Artificial Heart Valve Devices

Abstract

To provide prosthetic heart valve devices.SOLUTION: A prosthetic heart valve (100) includes a flexible anchoring member (110) at least partially surrounding and coupled to an inner valve support (120). The device can further include a prosthetic valve (130) coupled to, mounted within, or otherwise carried by the valve support. The valve support includes a plurality of posts (122) connected circumferentially by a plurality of struts (124), where the posts extend along an axial direction generally parallel to the longitudinal axis (101) and the struts extend circumferentially around and square to the longitudinal axis. The struts extend an entire longitudinal height HI of the valve support 120. The device also includes one or more sealing members (140) and tissue engaging elements (170) like spikes.SELECTED DRAWING: Figure 10A

Description

[Technical field]

[0001] (Citation of Related Application) This application claims priority to U.S. Provisional Patent Application No. 61 / 605,699, filed March 1, 2012, entitled "SYSTEM FOR MITRAL VALVE REPLACEMENT," and U.S. Provisional Patent Application No. 61 / 549,044, filed October 19, 2011, entitled "CONFORMABLE SYSTEM FOR MITRAL VALVE REPLACEMENT," both of which are incorporated herein by reference. This application incorporates by reference the entire subject matter of (1) International PCT Patent Application No. PCT / US2012 / 043636, entitled "PROSTHETIC HEART VALVE DEVICES AND ASSOCIATED SYSTEMS AND METHODS," filed June 21, 2012; (2) U.S. Provisional Patent Application No. 61 / 549,037, entitled "SYSTEM FOR MITRAL VALVE REPLACEMENT," filed October 19, 2011; and (3) International PCT Patent Application No. __________ (Attorney Docket No. 82829-8005WO00), entitled "DEVICES, SYSTEMS AND METHODS FOR HEART VALVE REPLACEMENT," filed October 19, 2012.

[0002] The present technology relates generally to prosthetic heart valve devices. In particular, some embodiments are directed to prosthetic mitral valves and devices, and related systems and methods, for percutaneous repair and / or replacement of native mitral valves. [Background technology]

[0003] Conditions that affect the proper function of the mitral valve include, for example, mitral regurgitation, mitral valve prolapse, and mitral valve stenosis. Mitral regurgitation is a cardiac disorder in which the mitral valve leaflets fail to coapt at peak systolic pressure, resulting in abnormal leakage of blood from the left ventricle into the left atrium. There are several structural factors that can affect the proper closure of the mitral valve leaflets. For example, many patients suffering from heart disease experience dilation of the myocardium, resulting in an enlarged mitral valve annulus. The enlargement of the mitral valve annulus makes it difficult for the leaflets to coapt during systole. Stretching or tearing of the chordae tendineae, the tendons that connect the papillary muscles to the underside of the mitral valve leaflets, can also affect the proper closure of the mitral valve annulus. Torn chordae tendineae can cause the leaflets to prolapse into the left atrium, for example, due to insufficient tension on the leaflets. Abnormal regurgitation can also occur when the function of the papillary muscles is impaired, for example, due to ischemia. When the left ventricle contracts during systole, the affected papillary muscles do not contract sufficiently to achieve proper closure.

[0004] Mitral valve prolapse, or when the mitral valve leaflets protrude abnormally into the left atrium, causes irregular behavior of the mitral valve and may also lead to mitral regurgitation. Normal function of the mitral valve may also be affected by mitral stenosis, or narrowing of the mitral orifice, causing impaired filling of the left ventricle during diastole.

[0005] Typically, treatment of mitral regurgitation has involved the application of diuretics and / or vasodilators to reduce the amount of blood flowing back into the left atrium. Other procedures have involved surgical approaches (open chest and endovascular) to either repair or replace the valve. For example, typical repair approaches have involved tightening or resecting portions of the dilated annulus.

[0006] Tightening of the annulus has generally been accomplished by implantation of annular or periannular rings that are secured to the annulus or surrounding tissue. Other repair procedures have also involved suturing or tightening the leaflets in partial apposition to one another.

[0007] Alternatively, more invasive procedures have involved replacement of the entire valve itself, where a mechanical valve or biological tissue is implanted into the heart in place of the mitral valve. These invasive procedures have traditionally been performed through a major open chest surgery and are therefore very painful, have significant morbidity, and require long recovery periods.

[0008] However, in many repair and replacement procedures, device durability or improper sizing of the annuloplasty ring or replacement valve can pose additional problems for the patient, and many repair procedures are highly dependent on the skill of the cardiac surgeon, where poor or incorrectly placed sutures can affect the success of the procedure.

[0009] Recently, minimally invasive approaches to aortic valve replacement have been developed. Examples of pre-assembled percutaneous prosthetic valves include, for example, the CoreValve Revalving® System from Medtronic / Corevalve Inc. (Irvine, CA, USA) and the Edwards-Sapien® Valve from Edwards Lifesciences (Irvine, CA, USA). Both valve systems include an expandable frame that houses a trileaflet bioprosthetic valve. The frame is expanded to fit a substantially symmetrical, circular, rigid aortic valve annulus. This gives the expandable frame in the delivery configuration a symmetrical circular shape at the aortic valve annulus that is suitable for supporting a trileaflet prosthetic valve (which requires such symmetry for proper coaptation of the prosthetic leaflets). Thus, the aortic valve anatomy is suitable for an expandable frame that houses a replacement valve because the aortic valve anatomy is substantially uniform, symmetrical, and extremely rigid.

[0010] Mitral valve replacement poses unique anatomical obstacles compared to aortic valve replacement, making percutaneous mitral valve replacement significantly more difficult 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, with a non-planar saddle-like geometry that often lacks symmetry. Such unpredictability makes it difficult to design a prosthetic mitral valve that has the ability to match the mitral annulus. The lack of a snug fit between the prosthesis and the native leaflets and / or annulus can leave gaps therebetween, resulting in regurgitation of blood through these gaps. The placement of a cylindrical prosthetic valve, for example, can leave gaps in the commissure regions of the native valve, potentially resulting in paravalvular leakage in these regions.

[0011] Current devices developed for percutaneous aortic valve replacement are inadequate to fit the mitral valve. First, many of the devices require a direct structural connection between the device structures that contact the valve annulus and / or leaflets and the device structures that support the prosthetic valve. In some devices, the same stent posts that support the prosthetic valve also contact the valve annulus or other surrounding tissues, directly transmitting to the device many of the distorting forces exerted by the tissue and blood as the heart contracts during each cardiac cycle. Most cardiac replacement devices also utilize tri-leaflet valves, which require substantially symmetrical cylindrical support around the prosthetic valve for proper opening and closing of the three leaflets over the years of life. When these devices are subject to motions and forces from the annulus and other surrounding tissues, the prosthesis may be compressed and / or distorted, causing the prosthetic leaflets to malfunction. Also, a typical diseased mitral valve annulus is much larger than any available prosthetic valve.

[0012] In addition to its irregular and unpredictable shape, the mitral annulus lacks a significant amount of radial support from the surrounding tissue. The aortic valve, for example, is completely surrounded by fibroelastic tissue, which helps to anchor 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 vascular wall, which separates the mitral annulus from the lower portion of the aortic outflow tract. As a result, significant radial forces on the mitral annulus, such as those exerted by expanding a stent prosthesis, can lead to collapse of the lower portion of the aortic tract, with potentially fatal consequences.

[0013] The chordae tendineae of the left ventricle may also present an obstacle in deploying a prosthetic mitral valve. This is unique to the mitral valve because the aortic valve anatomy does not contain chordae tendineae. The labyrinthine chordae tendineae in the left ventricle make it more difficult to navigate and position the deployment catheter in mitral valve replacement and repair. The deployment and positioning of a prosthetic valve or fixation device on the ventricular side of the native mitral valve is further complicated by the presence of the chordae tendineae. Summary of the Invention [Problem to be solved by the invention]

[0014] Given the difficulties associated with current procedures, there remains a need for simple, effective, minimally invasive devices and methods for treating incompetent heart valves. [Means for solving the problem]

[0015] Specific details of some embodiments of the present technology are described below with reference to Fig. 1-71. Although many of the embodiments are described below with respect to devices, systems, and methods for percutaneous replacement of a native mitral valve using a prosthetic valve device, other applications and other embodiments are within the scope of the present technology in addition to those described herein. In addition, some other embodiments of the present technology can have different configurations, components, or procedures than those described herein. Thus, those skilled in the art will understand that the present technology can have other embodiments with additional elements, or that the present technology can have other embodiments without some of the features shown and described below with reference to Fig. 1-71.

[0016] With respect to the terms "distal" and "proximal" in this description, unless otherwise specified, the terms can refer to the relative location of a portion of a prosthetic valve device and / or associated delivery device with reference to an operator and / or a location in the vasculature or heart. For example, in referring to a delivery catheter suitable for delivering and positioning the various prosthetic valve devices described herein, "proximal" can refer to a location closer to the operator of the device or an incision into the vasculature, and "distal" can refer to a location (e.g., the end of the catheter) that is more distal to the operator of the device or further from the incision along the vasculature. With respect to prosthetic heart valve devices, the terms "proximal" and "distal" can refer to the location of a portion of the device relative to the direction of blood flow. For example, proximal can refer to an upstream location or a location of blood inflow, and distal can refer to a downstream location or a location of blood outflow. For ease of reference, the same reference numbers and / or letters are used throughout this disclosure to identify like or similar components or features, but the use of the same reference numbers does not imply that the parts should be interpreted as being identical. Indeed, in many of the embodiments described herein, identically numbered parts are distinct in structure and / or function. The headings provided herein are for convenience only. The present invention provides, for example, the following: (Item 1) 1. A device for repairing or replacing a native valve of a heart, the native valve having an annulus and leaflets connected to the annulus, an anchoring member including a first portion and a second portion, the first portion configured to engage tissue above or below the annulus and to deform into a non-circular shape to conform to the tissue; a valve support coupled to the second portion of the anchoring member and configured to support a prosthetic valve, the valve support having a cross-sectional shape; wherein the first portion of the anchoring member is mechanically isolated from the valve support such that when the anchoring member is deformed to the non-circular shape, the cross-sectional shape of the valve support remains sufficiently stable such that the prosthetic valve remains competent. device. (Item 2) 1. A prosthetic heart valve device for implantation into a native mitral valve, the native mitral valve having an annulus and leaflets, an anchoring member positionable at a location between the valve leaflets, the anchoring member having a first portion and a second portion, the first portion of the anchoring member being expandable to a dimension greater than a corresponding dimension of the valve annulus such that upstream movement of the anchoring member is blocked by engagement of the first portion of the anchoring member with tissue on or near the valve annulus; a valve support coupled to the second portion of the anchoring member, the valve support spaced radially inward from at least the first portion of the anchoring member, the valve support configured to support a prosthetic valve; and A device comprising: (Item 3) 1. A prosthetic heart valve device for repairing or replacing a patient's native heart valve, the heart valve having an annulus and leaflets, an anchoring member having a first portion having a first cross-sectional dimension and a second portion having a second cross-sectional dimension smaller than the first cross-sectional dimension, the first portion configured to engage cardiac tissue to hold the anchoring member in a fixed longitudinal position relative to the annulus; a valve support coupled to the second portion of the anchoring member and configured to support a prosthetic valve, the valve support being radially separated from the first portion of the anchoring member such that the first portion of the anchoring member can deform inwardly without substantially deforming the valve support; A device comprising: (Item 4) 1. A device for repairing or replacing a native valve having an annulus and multiple leaflets, comprising: an expandable valve support configured for placement between the leaflets of the valve, the support having a first region, a second region, and an interior to which a valve can be coupled; an anchoring member having a first portion and a second portion, the second portion of the anchoring member coupled to the second region of the valve support, the first portion of the anchoring member extending outwardly away from the second region of the expandable valve support, the first portion of the anchoring member having a first perimeter configured to engage tissue on or near the valve annulus; wherein the anchoring member is mechanically isolated from the valve support such that forces exerted radially at or near the first periphery do not substantially change the shape of the valve support. device. (Item 5) 5. The device of claim 1, wherein the first portion of the anchoring member comprises an upstream portion and the second portion of the anchoring member comprises a downstream portion. (Item 6) 5. The device of claim 1, wherein the first portion of the fastening member comprises a downstream portion and the second portion of the fastening member comprises an upstream portion. (Item 7) 7. The device of claim 1, wherein the valve support has an upstream region spaced radially inward from the first portion of the anchoring member such that when the anchoring member is deformed inwardly, the upstream region of the valve support remains substantially undeformed. (Item 8) 7. The device of claim 1, wherein the first portion of the anchoring member is configured to engage valve tissue selected from an inward facing surface of the valve annulus and an inward facing surface of the leaflet below the valve annulus. (Item 9) 9. The device of claim 8, wherein the first portion of the fixation member is configured to apply an outward force against the valve tissue to resist movement of the device when blood flows downstream through the valve support when the valve is open and when blood pushes against the valve in an upstream direction when the valve is closed. (Item 10) 7. The device of claim 1, wherein the fixation member is self-expanding. (Item 11) Item 11. The device of item 10, wherein the anchoring member comprises Nitinol. (Item 12) 7. The device of claim 1, wherein the fixation member is formed of Nitinol tubing having a wall thickness of about 0.010 inches to about 0.130 inches. (Item 13) 7. The device of claim 1, wherein the anchoring member includes a plurality of longitudinal ribs having axial stiffness to resist migration of the device in an upstream direction toward the left atrium of the heart. (Item 14) 7. The device of claim 1, wherein the fastening member comprises a plurality of longitudinal ribs. (Item 15) Item 15. The device of item 14, wherein the plurality of ribs are arranged in a diamond configuration. (Item 16) 7. The device of claim 1, wherein the fixation member comprises a plurality of flexible filaments arranged in a diamond configuration around a circumference of the fixation member, the diamond configuration comprising one or more rows of diamonds and about 12 to about 36 columns of diamonds around the circumference. (Item 17) 7. The device of claim 1, wherein the valve support includes an upstream end and a downstream end, the upstream end extending an upstream distance beyond the upstream portion of the anchoring member. (Item 18) 7. The device of claim 1, wherein the valve support includes an upstream end and a downstream end, and the first portion of the anchoring member defines an upstream portion that extends an upstream distance beyond the upstream end of the valve support. (Item 19) 7. The device of claim 1, wherein the fixation member includes a rim at a proximal end of the first portion, the rim having an undeformed configuration, the undeformed configuration having a generally oval shape or a D-shape. (Item 20) 20. The device of claim 19, wherein the periphery includes a plurality of peaks and a plurality of valleys. (Item 21) the anchoring member includes a periphery at a proximal end of the first portion, the periphery having a generally oval or D-shaped configuration; the anchoring member includes a distal end of the second portion, the distance between the distal end and the periphery varying around a circumference of the anchoring member; The device according to items 1 to 6. (Item 22) 22. The device of claim 21, wherein the distance varies from about 6 mm to about 20 mm. (Item 23) 22. The device of claim 21, wherein the distance varies from about 9 mm to about 12 mm. (Item 24) The distance is: a first distance between the distal end and the periphery that is about 7 mm to about 8 mm in first and second regions of the fixation member, the first and second regions being configured to align with first and second commissures of the native mitral valve, respectively; a second distance between the distal end and the periphery in a third region of the anchoring member, the second distance being about 9 mm to about 11 mm, the third region being configured to align with an anterior leaflet of the native mitral valve; a third distance between the distal end and the periphery that is about 12 mm to about 13 mm at a fourth region of the fixation member opposite the third region, the fourth region configured to align with the posterior leaflet of the native mitral valve; , including multiple distances, Item 22. The device according to item 21. (Item 25) the anchoring member includes a periphery at a proximal end of the first portion, the periphery having a generally oval or D-shaped configuration; the tissue above or below the annulus has a non-circular shape having an inner diameter and an outer diameter substantially perpendicular to the inner diameter; the upstream portion of the anchoring member has an outer periphery having an outer periphery diameter and an inner periphery diameter generally perpendicular to the outer periphery diameter; the circumferential outer diameter is greater than the outer diameter; the circumferential inner diameter is greater than the inner diameter; The device according to items 1 to 6. (Item 26) Item 26. The device of item 25, wherein the circumferential outer diameter is about 2 mm to about 22 mm larger than the outer diameter. (Item 27) 26. The device of claim 25, wherein the circumferential outer diameter is about 8 mm to about 15 mm larger than the outer diameter. (Item 28) 26. The device of claim 25, wherein the outer circumferential diameter is from about 45 mm to about 60 mm. (Item 29) 26. The device of claim 25, wherein the inner circumferential diameter is from about 40 mm to about 55 mm. (Item 30) 7. The device of claim 1, wherein the valve support is a generally circular cylinder. (Item 31) 31. The device of item 30, wherein the valve support has a diameter of about 25 mm to about 30 mm. (Item 32) 7. The device of claim 1, wherein the valve support is a cylindrical valve support having a diameter of about 27 mm. (Item 33) 7. The device of claim 1, wherein the valve support is a cylindrical valve support having a vertical height of about 14 mm to about 17 mm. (Item 34) the first portion of the anchoring member has a proximal end periphery having apex and valley portions corresponding to natural apex and valley portions, respectively, of the valve annulus; the corresponding apex portion is configured to align with the natural valley portion, and the corresponding valley portion is configured to align with the natural apex portion; The device according to items 1 to 6. (Item 35) 7. The device of claim 1, wherein the valve support extends about a longitudinal axis and the first portion of the anchoring member flares outwardly from the longitudinal axis at a decreasing angle. (Item 36) Item 36. The device of item 35, wherein the tapered angle varies continuously between the first portion and the second portion. (Item 37) Item 36. The device of item 35, wherein the tapered angle varies around a circumference of the first portion. (Item 38) Item 36. The device of item 35, wherein the tapered angle is between about 30° and about 75°. (Item 39) Item 36. The device of item 35, wherein the tapered angle is between about 40° and about 60°. (Item 40) 7. The device of claim 1, wherein the valve support is oriented along the first longitudinal axis and the fixation member is oriented along a second longitudinal axis, the first and second longitudinal axes being non-collinear. (Item 41) Item 41. The device of item 40, wherein the second longitudinal axis is offset from the first longitudinal axis. (Item 42) Item 41. The device of item 40, wherein the second longitudinal axis is non-parallel to the first longitudinal axis. (Item 43) 7. The device of claim 1, wherein the first portion of the anchoring member includes a widened portion and a vertical portion, the vertical portion configured to radially expand to engage the valve annulus. (Item 44) Item 44. The device of item 43, wherein the flared portion includes a tissue engaging element configured to engage subannular tissue. (Item 45) 7. The device of claim 1, wherein the first portion is radially separated from the valve support by a gap. (Item 46) the anchoring member includes a periphery at a proximal end of the first portion, the periphery having an oval shape; the valve support is a cylindrical valve support at least partially surrounded by the fastening member; the gap varies around the circumference of the cylindrical valve support. Item 46. The device according to item 45. (Item 47) Item 47. The device of item 46, wherein the gap is larger on a side of the device facing the anterior leaflet than on a side of the device facing the posterior leaflet. (Item 48) The device of any one of items 1 to 6, wherein the device is configured to avoid obstruction of the left ventricular outflow tract (LVOT) of the heart. (Item 49) 7. The device of claim 1, further comprising a skirt covering a surface of the fixation member, the skirt configured to block blood flow between the fixation member and the valve support. (Item 50) 50. The device of claim 49, wherein the skirt is further configured to inhibit blood flow between the anchoring member and the tissue. (Item 51) 50. The device of item 49, wherein the skirt comprises one or more of Dacron®, ePTFE, bovine pericardium, a polymer, a thermoplastic polymer, polyester, Gore-tex®, synthetic fibers, natural fibers, or polyethylene terephthalate (PET). (Item 52) 7. The device of claim 1, wherein the valve support is coupled to the anchoring member with one or more of a plurality of rivets and a plurality of sutures. (Item 53) 7. The device of claim 1, wherein the valve support has a radial strength of about 42 mmHg to about 47 mmHg. (Item 54) 7. The device of claim 1, further comprising a valve coupled to the valve support to prevent retrograde blood flow. (Item 55) 55. The device of item 54, wherein the valve is a trileaflet valve. (Item 56) 55. The device of item 54, wherein the valve comprises bovine pericardium. (Item 57) Item 55. The device of item 54, wherein the valve has a plurality of commissure attachment structures, and the valve is coupled to the valve support at the commissure attachment structures. (Item 58) Item 58. The device of item 57, wherein the commissure attachment structures are permanently fixed to the valve support. (Item 59) Item 60. The device of item 57, wherein the commissure attachment structure is integral with an inner wall of the valve support. Item 58. The device of item 57, wherein the valve support has a first height and the commissure attachment structure has a second height that is less than the first height. (Item 61) 7. The device of claim 1, wherein the valve support is further configured to receive a replacement valve after the device is implanted in place of a native valve. (Item 62) Item 62. The device of item 61, further comprising a temporary valve coupled to the valve support. (Item 63) Item 63. The device of item 62, wherein the temporary valve is adapted to be displaced against an inner wall of the valve support when the replacement valve is received within the valve support. (Item 64) Item 62. The device of item 61, wherein the temporary valve comprises a removable valve and the replacement valve is secured within the valve support after the temporary valve is removed. (Item 65) 7. The device of claim 1, further comprising an artificial valve coupled to the valve support, at least in an area where the valve support is mechanically isolated from the first portion of the fixation member. (Item 66) 7. The device of claim 1, wherein the first portion of the fixation member has a first flexibility and the valve support comprises a second flexibility less than the first flexibility such that a region of the valve support remains substantially undistorted when the first portion of the fixation member bends to the native mitral valve. (Item 67) the anchoring member is defined by a structure separate from the valve support; the valve support is coupled to the anchoring member at the second portion of the anchoring member; the second portion of the fastening member is longitudinally spaced from the first portion of the fastening member; The device according to items 1 to 6. (Item 68) 7. The device of claim 1, further comprising a plurality of flexible coupling mechanisms configured to flexibly couple the valve support to the fixation member. (Item 69) Item 68. The device of item 67, wherein the flexible connection mechanism can include at least one of a suture, a wire, a flexible filament, a rivet, a screw, or a pin. (Item 70) The device comprises: a first configuration, wherein the valve support and the anchoring member are radially contracted; a second configuration, wherein the valve support and the anchoring member are radially expanded; and a third configuration, wherein the anchoring member is engaged with tissue on or near the valve annulus and at least partially deformed thereby;

