Steerable delivery systems for replacement of mitral valves and methods of use

Abstract

The invention relates to a steerable delivery system for replacement of a mitral valve and a method of use. Devices, systems, and methods are described herein to provide improved maneuverability for delivery of a prosthesis to a body location (e.g., delivery of a replacement mitral valve to a native mitral valve location). The delivery component may have a plurality of slots that provide a desired bend of the delivery component, in particular a composite bend of the delivery component, which may facilitate three-dimensional manipulation of the delivery component.

Description

[0001] This application is a divisional application. The application date of the original application is August 26, 2016, the application number is 2016800604422 (the application number of the divisional application is 202011277776X), and the name of the invention is "Manipulable delivery system and method of use for mitral valve replacement". background

[0003] field

[0004] Certain embodiments disclosed herein generally relate to prostheses and delivery systems for prostheses for implantation within a lumen or body cavity. Specifically, in some embodiments, the prostheses and delivery systems relate to replacement heart valves, such as replacement mitral heart valves.

[0005] background

[0006] The human heart valves, which include the aortic valve, pulmonary valve, mitral valve, and tricuspid valve, essentially act as one-way valves that operate in sync with the pumping heart. The valves allow blood to flow downstream, but prevent blood from flowing upstream. Diseased heart valves exhibit damage, such as valvular stenosis or regurgitation, which inhibit the valve's ability to control blood flow. Such damage reduces the heart's pumping efficiency and can be a debilitating and life-threatening condition. For example, valvular insufficiency can lead to conditions such as cardiac hypertrophy and ventricular dilatation. Therefore, extensive efforts have been made to develop methods and devices for repairing or replacing damaged heart valves.

[0007] Prosthesis exists to correct the problems associated with damaged heart valves. For example, mechanical and tissue-based heart valve prostheses can be used to replace damaged natural heart valves. Recently, a large amount of effort has been devoted to developing replacement heart valves, particularly tissue-based replacement heart valves, which can be delivered to patients with less trauma than through open heart surgery. Replacement valves are designed to be delivered through minimally invasive surgery and even percutaneous surgery. Such replacement valves often include a tissue-based valve body that is connected to an expandable frame that is subsequently delivered to the natural valve ring.

[0008] The development of prostheses, including but not limited to replacement heart valves, that can be compacted for delivery and then controllably expanded for controlled placement has proven to be extremely challenging. Additional challenges relate to the ability of such prostheses to be secured in a non-traumatic manner relative to intraluminal tissue (e.g., tissue within any body lumen or cavity).

[0009] Delivering a prosthesis to a desired location in the human body, such as delivering a replacement heart valve to the mitral valve, can also be challenging. Gaining access to the heart or other anatomical locations may require manipulating a percutaneous delivery device through a tortuous vasculature or through open or semi-open surgery. The ability to control the deployment of the prosthesis at the desired location can also be challenging. Overview

[0011] Embodiments of the present disclosure relate to prostheses, such as but not limited to replacement heart valves. Additional embodiments relate to delivery systems, devices, and / or methods of use to deliver and / or controllably deploy prostheses, such as but not limited to replacement heart valves, to a desired location within the body. In some embodiments, replacement heart valves and methods for delivering replacement heart valves to native heart valves, such as the mitral valve, are provided.

[0012] The present disclosure includes, but is not limited to, the following numbered embodiments.

[0013] Embodiment 1: A delivery system for delivering an expandable implant to a body location, the delivery system comprising an elongated shaft assembly, the elongated shaft assembly comprising a proximal end and a distal end, wherein the elongated shaft assembly comprises an implant retaining region configured to retain the expandable implant in a compressed configuration, wherein the elongated shaft assembly comprises an elongated tubular shaft, the elongated tubular shaft comprising a proximal end and a distal end and a longitudinal axis extending between the proximal end and the distal end, wherein the elongated tubular shaft comprises a plurality of grooves longitudinally spaced apart along the length of the elongated tubular shaft, each of the plurality of grooves being oriented substantially perpendicular to the longitudinal axis and comprising a proximal side, a distal side, and two circumferentially spaced apart opposite ends, wherein each groove forms a gap between the proximal and distal sides of the groove, the gap being configured to close upon application of a force to the elongated tubular shaft, wherein the opposite ends of the grooves are separated from each other by a ridge portion extending longitudinally along the length of the elongated tubular shaft, and wherein the positioning and / or shape of the grooves varies along the length of the elongated tubular shaft to provide different bending properties to different portions of the elongated tubular shaft.

[0014] Embodiment 2: The delivery system described in embodiment 1, wherein the plurality of grooves include a proximal groove portion extending parallel to the longitudinal axis of the elongated tubular shaft; a transition groove portion angled relative to the longitudinal axis to move the transition groove portion from a first circumferential position aligned with the proximal groove portion to a second circumferential position; and a distal groove portion extending from the second circumferential position and parallel to the longitudinal axis of the elongated tubular shaft, the distal groove portion being circumferentially offset from the proximal groove portion.

[0015] Embodiment 3: The delivery system of embodiment 2, wherein the proximal slot portion comprises a plurality of identical slots and the distal slot portion comprises a plurality of identical slots.

[0016] Embodiment 4: The delivery system of any of Embodiments 1-3, wherein the plurality of slots have varying widths over the length of the elongated tubular shaft, the width of the slots being defined between two circumferentially spaced opposite ends.

[0017] Embodiment 5: The delivery system described in embodiment 4, wherein the plurality of grooves includes a first groove portion having a plurality of grooves having a first width, a second groove portion having a plurality of grooves having a second width, and a third groove portion having a plurality of grooves having a third width, wherein the third width is greater than the second width and the second width is greater than the first width.

[0018] Embodiment 6: The delivery system described in embodiment 5, wherein the plurality of grooves include a first transition portion between a first groove portion and a second groove portion, and a second transition portion between the second groove portion and a third groove portion, wherein the first transition portion includes a plurality of grooves having different widths between a first width and a second width, and wherein the second transition portion includes a plurality of grooves having different widths between the second width and a third width.

[0019] Embodiment 7: The delivery system of any of Embodiments 1-6, wherein each of the plurality of grooves comprises a central tooth and a triangular gap positioned on opposite sides of the triangular gap.

[0020] Embodiment 8: The delivery system of any one of Embodiments 1-7, further comprising one or more puller wires configured to apply a force along the plurality of grooves that causes the elongated tubular shaft to bend.

[0021] Embodiment 9: The delivery system of any of Embodiments 1-8, further comprising a handle comprising an actuator configured to cause controlled bending of the elongated tubular shaft along the plurality of slots.

[0022] Embodiment 10: The delivery system described in embodiment 9 further includes one or more pull wires, which are configured to apply a force that causes the long tubular shaft to bend along the multiple grooves, wherein the one or more pull wires are attached to a teardrop-shaped connector that communicates with the actuator.

[0023] Embodiment 11: The delivery system of any of Embodiments 1-10, wherein the elongated shaft assembly further comprises a retaining ring at the distal end of the elongated tubular shaft configured to radially constrain at least a portion of the expandable implant.

[0024] Embodiment 12: The delivery system of embodiment 11, wherein one or more puller wires extend within the elongated tubular shaft and are attached to the proximal portion of the retaining ring, the one or more puller wires being configured to apply a force that causes the elongated tubular shaft to bend along the plurality of grooves.

[0025] Embodiment 13: The delivery system of any of Embodiments 1-12, wherein the elongated shaft assembly further comprises an outer shaft assembly slidable over the elongated tubular shaft, the outer shaft assembly being configured to radially constrain at least a portion of the expandable implant.

[0026] Embodiment 14: The delivery system of embodiment 13, further comprising an actuation knob configured to bend the elongated tubular shaft while simultaneously moving the outer shaft assembly distally.

[0027] Embodiment 15: The delivery system of any of Embodiments 1-14, wherein the elongated shaft assembly further comprises an inner shaft assembly slidable within the elongated shaft assembly and configured to engage the proximal end of the expandable implant.

[0028] Embodiment 16: The delivery system of any of embodiments 1-15, wherein the plurality of grooves of the elongated tubular shaft are configured to be positioned between a septum between the right atrium and the left atrium and a native mitral valve of the heart, and wherein the plurality of grooves are configured to bend the elongated tubular shaft to guide the implant retention area toward the native mitral valve.

[0029] Embodiment 17: The delivery system of any of Embodiments 1-16, wherein the plurality of slots are configured to bend the elongated tubular shaft first two-dimensionally and then three-dimensionally.

[0030] Embodiment 18: The delivery system of any of Embodiments 1-17, wherein the plurality of slots are configured to bend the elongated tubular shaft in multiple stages.

[0031] Embodiment 19: The delivery system of any of Embodiments 1-18, wherein the plurality of slots are configured to three-dimensionally bend the elongated tubular shaft.

[0032] Embodiment 20: The delivery system of any of Embodiments 1-19, further comprising a sheath surrounding the elongated tubular shaft configured to prevent bending of the proximal end of the elongated tubular shaft.

[0033] Embodiment 21: A method for delivering a replacement mitral valve by manipulating a delivery system to a native mitral valve, the method comprising advancing a delivery system into a patient's heart, the delivery system maintaining the replacement mitral valve in a collapsed configuration, the delivery system being delivered through a septum between the right atrium and the left atrium, manipulating a delivery component of the delivery system from the septum toward the native mitral valve, the delivery component comprising a plurality of grooves that enable the delivery component to bend toward the native mitral valve, and expanding the replacement mitral valve from the delivery system at the native mitral valve.

[0034] Embodiment 22: The method of Embodiment 21, further comprising actuating a puller wire coupled to the delivery member to bend the delivery member along the plurality of grooves toward the native mitral valve.

[0035] Embodiment 23: The method of Embodiment 22, further comprising releasing the puller wire to allow the delivery member to translate to the original position prior to bending.

[0036] Embodiment 24: The method of Embodiment 23, wherein the puller wire is never compressed during actuation and release.

[0037] Embodiment 25: The method of any of Embodiments 21-24, further comprising actuating two puller wires coupled to the delivery member to bend the delivery member along the plurality of grooves toward the native mitral valve.

[0038] Embodiment 26: The method of any of Embodiments 21-25, wherein the delivery member is first bent along a first plurality of slots in the proximal portion and then bent along a second plurality of slots in the distal portion, wherein the second plurality of slots is different than the first plurality of slots.

[0039] Embodiment 27: The method of any of Embodiments 21-26, wherein manipulating the delivery member causes the delivery member to bend within a single plane.

[0040] Embodiment 28: The method of Embodiment 27, wherein manipulating the delivery member causes the delivery member to bend three-dimensionally.

[0041] Embodiment 29: The method of any of Embodiments 21-28, wherein the delivery component is manipulated toward the native mitral valve without the use of a guidewire.

[0042] Embodiment 30: The method of any of Embodiments 21-29, wherein manipulating comprises actuating a knob on a handle of the delivery system.

[0043] Embodiment 31: The method of any of Embodiments 21-30, further comprising a rigid live-on sheath at least partially surrounding the proximal end of the delivery member to prevent substantial bending at the proximal end of the delivery member and to allow substantial bending at the distal end of the delivery member.

[0044] Embodiment 32: The method of embodiment 31, wherein the rigid movable sheath allows for some flexure of the proximal end of the delivery system.

[0045] Embodiment 33: A delivery system for delivering an expandable implant to a body location, the delivery system comprising an elongated axis assembly, the elongated axis assembly comprising a proximal end and a distal end, wherein the elongated axis assembly comprises an implant retention region configured to retain the expandable implant in a compressed configuration, wherein the elongated axis assembly comprises an elongated tubular shaft, the elongated tubular shaft comprising a proximal end and a distal end and a longitudinal axis extending between the proximal end and the distal end, wherein the proximal end of the elongated tubular shaft comprises a plurality of grooved rings longitudinally spaced apart along the length of the elongated tubular shaft, each of the plurality of grooved rings comprising a circumferentially repeating pattern of a first longitudinal groove longitudinally overlapping a second longitudinal groove, wherein the first longitudinal groove intersects with the first circumferential groove and the second longitudinal groove intersects with the second circumferential groove, wherein the first circumferential groove and the second circumferential groove overlap circumferentially.

[0046] Embodiment 34: The delivery system of Embodiment 33, wherein the distal end of the elongated tubular shaft comprises a plurality of generally H-shaped grooves.

[0047] Embodiment 35: A delivery system for delivering an expandable implant to a body location, the delivery system comprising a long axis assembly, the long axis assembly comprising a proximal end and a distal end and a lumen extending between the proximal end and the distal end, wherein the long axis assembly comprises an implant retaining region configured to retain the distal end of the expandable implant in a compressed configuration; a mid-axis assembly, the mid-axis assembly being located within the lumen of the long axis assembly and comprising a proximal end and a distal end and a lumen extending between the proximal end and the distal end, wherein the distal end of the mid-axis assembly comprises an implant retaining region configured to retain the expandable implant in a compressed configuration; The proximal end of the implant is retained by an outer retaining ring in a compression configuration; an inner component, which is located within the tubular cavity of the central axis component and includes a proximal end and a distal end and a tubular cavity extending between the proximal and distal ends, wherein the distal end of the inner component is configured to releasably retain the proximal end of the expandable implant; and a spacer sleeve, which includes a proximal end and a distal end and a tubular cavity extending between the proximal and distal ends, and the spacer sleeve is radially located between the central axis component and the inner component, wherein the spacer sleeve is located within the tubular cavity of the central axis component, and the inner component is located within the tubular cavity of the spacer sleeve.

[0048] Embodiment 36: The delivery system of embodiment 35, wherein the spacer sleeve is not connected to the inner component or the midshaft.

[0049] Embodiment 37: The delivery system of any of Embodiments 35-36, wherein the spacer sleeve is sized to prevent snaking of the inner component.

[0050] Embodiment 38: The delivery system of any of Embodiments 35-37, wherein the spacer sleeve comprises plastic.

