 opposite to the direction 605 in which the bent portion 600 deflected the distal end of the elongated shaft 12.

[0164] The implant contained within the capsule 106 may be deployed to position within the tricuspid annulus 1085, thereby replacing the native tricuspid valve 1083. With reference to FIGS. 20A-20C, once the distal end of the elongate shaft 12 is in a desired orientation relative to the native tricuspid valve 1083, a release mechanism may be utilized to deploy an implant, such as the implant 70 shown in FIG. 3E, among other forms of implants disclosed herein, from a deployment port 615 at the distal end of the capsule 106. The height of the deployment port 615 relative to the valve may be altered by deflecting the delivery device within the inferior vena cava or within the superior vena cava. FIGS. 20A-20C illustrate the release mechanism of the delivery system 10. Upon initial insertion of the implant 70 and delivery system 10 into the body, the implant 70 may be positioned within the system 10, similar to that shown in FIG. 2A. The distal end 303 of the implant 70, and particularly the distal anchor 80, is restrained within the capsule 106 of the outer sheath assembly 22, thereby preventing expansion of the implant 70. Similar to that shown in FIG. 2A, the distal anchor 80 can extend distally when disposed within the capsule. The proximal end 301 of the implant 70 is restrained within the capsule 106 and within a portion of the inner retention member 40, thereby being generally restrained between the capsule 106 and the inner retention member 40.

[0165] After the implant 70 is loaded into the delivery system 10, the user can thread a guidewire into the patient to the desired location. The guidewire passes through the lumen of the nosecone assembly 31, allowing the delivery system 10 to be driven generally forward through the patient's body following the guidewire. The delivery system 10 can be driven forward by the user manually driving the handle 14 axially. In some examples, the delivery system 10 can be placed into a stand while controlling the operation of the handle 14.

[0166] Once generally in the heart, the user can begin steering the rail assembly 20, and in particular the bends 600, 602, using the distal pull wire knob 206 and / or the proximal pull wire knob 208. By rotationally driving either of the knobs, the user can provide a deflection / bend to the rail assembly 20 (either the distal or proximal end), which can bend the distal end of the delivery system 10 into a desired configuration in one, two, or multiple locations. As discussed above, the user can provide multiple bends in the rail assembly 20 to orient the delivery system 10 toward the tricuspid valve. In particular, bending the rail assembly 20 can orient the distal end of the delivery system 10, and thus the capsule 106, toward the tricuspid valve along a central axis that passes through the native tricuspid valve. Thus, when the outer sheath assembly 22, mid shaft assembly 21, inner shaft assembly 18, and nosecone assembly 31 are driven together with the compressed implant over the rail assembly 20, the capsule 106 will be aligned with its axis for proper release of the implant 70. By utilizing the delivery system configurations shown in Figures 13A-14, the elongate shaft may be oriented in a desired orientation relative to the implantation site.

[0167] 15A-15B, a user may utilize a deflection mechanism to create a height from the native tricuspid valve or otherwise orient the distal end of elongate shaft 12 as desired. The height of the bent portion of elongate shaft 12 may be varied from the tricuspid valve.

[0168] The system 10 can be positioned to a particular location within the patient's body, such as at the location of the native tricuspid valve, by using the bending and deflection mechanisms described herein, or by using other techniques.

[0169] The user can also rotate and / or actuate the handle 14 itself within the stand to further fine-tune the distal end of the delivery system 10. The user can orient the delivery system 10 for release of the implant 70 within the body by sequentially rotating the proximal pull wire knob 208 and / or the distal pull wire knob 206, and by actuating the handle 14 itself. The user can also actuate other assemblies, such as proximally or distally, relative to the rail assembly 20. Once the distal end of the elongate shaft 12 is oriented as desired, the user may then rotate the depth knob 212. As described, this rotational actuation of the knob 212 drives the inner shaft assembly 18, the mid shaft assembly 21, the outer sheath assembly 22, and the nosecone assembly 31 forward together over / through the rail assembly 20 while the implant is maintained in a compressed configuration within the implant holding area 16. For example, due to the rigidity of any of the inner shaft assembly 18, mid shaft assembly 21, and / or outer sheath assembly 22, these assemblies are driven forward linearly into an aligned orientation by the rail assembly 20.

[0170] Once in the released position, the user can rotate the outer sheath knob 210, which independently translates the outer sheath assembly 22 (and thus the capsule 106) proximally toward the handle 14 relative to the other assemblies, particularly the inner assembly 18, as shown in FIG. 20A. In doing so, the distal end 303 of the implant 70 is exposed within the body, allowing expansion to begin. At this point, the distal anchor 80 can be inverted proximally, and the distal end 303 begins to expand radially outward. For example, if the system 10 is delivered to the location of the native tricuspid valve, the distal anchor 80 will expand radially outward within the right ventricle. The distal anchor 80 can be positioned above the papilla and below the tricuspid annulus and tricuspid leaflets.

[0171] In some instances, the distal anchor 80 may contact and / or extend between the chordae of the right ventricle and contact the valve leaflets as it radially expands. In some instances, the distal anchor 80 may not contact and / or extend between the chordae and may not contact the valve leaflets. Depending on the location of the implant 70, the distal end of the distal anchor 80 may be located at or below the location where the chordae connect to the free edge of the native valve.

[0172] As shown in the illustrated example, the distal end 303 of the implant 70 expands outward. Note that the proximal end 301 of the implant 70 may remain covered by an outer retaining ring during this step so that the proximal end 301 remains in radial compression. At this point, the system 10 may be withdrawn proximally so that the distal anchors 80 capture and engage the leaflets of the tricuspid valve, or may be driven proximally to reposition the implant 70. For example, the assembly may be driven proximally relative to the rail assembly 20. Additionally, by utilizing a deflection mechanism, the elongate shaft 12 may be pulled proximally relative to the tricuspid valve. Additionally, a torque may be applied to the system 10, which may cause the distal anchors 80 to apply tension to the chordae tendineae between which at least a portion of the distal anchor may extend. However, in some examples, the distal anchors 80 may not apply tension to the chordae tendineae. In some instances, the distal anchor 80 may capture the native valve leaflets and may be located between the chordae tendineae without further movement of the system 10 after the outer sheath assembly 22 has been withdrawn.

[0173] During this step, the system 10 may be driven proximally or distally to properly capture the distal or ventricular anchor 80 against the native tricuspid valve leaflets. This may be accomplished by driving the outer sheath assembly 22, mid shaft assembly 21, inner shaft assembly 18, and nosecone assembly 31 relative to the rail assembly 20. In particular, the tip of the ventricular anchor 80 may be driven proximally to engage the ventricular side of the native annulus, such that the native leaflets are disposed between the anchor 80 and the implant body 70. The distal anchor 80 may be disposed between at least some of the chordae, although the chordae may or may not be under tension when the implant 70 is in its final position.

[0174] The proximal end 301 of the implant 70 will remain within the outer retaining ring 42 after the capsule 106 is driven back. The capsule 106 may surround the implant retention area and may be driven back proximally to deploy the implant. As shown in FIG. 20B, once the distal end 303 of the implant 70 is fully expanded (or as fully expanded as possible at this point), the outer retaining ring 42 may be individually retracted proximally relative to the other assemblies, particularly the inner assembly 18, to expose the inner retention member 40, thereby initiating expansion of the proximal end 301 of the implant 70. For example, in a tricuspid valve replacement procedure, once the distal or ventricular anchor 80 is positioned between at least some of the chordae tendineae and / or engaged against the native tricuspid annulus, the proximal end 301 of the implant 70 may be expanded within the right atrium.

[0175] The outer retaining ring 42 can be driven proximally to radially expand the proximal end 310 of the implant 70 to a fully expanded configuration, as shown in FIG. 20C. The implant 70 can be deployed relative to the valve. After expansion and release of the implant 70, the inner shaft assembly 18, the nosecone assembly 31, the midshaft assembly 21, and the outer sheath assembly 22 can be simultaneously retracted proximally along or relative to the rail assembly 20 back to their original positions. In some instances, they are not retracted relative to the rail assembly 20 and remain in the extended position. Additionally, the nosecone 28 can be retracted through the center of the expanded implant 70 and into the outer sheath assembly 22, such as by translating the knob 216 proximally. The system 10 can then be removed from the patient.

[0176] In some examples, the implant 70 can be delivered under fluoroscopy so that the user can observe certain reference points for proper positioning of the implant 70. Additionally, echocardiography can be used for proper positioning of the implant 70.

[0177] Reference is now made to FIG. 21, which illustrates a schematic representation of a portion of an example replacement heart valve (such as the implant 70 shown in FIG. 3E) disposed within a native tricuspid valve of a heart 83. A portion of a native tricuspid valve is shown diagrammatically, depicting typical anatomical structures including a right atrium 1076 located above an annulus 1085 and a right ventricle 1077 located below the annulus 1085. The right atrium 1076 and the right ventricle 1077 communicate with each other via the tricuspid annulus 1085. Also shown diagrammatically in FIG. 21 are the native tricuspid valve leaflets 1087 with chordae tendineae 1089 connecting the downstream ends of the leaflets 1087 to the papillary muscles of the right ventricle 1077. The portions of the implant 70 disposed upstream of the annulus 1085 (towards the right atrium 1076) may be referred to as being supranulular. Portions disposed generally within the annulus 1085 are referred to as being intra-annular, and portions disposed downstream of the annulus 1085 are referred to as being sub-annular (towards the right ventricle 1077).

[0178] As shown in FIG 21, a replacement heart valve (e.g., implant 70) can be positioned such that the tricuspid annulus 1085 is located between the distal anchor 80 and the proximal anchor 82. In some circumstances, the implant 70 can be positioned such that an end or tip of the distal anchor 80 is in contact with the annulus 1085, as shown, for example, in FIG 21. In some circumstances, the implant 70 can be positioned such that an end or tip of the distal anchor 80 is not in contact with the annulus 1085. In some circumstances, the implant 70 can be positioned such that the distal anchor 80 does not extend around the leaflets 1087.

[0179] As shown in FIG. 21 , the replacement heart valve or implant 70 can be positioned such that an end or tip of the distal anchor 80 is on the ventricular side of the tricuspid annulus 1085 and an end or tip of the proximal anchor 82 is on the atrial side of the tricuspid annulus 1085. The distal anchor 80 can be positioned such that an end or tip of the distal anchor 80 is on the ventricular side of the native leaflet beyond where the chordae tendineae 1089 are connected to the free ends of the native leaflets. The distal anchor 80 can extend between at least some of the chordae tendineae 1089 and can contact or engage the ventricular side of the annulus 1085 in some circumstances, such as those shown in FIG. 21 . It is also envisioned that in some circumstances the distal anchor 80 may not contact the annulus 1085, although the distal anchor 80 may still contact the native leaflets 1087. In some circumstances, the distal anchor 80 may contact tissue of the right ventricle 1077 beyond the annulus 1085 and / or beyond the ventricular side of the leaflets.

[0180] 21 illustrates deployment relative to the tricuspid annulus, although other implantation sites may be utilized in examples including the mitral or aortic or pulmonary annulus.

[0181] Once the implant 70 has been deployed as desired, the elongate shaft 12 may be deflected using the deflection mechanisms disclosed herein, thereby allowing the elongate shaft 12 to be removed from the patient's heart.

[0182] In examples, other configurations of deployment mechanisms may be utilized as desired. Figures 22A-23B illustrate one example of a deployment mechanism including a diaphragm 750, for example, that may be utilized to deploy an implant from an elongate shaft of a delivery system. A retention body 752 may be provided that may be configured to retain the implant. The diaphragm 750 may be configured to extend proximally and be actuated distally such that the retention body 752 can be released from the implant.

[0183] 22A and 22B, the diaphragm 750 may include a proximal end portion 754 and a distal end portion 756, as well as a length between the proximal end portion 754 and the distal end portion 756 of the diaphragm 750. The diaphragm 750 may include an outer surface 758, which may face radially outward, and an inner surface 760, which may face radially inward and toward an internal cavity 762 of the diaphragm 750. The proximal end portion 754 may include an opening for the internal cavity 762.

[0184] A proximal end portion 754 of the diaphragm 750 may include a wide portion of the diaphragm 750, and a distal end portion 756 of the diaphragm 750 may include a narrow portion of the diaphragm 750. The wide portion of the diaphragm 750 may extend proximally from the narrow portion of the diaphragm 750. The diaphragm 750 may have a conical shape, such as a frusto-conical shape.

[0185] The diaphragm 750 may surround an inner shaft 764 that may extend distally to a coupling body 766 that may be configured to couple to an implant. The inner shaft 764 may pass through the diaphragm 750 and the retaining body 752. The coupling body 766 may be configured to couple to an end coupler 770 of an implant 772, similar to the operation of the inner retaining member or ring 40 shown in Figures 2A and 2B.

[0186] The implant 772 may be configured similarly to examples of implants disclosed herein. For example, the end couplers 770 of the implant 772 may be configured similarly to the mushroom-shaped tabs 74 shown in FIG. 3E, or may have another configuration. The implant may include a self-expanding implant, for example. Although the frame of the implant 772 is shown in FIGS. 22A-23B, the implant may include an implant having features for full deployment of the implant, including artificial leaflets, and any other features of the implants shown in FIGS. 3A-3E, for example.

[0187] The retention body 752 may include a proximal end portion 774, a distal end portion 776, and a length therebetween. The retention body 752 may include an outer surface 778 facing away from an inner surface 780. The outer surface 778 may face radially outward. The inner surface 780 may face an interior cavity 782 within which the coupling body 766 may be disposed. The retention body 752 may cover the coupling body 766. The retention body 752 may have a conical shape, such as a frusto-conical shape, where a wider portion extends distally and a narrower portion extends proximally. Other configurations for the retention body 752 may be utilized as desired.

[0188] The retention body 752 may be configured to apply sufficient radial compressive force to the implant 772 to prevent the implant 772 from being released from the coupling body 766 when the retention body 752 is extended over the implant 772.

[0189] A proximal end portion 774 of the retainer body 752 may be coupled to a distal end portion 756 of the diaphragm 750. The retainer body 752 and the diaphragm 750 may include a coupling portion 784 that may couple the retainer body 752 and the diaphragm 750 to the inner shaft 764 and allow the retainer body 752 and the diaphragm 750 to slide together along the inner shaft 764. The coupling portion 784 may include, for example, an opening located between the retainer body 752 and the diaphragm 750 and along which the inner shaft 764 may slide together.

[0190] The retainer body 752 and diaphragm 750 may have a length 781 extending from a distal end of the retainer body 752 to a proximal end of the diaphragm 750 in the configuration shown in FIGS. 22A and 22B.

[0191] In an example, the diaphragm 750 may be configured to be flexible, allowing the diaphragm 750 to be actuated by a compressive force applied thereto. For example, when a distal compressive force is applied to the diaphragm 750, the diaphragm 750 may invert and overlie onto an outer surface 778 of the retainer body 752. The diaphragm 750 may invert when actuated distally. In such a configuration, an inner surface 760 of the diaphragm 750 may face radially outward and an outer surface 758 may face radially inward. A wide portion of the diaphragm 750 may extend distally from a narrow portion of the diaphragm 750. FIGS. 23A and 23B, for example, illustrate such a configuration.

[0192] In examples, a pusher shaft 786 may be provided that may be configured to be driven forward in a distal direction to drive the diaphragm 750 in a distal direction. The pusher shaft 786 may be configured to drive the diaphragm 750 by applying a distally directed compressive force against the proximal end portion 754 of the diaphragm 750. The pusher shaft 786 may be configured to apply a compressive force against the proximal end portion 754 of the diaphragm 750, for example, by resisting compression.

[0193] 22A and B, the pusher shaft 786 may be configured to apply a force in a distal direction to the proximal end portion 754 of the diaphragm 750, causing the diaphragm 750 to transfer the force to the retention body 752. In this manner, the pusher shaft 786 may resist proximal movement of the retention body 752, allowing the retention body 752 to remain in place on the coupling body 766, thereby maintaining the coupling between the implant 772 and the coupling body 766.

[0194] At a desired time, the pusher shaft 786 may be driven forward distally to apply a compressive force to the diaphragm 750, compressing and driving the diaphragm 750 distally. The diaphragm 750 may be inverted as shown in FIGS. 23A and 23B. The force to invert the diaphragm 750 may be greater than the force that the implant applies to the diaphragm 750 as it attempts to self-expand. The movement of the diaphragm 750 may reduce the overall length of the diaphragm 750 and the retainer body 752, thereby creating space for the diaphragm 750 and the retainer body 752 to slide proximally along the inner shaft 764. In this manner, the length 781 from the proximal end of the diaphragm 750 to the distal end of the retainer body 752 may be configured to decrease as the diaphragm 750 is driven distally.

[0195] With space for the diaphragm 750 and retention body 752 to slide, the retention body 752 may be driven back in a proximal direction to release it from the implant, as shown, for example, in FIGS. 23A and 23B. The retention body 752 may be driven back from the mating body 766 when the diaphragm 750 is driven distally. The implant 772 may include a self-expanding implant, such as, for example, a self-expanding prosthetic valve, which may apply an outward radial force to push the retention body 752 proximally. Upon releasing the implant 772, the components of the delivery system may be retracted from the implantation site.

[0196] 22A-23B may allow for release of the implant when a distally directed compressive force is generated. Such distally directed compressive force may reduce the use of a tension body in the delivery system to provide a retraction force to release the implant (such as a retraction force into the interior of a capsule surrounding the implant holding region). Various modifications of the delivery system may be made as desired.

[0197] Components of the delivery system as shown in Figures 22A-23B may be used alone or in combination with features of other delivery systems disclosed herein. For example, components of the delivery system as shown in Figures 22A-23B may be used with other examples having handles for manipulating the delivery system. The proximal portion of the pusher shaft 786 and inner shaft 764 may be controlled, for example, at the handles to allow release and manipulation of the delivery system. In an example, the capsule may surround the implant 772 to reduce the diameter of the implant 772 prior to deployment.