[0033] The present invention relates to a method for manufacturing a multi-layered ... The device according to items 1 to 6. (Item 71) Item 71. The device of item 70, wherein the valve support has an expanded shape in the second configuration and the valve support remains substantially in the expanded shape in the third configuration. (Item 72) Item 71. The device of item 70, wherein the fixation member is in the second configuration in an unbiased state. (Item 73) Item 71. The device of item 70, wherein the anchoring member is transformable from the second configuration to the third configuration. (Item 74) Item 71. The device of item 70, wherein the device in the first configuration has a low-profile configured for delivery through a guide catheter positioned at or near the native mitral valve. (Item 75) Item 71. The device of item 70, wherein the first portion of the fixation member has a first diameter in the second configuration, the first diameter spanning at least a distance between the native commissures of the native mitral valve. (Item 76) Item 71. The device of item 70, wherein the first portion of the anchoring member has a first diameter and the valve support has a second diameter in the second configuration, the first diameter being about 1.2 to 1.5 times the second diameter. (Item 77) 7. The device of claim 1, wherein the first portion of the fixation member has a first expanded diameter of about 28 mm to about 80 mm. (Item 78) 78. The device of items 1-6 and 77, wherein the valve support has an expanded diameter of about 25 mm to about 32 mm. (Item 79) 7. The device of claim 1, wherein the first portion of the anchoring member is a downstream portion spaced longitudinally from the second portion of the anchoring member defining an upstream portion, the upstream portion having a first cross-sectional dimension, and the downstream portion having a second cross-sectional dimension smaller than the first cross-sectional dimension. (Item 80) 7. The device of claim 1, wherein the anchoring member resists upstream movement of the device without any elements of the device extending behind the leaflets of the native mitral valve. (Item 81) The device of any one of items 1 to 6, wherein the device does not engage supranulular tissue or tissue upstream of the annulus. (Item 82) 7. The device of claim 1, further comprising a sealing member extending around the first portion of the fixation member and configured to seal against the tissue above or downstream of the annulus to prevent blood flow between the fixation member and the tissue. (Item 83) Item 83. The device of item 82, wherein the sealing member promotes tissue ingrowth into the sealing member. (Item 84) Item 83. The device of item 82, wherein the sealing member includes a plurality of tissue engaging elements on an outer surface of the sealing member. (Item 85) 7. The device of claim 1, wherein the fixation member has a plurality of tips on an upstream end, the tips being configured to penetrate tissue above or downstream of the annulus so as to prevent upstream migration of the device. (Item 86) Item 86. The device of item 85, wherein the fixation member comprises a delivery mechanism for transitioning the plurality of tips from a retracted position to an engaged position, the engaged position comprising penetration of the annulus tissue by the tips. (Item 87) 7. The device of claim 1, further comprising a plurality of anchoring clips on ends of the anchoring members, the anchoring clips configured to engage the valve annulus. (Item 88) The fastening member is A plurality of longitudinal ribs; a plurality of circumferential connectors interconnecting the plurality of ribs; the anchoring member is flared such that ends of the ribs are oriented radially outward to engage tissue above or downstream of the annulus to prevent migration of the device in an upstream direction. The device according to items 1 to 6. (Item 89) Item 91. The device of item 88, wherein the anchoring member has a central longitudinal axis and each individual rib has a plurality of segments having different angles of expansion relative to the longitudinal axis. (Item 90) Item 90. The device of item 88, wherein the plurality of longitudinal ribs includes a first and a second plurality of ribs, the first plurality of ribs having different characteristics than the second plurality of ribs, the characteristics being selected from the group of size, shape, stiffness, expansion angle, and number of ribs in a given region of the anchoring member. (Item 91) Item 90. The device of item 88, wherein the longitudinal ribs are evenly spaced around the circumference of the fastening member. (Item 92) Item 91. The device of item 88, wherein the valve support includes a plurality of posts circumferentially connected by a plurality of struts, each individual longitudinal rib being integrally formed with a corresponding post on the valve support. (Item 93) Item 93. The device of item 92, wherein each of the plurality of longitudinal ribs includes a curved elbow portion integrally formed with the corresponding post, the elbow portion configured to urge the respective rib radially outward from an inward configuration to an outward configuration. (Item 94) Item 93. The device of item 92, further comprising a tether connecting each individual rib with the corresponding post, the tether configured to limit outward deflection of the ribs when the ribs are in the expanded configuration. (Item 95) Item 96. The device of item 92, wherein one or more individual circumferential connectors include a looped connector head and one or more individual struts include a looped strut head, said looped connector heads coupled to said looped strut heads to form a flexible coupling mechanism. Item 96. The device of item 95, wherein the looped connector head is passed through the looped strut head to form the flexible connection. (Item 97) Item 96. The device of item 95, wherein one or more flexible filaments connect the looped connector head to the looped strut head to form the flexible connection mechanism. (Item 98) Item 99. The device of item 88, wherein the plurality of circumferential connectors include a plurality of bands extending around a circumference of the fastening member, the bands being slidably coupled to each respective rib. 7. The device of claim 1, wherein the anchoring member has a downstream portion that is substantially tubular and the upstream portion of the anchoring member is deformable to a non-circular cross-section while the valve support remains substantially circular in cross-section. (Item 100) the valve support includes a plurality of first struts interconnected around a circumference of the valve support; the anchoring member includes a plurality of second struts interconnected around a circumference of the anchoring member; The first strut is stiffer than the second strut. The device according to items 1 to 6. (Item 101) 7. The device of claim 1, further comprising a plurality of tissue engaging elements configured to engage tissue of the valve annulus or leaflet. (Item 102) The tissue engaging element comprises: a piercing configuration, wherein the tissue engaging element has a low profile for penetrating the tissue; a retaining configuration, the tissue engaging element having an expanded profile to maintain the tissue engaging element within the tissue; Item 102. The device according to item 101, comprising: (Item 102) 7. The device of claim 1, wherein the anchoring member is coupled to a sleeve, the sleeve being configured to limit radial expansion of the anchoring member when the anchoring member is in an expanded configuration. (Item 103) Item 103. The device of item 102, wherein the sleeve includes an outer portion configured to cover the anchoring member and an inner portion configured to at least partially surround the valve support. (Item 104) Item 104. The device of item 103, wherein the sleeve includes a plurality of horizontal septa extending between the outer and inner portions of the sleeve. (Item 105) the anchoring member has an upstream portion configured to engage an upstream-facing surface of the leaflet downstream of the annulus; the valve support is at least partially within a fixation body, the valve support being configured to support a prosthetic valve; the fixation body is deformable to a non-circular cross-section while the valve support remains substantially circular in cross-section. The device according to items 1 to 6. (Item 106) Item 106. The device of item 105, wherein the second portion of the anchoring member defines a downstream portion and the first portion of the anchoring member defines an upstream portion, the downstream portion being longitudinally separated from the upstream portion, and the downstream portion being coupled to a downstream region of the valve support. (Item 107) Item 107. The device of item 106, further comprising a plurality of tethers connecting the upstream portion of the fixation body to the valve support, the tethers configured to limit radial expansion of the upstream portion. (Item 108) the anchoring member has a hyperboloid shape including a first end at the first portion and a second end at the second portion configured to engage an inward-facing surface of the leaflet downstream of the annulus; the first end has a larger cross-sectional area than the second end; the valve support is positioned within the anchoring member, the valve support being coupled to the anchoring member at a location substantially spaced from the first end and not coupled to the anchoring member at the first end. The device according to items 1 to 6. (Item 109) 7. The device of claim 1, further comprising an atrial retainer configured to engage supranulvular tissue such that downstream movement of the device is blocked by engagement of the atrial retainer with the supranulvular tissue. (Item 110) Item 110. The device of item 109, wherein the atrial retainer includes an outward extension of the valve support. (Item 111) Item 110. The device of item 109, wherein the atrial retainer includes an extension of the anchoring member configured to pass through the native valve and engage the supranulus tissue. (Item 112) 7. The device of claim 1, wherein the fixation member includes a plurality of atraumatic nodes that resist penetration of the inward-facing surface of the leaflet downstream of the annulus. (Item 113) 7. The device of claim 1, further comprising one or more positioning elements coupled to the fixation member, the positioning elements configured to engage ventricular tissue and position the device away from a left ventricular outflow tract (LVOT). (Item 114) The position element is a locator arm configured to extend from the anchoring member to the ventricular tissue; a tissue engaging portion at a distal end of the locator arm, the tissue engaging portion configured to atraumatically engage the ventricular tissue; Item 114. The device of item 113, comprising: (Item 115) 7. The device of claim 1, wherein the anchoring member resists upstream movement of the device without elements of the device extending behind the native valve leaflets. (Item 116) the valve support includes an upper region, a lower region, and an interior portion that holds a prosthetic valve; the anchoring member surrounds at least a portion of the valve support, the anchoring member being positionable between the valve leaflets and having a plurality of flexible wires arranged in a diamond pattern, an upper portion, and a lower portion; the top portion of the anchoring member flares outward in a proximal direction such that proximal ends of the wires point radially outward to engage cardiac tissue on or near the annulus and inhibit migration of the device in the upstream direction; the lower region of the support structure is connected to the lower portion of the fastening member, and the upper region of the support structure is mechanically isolated from deformation of at least the flared top portion of the fastening member; The device according to items 1 to 6. (Item 117) the valve support comprises a cylindrical support having a longitudinal axis and an interior along the longitudinal axis through which blood may flow; the anchoring member is defined by a structure separate from the cylindrical support, the anchoring member has a non-circular cross-section, the anchoring member has an outwardly flared upstream end configured to engage subannular tissue of the mitral valve, the anchoring member surrounds the cylindrical support and is coupled to the cylindrical support at a downstream end opposite the upstream end. The device according to items 1 to 6. (Item 118) Item 118. The device of item 117, further comprising a valve coupled within the interior of the support and configured to block blood flow through the support in the upstream direction and allow blood flow through the support in the downstream direction. (Item 119) Item 118. The device of item 117, further comprising a stabilization member extending outwardly from the downstream end of the fixation body, the stabilization member configured to engage native tissue downstream of the mitral valve annulus. (Item 120) Item 120. The device of item 119, wherein the stabilization member includes a plurality of arms extending from the downstream end, the arms configured to engage one or more of the subannular tissue, the native valve leaflets, or the ventricular wall. (Item 121) Item 121. The device of item 120, wherein the arms extend behind the native valve leaflets. (Item 122) Item 121. The device of item 120, wherein each individual arm includes an arm body and a tip at a distal end of the arm body, the tip configured to engage natural tissue. (Item 123) Item 121. The device of item 120, wherein the tip exerts a force on the native tissue without penetrating the native tissue. (Item 124) Item 121. The device of item 120, wherein the tip includes a tissue engaging element for piercing through at least a portion of the native tissue. (Item 125) Item 126. The device of items 1-6, further comprising a second anchoring structure coupled to the first portion of the anchoring member and extending outwardly therefrom to engage tissue on or near the valve annulus. Item 126. The device of item 125, wherein the second anchoring structure is coupled to an upstream periphery of the anchoring member, the second anchoring structure extending outward in a downstream direction. (Item 127) the valve support comprises an inner frame having an outer surface and an inner surface, the inner surface configured to support a prosthetic valve; the fixation member comprises an outer frame coupled to the inner frame, the outer frame having a first portion with a cross-sectional dimension greater than a corresponding cross-sectional dimension of the mitral valve annulus, the first portion configured to engage tissue at or below the mitral valve annulus to prevent migration of the device in an upward direction during ventricular systole, and at least the first portion of the frame is mechanically isolated from the inner frame. The device according to items 1 to 6. (Item 128) 7. The device of claim 1, wherein the fixation member has a first longitudinal length on a side facing the posterior leaflet and a second length on a side facing the anterior leaflet, the first length being greater than the second length. (Item 129) Item 130. The device of item 128, wherein the side facing the posterior leaflet further includes an arm configured to receive the posterior leaflet between the arm and the outer frame. (Item 130) the valve support comprises a cylindrical inner skeleton having an interior to which a prosthetic valve can be coupled; the fixation member comprises an outer skeleton coupled to the inner skeleton and positionable between the leaflets downstream of the annulus, the outer skeleton having a plurality of flexible wires arranged in a diamond configuration, at least a portion of the wires configured to engage sub-annular tissue to prevent migration of the device in the upstream direction; The outer skeleton is deformable to a non-circular cross-section while the inner skeleton remains substantially circular in cross-section. The device according to items 1 to 6. (Item 131) 7. The device of claim 1, wherein the valve support has a proximal end and a distal end, and the anchoring member is coupled to the valve support at a location intermediate the proximal and distal ends. (Item 132) 7. The device of claim 1, further comprising a second fixation member, the second fixation member having a second upstream end configured to engage tissue above or downstream of the valve annulus and having a second downstream end coupled to the valve support. (Item 133) 7. The device of claim 1, further comprising a second anchoring member at least partially surrounding the anchoring member, the second anchoring member having a second flared upstream portion and a second downstream portion coupled to the outer surface of the valve support, the second upstream portion being mechanically isolated from the valve support and configured to engage subannular tissue of the native valve. (Item 134) Item 134. The device of item 133, wherein the fastening member has a first height and the second fastening member has a second height, the first height being different from the second height. (Item 135) 7. The device of claim 1, further comprising an expandable fixation element configured to engage on or near the valve annulus, the fixation element including one or more inflatable chambers coupled to at least one of the valve support and the anchoring member. (Item 136) 7. The device according to items 1-6, wherein the fixation member has a first longitudinal length on a side facing the posterior leaflet and a second length on a side facing the anterior leaflet, the first length being greater than the second length such that obstruction of the left ventricular outflow tract (LVOT) is limited. (Item 137) Item 137. The device of item 136, wherein the side facing the posterior leaflet further includes an arm configured to receive the posterior leaflet between the arm and the anchoring member. (Item 138) 7. The device of claim 1, wherein the fixation member has a flared upstream portion having an upper ring and a lower ring coupled to the upper ring, the device further comprising a plurality of flexible annulus engaging elements distributed around a circumference of the fixation member and coupling the upper ring to the lower ring, the lower ring configured to move in an upstream direction toward the upper ring such that the annulus is received between the upper and lower rings and within the annulus engaging elements. (Item 139) 1. A method for replacement of a native heart valve having an annulus and leaflets connected to said annulus, comprising: Positioning a prosthesis including an anchoring member and a valve support coupled to the anchoring member at the patient's native mitral valve. Including, a first portion of the anchoring member engages tissue above or downstream of the annulus of the native mitral valve such that the first portion of the anchoring member deforms relative to a shape of the native mitral valve; the valve support expands within the anchoring member; a portion of the valve support, upon expansion, maintains a predetermined cross-sectional shape suitable for manipulating a prosthetic valve, while the first portion of the anchoring member deforms relative to the shape of the native mitral valve. method. (Item 140) 140. The method of claim 139, wherein the prosthesis comprises a device according to any one of claims 1 to 138. (Item 141) Item 140. The method of item 139, further comprising the step of delivering the device by a catheter prior to positioning the prosthesis between the valve leaflets. (Item 142) Item 142. The method of item 141, further comprising the steps of retracting a sheath on the catheter to expose the device in an expanded configuration and moving the device in an upstream direction such that the upstream portion of the anchoring member engages tissue. (Item 143) Item 142. The method of item 141, further comprising navigating the catheter configured to hold the device in a delivery configuration by one or more of a transseptal approach from the right atrium, a transapical approach via a left ventricular incision or puncture, or a transaortic approach through the aorta. (Item 144) positioning the device, the device comprising placing the device between the leaflets and downstream of the annulus when the device is in a delivery configuration; expanding the device from the delivery configuration to an expanded configuration with the anchoring members extending between the leaflets; moving the device in an upstream direction to engage the tissue above or downstream of the annulus with the upstream portion. Item 139. The method according to item 139, comprising: (Item 145) The upstream portion of the anchoring member has an oval shape when in a deployed configuration and tissue at or below the annulus has a corresponding oval shape, the method further comprising: visualizing the fixation member and the mitral valve by echocardiography or fluoroscopy; aligning the upstream portion of the anchoring member to engage the tissue above or downstream of the valve annulus based on the echocardiographic or fluoroscopic imaging. Item 145. The method according to item 144, comprising: (Item 146) Item 140. The method of item 139, wherein a valve is coupled to the valve support, the valve configured to allow blood flow from the left atrium to the left ventricle and to prevent blood flow from the left ventricle to the left atrium. (Item 147) Item 140. The method of item 139, wherein the fixation member prevents migration of the device toward the left atrium by engaging subannular tissue when the left ventricle contracts and the valve prevents blood flow from the left ventricle to the left atrium. (Item 148) Item 140. The method of item 139, further comprising the step of simultaneously delivering the anchoring member and the valve support coupled to the anchoring member by a catheter prior to implantation into the mitral valve. (Item 149) Item 140. The method of item 139, further comprising the steps of retracting a sheath over the catheter to expose the device in an expanded configuration and moving the device in an upstream direction such that the upstream portion of the anchoring member engages subannular tissue. (Item 150) Item 140. The method of item 139, further comprising navigating the catheter configured to hold the device in a delivery configuration by one or more of a transseptal approach from the right atrium, a transapical approach via a left ventricular incision or puncture, or a transaortic approach through the aorta. (Item 151) Item 140. The method of item 139, further comprising activating a temporary valve coupled to the valve support after the device is implanted. (Item 152) Item 152. The method of item 151, further comprising positioning a replacement valve within the valve support and expanding the replacement valve into engagement with the valve support. (Item 153) Item 140. The method of item 139, further comprising the step of coupling the valve to the valve support after the device is implanted in the mitral valve. (Item 154) Item 140. The method of item 139, further comprising the step of radially expanding the valve support after the anchoring members engage the tissue above or downstream of the valve annulus. (Item 155) The step of positioning the device comprises: a first configuration in which the valve support and the anchoring member are radially contracted, the valve support having a first cross-sectional shape; a second configuration in which the valve support and the anchoring member are radially expanded, the valve support having a second cross-sectional shape that is larger than the first cross-sectional shape; and a third configuration, wherein the anchoring member is engaged with and at least partially deformed by tissue on or downstream of the valve annulus while the valve support remains in the second cross-sectional shape; and Item 140. The method of item 139, comprising implanting the anchoring member and the valve support within or adjacent to the valve annulus by moving the device through a plurality of configurations including: (Item 156) Item 140. The method of item 139, further comprising engaging one or more stabilization members coupled to the anchoring member with natural tissue. (Item 157) 1. A system for treating a mitral valve in a patient, the mitral valve having an annulus, A device comprising the device according to any one of items 1 to 138; a catheter having a lumen configured to hold the device therein; A system comprising: (Item 158) Item 158. The system of item 157, further comprising a replacement valve configured to couple to the device after placement of the device in place of the native mitral valve. (Item 159) Item 159. The system of item 158, further comprising a delivery catheter coupled to the replacement valve. (Item 160) Item 158. The system of item 157, wherein the catheter comprises an expandable member configured to radially expand portions of the device. (Item 161) Item 158. The system of item 157, wherein the catheter comprises a retractable sheath, the device is contained within the sheath, and the device is configured to elastically expand when the sheath is retracted. (Item 162) Item 158. The system of item 157, wherein the catheter comprises a guidewire lumen adapted to slidably receive a guidewire, the guidewire lumen having proximal and distal ports through which the guidewire can be slidably inserted. [Brief description of the drawings]

[0017] Many aspects of the present disclosure can be better understood with reference to the following drawings. Components in the drawings are not necessarily drawn to scale. Instead, emphasis has been placed on clearly illustrating the principles of the present disclosure. Additionally, components may be shown as transparent in certain figures for clarity of illustration only, and not to indicate that the components shown are necessarily transparent. [Figure 1] 1 and 2 are schematic diagrams of a mammalian heart having native valve structures suitable for replacement with various prosthetic heart valve devices in accordance with embodiments of the present technology. [Diagram 2] 1 and 2 are schematic diagrams of a mammalian heart having native valve structures suitable for replacement with various prosthetic heart valve devices in accordance with embodiments of the present technology. [Diagram 3] FIG. 3 is a schematic cross-sectional side view of a native mitral valve showing the annulus and leaflets. [Figure 4A] FIG. 4A is a schematic diagram of the left ventricle of a heart having either i) a prolapsed leaflet in the mitral valve or ii) mitral regurgitation in the left ventricle of a heart with compromised papillary muscles, suitable for combination with various prosthetic heart valve devices in accordance with embodiments of the present technology. [Figure 4B] FIG. 4B is a schematic illustration of a patient's heart suffering from cardiomyopathy, suitable for combination with various prosthetic heart valve devices, in accordance with embodiments of the present technology. [Figure 5A] FIG. 5A is a schematic diagram of the native mitral valve of the heart showing normal closure of the native mitral valve leaflets. [Figure 5B] FIG. 5B is a schematic illustration of a native mitral valve of a heart showing abnormal closure of the native mitral valve leaflets in a dilated heart, suitable for combination with various prosthetic heart valve devices in accordance with embodiments of the present technology. [Figure 5C] FIG. 5C is a schematic diagram of a mitral valve of the heart showing annular dimensions suitable for combination with various prosthetic heart valve devices in accordance with embodiments of the present technology. [Figure 6A] FIG. 6A is a schematic cross-sectional view of the heart illustrating an antegrade approach to the native mitral valve from the venous vasculature, in accordance with various embodiments of the present technology. [Figure 6B] FIG. 6B is a schematic cross-sectional view of the heart illustrating access through the interatrial septum (IAS) maintained by placement of a guide catheter over a guidewire, in accordance with various embodiments of the present technology. [Figure 7] 7 and 8 are schematic cross-sectional views of the heart illustrating a retrograde approach to the native mitral valve through the aortic valve and arterial vasculature, in accordance with various embodiments of the present technology. [Figure 8] 7 and 8 are schematic cross-sectional views of the heart illustrating a retrograde approach to the native mitral valve through the aortic valve and arterial vasculature, in accordance with various embodiments of the present technology. [Figure 9] FIG. 9 is a schematic cross-sectional view of the heart illustrating an approach to the native mitral valve using transapical puncture, in accordance with various embodiments of the present technology. [Figure 10A]FIG. 10A shows an isometric view of a prosthetic heart valve device in accordance with an embodiment of the present technology. [Figure 10B] FIG. 10B illustrates a cutaway view of the heart showing the artificial treatment device of FIG. 10A implanted in a native mitral valve in accordance with an embodiment of the present technology. [Figure 10C] 10C-10F are side, perspective cutaway, top, and bottom views, respectively, of a prosthetic heart valve device in accordance with an embodiment of the present technology. [Figure 10D] 10C-10F are side, perspective cutaway, top, and bottom views, respectively, of a prosthetic heart valve device in accordance with an embodiment of the present technology. [Figure 10E] 10C-10F are side, perspective cutaway, top, and bottom views, respectively, of a prosthetic heart valve device in accordance with an embodiment of the present technology. [Figure 10F] 10C-10F are side, perspective cutaway, top, and bottom views, respectively, of a prosthetic heart valve device in accordance with an embodiment of the present technology. [Figure 11A] FIG. 11A is a side view of a valve support in an expanded configuration in accordance with an embodiment of the present technology. [Figure 11B] 11B-11D are isometric views of additional embodiments of valve supports with prosthetic valves mounted therein in accordance with embodiments of the present technology. [Figure 11C] 11B-11D are isometric views of additional embodiments of valve supports with prosthetic valves mounted therein in accordance with embodiments of the present technology. [Figure 11D] 11B-11D are isometric views of additional embodiments of valve supports with prosthetic valves mounted therein in accordance with embodiments of the present technology. [Figure 11E] FIG. 11E is an isometric view of a prosthetic heart valve device in accordance with another embodiment of the present technology. [Figure 12A] 12A-12C are side views of various longitudinal ribs bending in response to a distorting force in accordance with further embodiments of the present technology. [Figure 12B]12A-12C are side views of various longitudinal ribs bending in response to a distorting force in accordance with further embodiments of the present technology. [Figure 12C] 12A-12C are side views of various longitudinal ribs bending in response to a distorting force in accordance with further embodiments of the present technology. [Figure 13-1] FIG. 13A is a schematic cross-sectional view of a prosthetic heart valve device in accordance with another embodiment of the present technology. [Figure 13-2] 13B-13F are partial side views of a prosthetic heart valve device illustrating various longitudinal rib configurations in accordance with further embodiments of the present technology. [Figure 14A] FIG. 14A is a schematic top view of a native mitral valve illustrating the long and short axes. [Figure 14B] 14B-14C are schematic top views of an anchoring member in an expanded and deployed configuration, respectively, in accordance with an embodiment of the present technology. [Figure 14C] 14B-14C are schematic top views of an anchoring member in an expanded and deployed configuration, respectively, in accordance with an embodiment of the present technology. [Figure 15] FIG. 15 is an isometric view of a prosthetic heart valve device shown in a deployed configuration in accordance with an additional embodiment of the present technology. [Figure 16A] FIG. 16A is a top view of a prosthetic heart valve device shown in an expanded configuration in accordance with a further embodiment of the present technology. [Figure 16B] 16B-16C are first and second side views, respectively, of the prosthetic heart valve device of FIG. 16A. [Figure 16C] 16B-16C are first and second side views, respectively, of the prosthetic heart valve device of FIG. 16A. [Figure 16D] FIG. 16D is a side view of a prosthetic heart valve device showing the longitudinal axis of the anchoring members offset from the longitudinal axis of the valve support by an oblique angle in accordance with another embodiment of the present technology. [Figure 16E]FIG. 16E is a schematic top view of the native mitral valve in the heart from the left atrium, showing the prosthetic treatment device of FIGS. 16A-16C implanted in the native mitral valve in accordance with an embodiment of the present technology. [Figure 17] 17A-17C are schematic top and first and second side views of the prosthetic heart valve device of FIG. 16A showing various lateral dimensions and taper angles of the device in accordance with an embodiment of the present technology. [Figure 18] FIG. 18 is an isometric view of an anchoring member shown in an expanded configuration in accordance with yet another embodiment of the present technology. [Figure 19] 19A-19C are isometric, side, and top views, respectively, of a prosthetic heart valve device having a sealing member in accordance with a further embodiment of the present technology. [Figure 20-1] FIG. 20A is an isometric view of a prosthetic heart valve device lacking a sealing member in accordance with an embodiment of the present technology. [Figure 20-2] 20B-20E are isometric views of a prosthetic heart valve device having a sealing member in accordance with an additional embodiment of the present technology. [Figure 21] 21A-21B are cross-sectional and isometric views of a prosthetic heart valve device having a tubular valve support member according to further embodiments of the present technology, and FIGs. 21C-21F are cross-sectional and isometric views of a prosthetic heart valve device having a tubular valve support member according to other embodiments of the present technology, and FIGs. 21C-21F are cross-sectional and isometric views of a prosthetic heart valve device having a tubular valve support member according to other embodiments of the present technology. [Figure 22-1] 22A-22G and 22I-22K are close-up side views of various mechanisms for coupling the valve support to the anchoring member in accordance with additional embodiments of the present technology. FIG 22H is a side view of a post within the prosthetic heart valve device of FIG 40G. [Figure 22-2] 22A-22G and 22I-22K are close-up side views of various mechanisms for coupling the valve support to the anchoring member in accordance with additional embodiments of the present technology. FIG 22H is a side view of a post within the prosthetic heart valve device of FIG 40G. [Diagram 23]23A-23B are enlarged side views of additional mechanisms for coupling an anchoring member to a valve support member in accordance with further embodiments of the present technology. [Figure 24] 24A and 24B-24D are perspective and close-up views of additional embodiments of an integral connection between a valve support and an anchoring member in accordance with the present technology. [Diagram 25]

[0031] Figure 25A is a partial cross-sectional view of a prosthetic heart valve device having an anchoring member and a valve support in accordance with an embodiment of the present technology, and Figure 25B is an enlarged view of the designated box shown in Figure 25A. [Figure 26] 26A-26D are schematic cross-sectional views of a prosthetic heart valve device having an atrial retainer and implanted in a native mitral valve, in accordance with various embodiments of the present technology. [Figure 27] FIG. 27 is a side view of an anchoring member having a vertical portion at an upstream end for engaging the valve annulus in accordance with another embodiment of the present technology. [Figure 28] FIG. 28 is a side view of a prosthetic heart valve device in an expanded configuration having multiple stabilizing elements in accordance with an embodiment of the present technology. [Figure 29] FIG. 29 is an enlarged schematic side view of a prosthetic heart valve device with extended arms in accordance with an embodiment of the present technology. [Diagram 30] 30A-30C are enlarged, partial side views of a prosthetic heart valve device having arms connected to the device at various angles relative to the longitudinal axis of the device, in accordance with further embodiments of the present technology. [Diagram 31] 31A-31C are enlarged partial side views of a prosthetic heart valve device having arms of various lengths connected to the device in accordance with an additional embodiment of the present technology. [Diagram 32]32A, 32B, 32C, and 32D are cross-sectional views of a heart with an implanted prosthetic heart valve device having arms disposed on the inward-facing surfaces of the leaflets, in accordance with various embodiments of the present technology. Figures 32A-1, 32B-1, 32C-1, and 32D-1 are close-up views of the arms engaging the inward-facing surfaces of the leaflets as shown in Figures 32A, 32B, 32C, and 32D, respectively, in accordance with various embodiments of the present technology. [Diagram 33] 33A-33C are schematic diagrams illustrating various embodiments of tissue engaging elements for use with prosthetic heart valve devices in accordance with the present technology. [Diagram 34] 34A, 34B, and 34C are cross-sectional views of a heart with an implanted prosthetic heart valve device having arms with tissue engaging elements disposed on the inward-facing surfaces of the leaflets, in accordance with various embodiments of the present technology. Figures 34A-1, 34B-1, and 34C-1 are close-up views of arms engaging the inward-facing surfaces of the leaflets as shown in Figures 34A, 34B, and 34C, respectively, in accordance with various embodiments of the present technology. [Figure 35A] 35A-35C are side views of a prosthetic heart valve device shown implanted in a mitral valve (shown in cross section) according to a further embodiment of the present technology, the device having arms for engaging the outward facing surfaces of the native valve leaflets. [Figure 35B] 35A-35C are side views of a prosthetic heart valve device shown implanted in a mitral valve (shown in cross section) according to a further embodiment of the present technology, the device having arms for engaging the outward facing surfaces of the native valve leaflets. [Figure 35C] 35A-35C are side views of a prosthetic heart valve device shown implanted in a mitral valve (shown in cross section) according to a further embodiment of the present technology, the device having arms for engaging the outward facing surfaces of the native valve leaflets. [Figure 35C-1] FIG. 38 is a close-up view of the arms engaging the inward-facing surface of the leaflet as shown in FIG. 35C in accordance with various embodiments of the present technology. [Figure 36A]FIG. 36A is a side view of a prosthetic heart valve device shown implanted in a mitral valve (shown in cross section) in accordance with an additional embodiment of the present technology, the device having arms for engaging the outward facing surfaces of the native valve leaflets and arms for engaging the inward facing surfaces of the native valve leaflets. [Figure 36B] FIG. 36B is a close-up view of the arms engaging the inward and outward facing surfaces of the leaflets as shown in FIG. 36A. [Figure 37] 37A-37D are close-up side views of additional embodiments of arms suitable for use with prosthetic heart valve devices in accordance with the present technology. [Figure 38] 38A and 38B are side views of a prosthetic heart valve device having multiple non-interconnected arms in accordance with further embodiments of the present technology, respectively. [Figure 39] 39A-39D are schematic top view illustrations of arm position patterns in accordance with additional embodiments of the present technology. [Figure 40-1] 40A-40D are side views of a prosthetic heart valve device having tissue engaging elements on various structures of the device in accordance with additional embodiments of the present technology. FIGs. 40E-40G are enlarged side views of tissue engaging elements suitable for use with a prosthetic heart valve device in accordance with other embodiments of the present technology. [Figure 40-2] 40I-40T are enlarged side views of an embodiment of a tissue engaging element suitable for use with a prosthetic heart valve device, in accordance with an additional embodiment of the present technology. [Figure 40-3] 40I-40T are enlarged side views of an embodiment of a tissue engaging element suitable for use with a prosthetic heart valve device, in accordance with an additional embodiment of the present technology. [Diagram 41] FIG. 41 is an isometric view of a prosthetic heart valve device having multiple annulus engaging elements in accordance with a further embodiment of the present technology. [Diagram 42]42A-42B are cross-sectional side and close-up views of a prosthetic heart valve device having tissue engaging elements deployable from a plurality of tubular ribs in accordance with another embodiment of the present technology. [Diagram 43] 43A-43B are isometric and close-up detail views of a prosthetic heart valve device having a sealing member configured with a tissue engaging element in accordance with another embodiment of the present technology. [Diagram 44] 44A-44F are enlarged side views of embodiments of tissue engaging elements suitable for use with prosthetic heart valve devices, in accordance with additional embodiments of the present technology. [Diagram 45] 45A is an isometric view of a prosthetic heart valve device having multiple tethers between the anchoring member 110 and the valve support 120 in accordance with an embodiment of the present technology. FIG 45B is an isometric view of a prosthetic heart valve device having multiple septa between the anchoring member 110 and the valve support 120 in accordance with another embodiment of the present technology. [Figure 46A] FIG. 46A is a side partial cutaway view of a delivery system in accordance with an embodiment of the present technology. [Figure 46B] FIG. 46B is an enlarged cutaway view of a distal end of a delivery system in accordance with an embodiment of the present technology. [Figure 46C] 46C-46D are enlarged, partial side views of a valve support configured for use with the delivery system of FIG. 46B in accordance with an embodiment of the present technology. [Figure 46D] 46C-46D are enlarged, partial side views of a valve support configured for use with the delivery system of FIG. 46B in accordance with an embodiment of the present technology. [Figure 47] 47A-47D are cross-sectional views of the heart illustrating an antegrade or transseptal approach to the mitral valve in accordance with an embodiment of the present technology. [Figure 48A] 48A-48C are cross-sectional views of the heart illustrating a method of implanting a prosthetic heart valve device using a transseptal approach in accordance with another embodiment of the present technology. [Figure 48B]48A-48C are cross-sectional views of the heart illustrating a method of implanting a prosthetic heart valve device using a transseptal approach in accordance with another embodiment of the present technology. [Figure 48C] 48A-48C are cross-sectional views of the heart illustrating a method of implanting a prosthetic heart valve device using a transseptal approach in accordance with another embodiment of the present technology. [Figure 49] 49A-49B are cross-sectional views of the heart illustrating a retrograde approach to the mitral valve via the aorta and left ventricle in accordance with a further embodiment of the present technology. [Figure 50] 50A-50B are cross-sectional views of the heart illustrating a further embodiment of a method of implanting a prosthetic heart valve device using a transapical approach, in accordance with aspects of the present technology. [Figure 51] 51A-51B are partial side views of a delivery system in which a prosthetic heart valve device is mounted over an expandable balloon of a delivery catheter in accordance with another embodiment of the present technology. [Figure 52A] 52A-52D are cross-sectional views of a heart illustrating a method of delivering a prosthetic heart valve device having a valve support movably coupled to an anchoring member in accordance with a further embodiment of the present technology. [Figure 52B] 52A-52D are cross-sectional views of a heart illustrating a method of delivering a prosthetic heart valve device having a valve support movably coupled to an anchoring member in accordance with a further embodiment of the present technology. [Figure 52C] 52A-52D are cross-sectional views of a heart illustrating a method of delivering a prosthetic heart valve device having a valve support movably coupled to an anchoring member in accordance with a further embodiment of the present technology. [Fig. 52D] 52A-52D are cross-sectional views of a heart illustrating a method of delivering a prosthetic heart valve device having a valve support movably coupled to an anchoring member in accordance with a further embodiment of the present technology. [Figure 53]

