Artificial heart valve device, artificial mitral valve, and related systems and methods

Abstract

The artificial heart valve (100) includes a flexible anchoring member (110) that at least partially surrounds and is connected to an inner valve support (120). The device may also include an artificial valve (130) connected to the valve support, installed inside it, or otherwise carried by it. The valve support includes a plurality of posts (122) circumferentially connected by a plurality of rods (124), wherein the posts extend in an axial direction generally parallel to the longitudinal axis (101), and the rods extend around and transversely to the longitudinal axis. The posts extend the entire vertical height HI of the valve support 120. The device also includes one or more sealing members (140) and tissue engaging components (170), such as spikes.

Description

[0001] This application is a divisional application of the Chinese invention patent application No. 201910994619.1. This application is a divisional application of the Chinese invention patent application No. 201610916761.0, the application date of which is October 19, 2012, and the invention name is "Artificial heart valve device, artificial mitral valve and related systems and methods".

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims priority to U.S. Provisional Patent Application No. 61 / 605,699, entitled “SYSTEM FOR MITRAL VALVE REPLACEMENT,” filed on March 1, 2012, and U.S. Provisional Patent Application No. 61 / 549,044, entitled “CONFORMABLE SYSTEM FOR MITRAL VALVE REPLACEMENT,” filed on October 19, 2011, both of which are incorporated herein by reference in their entirety. This application incorporates by reference in its entirety (1) International PCT Patent Application No. PCT / US2012 / 043636, entitled “PROSTHETICHEAR VALVE DEVICES AND ASSOCIATED SYSTEMS AND METHODS,” filed on June 21, 2012; (2) U.S. Provisional Patent Application No. 61 / 549,037, entitled “SYSTEM FOR MITRAL VALVE REPLACEMENT,” filed on October 19, 2011; and (3) International PCT Patent Application No. WO2013 / 059743 (Attorney Docket No. 82829-8005WO00), entitled “Devices, SYSTEMs and methods for heart valve REPLACEMENT,” filed on October 19, 2012. Technical Field

[0004] The present technology generally relates to prosthetic heart valve devices. In particular, several embodiments relate to prosthetic mitral valves and devices and related systems and methods for percutaneous repair and / or replacement of native mitral valves. Background Art

[0005] Diseases that affect the normal function of the mitral valve include, for example, mitral regurgitation, mitral valve prolapse, and mitral stenosis. Mitral regurgitation is a heart disease in which the leaflets of the mitral valve fail to close into coaptation at peak systolic pressure, resulting in abnormal leakage of blood from the left ventricle into the left atrium. There are many structural factors that may affect the proper closure of the mitral valve. For example, many patients with heart disease experience dilation of the myocardium, resulting in an enlarged mitral valve annulus. The expansion of the mitral valve annulus makes it difficult for the leaflets to close during systole. Stretching or tearing in the chordae tendineae (the tendons that connect the papillary muscles to the inside of the mitral valve leaflets) may also affect the proper closure of the mitral valve annulus. For example, ruptured chordae tendineae may cause the leaflets to prolapse into the left atrium due to insufficient tension on the leaflets. Abnormal regurgitation may also occur when the function of the papillary muscles is impaired, for example, due to ischemia. As the left ventricle contracts during systole, the affected papillary muscles do not contract sufficiently to achieve proper closure.

[0006] Mitral valve prolapse, or when the mitral valve leaflets bulge abnormally into the left atrium, causes irregular behavior of the mitral valve and may also lead to mitral regurgitation. The proper functioning of the mitral valve may also be affected by mitral stenosis, or narrowing of the mitral valve orifice, which causes obstruction to the filling of the left ventricle during diastole.

[0007] Generally speaking, treatment of mitral regurgitation involves the use of diuretics and / or vasodilators to reduce the amount of blood flowing back into the left atrium. Other approaches have involved (open and endovascular) surgical solutions for repairing or replacing the valve. For example, common repair methods involve tightening or resecting a portion of the dilated valve ring.

[0008] Annular tightening has been accomplished by implanting an annular ring or peri-annular ring that is typically secured to the annulus or surrounding tissue. Other repair procedures also involve suturing or trimming the leaflets into partial apposition to one another.

[0009] Alternatively, more invasive procedures involve replacing the entire valve itself, where a mechanical valve or biological tissue is implanted in the heart in place of the mitral valve. These invasive procedures are routinely performed through a large open chest surgery and are therefore very painful, have significant morbidity, and require a lengthy recovery period.

[0010] However, with many repair and replacement procedures, device durability or incorrect sizing of the annuloplasty ring or replacement valve can cause additional problems for the patient. In addition, many repair procedures are highly dependent on the skill of the cardiac surgeon, where poor or inaccurately placed sutures may affect the success of the procedure.

[0011] Less invasive methods for aortic valve replacement have been developed in recent years. Examples of preassembled percutaneous prosthetic valves include, for example, the CoreValve from Medtronic / Corevalve Inc. system (Irvine, CA, USA) and Edwards- Valve. Both valve systems include an expandable frame that accommodates a tri-leaflet bioprosthetic valve. The frame expands to fit the substantially symmetrical circular and rigid aortic valve annulus. This creates an expandable frame in a delivery configuration (symmetrical circular shape) at the aortic valve annulus that is suitable for supporting a tri-leaflet prosthetic valve (which requires such symmetry so that the prosthetic valve leaflets close correctly). Therefore, since the aortic valve anatomy is substantially uniform, symmetrical and fairly rigid, the aortic valve anatomy is suitable for accommodating an expandable frame for a replacement valve.

[0012] Compared to aortic valve replacement, mitral valve replacement presents unique anatomical obstacles, making percutaneous mitral valve replacement significantly more challenging than aortic valve replacement. First, unlike the relatively symmetrical and uniform aortic valve, the mitral valve annulus has a non-circular D-shape or kidney-like shape, and the non-planar saddle-like geometry often lacks symmetry. This unpredictability makes it difficult to design a mitral valve prosthesis with the ability to fit the mitral valve annulus. The lack of a snug fit between the prosthesis and the native leaflets and / or valve annulus may leave gaps therein, resulting in blood backflow through these gaps. For example, the placement of a cylindrical valve prosthesis may leave gaps in the commissure areas of the native valve, potentially leading to paravalvular leakage in these areas.

[0013] Current artificial valves developed for percutaneous aortic valve replacement are not suitable for modification for mitral valve. First, many of these devices require direct structural connection between the device structure that contacts the valve ring and / or leaflets and the device structure that supports the artificial valve. In several devices, the same stent column that supports the artificial valve also contacts the valve ring or other surrounding tissues, thereby directly transferring many twisting forces generated by tissue and blood to the device as the heart contracts during each cardiac cycle. Most heart replacement devices further utilize a tri-leaflet valve, which requires a substantially symmetrical cylindrical support around the artificial valve for the three leaflets to open and close correctly within the life span. If these devices are subjected to movement and force from the valve ring and other surrounding tissues, the prosthesis may be compressed and / or twisted, causing abnormal function of the prosthetic valve leaflets. In addition, the common diseased mitral valve ring is much larger than any available artificial valve.

[0014] In addition to its irregular, unpredictable shape, the mitral valve annulus lacks a significant amount of radial support from surrounding tissue. For example, the aortic valve is completely surrounded by fibroelastic tissue, which helps to secure the prosthetic valve by providing natural structural support. The mitral valve, on the other hand, is bounded only by muscle tissue on the outer wall. The inner wall of the mitral valve is bounded by a thin vessel wall that separates the mitral valve annulus from the intrinsic portion of the aortic outflow tract. Therefore, significant radial forces on the mitral valve annulus, such as those imparted by an expandable stent prosthesis, may cause the intrinsic portion of the aortic outflow tract to collapse, with potentially fatal consequences.

[0015] The chordae tendineae of the left ventricle may also present an obstacle when deploying a mitral valve prosthesis. This is unique to the mitral valve, as the aortic valve anatomy does not contain chordae tendineae. The complex chordae tendineae in the left ventricle make navigation and positioning of the deployment catheter much more difficult during mitral valve replacement and repair. Deployment and positioning of a prosthetic valve or anchoring device on the ventricular side of the native mitral valve is further complicated by the presence of the chordae tendineae.

[0016] In view of the challenges associated with current methods, there remains a need for simple, effective, and less invasive devices and methods for treating dysfunctional heart valves. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Many aspects of the present disclosure may be better understood with reference to the following drawings. The components in the drawings are not necessarily to scale. Instead, emphasis is placed on clearly illustrating the principles of the present disclosure. In addition, components may be shown as transparent only for illustration clarity and are not intended to indicate that the components shown are necessarily transparent.

[0018] Figure 1 and Figure 2 is a schematic diagram of a mammalian heart having a native valve structure suitable for replacement with a variety of prosthetic heart valve devices in accordance with embodiments of the present technology.

[0019] Figure 3 is a schematic cross-sectional side view of a native mitral valve showing the annulus and leaflets.

[0020] Figure 4A Schematic diagram of the left ventricle of a heart having: i) prolapsed leaflets in the mitral valve, or ii) mitral regurgitation in the left ventricle of a heart with damaged papillary muscles, and suitable for combination with various artificial heart valve devices in accordance with embodiments of the present technology.

[0021] Figure 4B Schematic diagram of a heart in a cardiomyopathy patient and suitable for combination with various prosthetic heart valve devices in accordance with embodiments of the present technology.

[0022] Figure 5A is a schematic diagram of the native mitral valve of the heart showing the native mitral valve leaflets closed normally.

[0023] Figure 5B is a schematic diagram of a native mitral valve of the heart showing abnormal closure of the native mitral valve leaflets in a dilated heart and suitable for combination with a variety of artificial heart valve devices according to embodiments of the present technology.

[0024] Figure 5C is a schematic diagram of a mitral valve of the heart showing the dimensions of the valve annulus and being suitable for combination with various artificial heart valve devices according to embodiments of the present technology.

[0025] Fig. 6A is a schematic cross-sectional illustration of a heart showing an antegrade approach from the venous vasculature to the native mitral valve in accordance with various embodiments of the present technology.

[0026] Figure 6B is a schematic cross-sectional view of a heart showing a passage through the interatrial septum (IAS) maintained by placement of a guide catheter over a guidewire in accordance with various embodiments of the present technology.

[0027] Figure 7 and Figure 8 is a schematic cross-sectional illustration of a heart showing a retrograde approach through the aortic valve and arterial vasculature to the native mitral valve in accordance with various embodiments of the present technology.

[0028] Fig. 9 is a schematic cross-sectional illustration of a heart showing access to the native mitral valve using a transapical puncture in accordance with various embodiments of the present technology.

[0029] Fig. 10A An isometric view of an artificial heart valve device according to an embodiment of the present technology is shown.

[0030] Fig. 10B A cross-sectional view of a heart is shown showing a device implanted in a native mitral valve according to an embodiment of the present technology. Fig. 10A prosthetic treatment device.

[0031] Figures 10C-10F They are respectively a side view, a perspective cross-sectional view, a top view and a bottom view of an artificial heart valve device according to an embodiment of the present technology.

[0032] Fig.11A is a side view of a valve support in an expanded configuration in accordance with an embodiment of the present technology.

[0033] Figures 11B-11D is an isometric view of another embodiment of a valve support having a prosthetic valve installed therein in accordance with the present technology.

[0034] Fig.11E An isometric view of an artificial heart valve device according to another embodiment of the present technology is shown.

[0035] Figures 12A-12C is a side view of various longitudinal ribs flexing in response to twisting forces according to other embodiments of the present technology.

[0036] Fig.13A is a schematic cross-sectional view of an artificial heart valve device according to another embodiment of the present technology.

[0037] Figures 13B-13F It is a partial side view of an artificial heart valve device illustrating various longitudinal rib configurations according to another embodiment of the present technology.

[0038] Fig.14A is a schematic top view of a native mitral valve illustrating the major and minor axes.

[0039] Figures 14B-14C are schematic top views of an anchoring member in an expanded configuration and in a deployed configuration, respectively, according to an embodiment of the present technology.

[0040] Fig.15 is an isometric view of an artificial heart valve device in an expanded configuration according to another embodiment of the present technology.

[0041] Fig.16A is a top view of an artificial heart valve device in an expanded configuration according to yet another embodiment of the present technology.

[0042] Figures 16B-16C They are Fig.16A First and second side views of a prosthetic heart valve device.

[0043] Fig.16D is a side view of a prosthetic heart valve device showing a longitudinal axis of an anchoring member offset at an oblique angle from a longitudinal axis of a valve support according to another embodiment of the present technology.

[0044] Fig.16E is a schematic top view of a native mitral valve in a heart, the top view being viewed from the left atrium and showing a device implanted at the native mitral valve according to an embodiment of the present technology Figures 16A-16C prosthetic treatment device.

[0045] Figures 17A-17C yes Fig.16A Schematic top view and first and second side views of a prosthetic heart valve device showing the scale and taper angles of various aspects of the device according to an embodiment of the present technology.

[0046] Fig.18 is an isometric view of an anchoring member shown in an expanded configuration according to yet another embodiment of the present technology.

[0047] Figures 19A-19C3 and 4, respectively, are an isometric view, a side view, and a top view of an artificial heart valve device with a sealing member according to another embodiment of the present technology.

[0048] Fig. 20A is an isometric view of an artificial heart valve device without a sealing member in accordance with an embodiment of the present technology.

[0049] Figures 20B-20E is an isometric view of an artificial heart valve device with a sealing member according to another embodiment of the present technology.

[0050] Figures 21A-21B Detailed description of the invention is provided herein and isometrically and cross-sectionally depicts a prosthetic heart valve device having a tubular valve support member according to yet another embodiment of the present technology.

[0051] Figures 21C-21F Partial cross-sectional side and isometric views of an artificial heart valve device with a tubular valve support member according to other embodiments of the present technology.

[0052] Figures 22A-22G and 22I-22K are enlarged side views of various mechanisms for connecting a valve support to an anchoring member according to additional embodiments of the present technology.

[0053] Fig.22H yes Figure 40G Side view of a post in a prosthetic heart valve device.

[0054] Figures 23A-23B is an enlarged side view of an additional mechanism for connecting an anchoring member to a valve support member according to other embodiments of the present technology.

[0055] Fig.24A is a perspective view of an integral connection between a valve support and an anchoring member according to another embodiment of the present technology.

[0056] Figures 24B-24D is an enlarged view of another embodiment of an integral connection between a valve support and an anchoring member in accordance with the present technology.

[0057] Fig.25A is a partial cross-sectional view of an artificial heart valve device having an anchoring member and a valve support according to an embodiment of the present technology.

[0058] Fig.25B is an enlarged view of the naming box shown in Figure 25A.

[0059] Figures 26A-26D is a schematic cross-sectional view of an artificial heart valve device according to various embodiments of the present technology, wherein the artificial heart valve device has an atrial retainer and is implanted in a native mitral valve.

[0060] Fig. 27 is a side view of an anchoring member according to another embodiment of the present technology, the anchoring member having a vertical portion at the upstream end for engaging the valve annulus.

[0061] Fig.28 is a side view of a prosthetic heart valve device in accordance with an embodiment of the present technology, the prosthetic heart valve device being in an expanded configuration and having multiple stabilizing components.

[0062] Fig.29 is a schematic enlarged side view of an artificial heart valve device according to an embodiment of the present technology, which has an extended arm.

[0063] Figures 30A-30C is an enlarged partial side view of a prosthetic heart valve device according to other embodiments of the present technology, the prosthetic heart valve device having arms connected to the device at various angles relative to the longitudinal axis of the device.

[0064] Figures 31A-31C is a partially enlarged side view of an artificial heart valve device according to another embodiment of the present technology, the artificial heart valve device having arms of various lengths connected to the device.

[0065] Fig.32A , 32B , 32C and 32D are cross-sectional views of a heart implanted with an artificial heart valve device according to various embodiments of the present technology, the artificial heart valve device having arms positioned on the inward surfaces of the leaflets.

[0066] Figure 32A-1 , 32B-1, 32C-1 and 32D-1 are respectively shown in various embodiments according to the present technology. Fig.32A , 32B , 32C and 32D are enlarged views of the arms shown which engage the inward surfaces of the leaflets.

[0067] Figures 33A-33C are schematic diagrams illustrating various embodiments of tissue engaging members for use with prosthetic heart valve devices in accordance with the present technology.

[0068] Fig.34A , 34B 34C is a cross-sectional view of a heart implanted with a prosthetic heart valve device according to various embodiments of the present technology having arms with tissue engaging members positioned on the inward surfaces of the leaflets.

[0069] Figure 34A-1 , 34B-1 and 34C-1 are enlarged views of the arms shown in 34A, 34B and 34C, respectively, which engage the inward surface of the leaflet according to various embodiments of the present technology.

[0070] Figures 35A-35C is a side view of an artificial heart valve device implanted at the mitral valve (shown in cross-section) in accordance with other embodiments of the present technology, these devices having arms for engaging the outward surfaces of the native leaflets.

[0071] Figure 35C-1 According to various embodiments of the present technology, Fig.35C An enlarged view of the arms shown in , the arms engage the inward-facing surfaces of the leaflets.

[0072] Fig.36A is a side view of an artificial heart valve device according to another embodiment of the present technology and is implanted at the mitral valve (shown in cross-section), the device having arms for engaging the outward surfaces of the natural leaflets and arms for engaging the inward surfaces of the natural leaflets.

[0073] Fig.36B Yes Fig.36A An enlarged view of the arms shown in , which engage the inward and outward surfaces of the leaflets.

[0074] Figures 37A-37D is an enlarged side view of additional embodiments of arms suitable for use with prosthetic heart valve devices according to the present technology.

[0075] Fig.38A is a side view of an artificial heart valve device having multiple non-interconnected arms according to another embodiment of the present technology.

[0076] Fig.38B is a side view of an artificial heart valve device with multiple circumferential connecting arms according to another embodiment of the present technology.

[0077] Figures 39A-39D is a schematic top view of an arm position pattern according to another embodiment of the present technology.

[0078] Figures 40A-40D is a side view of an artificial heart valve device according to another embodiment of the present technology, which has tissue engaging components on different structures of the device.

[0079] Figures 40E-40G is an enlarged side view of tissue engaging components according to other embodiments of the present technology, which are suitable for use with prosthetic heart valve devices.

[0080] Figures 40H-40S is an enlarged side view of tissue engaging components according to additional embodiments of the present technology, which are suitable for use with prosthetic heart valve devices.

[0081] Fig.41is an isometric view of an artificial heart valve device according to another embodiment of the present technology, the artificial heart valve device having multiple valve ring coupling components.

[0082] Figures 42A-42B is a cross-sectional side view and an enlarged view of a prosthetic heart valve device according to another embodiment of the present technology, the prosthetic heart valve device having a tissue engaging member deployable from a plurality of tubular ribs.

[0083] Figures 43A-43B is an isometric view and enlarged detail view of a prosthetic heart valve device according to another embodiment of the present technology, the prosthetic heart valve device having a sealing member configured with a tissue engaging component.

[0084] Figures 44A-44F is an enlarged side view of tissue engaging components according to additional embodiments of the present technology, which are suitable for use with prosthetic heart valve devices.

[0085] Fig.45A is an isometric view of a prosthetic heart valve device having a plurality of tethers between an anchoring member 110 and a valve support 120 in accordance with an embodiment of the present technology.

[0086] Fig.45B is an isometric view of a prosthetic heart valve device having multiple septa between an anchoring member 110 and a valve support 120 in accordance with another embodiment of the present technology.

[0087] Fig.46A is a side partial cross-sectional view of a delivery system according to an embodiment of the present technology.

[0088] Fig.46B is an enlarged cross-sectional view of the distal end of a delivery system according to an embodiment of the present technology.

[0089] Figures 46C-46D is an enlarged partial side view of a valve support according to an embodiment of the present technology, wherein the valve support is configured to Fig.46B delivery system.

[0090] Figures 47A-47D is a cross-sectional view of the heart showing an antegrade or transseptal approach to the mitral valve in accordance with an embodiment of the present technology.

[0091] Figures 48A-48C is a cross-sectional view of the heart illustrating a method of implanting a prosthetic heart valve device using a transseptal approach according to another embodiment of the present technology.

[0092] Figures 49A-49Bis a cross-sectional view of the heart showing a retrograde approach to the mitral valve through the aorta and left ventricle according to yet another embodiment of the present technology.

[0093] Figures 50A-50B is a cross-sectional view of the heart illustrating yet another embodiment of a method of implanting a prosthetic heart valve device using a transapical approach according to aspects of the present technology.

[0094] Figures 51A-51B is a partial side view of a delivery system according to another embodiment of the present technology, wherein a prosthetic heart valve device is mounted on an expandable balloon of a delivery catheter.

[0095] Figures 52A-52D is a cross-sectional view of the heart showing a method of delivering a prosthetic heart valve device having a valve support movably connected to an anchoring member according to another embodiment of the present technology.

[0096] Figures 53A-53D is a partial side view showing various mechanisms for movably connecting a valve support to an anchoring member in accordance with additional embodiments of the present technology.

[0097] Fig.53E yes Fig.53D A partial top view of the device.

[0098] Fig.53F is a side view of an alternative mechanism for slidably connecting a valve support and an anchoring member in accordance with another embodiment of the present technology.

[0099] Figures 53G-53H is a schematic side view of a prosthetic heart valve device according to another embodiment of the present technology, which shows another mechanism for connecting a valve support to an anchoring member.

[0100] Fig.54A is a cross-sectional side view of another embodiment of a delivery system for a prosthetic heart valve device in accordance with other aspects of the present technology.

[0101] Fig.54B yes Fig.54A A partial cross-sectional side view of the distal portion of the delivery system.

[0102] Figures 55A-55C is a perspective view of the delivery system of Figure 46, which illustrates the steps of delivering the present prosthetic therapeutic device.

[0103] Fig.56 is a side cross-sectional view of yet another embodiment of a delivery system for the present prosthetic therapeutic device.

[0104] Figures 57A-57Dis an isometric view of a prosthetic therapeutic device according to another embodiment of the present technology.

[0105] Fig.57E According to an embodiment of the present technology Fig.57A Schematic cross-sectional view of a prosthetic heart valve device implanted in a native mitral valve.

[0106] Figures 58A-58D is a cross-sectional view of the heart showing a method of delivering a prosthetic heart valve device to a native mitral valve in the heart using a transapical approach in accordance with another embodiment of the present technology.

[0107] Figures 59A-59C is an isometric view of a prosthetic therapeutic device according to another embodiment of the present technology.

[0108] Fig.59D is a schematic cross-sectional view of an artificial heart valve device implanted in a native mitral valve according to another embodiment of the present technology.

[0109] Figures 60A-60B is a cross-sectional side view of the distal end of a delivery catheter according to another embodiment of the present technology, the delivery catheter being used to deliver Fig.59C The artificial heart valve is attached to the natural mitral valve in the heart.

[0110] Fig.61 is a side view of an artificial heart valve device according to another embodiment of the present technology, the artificial heart valve device having first and second anchoring members for engaging supra-annular tissue and sub-annular tissue of a mitral valve, respectively.

[0111] Figures 62A-62C is a partial cross-sectional side view of the distal end of a delivery system according to another embodiment of the present technology, showing delivery at the mitral valve Fig.61 Prosthetic heart valve device.

[0112] Fig.63 is an isometric side view of a prosthetic heart valve device according to another embodiment of the present technology, the prosthetic heart valve device having an anchoring member with a supra-annular engagement flange and a sub-annular engagement ring.

[0113] Figures 64A-64D yes Fig.63 A side view of a prosthetic heart valve device showing an embodiment of a method of deploying the device at the mitral valve annulus according to aspects of the present technology.

[0114] Fig.65A is a cross-sectional view of a prosthetic heart valve device according to another embodiment of the present disclosure having an expandable anchoring member and shown implanted in a native mitral valve of a heart.

[0115] Fig.65B is a partial cross-sectional side view of the distal end of a delivery system according to another embodiment of the present technology, the delivery system being suitable for delivering Fig.65A Prosthetic heart valve device.

[0116] Figures 66A-66D is a cross-sectional view of an artificial heart valve device according to another embodiment of the present technology, which has an inflatable chamber.

[0117] Figures 67A-67B is an isometric view of an additional embodiment of a prosthetic heart valve device in accordance with aspects of the present technology.

[0118] Figures 68A-68B is a side view of an artificial heart valve device according to another embodiment of the present technology, the artificial heart valve device having a positioning component.

[0119] Figures 69A-69E are cross-sectional and side views of prosthetic heart valve devices shown in an expanded configuration and configured in accordance with additional embodiments of the present technology.

[0120] Fig.70 is a cross-sectional side view of another artificial heart valve device configured in accordance with an embodiment of the present technology.

[0121] Fig.71 is a cross-sectional side view of yet another artificial heart valve device configured in accordance with an embodiment of the present technology. DETAILED DESCRIPTION OF THE INVENTION

[0122] References below Figure 1-71 Specific details of several embodiments of the technology are described. Although many embodiments are described below with respect to devices, systems, and methods for percutaneously replacing a native mitral valve using an artificial valve device, other applications and other embodiments in addition to those described herein are also within the scope of the technology. In addition, several other embodiments of the technology can have different configurations, components, or procedures than those described herein. Therefore, those skilled in the art will therefore understand that the technology can have other embodiments that employ additional components, or that the technology can be used without the components described below. Figure 1-71 While several of the features shown and described, there are other embodiments.

[0123] Unless otherwise specified, with respect to the terms "distal end" and "proximal end" within this specification, these terms may refer to the relative positions of multiple parts of an artificial valve device and / or a related delivery device relative to an operator and / or a position in the vascular system or heart. For example, when referring to a delivery catheter suitable for delivering and positioning various artificial valve devices described herein, "proximal end" may refer to a position closer to the device operator or a vascular system incision, and "distal end" may refer to a position farther from the device operator or farther from the incision along the vascular system (e.g., the end of the catheter). Relative to an artificial heart valve device, the terms "proximal end" and "distal end" may refer to the positions of multiple parts of the device relative to the direction of blood flow. For example, the proximal end may refer to an upstream position or a blood inflow position, and the distal end may refer to a downstream position or a blood outflow position. For ease of reference, throughout the disclosure, the same indicator and / or letter are used to determine similar or similar components or features, but the use of the same indicator does not imply that the part should be interpreted as being the same. In fact, in many examples described herein, parts with the same number are different in structure and / or function. The headings provided herein are for convenience only.

[0124] Overview

[0125] Provided herein are systems, devices, and methods for percutaneously replacing natural heart valves such as the mitral valve. Several details described below are provided to describe the following examples and methods in a manner sufficient to enable those skilled in the relevant art to implement, manufacture, and use them. However, several details and advantages described below may not be necessary to implement certain examples and methods of the present technology. In addition, the present technology may include other examples and methods that are within the scope of the claims but are not described in detail.

[0126] Embodiments of the present technology provide systems, methods and devices for treating body valves such as heart valves (including the mitral valve). These devices and methods make it possible to use a percutaneous method using a catheter, wherein the catheter is delivered to the heart intravascularly via a vein or artery. In addition, these devices and methods make it possible to use other less invasive methods, including transapical, transatrial and direct aortic delivery of a prosthetic replacement valve device to a target position in the heart. These devices and methods make it possible for a prosthetic device to be anchored at a natural valve position by engaging with the subannular surface of the valve annulus and / or leaflets. In addition, embodiments of the devices and methods as described herein can be combined with many known surgical techniques and procedures, such as known methods of reaching a heart valve (e.g., a mitral valve or a tricuspid valve) using antegrade or retrograde approaches and combinations thereof.

[0127] The devices and methods described herein provide a valve replacement device having flexibility that adapts to and conforms to the various shapes of natural mitral valve anatomy while mechanically separating the artificial valve from the anchoring portion of the device. Several embodiments of the device effectively absorb the twisting forces imposed by the natural anatomy. The device has the structural strength and integrity necessary to withstand the dynamic conditions of the heart over time, thereby firmly anchoring the replacement valve and making it possible for the patient to live a substantially normal life. These devices and methods further deliver such devices in a less invasive manner, providing not only a new permanent replacement valve for the patient, but also a lower risk surgery and faster recovery.

[0128] According to various embodiments of the present technology, a device for repairing or replacing a natural heart valve is disclosed. The natural valve has a valve ring and a valve leaflet, and the device includes an anchoring member having a first portion, the first portion being configured to engage tissue on or below the valve ring and deforming in a non-circular shape to fit the tissue. The anchoring member may also include a second portion. The device also includes a valve support that is connected to the second portion of the anchoring member and is configured to support an artificial valve and has a cross-sectional shape. In various embodiments, the first portion of the anchoring member is mechanically isolated from the valve support so that the cross-sectional shape of the valve support remains sufficiently stable so that the artificial valve remains effective when the anchoring member is deformed in a non-circular shape.

[0129] Some embodiments of the present disclosure relate to an artificial heart valve device for implantation at a natural mitral valve, wherein the mitral valve has a valve annulus and leaflets. In one embodiment, the device can have an anchoring member positionable in a position between the leaflets, wherein a first portion of the anchoring member can expand to a larger dimension than a corresponding dimension of the valve annulus. In this embodiment, upward movement of the anchoring member is blocked by engagement of the upstream portion with tissue on or near the valve annulus. The anchoring member can also include a second portion. The device can also include a valve support connected to the second portion of the anchoring member, wherein an upstream region of the valve support is radially inwardly separated from at least the first portion of the anchoring member. The valve support can be configured to support an artificial valve.

[0130] In another arrangement, a device for implantation at a native valve having a valve ring and leaflets may include a hyperbolic anchoring member having an upstream end and a downstream end, the upstream end being configured to engage an inwardly facing surface of a leaflet downstream of the valve ring, wherein the upstream end has a larger cross-sectional area than the downstream end. The device may also include a valve support positioned in the anchoring member and configured to support an artificial valve. The valve support is connected to the anchoring member at a position substantially spaced downstream from the upstream end and is not connected to the anchoring member at the upstream end.