[0051] Embodiment 39: A delivery system for delivering a replacement mitral valve prosthesis to a patient's native mitral valve, the delivery system comprising a handle comprising a first portion, the first portion comprising a rotatable outer sheath assembly knob and a translatable nose corn assembly actuator, threads on an outer surface of the first portion, wherein the threads are located between the rotatable outer sheath assembly knob and the translatable nose corn assembly actuator, a second portion, the second portion being configured to translate on the first portion and comprising a rotatable deflection knob, a rotatable mid-axis retraction knob having threads on an inner surface that match the threads on the outer surface of the first portion, a deflection indicator portion having at least one deflection indicator, wherein rotation of the rotatable mid-axis retraction knob translates the second portion along the threads on the outer surface of the first portion; a nose corn shaft having a proximal end and a distal end, the proximal end of the nose corn shaft being operably connected to the translatable nose corn assembly actuator and the distal end of the nose corn shaft being attached to the nose corn; and a nose corn shaft having a proximal end and a distal end. an inner shaft having a distal end and a lumen across the anterior cone shaft, the proximal end of the inner shaft being operably connected to the handle and the distal end being attached to the inner retaining ring; a middle shaft having a proximal end and a distal end and a lumen across the inner shaft, the proximal end of the middle shaft being operably connected to a rotatable middle shaft retraction knob and the distal end of the middle shaft being attached to an outer retaining ring, the middle shaft having a plurality of grooves configured to allow bending of the middle shaft; a pull wire having a proximal end and a distal end, the proximal end of the pull wire being operably connected to a rotatable deflection knob and the distal end of the pull wire being attached to the outer retaining ring or the middle shaft; a spacer sleeve located between the middle shaft and the inner shaft; an outer sheath assembly having a proximal end and a distal end and a lumen across the middle shaft, the proximal end of the outer sheath assembly being operably connected to a rotatable outer sheath assembly knob and the distal end of the outer sheath assembly comprising a capsule;A replacement mitral valve prosthesis comprising an expandable frame extending between a first end and a second end, a plurality of atrial anchors configured to be positioned on the atrial side of a native mitral valve, and a plurality of ventricular anchors configured to be positioned on the ventricular side of the native mitral valve, wherein the replacement mitral valve prosthesis is configured to expand from a compressed configuration to an expanded configuration, wherein, in the compressed configuration, the first end is releasably retained within an inner retaining ring and radially compressed within an outer retaining ring, and the second end is radially compressed within a shell, wherein the ventricular anchors extend distally in the compressed configuration, wherein rotation of a deflection knob is configured to pull a pull wire proximally and push a central shaft distally, thereby causing the central shaft to bend as desired to assist in manipulating the distal end of the system to the native mitral valve, wherein when the distal end of the system is positioned at the native mitral valve, the outer sheath assembly is rotatable wherein rotation of the rotatable front cone assembly knob is configured to proximally translate the outer sheath assembly to expose the second end of the replacement mitral valve, thereby allowing the second end to expand and allowing the ventricular anchor to flip so that it extends proximally while positioned on the ventricular side of the annulus of the native mitral valve, wherein rotation of the rotatable midshaft knob is configured to proximally translate the midshaft to expose the first end of the replacement mitral valve, allowing the first end to expand and release from the inner retaining ring, wherein the atrial anchor is positioned on the atrial side of the annulus of the native mitral valve, and wherein translation of the translatable front cone assembly actuator is configured to proximally translate the front cone shaft through the expanded replacement mitral valve.;

[0052] Embodiment 40: The delivery system of Embodiment 39, further comprising a fixed shaft having a proximal end and a distal end and a lumen spanning the outer sheath assembly, the proximal end of the fixed shaft being operably connected to the handle.

[0053] Embodiment 41: The delivery system described in Embodiment 40 further includes an active introducer sheath having a proximal end and a distal end and a lumen spanning the fixed axis, the active introducer sheath having a pad on an inner surface of the lumen in contact with the fixed axis.

[0054] Embodiment 42: A delivery system for delivering an expandable implant to a body location, the delivery system comprising a long deflectable delivery member configured to at least partially hold the expandable implant, the long deflectable delivery member configured to bend to assist in manipulating the delivery system to the body location; and a handle comprising a rotatable deflection actuator configured to cause the deflectable delivery member to bend as desired, threads on an outer surface of the handle, and a rotatable retrieval actuator configured to match the threads, the rotatable retrieval actuator being operably connected to the long deflectable delivery member, wherein rotation of the rotatable retrieval actuator causes the rotatable retrieval actuator and the rotatable deflection actuator to translate proximally along the threads, thereby translating the long deflectable delivery member proximally to at least partially release the expandable implant.

[0055] Embodiment 43: The delivery system of embodiment 42, wherein rotation of the rotational deflection actuator causes the deflectable delivery member to bend in a desired manner while simultaneously applying a distal force to the deflectable delivery member.

[0056] Embodiment 44: The delivery system of any of Embodiments 42-43, further comprising a pull wire operably connected between the rotatable deflection knob and the deflectable delivery member.

[0057] Embodiment 45: The delivery system of any of Embodiments 42-44, wherein the deflectable delivery member comprises a central shaft and an outer retaining ring configured to partially retain the expandable implant.

[0058] Embodiment 46: The delivery system of any of Embodiments 42-45, wherein the deflectable delivery member comprises a plurality of slots configured to allow bending of the midshaft.

[0059] Embodiment 47: The delivery system of any of Embodiments 42-46, further comprising an outer sheath assembly configured to slide over the deflectable delivery member, and wherein the handle comprises an outer sheath actuator configured to move the outer sheath relative to the deflectable delivery member.

[0060] Embodiment 48: The delivery system of any of Embodiments 42-47, further comprising an inner component configured to at least partially engage the expandable implant, wherein rotation of the rotatable retrieval actuator causes the elongated deflectable delivery member to translate proximally relative to the inner component.

[0061] Embodiment 49: The delivery system of any of Embodiments 42-48, further comprising a nose cone shaft and a nose cone at a distal end of the nose cone shaft, and wherein the handle comprises a nose cone actuator. BRIEF DESCRIPTION OF THE DRAWINGS

[0063] Figure 1 An embodiment of a delivery system is shown.

[0064] Figure 2A Display and Figure 3 The valve prosthesis is loaded together Figure 1 Cross-sectional view of the distal end of the delivery system.

[0065] Figure 2B Shown in No Figure 3 In the case of valve prosthesis Figure 1 Cross-sectional view of the distal end of the delivery system.

[0066] Figure 3Shown is a side view of an embodiment of a valve prosthesis that can be delivered using the delivery systems described herein.

[0067] Figure 4 show Figure 1 Perspective view of the distal end of the delivery system.

[0068] Figure 5 show Figure 4 Components of the delivery system in which the outer sheath assembly is moved proximally and out of view.

[0069] Figure 6 show Figure 5 Components of the delivery system where the midshaft assembly is moved proximally and out of view.

[0070] Figure 7 Flat pattern of the shaft implementation in the example.

[0071] Fig. 8A -B illustrates a planar pattern of an alternative embodiment of the medial axis.

[0072] Fig. 9 Show pull line in Figure 1 Positioning at the distal end of the delivery system.

[0073] Figures 10A-10D A planar pattern of the proximal portion of the outer sheath assembly is illustrated.

[0074] Fig.11A -E illustrates a planar pattern of the distal portion of the outer sheath assembly.

[0075] Fig. 12A -B illustrates a proximal wire connector for holding the puller wire in the handle.

[0076] Fig.13 Schematic diagram of an example transfemoral delivery route.

[0077] Fig.14 Curvature of the delivery system is illustrated.

[0078] Fig.15 Schematic diagram illustrating a valve prosthesis positioned within a native mitral valve.

[0079] Fig.16 A side view is shown of an alternative embodiment of a valve prosthesis that can be delivered using the delivery systems described herein.

[0080] Fig.17 Shown in the heart Fig.16 Valve prosthesis frame.

[0081] Figure 18-21 Show for delivery Fig.16 The steps of a method of inserting a valve prosthesis into an anatomical position.

[0082] Fig. 22 An alternative embodiment of the delivery system is shown.

[0083] Fig.23 show Fig. 22 Perspective view of the distal end of the delivery system.

[0084] Fig.24A -B shows examples of positioning at the distal and proximal ends respectively Fig. 22 The handle of the delivery system.

[0085] Fig.25 Example Fig. 22 Cross-section of the delivery system. Detailed Description

[0087] The present specification and the accompanying drawings provide disclosed aspects and features in the context of several embodiments of replacement heart valves, delivery systems and methods, which are configured to be used in the vascular structure of a patient, such as for replacing a natural heart valve in a patient. These embodiments may be discussed in conjunction with replacement of specific valves such as the aortic or mitral valve of a patient. However, it is to be understood that the features and concepts discussed herein may be applied to other products in addition to heart valve implants. For example, the controlled positioning, deployment and fixation features described herein may be applied to medical implants, such as other types of expandable prostheses, which are used in other parts of the body, such as in arteries, veins or other body cavities or locations. In addition, the specific features of valves, delivery systems, etc. should not be considered as limiting, and as desired and when appropriate, the features of any of the embodiments discussed herein may be combined with the features of other embodiments. Although some embodiments described herein are described in conjunction with a transfemoral delivery approach, it should be understood that these embodiments may be used for other delivery approaches such as, for example, a transapical approach. Moreover, it should be understood that certain features described in conjunction with some embodiments may be combined with other embodiments, including those described in conjunction with different delivery approaches.

[0088] Delivery System

[0089] refer to Figure 1, an embodiment of a delivery device or system 10 is shown. The delivery system can be used to deploy a prosthesis in vivo, such as a replacement heart valve. The replacement heart valve can be delivered to the patient's heart mitral annulus or other heart valve location in various ways (such as through open surgery, minimally invasive surgery, and percutaneous or transcatheter delivery through the patient's vascular structure). An example transfemoral approach can be found in U.S. Patent Publication No. 2015 / 0238315 filed on February 20, 2015, the entire contents of which are incorporated herein by reference in their entirety. Although the delivery system 10 is described in conjunction with a percutaneous delivery approach, and more specifically a transfemoral delivery approach, it should be understood that the features of the delivery system 10 can be applied to other delivery systems, including delivery systems for a transapical delivery approach. Additional examples of devices, systems, and methods are described in U.S. Provisional Application Nos. 62 / 163932, filed May 19, 2015, and 62 / 210165, filed August 26, 2015, and U.S. Application No. 15 / 141,684, filed April 26, 2016, each of which is incorporated by reference in its entirety. In particular, the delivery system 10 as described herein can have at least paragraphs

[0006] -

[0037] and

[0078] -

[0170] (including those relating to U.S. Provisional Application No. 62 / 163932, filed May 19, 2015). Figure 1-4 0B) and all of which are expressly incorporated herein by reference. Moreover, the delivery system 10 as described herein can have components, features and / or functions similar to those described in paragraphs

[0171] -

[0197] of U.S. Provisional Application No. 62 / 163932 filed on May 19, 2015 (including descriptions related to Figures A1-A5, B1-B6, C1-C2 and 41A-42B), and U.S. Provisional Application No. 62 / 210,165 filed on August 26, 2015. Components, features and / or functions similar to those described in the delivery systems, devices and methods described in the U.S. Provisional Application No. 62 / 210,165 filed on August 26, 2015, and all of which are expressly incorporated herein by reference.

[0090] The delivery system 10 can be used to deploy a prosthesis in vivo, such as a replacement heart valve as described elsewhere in this specification. The delivery system 10 can receive and / or cover a portion of a prosthesis as described below. Figure 3 301 and the second end 303 of the prosthesis 70 shown in the figure. For example, the delivery system 10 can be used to deliver an expandable implant or prosthesis 70, wherein the prosthesis 70 includes a first end 301 and a second end 303, and wherein the second end 303 is configured to be deployed or expanded before the first end 301.

[0091] The delivery system 10 can be relatively flexible. In some embodiments, the delivery system 10 is particularly suitable for delivering a replacement heart valve to the mitral valve position via a transseptal approach (eg, between the right and left atria, via a transseptal puncture).

[0092] like Figure 1 As shown in FIG. 1 , the delivery system 10 may include an elongated shaft assembly 12 including a proximal end 11 and a distal end 13, wherein a handle 14 is coupled to the proximal end of the assembly 12. The elongated shaft assembly 12 may be used to hold a prosthesis for advancement through the vascular structure to a treatment site. The delivery system 10 may further include a relatively rigid movable sheath 51 surrounding the elongated shaft assembly 12 to prevent unwanted movement of the elongated shaft assembly 12. At its distal end, which may be used for this purpose, the elongated shaft assembly 12 may include an implant retention region 16 (at Figure 2A -B shows, where Figure 2A The prosthesis 70 is shown, and Figure 2B The prosthesis 70 is removed). In some embodiments, the long shaft assembly 12 can hold the expandable prosthesis in a compressed state at the implant retention area 16 for advancing the prosthesis in vivo. The long shaft assembly 12 can then be used to allow controlled expansion of the prosthesis at the treatment location. Figure 2A -B shows the implant retention region 16 at the distal end of the delivery system, but may be at other locations. In some embodiments, the prosthesis 70 may be rotated within the implant retention region 16, such as by rotation of the inner component 18 as discussed herein.

[0093] like Figure 2A -B, the long shaft assembly 12 may include one or more subassemblies such as an inner assembly 18, a mid-shaft assembly 20, an outer sheath assembly 22, and a front cone assembly 31, as will be described in more detail below.

[0094] As shown, the outer sheath assembly 22 can form a radial shell, or sheath, to surround the implant retention area 16. Moving radially inward, the middle shaft assembly 20 can be composed of the middle shaft 50, wherein its distal end is attached to the outer retention member or outer retention ring 40. Moving further inward, the inner assembly 18 can be composed of the inner retention shaft 42 and the inner retention member 32. Further, the most radially inward component is the nose cone assembly 31, which includes the nose cone shaft 30, which has a distal end connected to the nose cone 28.

[0095] The long shaft assembly 12, more specifically the front cone assembly 31, the inner assembly 18, the midshaft assembly 20 and the outer sheath assembly 22, can be configured to deliver an implant positioned in the implant retention region 16 (at Figure 2A) to the treatment location. One or more of the subassemblies may then be moved to allow the prosthesis 70 to be released at the treatment location. For example, one or more of the subassemblies may be movable relative to one or more of the other subassemblies. The handle 14 may include various control mechanisms that may be used to control the movement of the various subassemblies, as will also be described in more detail below. In this way, the prosthesis 70 may be controllably loaded onto the delivery system 10 and subsequently deployed in the body.

[0096] Figure 2A Further shown is an example of a prosthesis 70 that can be inserted into the delivery system 10, specifically into the implant retention area 16. For ease of understanding, Figure 2A In the embodiment shown, the prosthesis is shown with only the bare metal frame as illustrated. The implant or prosthesis 70 may take any number of different forms. Specific examples of frames for the prosthesis are described in Figure 3 , although it will be appreciated that other designs may be used. The prosthesis 70 may include one or more sets of anchors, such as a distal (or ventricular) anchor 80 that extends proximally when the prosthesis frame is in the expanded configuration and a proximal (or atrial) anchor 82 that extends distally when the prosthesis frame is in the expanded configuration. The prosthesis may further include struts 72 that may terminate at a first end 301 with a mushroom-type tab 74 and at a second end 303 with a flat member (flap) 81 surrounding the frame. Further discussion of the annular flat member 81 may be found in U.S. Application No. 14 / 716,507, filed May 19, 2015, which is incorporated herein by reference in its entirety.