[00136] Figures 53A-53D are partial side views showing various mechanisms for movably coupling the valve support to the anchoring member according to additional embodiments of the present technology. Figure 53E is a partial top view of the device of Figure 53D. Figure 53F is a side view of an alternative mechanism for slidably coupling the valve support and the anchoring member according to another embodiment of the present technology. Figures 53G-53H are schematic side views of a prosthetic heart valve device showing yet another mechanism for coupling the valve support to the anchoring member according to a further embodiment of the present technology. [Figure 54A] FIG. 54A is a cross-sectional side view of another embodiment of a delivery system for a prosthetic heart valve device, in accordance with another aspect of the present technology. [Figure 54B] FIG. 54B is a partial cross-sectional side view of a distal portion of the delivery system of FIG. 54A. [Figure 55] 55A-55C are perspective views of the delivery system of FIG. 46 illustrating steps of delivering an artificial therapeutic device of the present invention. [Figure 56] FIG. 56 is a side cross-sectional view of a further embodiment of a delivery system for an artificial therapeutic device of the present invention. [Figure 57A] 57A-57D are isometric views of an artificial treatment device in accordance with an additional embodiment of the present technology. [Figure 57B] 57A-57D are isometric views of an artificial treatment device in accordance with an additional embodiment of the present technology. [Figure 57C] 57A-57D are isometric views of an artificial treatment device in accordance with an additional embodiment of the present technology. [Fig. 57D] 57A-57D are isometric views of an artificial treatment device in accordance with an additional embodiment of the present technology. [Figure 57E] FIG. 57E is a schematic cross-sectional view of the prosthetic heart valve device of FIG. 57A implanted in a native mitral valve in accordance with an embodiment of the present technology. [Figure 58-1] 58A-58D are cross-sectional views of the heart illustrating a method of delivering a prosthetic heart valve device to a native mitral valve within the heart using a transseptal approach in accordance with another embodiment of the present technology. [Figure 58-2]58A-58D are cross-sectional views of the heart illustrating a method of delivering a prosthetic heart valve device to a native mitral valve within the heart using a transseptal approach in accordance with another embodiment of the present technology. [Figure 59A] 59A-59C are isometric views of an artificial treatment device in accordance with an additional embodiment of the present technology. [Figure 59B] 59A-59C are isometric views of an artificial treatment device in accordance with an additional embodiment of the present technology. [Figure 59C] 59A-59C are isometric views of an artificial treatment device in accordance with an additional embodiment of the present technology. [Fig. 59D] FIG. 59D is a schematic cross-sectional view of a prosthetic heart valve device implanted in a native mitral valve in accordance with another embodiment of the present technology. [Figure 60] 60A-60B are cross-sectional side views of a distal end of a delivery catheter for delivering the prosthetic heart valve device of FIG. 59C to a native mitral valve in a heart in accordance with another embodiment of the present technology. [Figure 61] FIG. 61 is a side view of a prosthetic heart valve device having first and second anchoring members for engaging supranular and subannular tissue, respectively, of a mitral valve in accordance with yet another embodiment of the present technology. [Figure 62] 62A-62C are partial cross-sectional side views of a distal end of a delivery system illustrating delivery of the prosthetic heart valve device of FIG. 61 at the mitral valve in accordance with another embodiment of the present technology. [Figure 63] FIG. 63 is an isometric side view of a prosthetic heart valve device having an anchoring member with a supra-annular engaging rim and a sub-annular engaging ring in accordance with a further embodiment of the present technology. [Figure 64] 64A-64D are side views of the prosthetic heart valve device of FIG. 63, illustrating an embodiment of a method for deploying the device at the mitral valve annulus in accordance with aspects of the present technology. [Figure 65A] FIG. 65A is a cross-sectional view of a prosthetic heart valve device having an inflatable anchoring member shown implanted in a native mitral valve of a heart in accordance with another embodiment of the present technology. [Figure 65B]FIG. 65B is a partial cross-sectional side view of a distal end of a delivery system suitable for delivery of the prosthetic heart valve device of FIG. 65A in accordance with another embodiment of the present technology. [Figure 66A] 66A-66D are cross-sectional views of prosthetic heart valve devices having fillable chambers in accordance with additional embodiments of the present technology. [Figure 66B] 66A-66D are cross-sectional views of prosthetic heart valve devices having fillable chambers in accordance with additional embodiments of the present technology. [Figure 66C] 66A-66D are cross-sectional views of prosthetic heart valve devices having fillable chambers in accordance with additional embodiments of the present technology. [Figure 66D] 66A-66D are cross-sectional views of prosthetic heart valve devices having fillable chambers in accordance with additional embodiments of the present technology. [Figure 67A] 67A-67B are isometric views of additional embodiments of prosthetic heart valve devices in accordance with aspects of the present technology. [Figure 67B] 67A-67B are isometric views of additional embodiments of prosthetic heart valve devices in accordance with aspects of the present technology. [Figure 68] 68A-68B are side views of a prosthetic heart valve device having a positioning element in accordance with an additional embodiment of the present technology. [Figure 69-1] 69A-69E are cross-sectional and side views of a prosthetic heart valve device shown in an expanded configuration and configured in accordance with additional embodiments of the present technology. [Figure 69-2] 69A-69E are cross-sectional and side views of a prosthetic heart valve device shown in an expanded configuration and configured in accordance with additional embodiments of the present technology. [Figure 70] FIG. 70 is a cross-sectional side view of another prosthetic heart valve device constructed in accordance with an embodiment of the present technology. [Figure 71] FIG. 71 is a cross-sectional side view of yet another prosthetic heart valve device constructed in accordance with an embodiment of the present technology. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0018] (Overview) Systems, devices, and methods are provided herein for percutaneous replacement of native heart valves, such as the mitral valve. Some of the details described below are provided to explain the following examples and methods in a manner sufficient to enable a person skilled in the art to practice, make, and use them. However, some of the details and advantages described below may not be necessary to practice 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.

[0019] Embodiments of the present technology provide systems, methods, and devices for treating bodily valves, such as heart valves, including the mitral valve. The present devices and methods allow for percutaneous approaches using a catheter delivered intravascularly into the heart through a vein or artery. In addition, the present devices and methods allow for other minimally invasive approaches, including transapical, transatrial, and direct aortic delivery of prosthetic replacement valves to target locations within the heart. The present devices and methods allow for the prosthesis to be anchored in place at the native valve by engagement with the annulus and / or subannular surfaces of the leaflets. In addition, embodiments of the devices and methods as described herein can be combined with many known surgeries and procedures, such as known methods of accessing heart valves (e.g., mitral or tricuspid) with antegrade or retrograde approaches and combinations thereof.

[0020] The devices and methods described herein provide a valve replacement device that has the flexibility to adapt and conform to the variable shape of the native mitral valve anatomy while mechanically isolating the prosthetic valve from the anchoring portion of the device. Some embodiments of the device effectively absorb the distorting forces applied by the native anatomy. The device has the necessary structural strength and integrity to withstand the dynamic conditions of the heart over time, thus permanently anchoring the replacement valve and allowing the patient to resume a substantially normal life. The devices and methods further deliver such devices minimally invasively, providing the patient with not only a new permanent replacement valve, but also a lower risk procedure and faster recovery.

[0021] According to various embodiments of the present technology, a device for repair or replacement of a natural valve of the heart is disclosed. The natural valve has an annulus and leaflets, and the device includes an anchoring member having a first portion configured to engage tissue above or below the annulus and to deform into a non-circular shape to conform to the tissue. The anchoring member also includes a second portion. The device also includes a valve support coupled to the second portion of the anchoring member and configured to support the prosthetic valve, the valve support having a cross-sectional shape. In various embodiments, the first portion of the anchoring member is mechanically isolated from the valve support such that the cross-sectional shape of the valve support remains sufficiently stable such that the prosthetic valve remains competent when the anchoring member is deformed into a non-circular shape.

[0022] Some embodiments of the present disclosure are directed to a prosthetic heart valve device for implantation into a native mitral valve, the mitral valve having an annulus and leaflets. In one embodiment, the device can have an anchoring member positionable at a location between the leaflets, a first portion of the anchoring member being expandable to a dimension greater than a corresponding dimension of the annulus. In this embodiment, upstream movement of the anchoring member is blocked by engagement of the upstream portion with tissue on or near the annulus. The anchoring member can also include a second portion. The device can also include a valve support coupled to the second portion of the anchoring member, the upstream region of the valve support being spaced radially inward from at least the first portion of the anchoring member. The valve support can be configured to support the prosthetic valve.

[0023] In another arrangement, a device for implantation into a native valve having an annulus and leaflets can include a hyperboloid anchoring member having an upstream end configured to engage an inwardly facing surface of a leaflet downstream of the annulus, and a downstream end, the upstream end having a larger cross-sectional area than the downstream end. The device can also include a valve support positioned within the anchoring member and configured to support the prosthetic valve. The valve support is coupled to the anchoring member at a location spaced substantially downstream from the upstream end and is not coupled to the anchoring member at the upstream end.

[0024] Another aspect of the disclosure is directed to a prosthetic heart valve device for repair or replacement of a patient's native heart valve, the heart valve having an annulus and leaflets. In one embodiment, the device includes an anchoring member having a first portion having a first cross-sectional dimension and a second portion having a second cross-sectional dimension smaller than the first cross-sectional dimension. The first portion is configured to engage cardiac tissue to hold the anchoring member in a fixed longitudinal position relative to the annulus. The device can also include a valve support coupled to the second portion of the anchoring member and configured to support the prosthetic valve. The valve support can be radially separated from the first portion of the anchoring member such that the first portion can deform inwardly without substantially deforming the valve support.

[0025] In a further arrangement, the present disclosure is also directed to a device for implantation into a native heart valve. The device can include an anchoring member having an upstream end configured to engage tissue above or downstream of the native annulus of the heart valve, and a valve support configured to support the prosthetic valve. The valve support can be coupled to the anchoring member. In some arrangements, the anchoring member can resist upstream movement of the device without elements of the device extending behind the native leaflets.

[0026] In another embodiment, the device can include an anchoring member positionable between the native valve leaflets. The anchoring member can have a plurality of tissue-engaging elements on an upstream end and / or an outer surface configured to engage cardiac tissue on or near the annulus to prevent migration of the device in an upstream direction. The device can also include a valve support positioned within an interior of the anchoring member and coupled to a downstream portion of the anchoring member, the valve support being radially separated from at least the upstream portion of the anchoring member.

[0027] Further embodiments of the present disclosure are directed to a device for repair or replacement of a native mitral valve having an annulus and a pair of leaflets, the device including a support structure having an upper region, a lower region, and an interior that holds a prosthetic valve. The device can also include an anchoring member surrounding at least a portion of the support structure, the anchoring member being positionable between the leaflets and having a plurality of flexible elements (e.g., wires, laser cut metal elements, etc.) arranged in a diamond pattern, an upper portion, and a lower portion. The upper portion of the anchoring member can be flared outward in a proximal direction such that a proximal end of the flexible element points radially outward to engage cardiac tissue on or near the annulus and inhibit migration of the device in an upstream direction. The lower region of the support structure can be coupled to the lower portion of the anchoring member, and the lower region of the support structure can be mechanically isolated from deformation of at least the flared upper portion of the anchoring member.

[0028] Other embodiments of the present disclosure are directed to a prosthetic heart valve device having a cylindrical support and an anchoring body defined by a structure separate from the cylindrical support. The cylindrical support can have a longitudinal axis and an interior along the longitudinal axis through which blood can flow. The anchoring body can have a non-circular cross-section with an outwardly flared upstream end configured to engage subannular tissue of the mitral valve. The anchoring body can also surround the cylindrical support and be coupled to the support at a downstream end opposite the upstream end.

[0029] In further embodiments, the device can include an expandable valve support configured for placement between two valve leaflets. The support can have a first region, a second region, and an interior to which the valve can be coupled. The device can also include an anchoring member having a first portion and a second portion, the second portion being coupled to the second region of the valve support. The first portion of the anchoring member can extend outwardly away from the second portion. The anchoring member can have a first perimeter at the first portion configured to engage tissue on or near the valve annulus. The anchoring member can be mechanically isolated from the valve support such that forces exerted radially at or near the first perimeter do not substantially change the shape of the valve support.

[0030] An additional embodiment is directed to a device for treating a heart valve of a patient, including an inner frame and an outer frame coupled to the inner frame. The inner frame can have an outer surface and an inner surface configured to support a prosthetic valve. The outer frame can have an upper portion with a cross-sectional dimension larger than a corresponding cross-sectional dimension of the mitral valve annulus, the upper portion configured to engage tissue at or below the mitral valve annulus. The upper portion can also prevent migration of the device in an upward or upstream direction during ventricular systole. Additionally, the upper portion of the outer frame can be mechanically isolated from the inner frame.

[0031] In a further embodiment, the device can include a cylindrical inner skeleton and an outer skeleton coupled to the inner skeleton and positionable between the downstream leaflets of the valve annulus. The inner skeleton remains substantially circular in cross section while the outer skeleton can be deformable to a non-circular cross section. The inner skeleton can have an interior to which the prosthetic valve can be coupled. The outer skeleton can have a plurality of flexible elements (e.g., wires, laser cut metal elements, etc.), at least a portion of which can be configured to engage the native subannular tissue to prevent migration of the device in an upstream direction. In one embodiment, the plurality of flexible wires are arranged in a diamond configuration.

[0032] In yet further embodiments, the prosthetic mitral valve device can include a valve support having upstream and downstream ends, an interior to which the valve can be coupled, and a periphery. The device can also include an anchoring member having a wide-mouthed upstream portion and a downstream portion coupled to the periphery of the valve support. The upstream portion can be mechanically isolated from the valve support and configured to engage subannular tissue of the native mitral valve. In addition, the device can be movable to a plurality of configurations, including a first configuration in which the valve support and anchoring member are radially contracted, and the valve support has a first cross-sectional shape. The device can also be movable to a second configuration in which the valve support and anchoring member are radially expanded, and the valve support has a second cross-sectional shape. In addition, the device can be movable to a third configuration in which the anchoring member is engaged with and deformed by the subannular tissue, while the valve support remains in the second cross-sectional shape.

[0033] In some embodiments, the device may include an atrial retainer that extends from the anchoring member or valve support to a location at least partially upstream of the native mitral valve annulus. The atrial expansion member may include an atrial engagement structure adapted to engage an upstream surface of the annulus (e.g., a supranuclear surface) and / or an inner wall of the atrium to further stabilize or anchor the device. For example, the atrial retainer may prevent downstream migration of the device.

[0034] Some embodiments of the device may further include one or more stabilizing members to prevent the device from tilting or being laterally displaced. The stabilizing members may include multiple arms extending radially outward from the valve support and / or anchoring member. The arms may be configured to extend behind the native valve leaflets and / or to engage the ventricular wall or papillary muscles.

[0035] Further embodiments according to another aspect of the present disclosure are directed to a device for implantation into a native mitral valve, the native mitral valve having an annulus and leaflets. The device can include a valve support having upstream and downstream ends, an interior to which the valve can be coupled, and an exterior surface, and can include a first anchoring member having a first flared upstream portion and a first downstream portion coupled to the exterior surface of the valve support. In other embodiments, the first downstream portion can be coupled to the interior surface of the valve support, or in some embodiments, to an end of the valve support. The device can 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 supranulular tissue of the native mitral valve. The second anchoring member can have a second flared upstream portion and a second downstream portion coupled to the exterior surface of the valve support, the second upstream portion can be mechanically isolated from the valve support and configured to engage subannular tissue of the native mitral valve.

[0036] In yet a further embodiment, the device for implantation can include a radially expandable anchoring member configured to engage native tissue above or downstream of the annulus. The anchoring member can have a first longitudinal length on a side facing the posterior leaflet and a second length on a side facing the anterior leaflet. In an embodiment, the first length can be greater than the second length such that obstruction of the left ventricular outflow tract (LVOT) is limited. The device can also include a valve support, or alternatively a prosthetic valve, connected internally or to an end of the anchoring member.

[0037] Another embodiment of the present technology provides a device for implantation into a native mitral valve having an annulus and leaflets, the device including a valve support having upstream and downstream ends, an interior to which the valve can be coupled, and an exterior surface. The device can also include an anchoring member having a wide-mouthed upstream portion and a downstream portion coupled to the exterior surface of the valve support, the upstream portion having an upper ring and a lower ring coupled to the upper ring. The device can further include a plurality of flexible annulus-engaging elements distributed around the circumference of the anchoring member and connecting the upper ring to the lower ring. The lower ring is configured to move upstream toward the upper ring such that the annulus is received between the upper and lower rings and within the annulus-engaging elements.

[0038] The present disclosure further provides systems for delivery of prosthetic valves and other devices using endovascular or other minimally invasive forms of access. For example, embodiments of the present technology provide a system for treating a mitral valve in a patient, the mitral valve having an annulus. The system includes a device for treating the mitral valve as described herein and a catheter having a lumen configured to retain the device within the catheter.

[0039] In another aspect, a system for replacing a patient's native valve is provided. The system can include an elongate catheter body having a distal end and a proximal end, and a housing coupled to the distal end of the catheter body and having a closed end and an open end. The system can also include a plunger in the housing that is axially movable relative to the housing, and an actuator coupled to the plunger at the proximal end of the catheter body such that moving the actuator moves the housing axially relative to the plunger. The system can further include a prosthetic valve device having a collapsed configuration and an expanded configuration. The prosthetic valve device can be positionable within the housing in a collapsed configuration and can be proximally releasable from the housing by moving the actuator.

[0040] In yet another aspect, embodiments of the present technology provide a method of treating a heart valve in a patient. The mitral valve has an annulus and leaflets coupled to the annulus. The method can include implanting a device as described herein within or adjacent to the annulus. The device can include a valve support coupled to and at least partially surrounded by an anchoring member in some embodiments. The anchoring member can be disposed between the leaflets, and an upstream portion of the anchoring member can be configured to engage tissue above or downstream of the annulus to prevent migration of the device in an upstream direction. Additionally, the valve support can be mechanically isolated from the anchoring member at least at the upstream portion.

[0041] In yet a further aspect, embodiments of the present technology provide a method for replacement of a native mitral valve having an annulus and leaflets. The method can include positioning a device as described herein between the leaflets while the device is in a collapsed configuration. The method can also include allowing the prosthesis to expand such that an anchoring member of the prosthesis is in a subannular position where the anchoring member engages tissue above or downstream of the annulus. The anchoring member can have a diameter greater than a corresponding diameter of the annulus at the subannular position. The method can further include allowing the valve support to expand within the anchoring member, the valve support being coupled to the anchoring member. In various embodiments, the valve support can be mechanically isolated from the anchoring member such that deformation of the anchoring member as it engages tissue does not substantially deform the valve support. In some arrangements, certain regions of the valve support may deform, but support regions suitable for holding the prosthetic valve do not substantially deform such that leaflet coaptation of the prosthetic valve is not compromised.

[0042] The devices and methods disclosed herein can be configured to treat non-circular, asymmetrically shaped valves, such as the mitral valve, and bileaflet or bicuspid valves. Many of the devices and methods disclosed herein can further provide long-term (e.g., permanent) and secure fixation of the prosthesis, even in conditions where the heart or native valve may be subject to gradual enlargement or distortion.

[0043] (Heart and Mitral Valve Physiology) 1 and 2 show a normal heart H. The heart comprises a left atrium which receives oxygen-rich blood from the lungs via the pulmonary veins PV and pumps the oxygen-rich blood through the mitral valve MV into the left ventricle LV. The left ventricle LV of a normal heart H during systole is illustrated in FIG. 2. The left ventricle LV is contracting and blood flows outwardly through the aortic valve AV in the direction of the arrow. The mitral valve is configured as a "check valve" which prevents backflow when pressure in the left ventricle is higher than pressure in the left atrium LA, thus preventing reverse flow or "regurgitation" of blood through the mitral valve MV.

[0044] The mitral valve MV comprises a pair of leaflets with free edges FE that meet or "coapt" evenly to close, as illustrated in FIG. 2. Opposite ends of the leaflets LF are attached to the surrounding cardiac structures via an annular region of tissue called the annulus AN. FIG. 3 is a schematic cross-sectional side view of the mitral valve annulus and leaflets. As illustrated, the opposite ends of the leaflets LF are attached to the surrounding cardiac structures via a fibrous ring of dense connective tissue called the annulus AN, which is distinct from both the leaflet tissue LF and the adjacent muscle tissue of the heart wall. The leaflets LF and the annulus AN are composed of different types of cardiac tissue with various strengths, toughness, fibrousness, and flexibility. In addition, the mitral valve MV may also comprise a unique region of tissue interconnecting each leaflet LF to the annulus AN, referred to herein as the leaflet / annulus connecting tissue LAC (indicated by overlapping parallel lines). In general, the annulus tissue AN is tougher, more fibrous, and stronger than the leaflet tissue LF.

[0045] 2, the free edges FE of the mitral valve leaflets LF are anchored to the inferior portion of the left ventricle LV through chordae tendineae CT (herein referred to as "chordae"), which include multiple branching tendons anchored over the inferior surface of each of the leaflets LF. The chordae tendineae CT, in turn, are attached to papillary muscles PM, which extend upward from the inferior wall of the left ventricle LV and the interventricular septum IVS.

[0046] 4A-4B, several structural defects within the heart can cause mitral regurgitation. As shown in FIG. 4A, a torn chordae tendineae RCT can cause leaflet LF2 to prolapse because insufficient tension is transmitted to the leaflets via the chordae tendineae. While the other leaflet LF1 maintains a normal profile, the two leaflets do not meet properly and leakage from the left ventricle LV into the left atrium LA will occur as indicated by the arrow.

[0047] Regurgitation also occurs in patients with cardiomyopathy, in which the heart is dilated and the increased size prevents the leaflets LF from meeting properly, as shown in Figure 4B. The enlargement of the heart causes the mitral annulus to enlarge, making it impossible for the free edges FE to meet during systole. The free edges of the anterior and posterior leaflets normally meet along the coaptation line C, as shown in Figure 5A, but a significant gap G may be left in patients with cardiomyopathy, as shown in Figure 5B.

[0048] Mitral regurgitation can also occur in patients with ischemic heart disease in which the function of the papillary muscles PM is impaired, as illustrated in Figure 4A. When the left ventricle LV contracts during systole, the papillary muscles PM do not make sufficient contact to achieve proper closure. One or both of the leaflets LF1 and LF2 then prolapse. Again, leakage occurs from the left ventricle LV into the left atrium LA.

[0049] 5A-5C further illustrate the shape and relative size of the leaflets L of the mitral valve. With reference to FIG. 5C, it can be seen that the overall valve has a generally "D" or kidney-like shape with a long axis MVA1 and a short axis MVA2. In healthy humans, the long axis MVA1 typically ranges from about 33.3 mm to about 42.5 mm (37.9 + / - 4.6 mm) in length, and the short axis MVA2 ranges from about 26.9 to about 38.1 mm (32.5 + / - 5.6 mm) in length. However, in patients with reduced cardiac function, these values ​​may be larger, e.g., MVA1 may range from about 45 mm to 55 mm, and MVA2 may range from about 35 mm to about 40 mm. The coaptation line C is curved or C-shaped, thereby defining a relatively large anterior leaflet AL and a substantially smaller posterior leaflet PL (FIG. 5A). Both leaflets appear roughly crescent-shaped from the superior or atrial side, with the anterior leaflet AL being substantially wider than the posterior leaflet in the center of the valve. As illustrated in Figure 5A, at opposite ends of the coaptation line C, the leaflets coapt together at angles referred to as the anterolateral commissure AC and the posteromedial commissure PC, respectively.

[0050] FIG. 5C shows the shape and dimensions of the mitral annulus. The annulus is an annular region around the valve that is thicker and tougher than the leaflets LF and is composed of fibrous tissue distinct from the muscular tissue of the ventricular and atrial walls. The annulus may include a saddle-like shape with a first apex portion PP1 and a second apex portion PP2 located along an interapex axis IPD, and a first valley portion VP1 and a second valley portion VP2 located along an interval axis IVD. The first and second apex portions PP1 and PP2 are higher in elevation relative to the plane containing the bases of the two valley portions VP1, VP2, typically about 8-19 mm higher in humans, thus giving the valve an overall saddle-like shape. The distance between the first and second apex portions PP1, PP2, referred to as the interapex range IPD, is substantially shorter than the interval range IVD, which is the distance between the first and second valley portions VP1, VP2.

[0051] Those skilled in the art will recognize that although patient dimensions and physiology may vary between patients and some patients may have different physiology, the teachings as described herein can be adapted for use with many patients having various conditions, dimensions, and shapes of the mitral valve. For example, studies of the embodiments suggest that some patients may have long transannular dimensions and short transannular dimensions without distinct apex and valley portions, and methods and devices as described herein can be configured accordingly.

[0052] (access to the mitral valve) Access to the mitral valve or other atrioventricular valves can be achieved percutaneously through the patient's vasculature. Percutaneous typically means that a location in the vasculature remote from the heart is accessed through the skin using a surgical open or minimally invasive procedure, such as the use of needle access through the Seldinger technique. The ability to access remote vasculature percutaneously is well known and described in the patent and medical literature. Depending on the point of vascular access, the approach to the mitral valve may be antegrade and rely on entering into the left atrium by crossing the atrial septum. Alternatively, the approach to the mitral valve may be retrograde, entering the left ventricle through the aortic valve. Once percutaneous access is achieved, interventional tools and support catheters may be advanced intravascularly to the heart and positioned adjacent to the target heart valve in various manners as described herein.

[0053] 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.

[0054] As shown in Figure 6A, a catheter 1 having a needle 2 may be advanced from the inferior vena cava IVC into the right atrium RA. Once the catheter 1 reaches the anterior side of the interatrial septum IAS, the needle 2 may be advanced to penetrate the septum, for example, at the fossa ovalis FO or foramen ovale into the left atrium LA. At this point, a guidewire may be exchanged for the needle 2 and the catheter 1 may be withdrawn.

[0055] 6B, access through the interatrial septal IAS may usually be maintained by placement of a guide catheter 4 over a guidewire 6, typically positioned as described above. The guide catheter 4 provides subsequent access to allow for the introduction of a device to replace the mitral valve, as described in further detail herein.

[0056] In an alternative antegrade approach (not shown), surgical access may be gained, preferably through an intercostal resection, without removing a rib, and a small puncture and incision may be made in the left atrial wall. A guide catheter may then be placed directly through this puncture and incision into the left atrium and sealed with a purse string suture.

[0057] An antegrade or transseptal approach to the mitral valve as described above may be advantageous in many ways. For example, the use of an antegrade approach will usually allow for more accurate and effective centering and stabilization of the guide catheter and / or prosthetic valve device. Accurate positioning promotes accuracy of placement of the prosthetic valve device. An antegrade approach may also reduce the risk of damaging the subvalvular device during introduction and manipulation of the catheter and interventional tools. In addition, an antegrade approach may reduce the risks associated with crossing the aortic valve as in the case of a retrograde approach. This may be particularly relevant for patients with prosthetic aortic valves that cannot be crossed without any or significant risk of damage.

[0058] An example of a retrograde approach to the mitral valve is illustrated in Figures 7 and 8. The mitral valve MV may be accessed by an approach from the aortic arch AA, across the aortic valve AV, into the left ventricle LV below the mitral valve MV. The aortic arch AA may be accessed through a traditional femoral artery access route, as well as through a more direct approach via the brachial, axillary, radial, or carotid arteries. Such access may be achieved with the use of a guidewire 6. Once in place, the guide catheter 4 may be tracked over the guidewire 6. Alternatively, a surgical approach may be taken through a chest incision, placing the guide catheter through a puncture in the aorta itself, preferably between the ribs without removing the ribs. The guide catheter 4 gains subsequent access to allow for placement of a prosthetic valve device, as described in further detail herein.

[0059] In some specific cases, a retrograde arterial approach to the mitral valve may be chosen due to certain advantages. For example, the use of a retrograde approach can eliminate the need for a transseptal puncture. The retrograde approach is also more commonly used by cardiologists and therefore has the advantage of familiarity.

[0060] An additional approach to the mitral valve is via a transapical puncture, as shown in Figure 9. In this approach, access to the heart is gained via a chest incision, which may be a traditional thoracotomy or sternotomy, or a smaller intercostal or subxiphoid incision or puncture. An access cannula is then placed through a puncture in the wall of the left ventricle at or near the apex, which is sealed by a purse string suture. The catheter and prosthesis of the present invention may then be introduced into the left ventricle through this access cannula.

[0061] The transapical approach has the advantage of providing a shorter, straighter path to the mitral or aortic valve. Moreover, because it does not involve endovascular access, the transapical procedure can be performed by surgeons who may not have the necessary training in interventional cardiology to perform the catheterization required for other percutaneous approaches.