[0131] Other aspects of the present disclosure relate to an artificial heart valve device for repairing or replacing a patient's natural heart valve, wherein the heart valve has a valve ring and leaflets. In one embodiment, the device includes an anchoring member having a first portion and a second portion, the first portion having a first cross-sectional dimension, and the second portion having a second cross-sectional dimension that is smaller than the first cross-sectional dimension. The first portion is configured to engage cardiac tissue to maintain the anchoring member in a fixed longitudinal position relative to the valve ring. The device may also include a valve support connected to the second portion of the anchoring member and configured to support an artificial valve. The valve support can be radially separated from the first portion of the anchoring member so that the first portion can be deformed inwardly without substantially deforming the valve support.

[0132] In yet another arrangement, the present disclosure also relates to a device implanted at a native heart valve. The device may include an anchoring member having an upstream end configured to engage tissue on or downstream of the native valve ring of the heart valve and a valve support configured to support an artificial valve. The valve support may be connected to the anchoring member. In some arrangements, the anchoring member may resist upward migration of the device without extending components of the device behind the native valve leaflets.

[0133] In another embodiment, the device may include an anchoring member positionable between leaflets of a native valve. The anchoring member may have a plurality of tissue engaging components on an upstream end and / or on an outer surface that are configured to engage cardiac tissue on or near the valve annulus to prevent migration of the device in an upstream direction. The device may also include a valve support positioned within the anchoring member and connected to a downstream portion of the anchoring member, wherein the valve support is radially separated from at least the upstream portion of the anchoring member.

[0134] Other embodiments of the present disclosure relate to a device for repairing or replacing a natural mitral valve having a valve ring and a pair of leaflets, the device comprising a support structure having an upper region, a lower region, and an interior for holding an artificial valve. The device may also include an anchoring member surrounding at least a portion of the support structure, wherein the anchoring member may be positioned between the leaflets and has a plurality of flexible components (e.g., metal wires, laser-cut metal components, etc.) arranged in a diamond pattern, an upper portion, and a lower portion. The upper portion of the anchoring member may be deployed outwardly in a proximal direction so that the proximal ends of the flexible components point radially outwardly, thereby engaging cardiac tissue on or near the valve ring and inhibiting the device from migrating in an upstream direction. The lower region of the support structure may be connected to the lower portion of the anchoring member, and the lower region of the support structure may be mechanically isolated from deformation of at least the deployed upper portion of the anchoring member.

[0135] Other embodiments of the present disclosure relate to an artificial heart valve device having a cylindrical support member and an anchor member defined by a structure independent of the cylindrical support member. The cylindrical support member can have a longitudinal axis and an interior along the longitudinal axis through which blood can flow. The anchor member can have a non-circular cross-section, with the outwardly flared upstream end configured to engage tissue below the annulus of the mitral valve. The anchor member can also surround the cylindrical support member and be connected to the support member at a downstream end opposite the upstream end.

[0136] In yet another embodiment, the device may include an expandable valve support configured to be placed between two leaflets. The support may have a first area, a second area, and an interior in which a valve may be connected. The device may also include an anchoring member having a first portion and a second portion, the second portion being connected to the second area of ​​the valve support. The first portion of the anchoring member may extend outwardly away from the second portion. The anchoring member may have a first circumference at the first portion, the first circumference being configured to engage tissue on or near the valve annulus. The anchoring member may be mechanically isolated from the valve support so that forces radially emitted at or near the first circumference will not substantially change the shape of the valve support.

[0137] Additional embodiments relate to a device for treating a patient's heart valve, the device comprising an inner frame and an outer frame connected to the inner frame. The inner frame may have an outer surface and an inner surface configured to support an artificial valve. The outer frame may have an upper portion having a cross-sectional dimension larger than a corresponding cross-sectional dimension of a mitral valve annulus, wherein the upper portion is configured to engage tissue at or below the valve annulus of the mitral valve. The upper portion may also prevent the device from migrating in an upward or upstream direction during ventricular systole. In addition, the upper portion of the outer frame may be mechanically isolated from the inner frame.

[0138] In yet another embodiment, the device may include a cylindrical inner skeleton and an outer skeleton connected to the inner skeleton and positionable between the leaflets downstream of the valve annulus. The outer skeleton can be deformed into a non-circular cross-section while the inner skeleton remains substantially circular in cross-section. The inner skeleton can have an interior to which an artificial valve can be connected. The outer skeleton can have a plurality of flexible components (e.g., metal wires, laser-cut metal components, etc.), wherein at least a portion of these flexible components can be configured to engage natural tissue below the valve annulus, thereby preventing the device from migrating in an upstream direction. In one embodiment, a plurality of flexible metal wires are arranged in a diamond configuration.

[0139] In yet another embodiment, an artificial mitral valve device may include a valve support having an upstream end and a downstream end, an interior of the valve in which the valve can be connected, and a circumference. The device may also include an anchoring member having an expanded upstream portion and a downstream portion connected to the circumference of the valve support. The upstream portion can be mechanically isolated from the valve support and can be configured to engage the subannular tissue of the natural mitral valve. Additionally, the device may be variable to a plurality of configurations, including a first configuration in which the valve support and the anchoring member are radially contracted, and in which the valve support has a first cross-sectional shape. The device may also be variable to a second configuration in which the valve support and the anchoring member are radially expanded and in which the valve support has a second cross-sectional shape. Additionally, the device may be variable to a third configuration in which the anchoring member is coupled to the subannular tissue and deformed by it, while the valve support is still in the second cross-sectional shape.

[0140] In some embodiments, the device may include an atrial retainer extending from an anchoring member or a valve support to a position at least partially upstream of the native mitral valve annulus. The atrial extension member may include an atrial engagement structure adapted to engage an upstream surface of the valve annulus (e.g., a surface above the valve annulus) and / or an inner wall of the atrium to further stabilize or anchor the device. For example, the atrial retainer may block downward movement of the device.

[0141] Some embodiments of the device may also include one or more stabilizing members that inhibit tilting or lateral displacement of the device. These stabilizing members may include multiple arms extending radially outward from the valve support and / or anchoring member. These arms may be configured to extend behind the native leaflets and / or configured to engage the ventricular wall or papillary muscles.

[0142] According to another aspect of the present disclosure, yet another embodiment relates to a device implanted at a natural mitral valve, wherein the natural mitral valve has a valve ring and a valve leaflet. The device may include a valve support having an upstream end and a downstream end, wherein the interior of the valve can be connected, and an outer surface, and includes a first anchoring member having an expanded first upstream portion and a first downstream portion, wherein the first downstream portion is connected to the outer surface of the valve support. In other embodiments, the first downstream portion can be connected to the inner surface of the valve support, or in some embodiments, to the end of the valve support. The device may also include a second anchoring member at least partially surrounding the first anchoring member. The first upstream portion of the first anchoring member can be mechanically isolated from the valve support and configured to engage the tissue above the valve ring of the natural mitral valve. The second anchoring member can have an expanded second upstream portion and a second downstream portion connected to the outer surface of the valve support, wherein the second upstream portion can be mechanically isolated from the valve support and configured to engage the tissue below the valve ring of the natural mitral valve.

[0143] In yet another embodiment, the device for implantation may include a radially expandable anchoring member configured to engage native tissue on or downstream of the valve annulus. The anchoring member may have a first longitudinal length on the side facing the posterior leaflet and a second length on the side facing the anterior leaflet. In certain embodiments, the first length may be greater than the second length so that blockage of the left ventricular outflow tract (LVOT) is limited. The device may also include a valve support or alternatively an artificial valve connected to the interior of the anchoring member or to its end.

[0144] Other embodiments of the present technology provide a device for implantation at a natural mitral valve having a valve ring and leaflets, wherein the device includes a valve support having an upstream end and a downstream end, an interior of the valve to which it can be connected, and an exterior surface. The device may also include an anchoring member having an expanded upstream portion and a downstream portion connected to the exterior surface of the valve support, wherein the upstream portion may have an upper ring and a lower ring connected to the upper ring. The device may also include a plurality of flexible valve ring coupling components distributed around the circumference of the anchoring member and connecting the upper ring to the lower ring. The lower ring is configured to move toward the upper ring in an upstream direction to receive the valve ring between the upper ring and the lower ring and within the valve ring coupling component.

[0145] The present disclosure further provides systems for delivering artificial valves and other devices using intravascular or other minimally invasive access forms. For example, embodiments of the present technology provide a system for treating a patient's mitral valve, wherein the mitral valve has a valve annulus. The system includes a device for treating a mitral valve as described herein and a catheter having a lumen configured to retain the device inside the catheter.

[0146] In other aspects, a system for replacing a natural valve in a patient is provided. The system may include an extended catheter body having a distal end and a proximal end, and a housing connected to the distal end of the catheter body and having a closed end and an open end. The system may also include a plunger inside the housing, the plunger being movable axially relative to the housing, and an actuator, the actuator being at the proximal end of the catheter body and being connected to the plunger so as to move the actuator axially relative to the plunger to move the housing. The system may also include an artificial valve device having a collapsed configuration and an expanded configuration. The artificial valve device may be positionable in the housing in a collapsed configuration and may be releasable proximally from the housing by moving the actuator.

[0147] In yet another aspect, embodiments of the present invention provide a method for treating a patient's heart valve. The mitral valve has a valve annulus and leaflets connected to the valve annulus. The method may include implanting a device as described herein within or adjacent to the valve annulus. In some embodiments, the device may include a valve support connected to and at least partially surrounded by an anchoring member. The anchoring member may be positioned between the leaflets and the upstream portion of the anchoring member may be configured to engage tissue on or downstream of the valve annulus to prevent the device from migrating in an upstream direction. In addition, the valve support may be mechanically isolated from the anchoring member at least at the upstream portion.

[0148] In yet another aspect, an embodiment of the present technology provides a method for replacing a natural valve having a valve ring and leaflets. The method may include positioning a device as described herein between the leaflets while the device is in a collapsed configuration. The method may also include allowing a prosthetic device to expand so that an anchoring member of the prosthetic device is in a position below the valve ring, where it engages tissue on or downstream of the valve ring. The anchoring member may have a diameter larger than the corresponding diameter of the valve ring in a position below the valve ring. This method may further include allowing a valve support to expand inside the anchoring member, where the valve support is connected to the anchoring member. In various embodiments, the valve support may be mechanically isolated from the anchoring member so that deformation of the anchoring member when the anchoring member engages tissue does not substantially deform the valve support. In some arrangements, certain areas of the valve support may be deformed, but are suitable for maintaining the support area of ​​the artificial valve without substantial deformation, so that the closure of the leaflets of the artificial valve will not be impaired.

[0149] The devices and methods disclosed herein can be configured for treating valves of non-circular, asymmetrical shapes and bileaflet or bicuspid valves, such as the mitral valve. Many of the devices and methods disclosed herein can also provide long-term (e.g., permanent) and secure anchoring of prosthetic devices, even under conditions where the heart or native valves may experience progressive enlargement or distortion.

[0150] Heart and Mitral Valve Physiology

[0151] Figure 1 and 2 A normal heart H is shown. The heart comprises the left atrium, which receives oxygenated blood from the lungs via the pulmonary veins PV and pumps this oxygenated blood through the mitral valve MV into the left ventricle LV. Figure 2 , the left ventricle LV of a normal heart H during systole is shown. The left ventricle LV contracts and blood flows outward through the aortic valve AV in the direction of the arrow. Backflow or "regurgitation" of blood through the mitral valve MV is prevented by the mitral valve because the mitral valve is configured as a "one-way valve" that prevents backflow when the pressure in the left ventricle is higher than the pressure in the left atrium LA.

[0152] The mitral valve MV comprises a pair of leaflets having free edges FE that meet or "close" evenly to close, as Figure 2 The opposite ends of the leaflets LF are attached to the surrounding heart structures by means of a region of annular tissue called the annulus AN. Figure 3 is a schematic cross-sectional side view of the valve annulus and valve leaflets of the mitral valve. As shown, the opposite ends of the valve leaflets LF are attached to the surrounding heart structures by means of a fibrous ring of dense connective tissue (referred to as the valve annulus AN), which is distinguished from the valve leaflet tissue LF and the adjacent muscle tissue of the heart wall. The valve leaflets LF and the valve annulus AN are composed of different types of heart tissues, which have different strengths, toughness, fiber properties and flexibility. In addition, the mitral valve MV may also include a unique tissue region that interconnects each valve leaflet LF to the valve annulus AN, referred to herein as the valve leaflet / valve annulus connecting tissue LAC (indicated by overlapping cross-hatching). In general, the valve annulus tissue AN is tougher, more fibrous and stronger than the valve leaflet tissue LF.

[0153] Reference Figure 2 , the free edge FE of the mitral valve leaflet LF is fixed to the lower part of the left ventricle LV via chordae tendineae CT (hereinafter referred to as "chordae"), which consist of a plurality of branching tendons fixed on the lower half surface of each leaflet LF. The chordae tendineae CT in turn attach to the papillary muscles PM, which extend upward from the lower half wall of the left ventricle LV and the interventricular septum IVS.

[0154] Now refer to FIG. 4A to FIG. 4B Many structural defects in the heart can cause mitral regurgitation. Figure 4A As shown in , a ruptured chordae tendineae RCT can cause leaflet LF2 to prolapse due to insufficient tension being transmitted to the leaflet via the chordae tendineae. Although the other leaflet LF1 maintains a normal contour, the two leaflets do not meet properly and leakage from the left ventricle LV to the left atrium LA will occur, as shown by the arrow.

[0155] Regurgitation also occurs in patients with cardiomyopathy in which the heart is dilated and the increased size prevents the leaflets LF from properly meeting, as Figure 4B The enlargement of the heart causes the mitral valve annulus to become enlarged, making it impossible for the free edges FE to meet during systole. The free edges of the anterior and posterior leaflets normally extend along the Figure 5A The closure line C shown in FIG. 2 may merge, but in patients with cardiomyopathy, a significant gap G may be left, as shown in FIG. Figure 5B as shown in .

[0156] Mitral regurgitation can also occur in patients with pre-existing ischemic heart disease where the function of the papillary muscles PM is impaired, e.g. Figure 4A As the left ventricle LV contracts during systole, the papillary muscles PM do not contract sufficiently to achieve proper closure. One or both of the leaflets LF1 and LF2 then prolapse. Leakage occurs from the left ventricle LV to the left atrium LA.

[0157] Figures 5A-5C The shape and relative size of the leaflets L of the mitral valve are further shown. Figure 5C , it can be seen that the entire valve generally has a "D" shape or kidney-like shape with a major axis MVA1 and a minor axis MVA2. In healthy people, the major axis MVA1 generally has a length in the range of about 33.3 mm to about 42.5 mm (37.9+ / -4.6 mm), and the minor axis MVA2 has a length in the range of about 26.9 to about 38.1 mm (32.5+ / -5.6 mm). However, for patients with reduced cardiac function, these values ​​can be larger, for example, MVA1 can be in the range of about 45 mm to 55 mm and MVA2 can be in the range of about 35 mm to about 40 mm. The closure line C is curved or C-shaped, thereby defining a relatively large anterior leaflet AL and a substantially smaller posterior leaflet PL ( Figure 5A ). Both leaflets appear crescent-shaped when viewed from the superior or atrial side, with the anterior leaflet AL being substantially wider than the posterior leaflet in the middle of the valve. Figure 5A As shown in , at opposite ends of the closure line C, the leaflets unite at angles referred to as the anterolateral commissure AC and the posteromedial commissure PC, respectively.

[0158] Figure 5CThe shape and dimensions of the valve annulus of the mitral valve are shown. The valve annulus is an annular region surrounding the valve circumference, composed of fibrous tissue that is thicker and tougher than that of the leaflets LF and distinct from the muscular tissue of the ventricular and atrial walls. The valve annulus may comprise a saddle-like shape, with a first peak portion PP1 and a second peak portion PP2 present along an inter-peak axis IPD and a first valley portion VP1 and a second valley portion VP2 present along an inter-valley axis IVD. The first and second peak portions PP1 and PP2 are higher in altitude, typically about 8-19 mm higher in humans, relative to a plane containing the lowest points of the two valley portions VP1, VP2, thereby giving the valve an overall saddle-like shape. The distance between the first peak portion PP1 and the second peak portion PP2, called the inter-peak span IPD, is substantially shorter than the inter-valley span IVD, the distance between the first valley portion VP1 and the second valley portion VP2.

[0159] Those skilled in the art will recognize that the dimensions and physiology of a patient may vary from patient to patient, and while some patients may contain different physiologies, the teachings as described herein may be adapted for use by many patients with varying mitral valve pathologies, dimensions, and shapes. For example, work with respect to the embodiments has shown that some patients may have a long dimension across the annulus and a short dimension across the annulus without the peak and valley portions being well defined, and the methods and devices as described herein may be configured accordingly.

[0160] Access to the mitral valve

[0161] Access to the mitral valve or other atrioventricular valves can be achieved percutaneously through the patient's vascular system. Percutaneous means reaching a location in the vascular system distal to the heart through the skin, generally using a surgical incision or minimally invasive procedure, such as using needle access with, for example, the Seldinger technique. The ability to reach distant vascular systems percutaneously is well known and described in patent and medical literature. Depending on the point of vascular access, the approach to the mitral valve can be antegrade and can rely on entering the left atrium by crossing the atrial septum. Alternatively, the approach to the mitral valve can be retrograde, where the left ventricle is entered through the aortic valve. Once percutaneous access is achieved, the interventional tools and support catheters can be advanced intravascularly to the heart and placed adjacent to the target heart valve in a variety of ways, as described herein.

[0162] Using a transseptal approach, access is gained via the inferior vena cava IVC or superior vena cava SVC, through the right atrium RA, across the interatrial septum IAS, and into the left atrium LA above the mitral valve MV.

[0163] like Fig. 6AAs shown in , a catheter 1 with a needle 2 can be advanced from the inferior vena cava IVC into the right atrium RA. Once the catheter 1 reaches the anterior side of the atrial septum IAS, the needle 2 can be advanced so that it penetrates the atrial septum, for example at the fossa ovalis FO or foramen ovale, into the left atrium LA. At this point, the guidewire can be exchanged for the needle 2 and the catheter 1 can be withdrawn.

[0164] like Figure 6B As shown in , access through the interatrial septum IAS can generally be maintained by placing a guide catheter 4 (generally over a guidewire 6 that has been positioned as described above). The guide catheter 4 provides subsequent access allowing the introduction of a device to replace the mitral valve, as described in more detail herein.

[0165] In an alternative antegrade approach (not shown), surgical access can be obtained through an intercostal incision, preferably without removing the ribs, and a small puncture or incision can be made in the left atrium wall. A guiding catheter can then be placed through this puncture or incision directly into the left atrium, sealed by a purse-string suture.

[0166] As described above, an antegrade or transseptal approach to the mitral valve can be advantageous in many ways. For example, the use of an antegrade approach will generally allow for more precise and effective centering and stabilization of the guide catheter and / or prosthetic valve device. Precise positioning facilitates accuracy in placement of the prosthetic valve device. An antegrade approach can also reduce the risk of damaging the subvalvular device during the introduction and manipulation of catheters and interventional tools. In addition, an antegrade approach can reduce the risks associated with traversing the aortic valve as in a retrograde approach. This can be particularly meaningful for patients with prosthetic aortic valves that cannot be traversed at all or cannot be traversed without substantial risk of damage.

[0167] Figure 7 and Figure 8 An example of a retrograde approach to the mitral valve is shown in . The mitral valve MV can be reached by an approach from the aortic arch AA, across the aortic valve AV and into the left ventricle LV below the mitral valve MV. The aortic arch AA can be reached via conventional femoral artery access routes as well as more direct approaches via the brachial artery, axillary artery, radial artery or carotid artery. Such access can be achieved using a guide wire 6. Once in place, a guide catheter 4 can be advanced along the guide wire 6. Alternatively, surgical access can be obtained by making an incision in the chest, preferably in an intercostal manner without removing the ribs, and placing a guide catheter through a puncture in the aorta itself. The guide catheter 4 provides subsequent access to allow placement of a prosthetic valve device, as described in more detail herein.

[0168] In some specific cases, a retrograde arterial approach to the mitral valve may be chosen due to certain advantages. For example, use of a retrograde approach may eliminate the need for a transseptal puncture. The retrograde approach is also more commonly used by cardiologists and therefore has the advantage of familiarity.

[0169] Another approach to the mitral valve is via transapical puncture, such as Fig. 9 In this approach, access to the heart is gained via a thoracotomy, which may be a conventional open thoracotomy or a sternotomy, or via a smaller intercostal or subxiphoid incision or puncture. An access cannula is then placed through the puncture in the left ventricular wall at or near the apex of the heart and sealed with a purse-string suture. The catheter and prosthetic device of the present invention can then be introduced into the left ventricle through this access cannula.

[0170] The transapical approach has the following characteristics: It provides a shorter, straighter and more direct path to the mitral or aortic valve. In addition, because it does not involve intravascular access, the transapical procedure can be performed by surgeons who may not have the necessary training in interventional cardiology to perform the catheterization required in other percutaneous approaches.

[0171] The prosthetic treatment device may be designed specifically for this approach or may be interchangeable between multiple approaches. Based on the embodiments described herein, one skilled in the art may determine the appropriate approach for an individual patient and design a treatment device for the determined approach.

[0172] Orientation and guidance of the artificial valve device can be combined with many known catheters, tools and devices. Such orientation can be achieved by generally guiding the device to the desired position and then finely guiding the device components to achieve the desired result.

[0173] Gross steering can be achieved by many methods. A steerable guidewire can be used to direct the guide catheter and prosthetic treatment device into the correct position. The guide catheter can be introduced into the femoral artery in the patient's groin, for example, using a surgical incision or Seldinger approach. After the guidewire is placed, the guide catheter can be introduced into the desired position with the help of the guidewire. Alternatively, a shorter and differently shaped guide catheter can be introduced via the other approaches described above.

[0174] The guide catheter may be pre-shaped to provide a desired orientation relative to the mitral valve. For access via a transseptal approach, the guide catheter may have a bend, angle, or other suitable shape at its tip so that the distal end is oriented toward the mitral valve from the septal puncture site through which the guide catheter extends. For a retrograde approach, such as Figure 7 and Figure 8As shown in , the guide catheter 4 may have a preformed J-tip that is configured so that after it is placed on the aortic arch AA and through the aortic valve AV, it turns toward the mitral valve MV. Figure 7 As shown in , the guide catheter 4 can be configured to extend downward into the left ventricle LV and to adopt a J-shaped configuration so that the orientation of the interventional tool or catheter is more closely aligned with the axis of the mitral valve MV. In either case, the preformed guide catheter can be configured to be straightened for intravascular delivery with the aid of a guide needle or a hard guide wire, which passes through the lumen of the guide catheter. The guide catheter may also have a pull wire or other means for adjusting its shape for more precise guidance adjustment.

[0175] Selected Embodiments of Prosthetic Heart Valve Devices and Methods

[0176] Embodiments of the present technology as described herein can be used to treat one or more heart valves as described herein, and in specific embodiments, can be used to treat the mitral valve. Figure 10A-56 Introductory examples of prosthetic heart valve devices, system components, and related methods are described in accordance with embodiments of the present technology. It will be appreciated that reference Figure 10A-56 The specific components, substructures, advantages, uses and / or other features of the described embodiments may be appropriately combined with each other and / or with other embodiments according to the present technology, with reference to Figure 57A-71 The described embodiments may be interchanged, replaced or otherwise configured. Figure 10A-71 Suitable components of the described embodiments may be used as stand-alone and / or self-contained devices.

[0177] Provided herein are systems, devices, and methods for percutaneously implanting an artificial heart valve in a patient's heart. In some embodiments, methods and devices for treating valvular disease by implanting an artificial replacement heart valve in a minimally invasive manner are provided. In one embodiment, the artificial replacement valve can be an artificial valve device adapted to be implanted and replace the mitral valve between the left atrium and the left ventricle in the patient's heart. In another embodiment, the artificial valve device can be adapted to be implanted and replace another valve (e.g., the mitral valve or the tricuspid valve) in the patient's heart. Fig. 10A showing an isometric view of a prosthetic heart valve device 100 in an expanded configuration 102 in accordance with an embodiment of the present technology, and Fig. 10B is a schematic diagram of a cross-sectional view of the heart showing the left atrium, left ventricle, and native mitral valve of the heart. Fig. 10B Also shown is an embodiment of an expandable prosthetic valve device 100 implanted in the native mitral valve region of the heart.

[0178] like Fig. 10AAs shown in , the device 100 may include a flexible anchoring member 110 at least partially surrounding and connected to an intravalvular support 120. The device 100 may also include an artificial valve 130 connected to, mounted within, or otherwise carried by the valve support 120. Figures 10C-10F 1 and 10 are side views, perspective cross-sectional views, top views, and bottom views of an artificial heart valve device 100 according to the present technology. The device 100 may also include one or more sealing members 140 and tissue engaging members 170. For example, in one embodiment, the sealing member 140 may extend around the inner wall 141 of the anchoring member 110 and / or around the outer surface 127 of the valve support 120 to prevent perivalvular (e.g., periplasty) leakage between the device 100 and natural tissue and / or between the anchoring member 110 and the valve support 120. In another specific embodiment and as shown in FIG. Fig. 10A As shown in , the tissue engaging elements 170 can be spikes disposed on the upstream circumference 113 of the anchoring member 110 and extend in an upward and / or radially outward direction to engage and, in some embodiments, penetrate native tissue to facilitate the device to stay or maintain its position in a desired implantation location. The tissue engaging elements 170 can also be included around the outer wall 142 of the anchoring member 110 and can extend outwardly to engage and, in some embodiments, penetrate native leaflets or other adjacent tissue. Additionally, the valve support 120 can have a plurality of connection features 180, such as apertures, around the upstream end 121 to facilitate loading, staying, and deployment of the device 100 within and from a delivery catheter (not shown), as further described herein.

[0179] The prosthetic heart valve device 100 can be in a delivery configuration (not shown), an expanded configuration 102 ( FIG. 10A ), and a deployed configuration 104 ( FIG. Fig. 10B ) are variable between. In the delivery configuration, the artificial heart valve device 100 has a low profile suitable for delivery via a small diameter guide catheter placed in the heart, via the transseptal, retrograde or transapical approaches described herein. In some embodiments, the delivery configuration of the artificial heart valve device 100 will preferably have an outer diameter of no more than about 8-10 mm for a transseptal approach, an outer diameter of no more than about 8-10 mm for a retrograde approach, or an outer diameter of no more than about 8-12 mm for a transapical to mitral valve MV approach. As used herein, an "expanded configuration" refers to a configuration in which the device is allowed to expand freely to an unconstrained size in the absence of restraining or twisting forces. As used herein, an "expanded configuration" refers to the device once expanded at the native valve site and subjected to the restraining and twisting forces imposed by the native anatomy.

[0180] Refer again Figure 3As used herein, "below the annulus" refers to the portion of the mitral valve MV located above or downstream of the native orifice plane PO. As used herein, the native orifice plane PO is a plane generally perpendicular to the direction of blood flow through the valve and containing the major axis MVA1 or the minor axis MVA2 ( Figure 5C ) or both of the planes PO. Thus, the subannular surface of the mitral valve MV is a tissue surface located on the ventricular side of the plane PO, and is preferably a tissue surface facing the left ventricle LV generally upstream and downstream. The subannular surface can be disposed on the ventricular wall behind the annulus AN itself or the natural leaflets LF, or it can include a surface (inward surface IF or outward surface OF) of the natural leaflets LF, which is located below the plane PO. The subannular surface or subannular tissue may therefore include the annulus AN itself, the natural leaflets LF, the leaflet / annular connective tissue, the ventricular wall, or a combination thereof.

[0181] In operation, the prosthetic heart valve device 100 can be delivered intravascularly to a desired location in the heart, such as an intracardiac location near the mitral valve MV, while in a delivery (eg, collapsed) configuration within a delivery catheter (not shown). Fig. 10B The device 100 can be advanced to a position within or downstream of the native valve annulus AN, at which position the device 100 can be released from the delivery catheter and expanded into the expanded configuration 102 ( Fig. 10A The device 100 will engage the natural tissue at the desired location, which will deform or otherwise change the shape of the device 100 into the expanded configuration 104 ( Fig. 10B Once released from the catheter, the device 100 can be positioned such that at least a portion of the flexible anchoring member 110 engages the subannular surface of the native valve, thereby resisting the contractile forces and preventing upward migration of the device 100 ( Fig. 10B ).exist Fig. 10B In the embodiment shown in FIG. 1 , the upstream perimeter 113 of the anchoring member 110 engages the inwardly facing surface IF ( Figure 3 ), the inward surface is pushed outward and folded under the native valve annulus AN. The leaflets LF engage the ventricular side of the valve annulus AN and are prevented from being pushed further in the upstream direction, thereby maintaining the anchoring member 110 below the plane of the native valve annulus. The tissue engaging elements 170 can penetrate the tissue of the leaflets LF and / or the valve annulus AN to stabilize and securely fix the device 100. However, in some embodiments, some portions of the anchoring member 110 can extend above the valve annulus AN, while at least some portions of the anchoring member 110 engage tissue in a position below the valve annulus to prevent the device 100 from migrating toward the left atrium LA. Fig. 10B, the leaflets LF can be present in apposition against the outer wall 142 of the anchoring member 110, which forms a blood-tight seal with the sealing member 140. The tissue engaging elements 170 can apply pressure against the annulus AN or the leaflets LF along the outer wall 142 of the anchoring member 110 or penetrate the annulus AN or the leaflets LF in another embodiment to further stabilize the device 100 and prevent migration.

[0182] According to aspects of the present technology, while in the expanded configuration 104, the proximal or upper end of the anchoring member 110 conforms to the irregularly shaped mitral valve annulus AN, thereby effectively sealing the device 100 against the native valve annulus AN to secure the device and prevent paravalvular leakage. As further described herein, the anchoring member 110 mechanically isolates the valve support 120 from the torsional forces present in the heart, so that the anchoring member 110 can adapt to and / or conform to the natural forces while the valve support 120 maintains its structural integrity. Therefore, the anchoring member 110 can be sufficiently flexible and resilient and / or connected to the valve support 120 in such a manner as to mechanically isolate the valve support 120 from the forces exerted on the anchoring member 110 by the natural anatomy. Alternatively or in addition to the above features, the valve support 120 can be more rigid and / or have a radial strength greater than that of the anchoring member 110, thereby maintaining its cylindrical or other desired shape and ensuring proper opening and closing of the artificial valve 130 housed within the valve support structure 120. In some embodiments, the valve support 120 has a radial strength that is at least 100% greater than the radial strength of the anchoring member 110, or at least 200% greater in other embodiments, and at least 300% greater in other embodiments. In one embodiment, the valve support 120 can have a radial strength of approximately 10N to approximately 12N. Thus, if deformed from an unbiased shape by a force exerting radial compression against its circumference, the valve support 120 can exhibit a clamping force that is approximately 2 to about 20 times greater than the clamping force that would be exhibited by the anchoring member 110 for a given degree of deformation.