[0198] Each feature in each example of FIGS. 22A-23B may be used alone or in combination with any other example disclosed herein.

[0199] 24A-24E illustrate an example delivery system that includes one or more suction ports. The delivery system may include an elongate shaft 800 that may be configured to be driven forward into an implantation site, such as a native heart valve 802. The native heart valve 802 may include portions, such as native heart valve leaflets 804, that may control the opening and closing of the native heart valve 802.

[0200] The elongate shaft 800 may be flexible and configured to be driven forward to a desired position relative to the implantation site. The elongate shaft 800 may include an implant holding area surrounded by a capsule 806, which may be configured to be driven backward to at least partially deploy the implant from the implant holding area. In examples, the elongate shaft 800 may be configured similarly to other examples of elongate shafts disclosed herein. The elongate shaft 800 may be deflectable, for example, to approach the implantation site in a desired manner.

[0201] The one or more suction ports 808 may be configured to extend along the elongate shaft 800, and in some examples may be coupled to the elongate shaft 800. For example, the elongate shaft 800 may include an exterior surface 810, and the one or more suction ports 808 may be disposed on the exterior surface 810, in some examples.

[0202] 24E, for example, illustrates a cross-sectional view of the elongate shaft 800 taken along line 24E-24E in FIG. 24A. Multiple suction ports 808 may be provided and may be spaced apart circumferentially from one another. The multiple suction ports 808 may be spaced apart circumferentially on the outer surface 810 of the elongate shaft 800. Due to the circumferential spacing of the suction ports 808, the suction ports 808 may be able to apply a suction force to a portion of the heart valve to draw the portion towards the elongate shaft 800. The suction force may be applied around the outer surface 810 of the elongate shaft 800.

[0203] In examples, one or more suction conduits 812 may extend along the elongate shaft 800 and may be configured to provide suction to one or more suction ports 808. The suction conduits 812 may extend, for example, within the exterior surface 810 of the elongate shaft 800, and a distal end of each suction conduit 812 may be coupled to a corresponding suction port 808. A proximal end of each suction conduit 812 may be coupled to a device, such as a vacuum device (e.g., a syringe or other form of vacuum device) for providing suction. The device may be located outside the patient's body and connected to the suction conduit 812 at the handle or other location, as desired.

[0204] In examples, the suction port 808 and suction conduit 812 may not be coupled to the elongate shaft 800, but may comprise components that are separate from the elongate shaft 800 and that may apply suction in a manner similar to the suction port 808 coupled to the elongate shaft 800. For example, a separate suction port assembly may be driven forward into a location within the patient's body, in which case the suction port assembly includes the suction port 808.

[0205] The one or more suction ports 808 may be configured to apply a suction force to the native heart valve leaflets 804, thereby drawing the native heart valve leaflets 804 radially inward. For example, with reference to FIG. 24B , the one or more suction ports 808 may be positioned radially inward of the one or more native heart valve leaflets 804 during a deployment procedure for the implant. A distal end 814 of the capsule 806 may be positioned distal to the one or more suction ports 808.

[0206] The one or more suction ports 808 may apply a suction force to draw the native heart valve leaflets 804 radially inward into contact against the outer surface 810 of the elongate shaft 800. The suction force from the one or more suction ports 808 may hold the native heart valve leaflets 804 in position against the outer surface 810 of the elongate shaft 800.

[0207] The elongate shaft 800 may be configured to at least partially deploy the implant from the implant holding region into the native heart valve 802 with one or more suction ports 808 applying suction against the native heart valve leaflets 804. For example, with suction applied, the capsule 806 may be configured to be actuated back such that the implant is at least partially deployed from the implant holding region.

[0208] The implant may include a prosthetic heart valve for deployment relative to a native valve. The implant may be configured similarly to examples of implants disclosed herein, including, for example, the implants shown in Figures 3A-3E. The implant may include one or more anchors that may be configured to be anchored onto a distal tip of one or more native heart valve leaflets 804. Figure 24C, for example, illustrates an at least partially deployed implant 816, where a distal anchor 818 extends distally from capsule 806. The distal anchor 818 may be anchored onto a distal tip of a native heart valve leaflet 804.

[0209] The suction provided by the suction port 808 may improve the likelihood that the distal anchor 818 will lock onto the distal tip of the native heart valve leaflet 804 by drawing the distal tip of the native heart valve leaflet 804 radially inward. The radially inward location of the distal tip may reduce the likelihood that the anchor 818 will fail to lock onto the distal tip and will be positioned radially inward of the prosthetic leaflet 804, resulting in failure to capture the distal tip. In such a configuration, the anchor 818 that fails to capture a leaflet may support the leaflet with an opening, causing paravalvular leakage. Thus, the suction provided by the suction port 808 may improve the likelihood that the anchor 818 will lock onto the leaflet 804 by reducing such a possibility.

[0210] The suction force provided by the suction port 808 may be continued until the implant 816 is secured against the native heart valve 802. For example, the suction force provided by the suction port 808 may continue to be applied until the distal anchor 818 is locked onto the distal tip of the native heart valve leaflet 804. Once the implant 816 is secured, the suction force provided by the suction port 808 may be reduced and the implant 816 may be fully deployed against the implantation site. For example, FIG. 24D illustrates the implant 816 deployed against the native heart valve 802, where the suction port 808 and elongate shaft 800 have been driven back from the implantation site.

[0211] Each feature in each of the examples of Figures 24A-24E may be used alone or in combination with any other example disclosed herein. Variations regarding the delivery system and methods for utilizing the delivery system may be provided in each example.

[0212] Implants as disclosed herein may include one or more anchors that may be utilized to anchor the implant to an implantation site. For example, with reference to the implant shown in FIG. 3E, the implant may include a valve body and a plurality of distal anchors 80 and a plurality of proximal anchors 82 for anchoring the implant to an implantation site. With reference to the implant shown in FIGS. 3A-3C, the implant may include a plurality of prosthetic leaflets 424, and the valve body 406 may support a plurality of prosthetic leaflets. The valve body 406 may include a valve frame having a distal portion, and the plurality of distal anchors 430 may each have a proximal portion coupled to the distal portion of the valve frame 416.

[0213] Each distal anchor may have, for example, a distal tip and a proximal portion configured to be coupled to a distal portion of a valve frame of the valve body. The implant may be configured to transition from a compressed configuration in which the distal anchors have an elongated shape to a deployed configuration in which the anchors extend radially outward from the valve body. In the compressed configuration, the distal anchors may extend axially with the valve body. Figures 3A and 3E illustrate the implant in a deployed configuration.

[0214] 25 illustrates an implant 850 in a compressed configuration and disposed within a deployment capsule of a delivery device. The implant 850 may be configured similarly to the implants shown in FIGS. 3A and 3E and may include a valve body 852 and a number of distal anchors 854. Each distal anchor 854 may include a distal tip 856.

[0215] At least one distal tip 856a in the compressed configuration may be longitudinally offset from the location of another distal tip 856b in the compressed configuration. Such a configuration may provide various advantages, including allowing for a smaller compressed profile or smaller outer diameter due to the offset locations of the distal tips 856a, 856b. Also, sequential deployment of the anchors may be provided.

[0216] FIG. 26, for example, illustrates a flattened profile for the distal anchor 854 of the implant 850 shown in FIG. 25. Distal tip 856a is shown as being longitudinally offset from the location of distal tip 856b, where distal tip 856a extends to a greater length compared to distal tip 856b. As shown in FIG. 26, distal tips 856a, 856b may each have a greater width compared to the shaft 858 to which the respective distal tips 856a, 856b are coupled. In this manner, due to the offset of the locations of distal tips 856a, 856b from one another, the combined diameter of distal tips 856a, 856b may be reduced when implant 850 is compressed (e.g., as shown in FIG. 25).

[0217] In an example, distal anchor 854 may include a first plurality of distal anchors including distal tip 856a longitudinally offset from a second plurality of distal anchors including distal tip 856b. As shown in FIG. 26, for example, the first plurality of distal anchors may be circumferentially staggered with respect to the second plurality of distal anchors such that distal tips 856a are circumferentially staggered with respect to distal tips 856b. Distal tips 856a, 856b may be staggered such that a short distal tip 856b is circumferentially adjacent to a long distal tip 856a, and this pattern is repeated circumferentially around compressed implant 850. Other configurations may be provided as desired.

[0218] FIG. 27, for example, illustrates a flattened profile for distal anchor 860, in which a first plurality of distal anchors and distal tips 862a are circumferentially adjacent to one another, and a second plurality of distal anchors and distal tips 862b are circumferentially adjacent to one another. The first plurality of distal tips 862a may be longitudinally offset from the location of the second plurality of distal tips 862b. In such a configuration, a reduced diameter of the distal tips 862a, 862b may be provided in the compressed configuration. Additionally, the short distal tips 862b may be adjacent to one another, which may reduce the likelihood of the short distal tips 862b contacting a portion of the patient's anatomy in the deployed configuration. For example, the likelihood of contacting a ventricular wall may be reduced, which may reduce the likelihood of the distal tips 862b creating electrical conduction obstructions. Further variations in the pattern of distal tips may be provided as desired.

[0219] In examples, the order in which anchors may be deployed may be controlled by the length of the anchor. For example, in examples, longer anchors may be deployed first, followed by shorter anchors. In examples, a leaflet may be captured, and then another anchor may be deployed to further capture that leaflet or another leaflet. Other configurations for sequentially deploying multiple anchors may be utilized as desired.

[0220] In an example, the implant when deployed may have a configuration similar to that of the implant shown in Figures 3A and 3E, but with the length of the distal anchor 854 varied. Each of the features (e.g., artificial leaflets and seal body) of the implant shown in Figures 3A and 3E may be utilized with the implant. The distal anchor in the deployed configuration may be configured to have a hook shape and may extend radially outward from the valve body. The distal anchor may be configured to be anchored onto the distal tips of the leaflets of the native valve in the deployed configuration.

[0221] Each feature in each of the examples of Figures 25-27 may be used alone or in combination with any other example disclosed herein.

[0222] In an example, an implant may be provided that may include at least one distal tip configured to have a larger diameter than another distal tip. FIG. 28 illustrates a top cross-sectional view of an implant 870, for example, including a valve body 872 and a plurality of distal anchors 874a,b coupled to the valve body 872. Each distal anchor 874a, 874b may have a corresponding distal tip 876a, 876b. The distal tip 876b may have a larger diameter than the distal tip 876a, for example, as shown in FIG. 28. The implant 870 may otherwise be configured similarly to the implants shown in FIGS. 3A and 3E, including the plurality of prosthetic leaflets and the valve body supporting the plurality of prosthetic leaflets. The distal anchors may be configured to be anchored onto the distal tips of the leaflets of the native valve, where the distal tip of each of the plurality of distal anchors is disposed radially outward of the leaflets.

[0223] Distal tip 876b may be circumferentially spaced apart from distal tip 876a and may be circumferentially spaced apart from other larger diameter distal tips 876b. For example, as shown in FIG. 28, larger diameter distal tips 876b may be located on opposite sides of valve body 872 along an axis extending through the center of valve body 872. Smaller diameter distal tips 876a may be circumferentially spaced apart from larger diameter distal tips 876b and may be circumferentially adjacent to one another. Various other configurations of distal tips may be provided as desired.

[0224] 29 illustrates an example in which at least three larger diameter distal tips 880a may be provided spaced equidistantly apart in the circumferential direction, and one or more smaller diameter distal tips 880b may be circumferentially disposed between the larger diameter distal tips 880a and may be circumferentially adjacent to one another.

[0225] In examples, the larger diameter distal tip and the smaller diameter distal tip may be positioned to provide a desired anchoring at a portion of the implantation site. For example, the larger diameter distal tip may be provided at a portion of the implantation site that may require additional fixation or additional fluid sealing, such as at the commissures of the native heart valve leaflets. The smaller diameter distal tip may be provided at a portion of the implantation site that may require reduced interference with a portion of the patient's body, such as the heart wall. A configuration such as that shown in FIG. 28 may be utilized, for example, with a mitral valve having two leaflets and therefore two commissures. A configuration such as that shown in FIG. 29 may be utilized, for example, with a tricuspid heart valve having two leaflets and therefore three commissures. The larger diameter distal tip may be positioned at the commissures of the heart valve leaflets.

[0226] The larger diameter distal tip may have a larger diameter compared to the smaller diameter distal tip by being formed from a material in a manner that results in the larger diameter. For example, the larger diameter distal tip may be formed from a solid material to have a larger diameter. In an example, the larger diameter distal tip may include a coating that increases the diameter of the distal tip. For example, a pad may be provided on the larger diameter distal tip that increases the diameter of the distal tip. The size of the coating or pad may be smaller for the smaller diameter distal tip.

[0227] In an example, the diameter of the larger diameter distal tip and / or the smaller diameter distal tip may be variable to adjust the size of the larger diameter distal tip and / or the smaller diameter distal tip. In an example, the change in diameter of the larger diameter distal tip and / or the smaller diameter distal tip may be provided by the larger diameter distal tip and / or the smaller diameter distal tip being expandable.

[0228] FIG. 30A illustrates a side cross-sectional view of an implant in the form of a prosthetic heart valve 890 having a distal anchor 892 including a distal tip 894 configured to expand. At least one distal tip 894 may be configured to expand to have a larger diameter than another distal tip 894. Each of the distal tips 894 may include an expandable body 895 that may be configured to expand with blood, e.g., blood from a heart into which the prosthetic heart valve 890 is to be deployed, surrounding the distal tip 894. The blood may pass through openings 896 in each corresponding expandable body 895, causing the expandable body 895 to expand and increase in diameter. FIG. 30B illustrates the expandable body 895 expanded, e.g., due to blood filling the expandable body 895.

[0229] Expansion of the expandable body 895 may improve anchoring of the distal anchor 892 to the native heart valve. Additionally, an improved seal against the valve body 898 may be obtained. The expandable body 895 may, for example, expand to press a portion of the heart valve, such as the native heart valve leaflets 804, against the valve body 898. The pressure applied by the expandable body 895 against the valve body 898 of the leaflets 804 may improve the seal to reduce fluid flow around the valve body 898.

[0230] In examples, some of the distal anchors 892 may have expandable distal tips such that these expandable distal tips have a larger diameter compared to the other distal tips. For example, a first plurality of distal anchors 892 may have a distal tip configured to have a larger diameter than a distal tip of a second plurality of distal anchors 892. In examples, all of the distal anchors may include expandable distal tips that may expand to the same diameter as desired.

[0231] 31A-31C illustrate an example of an implant in the form of a prosthetic heart valve 891 having distal anchors 913 including distal tips 897 configured to expand. Each of the distal tips 897 may include an expandable body 899 having, for example, a bladder 901. The bladder 901 may be configured to be expanded with an expansion material to increase the size of the bladder 901. For example, one or more expansion conduits 903 may be provided, each of which may have a distal end coupled to a corresponding bladder 901. The expansion conduits 903 may extend along a length of the distal anchors 913 and into a corresponding bladder 901. The expansion conduits 903 may be for expanding the corresponding bladder 901 with an expansion material.

[0232] In an example, the proximal end 905 of the inflation conduit 903 may include a valve 907 that may be coupled to the prosthetic heart valve 891 and may be detachably coupled to a tube for passing an inflation material into the inflation conduit 903. In an example, the inflation conduit 903 may include a manifold 909 for distributing the inflation material to the multiple inflation conduits 903. In this manner, fluid passing through the valve 907 may be distributed via the manifold 909 to the multiple expandable bodies 899 and to the distal anchor 913. Other configurations for the expandable bodies and inflation conduits may be utilized as desired.

[0233] 31B illustrates a close-up view of a valve 907 that may be utilized to inflate the expandable body 899. The valve 907 may include a pinch valve or another configured valve that may be engaged with the tube 911 to pass the inflation material into the inflation conduit 903. The valve 907 may be configured such that upon inflation of the expandable body 899, the valve automatically closes and the tube 911 may be retracted from the valve 907. In examples, other configured valves, such as check valves, may be utilized as desired. The tube 911 may be part of a delivery system for the expandable body 899 and may be withdrawn after inflation of the expandable body 899.

[0234] The expandable body 899 may be expanded to a desired amount and may press the heart valve leaflets 804 against the valve body 893 of the prosthetic heart valve 891. Figure 31C, for example, illustrates the expandable body 899 after it has been expanded. The expandable body 899 may press the heart valve leaflets 804 against the valve body 893 to improve the seal against the valve body 893.

[0235] In an example, the expandable body may be shaped as desired to enhance sealing against the native heart valve. FIG. 32 illustrates a top cross-sectional view of a number of expandable bodies 919, each having a flattened arc shape, for example. For example, the shape may include a semi-cylindrical shape extending around the valve body 921. In such a configuration, the number of expandable bodies 919 may form a ring around the native heart valve leaflets, thereby pressing the native heart valve leaflets against the valve body 921. Such a configuration may enhance sealing against the native heart valve.

[0236] In examples, a portion of a distal tip of a distal anchor may include an expandable body configured to expand and a portion of the distal tip may be non-expandable. Thus, the expandable body may have a larger diameter than the non-expandable distal tip. In examples, each distal tip of a distal anchor may be expandable, as desired.

[0237] Expansion materials that may be utilized in the examples herein may include fluids, such as saline or other forms of fluid. The expansion materials may be liquids, foams, epoxies, gases, or other materials. The expansion materials may be liquid to provide hydraulic expansion of the bodies disclosed herein. Expansion materials in gas form may include carbon dioxide or helium, among other forms of gas.