[0062] The artificial therapeutic device may be specifically designed for the approach or may be interchangeable between approaches. A person skilled in the art can identify the appropriate approach for an individual patient and design a therapeutic device for the identified approach according to the embodiments described herein.

[0063] Orientation and steering of the prosthetic valve device can be combined with many known catheters, tools, and devices. Such orientation may be achieved by global steering of the device to the desired location, and then precise steering of the device components to achieve the desired result.

[0064] Overall steering may be accomplished by several methods. A steerable guidewire may be used to introduce the guide catheter and prosthetic treatment device to the correct location. The guide catheter may be introduced, for example, using a surgical cutdown or Seldinger access to the femoral artery in the patient's groin. After placement of the guidewire, the guide catheter may be introduced over the guidewire to the desired location. Alternatively, shorter, differently shaped guide catheters may be introduced through other routes described above.

[0065] 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 curved, angled, or other suitable shape at its tip to orient the distal end toward the mitral valve from the location of the septal puncture through which the guide catheter extends. For a retrograde approach as shown in Figures 7 and 8, the guide catheter 4 may have a pre-shaped J-tip configured to pivot toward the mitral valve MV after being positioned across the aortic arch AA and through the aortic valve AV. As shown in Figure 7, the guide catheter 4 may be configured to extend downward into the left ventricle LV in 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 pre-shaped guide catheter may be configured to be straightened for intravascular delivery with a stylet or rigid guidewire passed through the lumen of the guide catheter. The guide catheter may also have a pull wire or other means to adjust its shape for finer steering adjustments.

[0066] Selected Embodiments of Prosthetic Heart Valve Devices and Methods The embodiments of the technology as described herein can be used to treat one or more of the valves of the heart as described herein, and in certain embodiments, can be used for the treatment of the mitral valve. Examples of prosthetic heart valve devices, system components, and related methods according to embodiments of the technology are described in this section with reference to Figs. 10A-56. It will be understood that certain elements, substructures, advantages, uses, and / or other features of the embodiments described with reference to Figs. 10A-56 can be suitably interchanged, substituted, or otherwise configured with each other and / or with the embodiments described with reference to Figs. 57A-71, according to additional embodiments of the technology. Furthermore, suitable elements of the embodiments described with reference to Figs. 10A-71 can be used as stand-alone and / or self-contained devices.

[0067] Systems, devices, and methods are provided herein for percutaneous implantation of a prosthetic heart valve in a patient's heart. In some embodiments, methods and devices are presented for the treatment of valvular disease by minimally invasive implantation of a prosthetic replacement heart valve. In one embodiment, the prosthetic replacement valve may be a prosthetic valve device suitable for implantation and replacement of a mitral valve between the left atrium and left ventricle in a patient's heart. In another embodiment, the prosthetic valve device may be suitable for implantation or replacement of another valve (e.g., a bicuspid or tricuspid valve) in a patient's heart. FIG. 10A shows an isometric view of a prosthetic heart valve device 100 in an expanded configuration 102 according to an embodiment of the present technology, and FIG. 10B is a schematic diagram of a cross-sectional view of the heart depicting the left atrium, left ventricle, and native mitral valve of the heart. FIG. 10B also shows an embodiment of an expandable prosthetic valve device 100 implanted in the native mitral valve region of the heart.

[0068] As shown in FIG. 10A, the device 100 can include a flexible anchoring member 110 that at least partially surrounds and is coupled to the inner valve support 120. The device 100 can further include a prosthetic valve 130 that is coupled to, mounted inside, or otherwise carried by the valve support 120. FIGS. 10C-10F are side, perspective cutaway, top, and bottom views, respectively, of a prosthetic heart valve device 100 in accordance with the present technology. The device 100 can also include one or more sealing members 140 and tissue engaging elements 170. For example, the sealing member 140 can extend around an inner surface 141 of the anchoring member 110 and / or around an outer surface 127 of the valve support 120 to prevent paravalvular (e.g., prosthetic) leakage between the device 100 and the native tissue and / or between the anchoring member 110 and the valve support 120 in one embodiment. 10A, tissue engaging elements 170 may be spikes disposed on the upstream periphery 113 of the anchoring member 110 and may extend upwardly and / or radially outwardly to engage, and in some embodiments, penetrate, natural tissue to facilitate retention or hold the position of the device at the desired implantation location. Tissue engaging elements 170 may also be included around the outer wall 142 of the anchoring member 110 and may extend outwardly to engage, and in some embodiments penetrate, natural leaflets or other adjacent tissue. Additionally, the valve support 120 may have a number of interlocking features 180, such as eyelets, around the upstream end 121 to facilitate loading, retention, and deployment of the device 100 in and out of a delivery catheter (not shown), as described further herein.

[0069] The prosthetic heart valve device 100 may be movable between a delivery configuration (not shown), an expanded configuration 102 (FIG. 10A), and a deployed configuration 104 (FIG. 10B). In the delivery configuration, the prosthetic heart valve device 100 has a low profile suitable for delivery through a small diameter guide catheter positioned in the heart via a transseptal, retrograde, or transapical approach as described herein. In some embodiments, the delivery configuration of the prosthetic heart valve device 100 will preferably have a profile not exceeding about 8-10 mm for a transseptal approach to the mitral valve MV, about 8-10 mm for a retrograde approach, or about 8-12 mm for a transapical approach. As used herein, "expanded configuration" refers to the configuration of the device when allowed to freely expand to an unconstrained size in the absence of any constraining or distorting forces. As used herein, "deployed configuration" refers to the device once expanded at the native valve site and subject to any constraining or distorting forces exerted by the native anatomy.

[0070] Referring again to FIG. 3, "subannular" as used herein refers to a portion of the mitral valve MV located above or downstream DN of the plane PO of the native orifice. As used herein, the plane PO of the native orifice is a plane that is generally perpendicular to the direction of blood flow through the valve, containing either or both of the long axis MVA1 or the short axis MVA2 (FIG. 5C). Thus, the subannular surface of the mitral valve MV is a tissue surface located on the ventricular side of the plane PO, preferably facing generally downstream toward the left ventricle LV. The subannular surface may be located on the annulus AN itself, or on the ventricular wall behind the native leaflet LF, or may comprise a surface of the native leaflet LF, either the inward facing IF or the outward facing OF, located below the plane PO. Thus, the subannular surface or subannular tissue may comprise the annulus AN itself, the native leaflet LF, the leaflet / annulus connective tissue, the ventricular wall, or a combination thereof.

[0071] During surgery, the prosthetic heart valve device 100 can be delivered intravascularly to a desired location within the heart, such as a location within the heart near the mitral valve MV, while in a delivery (e.g., collapsed) configuration within a delivery catheter (not shown). With reference to FIG. 10B, the device 100 can be advanced to a location within or downstream of the native valve annulus AN, where it can be released from the delivery catheter to expand toward an expanded configuration 102 (FIG. 10A). The device 100 will engage native tissue at the desired location, deforming or otherwise changing the shape of the device 100 to a deployed 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 to resist systolic forces and prevent upstream migration of the device 100 (FIG. 10B). In the embodiment illustrated in FIG. 10B, the upstream periphery 113 of the anchoring member 110 engages the inwardly facing surface IF (FIG. 3) of the native leaflet LF, which is forced outward and folded under the native annulus AN. The leaflet LF engages the ventricular side of the annulus AN and is prevented from being forced further in the upstream direction, thus maintaining the anchoring member 110 below the plane of the native annulus. The tissue engaging element 170 can penetrate the tissue of the leaflet LF and / or the annulus AN to stabilize and securely anchor the device 100. However, in some embodiments, some portions of the anchoring member 110 may extend above the annulus AN, with at least some portions of the anchoring member 110 engaging tissue at a subannular location to prevent migration of the device 100 toward the left atrium LA. As shown in FIG. 10B, the leaflet LF can be juxtaposed against the outer wall 142 of the anchoring member 110 and form a blood-tight seal with the sealing member 140. The tissue engaging element 170 can apply pressure against, or in another embodiment penetrate, the valve annulus AN or leaflets LF along the outer wall 142 of the fixation member 110 to further stabilize the device 100 and prevent migration.

[0072] In accordance with aspects of the present technology, the proximal or upper end of the anchoring member 110, while in the deployed configuration 104, conforms to the irregularly shaped mitral valve annulus AN, effectively sealing the device 100 against the native annulus AN to anchor the device and prevent paravalvular leakage. As described further herein, the anchoring member 110 mechanically isolates the valve support 120 from the distorting forces present in the heart such that the anchoring member 110 can accommodate and / or conform to natural forces while the valve support 120 maintains its structural integrity. Thus, the anchoring member 110 can be sufficiently flexible and resilient and / or coupled to the valve support 120 in a manner to mechanically isolate the valve support 120 from forces exerted on the anchoring member 110 by the native anatomy. Alternatively, or in addition to the above features, the valve support 120 may be more rigid and / or have a radial strength greater than that of the anchoring member 110 to maintain its cylindrical or other desired shape and to ensure proper opening and closing of the prosthetic valve 130 housed within the valve support structure 120. In some embodiments, the valve support 120 has a radial strength at least 100%, or in other embodiments 200%, and in further embodiments at least 300% greater than the radial strength of the anchoring member 110. In one embodiment, the valve support 120 can have a radial strength of about 10 N to about 12 N. Thus, when deformed from its natural shape by exerting a radial compressive force about its circumference, the valve support 120 can exhibit a hoop force that is about 2 to about 20 times greater than would be exhibited by the anchoring member 110 for a given degree of deformation.

[0073] As illustrated in FIGS. 10A-10F, 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, as shown in FIG. 10D. In one embodiment, the anchoring member 110 has a generally hyperboloid shape, such as that of a bilayer 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 can include a series of circumferentially positioned, elastically deformable, flexible longitudinal ribs 114 that are circumferentially connected by a deformable and / or flexible connector 116 in some embodiments. Once deployed, at least a portion of the upstream ends of the longitudinal ribs 114 engage the subannular surface of a native valve (e.g., mitral valve). As described in more detail below, certain embodiments of longitudinal ribs 114 are configured to penetrate subannular tissue to anchor and further stabilize device 100.

[0074] In addition, Figures 10A-10F also illustrate that the longitudinal ribs 114 and / or the circumferential connectors 116 may be arranged in various geometric patterns. In the example shown in Figures 10A-10F, the connectors 116 are formed in a chevron configuration. One skilled in the art will recognize that diamond patterns, sinusoidal configurations, closed cells, open cells, or other circumferentially expandable configurations are also possible. In some embodiments, the longitudinal ribs 114 may be divided into multiple separate segments (not shown) along their length, for example, where the connectors 116 interconnect the longitudinal ribs 114. The multiple connectors 116 and the ribs 114 may be formed from a deformable material or from an elastic or shape memory material (e.g., Nitinol). In other embodiments, the anchoring member 110 may comprise a mesh or woven structure in addition to or in place of the longitudinal ribs 114 and / or the circumferential connectors 116. For example, the anchoring member 110 can include a tube or braided mesh formed from multiple flexible wires or filaments arranged in a diamond pattern or other configuration. In another example, a metal tube can be laser cut to provide the desired rib or strut geometry. The diamond configuration can provide sufficient column strength in some embodiments to prevent movement of the device 100 relative to the valve annulus under the force of systolic blood pressure against a valve 130 mounted within the valve support 120. In certain examples, the anchoring member 120 can be formed of a preformed Nitinol tube, for example, having a wall thickness of about 0.010 inches to about 0.030 inches.

[0075] 11A-11E show several embodiments of a valve support 120 that can be used in the embodiment of the prosthetic heart valve device 100 shown in FIG. 10A-10F. FIG. 11A-11D shows a side view and an isometric view of the valve support 120 shown in an expanded configuration 102, and FIG. 11E shows an isometric view of another embodiment of the prosthetic heart valve device 100 deployed in an expanded configuration 102 in accordance with the present technology. With reference to both FIG. 10A-10F and 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 with a circular, oval, elliptical, kidney-shaped, D-shaped, or other suitable cross-sectional shape configured to support a tricuspid or other prosthetic valve 130. In some embodiments, the valve support 120 includes a plurality of posts 122 connected circumferentially by a plurality of struts 124. The posts 122 and struts 124 can be arranged in a variety of geometric patterns that can provide sufficient resiliency and column strength to expand and maintain the integrity of the prosthetic valve 130. For example, a plurality of posts 122 can extend longitudinally across multiple rows of struts 124 to provide column strength to the valve support 120. However, in other embodiments, the valve support 120 can include a metal, polymer, or fiber mesh or woven structure.

[0076] In general, the plurality of posts 122 may extend along an axial direction generally parallel to the longitudinal axis 101, and the posts 124 may extend circumferentially around and perpendicular to the longitudinal axis 101. The posts 122 may extend along the longitudinal height H _mstmutation=1>1 (as shown in FIG. 11A ), or in another embodiment, the posts 122 extend over the entire valve support height H _mstmutation=1>1 In one embodiment, the column may include multiple separate and distinct column segments (not shown) along the height H _mstmutation=1>1may be about 14 mm to about 17 mm. The struts 124 may form a series of rings around the longitudinal axis 101, each ring having a circumferentially expandable geometry. In the embodiment shown in Figures 11A, 11D, and 11E, the struts 124 are formed into a series of zigzags and arranged in pairs 180 degrees out of plane with each other to form a series of diamonds. Alternative expandable geometries may include sinusoidal patterns, chevron configurations (Figure 11B), closed cells (Figure 11C), open cells, or other expandable configurations. The multiple struts 124 may be attached to the multiple posts 122 to define multiple nodes 125 where the struts and posts intersect. The multiple struts 124 and the multiple posts 122 may be formed from a deformable material or from an elastic or shape memory material (e.g., Nitinol).

[0077] The anchoring member 110 and the valve support 120 may be made of the same material, or in some embodiments, different materials. In some embodiments, both the anchoring member 110 and the valve support 120 include 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. A superelastic shape-memory material, such as Nitinol, may allow the device to be folded into a very low-profile delivery configuration suitable for delivery through the vasculature via a catheter, and self-expand into a deployed configuration suitably sized to replace the target valve. In some embodiments, the anchoring member 110 and / or the valve support 120 may be laser cut into the desired geometry from a single metal tube, creating a tubular scaffold of interconnected struts. The anchoring member 110 may then be formed into the desired configuration, for example, a flared, funnel-like, or hyperboloid shape, using known shape-setting techniques for such materials.

[0078] As shown in FIGS. 11B-11E, 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 the prosthetic valve 130 within the internal lumen of the valve support 120 to prevent retrograde blood flow (e.g., blood flow from the left ventricle into the left atrium). Thus, the valve support 120 can provide a scaffolding to which the prosthetic valve tissue can be secured and can provide a scaffolding with sufficient axial rigidity to maintain the longitudinal position of the prosthetic valve 130 relative to the anchoring member 110. The valve support 120 can further provide such a scaffolding with radial rigidity to maintain a circular shape (or other desired cross-sectional shape) to ensure that the leaflets 132 of the prosthetic valve 130 coapt or otherwise seal when the device 100 is subjected to external radial pressure. In one embodiment, the valve support 120 can have a support region 145 along the longitudinal axis 101 (shown in FIG. 11B) configured to attach to the prosthetic valve or, in other embodiments, to be aligned with the coapting portions of the leaflets 132.

[0079] The valve 130 may comprise a temporary or permanent valve adapted to block blood flow in an upstream direction and allow blood 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 the device 100 is implanted in the native mitral valve. The valve 130 may have multiple leaflets 132 and may be formed of a variety of flexible and impermeable materials, including PTFE, Dacron®, pyrolytic carbon, or other biocompatible materials or biological tissues, such as pericardial tissue, or xenograft valve tissue, such as porcine heart tissue or bovine pericardium. Other aspects of the valve 130 are further described below. The intraluminal inner surface 126 of the valve support 120 may be at least partially covered by an impermeable sealing member 140 to prevent blood flow from inside the valve support 120 to outside the valve support 120, where blood may leak around the exterior of the valve support 120. In another embodiment, the sealing member 140 can be affixed to the outer surface 127 of the valve support 120, and in either embodiment may be integrally formed with the valve 130 or attached directly to the valve 130. In additional embodiments, the sealing member 140 can be applied over at least a portion of both the inner surface 126 and the outer surface 127 of the valve support 120.

[0080] As shown in Figures 11B-11E, the prosthetic valve 130 can be sutured, riveted, glued, bonded, mechanically interlocked, or otherwise fastened to the posts 122 or commissure attachment structures 128 configured to align with the valve commissures C. The posts 122 or commissure attachment structures 128 can include eyelets 129, loops, or other features formed thereon to facilitate attachment of sutures or other fastening means to facilitate attachment of the prosthetic valve 130. In one embodiment, as shown in Figure 11B, the attachment structures 128 can be integrated into the structural frame of the valve support 120 such that the attachment structures 128 are distributed around the circumference of the valve support 120 and function as posts 122. In another embodiment, shown in Figure 11D, the attachment structures 128 can be attachment pads formed on portions of the posts 122 (e.g., along the top ends of the posts 122). In a further embodiment, shown in FIG. 11E, the attachment structure 128 can be a separate structure that can be coupled to the posts 122 , struts 124 , or other components along the inner surface 126 of the valve support 120 .

[0081] As illustrated in FIG. 11C, the prosthetic valve 130 may also be attached to a sealing member 140 or sleeve, as described above, that is attached to the inner surface 126 of the valve support 120. Once attached, the prosthetic valve 130 may be suitable for folding or compressing with the device 100 for loading into a delivery catheter (not shown). In one embodiment, the prosthetic valve 130 has a trileaflet configuration, although various alternative valve configurations, such as a bileaflet configuration, may be used. The design of the prosthetic valve 130, such as the selection of a trileaflet vs. bileaflet configuration, may be used to determine the preferred shape of the valve support 120. For example, for a trileaflet valve, the valve support 120 may have a circular cross-section, while for a bileaflet valve, alternative cross-sectional shapes, such as an oval or D-shaped cross-section, are possible. In certain examples, the valve support may have a circular cross-sectional diameter of about 25 mm to about 32 mm, such as 27 mm.

[0082] In some arrangements, the valve support 120 can have a permanent prosthetic valve pre-loaded therein, or the valve support 120 can be configured to receive a separate catheter-delivered valve following implantation of the device 100 at the native mitral valve. In arrangements where a permanent or replacement valve is desired, the valve support 120 can further include a temporary valve pre-loaded within the internal lumen. If a period of time is desired between placement of the device 100 and further implantation of the native prosthetic valve, a temporary valve sewn or otherwise secured within the valve support 120 can ensure regulation of blood flow during that time. For example, the temporary valve may be used for a period of time from about 15 minutes to several hours or up to several days. The permanent or replacement prosthetic valve may be embedded within the temporary valve, or may be embedded after the temporary valve is removed. Examples of pre-assembled percutaneous prosthetic valves include, for example, the CoreValve ReValving® System from Medtronic / Corevalve Inc. (Irvine, Calif., USA), or the Edwards-Sapien® valve from Edwards Lifesciences (Irvine, Calif., USA). When adapted to receive a separate catheter-delivered valve, the valve support 120 may have features such as inwardly extending ridges, steps, projections, or flaps within its internal lumen or on its upper or lower ends to engage and retain the catheter-delivered valve therein. Additional details and embodiments regarding the structure, delivery, and installation of prosthetic, temporary, and replacement valves suitable for use with the prosthetic heart valve devices disclosed herein can be found in International PCT Patent Application No. PCT / US2012 / 043636, entitled "PROSTHETIC HEART VALVE DEVICES AND ASSOCIATED SYSTEMS AND METHODS," filed June 21, 2012, the entire contents of which are incorporated herein by reference.

[0083] In some arrangements, the anchoring member 110 is defined by a structure separate from 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. As such, 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 coupled to the valve support 120, while the upstream portion 112 is not connected or coupled 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 to the shape of the native tissue above or below the valve annulus, while the cross-sectional shape of the valve support 120 remains sufficiently stable. For example, when the anchoring member 110 is deformed inwardly, the valve support 120 (e.g., at least at the upstream end 121) can be spaced radially inward from the upstream portion 112 of the anchoring member 110 such that 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 scenario in which the valve support 120 can be slightly deformed, but the prosthetic valve 130 remains competent in its original state (e.g., the leaflets 132 are sufficiently coapted to prevent retrograde 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.

[0084] The longitudinal ribs 114 and / or circumferential connectors 116 may be less rigid than the posts 122 and / or struts 124 of the valve support 120, allowing for greater flexibility of the anchoring member 110 and / or additional stability to the shape and position of the valve support 120. In some embodiments, the flexibility of the anchoring member 110 may allow the anchoring member 110 to absorb distorting forces and allow the device 100 to conform to the irregular, non-circular shape of the native annulus (while leaving the valve support 120 substantially unaffected), encouraging tissue ingrowth and creating a seal to prevent leakage between the device 100 and the native tissue. Additionally, the longitudinal ribs 114 and / or circumferential connectors 116 may be configured to anchor the device 100 in a desired location while maintaining an upstream deployment circumference 150' that is greater than the native annulus such that the sub-annular positioning effectively prevents upstream migration of the device 100. Connectors 116 can be configured to urge radially outward against native valve, ventricle, and / or aortic structures (described further below in FIG. 14C). Additionally, longitudinal ribs 114 can have sufficient elasticity and column strength (e.g., axial stiffness) to prevent longitudinal collapse or eversion of anchoring members 110 and / or device 100 and to resist migration of the device in an upstream direction.

[0085] By structurally isolating the anchoring member 110 from the valve support 120, the valve 130 and valve support 120 are effectively mechanically isolated from distorting forces exerted on the anchoring member 110 by native tissue, such as radial compressive forces, longitudinal diastolic and systolic forces, hoop stresses, etc. exerted by the native annulus and / or leaflets. For example, while deformation of the anchoring member 110 by the native tissue can change the cross-section of the anchoring member 110 (e.g., to a non-circular or asymmetric cross-section), the valve support 120 may be substantially undeformed. In one embodiment, for example, at least a portion of the valve support 120 can be deformed by the radial compressive forces when the anchoring member 110 is coupled to the valve support 120 (e.g., downstream end 123). However, the upstream end 121 and / or valve support region 145 (FIG. 11B) of the valve support 120 are mechanically isolated from the anchoring member 110 and the compressive forces such that at least the valve support region 145 may be substantially undeformed. Thus, the valve support 120, and at least the valve support region 145, may maintain a circular or other desired cross-section such that the valve remains stable and / or competent. The flexibility of the longitudinal ribs 114 may contribute to absorbing distorting forces and may also serve to mechanically isolate the valve support 120 and valve 130 from the anchoring member 110.

[0086] At the upstream end of the device 100 oriented toward the left atrium, the valve support 120 can be configured to be below, level with, or above the top end of the upstream portion 112 of the anchoring member 110. At the downstream end of the device 100 oriented toward and inside the left ventricle, the anchoring member 110 can be coupled to the valve support 120. Alternatively, the anchoring member 110 can be coupled to the valve support 120 anywhere along its length. The valve support 120 and the anchoring member 110 can be coupled by various methods known in the art, such as 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 one another. In yet another embodiment, a sleeve or other layered structure (not shown) can be attached to both the anchoring member 110 and the valve support 120 to interconnect the two structures.

[0087] 12A-12C are side views of various longitudinal ribs 114 deflecting in response to a deflection force F, in accordance with a further embodiment of the present technology. The degree of flexibility of the individual longitudinal ribs 114 (and thus the fastening member 110) may be consistent among all ribs of the fastening member 110, or alternatively, some ribs 114 may be more flexible than other ribs 114 within the same fastening member 110. Similarly, the degree of flexibility of the individual ribs 114 may be consistent throughout the entire length of the rib 114, or the degree of flexibility can vary along the length of each rib 114.

[0088] 12A-12C, longitudinal ribs 114 (individually shown as 114A-114C) may flex along their respective lengths in response to a bending force F, which may be applied by surrounding tissue during or after implantation of device 100. In FIG. 12A, rib 114A is flexed along their respective lengths in response to an upward or downward force F, _mstmutation=1>1In response to a force F, the rib 114B may deflect downward to a position 75′ or upward to a position 75″. Similarly, in FIG. 12B, the rib 114B with multiple differential segments 85A, 85B, 85C may deflect downward to a position 75′ or upward to a position 75″ in response to a force F _mstmutation=1>2 The distinct segments 85A at the ends of the ribs 114B may bend and / or rotate inward / outward or side to side in response to forces F that are distinct from the distinct segments 85B and 85C below. _mstmutation=1>2 In response to a laterally directed force F, the segment 114C may flex and / or rotate inward / outward or side to side (e.g., to position 85A'). In other arrangements, the segment 85A, along with the specific segment 85B, may flex and / or rotate (e.g., to position 85AB') along with both segments 85B and 85C together (not shown). As shown in FIG. 12, the rib 114C, which has a substantially straight shape when in a relaxed state, may also flex and / or rotate inward / outward or side to side (e.g., to position 85A') in response to a laterally directed force F, by bending to create a curved shape, or in another embodiment not shown, by bending to create two substantially straight segments. _mstmutation=1>3 , may flex and / or rotate inward / outward or left / right (e.g., to position 95' or 95") in response to.

[0089] The individual ribs 114 can also have various shapes and be located at various positions around the circumference of the fixation member 110. In some embodiments, the device 100 can include a first and a second plurality of ribs, where the first plurality of ribs has different characteristics than the second plurality of ribs. The different characteristics can include rib size, rib shape, rib stiffness, expansion angle, and number of ribs in a given region of the fixation member. In other embodiments, the longitudinal ribs can be unevenly or evenly spaced around the circumference of the fixation member.

[0090] The ribs 114 can be positioned around a circumference oriented along the longitudinal axis 101 of the anchoring member 110 to create any number of overall cross-sectional geometries of the anchoring member 110, e.g., circular, D-shaped, oval, kidney-shaped, irregular. FIG. 13A is a schematic cross-sectional view of a prosthetic heart valve device according to another embodiment of the present technology, and FIGS. 13B-13F are partial side views of a prosthetic heart valve device illustrating various longitudinal rib configurations according to additional embodiments of the present technology. With reference to FIG. 13A, the individual ribs 114 can comprise multiple linear segments, such as segments 85A and 85B. In the illustrated example, rib segment 85B is angled at a first angle A. _mstmutation=1>1 Rib segment 85B is angled radially outward (e.g., angled away from longitudinal axis 101) by a distance D. The rib segment 85B extends upstream from its attachment point to the valve support 120 at the downstream end of segment 85B, thereby forming a larger diameter D at the upstream portion 112 of anchoring member 110. _mstmutation=1>2 , and a smaller diameter D3 at the downstream portion 112, giving the anchoring member 110 a conical or flared shape. In one embodiment, the upper rib segment 85A is angled at a steeper second angle A relative to the longitudinal axis 101 than the lower rib segment 85B. _mstmutation=1>2 13B , resulting in a wider flared upstream portion 112A at the upstream portion 112 of the anchoring member 110. In some arrangements, the wider flared upstream portion 112A may enhance a seal between the anchoring member 110 and the natural tissue, while the downstream portion 111 can provide a stiffer geometry to resist upstream movement of the device 100 when systolic forces are exerted on the device 100. Alternatively, the rib 114 can be arcuate over all or a portion of its length, as shown in the partial side view of FIG.

[0091] In yet other embodiments, as illustrated by Figures 13C-13F, the rib 114 can have a more complex shape defined by a plurality of distinct segments 85A, 85B, 85C. For example, as shown in Figure 13C, the rib 114 can include a straight rib segment 85C, generally parallel to the longitudinal axis 101, that is connected at its upstream end to a straight, radially outwardly extending rib segment 85B, which is connected at its upstream end to a more vertical rib segment 85A, which is generally parallel to the longitudinal axis 101. With reference to Figure 13D, the rib 114 can include a straight rib segment 85B, generally parallel to the longitudinal axis 101, that is connected at its upstream end to a straight, radially outwardly extending rib segment 85A, which is generally perpendicular to the longitudinal axis 101. 13E, the rib 114 may include a straight rib segment 85C that is generally parallel to the longitudinal axis 101 and connected at its upstream end to a straight radially outwardly extending rib segment 85B that is generally perpendicular to the longitudinal axis 101. The rib segment 85B may further be connected at its radially outward most end to a vertical rib segment 85C that is generally parallel to the longitudinal axis 101. With reference to FIG. 13F, the rib 114 includes a straight segment 85D that is generally parallel to the longitudinal axis 101 and connected at its upstream end to a radially outwardly extending rib segment 85C that is generally perpendicular to the longitudinal axis 101. The rib segment 85C may further be connected at its radially outward most end to a straight vertical segment 85B that is generally parallel to the longitudinal axis 101, which is connected at its radially outward most end to a straight radially inwardly extending segment 85A.