[0183] like Figures 10A-10F As shown in FIG. 1 , the anchoring member 110 has a downstream portion 111 and an upstream portion 112 opposite the downstream portion 111 relative to the longitudinal axis 101 of the device 100. The upstream portion 112 of the anchoring member 110 can be a generally outwardly oriented portion of the device 100, such as Fig. 10DAs shown in . In one embodiment, the anchoring member 110 has a generally hyperbolic shape, such as the shape of a bicuspid hyperboloid. In another example, the downstream portion 111 can be substantially circular in cross-section, while the upstream portion 112 can be generally non-circular. In some embodiments, the anchoring member 110 may include a series of circumferentially positioned, elastically deformable and flexible longitudinal ribs 114, wherein in some embodiments, the longitudinal ribs are circumferentially connected by deformable and / or flexible connectors 116. Once deployed, at least a portion of the upstream end of the longitudinal ribs 114 engages the subannular surface of a native valve (e.g., a mitral valve). As described in more detail below, certain embodiments of the longitudinal ribs 114 are configured to penetrate subannular tissue to anchor and further stabilize the device 100.

[0184] in addition, Figures 10A-10F It is also shown that the longitudinal ribs 114 and / or the circumferential connectors 116 can be arranged in a variety of geometric patterns. Figures 10A-10F In the example shown in , the connector 116 is formed in a herringbone configuration. Ordinary technicians will recognize that a diamond pattern, a sinusoidal configuration, a closed cell, an open cell or other circumferential expandable configuration is also possible. In some embodiments, the longitudinal ribs 114 can be divided into a plurality of discrete sections (not shown) along their length, such as where the connector 116 is interconnected with the longitudinal ribs 114. Multiple connectors 116 and ribs 114 can be formed from a deformable material or from a rebound or shape memory material (e.g., Nitinol). In other embodiments, in addition to the longitudinal ribs 114 and / or the circumferential connectors 116 or as an alternative, the anchoring member 110 can include a mesh or woven structure. For example, the anchoring member 110 can include a tube or a braided mesh formed from a plurality of flexible metal wires or filaments arranged in a diamond pattern or other configurations. In another example, the metal tube can be laser cut to provide the desired rib or rod geometry. In some embodiments, the diamond configuration can provide column strength sufficient to inhibit movement of the device 100 relative to the valve annulus under systolic blood pressure against the valve 130 mounted in the valve support 120. In one specific example, the anchoring member 120 can be formed from a preformed nitinol tube having a wall thickness of, for example, about 0.010 inches to about 0.030 inches.

[0185] Figures 11A-11E Display can be Figures 10A-10F Several embodiments of valve supports 120 used in the embodiments of prosthetic heart valve devices 100 are shown in FIG. Figures 11A-11D 11E is an isometric view of another embodiment of a prosthetic heart valve device 100 in accordance with the present technology, the prosthetic heart valve device being disposed in the expanded configuration 102. Figures 10A-10Fand 11A-11E, several embodiments of the valve support 120 can be generally cylindrical, having an upstream end 121 and a downstream end 123 formed about a longitudinal axis 101, and having a circular, oval, elliptical, kidney-shaped, D-shaped, or other suitable cross-sectional shape configured to support a tricuspid valve or other artificial valve 130. In some embodiments, the valve support 120 includes a plurality of rods 122 circumferentially connected by a plurality of posts 124. The posts 122 and the rods 124 can be arranged in a variety of geometric patterns that can expand and provide sufficient resilience and column strength for maintaining the integrity of the artificial valve 130. For example, a plurality of posts 122 can extend longitudinally across multiple rows of rods 124 to provide column strength to the valve support 120. However, in other embodiments, the valve support 120 can include a metal mesh, a polymer mesh, or a fabric mesh or a woven structure.

[0186] Typically, the plurality of posts 122 may extend in an axial direction generally parallel to the longitudinal axis 101 and the rods 124 may extend circumferentially around the longitudinal axis 101 and extend transversely to the longitudinal axis 101. The posts 122 may extend the entire longitudinal height H1 ( Fig.11A ), or in another embodiment, the pillar 122 can include multiple independent and discrete pillar segments (not shown) along the valve support height H1. In one embodiment, the height H1 can be about 14 mm to about 17 mm. The rod 124 can form a series of rings around the longitudinal axis 101, wherein each ring has a circumferentially expandable geometry. Fig.11A , 11D In the example shown in FIG. 11E , the rods 124 are formed in a series of zigzags and are arranged in pairs 180 degrees out of phase with each other, thereby forming a series of diamond shapes. Alternative expandable geometries may include sinusoidal patterns, herringbone configurations ( Fig. 11B ), closed chamber ( Fig. 11C ), open cells or other expandable configurations. Multiple rods 124 can be attached to multiple posts 122, thereby defining multiple nodes 125 where the rods and posts meet. Multiple rods 124 and multiple posts 122 can be formed from a deformable material or a resilient or shape memory material (e.g., Nitinol).

[0187] The anchoring member 110 and the valve support 120 can be made of the same material or, in some embodiments, of different materials. In some embodiments, the anchoring member 110 and the valve support 120 both comprise a resilient biocompatible metal, such as stainless steel, a nickel-cobalt or cobalt-chromium alloy such as MP35N, or a nickel-titanium alloy such as Nitinol. Superelastic shape memory materials such as Nitinol can allow the device to collapse into a very low delivery configuration suitable for delivery via a catheter through the vascular system, and allow self-expansion to an expanded configuration that is appropriately sized to replace the target valve. In some embodiments, the anchoring member 110 and / or the valve support 120 can be laser cut from a single metal tube into the desired geometry to produce a tubular stent of interconnected rods. Using known shape forming techniques for such materials, the anchoring member 110 can then be formed into a desired configuration, such as an expanded shape, a funnel-like, or a hyperbolic shape.

[0188] like Figures 11B-11E As shown in , the valve support 120 has an inner surface 126 and an outer surface 127, and the valve support 120 is configured to receive or support an artificial valve 130 inside the lumen of the valve support 120 to inhibit reverse blood flow (e.g., blood flow from the left ventricle to the left atrium). Therefore, the valve support 120 can provide a stent that can be fixed to the artificial valve tissue and provide a stent with sufficient axial rigidity to maintain the longitudinal position of the artificial valve 130 relative to the anchoring member 110. The valve support 120 can also provide a stent having radial rigidity to maintain roundness (or other desired cross-sectional shape) to ensure that the leaflets 132 of the artificial valve 130 are closed or otherwise sealed when the device 100 experiences external radial pressure. In one embodiment, the valve support 120 can have a support area 145 along the longitudinal axis 101, which is configured to be attached to the artificial valve or aligned with the closed portion of the leaflets 132 in other embodiments (shown in Figure 11b).

[0189] The valve 130 may include a temporary or permanent valve adapted to block blood flow in an upstream direction and allow blood to flow in a downstream direction through the valve support 120. The valve 130 may also be a replacement valve configured to be placed in the valve support 120 after implantation of the device 100 at the native mitral valve. The valve 130 may have a plurality of leaflets 132 and may be made of a variety of flexible and impermeable materials including PTFE, The valve 130 may be made of a polyvinyl chloride (PFC) or other biocompatible material (e.g., pyrolytic carbon or other biocompatible material) or biological tissue (e.g., pericardial tissue or allogeneic valve tissue such as porcine heart tissue or bovine pericardium). Other aspects of the valve 130 are further described below. The inner surface 126 inside the lumen of the valve support 120 may be at least partially covered by an impermeable sealing member 140 to prevent blood from flowing from the inside of the valve support 120 to the outside of the valve support 120, where it would leak around the outside of the valve support 120. In another embodiment, the sealing member 140 may be fixed to the outer surface 127 of the valve support 120 and in either embodiment, may be integrally formed with the valve 130 or directly attached thereto. In an additional embodiment, the sealing member 140 may be applied to at least a portion of the inner surface 126 and the outer surface 127 of the valve support 120.

[0190] like Figures 11B-11E As shown in , the artificial valve 130 can be sutured, riveted, bonded, tied, mechanically interlocked, or otherwise fastened to the posts 122 or to the commissure attachment structures 128 configured to align with the valve commissures C. The posts 122 or commissure attachment structures 128 may include eyelets 129, hoops, or other features formed thereon to facilitate attachment of sutures or other fastening devices to facilitate attachment of the artificial valve 130. In one embodiment, shown in FIG. 11B , the attachment structures 128 can be integrated into the structural frame of the valve support 120 so that the attachment structures 128 are distributed around the circumference of the valve support 120 and function as posts 122. In another embodiment, in Fig.11D , the attachment structure 128 may be an attachment pad formed on a portion of the column 122 (e.g., along the upper end of the column 122). Fig.11E As shown in FIG. 1 , the attachment structures 128 can be independent structures that can be connected to the posts 122 , rods 124 , or other components along the inner surface 126 of the valve support 120 .

[0191] like Fig. 11CAs shown in , the artificial valve 130 can also be attached to a sealing member 140 or a sleeve that is attached to the inner surface 126 of the valve support 120, as described above. Once attached, the artificial valve 130 can be adapted to collapse or compress with the device 100 for loading into a delivery catheter (not shown). In one embodiment, the artificial valve 130 has a three-leaflet configuration, although various alternative valve configurations, such as a bi-leaflet configuration, can be used. The design of the artificial valve 130, such as the selection of a three-leaflet configuration versus a bi-leaflet configuration, can be used to determine the appropriate shape of the valve support 120. For example, for a three-leaflet valve, the valve support 120 can have a circular cross-section, while for a bi-leaflet valve, alternative cross-sectional shapes are possible, such as an oval or D-shaped cross-section. In a specific example, the valve support can have a circular cross-sectional diameter of approximately 25 mm to approximately 32 mm (e.g., 27 mm).

[0192] In some arrangements, the valve support 120 can have a permanent prosthetic valve preinstalled therein, or the valve support 120 can be configured to receive a valve delivered by a separate catheter after the device 100 is implanted in the native mitral valve. In arrangements in which a permanent or replacement valve is desired, the valve support 120 can also include a temporary valve preinstalled within the internal lumen. If a period of time is required between placement of the device 100 and further implantation of a permanent prosthetic valve, a temporary valve sewn into the valve support 120 or otherwise secured thereto can ensure temporary regulation of blood flow. For example, the temporary valve can be used for a period of about 15 minutes to several hours or up to a few days. A permanent or replacement prosthetic valve can be implanted within the temporary valve or can be implanted after the temporary valve has been removed. Examples of preassembled percutaneous prosthetic valves include, for example, the CoreValve from Medtronic / Corevalve Inc. system (Irvine, CA, USA) or Edwards- Valve. If adapted to receive a separate catheter-delivered valve, the valve support 120 may have features within its interior lumen or on its upper or lower end for engaging and retaining therein a catheter-delivered valve, such as an inwardly extending ridge, bulge, prong, or flap. Additional details and embodiments regarding the structure, delivery, and attachment of artificial valves, temporary valves, and replacement valves suitable for use with the artificial heart valve devices disclosed herein may be found in International PCT Patent Application No. PCT / US2012 / 043636, filed on June 21, 2012, entitled "Artificial Heart Valve Devices and Related Systems and Methods," the entire contents of which are incorporated herein by reference.

[0193] In some arrangements, the anchoring member 110 is defined by a structure that is independent of the valve support 120. For example, the anchoring member 110 can be a first or outer frame or skeleton and the valve support 120 can be a second or inner frame or skeleton. In this manner, the anchoring member 110 can at least partially surround the valve support 120. In some embodiments, the downstream portion 111 of the anchoring member 110 can be connected to the valve support 120 while the upstream portion 112 is not connected or connected to the valve support 120 in a manner that unduly affects the shape of the valve support 120. For example, in some embodiments, the upstream portion 112 of the anchoring member 110 can be configured to engage and deform into the shape of native tissue on or below the valve annulus while the cross-sectional shape of the valve support 120 remains substantially stable. For example, the valve support 120 (e.g., at least at the upstream end 121) can be radially inwardly spaced from the upstream portion 112 of the anchoring member 110 so that if the anchoring member 110 is deformed inwardly, at least the upstream end 121 of the valve support 120 remains substantially undeformed. As used herein, "substantially undeformed" can refer to a situation in which the valve support 120 is not engaged or deformed, or can refer to a situation in which the valve support 120 can be slightly deformed but the prosthetic valve 130 remains intact and effective (e.g., the leaflets 132 are sufficiently closed to prevent reverse blood flow). In such an arrangement, the leaflets 132 of the prosthetic valve 130 can be sufficiently closed even when the device 100 is under systolic pressure or forces from the pumping action of the heart.

[0194] The longitudinal ribs 114 and / or circumferential connectors 116 can be less rigid than the posts 122 and / or rods 124 of the valve support 120, thereby allowing greater flexibility in the anchoring member 110 and / or greater stability in the shape and position of the valve support 120. In some embodiments, the flexibility of the anchoring member 110 can allow the anchoring member 110 to absorb torsional forces and allow the device 100 to conform to the irregular, non-circular shape of the native valve annulus (while leaving the valve support 120 substantially unaffected), thereby encouraging tissue ingrowth and creating a seal to prevent leakage between the device 100 and the native tissue. In addition, the longitudinal ribs 114 and / or connectors 116 can be configured to press radially outward against the native valve, ventricular and / or aortic structures to anchor the device 100 in a desired position, as well as maintain the upstream deployed circumference 150' greater than the circumference of the native valve annulus, such that the subannular positioning of the device 100 effectively prevents upward migration of the device 100 (described below Fig. 14C ). Additionally, the longitudinal ribs 114 can have sufficient resilience and column strength (eg, axial stiffness) to prevent the anchoring member 110 and / or the device 100 from longitudinally collapsing or flipping and to resist movement of the device in an upstream direction.

[0195] By structurally separating the anchoring member 110 from the valve support 120, the valve 130 and the valve support 120 are effectively mechanically isolated from torsional forces exerted on the anchoring member 110 by natural tissue (e.g., radial compression forces, longitudinal tension and contraction forces, hoop stress, etc. exerted by the natural valve annulus and / or leaflets). For example, deformation of the anchoring member 110 by natural tissue may change the cross-section of the anchoring member 110 (e.g., to a non-circular or asymmetric cross-section), while the valve support 120 may not be substantially deformed. In one embodiment, for example, with the anchoring member 110 connected to the valve support 120, at least a portion of the valve support 120 (e.g., the downstream end 123) may be deformed by radial compression forces. However, the upstream end 121 (e.g., the downstream end 123) of the valve support 120 and / or the valve support region 145 may not be deformed. Fig. 11B ) are mechanically isolated from the anchoring member 110 and the compressive forces, so that at least the valve support region 145 can be substantially undeformed. Thus, the valve support 120 and at least the valve support region 145 can maintain a circular or other desired cross-section, so that the valve remains stable and / or effective. The flexibility of the longitudinal ribs 114 can help absorb twisting forces and also help mechanically isolate the valve support 120 and the valve 130 from the anchoring member 110.

[0196] At the upstream end of the device 100 pointing to the left atrium, the valve support 120 can be configured to be located below, flush with, or above the uppermost end of the upstream portion 112 of the anchoring member 110. At the downstream end of the device 100 pointing to the left ventricle and located inside it, the anchoring member 110 can be connected to the valve support 120. Optionally, the anchoring member 110 can be connected to the valve support 120 at any position along the length of the valve support 120. The valve support 120 and the anchoring member 110 can be connected by a variety of methods known in the art (e.g., suturing, soldering, welding), staples, rivets or other fasteners, mechanical interlocking, friction, interference fit, or any combination thereof. In other embodiments, the valve support 120 and the anchoring member 110 can be integrally formed with each other. In another embodiment, a sleeve or other covering structure (not shown) can be attached to the anchoring member 110 and the valve support 120 at the same time to interconnect the two structures.

[0197] Figures 12A-12Cis a side view of various longitudinal ribs 114 flexing in response to a twisting force F according to other embodiments of the present technology. The degree of flexibility of an individual longitudinal rib 114 (and thus the anchor member 110) may be consistent across all ribs of the anchor member 110, or, alternatively, some ribs 114 may be more flexible than other ribs 114 within the same anchor member 110. Likewise, the degree of flexibility of each rib 114 may be consistent throughout the entire length of the rib 114, or the degree of flexibility may vary along the length of each rib 114.

[0198] like Figures 12A-12C As shown, the longitudinal ribs 114 (individually shown as 114A-114C) can flex along their respective lengths in response to a twisting force F applied by surrounding tissue during or after implantation of the device 100. Fig. 12A In the embodiment, rib 114A can be deflected downward toward a position 75' or upward toward a position 75" in response to an upward or downward force F1, respectively. Similarly, in Fig. 12B In the embodiment, a rib 114B having a plurality of distinct segments 85A, 85B, 85C can flex and / or rotate inwardly / outwardly or side-to-side in response to a lateral guiding force F2. The distinct segment 85A at the end of the rib 114B can flex and / or rotate inwardly / outwardly or side-to-side in response to the lateral guiding force F2 independently of the distinct segments 85B and 85C below (e.g., to position 85A′). In other arrangements, segment 85A can flex and / or rotate together with the distinct segment 85B (e.g., to position 85AB′) or with both segments 85B and 85C (not shown). Fig. 12C As shown in the figure, rib 114C having a generally linear shape when in a relaxed state can also flex and / or rotate inwardly / outwardly or side-to-side (e.g., to position 95′ or 95″) in response to a lateral guiding force F3 by bending to form a curved shape, or in another embodiment not shown, by bending so as to form two substantially linear segments.

[0199] The ribs 114 may also have different shapes and be placed at different locations around the circumference of the anchoring member 110. In some embodiments, the device 100 may include a first and a second plurality of ribs, wherein the first plurality of ribs have different characteristics than the second plurality of ribs. The different characteristics may include rib size, rib shape, rib stiffness, extension angle, and number of ribs within a given area of ​​the anchoring member. In other embodiments, the longitudinal ribs may be unevenly or evenly spaced around the outer circumference of the anchoring member.

[0200] The ribs 114 can be positioned around a circumference oriented along the longitudinal axis 101 of the anchoring member 110 to form many overall cross-sectional geometries of the anchoring member 110, such as circular, D-shaped, oval, kidney-shaped, irregular, etc. According to another embodiment of the present technology, Fig.13A is a schematic cross-sectional view of an artificial heart valve device, and according to another embodiment of the present technology, Figures 13B-13F is a partial side view of an artificial heart valve device showing different longitudinal rib configurations. Fig.13A , the independent rib 114 can include multiple linear segments, such as segments 85A and 85B. In the example shown, the rib segment 85B is angled radially outward at a first angle A1 (e.g., angled away from the longitudinal axis 101). The rib segment 85B extends in an upstream direction from its attachment point to the valve support 120 at the downstream end of the segment 85B, thereby giving the anchoring member 110 a conical or expanded shape and a larger diameter D2 at the upstream portion 112 of the anchoring member 110 and a smaller diameter D3 at the downstream portion 112. In one embodiment, the upper rib segment 85A can be angled at a steeper second angle A2 relative to the longitudinal axis 101 than the lower rib segment 85B, resulting in a wider expanded upstream portion 112A at the upstream portion 112 of the anchoring member 110. In some arrangements, the wider flared upstream portion 112A can enhance the seal between the anchoring member 110 and the native tissue, while the downstream portion 111 can provide a more rigid geometry for resisting upward movement of the device 100 when a contraction force is applied to the device 100. Alternatively, the ribs 114 can be arcuate over all or a portion of their length, such as Fig. 13B is shown in a partial side view.

[0201] In other embodiments, as Figures 13C-13F As shown, the rib 114 may have a more complex shape defined by a plurality of distinct segments 85A, 85B, 85C, etc. For example, Fig. 13C As shown in , the rib 114 includes a linear rib segment 85C generally parallel to the longitudinal axis 101, which is connected at its upstream end to a linear and radially outwardly extending rib segment 85B, wherein the rib segment 85B is connected at its upstream end to a more perpendicular rib segment 85A approximately parallel to the longitudinal axis 101. Fig.13D The rib 114 may include a linear rib segment 85B that is generally parallel to the longitudinal axis 101 and connected at its upstream end to a linear and radially outwardly extending rib segment 85A that is generally perpendicular to the longitudinal axis 101. Fig.13EThe rib 114 may include a linear rib segment 85C that is generally parallel to the longitudinal axis 101 and connected at its upstream end to a linear and radially outwardly extending rib segment 85B that is generally perpendicular to the longitudinal axis 101. The rib segment 85B may be further connected at its radially outermost end to a vertical rib segment 85C that is generally parallel to the longitudinal axis 101. Fig.13F The rib 114 includes a linear segment 85D that is generally parallel to the longitudinal axis 101 and connected at its upstream end to a radially outwardly extending segment 85C that is generally perpendicular to the longitudinal axis 101. The rib segment 85C may be further connected at its radially outermost end to a linear vertical segment 85B that is generally parallel to the longitudinal axis 101, and wherein 85B is connected at its radially outermost end to a linear and radially inwardly extending segment 85A.

[0202] exist Figures 13C-13F 13A-13F, any or all of the rib segments may have a curvature, and any interconnections of segments shown as transition angles may be curved instead. Thus, any of these various geometries can be configured to allow the anchoring member 110 to conform to native body structures, resist migration of the device 100, and mechanically isolate the valve support 120 and / or the prosthetic valve 130 contained therein from forces exerted on the anchoring member 110 by native tissue.

[0203] The flexible characteristics of each rib 114 can allow for flexibility and conformability of the anchoring member 110 to engage and seal against uneven and uniquely shaped natural tissues of the device 100. Additionally, flexibility can aid in forming a seal between the device 100 and surrounding body structures. According to embodiments of the present technology, Fig.14A is a schematic top view of a native mitral valve MV showing a minor axis 50 and a major axis 55, and Figures 14B-14C 10 and 110. are schematic top views of the anchoring member 110 in an expanded configuration 102 and a deployed configuration 104, respectively, superimposed on a schematic view of the native mitral valve MV.

[0204] See also Fig. 14B , the upstream portion 112 of the anchor member 110 ( Fig. 10A) can have an outer perimeter 150 when the anchoring member 110 is in the expanded configuration 102 (shown as a dashed line) that has a diameter D1 that is smaller than the minor axis 50 ( Fig.14A ) and is typically smaller than the major axis 55 of the valve annulus. In other embodiments, the diameter D1 of the anchoring member 110 can be at least as large as the distance between the native commissures C, and can be as large as or even larger than the major axis 55 of the native valve annulus. In some embodiments, the diameter D1 of the outer circumference 150 of the anchoring member 110 is approximately 1.2 to 1.5 times the diameter (not shown) of the valve support 120 (or artificial valve 130), and can be as large as 2.5 times the diameter of the valve support 120 (or artificial valve 130). While conventional valves must be manufactured in multiple sizes to treat diseased valves of different sizes, according to aspects of the present technology, the valve support 120 and the artificial valve 130 can be manufactured in only a single diameter to match a variety of native valve sizes. For example, the valve support 120 and the artificial valve 130 do not need to precisely engage and match the natural body structure. In one particular example, the diameter of the valve support 120 (not shown) can be in the range of about 25 mm to 32 mm for use in adult human patients. Also in accordance with aspects of the present technology, the anchoring member 110 can be provided in a variety of diameters to fit different native valve sizes, and the diameter at the upstream end can be in the range of about 28 mm to about 80 mm, or greater than 80 mm in other embodiments.

[0205] Fig. 14C The top view of the anchoring member 110 shown in FIG. 14C shows how the flexibility and / or deformation of one or more longitudinal ribs 114 and / or rib segments allows the anchoring member 110 to be twisted relative to the expanded configuration 102 (as shown by the dashed lines) to the deployed configuration 104 (as shown by the bold lines). As shown in FIG. 14C, the anchoring member 110 can conform to the highly variable native mitral valve tissue shape MV (as shown in dashed lines) when deployed or implanted at or below the mitral valve annulus, while the ribs 114 bend, twist and stretch so that the overall shape of the anchoring member 110 has an expanded (e.g., generally more oval or D-shaped or other irregular shape) configuration 104 instead of the fully expanded configuration 102. See also FIG. Figures 14B-14C , the anchoring member 110 covers the mitral valve commissures C in the deployed configuration 104, while these commissures C will remain unsealed or exposed in the more circular expanded configuration 102, potentially allowing paravalvular leakage. The anchoring member 110 can also be pre-formed in a generally oval or D-shaped or other shape when in an unbiased condition.

[0206] According to one embodiment of the present technology, Fig.15 is an isometric view of an embodiment of a prosthetic heart valve device 100 shown in an expanded configuration 104 . Fig.15A device 100 is shown having a plurality of ribs 114, wherein a first set of ribs 160 can be configured to bend inwardly or squeeze toward a central longitudinal axis 101 of the device 100, and a second set of ribs 162 can be configured to bend outwardly or flex in response to twisting forces present in the subannular space of the native valve. Thus, the outer circumference 150 of the anchoring member 110 can be twisted from a more circular shape in the expanded configuration 102 (as shown by the dashed lines) to a generally more oval or D-shaped shape in the expanded configuration 104 (as shown by the solid lines), thereby conforming to the shape of the native body structure. In an alternative arrangement, the upstream portion 112 of the anchoring member 110 can be sized to be slightly larger than the subannular space in which it is deployed midway, such that the anchoring member 110 is squeezed into a slightly smaller diameter in its deployed configuration 104. This can cause a slight relaxation of the sealing member 142, such that the sealing member segments between adjacent ribs 114 relax sufficiently to undulate or bend inwardly or outwardly to form relaxed segments Bi, as shown in FIG. Fig.15 This undulation may be desirable in some arrangements because the curvature of the relaxed sleeve segment Bi may engage and conform to mitral valve leaflet tissue, thereby enhancing the seal formed between the device 100 and the native tissue.

[0207] like Fig.15, the unbiased expanded configuration of the valve support 120 (which is circular in cross-section in the illustrated embodiment) remains substantially unaffected while the anchoring member 110 conforms to the non-circular shape of the native mitral annulus MV. Thus, the valve support 120 is mechanically isolated from these forces and maintains its structural shape and integrity. The mechanical isolation of the valve support 120 from the anchoring member 110 can be attributed to several aspects of the prosthetic heart valve device 100. For example, the relatively high flexibility of the anchoring member 110 compared to the lower flexibility of the valve support 120 allows the anchoring member 110 to deform significantly when deployed and when in operation (e.g., to conform to the shape and movement of body structures under ventricular contractile forces), while the valve support 120 remains substantially undeformed (e.g., generally circular) under these same conditions. Additionally, the radial spacing between the anchoring member 110 and the valve support 120 (particularly at the upstream portion / upstream end where the anchoring member 110 engages the native valve annulus and / or tissue beneath the valve annulus) allows the anchoring member 110 to deform inwardly a substantial amount without engaging the valve support 110. Additionally, the anchoring member 110 can be connected to the valve support 120 at a location (e.g., the downstream portion 111 of the anchoring member 110) that is longitudinally spaced a substantial distance from the location where the anchoring member 110 engages the native valve annulus (e.g., the upstream portion 112 of the anchoring member 110), allowing the ribs 114 of the anchoring member 110 to absorb a majority of the distortion forces applied thereto rather than transmitting those forces directly to the valve support 120. Furthermore, the connection mechanism for attaching the anchoring member 110 to the valve support 120 can be configured (e.g., made flexible or variable) so as to reduce the transmission of forces from the anchoring member 110 to the valve support 120 (discussed in more detail herein).

[0208] In many embodiments, the anchoring member 110 can be sufficiently flexible so that the anchoring member 110 can be in the expanded configuration 104 ( Fig. 14C and 15 ) is attached to the native mitral annulus; however, the anchoring member 110 can be configured to be in its expanded configuration 102 (e.g. Fig. 10A 14B) are biased so that when in the expanded configuration 104, the anchoring member 110 pushes radially outward against the native valve annulus, leaflets, and / or the ventricular wall just below the valve annulus. In some arrangements, the radial force generated by the biased anchoring member shape can be sufficient to deform the native body structure so that the minor axis 50 ( Fig.14A) is slightly increased, and / or the shape of the valve annulus is otherwise changed. This radial force can enhance the anchoring of the device 100 to resist movement toward the atrium when the valve 130 is closed during ventricular systole and toward the ventricle when the valve 130 is open. In addition, the resulting compression fit between the anchoring member 110 and the leaflets and / or ventricular wall or other structures helps to form a long-term bond between the tissue and the device 100 by promoting tissue ingrowth and encapsulation.

[0209] Figures 16A-17C A prosthetic heart valve device 100 configured in accordance with another embodiment of the present disclosure is shown. Figures 16A-16C The present invention includes a top view and first and second side views of a prosthetic heart valve device 100 shown in an expanded configuration 102, the prosthetic heart valve device including a prosthetic heart valve device generally similar to that described above with reference to FIG. Figure 10A-15 The features of the artificial heart valve device 100 described in the present invention are similar to those of the features of the artificial heart valve device 100. For example, the device 100 includes a valve support 120 and an artificial valve 130 housed within the interior lumen of the valve support 120. However, in Figures 16A-16C In the embodiment shown in , the device 100 includes an anchoring member 210 having an oval or D-shaped upstream circumference 213 and multiple heights around a circumference 250 of the anchoring member 210 such that the anchoring member 210 is suitable for engaging and conforming to tissue in the subannular region of the mitral valve.