[0238] In an example, the expansion material may include a hardenable material. The expansion material may be configured to harden over time to enhance the seal of the seal body. The hardenable material may be introduced into the expandable body at a first, relatively low viscosity and converted to a second, relatively high viscosity. The increase in viscosity may be achieved by various UV-initiated polymerization reactions, various catalyst-initiated polymerization reactions, or other chemical systems. The goal of the viscosity increase process may be to produce a consistency anywhere from a gel to a rigid structure, depending on the desired performance.

[0239] The hardenable material may include an epoxy. The epoxy may be cured by mixing materials that harden when combined. A curing catalyst may be provided at the time of implantation or may be provided after implantation. The hardenable material may be biocompatible and may be capable of conforming to the shape of the local native valve. In an example, the hardenable material may be bioabsorbable.

[0240] In examples, the expansion material may be radiopaque for visualization during implantation. Radiopaque material may be added during filling, such as as part of the curing process. In examples, portions of the seal body, such as the seal skirt, may be radiopaque to allow visualization during implantation.

[0241] In examples, the expansion material may include a gel or foam, which may be biocompatible and configured to harden over time. The gel or foam may be inserted into the seal body or may be provided in a capsule that dissolves upon implantation to allow expansion.

[0242] In an example, gels may be utilized that may be produced via polymer precipitation from a biocompatible solvent. Various siloxanes may also be utilized as swelling gels. Other gel systems that may be utilized may include phase change systems that gel upon heating or cooling from an initial liquid or thixotropic state. Gels may also include thixotropic materials that undergo sufficient shear thinning so that they may be easily injected through a fluid conduit yet remain gel-like at zero or low shear rates.

[0243] In an example, the expansion material may include a blowing agent, which may create pressure within the expandable body.

[0244] Any of the expansion materials disclosed herein may be biocompatible, by way of example, and may be bioabsorbable if desired. A bioabsorbable seal body may improve the seal by tissue adhesion to the native valve.

[0245] Each feature in each of the examples of Figures 28-32 may be used alone or in combination with any other example disclosed herein.

[0246] A delivery system that may be utilized herein may include one or more sutures that may be configured to couple to the implant and apply a radially inward compressive force to the implant. The one or more sutures may be for adjusting the position of at least one distal anchor on the implant. FIG. 33A illustrates an example of an elongate shaft 900 in a delivery system that includes, for example, a capsule 902 that surrounds an implant holding region 904 for holding the implant. The capsule 902 may surround an inner shaft 906 that may include a coupler 908 that may be configured to couple to a portion of the implant, such as a proximal end 915 of the implant. The coupler 908 may be configured to couple to an end coupler of the implant 915, for example, similar to the operation of the inner retention member or ring 40 shown in FIGS. 2A and 2B.

[0247] The implant 915 may be configured similarly to the implants shown in Figures 3A and 3E, in examples. For example, the implant 915 may include a plurality of prosthetic leaflets 910 and may include a valve body 912 supporting the plurality of prosthetic leaflets 910. A plurality of distal anchors 914 may be coupled to the valve body 912. The valve body 912 may include a valve frame 916 that may be coupled to the plurality of distal anchors 914. The implant 915 is shown in a compressed configuration in Figure 33A, where the proximal end is coupled to the coupler 908.

[0248] The one or more sutures 918 may be configured to couple to the implant 915 and may be configured to apply a compressive force radially inward to the implant 915. The compressive force may drive the anchors radially inward. The one or more sutures 918 may include, for example, a first portion 920 configured to couple to the implant 915. The first portion 920 may be configured to couple to a body of the implant 915. The sutures 918 as shown in FIG. 33A may be configured to couple to a distal anchor 914 of the implant 915. The sutures 918 may be configured to couple to at least one of the distal anchors 914 and may be configured to apply a compressive force radially inward. Each suture 918 may include a loop formed, for example, by a first suture length 918a and a second suture length 918b, where the loop passes through a portion of a respective distal anchor 914. Each distal anchor 914 may include, for example, an opening or other structure for passing a loop of suture 918 therethrough.

[0249] In an example, each suture 918 may pass from an interior of the implant 915 to a location radially outside the implant 915. For example, each suture 918 may include a second portion 922 extending proximally from the first portion 920, where the second portion 922 is configured to pass through the valve frame 916 to a location radially outside the plurality of prosthetic leaflets 910. In such a configuration, the suture 918 may reduce the likelihood of interference between the suture 918 and the prosthetic leaflets 910 by reducing the likelihood of the suture 918 interfering with the operation of the prosthetic leaflets 910. The second portion 922 of the suture 918 may extend proximally from a distal end of the valve frame 916 to the elongate shaft 900. In an example, the suture 918 may pass directly through the implant's flow channel from a distal anchor through the implant's flow channel to the distal end of the implant.

[0250] A second portion 922 of the suture may extend proximally from a distal end of the body of the implant 915 into the elongate shaft 900. The second portion 922 of the suture may extend proximally through the elongate shaft 900 for access at a proximal portion of the elongate shaft 900. For example, the second portion 922 of the suture 918 may be accessible at a proximal portion of the elongate shaft 900 for control by a user. The user may control the suture 918 and may retract or release the suture 918 to control the compressive force that the suture 918 applies against the distal anchor 914.

[0251] In examples, a control mechanism may be utilized to control the movement or deflection of the anchor. For example, features of the control mechanism as shown in FIGS. 54-63 may be utilized as desired. In examples, one or more actuators may be provided at a proximal portion of the delivery device. The handle of the delivery device may utilize one or more actuators (e.g., a control knob or other configured actuator) to allow a user to actuate the movement of the suture 918. The one or more actuators may be coupled to the second portion 922 of the suture 918, for example. The handle may have a configuration as shown in FIG. 10 or may have other configurations as desired. In examples, other configured controls may be utilized as desired.

[0252] Routing of the sutures 918 from the interior of the implant 915 to the exterior of the implant 915 may apply a radially inward compressive force to the implant 915 by allowing a proximal force on the sutures 918. The radially inward force may, for example, control the deployment of the implant and may control the radial position of the distal anchors 914. For example, retracting the sutures 918 may compress the distal anchors 914 radially inward and advancing the sutures 918 may drive the distal anchors 914 radially outward. Such actuation may be utilized to actuate individual anchors, control flow channel size, and / or recapture the implant, as desired.

[0253] 33B, for example, illustrates the deployment of the implant 915 relative to a native heart valve. The distal anchor 914 may be anchored to the heart valve leaflet 804 by releasing the suture 918, allowing the distal anchor 914 to expand radially outward. The distal anchor 914 may be anchored onto the distal tip of the prosthetic leaflet 804.

[0254] The distal anchor 914 may be configured to be retracted by retracting the one or more sutures 918. For example, retracting the second portion 922 proximally may apply a proximal force to the sutures 918, causing the one or more sutures 918 to apply a radially inward compressive force against the implant 915 and retract the distal anchor 914 radially inward. Retracting the second portion 922 proximally may cause the sutures 918 to adjust the position of the anchor 914. Such a feature may be utilized in the event of a failure to capture a leaflet or when recapture of a leaflet is desired.

[0255] 33C, for example, illustrates an example where implant 915 has been deployed and anchor 914a has captured leaflet 804a, but anchor 914b has failed to capture leaflet 804b. Anchor 914b may leave an opening at the location of leaflet 804b, which may lead to undesirable leakage around the valve body. Suture 918b may be driven back. Retracting suture 918b may drive distal anchor 914b radially inward.

[0256] FIG. 33D illustrates anchor 914b in a back-actuated state, which may allow heart valve leaflet 804b to move radially inward. Anchor 914b may be actuated from a hook-like configuration toward an elongated configuration. Suture 918b may then be released, allowing distal anchor 914b to extend radially outward and to be anchored onto and anchored to the distal tip of heart valve leaflet 804b, similar to the configuration shown in FIG. 33B. In an example, suture 918b may be actuated back independently of suture 918a. One or more distal anchors may be independently manipulated by controlling one or more sutures. Each suture may actuate a distal anchor of an implant radially inward independently of another distal anchor of the implant.

[0257] In examples, each suture 918a, 918b may be configured as a continuous loop that may extend from the implant to a proximal portion of the delivery device. Control of the sutures 918a, 918b may be achieved at the proximal portion of the delivery device by tensioning and releasing the proximal portion of the suture. The looped configuration of the sutures 918a, 918b may allow each suture 918a, 918b to be cut and pulled through the delivery device and released from the implant. In examples, other suture configurations may be utilized.

[0258] 34 illustrates a suture configuration in which multiple sutures may be utilized to control each distal anchor 914a, 914b of an implant 927. A first suture loop 924a may be coupled to the distal anchor 914a and may pass through the valve body. A second suture loop 926a may be coupled to the first suture loop 924a and may extend proximally through the elongate shaft of the delivery device. The first suture loop 924b and the second suture loop 926b may be configured similarly to the first suture loop 924a and the second suture loop 926a.

[0259] When the implant 927 is deployed, the second suture loops 926a, 926b may be cut and pulled from the first suture loops 924a, 924b. The first suture loops 924a, 924b may remain in place during deployment.

[0260] 35A illustrates an example in which one or more sutures 930 form a loop 932 that extends circumferentially around an implant 934 and are configured to apply a radially inward compressive force to the implant. The one or more sutures 930 may, for example, extend within the implant 934 and then pass radially outwardly therethrough to form the loop 932. A first portion 936 of the one or more sutures 930 may form the loop 932 and extend outwardly of the implant 934. A second portion 938 may extend within the implant 934 and extend proximally through the delivery device. The second portion 938 may include a first suture length 940a coupled to a first end of the loop 932 and a second suture length 940b coupled to a second end of the loop 932.

[0261] FIG 35B, for example, illustrates a cross-sectional view from above of implant 934. First suture length 940a and second suture length 940b are shown passing radially outward from a portion of the valve body to form loop 932 around the valve body. Referring to FIG 35A, when second portion 938 of one or more sutures 930 is driven back, loop 932 may be drawn radially inward to compress implant 934.

[0262] 35C illustrates that the second portion 938 of the suture(s) 930 is driven back while the loops 932 apply a compressive force, drawing the implant 934 radially inward. Such a feature may control the deployment of the implant 934 and may allow the distal anchor to be recaptured or repositioned, if desired.

[0263] In examples, a control mechanism may be utilized to control the movement or deflection of the anchor. For example, features of the control mechanism as shown in FIGS. 54-63 may be utilized as desired. In examples, one or more actuators may be provided at a proximal portion of the delivery device. The handle of the delivery device may utilize one or more actuators (e.g., a control knob or other configured actuator) to allow a user to actuate the movement of the suture 930. The one or more actuators may be coupled to the second portion 938 of the suture 930, for example. The handle may have a configuration as shown in FIG. 10 or may have other configurations as desired. In examples, other configured controls may be utilized as desired.

[0264] The loop 932 may extend around the valve body, in examples, or may extend circumferentially around one or more distal anchors, in examples. Other configured sutures may be utilized, in examples.

[0265] FIG. 36 illustrates an example where, for example, the elongate shaft 950 includes an inner shaft 952 through which the second portion 954 of the suture 956 forming the loop 958 may pass. The inner shaft 952 may extend, for example, within the capsule 960 of the elongate shaft 950. The inner shaft 952 may pass through the implant (e.g., through a flow channel) and may have a tip, where the tip is located at a central portion of the implant, or at a distal portion of the implant, or at another location relative to the implant. The inner shaft 952 may be configured to engage the second portion 954 of one or more sutures 956. The inner shaft 952 may include a lumen 962 through which the second portion 954 of the suture 956 may pass proximally.

[0266] The second portion 954 of the suture 956 can be configured to be driven proximally back through the inner shaft 952, causing the suture 956 to apply a radially inward compressive force against the implant. The second portion 954 can be driven back to cause the suture 956 to adjust the position of the anchor.

[0267] In examples, a control mechanism may be utilized to control the movement or deflection of the anchor. For example, features of the control mechanism as shown in FIGS. 54-63 may be utilized as desired. In examples, one or more actuators may be provided at a proximal portion of the delivery device. The handle of the delivery device may utilize one or more actuators (e.g., a control knob or other configured actuator) to allow a user to actuate the movement of the suture 956, for example. The one or more actuators may be coupled to the second portion 954 of the suture 956, for example. The handle may have a configuration as shown in FIG. 10 or may have other configurations as desired. In examples, other configured controls may be utilized as desired.

[0268] In an example, the distal end 967 of the inner shaft 952 may include an opening 966 for the internal lumen 962. The opening 966 may be located in the same plane as the loop 958 of the suture 956, or may have another location, as desired. The opening 966 may be positioned to receive the suture 956, which may pass through the internal lumen 962.

[0269] In an example, the inner shaft 952 may be utilized with one or more sutures 964 extending radially outward from the inner shaft 952 to couple to the valve frame. FIG. 37A illustrates, for example, that one or more sutures 964 may be coupled to the valve frame by extending radially outward from the inner shaft 952. A distal end 969 of the sutures 964 may be coupled to the valve frame. For example, the valve frame may include a distal tip 971 to which the distal end 969 of the sutures 964 may be coupled. The sutures 964 may be configured to be pulled radially inward to compress the valve frame radially inward.

[0270] FIG. 37B, for example, illustrates that the sutures 964 have been driven radially inward and further back into the inner shaft 952 to radially compress the implant.

[0271] 38A-38B illustrate an example where the inner shaft 968 can be configured to couple to one or more sutures 977 such that retraction of the inner shaft 968 causes the one or more sutures 977 to apply a radially inward compressive force to the implant. Retraction of the inner shaft 968 can cause the sutures 977 to adjust the position of the anchors. FIG. 38A illustrates, for example, the inner shaft 968 having one or more couplers 973 configured to engage a second portion 975 of the sutures 977. The sutures 977 can include a first portion 976 that can be coupled to a valve frame. The couplers 973 of the inner shaft 968 can be configured to lock onto or otherwise engage the second portion 975 of the sutures 977 such that proximal movement of the inner shaft 968 causes the one or more sutures 977 to apply a radially inward compressive force to the implant.

[0272] 38B, for example, illustrates how the inner shaft 968 is driven back and the coupler 973 is drawn proximally, and thus radially inward. The implant may be compressed radially inward due to the movement of the inner shaft 968.

[0273] Once the implant has been deployed to a desired amount, the inner shaft 968 may be driven forward distally, which may release the suture 977 from the inner shaft 968. A second portion 975 of the suture 977 may be released from the inner shaft 968, which may allow the inner shaft 968 to be separated from the suture 977 and implant. Various other configurations for coupling the sutures to the inner shaft may be provided.

[0274] In examples, a control mechanism may be utilized to control the movement or deflection of the inner shaft 968, and thus the anchor. In examples, one or more actuators may be provided at a proximal portion of the delivery device. The handle of the delivery device may utilize one or more actuators (e.g., a control knob or other configured actuators) to allow a user to actuate the movement of the inner shaft 968, for example. The one or more actuators may be coupled to the proximal portion of the inner shaft 968, for example. The handle may have a configuration as shown in FIG. 10 or may have other configurations as desired. In examples, other configured controls may be utilized as desired.

[0275] FIG. 39 illustrates an example in which, for example, the inner shaft 970 may be rotated to cause one or more sutures 972 to apply a radially inward compressive force to the implant. Rotating the inner shaft 970 may cause the sutures 972 to adjust the position of the anchor. Each of the one or more sutures 972 may include a second portion 974 that may be coupled to the inner shaft 970. The inner shaft 970 may include a coupler for engaging the second portion 974 of the one or more sutures 972. The second portion 974 may be coupled to the inner shaft 970 such that, when the inner shaft 970 is rotated, the sutures 972 may apply a radially inward compressive force to the implant. When the inner shaft 970 is rotated, the second portion 974 of the one or more sutures 972 may wrap around the inner shaft 970 as the inner shaft 970 is rotated, thereby applying a radially inward compressive force to the implant. The inner shaft 970 may be rotated in the opposite direction to allow one or more sutures 972 to expand radially outward, which may allow the implant to expand radially outward.

[0276] Once the implant has been deployed to a desired amount, the inner shaft 970 may be released from the suture(s) 972. For example, the inner shaft 970 may be driven forward distally, which may cause the suture(s) 972 to be released from the inner shaft 970 in a manner similar to the inner shaft 968. In examples, a combination of a retraction drive or a rotational drive, or a retraction drive alone, or a rotational drive alone may be utilized to cause the suture(s) to apply a compressive force against the anchor. A retraction drive or a rotational drive may be utilized in any of the examples disclosed herein, including examples having a loop coupled to the implant.

[0277] In examples, a control mechanism may be utilized to control the movement or deflection of the inner shaft 970, and thus the anchor. In examples, one or more actuators may be provided at a proximal portion of the delivery device. The handle of the delivery device may, for example, utilize one or more actuators (e.g., a control knob or other configured actuator) to allow a user to drive the movement of the inner shaft 970. The one or more actuators may, for example, be coupled to a proximal portion of the inner shaft 970. The handle may have a configuration as shown in FIG. 10 or may have other configurations as desired. In examples, other configured controls may be utilized as desired.

[0278] The radially inward compressive forces described with respect to Figures 33A-39 may be utilized to drive the anchors, for inflow expansion, for implant release, and / or for implant recapture. The radially inward compressive forces may control the release of the implant, for example, by controlling the rate of implant expansion or by controlling the rate of anchor deployment, among various other features. Each feature in each of the examples of Figures 33A-39 may be utilized alone or in combination with any other examples disclosed herein.

[0279] 40A-45C illustrate an example of an artificial valve including one or more anchors each configured to anchor the artificial valve to the native valve, each of the one or more anchors including a first arm and a second arm configured to extend radially outward to a tip, the tip including a loop connecting the first arm and the second arm, and the first arm configured to be driven relative to the second arm such that the distance between the first arm and the second arm is variable.