[0097] Other details and example designs of the prosthesis are described in U.S. Patent Nos. 8,403,983, 8,414,644, 8,652,203 and U.S. Patent Publication Nos. 2011 / 0313515, 2012 / 0215303, 2014 / 0277390, 2014 / 0277422, 2014 / 0277427, the entire contents of which are incorporated herein by reference and made a part of this specification. Additional details and embodiments of replacement heart valves or prostheses and methods of implanting them are described in U.S. Patent Application Nos. 14 / 716,507, filed on May 19, 2015, and 15 / 141,684, filed on April 28, 2016, the entire contents of each of which are incorporated herein by reference and made a part of this specification.

[0098] As discussed below, the inner retaining member 32, the outer retaining ring 40, and the outer sheath assembly 22 can cooperate to retain the prosthesis 70 in a compacted configuration. The inner retaining member 32 is shown engaging struts 72 at the proximal end of the prosthesis 70. For example, grooves between radially extending teeth on the inner retaining member 32 can receive and engage struts 72, which can terminate in mushroom-type fittings 74 on the proximal end of the prosthesis 70. The outer retaining ring 40 can be positioned on the inner retaining member 32 so that the first end 301 of the prosthesis 70 is sandwiched therebetween, securely attaching it to the delivery system 10.

[0099] like Figure 2A As shown in , the distal anchor 80 can be positioned in a delivery configuration in which the distal anchor 80 points generally distally (as illustrated, axially away from the body of the prosthesis frame and away from the handle of the delivery system). The distal anchor 80 can be restrained in this delivery configuration by the outer sheath assembly 22. Thus, when the outer sheath 22 is retracted proximally, the distal anchor 80 can be flipped to position in a deployed configuration (e.g., pointing generally proximally). Figure 2A Also shown is a proximal anchor 82 extending distally in its delivery configuration within the outer sheath assembly 22 and the outer retaining ring 40. In other embodiments, the distal anchor 80 can be retained to point generally proximally and compress against the body of the prosthesis frame in the delivery configuration.

[0100] The delivery system 10 may be provided to the user with a pre-installed prosthesis 70. In other embodiments, the prosthesis 70 may be loaded onto the delivery system shortly before use, such as by a physician or nurse.

[0101] Figure 4-6 Further views of the delivery system 10 are illustrated, with the various components translated proximally and described in detail.

[0102] The outer sheath assembly 22 will now be described. Figure 4 Specifically, relative to the front cone 28, Figure 4Shown is the outer sheath assembly 22 that is positioned at its farthest end. Further, as shown, movable sheath 51 can be used to cover outer sheath assembly 22 and provide structural support during bending, although its application is optional.Arrange outer sheath assembly 22 so that it is slidable on inner assembly 18, middle shaft assembly 20 and front cone assembly 31.Like front cone assembly 31, inner assembly 18 and middle shaft assembly 20, outer sheath assembly 22 can be a single piece tube or multiple pieces connected together to provide different characteristics along the different parts of pipe.As already mentioned, in some embodiments, for delivery system 10, having greater flexibility at the far end of device can be desirable and / or necessary, wherein flexibility is not necessary for proximal end.Exemplified outer sheath assembly 22 has first section (segment) 56, second section 58 and third section 60, wherein first section 56 is located at the proximal end of second section 58, and second section 58 is located at the proximal end of third section 60.Show that the third section 60 of outer sheath contacts with the proximal end of front cone 28. In this orientation, the prosthesis 70 can be retained within the outer shaft assembly 22 for advancement through the vasculature to the treatment site. The first section 56 can be a tube and is preferably formed of plastic, but can also be a metal hypotube or other material. Figures 10A-10D , the first section 56 is discussed further below.

[0103] The second section 58 may be a metal hypotube, which in some embodiments may be cut or have grooves. The tube 58 may be covered or encapsulated with a layer of ePTFE, PTFE or other material so that the outer surface of the outer sheath assembly is generally smooth. The covered second section 58 may be provided at Figure 4 . The third section 60 can be a tube formed of a plastic or metal material. In a preferred embodiment, the third section is formed of ePTFE or PTFE. In some embodiments, this coating material can be relatively thick to prevent tearing and help hold the self-expanding implant in a compressed configuration. In some embodiments, the material of the third section 60 is the same material as the coating on the cutting hypotube 1058. The overall structure of the second section 58 and the third section 60 is described below with respect to Fig.11A -E is discussed in detail.

[0104] In some embodiments, the third section 60 may include one or more wings or tabs 63. Figure 4, which extends distally from the distal end of the third segment 60. The winglet 63 can be configured to bend, curve or fold radially outward from the third segment 60. One or more winglets 63 can facilitate loading of the replacement valve into the third segment 60 when the replacement valve is initially loaded into the delivery system 10. In some embodiments, one or more winglets 63 can be removed before use in a patient, as shown in FIG. 10 of U.S. Provisional Application No. 62 / 210,165 filed on August 26, 2015. One or more winglets 63 can be formed by cutting the third segment 60 via methods including, but not limited to, laser cutting.

[0105] Figure 5 The system 10 is illustrated in which the outer sheath assembly 22 is removed (e.g., by pulling the outer sheath assembly 22 proximally), thereby partially exposing the midshaft assembly 20 including part or all of the prosthesis (not shown) in the implant retention area 16. As with the front cone assembly 31, the inner assembly 18, and the outer sheath assembly 22, the midshaft assembly 20 can be a single-piece tube or multiple pieces connected together to provide different properties along different portions of the tube. As already mentioned, in some embodiments, it may be desirable and / or necessary for the delivery system 10 to have greater flexibility at the distal end of the device, wherein flexibility is not required for the proximal end. The illustrated midshaft assembly 20 has a first section 53, a second section or midshaft 50 located distal to the first section, and a third section 40, i.e., an outer retaining ring 40, located distal to the midshaft 50. The first section can extend distally away from the handle and be connected to the second section or midshaft 50 at the distal end of the first section. As Figure 5 As shown in , the distal end of the second segment 50 can be attached to the outer retaining ring 40 (eg, the third segment). Each of the segments can be a tube, such as a metal or polymer tube, as described with respect to the outer sheath assembly 22. Figure 7 -8, a further description of the structure of the middle shaft 50 can be found below.

[0106] By using the handle 14, the midshaft assembly 20 can be translated or slid on the inner assembly 18, which causes the outer retaining ring 40 to slide on the inner assembly 18 and surround the inner retaining member 32 described below. Figure 2A, the outer retaining ring 40 surrounds a portion of the prosthesis 70, specifically the proximal portion, thereby preventing the prosthesis 70 from expanding. The outer retaining ring 40 may also circumferentially surround the inner retaining member 32. Further, the midshaft assembly 20 may be translated proximally relative to the inner assembly 18 into the proximally retracted outer sheath assembly 22, thereby exposing the proximal portion of the prosthesis 70 retained within the outer retaining ring 40. A tapered structure (taper) 61 may be provided at the proximal end of the outer retaining ring 40 to allow it to slide more easily into the outer sheath assembly 22. In this way, the outer retaining ring 40 can be used to help secure the prosthesis to the delivery system 10 or release it from the delivery system 10. The outer retaining ring 40 may have a cylindrical or long tubular shape.

[0107] Further, if Figure 2A , the outer retaining ring 40 can cover a considerable length of the prosthesis 70. For example, the outer retaining ring 40 can cover more than 1 / 8, 1 / 4, 1 / 3, or 1 / 2 of the prosthesis 70. In addition, the outer retaining ring 40 can cover a considerable length of the atrial anchor 82. For example, the outer retaining ring 40 can cover more than 75%, more than 80%, more than 85%, or more than 90% of the atrial anchor 82. The length of the outer retaining ring 40 can be about 15, 17, 17, 18, 19, or 20 mm or a range between those lengths. In some embodiments, the length of the outer retaining ring 40 can be between about 10 and about 30 mm.

[0108] Figure 6 Display and Figure 5 Approximately the same view, but with the midshaft assembly 20 including the outer retaining ring 40 and midshaft 50 removed, thereby partially exposing the inner assembly 18 (including the inner retaining member 32 attached to the inner retaining shaft 42) and the nose cone assembly 31 (including the nose cone shaft 30 attached to the nose cone 28).

[0109] As mentioned, the inner assembly 18 can be composed of an inner retaining shaft 42, wherein the inner retaining member 32 is attached to the distal end of the inner retaining shaft 42. Similar to the above assembly, the inner retaining shaft 42 can include a tube, such as a hypodermic tube or a hypotube (not shown). The tube can be made of one of any number of different materials, including nitinol, stainless steel, and medical grade plastics. The tube can be a single piece tube or multiple pieces connected together. Using a tube made of multiple pieces can allow the tube to provide different properties along different portions of the tube, such as rigidity and flexibility.

[0110] In some embodiments, the first section (not shown) of the inner component 18 can be made of a hypotube, which can extend along most of the length of the inner component 18. For example, a metal hypotube extends distally from the handle 16 at the proximal end until the second section (or inner holding shaft) 42 of the inner component 18 before the implant holding area 16. The hypotube can provide column strength (pushing ability) to the inner component. Further, the handle 16 can allow the second section 42 to be rotated, which can allow the prosthesis 70 to be rotated. The second section 42 of the inner component 18 can be made of a more flexible material. For example, the second section 42 can include a wire such as a multi-strand wire, a wire rope, or a wire coil. The wire can be around a more flexible tube, such as a plastic tube, or it can be formed as a tube without any additional internal material or core. Therefore, in some embodiments, the wire can be a hollow core wire rope. The wire can provide the inner component 18 with strength, but it can also provide more flexibility to allow, for example, navigating the curvosities of the vascular structure in the heart.

[0111] The inner assembly 18 may also include a prosthesis retaining mechanism such as an inner retaining member 32 at the distal end of the second section 42, which may be used to engage with a prosthesis, such as for Figure 2A For example, the inner retaining member 32 can be a ring and can include a plurality of grooves configured to engage with the struts 72 on the prosthesis 70. The inner retaining member 32 can also be considered to be part of the implant retention area 16 and can be proximal to the implant retention area 16. With the struts or other portions of the prosthesis 70 engaged with the inner retaining member 32, an external retaining member such as the outer retaining ring 40 can cover both the prosthesis and the inner retaining member 32 to secure the prosthesis to the delivery system 10.

[0112] Further, if Figure 6 As shown in , the nose cone assembly 31 can be a long member, and in some embodiments, can have a nose cone 28 on its distal end. The nose cone 28 can be made of polyurethane for non-traumatic access and minimize damage to venous vessels. The nose cone 28 can also be radiopaque to provide visibility under fluoroscopy.

[0113] The nose cone shaft 30 may include a lumen that is sized and configured to slidably accommodate a guide wire so that the delivery system 10 can be advanced through the vascular structure via the guide wire. However, embodiments of the system 10 discussed herein may not use a guide wire, and therefore the nose cone shaft 30 may be solid. The nose cone shaft 30 may be connected to a handle from the nose cone 28, or may be formed by different sections such as other components. Further, the nose cone shaft 30 may be formed by different materials, such as plastics or metals similar to those described in detail above.

[0114] This view also illustrates that the nose cone shaft 36 may be slidably disposed within the inner assembly 18 , thereby allowing the nose cone shaft 28 (and thus the nose cone 28 ) and the inner retaining member 32 to move apart from one another during deployment and use.

[0115] The inner retaining member 32 and the outer retaining ring 40 and the delivery system 10 may be generally similar to those disclosed in U.S. Pat. Nos. 8,414,644 and 8,652,203, both of which are incorporated herein by reference in their entirety and made a part of this specification. This includes the entire disclosure, including other devices and methods described therein, and is not limited in any way to the disclosure of internal and external retention and / or delivery systems.

[0116] Maneuverable center axis structure

[0117] Advantageously, embodiments of the system 10 can be configured to be flexible when positioned in a patient, and can allow the system 10 to be manipulated by a user in a specific desired orientation. Specifically, in a transfemoral approach to the mitral valve, embodiments of the system 10 can provide controlled maneuverability to allow a user to better navigate and rotate the distal end of the system 10 - from the septum between the left and right atria, into the native mitral annulus. In some embodiments, a guidewire is not required to manipulate the system 10. Although specific shaft structures are described below with respect to the mid-shaft assembly 20, it will be appreciated that these structures may also be applied to other components.

[0118] As mentioned, Figure 5 illustratively illustrates an embodiment of the second section (eg, the middle shaft) 50 of the middle shaft assembly 20. Figure 5 As shown in , the central shaft 50 can be formed by a tube that includes a series of discrete slots 402 that can be positioned along the length of the central shaft 50. The slots 402 can be oriented substantially perpendicular to the longitudinal axis of the central shaft 50, wherein each slot has a proximal side, a distal side, and two circumferentially spaced opposite ends. The slots 402 in the central shaft 50 partially rotate circumferentially around the central shaft 50. The slots 402 can form a gap that is configured to close after a force is applied, and in this particular slot configuration, the gap allows the central shaft 50 to be manipulated as directed by the configuration of the slots 402, as described below. By varying the characteristics of the slots 402, different bending characteristics of the central shaft 50 can be produced.

[0119] Figure 7 show Figure 5900 of the center shaft 50 is shown in FIG. 1 , wherein the planar pattern illustrates how a tube forming the center shaft 50 would be cut if the tube were cut longitudinally along its length to form slots 902 and laid horizontally. The tube formed by planar pattern 900, as well as other planar patterns discussed below, can be formed from seamless drawn tubing with slots laser cut into the tube. When in tube form, ridges 931 can be formed along its length between the ends of each slot 902. For example, the center shaft 50 can be made from laser cut metal tubing with the tube having a plurality of slots 902, such as the slots 902 of FIG. 1 . Figure 7 900. As shown, the planar pattern 900 can have a series of grooves 902 along its length from the proximal end 904 to the distal end 906, and in some embodiments, greater than 40 grooves 902. The grooves 902 can be discrete grooves that are longitudinally spaced apart from each other. Although Figure 7 The slots 902 are shown spaced approximately equidistant longitudinally from one another, but other embodiments may include slots with varying spacing therebetween.The slots 902 may be provided along substantially the entire length of the tube as illustrated, or may be provided only partially along the length of the tube.

[0120] The planar pattern 900 can be considered to include a midline 908 extending longitudinally from the proximal end to the distal end, with the slots 902 oriented perpendicularly or substantially perpendicularly to the midline. In other words, the slots 902 can be oriented perpendicularly or substantially perpendicularly to the longitudinal axis of the central axis 50 and can extend or rotate circumferentially around the central axis 50. The slots 902 can rotate circumferentially around the tubular form planar pattern 900 through nearly the entirety of the central axis 50, such as more than 80, 100, 120, 170, 180, 200, 220, 280, 300, 320, or 340 degrees circumferentially, leaving a small gap between the lateral ends of each slot.