[0210] Also see Figures 16A-16C , the device 100 may include a flexible anchoring member 210 at least partially surrounding the valve support 120 and connected to the valve support 120 at the downstream portion 211 of the anchoring member 210. The device 100 may also include one or more sealing members 140 extending around the inner wall 241 of the anchoring member 210 and / or around the outer surface 127 or the inner surface 126 of the valve support 120 to prevent paravalvular leakage between the device 100 and the native tissue and / or between the anchoring member 210 and the valve support 120. In one embodiment, the sealing member 140 may wrap around and / or cover the upstream circumference 213 of the anchoring member 210. For example, the sealing member 140 may be sewed, stitched or adhered to the walls 241, 242 and have an extension (not shown) folded over the upstream circumference 213. In one embodiment, the sealing member 140 can be adhered to the opposing wall (e.g., extending from the inner wall 241 to cover the upstream perimeter 213 and attached to the upper portion of the outer wall 242). However, in other embodiments, the sealing member 140 can have a longer free edge (not shown) that remains unattached. The free edge of the sealing member 140 can be adapted to inhibit blood flow between the upper perimeter 213 and the native tissue in some arrangements.

[0211] like Figures 16B-16CAs shown in FIG. 2 , the anchoring member 210 has a downstream portion 211 and an upstream portion 212 relative to the downstream portion 111 along the longitudinal axis 201 of the device 100. Fig. 10A ), the upstream portion 212 of the anchoring member 210 can be a generally outwardly oriented portion of the device 100. In some embodiments, the anchoring member 110 can include a series of circumferentially positioned, elastically deformable and flexible ribs 214 that can be arranged in a checkered pattern around the circumference 250 of the anchoring member 210 to form a diamond pattern. In one embodiment, the ribs 214 can be flexible metal wires or filaments arranged in a diamond pattern or configuration. In some embodiments, the diamond configuration can provide a column strength sufficient to inhibit the device 100 from resisting the movement of the valve 130 installed in the valve support 120 relative to the valve annulus under systolic blood pressure. In a specific example, the anchoring member 120 can be formed of a preformed nitinol tube having a wall thickness of, for example, about 0.010 inches to about 0.030 inches. The diamond pattern or configuration can, for example, include one or more rows of diamonds around the circumference 250 of the anchoring member 210 and between about 12 columns and about 36 columns of diamonds in some embodiments.

[0212] In some embodiments, the upstream perimeter 213 of the anchoring member 210 does not lie in a single plane. For example, the ribs 214 can have variable lengths and / or be offset from each other at variable angles so that the distance (e.g., height) between the downstream perimeter 215 and the upstream perimeter 213 can vary around the circumference 250. For example, the upstream perimeter 213 can form a flange ( Fig. 16B ) to adapt to the shape of the native mitral valve (see Figure 5C ). As used herein, "peaks" and "valleys" do not refer to the diamond-shaped peaks and diamond-shaped valleys of the diamond pattern formed by the plurality of ribs 214, but rather to the portion of the upstream perimeter 213 having a wavy shape formed by a height variation relative to the downstream perimeter 215. In one embodiment, the distance (e.g., height) between the downstream perimeter 215 and the upstream perimeter can vary between about 6 mm and about 20 mm, and in another embodiment between about 9 mm and about 12 mm.

[0213] In one embodiment, the upstream circumference 213 of the anchoring member 210 can have two peaks 251 separated by two valleys 252. In some embodiments, the first peak can have a shape or height that is different from the shape or height of the second peak. In other embodiments, the shape of the valley 252 can be different from the shape of the inverted peak 251. Thus, the peaks 251 and valleys 252 can be asymmetrically positioned and shaped around the circumference 250 of the anchoring member 210. In different arrangements, the valley 252 can be configured to be positioned along the junction area of ​​the native valve annulus, and the peaks 251 can be configured to be positioned along the leaflet area of ​​the native valve annulus. In one embodiment, the peak 251 can have an apex configured to be positioned near the midpoint area of ​​the leaflet.

[0214] See also Figures 17A-17C , a specific example of the anchoring member 210 can have a first height E1 of about 7 mm to about 8 mm between the downstream perimeter 215 and the upstream perimeter 213 at the first and second regions 253, 254 of the anchoring member. The first and second regions 253, 254 are configured to mate with the first and second commissures (e.g., the anterolateral commissure AC and the posteromedial commissure PC) of the native mitral valve. Figure 5A The anchoring member 210 may also have a second height E2 of about 9 mm to about 11 mm between the downstream perimeter 215 and the upstream perimeter 213 at a third region 255 of the anchoring member 210, wherein the third region 255 is configured to align with the anterior leaflet AL ( Figure 5A The anchoring member 210 may further have a third height E3 of about 12 mm to about 13 mm between the downstream perimeter 215 and the upstream perimeter 213 at a fourth region 256 of the anchoring member 210 relative to the third region 255, wherein the fourth region 256 is configured to align with the posterior leaflet PL ( Figure 5A ) are aligned. One of ordinary skill in the art will recognize that these heights E1, E2, and E3 may have other measurements, and in some embodiments, these heights E1, E2, and E3 may be different or the same as each other.

[0215] In addition, the upstream perimeter 213 can be formed with a generally oval or D-shaped or other irregularly shaped flange to adapt to the shape of the native mitral valve. For example, and referring to FIG. 17A , the upstream perimeter 213 of the anchoring member 210 can have a major perimeter diameter Dm1 and a minor perimeter diameter Dm2 perpendicular to the major perimeter diameter Dm1. In one embodiment, the major perimeter diameter Dm1 is substantially equal to the diameter of the device 100 when the device 100 is in the expanded configuration 102 ( Fig.17A ) is larger than the long axis of the native mitral valve MVA1 (shown in Figure 5CIn another embodiment, the major circumference diameter Dm1 is less than the major axis MVA1 when the device 100 is in the expanded configuration 102. In these embodiments, the device 100 can be configured to have a greater diameter than the major axis MVA1 when the device is in the deployed configuration (e.g., when engaging tissue above or below the native valve annulus, see Fig.16E ) is greater than the major axis MVA1. In addition, the minor axis Dm2 can be greater than the major axis MVA1 when the device 100 is in the expanded configuration 102 ( Fig.17A ) or alternatively in an expanded configuration ( Fig.16E ) is greater than the short axis MVA2 of the native mitral valve (shown in Figure 5C In one embodiment, the major circumference diameter Dm1 and / or the minor circumference diameter Dm2 may be approximately 2 mm to approximately 22 mm, or in another embodiment approximately 8 mm to approximately 15 mm, larger than the major axis MVA1 and / or the minor axis MVA2 of the native mitral valve, respectively. In some embodiments, the major circumference diameter may be approximately 45 mm to approximately 60 mm, and the minor circumference diameter may be approximately 40 mm to approximately 55 mm.

[0216] See again Fig. 16C , the upstream portion 212 of the anchoring member 210 can be radially separated from the valve support 120 by a gap 257. In one embodiment, the gap 257 is larger on the side of the device 100 facing the anterior leaflet (e.g., along the third region 255) than on the side of the device 100 facing the posterior leaflet (e.g., along the fourth region 256).

[0217] Referring back to Figures 16A and 16C, the valve support 120 can be oriented along the first longitudinal axis 101, and the anchoring member 210 can be oriented along the second longitudinal axis 201. The second longitudinal axis 201 can be offset from the first longitudinal axis 101. "Offset" can refer to an arrangement in which the axes 101, 201 are parallel but spaced apart such that the gap 257 can vary around the circumference 250 ( Fig. 16C ). Fig.16D Another embodiment is shown, where "offset" can refer to an arrangement where the second axis 201 can be angled from the first axis 101 (e.g., the first and second 101, 201 axes are non-colinear or non-parallel) such that the anchoring member 210 is generally tilted relative to the valve support 120. In one embodiment, the second longitudinal axis 201 is disposed at an inclination angle ATL of between 15° and 45° relative to the first longitudinal axis 101.

[0218] In other embodiments, and as Fig.18254, the first and second regions 253 and 254 of the upstream perimeter 213 can extend further away from the longitudinal axis 201 than the third 255 and fourth regions 256. For example, the anchoring member 210 can have a generally conical body (shown in phantom) and have an upstream flange extension 258 in the first and second regions 253 and 254. In some embodiments, the third region 255 of the upstream perimeter 213 can extend further away from the longitudinal axis 201 than the fourth region 256. In some arrangements, the third region 255 can have a size and shape that allows the anchoring member 210 to engage the inward surface of the anterior leaflet without substantially occluding the left ventricular outflow tract (LVOT).

[0219] Also see Figures 17A-17C , the valve support 120 can be oriented along the longitudinal axis 101, and the upstream portion 212 of the anchoring member 210 can flare outward from the longitudinal axis 101 at a taper angle AT. In embodiments where the ribs 214 curve generally outward from the downstream portion 211 to the upstream portion 212 (rather than linearly), the taper angle AT can vary continuously between the downstream portion and the upstream portion. In some embodiments, the taper angle AT can be the same around a circumference 250 of the upstream portion 212 of the anchoring member 210; however, in other embodiments, the taper angle AT can vary around the circumference 250. For example, the anchoring member 210 can have ribs that can be configured to engage with the anterior lateral commissure AC and the posteromedial commissure PC, respectively (see Figure 5C ) at the first taper angle AT1 of the first and second regions 253 and 254 aligned with each other ( Fig. 17B The anchoring member 210 may further have a second taper angle AT2 at a third region 255 that may be configured to align with the anterior leaflet and a third taper angle AT3 at a fourth region 256 that may be configured to align with the posterior leaflet. Fig. 17C ). In one embodiment, the cone angle may be about 30° to about 75°, and in another embodiment between about 40° and about 60°.

[0220] According to an embodiment of the present technology, Fig.16E is a schematic top view of a native mitral valve in a heart viewed from the left atrium, and the schematic top view shows a Figures 16A-16C The artificial treatment device 100. Once deployed, and as Fig.16E As shown in FIG, at least a portion of the upstream end of the rib 214 (shown in FIG. Figures 16B-16C ) that is, engaging the subannular surface of a native valve (eg, mitral valve). As described in more detail below, certain embodiments of ribs 114 or 214 are configured to penetrate subannular tissue to fix and further stabilize the device 100.

[0221] Although the anchoring member 210 is deformable in response to distorting forces generated by the natural body structure, the valve support 120 can have sufficient rigidity to maintain a circular or other initial cross-sectional shape, thereby ensuring proper functioning of the prosthetic valve leaflets 132 when opening and closing. This mechanical isolation from the anchoring member 210 can be achieved by utilizing a valve support 120 that has sufficient rigidity to resist deformation while the anchoring member 210 deforms, and by selecting a location and manner for connecting the valve support 120 to the anchoring member 210 such that the forces transmitted to the valve support 120 or the prosthetic valve 130 contained therein through the anchoring member 210 are reduced. For example, the valve support 120 can be connected to the anchoring member 210 only at the downstream end 123 of the valve support 120 separated from the upstream end 121 where the anchoring member 210 engages the valve annulus. At the upstream end 121 of the anchoring member 210, the valve support 120 may be completely unattached to the anchoring member 210 and radially spaced apart therefrom by the gap 257, thereby allowing deformation of the anchoring member 210 without affecting the shape of the valve support 120 (see the embodiment of the embodiment of the invention in which the artificial valve 130 is positioned). Figures 16A-16C ). Therefore, the forces generated by the valve ring on the anchoring member 210 can be absorbed by the flexible ribs 214 of the anchoring member 210 to reduce the transmission of these forces to the downstream end 123 of the valve support 120.

[0222] In some embodiments, it is desirable to limit the distance that the device 100 extends into the left ventricle downstream of the valve annulus (e.g., to limit obstruction of the left ventricular outflow tract (LVOT)). Thus, some embodiments of the device 100 may include a relatively low overall height (e.g., heights E1, E2, and E3, Figures 17B-17C ) such that the anchoring member 210 does not extend into or block the LVOT. Fig. 16B , the anchoring member 110 can have a lower overall height EL (e.g., the distance between the upstream circumference 213 and the downstream circumference 215 of the anchoring member 210) relative to the height HV of the valve support 120. In these embodiments, the upstream circumference 213 of the anchoring member 110 can be directly below, adjacent to, or positioned within the annulus of the native mitral valve, while the downstream circumference 215 of the anchoring member 210 is configured to extend minimally into the left ventricle below the native mitral valve annulus when the device 100 is implanted. In some arrangements, the valve support 120 can be connected to the anchoring member 210 so as to also minimize protrusion into the left ventricle, and in some embodiments may extend upward through the plane of the native valve annulus into the left atrium.

[0223] Additional components and features suitable for use with prosthetic heart valve devices

[0224] Additional components and features applicable to artificial heart valve devices (e.g., device 100 described above) are described herein. One of ordinary skill in the art will recognize that although certain components and features are described with respect to a specific device (e.g., device 100), these components and features may also be applicable to or incorporated with other devices as further described herein.

[0225] As above relative to Fig. 10A As discussed, some embodiments of the prosthetic heart valve device 100 may include a sealing member 140 that extends around a portion of the anchoring member 110 and / or the valve support 120. For example, Fig. 10A The embodiment shown in FIG. 1 has a sealing member 140 surrounding an inner wall 141 of the anchoring member 110 and surrounding an outer surface 127 of the valve support 120 , thereby preventing paravalvular leakage both between the device 100 and body structures and through components of the device 100 .

[0226] According to another embodiment of the present technology, Figures 19A-19C 1 and 2 are an isometric view, a side view, and a top view of the artificial heart valve device 100 having the sealing member 140. Figures 19A-19C , the device 100 includes a sealing member 140, such as a skirt 144. The skirt 144 can be disposed on the outer wall 142 or disposed on the inner wall 141 and at least partially on the upstream perimeter 113 of the anchoring member 110. Thus, the skirt 144 can be fixed and / or connected to any surface of the anchoring member 110. The skirt 144 can also cover the inner surface 126 of the valve support 120 (shown in Fig.19A ) and / or outer surface 127. The skirt 144 and / or other variations of the sealing member 140 can be configured to (1) form a blood flow inhibiting sealing member between the anchoring member 110 and native tissue, (2) block blood flow through the walls 141, 142 of the anchoring member 110 and / or through the surfaces 126, 127 of the valve support 120, and (3) block blood flow through the space between the valve support 120 and the anchoring member 110. In some embodiments, the sealing member 140 can be configured to promote ingrowth of adjacent tissue. The sealing member 140 can facilitate sealing between the anchoring member 110 and the valve support 120 and between the device 100 and surrounding body structures such that blood flow is limited to flowing from the left atrium to the left ventricle through the prosthetic valve 130. In addition, the sealing member 140 can be configured to seal the anchoring member 110 when it is in the expanded configuration 102 ( Fig. 10A , 16A and 19A) or in the expanded configuration 104 ( Fig. 10B and 16B) to provide circumferential support. In some embodiments, the sealing member 140 can be further used to attach the anchoring member 110 to the valve support 120. For example, the skirt 144 can be connected to the inner wall 141 of the anchoring member 110 and be integrally formed or otherwise attached to the sealing member 140 connected to the valve support 120. In other embodiments, the sealing member 140 can be used to connect the valve support 120 to the artificial valve 130 housed inside the valve support 120. The sealing member 140 (such as the skirt 144) can be connected to the anchoring member 110 and / or the valve support 120 with sutures, rivets or other known mechanical fasteners. In other embodiments, adhesives, glues and other bonding materials can be used to connect the sealing member to components of the device 100.

[0227] According to another embodiment of the present technology, Fig. 20A is an isometric view of the prosthetic heart valve device 100 without the sealing member 140, and Figures 20B-20E is an isometric view of a prosthetic heart valve device 100 having a sealing member 140. For example, Figures 20B-20C An embodiment of the device 100 is shown in which the sealing member 140 is a sleeve 146. The sleeve 146 may include an impermeable sealing material that is cylindrical and configured to fit within or onto a different frame or skeleton structure of the device 100 as further described below. Fig. 20B In the embodiment, the sleeve 146 is on the outer surface 127 of the valve support 120, and Fig. 20C In the embodiment of the present invention, the sleeve 146 is also disposed on the inner wall 141 of the anchoring member 110 and on the outer surface 127 of the valve support 120. Fig.20D An embodiment of the device 100 is shown in which the sleeve 146 is disposed on the outer wall 142 of the anchoring member 110 and on the outer surface 127 of the valve support 120. Fig.20E The device 100 may also have a sleeve 146 on both the outer wall 142 and the inner wall 141 of the anchoring member 110 and on the outer surface 127 of the valve support 120.

[0228] Those skilled in the art will recognize that the sealing member 140 (eg Figures 19A-20EThe skirt 144 and sleeve 146 shown in Figure 140 can completely cover the walls 141, 142 or surfaces 126, 127 of the anchoring member 110 and the valve support 120, respectively, or at least partially cover the walls 141, 142 and / or surfaces 126, 127 in other embodiments. Any combination of sealing members 140 is contemplated. In addition, the sealing member 140 may include a single continuous sheet of fluid-impermeable material (e.g., for covering the inner surface 141 of the anchoring member 110 and the outer surface 127 of the valve support 120), which can form a seal between the anchoring member 110 and the valve support 120. In different embodiments, the sealing member 140 (such as the skirt 144 or the sleeve 146) may include fabric or other flexible and biocompatible material (such as ePTFE, bovine pericardium) or other suitable flexible materials to integrate with the tissue and minimize paravalvular leakage. In other embodiments, the sealing member 140 may include a polymer, a thermoplastic polymer, a polyester, a Gore- Synthetic fibers, natural fibers, or polyethylene terephthalate (PET). The valve 130 may also be attached to or integrally formed with the sealing member 140 .

[0229] In another embodiment, Figures 21A-21F As shown in , the valve support 120 may include a tubular member 148 of fabric, polymer, or pericardium with little or no metal or other structural support.

[0230] Figures 21A-21B , the tubular member 148 can be a thicker and more rigid portion of the sleeve 146 that can maintain its shape and have sufficient strength to resist radial and axial stretching forces during systole and axial compressive forces during diastole. The leaflets 132 of the prosthetic valve 130 can be integrally formed with, sewn onto, or otherwise attached to the tubular member 148. In one embodiment, the tubular member 148 can be integrally formed with the outer portion 146A of the sleeve 146 that extends around the anchoring member 110 (shown in FIG. Fig.21A In another embodiment, the tubular member 148 may be a separate and / or thicker member that is sutured, bonded, or otherwise secured to the sleeve 146 in a blood-tight manner. The tubular member 148 may optionally include a reinforcing member to give it greater strength and help it maintain a desired shape suitable for operating the valve 130. For example, a series of relatively rigid longitudinal rods 190 of metal or polymer may be connected to or embedded within the wall of the tubular member 148 ( Fig. 21C ), and / or the coil 192 may extend around the wall of the tubular member 148 or be embedded within it ( Fig.21DIn another embodiment, a series of lanyards 194 may be connected between the outer portion 146A of the sleeve 146 and the tubular member 148 ( Fig.21E In one arrangement, the tether 194 can extend from the upstream portion 112 of the anchoring member 110 at a downstream angle to inhibit rupture or structural damage to the tubular member 148 during atrial contraction. In yet another embodiment, a plurality of vertical septa 196 can be interconnected between the anchoring member 110 (and / or the sealing member 140 coupled to the inner wall 141 of the anchoring member 110) and the tubular member 148 ( Fig.21F ). A plurality of vertical septa 196 connected between the anchoring member 110 and the valve support 120 can be a flexible fabric or polymer, and in some embodiments, can be the same material used for the sleeve 146. The septa 196 (which can collapse with the anchoring member 110 into a low-profile delivery configuration (not shown)) can also constrain the outward deflection of the ribs 114 when the device 100 is in the expanded configuration 102.

[0231] As described herein, the anchoring member 110 can be a structure or component that is independent of the valve support 120. In one embodiment, the anchoring member 110 can be connected to the valve support 120, for example, at the downstream end 123 of the valve support 120, while the upstream portion of the anchoring member 110 can remain unconnected to the valve support 120 and / or otherwise mechanically isolated from the valve support 120. The anchoring member 110 can be connected to the valve support 120 using different mechanisms, including flexible or non-rigid connection mechanisms. According to other embodiments of the present technology, Figures 22A-22G and 22I-22K are enlarged side views of various mechanisms for connecting the valve support 120 to the anchoring member 110 that allow relative movement between the downstream portion or the anchoring member 110 and the valve support 120 or otherwise provide mechanical isolation of the valve support 120 from the anchoring member 110.

[0232] Figures 22A-22B The downstream end 326 of the rib 114 of the anchoring member 110 connected to the post 122 of the valve support 120 is shown. In a first embodiment, the rib 114 can be connected to the post 122 by a suture, wire or other suitable filament 310 that is wrapped around adjacent components and knotted ( Fig. 22B In some embodiments, either or both of the ribs 114 and posts 122 may have a feature to which the filaments 310 may be secured, such as a through hole 312 ( FIG. 22C ), a ring or eyelet 314 ( Fig.22D ) or a groove 316 configured to retain the filament 310 therein and inhibit sliding along the rib 114 or the post 122.

[0233] exist Fig.22F In another embodiment shown in FIG. 1 , the rib 114 may be connected to the post 122 by a rivet, screw, pin or other fastener 318 passing through aligned holes 319 in the rib 114 and the post 122. Alternatively, and as Figures 22G-22H As shown in , the post 122 can have a cavity 320 in its outer wall that is configured to receive the downstream end 326 of the rib 144, and the two components 114, 122 can be fastened together by a filament or fastener 322. In this arrangement, a substantial portion of the contraction force exerted on the valve support 110 can be directly transferred to the rib 114 because the downstream end of the rib 114 engages the bottom surface of the cavity 320, thereby relieving the suture or fastener 322 from having to resist this force.

[0234] exist Figures 22I-22J In another embodiment shown in FIG, the downstream end 326 of the rib 114 passes through a passage 324 formed through the post 122. The downstream end 326 is then secured to the post 122 by a fastener 328 or filament (such as those described above). In addition, because the rib 114 is retained within the passage 324, the contraction load applied to the valve support 120 can be directly transferred to the rib 114 rather than the fastener 328. Figure 22K In yet another embodiment shown in FIG. 1 , the downstream end 330 of the post 122 is formed radially outward in a hook or J-shape, forming a channel 332 in which the downstream end 326 of the rib 114 can be received. The ends 330, 326 of the two components can be secured by fasteners 334 that pass through holes 319 in the rib 114 and the post 122. The contraction load applied to the post 122 can be directly transferred to the rib 114 through the channel 332, freeing the fasteners 334 from bearing a substantial portion of the load.

[0235] Figures 23A-23B Additional embodiments of mechanisms suitable for connecting the anchoring member 110 to the valve support 120 are shown. Figures 23A-23B In the embodiment shown in FIG, the circumferential connector 116 of the anchoring member 110 is connected to the rod 124 of the valve support 120. For example, in Fig.23A, the connector 116 is formed so as to have an hourglass-shaped portion 336 forming a waist 338 and an enlarged connector head 340 forming a connector unit 341. The rod 124 similarly has an enlarged rod head 346 forming a rod unit 347. The hourglass portion 336 of the connector 116 can be configured to pass through the rod unit 347 so that the rod head 346 extends around the waist 338 of the connector 116. The connector head 340 can be sufficiently large to prevent it from being released from the rod unit 347. In addition, due to the divergent angles of the connector segments 116A, 116B, the rod head 346 can be prevented from sliding upward relative to the connector head 340. In these arrangements, contraction loads applied to the valve support 120 in an upward direction can be transferred through the rod 124 to the connectors 116, which in turn transfer these forces to the ribs 114 that push into the natural body structure to fix the device 100 in place.

[0236] exist Fig. 23B In the embodiment of the present invention, the connector 116 can be formed so as to have a downwardly extending ring portion 348 that is nested in a concave portion 350 formed in the rod 124. The ring portion 348 can be secured to the concave portion 350 in a variety of ways, such as by wrapping a suture 352 around each member 348, 350. In this arrangement, a contraction load applied to the valve support 120 in an upward direction can be transferred to the ring portion 348 of the anchoring member 110 through the concave portion 350.

[0237] In other embodiments, the anchoring member 110 or selected components thereof can be integrally formed with the valve support 120. Fig.24A As shown in , the ribs 114 of the anchoring member 110 can be integrally formed with the posts 122 of the valve support 120 with U-shaped bridging members 356 interconnecting each rib 114 with a corresponding aligned post 122. The ribs 114 can be circumferentially interconnected by an expandable connector 116 integrally formed therewith. Fig.24A In the embodiment shown in FIG. 1 , a plurality of independent straps or wires 358 extend around the circumference 150 of the anchoring member 110 and are each slidably connected to the ribs 114, for example by extending through holes 360 formed in each independent rib 114. The flexible straps or wires 358 allow the ribs 114 to collapse inwardly into a low-profile delivery configuration (not shown) while limiting outward deflection of the ribs 114 when in the expanded configuration 102. Alternatively, a tether 361 of wire or suture may be connected between each rib 114 and the post 122 (shown in FIG. 1 ). Fig. 24B ), thereby limiting outward deflection of the ribs 114 when in the expanded configuration 102.

[0238] In other embodiments, sleeve 146 may be secured to rib 114 in a manner that limits outward deflection of rib 114 when device 100 is in the expanded configuration (shown in FIG. Fig.24C The sleeve 146 may be as follows. Fig.24C 144, for example, extending around the outside of each rib 114, thereby constraining it from expanding outwardly beyond a predetermined limit. Optionally, the sleeve 146 may further include a horizontal diaphragm 359 extending between an inner portion 146B of the sleeve 146 extending around the valve support 120 and an outer portion 146A of the sleeve 146 extending around the anchoring member 110. The horizontal diaphragm 359 can more rigidly constrain the outward deflection of the rib 114. In some embodiments, the diaphragm 359 can also seal the annular cavity 163 formed by the diaphragm 359 between the inner portion 146B and the outer portion 146A, thereby limiting the flow of blood into this cavity 163 and minimizing the formation of clots therein. Alternatively, openings (not shown) can be formed in the sleeve 146 downstream of the diaphragm 359, which can allow blood to flow into the closed cavity 163 to form a clot area, thereby limiting the deflection of the rib 114 and making the device more rigid and firmly anchored. The septum 359, which may be a flexible fabric, polymeric or pericardial material, may be positioned at the upstream end of the device 100 as shown or at a location spaced further downstream from the upstream end 121 of the valve support 120. Fig.24D In another embodiment shown in FIG. 1 , each individual rib 114 can be constrained within a passage 364 formed in the sleeve 146 by sewing or bonding together two layers of sleeve fabric. In the expanded configuration 102, movement of the rib 114 can be restricted relative to the sleeve 146.

[0239] According to an embodiment of the present technology, Fig.25A is a partial cross-sectional view of a prosthetic heart valve device 100 having an anchoring member 110 and a valve support 120, and Fig.25B yes Fig.25A An enlarged view of the specified box is shown in . Fig.25A and 25B As shown in , there can be a gap 108 between the valve support 120 and the lower portion 111 of the anchoring member 110. If there is a gap 108, the gap 108 can be protected by a sleeve 146 to prevent blood from leaking between the anchoring member 110 and the valve support 120 in an upward or downward direction.

[0240] According to various embodiments of the present technology, Figures 26A-26D is a schematic cross-sectional view of a prosthetic heart valve device 100 having an atrial retainer 410 and implanted at a native mitral valve MV. Figures 26A-26CSeveral embodiments of the device 100 are shown, wherein the device 100 includes an atrial retainer 410 configured to engage the supra-annular surface or other tissue of the annulus AN inside the left atrium, thereby assisting the native leaflets in preventing the downward migration of the device 100 into the left ventricle. In these arrangements, the annulus AN can be clamped between the top circumference 150 of the anchoring member 110 and the bottom surface of the atrial retainer 410.

[0241] like Fig.26A As shown in , an embodiment of the device 100 may include an atrial retainer 410 connected to or integrally formed with the inner valve support 120. The atrial retainer 410 may extend upward through the valve annulus AN and enter the supra-annular space inside the atrium and engage the supra-annular surface or other atrial tissue with an outwardly extending flange 420. Fig.26B In another embodiment shown in FIG. 4 , the atrial retainer 410 may include a plurality of fingers 412 that may be integrally formed with the valve support 120 or otherwise connected thereto (e.g., including an upward extension of the post 122 or an upward extension of the anchoring member 110). The fingers 212 may be substantially uncovered or exposed within the left atrium, such as Fig.26B ; however, in another embodiment, the finger 412 may be covered with a sealing member (not shown) or other covering of fabric, a polymer sheet, or pericardial tissue extending around the outer or inner surface of the finger 412, thereby forming a conical shape to facilitate sealing the device 100 with natural tissue on the atrial side of the valve annulus AN and to facilitate blood delivery to the artificial valve 130 ( Fig. 10A ). The fingers 412 may also include a circumferential rod (not shown) interconnecting the fingers 412 to limit lateral deflection of the fingers and enhance the rigidity of the fingers. The fingers 412 may include an elastic shape memory material (e.g., nitinol) so that the fingers can straighten and deflect inward for delivery and be released to an unbiased radially outwardly protruding position in the expanded configuration 102 as shown. For example, the fingers 412 may have finger tips 414 that are biased outwardly and in some arrangements in a downstream direction in the expanded configuration 102. During delivery to a desired location inside the native mitral valve MV, the device 100 may be unsheathed in a distal or downstream direction (discussed in more detail below) so that the fingers 412 are first released to engage the atrial side of the valve annulus AN. This indicates the position of the device 100 relative to the native valve, thereby ensuring that the anchoring member 110 is positioned on the ventricular side of the native valve annulus AN without over-extending into the ventricle when it is withdrawn and expanded.

[0242] Atrial retainer 410 may alternatively be an extension of anchoring member 110. Fig.26CIn one embodiment shown in FIG. 4 , the atrial retainer 410 may include a plurality of atrial rings 416 that, although depicted in a more vertical plane, may alternatively be located in a plane more parallel to the plane of the native valve annulus AN and extend upward through the valve annulus AN and then extend radially outward to engage the superior surface of the valve annulus. The rings 416 (which may include extensions of one or more ribs 114 of the anchoring member 110) may include a plurality of atrial rings 416 that may be extruded into a low profile shape for delivery and then released to expand into a Fig.26C A resilient shape memory metal (e.g., Nitinol) or other material in a radially extending configuration as shown in FIG. Fig.26C Similar to the device 100, Fig.26D 1 is also a cross-sectional view of a prosthetic heart valve device 100 including an atrial retainer 410 formed by an extension of the anchoring member 110. Fig.26D As shown in , the atrial retainer 410 may include a cylindrical portion 418 extending upward from the anchoring member 110 through the native valve ring AN and having a flange 420 at a proximal region extending on the atrial side of the native valve ring AN to engage the surface above the valve ring. The flange 420 may include an elastic shape memory material (e.g., nitinol) that can collapse for delivery and expansion when deployed at the native mitral valve MV. The cylindrical portion 418 and the flange 420 may be integrally formed with the anchoring member 110 (e.g., including an extension of the rib 114), or in another embodiment may be connected to one or more portions of the anchoring member 110 and / or the valve support 120.