[0280] FIG 40A, for example, illustrates a prosthetic valve in an extended configuration in which a first arm 980 is actuated away from a second arm 982. The first arm 980 and the second arm 982 may be elongated, with the first arm 980 being located more proximally than the second arm 982. A portion 986 of an anchor 984 located between the first arm 980 and the second arm 982 may form a tip of the respective anchor 984. In FIG 40A, the tip loop (shown in FIG 40B) may be straight.

[0281] The second arm 982 may include a distal end 988 that may be configured to couple to a coupler 990 of a delivery system. The coupler 990 may be configured to couple to a tab, for example, at the distal end 988 of the second arm 982. A retention body 993 may extend over the distal end 988 and may hold the distal end 988 of the second arm 982 to the coupler 990. The distal end 988 of the second arm 982 may be configured to expand radially outward when released from the coupler 990.

[0282] The second arm 982 may be configured to extend proximally to a proximal portion 991 that may be coupled to a portion 986 that forms a tip in the deployed configuration. The second arm 982 may have an elongated shape from the distal end 988 to the proximal portion 991.

[0283] The first arm 980 can have a distal portion 992 that can be coupled to a portion 986 that forms a tip in the deployed configuration. The first arm 980 can extend proximally from the distal portion 992 to be coupled to a valve body 989 for an implant, for example, as shown in FIG.

[0284] The first arm 980 and the second arm 982 may be flexible and may be configured to transition from the extended configuration to the deployed configuration. The tip portion 986 may be flexible and the first arm 980 and the second arm 982 may be configured to pivot about the tip portion 986 when transitioning from the extended configuration to the deployed configuration.

[0285] 40B, for example, illustrates an anchor transitioning from an extended configuration to a deployed configuration. A first arm 980 and a second arm 982 are actuated toward one another. A portion 986 is shown forming a tip 994 of each corresponding anchor, where the tip 994 includes a loop connecting the first arm 980 to the second arm 982. The first arm 980 and the second arm 982 each extend radially inward from the tip 994.

[0286] The first arm 980 may be located proximally relative to the second arm 982. The first arm 980 may be located radially inward relative to the second arm 982. In an example, the first arm 980 may extend parallel to the second arm 982.

[0287] The first arm 980 may include a radially outer portion 995 that may be coupled to a loop of a tip 994 of a respective anchor. The first arm 980 may include a radially inner portion 997 that may be coupled to a valve body.

[0288] The second arm 982 may include a radially outer portion 996 that may be coupled to the loop of the tip 944. The second arm 982 may include a radially inner portion 998 that may include a distal end 988 of the second arm 982. The distal end 988 of the second arm 982 may include a free end of the second arm 982 that may be coupled to a coupler 990 of a delivery device in FIG.

[0289] The first arm 980 and the second arm 982 may have a hook shape that allows the anchor to be anchored around a distal tip of a prosthetic leaflet. The first arm 980 and the second arm 982 may include a distal anchor configured to be anchored onto a distal tip of a leaflet of a native valve. The first arm 980 and the second arm 982 may extend parallel to one another from corresponding radially inner portions 997, 998 of the arms 980, 982, respectively, to corresponding radially outer portions 995, 996 of the arms 980, 982, respectively.

[0290] In examples, transition of the anchor from the extended configuration to the deployed configuration may be controlled by operation of a delivery system. The delivery system may include, for example, a coupler 990 and a retaining body 993. The coupler 990 may be disposed at a distal portion of the inner shaft 1000, which may extend inside the implant. The retaining body 993 may be disposed at a distal portion of the sheath 1002 and may extend onto the distal end 988 of the implant. The retaining body 993 may hold the distal end 988 of the implant against the coupler 990, which may prevent the distal end 988 from disengaging from the coupler 990.

[0291] In examples, a control mechanism may be utilized to control the movement or deflection of the anchor. In examples, one or more actuators may be provided at a proximal portion of the delivery device. The handle of the delivery device may utilize one or more actuators (e.g., control knobs or other configured actuators) to allow, for example, a user to actuate the movement of the coupler 990 and the retaining body 993. The one or more actuators may be coupled, for example, to the proximal portion of the inner shaft 1000 and the sheath 1002. The handle may have a configuration as shown in FIG. 10 or may have other configurations as desired. In examples, other configured controls may be utilized as desired.

[0292] The delivery system may be configured such that the inner shaft 1000 may be slidably driven proximally and distally together with the sheath 1002 to maintain the position of the retaining body 993 relative to the coupler 990. The inner shaft 1000 and sheath 1002 may be slidably driven proximally together to axially compress the distal anchor and transition the distal anchor from the extended configuration to the deployed configuration. The inner shaft 1000 and sheath 1002 may be slidably driven proximally back together a desired amount to allow the distal anchor to transition to the deployed configuration and to allow the distal anchor to expand radially outward a desired amount.

[0293] The inner shaft 1000 and sheath 1002 may be driven forward distally together to drive the distal anchor back before it is released from the coupler 990. In this manner, in the event of a failure to capture the heart valve leaflet, the distal anchor may be driven back to attempt to recapture the heart valve leaflet as the distal anchor is again expanded. Once the distal anchor is in the desired position, the retention body 993 may be driven forward relative to the coupler 990 to release the distal end 988 of the implant from the coupler 990.

[0294] 40C, for example, illustrates the retention body 993 being driven forward relative to the coupler 990. The retention body 993 may uncover the distal end 988 of the second arm 982, thereby releasing the distal end 988 from the coupler 990. The distal anchor may engage around the prosthetic heart valve leaflets to anchor the implant to the heart valve. The first arm 980 may have a hook shape in the deployed configuration and the second arm 982 may have a hook shape in the deployed configuration.

[0295] With the distal anchors deployed, the capsule 1004 surrounding the implant may be retracted to deploy the implant. FIG. 40D, for example, illustrates the capsule 1004 retracted. The implant is deployed relative to the implantation site and the distal anchors are anchored around the prosthetic leaflets. The first arm 980 may be integral to the valve body 989.

[0296] The implant may be configured similarly to examples of implants disclosed herein, such as the implants shown in Figures 3A-3E, and may include a plurality of prosthetic leaflets and a valve body 989 that supports the plurality of prosthetic leaflets.

[0297] In an example, the valve body may include an inner body and an outer body. FIG. 41 illustrates an example where, for example, a radially inner portion of the first arm 1006 is integral to the inner body 1008. An outer body 1010 may be provided that may be coupled to the inner body 1008. The outer body 1010 may include a seal body that may be configured to form a seal against a portion of the native heart valve. In an example, the outer body 1010 may include an outer frame and the inner body 1008 may include an inner frame of the valve body. The outer frame may be located radially outward from the inner frame.

[0298] 42 illustrates an example of a distal anchor tip 1012 as may be utilized in the examples herein. The tip 1012 may include a portion located between the first arm 1014 and the second arm 1015 that is thinner than the first arm 1014 and / or the second arm 1015. The thinness of the tip 1012 may allow for flexibility of the distal anchor at the tip 1012.

[0299] FIG 43 illustrates one example of a tip 1019 that includes a hinge 1022 that forms a loop and connects a first arm 1024 to a second arm 1026. FIG 44 illustrates a top view of the hinge 1022. The hinge 1022 can include a pivot 1028 that can pass through the first arm 1024 and connect the first arm 1024 to the second arm 1026. The hinge 1022 can be configured to allow the first arm 1024 to be rotationally driven relative to the second arm 1026.

[0300] 45A-C illustrate an example where a radially inner portion 1011 of the second arm 1013 may be coupled to the valve body 1016. A radially outer portion of the second arm 1013 may be coupled to a distal loop. A proximal end 1018 of the first arm 1020 (shown in FIG. 45C) may comprise a free end of the first arm 1020.

[0301] 45A , the distal anchor may be in an extended configuration and extend axially along the valve body 1016. The valve body 1016 may include a guide 1023 extending radially outward from the valve body 1016 through which the distal anchor may pass. The guide 1023 may include, for example, a loop or other structure for guiding the distal anchor. The distal anchor may be slidably driven along the valve body 1016 and through the guide 1023 to the deployed configuration. The distal anchor may be slidably driven relative to the valve body 1016 by the valve body 1016 being driven proximally backward or the distal anchor being driven distally forward.

[0302] FIG. 45B illustrates, for example, a deployed distal anchor. The distal anchor may be held in place, for example, and the valve body 1016 may be driven back proximally. The distal anchor may expand radially outward. The anchor may be configured to slide relative to the valve body to transition from the extended state to the deployed state. As with the example shown in FIGS. 40A-40D, the distal anchor may also be driven back by controlling the relative sliding movement of the distal anchor. The arms may be controllable such that one or more anchors are configured to transition from the deployed configuration to the extended configuration. For example, the valve body 1016 may be driven forward relative to the distal anchor to drive the distal anchor back radially inward and drive the distal anchor to the extended configuration. The position of the distal anchor may be readjusted until it is in a desired position. The distal anchor may be repositioned to allow recapture of the valve leaflet, as with the similar example shown in FIGS. 40A-40D.

[0303] With the distal anchor in the desired position, the first arm 1020 may be released from the delivery system. Figure 45C, for example, illustrates a configuration of the implant with the first arm 1020 released. The proximal end 1025 of the valve body 1016 may be released from the delivery system.

[0304] In an example, a radially inner portion of the first arm 1020 may be integral with a flange 1029 configured to extend radially outward from the valve body 1016. The flange 1029 may include a seal body that may provide a seal against the native heart valve to reduce fluid flow. The flange 1029 may help reduce the likelihood of the prosthetic valve migrating distally or toward the ventricle. The flange 1029 may include an atrial flange that may impede distal or toward the ventricle migration in an example. The flange 1029 may be configured to be positioned proximal to the native valve and the distal anchor is positioned distal to the native valve.

[0305] In an example, the arms 1013, 1020 may be independently controllable between the extended configuration and the deployed configuration. For example, the proximal end 1018 of the first arm 1020 may be independently controlled to control the deployment of an individual anchor. Each anchor may be configured to be driven, for example, from the extended configuration to the deployed configuration and from the deployed configuration to the extended configuration independently of other anchors of the plurality of anchors.

[0306] In an example, the arms may be shaped to transition from an extended configuration to a deployed configuration. The arms may be self-expanding. For example, the arms may be made of a shape memory material and configured to transition to the deployed configuration. Thus, upon release from the delivery system, the arms may transition to the deployed configuration as shown in FIG. 45C, FIG. 40D, and FIG. 41.

[0307] In an example, a control mechanism may be utilized to control the movement or deflection of the arms 1013, 1020. In an example, one or more actuators may be provided at a proximal portion of the delivery device. The handle of the delivery device may utilize one or more actuators (e.g., control knobs or other configured actuators) to, for example, allow a user to drive the movement of one or more shafts of the delivery device coupled to the arms 1013, 1020. The one or more actuators may be coupled to a proximal portion of one or more shafts in the delivery system, for example. The handle may have a configuration as shown in FIG. 10 or may have other configurations as desired. In an example, other configured controls may be utilized as desired.

[0308] Each feature in each example of FIGS. 40A-45C may be used alone or in combination with any other example disclosed herein.

[0309] 46A-46F illustrate an example of a prosthetic valve, where each anchor is configured to anchor the prosthetic valve to the native valve and is configured to be slidably driven relative to the valve body. At least one of the anchors may be axially slidable relative to the valve body. FIG. 46A illustrates a prosthetic valve 1030 that includes a valve body 1032 having, for example, a valve frame 1034. In an example, the valve body 1032 may include one or more guides 1036 that may guide movement of the anchors. The prosthetic valve may be configured similarly to the examples of prosthetic valves disclosed herein and may include multiple prosthetic leaflets and may further include a valve body supporting the multiple prosthetic leaflets.

[0310] The anchors may include a distal anchor 1038 that may include an elongated arm configured to extend radially outward from the valve body 1032. With reference to FIG. 46C, each distal anchor 1038 may include a tip 1040 and a proximal portion 1042. Each anchor 1038 may extend radially outward to the tip 1040. The proximal portion 1042 may include the proximal arm of the respective anchor and may be slidably coupled to the valve body 1032. A bent portion 1044 may be disposed between the tip 1040 and the proximal portion 1042. The bent portion 1044 may form a hook shape between the tip 1040 and the proximal portion 1042. Each distal anchor 1038 may be configured to be anchored onto the distal tip, i.e., downstream end, of the leaflet of the native valve. Each distal anchor 1038 may be configured to extend radially outward to a tip 1040 of a respective anchor.

[0311] Each distal anchor 1038 may be flexible and configured to transition from an elongated configuration, as shown in FIG. 46A, to a deployed configuration, as shown in FIG. 46C. Each distal anchor 1038 may have a hook shape in the deployed configuration. Each distal anchor 1038 may be configured to be slidably driven distally, allowing the distal anchor 1038 to pass through the guide 1036 and extend radially outward from the valve body 1032. A proximal portion 1042 of the anchor may be configured to be slidably driven along the valve body 1032.

[0312] Similar to the implant examples shown in Figures 3A-3E, the valve body 1032 may include a valve frame surrounding a central axis. Although the valve frame is shown in Figures 46A-46F, additional features may be utilized, such as prosthetic leaflets and a seal body, as described with respect to Figures 3A-3E, if desired. The anchors may be slidably actuated relative to the valve body 1032 to vary the axial position of the anchor tips 1040 relative to the valve body 1032. One or more anchors may be configured to be axially slidable relative to the valve frame. Each anchor may be slidable relative to the valve body to position the tips about the leaflets of the native heart valve.

[0313] Each distal anchor 1038 may be shaped to form a hook-like configuration as it passes radially outward from the valve body 1032. For example, the distal anchors 1038 may be made from a shape memory material that causes the distal anchors 1038 to form a hook shape as it passes radially outward from the valve body 1032. Each anchor may be formed with a hook shape. The distal anchors 1038 may transition from a configuration having an elongated shape to a configuration having a hook shape as shown in FIG. Each anchor 1038 may be shaped to extend around the downstream edge of the leaflets of the native heart valve.

[0314] 46H , each distal anchor 1038 may include a proximal end 1045 that may be configured to couple to a control device 1046 for controlling movement of the anchor 1038. The control device 1046 may include, for example, a tether 1048 for controlling a rearward drive of the anchor 1038 and a pusher shaft 1050 for controlling a forward drive of the anchor 1038. The tether 1048 may be disposed internally of the pusher shaft 1050 in examples, or may be disposed externally of the pusher shaft 1050 as desired. Each distal anchor 1038 may be controlled by a separate control device 1046 in examples.

[0315] The locking member 1052 may be configured to lock the position of the distal anchor 1038 relative to the valve body 1032. The locking member 1052 may fix the position of the distal anchor 1038 relative to the valve body 1032. The locking member 1052 may be configured to engage with the locking portion 1054 of each distal anchor 1038, for example. The locking member 1052 may include one or more teeth or a contoured body that may engage with the locking portion 1054. The locking portion 1054 may have a configuration that engages with the locking member 1052 and, in an example, may have a corresponding shape. In an example, the locking member 1052 may include a ratchet locking member or mechanism that allows movement in one direction and prevents movement in the opposite direction.

[0316] Referring to FIG. 46A, the implant may be driven forward to the implantation site and the distal anchor 1038 may be held in a retracted position. Once the implant reaches the implantation site, the distal anchor 1038 may be slid distally to anchor it to the implantation site. FIG. 46B, for example, illustrates the distal anchor 1038 slightly forward. FIG. 46C illustrates the distal anchor 1038 slid distally and expanded radially outward from the valve body 1032. The distal anchor 1038 may be slid distally to expand radially and slid proximally to retract. The distal anchor 1038 may be slid such that a portion 1056 of the distal anchor 1038 distal to the locking portion 1054 may be slid through the locking member 1052. In this manner, the locking member 1052 may avoid engagement with the locking portion 1054 when the distal anchor 1038 is slidably actuated.

[0317] The distal anchor 1038 may be slidably driven in a distal-proximal direction relative to the valve body, allowing the distal anchor 1038 to be anchored onto the distal tip of the heart valve leaflet. The distance of the anchor from the valve body may be configured to be variable. For example, as shown in FIG. 46C, the anchor 1038a may be driven forward radially outward to be anchored onto the heart valve leaflet. Additionally, the anchor 1038b may be driven forward radially outward to be anchored onto the heart valve leaflet, but may fail to capture the leaflet.

[0318] Referring to Fig. 46D, the distal anchor 1038b may be slid proximally to drive the distal anchor 1038b backward. Thus, the distal anchor 1038b may be slid backward to move the heart valve leaflet to a position where it is captured by the distal anchor 1038b. Fig. 46E illustrates the distal anchor 1038b that has been slid backward. The distal anchor 1038b may be slid forward again distally to allow the distal anchor 1038b to capture the heart valve leaflet. The distal anchor 1038b may be slid in a distal-proximal direction or a combination of distal and proximal movements until the heart valve leaflet is captured.

[0319] FIG. 46F, for example, illustrates distal anchor 1038b being driven forward to recapture the heart valve leaflet.

[0320] Once the distal anchors are in the desired position, they may be locked in place relative to the valve body 1032. For example, each distal anchor 1038a, 1038b may be driven forward distally such that locking portion 1054 engages locking member 1052. Once the distal anchors are locked in place, each corresponding tether 1048 may be cut and pulled from the distal anchor. The tether 1048 may be looped, allowing the end of the tether to be cut and pulled through the delivery system.

[0321] Each anchor may be configured to be slidably actuated relative to the valve body independent of other anchors in the plurality of anchors. Each anchor may be independently controllable. Each anchor may be independently slidable to allow the anchors to be disposed at different axial positions relative to the valve body 1032. In an example, anchors 1038 may be provided in two or more groups, and each group may be axially slidable independent of the other groups.