[0121] Some of the slots 902, such as those near the proximal end 904 of the tube (referred to herein as proximal slots 921), may have the same circumferential positioning over a portion of the length of the tube (here, the proximal slot portion). As illustrated, there are 16 proximal slots 921, which may be identical to one another, all having a center portion located on the midline 908 and extending laterally from the midline 908 in a symmetrical pattern around the midline 908 (e.g., parallel to the longitudinal axis of the central shaft 50). Distal to the proximal slots 921 are a plurality of transition slots 923 that are similar in shape to the proximal slots 921, but have center portions that gradually move laterally further away from the midline 908 so that the transition slots 923 are angled relative to the midline 908. As illustrated, there may be 5 such transition slots 923. Although the proximal slots 921 are oriented perpendicularly or substantially perpendicularly to the longitudinal axis of the shaft 50, the transition slots 923 are slightly angled relative to the proximal slots 921.

[0122] Distal to the transition slot 923 are a plurality of distal slots 925, for example 21 distal slots 925, in the distal slot portion, which may have the same circumferential positioning as on the proximal portion of the tube. The distal slots 925 may be identical to each other. The distal slots 925 may also be identical to the proximal slots 921. The distal slots 925 may each have a central portion circumferentially offset from the central portion of the proximal slot 921 and may continue longitudinally along the length of the tube from the most proximal transition slot. Like the proximal slots 921, the distal slots 925 may be oriented perpendicularly or substantially perpendicularly to the longitudinal axis of the axis 50 and the midline 908.

[0123] Thus, it will be appreciated that the grooves 902 can be located at different circumferential positions along the length of the planar pattern 900. For example, the center portion of the distal groove 925 and the center portion of the proximal groove 921 can be separated by about 0-180°, preferably from about 45° to about 90°. Other circumferential variations, such as, for example, 10, 20, 30, 40, 45, 50, 60, 70, 80 or 90° can also be used. The majority of the grooves 902 can be proximal grooves 921 and distal grooves 925, with only a few transition grooves 923 between the two positions. Further, approximately half or more of the grooves 902 can be proximal grooves, although the number of grooves 902 in these positions can vary in other embodiments. Further, as Figure 7 As shown in , ridge 931 will also rotate along the circumference of the tube. Ridge 932 will extend linearly along the proximal slot 921, turn at a certain angle to follow the transition slot 923, and extend linearly along the distal slot 925 again.

[0124] The slot 902 itself can be substantially the same throughout the length of the central shaft 50, although there may be some minor variations. This can allow the proximal end 904 to be substantially always mobile (e.g., at least some minor flexion) during the application of force at the distal end 906. Figure 7Each individual slot 902 illustrated in the example has a width (as measured circumferentially or transversely to the longitudinal axis of the midshaft 50) that is much greater than its length (as measured along the longitudinal axis of the midshaft 50). Each slot 902 forms three teeth extending toward the distal end 906 of the midshaft 50, with a larger tooth 916 located in the center of the slot 902, and two smaller teeth 918 located symmetrically on opposite sides of the larger tooth 916, extending away from the midline 908 at a slight angle. At the distal end of each tooth, the slot 902 forms a central gap 919 and two side gaps 914 into which the teeth move distally when the midshaft 50 is longitudinally compressed. Between the larger tooth 916 and the two side teeth 918 is a gap 920, and outwardly from the smaller side teeth is a triangular gap 912. At the side ends of each slot, there is a W-shaped slot 910 that partially defines an end gap 922, which has a greater length than the small end of the triangular slot 912. More generally, the ends of the slots 902 can be considered T-shaped, which can evenly distribute strain on the edges of the slots 902 and allow the midshaft 50 to return to its original position after bending. All portions of each slot 902 can be connected as a single slot, or can be separated into multiple different pieces.

[0125] The groove patterns described herein advantageously provide desired deformation of the grooves 902, and thus the central shaft 50, as force is applied to the central shaft 50. For example, using a pull wire (or wires) as described below, a proximal force applied to the distal end of the central shaft 50 will bend or manipulate the central shaft 50 in a direction aligned with the grooves 902, thereby closing the grooves and bending the central shaft 50 in a closed direction. Thus, when force is applied, the central shaft 50 can bend in more than one dimension to follow the closure of the grooves 902, allowing for partial three-dimensional bending (and therefore three-dimensional manipulation) due to the transition grooves 923. Moreover, the bending in the proximal and distal portions can occur simultaneously or in a two-part manner, depending on the size of the grooves 902 and / or the intensity of the force applied to the central shaft 50. Generally, when a pulling force is applied to the distal end of the central shaft, the proximal portion having the proximal grooves 921 will first undergo bending, followed by the transition portion having the transition grooves 923, followed by the distal portion having the distal grooves 925. However, in some embodiments, the movable sheath 51 referred to above can at least partially surround the proximal portion and can stiffen the proximal portion during delivery. For example, when passing through the native mitral annulus from a trans-septal entry position, the movable sheath can at least partially cover the proximal portion, provide an outer wall barrier to prevent bending of the proximal portion and the proximal slot 921, because it can be advantageous to provide more guidance for the distal portion and the distal slot 925 than the proximal slot 921 during implantation. Specifically, the farther away from the distal end 906, the greater the torque generated per pound of pull, causing the proximal end 904 to bend first, followed by the distal end 906. Therefore, the user can better control the articulation of the central axis 50. However, it is advantageous for the proximal slot 921 to be movable with minimal force because it can then always be movable during bending, thereby providing stability for fine-tuning the distal portion 925 and providing torque to the entire delivery system 10 for additional positioning.

[0126] Fig. 8A -B shows an alternative embodiment of a planar pattern 1000 of the central shaft 50. As shown, a series of grooves 1002 can extend generally linearly over the entire length of the central shaft 50, extending from a proximal end 1004 to a distal end 1006, wherein the centers of the grooves 1002 remain parallel to the longitudinal axis. Further, when in the form of a tube, ridges 1031 can be formed along its length between the ends of each groove 1002. Thus, unlike in Figure 7 The plane mode shown in 900, Figures 8A-8B The planar pattern 1000 will generally have a single plane of motion, which will be generally aligned with the center 1010 of the slot 1002. Thus, when a force is applied, as discussed below, the planar pattern 1000 will bend along the plane formed by the center 1010, allowing for two-dimensional movement. Fig. 8A-B shows slots 1002 spaced approximately equally apart longitudinally from one another, but other embodiments may include slots with varying spacing therebetween.Slots 1002 may be provided along substantially the entire length of the tube as illustrated, or may be provided only partially along the length of the tube.

[0127] The planar pattern 1000 can be considered to include a midline 1010 extending longitudinally from the proximal end 1004 to the distal end 1006, wherein the slots 1002 are oriented perpendicularly or substantially perpendicularly to the midline. In other words, the slots 1002 can be oriented perpendicularly or substantially perpendicularly to the longitudinal axis of the medial axis 50 and can extend or rotate circumferentially around the medial axis 50.

[0128] Further, if Fig. 8A As shown in FIG. 1-B, the slot can change size from the proximal end 1004 to the distal end 1006. This can allow the central shaft 50 to articulate differently at different portions, creating a segmented effect so that different portions of the central shaft 50 bend at different multiples. Specifically, the farther away from the distal end 1006, the greater the torque generated per pound of pull, causing the proximal end 1004 to bend first, followed by the distal end 1006. Thus, the user can better control the articulation of the central shaft 50.

[0129] Some slots 1002, such as those near the proximal end of the tube (referred to herein as the proximal slot portion or proximal slots 1021), may be smaller over a portion of the tube length. Fig. 8A As illustrated in FIG, there are 16 proximal slots 1021, which may be identical to one another, each having a central portion located on the midline 1010 and extending transversely from the midline 1010 in a symmetrical pattern around the midline 1010. Distal to the proximal slots 1021 are a plurality of intermediate slots 1023 (or intermediate slot portions) having a greater width than the proximal slots 1021 but remaining centered on the midline 1010. As illustrated, there may be 21 such intermediate slots 1023.

[0130] Distal to the middle slot 1023 are a plurality of distal slots 1025 (or distal slot portions), for example 18 distal slots 1025, having a greater width than the middle slots 1023 and the proximal slots 1021. The distal slots 1025 may be identical to one another. The distal slots 1025 may each be centered on the midline 1010 and may extend longitudinally from the most distal middle slot 1023 along the length of the tube. Figure 8B With Fig. 8A A similar configuration, but with transition portions between the proximal and middle groove portions, and between the middle and distal groove portions. In these transition portions, there are grooves that gradually increase in width from the more proximal groove portion to the more distal groove portion. The ridge 1031 will therefore extend linearly parallel to the midline 1010, but will increase in width from the proximal groove 1021 to the middle groove 1023, and further increase in width from the middle groove 1023 to the distal groove 1025.

[0131] The reduction in slot width from the distal end 1006 to the proximal end 1004 can allow the midshaft 50 to bend at the distal end 1006 before the proximal end 1004. Specifically, generally the higher the moment (e.g., force x vs. distance of the force), the faster a particular region will bend / deflect. In the midshaft 50, the force is located at the distal end 1006, and thus the proximal end 1004 will experience the greatest moment - since it has the greatest distance from the force. However, by making the distal slot 1025 larger than the proximal slot 1021, and thus the ridge 1031 surrounding the distal slot 1025 smaller than surrounding the proximal slot 1021, the distal end 1006 will bend first - since there is significantly less material to bend, and thus a lower moment is required to bend, even though the distance from the force is the smallest. Further, making the transition groove 1023 have a width between the width of the distal groove 1025 and the width of the proximal groove 1021, thereby creating a generally gradually changing width, can provide stress relief that would otherwise be concentrated near the proximal end 1004.

[0132] The slot 1002 itself may be generally the same in shape throughout the length of the midshaft 50, although the size (e.g., width) of the slot 1002 may vary. Fig. 8A Each individual slot 1002 illustrated in -B has a width (as measured circumferentially or transversely to the longitudinal axis of the midshaft 50) that is much greater than its length. Each slot 1002 forms a single tooth 1016 that extends toward the proximal end 1004 of the midshaft 50 and is generally centered on the longitudinal centerline 1010. Proximal to the tooth 1016, the slot 1002 forms a central gap 1018 into which the tooth 1016 can move proximally when the midshaft 50 is longitudinally compressed. At the side ends of each slot, there is a circular slot 1014 that partially defines an end gap that has a greater length than the small end of the triangular slot 1012 located between the circular slot 1014 and the central gap 1018. All portions of each slot 1002 may be connected as a single slot, or may be separated into multiple distinct pieces.

[0133] Further, in Fig. 8A The planar mode 1000 shown in -B can also allow the organic compound to bend. Fig. 8A-B generally bends only in a single plane, but the central shaft 50 can be configured to provide slight flexure out of plane, which can be used to properly place the implant 70 in the patient. Specifically, when the central shaft 50 is manipulated under the guidance of the user, there can be flexure out of two dimensions. For example, when the central shaft 50 impacts a portion of the patient's anatomy, there is room on the circumferential side of the teeth 1016 for lateral movement, which imparts some lateral flexibility (e.g., outside of a single plane of motion). During the movement of the entire central shaft 50, a small amount of lateral movement can provide similar to the movement in the patient's anatomy. Figure 7 Thus, the planar pattern 1000 may allow for a wider pattern that can conform to the patient's specific anatomy, while Figure 7 The planar pattern 900 is more repeatable and provides greater control - because it does not conform to the anatomy.

[0134] Described next is the structure for implementing the force and thus bending the above disclosed central shaft 50 having the planar pattern as described above. Fig. 9 , which has an outer sheath assembly 22 and a midshaft assembly 20 in addition to the outer retaining ring 40 removed, a pull wire 612 (e.g., a 0.018 inch diameter pull wire) can be used to connect the outer retaining ring 40 to the handle 14. The handle 14 can have a manipulation knob / actuator 610 (at Figure 1 ) in order to apply force and control the bending of the middle shaft 50. In some embodiments, the pull wire 612 can be connected to the front cone 28, thereby providing a manipulation point further away than the outer retaining ring 40.

[0135] Further, the manipulation knob 610 can compensate for the shortening of the delivery system 10 during bending. When different components of the delivery system 10 are bent (e.g., the central shaft 50 is bent to close the slot 402 or the hypotube 150 of the outer sheath assembly 22 is bent to close the slot 152 described below), the length of the central shaft 50 and the outer sheath assembly 22 will be reduced due to the closure of the slot, which can cause the prosthesis 70 to be released accidentally. Therefore, during the activation of the manipulation knob 610, the manipulation knob 610 can be configured to move the outer sheath assembly 22 distally while pulling the pull wire 612. This can prevent unwanted relative movement or unbalanced forces of the components of the delivery system 10, particularly unwanted release of the prosthesis 70.

[0136] Generally at the proximal end of the system 10, a manipulation knob 610 in the handle 14 can be connected to a pull wire 612. The pull wire 612 can extend through the lumen of the central shaft 50 and outside the inner assembly 18. The pull wire 612 can be connected to an outer retaining ring connector 614 that connects the distal portion of the central shaft 50 to the outer retaining ring 40. Specifically, the outer retaining ring connector 614 can act as a weld for the pull wire 612 by, for example, a groove in the outer retaining ring connector 614. The outer retaining ring connector 614 can be connected to the central shaft 50 by a series of rivets, although the attachment mechanism is not limited.

[0137] The pull wire 612 can be passed through Figures 12A-12B 12 and 12. A proximal wire connector 1200 having a proximal end 1202 and a distal end 1204 is shown connected to the handle 14. The proximal wire connector 1200 has a generally tubular shape that can be located / attached within a housing of the handle 14. The proximal wire connector 1200 can have a length of about 0.50 inches. The pull wire 612 can extend at the distal end 1204 through a hole 1212 that forms a longitudinal lumen along the length of the proximal wire connector 1200. As shown, the pull wire 612 can be attached within the longitudinal lumen radially inward from a generally teardrop-shaped groove 1206 having a larger end 1208 proximal to the proximal end 1202 and a smaller end 1210 near the distal end 1204. The groove 1206 can extend through the radius of the proximal wire connector 1200 to meet the longitudinal lumen. The larger end 1208 may have a radius of curvature of approximately 0.250 inches, and the smaller end 1210 may have a radius of curvature of approximately 0.0050 inches.

[0138] The puller wire 612 can then be welded in place in the longitudinal lumen radially inward from the larger end 1208. The teardrop-shaped groove 1206 is advantageous because the heat to which the puller wire 612 is exposed during welding decreases from the proximal end 1202 to the distal end 1204 as more mass is present near the distal end 1204. Thus, the weld can be more consistent and less prone to problems caused by any heat affected zone during welding. Further, while most welds occur with a 20% loss, the teardrop-shaped groove 1206 allows for about a 5% loss or less.

