Prosthetic valve with natural blood flow

Abstract

A prosthetic valve can be formed to guide flow from an outflow orifice into a posterior portion of the heart wall. The prosthetic valve includes an expandable frame that can be covered by a cover that is seamlessly attached to the frame. The prosthetic valve may also include a controlled outflow orifice size. Methods of using these devices are also disclosed.

Description

[0001] Priority requirements

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 62 / 831,922 (Attorney’s File No. 5131.017PRV), filed April 10, 2019; the entire contents of which are incorporated herein by reference.

[0003] Cross-referencing of relevant patent documents

[0004] This application relates to U.S. Patent Application No. 16 / 559,169 (Attorney’s File No. 5131.008US2), filed September 3, 2019; U.S. Patent Application No. 15 / 418,511 (Attorney’s File No. 5131.008US1), filed January 27, 2017 (now U.S. Patent No. 10,433,952); and U.S. Provisional Patent Application No. 62 / 288,987 (Attorney’s File No. 5131.008PRV), filed January 29, 2016; the entire contents of each of these patents are incorporated herein by reference. Background Technology

[0005] The vertebrate heart is divided into four chambers and equipped with four valves (mitral, aortic, pulmonary, and tricuspid valves) that ensure blood pumped by the heart flows forward (sometimes also called downstream or anterograde) through the cardiovascular system. In a healthy heart, the mitral valve prevents blood from flowing back (sometimes also called retrograde or upstream) from the left ventricle into the left atrium and contains two flexible leaflets (anterior and posterior leaflets) that close when the left ventricle contracts. The leaflets are attached to the annulus fibrosus, and their free edges are tethered to the papillary muscles in the left ventricle by subvalvular chordae tendineae to prevent the leaflets from detaching into the left atrium during left ventricular contraction.

[0006] Various heart diseases or degenerative changes can cause dysfunction in any of these parts of the mitral valve apparatus, resulting in the mitral valve becoming abnormally narrowed or dilated, or allowing blood to leak from the left ventricle back into the left atrium (also known as regurgitation). Any such damage can impair heart function and can weaken or endanger a person's life.

[0007] Therefore, various surgical methods and devices have been developed to treat mitral valve dysfunction, including open-heart surgical techniques for replacing, repairing, or reshaping the natural mitral valve organ, and surgical implantation of various prosthetic devices (e.g., annuloplasty rings) to alter the anatomy of the natural mitral valve. Recently, less invasive transcatheter techniques for delivering replacement mitral valve components have been developed. In such techniques, the prosthetic valve is typically mounted in a coiled position on the tip of a flexible catheter and advanced through a blood vessel or the patient's body until the valve reaches the implantation site. The prosthetic valve is then expanded to its functional size at the site of the defective natural valve. This application discloses some examples for the mitral valve, but this is not intended to be limiting, and those skilled in the art will understand that the prosthetic valves disclosed herein can be used for other heart valves, such as the tricuspid valve, aortic valve, pulmonary valve, or any other valve in the body, such as a venous valve. Brief description of the attached diagram

[0009] In the accompanying drawings, where to-scale is not required, similar numerals may describe similar components in different views or similar steps. Similar numerals with different letter suffixes may represent different instances of similar components. The accompanying drawings generally illustrate multiple instances discussed in this document by way of example rather than limitation.

[0010] Figure 1 This is a schematic diagram of the left ventricle of the heart, with arrows indicating blood flow during cardiac contraction.

[0011] Figure 2 This is a schematic diagram of the left ventricle of a heart with prolapsed leaflets in the mitral valve.

[0012] Figure 3 This is a schematic diagram of the heart of a patient with cardiomyopathy, in which the heart is dilated and the lobules are not connected.

[0013] Figure 3A This shows the normal closure of the leaflet.

[0014] Figure 3B This illustrates abnormal lobule closure in an dilated heart.

[0015] Figure 4 This shows mitral regurgitation in the left ventricle of a heart with damaged papillary muscles.

[0016] Figures 5A to 5B The basic anatomical structure of the mitral valve is shown.

[0017] Figure 6 A partial cross-sectional view of the bottom of the prosthetic mitral valve is shown.

[0018] Figure 7 yes Figure 6 A perspective view of the anchoring portion of the prosthetic mitral valve as seen in the image.

[0019] Figure 8A This is a perspective view of a prosthetic mitral valve.

[0020] Figure 8B yes Figure 8A A top view of the atrium with a prosthetic valve.

[0021] Figure 9A It shows the atrium Figure 8A A perspective view of the prosthetic valve in the image.

[0022] Figure 9B It shows the ventricle Figure 8A A perspective view of the prosthetic valve in the image.

[0023] Figure 10 This shows a planar unexpanded mode, which is not covered and is unfolded. Figure 8A The prosthetic valve.

[0024] Figure 11 This is a side view of the delivery device used for implanting a prosthetic valve.

[0025] Figure 12 yes Figure 11 An exploded perspective view of the proximal portion of the delivery device.

[0026] Figure 13 yes Figure 11 An exploded perspective view of the distal portion of the delivery device.

[0027] Figure 14 yes Figure 11 A cross-section of the proximal portion of the delivery device in the image.

[0028] Figures 15A to 15C yes Figure 11 A cross-sectional view of the distal portion of the delivery device in the image.

[0029] Figure 16 This is a side view of another example of a delivery device for implanting a prosthetic valve.

[0030] Figure 17 yes Figure 16 A perspective view of the delivery device in the image.

[0031] Figure 18 yes Figure 16 An exploded view of the delivery device.

[0032] Figures 19A to 19B yes Figure 16 Side view of the delivery device during multiple stages of operation.

[0033] Figure 20 It shows Figure 16 The distal portion of the delivery device is adapted to engage a portion of the prosthetic valve.

[0034] Figure 21 It shows Figure 16 Delivery device in Figure 8A The connection of the prosthetic valve.

[0035] Figures 22A to 22G An example of a method for delivering a prosthetic mitral valve transapically is shown.

[0036] Figures 23A to 23G An example of a method for delivering a prosthetic mitral valve via the septum is shown.

[0037] Figure 24 A prosthetic mitral valve implanted in the mitral valve space is shown.

[0038] Figure 25 This shows a top view of the mitral valve implanted in the mitral valve space, viewed from the left ventricle upwards.

[0039] Figures 26A to 26C Examples of prosthetic valves are shown, in which the outflow orifice points in the desired direction.

[0040] Figure 27 Another example of a prosthetic valve is shown, in which the outflow orifice points in the desired direction.

[0041] Figure 28 The covered prosthesis is shown.

[0042] Figures 29A to 29B The diagram shows the opening and closing commissure post on the prosthetic valve.

[0043] Figures 30A to 30B The opening and closing connecting posts on the prosthetic valve are shown.

[0044] Figures 31A to 31B An example of a prosthetic valve with leaflets that guide blood flow in a posterior direction is shown.

[0045] Figure 32A An example of the effective orifice area in a prosthetic valve is shown.

[0046] Figure 32B Another example of the offset effective orifice area in a prosthetic valve is shown.

[0047] Figure 33A The prosthetic valve implanted in a natural mitral valve is shown.

[0048] Figures 33B to 33DIt shows the way Figure 33A Possible flow patterns of the valve. Invention Details

[0050] While some surgical and less invasive treatments for valvular regurgitation are promising, they may be difficult to deliver, expensive to manufacture, or unsuitable for all patients or fail to deliver optimal clinical outcomes. Therefore, there is a desire to provide improved devices and methods for treating valvular insufficiency, such as mitral regurgitation. At least some of these goals will be achieved through the devices and methods disclosed herein.

[0051] Specific examples of the disclosed apparatus, delivery systems, and methods will now be described with reference to the accompanying drawings. Nothing in this detailed description is intended to imply that any particular component, feature, or step is essential to the invention.

[0052] Cardiac Anatomy

[0053] Figure 1 The image shows the left ventricle (LV) of a normal heart during systole. The left ventricle (LV) is contracting, and blood flows outwards in the direction of the arrow through the aortic valve (AV), which is the tricuspid valve. Because the mitral valve is configured as a "check valve" to prevent backflow when the pressure in the left ventricle is higher than the pressure in the left atrium (LA), backflow or "reflux" of blood through the mitral valve (MV) is prevented. Figure 1 As shown, the mitral valve (MV) comprises a pair of leaflets with free edges (FE) that are uniformly joined together to close. The opposite ends of the leaflets (LF) attach to surrounding cardiac structures along an annular region called the valve annulus (AN). The free edges (FE) of the leaflets (LF) are secured to the lower portion of the left ventricle (LV) by chordae tendineae (CTs) (also referred to herein as tendons), which comprise multiple branch tendons secured to the lower surface of each leaflet (LF) within the valve leaflet. The tendon CTs then attach to the papillary muscles (PM) extending upward from the lower portion of the left ventricle and the interventricular septum (IVS).