[0322] Figure 46G illustrates a cross-sectional view of the distal anchors 1038a, 1038b along line 46G-46G in Figure 46F. In Figure 46G, the heart valve leaflets are out of view. The distal anchors are shown passing through guide 1036 in the valve body.

[0323] 47 illustrates an example locking member 1058 as may be utilized in the examples herein. The locking member 1058 may include a ratcheting locking member that engages a locking portion 1060 of a distal anchor. The distal anchor may be capable of being slid distally, for example, and the locking member 1058 may engage the locking portion 1060 to prevent proximal movement of the distal anchor.

[0324] 48 illustrates an example locking member 1062 as may be utilized in the examples herein. The locking member 1062 may have a contour that may match a locking member 1064 of a distal anchor having a corresponding contour. The locking member 1064 may fit into and engage the locking member 1062.

[0325] FIG. 49 illustrates an example locking member 1066 that may be selectively controlled. A sheath 1068 may extend over the distal anchor, for example, and may block engagement of the locking member 1066 with the locking portion 1070. Upon retraction of the sheath 1068 at a desired time, the locking member 1066 may engage the locking portion 1070 and lock the distal anchor in place. In examples, other configured locking members may be utilized, such as drive fins or other configured locking members. The locking members may be selectively controlled in examples, or may include passive locking members in examples. In examples, the locking members may be operated using a control mechanism as disclosed herein. The locking members may include selectively controlled locking members. For example, a control mechanism as shown in FIG. 51 or FIG. 52 may be configured to operate a locking member, such as a selectively controlled locking member, as desired.

[0326] In an example, a control mechanism may be utilized to drive at least one anchor 1038 to slide axially relative to the valve body 1032. The control mechanism may have a variety of configurations. For example, the control mechanism may include the features of the control mechanisms illustrated in FIGS. 54-63, as desired. Such a control mechanism may be utilized to, for example, drive the tether 1048 and pusher shaft 1050 in a proximal-distal direction, which may, for example, drive the anchor 1038 to slide axially relative to the valve body 1032. Other configurations of control mechanisms may be utilized as desired.

[0327] For example, FIG. 50 illustrates a control mechanism 1080 for actuating at least one anchor 1038 to slide axially relative to the valve body 1032. The control mechanism 1080 may be operable to actuate at least one of the anchors 1038a, 1038b to slide proximally or distally relative to the valve body 1032. As shown in FIG. 50, the control mechanism 1080 may include one or more control devices 1046, which may be configured with a tether 1048 and a pusher shaft 1050 for actuating the anchors 1038a, 1038b in a proximal-distal direction. The tether 1048 and pusher shaft 1050 may actuate the anchors 1038a, 1038b to slide axially relative to the valve body 1032. Other configurations of control devices may be utilized as desired.

[0328] The control mechanism 1080 may include one or more actuators 1082a, 1082b that may be actuated to axially slide at least one of the anchors 1038a, 1038b. The actuators 1082a, 1082b may be operable by a user to axially drive at least one of the anchors 1038a, 1038b. For example, the actuators 1082a, 1082b may have the form of a control knob that may be manipulated by a user. The control knob may have portions 1084a, 1084b that are disposed externally relative to a portion of the delivery device, such as a handle of the delivery device. A user may actuate the actuators 1082a, 1082b to axially drive at least one of the anchors 1038a, 1038b. In examples, other configurations for the actuators 1082a, 1082b may be utilized.

[0329] The actuators 1082a, 1082b may be configured to drive the control device 1046 in a proximal or distal direction. For example, the actuators 1082a, 1082b may include threaded portions 1086a, 1086b that may be configured to engage threads on corresponding drive bodies 1088a, 1088b coupled to the control device 1046. In this manner, rotationally driving the actuators 1082a, 1082b in a first direction may slidably drive the control device 1046 in a proximal direction, and rotationally driving the actuators 1082a, 1082b in a second, opposite direction may slidably drive the control device 1046 in a distal direction. Thus, the sliding movement of the control device 1046 may slidably drive the anchors 1038a, 1038b. In an example, control mechanism 1080 may be configured to control a locking member for anchor 1038. In an example in which the locking member is selectively controlled, such as shown in Fig. 49, for example, control mechanism 1080 may be configured to retract sheath 1068. Other forms of control may be provided as desired.

[0330] Control mechanism 1080 may be operable to drive anchor 1038a in an axially sliding motion relative to valve body 1032, and may be operable to drive anchor 1038b in an axially sliding motion relative to valve body 1032 independently of anchor 1038a. In this manner, independent control of anchors 1038a, 1038b, or groups of anchors 1038, may be provided.

[0331] The control mechanism 1080 may include an engagement portion 1090 for engaging at least one of the anchors 1038a, 1038b. For example, the engagement portion 1090 may include a portion of the tether 1048 that engages the anchors 1038a, 1038b. The engagement portion 1090 may be configured to be released from the anchors 1038a, 1038b upon deployment of the prosthetic valve relative to the native heart valve. For example, the tether 1048 may be cut to release the anchors 1038a, 1038b. FIG. 50 illustrates a knot portion 1092 that may be accessible by a user to cut and release the tether 1048 upon deployment.

[0332] In examples, the control mechanism 1080 may include a portion of a delivery device for delivering the prosthetic valve to the implantation site. The control mechanism 1080 may extend, for example, along the elongate shaft 1094 of the delivery device. The actuators 1084a, 1084b may be located at a proximal end portion of the elongate shaft 1094 of the delivery device or at a handle 1096 of the delivery device, as desired. As desired, the portion of the control mechanism may have other locations in examples. The delivery device may include other features, such as those described with respect to the delivery system 10. In examples, other configurations for the delivery device may be utilized.

[0333] In examples, other forms of control mechanisms may be used. FIG. 51A illustrates a control mechanism 1051 using, for example, a gear drive to drive the anchors 1061a, 1061b to slide axially relative to the valve body 1053. The gear drive may include, for example, an engagement portion 1055 configured to engage a displacement mechanism 1057 of the prosthetic valve 1059. The displacement mechanism 1057 may include, for example, a worm gear or other form of displacement mechanism to drive the sliding movement of the anchors 1061a, 1061b. Rotating the worm gear in a first direction may cause one of the anchors 1061a, 1061b to slide distally, and rotating the worm gear in a second, opposite direction may cause the corresponding anchor 1061a, 1061b to slide proximally. The engagement portion 1055 may include a distal end portion of the control mechanism 1051 that may engage with a worm gear (eg, may mesh with a protrusion or recess of the worm gear).

[0334] One or more actuators 1063a, 1063b may be provided to drive the control mechanism 1051. Each actuator 1063a, 1063b may be configured, for example, to individually drive each anchor 1061a, 1061b. A gear system 1065 may, for example, rotationally drive a corresponding drive shaft 1067a, 1067b, thereby generating axial movement of each corresponding anchor 1061a, 1061b.

[0335] In an example, the control mechanism 1051 may be motorized and may include a motor 1069 for driving the movement of the anchors 1061a, 1061b. In an example, the motor 1069 may receive input from the actuators 1063a, 1063b. The motor 1069 may be configured to independently drive the anchors 1061a, 1061b. The motor 1069 may drive a gear system 1065, as desired.

[0336] Each component of the control mechanism 1051 may be located in a similar position to that of the control mechanism 1080.

[0337] The engagement portion 1055 may be configured to release from the anchors 1061 a, 1061 b when the prosthetic valve 1059 is deployed relative to the native heart valve. For example, the distal end portions of the drive shafts 1067 a, 1067 b may be driven back from the displacement mechanism 1057. Figure 51B illustrates a deployed prosthetic valve 1059 configuration with the drive shafts 1067 a, 1067 b driven back.

[0338] In examples, other forms of control mechanisms may be utilized, such as hydraulic, electrical, magnetic, or thermal control mechanisms, as desired, and other forms of mechanical devices (e.g., pulleys, wheel drives, pistons, scissor arms, among others) may be utilized, as desired.

[0339] In examples, the anchor may be formed with a hook shape such that the hook shape is retained when the anchor is axially slidably driven. For example, the anchor may be configured into the retained hook shape or may be otherwise formed into the retained hook shape. The anchor may be deployed in the hook shape in examples.

[0340] 52A, the anchors 1101a, 1101b may be elongated in an undeployed or compressed configuration, which may include a configuration in which the prosthetic valve 1103 is retained within, for example, a capsule 1105 of a delivery device.

[0341] When transitioning to the deployed or expanded configuration, the anchors 1101a, 1101b may expand radially outward into a hook shape. For example, FIG. 52B illustrates the anchors 1101a, 1101b having a hook shape. The anchors 1101a, 1101b may retain the hook shape upon movement in the proximal-distal direction. The anchors 1101a, 1101b may be axially slidably actuated relative to the valve body 1109 using any of the methods disclosed herein.

[0342] For example, anchor 1101b may be slid distally to allow for contact point 1111 against the valve annulus. Anchor 1101a may be slid proximally to adjust the distance of anchor 1101a from the native valve leaflets. FIG. 52C illustrates the resulting adjustment in the position of anchors 1101a, 1101b. In this manner, a lowered position of anchor 1101b relative to the valve body may be provided upon distal movement of anchor 1101b, and a raised position of anchor 1101a relative to the valve body may be provided upon proximal movement of anchor 1101a.

[0343] The anchors 1101a, 1101b may be actuated for various purposes, including to accommodate the shape of the native heart valve or to accommodate the failure of the leaflets to capture. The anchors 1101a, 1101b may be adjusted to provide a fit of the prosthetic valve 1103 to the native valve, which may be to improve the seal against the native valve, or to accommodate the contact of the anchors against a portion of the native valve. For example, the contact point 1111 of the anchor 1101b against the native valve may result in conduction disturbance of the native valve, which may be undesirable. To reduce the possibility of such conduction disturbance, the position of the anchor 1101b may be adjusted.

[0344] FIG 53A illustrates an example where the anchor 1101b fails to capture the leaflet. Referring to FIG 53B, the anchor 1101b may be driven to slide distally to allow the leaflet to move radially inward and to be recaptured by the anchor 1101b. Referring to FIG 53C, the anchor 1101b may be driven proximally back to capture the native leaflet. The anchors 1101a, 1101b may retain a hook shape as the anchors 1101a, 1101b are driven proximally and distally.

[0345] Each feature in each example of Figures 46A-53C may be used alone or in combination with any other example disclosed herein.

[0346] 54 illustrates a schematic diagram of a delivery system 1100 for an implant. The delivery system 1100 may include a control mechanism 1102. The control mechanism 1102 may be configured to control the deflection of at least one distal anchor 1104a of the implant 1106 independently from the deflection of at least one other distal anchor 1104b of the implant 1106.

[0347] The implant 1106 may have a variety of configurations. For example, the implant 1106 may be configured similarly to the implant 915 shown in FIG. 33B. The implant 1106 may have a configuration related to any other implant as disclosed herein. In examples, the implant 1106 may have other configurations, as desired.

[0348] The control mechanism 1102 may include a coupler assembly 1107. The coupler assembly 1107 may be configured to couple the anchors 1104a, 1104b of the implant 1106 to a drive assembly 1118, in examples.

[0349] The coupler assembly 1107 may include, in example, a tether assembly, and may include one or more tethers 1108a, 1108b that may be utilized to control the deflection of the anchors 1104a, 1104b independently of one another. For example, each tether 1108a, 1108b may include a corresponding distal portion 1110a, 1110b and a proximal portion 1112a, 1112b, respectively. The first tether 1108a may be configured to control the deflection of at least one distal anchor 1104a. The second tether 1108b may be configured to control the deflection of at least one other distal anchor 1104b.

[0350] Distal portions 1110a, 1110b of tethers 1108a, 1108b may be configured to couple to respective portions of implant 1106. For example, each distal portion 1110a, 1110b may be configured to couple to one or more anchors for controlling the respective anchors. Distal portion 1110a may be coupled to anchor 1104a, for example. Distal portion 1110b may be coupled to anchor 1104b. Distal portion 1110a may be configured to drive anchor 1104a independently of the other anchor 1104b. Similarly, distal portion 1110b may be configured to drive anchor 1104b independently of anchor 1104a.

[0351] In an example, distal portion 1110a may be configured to couple to a first plurality of anchors and to control the first plurality of anchors independently of the second plurality of anchors, and similarly, distal portion 1110b may be configured to couple to a second plurality of anchors and to control the second plurality of anchors independently of the first plurality of anchors.

[0352] The tethers 1108a, 1108b may control the corresponding anchors 1104a, 1104b by applying a compressive force to the anchors 1104a, 1104b. The tethers 1108a, 1108b may be configured to couple to the corresponding anchors 1104a, 1104b and apply a radially inward compressive force to the corresponding anchors 1104a, 1104b. Such compressive methods may include those disclosed herein. For example, the tethers 1108a, 1108b may be positioned relative to the implant 1106 such that the compressive force on the corresponding anchors 1104a, 1104b is caused by a proximal tension in the tethers 1108a, 1108b. In an example, the elongate shaft 1114 may be configured to pass through the tethers 1108a, 1108b. The elongate shaft 1114 may be positioned such that pulling the tethers 1108a, 1108b through the elongate shaft 1114 applies a compressive force to the anchors 1104a, 1104b. The proximal portions 1112a, 1112b may be configured such that, when driven proximally back through the elongate shaft 1114, the tethers 1108a, 1108b apply a radially inward compressive force to their respective anchors 1104.

[0353] In examples, a portion of the elongate shaft (e.g., inner shaft 1113) may be positioned flush against anchors 1104a, 1104b by passing through implant 1106 or by passing through a flow channel of the implant. In this manner, a proximal force applied to tethers 1108a, 1108b may include a compressive force applied to anchors 1104a, 1104b. In examples, other configurations of control or other configurations of placement may be utilized.

[0354] The proximal portions 1112a, 1112b of the respective tethers 1108a, 1108b may be configured to couple to a drive assembly 1118 of the control mechanism 1102. The proximal portions 1112a, 1112b may be configured to pass through the elongate shaft 1114, for example, and the distal portions 1110a, 1110b may be configured to couple to distal anchors 1104a, 1104b of the implant.

[0355] The tethers 1108a, 1108b may include materials having various configurations. For example, the distal portions 1110a, 1110b of the tethers 1108a, 1108b may include sutures. The proximal portions 1112a, 1112b may include wires or may have other configurations as desired. The corresponding couplers 1120a, 1120b may be configured to couple the distal portions 1110a, 1110b of the tethers 1108a, 1108b to the proximal portions 1112a, 1112b. In examples, the tethers 1108a, 1108b may have other configurations.

[0356] In examples, coupler assembly 1107 may have other configurations, as desired.

[0357] The delivery system 1100 may include an elongate shaft 1114. The elongate shaft 1114 may be configured to drive the implant 1106 forward to the implantation site. The elongate shaft 1114 may be configured similarly to the examples of shafts in the delivery systems disclosed herein, or may have other configurations, as desired. The elongate shaft 1114 may be configured to be deflectable to a desired position, for example, to orient the implant 1106 at the implantation site (e.g., a natural valve), as desired. The elongate shaft 1114 may include an implant holding region for holding the implant 1106. The implant holding region may include, for example, a capsule 1115 for surrounding the implant 1106, or may have another configuration, as examples. In examples, the capsule 1115 may be omitted, and other configurations of the implant holding region may be utilized.

[0358] The elongate shaft 1114 may include multiple shafts or multiple sheaths. For example, the elongate shaft 1114 may include a first inner shaft 1113 or first tether shaft. The first inner shaft 1113 may include an interior lumen 1122 along which the tethers 1108a, 1108b may extend. A second inner shaft 1124 or coupler shaft may be disposed within the interior lumen 1122. In an example, one or more couplers 1116 may be coupled to the inner shaft 1124.

[0359] The elongate shaft 1114 may include a distal end portion 1126 at which the implant 1106 may be deployed. The elongate shaft 1114 may extend to a proximal end portion 1128. In an example, the proximal end portion 1128 may be configured to be disposed outside the patient's body during an implantation procedure. The elongate shaft 1114 may extend into the patient's vasculature with the proximal end portion 1128 accessible by a user. In an example, the proximal end portion 1128 may be disposed within the patient's body during an implantation procedure.

[0360] The coupler assembly 1107 may be actuated using a drive assembly 1118 of the control mechanism 1102. The drive assembly 1118 may be configured, for example, to apply tension to or release one or more of the tethers 1108a, 1108b. The drive assembly 1118 may be configured to be manipulated to deflect at least one distal anchor 1104a of the implant 1106 independent of the deflection of at least one other distal anchor 1104b of the implant 1106. The drive assembly 1118 may have a variety of configurations.

[0361] For example, with reference to FIG. 54, the drive assembly 1118 may include one or more drive bodies 1130a, 1130b, 1130c. The drive bodies 1130a, 1130b, 1130c may each be configured to couple to a proximal end portion of one tether (the tether 1108c to which the drive body 1130c may be coupled is omitted from FIG. 54 for clarity and is shown in FIG. 55). For example, the drive body 1130a may be coupled to the proximal portion 1112a of the tether 1108a. The drive body 1130b may be coupled to the proximal end portion 1112b of the tether 1108b. The drive body 1130a may be configured to control the deflection of the anchor 1104a. The drive body 1130b may be configured to control the deflection of the anchor 1104b. In an example, additional drive bodies may be provided. For example, a drive body may be provided for each corresponding tether as desired (eg, six drive bodies for six tethers, nine drive bodies for nine tethers, etc.).