[0139] The user can therefore operate the manipulation knob 610 to provide or alleviate the proximal force on the pull wire 612. Specifically, the proximal wire connector 1200 can be placed in a channel of the handle 14, which narrows at a point distal to the proximal wire connector 1200. The channel can be pulled proximally by manipulating the knob 610, and once the proximal wire connector 1200 contacts the narrowed portion of the channel on its distal end, the proximal wire connector 1200 (and therefore the pull wire 612) will be pulled proximally along the channel, thereby generating a proximal force on the pull wire 612. When the proximal force is applied to the pull wire 612, the central shaft 50 will bend in the direction of the slot opening. The slot pattern on the central shaft 50 will cause the central shaft 50 to bend in the direction of the slot 402 in which the pull wire 612 force is applied. As mentioned above, in Figure 7 In the embodiment shown in , the central shaft 50 can be bent in at least two directions, thus imparting three-dimensional maneuverability to the device 10. The disclosed method is advantageous because the puller wire 612 will not be compressed, which can cause kinking.

[0140] As the force on the pull wire 612 is removed, the central shaft 50 can translate back (e.g., "spring back") to its original position. This can occur—at least in part due to the material (e.g., Nitinol) and in part due to the configuration of the ends of the slot 902, which are generally T-shaped. This can be advantageous because, as discussed below, the pull wire 612 will not be compressed, thereby avoiding kinking. In some embodiments, the central shaft 50 will remain in a bent configuration even after the force is removed. In some alternative embodiments, a second pull wire can be used, which is located at a different portion of the central shaft 50. For example, the second pull wire can be positioned at 90° or 180° from the pull wire 612, thereby allowing bidirectional manipulation of the central shaft 50. The user can operate the two pull wires independently, or they can operate in tandem with each other to produce the desired bend in the central shaft 50.

[0141] Outer sheath assembly structure

[0142] As mentioned above, the outer sheath assembly 22 can be constructed of a plurality of different sections, namely the first section 56, the second section 58, and the third section 60. These different sections can have different features, configurations, or structures, allowing the sections to have properties that are advantageous for a particular section.

[0143] The most proximal portion of the outer sheath assembly 22 begins with a first section 56 which may be in the form of a tube having a lumen running through its length. Figures 10A-10D A first section 56, or planar pattern of the tube, is illustrated in an expanded configuration. This section 56 may be formed from laser cut stainless steel, although the specific material or method of cutting is not limited.

[0144] As shown in the figure, the first section can be formed by a series of transverse and longitudinal slot pairs 710, which are designed to transmit torque while being flexible (e.g., clockwise / counterclockwise rotation of the delivery system 10). The delivery system 10 can be rotated anywhere between 0 and 180° to reposition the prosthesis 70. Each slot of the slot pair 710 can be composed of a shorter longitudinal slot 712 and a longer circumferential slot 714, wherein the ends of the circumferential slot 714 are connected approximately in the middle of the longitudinal slot 712. The circumferential groove 714 can be slightly angled with the longitudinal slot 712 and therefore not perpendicular to the longitudinal axis. Therefore, each of the slot pairs 710 can form a generally T-shaped pattern. This T-shape will allow the first section 56 to translate back to its original position because the T-shaped pattern can distribute strain more evenly. As Figures 10A-10D , the groove pattern can be formed by the circumferential grooves 714 of each groove pair, which generally overlap each other circumferentially and are spaced apart in the longitudinal direction. Subsequently, the longitudinal grooves 712 of the pair 710 can be located on circumferentially opposite sides of the circumferential grooves 714 so that they can each longitudinally overlap two longitudinal grooves 712. Subsequently, these groove pairs 710 can be repeated around the circumference of the first segment 56 to form a groove ring 716. The pairs 710 can be spaced apart on the groove ring 714 to provide tensile strength.

[0145] Further, the groove rings 714 can repeat along the length of the first section 56, where they can repeat at a length of about 0.251 inches. The groove rings 716 can extend along the first section 56 of about 38.251 inches. In some embodiments, the groove rings 716 are not found in the portion at the beginning and end of the first section 56. The length of this portion can be about 0.719 inches. Any number of groove rings 716 can be used, and the number of groove rings 716 is not limited.

[0146] The length of the longitudinal groove 712 can be about 0.5, 0.6, 0.61, 0.7 or 0.8 inches, although the specific length is not limited. Further, the width of the longitudinal groove 712 can be about 0.0005, 0.001, 0.0015 or 0.0002 inches. The longitudinal grooves 712 of the groove pair 712 can be spaced apart by about 0.302 inches.

[0147] On the other hand, the circumferential groove 714 can have a width of about 0.2765 inches (as measured circumferentially or transversely to the longitudinal axis of the mid-axis 50). In some embodiments, the circumferential groove 714 can have a width with an increased thickness, wherein the thickness portion of the circumferential groove 714 can be located in the middle of the circumferential groove 714, thereby forming an extended oval shape. This oval can have a radius of about 1.881 inches. For example, the thickness of the circumferential groove 714 can transition from about 0.001 inches at the beginning and end of the circumferential groove 714 to about twice the thickness. The circumferential grooves 714 of the groove pair 710 can have an overlap of about 0.251 inches. They can be spaced apart by about 0.026 inches.

[0148] As shown, Fig. 10A Having a generally flat proximal end 702, although Fig. 10C The proximal end 702 is shown having a pair of cutouts 704 that may aid in aligning the portion with the handle 14, such as providing an audible or tactile "click" when properly installed.

[0149] Advantageously, the disclosed embodiment of the slot configuration can maintain, for example, the strength and torque-transmission of stainless steel while providing new flexibility. In the case of no stretching, the configuration can handle compression, tension and torque transmission with almost 1:1. For example, the knob on the handle 14 can translate the outer sheath assembly 22, wherein the rotation of each inch of the knob causes the translation of one inch of the outer sheath assembly 22, so 1:1 ratio. This is more advantageous than other types of shafts (such as those formed by PEBAX), which are formed by PEBAX and work like rubber bands, wherein the user will not see the response of the one inch stroke of the knob, because PEBAX will stretch all the time, and the user will not be sure when the translation will reach the far end. Subsequently, the far end will suddenly translate and there is no control, which may cause serious problems in the patient. Further, the disclosed embodiment of the outer sheath assembly 22 can have minimum stretching. For example, if a 40lb weight is attached to the outer sheath assembly, it will only stretch about 0.1 inch on a length of about 40 inches. Other sheath types, such as PEBAX, will stretch as much as 1.5 inches with the same applied force.

[0150] Moving distally, the outer sheath assembly 22 can include a third section 60 and a second section 58, the second section 58 being proximal to the third section 60. The third section 60 can have a larger inner and outer diameter than the second section 58, and can be sized in length and inner diameter to receive a prosthesis 70 as described herein in a collapsed configuration. Both sections can have different diameters, thereby forming a stepped configuration.

[0151] It should be noted that the second segment 58, relative to the overall length of the delivery system 10, is still generally positioned at the distal portion of the delivery system 10 while the delivery system 10 is being used to deliver a replacement valve to an in situ implantation site. Moreover, the outer sheath assembly 22 may include other segments positioned proximal to the second segment 58. Such segments may, for example, couple the second segment 58 to a handle of the delivery system 10. When the delivery system 10 is in the initial delivery configuration, the third segment 60 may be positioned radially outward from the replacement valve so that the replacement valve remains in the delivery system 10 in an undeployed configuration.

[0152] The second section 58 may be composed of Fig.11A -E is formed by a hypotube 150 (such as a nitinol hypotube), Fig.11A -E shows a planar pattern of the hypotube 150. As shown, the hypotube 150 can have a plurality of spaced grooves 152 extending along the length from the distal end 156 to the proximal end 154 of the hypotube 150. Thus, when wrapped in a tube form, a ridge 161 can be formed along the length between the ends of each of the grooves 152 thereof. As shown, the grooves 152 can be generally flared and wide toward the middle, thereby allowing ePTFE to pass through the grooves so that the first side and the second side can be sintered together during manufacturing, thereby completely covering the hypotube 150 in ePTFE. The grooves 152 can be a certain number, for example, greater than 40, generally repeated and identical grooves that extend along the length of the hypotube 150. The grooves 152 can be provided substantially along the entire length of the tube as illustrated, or can be provided only partially along the length of the tube. In some embodiments, as shown, Fig. 11B As shown in FIG. 1-C, the hypotube 150 may have a pair of rectangular slots 157 at its proximal and distal ends 156. The rectangular slots 157 may be different in size between the two ends or may be the same size. In some embodiments, the hypotube 150 may have rectangular slots 157 only at the proximal end 154, and conversely, the spaced slots 152 may extend almost to the distal end 156. This configuration is Fig.11A Displayed in.

[0153] As shown, the groove 152 can be formed with a generally H-shaped structure centered on the hypotube 150. The groove 152 can have generally T-shaped ends 153 that are circumferentially spaced relative to each other on the flat hypotube 150. These T-shaped ends 153 can be connected by a circumferential groove 155 that extends circumferentially between the two grooves. The circumferential groove 155 can change height between the two W-shaped grooves. For example, the circumferential groove 155 can have a greater height in the middle than where the circumferential groove 155 connects to the T-shaped ends 153. As shown in FIG. Fig.11A As shown in FIG. 1B , each of the slots 152 may have substantially the same dimensions along the length of the hypotube 150 .

[0154] exist Fig. 11C In the embodiment shown in , the groove 152 can change width between the proximal end 154 and the distal end 156. For example, as shown, the proximal end can have a groove 152 with a smaller width relative to the groove at the distal end 156. Further, the width of the groove 152 can gradually increase from the proximal end 154 to the distal end 154, wherein most of the grooves are grooves of large width. Fig. 11C As shown in , the first three grooves 152 from the proximal end can have a shorter width relative to the grooves 152 on the proximal end, wherein the width of the first three grooves 152 increases from the most proximal groove to the most distal groove of the first three grooves 152. Any number of grooves and groove configurations can be used. This increase in groove size can be useful in applying strain more evenly through the hypotube 150 because the proximal force applied to the distal end 154 tends to be applied to the most proximal groove first. Therefore, the smaller grooves 152 at the proximal end 154 can withstand greater forces due to the presence of more material. Further, the width of the ridge 161 will increase from the proximal end 154 to the distal end 156 while remaining generally parallel to the longitudinal axis of the hypotube 150.

[0155] In some embodiments, smaller grooves may be used. For example, the grooves may be spaced offset from each other to create, for example, a spiral pattern. In some embodiments, adjacent grooves may be offset by about 90°, thereby forming a repeating pattern along the longitudinal length of the hypotube 150.

[0156] The outer sheath assembly 22 may include a lumen passing therethrough to allow the sheath assembly 22 to be movable or slidable relative to the components contained therein. The wall forming the third segment 60 and / or the wall forming the second segment 58 may be formed by one or more materials, such as PTFE, ePTFE, PEBAX, ULTEM, PEEK, polyurethane, nitinol, stainless steel and / or any other biocompatible material. Preferably, the third segment 60 is formed by one or more materials, which allow the third segment 60 to be compliant and flexible, while still maintaining a sufficient degree of radial strength to maintain the replacement valve in the third segment 60 without a large amount of radial deformation, which can increase the friction between the third segment 60 and the replacement valve contained therein, resist the sufficient column strength of the third segment 60 buckling (wavy deformation, buckling) and reduce the sufficient tear resistance of the replacement valve causing the possibility of the third segment 60 tearing. The flexibility of the third segment 60 may be advantageous, especially for the trans-septal approach. For example, when retracting along a curved member, the third section 60 can follow the curved member without exerting significant forces on the curved member, which can reduce the radius of the curved member. Conversely, when it retracts along such a curved member, the third section 60 can bend and / or kink, thereby maintaining the radius of the curved member.

[0157] The hypotube 150 can be optimized for maximum flexibility and minimum strain while providing structural rigidity. Thus, the hypotube 150 can be formed from stainless steel rather than nitinol, which can advantageously increase processing / manufacturing, although other materials can also be used. The length of the hypotube 150 can be approximately 5.5, 6.0, 6.3, 6.5, 7.0, or 7.5 inches, and the specific size of the hypotube 150 is not limited.

[0158] Delivery Method

[0159] The method of using the delivery system will now be described in conjunction with a replacement mitral valve. Specifically, the delivery system 10 can be used in a method of percutaneously delivering a replacement mitral valve to treat patients with moderate to severe mitral regurgitation. The following methods are only a few examples of how the delivery system can be used. It will be understood that the delivery system described herein can also be used as part of other methods.

[0160] like Fig.13 As shown in FIG. 1 , in one embodiment, the delivery system 10 can be placed in the ipsilateral femoral vein 1074 and advanced to the right atrium 1076. A transseptal puncture using known techniques can then be performed to access the left atrium 1078. The delivery system 10 can then be advanced into the left atrium 1078 and then to the left ventricle 1080. Fig.13 The delivery system 10 is shown extending from the ipsilateral femoral vein 1074 to the left atrium 1078. In the disclosed embodiments, a guidewire is not necessary to hold the delivery system 10 in place, although in other embodiments, one or more guidewires may be used.

[0161] Therefore, it can be advantageous for the user to be able to manipulate the delivery system 10 through complex cardiac regions to place the replacement mitral valve in line with the native mitral valve. This task can be performed using the system disclosed above with or without the use of a guidewire. The distal end of the delivery system can be inserted into the left atrium 1078. The user can then turn the manipulation knob 610 on the handle 14 so as to bend the central axis 50, and thus bend the distal end of the delivery system 10. The user can then continue to pass the curved delivery system through the atrial septal puncture and enter the left atrium 1078. The user can then further manipulate the manipulation knob 610 to create an even greater bend in the central axis 50. Further, the user can torque the entire delivery system 10 to further manipulate and control the positioning of the delivery system 10. In the fully bent configuration, the user can then place the replacement mitral valve in the appropriate position. This can advantageously allow a wider variety of approaches, such as delivering the replacement valve to an in situ implantation site, such as a native mitral valve, through a transseptal approach.

[0162] Fig.14 The bending motion of the outer sheath assembly 22 is illustrated. As discussed above, the central axis 50 (not shown but within the outer sheath assembly 22) can be bent by actuating the manipulation knob 610. When the central axis 50 is bent, it will press against the inner surface of the outer sheath assembly 22, thereby driving the outer sheath assembly 22 to bend along the central axis 50. Further, the inner surface of the central axis 50 will press against the outer surface of the inner retaining shaft 42, and the outer surface of the inner retaining shaft 42 will press against the front cone shaft 30, thereby bending the inner retaining shaft 42 and the front cone shaft 30 together with the central axis 50. Therefore, as shown in FIG. Fig.14 As shown in , the distal end of the delivery system 50 will bend due to actuation of the central shaft 50.