[0054] Now for reference Figures 2 to 4 Many structural defects in the heart can lead to mitral valve prolapse because insufficient tension is transmitted to the leaflets via the tendon. When the other leaflet, LF1, maintains its normal contour, the two leaflets do not properly align, and leakage will occur from the left ventricle (LV) to the left atrium (LA), as indicated by the arrow.

[0055] Regurgitation can also occur in patients with cardiomyopathy, where the heart dilates and the enlarged size prevents the valve leaflets from properly engaging, such as... Figure 3As shown in the diagram. The enlargement of the heart causes the mitral valve annulus to enlarge, thus preventing the free edges (FE) from meeting during systole. The free edges of the anterior and posterior lobules typically follow a line as shown in the diagram. Figure 3A The junction lines C shown are connected, but in patients with cardiomyopathy, a noticeable gap G may remain, such as... Figure 3B As shown in the image.

[0056] like Figure 4 As shown, mitral regurgitation can also occur in patients with ischemic heart disease in which the papillary muscles (PM) are already impaired. When the left ventricle (LV) contracts during systole, the papillary muscles (PM) cannot contract sufficiently to achieve proper closure. As illustrated, lobules LF1 and LF2 then prolapse. Leakage again occurs from the left ventricle (LV) to the left atrium (LA), as indicated by the arrows.

[0057] Figure 5A The anatomy of the mitral valve MV is shown more clearly; the mitral valve MV is a mitral valve with an anterior portion (ANT) and a posterolateral portion (POST). The valve comprises the anterior (aortic) leaflet AL and the posterior (mural) leaflet PL. The chordae tendineae connect the leaflets AL and PL to the anterolateral papillary muscles ALPM and PMPM, respectively. The leaflets AL and PL are connected to each other along lines called the anterolateral commissure (ALC) and the posteromedial commissure (PMC). The annulus AN lateralizes the leaflets, and two regions on opposite sides of the anterior leaflet, adjacent to the anterior portion of the annulus, are called the left fibrous triangle (LFT) and the right fibrous triangle (RFT). These regions are typically represented by solid-lined triangles. Figure 5B The left fiber triangle region (LFT) and the right fiber triangle region (RFT) are shown more clearly.

[0058] While various surgical techniques and implantable devices have been proposed and shown to be promising treatments for mitral regurgitation, these surgical approaches can require long recovery periods, and implantable devices have varying clinical outcomes. Therefore, there remains a need for improved devices and methods for treating mitral regurgitation. Although the examples disclosed herein pertain to implantable prosthetic mitral valves for treating mitral regurgitation, those skilled in the art will understand that this is not intended to be limiting, and the devices and methods disclosed herein can also be used to treat other heart valves, such as the tricuspid, aortic, and pulmonary valves, as well as other valves in the body such as venous or nonvascular valves.

[0059] Prosthetic valve

[0060] Prosthetic valves have been surgically implanted into the heart as a treatment for mitral regurgitation. Some of these valves are harvested from animals, such as porcine valves, and others are prosthetic mechanical valves with or without tissue covering. Recently, minimally invasive catheter techniques have been used to deliver prosthetic valves to the heart. These valves typically include anchors for securing the valve to the patient's heart, and a valve mechanism that can be a mechanical valve, a valve with animal tissue, or a combination thereof. Once implanted, a prosthetic valve takes over the faulty natural valve, thereby reducing or eliminating valvular insufficiency. While some of these valves have shown promise, the need for improved valves remains. Examples of prosthetic valves, delivery systems for prosthetic valves, and methods for delivering valves are disclosed below, which can overcome some of the challenges associated with existing prosthetic valves.

[0061] Now for reference Figures 6 to 7 The examples of mitral valve prostheses generally indicated by numeral 10 in the accompanying drawings include a tricuspid valve tissue-type prosthetic one-way valve structure 12, which includes leaflets 14 attached to a self-expanding or expandable anchoring portion 16 having a geometry that expands into a small-profile atrial skirt region 18, an annular region 20, a ventricular skirt region 22, and a plurality of leaflet junctions 24 (also referred to herein as junction posts), the leaflet junctions 24 extending axially downstream in a cantilevered fashion into a sub-annular space defined by the ventricular skirt region 22.

[0062] Figure 6 A partial cross-section of valve 10 is shown, viewed from the left ventricle upwards toward the right atrium. The atrial skirt region 18 is anchored to the lower portion of the right atrium 19. Valve leaflets 14 have an open position (not shown) and... Figure 6 The closed position is shown. In the open position, the leaflets 14 are displaced away from each other to allow blood flow through the leaflets, and in the closed position, the leaflets 14 engage with each other to close the valve and prevent retrograde blood flow through the leaflets. The valve junction 24 can be configured to extend along the arcuate suture 28 (in... Figure 7 (Best viewed in the middle) provides attachment of leaflets 14 and optimizes the efficiency of the prosthetic valve structure 12 and the load distribution on leaflets 14 by selectively flexing along their axial length at different points or regions by means of adding / removing reinforcing struts.

[0063] Figure 7A perspective view of the anchoring portion 16 of valve 10 is shown, which is formed by a series of interconnected struts. The atrial skirt region 18 forms an annular flanged area on the anchor to help secure the upper portion of the prosthetic valve in the atrium, and the annular region 20 is a cylindrical region for anchoring the valve along the natural valve ring. The ventricular skirt region 22 is similarly cylindrical and helps anchor the lower portion of the valve in the patient's left ventricle. Any or all portions of the anchor may be covered with tissue, such as the pericardium or other tissues disclosed herein, or may be covered with synthetic materials such as Dacron or ePTFE. Covering helps seal the anchor to the natural valve, and this helps guide blood into and through the prosthetic valve, rather than around it. In some instances, the anchor may remain uncovered. The prosthetic valve has both an expanded configuration and a collapsed configuration. The folded configuration has a small-profile cylindrical shape suitable for mounting on a delivery system, and delivery is preferably performed transluminally over a catheter or through the heart wall at the apex. The expanded configuration (as shown) allows the prosthetic valve to be anchored in the desired location.

[0064] Figure 8A A perspective view of an example of a prosthetic mitral valve is shown, with the optional covering removed to allow the anchor struts and frame to be visible. Figure 8B This shows a view of the ventricles from the atrium downwards. Figure 8A A top view of the prosthetic valve. The valve 800 includes an asymmetric expansion anchoring portion with a D-shaped cross-section. As shown, the anchoring portion generally includes anterior aspect 802 and rear aspect 804 along the longitudinal axis of the anchoring portion, and an aspect connected to the above-mentioned... Figures 6 to 7 The atrial skirt 18, annular portion 20, and ventricular skirt 22 regions described in the example generally correspond to the atrium 806, annular portion 808, and ventricular portion 810 regions. The junction (also referred to herein as the junction post) 813 also corresponds to... Figures 6 to 7The example in the text largely corresponds to leaflet 14. The prosthetic valve 800 has a folded configuration and an expanding configuration. The folded configuration is adapted to be mounted on an axis for transcavitary delivery to the heart (e.g., a delivery catheter), or on an axis for transapical delivery through the heart wall. The radially expanding configuration is adapted to anchor the valve adjacent to a diseased or damaged valve to the patient's natural heart. To allow the valve to expand from the folded configuration to the expanding configuration, the anchoring portion of the valve can be made of a self-expanding material, such as a nickel-titanium alloy, like nitinol, or the anchoring portion can also be made of spring-tempered stainless steel, cobalt-chromium alloy, or an elastic polymer. In other instances, the anchor can be expanded using an expandable member such as a balloon. In some instances, the anchor is manufactured by laser cutting, electrical discharge machining (EDM), or photochemical etching of the tube. The anchor can also be manufactured by photochemical etching of a flat sheet material, then rolling up the sheet material and welding the opposite ends together.

[0065] The atrial skirt portion 816 forms a flange region that helps anchor the prosthetic valve to the atrium above the mitral valve. The atrial skirt comprises multiple triangular fingers extending radially outward from the anchor to form the flange. The posterior portion 804 of the atrial skirt 816 is typically annular or rounded, while a portion of the anterior portion 802 of the atrial skirt 816 is flat. Therefore, the atrial skirt region can have a D-shaped cross-section. This allows the prosthetic valve to conform to the anatomy of the patient's heart without obstructing other parts of the heart, as discussed below. Each triangular finger is formed by a pair of interconnected struts. The triangular fingers of the atrial skirt typically curve radially outward from the central axis of the prosthetic valve and lie in a plane transverse to the central axis of the valve. In some instances, the atrial skirt lies in a plane substantially perpendicular to the central axis of the valve. The anterior portion 802 of the atrial skirt 806 optionally includes an alignment element 814, which may be one or more pillars extending vertically upward and substantially parallel to the prosthetic valve. The alignment element 814 may include a radiopaque marker (not shown) to facilitate visualization under fluoroscopy. The alignment element helps the physician align the prosthetic valve with the natural mitral valve anatomy, as discussed later.