[0362] Each of the drive bodies 1130a, 1130b, 1130c may be configured to be driven in a distal-proximal direction. A distal drive may drive each corresponding tether distally, thereby releasing the corresponding tether distally. A proximal drive may drive each corresponding tether proximally, thereby driving each corresponding tether back proximally. Driving the tether 1108a distally may, for example, allow the anchor 1104a to expand radially outward or may allow the hook shape of the anchor 1104a to assume a greater curvature. The anchor 1104a may transition from an elongated configuration to a hook-like configuration. The anchors 1104a, 1104b may be biased toward the hook-like configuration or toward a configuration with a greater curvature, for example. Proximal actuation of tether 1108a may, for example, overcome the bias and provide a compressive force against anchor 1104a or may drive anchor 1104a radially inward. Anchor 1104a may have a smaller curvature or a more elongated shape relative to the hook shape of anchor 1104a. The elongated configuration may be similar to configurations disclosed herein (e.g., to the elongated configuration shown in FIG. 33A). Anchor 1104a may transition from the hook-like configuration to the elongated configuration.

[0363] In an example, the control mechanism 1102 may include at least one actuator 1132a, 1132b, 1132c for controlling deflection of at least one distal anchor in the implant. One or more actuators 1132a, 1132b, 1132c may be provided that may be configured to drive a respective one of the drive bodies 1130a, 1130b, 1130c. The actuators 1132a, 1132b, 1132c may have various configurations, in an example. With reference to FIG. 54, in an example, the actuators 1132a, 1132b, 1132c may include a respective corresponding drive shaft 1134a, 1134b, 1134c and may include a respective corresponding control surface 1136a, 1136b, 1136c. The drive shafts 1134a, 1134b, 1134c may include threaded shafts, in examples, and may be configured such that rotational driving of the drive shafts 1134a, 1134b, 1134c may drive the corresponding drive bodies 1130a, 1130b, 1130c. The control surfaces 1136a, 1136b, 1136c may include surfaces for a user to manipulate to control the drive shafts 1134a, 1134b, 1134c and the corresponding drive bodies 1130a, 1130b, 1130c. For example, each control surface 1136a, 1136b, 1136c may include a knob that allows rotational driving of the corresponding drive shaft 1134a, 1134b, 1134c, or may have another configuration, as desired.

[0364] In examples, the drive bodies 1130a, 1130b, 1130c may be non-threaded and each may include a corresponding opening that may allow the drive body 1130a, 1130b, 1130c to be driven along the drive shaft 1134a, 1134b, 1134c. Thus, the drive bodies 1130a, 1130b, 1130c, in examples, may be non-interlocking with the corresponding drive shaft 1134a, 1134b, 1134c and may be slidably driven along the drive shaft 1134a, 1134b, 1134c.

[0365] In an example, an adapter 1140a, 1140b, 1140c may be utilized to transfer force from the drive shaft 1134a, 1134b, 1134c to a corresponding one of the drive bodies 1130a, 1130b, 1130c. For example, each adapter 1140a, 1140b, 1140c may include threads that may engage with threads on the drive shaft 1134a, 1134b, 1134c. Each adapter 1140a, 1140b, 1140c may be driven longitudinally upon rotational driving of the corresponding drive shaft 1134a, 1134b, 1134c. Proximal driving of the adapter 1140a, 1140b, 1140c may urge the corresponding drive body 1130a, 1130b, 1130c in a proximal direction. Distal actuation of the adaptors 1140a, 1140b, 1140c may enable the respective drive bodies 1130a, 1130b, 1130c to be driven distally due to tension applied by the respective tethers.

[0366] In an example, the control mechanism 1102 may include a housing 1142. The housing 1142 may be configured to hold the components of the drive assembly 1118, or other components as desired. With reference to FIG. 55 , the housing 1142 may include a distal face 1144 and a proximal face 1146. The housing 1142 may include a side or outer surface 1148. The side or outer surface may be configured to be gripped by a user, in an example. The housing 1142 may include an internal cavity 1150 that may be configured to hold the components of the drive assembly 1118.

[0367] The distal surface 1144 of the housing 1142 may include one or more openings 1152 through which components of the control mechanism 1102 may pass. For example, the tethers 1108a-1108c may pass through the distal surface 1144 of the housing 1142. Pivots 1154a, 1154b, 1154c about which respective drive shafts 1134a, 1134b, 1134c may be rotationally driven may pass through the distal surface 1144 of the housing 1142, as desired.

[0368] The proximal face 1146 of the housing 1142 may include one or more openings 1156. The openings 1156 may be configured to allow passage therethrough of a corresponding one of the actuators 1132a, 1132b, 1132c. The openings 1156 may be non-threaded, in examples. Each corresponding drive shaft 1134a, 1134b, 1134c may pass through the non-threaded opening, such that the control surfaces 1136a, 1136b, 1136c are accessible from the exterior of the housing 1142.

[0369] The housing 1142 may be formed from one or more shells that may retain the components within the interior cavity 1150. Figure 56, for example, illustrates an assembly diagram of the components of the control mechanism 1102. The shells 1142a, 1142b of the housing 1142 are shown as including the halves that make up the housing 1142.

[0370] FIG. 57 illustrates an external perspective view of the housing 1142.

[0371] The housing 1142 may be positioned such that it is accessible by a user, in examples. For example, the housing 1142 may be configured to be positioned outside the patient's body during an implantation procedure. The housing 1142 may be integral to or coupled to a housing that may be utilized to control other features of the delivery system 1100, such as deflection of the elongate shaft 1114 or release of the implant 1106, among other features. The housing 1142 may be positioned in-line with other components of the housing or handle, as shown, for example, in FIG. 10. In examples, the housing 1142 may be utilized separate from other components of the housing or handle. Various other arrangements for the housing 1142 may be utilized.

[0372] In operation, the control mechanism 1102 controls the deflection of at least one distal anchor 1104a of the implant 1106 independently of the deflection of at least one other distal anchor 1104b of the implant 1106, which may take into account failure to capture the leaflets of the native valve or may take into account the shape of the implantation site (e.g., the shape of the native valve).

[0373] For example, with reference to FIG. 58, deployment of one or more anchors 1104a, 1104b may result in failure to capture leaflet 1158a and capture of leaflet 1158b. At this point in the procedure, the user may need to decide whether to backdrive or recapture all of the anchors in an example where all anchors are controlled together. However, independent control over anchors 1104a, 1104b may also be provided using control mechanism 1102. In this manner, the user may attempt to recapture leaflet 1158a by deflecting anchor 1104a without releasing the capture of leaflet 1158b. Various other advantages of control mechanism 1102 may be provided during the deployment procedure. For example, the user may adjust the shape of anchor 1104a to account for the longer geometry of leaflet 1158a while retaining the shorter geometry of anchor 1104b based on the shorter leaflet 1158b.

[0374] FIG 55 illustrates an exemplary use of control mechanism 1102 to independently control deflection of at least one anchor 1104a. Referring to FIG 55, for example, actuator 1132a is actuated to drive drive body 1130a in a retracted manner. Adapter 1140a urges drive body 1130a proximally to drive drive body 1130a in a retracted manner. Thus, tether 1108a is retracted independently of tethers 1108b, 1108c.

[0375] 59, tether 1108a is shown actuated back by a distance or length 1160. Anchor 1104a thus deflects distally or inwardly, allowing for recapture of leaflet 1158a. Anchor 1104b may remain in the same position even as anchor 1104a is actuated. Anchors 1104a, 1104b and tethers 1108a, 1108b may be provided with a positional offset.

[0376] Thus, the user may utilize the actuator 1132a in an attempt to recapture the leaflet 1158a. The actuator 1132a may then drive the adapter 1140a distally. Distal tension provided by the tether 1108a may drive the drive body 1130a slidingly distally, which may allow the anchor 1104a to return to a position having greater curvature, such as that shown in FIG. 58.

[0377] In an example, the control mechanism 1102 may include an offset controller 1162. The offset controller 1162 may be configured to control the deflection of at least one anchor 1104a simultaneously with the deflection of at least one other anchor 1104b of the implant, with a deflection offset existing between the at least one distal anchor 1104a and the at least one other distal anchor 1104b. The positional offset relative to the anchors 1104a, 1104b may be maintained.

[0378] The offset controller 1162 may include, for example, an actuator 1164 for driving the drive bodies 1130a, 1130b, 1130c. The offset controller 1162 may be configured to drive the drive bodies 1130a, 1130b, 1130c simultaneously. The actuator 1164 may drive the drive bodies 1130a, 1130b, 1130c simultaneously in a sliding proximal direction while maintaining a positional offset relative to the drive bodies 1130a, 1130b, 1130c. The actuator 1164 may allow the drive bodies 1130a, 1130b, 1130c to be driven simultaneously in a sliding distal direction while maintaining a positional offset relative to the drive bodies 1130a, 1130b, 1130c.

[0379] The actuator 1164 may include a control surface 1166 and a push body 1168. The control surface 1166 may be configured to be manipulated by a user to actuate the actuator 1164. The control surface 1166 may include an outer gripping surface, for example, on the housing 1142. The control surface 1166 may be rotationally actuated. The control surface 1166 may include threads 1170 that may be configured to engage threads 1172 on the push body 1168. The control surface 1166 may be coupled to the housing 1142 such that an axial position of the control surface 1166 does not change when the control surface 1166 is rotationally actuated.

[0380] The push body 1168 may be disposed within the control surface 1166. The push body 1168 may be configured to be driven to slide axially along the housing 1142 when the control surface 1166 is driven to rotate. The push body 1168 may include an outer surface having a screw thread 1172. Thus, when the control surface 1166 is rotated, the push body 1168 may be driven axially in a proximal-distal direction.

[0381] The push body 1168 may be configured to contact the control surfaces 1136a, 1136b, 1136c of the actuators 1132a, 1132b, 1132c. The control surfaces 1136a, 1136b, 1136c of the actuators 1132a, 1132b, 1132c may each have a diameter larger than the opening of the push body 1168, such that the surfaces of the push body 1168 may be pressed against when the push body 1168 is actuated. In particular, the opening of the push body 1168 and the opening 1156 in the proximal surface 1146 of the housing 1142 may be non-threaded, such that the drive shafts 1134a, 1134b, 1134c may be freely slidably actuated through the openings when the control surfaces 1136a, 1136b, 1136c are axially actuated.

[0382] FIG. 60, for example, illustrates the positions of the actuators 1132a, 1132b, 1132c upon operation of the offset controller 1162. The actuators 1132a, 1132b, 1132c may be driven back to correspondingly drive the drive bodies 1130a, 1130b, 1130c and tethers 1108a, 1108b, 1108c back. The positional offsets for the drive bodies 1130a, 1130b, 1130c and tethers 1108a, 1108b, 1108c may be maintained from the positions shown in FIG. 59, for example. Thus, referring to FIG. 61, the anchors 1104a, 1104b may be deflected simultaneously while maintaining the offsets shown in FIG. 59. Such manipulation may allow for collective capture, recapture, or back-drive of the anchors 1104a, 1104b while maintaining the offset. The offset may take into account variations in size of the leaflets 1158a, 1158b, for example.

[0383] 60, the offset controller 1162 may be manipulated until the proximal surface 1146 of the housing 1142 contacts one of the drive bodies 1130a. Such a feature may reduce the likelihood that the offset controller 1162 will undesirably change the offset between the drive bodies 1130a, 1130b, 1130c and between the tethers 1108a, 1108b, 1108c.

[0384] In an example, the control mechanism 1102 may include an override mechanism 1173. The override mechanism 1173 may be configured to override the deflection offset between the anchors 1104a, 1104b.

[0385] 62, the override mechanism 1173 may include an actuator 1175 for driving at least one of the drive bodies 1130a, 1130b, 1130c. The actuator 1175 may slidably drive the drive bodies 1130a, 1130b, 1130c relative to one another to override any bias offset that may exist between the drive bodies 1130a, 1130b, 1130c.

[0386] The actuator 1175 may include a control surface 1174 and a push body 1176. The control surface 1174 may be configured to be manipulated by a user to actuate the actuator 1175. The control surface 1174 may include an outer gripping surface, for example, on the housing 1142. The control surface 1174 may be rotationally actuated. The control surface 1174 may include threads 1178 that may be configured to engage threads 1180 on the push body 1176. The control surface 1174 may be coupled to the housing 1142 such that an axial position of the control surface 1174 does not change when the control surface 1174 is rotationally actuated.

[0387] The push body 1176 may be disposed within the control surface 1174. The push body 1176 may be configured to be driven to slide axially along the housing 1142 when the control surface 1174 is driven in rotation. The push body 1176 may include an outer surface having a screw thread 1180. Thus, when the control surface 1174 is rotated, the push body 1176 may be driven axially in a proximal-distal direction.

[0388] The push body 1176 may be configured to contact the drive body 1130a, 1130b, 1130c. For example, a portion of the drive body 1130a, 1130b, 1130c may protrude from an outer profile of the respective adaptor 1140a, 1140b, 1140c such that the drive body 1130a, 1130b, 1130c is pushed by the push body 1176 without pushing the adaptor 1140a, 1140b, 1140c. Thus, the drive body 1130a, 1130b, 1130c may be driven independently of the respective adaptor 1140a, 1140b, 1140c, as shown in FIG. Actuation of the drive bodies 1130a, 1130b, 1130c may cause the drive bodies 1130a, 1130b, 1130c to align, thereby overriding the offset of the drive bodies 1130a, 1130b, 1130c and the offset of the tethers 1108a, 1108b, 1108c.

[0389] 63 illustrates tether 1108b driven proximally back to the same position as tether 1108a by override mechanism 1173. Such a feature may allow a user to provide a similar deflection for all anchors 1104a, 1104b of implant 1106. The override mechanism may drive tether 1108b a greater distance than tether 1108a.

[0390] 62, the override mechanism 1173 may operate until the push body 1176 pushes all of the drive bodies 1130a, 1130b, 1130c against the proximal face 1146 of the housing 1142. Such a feature may function to ensure that the offsets between the drive bodies 1130a, 1130b, 1130c and between the tethers 1108a, 1108b, 1108c have been overridden.

[0391] In an example, the actuators 1132a, 1132b, 1132c may be operated without rotationally driving the control surfaces 1136a, 1136b, 1136c. For example, referring to FIG. 58, the actuator 1132a may be operated by being pulled proximally through the opening 1156 (shown in FIG. 55) in the housing and push body 1168. Such a feature may be achieved by the opening 1156 (shown in FIG. 55) in the housing and push body 1168 not being threaded. Thus, the user may manually and quickly back-drive the tether 1108a to independently adjust the deflection of the anchor 1104a as desired. Tension in the tether 1108a may drive the actuator 1132a forward distally upon release by the user.

[0392] Once the anchors 1104a, 1104b are in the desired position, the tether may be cut or otherwise released from the implant 1106, allowing the implant to remain in the implanted position.

[0393] Other configurations for the control mechanism 1102 may be utilized. Each of the features in the delivery system 1100 and each of the features in the control mechanism 1102 may be utilized alone or in combination with any of the examples disclosed herein.

[0394] 64 illustrates an example prosthetic valve 1190 that includes one or more pacemaker leads 1192. The pacemaker leads 1192 may be configured to anchor the prosthetic valve 1190 in place at a native valve 1194.

[0395] The prosthetic valve 1190 may include a number of prosthetic leaflets 1196 and a valve body 1198 that supports the number of prosthetic leaflets 1196. The prosthetic valve 1190 may be configured to be deployed relative to the native valve 1194.

[0396] The pacemaker lead 1192 may be configured to be anchored to an endocardial wall. The pacemaker lead 1192 may be configured to extend from the valve body 1198 to engage an inner surface 1201 of the endocardial wall. The endocardial wall may include, for example, a ventricle (e.g., the right ventricle when the valve 1194 is tricuspid or the left ventricle when the valve 1194 is mitral). The inner surface 1201 may include a desired surface for implanting the pacemaker lead 1192. For example, the inner surface 1201 may include the ventricular apex or another ventricular portion for implantation.

[0397] The pacemaker lead 1192 may include a distal portion 1193 having a tip 1195. The tip 1195 may be configured to penetrate and anchor to an endocardial wall. In examples, other forms of anchoring may be utilized.

[0398] The pacemaker lead 1192 may extend transventricularly into the valve body 1198. A proximal portion 1202 of the pacemaker lead 1192 may be coupled to the valve body 1198. The pacemaker lead 1192 may have sufficient strength to anchor the valve body 1198 in place against forces toward the atrium. In an example, the pacemaker lead 1192 may have sufficient strength to anchor the valve body 1198 in place against forces toward the ventricle.

[0399] The proximal portion 1202 of the pacemaker lead 1192 may include one or more electrical terminals 1204 for coupling to a pacemaker. The electrical terminals 1204 may be configured to be electrically coupled to a pacemaker. The pacemaker may be provided to the patient at the time of implantation of the prosthetic valve 1190 or may be provided after implantation.

[0400] In examples, the pacemaker lead 1192 may be deployed first and the valve body 1198 may be deployed thereafter. FIGURE 65 illustrates a step in a deployment procedure where, for example, the pacemaker lead 1192 may be deployed first against the inner surface 1201 of the heart wall. The valve body 1198 may remain within an implant retaining region of the delivery system, such as capsule 1206. The valve body 1198 may then be deployed from the capsule 1206, as desired. In examples, other configured implant retaining regions may be utilized.

[0401] The prosthetic valve 1190 may, in examples, be free of other anchors for anchoring to the native leaflets or to other parts of the native valve. Thus, the likelihood of failure to capture or entanglement with the leaflets or chordae may be reduced. As a result, the likelihood of the chordae being severed may be reduced. Conduction disturbances caused by such anchors may also be reduced. In examples, the prosthetic valve 1190 may include anchors for anchoring to the native leaflets or to other parts of the native valve, as may be disclosed herein.

[0402] The pacemaker lead 1192 may be configured to have an adjustable length. For example, the pacemaker lead 1192 may be configured to be slidably driven relative to the valve body 1198. During deployment of the valve body 1198, a delivery system may be utilized to pull the pacemaker lead 1192 relative to the valve body 1198. The length of the pacemaker lead 1192 may be adjusted in vivo to account for variations in patient anatomical size.