[0163] like Fig.14 As shown, the outer sheath assembly 22 , and specifically the second section 58 , can be substantially curved to conform to the curvature of the central shaft 50 . Fig.14 The embodiment shown in can allow three-dimensional bending of the delivery system 10. For example, as shown, when in an unbent position, the front cone 28 can be at an angle of approximately 90° to the longitudinal axis of the delivery system 10. However, Fig.14 One particular positioning is shown, and the delivery system 10 may also be bent at other angles. The delivery system 10 may be bent in a manner that aligns with the anatomy of the heart, thereby allowing the delivery system 10 to be passed through a transseptal puncture and positioning the delivery system 10 to deliver the prosthesis 70 into the mitral annulus.

[0164] It should be understood that the bends experienced by the delivery system, particularly between the right atrium 1076 and the mitral valve, are relatively complex and generally not in a single plane, although single-plane flexibility may be used. This portion of the delivery system may experience bends between 110-180 degrees, and typically between 130-160 degrees, depending of course on the patient's actual anatomy.

[0165] Further description of delivery methodology, as well as a discussion of guidewires that may be used in some embodiments, may be found in U.S. Provisional Application No. 62 / 210,165, filed on August 26, 2015.

[0166] Reference Fig.15 , which illustrates a schematic diagram of an embodiment of a replacement heart valve (prosthesis 70) positioned within a native mitral valve of a heart 83. Further details on how the prosthesis 70 may be positioned at the native mitral valve are described in U.S. Patent Application No. 14 / 716,507 filed on May 19, 2015, the entire contents of which are incorporated herein by reference, including but not limited to Fig.13A-15 and paragraphs

[0036] -

[0045] . A portion of a native mitral valve is shown schematically and depicts typical anatomical structures, including a left atrium 1078 positioned above the annulus 106 and a left ventricle 1080 positioned below the annulus 106. The left atrium 1078 and the left ventricle 1080 are in communication with each other through the mitral valve annulus 106. Fig.15 Also schematically shown is a native mitral valve leaflet 108 with chordae tendineae 110 connecting the downstream end of the mitral valve leaflet 108 to the papillary muscles of the left ventricle 1080. The portion of the prosthesis 70 disposed upstream of the annulus 106 (toward the left atrium 1078) may be referred to as being supra-annularly positioned. The portion generally within the annulus 106 is referred to as being intra-annularly positioned. The portion downstream of the annulus 106 is referred to as being sub-annularly positioned (toward the left ventricle 1080).

[0167] like Fig.15 As shown in the illustrated embodiment, a replacement heart valve (e.g., prosthesis 70) can be arranged so that the mitral valve annulus 106 is between the distal anchor 80 and the proximal anchor 82. In some cases, the prosthesis 70 can be positioned so that the end or tip of the distal anchor 80 contacts the annulus 106, such as, for example, Fig.15 . In some cases, the prosthesis 10 can be positioned so that the end or tip of the distal anchor 80 does not contact the annulus 106. In some cases, the prosthesis 70 can be positioned so that the distal anchor 80 does not extend around the leaflet 108. Further, the prosthesis 70 can be at least partially surrounded by an annular flat member 81 between the distal anchor 82 and the proximal anchor 82. This flat member 81 can wrap around the frame of the prosthesis 70 and help position the prosthesis 70 at a desired location in the body.

[0168] like Fig.15 , the replacement heart valve 70 can be positioned so that the end or tip of the distal anchor 80 is on the ventricular side of the mitral valve annulus 106, and the end or tip of the proximal anchor 82 is on the atrial side of the mitral valve annulus 106. The distal anchor 80 can be positioned so that the end or tip of the distal anchor 80 is on the ventricular side of the native leaflet, beyond the location where the chordae 110 connect to the free ends of the native leaflets. The distal anchor 80 can extend between at least some of the chordae 110, and in some cases, such as in Fig.15 106—can contact or engage the ventricular side of the annulus 106. It is also contemplated that in some cases, the distal anchor 80 may not contact the annulus 106, although the distal anchor 80 may still contact the native leaflets 108. In some cases, the distal anchor 80 may contact tissue of the left ventricle 104 beyond the ventricular side of the annulus 106 and / or leaflets.

[0169] During delivery, the distal anchor 80 (along with the frame) can be moved toward the ventricular side of the annulus 106, with the distal anchor 80 extending between at least some of the chordae 110 to provide tension on the chordae 110. The degree of tension provided on the chordae 110 can vary. For example, when the leaflets 108 are shorter than or similar in size to the distal anchors 80, there can be little or no tension in the chordae 110. When the leaflets 108 are longer than the distal anchors 80, there can be a greater degree of tension in the chordae 110, and thus appear to be compressed and pulled proximally. When the leaflets 108 are even longer relative to the distal anchors 80, there can be an even greater degree of tension in the chordae 110. The leaflets 108 can be long enough so that the distal anchors 80 do not contact the annulus 106.

[0170] The proximal anchor 82 may be positioned such that the end or tip of the proximal anchor 82 is adjacent to the atrial side of the ring 106 and / or the tissue of the left atrium 1078 beyond the ring 106. In some cases, some or all of the proximal anchor 82 may only occasionally contact or engage the atrial side of the ring 106 and / or the tissue of the left atrium 1078 beyond the ring 106. For example, Fig.15 , the proximal anchor 82 may be spaced apart from the atrial side of the ring 106 and / or the tissue beyond the ring 106 of the left atrium 1078. The proximal anchor 82 can provide axial stability to the prosthesis 10. In some cases, some or all of the proximal anchors 82 may not contact the annular flat member 81. This may occur when the annular flat member 81 is in a collapsed configuration, although it may also occur when the annular flat member 81 is in an expanded configuration. In some cases, some or all of the proximal anchors 82 may contact the annular flat member 81. This may occur when the annular flat member 81 is in an expanded configuration, although it may also occur when the annular flat member 81 is in a collapsed configuration. It is also contemplated that some or all of the proximal anchors 82 may contact the atrial side of the ring 106 and / or the tissue beyond the ring 106 of the left atrium 1078.

[0171] The annular flat member 81 can be positioned such that the proximal portion of the annular flat member 81 is positioned along or adjacent to the atrial side of the ring 106. The proximal portion can be positioned between the atrial side of the ring 106 and the proximal anchor 82. The proximal portion can extend radially outward such that the annular flat member 81 is positioned along or adjacent to tissue of the left atrium 1078 beyond the ring 106. When the flat member 81 is in an expanded state, the annular flat member 81 can form a seal on the atrial side of the ring 106.

[0172] Replacement valve prosthesis

[0173] Fig.16An alternative embodiment of a valve prosthesis 1010 that can be used in conjunction with the delivery system disclosed herein is illustrated. The illustrated prosthesis 1010 includes a frame 1020 that can be self-expanding or balloon expandable. The prosthesis 1010 can be a replacement valve as discussed above that can be designed to replace a damaged or diseased native heart valve, such as the mitral valve. Additional features of the replacement valve are not Fig.16 1020 to more clearly illustrate the features of the frame 1020. It will also be understood that the prosthesis 1010 is not limited to replacing a valve. Fig.16 It will be appreciated that only the front portion of the frame 1020 is shown for further ease of illustration.

[0174] The frame 1020 can be made of a variety of different materials, but is preferably made of metal. In some embodiments, the frame 1020 can be made of a shape memory material, such as Nitinol. A wire frame or a metal tube can be used to prepare the frame 1020. The wire frame of the metal tube can be cut or etched to remove all metal skeleton except what is desired. In some embodiments, the metal tube is laser cut in a repeating pattern to form the frame 1020. As shown, one of the anchors 1022 can include an eyelet, which can help with alignment manufacturing. Since the frame 1020 can be generally circular and symmetrical, the eyelet can serve as a reference location for frame size measurement and alignment. However, the eyelet may not be included in all embodiments. Further, more eyelets can also be included on the anchor 1022, and the specific number of eyelets is not limited. The flat pattern can be cut from the metal tube, and the tube can then be shaped and / or bent to Fig.16 In some embodiments, the frame 1020 is self-expanding so that it naturally assumes an expanded shape or configuration. The frame 1020 can be further expanded and / or compressed and / or otherwise worked to have a desired shape or shapes, such as for introduction and implantation.

[0175] As shown, when in an expanded configuration, such as in a fully expanded configuration, the frame has a bulbous or slightly spherical shape, wherein the middle portion 1033 is larger than the proximal end 1032 and the distal end 1034. In some embodiments, the inner diameter of both ends can be the same, or it can be larger at one end than the other, while still having a middle portion 1033 that is larger than both the proximal and distal ends 1032 / 1034. In some embodiments, the effective diameter of the distal frame end 1034 is smaller than the effective diameter of the middle portion 1033. The bulbous shape of the frame 1020 can advantageously allow the frame 1020 to engage the native valve annulus or other body cavity while isolating the inlet and outlet from the heart or blood vessel wall. This can help reduce undesirable contact between the prosthesis and the heart or blood vessel, such as the ventricle wall of the heart. In some embodiments, the frame 1020 can have no bulbous portion and can have substantially the same outer contour (dimension) along its entire length (e.g., cylindrical), or it can have one end that is larger than the other end. The prosthesis 1010 and frame 1020 may be similar to replacement heart valves and related frames disclosed in U.S. Patent No. 8,403,983, U.S. Publication Nos. 2010 / 0298931, 2011 / 0313515, 2012 / 0078353, 2014 / 0277390, 2014 / 0277422, and 2014 / 0277427, and U.S. Patent Application No. 15 / 141,684 filed on April 26, 2016, each of which is incorporated herein by reference in its entirety and made a part of this specification. This includes all disclosures and is not in any way limited to the disclosure of replacement heart valves and related frames.

[0176] Multiple pillars together form a frame 1020. Fig.16 A framework having a plurality of proximal struts 1012 in an expanded configuration is illustrated, the plurality of proximal struts 1012 extending substantially longitudinally to an enlarged proximal end 1013. A proximal row of circumferentially expandable struts 1017 connects the proximal struts 1012, the struts 1017 having a zigzag or undulating shape such that between each proximal strut 1012, the struts 1017 form a V-shape. From the distal end of each of the Vs, a vertical strut 1015 extends substantially longitudinally in a distal direction. The distal ends of the vertical struts 1015 are then connected to a row of diamond-shaped units 1023, the diamond-shaped units 1023 being formed by a plurality of circumferentially expandable struts 1014 having a zigzag or undulating shape. As illustrated, the proximal-most row of struts 1014 extends distally in a V-shape away from the distal ends of the vertical struts 1015 , thereby forming a hexagonal cell 1021 defined by the proximal row of struts 1017 , the vertical struts 1015 , and the proximal-most row of struts 1014 . Fig.16The embodiment further includes a second, distal row of rhombus cells 1023, which are further defined by additional circumferential expandable struts 1014, wherein the proximal-most angle of the second row of rhombus cells 1023 coincides with the distal-most angle of the hexagonal cells 1021 and the side angle of the rhombus cells in the first, proximal row.

[0177] The proximal struts 1012 and the vertical struts 1015 can be arranged so that they are parallel or substantially or substantially parallel to the longitudinal axis of the frame. The proximal struts 1012 and the vertical struts 1015 can be further inclined relative to the longitudinal axis so that the proximal ends of the proximal struts 1012 are closer to the longitudinal axis than the distal ends of the proximal struts 1012. The longitudinal axis of the frame 1020 can be defined as a central axis extending through the center of the frame 1020 between the proximal end 1032 and the distal end 1034.

[0178] The illustrated embodiment includes a circle or row of hexagonal or substantially hexagonal cells 1021 shown in the proximal portion 1016 of the frame 1020, and two rows of diamond-shaped cells 1023 shown in the distal portion 1018. As discussed in more detail below, the proximal portion 1016 includes the portion of the hexagonal cells 1021 extending from the distal end of the vertical struts 1015 to the proximal end, and can be considered to be or include a substantially non-shortened portion. Shortening refers to the ability of the frame to shorten longitudinally when the frame is radially expanded. The distal portion 1018 includes diamond-shaped cells 1023 extending from the distal end of the vertical struts 1015 to the distal end, and can be considered to be a shortened portion. In some embodiments, the hexagonal cells 1021 can be irregular hexagons. For example, the hexagonal cells 1021 can be symmetrical about a vertical axis extending from the proximal end to the distal end of the hexagonal cells 1021. The vertical struts 1015 may form opposing sides, while the two circumferential expandable struts 1014 adjacent to the diamond-shaped units 1023 in the most proximal row may form the base of the hexagonal unit 1021, the base of the hexagonal unit 1021 terminating at the most distal corner, which is located distal to the distal end of the vertical struts 1015. These circumferential expandable struts 1014 may be connected to the vertical struts 1015. Further, the circumferential expandable struts 1017 of the proximal row may form the upper sides of the hexagonal unit 1021, the upper sides of the hexagonal unit 1021 extending to the most proximal corner of the hexagonal unit 1021, which is located proximal to the proximal end of the vertical struts 1015. These circumferential expandable struts 1017 may be connected to the proximal end of the vertical struts 1015. In some embodiments, two sides of the hexagonal unit 1021 may have one length, while the other four sides of the hexagonal unit 1021 may have a greater length. In some embodiments, two sides having the same length may be substantially parallel to each other.

[0179] As described above, the frame 1020 has a proximal portion 1016 and a distal portion 1018. Fig.16 1016, while the circumferentially expandable struts 1014 form a distal portion 1018 having a first, proximal row of rhombic cells 1023 and a second, distal row of rhombic cells 1023. As illustrated, adjacent cells between the proximal and distal rows may share a common strut. In some embodiments, the rhombic cells 1023 in the second, distal row may have a greater longitudinal height than the rhombic cells 1023 in the first, proximal row. When the frame is radially contracted or compacted, the struts 1014 become more parallel relative to the longitudinal axis of the frame, causing the outer diameter of the frame in the distal portion 1018 to decrease and the longitudinal length of the frame to increase. When the frame moves from the compacted position to the expanded position, the longitudinal length of the frame may decrease due to the shortening of the rhombic cells 1023 in the distal portion 1018. However, due to the vertical struts 1015, the frame length does not substantially change in length in the proximal portion 1016, although the proximal row of circumferentially expandable struts 1017 in the proximal portion 1016 may allow for some shortening.