[0243] In other embodiments, the prosthetic heart valve device 100 may include atrial extension features that help maintain the device 100 in a desired position within the native mitral valve but do not substantially engage the atrial or supra-annular tissue. For example, according to another embodiment of the present technology, Fig. 274 is a side view of an anchoring member 110 having a vertical portion 422 at an upstream end 424 for engaging the valve annulus AN. The anchoring member 110 may include a lower portion 111 and an upper expanded portion 112, which may be positioned in a subannular position between the leaflets LF and the downstream of the valve annulus AN. The upstream portion 112 may be expandable to a larger dimension than the corresponding dimension of the subannular tissue and / or the inward leaflets LF. The vertical portion 422 may fit inside the valve annulus orifice so as to engage the valve annulus AN around the entire upstream circumference 150 of the anchoring member 110. The vertical portion 422 may be expandable to a larger dimension than the corresponding dimension of the valve annulus AN, so that the radial expansion of the vertical portion 422 presses outward against the native tissue, thereby helping to maintain the device in a desired position inside the native mitral valve. Optionally, the anchoring member 110 may also include a plurality of tissue engaging components 170, such as spikes. In one embodiment, the spikes (shown here as tissue engaging elements 170) can be distributed around the circumference 150 of the upper portion 112 of the anchoring member 110 and be oriented so that the spikes can penetrate tissue in a position below the valve annulus and can be configured to help the anchoring member 110 resist movement in an upward or downward direction.

[0244] Artificial heart valve device with stabilizing member

[0245] Fig.28 An embodiment of a prosthetic heart valve device 100 is shown in an expanded configuration 102, further comprising one or more stabilizing members 501 to help stabilize the device 100 at the native valve site and, in some embodiments, prevent tilting or lateral migration of the device 100 or inhibit its upward or downward migration. In some embodiments, the stabilizing member 501 may include one or more arms 510 extending from the lower or downstream portion 111 of the anchoring member 110. The arms 510 are configured to engage native tissue, such as the leaflets, subannular tissue, or the ventricular wall, either inside or outside the native leaflets (depending on the configuration).

[0246] According to an embodiment of the present technology, Fig.29 FIG. 1 is an enlarged side view of an artificial heart valve device with an extended arm. Fig.29As shown in , the independent arm 510 may include an arm body 512, an arm extension 514, and an arm tip 516. The arm body 512 has an arm body length L1 and may be connected to the post 511 at the first joint 508. The post 511 may be a valve support post 122, an anchoring member rib 114, and / or another feature (e.g., a rod 124 or a connector 116) of the device 100. The first arm angle AA1 is formed by the intersection of the axes of the post 511 and the arm body 512; the first arm angle AA1 is selected so that the arm 512 is positionable so that the tip 516 can engage the natural tissue at a desired location (e.g., tissue below the valve annulus or in the ventricular wall behind the natural valve leaflet). According to another embodiment of the present technology, Figures 30A-30C FIG. 30A is an enlarged partial side view of an artificial heart valve device 100 having arms 510 connected to the device at different angles relative to the longitudinal axis 101 of the device. In one embodiment, the first arm angle AA1 can be about 10° to about 45°. In other embodiments, the first arm angle AA1 can be an obtuse angle ( FIG. 30A ), substantially vertical, or about a 90° angle ( FIG. 30B ). Fig. 30B ), or acute angles ( Fig. 30C ).

[0247] Return to view Fig.29 , the arm body 512 can be connected to the arm extension 514 at the distal end of the arm body 512. The arm extension 514 can have an arm extension length L2, which can be selected or optimized to penetrate into the natural tissue at a desired distance (such as about 0.5-2mm). The arm extension 514 can extend from the arm body 212 at a second arm angle AA2. The second arm angle AA2 can be formed by the intersection between the arm extension 514 and the arm body 512 and is selected to provide a desired angle for engagement with natural tissue, such as about 100° to about 135°. In other embodiments, the arm extension 514 can be parallel or colinear with the arm body 512 (not shown), or can be completely eliminated. The arm extension 514 is terminated at the arm tip 516. In an embodiment without the arm extension 514, the arm tip 516 can be the distalmost portion of the arm body 512 (not shown).

[0248] The arm 510 can have an arm height HA1 (shown in FIG. 1 ) extending from the first joint 508 to the most distal reach of the arm (which can be the arm tip 516) along an axis parallel to the longitudinal axis 101 of the device 100. Fig.29 The arm height HA1 can be selected or optimized so that when the device 100 is in a desired longitudinal position relative to the native mitral valve (e.g., when the anchoring member 110 is in engagement with the subannular tissue), the arm tip 516 engages a desired location in the anatomy below the annulus. The arm height HA1 will depend on the overall height of the anchoring member 110 and / or valve support 120 and the location of the joint 508. Figures 31A-31C1 is an enlarged partial side view of a prosthetic heart valve device having arms 510 of varying lengths (L1+L2) and, therefore, a variable height HA1. As shown, the arm height HA1 can be greater than the overall height HD1 (represented by ribs 114) of the anchoring member 110 or the valve support. Fig.31A ), is an intermediate value between the respective heights HD1 and HV1 of the anchoring member 110 (represented by the rib 114) and the valve support 120 (represented by the post 122). Fig.31B ), or less than the total height HD1 of the anchoring member 110 (represented by the rib 114) and the valve support 120 ( Fig.31C ).

[0249] Additional details and embodiments regarding the structure and attachment of arms or other stabilizing members suitable for device 100 may be found in International PCT Patent Application No. PCT / US2012 / 043636, entitled “PROSTHETICHEART VALVE DEVICES AND ASSOCIATED SYSTEMS AND METHODS,” filed on June 21, 2012, the entire contents of which are incorporated herein by reference.

[0250] Fig.32A , 32B , 32C and 32D are cross-sectional views of a heart having an implanted prosthetic heart valve device 100 having arms 510a disposed on the inwardly facing surface of the leaflet LF, and Figure 32A-1 , 32B-1, 32C-1 and 32D-1 are respectively connected as Fig.32A , 32B , 32C and 32D-1 are enlarged views of the arms 510a of the inward surface of the leaflets. The embodiment of the artificial heart valve device 100 shown in Figures 32A-32D-1 has arms 510a that are configured to expand to positions radially inside the leaflets LF, radially outside the leaflets LF, or a combination of inside and outside the leaflets LF. For example, Fig.32A and 32A-1 The arm 510a is shown expanded and engaging the inward surface of the leaflet LF and the arm 510a is shown partially piercing the leaflet LF. Fig.32B and 32B-1 In another example shown in FIG. 1 , arms 510a can completely penetrate the leaflets LF. In another example, device 100 can include arms 510a that 1) completely penetrate the leaflets LF and 2) partially puncture the subannular tissue ( Fig.32C and 32C-1 ). Fig.32D and 32D-1, the device 100 can be configured to have arms 510a that completely penetrate both the leaflets LF and the annular tissue of the mitral valve MV.

[0251] According to this technology, Figures 33A-33C 1 is a schematic diagram showing different embodiments of tissue engaging components 170 for use with prosthetic heart valve devices 100. Tissue engaging components 170 may include any features that engage tissue in an atraumatic manner (e.g., a blunt-tipped component) or partially pierce or completely penetrate cardiac tissue (e.g., a barb or thorn). As used herein, "tissue engaging" refers to a component 170 that exerts force on tissue T but does not necessarily pierce tissue T (e.g., atraumatic to tissue T), such as Fig.33A As used herein, "partially piercing" refers to at least partially penetrating the tissue T but not breaking through the tissue engagement feature 170 of the opposing surface S, such as Fig.33B As used herein, "completely piercing" refers to a tissue engaging feature 170 that can both enter and exit tissue T, such as Fig.33C . "Piercing" alone may refer to partial or complete puncture. Tissue engaging member 170 may take the form of spikes, barbs, or any structure known in the art capable of piercing cardiac tissue, or alternatively any blunt or non-invasive feature configured to apply pressure to cardiac tissue without piercing the tissue. Additional details regarding positioning these components are described herein.

[0252] Fig.34A , 34B and 34C is a cross-sectional view of a heart having an implanted prosthetic heart valve device 100 with arms 510a having tissue engaging members 170 disposed on the inwardly facing surfaces of leaflets LF, and Figure 34A-1 , 34B-1 and 34C-1 are respectively connected as Fig.34A , 34B and 34C are enlarged views of the arm 510a of the inward surface of the leaflet LF. Figure 34A-34C-1 As shown in FIG. 5 , the tissue engaging member 170 may be attached to the arm 510a and in a downward direction ( Fig.34A and 34A-1 ), Upward direction( Fig.34B and 34B-1 ) or both downward and upward directions ( Fig.34C and 34C-1 ) extend from these arms. In other embodiments, the tissue engaging element 170 can be on a component of the anchoring member 110 and / or the valve support 120 and extend therefrom in either or both an upstream and downstream direction.

[0253] According to various embodiments of the present technology, Figures 35A-35C35A shows an embodiment of a device 100 including arms 510b that are configured to extend from a downstream end of the device 100 (e.g., a ventricular end of the device implanted at the native mitral valve downstream of the leaflets) to reach behind the leaflets LF so that the leaflets LF are effectively sandwiched between the arms 510b of the anchoring member 110 and the outer wall 142. In another embodiment, and as shown in FIG. Fig.35B As shown in , the arm 510b can cause the leaflet LF to fold over itself in the space between the arm 510b of the anchoring member 110 and the outer wall 142. Fig.35C In another embodiment shown in FIG. 5 , arm 510 b may further include a tissue engaging component 170 . Figure 35C-1 is an enlarged view of arm 510b, as shown Fig.35C As shown in , the arm has a tissue engaging member 170 for engaging the outward surface of the leaflet LF. Figure 35C-1 As shown in , arms 510b configured to engage the outward-facing surface of the native leaflets LF can include tissue engaging features 170 on the inner surface of the arms 510b such that they are oriented toward the leaflet tissue.

[0254] According to another embodiment of the present technology, Fig.36A is a side view (shown in cross-section) illustrating the prosthetic heart valve device 100 implanted at the mitral valve MV. Fig.36A The device shown in FIG. 100 has arms 510b for engaging the outward-facing surface of the native leaflet LF and arms 510a for engaging the inward-facing surface of the native leaflet LF. The inner / outer arms 510a, 510b may further include tissue engaging members 170 on the radially inner or radially outer surface of the arms 510a, 510b, respectively, for engaging or piercing the leaflet tissue. The arrangement of the inner / outer arms 510a, 510b around the circumference of the device 100 may alternate in a pre-designed pattern. For example, the inner arms 510a may be arranged as follows: Fig.36B , alternating with the outer arm 510b, or alternatively, the arms 510a, 510b may extend radially outward and / or radially inward at random or at irregular intervals, depending on the placement of the device 100 and relative to the alignment with the natural posterior and anterior leaflets.

[0255] According to this technology, Figures 37A-37D is an enlarged side view of another embodiment of an arm 510 suitable for use with the prosthetic heart valve device 100. Figures 37A-37DIn some embodiments, the arm 510 can have an overall profile similar to the shape of the anchoring member 110. The anchoring member 110 can include ribs having rib segments 85 of different shapes, sizes, and / or outward or inward orientations to form the overall anchoring member profile. Thus, the arm 510 can also have arm segments of different shapes, sizes, and / or outward or inward orientations that mimic the shape of the anchoring member 110. In some arrangements, Figures 37A-37D The embodiment shown in is configured to sandwich the leaflet LF and / or annulus AN tissue between the arms 510 and the ribs 114 so that the leaflet tissue conforms to the shape of the anchoring device 110 to enhance the sealing and anchoring of the device. For example, Fig.37A One embodiment is shown in which the arm extension 514 and / or the arm body 512 may partially mimic the shape of the rib 114 and / or the rib segment 85, and Fig.37B Another embodiment is shown in which the arm extension 514 and / or the arm body 512 more closely follows the shape of the rib 114. Figures 37A-37B Contemplated embodiments may be adapted to engage the outwardly facing surface arm 510b and / or the inwardly facing surface arm 510a. Figures 37A-37B As shown in FIG. 1 , the arm extension 514 may extend radially outwardly so as to be generally parallel to the upstream section 85A of the rib 114. The arm extension 514 may be configured to extend partially along the length ( Fig.37A and 37C ) or completely along the length of the rib 114 and / or rib segment 85. Fig.37D , the arms 510 have second arm extensions 518 that are connected to upstream portions of the first arm extensions 514 and extend outwardly so as to be generally parallel to the second rib segment 85B and the third rib segment 85A.

[0256] In some embodiments, the artificial heart valve device 100 can have multiple arms 510 around the circumference of the device 100; however, in other embodiments, the device can include multiple arms in multiple groups (e.g., first and second groups to engage the posterior leaflet and the anterior leaflet, respectively). In addition, the arms 510 can extend from the anchoring member 110 and / or the valve support 120 independently of other components including other arms 510, such as Fig.38A In other embodiments and as Fig.38B As shown in FIG. 1 , the device 100 may further include at least one first arm 510x interconnected with at least one second arm 510y via an interconnecting arm 520. The arm 520 may be configured to be circumferentially expandable and may connect all arms 510 (e.g., arms 510x and 510y) or one or more groups of arms 510. In some embodiments, the arm 520 may limit outward extension of the arms 510x, 510y away from the device 100.

[0257] In accordance with aspects of the present technique, the arms 510 may be connected to and / or extend from components of the device 100 symmetrically and / or asymmetrically around the perimeter 150 of the device 100 . Figures 39A-39D is relative to the rib 114 of the anchoring member 110 (e.g., Fig.38A 14. The arm 510 may be interspersed with ribs 114 ( Fig.39A and 39C ), in the same radial plane as the rib 114 of the anchoring member 110 ( Fig.39B ), or both interspersed with ribs 114 and in its plane ( Fig.39D Additionally, the arms 510 can be configured to extend outside the expanded outer perimeter 150 of the anchoring member 110 ( Fig.39B ), extending within the expanded outer perimeter 150 of the anchoring member 110 ( Fig.39A ), extending to the same outer perimeter 150 of the anchoring member 110 ( Fig.39C ), or a combination of these configurations ( Fig.39D ).

[0258] In the above-described embodiments, the arms 510 can be configured to engage tissue independently of the deployment of the anchoring member 110. For example, a delivery catheter suitable for delivering the artificial heart valve device 100 can be equipped with an independent mechanism operable to deploy the arms 510 and the anchoring member 110 individually or otherwise independently of each other. In this way, the anchoring member 110 can be first released into engagement with the natural tissue so that the position of the device 100 can be assessed and adjusted by the operator until the desired final position has been reached. After the deployment and positioning of the anchoring member 110, the arms 510 can be released to engage the tissue. These deployment systems and methods are applicable when the arms 510 are equipped with tissue engagement components 170, which, once deployed, can inhibit any repositioning of the device 100. In some embodiments, the anchoring member 110 will be equipped with a non-invasive tissue engagement component 170 that does not penetrate tissue or inhibit device repositioning when the anchoring member 110 has been deployed. Thus, some embodiments of device 100 may be repositionable even with anchoring member 110 expanded, as long as arms 510 are constrained in an undeployed configuration, and device 100 becomes permanently anchored only when arms 510 are released.

[0259] Alternatively or in addition to the presence of tissue engaging elements 170 on arms 510 as described above, tissue engaging elements 170 may be present on other components of device 100. According to further embodiments of the present technology, Figures 40A-40E1 is a side view of a prosthetic heart valve device 100 having tissue engaging elements 170 on different structures of the device 100. For example, the tissue engaging elements 170 can be incorporated on the ribs 114 of the anchoring member 110. Fig.40A A tissue engaging member 170 is shown and is on the upper rib section 85A, and Fig.40B Tissue engaging member 170 is shown on lower rib segment 85B. Fig.40C An embodiment of the device is shown having tissue engaging elements 170 along the entire rib 114. The tissue engaging elements 170 are schematically shown in Figures 40A-40C , but one of ordinary skill in the art will recognize that these components can be any of the different tissue engaging components 170 described herein (e.g., non-invasive, partially puncturing, fully penetrating, etc.), or a combination of different types of tissue engaging components 170 in other embodiments. In addition, the tissue engaging components 170 are shown as being oriented in an upward direction (e.g., to inhibit upward migration of the device 100); however, in other embodiments, the tissue engaging components 170 can be oriented in a downward direction (e.g., to inhibit downward migration of the device 100) or in a combination of downward and upward orientations. The tissue engaging components 170 can be incorporated symmetrically around the circumference of the device 100, or in other embodiments, the tissue engaging components 170 can be incorporated asymmetrically. For example, in some embodiments, the tissue engaging components 170 can be present on the side of the device 100 aligned with the posterior leaflet, but not present or arranged differently on the side of the device 100 aligned with the anterior leaflet, so that the wall separating the aortic valve from the left ventricle is not affected by the tissue engaging components 170.

[0260] Fig.40D An embodiment of a device 100 having tissue engaging members 170 (e.g., spikes) on the upstream tips 175 of the ribs 114 is shown, wherein the spikes can be configured to fully or partially penetrate the subannular tissue when the device 100 is deployed above or below the annulus of the mitral valve. In some embodiments, the tissue engaging members 170 (e.g., spikes) can include barbs 176 or other features for retaining the tissue engaging members 170 (e.g., spikes) in the tissue. In other embodiments, the tissue engaging members 170 (e.g., spikes) can be blunt-tipped so as to engage but not penetrate the subannular tissue. Figures 40E-40G1 is an enlarged side view of a tissue engaging member 170 (e.g., spike) adapted for use on an upstream tip 175 of a rib 114. The device 100 having the tissue engaging member 170 on the upstream tip 175 may also incorporate features for limiting the distance of penetration into the tissue. For example, the upstream tip 175 may have a handle 177 formed a short distance (e.g., 1-5 mm) proximal to the tip of each tissue engaging member 170, thereby limiting the distance (e.g., 1-5 mm) that the tissue engaging member 170 can penetrate into the tissue beneath the annulus. Fig.40E ). Alternatively, Fig.40F As shown in , the depth of penetration of the tissue engaging member 170 into the tissue can be limited by positioning the connector 116 a desired distance from the tip of the tissue engaging member 170. Figure 40G In another embodiment shown in , sealing member 140 can be attached to rib 114 so that upstream edge 178 of sealing member 140 can limit the penetration depth of tissue engaging element 170. To prevent sealing member 140 from sliding downward, an attachment feature (such as hole 173) configured to receive a suture can be formed in rib 114 at a desired distance from its upstream tip 175, and sealing member 140 can be firmly fixed to the attachment feature.

[0261] Alternatively, tissue engaging features 170 (e.g., bumps, ridges, or other protrusions) configured to generate frictional forces against cardiac tissue may also be present on one or more valve support rods 124, valve support posts 122, and / or other components (e.g., sealing member 140). These tissue engaging features 170 may be disposed on the exterior portions of these features and may be configured to extend outwardly to engage the native leaflets and stabilize and firmly anchor the device 100 in a desired position. Alternatively, directional ridges, scales, bristles, or other features may be formed on the surface of the ribs 114, connectors 116, or sealing member 140 to allow movement in one direction relative to the native tissue while restricting movement in the opposite direction.

[0262] The tissue engaging parts 170 on the anchoring member 110 can be barbs, spikes or other retaining features, which are configured to have delayed expansion so as to allow the device to be repositioned or removed for a period of time until these parts become fully expanded. For example, the tissue engaging parts 170 can be constructed by shape memory materials (such as nitinol), which are preformed in an expanded configuration and are suitable for maintaining the tissue engaging parts 170 in natural tissue. The tissue engaging parts 170 can be deformed into a contracted configuration that allows removal from tissue, and are maintained in this shape by bioerodible materials or adhesives. Once immersed in tissue, this material can be eroded in a period of time (such as 10 minutes-2 hours), allowing the tissue engaging parts 170 to return to its unbiased expanded shape, which will help to maintain the tissue engaging parts 170 in the tissue.

[0263] Several examples of these delayed deployable tissue engaging members 170 are shown in FIGS. 40H-40S. Figure 40H In an embodiment of the present invention, the tissue engaging member 170 comprises a shape memory alloy shaft 450 that is laser cut to have a diamond-shaped window 451 near its distal tip 452, which can be sharp enough to penetrate tissue. The shape is set so that the window 451 is biased toward opening in an expanded configuration, as shown in Figure 40H. Prior to delivery of the device, the window 451 can be pressed closed, and a bio-erodible glue 455 can be injected into the window 451 to keep it in a closed configuration, as shown in Figure 40H. Fig.40I When the device is deployed, the distal tip 452 can penetrate native tissue, such as a valve leaflet or a valve annulus, as shown in FIG. Fig.40J . The glue 455 inside the window 451 maintains it in a closed configuration for a period of time to allow the operator to reposition or remove the device if necessary. If left in place, the glue 455 will erode, allowing the window 451 to reopen to an expanded configuration that will retain the tissue engaging member 170 in the tissue, such as Figure 40K as shown in .

[0264] exist Figure 40L-40O In the embodiment shown in FIG. 1 , the tissue engaging member 170 includes an arrowhead-shaped tip 453 having two or more wings 454 that are offset to a radially outward angle and point in a proximal direction, such as Figure 40L A bio-erodible glue or coating 455 is applied to the arrow tip 453 to keep the wings 454 in a radially contracted configuration, as shown in FIG. Figure 40M In the collapsed configuration, the device 100 is deployed such that the tissue engaging member 170 penetrates the native tissue, such as Figure 40NThe bioerodible coating 455 then gradually erodes until it allows the wing 454 to return to its original position. Fig.40O , thereby retaining tissue engaging elements 170 in the tissue.

[0265] Another embodiment is shown in Figure 40P-40S In this embodiment, the tissue engaging member 170 includes a helical tip 456 in an unbiased state. The bioerodible coating 455 can be used to maintain the helical tip 456 in a straightened configuration, such as Figure 40Q . The tissue engaging member 170 can penetrate tissue in the collapsed configuration and can remain in the tissue when the bioerodible coating 455 is sufficiently eroded to allow the helical tip 456 to return to its expanded configuration.

[0266] The artificial heart valve device 100 can also be configured with additional tissue engagement components 170 for engaging the valve annulus. For example, according to another embodiment of the present technology, FIG. 41 is an isometric view of an artificial heart valve device 100 having multiple valve annulus engagement components 179. The valve annulus engagement components 179 can be C-shaped hook features or other shapes that allow the components 179 to engage the tissue on the valve annulus, as well as a portion of the tissue above the valve annulus and the tissue below the valve annulus. As shown, the valve annulus engagement components 179 can be symmetrically arranged around the upstream circumference of the anchoring member 110 (shown in FIG. 41). Fig.41 The annulus engaging element 179 may be arranged in a symmetrical manner and connected to the rib 114, the connector 116 (not shown), or the sealing member 140. The annulus engaging element 179 may also be connected to the anchoring member 110 at other locations downstream of the upstream circumference 113, or in other embodiments, may be connected to a portion of the annulus extending through at least the annulus plane PO ( Figure 3 ) is connected to a portion of the valve support 120 of the annulus. In addition, the annulus engagement component 179 can be blunt (e.g., for pressing rather than penetrating into the annulus tissue), or it can be sharp for penetrating the annulus tissue on either or both of the annular surface above or below the annulus. The annular engagement component 179 can be adapted to position the device 100 in a desired position (e.g., with the anchoring member 110 below the annulus) and inhibit movement of the device in an upstream or downstream direction.

[0267] exist Figures 42A-42B In another embodiment shown in FIG. 1 , the prosthetic heart valve device 100 can have a tissue engaging member 372 deployable from a plurality of tubular ribs 314. Fig.42A , the prosthetic heart valve device 100 can have an anchoring member 110 having a plurality of tubular ribs 314 configured to retain a plurality of deployable tissue engaging elements 372. Fig.42B314 and an expandable tissue engaging member 372 retained within the lumen 316 of the rib 314 and displayed prior to the expansion member 372. The tissue engaging member 372 may include a shape memory material (e.g., nitinol) configured to expand into a preformed shape when the tissue engaging member 372 is released from the interior lumen 316 of the rib 314. The release of the tissue engaging member 372 may be achieved by engaging the proximal end 374 of the tissue engaging member 372. For example, the proximal end 374 may be engaged during deployment of the device 100, thereby releasing the tissue engaging member 372 after the anchoring member 110 is positioned at a desired position below the valve annulus AN. The tubular rib 314 may include a U-shaped deflector 318 and a pivot point 320 configured to guide the tissue engaging member 372 distally through the distal opening 315 of the rib 314. 42B , engagement of the proximal ends 374 of the members 372 will facilitate penetration of the distal ends 376 of the tissue engaging members 372 into the adjacent subannular tissue from the distal openings 315 of the tubular ribs 314. Once deployed and after leaving the opposing surface S (e.g., the surface above the annulus), the tissue engaging members 372 can transition into their preformed shape (e.g., the curled shape 378), which can resist retraction of the distal ends 376 from the tissue.

[0268] According to another embodiment of the prosthetic device 100, the tissue engaging element 170 may be incorporated into the sealing member 140 (eg, the sleeve 146). Figures 43A-43B 1 is an isometric view and an enlarged detailed view of a prosthetic heart valve device 100 having a sealing member 140 configured with tissue engaging elements 170. Figures 43A-43B , the tissue engaging elements 170 may include metal or polymeric wires 274 or fibers that are rigid and sharp enough to penetrate tissue and are woven into or otherwise connected to the sealing member 140 material. The sealing member 140 may then be attached to the outer and / or inner walls 141, 142 of the anchoring member 110 and / or the inner and / or outer surfaces 126, 127 of the valve support 120 such that the tissue engaging elements 170 extend radially outward from the sealing member 140 to engage adjacent leaflets or other tissue.

[0269] Figures 44A-44F 1 is an enlarged side view of an embodiment of an additional tissue engaging member that may be incorporated into various device structures (collectively referred to as "ST"), such as a rod, connector, post, arm, and / or rib that may be incorporated into a device feature (such as anchoring member 110 or valve support 120). For example, in lieu of or in addition to tissue engaging member 170, the additional tissue engaging member may include one or more breakaway projections 350 ( Fig.44A and 44B ). In the collapsed or stretched configuration, as Fig.44CAs shown in the side view of FIG. 1 , the disconnected protrusion 350 maintains a low relief relative to the surface of the structure ST to maintain a low profile during delivery. As the device 100 expands and the structure ST changes to its deployed configuration (e.g., curvature, such as Fig.44D ), the protrusion is separated from the ST to a higher relief. The protrusion 350 can also be configured to grab the tissue below the valve ring, even if it is pulled away from the structure ST. The device structure ST can also be formed to include a sharp protrusion 352 along one or more of its edges or faces, such as Fig.44E As shown in , or may also include sharp scale-like protrusions 354, such as Fig.44F as shown in .

[0270] In addition to the stabilizing member 501 described above, the prosthetic heart valve devices described herein (e.g., device 100) may also include support features (e.g., tethers 360 and sealing member septum 370) for stabilizing the anchoring member 110 and / or valve support 120 and / or for evenly distributing pressure gradient loads over a larger area of ​​the device 100 (e.g., during ventricular contraction). Fig.45A , an example of the device 100 can include a plurality of tethers 360 that at least loosely connect the upper portion 112 of the anchoring member 110 to the upstream end 121 of the valve support 120. In one embodiment, the tether 360 can include a single suture that is continuously arranged around the circumference 150 of the anchoring member 110. In another embodiment, the device 100 can include several sutures of an inconspicuous length that are knotted between the anchoring member 110 and the valve support 120. In one embodiment, the tether can be a suture that includes polytetrafluoroethylene (PTFE). In general, the tether 360 helps to evenly distribute the force along the anchoring member 110 without deforming the valve support 120 or compromising the closure of the artificial valve 130. In some arrangements, the tether 360 can help to limit radial expansion of the upstream portion. Therefore, even with the incorporation of the tether 360, the valve support 120 remains mechanically isolated from at least the upstream portion of the anchoring member 110.

[0271] Fig.45B Another example of a stabilizing member 501 suitable for stabilizing the anchoring member 110 and / or the valve support 120 and / or for evenly distributing the pressure gradient load over a larger area of ​​the device 100 (e.g., during ventricular systole) is shown. Fig.45BAs shown in , the device 100 may include a plurality of sealing member membranes 370 extending between the anchoring member 110 and the valve support 120. In the illustrated embodiment, the membranes 370 may be an extension of sealing member material configured to span between the sealing member 140 (such as the skirt 144) connected to the inner wall 141 of the anchoring member 110 and the sealing member 140 (such as the sleeve 146) connected to the inner or outer surface 126, 127 of the valve support 120. Thus, the membranes 370 may be made of fabric or other flexible and biocompatible materials (such as ePTFE, bovine pericardium or other suitable materials). Fig.45A Similar to the embodiment shown in FIG. 1 , the septum 370 can help distribute forces evenly along the anchoring member 110 without deforming the valve support 120 or otherwise compromising the closure of the prosthetic valve 130. In some arrangements, the septum 370 can help prevent the device 100 from everting during ventricular systole. Thus, even with the incorporation of the septum 370, the valve support 120 is mechanically isolated from at least the upstream portion of the anchoring member 110.

[0272] Each of the components and members of the device 100 can be made of a number of suitable biocompatible materials, such as stainless steel, nickel-titanium alloys (such as Nitinol™), cobalt-chromium alloys (such as MP35N), other alloys (such as (Elgin, IL), various polymers, pyrolytic carbon, silicone, polytetrafluoroethylene (PTFE), or many other materials or combinations of materials, depending on the desired results. The arm members 510, sealing member 140, sleeve 146, anchoring member 110, and / or valve support 120 or other components of the device 100 may also be made of materials that promote tissue ingrowth (e.g., PTFE, etc.) coating or covering.