[0403] The pacemaker lead 1192, in examples, may be configured to be disposed between the inner valve body and the outer valve body. The pacemaker lead 1192, in examples, may be configured to be disposed between the inner frame and the outer frame. The valve body configuration may be similar to other configurations for the valve body disclosed herein. Other shaped valve bodies may be utilized. Other configurations of the pacemaker lead 1192 may be utilized in examples.

[0404] A locking member may be utilized to lock the pacemaker lead 1192 in position relative to the valve body 1198. The locking member may be activated at the time of deployment and at the time of placement. The length of each pacemaker lead 1192 may be determined. For example, referring to FIG. 66, the locking member 1208 may be engaged when the length of the pacemaker lead 1192 is determined. The locking member 1208 may be positioned on the proximal or atrial side of the prosthetic valve, in examples. Other locations may be utilized. An unlocking member 1210 or other mechanism may be utilized to allow the locking member 1208 to engage. The unlocking member 1210 may be activated or removed to allow the locking member 1208 to engage. For example, an unlocking member 1210 in the form of a spacer is shown in FIG. 66. Removal of the spacer may allow the locking member to be locked in position. The locking member 1208 may have a variety of configurations. For example, the locking member may include, in example, a protrusion 1212 configured to contact the engagement surface 1214. Other configurations of locking members may be utilized (e.g., electrical or mechanical) as desired.

[0405] A pacemaker 1216 may be provided to the patient when the prosthetic valve 1190 is deployed. With reference to FIG. 67 , the pacemaker 1216 may be provided and coupled to the electrical terminals 1204 of the prosthetic valve 1190. In an example, the pacemaker 1216 may be deployed in a subsequent procedure and connected to the electrical terminals 1204 at that time. In an example, the pacemaker 1216 may be provided during the implantation procedure of the prosthetic valve 1190. In an example, the pacemaker 1216 may be connected to the pacemaker lead 1192 and may be implanted simultaneously with the pacemaker lead 1192.

[0406] Other configurations for the prosthetic valve and for the pacemaker lead may be utilized. FIG. 68 illustrates, for example, an alternative prosthetic valve 1190 in which the valve body 1191 includes an atrial flange 1197. The atrial flange 1197 may include an anchor for resisting ventricular migration of the prosthetic valve. The prosthetic valve may include other features described above with respect to the prosthetic valve 1190. The features described with respect to FIGS. 64-68 may be utilized alone or in combination with any of the examples disclosed herein.

[0407] The devices, systems, and methods disclosed herein may be directed to manufacturing at least a portion of a prosthetic heart valve based on imaging of a native heart valve. Although Figures 69-77 illustrate exemplary devices, systems, and methods that may be utilized, such devices, systems, and methods are not intended to be limiting.

[0408] 69, for example, a native heart valve 1220 may be imaged. The imaging may have a variety of forms. The imaging may include x-ray imaging (e.g., computed tomography (CT) scan), or other forms of x-ray imaging. The imaging may include ultrasound imaging (e.g., echocardiogram imaging). In examples, combinations of each form of imaging with each other or with other forms of imaging may be utilized.

[0409] By utilizing imaging, the shape of the native heart valve 1220 may be determined. The shape of the native heart valve 1220 may include the shape of the annulus 1222 of the native heart valve 1220. The shape of the native heart valve 1220 may include the length or position of the native leaflets 1224a, 1224b. Other features related to the native heart valve 1220 may be determined by imaging.

[0410] Imaging may be performed using an imaging device 1226 (e.g., an x-ray scanning device or an ultrasound scanning device) which may provide a full scan of the native heart valve 1220 or may provide a partial scan as desired. The imaging device 1226 may, in examples, be driven to various positions to provide the desired scan of the native heart valve 1220. Although a three-dimensional scan or model of the native heart valve 1220 may be provided, other forms of scans (e.g., two-dimensional scans or models) may be provided as desired.

[0411] The imaging may determine irregular shapes of the native heart valve 1220 (eg, the irregularly shaped annulus 1222) or may determine other features of the native anatomy, as desired.

[0412] In an example, imaging may be performed prior to a procedure to deploy the prosthetic heart valve. For example, imaging may be performed as a separate procedure that may occur days or weeks prior to the prosthetic heart valve implantation procedure. Imaging may be performed for the purpose of determining the shape of the native heart valve 1220 for manufacturing at least a portion of the prosthetic heart valve.

[0413] Images of the native heart valve 1220 generated during the imaging procedure may be stored or transmitted to a processing system. Figure 70, for example, illustrates an exemplary processing system 1228. The processing system 1228 may include an input 1230, an output 1232, a processor 1234, and a memory 1236. In examples, other configurations for the processing system 1228 may be utilized.

[0414] The input 1230 may have a variety of forms and may include a data port, a wireless transceiver, or an input terminal, among other forms of input. The input 1230 may be configured to receive signals or data for use by the processing system 1228.

[0415] The output 1232 may include a data port, a wireless transceiver, or an output terminal, among other forms of output. The output 1232 may be configured to output signals or data provided by the processing system 1228.

[0416] Memory 1236 may be configured to store data (e.g., programs, instructions, parameters, etc.) for processing by processor 1234. Memory 1236 may include non-transitory memory for storing such data for use by processor 1234. Memory 1236 may include a hard drive (e.g., mechanical or solid state), flash memory, or random access memory (RAM), among other forms of memory.

[0417] The processor 1234 may be configured to execute the processes disclosed herein. The processor 1234 may have various forms and may include a microprocessor, a controller, a distributed processing network, among other forms of processors. In examples, the components of the processing system 1228 may be remote and may be operated using wired or wireless transmissions, the Internet, or may include a cloud computing environment.

[0418] The processor 1234 may be configured to operate based on data received from the memory 1236 or provided to the processor 1234 in any other manner. The processor 1234 may receive data from the input 1230, process the data, and provide it to the output 1232. The processor 1234 may perform some or all of the processes disclosed herein.

[0419] In an example, the processor 1234 may receive image data from the input 1230 that may be generated during an imaging procedure depicted in Fig. 69. The image data may include a model of the native heart valve 1220 or may include data that allows the processor 1234 to form a model of the native heart valve 1220. In an example, the image data may be in a format that allows the processor 1234 to generate an output 1232 related to one or more characteristics of the prosthetic heart valve based on the image data generated during the imaging procedure. The image data may include, for example, parameters related to the shape of the native heart valve 1220 for use by the processor 1234.

[0420] The processor 1234 may be configured to generate an output 1232 for use in manufacturing at least a portion of the prosthetic heart valve. The output 1232 may include, for example, a shape or other configuration for at least a portion of the prosthetic heart valve or may include a shape or other configuration for a tool utilized to form at least a portion of the prosthetic heart valve. Other forms of the output 1232 may be provided.

[0421] In an example, the processor 1234 may be configured to qualify the determined shape against one or more constraints. For example, fatigue or compressive strain constraints for the frame may be evaluated by the processor 1234 to qualify the frame. The constraints may have been previously determined and stored in the memory 1236 and may be provided to the processor 1234. The processor 1234 may determine such a shape and generate a shape that satisfies the one or more constraints. Finite element analysis may be utilized by the processor 1234. The processor 1234 may be configured to determine whether at least a portion of the prosthetic heart valve complies with the constraints, such as strain constraints.

[0422] In an example, the processor 1234 may use one or more artificial intelligence algorithms to determine an optimized shape for a portion of the prosthetic valve. An artificial intelligence algorithm may be used to determine whether a shape (for a portion of the prosthetic valve or for a tool) qualifies for one or more constraints. An artificial intelligence algorithm may use image data to generate a portion of the prosthetic valve or a tool based on the image data. Other inputs may be provided to the artificial intelligence algorithm (e.g., previous data from other prosthetic valves or tools, or other parameters input by a user to the artificial intelligence algorithm). In an example, an artificial intelligence algorithm may not be used.

[0423] The processing system 1228 may include a portion of a manufacturing assembly 1240 that may be utilized to manufacture at least a portion of a prosthetic heart valve, or may include at least a portion of a tool utilized to form at least a portion of a prosthetic heart valve. FIG. 71 illustrates, for example, an exemplary manufacturing assembly 1240. The manufacturing assembly 1240 may be utilized to mold, form, or generate a prosthetic heart valve, or to mold, form, or generate at least a portion of a tool utilized to form at least a portion of a prosthetic heart valve. The manufacturing assembly 1240 may include an automated manufacturing assembly, in examples. For example, inputs may be provided to the manufacturing assembly 1240 such that the manufacturing assembly 1240 performs manufacturing in an automated manner. The inputs may be provided from an output 1232 of the processing system 1228.

[0424] In an exemplary procedure, the manufacturing assembly 1240 may be configured to form a tool. The manufacturing assembly 1240 may, for example, mold, form, or produce the tool. The tool may include a mandrel 1242, as shown in FIG. 71. The mandrel 1242 may be configured such that at least a portion of the valve body (e.g., a frame of the valve body) is formed on a top surface thereof.

[0425] In an example, mandrel 1242 may be formed by manufacturing assembly 1240 using additive manufacturing based on imaging of native heart valves. Three-dimensional printing or other forms of additive manufacturing may be used to form the shape of mandrel 1242. Figure 71, for example, illustrates mandrel 1242 formed by an additive manufacturing process.

[0426] The mandrel 1242 may be shaped based on output provided by the processor 1234. For example, the processor 1234 may determine a desired shape for the mandrel 1242 based on image data provided from an imaging procedure. The prosthetic heart valve may include a valve body. The valve body may be configured to support a number of prosthetic leaflets. With the shape of the mandrel 1242 determined, the valve body may be manufactured based on the shape of the native heart valve 1220.

[0427] The shape of the mandrel 1242 may be determined, for example, based on the imaged shape of the annulus 1222 of the native heart valve 1220. The mandrel 1242 may be utilized to provide a shape for at least a portion of the valve body based on the imaged shape of the native heart. The mandrel 1242, in examples, may be shaped to produce a valve body that matches the shape of the annulus 1222. The mandrel 1242 may be formed, shaped, or created to produce such a shape for the valve body to be formed on its upper surface.

[0428] The shape may be non-circular, in examples. For example, FIG. 72 is a cross-sectional top view of the generated mandrel 1242 showing the outer profile of the mandrel 1242. The outer profile may include a non-circular shape. The outer profile may include an irregular shape. For example, the outer profile may be a non-uniform elliptical shape. The outer profile may be adapted to the non-circular and irregular shape of the native heart valve 1220.

[0429] The mandrel 1242 may be configured such that at least a portion of the valve body to be formed on its upper surface conforms to the shape of the mandrel 1242 .

[0430] The valve body may be manufactured according to the methods disclosed herein. At least a portion of the valve body may be manufactured based on imaging of a native heart valve. For example, with reference to FIG. 73, at least a portion of the valve body may be formed, molded, or produced by utilizing a manufacturing assembly 1240. The manufacturing assembly 1240 may form the valve body 1244, for example, using additive manufacturing methods. A shape or other configuration for the valve body 1244 may be provided based on output provided by the processor 1234. For example, the processor 1234 may determine a desired shape for at least a portion of the prosthetic heart valve based on imaging of a native heart valve.

[0431] The processor 1234 may determine the portion of the valve body 1244 based on image data provided from the imaging procedure. An optimized shape may be determined. The shape of the valve body 1244 may be determined such that the valve body is manufactured based on the imaged shape of the native heart valve 1220. The shape of the valve body 1244 may be determined, for example, based on the shape of the annulus 1222 of the native heart valve 1220. The valve body 1244 may be shaped to match the shape of the annulus 1222, in examples.

[0432] The valve body 1244 may have a non-circular or irregular outer profile, in examples. In examples, other configured valve bodies may be provided.

[0433] In an example, a portion of the valve body 1244 may include a frame of the valve body. At least a portion of the frame may be manufactured. In an example, a shape of the frame may be determined based on the output provided by the processor 1234. A shape of at least a portion of the frame may be provided based on an imaged shape of the native heart valve. Other characteristics of the frame may be determined based on the output provided by the processor 1234. For example, a cut pattern for the frame may be determined based on the output provided by the processor 1234. The manufacturing assembly 1240 may be configured to process (e.g., laser machine or other form of machining) the material of the frame based on the output provided by the processor 1234. FIG. 73 illustrates, for example, the manufacturing assembly 1240 machining the material of the frame into a desired shape.

[0434] In examples, the valve body 1244 may be molded over the mandrel 1242 which may then be formed. FIG. 74, for example, illustrates the valve body 1244 over the mandrel 1242, conforming to the shape provided by the mandrel 1242. The valve body 1244 may be heat set over the mandrel 1242. In examples, the use of the mandrel 1242 may be omitted and the manufacturing assembly 1240 may directly form a portion of the valve body 1244 without molding over the mandrel 1242.

[0435] The molded portion of the valve body 1244 may include, in an example, an outer valve body. For example, referring to FIG. 75, the outer valve body 1244 may be disposed radially outward from the inner valve body 1246. At least a portion of the outer valve body 1244 may be formed. The outer valve body 1244 may be held in a shape determined by the processor 1234. However, the inner valve body 1246 may include a different shape and may include a circular outer profile or other standard or uniform shape, as desired. In this manner, the outer valve body 1244 may be contoured to the shape of the native heart valve, and the inner valve body 1246 may include a standard or uniform shape. Thus, the inner valve body 1246 may better support the prosthetic leaflets and provide a symmetrical flow channel for the native heart valve. The inner valve body 1246 may include a standard, non-custom shape that has been previously qualified to meet fatigue and strain limits, for example.

[0436] The outer valve body 1244 may include a seal body for forming a seal against the native heart valve. The outer valve body 1244 may include a seal skirt, an outer seal frame, or may have another configuration, as desired. In examples, the manufactured prosthetic valve may include a single frame, or may include a frame that does not have both an outer frame and an inner frame.

[0437] The processing system 1228 may determine if a portion of the prosthetic valve to be manufactured does not meet one or more constraints (e.g., a strain limit or a fatigue limit) and may adjust the determined shape of the prosthetic valve or tool to meet the one or more constraints.

[0438] Any portion of the frame may be self-expanding. In examples, portions of the frame may be balloon expandable or mechanically expandable, as desired.

[0439] In an example, the portion of the valve body 1244 may include a skirt of the valve body. At least a portion of the skirt may be manufactured based on imaging of the native heart valve. In an example, a shape of the skirt may be determined based on the output provided by the processor 1234. Other characteristics of the skirt may be determined based on the output provided by the processor 1234. For example, a stitching or suture pattern of the skirt may be determined based on the output provided by the processor 1234. With reference to FIG. 76, the manufacturing assembly 1240 may be configured to machine (e.g., laser machine or other form of machining) the material of the skirt 1248 based on the output provided by the processor 1234. The manufacturing assembly may be configured to generate a stitching or suture pattern for the skirt. FIG. 76 illustrates the manufacturing assembly 1240 providing a stitching or suture pattern on the skirt 1248, for example.

[0440] In examples, the configuration of the skirt may be determined based on the determined configuration of the valve body 1244. For example, the stitching or suture pattern of the skirt may be determined to correspond to the shape of the frame of the valve body 1244.

[0441] In an example, the frame of the valve body 1244 may be coated using electrospinning techniques.

[0442] One or more features of the prosthetic leaflet may be manufactured according to the methods disclosed herein. For example, the processor 1234 may determine a desired shape for the prosthetic leaflet to be utilized in conjunction with the shape of the valve body 1244. Using the manufacturing assembly 1240, one or more prosthetic leaflets may be fabricated or otherwise formed.

[0443] The manufacturing assembly 1240, in examples, may assemble each component of the prosthetic valve. For example, an automated assembly process may be utilized to form the prosthetic valve. In examples, the assembly process may be autonomous. The manufacturing assembly may, for example, receive input and generally manufacture the prosthetic valve based on the input. An autonomous assembly line process may be utilized. In examples, a semi-autonomous process (e.g., including portions of manual assembly) may be utilized.

[0444] The resulting prosthetic valve 1249 configuration may be that depicted in FIG. 77. Additionally, one or more anchor 1250 configurations may be fabricated according to the methods disclosed herein. Anchor 1250 configurations may be provided based on imaging of the native heart valve. For example, the number, location, and size of the anchors may be fabricated based on output provided by processor 1234. Processor 1234 may determine, for example, based on image data, that anchor 1250b should have a longer length than anchor 1250a based on the geometry of the native valve (e.g., the length of the native leaflets, or other configuration of the native valve). Processor 1234 may determine, for example, that the location of the anchors should be provided to reduce conduction impairment to the native heart valve and should be shorter or located in a particular location. Processor 1234 may determine the number of anchors 1250 to be utilized. Anchors 1250 may include distal anchors configured similarly to other shaped distal anchors disclosed herein. In examples, the anchors may include other shaped anchors.

[0445] The resulting prosthetic valve 1249 may be manufactured on a custom basis for the particular heart valve imaged. In this manner, a patient may receive a heart valve that is custom shaped for the patient's particular anatomy. Customization may enhance sealing, anchoring, and other functionality at the implantation site. At least a portion of the prosthetic valve 1249 may be manufactured to fit against the shape of the native heart valve. At implantation sites with non-circular or irregular shapes, sealing, anchoring, and functionality may be improved. A custom fit to the native valve may be utilized.

[0446] Automated manufacturing processes may increase the speed and efficiency with which the prosthetic valve may be manufactured. In-line rapid prototyping or other forms of rapid manufacturing processes may be utilized. Rapid manufacturing, testing, validation, and shipping may occur. Artificial intelligence may be utilized. The prosthetic valve may be sterilized and shipped for implantation into the particular patient that was imaged.

[0447] The prosthetic valve 1249 may be designed to be deployed for the particular patient being imaged.

[0448] Each of the features in Figures 69-77 may be used alone or in combination with any of the examples disclosed herein.