[0180] exist Fig.16 The frame 1020 shown in FIG. 1020 can have a relatively short and thick configuration. For example, when the frame is in its expanded configuration, the ratio of the width of the largest portion of the frame 1020 to the height of the frame 1020 (e.g., extending from the proximal end 1032 to the distal end 1034) can be about 3:1, about 2.5:1, about 2.0:1, about 1.5:1, about 4:3, about 1.3:1, about 1.25:1, or about 1.0:1. Thus, in some embodiments, the width at the largest portion of the frame 1020 can be greater than the height. In general, the frame 1020 can have a relatively short and thick configuration. Fig.15 In some embodiments, the height of portion 1016 can be greater than, equal to, or less than the height of portion 1018. In some embodiments, the height of proximal portion 1016 can be approximately 1 / 2 of the height of distal portion 1018. In some embodiments, frame 1020 can have an overall height of about 32 mm (or about 32 mm). Frame 1020 can have an inner diameter of 40 mm (or about 40 mm). In some embodiments, frame 1020 can have a height of 29, 30, 31, 33, 34, 35, or 36 mm (or about 29, about 30, about 31, about 33, about 34, about 35, or about 36 mm).

[0181] The shortening of the frame 1020 can be used to engage and secure the prosthesis to luminal tissue in a body cavity, such as tissue in or adjacent to a native valve, such as a native valve annulus and / or leaflets. Opposing anchors 1022, 1024 can be constructed on the frame 1020 so that portions of the anchors, such as the tips or ends 1026, 1028, move closer together when the frame shortens. As an example, this can allow the anchors 1022, 1024 to grasp tissue on opposite sides of the native mitral valve annulus, thereby securing the prosthesis to the mitral valve. In some embodiments, one set of anchors (such as anchors 1024) is secured to tissue or grasps tissue, while another set of anchors (such as anchors 1022) is used to provide stability and help align the prosthesis, and may or may not directly engage tissue, as further described below.

[0182] The anchors 1022, 1024 and anchor tips 1026, 1028 are preferably positioned along the frame 1020 with at least a portion of the shortened portion positioned between the anchors so that portions of the anchors will move closer together in the event of expansion of the frame. As shown, the distal anchor 1024 is connected to the distal portion 1018 and can extend from the most distal corner of the diamond-shaped elements 1023. As illustrated, the distal anchor 1024 extends distally from the most distal corner of the proximal row of diamond-shaped elements 1023 such that the second, distal row of diamond-shaped elements 1023 extends longitudinally on a portion of the side of the distal anchor.

[0183] Preferably, each of the anchors 1022, 1024 is positioned or extends generally radially outward from the frame 1020 so that the anchor tips 1026, 1028 are generally spaced apart or radially outward from the remainder of the frame 1020 and from where the anchor base is connected to the frame. For example, the anchor tips can be disposed radially outward from a middle portion 1033 of the frame, wherein the tips 1026 and 1028 are axially spaced from each other. The middle portion 1033, which has the largest cross-sectional dimension when the frame is radially expanded, can be defined by the most proximal row of diamond-shaped units 1023. The anchors 1022, 1024 can include a base located on a side of the anchor opposite the tip. The base can be, for example, where the anchor begins to extend from or extend away from the frame 1020.

[0184] The proximal anchor 1022 is shown having a single strut extending into the hexagonal cell 1021 of the portion 1016. Thus, the anchor 1022 extends from the proximal intersection of two segments of the hexagonal cell 1021, e.g., from the proximal-most corner of the hexagonal cell 1021. As shown, the proximal anchor 1022 extends generally distally into the hexagonal cell 1021 while curving outwardly away from the frame 1020. Thus, as the anchor 1022 extends generally distally toward the tip 1026, it extends radially outwardly from the frame 1020. After extending approximately half the length of the hexagonal cell 1021 or more, the tip 1026 of the proximal anchor 1022 can terminate. Further, the tip 1026 can extend further outwardly relative to the body of the frame 1020.

[0185] In some embodiments, the tip 1026 of the anchor 1022 also includes an enlarged or spherical portion 1026, which can be generally circular in shape, although the specific shape is not limited. As illustrated, the spherical portion 1026 is located at the distal end, although the spherical portion 1026 can be located at other locations along the anchor 1022. The spherical portion 1026 can have a radius greater than the width of the rest of the anchor 1022, so that the spherical portion 1026 is larger than the rest of the anchor 1022. As illustrated, the enlarged or spherical portion can extend in a direction generally or substantially perpendicular to the longitudinal axis - for example, caused by gradually bending the anchor 1022 distally and radially outward.

[0186] As another example, the distal anchor 1024 is shown having a looped end 1048. The looped end can be larger near the tip to form a type of long teardrop. In some embodiments, the tip 1028 can be substantially flat. The looped end can help the frame not to get tangled on structures at or near the treatment site. For example, each ring can be configured so that when the frame is deployed and expanded in situ, each ring moves from the delivery position to the deployed position to avoid being caught on the papillary muscle.

[0187] Each distal anchor 1024 is connected to the frame at a base 1042. Fig.21, the base of the distal anchor may be located where the corners of adjacent cells meet, such that the base is located proximal to the distal end 1034 of the frame. In other embodiments, the base of the distal anchor may be located at the most distal corner of the cell, which corresponds to the most distal point on the frame. The distal anchor as illustrated extends generally distally from the base 1042 and then bends back around an arcuate and / or curved section in which the distal anchor extends generally proximally and radially outward from the frame. As shown, the anchor 1024 may also extend generally distally and radially inward from the base relative to the frame, such that the most distal point on the prosthesis has a smaller inner diameter than the location where the base 1042 is connected to the frame. The inner diameter at the most distal point may be the same or substantially the same as the inner diameter at the proximal end, or may be smaller. As illustrated, the anchor 1024 may extend distally from the base 1042 and bend or curve radially inward, then first curve further radially inward in approximately a semicircle, then wrap around so that the anchor extends radially outward. This semicircle can provide space for the distal end of the leaflet to be stored as configured below. The anchor may then extend radially outward and proximally in a linear segment. Finally, the anchor may extend toward the tip 1028 in a direction parallel or substantially parallel to the longitudinal axis. Thus, as illustrated, the anchor bends around approximately 180 degrees from its base so that the tip 1028 extends in an opposite, proximal direction, which may be parallel or substantially parallel to the longitudinal axis of the frame. For example, in Fig.16 As can be seen in the figure, the distal anchor 1024 is bent near the tip 1028 so that the end of the anchor points proximally and is generally parallel to the longitudinal axis of the frame. Alternatively, the tip 1028 can extend generally proximally but still be inclined radially outward or extend at an acute angle relative to the longitudinal axis of the frame.

[0188] It will be appreciated that the anchors can have various other configurations, including the various embodiments that follow. In some embodiments, each of the anchors can extend radially outward from the anchor base of the frame and terminate at the anchor tip. The anchors can be connected to the frame at one of a plurality of different locations, including the tip, the contact, other portions of the strut, etc. Along the length of each anchor, the anchor can include a first, second, third, or more spaced apart bending stages. Before and / or after one or more bending stages, the anchors can also extend distally or proximally. Before or after any bending stage, portions of the anchors can extend with the frame.

[0189] The tip or end 1013 of the proximal strut 1012 can be enlarged relative to the rest of the tip 1013. For example, the end of the tip 1013 can have a generally "mushroom" shape. The proximal strut 1012 and the enlarged tip 1013 can form a locking joint for engaging a locking mechanism of a delivery system of the prosthesis. In some embodiments, the longitudinal extension 1012 and the mushroom tip 1013 can be generally radially inwardly inclined.

[0190] Fig.17 The position of the prosthesis 1010 (with only the frame 1020 shown) delivered to the native mitral valve and positioned between the left atrium 1078 and the left ventricle 1080 is shown. The prosthesis 1010 may be similar to the one above combined with the Fig.15 Discuss in detail the approaches to joining native tissues.

[0191] Delivery Method

[0192] Figure 18-21 A method of delivering a prosthesis 1010 to a desired anatomical location in a patient, such as to replace a mitral valve, is illustrated, thereby illustrating how the delivery system 10 can be used to release the prosthesis. Although the following disclosure is discussed with respect to the prosthesis 1010, similar or identical procedures may also be performed with respect to the prosthesis 70. During the initial insertion of the prosthesis 1010 and the delivery system 10 into the body, the prosthesis 1010 may be located within the system 10, similar to the example of FIG. Figure 2A The distal end 1034 of the prosthesis 1010, specifically the distal anchor 1024, is constrained within the third section 60 of the outer sheath assembly 22, thereby preventing expansion of the prosthesis 1010. Figure 2A As shown in FIG. 1 , the distal anchor 1024 can extend distally when positioned in the third section 60 . The proximal end 1032 of the prosthesis 1010 is defined within the outer retention ring 40 and within a portion of the inner retention member 32 .

[0193] By using the manipulation mechanisms or other techniques discussed herein, the system 10 can first be positioned at a specific location in the patient's body, such as the native mitral valve. Fig.18Following the step of delivering the prosthesis 1010 to the native mitral valve, once the system 10 has positioned the prosthesis 1010 at the in situ target location, such as a native mitral valve, the outer sheath assembly 22 can be moved proximally relatively away from the front cone 28, thereby exposing at least a portion of the prosthesis 1010, specifically the distal end 1034 of the prosthesis 1010. At this point, the distal anchor 1024 can be flipped proximally and the distal end 1034 begins to expand radially outward. For example, if the system 10 has been delivered to the native mitral valve location via a transseptal approach, the front cone is positioned in the left ventricle, thereby positioning the prosthesis 1010 substantially perpendicular to the plane of the mitral annulus. The distal anchor 1024, which can be considered a ventricular anchor, expands radially outward within the left ventricle. The distal anchor 1024 can be located above the papillary head, but below the mitral annulus and mitral valve leaflets. In some embodiments, the distal anchor 1024 can contact and / or extend between chordae in the left ventricle and contact the leaflets when it expands radially. In some embodiments, the distal anchor 1024 may not contact and / or extend between chordae or contact the leaflets. Depending on the positioning of the prosthesis 1010, the distal end of the distal anchor 1024 can be at or below the location where the chordae connect to the free edge of the native leaflets.

[0194] Next reference Fig.19 In the step of removing the prosthesis 1010 from the outer sheath assembly 22, the outer sheath assembly 22 can be further relatively moved away from the front cone 28, thereby further exposing the prosthesis 1010. As shown in the illustrated embodiment, the distal end 1034 of the prosthesis 1010 expands radially outward. It should be noted that during this step, the proximal end 1032 of the prosthesis 1010 can remain covered by the outer retaining ring 40, so that the proximal end 1032 remains in a radially compressed state. At this time, the system 10 can be retracted proximally so that the distal anchor 1024 captures and engages the leaflets of the mitral valve, or can be moved proximally to reposition the prosthesis 1010. Further, the system 10 can be twisted, which can cause the distal anchor 1024 to apply tension to the cable, and at least some of the distal anchor can extend between the cable. However, in some embodiments, the distal anchor 1024 may not apply tension to the cable. In some embodiments, after retraction of the outer sheath assembly 22, without any further movement of the system 10, the distal anchor 1024 can capture the native leaflets and lie between the cords.

[0195] Thus, during this step, the system 10 may be moved proximally or distally to properly capture the native mitral valve leaflets with the distal or ventricular anchor 1024. Specifically, the tip of the ventricular anchor 1024 may be moved proximally to engage the ventricular side of the native annulus so as to position the native leaflets between the anchor 1024 and the body of the prosthesis 1010. When the prosthesis 1010 is in its final position, there may or may not be tension on the cables, although the distal anchor 1024 may be located between at least some of the cables.

[0196] like Fig. 20 , once the distal end 1034 of the prosthesis 1010 is fully expanded (or as fully expanded as possible at this time), the outer retaining ring 40 can be relatively moved proximally to expose the inner retaining member 32, thereby beginning to expand the proximal end 1032 of the prosthesis 1010. For example, in a mitral valve replacement procedure, after the distal or ventricular anchor 1024 is positioned between at least some of the chordae tendineae and / or engages the native mitral valve annulus, the proximal end 1032 of the prosthesis 1010 can be expanded within the left atrium.

[0197] Next reference Fig.21 In the step of removing the proximal end 1032 of the prosthesis 1010, the outer retaining ring 40 can continue to move proximally so that the proximal end 1032 of the prosthesis 1010 can radially expand to its fully expanded configuration. After the prosthesis 1010 is expanded and released, the front cone 28 can be retracted through the center of the expanded prosthesis 1010 and into the outer sheath assembly 22. The system 10 can then be removed from the patient.

[0198] Alternative systems and modifications

[0199] Figure 22-24B An embodiment of a delivery system 5000 is shown, which can have some modifications over the system 10 discussed above. However, it will be appreciated that the components discussed below can be incorporated into the system 10 above, but for ease of disclosure, they will be discussed separately below. Further, the reference numbers discussed above are used for the unmodified components discussed below. The delivery system 5000 can be used similarly to how the system 10 is described to deliver prostheses such as prostheses 70 and 1010.

[0200] like Fig. 22 As shown in , delivery system 5000 may include an elongated shaft assembly 5012 including a proximal end 5011 and a distal end 5013, wherein a handle 5014 is coupled to the proximal end of assembly 5012. Elongated shaft assembly 5012 may be used to hold prosthesis 70 / 1010 to advance it through the vascular structure to the treatment site.

[0201] Surrounding the outer sheath assembly 22 may be a retainer sheath (or shaft) 5021. The retainer sheath 5021 may extend partially down the length of the system 5000. The proximal end of the retainer sheath 5021 may be secured to the handle 5014.

[0202] Surrounding the retaining sheath 5021 may be an integral (or removable) introducer sheath 5023. The introducer sheath 5023 may be relatively rigid and approximately one foot in length, although the specific dimensions are not limited. The introducer sheath 5023 may contain a hemostatic pad within its lumen, which may be sealed with the retaining sheath 5021. In some embodiments, the introducer sheath 5023 may be a braided 72D Pebax shaft with a PTFE liner, although other materials may also be used. Further, the introducer sheath 5023 may include a port assembly 5025 for flushing the lumen of the introducer sheath 5023.

[0203] The retainer sheath 5021 allows the outer sheath assembly 22 to be retracted through the introducer sheath 5023 without undesired movement of the system 5000. For example, if the cushion of the introducer sheath 5023 is sealed to the outer sheath assembly 22, then attempting to retract the outer sheath assembly 22 may instead cause the entire system 5000 to move forward due to the high friction of the cushion on the outer sheath assembly 22.