[0092] 13C-13F, the ribs 114 can be coupled to the valve support 120 (e.g., coupled to the posts 122) in a manner that enhances mechanical isolation of the valve support 120. For example, the ribs 114 can be attached to the valve support 120 near their downstream ends such that a majority of each rib 114 upstream of the attachment point is movable and deformable relative to the valve support 120, thereby allowing the rib 120 to flex radially outward or circumferentially back and forth relative to the valve support 120. Additionally, one of ordinary skill in the art will recognize that in any of the embodiments illustrated in FIGS. 13A-13F, any or all of the rib segments can have a curvature, and any interconnections of segments shown as angled can instead be curved. Thus, any of these various geometric shapes may be configured to enable the anchoring member 110 to conform to the native anatomy, resist movement 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 the native tissue.

[0093] The flexible properties of the individual ribs 114 can allow the anchoring member 110 to flex and conform to engage and seal against uneven and uniquely shaped native tissue. Additionally, flexibility can assist in creating a seal between the device 100 and the surrounding anatomy. Figure 14A is a schematic top view of a native mitral valve MV illustrating the short axis 50 and long axis 55, and Figures 14B-14C are schematic top views of the anchoring member 110 in the expanded configuration 102 and deployed configuration 104, respectively, overlying a schematic view of the native mitral valve MV, in accordance with an embodiment of the present technology.

[0094] 14B, the upstream portion 112 (FIG. 10A) of the anchoring member 110 has a diameter D (FIG. 14B) that is greater than the minor axis 50 (FIG. 14A) of the native annulus and typically less than the major axis 55 of the annulus when the anchoring member 110 is in the expanded configuration 102 (shown as a dashed line). _mstmutation=1>1In other embodiments, the anchoring member 110 can have a diameter D at least as large as the distance between the natural commissures C. _mstmutation=1>1 , which may be as large as or even larger than the long axis 55 of the native annulus. In some embodiments, the circumference 150 of the anchoring member 110 has a diameter D that is about 1.2 to 1.5 times the diameter (not shown) of the valve support 120 (or prosthetic valve 130). _mstmutation=1>1 and may be 2.5 times larger than the diameter of the valve support 120 (or prosthetic valve 130). While conventional valves must be manufactured in multiple sizes to treat diseased valves of various sizes, the valve support 120 and prosthetic valve 130 may be manufactured in only a single diameter to fit multiple native valve sizes in accordance with aspects of the present technology. For example, the valve support 120 and prosthetic valve 130 do not need to precisely engage and fit the native anatomy. In specific examples, the valve support 120 may have a diameter (not shown) in the range of about 25 mm to about 32 mm for an adult patient. Also, in accordance with aspects of the present technology, the anchoring member 110 may be provided in multiple diameters to fit various native valve sizes, ranging from about 28 mm to about 80 mm in diameter at the upstream end, or greater than 80 mm in other embodiments.

[0095] 14C illustrates how the flexibility and / or deformation of one or more longitudinal ribs 114 and / or rib segments allows the fixation member 110 to distort to a deployed configuration 104, as indicated by the bold lines, relative to an expanded configuration 102, as indicated by the dashed lines. As shown in FIG. 14C, the fixation member 110, when deployed or implanted at or beneath the mitral valve annulus, can conform to the highly variable native mitral valve tissue shape MV, as indicated by the dotted lines, while the ribs 114 bend, twist, and stretch such that the overall shape of the fixation member 110 has a deployed (e.g., generally more oval or D-shaped, or other irregular shape) configuration 104 instead of a fully expanded configuration 102. 14B-14C together, the anchoring members 110 cover the mitral valve commissures C in the deployed configuration 104, while the commissures C are left unsealed or exposed in the more circular expanded configuration 102, potentially allowing for paravalvular leakage. The anchoring members 110 can also be preformed into a generally oval or D-shape, or other shape, when in the unbiased state.

[0096] FIG. 15 is an isometric view of an embodiment of a prosthetic heart valve device 100 illustrated in a deployed configuration 104, in accordance with an embodiment of the present technology. FIG. 15 illustrates a device 100 having a plurality of ribs 114, where a first set of ribs 160 can be configured to bend inwardly or compress 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 distorting forces present in the subannular space of a native valve. As a result, the periphery 150 of the anchoring member 110 may be distorted 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 bold lines, thus conforming to the shape of the native anatomy. In a further arrangement, the upstream portion 112 of the anchoring member 110 may be sized slightly larger than the subannular space in which it is deployed, such that the anchoring member 110 is compressed to a slightly smaller diameter in its deployed configuration 104. This may cause a slight relaxation of the sealing member 142 such that the sealing member sections between adjacent ribs 114 are loose enough to bulge or curve inwardly or outwardly to form loose sections Bi, as shown in Fig. 15. Such bulging may be desirable in some arrangements because the curvature of the relaxed sleeve segments Bi can engage and conform to the mitral leaflet tissue, thereby enhancing the seal formed between the device 100 and the native tissue.

[0097] 15, in the illustrated embodiment, the unbiased expanded configuration of the valve support 120, which is circular in cross section, 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 significantly deform (e.g., conform to the shape and motion of the anatomy under ventricular systolic forces) when deployed and during operation, while the valve support 120 remains undeformed (e.g., approximately circular) under these same conditions. Additionally, the radial spacing between the anchoring member 110 and the valve support 120 allows the anchoring member 110 to be deformed inwardly a significant amount without engaging the valve support 110, particularly at the upstream portion / end where the anchoring member 110 engages the native annulus and / or sub-annular tissue. Further, the anchoring member 110 can be coupled to the valve support 120 at a location (e.g., the downstream portion 111 of the anchoring member 110) that is spaced a substantial distance longitudinally from where the anchoring member 110 engages the native annulus (e.g., the upstream portion 112 of the anchoring member 110), allowing the ribs 114 of the anchoring member 110 to absorb many of the distorting forces exerted thereon, rather than directly transmitting these forces to the valve support 120. Additionally, the coupling mechanism employed to attach the fixation member 110 to the valve support 120 can be configured (e.g., to be flexible or movable) to reduce the transmission of forces from the fixation member 110 to the valve support 120 (discussed further herein).

[0098] In many embodiments, the anchoring member 110 can be sufficiently flexible so that it conforms to the native mitral annulus when in the deployed configuration 104 (FIGS. 14C and 15), but can be configured to remain biased toward its expanded configuration 102 (e.g., FIGS. 10A and 14B) when in the deployed configuration 104, such that the anchoring member 110 presses radially outward against the native annulus, leaflets, and / or ventricular wall immediately below the annulus. In some arrangements, the radial force generated by the biased anchoring member shape can be sufficient to deform the native anatomy such that the minor axis 50 (FIG. 14A) of the native valve is slightly increased and / or the shape of the annulus is otherwise changed. Such radial force can enhance anchoring of the device 100 to resist movement toward the atrium when the valve 130 is closed during ventricular systole, as well as movement toward the ventricle when the valve 130 is open. Additionally, the resulting compressive fit between the anchoring members 110 and the valve leaflets and / or ventricular walls or other structures helps to create a long-term bond between the tissue and the device 100 by encouraging tissue ingrowth and encapsulation.

[0099] 16A-17C illustrate a prosthetic heart valve device 100 configured in accordance with additional embodiments of the present disclosure. Figures 16A-16C are a top view and first and second side views of the prosthetic heart valve device 100 illustrated in an expanded configuration 102, which includes features generally similar to those of the prosthetic heart valve device 100 described above with reference to Figures 10A-15. For example, the device 100 includes a valve support 120 and a prosthetic valve 130 housed within an internal lumen of the valve support 120. However, in the embodiment shown in Figures 16A-16C, the device 100 includes an anchoring member 210 having an oval or D-shaped upstream periphery 213 and multiple elevations 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.

[0100] 16A-16C , the device 100 can include a flexible anchoring member 210 that at least partially surrounds and is coupled to the valve support 120 at a downstream portion 211 of the anchoring member 210. The device 100 can also include one or more sealing members 140 that extend around an inner wall 241 of the anchoring member 210 and / or around an outer surface 127 or an 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 can encase and / or cover the upstream perimeter 213 of the anchoring member 210. For example, the sealing member 140 can be sewn, sutured, or glued to the walls 241, 242 and can have an extension portion (not shown) that folds over the upstream perimeter 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 an upper portion of the outer wall 242). However, in other embodiments, the sealing member 140 can have a longer free edge (not shown) in an unattached state. The free edge of the sealing member 140 can be suitable in some arrangements to prevent blood flow between the upper perimeter 213 and the native tissue.

[0101] As illustrated in FIGS. 16B-16C, the anchoring member 210 has a downstream portion 211 and an upstream portion 212 opposite the downstream portion 111 along the longitudinal axis 201 of the device 100. Similar to the anchoring member 110 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 flexible ribs 214 that can be a crisscross pattern around the circumference 250 of the anchoring member 210 to form a diamond pattern. In one embodiment, the ribs 214 can be flexible wires or filaments arranged in a diamond pattern or configuration. The diamond configuration can provide sufficient column strength to resist movement of the device 100 relative to the valve annulus under the force of systolic blood pressure against a valve 130 mounted within the valve support 120 in some embodiments. In certain examples, the anchoring member 120 can be formed of a pre-formed Nitinol tube, for example, having a wall thickness of about 0.010 inches to about 0.030 inches. The diamond pattern or configuration can include, for example, one or more rows of diamonds, and in some embodiments, from about 12 to about 36 rows of diamonds around the circumference 250 of the anchoring member 210.

[0102] 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 can be offset from one another at variable angles such that the distance (e.g., elevation) 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 perimeter having a plurality of peaks 251 and valleys 252 (FIG. 16B) to match the shape of the native mitral valve (see FIG. 5C). As used herein, "peaks" and "valleys" do not refer to the peaks and valleys of the diamond pattern formed by the plurality of ribs 214, but to the portion of the upstream perimeter 213 that has an undulating shape formed by the elevation changes relative to the downstream perimeter 215. In one embodiment, the distance (e.g., elevation) between the downstream perimeter 215 and the upstream perimeter can vary from about 6 mm to about 20 mm, and in another embodiment, from about 9 mm to about 12 mm.

[0103] In one embodiment, the upstream circumference 213 of the anchoring member 210 can have two apexes 251 separated by two valleys 252. In some embodiments, the first apex can have a different shape or elevation than the second apex. In other embodiments, the shape of the valley 252 can be different from the shape of the inverse apex 251. Thus, the apex 251 and valley 252 can be asymmetrically positioned and shaped around the circumference 250 of the anchoring member 210. In various arrangements, the valley 252 can be configured for positioning along the commissure region of the native annulus and the apex 251 can be configured for positioning along the leaflet region of the native annulus. In one embodiment, the apex 251 can have a tip configured for positioning near the midpoint region of the leaflet.

[0104] 17A-17C, one specific embodiment of the fastening member 210 has a first elevation E of about 7 mm to about 8 mm in the first and second regions 253, 254 of the fastening member. _mstmutation=1>1The anchoring member 210 can have a second elevation E of about 9 mm to about 11 mm in a third region 255 of the anchoring member 210. The first and second regions 253, 254 can be configured to align with first and second commissures (e.g., the anterior lateral commissure AC and the posteromedial commissure PC, FIG. 5A ) of the native mitral valve. _mstmutation=1>2 The anchoring member 210 can have a third elevation E of about 12 mm to about 13 mm in a fourth region 256 of the anchoring member 210 opposite the third region 255. _mstmutation=1>3 The fourth region 256 may have a diameter between the downstream perimeter 215 and the upstream perimeter 213, and is configured to align with the posterior leaflet PL of the native mitral valve (FIG. 5A). _mstmutation=1>1 , E2, and E3 may have other measurements, and in some embodiments, the altitude E _mstmutation=1>1 It will be appreciated that E1, E2, and E3 may be different from one another or may be identical.

[0105] Additionally, the upstream perimeter 213 can form a perimeter having a generally oval or D-shaped, or other irregular shape, to conform to the shape of the native mitral valve. For example, with reference to FIG. 17A, the upstream perimeter 213 of the anchoring member 210 can have an outer peripheral diameter D _mstmutation=1>m1 and the outer circumference D m1 and the inner perimeter D perpendicular to _mstmutation=1>m2 In one embodiment, the outer peripheral diameter D m1 is longer than the long axis MVA1 of the native mitral valve (shown in FIG. 5C) when the device 100 is in the expanded configuration 102 (FIG. 17A). _mstmutation=1>m1 is less than the long axis MVA1 when the device 100 is in the expanded configuration 102. In such embodiments, the device 100 has a circumferential outer diameter D that is greater than the long axis MVA1 when the device is in the deployed configuration (e.g., when engaging tissue above or below the native annulus, see FIG. 16E). _mstmutation=1>m1 Further, the inner peripheral diameter Dm2 can be greater than the short axis MVA2 (shown in FIG. 5C) of the native mitral valve when the device 100 is in the expanded configuration 102 (FIG. 17A) or, alternatively, in the deployed configuration (FIG. 16E). _mstmutation=1>m1 and / or the inner circumference D m2 may be about 2 mm to about 22 mm, or in another embodiment about 8 mm to about 15 mm, larger than the long axis MVA1 and / or short axis MVA2 of the native mitral valve, respectively. In some embodiments, the outer circumferential diameter may be about 45 mm to about 60 mm, and the inner circumferential diameter may be about 40 mm to about 55 mm.

[0106] 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 a side of the device 100 facing the anterior leaflet (e.g., along the third region 255) than on a side of the device 100 facing the posterior leaflet (e.g., along the fourth region 256).

[0107] 16A and 16C, the valve support 120 can be oriented along a first longitudinal axis 101, and the anchoring member 210 can be oriented along a 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 separated such that the gap 257 can vary around the circumference 250 (FIG. 16C). FIG. 16D shows another embodiment in which "offset" can refer to an arrangement in which the second axis 201 can be angled from the first axis 101 (e.g., the first and second axes 101, 201 are non-collinear 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 tilted at an angle A between 15° and 45° relative to the first longitudinal axis 101. _mstmutation=1>TL are placed in.

[0108] In additional embodiments, the first and second regions 253 and 254 of the upstream perimeter 213 can extend farther from the longitudinal axis 201 than the third and fourth regions 255 and 256, as shown in further detail in FIG. 18. For example, the anchoring member 210 can have a generally conical shape (shown in dotted lines) and have an upstream circumferential 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 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-facing surface of the anterior leaflet without substantially occluding the left ventricular outflow tract (LVOT).

[0109] 17A-17C, the valve support 120 can be oriented along a longitudinal axis 101 with the upstream portion 212 of the anchoring member 210 at a tapered angle A. _mstmutation=1>T In embodiments where the ribs 214 are generally curved outwardly from the downstream portion 211 to the upstream portion 212 (rather than straight), the angle of decrease A _mstmutation=1>T can vary continuously between the downstream and upstream portions. In some embodiments, the tapered angle A _mstmutation=1>T may be the same around the circumference 250 of the upstream portion 212 of the fastening member 210, but in other embodiments, the tapered angle A _mstmutation=1>T can vary around circumference 250. For example, fixation member 210 can have a first tapered angle A in first and second regions 253 and 254 (FIG. 17B), which can be configured to align with anterior lateral commissure AC and posteromedial commissure PC (see FIG. 5C), respectively. _mstmutation=1>T1 The anchoring member 210 can further have a second tapered angle A in a third region 255 that can be configured to align with the anterior leaflet. _mstmutation=1>T2 and a third tapered angle A in a fourth region 256 that can be configured to align with the posterior leaflet. _mstmutation=1>T3(FIG. 17C). In one embodiment, the tapered angle can be from about 30° to about 75°, and in another embodiment, from about 40° to about 60°.

[0110] 16E is a schematic top view of the native mitral valve in the heart from the left atrium, showing the prosthetic treatment device 100 of FIG. 16A-16C implanted in the native mitral valve MV, according to an embodiment of the present technology. Once deployed, as illustrated in FIG. 16E, at least a portion of the upstream end of the rib 214 (shown in FIG. 16B-16C) engages the subannular surface of the native valve (e.g., mitral valve). As described in more detail below, certain embodiments of the rib 114 or 214 are configured to penetrate the subannular tissue to anchor and further stabilize the device 100.

[0111] Although the anchoring member 210 is deformable in response to distorting forces exerted by the native anatomy, the valve support 120 has sufficient rigidity to maintain a circular or other original cross-sectional shape, thus ensuring proper function of the prosthetic valve leaflets 132 as they open and close. Such mechanical isolation from the anchoring member 210 may be achieved by the valve support 120 having sufficient rigidity to resist deformation while the anchoring member 210 is being deformed, and by selecting a location and means for coupling the valve support 120 to the anchoring member 210 to reduce transmission of forces through the anchoring member 210 to the valve support 120 or the prosthetic valve 130 contained therein. For example, the valve support 120 may be coupled to the anchoring member 210 only at the upstream end 121 of the valve support 120, which is separated from the upstream end 121 where the anchoring member 210 engages the valve annulus. Above the upstream end 121 of the anchoring member 210, the valve support 120 may not be fully connected to the anchoring member 210 but may be radially spaced from the anchoring member 210 by a gap 257 (see FIGS. 16A-16C where the prosthetic valve 130 is located) to allow deformation of the anchoring member 210 without affecting the shape of the valve support 120. Thus, forces exerted by the valve annulus on the anchoring member 210 can be absorbed by the flexible ribs 214 of the anchoring member 210 to mitigate transmission of such forces to the downstream end 123 of the valve support 120.

[0112] In some embodiments, it may be desirable to limit the distance that device 100 extends into the left ventricle downstream of the valve annulus (e.g., to limit obstruction of the left ventricular outflow tract (LVOT)). Accordingly, some embodiments of device 100 have a relatively low overall height (e.g., elevation E) such that anchoring members 210 do not extend into or obstruct the LVOT. _mstmutation=1>1 16B, for example, the anchoring member 110 may include an anchoring member 210 having a height H of the valve support 120. _mstmutation=1>V Low overall altitude E L (e.g., the distance between the upstream perimeter 213 and the downstream perimeter 215 of the anchoring member 210). In such embodiments, the upstream perimeter 213 of the anchoring member 110 may be positioned immediately below, adjacent to, or within the native mitral valve annulus, while the downstream perimeter 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 coupled to the anchoring member 210 to also minimize protrusion into the left ventricle, and in some embodiments may extend upward through the plane of the native annulus into the left atrium.

[0113] Additional Components and Features Suitable for Use with Prosthetic Heart Valve Devices Additional components and features are described herein that are suitable for use with prosthetic heart valve devices, such as device 100 described above. It will be recognized by those skilled in the art that although certain components and features are described with respect to a particular device, such as device 100, the components and features may also be suitable for use with or can be incorporated into other devices, as further described herein.

[0114] As discussed above with respect to Figure 10A, some embodiments of the prosthetic heart valve device 100 can include a sealing member 140 that extends around portions of the anchoring member 110 and / or the valve support 120. For example, the embodiment illustrated in Figure 10A has a sealing member 140 around an inner wall 141 of the anchoring member 110 and around an outer surface 127 of the valve support 120 to prevent paravalvular leakage not only between the device 100 and the anatomy, but also through components of the device 100.

[0115] 19A-19C are isometric, side, and top views, respectively, of a prosthetic heart valve device 100 having a sealing member 140 in accordance with a further embodiment of the present technology. Referring together to FIGS. 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 on the inner wall 141 at least partially covering the upstream perimeter 113 of the anchoring member 110. Thus, the skirt 144 can be secured and / or coupled to any surface of the anchoring member 110. The skirt 144 can also overlap the inner surface 126 (shown in FIG. 19A) and / or the outer surface 127 of the valve support 120. Variations of the skirt 144 and / or sealing member 140 can be configured to (1) create a blood flow blocking seal 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 help to seal between the anchoring member 110 and the valve support 120, as well as between the device 100 and the surrounding anatomy, such that blood flow is restricted to flow from the left atrium to the left ventricle through the prosthetic valve 130. Additionally, the sealing member 140 can provide circumferential support for the anchoring member 110 when in the expanded configuration 102 (FIGS. 10A, 16A, and 19A) or the deployed configuration 104 (FIGS. 10B and 16B). In some embodiments, the sealing member 140 may further serve to attach the anchoring member 110 to the valve support 120. For example, a skirt 144 may couple to the inner wall 141 of the anchoring member 110 and be integrally formed with or otherwise attached to the sealing member 140 which is coupled to the valve support 120. In other embodiments, the sealing member 140 may be used to couple the valve support 120 to the prosthetic valve 130 housed within the valve support 120. The sealing member 140, such as the skirt 144, may be coupled 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 members to the components of the device 100.

[0116] FIG. 20A is an isometric view of the prosthetic heart valve device 100 without the sealing member 140, and FIGS. 20B-20E are isometric views of the prosthetic heart valve device 100 with the sealing member 140 according to additional embodiments of the present technology. For example, FIGS. 20B-20C show an embodiment of the device 100 in which the sealing member 140 is a sleeve 146. The sleeve 146 is cylindrical and can include an impermeable sealing material configured to fit within or on various frames or skeletal structures of the device 100 as described further below. In FIG. 20B, the sleeve 146 is on the outer surface 127 of the valve support 120, while in FIG. 20C, 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 illustrates an embodiment of the device 100 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. With reference to FIG. 20E, the device 100 may also incorporate sleeves 146 on both the outer wall 142 and the inner wall 141 of the anchoring member 110 as well as on the outer surface 127 of the valve support 120.

[0117] Those skilled in the art will recognize that the sealing member 140, such as the skirt 144 and sleeve 146 shown in FIGS. 19A-20E, can completely cover the walls 141, 142, or surfaces 126, 127, or in other embodiments, can at least partially cover the walls 141, 142 and / or surfaces 126, 127 of the anchoring member 110 and the valve support 120, respectively. Any combination of sealing members 140 is contemplated. Additionally, the sealing member 140 can 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) that can create a seal between the anchoring member 110 and the valve support 120. In various embodiments, the sealing member 140, such as the skirt 144 or sleeve 146, can comprise a fabric or other flexible and biocompatible material, such as Dacron®, ePTFE, bovine pericardium, or other suitable flexible material, to integrate with tissue and minimize paravalvular leakage. In other embodiments, the sealing member 140 can comprise a polymer, a thermoplastic polymer, polyester, Gore-tex®, synthetic fibers, natural fibers, or polyethylene terephthalate (PET). The valve 130 can also be attached to or integrally formed with the sealing member 140.

[0118] In a further embodiment, shown in Figs. 21A-21F, the valve support 120 may comprise a tubular member 148 of fabric, polymer, or pericardium with little or no metal or other structural support. With reference to Figs. 21A-21B, the tubular member 148 may be a thicker, stiffer portion of the sleeve 146 that is capable of retaining its shape and has sufficient strength to resist radial and axial tension during systole and axial compression during diastole. The leaflets 132 of the prosthetic valve 130 may be integrally formed with, sewn to, or otherwise attached to the tubular member 148. In one embodiment, the tubular member 148 may be integrally formed with the outer portion 146A of the sleeve 146 that extends around the anchoring member 110 (shown in Fig. 21A), or in another embodiment, the tubular member 148 may be a separate and / or thicker member that is sewn, bonded, or otherwise fastened to the sleeve 146 in a blood-tight manner. The tubular member 148 can optionally include a reinforcing member to give it greater strength and to help retain a desired shape suitable for manipulating the valve 130. For example, a series of relatively rigid longitudinal struts 190 of metal or polymer can be coupled to or embedded within the wall of the tubular member 148 (FIG. 21C), and / or a wire coil 192 can extend around or embedded within the wall of the tubular member 148 (FIG. 21D). In a further embodiment, a series of tethers 194 can be coupled between the outer portion 146A of the sleeve 146 and the tubular member 148 (FIG. 21E). In one arrangement, the tethers 194 can extend at a downstream angle from the upstream portion 112 of the anchoring member 110 to prevent collapse or structural weakening of the tubular member 148 during atrial systole. In yet another embodiment, multiple vertical septa 196 may 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). The coupled multiple vertical septa 196 between the anchoring member 110 and the valve support 120 may be a flexible fabric or polymer, and in some embodiments, may be the same material used for the sleeve 146.The septum 196, which may be folded along with the anchoring member 110 into a low-profile delivery configuration (not shown), may also constrain outward deflection of the ribs 114 when the device 100 is in the expanded configuration 102.

[0119] As described herein, the anchoring member 110 can be a separate structure or component from the valve support 120. In one embodiment, the anchoring member 110 can be coupled to the valve support 120, for example, at the downstream end 123 of the valve support 120, while an upstream portion of the anchoring member 110 can remain uncoupled and / or otherwise be mechanically isolated from the valve support 120. The anchoring member 110 can be coupled to the valve support 120 using a variety of mechanisms, including flexible or non-rigid coupling mechanisms. Figures 22A-22G and 22I-22K are enlarged side views of various mechanisms coupling the valve support 120 to the anchoring member 110 that allow for relative movement between the downstream portion or anchoring member 110 and the valve support 120, or that otherwise provide mechanical isolation of the valve support 120 from the anchoring member 110, in accordance with additional embodiments of the present technology.

[0120] 22A-22B illustrate the downstream end 326 of the rib 114 of the anchoring member 110 coupled to the post 122 of the valve support 120. In a first embodiment, the rib 114 can be coupled to the post 122 by a suture, wire, or other suitable filament 310 that is wrapped around and tied to an adjacent element (FIG. 22B). In some embodiments, either or both of the rib 114 and the post 122 can have features to which the filament 310 can be secured, such as through holes 312 (FIG. 22C), loops or eyelets 314 (FIG. 22D), or grooves 316 configured to retain the filament 310 therein and prevent it from sliding along the rib 114 or post 122.

[0121] In another embodiment shown in FIG. 22F, the rib 114 can be coupled to the post 122 by a rivet, screw, pin, or other fastener 318 that passes through matching holes 319 in the rib 114 and the post 122. Alternatively, as shown in FIGS. 22G-22H, the post 122 can have a cavity 320 in its outer wall configured to receive the downstream end 326 of the rib 144, and the two elements 114, 122 can be fastened together by a filament or fastener 322. In this arrangement, the downstream end of the rib 114 engages the bottom of the cavity 320, thereby relieving the fastener 322 from having to resist systolic forces exerted on the suture or valve support 110, allowing a majority of such forces to be transferred directly to the rib 114.

[0122] In a further embodiment, shown in Figs. 22I-22J, 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. Additionally, because the rib 114 is held within the passage 324, systolic loads exerted on the valve support 120 can be transferred directly to the rib 114 rather than the fastener 328. In yet another embodiment, shown in Fig. 22K, the downstream end 330 of the post 122 is formed radially outwardly in a hook or J-shape to form a channel 332 that can receive the downstream end 326 of the rib 114. The ends 330, 326 of the two elements may be secured by a fastener 334 that passes through holes 319 in the rib 114 and the post 122. Systolic loads applied to the posts 122 can be transferred directly to the ribs 114 through the channels 332, relieving the fasteners 334 from bearing the majority of the load.

[0123] 23A-23B illustrate further embodiments of mechanisms suitable for coupling the fixation member 110 to the valve support 120. In the embodiment shown in FIGS. 23A-23B, the circumferential connector 116 of the fixation member 110 is coupled to the struts 124 of the valve support 120. For example, in FIG. 23A, the connector 116 is formed to have an hourglass shaped portion 336 that forms a waist 338 and an enlarged connector head 340 that forms a connector cell 341. The strut 124 similarly has an enlarged strut head 346 that forms a strut cell 347. The hourglass portion 336 of the connector 116 can be configured to pass through the strut cell 347 such that the strut head 346 extends around the waist 338 of the connector 116. The connector head 340 can be large enough to be prevented from being released from the strut cell 347. Additionally, the diverging angle of the connector segments 116A, 116B can prevent the post head 346 from sliding upwardly relative to the connector head 340. In such an arrangement, systolic loads exerted on the valve support 120 in an upward direction can be transferred through the post 124 to the connector 116, which in turn transfers these forces to the ribs 114 that are driven into the native anatomy to anchor the device 100 in place.

[0124] 23B, the connector 116 can be formed with a downwardly extending loop portion 348 nested within a recessed portion 350 formed in the strut 124. The loop portion 348 can be fastened to the recessed portion 350 in a variety of ways, for example, by a suture 352 wrapped around each member 348, 350. In this arrangement, systolic loads applied to the valve support 120 in an upstream direction can be transferred through the recessed portion 350 to the loop portion 348 of the anchoring member 110.

[0125] In other embodiments, the anchoring member 110 or selected components thereof can be integrally formed with the valve support 120. As shown in FIG. 24A, the ribs 114 of the anchoring member 110 can be integrally formed with the posts 122 of the valve support 120 with U-shaped bridge members 356 interconnecting each rib 114 to a respective aligned post 122. The ribs 114 may be circumferentially interconnected by expandable connectors 116 integrally formed therewith. Alternatively, in the embodiment shown in FIG. 24A, a plurality of separate bands or wires 358 extend around the circumference 150 of the anchoring member 110 and are each slidably coupled to the ribs 114, for example, by extending through holes 360 formed in each individual rib 114. The flexible bands or wires 358 allow the ribs 114 to be folded inwardly into a low-profile delivery configuration (not shown) while limiting outward deflection of the ribs 114 when in the expanded configuration 102. Alternatively, wire or suture tethers 361 may be connected between individual ribs 114 and posts 122 (shown in FIG. 24B) to limit outward deflection of the ribs 114 when in the expanded configuration 102.