[0066] Located beneath the atrial skirt region is an annular region 820, which also has a folded configuration for delivery and an expanded configuration for anchoring the prosthetic valve along the natural valvular annulus. The annular region also includes multiple interconnected struts forming a series of units, closed units, or open units. Suture holes 821 in some of the struts allow tissue or other coverings (not shown) to be attached to the annular region. Covering all or part of the anchor with tissue or other coverings helps to seal the anchor relative to the heart valve and adjacent tissue, thereby ensuring that blood is guided through the valve, rather than around it. The annular region may be cylindrical, but in some instances has a rounded posterior portion 804 and a flat anterior portion 802, forming a D-shaped cross-section. This D-shaped cross-section conforms more closely to the anatomy of the natural mitral valve without obstructing blood flow in other areas of the heart.

[0067] The lower portion of the prosthetic valve includes a ventricular skirt region 828. The ventricular skirt region also has a folded configuration for delivery and an expanded configuration for anchoring. The ventricular skirt region is formed by a plurality of interconnected struts forming a series of radially expandable units, which are preferably closed. In the expanded configuration, the ventricular skirt anchors the prosthetic valve to the ventricle by expanding against the natural mitral valve leaflets. Optional barbs 823 in the ventricular skirt can be used to further assist in anchoring the prosthetic valve to the ventricular tissue. Barbs may also optionally be included in the atrial skirt portion of the anchor and in the annular region. Additionally, similar to those discussed above, optional suture holes 821 in the ventricular skirt can be used to assist in suturing tissue or another material to the ventricular skirt region. The anterior portion 802 of the ventricular skirt can be flat, and the posterior portion 804 of the ventricular skirt can be rounded, thus forming a D-shaped cross-section for anchoring and conforming to the natural anatomy without obstructing other parts of the heart. Additionally, the lower portion of the ventricular skirt serves as a placement control area, as this lower portion can remain covered, thereby restraining the radial expansion of the ventricular skirt until the optional trigonal tab and posterior tab have expanded, as will be explained in more detail below.

[0068] The ventricular skirt portion may optionally include a pair of ventricular triangular flaps 824 (only one visible in this view) located on the anterior portion of the anchor, the ventricular triangular flaps 824 serving to aid in anchoring the prosthetic valve, as will be discussed in more detail below. The ventricular skirt portion may also optionally include a posterior flap 826 located on the posterior portion 804 of the ventricular skirt, the posterior flap 826 serving to anchor the prosthetic valve to the posterior portion of the valve annulus. The triangular flap 824 or the posterior flap 826 is a flap extending radially outward from the anchor, and the triangular flap 824 or the posterior flap 826 is inclined upward in the upstream direction.

[0069] The actual valve assembly is formed by three connecting posts (also called joints) 813, which extend downstream substantially parallel to the longitudinal axis of the prosthetic valve or radially inward toward the central axis of the anchor in a funnel or cone-shaped manner. The joint 813 is formed by a plurality of interconnected struts forming a triangular shape. The struts of the joint may contain one or more suture holes 821, which allow for the attachment of tissue or synthetic material to the joint. In this example, the valve is a tricuspid valve, therefore it contains three joints 813. The tip of the joint may contain a commissure tab 812 (also called a tab) for engaging a delivery catheter. In this example, the tab has an enlarged head region that connects to a narrower neck to form a mushroom shape. The junctions can be offset in any position, but are preferably angled slightly inward toward the central axis of the prosthetic valve, such that retrograde blood flow forces the junctions to juxtapose with each other to close the valve, and antegrade blood flow pushes the junctions radially outward to fully open the valve. Figure 8B It shows the view from the atrial side. Figure 8A A top view of the prosthetic valve, showing a cross-section of the preferred D-shaped form.

[0070] Figure 9A It shows Figures 8A to 8BA prosthetic mitral valve, wherein the covering 870 is connected to the various parts of the anchor by sutures 872. This view is taken from an atrial angle. In this example, the covering may be pericardium, which may be from multiple sources as disclosed elsewhere in this specification. In alternative examples, the covering may be a polymer such as polyester, ePTFE, or another synthetic material. The covering may be disposed on the annular region 820 and the ventricular skirt region 828, and in some examples, the anterior ventricular triangle flap 824 and the posterior ventricular flap 830 may also be covered with the same or different materials. The covering helps to seal the anchor relative to adjacent tissue, allowing blood to be guided through the valve mechanism. In this example, the atrial skirt and flaps 824, 830 are not covered. Additionally, radiopaque marker 814a forms part of the alignment element and facilitates visualization of the prosthetic valve under fluoroscopy, which is important during valve alignment.

[0071] Figure 9B It is as if viewed from the ventricle. Figure 9A The image shows a perspective view of the prosthetic mitral valve. The struts at the valve junction are covered with the same or a different material as the annular region and the ventricular region described above, thus forming the tricuspid leaflet 813. Figure 9B A valve in a closed configuration is shown, in which the three leaflets interlock to prevent retrograde blood flow. The interlocking flap 812 remains uncovered and allows the interlocking portion to engage with a delivery device, as will be explained below. Figures 9A to 9B The prosthetic valve can be sterilized, making it suitable for implantation into a patient using methods known in the art.

[0072] Figure 10 It shows Figure 9AThe prosthetic valve 800 is constructed by removing the covering and unfolding, flattening, and not expanding the remaining anchors. The prosthetic valve 800 is formed by multiple interconnected struts. For example, the atrial skirt region 806 includes multiple interconnected struts forming a series of peaks and troughs. The peaks and troughs of the flat anterior region 802 of the prosthetic valve are axially offset relative to the peaks and troughs of the rest of the atrial skirt, and this region becomes part of the alignment element 814. Radiopaque markers 814a are arranged on either side of the offset peaks and troughs and aid in visualization during valve implantation. Axially oriented connectors connect the struts of the skirt region 806 to the struts of the annular region 808. The annular region also includes multiple axially oriented and interconnected struts forming peaks and troughs. Connector struts connect the struts of the annular region to the struts of the ventricular region 810. The ventricular region also includes multiple interconnected struts forming peaks and troughs. Additionally, the struts form the leaflet junction 813, the ventricular skirt 828, and the triangular flap 824 and posterior flap 830. Suture holes 821 are arranged along the struts in the annular and ventricular regions to allow attachment of coverings such as pericardium or polymers, such as polyester or ePTFE. Barbs 823 are arranged along the ventricular skirt 828 to help anchor the prosthetic valve to adjacent tissue.

[0073] Engaging tabs or tabs 812 are disposed on the tip of the engagement portion 813 and can be used to releasably connect the prosthetic valve to the delivery system discussed below. Those skilled in the art will understand that various strut geometries can be used, and additionally, strut dimensions such as length, width, thickness, etc., can be adjusted to provide the anchor with desired mechanical properties such as stiffness, radial crush strength, engagement deflection, etc. Therefore, the geometries shown are not intended to be limiting.

[0074] Once a flat anchor pattern has been formed using EDM, laser cutting, photochemical etching, or other techniques known in the art, the anchor is radially expanded into the desired geometry. The anchor is then heat-treated using known methods to set its shape. Thus, the anchor can be loaded onto a delivery conduit in a stacked configuration and constrained within the stacked configuration using a restraint sleeve. Removing the restraint sleeve allows the anchor to self-expand into its unbiased, predetermined shape. In another instance, an expandable component, such as an airbag, can be used to radially expand the anchor into a preferred expanded configuration.

[0075] Delivery system

[0076] Figures 11 to 15CA delivery device 1124 configured to deliver a prosthetic mitral valve transapically to the heart is shown. However, those skilled in the art will understand that the delivery system can be modified and the relative movement of the various components adjusted to allow transseptal delivery of the prosthetic mitral valve using the device. The delivery device generally includes: a handle 1101, which is a combination of handle segments 1102 and 1103. Figure 12 (best seen in the middle); and a flexible tip 1110 that can smoothly penetrate the apex of the heart; and a sheath catheter 1109 that accommodates multiple additional catheters designed for axial translation and will be described in detail below.

[0077] Handle 1101 includes a female-threaded Luer adapter 1113, which connects to a TuohyBorst adapter 1114 to provide a hemostatic seal with a 0.035″ diameter guide wire (not shown). The female-threaded Luer adapter 1113 passes through a threaded port 1131 (in... Figure 12 (best seen in the middle) is in threaded contact with the proximal portion of the handle 1101.

[0078] like Figure 11 As can be seen, the handle 1101 provides positioning for the control mechanism used to position and place the prosthetic mitral valve. The handle 1101 provides housing for the thumbwheel 1106, which is accessible through windows 1137 appearing on both the top and bottom of the handle 1101. The thumbwheel 1106 internally engages with the threaded insert 1115 of the actuating sheath catheter 1109 (in... Figure 12 (As can be seen from the best part,) they work together, and the mechanism of this interaction will be explained in detail below.