[0204] Now moved to Fig.23 , the outer sheath component 60 (in Figure 4 ) and the middle shaft assembly 20 (shown in Figure 5 ) has been Fig. 22 The distal end 5013 of the delivery system 5000 is removed, although the outer retaining ring 40 is retained for clearance. As shown, the delivery system 5000 may include a spacer sleeve 5020, which is concentrically located between the middle shaft 50 of the middle shaft assembly 20 and the inner retaining shaft 42 of the inner assembly 18, and is located at the proximal end of the outer retaining ring 40. The pull wire 612 can pass along the outer surface of the spacer sleeve 5020. The spacer sleeve 5020 can be made of a polymer material such as braided Pebax, and can be lined on the inner diameter with PTFE, for example, although the specific material is not limited. The spacer sleeve 5020 can advantageously reduce friction due to the middle shaft 50 and the inner retaining shaft 42 being made of metal. Further, the middle shaft 50 can have teeth on the inner retaining shaft 42 that can be damaged when the middle shaft assembly 20 is bent. Therefore, the spacer sleeve 5020 can act as a buffer between the middle shaft 50 and the inner retaining shaft 42. Further, the spacer sleeve 5020 can take up any gap in the radius between the central shaft 50 and the inner retaining shaft 42, preventing the inner assembly 18 from compressing or winding during bending.

[0205] Thus, the spacer sleeve 5020 can float between the two layers (the inner component 18 running through its lumen and the mid-shaft component 20 on the outside), which can remove any extra space. Thus, when the prosthesis 70 / 1010 is released, the inner component 18 no longer meanders and is held concentrically. This can result in 1:1 motion during prosthesis 70 / 1010 release and smooth and secure prosthesis 70 / 1010 release.

[0206] The spacer sleeve 5020 can be mechanically contained by another lumen and component (e.g., radially contained by the inner assembly 18 and the midshaft assembly 20 and longitudinally contained by the outer retaining ring 40 and the first section 43 of the midshaft assembly 20), and therefore not physically attached to any other components, allowing the spacer sleeve 5020 to "float" in this area. In some embodiments, the spacer sleeve 5020 can have a shorter length than the midshaft 50, in some embodiments less than about 1 cm. The floating aspect of the spacer sleeve 5020 allows it to move in a desired position during deflection, and provide a bearing surface / surfaces for support and / or lubrication. However, in some embodiments, the spacer sleeve 5020 can be connected to other components.

[0207] further, Fig.24A -B shows an embodiment of a handle 5014 that may be used in conjunction with the system discussed in detail above. Fig.25 A cross section of the handle 5014 in a distal position is illustrated. As shown, the handle 5014 can include an outer sheath assembly knob 5033 that can be rotated to translate the outer sheath 22; a deflection knob 5032 that can be rotated to bend the system 5000 (specifically to move the pull wire 612 to deflect the middle shaft 50); an indicator 5036 (discussed below); a middle shaft retraction knob 5035 that can be rotated to translate the middle shaft assembly 20; and a nose cone articulator 5037 that can be translated longitudinally to translate the nose cone assembly 31. In some embodiments, the deflection knob 5032 can pull the pull wire 612 distally while also pushing the middle shaft assembly 20 proximally, thereby preventing accidental release of the prosthesis 70 / 1010.

[0208] The deflection knob 5032, indicator portion 5036, and mid-shaft retraction knob 5035 may be generally connected and translate as one portion or sleigh 5038 on the remainder of the handle 5014 designated as the fixed portion 5030.

[0209] Specifically, as shown, the fixing portion 5030 includes an external thread 5031, which can be threadably attached to a mid-shaft retraction knob 5035, such as having an internal thread 5041. The proximal end of the mid-shaft assembly 20 can be attached to the inner surface of the mid-shaft retraction knob 5035. Therefore, when the mid-shaft retraction knob 5035 is rotated, it translates proximally or distally on the external thread 5031 of the handle 5014. Therefore, when the mid-shaft retraction knob 5035 is rotated, the mid-shaft assembly 20, the deflection knob 5032 and the indicator portion 5036 also translate along the thread. Therefore, the slider 5038 can have a distal positioning ( Fig.24A ) and proximal positioning ( Fig. 24B), wherein the slide 5038 translates on the thread 5031 of the fixed portion 5030 of the handle 5014.

[0210] The indicator portion 5036 can include indicators on the outer surface of the handle 5014 to provide a user with a visual or audible indication of the position of certain components of the system 5000. For example, in some embodiments, the indicator 5036 can provide a visual or audible indication of the deflection of the distal end of the system 5000. The indicator 5036 can include a "speed bump" on the inner surface of the slot that can provide a click when the distal end of the system 5000 is deflected. In some embodiments, the indicator 5036 can include a plurality of tabs running through the slot with a plurality of markings, each marking being one rotation of the deflection knob 5032 as the tab passes through the slot.

[0211] In some embodiments, the proximal connection of the midshaft assembly 20 and the inner assembly 18 can include snap-fit ​​components to secure them (typically as a hard hypotube on their proximal ends) to the inner portion of the handle 5014. These snap-fit ​​components can provide a strong connection and can resist both torque and compression / tension. In some embodiments, the snap-fit ​​connection can be supported from the outside by another component, which further prevents them from disengaging during use. In addition, in some embodiments an O-ring can be used to hemostatically seal the snap-fit ​​mechanism.

[0212] Handle Operation

[0213] Next, based on Figure 22-24B Discussion of the implementation methods discussed Figure 18-21 Operation of the distal end of the system 5000 is shown in FIG. Operation of the handle is described with reference to the delivery of a replacement mitral valve prosthesis, although the handle and delivery system may also be used to deliver other devices.

[0214] First, the distal end 5013 of the system 5000 is positioned in a desired location, such as at the mitral valve. The deflection knob 5032 can be rotated to pull the pull wire 612 attached to the outer retaining ring 40. Therefore, when the deflection knob 5032 is rotated, the central axis 50 will bend in the direction of the pull wire 612. Therefore, this bend can be used to position the system 5000, specifically the distal end, at a desired patient location, such as at the native mitral valve. In some embodiments, rotation of the deflection knob can help manipulate the distal end of the delivery system 5000 through the septum and left atrium and into the left ventricle so that the prosthesis 1010 is located at the native mitral valve.

[0215] Further, rotation of the deflection knob 5032 can push the central shaft 50 distally, in some cases, simultaneously pulling the pull wire 612, thus preventing an unwanted release of the prosthesis 1010. The deflection knob 5032 can do this by having two sets of threads 5043 / 5045 in opposite directions on its inner surface. One of the threads is attached to the pull wire 612, and the other is attached to the central shaft 50. Thus, when the deflection knob 5032 is rotated, one set of threads 5043 pulls the pull wire 612 proximally, while the other set of threads 5045 pushes the central shaft 50 distally.

[0216] At this time, the system 5000 can be used to place the prosthesis 1010 covered by the outer sheath assembly 22 so that the central portion of the prosthesis 1010 is along the plane formed by the natural mitral valve annulus. Therefore, at this time, the atrial anchor 1022 can be located in the left atrium and the ventricular anchor 1024 can be located in the left ventricle.

[0217] Next, the outer sheath assembly knob 5033 can be rotated to retract the outer sheath assembly 22 proximally relative to the nose cone 28, as shown in FIG. Fig.18 As shown in . Thus, the distal end of the prosthesis 1010 begins to expand, and the ventricular anchor 1024 flips from the distal position within the outer sheath assembly 22 to the proximal position outside the outer sheath assembly 22. At this point, the ventricular anchor 1024 can be located below the natural mitral valve leaflet and between the ties, or can be located distal to the location where the ties are connected to the free edge of the natural valve leaflet. Further, the outer sheath assembly knob 5033 can be further rotated to further retract the outer sheath assembly 22, thereby exposing the outer sheath assembly 22. Fig.19 The outer retaining ring 40 is shown in FIG.

[0218] At this point, the prosthesis 1010 can be repositioned in the mitral valve region as desired. For example, the system 5000 can be moved proximally or distally to capture the native valve leaflets via the ventricular anchor 1024, which is positioned behind (or radially outward of) the native valve leaflets. In some embodiments, such as in Fig.15 , rotating the outer sheath assembly knob 5033 to release the prosthesis 1010 will cause the ventricular anchor 1024 to hold the native mitral valve leaflets and extend between the cords. In some embodiments, the system 5000 can be moved proximally to capture and hold the native mitral valve leaflets.

[0219] Once the prosthesis 1010 is in the desired position, such as with the ventricular anchor 1024 secured to tissue on the ventricular side of the native mitral annulus, the midshaft retraction knob 5035 can then be rotated to retract the midshaft assembly 20 proximally, such as Fig. 20This allows the proximal end of the prosthesis 1010 to begin to expand. Further rotation of the midshaft retraction knob 5035 exposes the inner retaining ring 32, thereby releasing the prosthesis 1010 and allowing it to fully expand to the position shown in FIG. Fig.21 The positioning shown in FIG. 1 gives the prosthesis 1010 a Fig.15 and Fig.17 The final positioning is shown in .

[0220] After the prosthesis 1010 is released, the nose cone hinge 5037 can be moved proximally to retract the nose cone 28 through the prosthesis 1010 and into the outer sheath assembly 22 so that the nose cone 28 is not stuck on the tissue while removing the system 5000. Once the nose cone 28 is in the proper position, the entire system 5000 can be withdrawn from the patient.

[0221] From the preceding description, it will be appreciated that the inventive product and method for implant delivery system are disclosed. Although some parts, techniques and aspects have been described with a certain degree of particularity, many changes can obviously be made in the specific design, structure and methodology described above in this paper without departing from the spirit and scope of the present disclosure.

[0222] Certain features described in this disclosure may also be implemented in combination in the context of separate embodiments. Conversely, various features described in the context of separate embodiments may also be implemented in multiple embodiments individually or in any suitable subcombination. Moreover, although features may be described above as functioning in certain combinations, in some cases, one or more features from a claimed combination may be deleted from the combination, and the combination may be claimed as any subcombination or variation of any subcombination.

[0223] Moreover, although the method may be described in the drawings or described in the specification in a particular order, such a method need not be performed in the particular order shown or in sequence, and all methods need not be performed to achieve the desired result. Other methods not described or described may be incorporated into the example methods and processes. For example, one or more additional methods may be performed before, after, simultaneously or between any of the methods. Further, the method may be rearranged or reordered in other embodiments. Moreover, the separation of the various system components in the above-described embodiments should not be understood as requiring such separation in all embodiments, and it should be understood that the described components and systems may be substantially integrated in a single product or packaged into a variety of products. In addition, other embodiments are within the scope of the present disclosure.

[0224] Conditional language, such as "may," "can," "might," or "could," unless otherwise specifically stated or understood otherwise in the context of use, is generally intended to convey that certain embodiments include or exclude certain features, elements, and / or steps. Thus, such conditional language is not generally intended to imply that features, elements, and / or steps are in any way essential to one or more embodiments.

[0225] Linking language, such as the phrase "at least one of X, Y, and Z," unless specifically stated otherwise, is understood to mean that the context in which the item, term, etc. is normally used to express it may be X, Y, or Z. Thus, such linking language is generally not intended to imply that certain embodiments require the presence of at least one X, at least one Y, and at least one Z.

[0226] The degree language used herein, such as the terms "approximately", "about", "substantially" and "substantially" used herein, represents a value, amount or feature close to the declared value, amount or feature, which still performs the desired function or achieves the desired result. For example, the terms "approximately", "about", "generally" and "substantially" may refer to an amount less than or equal to 10% of the declared amount, less than or equal to 5% of the declared amount, less than or equal to 1% of the declared amount, less than or equal to 0.1% of the declared amount, and less than or equal to 0.01% of the declared amount. If the declared amount is 0 (e.g., nothing, not having), the above range can be a specific range and is not within a specific percentage of the value. For example, less than or equal to 10wt. / vol.% of the declared amount, less than or equal to 5wt. / vol.% of the declared amount, less than or equal to 1wt. / vol.% of the declared amount, less than or equal to 0.1wt. / vol.% of the declared amount, and less than or equal to 0.01wt. / vol.% of the declared amount.

[0227] Some embodiments have been described in conjunction with the accompanying drawings. These figures are drawn to scale, but such scale should not be limiting, as sizes and proportions different from those shown are considered and within the scope of the disclosed invention. Distances, angles, etc. are merely illustrative and do not necessarily have an exact relationship to the actual size and layout of the device of the example. Components may be added, removed, and / or rearranged. Further, in conjunction with various embodiments, any particular feature, aspect, method, property, feature, quality, attribute, element, etc. disclosed herein may be used in all other embodiments set forth herein. In addition, it will be appreciated that any method described herein may be practiced using any device suitable for performing the steps.

[0228] Although multiple embodiments and variations thereof have been described in detail, other modifications and methods of using the same will be apparent to those skilled in the art. Therefore, it should be understood that various applications, modifications, materials and substitutions may be made by equivalents without departing from the unique and creative disclosure herein or the scope of the claims.

Claims

1. A system for replacing a defective native mitral valve, comprising: Expandable implants; and A delivery catheter, the delivery catheter comprising: an elongated tubular shaft having an enlarged distal portion sized to radially restrain the expandable implant in a compressed configuration; a steerable shaft disposed within the tubular shaft, the steerable shaft having a distal portion and a proximal portion, the distal portion including a plurality of distal grooves forming a first pair of longitudinal ridges, and the proximal portion including a plurality of proximal grooves forming a second pair of longitudinal ridges, the first pair of longitudinal ridges being circumferentially offset from the second pair of longitudinal ridges; one or more puller wires operably connected to the steerable shaft to cause the distal portion to bend ahead of the proximal portion during application of a proximal force on the one or more puller wires; and An inner shaft is positioned radially within the steerable shaft, the inner shaft including a distal portion adapted for releasable attachment to the proximal end of the expandable implant.

2. The delivery system of claim 1, wherein the first pair of longitudinal ridges are offset 45 degrees from the second pair of longitudinal ridges.

3. The delivery system of claim 1, wherein the first pair of longitudinal ridges are offset 90 degrees from the second pair of longitudinal ridges.

4. The delivery system of any one of claims 1-3, wherein the steerable shaft is configured to bend in more than one plane.

5. The delivery system of any one of claims 1-4, further comprising two puller wires.

6. The delivery system of any one of claims 1-5, wherein the inner shaft comprises a wire rope.

7. The delivery system of claim 1, further comprising a handle at the proximal end of the delivery catheter, wherein the handle is connected to the proximal ends of the one or more puller wires, and wherein rotational movement of the actuator on the handle provides the proximal force on the one or more puller wires.

8. The delivery system of any one of claims 1-7, wherein bending of the steerable shaft causes the steerable shaft to bend the inner shaft and the elongated tubular shaft.

9. The delivery system of any one of claims 1-8, wherein the delivery system is configured to release the expandable implant in two steps.

10. The delivery system of any one of claims 1-9, wherein the one or more puller wires extend along a radially inner surface of a lumen formed by the steerable shaft.

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