[0126] In a further embodiment, a sleeve 146 may be secured to the ribs 114 in a manner that limits outward deflection of the ribs 114 when the device 100 is in an expanded configuration (as shown in FIG. 24C). The sleeve 146 may extend around the outside of each rib 114, for example, to constrain the ribs 114 from expanding outward beyond a predetermined limit, as shown in FIG. 24C. Optionally, the sleeve 146 may further include a horizontal septum 359 extending between an inner portion 146B of the sleeve 146 that extends around the valve support 120 and an outer portion 146A of the sleeve 146 that extends around the anchoring member 110. The horizontal septum 359 may more firmly constrain the ribs 114 from bending outward. In some embodiments, the septum 359 may also seal the annular cavity 163 formed by the septum 359 between the inner portion 146B and the outer portion 146A to restrict blood flow into this cavity 163 and minimize thrombus formation therein. Alternatively, an opening (not shown) may be formed in the sleeve 146 downstream of the septum 359 that allows blood to flow into the enclosed cavity 163 to form an area of ​​thrombus, thereby limiting deflection of the ribs 114 and making the device more rigid and firmly anchored. The septum 359, which may be a flexible fabric, polymer, or pericardial material, may be located 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. In a further embodiment, shown in FIG. 24D, each individual rib 114 may be constrained within a passage 364 formed in the sleeve 146 by suturing or bonding two layers of sleeve fabric together. In the expanded configuration 102 , the movement of the ribs 114 relative to the sleeve 146 can be limited.

[0127] 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 is an enlarged view of the designated box shown in FIG 25A in accordance with an embodiment of the present technology. As shown in FIG 25A and 25B, there may be a gap 108 between the valve support 120 and the lower portion 111 of the anchoring member 110. If a gap 108 is present, the gap 108 may be protected by a sleeve 146 to prevent blood from leaking between the anchoring member 110 and the valve support 120 in either the upstream or downstream direction.

[0128] 26A-26D are schematic cross-sectional views of a prosthetic heart valve device 100 having an atrial retainer 410 and implanted in a native mitral valve MV, according to various embodiments of the present technology. Figures 26A-26C show several embodiments of the device 100 including an atrial retainer 410, where the device 100 is configured to engage the supranulular surface of the valve annulus AN or other tissue in the left atrium to assist the native leaflets in preventing downstream migration of the device 100 into the left ventricle. In these arrangements, the valve annulus AN can be clamped between the top circumference 150 of the anchoring member 110 and the bottom surface of the atrial retainer 410.

[0129] As shown in Fig. 26A, one embodiment of the device 100 can include an atrial retainer 410 coupled to or integrally formed with the inner valve support 120. The atrial retainer 410 can extend upstream through the valve annulus AN into the supranulular space in the atrium and engage the supranulular surface or other atrial tissue with an outwardly extending flange 420. In another embodiment, shown in Fig. 26B, the atrial retainer 410 can comprise a plurality of fingers 412 that can be integrally formed with or otherwise coupled to the valve support 120 (e.g., comprising upward extensions of the posts 122 or upward extensions of the anchoring members 110). The fingers 212 can generally be uncovered or exposed in the left atrium as illustrated in FIG. 26B, but in another embodiment, the fingers 412 can be covered with a sealing member (not shown) or fabric, polymer sheet, or other covering of pericardial tissue extending around the outer or inner surface of the fingers 412 to form a cone shape and help seal the device 100 with the native tissue on the atrial side of the annulus AN and to help funnel blood into the prosthetic valve 130 (FIG. 10A). The fingers 412 may also include circumferential struts (not shown) interconnecting the fingers 412 to limit outward deflection and increase the stiffness of the fingers. The fingers 412 can include an elastic shape memory material (e.g., Nitinol) to allow the fingers to straighten and deflect inward for delivery and release to an unbiased radially protruding outward position in the expanded configuration 102 as shown. For example, the fingers 412 can have finger tips 414 that are biased outward, and in some arrangements, downstream, in the expanded configuration 102. During delivery to a desired location within the native mitral valve MV, the device 100 can be withdrawn in a distal or downstream direction (discussed in more detail below) such that the fingers 412 are first released to engage the atrial side of the annulus AN. This indexes the position of the device 100 relative to the native valve to ensure that the anchoring member 110 is positioned on the ventricular side of the native annulus AN but does not overly extend into the ventricle when withdrawn and expanded.

[0130] The atrial retainer 410 may alternatively be an extension of the anchoring member 110. In one embodiment shown in FIG. 26C, the atrial retainer 410 is depicted in a more vertical plane, but may alternatively lie in a plane more parallel to the plane of the native annulus AN and may include multiple atrial loops 416 that extend upstream through the annulus AN and then extend radially outward to engage the supranuclear surface. The loops 416, which may comprise an extension of one or more ribs 114 of the anchoring member 110, may include a resilient shape memory metal (e.g., Nitinol) or other material that may be compressed into a low-profile shape for delivery and then released to expand to the radially expanded configuration shown in FIG. 26C. Similar to the device 100 of FIG. 26C, FIG. 26D is also a cross-sectional view of the prosthetic heart valve device 100 including the atrial retainer 410 formed by the extension of the anchoring member 110. 26D, the atrial retainer 410 can include a cylindrical portion 418 extending upward from the anchoring member 110 through the native annulus AN, with a flange 420 at a proximal region extending over the atrial side of the native annulus AN to engage the supra-annular surface. The flange 420 can include an elastic shape memory material (e.g., Nitinol) that can be folded for delivery and expanded when deployed at the native mitral valve MV. The cylindrical portion 418 and flange 420 can be integrally formed with the anchoring member 110, for example, comprised of an extension of the rib 114, or in another embodiment, can be coupled to one or more portions of the anchoring member 110 and / or the valve support 120.

[0131] In other embodiments, the prosthetic heart valve device 100 can include an atrial expansion feature that helps retain the device 100 at a desired location within the native mitral valve, but does not substantially engage the atrial or supranullar tissue. For example, FIG. 27 is a side view of an anchoring member 110 having a vertical portion 422 at an upstream end 424 for engaging the annulus AN, according to another embodiment of the present technology. The anchoring member 110 can include a lower portion 111 and an upper wide-mouthed portion 112 that is positionable at a subannular location between the leaflet LF and downstream of the annulus AN. The upstream portion 112 can be expandable to a dimension greater than the corresponding dimension of the subannular tissue and / or the inwardly facing leaflet LF. The vertical portion 422 can fit within the annular orifice to engage the annulus AN around the entire upstream circumference 150 of the anchoring member 110. The vertical portion 422 may be expandable to a dimension greater than a corresponding dimension of the annulus AN such that radial expansion of the vertical portion 422 compresses native tissue outward to assist in retaining the device at a desired location with the native mitral valve. Optionally, the anchoring member 110 may also include a plurality of tissue engaging elements 170, such as spikes. In one embodiment, the spikes (shown here as tissue engaging elements 170) are distributed around the circumference 150 of the top portion 112 of the anchoring member 110 and may be oriented such that the spikes can penetrate tissue at a sub-annular location and may be configured to help the anchoring member 110 resist migration in either the upstream or downstream direction.

[0132] (Prosthetic heart valve device having stabilizing members) 28 illustrates one embodiment of the prosthetic heart valve device 100 in the expanded configuration 102, further comprising one or more stabilizing members 501 to stabilize the device 100 at the native valve site and, in some embodiments, to help prevent tilting or lateral movement or to inhibit upstream or downstream movement of the device 100. In some embodiments, the stabilizing members 501 may comprise 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, e.g., the leaflets, subannular tissue, or the ventricular wall, either medial or lateral to the native leaflets, depending on the configuration.

[0133] 29 is an enlarged schematic side view of a prosthetic heart valve device having extended arms, in accordance with an embodiment of the present technology. As shown in FIG. 29, an individual 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 L _mstmutation=1>1 and may connect to a post 511 at a first joint 508. The post 511 may be a valve support post 122, an anchoring member rib 114, and / or another feature of the device 100 (e.g., a post 124 or a connector 116). _mstmutation=1>A1 is formed by the intersection of the axes of the post 511 and the arm body 512, and a first arm angle A _mstmutation=1>A1 is selected such that the arms 512 are positionable so that the tips 516 can engage native tissue at a desired location, for example, subannular tissue or at the ventricular wall behind the native valve leaflets. Figures 30A-30C are enlarged partial side views of a prosthetic heart valve device 100 having arms 510 coupled to the device at various angles relative to the longitudinal axis 101 of the device, in accordance with further embodiments of the present technology. In one embodiment, a first arm angle A _mstmutation=1>A1 In other embodiments, the first arm angle A A1 can be an obtuse angle (FIG. 30A), a near perpendicular or approximately 90° angle (FIG. 30B), or an acute angle (FIG. 30C).

[0134] 29, the arm body 512 can be connected to an arm extension 514 at a distal end of the arm body 512. The arm extension 514 can have an arm extension length L that can be selected or optimized to penetrate a desired distance into the natural tissue, such as about 0.5 to 2 mm. _mstmutation=1>2 The arm extension 514 can have a second arm angle A A2 The second arm angle A _mstmutation=1>A2 is formed by the intersection between the arm extension 514 and the arm body 512 and can be selected to provide a desired angle of engagement with natural tissue, such as from about 100° to about 135°. In other embodiments, the arm extension 514 can be parallel or collinear with the arm body 512 (not shown) or may be eliminated entirely. The arm extension 514 terminates in an arm tip 516. In embodiments without the arm extension 514, the arm tip 516 can be the distal most portion of the arm body 512 (not shown).

[0135] The arm 510 extends from a first junction 508 to a distal end of the arm, which may be an arm tip 516 (shown in FIG. 29 ) along an axis parallel to the longitudinal axis 101 of the device 100, with an arm height H _mstmutation=1>A1 The arm height H A1 can be selected or optimized such that when the device 100 is in a desired longitudinal position relative to the native mitral valve (e.g., when the anchoring members 110 are engaged with the subannular tissue), the arm tips 516 engage the desired location within the subannular anatomy. _mstmutation=1>A1 will depend on the overall height of the anchoring member 110 and / or valve support 120, as well as the location of the junction 508. _mstmutation=1>1 +L2) and therefore has a variable height H _mstmutation=1>A1 1 is an enlarged, partial side view of a prosthetic heart valve device having an arm height H _mstmutation=1>A1 is the overall height H of the fastening member 110 (represented by the ribs 114) D1or greater than the valve support (FIG. 31A), and the respective heights H of the anchoring member 110 (represented by the ribs 114) and the valve support 120 (represented by the posts 122) are _mstmutation=1>D1 , H V1 (FIG. 31B), or the overall height H of both the anchoring member 110 and the valve support 120 (represented by the ribs 114). _mstmutation=1>D1 (FIG. 31C).

[0136] Additional details and embodiments regarding the structure and attachment of arms or other stabilizing members suitable for use with device 100 are found in "PROSTHETIC HEART TRANSFER SYSTEM" filed on June 21, 2012, the entire contents of which are incorporated herein by reference. No. PCT / US2012 / 043636, entitled "METHODS AND METHODS FOR VALVE DEVICES AND ASSOCIATED SYSTEMS AND METHODS."

[0137] Figures 32A, 32B, 32C, and 32D are cross-sectional views of a heart with an implanted prosthetic heart valve device 100 having arms 510a disposed on the inwardly facing surface of the leaflet LF, and Figures 32A-1, 32B-1, 32C-1, and 32D-1 are close-up views of the arms 510a engaging the inwardly facing surface of the leaflet as shown in Figures 32A, 32B, 32C, and 32D, respectively. The embodiment of the prosthetic heart valve device 100 illustrated in Figures 32A-32D-1 has arms 510a configured to extend to a radially inner position of the leaflet LF, a radially outer position of the leaflet LF, or a combination of the inner and outer sides of the leaflet LF. For example, Figures 32A and 32A-1 show arms 510a extending to engage the inwardly facing surface of the leaflet LF and partially piercing the leaflet LF. In another embodiment, illustrated in Figures 32B and 32B-1, the arm 510a may completely penetrate the leaflet LF. In a further embodiment, the device 100 can incorporate an arm 510a that 1) completely penetrates the leaflet LF and 2) partially punctures the subannular tissue (Figures 32C and 32C-1). With reference to Figures 32D and 32D-1, the device 100 can be configured to incorporate an arm 510a that completely penetrates both the leaflet LF and the annular tissue of the mitral valve MV.

[0138] 33A-33C are schematic diagrams illustrating various embodiments of tissue engaging elements 170 for use with a prosthetic heart valve device 100 according to the present technology. The tissue engaging elements 170 can include any feature that engages tissue atraumatically, such as a blunt element, or that partially punctures or fully penetrates cardiac tissue, such as a barb or spike. As used herein, "tissue engaging" refers to an element 170 that exerts a force on tissue T, but does not necessarily puncture tissue T, such as being atraumatic to tissue T, as shown in FIG. 33A. As used herein, "partially puncturing" refers to a tissue engaging feature 170 that at least partially penetrates tissue T, but does not break through opposing surface S, as shown in FIG. 33B. As used herein, "fully puncturing" refers to a tissue engaging feature 170 that can enter and exit tissue T, as shown in FIG. 33C. Only "puncturing" may refer to either partial or full puncturing. The tissue engaging elements 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 atraumatic feature configured to apply pressure to cardiac tissue without piercing the tissue. Further details regarding the positioning of such elements are described herein.

[0139] Figures 34A, 34B, and 34C are cross-sectional views of a heart with an implanted prosthetic heart valve device 100 having arms 510a with tissue engaging elements 170 disposed on the inward facing surfaces of the leaflets LF, and Figures 34A-1, 34B-1, and 34C-1 are close-up views of the arms 510a engaging the inward facing surfaces of the leaflets LF as shown in Figures 34A, 34B, and 34C, respectively. As illustrated in Figures 34A-34C-1, the tissue engaging elements 170 can be incorporated onto and extend from the arms 510a in either the downstream direction (Figures 34A and 34A-1), the upstream direction (Figures 34B and 34B-1), or both the downstream and upstream directions (Figures 34C and 34C-1). In other embodiments, the tissue engaging elements 170 can be incorporated onto and extend from components of the anchoring member 110 and / or the valve support 120 in either or both the upstream and downstream directions.

[0140] 35A-35C are side views showing a prosthetic heart valve device 100 implanted in a mitral valve MV (illustrated in cross section) in a deployed configuration 104, where the device has arms 510b for engaging the outwardly facing surfaces of the native leaflets LF, according to various embodiments of the present technology. FIG. 35A shows an embodiment of the device 100 including arms 510b configured to extend from a downstream end of the device 100 (e.g., the ventricular end of the device implanted in the native mitral valve downstream of the leaflets) to reach behind the leaflets LF, such that the leaflets LF are effectively pinched between the arms 510b and the outer wall 142 of the anchoring member 110. In another embodiment, as shown in FIG. 35B, the arms 510b may cause the leaflets LF to fold in the space between the arms 510b and the outer wall 142 of the anchoring member 110. In a further embodiment illustrated in FIG. 35C, the arms 510b may also include tissue engaging elements 170. Figure 35C-1 is a close-up view of an arm 510b having a tissue engaging element 170 for engaging the outward facing surface of the leaflet LF as shown in Figure 35C. As shown in Figure 35C-1, the arm 510b configured to engage the outward facing surface of the native leaflet LF may include a tissue engaging element 170 on an inner surface of the arm 510b such that it is oriented toward the leaflet tissue.

[0141] In accordance with another embodiment of the present technology, Fig. 36A is a side view showing a prosthetic heart valve device 100 implanted in a mitral valve MV (illustrated in cross section). The device shown in Fig. 36A has arms 510b for engaging an outward facing surface of the native leaflet LF and arms 510a for engaging an inward facing surface of the native leaflet LF. The medial / lateral arms 510a, 510b may further comprise tissue engagement elements 170 on the radially inner or radially outer surfaces of the arms 510a, 510b, respectively, for engaging or piercing leaflet tissue. The arrangement of the medial / lateral arms 510a, 510b around the circumference of the device 100 may be alternated in a predesigned pattern. For example, the inner arms 510a can alternate with the outer arms 510b as shown in FIG. 36B, or alternatively, the arms 510a, 510b may extend radially outward and / or radially inward at random or irregular intervals depending on the placement of the device 100 and relative to alignment with the natural posterior and anterior leaflets.

[0142] 37A-37D are close-up side views of additional embodiments of arms 510 suitable for use with a prosthetic heart valve device 100 in accordance with the present technology. For example, in FIGS. 37A-37D, the arms 510 can have an overall profile similar to that of the anchoring member 110. The anchoring member 110 can include ribs having various shapes, sizes, and / or outwardly or inwardly oriented rib segments 85 to form the overall anchoring member profile. Thus, the arms 510 can also have various shapes, sizes, and / or outwardly or inwardly oriented arm segments that mimic the profile of the anchoring member 110. In some arrangements, the embodiments shown in FIGS. 37A-37D are configured to clamp the leaflet LF and / or annulus AN tissue between the arms 510 and the ribs 114 to force the leaflet tissue to conform to the shape of the anchoring device 110 for enhanced sealing and anchoring of the device. For example, FIG. 37A illustrates one embodiment in which the arm extension 514 and / or arm body 512 may partially mimic the shape of the rib 114 and / or rib segment 85, while FIG. 37B illustrates another embodiment in which the arm extension 514 and / or arm body 512 more closely follows the shape of the rib 114. The embodiments encompassed by FIGS. 37A-37B can be applied to the outward surface engaging arm 510b and / or the inward surface engaging arm 510a. Additionally, as shown in FIGS. 37A-37B, the arm extension 514 can extend radially outward to be generally parallel to the upstream segment 85A of the rib 114. The arm extension 514 can be configured to extend partially along the length of the rib 114 and / or rib segment 85 (FIGS. 37A and 37C) or completely along the length of the rib 114 and / or rib segment 85. In FIG. 37D, arm 510 has a second arm extension 518 connected to an upstream portion of first arm extension 514 and extending outwardly so as to be generally parallel to second rib segment 85B and third rib segment 85A.

[0143] In some embodiments, the prosthetic heart valve device 100 may incorporate multiple arms 510 around the circumference of the device 100, while in other embodiments, the device may include multiple arms in groups (e.g., first and second groups to engage the posterior and anterior leaflets, respectively). In addition, the arms 510 may extend from the anchoring member 110 and / or the valve support 120 independently of other components including the other arms 510, as shown in FIG. 38A. In other embodiments, as shown in FIG. 38B, the device 100 may further include at least one first arm 510x interconnected with at least one second arm 510y by interconnecting arm struts 520. The arm struts 520 may be configured to be circumferentially expandable and may connect all the arms 510 (e.g., arms 510x and 510y) or one or more groups of arms 510. In some embodiments, the arm struts 520 can limit the outward extension of the arms 510x, 510y away from the device 100.

[0144] In accordance with aspects of the present technology, the arms 510 can couple to and / or extend from components of the device 100 symmetrically and / or asymmetrically around the circumference 150 of the device 100. Figures 39A-39D are schematic top views of arm position patterns relative to the ribs 114 of the anchoring member 110 (e.g., as shown in Figure 38A). The arms 510 can incorporate the ribs 114 (Figures 39A and 39C) and be in the same radial plane as the ribs 114 of the anchoring member 110 (Figure 39B), or can incorporate the ribs 114 and be coplanar therewith (Figure 39D). Further, the arms 510 may be configured to extend outside the expanded circumference 150 of the fixation member 110 (FIG. 39B), extend inside the expanded circumference 150 of the fixation member 110 (FIG. 39A), extend to the same circumference 150 of the fixation member 110 (FIG. 39C), or a combination of these configurations (FIG. 39D).

[0145] In the above embodiments, the arms 510 may be configured to engage tissue independent of the deployment of the anchoring member 110. For example, a delivery catheter suitable for delivery of the prosthetic heart valve device 100 may be equipped with separate mechanisms operable to deploy the arms 510 and the anchoring member 110 individually or otherwise independent of each other. In this manner, the anchoring member 110 may first be released to engage with the native tissue so that the position of the device 100 may be assessed and adjusted by the operator until the desired final position is obtained. Following deployment and positioning of the anchoring member 110, the arms 510 may be released to engage with the tissue. Such deployment systems and methods are useful when the arms 510 are equipped with tissue engaging elements 170 that may inhibit any repositioning of the device 100 once deployed. In some embodiments, the anchoring member 110 will be equipped with atraumatic tissue engaging elements 170 that do not penetrate tissue or inhibit device migration once the anchoring member 110 is deployed. Thus, some embodiments of device 100 may be repositionable even with anchoring member 110 in an expanded state, so long as arms 510 are restrained in a non-deployed configuration, with device 100 only permanently anchored when arms 510 are released.

[0146] Alternatively, or in addition to tissue engaging elements 170 being present on arms 510 as described above, tissue engaging elements 170 may be present on other components of device 100. FIGS. 40A-40E are side views of a prosthetic heart valve device 100 having tissue engaging elements 170 on various structures of device 100 in accordance with additional embodiments of the present technology. For example, tissue engaging elements 170 can be incorporated on ribs 114 of anchoring member 110. FIG. 40A shows tissue engaging elements 170 incorporated on upper rib segment 85A, and FIG. 40B shows tissue engaging elements 170 incorporated on lower rib segment 85B. FIG. 40C illustrates an embodiment of the device having tissue engaging elements 170 along the entire rib 114. 40A-40C, one skilled in the art will recognize that the elements may be any of the various tissue engaging elements 170 described herein (e.g., atraumatic, partially piercing, fully penetrating, etc.), or in other embodiments, a combination of different types of tissue engaging elements 170. Additionally, while the tissue engaging elements 170 are shown oriented in an upstream direction (e.g., to block upstream movement of the device 100), in other embodiments, the tissue engaging elements 170 may be oriented in a downstream direction (e.g., to block downstream movement of the device 100), or a combination of downstream and upstream orientations. The tissue engaging elements 170 may be incorporated symmetrically around the circumference of the device 100, or in other embodiments, the tissue engaging elements 170 may be incorporated asymmetrically. For example, in some embodiments, tissue engaging element 170 may be present on the side of device 100 aligned with the posterior leaflet, but may be absent or have a different arrangement on the side of device 100 aligned with the anterior leaflet, such that the wall separating the aortic valve from the left ventricle is not affected by tissue engaging element 170.

[0147] FIG. 40D illustrates an embodiment of the device 100 having tissue engaging elements 170, such as spikes, on the upstream ends 175 of the ribs 114, which can be configured to fully or partially penetrate the subannular tissue when the device 100 is deployed above or below the mitral valve annulus. In some embodiments, the tissue engaging elements 170 (e.g., spikes) can include barbs 176 or other features for holding the tissue engaging elements 170 (e.g., spikes) in tissue. In other embodiments, the tissue engaging elements 170 (e.g., spikes) can be blunt to engage but not penetrate the subannular tissue. FIGS. 40E-40G are enlarged side views of tissue engaging elements 170 (e.g., spikes) suitable for use on the upstream tips 175 of the ribs 114. The device 100 having tissue engaging elements 170 on the upstream tips 175 can also incorporate features to limit the distance of penetration into the tissue. For example, the upstream tip 175 can have a stalk 177 formed a short distance, e.g., 1-5 mm, proximal to the tip of each tissue engaging element 170 to limit the distance the tissue engaging element 170 can penetrate the subannular tissue (FIG. 40E). Alternatively, as shown in FIG. 40F, the penetration depth of the tissue engaging element 170 into the tissue can be limited by positioning the connector 116 a desired distance from the tip of the tissue engaging element 170. In a further embodiment, shown in FIG. 40G, the sealing member 140 can be attached to the rib 114 such that an upstream edge 178 of the sealing member 140 can limit the penetration depth of the tissue engaging element 170. To prevent downward sliding of the sealing member 140, an attachment feature, such as a hole 173 configured to receive a suture, can be formed in the rib 114 a desired distance from its upstream tip 175 to which the sealing member 140 can be securely secured.

[0148] Alternatively, tissue-engaging elements 170, such as steps, ridges, or other protrusions, configured to exert a frictional force on cardiac tissue may also be present on one or more of the valve support struts 124, valve support posts 122, and / or other components (e.g., sealing member 140). These tissue-engaging elements 170 may be located on the outer portions of these features and may be configured to extend outward to engage the native valve leaflets and to stably and securely anchor the device 100 at a desired location. Alternatively, ridges, nubs, barbs, or other directional features may be formed on the surfaces of the ribs 114, connectors 116, or sealing member 140 to allow movement against the native tissue in one direction while restricting movement in the opposite direction.

[0149] The tissue engaging elements 170 on the anchoring member 110 may be barbs, spikes, or other retention features configured to have a delayed deployment to allow the device to be repositioned or removed over a period of time until the elements are fully deployed. For example, the tissue engaging elements 170 may be constructed of a shape memory material (e.g., Nitinol) that is preformed in a deployed configuration and adapted to retain the tissue engaging elements 170 within the native tissue. The tissue engaging elements 170 may be transformed to a contracted configuration that allows removal from the tissue and retained in this shape by a bioerodible material or adhesive. Once immersed in tissue, the material may erode over a period of time (e.g., 10 minutes to 2 hours), allowing the tissue engaging elements 170 to return to their unbiased deployed shape and helping to retain the tissue engaging elements 170 within the tissue.

[0150] Some examples of such delayed deployable tissue engaging elements 170 are shown in FIGS. 40I-40T. In the embodiment of FIG. 40I, the tissue engaging element 170 comprises a shape memory alloy shaft 450 that is laser cut to have a diamond shaped window 451 near its distal tip 452 that 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 FIG. 40I. Prior to delivery of the device, the window 451 may be clamped closed and a bioerodible glue 455 may be injected into the window 451 to hold it in a closed configuration as shown in FIG. 40J. Upon deployment of the device, the distal tip 452 may penetrate native tissue, e.g., a valve leaflet or annulus, as shown in FIG. 40K. The glue 455 in 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 windows 451 to reopen to the expanded configuration, retaining the tissue engaging elements 170 within the tissue, as shown in FIG. 40L.

[0151] In the embodiment shown in Figures 40M-40P, the tissue engaging element 170 comprises an arrowhead-shaped tip 453 with two or more wings 454 biased to angle radially outward and pointing proximally, as shown in Figure 40M. A bioerodible glue or coating 455 is applied over the arrowhead tip 453 to hold the wings 454 in a radially contracted configuration, as shown in Figure 40N. In the contracted configuration, the device 100 is deployed such that the tissue engaging element 170 pierces the native tissue, as shown in Figure 40O. The bioerodible coating 455 then gradually erodes until it allows the wings 454 to return to the laterally expanded configuration shown in Figure 40P, thus retaining the tissue engaging element 170 within the tissue.

[0152] A further embodiment is shown in Figures 40Q-40T. In this embodiment, the tissue engaging element 170 comprises a helical tip 456 in an unbiased state. A bioerodible coating 455 may be used to hold the helical tip 456 in a straightened configuration, as shown in Figure 40R. The tissue engaging element 170 can penetrate tissue in a contracted configuration and hold the tissue engaging element 170 within the tissue when the bioerodible coating 455 erodes sufficiently to allow the helical tip 456 to return to its deployed configuration.

[0153] The prosthetic heart valve device 100 can also be configured with additional tissue engaging elements 170 for engaging the annulus. For example, FIG. 41 is an isometric view of a prosthetic heart valve device 100 having multiple annulus engaging elements 179, in accordance with a further embodiment of the present technology. The annulus engaging elements 179 can be C-shaped hook features or other shapes that allow the elements 179 to engage tissue over the annulus, as well as portions of the supranuclear and subannular tissue. As shown, the annulus engaging elements 179 can be symmetrically (as shown in FIG. 41) or asymmetrically scattered around the upstream periphery of the anchoring member 110 and coupled to the ribs 114, the connectors 116 (not shown), or the sealing member 140. The annulus engaging elements 179 can also be coupled to the anchoring member 110 elsewhere downstream of the upstream periphery 113, or in other embodiments, to a portion of the valve support 120 that extends through at least the annulus plane PO (FIG. 3). In addition, the annulus engaging element 179 may be blunt (e.g., to push against but not penetrate the annulus tissue) or may be sharp to penetrate the annulus tissue on either or both of the supra-annular or sub-annular surfaces. The annulus engaging element 179 may be suitable for both positioning the device 100 at a desired location (e.g., with the anchoring member 110 below the annulus) as well as for preventing migration of the device in either the upstream or downstream direction.