[0079] Figure 11 Also shown is a placement wheel 1104, which, when rotated, provides placement conduit 1120 (in... Figure 12 The linear translation (best seen in the image) is due to the rotational movement of the mounting wheel 1104 acting as a power screw, which pushes the pin 1128 forward and away from the user. The mechanism behind the pin 1128 will be described in further detail below. The wheel lock 1105 provides a safety measure to prevent unintended rotation of the mounting wheel 1104 by acting as a physical barrier to rotation. In order to rotate the mounting wheel 1104, the user must push the wheel lock 1105 forward, thereby engaging the wheel lock 1105 with the two slots 1147 in the mounting wheel 1105 (see [link to image]). Figure 12 Disconnect the connection.

[0080] As in Figure 11As can also be seen, the bleed valve 1108 and fluid line 1107 are connected to an internal mechanism located in the distal portion of the handle 1101, which provides a hemostatic seal for the sheathed catheter 1109. Details of this connection will be described below.

[0081] The internal mechanism of the delivery device 1124 is in Figure 12 The details are shown in the diagram, and the following description will reveal the interactions between the various components and how these components are combined to realize a prosthetic heart valve delivery device.

[0082] like Figure 12 As seen in the image, handle section 1103 and handle section 1102 combine to form handle 1101, which forms the base of delivery device 1124. To advance the sheathed catheter 1109 during valve loading or to retract the sheathed catheter 1109 during placement, a rotatable rotary wheel 1106 is coupled with a threaded insert 1115. Figure 13 External thread 1130) thread contact ( Figure 14 The threaded insert 1115, visible internally, is linearly translated from a proximal position to a distal position along the axis of the delivery device. The sheathed conduit 1109 engages with the threaded insert 1115 and is secured by a collar 1117 that aligns and engages with the insert. The collar 1117 is secured using a screw 1116. Figure 14 (See details in section A for best viewing) Fastened to threaded insert 1115 and includes fluid port 1142 (in Figure 14 (Best seen in detail A), fluid port 1142 provides positioning for fluid line 1117, allowing hemostasis to be maintained between the patient and the delivery device. O-ring 1118 (in...) Figure 14 (See details in section A for best viewing) Fix the catheter 1119 (in Figure 14 (Best viewed from the center) a seal is provided relative to the sheathed conduit 1109. The fluid line 1107 also provides a method for visually positioning the sheathed conduit 1109 in terms of location, because the groove 1138 in the handle 1101 allows the fluid line 1107 to translate along with the sheathed conduit 1109 through the orifice 1151 during operation (in...). Figure 14(See detail A best in the image), and the translation is highly visible. To prevent the threaded insert from rotating during translation, flat surfaces 1164 have been machined on both sides of the threaded insert 1115. Flat surfaces 1164 maintain contact with bosses 1139 and 1140 located on both handle sections 1102 and 1103, such that bosses 1139 and 1140 are used to clamp the threaded insert 1115 and prevent rotation. Textured pattern 1155 allows the user to easily rotate the rotary wheel 1106 in the surgical area. Stopper 1141 ( Figure 14 (Best viewed in the center) The flange 63 located on the finger wheel 1116 (see) Figure 14 (In the middle) so that rotation is allowed.

[0083] exist Figure 12 The diagram illustrates the movement of the individual catheters (there are four catheters) relative to each other. A sheathed catheter 1109 provides a housing for a fixed catheter 1119, which in turn provides a housing for a movable hub catheter 1120. The hub catheter 1120 translates linearly relative to a nasal catheter 1121, which can also translate relative to each preceding catheter and handle 1101. The fixed catheter 1119 mates with a handle segment 1103 within an inner bore 1150, which also forms a seal between the fixed catheter 1119 and the hub catheter 1120. The distal portion of the fixed catheter 1119 is shaped like a bell 1122 (see [link to documentation]). Figure 15A Detail A), the bell-shaped part 1122 serves to hold the hub capture 1123 (see details). Figure 15A Details A) of the shell.

[0084] As previously stated, the rotary lock 1105 prevents the rotary wheel 1104 from rotating. To provide a settling force that holds the rotary lock 1105 in the locked position until it is actuated, a recess 62 (in...) Figure 14 The spring 1125 is housed within the (best viewed in the center) and abuts against the shoulder 1161 located inside the rotary lock 1105. Figure 14 (Best viewed in the middle). Spring 1125 holds the front edge 1149 of the rotary lock 1105 in the locked position within the two slots 1147 where the rotary wheel 1104 is housed. For ease of use, gripping texture 1154 is provided on the rotary lock 1105. To position and hold the rotary lock 1105 inside the handle 1101, slots 1135 are provided in both the handle section 1102 and the handle section 1103.

[0085] like Figure 12As shown, a slider 1127 is housed within a flat, parallel surface 1134 that appears inside the handle 1101. The slider 1127 mates with the hub guide 1120 and is a physical mechanism that linearly actuates the guide. A spring 1126 is mounted on the outer post 1159 and abuts against a shoulder 1133 located at the distal end of the slider 1127. This spring 1126 holds the pin 1128 (located at...) Figure 14 The through-hole 1156 is pressed into contact with the proximal edge of the angled groove 1148 cut into the mounting wheel 1104. The mounting wheel 1104 is received between a shoulder 1136 and a retaining ring (not shown), both of which are features of the handle 1101. The grip texture 1153 on the mounting wheel 1104 allows the user to easily rotate the wheel clockwise, thereby actuating the pin 1128 to travel distally along the groove 1148 and moving the slider 1127, which connects the hub guide 1120 and the hub 1123 (in Figure 15A (See detail A for best view) Push forward and away from bell-shaped part 1122 (see details A) Figure 15A Detail A). The groove 1132 appears in the handle section 1102 and handle section 1103 and prevents the pin 1128 from translating beyond the desired range.

[0086] The nasal cannula 1121 extends from the TuohyBorst adapter 1114 located at the proximal end of the handle 1101 and internally penetrates the handle and the various cannulas (sheathed cannula 1109, fixed cannula 1119, and hub cannula 1120), terminating at a flexible tip 1110 abutting against the distal end of the sheathed cannula 1109 (see [link]). Figure 15A Rigid insert 1112 (see) Figure 15A (the interior of)

[0087] Figure 13 An exploded view of the tip portion of the delivery device 1124 is shown, illustrating the relationship between the prosthetic mitral valve 1165 and the internal and external catheters. When coiled and loaded, the prosthetic mitral valve 1165 is encased between the inner surface of the sheath catheter 1109 and the outer surface of the nasal catheter 1121. To capture and anchor the prosthetic mitral valve 1165 within the delivery device 1124, three engaging tabs 1160 (circumferentially spaced at approximately 120°) appearing on the proximal end of the prosthetic mitral valve 1165 provide the valve with three grooves 1143 (circumferentially spaced at approximately 120°) machined into the outer surface of the hub 1123 (see [reference]). Figure 15A The contact point between ) is located by rotating the finger wheel 1104 clockwise (see Figure 12 First, make hub guide 1120 ( Figure 15A After advancing, the three engagement tabs 1160 can be captured in the three slots 1143 (see...). Figure 15A Inside. Then it can be placed by releasing the spinner 1104 (see...) Figure 12 The hub 1123 is retracted into the bell-shaped member 1122. In this position, the prosthetic mitral valve 1165 is anchored to the delivery device 1124, and further curling of the valve will allow the sheath catheter 1109 to advance over the valve.

[0088] Figures 15A to 15C It also details how to achieve the insertion of a prosthetic mitral valve 1165 (see [link]). Figure 13 The flexible tip 1110 is loaded into the delivery device 1124. Initially, the flexible tip 1110 abuts against the distal edge 1157 of the sheathed catheter 1109. The flexible tip 1110 includes a rigid insert 1112 and a soft, flexible tip portion 1111 overmolded onto the rigid insert 1112. The shoulder 1145 and the reduction surface 1146 of the rigid insert 1112 guide and position the distal edge 1157 of the sheathed catheter 1109, allowing the catheter to rest against and be reinforced by the flexible tip 1110, and to be more easily introduced into the apex of the heart.