[0273] Delivery System

[0274] Figures 46A-46D One embodiment of a delivery system 10 suitable for delivering a prosthetic heart valve device disclosed herein is shown. As used with reference to a delivery system, "distal" refers to a location along the longitudinal axis of the system 10 that is a distance further away from the handle of the delivery system 10, and "proximal" refers to a location along the longitudinal axis of the system 10 that is a distance closer to the handle of the delivery system 10.

[0275] Fig.46AAn embodiment of a delivery system 10 is shown, which can be used to deliver and deploy an embodiment of an artificial heart valve device 100 disclosed herein through a vascular structure and to reach the patient's heart. The delivery system 10 can optionally include a guide catheter GC having a handle 12 connected to a delivery shaft 16, whose diameter is 34F or less in one embodiment and 28F or less in another embodiment. The guide catheter GC can be manipulable or preformed in a configuration suitable for a specific approach to the target valve. The delivery catheter 18 is placed on the proximal end of the guide catheter GC through the hemostatic valve HV, and includes a flexible tubular outer shaft 19 extending to a delivery sheath 20 in which the device 100 is positioned in a collapsed or delivery configuration 106. The flexible inner shaft 28 is slidably positioned inside the outer shaft 19 and extends through the device 100 to a nose cone 21 at the distal end. The inner shaft 28 has a guidewire lumen through which a guidewire 24 can be slidably positioned. The device 100 is connected to the inner shaft 28 and is releasable from the inner shaft 28 by a release line 30, as described more fully below. The delivery sheath 20 can protect and fix the device 100 in its collapsed configuration 106 during delivery. The outer shaft 20 is connected to a retraction mechanism 23 on the handle 14 of the delivery catheter 18. Different retraction mechanisms 23 can be used, such as an axially slidable lever, a rotatable rack and pinion linkage, or other known mechanisms. In this way, the outer shaft 20 can be retracted relative to the inner shaft 28 to release (e.g., deploy) the device 100 from the sheath 20.

[0276] Fig.46B The distal end of the delivery catheter 18 is shown with the sheath 20 removed to illustrate the connection of the device 100 to the inner shaft 28. A plurality of locking fingers 32 are connected to the nose cone 21 and extend proximally through the interior of the valve support 120 of the device 100. Fig.46C As shown in FIG. 1 , a selected number of posts 122 of the valve support 120 have a connecting member 61 that includes a tab 34 cut out of each post 122 at its proximal end. The tab 34 may be as shown in FIG. Fig.46B 122 and is deflected inwardly from the column 122 as shown in Fig.46D32 is configured to extend through a window 42 in the locking finger 32. The release wire 30 passes through the hole 40 in the tab 34, which prevents the tab 34 from withdrawing from the window 42, thereby fixing the device 100 to the internal shaft 28. The pull wire 30 can be tightly clamped between the tab 34 and the locking finger 32, so that friction temporarily prevents the pull wire 30 from sliding in the proximal or distal direction. In this way, the sheath 20 can be retracted relative to the device 100, thereby allowing the device 100 to expand, while the internal shaft 28 maintains the longitudinal position of the device 100 relative to the body structure. The pull wire 30 can extend proximally to the handle 14, for example, between the internal shaft 28 and the external shaft 19 or inside one or more designated lumens. A suitable mechanism (not shown) on the handle 14 can allow the operator to retract the release wire 30 in the proximal direction until they are disengaged from the tab 34. Therefore, the device 100 can be released from the locking finger 32 and expand at the target site to achieve deployment.

[0277] Figures 47A-47D is a schematic cross-sectional side view of a heart H illustrating a transseptal or antegrade approach for delivering and deploying a prosthetic heart valve device 100. Fig.47A As shown in , the guidewire 24 can be advanced intravascularly using many techniques, such as through the inferior vena cava IVC or the superior vena cava SVC, through the atrial septum IAS and into the right atrium RA. The guide catheter GC can be advanced along the guidewire 24 and into the right atrium RA until the anterior side of the atrial septum AS is reached, as shown in FIG. Fig.47B At this point, the guidewire 24 can be replaced with a needle 25, which is used to penetrate through the atrial septum IAS ( Fig.47C ). The guiding catheter GC may then be advanced over the needle 25 into the left atrium LA, as shown in FIG. Fig.47D The guide catheter GC may have a pre-shaped or steerable distal end to shape or steer the guide catheter GC so that it will guide the delivery catheter 18 ( Fig.46A ).

[0278] As an alternative to the transseptal approach, the mitral valve can also be approached directly through an incision in the left atrium. Access to the heart can be obtained through an intercostal incision in the chest without removing the ribs, and a guide catheter can be placed into the left atrium through the atrial incision sealed with a purse-string suture. The delivery catheter can then be advanced to the mitral valve through the guide catheter. Alternatively, the delivery catheter can be placed directly through the atrial incision without the use of a guide catheter.

[0279] Figures 48A-48C is a cross-sectional view of a heart illustrating a method of implanting a prosthetic heart valve device 100 using a transseptal approach. Figures 48A-48C, the distal end 21 of the delivery catheter 18 can be advanced to near the mitral valve MV. Optionally, and as Fig.48A As shown in , a guidewire GW may be used over which the catheter 18 may be slidably advanced. The sheath 20 of the delivery catheter 18 containing the device 100 in the collapsed configuration 106 is advanced through the mitral annulus AN between the native leaflets LF, as shown in FIG. Fig.48A See Fig.48B , the sheath 20 is then pulled back proximally relative to the distal nose cone 27, allowing the device 100 to expand, so that the anchoring member 110 pushes the leaflets LF outwardly to fold under the mitral annulus AN. The tips of the ribs 114 engage the tissue of the annulus AN and can penetrate into or through the leaflet tissue to further engage the tissue of the annulus AN. After the sheath 20 has been removed and the device 100 has been allowed to expand, the delivery system can still be connected to the device 100 (e.g., the system eyelet (not shown) is connected to the device eyelet 180, shown in Fig. 10A ) so that the operator can further control the placement of the device 100 in the expanded configuration 102. For example, the device 100 can be expanded upstream or downstream of the target location, and then pushed downward or upward into the desired target location, respectively, and then released from the delivery system 10. Once the device 100 is positioned at the target site, the pull wire 30 ( Figures 46A-46B ) can be retracted in a proximal direction, thereby allowing the device 100 to be removed from the delivery catheter 18 in the expanded configuration 104. The delivery catheter 18 can then be as follows Fig.48C Alternatively, the device 100 may not be connected to the delivery system 10 , such that the device 100 is deployed and completely released from the delivery system 10 .

[0280] Fig.49A and 49B Another variation for delivering and deploying one or more prosthetic heart valve devices 100 through the aorta and left ventricle to the mitral valve using a retrograde approach is shown. In this example, a guidewire GW may be advanced intravascularly from the femoral or radial artery or through a guided aortic puncture through the aorta AO and aortic valve AV and into the left ventricle LV of the heart H ( Fig.49A The guide catheter GC (or alternatively the delivery catheter 18) may be advanced over the guidewire GW until the distal end is positioned within the left ventricle proximal to the mitral valve MV, as shown in FIG. Fig.49A and 49B In many arrangements, the guide catheter GC and / or the delivery catheter 18 will have a steering mechanism or pre-shaped distal tip that allows it to be steered around a 180° turn from the aortic valve AV to the mitral valve MV. The distal end of the delivery catheter 18 can optionally be advanced at least partially through the mitral valve MV into the left atrium LA.

[0281] Figures 50A-50B The device 100 is shown in a collapsed configuration 106 for delivery to the mitral valve MV in a transapical approach. Fig.50A , the delivery catheter 18 is advanced through a guide catheter GC that has been inserted into the left ventricle of the heart through a puncture in the left ventricle wall at or near the apex of the heart. The catheter can be sealed using a purse-string suture. Alternatively, the delivery catheter 18 can be placed directly through a purse-string sealed transapical incision without a guide catheter. The sheath 20 and the device 100 (e.g., in a collapsed configuration 106) inside the sheath 20 are advanced through the mitral annulus AN between the native leaflets LF, as shown in FIG. Fig.50A See Fig.50B , the sheath 20 is pulled proximally, causing the device 100 to expand to the expanded and / or deployed configuration 102, 104. After the sheath 20 is removed, the delivery system 10 can still be connected to the device 100 (e.g., the system eyelet (not shown) is connected to the device eyelet 180, Fig. 10A ) so that an operator can control the placement of the device 100 when in the expanded configuration 102. The pull wire 30 can be retracted in a proximal direction to release the device 100 from the delivery system 10, allowing the delivery system 10 to be removed and the device fully implanted at the mitral valve MV in the deployed configuration 104. In one embodiment, the device 100 can be expanded upstream or downstream of a desired target location, followed by downward or upward pulling or pushing, respectively, into the target location, followed by release of the device 100 from the delivery system 10. Alternatively, the device 100 can be unattached to the delivery system 10, such that the device 100 is deployed and fully released from the delivery system 10.

[0282] According to another embodiment of the present technology, Figures 51A-51B is a partial side view of the delivery system 10, wherein the prosthetic heart valve device 100 is mounted on the expandable balloon 300 of the delivery catheter 18. Fig.51A and 51B , the device 100, when in the collapsed configuration 106, can be mounted on an expandable balloon 300 of a delivery catheter and delivered to a desired location at or near the native mitral valve ( Fig.51A When the device 100 is released from the sheath 20 ( FIGS. 46A-46B ), the device 100 may be expanded to its expanded configuration 102 ( Fig.51B). When the balloon 300 is used with the delivery system 10, the device 100 can be advanced from the delivery shaft 16 to initially position the device 100 in the target location. The balloon 300 can be inflated to fully expand the device 100. The position of the device 100 relative to the mitral valve can then be adjusted using the device locking hub to position the device in a desired implantation site (e.g., just below the annulus of the native mitral valve). In another embodiment, the balloon 300 can initially be partially inflated to partially expand the device 100 in the left atrium. The delivery system 10 can then be adjusted to push or pull (depending on the approach) the partially expanded heart valve device 100 into the implantation site, after which the device 100 can be fully expanded to its functional size. In other alternative methods, the anchoring member 110 is a self-expanding structure that is first extended from the sheath 20 ( Figures 46A-46B ) is released to engage the natural body structure, and the valve support 120 is a balloon-expandable component mounted on a balloon 300, which then expands to fully deploy the valve support 120 after the anchoring member 110 has been released.

[0283] In yet another embodiment, the valve support 120 of the device 100 can be configured to be axially movable or detachable from the anchoring member 110. In these arrangements, the two components 110, 120 can be loaded inside the delivery system 10 in an axially spaced configuration, thereby reducing the overall size of the system 10. After delivery to the target valve site, the components 110, 120 can be assembled simultaneously. Figures 52A-52D An embodiment of assembling the valve support 120 and the anchoring member 110 in the heart is shown. Fig.52A As shown in FIG. 1 , a delivery catheter 380 is advanced into the left atrium through a guide catheter GC placed through the atrial septum or atrial wall. The delivery catheter 380 has a split sheath 382, ​​384 including a distal nose cone 382 and a proximal capsule 384. The delivery catheter 380 is advanced through the native valve MV until the nose cone 382 is positioned distal to the native valve annulus AN ( Fig.52A ). The nose cone 382 is then further advanced distally while maintaining the position of the rest of the delivery catheter 380, thereby releasing the anchoring member 110 from the nose cone 382 (FIG. 52B). The anchoring member 110 self-expands outwardly, engaging the native leaflets LF and causing them to fold outwardly beneath the native valve annulus AN, as shown in FIG. Fig.52B. The upstream tips of the ribs 114 (FIG. 52B) engage the tissue beneath the annulus to anchor the device 100 in place. The sealing member 140 is secured around the perimeter 113 of the anchoring member 110 and has a connecting portion 386 extending into the proximal capsule 384 where it is secured to the valve support 120 which remains constrained within the proximal capsule 384. The delivery catheter 380 is then advanced to position the proximal capsule 384 within the anchoring member 110, as shown in FIG. Fig.52C . Proper positioning can be achieved by advancing the catheter 380 until the sealing member 140 becomes taught. The proximal capsule 384 is then retracted relative to the nose cone 382 to release the valve support 120 from the proximal capsule 384. The valve support 120 can self-expand to engage with the downstream end of the anchoring member 110 to simultaneously connect the two components. The delivery catheter 380 can then be removed from the patient.

[0284] Figures 53A-53H Demonstrated that it can be used in Figures 52A-52D The process shown in FIG. 1 shows different mechanisms for connecting the valve support 120 to the anchoring member 110. For example, Fig.53A As shown in , the valve support 120 can include a circumferential ridge or retaining portion 388 near its downstream end that engages in a groove 390 in the anchoring member 110 to inhibit disassembly of the two components. Alternatively, the valve support 120 can have a hook 392 formed at the downstream end of each post 122 that is configured to extend around the downstream end of the anchoring member 110 (e.g., around the downstream tip of the rib 114 or connector 116), as shown in FIG. Figures 53B-53C For example, the hook 392 can be configured to flex inwardly when it engages the inner surface of the rib 114 when the valve support member 120 is advanced, and can be configured to elastically rebound to its outward configuration when it extends beyond the downstream end of the rib 114, as shown in FIG. Fig.53C Optionally, a depth limiting feature (such as a short protrusion 394) can extend outwardly from the valve support 120, which is configured to engage a complementary feature (such as a protrusion or ridge 396) on the anchoring member 110 to prevent the valve support 120 from being inserted beyond a predetermined depth.

[0285] exist Figures 53D-53F In another embodiment shown in FIG. 1 , the valve support 120 can have a connection member 398 on its outer surface configured to be slidably connected to the anchoring member 110. In a first configuration, the connection member 398 includes a ring 400, shown in FIG. Fig.53EIn the embodiment of the present invention, the vertical guide members 402 on the anchoring member 110 can slide through the ring. The anchoring member 110 can have a plurality of such guide members 402 extending upward from its downstream end at positions spaced around its circumference. A protrusion 404 can be formed near the downstream end of each guide member 402 on which the ring 400 can slide to inhibit the valve support 120 from sliding back in the upstream direction ( Fig.53D ).exist Fig.53F In the alternative configuration shown in , the guide member 402 has a vertical slot 406 into which a radially extending pin 408 on the valve support 120 can extend. The pin 408 can slide to the downstream end of the slot 406, where it can be pushed through the waist 411, which prevents the pin 408 from sliding back in the upstream direction.

[0286] exist Figures 53G-53H In another embodiment shown in FIG. 1 , the connecting member 398 on the valve support 120 is configured to slidably receive the ribs 114, which themselves perform a similar function to the guide member 402 (relative to FIG. 1 ). Figures 53D-53F Description). Figure 53G As shown in , the connection of the rib 114 to the valve support 120 helps to restrain the rib 114 from being in a radially compact configuration when the valve support 120 slides axially upward relative to the anchoring member 110. Figure 53G In the arrangement shown in G-53H, delivery of the device 100 may not require the need for a separate sheath to constrain the ribs 114 during delivery. Fig.53H As shown in , the valve support 120 can slide in the downstream direction relative to the anchoring member 110 until the ribs 114 assume their radially outward configuration. As with the guide member 402, each rib 114 can have a protrusion 412 formed near its downstream end, through which the connecting member 398 can be pushed, but which then inhibits the valve support 120 from sliding in the upstream direction ( Fig.53H ).

[0287] According to another embodiment of the present technology, Figures 54A-55C A delivery catheter 400 of the delivery system 40 is shown. Fig.54A is a cross-sectional side view of a delivery system 40 for a prosthetic heart valve device 100, and Fig.54B yes Fig.54A A partial cross-sectional side view of the distal portion of the delivery system 40 is shown in FIG. Fig.54A and 54BAs shown in the figure, the delivery catheter 400 includes a sheath 402 having an outer wall 403 and a closed distal nose 406 defining an annular blind cavity 408. The inner wall 405 extends close to the proximal end (not shown) of the catheter, thereby forming a tubular catheter shaft 407, which defines an internal lumen extending axially through which a guidewire GW can be slidably positioned. A piston 412 is slidably disposed in the cavity 408 and has an O-ring 413 around its circumference to form a liquid seal with the wall of the cavity 408. A tubular piston shaft 414 extends proximally from the piston 412 and is slidably mounted on the catheter shaft 407. The piston shaft 414 is oversized relative to the catheter shaft 407 to define a fluid lumen 416 communicating with the cavity 408. The device 26 is held within the cavity 408 in its radially collapsed delivery configuration, and the piston shaft 414 and the catheter shaft 407 extend through the interior of the valve support 120 (shown in FIG. Figures 55A-55C Preferably, the device 100 is releasably connected to the piston 412 by, for example, a pin (not shown) extending radially outward from the piston shaft 414.

[0288] The sheath 402 may have features that will limit its travel. For example, a wire (not shown) may tether the protective sheath to a handle on the proximal end of the catheter 400. The wire may be attached to an adjustable stop on the handle, allowing the length of piston travel to be adjusted. When fluid is injected into the cavity 408, the piston 412 will travel until this stop is reached. In this way, the deployment progress may be controlled.

[0289] To facilitate retraction of the sheath 402 through the valve of the device 100 after deployment, the tapered feature may be advanced to abut the proximal end of the sheath 402 (see Fig.56 ). Alternatively, the piston 412 can have a tapered or soft buffer material attached directly to the back of the piston 412 facing the proximal direction. In this way, the proximal side of the piston will itself provide an atraumatic leading surface to facilitate the retraction of the sheath 402 through the valve support 120.

[0290] Features intended to control the deployment of the device 100 and make it smooth can be incorporated. For example, a common problem during the deployment of a self-expanding stent is the tendency of the deployed device to "pop" or jump forward or backward when the last component leaves the deployment device. It may be important to prevent the sheath 402 from being pushed forward by the skeleton of the expanded device 100 to avoid accidental damage to the ventricle or other tissues. These features can be inside the deployment system and have baffles or tethers designed to maintain the position of the sheath 402 relative to the deployed device 100. For example, the proximal edge of the sheath 402 can be slightly forged inward to prevent the piston from leaving the sheath and accurately position the tapered or buffer features described above, thereby making it easy to withdraw the system through the deployed valve. Alternatively or additionally, a spring mechanism (not shown) can be built into the delivery system 40 so that when the last feature of the device 100 leaves the sheath 402, the sheath is slightly actively retracted into the downstream end of the newly deployed device 100.

[0291] The operation of the delivery catheter 400 is shown in Figures 55A-55C The delivery catheter 400 is positioned at the target valve site using one of the approaches described elsewhere herein. The delivery catheter 400 is particularly well suited for placement through a native valve from an ascending direction. The catheter 400 is advanced until the sheath 402 is positioned downstream of the native valve annulus ( Fig.55A ). Fluid may then be injected into cavity 408 at the distal end of piston 412 through fluid lumen 416 ( Fig.55B This pushes the sheath 402 distally, releasing the device 100 from the cavity 408 ( Fig.55C ). The delivery catheter 400 and device 100 can be maintained in a fixed longitudinal position relative to the native valve while the device 100 is deployed, thereby improving the accuracy of deployment. In addition, the device 100 can be deployed in a slow and controlled manner, avoiding sudden and uncontrolled jumping of the device 100. In addition, such hydraulic actuation allows the sheath 402 to move in gradual steps to only partially deploy the device 100, allowing the operator to assess its position relative to the native valve and reposition it as needed before full deployment.

[0292] In one embodiment, the piston 412 may be hydraulically actuated, however, in another embodiment, the piston 412 may be operated by manually retracting the piston shaft 414 or the advancement sheath 402. The delivery catheter 400 may be equipped with a handle on its proximal end having a retraction mechanism connected to the piston shaft 414 and / or the catheter shaft 407. Such a mechanism may use a linkage or pulley to provide a mechanical advantage, thereby reducing the force required to retract the piston or advancement sheath.

[0293] Delivery catheters according to aspects of the present technology may be further configured to be reversible, thereby allowing the device 100 to be retracted into the catheter 400 after full or partial deployment. One embodiment of such a catheter is shown in Fig.56 Among them Figures 54A-55C The delivery catheter 400 is adapted to retract the device 100 into the sheath 402 after being fully or partially deployed therefrom. The piston 412 has at least a first pulley 420 connected thereto, and the distal nose 406 has at least a second pulley 422 connected thereto. A plurality of additional pulleys 423 may also be provided at locations around the circumference of the piston 412 for additional mechanical assistance. A cable 424 (which may include a length of wire or suture) extends through the fluid lumen 416 and the cavity 408, passes around the first and second pulleys 420, 422 and any additional pulleys 423, and is secured to the piston 412. The device 100 may be releasably connected to the piston shaft 414, preferably near its downstream end 428, by a plurality of pins 426 extending radially from the piston shaft 414 to engage with the device 100.

[0294] To deploy the device 100, Fig.56 The delivery catheter 400 is combined with Figures 55A-55C The device 100 is operated similarly; however, in another embodiment and before the downstream end 428 has been completely released from the sheath 402, the operator can check the position of the device 100. When deployed, the upstream end 430 of the device 100 will expand toward its expanded configuration. The operator can use ultrasound, fluoroscopy, MRI or other methods to observe the position and shape of the deployed device 100 in the native tissue. After positioning, the sheath 402 can be further advanced relative to the piston 412 to fully deploy the device 100 from the sheath 402, so that the downstream end 428 is fully expanded and the pin 426 is disengaged from the device 100. In the case where the operator wishes to restore the device 100 back to the sheath 402 for repositioning or other reasons, the cable 424 is pulled to move the piston 412 in the distal direction relative to the sheath 402. The pin 426 pulls the device 100 back into the sheath 402 with the piston 412, and the device 100 collapses when it is pulled in the sheath 402. The delivery catheter 400 can then be repositioned and the device redeployed.

[0295] In one embodiment, the prosthetic heart valve device 100 can be specifically designed for a specific approach or delivery method to reach the mitral valve, or in another embodiment, the device 100 can be designed to be interchangeable among approaches or delivery methods.

[0296] Additional embodiments of prosthetic heart valve devices, delivery systems, and methods

[0297] Figures 57A-57Eis an isometric view of a prosthetic heart valve device 600 shown in an expanded configuration 602 and configured in accordance with another embodiment of the present technology. The prosthetic heart valve device 600 includes a prosthetic heart valve device generally similar to that described above with reference to Figure 10A-56 The artificial heart valve device 600 has features similar to those of the artificial heart valve device 100 described above. For example, the artificial heart valve device 600 includes a valve support 120 configured to support an artificial valve 130 and an anchoring member 610 connected to the valve support 120 in a manner that mechanically isolates the valve support 120 from forces applied to the anchoring member 610 when implanted at the native mitral valve. However, in Figures 57A-57E In the embodiment shown in , the upstream region 612 of the anchoring member 610 is connected to the valve support 120 such that the downstream region 611 of the anchoring member 610 is configured to engage native tissue on or downstream of the valve annulus to prevent the device 600 from migrating in an upstream direction.

[0298] Fig.57A and 57B An embodiment of the device 600 is shown in which the anchoring member 610 includes a plurality of longitudinal ribs 614 connected to the upstream end 121 of the valve support 120 and extending in a downstream to distal direction. Fig.57A As shown in FIG, the ribs 614 can protrude radially outwardly away from the longitudinal axis 101 at the downstream region 611 of the anchoring member 610 such that the downstream region 611 flares outward for engaging subannular tissue below the mitral valve annulus. Fig.57B An embodiment of a device 600 is shown having an anchoring member 610 with an upward-facing lip 617 at a downstream region. In this embodiment, the ribs 614 can be shaped so that the downstream region generally flares outward from the longitudinal axis 101, but the tips 615 of the ribs 614 are reoriented so as to point in an upstream direction at the lip 617. The lip 617 can assist the anchoring member 610 in engaging tissue below the valve annulus and can be configured to include a tissue engaging component (not shown) as described above with respect to the device 100. The anchoring member 610 can also be connected to the valve support 120 at a location desirable for positioning the valve support 120 and the artificial valve 130 within the native valve. For example, Fig.57C An embodiment of the device 600 is shown in which the anchoring member 610 can be connected to the valve support 120 at a location downstream of the upstream end 121.

[0299] Also see Figures 57A-57C, the anchoring member 610 can have a first cross-sectional dimension DC1 at the upstream region 612 that is smaller than a second cross-sectional dimension DC2 at the downstream region 611. In addition, the valve support 120 is radially spaced from the downstream region 611 of the anchoring member 610 so that when the device 600 is deployed, the downstream region 611 can deform inwardly without deforming the upstream portion of the valve support 120. In addition, the anchoring member 610 can have a generally oval or D-shaped or other irregular shape, as described above with respect to Figures 16A-17C In these embodiments, the second cross-sectional dimension DC2 may be larger than the corresponding cross-sectional dimension of the valve ring of the native mitral valve (eg, MVA1 or MVA2) ( Figure 5C ).

[0300] Fig.57D Yet another embodiment of the device 600 is shown in an expanded configuration 602. As shown, the valve support 120 can include a flange 620 at the downstream end 123 of the valve support 120. The flange 620 can extend radially outward from the longitudinal axis 101 at the downstream end 123 to radially engage tissue below the valve annulus. The anchoring member 610 can include a plurality of ribs 614 that are attached to the upstream end 121 of the valve support 120 and extend radially outward in a downstream direction to connect to an outer flange 622 of the flange 620. The anchoring member 610 can be configured to engage tissue below the valve annulus, such as the inward surface of the leaflet. In this embodiment, the rib 614 can be flexible so that deformation of the anchoring member 610 between the connection at the upstream region 612 and the connection to the flange 620 at the lower region 611 does not substantially deform the valve support 120 in which the artificial valve is connected.

[0301] According to an embodiment of the present technology, Fig.57E It is implanted in the native mitral valve MV Fig.57ASchematic cross-sectional view of an artificial heart valve device 600. As shown, the expanded downstream region 611 of the anchoring member 610 can engage tissue below the valve annulus, such as the inward surface of the leaflet LF, the surface below the valve annulus, etc. The rib 614 can have a tissue engaging member 170 at the rib tip 615 for penetrating and / or partially penetrating the tissue. In addition, the anchoring member 610 can expand radially outward to resist a tissue seal (not shown), thereby preventing the device 600 from migrating in an upward or downward direction and / or preventing paravalvular leakage between the tissue and the device 600. Therefore, the device 600 can be combined with one or more sealing members 140 as described above with respect to the device 100. In addition, the device 600 can also include an atrial extension member or atrial retainer 410 (shown in dotted lines) as described above with respect to the device 100. The atrial retainer, if present, can be configured to engage tissue above the annulus AN (eg, the supra-annular surface) or some other tissue in the left atrium LA to inhibit downward migration of the device (eg, during atrial contraction).

[0302] According to another embodiment of the present technology, Figures 58A-58D is a cross-sectional view of a heart illustrating a method of delivering a prosthetic heart valve device 600 to a native mitral valve MV in the heart using a transapical approach. Fig.58A , the delivery catheter 18 is advanced through a guiding catheter GC (not shown) which enters the left ventricle LV of the heart through a puncture in the left ventricle wall at or near the apex of the heart and is sealed by a purse-string suture. Alternatively, the delivery catheter 18 may be placed directly through a purse-string sealed transapical incision without a guiding catheter. The collapsed device 600, 606 (shown in Fig.58B The sheath 20 is advanced through the mitral annulus AN between the natural leaflets LF, as shown in FIG. Fig.58A Referring to FIGS. 58B-58D simultaneously, the sheath 20 is pulled proximally to allow the device 600 to expand to the expanded and / or deployed configurations 602, 604 ( Fig.58C and 58D ).

[0303] Although the sheath 20 may be retracted and the device 600 allowed to expand, the delivery system may still be connected to the device 600 (e.g., a system eyelet (not shown) connected to a device eyelet (not shown)) so that an operator can control the placement of the device 600 when in the expanded configuration 602 ( Fig.58C58D). For example, as the sheath 20 is detached from the device 600, the upstream region 612 of the anchoring member 610 can remain collapsed inside the sheath, preventing the anchoring member 610 from fully expanding (FIG. 58C). During this stage of delivery, the position of the device 600 inside the mitral valve region can be adjusted or changed. After the device 600 is positioned at the target site, the sheath 20 can be completely removed from the device 600, and the anchoring member 610 of the device 600 can expand outwardly at the downstream region 611 to engage the subannular tissue (such as the leaflets LF) and maintain the device 600 at the desired target position. The pull wire (not shown) can be retracted in the proximal direction to release the device 600 from the delivery system, allowing the delivery system to be removed and the device to be fully implanted at the mitral valve MV in the expanded configuration 104. Alternatively, the device 600 may be expanded upstream or downstream of a desired target location, then pulled or pushed downwardly or upwardly, respectively, into the target location, followed by release of the device 600 from the delivery system.

[0304] Figures 59A-59C is an isometric view showing a prosthetic heart valve device 700 in an expanded configuration 702, and Fig.59D is a schematic cross-sectional view of an artificial heart valve device 700 implanted at a native mitral valve configured in accordance with another embodiment of the present technology. The artificial heart valve device 700 includes a device generally similar to that described above with reference to Fig. 10A-58D The features of the artificial heart valve devices 100 and 600 are similar. For example, the artificial heart valve device 700 includes a valve support 120 configured to support an artificial valve 130 and a first anchoring member 610 connected to the valve support 120 in a manner that mechanically isolates the valve support 120 from forces applied to the first anchoring member 610 when implanted at the native mitral valve. Specifically, an upstream region 612 of the first anchoring member 610 is connected to the valve support 120, and a downstream region 611 of the first anchoring member 610 is configured to expand outward to engage native tissue on or downstream of the valve annulus so as to prevent the device 600 from migrating in an upstream direction. However, in Figures 59A-59D , the device 700 further comprises a second anchoring member 710 having a downstream region 711 connected to the valve support 120 and an upstream region 712 extending radially outward in an upstream direction. Thus, the device 700 comprises both the first and second anchoring members 610 and 710 for engaging tissue on or below the annulus of the mitral valve.