[0154] In another embodiment shown in Figures 42A-42B, the prosthetic heart valve device 100 can have tissue-engaging elements 372 deployable from a plurality of tubular ribs 314. With reference to Figure 42A, the prosthetic heart valve device 100 can have an anchoring member 110 having a plurality of tubular ribs 314 configured to hold a plurality of deployable tissue-engaging elements 372. Figure 42B is an enlarged view of the tubular ribs 314 and the deployable tissue-engaging elements 372 held within the lumen 316 of the ribs 314 and shown prior to deployment of the elements 372. The tissue-engaging elements 372 can include a shape-memory material (e.g., Nitinol) configured to deploy into a preformed shape upon release of the tissue-engaging elements 372 from the inner lumen 316 of the ribs 314. Release of the tissue-engaging elements 372 can be accomplished by engaging a proximal end 374 of the tissue-engaging elements 372. For example, the proximal end 374 can be engaged during deployment of the device 100 to release the tissue engaging element 372 after the anchoring member 110 is positioned at a desired location below the valve annulus AN. The tubular rib 314 can include a U-shaped deflector 318 and a pivot point 320 configured to guide the tissue engaging element 372 distally through a distal opening 315 of the rib 314. As illustrated in dotted lines in FIG. 42B, engagement of the proximal end 374 of the element 372 will urge the distal end 376 of the tissue engaging element 372 from the distal opening 315 of the tubular rib 314 to penetrate adjacent subannular tissue. Once deployed and exiting the opposing surface S, such as the supranuclear surface, the tissue engaging element 372 can transition to its preformed shape, such as a spiral shape 378, that can resist retraction of the distal end 376 from tissue.

[0155] According to another embodiment of the artificial treatment device 100, a tissue engaging element 170 can be incorporated into the sealing member 140 (e.g., sleeve 146). Figures 43A-43B are isometric and close-up detail views of a prosthetic heart valve device 100 having a sealing member 140 configured with a tissue engaging element 170. Referring together to Figures 43A-43B, the tissue engaging element 170 can comprise a metal or polymer wire 178 or fiber woven into or otherwise connected to the sealing member 140 material, which is sufficiently stiff and sharp to penetrate tissue. The sealing member 140 can 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 element 170 extends radially outward from the sealing member 140 to engage adjacent valve leaflets or other tissue.

[0156] 44A-44F are close-up side views of embodiments of additional tissue-engaging elements that can be incorporated onto various device structures (collectively referred to as "ST"), such as struts, connectors, posts, arms, and / or ribs that can be incorporated into device features such as the anchoring member 110 or the valve support 120. For example, the additional tissue-engaging elements may comprise one or more notched projections 350 (FIGS. 44A and 44B) instead of or in addition to tissue-engaging elements 170. In a folded or straightened configuration as shown by the side view of FIG. 44C, the notched projections 350 maintain 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 as shown in FIG. 44D), the projections separate from the ST to a higher relief. The projections 350 may also be configured to grip subannular tissue and pull the notched projections further away from the structure ST. The device structure ST may also be shaped to include sharp protrusions 352 along one or more of its edges or faces, as illustrated in FIG. 44E, or may also include pointed scale-like protrusions 354, as shown in FIG. 44F.

[0157] 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 such as tethers 360 and sealing member septum 370 to stabilize the anchoring member 110 and / or valve support 120 and / or to spread pressure gradient loads evenly over a larger area of ​​the device 100 (e.g., during ventricular systole). With reference to FIG. 45A, one example of the device 100 may incorporate multiple tethers 360 that at least loosely connect the top portion 112 of the anchoring member 110 to the upstream end 121 of the valve support 120. In one embodiment, the tether 360 may include a single suture that runs continuously around the circumference 150 of the anchoring member 110. In another embodiment, the device 100 may include several discrete lengths of suture tied between the anchoring member 110 and the valve support 120. In one embodiment, the tether may be a suture that includes polytetrafluoroethylene (PTFE). Generally, the tether 360 helps to distribute forces evenly along the anchoring member 110 without deforming the valve support 120 or compromising closure of the prosthetic valve 130. In some arrangements, the tether 360 can help to limit radial expansion of the upstream portion. Thus, 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.

[0158] 45B illustrates another example of a stabilization member 501 suitable for stabilizing the anchoring member 110 and / or the valve support 120 and / or for spreading pressure gradient loads evenly over a larger area of ​​the device 100 (e.g., during ventricular systole). As shown in FIG. 45B, the device 100 can include multiple sealing member septa 370 extending between the anchoring member 110 and the valve support 120. In the illustrated embodiment, the septa 370 can be an extension of sealing member material configured to extend between a sealing member 140, such as a skirt 144, coupled to an inner wall 141 of the anchoring member 110 and a sealing member 140, such as a sleeve 146, coupled to an inner or outer surface 126, 127 of the valve support 120. Thus, the septa 370 can be formed of a fabric or other flexible and biocompatible material, such as Dacron®, ePTFE, bovine pericardium, or other suitable material. 45A, the septum 370 can help distribute forces evenly along the anchoring member 110 without deforming the valve support 120 or compromising 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.

[0159] Each of the elements and components of the device 100 may be made from any number of suitable biocompatible materials, depending on the desired outcome, e.g., stainless steel, Nitinol, _mstmutation=1>TM The valve support 120 may be made from nickel titanium alloys such as CrMo, cobalt chromium alloys such as MP35N, other alloys such as ELGILOY® (Elgin, Ill.), various polymers, pyrolytic carbon, silicone, polytetrafluoroethylene (PTFE), or any number of other materials or combinations of materials. The arm members 510, sealing member 140, sleeve 146, fixation member 110, and / or valve support 120, or other elements of device 100 may also be coated or covered with a material that promotes tissue ingrowth (e.g., Dacron®, PTFE, etc.).

[0160] Delivery System 46A-46D illustrate one embodiment of a delivery system 10 suitable for delivery of the prosthetic heart valve devices disclosed herein. As used in reference to the delivery system, "distal" refers to a position having a farther distance along the longitudinal axis of the system 10 from the handle of the delivery system 10, and "proximal" refers to a position having a closer distance along the longitudinal axis of the system 10 to the handle of the delivery system 10.

[0161] FIG. 46A illustrates one embodiment of a delivery system 10 that may be used to deliver and deploy an embodiment of a prosthetic heart valve device 100 disclosed herein through the vascular system to a patient's heart. The delivery system 10 may optionally include a guide catheter GC having a handle 12 coupled to a delivery shaft 16, which in one embodiment is 34F or less in diameter, and in another embodiment is 28F or less. The guide catheter GC may be steerable or pre-shaped in a configuration suitable for a particular approach to the target valve. The delivery catheter 18 includes a flexible tubular outer shaft 19 that is disposed on the proximal end of the guide catheter GC through the hemostatic valve HV and extends to a delivery sheath 20 where the device 100 is positioned in a collapsed or delivery configuration 106. A flexible inner shaft 28 is slidably positioned within the outer shaft 19 and extends through the device 100 to a nosecone 21 at the distal end. The inner shaft 28 has a guidewire lumen through which a guidewire 24 may be slidably positioned. The device 100 is coupled to an inner shaft 28 and is releasable from the inner shaft 28 by a release wire 30, as described more fully below. The delivery sheath 20 can protect and protect the device 100 in its collapsed configuration 106 during delivery. The outer shaft 20 is coupled to a retraction mechanism 23 on the handle 14 of the delivery catheter 18. A variety of retraction mechanisms 23 may be used, such as an axially slidable lever, a rotatable rack and pinion gear, or other known mechanisms. In this manner, the outer shaft 20 may be retracted relative to the inner shaft 28 to release (e.g., deploy) the device 100 from the sheath 20.

[0162] FIG. 46B shows the distal end of the delivery catheter 18 with the sheath 20 cut away to illustrate the connection of the device 100 to the inner shaft 28. A plurality of locking fingers 32 are connected to the nosecone 21 and extend proximally through the interior of the valve support 120 of the device 100. As shown in FIG. 46C, a selected number of posts 122 of the valve support 120 have a connecting element 61 with a tab 34 cut from each post 122 at its proximal end. The tabs 34 may be deflected inwardly from the posts 122 as shown in FIG. 46B and are configured to extend through a window 42 in the locking fingers 32 as shown in FIG. 46D. A release wire 30 passes through a hole 40 in the tab 34 to prevent the tab 34 from being pulled out of the window 42 to secure the device 100 to the inner shaft 28. The pull wire 30 can be tightly pinched between the tab 34 and the locking fingers 32 such that friction temporarily prevents the pull wire 30 from sliding proximally or distally. In this manner, the sheath 20 can be retracted relative to the device 100 to allow expansion of the device 100 while the inner shaft 28 maintains the longitudinal position of the device 100 relative to the anatomy. The pull wire 30 can extend proximally to the handle 14, for example, between the inner shaft 28 and the outer shaft 19, or within one or more designated lumens. A suitable mechanism (not shown) on the handle 14 can allow the operator to retract the release wire 30 proximally until it disengages from the tab 34. Thus, the device 100 can be released from the locking fingers 32 and expanded for deployment at the target site.

[0163] 47A-47D are schematic cross-sectional side views of a heart H illustrating a transseptal or antegrade approach for delivering and deploying a prosthetic heart valve device 100. As shown in FIG. 47A, a guidewire 24 may be advanced intravascularly using any number of techniques, for example, through the inferior vena cava IVC or superior vena cava SVC, through the atrial septum IAS, and into the right atrium RA. A guide catheter GC may be advanced along the guidewire 24 into the right atrium RA until it reaches the anterior side of the atrial septum AS, as shown in FIG. 47B. At this point, the guidewire 24 may be exchanged for a needle 25 that is used to penetrate the atrial septum IAS (FIG. 47C). The guide catheter GC may then be advanced over the needle 25 into the left atrium LA, as shown in FIG. 47D. The guide catheter GC may have a pre-shaped or steerable distal end to shape or steer the guide catheter GC to direct the delivery catheter 18 (FIG. 46A) toward the mitral valve.

[0164] As an alternative to the transseptal approach, the mitral valve may be accessed directly through an incision in the left atrium. Access to the heart may be gained through an intercostal incision in the chest without removing the ribs, and a guide catheter may be placed into the left atrium through an atriotomy that is sealed with a purse string suture. A delivery catheter may then be advanced through the guide catheter to the mitral valve. Alternatively, the delivery catheter may be placed directly through the atriotomy without the use of a guide catheter.

[0165] 48A-48C are cross-sectional views of the heart illustrating a method of implanting a prosthetic heart valve device 100 using a transseptal approach. Referring together to FIGS. 48A-48C, the distal end 21 of the delivery catheter 18 may be advanced adjacent to the mitral valve MV. Optionally, a guidewire GW may be used over which the catheter 18 may be slidably advanced, as shown in FIG. 48A. The sheath 20 of the delivery catheter 18 containing the device 100 in a folded configuration 106 is advanced through the mitral annulus AN between the native leaflets LF, as shown in FIG. 48A. Then, referring to FIG. 48B, the sheath 20 is retracted proximally relative to the distal nosecone 27, allowing the device 100 to expand such that the anchoring members 110 urge the leaflets LF outward to fold under the mitral annulus AN. The tips of the ribs 114 may engage the leaflet tissue and penetrate into or through it to further engage the tissue of the annulus AN. After the sheath 20 is removed and the device 100 is expanded, a delivery system may still be connected to the device 100 so that the operator can further control the placement of the device 100 in the expanded configuration 102 (e.g., a system eyelet, not shown, is connected to the device eyelet 180 shown in FIG. 10A). For example, the device 100 may be expanded upstream or downstream of the target location and then pushed downstream or upstream, respectively, into the desired target location before releasing the device 100 from the delivery system 10. Once the device 100 is positioned at the target site, the pull wire 30 (FIGS. 46A-46B) may be retracted proximally to decouple the device 100 in the deployed configuration 104 from the delivery catheter 18. The delivery catheter 18 may then be removed as shown in FIG. 48C. Alternatively, the device 100 may not be connected to the delivery system 10 such that the device 100 deploys and is completely released from the delivery system 10 .

[0166] Figures 49A and 49B illustrate another variation for delivering and deploying one or more prosthetic heart valve devices 100 using a retrograde approach to the mitral valve via the aorta and left ventricle. In this example, a guidewire GW may be advanced intravascularly from the femoral or radial artery or through a direct aortic puncture through the aorta AO and aortic valve AV into the left ventricle LV of the heart H (Figure 49A). A guide catheter GC, or alternatively, a delivery catheter 18, may be advanced along the guidewire GW until the distal end is positioned within the left ventricle proximate to the mitral valve MV, as shown in Figures 49A and 49B. In many arrangements, the guide catheter GC and / or delivery catheter 18 will have a steering mechanism or a pre-shaped distal tip that allows it to be steered in a 180° turn from the aortic valve AV to the mitral valve MV. The distal end of the delivery catheter 18 may optionally be advanced at least partially through the mitral valve MV into the left atrium LA.

[0167] 50A-50B illustrate the delivery of the device 100 in a folded configuration 106 to the mitral valve MV in a transapical approach. With reference to FIG. 50A, the delivery catheter 18 is advanced through a guide catheter GC inserted into the left ventricle of the heart through a perforation in the left ventricular wall at or near the apex. The catheter can be sealed by a purse string suture. The catheter can be sealed by a purse string suture. Alternatively, the delivery catheter 18 may be placed directly through a transapical incision sealed with a purse string suture without a guide catheter. The sheath 20 and the device 100 within the sheath 20 (e.g., in a folded configuration 106) are advanced through the mitral annulus AN between the native leaflets LF as shown in FIG. 50A. With reference to FIG. 50B, the sheath 20 is pulled proximally such that the device 100 expands to the expanded and / or deployed configurations 102, 104. The delivery system 10 can remain connected to the device 100 after removal of the sheath 20 so that the operator can control the placement of the device 100 while in the expanded configuration 102 (e.g., a system eyelet, not shown, is connected to the device eyelet 180, FIG. 10A). The pull wire 30 may be retracted proximally to release the device 100 from the delivery system 10, and the delivery system 10 is removed, allowing the device to be fully embedded in the mitral valve MV in the deployed configuration 104. In one embodiment, the device 100 may be expanded upstream or downstream of the desired target location and then retracted or pushed downstream or upstream, respectively, into the target location before releasing the device 100 from the delivery system 10. Alternatively, the device 100 may not be connected to the delivery system 10 so that the device 100 is deployed and fully released from the delivery system 10.

[0168] 51A-51B are partial side views of a delivery system 10 in which a prosthetic heart valve device 100 is mounted on an expandable balloon 300 of a delivery catheter 18 according to another embodiment of the present technology. Referring together to FIGS. 51A and 51B, the device 100 can be mounted on an expandable balloon of a delivery catheter while in a folded configuration 106 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 can be expanded to its expanded configuration 102 by inflation of the balloon 300 (FIG. 51B). When using the balloon 300 with the delivery system 10, the device 100 can be advanced from the delivery shaft 16 to initially position the device 100 at 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 may then be adjusted using the device locking hub to position the device at the desired implantation site (e.g., directly below the native mitral annulus). In another embodiment, the balloon 300 can first 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 the partially expanded heart valve device 100 (depending on the approach) into the implantation site, after which the device 100 can be fully expanded to its functional size. In another alternative method, the anchoring member 110 is a self-expanding construct that is first released from the sheath 20 at the target site to engage the native anatomy (FIGS. 46A-46B), while the valve support 120 is a balloon-expandable element mounted on the balloon 300 that is then expanded to fully deploy the valve support 120 after the anchoring member 110 is released.

[0169] In still further embodiments, the valve support 120 of the device 100 may be configured to be axially movable or detachable from the anchoring member 110. In such an arrangement, the two components 110, 120 may be loaded in an axially separated configuration within the delivery system 10, thereby reducing the overall profile of the system 10. After delivery to the target valve site, the components 110, 120 can be assembled together. FIGS. 52A-52D show an embodiment of assembling the valve support 120 and the anchoring member 110 in the heart. As shown in FIG. 52A, a delivery catheter 380 is advanced into the left atrium via a guide catheter GC placed through the atrial septum or atrial wall. The delivery catheter 380 has a split sheath 382, ​​384, which includes a distal nosecone 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 annulus AN (FIG. 52A). The nose cone 382 is then advanced further distally while maintaining the position of the remainder 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 folding them outwardly under the native annulus AN, as shown in FIG. 52B. The upstream tips of the ribs 114 (FIG. 52B) engage the subannular tissue to anchor the device 100 in place. The sealing member 140 is secured to the periphery 113 of the anchoring member 110 and has a connecting portion 386 that extends into the proximal capsule 384 where it is secured to the valve support 120 still restrained 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. 52C. Proper positioning may be achieved by advancing the catheter 380 until the sealing member 140 is in a taut state. The proximal capsule 384 is then retracted relative to the nosecone 382 to release the valve support 120 from the proximal capsule 384. The valve support 120 may self-expand to engage the downstream end of the anchoring member 110, coupling the two components together. The delivery catheter 380 may then be withdrawn from the patient.

[0170] Figures 53A-53H show various mechanisms that may be used to couple the valve support 120 to the anchoring member 110 in the process shown in Figures 52A-52D. For example, as shown in Figure 53A, the valve support 120 may include a circumferential ridge or detent 388 near its downstream end that engages into a groove 390 in the anchoring member 110 to prevent attachment and detachment of the two components. Alternatively, the valve support 120 may have hooks 392 formed at the downstream end of each post 122 that are configured to extend around the downstream end of the anchoring member 110, for example, around one of the downstream tips of the ribs 114 or connectors 116, as shown in Figures 53B-53C. For example, the hooks 392 may be configured to flex inwardly when they engage the inner surfaces of the ribs 114 as the valve support 120 is advanced, as shown in FIG 53C, and to resiliently recoil to their outward configuration when extended beyond the downstream ends of the ribs 114. Optionally, a depth limiting feature, such as a stub 396, may extend outwardly from the valve support 120, configured to engage a complementary feature, such as a step or ridge 396 on the anchoring member 110, to prevent insertion of the valve support 120 beyond a predetermined depth.

[0171] In a further embodiment, shown in Figs. 53D-53F, the valve support 120 may have a coupling element 398 on its outer surface configured to slidably couple to the anchoring member 110. In a first configuration, the coupling element 398 comprises a loop 400, shown in Fig. 53E, through which a vertical guide member 402 on the anchoring member 110 may slide. The anchoring member 110 may have a plurality of such guide members 402 extending upwardly from its downstream end at spaced locations around its circumference. A step 404 may be formed near the downstream end of the guide member 402 over which the loop 400 may slide to prevent the valve support 120 from sliding backward in the upstream direction (Fig. 53D). In an alternative configuration, shown in Fig. 53F, the guide member 402 has a vertical slot 406 into which a radially extending pin 408 on the valve support 120 may extend. The pin 408 may slide into the downstream end of the slot 406 where it may be pushed through the waist 411, preventing the pin 408 from sliding backward in the upstream direction.

[0172] In a further embodiment, shown in Figs. 53G-53H, coupling elements 398 on the valve support 120 are configured to slidably receive ribs 114, which themselves perform a similar function as guide members 402 (described with respect to Figs. 53D-53F). As shown in Fig. 53G, coupling of the ribs 114 to the valve support 120 serves to constrain the ribs 114 in a radially compact configuration as the valve support 120 slides axially upward relative to the anchoring member 110. In the arrangement shown in Figs. 53GG-53H, delivery of the device 100 may not require the need for a separate sheath to constrain the ribs 114 during delivery. As shown in Fig. 53H, the valve support 120 may slide downstream relative to the anchoring member 110 until the ribs 114 are in their radially outward configuration. Similar to the guide member 402, each rib 114 may have a step 412 formed near its downstream end past which the connecting element 398 may be pushed but which then prevents the valve support 120 from sliding in the upstream direction (FIG. 53H).

[0173] 54A-55C illustrate a delivery catheter 400 of a delivery system 40 in accordance with an additional aspect of the present technology. FIG. 54A is a cross-sectional side view of a delivery system 40 for a prosthetic heart valve device 100, and FIG. 54B is a partial cross-sectional side view of a distal portion of the delivery system 40 shown in FIG. 54A. As shown in FIGS. 54A and 54B, the delivery catheter 400 comprises a sheath 402 having an outer wall 403 and a closed distal projection 406 that defines a blind annular cavity 408. An inner wall 405 extends proximally to a proximal end of the catheter (not shown), thus forming a tubular catheter shaft 407 that defines an axially extending inner lumen therethrough through which a guidewire GW may be slidably positioned. A piston 412 is slidably disposed within the cavity 408 and has an O-ring 413 about its circumference to create a fluid-tight seal with the wall of the cavity 408. A tubular piston shaft 414 extends proximally from the piston 412 and is slidably mounted over the catheter shaft 407. The piston shaft 414 is oversized relative to the catheter shaft 407 to define a fluid lumen 416 in communication with the cavity 408. The device 26 is held in its radially folded delivery configuration within the cavity 408 (shown in FIGS. 55A-55C ), with the piston shaft 414 and catheter shaft 407 extending through the interior of the valve support 120. Preferably, the device 100 is releasably coupled to the piston 412, for example, by a pin (not shown) extending radially outward from the piston shaft 414.

[0174] The sheath 402 may have features that limit its progression. 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 progression to be adjusted. When fluid is injected into the cavity 408, the piston 412 will progress until it reaches this stop. In this way, the progress of the deployment can be controlled.

[0175] To facilitate retraction of the sheath 402 through the valve of the device 100 after deployment, a tapered feature may be advanced adjacent the proximal end of the sheath 402 (see FIG. 56). Alternatively, the piston 412 may have a taper or soft cushioning material affixed directly to the rear of the piston 412 facing proximally. In this manner, the proximal side of the piston will itself provide an atraumatic leading surface to facilitate retraction of the sheath 402 through the valve support 120.

[0176] Features may be incorporated that are intended to control and smooth the deployment of the device 100. For example, a common problem during deployment of self-expanding stents is the tendency of the deployed device to "pop" or bounce forward or backward as the final element exits the deployment device. A feature that prevents the sheath 402 from projecting forward by the expansion backbone of the device 100 may be important to prevent accidental damage to the ventricle or other tissue. Such features may incorporate stops or tethers in the deployment system that are designed to hold the position of the sheath 402 relative to the deployed device 100. For example, the proximal edge of the sheath 402 may be swaged slightly inward to prevent the piston from exiting the sheath and to precisely place the taper or dampening features described above to facilitate withdrawal of the system through the deployed valve. Alternatively, or in addition, a spring mechanism (not shown) can be incorporated into the delivery system 40 so that when the final feature of the device 100 is withdrawn from the sheath 402, the sheath actively retracts slightly into the downstream end of the newly deployed device 100.

[0177] The operation of the delivery catheter 400 is illustrated in Figs. 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 the native valve from an upstream direction. The catheter 400 is advanced until the sheath 402 is positioned downstream of the native valve annulus (Fig. 55A). Fluid can then be injected through the fluid lumen 416 into the cavity 408 distal to the piston 412 (Fig. 55B). This drives the sheath 402 distally and releases the device 100 from the cavity 408 (Fig. 55C). The delivery catheter 400 and the device 100 may remain in a stationary longitudinal position relative to the native valve while the device 100 is deployed, thereby increasing the accuracy of the deployment. In addition, the device 100 may be deployed in a slow and controlled manner, avoiding sudden, uncontrolled bouncing of the device 100. Moreover, such hydraulic actuation allows the sheath 402 to be moved in incremental steps to only partially deploy the device 100, allowing the operator to assess its position relative to the native valve and reposition it, if necessary, prior to full deployment.

[0178] In one embodiment, the piston 412 can be hydraulically actuated, while in another embodiment, the piston 412 can be operated by manual retraction of the piston shaft 414 or advancement of the sheath 402. The delivery catheter 400 may be equipped with a handle on its proximal end having a retraction mechanism coupled to the piston shaft 414 and / or the catheter shaft 407. Such a mechanism may use gears or pulleys to provide mechanical efficiencies that reduce the force required to retract the piston or advance the sheath.

[0179] A delivery catheter according to aspects of the present technology may further be configured to be reversible to allow the device 100 to be retracted back into the catheter 400 after full or partial deployment. One embodiment of such a catheter is illustrated in FIG. 56, where the delivery catheter 400 of FIGS. 54A-55C is adapted to retract the device 100 back into the sheath 402 after being fully or partially deployed therefrom. The piston 412 has at least a first pulley 420 coupled thereto, while the distal projection 406 has at least a second pulley 422 coupled thereto. A number 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 comprise a wire or suture, extends through the fluid lumen 416 and 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 coupled to the piston shaft 414 by a number of pins 426 that extend radially from the piston shaft 414 to engage the device 100, preferably near its downstream end 428.

[0180] To deploy the device 100, the delivery catheter 400 of FIG. 56 operates similarly as described above in connection with FIGS. 54A-55C, but in an additional embodiment, an operator can check the location of the device 100 before the downstream end 428 is fully released from the sheath 402. Upon deployment, the upstream end 430 of the device 100 will expand toward its expanded configuration. The operator can visualize the location and shape of the deployed device 100 within the native tissue using ultrasound, fluoroscopy, MRI, or other means. After positioning, the sheath 402 may be advanced further relative to the piston 412 to fully deploy the device 100 from the sheath 402, causing the downstream end 428 to fully expand and the pin 426 to disengage from the device 100. In the event that the operator desires to retrieve device 100 back into sheath 402 for repositioning or other reasons, cable 424 is pulled to move piston 412 distally relative to sheath 402. Pin 426 pulls vice 100 along with piston 412 back into sheath 402, with device 100 collapsing as it is retracted into sheath 402. Delivery catheter 400 may then be repositioned and the device redeployed.

[0181] In one embodiment, the prosthetic heart valve device 100 may be specifically designed for a particular approach or delivery method to reach the mitral valve, or in another embodiment, the device 100 may be designed to be interchangeable between approaches or delivery methods.

[0182] Additional Embodiments of Prosthetic Heart Valve Devices, Delivery Systems, and Methods 57A-57E are isometric views of a prosthetic treatment device 600 shown in an expanded configuration 602 and configured in accordance with additional embodiments of the present technology. The prosthetic heart valve device 600 includes features generally similar to those of the prosthetic heart valve device 100 described above with reference to FIGS. 10A-56. For example, the prosthetic heart valve device 600 includes a valve support 120 configured to support a prosthetic valve 130 and an anchoring member 610 coupled to the valve support 120 in a manner that mechanically isolates the valve support 120 from forces exerted on the anchoring member 610 when implanted in a native mitral valve. However, in the embodiment shown in FIGS. 57A-57E, the upstream region 612 of the anchoring member 610 is coupled to the valve support 120 such that the upstream region 612 of the anchoring member 610 is configured to engage native tissue above or downstream of the valve annulus to prevent movement of the device 600 in the upstream direction.

[0183] 57A and 57B illustrate an embodiment of the device 600 in which the anchoring member 610 is coupled to the upstream end 121 of the valve support 120 and includes a plurality of longitudinal ribs 614 extending in a downstream to distal direction. As shown in FIG. 57A, the ribs 614 can project radially outward from the longitudinal axis 101 at the downstream region 611 of the anchoring member 610 such that the downstream region 611 is flared outward to engage subannular tissue below the mitral annulus. FIG. 57B illustrates an embodiment of the device 600 having an anchoring member 610 with an upwardly facing lip 617 at the downstream region. In this embodiment, the ribs 614 can be formed such that the downstream region is generally flared outward from the longitudinal axis 101, but the tips 615 of the ribs 614 are reoriented to point in an upstream direction at the lip 617. The hole lip 617 may assist the anchoring member 610 in engaging subannular tissue and can be configured to include a tissue engaging element (not shown) as described above with respect to device 100. The anchoring member 610 can also be coupled to the valve support 120 at a desired location to position the valve support 120 and prosthetic valve 130 within the native valve. For example, FIG. 57C illustrates an embodiment of a device 600 in which the anchoring member 610 can be coupled to the valve support 120 at a location downstream from the upstream end 121.

[0184] 57A-57C, the anchoring member 610 has a second cross-sectional dimension D C2 The first cross-sectional dimension D is smaller than _mstmutation=1>C1 at the upstream region 612. Additionally, the valve support 120 is radially separated from the downstream region 611 of the anchoring member 610 such that the downstream region 611 can deform inwardly when the device 600 is deployed without deforming the upstream portion of the valve support 120. Additionally, the valve support 120 can be generally cylindrical in shape while the anchoring member 610 can have a generally oval or D-shaped, or other irregular shape, such as those described above with respect to FIGS. 16A-17C. In such an embodiment, the second cross-sectional dimension D _mstmutation=1>C2 may be larger than the corresponding cross-sectional dimension of the native mitral valve annulus (eg, MVA1 or MVA2) (FIG. 5C).

[0185] 57D illustrates yet another embodiment of the device 600 in an expanded configuration 602. As shown, the valve support 120 can include a flange 620 at a 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 subannular tissue. The anchoring member 610 can include a plurality of ribs 614 coupled to the upstream end 121 of the valve support 120 and extending radially outward in the downstream direction to attach to an outer periphery 622 of the flange 620. The anchoring member 610 can be configured to engage subannular tissue, such as the inward-facing surfaces of the leaflets. In this embodiment, the ribs 614 can be flexible such 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 to which the prosthetic valve is connected.