[0449] Although many of the systems and methods disclosed herein have been described with respect to implanting prosthetic valve implants, it will be understood that the systems and methods may be utilized to deliver a variety of implants, including implants for repairing heart valves. For example, different types of heart valve implants than those shown herein may be utilized, among other types of implants (e.g., mitral, tricuspid, pulmonary, and aortic valve implants, as well as other repair implants). Any of the implants and any of the valves disclosed herein may include valves for implantation at the tricuspid or mitral valve, and may also include valves for implantation at the aortic or pulmonary valve. In examples, other implantation locations may be utilized.

[0450] The methods and systems disclosed herein need not be limited to the delivery of implants in certain examples, but may extend to any medical intervention or insertion into a patient's body, including performing medical procedures within the body. The methods and systems disclosed herein may be utilized in general use of catheters, as desired. For example, the handles shown herein, and each of the components disclosed herein, may include general catheter handles in certain examples. Additionally, configurations related to the delivery device may be modified in other examples. For example, in the case of an aortic valve delivery device, the configuration of the implant holding area, and other features related to the delivery device may be modified. A delivery device as disclosed herein may include a delivery catheter in examples.

[0451] The deflection mechanisms and other examples disclosed herein may be utilized in connection with a variety of implementations including the delivery of tricuspid or mitral valve replacement valves or aortic or pulmonary valves, or may be utilized in connection with valve repair procedures including tricuspid or mitral valve repair, or aortic or pulmonary valve repair.

[0452] From the foregoing, it will be appreciated that an inventive product and approach for an implant delivery system has been disclosed. Although certain components, techniques, and aspects have been described in some detail, it will be apparent that many changes can be made to the specific designs, constructions, and methodologies described hereinabove without departing from the spirit and scope of the present disclosure. [Example]

[0453] For purposes of this specification, certain aspects, advantages, and novel features of the embodiments of the present disclosure are described herein. The disclosed methods, devices, and systems should not be construed as limiting in any manner. Instead, the present disclosure is directed to all novel and non-obvious features and aspects of the various disclosed embodiments in various combinations with each other and in various subcombinations with each other. The methods, devices, and systems are not limited to any particular aspect or feature, or combination thereof, nor are they required to have any one or more particular advantages or problems solved. Features, elements, or combinations of one embodiment may be combined in other embodiments herein.

[0454] Example 1: A delivery system for an implant, comprising: an elongate shaft having a distal end; an implant holding region for holding an implant; a first bent portion configured to deflect the distal end in a first plane; a first extension portion disposed proximally from the first bent portion, the first extension portion extending along a first axis; a second bent portion disposed proximally from the first extension portion, the second bent portion configured to be rotationally driven in a first rotational orientation in a second plane extending transversely to the first plane; and a third bent portion disposed proximally from the second bent portion. and a biasing mechanism configured to bias the second bent portion in the first rotational orientation in the second plane and the third bent portion in the second rotational orientation in the second plane to offset the first axis from the second axis with the first axis extending parallel to the second axis.

[0455] Example 2: The delivery system of any embodiment herein, particularly embodiment 1, wherein the implant holding region is located distal to the first bent portion.

[0456] Example 3: The delivery system of any embodiment herein, particularly embodiment 1 or 2, wherein the implant holding region comprises a capsule configured to be driven back for deployment of the implant.

[0457] Example 4: The delivery system of any embodiment herein, particularly any one of embodiments 1-3, wherein the distal end comprises a nosecone.

[0458] Example 5: A delivery system described in any embodiment herein, particularly any one of embodiments 1-4, wherein the first bent portion is configured to deflect the distal end such that the distal end extends laterally relative to the first axis.

[0459] Example 6: A delivery system described in any embodiment herein, particularly any one of embodiments 1-5, wherein the first bent portion is configured to deflect the distal end such that the distal end extends perpendicular to the first axis.

[0460] Example 7: The delivery system of any embodiment herein, particularly any one of embodiments 1-6, wherein the first extension portion and the second extension portion are configured such that the first axis extends coaxially relative to the second axis.

[0461] Example 8: The delivery system of any of the embodiments herein, particularly any one of embodiments 1-7, further comprising a third extension portion located between the second bent portion and the third bent portion, the third extension portion configured to extend transversely to the first axis and to the second axis.

[0462] Example 9: The delivery system of any embodiment herein, particularly any one of embodiments 1-8, wherein the deflection mechanism is configured to simultaneously deflect the second bending portion to a first rotational orientation in the second plane and deflect the third bending portion to a second rotational orientation in the second plane.

[0463] Example 10: The delivery system of any embodiment herein, particularly any one of embodiments 1-9, wherein the deflection mechanism is configured to deflect the second bending portion in the first rotational orientation in the second plane by the same amount as the deflection mechanism deflects the third bending portion in the second rotational orientation in the second plane.

[0464] Example 11: The delivery system described in any embodiment herein, particularly any one of embodiments 1-10, wherein the deflection mechanism includes at least one tension tether configured to deflect the second bending portion and the third bending portion.

[0465] Example 12: The delivery system described in any embodiment herein, particularly any one of embodiments 1-11, wherein the deflection mechanism includes at least one tension tether coupled to the elongate shaft distal to the second bend portion and configured to deflect the second bend portion and the third bend portion.

[0466] Example 13: A delivery system described in any embodiment herein, particularly any one of embodiments 1-12, wherein the deflection mechanism includes a first tensioning tether coupled to the elongate shaft and configured to deflect the second bent portion in a first rotational orientation within the second plane, and a second tensioning tether coupled to the elongate shaft and configured to deflect the third bent portion in a second rotational orientation within the second plane.

[0467] Example 14: The delivery system described in any of the embodiments herein, particularly embodiment 13, wherein a first tensioning tether is attached to a first portion of the elongate shaft and a second tensioning tether is attached to a second portion of the elongate shaft opposite the first portion.

[0468] Example 15: The delivery system of any embodiment herein, particularly embodiment 14, wherein the first tensioning tether extends parallel to the second tensioning tether.

[0469] Example 16: A delivery system described in any embodiment herein, particularly any one of embodiments 13-15, wherein each of the first tensioning tether and the second tensioning tether includes a proximal portion coupled to a first tensioning body configured to drive the first tensioning tether and the second tensioning tether back simultaneously.

[0470] Example 17: The delivery system described in any embodiment herein, particularly embodiment 16, further comprises a handle at the proximal end of the elongate shaft, and the first tensioning body is configured to be driven retractably within the handle, thereby simultaneously driving the first tensioning tether and the second tensioning tether retractably.

[0471] Example 18: The delivery system described in any embodiment herein, particularly any one of embodiments 11-17, further comprising at least one tension tether configured to deflect the distal end in a first plane.

[0472] Example 19: The delivery system described in any embodiment herein, particularly any one of embodiments 1-18, wherein the second bending portion includes at least one flexible notch configured to allow the second bending portion to deflect, and the third bending portion includes at least one flexible notch configured to allow the third bending portion to deflect.

[0473] Example 20: The delivery system described in any embodiment herein, particularly any one of embodiments 1-19, wherein the first bending portion includes at least one flexibility notch configured to allow the first bending portion to deflect.

[0474] Example 21: The method includes delivering a delivery device for an implant into a portion of a patient's body, the delivery device having an elongate shaft having a distal end, an implant holding region for holding the implant, a first bent portion configured to deflect the distal end in a first plane, a first extension portion disposed proximally from the first bent portion, the first extension portion extending along a first axis, a second bent portion disposed proximally from the first extension portion, the second extension portion configured to be rotationally driven in a first rotational orientation in a second plane extending transversely to the first plane, and a second extension portion disposed proximally from the second bent portion. and a biasing mechanism configured to bias the second bent portion in the first rotational orientation in the second plane and the third bent portion in the second rotational orientation in the second plane to offset the first axis from the second axis with the first axis extending parallel to the second axis.

[0475] Example 22: The method of any of the embodiments herein, particularly embodiment 21, wherein the implant holding region comprises a capsule configured to be driven back for deployment of the implant.

[0476] Example 23: The method of any of the embodiments herein, particularly embodiment 21 or 22, wherein the first bent portion is configured to deflect the distal end such that the distal end extends perpendicular to the first axis.

[0477] Example 24: The method of any one of the embodiments herein, particularly any one of embodiments 21-23, wherein the first extension portion and the second extension portion are configured such that the first axis extends coaxially relative to the second axis.

[0478] Example 25: The method of any one of the embodiments herein, particularly any one of embodiments 21-24, further comprising a third extension portion located between the second bent portion and the third bent portion, the third extension portion configured to extend transversely to the first axis and to the second axis.

[0479] Example 26: The method according to any of the embodiments herein, particularly any one of embodiments 21-25, wherein the deflection mechanism is configured to simultaneously deflect the second bending portion to a first rotational orientation in the second plane and deflect the third bending portion to a second rotational orientation in the second plane.

[0480] Example 27: The method of any of the embodiments herein, particularly any one of embodiments 21-26, wherein the deflection mechanism is configured to deflect the second bending portion in the first rotational orientation in the second plane by the same amount as the deflection mechanism deflects the third bending portion in the second rotational orientation in the second plane.

[0481] Example 28: The method of any of the embodiments herein, particularly any of embodiments 21-27, wherein the deflection mechanism includes at least one tension tether configured to deflect the second bend portion and the third bend portion.

[0482] Example 29: The method according to any of the embodiments herein, particularly any one of embodiments 21-28, further comprising the step of delivering the implant to the native mitral valve or to the native tricuspid valve.

[0483] Example 30: The method of any embodiment herein, particularly any one of embodiments 21-29, further comprising, within the atrium, deflecting the second bent portion in a first rotational orientation in the second plane, and deflecting the third bent portion in a second rotational orientation in the second plane.

[0484] Example 31: A delivery system for an implant, comprising: an elongate shaft having a retaining body configured to retain the implant; and a proximally extending diaphragm configured to be driven distally to enable the retaining body to be released from the implant.

[0485] Example 32: The delivery system of any embodiment herein, particularly embodiment 31, wherein the diaphragm is configured to invert when driven distally.

[0486] Example 33: The delivery system of any embodiment herein, particularly embodiment 31 or 32, wherein the diaphragm has a narrow portion and a wide portion, the wide portion extending proximally from the narrow portion.

[0487] Example 34: The delivery system of any embodiment herein, particularly embodiment 33, wherein the diaphragm is configured to invert so that the wider portion extends distally from the narrower portion.

[0488] Example 35: The delivery system of any embodiment herein, particularly any one of embodiments 31-34, wherein the diaphragm has a conical shape.

[0489] Example 36: A delivery system described in any embodiment herein, particularly any one of embodiments 31-35, wherein the diaphragm has an internal cavity and an inner surface that faces radially inward and toward the internal cavity, and the diaphragm is configured to be inverted so that the inner surface faces radially outward.

[0490] Example 37: A delivery system described in any embodiment herein, particularly any one of embodiments 31-36, wherein the diaphragm includes a distal end portion and the retention body includes a proximal end portion coupled to the distal end portion of the diaphragm.

[0491] Example 38: A delivery system described in any embodiment herein, particularly any one of embodiments 31-37, wherein the retention body is configured to be released from the implant by being driven back in a proximal direction.

[0492] Example 39: A delivery system as described in any embodiment herein, particularly embodiment 38, wherein the retaining body includes an outer surface, and the diaphragm is configured to invert to overlap the outer surface of the retaining body when driven distally.

[0493] Example 40: A delivery system described in any embodiment herein, particularly any one of embodiments 31-39, wherein the retention body covers a coupling body configured to couple to the implant, and the retention body is configured to be driven back from the coupling body when the diaphragm is driven distally.

[0494] Example 41: A delivery system described in any embodiment herein, particularly any one of embodiments 31-40, wherein the diaphragm includes a proximal end and the retaining body includes a distal end, and the length from the proximal end of the diaphragm to the distal end of the retaining body is configured to shorten when the diaphragm is driven distally.

[0495] Example 42: A delivery system described in any embodiment herein, particularly any one of embodiments 31 to 41, wherein the elongate shaft includes an inner shaft, and the retaining body and diaphragm are configured to be slidably driven proximally along the inner shaft.

[0496] Example 43: A delivery system described in any embodiment herein, particularly any one of embodiments 31-42, wherein the elongate shaft includes a pusher shaft configured to be driven forward in a distal direction to drive the diaphragm distally.

[0497] Example 44: The delivery system of any embodiment herein, particularly embodiment 43, wherein the diaphragm includes a proximal end portion, and the pusher shaft is configured to apply a force against the proximal end portion of the diaphragm.

[0498] Example 45: The delivery system of any embodiment herein, particularly any one of embodiments 31-44, further comprising an implant, the implant comprising a self-expanding prosthetic heart valve.

[0499] Example 46: 1. A method comprising: delivering a delivery device for an implant into a portion of a patient's body, the delivery device comprising an elongate shaft having a retaining body that retains the implant, and a proximally extending diaphragm configured to be driven distally to enable the retaining body to be released from the implant.

[0500] Example 47: The method of any embodiment herein, particularly embodiment 46, wherein the diaphragm is configured to invert when driven distally.

[0501] Example 48: The method of any one of the embodiments herein, particularly embodiment 46 or 47, wherein the diaphragm has a narrow portion and a wide portion, the wide portion extending proximally from the narrow portion.

[0502] Example 49: The method of any embodiment herein, particularly embodiment 48, wherein the diaphragm is configured to invert so that the wider portion extends distally from the narrower portion.

[0503] Example 50: The method of any of the embodiments herein, particularly any one of embodiments 46-49, wherein the diaphragm has an internal cavity and an inner surface that faces radially inward and toward the internal cavity, and the diaphragm is configured to be inverted so that the inner surface faces radiall...

Claims

1. A system for implanting a prosthetic valve into a native heart valve, comprising: An artificial valve, a plurality of prosthetic valve leaflets; a valve frame supporting the plurality of artificial valve leaflets; one or more anchors for anchoring the prosthetic valve to the native heart valve, at least one of the anchors being axially slidable relative to the valve frame; and an artificial valve including: a delivery device for delivering the prosthetic valve to the native heart valve, the delivery device including an elongate shaft having a retention area for retaining the prosthetic valve; a control mechanism for driving the at least one anchor to slide axially relative to the valve frame, the control mechanism including: a tether for controlling rearward driving of the at least one anchor relative to the valve frame; and a pusher shaft for controlling forward driving of the at least one anchor relative to the valve frame; Including, the system.

2. The system of claim 1 , wherein the tether is configured to be released from the at least one anchor upon deployment of the prosthetic valve relative to the native heart valve.

3. The system of claim 1 , wherein the control mechanism includes at least one actuator operable by a user to axially slide the at least one anchor relative to the valve frame.

4. The system described in claim 3, wherein the delivery device includes a handle and the at least one actuator is disposed on the handle.

5. The system described in claim 1, wherein the control mechanism is operable to drive a first anchor of the anchor to slide axially relative to the valve frame, and is operable to drive a second anchor of the anchor to slide axially relative to the valve frame independently of the first anchor of the anchor.

6. The system described in claim 1, wherein each of the anchors is formed with a hook shape and configured to extend around the downstream end of the leaflets of the natural heart valve.

7. The system described in claim 6, wherein each of the anchors extends radially outward to a tip.

8. The system described in claim 1, wherein the valve frame includes an inner frame and an outer frame positioned radially outward from the inner frame.

9. The system described in claim 1, wherein at least a portion of the artificial valve is manufactured based on imaging of the natural heart valve.

10. The system described in claim 1, wherein the artificial valve is sized to replace a tricuspid valve or a mitral valve.

11. An artificial valve, a plurality of prosthetic valve leaflets; a valve frame supporting the plurality of artificial valve leaflets; a plurality of anchors for anchoring the prosthetic valve to a native heart valve, each of the plurality of anchors being movable relative to the valve frame; and an artificial valve including: a control mechanism including a motor for driving movement of the plurality of anchors relative to the valve frame, the motor configured to drive movement of at least one of the plurality of anchors independently of movement of at least one other of the plurality of anchors; Including, the system.

12. The system described in Claim 11, wherein at least one of the plurality of anchors is axially slidable relative to the valve frame, and the motor is configured to slide the at least one of the plurality of anchors axially relative to the valve frame.

13. The system described in claim 11, further comprising a gear system configured to be operated by the motor to drive movement of at least one of the plurality of anchors.

14. The system described in Claim 11, wherein the motor is configured to control the deflection of at least one of the plurality of anchors relative to the valve frame.

15. The system described in claim 14, wherein the control mechanism includes an offset controller configured to control the deflection of at least one of the plurality of anchors relative to the valve frame simultaneously with the deflection of at least one other anchor of the plurality of anchors when a deflection offset exists between the at least one of the plurality of anchors and the at least one other anchor.

16. A system for implanting a prosthetic valve into a native heart valve, comprising: An artificial valve, a plurality of prosthetic valve leaflets; a valve frame supporting the plurality of artificial valve leaflets; one or more anchors for anchoring the prosthetic valve to the native heart valve; an artificial valve including: a delivery device for delivering the prosthetic valve to the native heart valve, the delivery device including an elongate shaft having a retention area for retaining the prosthetic valve; one or more sutures for connecting to at least one of the anchors and for adjusting the position of the at least one anchor; Including, the system.

17. The system described in claim 16, further comprising a plurality of sutures, each suture for moving one of the anchors of the artificial valve radially inward independently of another anchor of the artificial valve.

18. The system described in claim 16, wherein the one or more sutures are shaped to form a loop extending circumferentially around the one or more anchors.

19. The system described in claim 16, wherein each of the one or more anchors has a distal tip, and at least one of the distal tips is configured to expand to have a larger diameter than another of the distal tips.

20. The system of claim 16, further comprising an expandable body adapted to expand radially outward from the delivery device to secure the delivery device in a desired position.

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