[0089] The initial loading position can be achieved at Figure 15A The image in the middle shows the prosthetic mitral valve 1165 (see [reference]). Figure 13 The first step, loading the sheathed conduit 1109 into the delivery device 1124, involves retracting it by rotating the rotary wheel 1106 clockwise. Figure 15B As shown in detail A, the distal edge 1157 of the sheath catheter 1109 is retracted until the distal edge 1157 passes the distal edge of the bell-shaped member 1122. This is in contrast to the placement of the prosthetic mitral valve 1165 (see...). Figure 13 The second step, as shown, involves loading the contents into the delivery device 1124. Figure 15C As shown in detail A, the rotary wheel 1104 is positioned by rotating it clockwise (see...). Figure 12 This allows hub 1123 to advance beneath bell-shaped member 1122. The rotary wheel can be positioned only at rotary wheel lock 1105 (see...). Figure 12 It is only rotated when it is already set in the forward position, thus disengaging from the rotary wheel. The forward movement of the hub 1123 exposes three slots 1143, and the three engaging tabs 1160 of the prosthetic mitral valve 1165 (see...). Figure 13 The assembly will be fitted and anchored into the three slots 1143. After the engagement tab 1160 has been anchored into the slots 1143 by retracting the hub 1123, the prosthetic mitral valve 1165 (see [link to product]) can be inserted. Figure 13 The third step is loading the prosthetic mitral valve into the delivery device 1124. (See also: [see also: 1165]) Figure 13The mitral valve can be rolled down to its minimum diameter by a loading mechanism (not shown), and then the sheath cannula 1109 can be advanced forward to cover the valve by rotating the finger wheel 1106 counterclockwise. The delivery device 1124 and the prosthetic mitral valve 1165 are then ready for placement.

[0090] Figures 16 to 19B Another example of a delivery device for implanting a prosthetic valve into the heart via the apex is shown. However, those skilled in the art will understand that the delivery system can be modified and the relative movement of various components adjusted to allow for transseptal delivery of the prosthesis using the device. The delivery device generally comprises a handle 1601 composed of two halves (1610 and 1635), a tip 1603 capable of smoothly penetrating the apex of the heart, and a flexible sheath 1602 containing a concentric catheter designed for axial translation, which will be described in detail below.

[0091] Handle 1601 includes a handle cap 1611, which connects to a female-threaded Luer adapter 1612 to provide a sealable outlet for a 0.035″ diameter guide wire (not shown). Handle cap 1611 is attached to handle 1601 via a threaded fastener 1613. Female-threaded Luer adapter 1612 makes threaded contact with handle cap 1611 via a tap port and abuts against an O-ring (1636, in...) when fully inserted. Figure 18 (Best seen in the middle) compression, the O-ring seals the guide wire conduit (1621, in) Figure 18 The outer diameter (which is best seen in the middle).

[0092] like Figure 17 As can be seen, the handle 1601 provides positioning for the control mechanism used to position and place the prosthetic mitral valve. The handle 1601 provides a housing for the rotary wheel 1616, which is accessible through windows 1606 appearing on both the top and bottom of the handle 1601. The rotary wheel 1616 internally engages with a threaded insert that actuates the sheath catheter 1604. Figure 18 The interaction between the two molecules (1627) will be explained in detail below.

[0093] Figure 17 A first blood vessel stop 1617 is also shown, which is inserted into the groove 1605 and mates with the first blood port through a hole (respectively). Figure 18 (Referring to 1625 and 1626 in the diagram). The first stop vessel 1617 allows for fluid purging between the internal catheters. The location of the first stop vessel 1617 along the groove 1605 provides visual cues regarding the position of the sheath catheter 1604 and the relative placement stage of the prosthetic mitral valve (not shown). The relationship between the connection of the first stop vessel 1617 and the sheath catheter 1604 will be described below.

[0094] If it is still possible Figure 17 As seen in the image, the second blood vessel 1614 is inserted into the handle 1601 and connected to the second blood port. Figure 18 The 1629) in the middle is designed to allow fluid purging between the internal catheters, and the details of this insertion will be described below. Finally, the pin 1608 provides a safety measure to prevent premature release of the prosthetic mitral valve by acting as a physical barrier to translation between the internal mechanisms. The pin fork 1615 holds the pin 1608 in the handle 1601 by spring force, and the user must first pull out the pin 1608 before finally placing the prosthetic valve.

[0095] Figure 17 It also shows how the handle 1601 can be used with threaded fasteners and nuts (separately). Figure 18 The 1607 and 1639) and the countersunk locator hole 1609, which runs through the length of the handle, are fastened together.

[0096] exist Figure 18 The internal mechanisms of the delivery system are shown in detail, and the following description will reveal the interactions between the various components and how these components are combined to create a system capable of delivering a prosthetic mitral valve preferably transapically.

[0097] like Figure 18As seen in the diagram, the flexible sheath 1602 comprises four concentrically nested conduits. The concentrically nested conduits will be described in detail in order of diameter from smallest to largest. The innermost conduit is the guide wire conduit 1621, which runs internally throughout the delivery system, starting at the tip 1603 and terminating in the female-threaded Luer adapter 1612. The guide wire conduit 1621 comprises a lower-hardness single-lumen PEEK extrusion and is fixed. The guide wire conduit 1621 provides a channel through which a guide wire (not shown) can communicate with the delivery system. The next conduit is the hub conduit 1622, which provides support for the hub 1620 and generally comprises a higher-hardness single-lumen PEEK extrusion. The hub conduit 1622 mates with the hub 1622 at its distal end and with a stainless steel support rod 1634 at its proximal end. The stainless steel support rod 1634 is held in place by a stop 1637 encased in the handle 1601. The hub conduit 1622 is fixed and provides support and axial stiffness for the concentrically nested conduits. The next conduit is the bell-shaped conduit 1624, which provides a housing for the hub 1620 and generally comprises a medium-rigidity single-lumen PEBAX extrusion. The bell-shaped conduit 1624 includes an internal steel-braided, lubricated liner and a radiopaque marking strip (not shown). The bell-shaped conduit 1624 is axially translatable and can advance and retract relative to the hub 1620. The bell-shaped conduit 1624 mates with a second blood port 1629 at its proximal end, and hemostasis between the bell-shaped conduit 1624 and the stainless steel support rod 1634 can be achieved by purging the second tamponade 1614. The bell-shaped conduit 1624 protrudes to a larger diameter 1623 at its distal end to enclose the hub 1620. The outermost and final catheter is a sheathed catheter 1604, which provides the object for the prosthetic mitral valve (not shown) and is capable of penetrating the apex (not shown) by supporting and guiding the tip 1603 and helping to widen the incision in the cardiac wall muscle. The sheathed catheter 1604 generally comprises a medium-rigidity single-lumen PEBAX extrusion and includes an internal steel-braided, lubricated lining and a radiopaque marking strip (not shown). The sheathed catheter 1604 is axially translatable and can advance and retract relative to the hub 1620. The sheathed catheter 1604 mates with a first blood port 1625 at its proximal end, and hemostasis between the sheathed catheter 1604 and the bell-shaped catheter 1624 can be achieved by purging the first tamponade vessel 1617.

[0098] like Figure 18As seen in the image, the proximal end of the sheathed catheter 1604 mates with the first blood port 1625. The first blood port mates with a threaded insert 1627 and an O-ring 1638, which is clamped between the first blood port 1625 and the threaded insert 1627 to press against the bell-shaped catheter 1624 to form a hemostatic seal. When the rotary wheel 1616 is rotated, the screw insert 1627 translates, and the sheathed catheter 1624 can be retracted or advanced by attachment. To provide sufficient rigidity to expand the cardiac wall tissue, the distal edge of the sheathed catheter 1604 abuts against the shoulder 1618 located on the tip 1603. This connection allows the tip 1603 to remain fixed and aligned with the sheathed catheter 1604 during delivery and provides puncture rigidity.

[0099] Figure 18 The mechanism by which the bell-shaped conduit 1624 can retract or advance relative to the hub 1620 is also detailed. The rotary wheel 1616 can be rotated to such an extent that the screw insert 1627 will contact the two pins 1628 press-fitted into the second blood port 1629. When the bell-shaped conduit 1624 is in contact with the second blood port 1629, further rotation of the rotary wheel 1616 will cause the second blood port 1629 to translate and press against the spring 1633 via its connection to the second blood port cap 1632. This advance will cause the larger diameter convex portion 1623 of the bell-shaped conduit 1624 to retract from the hub 1620. When the finger wheel 1616 rotates in the opposite direction, the restoring force generated by the spring 1633 will cause the second blood port 1629 to be pushed in the opposite direction, thereby pulling the larger diameter section 1623 of the bell-shaped catheter 1624 back onto the hub 1620. This action is necessary during the initial loading of the valve prosthesis.

[0100] Figure 18 The method of achieving hemostasis between the stainless steel support rod 1634 and the bell-shaped conduit 1624 is further described in detail. An O-ring 1631 is compressed between the second blood port 1629 and the second blood port cap 1632, thereby forming a seal against the stainless steel support rod 1634. Hemostasis between the bell-shaped conduit 1624 and the stainless steel support rod 1634 can be achieved by purging the second stop tube 1614, which communicates with the gap to be purged through a groove and a hole 1630.