[0186] FIG. 57E is a schematic cross-sectional view of the prosthetic heart valve device 600 of FIG. 57A implanted in a native mitral valve MV, according to an embodiment of the present technology. As shown, the wide-mouthed downstream region 611 of the anchoring member 610 can engage subannular tissue, e.g., the inward-facing surface of the leaflet LF, the subannular surface, etc. The ribs 614 can incorporate tissue engaging elements 170 on the rib tips 615 to penetrate and / or partially penetrate the tissue. Additionally, the anchoring member 610 can expand to seal radially outward against the tissue (not shown) to prevent migration of the device 600 in an upstream or downstream direction and / or to prevent paravalvular leakage between the tissue and the device 600. Thus, the device 600 can incorporate one or more sealing members 140, as described above with respect to the device 100. Additionally, the device 600 can also include an atrial expansion member or atrial retainer 410 (shown in dotted lines), as described above with respect to the device 100. If present, the atrial retainer can be configured to engage tissue above the annulus AN, such as the supranulular surface or some other tissue within the left atrium LA, to prevent downstream movement of the device (e.g., during atrial systole).

[0187] 58A-58D are cross-sectional views of the heart showing a method of delivering a prosthetic heart valve device 600 to the native mitral valve MV in the heart using a transapical approach according to another embodiment of the present technology. With reference to FIG. 58A, the delivery catheter 18 is advanced through a guide catheter (not shown) that enters the left ventricle LV of the heart through a puncture in the left ventricular wall at or near the apex and is sealed with a purse string suture. Alternatively, the delivery catheter 18 may be placed directly through a transapical incision sealed with a purse string suture without a guide catheter. The sheath 20 containing the folded device 600, 606 (shown in FIG. 58B) is advanced through the mitral annulus AN between the native leaflets LF as shown in FIG. 58A. With reference together to FIGS. 58B-58D, the sheath 20 is pulled proximally such that the device 600 expands to an expanded and / or deployed configuration 602, 604 (FIGS. 58C and 58D).

[0188] The sheath 20 can be retracted and the device 600 can be expanded, but the delivery system can remain connected to the device 600 (e.g., a system eyelet, not shown, is connected to a device eyelet, not shown) so that the operator can control the placement of the device 600 while in the expanded configuration 602 (FIGS. 58C and 58D). For example, when the sheath 20 is disengaged from the device 600, the upstream region 612 of the anchoring member 610 can remain folded within the sheath, preventing the anchoring member 610 from fully expanding (FIG. 58C). During this stage of delivery, the position of the device 600 within the mitral valve region can be adjusted or changed. After the device 600 is located 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 be expanded outward in the downstream region 611 to engage subannular tissue, such as the leaflets LF, and to retain the device 600 at the desired target location. The pull wire (not shown) may be retracted proximally to release the device 600 from the delivery system, and the delivery system removed, allowing the device to be fully implanted in the mitral valve MV in the deployed configuration 104. Alternatively, the device 600 may be expanded upstream or downstream of the desired target location and then retracted or pushed downstream or upstream, respectively, into the target location before releasing the device 600 from the delivery system.

[0189] 59A-59C are isometric views of the artificial treatment device 700 shown in an expanded configuration 702, and FIG. 59D is a schematic cross-sectional view of the artificial heart valve device 700 implanted in a native mitral valve configured according to a further embodiment of the present technology. The artificial heart valve device 700 includes features generally similar to those of the artificial heart valve devices 100 and 600 described above with reference to FIGS. 10A-58D. For example, the artificial heart valve device 700 includes a valve support 120 configured to support the artificial valve 130 and a first anchoring member 610 coupled to the valve support 120 in a manner that mechanically isolates the valve support 120 from forces exerted on the first anchoring member 610 when implanted in the native mitral valve. In particular, an upstream region 612 of the first anchoring member 610 is coupled to the valve support 120, and a downstream region 611 of the first anchoring member 610 is configured to flare outward to engage native tissue above or downstream of the valve annulus to prevent migration of the device 600 in the upstream direction. However, in the embodiment shown in Figures 59A-59D, the device 700 also includes a second anchoring member 710 having a downstream region 711 coupled to the valve support 120 and an upstream region 712 that extends radially outward in the upstream direction. Thus, the device 700 includes both first and second anchoring members 610 and 710 for engaging tissue above or below the mitral valve annulus.

[0190] 59A-59D, the first fastening member 610 has a second cross-sectional dimension D C2 The first cross-sectional dimension D is smaller than _mstmutation=1>C1 in the upstream region 612. The second anchoring member 710 can have a fourth cross-sectional dimension D _mstmutation=1>C4 The third cross-sectional dimension D is greater than C3 in the upstream region 712. In some embodiments, the third cross-sectional dimension D _mstmutation=1>C3 The second cross-sectional dimension D is such that the second fastening member 710 can be partially surrounded by the first fastening member 610. _mstmutation=1>C2In such an embodiment, the upstream region 712 can exert a radially outward pressure against an inner wall (not shown) of the first anchoring member 610 to further support the fixation of the first anchoring member 610 to tissue above or below the annulus. In another embodiment shown in FIG. 59B, the third cross-sectional dimension D _mstmutation=1>C3 The second cross-sectional dimension D is such that the first and second fastening members 610, 710 meet at a flared joint 740. _mstmutation=1>C2 59C shows another embodiment of the device 700 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, the device 700 shown in FIG. 59C can be implanted in a native heart valve such that the first anchoring member 610 can engage supranular tissue or other cardiac tissue upstream of the annulus and the second anchoring member 710 can engage subannular tissue or other cardiac tissue downstream of the annulus such that the annulus is held or captured within the gap 750.

[0191] In a further embodiment, illustrated in FIG. 59D, the third cross-sectional dimension D C3 The second cross-sectional dimension D is such that the second fastening member 710 can partially surround the first fastening member 610. _mstmutation=1>C2 In such embodiments, the downstream region 611 of the first anchoring member 610 can apply a radially outward pressure against the inner wall 741 of the second anchoring member 710 to further support fixation of the second anchoring member 710 to tissue above or below the valve annulus AN.

[0192] 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 such that when the device 700 is deployed, the downstream region 611 and / or the upstream region 712 can deform inwardly without substantially deforming the valve support 120 or the support region 734 of the valve support 120 that supports the prosthetic valve 130. In addition, the valve support 120 can be generally cylindrical in shape while the first and second anchoring members 610, 710 can have a generally oval or D-shaped or other irregular shape such as those described above with respect to FIGS. 16A-17C. Additional features such as the sealing membrane 140 and tissue engaging element 170 as described above with respect to the device 100 may also be incorporated onto the device 700.

[0193] 60A-60B are cross-sectional side views of the distal end of a delivery catheter 18 for delivering the prosthetic heart valve device of FIG. 59C to a native mitral valve in a heart according to another embodiment of the present technology. As shown in FIGS. 60A-60B, the prosthetic heart valve device 700 is folded into a delivery configuration 706 and held within a two-part delivery sheath 70 at the distal end of the catheter 18 (FIG. 60A). Upon delivery of the distal end of the catheter 18 to a desired location at or near the native mitral valve, the device 700 can be released from the two-part sheath 70 by retracting the upper portion 72 distally and / or the lower portion 74 proximally (indicated by arrows in FIG. 60A), thereby separating the sheaths and exposing the folded device 700 from within the sheath 70. In one embodiment, the device 700 can self-expand to its expanded configuration 702 after retraction of the sheath 70 (FIG. 60B). 60B, when the sheath 70 is retracted in both the proximal and distal directions, the first and second anchoring members 610, 710 can self-expand outwardly to engage native tissue. When using the balloon 300 to expand the support valve 120, the balloon 300 can be inflated to fully expand the device 700.

[0194] FIG. 61 illustrates a prosthetic heart valve device 800 configured in accordance with another embodiment of the present technology. FIG. 61 is a side view of the device 800, which includes features generally similar to those of the prosthetic heart valve devices 100, 600, 700 described above with reference to FIGS. 10A-60B. 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 coupled. The device also includes first and second anchoring members 810 and 850. The first anchoring member 810 has a first flared upstream portion 812 and a first downstream portion 811 coupled to the exterior or outer surface 127 of the valve support 120. The first flared upstream portion 812 can be mechanically isolated from the valve support 120. In addition, the first flared upstream portion 812 can be configured to engage 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 to have a second flared upstream portion 852 for engaging subannular tissue of the native mitral valve. The second anchoring member 850 can also have a second downstream portion 851 coupled 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.

[0195] 61, the first fastening member 810 can have a plurality of first longitudinal ribs 814, and the second fastening member 850 can have a plurality of second longitudinal ribs 854. In one embodiment, each of the first ribs 814 extends beyond the height H of the first fastening member 810 relative to the height H of the second fastening member 850. _mstmutation=1>AM2 Height H greater than AM1 4. Thus, the second anchoring member 850 is oriented to engage the subannular tissue with a height H _mstmutation=1>AM2 , while orienting the first anchoring member 810 to extend from the left ventricle through the mitral valve to engage supranulular tissue in the left atrium at height H _mstmutation=1>AM1 can be selected.

[0196] FIG. 61 illustrates an embodiment of the device 800 that can include a lower ring 808 on which the ribs 814, 854 can interconnect. The lower ring 808 can allow the ribs 814, 854 to expand radially outward away from the valve support 120 at the upstream portions 812, 852. The device 800 can also include a first upper ring member 816 coupled to a plurality of first longitudinal ribs 814. The first upper ring member 816 can be shaped and / or patterned to have a downwardly oriented periphery 818 for engaging supranulus tissue. The device can further include a second upper ring member 856 coupled to a plurality of second longitudinal ribs 854. The second upper ring member 856 can be shaped and / or patterned to have an upwardly oriented periphery 858 for engaging subannular tissue.

[0197] 62A-62C are partial cross-sectional side views of the distal end of the delivery system 10 illustrating delivery of the prosthetic heart valve device 800 of FIG. 61 at the mitral valve MV according to another embodiment of the present technology. The device 800 can be held in a folded configuration 806 within the sheath 20 of the delivery system (FIG. 62A). When the distal end of the delivery system engages the target location, the sheath 20 can be retracted proximally from the device 800, thereby releasing the features of the device 800 to expand to the expanded configuration 102 (FIGS. 62B-62C). As shown in FIG. 62B, the second anchoring member 850 can be released from the sheath 20 retracted first, and the upwardly oriented periphery 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 disengaging from the delivery system 10 and / or moving out of the sheath 20 until the periphery 858 of the second anchoring member 850 is moved into position to engage subannular tissue. With reference to FIG. 62C, the plunger 11 can engage the first anchoring member 810 (as indicated by the downward arrow in FIG. 62B) and / or the sheath 20 can be disengaged / retracted from the first anchoring member 810 (as indicated by the upward arrow in FIG. 62C), thereby allowing the second anchoring member 850 to move radially outward to the expanded configuration 802. The downwardly oriented periphery 818 of the first top ring member 816 can be positioned to engage supranuclear tissue (FIG. 62C). Once deployed, the rings 816, 856 can clamp the mitral valve annulus AN and prevent migration of the device 800 in both the upstream and downstream directions.

[0198] 63 is an isometric side view of a prosthetic heart valve device 900 in accordance with a further embodiment of the present technology. The device 900 includes features generally similar to those of the prosthetic heart valve devices 100, 600, 700, and 800 described above with reference to FIGS. 10A-62C. 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) may be coupled. The device 900 includes an anchoring member 910 having a wide upstream portion 912 and a downstream portion 911 that is coupled to the valve support 120. However, the device 900 also includes upper and lower rings 950, 952 and a plurality of flexible annulus-engaging elements 970 distributed around a circumference 980 of the anchoring member 910 and configured to couple the upper ring 950 to the lower ring 952. The flexible annulus engaging element 970 can have a shape, such as a C-shape or U-shape, oriented with an open portion facing outward from the device 900 so that the native annulus AN can be engaged into a recess 971 in the annulus engaging element 970. The annulus engaging element 970 can also include tips 972, 973 for engaging and potentially piercing supra-annular or sub-annular tissue, respectively. The annulus engaging element 970 can be suitably flexible to flex in a manner that brings the tips 972, 973 together to secure the device 900 to the annulus AN when the device 900 is deployed.

[0199] 64A-64B illustrate a method for deploying the device 900 in a native mitral valve annulus. Referring together to FIGS. 63 and 64A-64B, the annulus engaging element 970 can be substantially relaxed or have a wide recess 971 in the open state 903. As such, the top ring 950 is spaced apart from the first distance D when the element 970 is in the open state 903. _mstmutation=1>R1The device 900 can rest above the lower ring 952 at a distance D above the upper 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 secured to the lower ring 952. When the wires 974 are pulled in an upward or upstream direction, the lower ring 952 moves in an upward / upstream direction toward the upper ring 950. As the lower ring 952 approaches the upper ring 950, the annulus engagement element 970 can bend such that the tips 972, 973 are brought closer together and / or engage or pierce the annulus tissue (FIG. 64B). Thus, when the device 900 is in the deployed state 904, the upper ring 950 is positioned above the lower ring 952 at a second distance D above the lower ring 952. _mstmutation=1>R2 and can be held by the pull wire 974 at a second distance D R2 is the first distance D _mstmutation=1>R1 Less than.

[0200] 64C-64D show an alternative arrangement of the pull wire 974 where the wire 974 is fixed to the upper ring 950 and slidably engaged (e.g., through hole 976) with the lower ring 952. The pull wire 974 can also be slidably engaged (e.g., through hole 975) with the upper ring 950 such that the pull wire can be pulled in an upward direction to bring the rings 950, 952 closer together in the deployed state 904.

[0201] FIG. 65A is an isometric view of a prosthetic heart valve device 1000 in accordance with a further embodiment of the present technology. The device 1000 includes features generally similar to those of the prosthetic heart valve devices 100, 600, 700, 800, and 900 described above with reference to FIGS. 10A-64D. For example, the device 1000 includes a support valve 120 having upstream and downstream ends 121, 123 and an interior 134 to which the valve 130 may be coupled. However, the device 1000 includes an inflatable anchoring member 1010 coupled to and at least partially surrounding the valve support 120. The inflatable anchoring member 1010 can be configured to inflate / expand upon deployment and engage native tissue at a desired target location. As shown in FIG. 65A, the inflatable anchoring member 1010 can be configured to inflate / expand the prosthetic heart valve 1000 after implantation of the device 1000 by inflating the prosthetic heart valve 1000 with a solution (e.g., saline or other liquid) or gas (e.g., helium, CO _mstmutation=1>2 In one embodiment, the fillable chamber 1014 may have one or more fillable chambers 1014 for receiving a fill substance, such as a resin, a hardening substance (e.g., an epoxy, cement, or other resin). In another embodiment, the fillable chambers 1014 may be filled with a hardening substance (e.g., an epoxy, cement, or other resin).

[0202] In one embodiment, the fillable chamber 1014 and / or the anchoring member 1010 can be formed of polytetrafluoroethylene (PTFE), urethane, or other expandable polymer or biocompatible material. The fillable chamber 1014 can have a predetermined shape such that when the fillable chamber 1014 is inflated, it forms a fixation element 1015 for engaging native anatomy. For example, the fixation element 1015 can include a supra-annular flange 1016 for engaging a surface of the annulus AN in the left atrium LA. The element 1015 can also include a sub-annular flange 1018 for engaging sub-annular tissue and / or an arm 1020 for engaging the leaflet LF (e.g., behind the leaflet). Thus, the chambers 1014 can be incorporated or shaped to allow the anchoring member 1010 to engage supranulular tissue, subannular tissue, leaflets, or other tissue at or near the mitral valve MV, while mechanically isolating the valve support 120 from diastolic and systolic bending forces generated within the heart, particularly radial forces exerted on the device 1000 at or near the native mitral valve. For example, after deployment, the inflatable anchoring member 1010 can absorb pulsatile loads and other forces generated against the device 1000, such that deformation of the anchoring member 1010 does not substantially deform the valve support 120.

[0203] FIG. 65B is a partial cross-sectional side view of a distal end of a delivery system 10 suitable for delivery of the prosthetic heart valve device 1000 of FIG. 65A according to another embodiment of the present technology. As shown in FIG. 65B, the delivery system 10 can include a delivery catheter 18 configured to hold 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 suitable for delivering a filling substance when the device 1000 is in place and ready for deployment. With reference together to FIGS. 65A-65B, in one embodiment, the inflatable anchoring member 1010 can be partially filled with a filling substance such that the position of the device 1000 at the implantation site can be adjusted to align the fixation element 1015 with natural tissue features before fully expanding and / or inflating the anchoring member 1010 to hold the device 1000 in place at the target location.

[0204] 66A-66D are cross-sectional views of a prosthetic heart valve device 1100 having a fillable chamber 1114 in accordance with additional embodiments of the present technology. Similar to the device 1000 discussed with respect to FIGS. 65A-65B, the device 1100 includes features such as a support valve 120 having an interior 134 to which the valve 130 may be coupled, and includes an expandable anchoring member 1110 coupled to the valve support 120 in a manner that mechanically isolates the valve support 120 from forces exerted on the anchoring member 1110 when implanted in a native mitral valve. The anchoring member 1110 can be coupled 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 annulus to prevent migration of the device 1100 in an upstream direction. In the embodiment shown in Figs. 66A-66D, the device 1100 can also include one or more fillable chambers 1114 configured to expand and / or inflate in an outward direction to support the outward expansion of the fixation members 1100 (Figs. 66A, 66C-66D) or to engage natural tissue (Fig. 66B). In one embodiment, the fillable chambers 1114 and / or the fixation members 1010 can be formed of polytetrafluoroethylene (PTFE), urethane, or other expandable polymer or biocompatible material. The fillable chambers 1114 can have a predetermined shape such that when expanded, the fillable chambers 1114 form a fixation element for engaging natural anatomy (as shown in Fig. 66B) or for engaging the fixation members 1110 (as shown in Figs. 66A, 66C, and 66D).

[0205] 66A, the fillable chamber 1114 may be a chamber 1114 created with a space between the valve support 120 and the anchoring member 1110. After expansion of the device 1100, the fillable chamber 1114 may be filled with a solution (e.g., saline or other liquid) or a gas (e.g., helium, CO _mstmutation=1>266C-66D, for example, the ring-shaped chamber 1150 can provide additional support to the fixation member 1110 such that inward deformation is countered by the presence of the ring-shaped chamber 1150. Additionally, as shown in FIG. 66D, the fillable chamber 114 can be a ring-shaped chamber 1150 that deforms the fixation member 1110 in an outward direction relative to the natural tissue.

[0206] In accordance with another aspect of the present technology, Figures 67A-67B illustrate another embodiment of a prosthetic heart valve device 1200. Referring together to Figures 67A-67B, the device 1200 can include a radially expandable anchoring member 1210 configured to engage native tissue above or downstream of the valve annulus, and a support valve 120 and / or prosthetic valve 130 coupled to an interior 1234 of the anchoring member 1210. The anchoring member 1210 can include a first longitudinal length L1, L2, and L3 on a posterior leaflet-facing side 1222 of the anchoring member 1210. _mstmutation=1>L1 and a second longitudinal length L L2 As shown in FIG. 67A, the first length L _mstmutation=1>L1 The second length L is set so that obstruction of the left ventricular outflow tract (LVOT) is limited. L2 Thus, in one embodiment, the posterior leaflet-facing side 1222 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 anterior leaflet-facing side 1224 of the anchoring member 1210 can have a sufficient seal and conformance to engage the anterior leaflet and / or subannular tissue aligned with the anterior leaflet of the native valve.

[0207] Optionally, device 1200 can also include one or more stabilizing elements, such as arms 1250, coupled to anchoring member 1210 for engaging the leaflet and / or subannular surface. In FIG. 67A , arm 1250 can be coupled to a downstream end 1223 of anchoring member 1210 on a side 1222 of anchoring member 1210 facing the posterior leaflet and can be configured to extend behind the posterior leaflet. In one embodiment, arm 1250 can be configured to sandwich the posterior leaflet between arm 1250 and anchoring member 1210.

[0208] In FIG. 67B, device 1200 can include first and second arms (individually identified as 1250a and 1250b) coupled to anchoring member 1210 for engaging the leaflets and / or subannular surfaces. For example, first arm 1250a can be coupled to downstream end 1223 at anterior leaflet-facing side 1224 of anchoring member 1210 at extension 1251a and can be configured to extend further behind the anterior leaflet. Second arm 1250b can be coupled to downstream end 1223 at posterior leaflet-facing side 1222 of anchoring member 1210 at extension 1251b and configured to extend behind the posterior leaflet. In the illustrated embodiment, extensions 1251a and 1251b vary relative to one another and can be selected based on the anatomy of the target tissue. In other embodiments not shown, the arms 1250 and / or anchoring members 1210 can include tissue engaging elements as described above with respect to device 100 for further positioning and stabilizing the device 1200 at a desired target location. One skilled in the art will recognize that the valve support 120 can also be unequal or have sides with different lengths such that the valve support does not substantially occlude the left ventricular outflow tract (LVOT).

[0209] 68A-68B are side views of a prosthetic heart valve device 1300 shown in an expanded configuration 1302 and configured in accordance with additional embodiments of the present technology. The prosthetic heart valve device 1300 includes features generally similar to those of the prosthetic heart valve device 100 described above with reference to FIGS. 10A-56. For example, the prosthetic heart valve device 1300 includes a valve support 120 configured to support the prosthetic valve 130 and an anchoring member 110 coupled to the valve support 120 in a manner that mechanically isolates the valve support 120 from forces exerted on the anchoring member 110 when implanted in the native mitral valve. However, in the embodiment shown in FIGS. 68A-68B, the device 1300 also includes a positioning element 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 element 1350 can couple to the downstream portion 111 of the anchoring member 110, the upstream portion 112 of the anchoring member 110, or the valve support 120 (as shown in FIGS. 68A-68B ) at element connection point 1352 and extend outwardly from the element connection point 1352 to engage ventricular tissue at a desired location. In one embodiment, the positioning element 1350 can extend outwardly from the device 1300 in a direction generally perpendicular to the longitudinal axis 101. In other embodiments not shown, the positioning element 1350 can extend outwardly from the device 1300 at an obtuse or acute angle relative to the longitudinal axis 101 to engage ventricular tissue at a desired location.

[0210] 68A, the locator element 1350 can include a locator arm 1354 and a tissue engaging portion 1356 coupled to a distal arm end 1358 of the locator arm 1354. Together, the locator arm 1354 and the tissue engaging portion 1356 can be positioned at a desired locator distance D away from an element connection point 1352 on the device 1300 (e.g., from the anchoring member 110) such that a distal end 1360 of the locator element 1350 can engage ventricular tissue, such as a ventricular wall. _mstmutation=1>P1 In some embodiments, the positioning distance D P1can be selected to be greater than the distance between the implanted device 1300 and the ventricular tissue such that the positioning element 1350 extends the distance between the implant device 1300 and the ventricular tissue after engaging the ventricular tissue. In this manner, the device 1300 can be positioned, aligned, and maintained at alternative locations within or near the mitral valve.

[0211] The tissue engaging portion 1356 can be configured to contact ventricular tissue or other tissue (e.g., valve annulus tissue, valve leaflet tissue, etc.) atraumatically such 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 tissue. For example, the tissue engaging portion 1356 can be configured to transmit movement or absorb forces generated by the ventricular tissue (e.g., ventricular wall) during, for example, systole, without changing the desired position of the device 1300 relative to the native mitral valve. In other embodiments, the distal end 1360 of the positioning element 1350 can have other shapes or configurations that penetrate the ventricular tissue. The device 1300 can include one or more positioning elements 1350 disposed about the device 1300 to position and / or maintain the desired position of the device 1300 relative to the native anatomy. For example, it may be desirable to increase the distance between device 1300 and the left ventricular outflow tract (LVOT), and positioning element 1350 can be configured to engage ventricular tissue to urge or urge device 1300 a selected distance away from the LVOT.

[0212] 68B, the positioning element 1350 can include a looped tissue engaging portion 1358 that is coupled to the device 1300 at a connection point 1352. The looped tissue engaging portion 1358 can be positioned at a desired positioning distance D away from the element connection point 1352 on the device 1300 (e.g., from the anchoring member 110) such that a distal end 1360 of the looped tissue engaging portion 1358 can engage ventricular tissue, such as a ventricular wall._mstmutation=1>P1 The looped tissue engaging portion 1358 can be configured to absorb radial contraction forces or other forces generated and transmitted by ventricular tissue (e.g., in the left ventricle) such that they are not transmitted to 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 in or near the mitral valve.

[0213] In another embodiment not shown, a positioning structure separate from the prosthetic heart valve device 100 can be implanted or otherwise positioned in the left ventricle (e.g., at or near the LVOT) and configured to engage portions of the device 100, such as the anchoring member 110. Such a positioning structure can thus 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 cylinder or cage that expands to engage the ventricular wall and keeps the LVOT clear to allow blood to flow freely from the left ventricle to the aorta. In one example, the positioning structure can be delivered by a catheter inserted through the aorta and aortic valve into the left ventricle or through the apex or left atrium via the same delivery catheter used to deliver and implant the device 100.

[0214] 69A-69E are cross-sectional and side views of a prosthetic heart valve device 1400 shown in an ex...

Claims

1. 1. A prosthetic heart valve device for implantation into a native heart valve, said prosthetic heart valve device comprising: A frame, an artificial valve coupled to the frame; a sealing member attached to a surface of the frame, the sealing member including a tissue engaging element configured to penetrate tissue at the native heart valve; Equipped with the frame includes an outer fixation member and an inner valve support, the prosthetic valve being coupled within the inner valve support; The sealing member is attached to a surface of the outer anchoring member.

2. 10. The prosthetic heart valve device of claim 1, wherein the tissue engaging elements comprise metal or polymeric wires or fibers that are sufficiently stiff and sharp to penetrate tissue in the native heart valve.

3. 3. The prosthetic heart valve device of claim 2, wherein the metal or polymer wires or fibers are woven into the material of the sealing member.

4. The prosthetic heart valve device of claim 1 , wherein the sealing member is attached to an outer surface of the outer anchoring member.

5. The prosthetic heart valve device of claim 1 , wherein the sealing member is attached to an inner surface of the outer anchoring member.

6. The artificial heart valve device of claim 1, wherein the sealing member is a first sealing member, and the artificial heart valve device further comprises a second sealing member, the second sealing member being attached to an outer surface of the inner valve support.

7. The artificial heart valve device of claim 1, wherein the sealing member is a first sealing member, and the artificial heart valve device further comprises a second sealing member, the second sealing member being attached to an inner surface of the inner valve support.

8. 2. The prosthetic heart valve device of claim 1, wherein the outer anchoring member is coupled to the inner valve support at a downstream portion of the outer anchoring member and the inner valve support.

9. 9. The prosthetic heart valve device of claim 8, wherein a longitudinal axis extends in an upstream direction from the downstream portion, and the outer anchoring member extends radially outward from the longitudinal axis in the upstream direction from the downstream portion where it is coupled to the inner valve support.

10. 2. The prosthetic heart valve device of claim 1, wherein the outer anchoring member is configured to engage tissue of the native heart valve, and the outer anchoring member is configured to deform to absorb forces from the native heart valve such that the inner valve support remains sufficiently stable so that the prosthetic valve remains competent when the outer anchoring member is deformed.

11. 1. A prosthetic heart valve device for implantation into a native heart valve having a plurality of native leaflets, the prosthetic heart valve device comprising: an outer anchoring member having a compressed configuration and an expanded configuration, the outer anchoring member configured to be positioned at a location between the native valve leaflets in the expanded configuration; an inner valve support coupled to the downstream portion of the outer anchoring member, the inner valve support having a compressed configuration and an expanded configuration; a prosthetic valve coupled to an interior of the inner valve support; a sealing member attached to a surface of the outer anchor member, the sealing member including a tissue engaging element configured to penetrate tissue at the native heart valve with the outer anchor member in the expanded configuration; 1. A prosthetic heart valve device comprising:

12. 12. The prosthetic heart valve device of claim 11, wherein the tissue engaging elements comprise metal or polymeric wires or fibers that are sufficiently stiff and sharp to penetrate tissue in the native heart valve.

13. 13. The prosthetic heart valve device of claim 12, wherein the metal or polymer wires or fibers are woven into the material of the sealing member.

14. The prosthetic heart valve device of claim 11 , wherein the sealing member is attached to an outer surface of the outer anchoring member.

15. The prosthetic heart valve device of claim 11 , wherein the sealing member is attached to an inner surface of the outer anchoring member.

16. 12. The prosthetic heart valve device of claim 11, wherein a longitudinal axis extends in an upstream direction from the downstream portion, and the outer anchoring member extends radially outward from the longitudinal axis in the upstream direction from the downstream portion where it is coupled to the inner valve support.

17. 12. The prosthetic heart valve device of claim 11, wherein the outer anchoring member is configured to engage tissue of the native heart valve, and the outer anchoring member is configured to deform to absorb forces from the native heart valve such that the inner valve support remains sufficiently stable so that the prosthetic valve remains competent when the outer anchoring member is deformed.

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