[0305] Also see Figures 59A-59D, the first anchoring member 610 may have a first cross-sectional dimension DC1 at the upstream region 612 that is smaller than the second cross-sectional dimension DC2 at the downstream region 611. The second anchoring member 710 may have a third cross-sectional dimension DC3 at the upstream region 712 that is larger than the fourth cross-sectional dimension DC4 at the downstream region 711. In some embodiments, the third cross-sectional dimension DC3 is smaller than the second cross-sectional dimension DC2, so that the second anchoring member 710 may be partially surrounded by the first anchoring member 610 ( Fig.59A ). In such an embodiment, the upstream region 712 can apply radially outward pressure against an inner wall (not shown) of the first anchoring member 610 and further support the first anchoring member 610 to be fixed to tissue on or below the valve annulus. Fig.59B In another embodiment shown in FIG. 5 , the third cross-sectional dimension DC3 can be substantially the same as the second cross-sectional dimension DC2 such that the first and second anchoring members 610, 710 meet at the deployed junction 740. In one embodiment, the first and second anchoring members 610 and 710 can be connected at the deployed junction 740; however, in other embodiments, the first and second anchoring members 610 and 710 are not connected. Fig.59C Another embodiment of the device 700 is shown in which the downstream region 615 of the first anchoring member 610 is separated from the upstream region 713 of the second anchoring member 710 by a gap 750. In one embodiment, Fig.59C The device 700 shown in can be implanted at a natural heart valve so that the first anchoring member 610 can engage tissue above the valve annulus or other cardiac tissue upstream of the valve annulus, and the second anchoring member 710 can engage tissue below the valve annulus or other cardiac tissue downstream of the valve annulus, so that the valve annulus is retained or captured within the gap 750.

[0306] exist Fig.59D In another embodiment shown in FIG. 5 , the third cross-sectional dimension DC3 is greater than the second cross-sectional dimension DC2, such that the second anchoring member 710 can partially surround the first anchoring member 610. In such an embodiment, the downstream region 611 of the first anchoring member 610 can apply radially outward pressure against the inner wall 741 of the second anchoring member 710 and further support the second anchoring member 710 to be fixed to tissue on or below the valve annulus AN.

[0307] In addition, the valve support 120 can be radially separated from the downstream region 611 of the first anchoring member 610 and the upstream region 712 of the second anchoring member 710, so that when the device 700 is deployed, the downstream region 611 and / or the upstream region 712 can be deformed inwardly without substantially deforming the valve support 120 or without deforming the support region 734 of the valve support 120 that supports the artificial valve 130. In addition, the first and second anchoring members 610, 710 can have a generally oval or D-shaped or other irregular shape, as described above with respect to Figures 16A-17C Those described above, while the shape of the valve support 120 can be generally cylindrical. In addition, additional features can be incorporated into the device 700, such as the sealing membrane 140 and tissue engaging member 170 described above with respect to the device 100.

[0308] According to another embodiment of the present technology, Figures 60A-60B is used to Fig.59C A cross-sectional side view of the distal end of a delivery catheter 18 delivering a prosthetic heart valve device 700 to a native mitral valve in a heart. Figures 60A-60B As shown in FIG. 7 , the prosthetic heart valve device 700 is collapsed into a delivery configuration 706 and retained within a two-part delivery sheath 70 at the distal end of the catheter 18 ( Fig.60A Upon delivery of the distal end of catheter 18 to a desired location at or near the native mitral valve, device 700 may be retracted by retracting upper portion 72 in a distal direction and / or lower portion 74 in a proximal direction (shown by arrows in the figure). Fig.60A The device 700 is released from the two-part sheath 70 by being released from the two-part sheath 70, thereby separating the sheaths and exposing the collapsed device 700 from the interior of the sheath 70. In one embodiment, the device 700 can self-expand into its expanded configuration 702 ( Fig.60B ).like Fig.60B As shown in , when the sheath 70 is retracted in both the proximal and distal directions, the first and second anchoring members 610, 710 can self-expand outward to engage native tissue. When the balloon 300 is used to expand the support valve 120, the balloon 300 can be inflated to fully expand the device 700.

[0309] Fig.61 An artificial heart valve device 800 configured in accordance with another embodiment of the present technology is shown. Fig.61 is substantially the same as above Figure 10A-60BA side view of a device 800 having features similar to the features of the artificial heart valve devices 100, 600, 700 described above. For example, the device 800 includes a support valve 120 having upstream and downstream ends 121, 123 and an interior to which a valve (not shown) can be connected. The device also includes first and second anchoring members 810 and 850. The first anchoring member 810 has an expanded upstream portion 812 and a first downstream portion 811 connected to the exterior or outer surface 127 of the valve support 120. The first expanded upstream portion 812 can be mechanically isolated from the valve support 120. In addition, the first expanded upstream portion 812 can be configured to engage the supra-annular tissue of the native mitral valve. The second anchoring member 850 can be configured to at least partially surround the first anchoring member 810 and have a second expanded upstream portion 852 for engaging the sub-annular tissue of the native mitral valve. The second anchoring member 850 can also have a second downstream portion 851 connected to the outer surface 127 of the valve support 120 in a manner that mechanically isolates the valve support 120 from at least the second upstream portion 852.

[0310] like Fig.61 , the first anchoring member 810 can have a plurality of first longitudinal ribs 814, and the second anchoring member 850 can have a plurality of second longitudinal ribs 854. In one embodiment, each of the independent first ribs 814 is longer than each of the independent second ribs 854, such that the first anchoring member 810 has a height HAM1 that is greater than a height HAM2 of the second anchoring member 850. Thus, the height HAM2 can be selected to orient the second anchoring member 850 to engage subannular tissue, while the height HAM1 can be selected to orient the first anchoring member 810 to extend from the left ventricle through the mitral valve to engage supraannular tissue in the left atrium.

[0311] Fig.61 An embodiment of a device 800 is shown, which can include a lower ring 808 on which the ribs 814, 854 can be interconnected. The lower ring 808 can allow the ribs 814, 854 to expand radially outward away from the valve support 120 at the upstream portion 812, 852. The device 800 can also include a first upper ring member 816 connected to the plurality of first longitudinal ribs 814. The first upper ring member 816 can be shaped and or patterned to have a downwardly oriented flange 818 for engaging tissue above the valve annulus. The device can further include a second upper ring member 856 connected to the plurality of second longitudinal ribs 854. The second upper ring member 856 can be shaped and or patterned to have an upwardly oriented flange 858 for engaging tissue below the valve annulus.

[0312] According to another embodiment of the present technology, Figures 62A-62Cis demonstrated to deliver at the mitral valve MV Fig.61 800 is a partial cross-sectional side view of the distal end of the delivery system 10 of the prosthetic heart valve device 800. The device 800 can be maintained in a collapsed configuration 806 ( Fig.62A When the distal end of the delivery system engages the target site, the sheath 20 can be proximally retracted from the device 800, thereby releasing the features of the device 800 to expand into the expanded configuration 102 ( Figures 62B-62C ).like Fig.62B As shown in , the second anchoring member 850 can be first released by retracting the sheath 20, and the upwardly oriented flange 858 of the second upper ring member 856 can be positioned to engage the subannular tissue. The sheath 20 can prevent the first anchoring member 810 from being detached from the delivery system 10 and / or moving outside the sheath 20 until the flange 858 of the second anchoring member 850 is moved into position to engage the subannular tissue. Fig.62C , the plunger 11 can engage the first anchoring member 810 (eg Fig.62B ) and / or the sheath 20 may be detached / retracted from the first anchoring member 810 ( Fig.62C The downwardly oriented flange 818 of the first upper ring member 816 can be positioned to engage the supra-annular tissue ( Fig.62C Once deployed, the rings 816, 856 can clamp into the annulus AN of the mitral valve and inhibit movement of the device 800 in both the ascending and descending directions.

[0313] According to another embodiment of the present technology, Fig.63 is an isometric side view of an artificial heart valve device 900. The device 900 includes a prosthetic heart valve device generally as described above with reference to Figure 10A-62CThe features of the artificial heart valve devices 100, 600, 700 and 800 described above are similar. For example, the device 900 includes a support valve 120 having upstream and downstream ends 121, 123 and an interior to which a valve (not shown) can be connected. The device 900 includes an anchoring member 910 having an expanded upstream portion 912 and a downstream portion 911 connected to the valve support 120. However, the device 900 also includes upper and lower rings 950, 952 and a plurality of flexible valve ring engagement components 970 distributed around the circumference 980 of the anchoring member 910 and configured to connect the upper ring 950 to the lower ring 952. The flexible valve ring engagement component 970 can have a certain shape (such as a C-shape or a U-shape) that is oriented to have an open portion outward from the device 900 so that the natural valve ring AN can be engaged in the notch 971 of the valve ring engagement component 970. The annulus engaging member 970 may also include points 972, 973 for engaging and potentially piercing the supra-annular and sub-annular tissues, respectively. The annulus engaging member 970 may be suitably flexible so as to bend in such a way that the points 972, 973 are brought close together for securing the device 900 to the annulus AN when the device 900 is deployed.

[0314] Figures 64A-64B A method of deploying the device 900 at the native mitral valve is shown. Fig.63 and 64A -64B, the annulus engagement component 970 can be generally relaxed or have a wide notch 971 in the open state 903. Thus, when the component 970 is in the open state 903, the upper ring 950 can rest a first distance DR1 above the lower ring 952. The device 900 can also include a plurality of pull wires 974 slidably engaged with the upper ring 950 (e.g., through holes 975) and fixed to the lower ring 952. When these wires 974 are pulled in an upward or upstream direction, the lower ring 952 moves toward the upper ring 950 in an upward / upward direction. As the lower ring 952 approaches the upper ring 950, the annulus engagement component 970 can bend so that the points 972, 973 are closer together and / or engage or puncture the annular tissue ( Fig.64B ). Thus, when the device 900 is in the deployed state 904, the upper ring 950 can be held by the pull wire 974 at a second distance DR2 above the lower ring 952, wherein the second distance DR2 is less than the first distance DR1.

[0315] Figures 64C-64DAn alternative arrangement of a pull wire 974 is shown, wherein the wire 974 is fixed to the upper ring 950 and slidably engages with the lower ring 952 (e.g., through hole 976). The pull wire 974 can also be slidably engaged with the upper ring 950 (e.g., such as through hole 975) so that the pull wire can be pulled in an upward direction, thereby bringing the rings 950, 952 closer together in the deployed state 904.

[0316] According to another embodiment of the present technology, Fig.65A is an isometric side view of an artificial heart valve device 1000. The device 1000 includes a device generally similar to that described above with reference to Figure 10A-64D The features of the artificial heart valve devices 100, 600, 700, 800 and 900 described above are similar. For example, the device 1000 includes a support valve 120 having upstream and downstream ends 121, 123 and an interior 134 to which a valve 130 can be connected. However, the device 1000 includes an inflatable anchoring member 1010 connected to the valve support 120 and at least partially surrounding the valve support. The inflatable anchoring member 1010 can be configured to inflate / expand and engage natural tissue at a desired target location when deployed. Fig.65A As shown in FIG. 1 , the inflatable anchoring member 1010 can have one or more fillable cavities 1014 for receiving a filling substance such as a solution (e.g., saline or other liquid) or a gas (e.g., helium, CO2, or other gas) after implantation of the device 1000. In other embodiments, the fillable cavity 1014 can be filled with a hardening material (e.g., epoxy, cement, or other resin).

[0317] In one embodiment, the fillable cavity 1014 and / or the anchoring member 1010 can be formed of polytetrafluoroethylene (PTFE), urethane, or other expandable polymers or biocompatible materials. The fillable cavity 1014 can have a predetermined shape so that the fillable cavity 1014 forms a fixed component 1015 when inflated for engaging a natural body structure. For example, the fixed component 1015 may include a flange 1016 above the valve ring for engaging the surface of the valve ring AN inside the left atrium LA. The component 1015 may also include a flange 1018 below the valve ring for engaging tissue below the valve ring and / or an arm 1020 for engaging the leaflet LF (e.g., behind the leaflet). Thus, the cavity 1014 can be incorporated or shaped so that the anchoring member 1010 engages supra-annular tissue, sub-annular tissue, leaflets, or other tissue at or near the mitral valve MV while mechanically isolating the valve support 120 from torsional diastolic and systolic forces generated in the heart and radial forces exerted on the device 1000, particularly at or near the native mitral valve. For example, after deployment, the inflatable anchoring member 1010 can absorb pulsatile loads and other forces generated by the device 1000 such that deformation of the anchoring member 1010 does not substantially deform the valve support 120.

[0318] According to another embodiment of the present technology, Fig.65B Is suitable for delivery Fig.65A 65B , the delivery system 10 can include a delivery catheter 18 configured to maintain the device 1000 in a collapsed configuration 1006. In the collapsed configuration 1006, the inflatable anchoring member 1010 is deflated. The delivery system 10 can also include a filling tube 90 adapted to deliver a filling substance when the device 1000 is in position and ready for deployment. See also FIG. Figures 65A-65B , and in one embodiment, the inflatable anchoring member 1010 can be partially filled with a filler material so that the position of the device 1000 at the implantation site can be adjusted to align the fixation component 1015 with the natural tissue feature, and then the anchoring member 1010 is fully expanded and / or inflated to maintain the device 1000 in the proper position at the target location.

[0319] According to another embodiment of the present technology, Figures 66A-66D is a cross-sectional view of an artificial heart valve device 1100 having a fillable cavity 1114. Figures 65A-65BSimilar to the device 1000 discussed above, the device 1100 includes features such as a valve support 120 having an interior 134 in which a valve 130 is connected, and includes an expandable anchoring member 1110 connected to the valve support 120 in a manner that mechanically isolates the valve support 120 from forces applied to the anchoring member 1110 when implanted at the native mitral valve. The anchoring member 1110 can be connected to the valve support 120 such that an upstream region 1112 of the anchoring member 1110 is configured to engage native tissue above or downstream of the valve annulus to prevent migration of the device 1100 in an upstream direction. In the embodiment shown in Figures 66A-66D, the device 1100 can also include one or more fillable cavities 1114 that are configured to expand and / or inflate in an outward direction to support outward expansion of the anchoring member 1100 ( Fig.66A , 66C -66D) or joined to natural tissue ( Fig.66B In one embodiment, the fillable cavity 1114 and / or the anchoring member 1010 can be formed of polytetrafluoroethylene (PTFE), urethane, or other expandable polymer or biocompatible material. The fillable cavity 1114 can have a predetermined shape so that the fillable cavity 1114, when inflated, forms a fixation component for engaging a natural body structure (e.g., Fig.66B ) or engaging anchoring member 1110 (as shown in Fig.66A , 66C and as shown in 66D).

[0320] See also Fig.66A , the fillable cavity 1114 can be a cavity 1114 formed by the space between the valve support 120 and the anchoring member 1110. After expansion of the device 1100, the fillable cavity 1114 can be filled with a filling substance such as a solution (e.g., saline or other liquid) or a gas (e.g., helium, CO2, or other gas). In other embodiments, the fillable cavity 1114 can be filled with a hardening material (e.g., epoxy, cement, or other resin). In other embodiments, the fillable cavity 1114 can be a separate component of the device 1100, such as an outer surface 1142 ( Fig.66B ) or the inner surface 1141 of the anchoring member 1110 or the outer surface 127 of the supporting valve 120. Figures 66C-66D In the embodiment of the present invention, for example, the annular cavity 1150 can provide additional support to the anchoring member 1110, so that the inward deformation is offset by the presence of the annular cavity 1150. Fig.66D As shown in FIG, the fillable cavity 114 can be an annular cavity 1150 that causes the anchoring member 1110 to deform in an outward direction against the native tissue.

[0321] According to another aspect of the present technology, Figures 67A-67B Other embodiments of the prosthetic heart valve device 1200 are shown. Figures 67A-67B , the device 1200 may include a radially expandable anchoring member 1210 configured to engage native tissue on or downstream of the valve annulus and a support valve 120 and / or a prosthetic valve 130 connected to an inner portion 1234 of the anchoring member 1210. The anchoring member 1210 may have a first longitudinal length LL1 on a side 1222 of the anchoring member 1210 facing the posterior leaflet and a second longitudinal length LL2 on a side 1224 of the anchoring member 1210 facing the anterior leaflet. Fig.67A As shown in , the first length LL1 is greater than the second length LL2, so that the obstruction of the left ventricular outflow tract (LVOT) is limited. Therefore, in one embodiment, the side 1222 facing the posterior leaflet can provide suitable fixation and support for the anchoring member 1210 by engaging the thicker ventricular wall and tissue on the posterior leaflet side of the mitral valve. At the same time, the shorter side 1224 facing the anterior leaflet of the anchoring member 1210 can have sufficient sealing and compliance to engage the anterior leaflet and / or the subannular tissue aligned with the anterior leaflet of the native valve.

[0322] Optionally, the device 1200 may also include one or more stabilizing components (such as arms 1250) connected to the anchoring member 1210 for engaging the leaflets and / or the surface below the annulus. In FIG. 67A, the arm 1250 may be connected to the downstream end 1223 of the anchoring member 1210 on the side 1222 of the anchoring member 1210 facing the posterior leaflet and configured to extend behind the posterior leaflet. In one embodiment, the arm 1250 may be configured to sandwich the posterior leaflet between the arm 1250 and the anchoring member 1210.

[0323] exist Fig.67BIn the embodiment shown, the device 1200 may include first and second arms (individually identified as 1250a and 1250b) connected to the anchoring member 1210 for engaging the leaflets and / or the surface below the valve annulus. For example, the first arm 1250a can be connected to the downstream end 1223 at the side 1224 of the anchoring member 1210 facing the anterior leaflet with the extension 1251a and can be configured to extend further behind the anterior leaflet. The second arm 1250b can be connected to the downstream end 1223 of the side 1222 of the anchoring member 1210 facing the posterior leaflet with the extension 1251b and be configured to extend further behind the posterior leaflet. In the embodiment shown, the extensions 1251a and 1251b can be varied relative to each other and selected based on the anatomy of the target tissue. In other embodiments not shown, the arms 1250 and or the anchoring member 1210 may include tissue engaging features as described above with respect to the device 100 for further positioning and stabilizing the device 1200 at a desired target location. One of ordinary skill in the art will recognize that the valve support 120 may also be non-planar or have sides of varying lengths such that the valve support does not substantially obstruct the left ventricular outflow tract (LVOT).

[0324] Figures 68A-68B 1 is a side view of a prosthetic heart valve device 1300 shown in an expanded configuration 1302 and configured in accordance with another embodiment of the present technology. The prosthetic heart valve device 1300 includes a prosthetic heart valve device generally similar to that described above with reference to FIG. Figure 10A-56 The artificial heart valve device 100 described above has features similar to those of the artificial heart valve device 100. For example, the artificial heart valve device 1300 includes a valve support 120 configured to support the artificial valve 130 and an anchoring member 110 connected to the valve support 120 in a manner that mechanically isolates the valve support 120 from forces applied to the anchoring member 110 when implanted at the native mitral valve. Figures 68A-68B In the embodiment shown in FIG. 1 , the device 1300 further includes a positioning component 1350 configured to adjust or maintain a desired position of the device 1300 within or near the native mitral valve (e.g., away from the LVOT). The positioning component 1350 can be connected to the downstream portion 111 (e.g., distal to the LVOT) of the anchoring member 110 at a component connection point 1352. Figures 68A-68B ), the upstream portion 112 of the anchoring member 110 or the valve support 120, and extends outwardly from the component connection point 1352 to engage the ventricular tissue at a desired location. In one embodiment, the positioning component 1350 can extend outwardly from the device 1300 in a direction generally transverse to the longitudinal axis 101. In other embodiments not shown, the positioning component 1350 can extend outwardly from the device 1300 at an obtuse angle or an acute angle relative to the longitudinal axis 101 for engaging the ventricular tissue at a desired location.

[0325] exist Fig.68A , the positioning component 1350 can include a positioning arm 1354 and a tissue engaging portion 1356 connected to a distal arm end 1358 of the positioning arm 1354. The positioning arm 1354 and the tissue engaging portion 1356 together can extend a desired positioning distance DP1 away from the component connection point 1352 on the device 1300 (e.g., away from the anchoring member 110) so that the distal end 1360 of the positioning component 1350 can engage ventricular tissue, such as a ventricular wall. In some embodiments, the positioning distance DP1 can be selected to be greater than the distance between the implanted device 1300 and the ventricular tissue so that the positioning component 1350 extends the distance between the implanted device 1300 and the ventricular tissue after engaging the ventricular tissue. In this way, the device 1300 can be positioned, aligned, and maintained in an alternative position within or near the mitral valve.

[0326] The tissue engaging portion 1356 can be configured to contact ventricular tissue or other tissue (e.g., annular tissue, leaflet tissue, etc.) in a non-invasive manner so that the tissue engaging portion 1356 does not penetrate or puncture the tissue. In one embodiment, the tissue engaging portion 1356 can be elastic and / or formed of a shape memory material (e.g., nitinol) that can be partially deformed when engaging the tissue. For example, the tissue engaging portion 1356 can be configured to absorb forces generated by ventricular tissue (e.g., ventricular wall) during, for example, systole and not translate or change the desired position of the device 1300 relative to the natural mitral valve. In other embodiments, the distal end 1360 of the positioning component 1350 can have other shapes or configurations that will penetrate the ventricular tissue. The device 1300 may include one or more positioning components 1350 disposed around the device 1300 for positioning and / or maintaining the desired position of the device 1300 relative to the natural body structure. For example, it may be desirable to increase the distance between the device 1300 and the left ventricular outflow tract (LVOT), and the positioning member 1350 may be configured to engage ventricular tissue to push or urge the device 1300 a selected distance away from the LVOT.

[0327] exist Fig.68BIn the embodiment shown in , the positioning component 1350 can include a looped tissue engaging portion 1358 connected to the device 1300 at a connection point 1352. The looped tissue engaging portion 1358 can extend a desired positioning distance DP1 away from the component connection point 1352 on the device 1300 (e.g., away from the anchoring member 110) so that the distal end 1360 of the looped tissue engaging portion 1358 can engage ventricular tissue, such as a ventricular wall. The looped tissue engaging portion 1358 can be configured to absorb radial contraction forces or other forces generated and transmitted by the ventricular tissue (e.g., inside the left ventricle) so that these forces are not transmitted or can change the position of the device 1300 relative to the native heart valve. Thus, the device 1300 can be positioned, aligned, and maintained in an alternative position within or near the mitral valve.

[0328] In another embodiment not shown, a positioning structure independent of the artificial heart valve device 100 can be implanted or otherwise positioned in the left ventricle (e.g., at or near the LVOT), and it can be configured to engage a portion of the device 100, such as the anchoring member 110. Thus, such a positioning structure can be provided to prevent the device 100 from occluding or partially occluding the LVOT. In one embodiment not shown, the positioning structure can be a stent-like cylindrical body or cage that expands to engage with the ventricular wall and keeps the LVOT unobstructed to allow blood to flow freely from the left ventricle through the aortic valve. In one example, the positioning structure can be delivered by a catheter that is inserted into the left ventricle through the aorta and the aortic valve or inserted through the apex or left atrium via the same delivery catheter used to deliver and implant the device 100.

[0329] Figures 69A-69E 14 is a cross-sectional view and a side view of a prosthetic heart valve device 1400 shown in an expanded configuration 1402 and configured in accordance with another embodiment of the present technology. The prosthetic heart valve device 1400 includes a prosthetic heart valve device generally similar to that described above with reference to FIG. Figure 10A-57E The artificial heart valve device 100 and 600 described above have similar features. For example, the artificial heart valve device 1400 includes a valve support 120 configured to support the artificial valve 130 and an anchoring member 110 or 610 connected to the valve support 120 in a manner that mechanically isolates the valve support 120 from forces applied to the anchoring member 110 when implanted at the native mitral valve. However, in Figures 69A-69E In the embodiment shown in , the device 1400 also includes an expandable tissue engaging ring 1450 that is connected to the tissue engaging portion of the anchoring member 110 and is configured to provide another contact surface for engaging native tissue at or near the annulus of the heart valve.

[0330] exist Figures 69A-69BIn one embodiment shown in FIG. 69A , an expandable tissue engaging ring 1450 can be coupled to the upstream perimeter 113 of the anchoring member 110 and have a tissue engaging surface 1452 facing in an outward direction relative to the device 1400. In some embodiments, the tissue engaging surface 1452 can have a tissue engaging member 170 for engaging and / or piercing tissue. In another embodiment shown in FIG. 69C , an expandable tissue engaging ring 1450 can be coupled to the downstream perimeter 115 of the anchoring member 1410 and have a tissue engaging surface 1452 facing in an outward direction relative to the device 1400. Fig.69D In another embodiment shown in , the expandable tissue engaging ring 1450 can include a plurality of fibrous components 1454 (e.g., fibrous components) that can be configured to promote tissue ingrowth, thrombosis, and / or configured to provide a seal between the anchoring member 110 and the tissue. In different arrangements, the expandable tissue engaging ring 1450 can expand and contract between different deployment and delivery configurations.

[0331] Fig.69E Another embodiment of an artificial heart valve device 1400 having an expandable tissue engagement ring 1450 is shown. In this embodiment, the device 1400 can have a valve support 120 connected to a first anchoring member 110 and a second anchoring member. In one embodiment, the first anchoring member 110 can be connected to the valve support 120 at a downstream end 123 and extend outward and in an upward direction. The second anchoring member 1410 can be connected to the valve support 120 at an upstream end 121 and extend outward and in a downward direction. The expandable tissue engagement ring 1450 can be connected to the distal portions of the first and second anchoring members 110, 1410 and have a tissue engagement surface 1452 facing in an outward direction relative to the device 1500 for engaging tissue at or near the valve annulus AN or leaflet LF. In a specific example, the expandable tissue engagement ring 1450 can have a first end 1460 connected to the upstream end 1461 of the first anchoring member 110. The expandable tissue engaging ring 1450 may also have a second end 1470 connected to the downstream end 1471 of the second anchoring member 1410. The tissue engaging surface 1452 may also include tissue engaging elements 170 for engaging and / or piercing tissue at a target location.

[0332] Also see Figures 69A-69E, the outward radial force of the expandable tissue engaging ring 1450 against the tissue and supported by the anchoring members 110 and / or 1410 can prevent the device 1400 from migrating in an upward direction. In addition, the expandable tissue engaging ring 1450 and at least the portion of the anchoring members 110 and / or 1410 that is not connected to the valve support 120 can effectively mechanically isolate the valve support 120 and the valve 130 from damaging radial compressive forces exerted on the device 1400 from the heart valve tissue.

[0333] Fig.70 1 is a cross-sectional side view of another artificial heart valve device 1500 configured in accordance with an embodiment of the present technology. The device 1500 may also include the features described above, including a valve support 120 and an artificial valve 130 retained within the valve support 120. The device 1500 may also include a plurality of anchoring members (individually identified as 110a-c). The anchoring members 110a-c may be connected to the valve support 120 at corresponding downstream circumferences 115a-c and separated by gaps 1515 so that corresponding upstream circumferences 113a-c may engage heart tissue at variable target locations at the native valve. Optionally, the device 1500 may also include an expandable tissue engaging ring 1450 ( Fig.69A -D) (such as those having tissue engagement features 170) for further engaging tissue at the native valve. In one embodiment, the expandable tissue engagement ring 1450 can be connected to the upstream perimeter of one or more anchoring members (e.g., upstream perimeters 113b and 113c of anchoring members 110b and 110c). However, in other arrangements, the device 1500 will not have the expandable tissue engagement ring 1450.

[0334] Fig.71 is a cross-sectional side view of yet another artificial heart valve device 1600 configured in accordance with an embodiment of the present technology. The device 1600 may also include the features described above, including a valve support 120 and an artificial valve 130 retained within the valve support 120. The device 1500 may also include an anchoring member 110. However, the device 1600 may also include an expandable locator 1610 for further engaging tissue at or near the native valve annulus. In one embodiment, the locator 1610 may be an extension of the upstream end 121 of the valve support 120, however, in another embodiment, the locator 1610 may include an independent expandable feature connected to the upstream end 121 of the valve support. In some arrangements, the locator 1610 may be mechanically isolated from the valve support 120 such that forces generated at the native valve are absorbed or otherwise transferred by the locator 1610. In this manner, the retainer 1610 can be deformed by radial forces applied to the retainer 1610 while the valve support remains substantially undeformed.

[0335] In one embodiment, as shown, the anchoring member 110 can be configured to engage the positioner 1610; however, in other embodiments, the anchoring member 110 can be positioned differently so that the anchoring member 110 contacts tissue different from the positioner 1610. For example, the anchoring member 110 can extend outside the radius of the positioner (not shown) to contact tissue below the valve annulus. Additional details and embodiments regarding the structure, delivery, and attachment of the positioner 1610 suitable for use with the artificial heart valve device disclosed herein can be found in International PCT Patent Application No. ________ (Attorney Docket No. 82829-8005WO00), filed on October 19, 2012, entitled "DEVICES, SYSTEMS AND METHODS FOR HEART VALVE REPLACEMENT", the entire contents of which are incorporated herein by reference.

[0336] Other Examples

[0337] Described above and shown in Figure 10A-71 Features of the prosthetic heart valve device components in can be modified to form additional embodiments configured according to the present technology. For example, the prosthetic heart valve device 1100 shown in Figures 65A-65B without a deployed anchoring member can include an anchoring member connected to a valve support or other feature and configured to extend radially outward to engage tissue below the valve annulus. Similarly, the prosthetic heart valve device described above and shown in Figures 57A-71 can include multiple features such as a sealing member and multiple stabilizing features such as arms and tissue engaging components.

[0338] The features of the artificial heart valve device components described above can also be interchanged to form additional embodiments of the present technology. For example, Fig.67A The anchoring member 1210 of the prosthetic heart valve device 1200 shown in FIG. 1 may be incorporated into Figures 57A-57C An artificial heart valve device 600 is shown in FIG.

[0339] The following examples illustrate several embodiments of the present technology.

[0340] Examples

[0341] 1. A device for repairing or replacing a natural heart valve, the natural heart valve having a valve ring and a valve leaflet connected to the valve ring, the device comprising:

[0342] an anchoring member having an upstream portion or first portion and a downstream portion or second portion, the upstream portion or first portion being configured to engage tissue on or below the annulus to deform in a non-circular shape to conform to the tissue; and

[0343] a valve support connected to the downstream portion of the anchoring member and configured to support a prosthetic valve, wherein the valve support has a cross-sectional shape;

[0344] Wherein the upstream portion of the anchoring member is mechanically isolated from the valve support so that the cross-sectional shape of the valve support remains sufficiently stable that the prosthetic valve remains effective when the anchoring member is deformed in a non-circular shape.