[0101] exist Figures 19A to 19B The procedure and actions required to activate the placement facility are detailed in the document. When performed in reverse order, these actions also require an initial loading of the valve (not shown) prior to the surgery.

[0102] like Figure 19AAs seen in the image, the operation of the rotary wheel 1616 provides translational control of the sheath catheter 1604. To place the heart valve (not shown), the user must withdraw the sheath catheter 1604 from contact with the shoulder 1618 of the tip 1603 until the sheath catheter 1604 passes through the larger diameter section 1623 of the bell-shaped catheter 1624. The heart valve (not shown) will then be concentrically positioned above the guide catheter 1621. Figure 19A The position indicated by the lead wire used for 1621 is similar to... Figure 13 The example shown is illustrated. The sheathed conduit 1604 can be withdrawn until the screw insert 1627 contacts the locking pin 1608. The locking pin 1608 must then be removed before further travel of the screw insert 1627 can be achieved.

[0103] like Figure 19B As seen in the image, the locking pin 1608 is removed from the handle 1601 to allow further translation of the sheath catheter 1604. When the sheath catheter 1604 is fully retracted, the larger diameter section 1623 of the bell-shaped catheter 1624 is also fully retracted, which completely releases the heart valve (not shown) from the delivery system. Three hubs 1619, circumferentially spaced from each other at approximately 120 degrees, provide an anchoring mechanism and physical connection between the delivery system and the heart valve. Once the larger diameter section 1623 of the bell-shaped catheter 1624 has been withdrawn, the hubs 1619 become uncovered, allowing the heart valve anchors (not shown) to fully expand.

[0104] Figure 20 It shows Figure 16 The distal portion of the delivery device. Three hub grooves 1619 are slidably arranged distally relative to the larger diameter tip 1623 of the bell-shaped conduit 1624. These grooves allow engagement with a prosthetic valve. The valve can be releasably held by the grooves by positioning the engagement tab or tab 812 of the prosthetic valve into the grooves 1619 and then retracting the grooves 1619 below the tip 1623 of the bell-shaped conduit 1624. When the constraint on the tip 1623 on the bell-shaped conduit 1624 has been removed, the prosthetic valve can be released from the delivery conduit by advancing the grooves distally relative to the bell-shaped conduit so that the loading anchor or tab 812 can expand out of and leave the grooves 1619.

[0105] Figure 21 The prosthetic mitral valve 800 is shown (as referenced above). Figure 8AAs discussed, the anchoring tab 812 is arranged in a hub groove (not visible), and the bell-shaped conduit 1623 advances over the anchoring tab 812. Therefore, even though most of the prosthetic valve 800 has self-dilated into the expanded configuration of the prosthetic valve, the valve junction remains in a collapsed configuration, where the tab 812 is trapped in the groove 1619. Once the constraint provided by the bell-shaped conduit 1623 has been removed from the groove 1619, the tab 812 can self-dilate out of the groove 1619, and the junction will open to the unbiased position of the junction. The prosthetic valve is then disconnected from the delivery device and released from the delivery device.

[0106] transapical delivery method

[0107] Figures 22A to 22G An example of a method for transapical delivery of a prosthetic mitral valve is shown. This example can use any prosthetic valve described herein, and any delivery device described herein. Figure 22A The overall transapical route is shown, obtained by entering the heart at the tip 2202, passing through the left ventricle 2204, through the mitral valve 2206, and into the left atrium 2208. The aortic valve 2210 remains unaffected. The transapical delivery method has been described in patents and scientific literature, for example, in International PCT Publication No. WO2009 / 134701, the entire contents of which are incorporated herein by reference.

[0108] exist Figure 22B In this embodiment, the delivery device 2214 is introduced through an incision in the tip 2202 and passes along the guide wire GW through the ventricle 2204 and the mitral valve 2206, with the distal portion of the delivery device 2214 positioned in the atrium 2208. The delivery device has a rounded tip 2212 configured to pass through and widen the incision, allowing it to be advanced through the heart without causing undesirable trauma to the mitral valve 2206 or adjacent tissue. A suture 2216 may be used, such as a purse-string suture or other patterns known in the art, to suture around the tip 2202 of the delivery device 2214 to prevent excessive bleeding and to help hold the delivery device in place.

[0109] exist Figure 22CIn this process, the outer sheath 2214a of the delivery device 2214 is retracted proximally relative to the prosthetic mitral valve 2220 (or the prosthetic mitral valve is advanced distally relative to the outer sheath 2214a) to expose the alignment element 2218 and a portion of the atrial skirt region 2222 on the prosthetic mitral valve 2220. This allows the atrial skirt region 2222 to begin to partially expand radially outward and open. The alignment element 2218 may include a pair of radiopaque markers 2218a that facilitate visualization under fluoroscopy. The physician can then align the alignment element such that the radiopaque markers 2218a are positioned on either side of the anterior mitral leaflet. The delivery device 2214 may be rotated to aid in aligning the alignment element. The alignment element is preferably located near the aortic root and between the fibrous triangles of the natural anterior leaflet.

[0110] exist Figure 22D Once alignment is achieved, the sheath 2214a is further retracted proximally, allowing the atrial skirt 2222 to expand radially, opening outward to form a flange. The proximal retraction of the delivery device 2214 and the prosthetic valve 2220 causes the atrial skirt 2222 to sit against the atrial surface near the mitral valve 2206, thereby anchoring the prosthetic valve in the first position.

[0111] Figure 22E The further proximal retraction of the sheath 2214a exposes the prosthetic valve 2220 and removes additional constraints on the prosthetic valve 2220 axially, thereby allowing for further self-expansion of the valve. The annular region 2224 expands to engage with the mitral valve annulus, and the ventricular triangular flap 2226 and posterior flap 2228 expand radially. A portion of the ventricular skirt serves as a placement control area and prevents the entire ventricular skirt from expanding, as it remains constrained. The flaps are captured between the anterior mitral leaflet and the ventricular wall, and between the posterior mitral leaflet and the ventricular wall. The posterior ventricular anchoring flap 2228 is preferably aligned in the middle of the posterior mitral leaflet in which no tendon attachments are present, and extends beyond the posterior leaflet to sit between the posterior leaflet and the ventricular wall. The two ventricular triangular anchoring flaps 2226 are positioned on either side of the anterior leaflet, with the head of the central ventricular triangular anchoring flap 2226 positioned at the fibrous triangle. Slight rotation and realignment of the prosthesis can then occur. As the prosthesis expands, the anterior triangular flap is anchored against the fibrous triangle, thereby capturing the natural anterior leaflet and tendon between the flap and the anterior surface of the prosthetic valve, while the posterior ventricular flap is anchored between the ventricular wall and the posterior leaflet, thereby capturing the posterior leaflet between the posterior anchoring flap and the posterior surface of the prosthetic valve assembly.

[0112] Figure 22FFurther retraction of sheath 2214a is shown to release the ventricular triangular flap and posterior flap, and the placement control area of ​​the ventricular skirt 2230 is also released, allowing radial outward expansion against the natural mitral valve leaflet. This forms a sealing funnel within the natural leaflet and helps guide blood flow through the prosthetic mitral valve. Because the prosthesis's junction remains trapped within the delivery system, very minor adjustments can still be made to ensure accurate positioning, anchoring, and sealing. The prosthetic valve is now anchored in four positions. The anchoring flap 2232 is then released from the delivery device by retraction of the inner axis, allowing the flap to expand out of the groove on the delivery catheter, as previously discussed above. Figure 22G As shown in the diagram, the prosthetic valve is now implanted in the patient's heart and takes over the natural mitral valve. The delivery device 2214 can then be removed from the heart by retracting it proximally and removing it from the tip incision. The suture 2216 can then be knotted to seal the puncture site.

[0113] Interval delivery method

[0114] Figures 23A to 23G An example of a method for delivering a prosthetic mitral valve via the septum is illustrated. This example can use any prosthetic valve described herein, and any delivery device described herein can be used if appropriately modified. Those skilled in the art will understand that it may be necessary to reverse the relative motions of various axes in the above-disclosed delivery system examples to adapt to the transseptal method. Figure 23A The overall transseptal approach is shown, obtained by delivering a device upward through the vena cava 2302 into the right atrium 2304. A transseptal puncture 2306 is performed through the atrial septum, typically via the foramen ovale, allowing the device to be inserted into the left atrium 2308, reaching above the mitral valve 2310 and near the left ventricle 2312. Transseptal techniques have been disclosed in patents and scientific literature, for example in U.S. Patent Publication No. 2004 / 0181238 to Zarbatany et al., the entire contents of which are incorporated herein by reference.

[0115] exist Figure 23B In this configuration, the delivery device 2314 passes through the vena cava 2302 along the guide wire GW and enters the right atrium 2306. The delivery device 2314 then passes through the septum and atrial wall, entering the left atrium 2308 near the mitral valve 2310. The guide wire GW can pass through the mitral valve 2310 and be positioned in the left ventricle 2312. The distal tip of the delivery device typically includes a nasal cone or other non-traumatic tip to prevent damage to the mitral valve or adjacent tissues.