[0345] 2. The device of example 1, wherein the valve support has an upstream region spaced radially inwardly from an upstream portion of the anchoring member such that if the anchoring member is deformed inwardly, the upstream region remains substantially undeformed.

[0346] 3. The device of example 1, wherein the upstream portion is configured to engage valve tissue selected from the inward surface of the valve annulus and the inward surface of the subannular leaflet.

[0347] 4. The device of Example 3, wherein the anchoring member is configured to apply an outward force against the valve tissue to resist movement of the device when blood flows through the valve support in a downstream direction when the valve is open and when blood pushes against the valve in an upstream direction when the valve is closed.

[0348] 5. The device of example 1, wherein the anchoring member is self-expanding.

[0349] 6. The device of example 5, wherein the anchoring member comprises nitinol.

[0350] 7. The device of Example 5, wherein the valve support is self-expanding.

[0351] 8. The device of example 1, wherein the anchoring member and the valve support both comprise metal.

[0352] 9. The device of example 1 wherein the anchoring member is formed from a nitinol tube having a wall thickness of about 0.010 inches to about 0.130 inches.

[0353] 10. The device of example 1, wherein the anchoring member comprises a plurality of longitudinal ribs having an axial stiffness that resists movement of the device in an upstream direction.

[0354] 11. The device of example 1, wherein the anchoring member comprises a plurality of interconnected rods.

[0355] 12. The device of example 11, wherein the plurality of interconnected rods are arranged in a diamond configuration.

[0356] 13. The device of example 1, wherein the anchoring member comprises a plurality of metal wires.

[0357] 14. The device of example 13, wherein the plurality of metal wires are woven and / or welded together.

[0358] 15. The device of Example 1, wherein the anchoring member comprises a plurality of flexible filaments arranged in a diamond configuration around a circumference of the anchoring member, and wherein the diamond configuration comprises one or more rows of diamonds and between approximately 12 and approximately 36 columns of diamonds around the circumference.

[0359] 16. The device of example 1, wherein the valve support comprises an upstream end and a downstream end, and wherein the upstream end extends a distance in an upstream direction beyond the upstream portion of the anchoring member.

[0360] 17. The device of example 1, wherein the valve support comprises an upstream end and a downstream end, and wherein the upstream portion of the anchoring member extends a distance beyond the upstream end of the valve support in an upstream direction.

[0361] 18. The device of example 1 wherein the anchoring member comprises a flange at a proximal end of the upstream portion, the flange having a non-deformable configuration having a generally oval or D-shape.

[0362] 19. The device of example 14, wherein the flange comprises a plurality of peaks and a plurality of valleys.

[0363] 20. The device of example 1, wherein:

[0364] The anchoring member includes a flange at a proximal end of the upstream portion, the flange having a generally oval or D-shape; and

[0365] The anchor member includes a downstream end, and wherein a distance between the downstream end and the flange varies around a circumference of the anchor member.

[0366] 21. The device of example 20, wherein the distance ranges from about 6 mm to about 20 mm.

[0367] 22. The device of example 20, wherein the distance ranges from about 9 mm to about 12 mm.

[0368] 23. The device of example 20, wherein the distance comprises a plurality of distances, the plurality of distances comprising:

[0369] a first distance between the downstream end and the flange of approximately 7 mm to approximately 8 mm at first and second regions of the anchoring member, the first and second regions being configured to align with first and second commissures of a native mitral valve, respectively;

[0370] a second distance between the downstream end and the flange of about 9 mm to about 11 mm at a third region of the anchoring member, the third region being configured to align with an anterior leaflet of a native mitral valve; and

[0371] A third distance between the downstream end and the flange is approximately 12 mm to about 13 mm at a fourth region of the anchoring member opposite the third region, the fourth region being configured to align with a posterior leaflet of a native mitral valve.

[0372] 24. The device of example 1, wherein:

[0373] The anchoring member includes a flange at a proximal end of the upstream portion, the flange having a generally oval or D-shape;

[0374] Tissue on or below the annulus has a non-circular shape having a minor diameter and a major diameter substantially perpendicular to the minor diameter;

[0375] The upstream portion of the anchor member has an outer perimeter having a major perimeter diameter and a minor perimeter diameter substantially perpendicular to the major perimeter diameter;

[0376] The major circumference diameter is greater than the major diameter; and

[0377] The minor perimeter diameter is larger than the minor diameter.

[0378] 25. The device of example 24, wherein the major circumference diameter is approximately 2 mm to approximately 22 mm longer than the major diameter.

[0379] 26. The device of example 24, wherein the major circumference diameter is approximately 8 mm to approximately 15 mm longer than the major diameter.

[0380] 27. The device of example 24, wherein the major circumference diameter is approximately 45 mm to about 60 mm.

[0381] 28. The device of example 24, wherein the minor perimeter diameter is approximately 40 mm to about 55 mm.

[0382] 29. The device of example 1 wherein the valve support is a generally circular cylinder.

[0383] 30. The device of example 29 wherein the valve support has a diameter of approximately 25 mm to about 30 mm.

[0384] 31. The device of example 1 wherein the valve support is a cylindrical valve support having a diameter of approximately 27 mm.

[0385] 32. The device of example 1 wherein the valve support is a cylindrical valve support having a vertical height of about 14 mm to about 17 mm.

[0386] 33. The device of example 1, wherein:

[0387] The upstream portion of the anchoring member has a proximal circumference having peak and valley portions corresponding to natural peak and valley portions of the annulus, respectively; and

[0388] The corresponding peak portions are configured to align with the natural valley portions and the corresponding valley portions are configured to align with the natural peak portions.

[0389] 34. The device of example 1 wherein the valve support extends about a longitudinal axis and wherein the upstream portion of the anchoring member flares outwardly from the longitudinal axis at a taper angle.

[0390] 35. The device of example 34, wherein the cone angle varies continuously between the downstream portion and the upstream portion.

[0391] 36. The device of Example 34, wherein the cone angle varies around the circumference of the upstream portion.

[0392] 37. The device of example 34, wherein the cone angle is between about 30° and about 75°.

[0393] 38. The device of example 34, wherein the cone angle is between about 40° and about 60°.

[0394] 39. The device of example 1, wherein the valve support is oriented along a first longitudinal axis and the anchoring member is oriented along a second longitudinal axis, and wherein the first and second longitudinal axes are non-collinear.

[0395] 40. The device of Example 39, wherein the second longitudinal axis is offset from the first longitudinal axis.

[0396] 41. The device of Example 39, wherein the second longitudinal axis is not parallel to the first longitudinal axis.

[0397] 42. The device of example 41, wherein the second longitudinal axis is disposed at an angle between 15° and 45° relative to the first longitudinal axis.

[0398] 43. The device of Example 1, wherein the upstream portion of the anchoring member comprises an expanding portion and a vertical portion, the vertical portion being configured to radially expand and engage the valve annulus.

[0399] 44. The device of example 43 wherein the expansion portion includes a tissue engaging member configured to engage tissue beneath the valve annulus.

[0400] 45. The device of example 1 wherein the upstream portion is radially separated from the valve support by a gap.

[0401] 46. ​​The device of example 45, wherein:

[0402] The anchoring member includes a flange at a proximal end of the upstream portion, the flange having an oval shape;

[0403] The valve support is a cylindrical valve support at least partially surrounded by the anchoring member; and

[0404] The gap varies around the circumference of the cylindrical valve support.

[0405] 47. The device of example 46 wherein the gap is larger on the side of the device facing the anterior leaflet than on the side of the device facing the posterior leaflet.

[0406] 48. The device of example 1, wherein the device is configured to avoid occlusion of the left ventricular outflow tract (LVOT) of the heart.

[0407] 49. The device of Example 1, further comprising a skirt covering a surface of the anchoring member, the skirt being configured to inhibit blood flow between the anchoring member and the valve support.

[0408] 50. The device of example 49 wherein the skirt is further configured to inhibit blood flow between the anchoring member and the tissue.

[0409] 51. The device of example 49, wherein the skirt comprises at least one of the following: ePTFE, bovine pericardium, polymers, thermoplastic polymers, polyesters, Synthetic fibers, natural fibers or polyethylene terephthalate (PET).

[0410] 52. The device of example 1, wherein the valve support is connected to the anchoring member with one or more of a plurality of rivets and a plurality of sutures.

[0411] 53. The device of example 1 wherein the valve support has a radial strength of approximately 42 mm Hg to about 47 mm Hg.

[0412] 54. The device of example 1 wherein the valve support has a radial strength that is at least 100% greater than the radial strength of the anchoring member.

[0413] 55. The device of Example 1, further comprising a valve connected to the valve support to inhibit retrograde blood flow.

[0414] 56. The device of example 55, wherein the valve is a tri-leaflet valve.

[0415] 57. The device of Example 55, wherein the valve comprises bovine pericardium.

[0416] 58. The device of Example 55, wherein the valve has a plurality of commissure attachment structures, and the valve is connected to the valve support at the commissure attachment structures.

[0417] 59. The device of example 58 wherein the commissural attachment structure is permanently fixed to the valve support.

[0418] 60. The device of Example 58 wherein the commissural attachment structure is integral with the inner wall of the valve support.

[0419] 61. The device of Example 58 wherein the valve support has a first height and the commissure attachment structure has a second height that is less than the first height.

[0420] 62. The device of example 1, wherein the valve support is further configured to receive a replacement valve after implantation of the device in place of a native valve.

[0421] 63. The device of Example 62, further comprising a temporary valve connected to the valve support.

[0422] 64. The device of example 63 wherein the temporary valve is adapted to be displaced against an inner wall of the valve support when the replacement valve is received in the valve support.

[0423] 65. The device of example 63 wherein the temporary valve comprises a removable valve and wherein the replacement valve is secured within the valve support after the temporary valve has been removed.

[0424] 66. An artificial heart valve device for implantation at a natural mitral valve, the natural mitral valve having a valve ring and valve leaflets, the artificial heart valve device comprising:

[0425] an anchoring member positionable in position between the leaflets, wherein an upstream portion or first portion of the anchoring member is expandable to a dimension greater than a corresponding dimension of the annulus such that upward movement of the anchoring member is blocked by engagement of the upstream portion with tissue on or near the annulus; and the anchoring member has a downstream portion or second portion; and

[0426] A valve support is connected to the downstream portion of the anchoring member, wherein the valve support is radially inwardly spaced from at least the upstream portion of the anchoring member, and wherein the valve support is configured to support a prosthetic valve.

[0427] 67. The device of Example 66 wherein the valve support is mechanically isolated from at least an upstream portion of the anchoring member.

[0428] 68. The device of Example 66 wherein the upstream portion of the anchoring member has a first flexibility and the valve support has a second flexibility that is less than the first flexibility such that if the upstream portion of the anchoring member is twisted, the valve support remains substantially untwisted.

[0429] 69. The device of Example 66 wherein the upstream region of the valve support is radially inwardly spaced from the upstream portion of the anchoring member such that the valve support does not engage if the anchoring member is deformed inwardly.

[0430] 70. The device of example 66, wherein:

[0431] The anchoring member is defined by a structure independent of the valve support;

[0432] the valve support is connected to the anchoring member at a downstream portion of the anchoring member; and;

[0433] The downstream portion is longitudinally spaced apart from the upstream portion.

[0434] 71. The device of Example 66, further comprising a plurality of flexible connection mechanisms configured to flexibly connect the valve support to the downstream portion of the anchoring member.

[0435] 72. The device of example 71, wherein the flexible connection mechanism may include at least one of the following: a suture, a wire, or a flexible filament.

[0436] 73. The device of Example 71, wherein the flexible connection mechanism may include at least one of the following: a rivet, a screw, or a pin.

[0437] 74. The device of example 66, wherein the device is changeable into a plurality of configurations, the configurations comprising:

[0438] a first configuration in which the valve support and the anchoring member are radially contracted;

[0439] a second configuration wherein the valve support and the anchoring member are radially expanded; and

[0440] A third configuration in which the anchoring member engages tissue at or near the annulus and is at least partially deformed thereby.

[0441] 75. The device of Example 74 wherein the valve support has an expanded shape in the second configuration and wherein the valve support substantially remains in the expanded shape in the third configuration.

[0442] 76. The device of Example 74, wherein the anchoring member adopts the second configuration under unbiased conditions.

[0443] 77. The device of Example 74 wherein the anchoring member is deformable from the second configuration to the third configuration.

[0444] 78. The device of example 74 wherein the device in the first configuration has a low profile configured for delivery via a guide catheter positioned at or near the native mitral valve.

[0445] 79. The device of Example 76 wherein the upstream portion of the anchoring member has a first diameter in the second configuration, and wherein the first diameter spans at least the distance between the native commissures of the native mitral valve.

[0446] 80. The device of example 76 wherein the upstream portion of the anchoring member has a first diameter and the valve support has a second diameter in the second configuration, and wherein the first diameter is approximately 1.2 to 1.5 times greater than the second diameter.

[0447] 81. The device of example 66 wherein the upstream portion of the anchoring member has a first expanded diameter of approximately 28 mm to about 80 mm.

[0448] 82. The device of example 66 wherein the valve support has an expanded diameter of approximately 25 mm to about 32 mm.

[0449] 83. The device of Example 66, wherein the downstream portion is longitudinally spaced apart from the upstream portion, and wherein the upstream portion has a first cross-sectional dimension and the downstream portion has a second cross-sectional dimension that is smaller than the first cross-sectional dimension.

[0450] 84. The device of Example 66 wherein the upstream portion is configured to engage an inward surface of the leaflet downstream of the valve annulus.

[0451] 85. The device of Example 66 wherein the anchoring member resists upward migration of the device without any component of the device extending behind the native mitral valve leaflet.

[0452] 86. The device of Example 66 wherein the device does not engage tissue above or upstream of the annulus.

[0453] 87. The device of Example 66, further comprising a sealing member extending around the upstream portion of the anchoring member and configured to seal against tissue on or downstream of the valve annulus to inhibit blood flow between the anchoring member and the tissue.

[0454] 89. The device of Example 87 wherein the sealing member promotes tissue ingrowth into the sealing member.

[0455] 89. The device of example 87, wherein the sealing member comprises one or more of the following: a polymer, a thermoplastic polymer, a polyester, a synthetic fiber, a fiber, polyethylene terephthalate (PET), PTFE, Gore- or

[0456] 90. The device of Example 87 wherein the sealing member includes a plurality of tissue engaging elements on an outer surface of the sealing member.

[0457] 91. The device of Example 87 wherein the anchoring member has multiple points on the upstream end and wherein the points are configured to penetrate tissue on or downstream of the valve annulus to prevent upward movement of the device.

[0458] 92. The device of example 91 wherein the anchoring member comprises a delivery mechanism for moving the plurality of points from a retracted position to an engaged position, and wherein the engaged position comprises penetrating the annular tissue with the points.

[0459] 93. The device of Example 66, further comprising a plurality of anchoring clips on the upstream end of the anchoring member, wherein the anchoring clips are configured to engage the valve annulus.

[0460] 94. The device of example 66, wherein the anchoring member comprises-

[0461] Multiple longitudinal ribs; and

[0462] a plurality of circumferential connectors interconnecting the plurality of ribs;

[0463] Wherein the anchoring member is deployed in a proximal direction such that the proximal ends of the ribs are oriented radially outward to engage tissue on or downstream of the valve annulus, thereby preventing migration of the device in an upstream direction.

[0464] 95. The device of example 94, wherein the anchoring member has a central longitudinal axis and wherein each independent rib has a plurality of segments having different extension angles relative to the longitudinal axis.

[0465] 96. The device of Example 94, wherein the plurality of longitudinal ribs include a first and a second plurality of ribs, and wherein the first plurality of ribs have characteristics that are different from the second plurality of ribs, the characteristics being selected from the group consisting of size, shape, stiffness, extension angle, and number of ribs within a given area of ​​the anchoring member.

[0466] 97. The device of Example 94 wherein the longitudinal ribs are unevenly spaced around the outer circumference of the anchoring member.

[0467] 98. The device of Example 94, wherein the valve support comprises a plurality of posts circumferentially connected by a plurality of rods, and wherein each independent longitudinal rib is integrally formed with a corresponding post on the valve support.

[0468] 99. The device of Example 98, wherein each of the plurality of longitudinal ribs includes a bent elbow portion integrally formed with the corresponding column, the elbow portion being configured to radially outwardly urge each rib from an inward configuration to an outward configuration.

[0469] 100. The device of Example 98, further comprising a tether connecting each independent rib to the corresponding post, wherein the tether is configured to limit outward deflection of the rib when the rib is in an expanded configuration.

[0470] 101. The device of Example 98, wherein one or more independent circumferential connectors include a looped connector head, and wherein one or more independent rods include a looped rod head, and wherein these looped connector heads are connected to these looped rod heads to form a flexible connection mechanism.

[0471] 102. The device of Example 101, wherein the looped connector head passes through the looped rod head to form the flexible connection mechanism.

[0472] 103. The device of Example 101, wherein one or more flexible filaments connect the looped connector head to the looped rod head to form the flexible connection mechanism.

[0473] 104. The device of Example 94 wherein the plurality of circumferential connectors comprises a plurality of straps extending around the circumference of the anchoring member and wherein the straps are slidably connected to each independent rib.

[0474] 105. The device of Example 66, wherein the anchoring member comprises a plurality of longitudinal ribs arranged in a crisscross pattern to form a diamond configuration, and wherein the anchoring member is deployed in a proximal direction such that the proximal ends of the ribs are oriented radially outward to engage tissue on or near the valve annulus, thereby preventing the device from migrating in an upstream direction.

[0475] 106. The device of Example 66 wherein the valve support is substantially cylindrical and at least the upstream portion of the anchoring member is substantially non-circular.

[0476] 107. The device of Example 106, wherein the upstream portion of the anchoring member is D-shaped.

[0477] 108. The device of Example 66 wherein the upstream portion has a proximal end with a flange and wherein the flange does not lie in a single plane.

[0478] 109. The device of Example 108, wherein the flange has an undulating shape with peaks extending in an upstream direction and valleys extending in a downstream direction.

[0479] 110. The device of example 109, wherein at least one peak has a different shape or size than at least one other peak.

[0480] 111. The device of example 109 wherein if inverted longitudinally, at least one peak has a different shape or dimension than at least one valley.

[0481] 112. The device of Example 109 wherein the flange has two peaks separated by two valleys.

[0482] 113. The device of Example 109 wherein the valleys are configured for positioning along the commissures of the valve annulus.

[0483] 114. The device of Example 109 wherein the peak has an apex configured to be positioned near a midpoint region of the leaflet.

[0484] 115. The device of example 66, wherein:

[0485] The valve ring includes a natural peak portion and a natural valley portion;

[0486] The upstream portion of the anchoring member has a proximal perimeter having respective peak portions and respective valley portions; and

[0487] The corresponding peak portions are configured to align with the natural valley portions and the corresponding valley portions are configured to align with the natural peak portions.

[0488] 116. The device of example 66, wherein:

[0489] The upstream portion of the anchoring member has a cross-sectional dimension that is larger than a corresponding cross-sectional dimension of the annulus of the native mitral valve; and

[0490] The valve support has a support cross-sectional dimension that is smaller than a corresponding cross-sectional dimension of the valve annulus.

[0491] 117. The device of Example 66 wherein at least the upstream portion is mechanically isolated from the valve support.

[0492] 118. The device of Example 66 wherein the downstream portion is substantially tubular and wherein the upstream portion of the anchoring member is deformable into a non-circular cross-section while the valve support remains substantially circular in cross-section.

[0493] 119. The device of example 66, wherein:

[0494] The valve support includes a plurality of first rods interconnected around a circumference of the valve support;

[0495] The anchoring member includes a plurality of second rods interconnected around a circumference of the anchoring member; and

[0496] These first rods are more rigid than these second rods.

[0497] 120. The device of Example 94 wherein the longitudinal ribs are configured to absorb torsional diastolic and systolic forces generated in a heart having a native mitral valve.

[0498] 121. The device of Example 94 wherein the ribs and connectors are formed in a herringbone configuration.

[0499] 122. The device of Example 119, wherein the plurality of second rods are interconnected in a herringbone configuration.

[0500] 123. The device of Example 94, wherein the plurality of second rods are interconnected in a diamond configuration.

[0501] 124. The device of Example 119 wherein the posts and rods are formed in a herringbone configuration.

[0502] 125. The device of Example 94 wherein the ribs and connectors are made of shape memory material.

[0503] 126. The device of example 125 wherein the shape memory material comprises nitinol.

[0504] 127. The device of Example 94, further comprising a plurality of tissue engaging elements on at least one of the ribs or the circumferential connectors, wherein the tissue engaging elements are configured to engage tissue of the valve annulus or the leaflets.

[0505] 128. The device of Example 119, further comprising a plurality of tissue engaging elements on at least the second rods, wherein the tissue engaging elements are configured to engage tissue of the valve annulus or leaflets.

[0506] 129. The device of example 127 wherein the tissue engaging member is one of a barb, a hook, or a spike.

[0507] 130. The device of example 127 wherein the one or more tissue engaging elements are oriented in an upstream direction, the one or more tissue engaging elements being configured to limit movement of the device in the upstream direction during ventricular systole.

[0508] 131. The device of Example 127 wherein one or more tissue engaging members are oriented in a downstream direction, the one or more tissue engaging members being configured to limit movement of the device in a downstream direction.

[0509] 132. The device of example 127 wherein the tissue engaging components have:

[0510] a piercing configuration in which the tissue engaging members have a low profile for penetrating the tissue; and

[0511] A retention configuration wherein the tissue engaging elements have an expanded profile for maintaining the tissue engaging elements within the tissue.

[0512] 133. The device of example 132, wherein the tissue engaging elements are maintained in the piercing configuration using one or more biodegradable glues or biodegradable coatings.

[0513] 134. The device of example 132 wherein, when in the retaining configuration, the tissue engaging elements expand into one of a diamond shape, an arrow shape, or a spiral shape.

[0514] 135. The device of Example 66, wherein the anchoring member is connected to a sleeve, and wherein the sleeve is configured to limit radial expansion of the anchoring member when the anchoring member is in an expanded configuration.

[0515] 136. The device of Example 135 wherein the sleeve comprises an outer portion configured to cover the anchoring member and an inner portion configured to at least partially surround the valve support.

[0516] 137. The device of Example 136, wherein the sleeve includes a plurality of horizontal diaphragms extending between an outer portion and an inner portion of the sleeve.

[0517] 138. The device of Example 84, wherein each individual rib has a flexibility that is independent of the flexibility of the other ribs.

[0518] 139. The device of Example 94, wherein each independent rib has a flexibility that is variable along the length of the rib.

[0519] 140. The device of Example 66 wherein the upstream portion of the anchoring member conforms to the shape of the native mitral valve annulus while in the expanded configuration.

[0520] 141. A device for treating a native valve having a valve annulus and valve leaflets, the device comprising:

[0521] an anchor having an upstream portion configured to engage an upstream-facing surface of a leaflet downstream of the annulus; and

[0522] a valve support at least partially within the anchor, wherein the valve support is configured to support a prosthetic valve;

[0523] The anchoring member may be deformed into a non-circular cross-section while the valve support member remains substantially flat in cross-section.

[0524] 142. The device of Example 141, further comprising a sleeve at least partially surrounding the valve support, wherein the sleeve provides a fluid barrier.

[0525] 143. The device of Example 141, further comprising a sealing member extending around an upstream portion of the anchor and configured to seal against at least an upstream-facing surface of the leaflets to inhibit blood flow between the anchor and the leaflets.

[0526] 144. The device of Example 143, wherein the sealing member further extends around the valve support and wherein the sealing member is configured to inhibit blood flow within the space between the valve support and the anchor.

[0527] 145. The device of Example 141 wherein the anchor has a downstream portion longitudinally separated from the upstream portion, and wherein the downstream portion is connected to the downstream end of the valve support.

[0528] 146. The device of Example 145 wherein the upstream portion is not directly connected to the valve support member.

[0529] 147. The device of Example 141, wherein the valve support has an upstream end and a downstream end oriented along the longitudinal axis, and wherein the anchor is connected to the valve support at an intermediate position between the upstream end and the downstream end.

[0530] 148. The device of Example 141 further comprises a plurality of tethers connecting the upstream portion of the anchor to the valve support, the tethers being configured to limit radial expansion of the upstream portion.

[0531] 150. A device for implantation at a native valve having a valve annulus and valve leaflets, the device comprising:

[0532] a hyperbolic anchoring member having an upstream end and a downstream end, the upstream end being configured to engage an inwardly facing surface of a downstream leaflet of the annulus, wherein the upstream end has a different cross-sectional area than the downstream end;

[0533] A valve support disposed in the anchoring member and configured to support a prosthetic valve, wherein the valve support is connected to the anchoring member at a location substantially spaced downstream from the upstream end and is not connected to the anchoring member at the upstream end.

[0534] 151. The device of Example 150, wherein the anchoring member is formed of a flexible and shape memory material molded in a diamond pattern and configured to self-expand radially outward.

[0535] 152. The device of Example 150, wherein the deployed anchoring member has a bilobed hyperboloid shape.

[0536] 153. The device of Example 150, further comprising an atrial retainer configured to engage supra-annular tissue such that downward movement of the device is blocked by engagement of the atrial retainer with supra-annular tissue.

[0537] 154. The device of Example 153 wherein the atrial retainer comprises an outward extension of the valve support.

[0538] 155. The device of Example 153 wherein the atrial retainer comprises an anchoring member extension configured to pass through the native valve to engage tissue above the annulus.

[0539] 156. The device of Example 150, further comprising a sealing member disposed on the anchoring member and the valve support, the sealing member being configured to block blood flow between the valve support and the anchoring member.

[0540] 157. The device of Example 156 wherein the sealing member surrounds an outer surface of the valve support and an inner surface of the anchoring member.

[0541] 158. The device of Example 156, wherein the sealing member comprises a sleeve configured to cover at least a portion of the upstream end of the anchoring member and configured to seal against an inward surface of at least the leaflets to inhibit blood flow between the anchoring member and the leaflets.

[0542] 159. The device of Example 156, wherein the sealing member comprises a flexible and biocompatible material.

[0543] 160. The device of example 159, wherein the material comprises One or more of ePTFE or bovine pericardium.

[0544] 160. The device of example 150 wherein the upstream end is configured with a plurality of atraumatic nodules such that the upstream end resists penetration of the inward surface of the leaflets downstream of the valve annulus.

[0545] 170. The device of example 150, wherein the upstream end is configured with a plurality of non-invasive nodules, and wherein the non-invasive nodules are unevenly spaced circumferentially around the upstream end.

[0546] 171. The device of example 170, wherein the anchoring member includes a posterior-facing side and an anterior-facing side, and wherein a first non-invasive nodule configuration on the posterior-facing side is different from a second non-invasive nodule configuration on the anterior-facing side.

[0547] 172. An artificial heart valve device for repairing or replacing a patient's natural heart valve, the heart valve having a valve ring and valve leaflets, the artificial heart valve device comprising:

[0548] an anchoring member having an upstream portion or first portion having a first cross-sectional dimension and a downstream portion or second portion having a second cross-sectional dimension that is smaller than the first cross-sectional dimension, w...

Claims

1. A device for repairing or replacing a natural valve having a valve ring and a plurality of leaflets, the device comprising: an expandable valve support configured to be disposed between leaflets, the support having a first region, a second region, and an interior portion in which a valve can be coupled; as well as an anchoring member having a first portion and a second portion, wherein the second portion of the anchoring member is coupled to the second region of the valve support and wherein the first portion of the anchoring member extends outwardly away from the second region of the expandable valve support, the first portion of the anchoring member having a first circumference configured to engage tissue at or near the valve annulus; wherein the second portion of the anchoring member is longitudinally spaced apart from the first portion of the anchoring member, and The anchoring member is mechanically isolated from the valve support such that radially-directed forces at or near a first circumference do not substantially change the shape of the valve support.

2. A device as described in claim 1, wherein the anchoring member is defined by a structure spaced apart from the valve support member.

3. A device as described in claim 1 or 2, wherein the first portion of the anchoring member is configured to engage valve tissue selected from the inward surface of the valve annulus and the inward surface of the leaflet below the valve annulus.

4. The device of claim 1 or 2, wherein the anchoring member is self-expanding, wherein the anchoring member comprises nitinol.

5. A device as described in claim 1 or 2, wherein the anchoring member includes a plurality of flexible filaments arranged in a diamond configuration around a circumference of the anchoring member, and wherein the diamond configuration includes one or more rows of diamonds and between 12 and 36 columns of diamonds around the circumference.

6. A device as described in claim 1 or 2, wherein the anchoring member includes a flared portion and a vertical portion, and the vertical portion is configured to radially expand and engage the valve ring.

7. A device as described in claim 1 or 2, wherein the valve support is connected to the anchoring member with one or more of a plurality of rivets and a plurality of sutures.

8. A device as described in claim 1 or 2, wherein the valve support is at least partially located within the anchoring member and the valve support is configured to support an artificial valve.

9. The device of claim 1 or 2, further comprising a valve coupled to the valve support to inhibit retrograde blood flow, wherein the valve is trileaflet and / or comprises bovine pericardium.

10. A device as described in claim 1 or 2, further comprising a sealing member extending around a first portion of the anchoring member, the sealing member being configured to seal the tissue on or downstream of the valve ring to inhibit blood flow between the anchoring member and the tissue.

11. The device as described in claim 1 or 2, further comprising one or more stabilizing members (501), which are configured to stabilize the device at the native valve position and inhibit upstream migration of the device.

12. The device of claim 11, wherein the stabilizing member (501) comprises one or more arms extending from a lower portion of the anchoring member.

13. A device as described in claim 1 or 2, wherein the device does not engage with tissue above the valve annulus or tissue upstream of the valve annulus.

14. A system for treating a mitral valve of a patient, the mitral valve having a valve annulus, the system comprising: A device comprising a device according to any one of claims 1 to 13; as well as A catheter having a lumen configured to retain the device therein.

15. The system of claim 14, wherein the catheter is configured to be reversible, thereby allowing the device to be retracted into the catheter after full or partial deployment.

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