[0116] exist Figure 23CIn this configuration, the outer sheath 2214a of the delivery device 2214 is retracted proximally relative to the prosthetic mitral valve 2319. Alternatively, the distal portion 2314b of the delivery device 2214 may be advanced distally relative to the prosthetic valve 2319 to expose the alignment element 2316 and a portion of the atrial skirt region 2318 on the prosthetic mitral valve 2319, allowing the atrial skirt region 2318 to initially expand radially outward and open. The alignment element 2316 may include a pair of radiopaque markers 2316a that facilitate visualization under fluoroscopy. The physician can then align the alignment element such that the radiopaque markers 2316a are positioned on either side of the anterior mitral leaflet. The alignment element is preferably located near the aortic root and between the fibrous triangles of the natural anterior leaflet. The delivery device 2214 may be rotated to aid in aligning the alignment element.

[0117] exist Figure 23D Once aligned, the distal portion 2314b is further advanced distally, allowing the atrial skirt 2318 to expand radially, opening outward to form a flange. Advancing the delivery device 2214 and the prosthetic valve 2319 distally causes the atrial skirt 2318 to sit against the atrial surface near the mitral valve 2310, thereby anchoring the prosthetic valve in the first position.

[0118] Figure 23E Further distal advancement of the distal portion 2314b exposes the prosthetic valve 2319 and removes additional constraints on the prosthetic valve 2319 axially, thereby allowing further self-expansion of the valve. The annular region 2320 expands to engage with the mitral valve annulus, and the ventricular triangular flap 2324 and posterior flap 2322 expand radially. A portion of the ventricular skirt serves as a placement control region because it remains constrained, and therefore the entire ventricular skirt cannot expand. The flaps are captured between the anterior mitral leaflet and the ventricular wall, and between the posterior mitral leaflet and the ventricular wall. The posterior ventricular anchoring flap 2322 is preferably aligned in the middle of the posterior mitral leaflet in which no tendon attachments are present, and extends beyond the posterior leaflet to sit between the posterior leaflet and the ventricular wall. The two ventricular triangular anchoring flaps 2324 are positioned on either side of the anterior leaflet, with the head of the central ventricular triangular anchoring flap 2324 positioned at the fibrous triangle region. At this point, slight rotation and realignment of the prosthesis may occur. As the prosthesis expands, the anterior triangular flap is anchored against the fibrous triangle, thereby capturing the natural anterior leaflet and tendon between the flap and the anterior surface of the prosthetic valve, and the posterior ventricular flap is anchored between the ventricular wall and the posterior leaflet, thereby capturing the posterior leaflet between the posterior anchoring flap and the posterior surface of the prosthetic valve assembly.

[0119] Figure 23FFurther distal advancement of the distal portion 2314b is shown to release the ventricular triangular flap and posterior flap, and the ventricular skirt 2326 is also released and allowed to expand radially outward against the natural mitral leaflet without engaging the ventricular wall. This forms a sealing funnel within the natural leaflet and facilitates the collection of blood flow through the prosthetic valve. Because the confluence of the prosthetic valve remains captured by the delivery system, very minor adjustments can still be made to ensure accurate positioning, anchoring, and sealing. The prosthetic valve is now anchored in four positions. The anchoring flap 2328 is then released from the delivery device by further advancement of the inner axis, allowing the flap to expand out of the groove on the delivery catheter, as previously discussed above. Figure 23G As shown in the diagram, the prosthetic valve is now implanted in the patient's heart and takes over the natural mitral valve. The delivery device 2314 can then be removed from the heart by retracting it proximally through the atrial septum and away from the vena cava.

[0120] Figure 24 A prosthetic valve 2418 is shown, anchored in the mitral valve space after delivery via the apex or septum. The prosthetic valve 2418 is preferably... Figure 8A The prosthetic mitral valve shown is, and through Figures 22A to 22G or Figures 23A to 23GDelivery is performed as shown. The prosthetic valve 2418 has been radially self-expanded to engage with the mitral valve to anchor the prosthetic valve 2418 in place without obstructing other parts of the heart, including the left ventricular outflow tract, such as the aortic valve 2402. The anterior triangular flap 2408 (only one is seen in this figure) and the posterior ventricular flap 2405 expand radially outward from the remainder of the ventricular skirt 2410, and the anterior leaflet 2406 and posterior leaflet 2404 are captured between the respective flaps and the ventricular skirt 2410 to form anchoring points. The ventricular skirt 2410 also expands radially outward to engage and compress at least some of the chordae tendineae and papillary muscles, but preferably not against the ventricular wall. The annular region 2416 expands radially outward to engage and compress against the mitral valve annulus, and the atrial skirt 2414 has also been expanded outward to form a flange resting against the atrium on the top of the mitral valve. Therefore, the prosthetic valve 2418 is anchored in four locations within the mitral valve space, which prevents the prosthetic valve from migrating or dislodging during cardiac systole. Furthermore, using four anchor points reduces the anchoring pressure required in any given anchoring region compared to a prosthesis anchored only in a single anchoring region or in any combination of these four anchoring regions. The corresponding reduction in radial force required to be applied to the natural structure in each region minimizes the risk of obstruction or impingement of the nearby aortic valve or aortic root caused by displacement of the natural mitral valve assembly. The leaflet 2420 forms the tricuspid valve, which opens with antegrade blood flow and closes with retrograde blood flow. The tab 2412 on the tip of the junction 2421 (in...) Figure 25 (best shown in the image) Remains free after being disconnected from the delivery device.

[0121] Figure 25 This shows the mitral valve anchored in the space between the mitral valves, viewed from the left ventricle upwards towards the atrium. Figure 24 The prosthetic valve 2418. As previously described, the prosthetic valve 2418 can be delivered transapically or transseptally, and preferably is Figure 8A As shown, by Figures 22A to 22G or Figures 23A to 23G The method shown illustrates the delivery of a prosthetic mitral valve. This view more clearly shows the anchoring and engagement of the prosthetic mitral valve 2418 with adjacent tissues. For example, the three leaflets 2420 forming the tricuspid valve are shown in the open position, allowing blood flow through the leaflets. Additionally, the anterior triangular flap 2408 and the posterior ventricular flap 2405 are shown expanding radially outward to engage with the ventricular cardiac tissue 2425. The anterior portion of the prosthetic valve between the anterior triangular flaps 2408 is approximately flat to mate with corresponding flat anatomical structures, as previously discussed above. The flat shape of the anterior portion of the prosthetic valve prevents the prosthetic valve from impinging on and obstructing adjacent anatomical structures, such as the left ventricular outflow tract, including the aortic valve. Figure 25It also shows how the ventricular skirt 2410 expands radially outward against the natural mitral valve leaflets.

[0122] Drug delivery

[0123] Any prosthetic valve can also be used as a drug delivery device for local drug elution. Therapeutic agents can be applied to the prosthetic valve, to the tissue covering the anchor, to both, or otherwise carried by the prosthetic valve and eluted from it in a controlled manner after implantation. Some examples of drugs include anticalcifying agents, antibiotics, antiplatelet aggregation agents, anti-inflammatory agents, agents that inhibit tissue rejection, anti-restenosis agents, antithrombotic agents, thrombolytic agents, etc. Drugs with these therapeutic effects are well known to those skilled in the art.

[0124] Flow control

[0125] Figures 26A to 26C This demonstrates how the orientation of a prosthetic valve can be used to control fluid outflow patterns.

[0126] exist Figure 26A In this design, the prosthetic valve 2600 (which may be any prosthetic valve disclosed herein and may be implanted using any of the methods and delivery systems disclosed herein) comprises an expandable frame having an atrial flange 2602, a ventricular skirt, an annular region 2604, and anterior anchoring tabs (only one is visible in this view) and posterior anchoring tabs, 2606, 2608. The atrial flange forms an angle 2612 substantially perpendicular to the longitudinal axis 2610 of the prosthetic valve. The flange angle can be formed by heat-treating the struts in the prosthetic valve during manufacturing. The longitudinal axis of the prosthetic valve is also substantially parallel to the fluid flow path through and out of the prosthetic valve via the outflow orifice. Therefore, the atrial flange is substantially flush with and parallel to the plane of the natural valve, and the flow path is substantially perpendicular to that plane, meaning that the blood flow path is substantially parallel to the longitudinal axis of the prosthetic valve. Blood flowing directly out of the prosthetic valve orifice and downwards can differ from the natural anatomical blood flow pathway, which can vary from patient to patient. In a healthy heart, the natural blood flow pathway is that blood flows towards the posterior wall of the heart, along the posterior wall to the apex, around the apex, and then upwards towards the LVOT, exiting the aorta via the aortic valve. Figure 26A The configuration in the blood flow may produce unnatural hemodynamics in some patients.

[0127] exist Figure 26BIn this design, the atrial flange 2602 is angled relative to the longitudinal axis of the prosthetic valve, such that the anterior portion of the atrial flange is radially outwardly angled in an upwardly inclined direction and radially inwardly downward toward the longitudinal axis, while the posterior portion of the atrial flange is downwardly angled in a radially outward direction and away from the longitudinal axis to form a flange that is upwardly deflected or inclined in the anterior direction and downwardly inclined in the posterior direction. Angled atrial flanges allow for positioning of the prosthetic valve to guide prosthetic valve outflow in a desired direction. The angle of the posterior portion of the flange relative to the longitudinal axis of the prosthetic valve may be the same as the angle of the anterior portion of the flange relative to that longitudinal axis. The angle of the atrial flange can be formed by heat-treating the struts in the prosthetic valve during manufacturing prior to implantation, and the prosthetic valve may be any prosthetic valve disclosed herein. Figure 26A Apart from the angle of the atrial flange 2602 shown, other aspects of the atrial flange may generally take the same form as any other atrial flange described herein. For example, the atrial flange may have a D-shaped shape conforming to natural anatomy. In other instances, the atrial flange may be at different angles; for example, instead of the flange being inclined upward in the posterior-to-anterior direction, the flange may be inclined downward in the posterior-to-anterior direction. Alternatively, the posterior portion of the flange may be arranged at an angle different from the anterior angle. In any instance, when the atrial flange is in a collapsed configuration, such as when the atrial flange is constrained during delivery by being positioned in a lumen within the outer axis, the strut forming the atrial flange will be in a flat, linear configuration substantially parallel to the longitudinal axis of the prosthetic valve. When the constraint on the atrial flange is removed by retracting the outer axis, the atrial flange can self-expand.

[0128] Figure 26C The image shows the implanted mitral valve in the patient. Figure 26B The prosthetic valve 2600. When the atrial flange 2602 is anchored, it sits flush with the floor of the atrium to form a non-perpendicular angle 2612 between the plane of the natural valve and the longitudinal axis of the prosthetic valve. This causes the outflow orifice to point posteriorly, directing blood flow 2614 toward the posterior P wall of the heart H. The inflow and outflow axes intersect the longitudinal axis of the natural valve. The flow remains substantially parallel to the longitudinal axis of the prosthetic valve. Blood then flows down the posterior wall toward the apex, bends around the apex, and flows up into the left ventricular outflow tract (LVOT) and into the aorta (Ao). For some patients, this is considered a physiologically more normal blood flow pattern in a healthy heart and therefore less disruptive to circulation. It helps maintain flow momentum and conserve flow energy, allowing the heart to function more efficiently. Anchor plates 2606 and 2608 may be anchored to the fibrous triangle / posterior ring as previously described in this specification. Other aspects of the prosthetic valve may take the form of any other prosthetic valve disclosed herein, such as having a D-shape, anterior and posterior anchors, a ventricular skirt, etc.

[0129] Figure 27 Another example of a prosthetic valve is shown, which can be used to guide fluid flow in a desired direction. The prosthetic valve 2700 can be any prosthetic valve disclosed herein and may have an atrial flange 2702, anterior anchoring flaps, and posterior anchoring flaps 2706, 2704, but the expandable frame 2710 can be shaped such that the outflow 2708 is directed in a desired direction (e.g., the posterior wall of the patient's heart) to provide a more natural blood flow. Thus, the outlet orifice of the prosthetic valve can be tilted relative to the longitudinal axis of the prosthetic valve. The prosthetic valve 2700 can be shaped to guide this flow to any desired location (where the outflow end is angled relative to the longitudinal axis of the prosthetic valve), such that the flow is directed to the posterior wall of the ventricle to facilitate downward flow towards the apex, around the apex, and subsequently upward flow towards the LVOT and outflow from the aorta through the aortic valve. The atrial flange can be any atrial flange disclosed herein, but here it can be D-shaped and located in a plane substantially orthogonal to the longitudinal axis of the prosthetic valve, and the atrial flange will also be located in a plane parallel to the plane of the natural valve annulus. The valve may also include anterior anchoring flaps, posterior anchoring flaps, an annular region, and a ventricular skirt, such as those disclosed herein. The inflow axis of the prosthetic valve is substantially parallel to the longitudinal axis of the prosthetic valve.

[0130] Figure 28 A prosthetic valve 2800 is shown, which can be any prosthetic valve disclosed herein, including a prosthetic mitral valve, and any features of the prosthetic valves disclosed herein may be included. Figure 28 Examples of such features include the atrial flange, annular region, ventricular region, anterior anchoring flap, and posterior anchoring flap. The expandable frame of the prosthetic valve may be covered with fabric, tissue, or any other material 2802, as discussed previously. However, instead of attaching the covering to the frame with sutures, the covering may be welded to the expandable frame. Thus, by eliminating sutures, the prosthetic valve will have a smaller profile in the collapsed configuration, thereby facilitating delivery to the target therapeutic valve. Similarly, the prosthetic valve leaflets may be attached to the expandable frame and connecting posts without sutures (not shown) to further help reduce the profile of the collapsed device during delivery. All or only selected portions of the expandable frame may be attached to the covering. For example, some or all of the atrial flange, annular region, ventricular skirt, anchoring flap, etc., may be covered or uncovered by the covering material. Additionally, a combination of sutured or sutureless connections between the covering and the prosthetic valve frame may be used to join the materials together.

[0131] Figures 29A to 29B Optional positioning of the conjoint column in any of the prosthetic valve examples disclosed herein is shown. Figure 29AIn this design, the prosthetic valve 2900 can be a prosthetic mitral valve comprising the same structures as other examples disclosed herein, such as an atrial flange 2906, anterior anchoring flap 2908, and posterior anchor 2910. When the prosthetic valve assembly is in the open position, the engagement posts (only two are shown in this view, but may include more or fewer) 2904 are coupled at one end to the expandable frame and extend downstream and substantially parallel to the longitudinal axis of the prosthetic valve. Tissue, fabric, or other materials are typically attached to the expandable frame and engagement posts to form a mitral, tricuspid, or other number of prosthetic valve leaflets in the prosthetic valve assembly. For ease of observation of the engagement posts, the prosthetic leaflets are not shown.

[0132] exist Figure 29B In this configuration, when the valve is in the closed position, the connecting posts 2904 are arranged closer together and engage or nearly engage with each other to prevent regurgitation through the valve mechanism. In this example, prosthetic valves of different sizes can have valve orifice sizes. It is desirable to provide prosthetic valves with uniform outflow orifice sizes, such as… Figures 30A to 30B As shown in the image.

[0133] Figures 30A to 30B An example of a prosthetic valve 3000 is shown, which maintains a consistent outflow orifice size even for different valve sizes. Furthermore, the orifice size is smaller than in the case where the connecting post is straight, such as... Figure 29A I saw it in [the video / video]. Figure 30A In this specification, the prosthetic valve 3000 may be similar to any prosthetic valve disclosed herein, such as comprising an expandable frame having an atrial flange 3002, an anterior anchor 3004, and a posterior anchor 3006. Engagement posts (only two are shown, but more or fewer may be present) 3008 are radially angled inward toward the center of the prosthetic valve to form a consistent outflow orifice size (e.g., diameter). Figure 30A The diagram shows an interlocking post in an open configuration, where the interlocking post and the prosthetic valve leaflet (not shown for convenience) connected to it are angled but not in contact, and the orifice is open. A consistent-sized opening can be used to design different prosthetic valve sizes for implantation in different natural valve sizes. Figure 30B In the middle, the prosthetic valve mechanism is closed, with the connecting posts 3008 arranged abutting each other to close the orifice. The angle of the connecting posts can be established by heat treatment during manufacturing.

[0134] Figures 31A to 31BAnother example of a prosthetic valve 3102 is shown, which may have a radially expandable frame of any prosthetic valve frame described herein. The frame generally adopts the same form as any frame disclosed herein, including a frame optionally having an atrial flange, an annular region, a ventricular skirt, an anterior anchoring flap and a posterior anchoring flap, and a covering. The frame may be a D-shaped form with a flat anterior portion 3104 and a partially cylindrical posterior portion 3106. In this example, the prosthetic leaflet is used to guide flow to a desired location in the heart, rather than the overall shape of the expandable frame controlling the flow direction, as described above. Figure 27 As seen in the image. Here, the prosthetic valve assembly comprises two prosthetic valve leaflets, a wide anterior leaflet 3112 and a smaller posterior leaflet 3110. The leaflets are connected to two connecting posts 3108, which generally adopt the same form as the connecting posts previously described. The wide anterior prosthetic leaflet 3112 is wide enough to span the width of the natural fibrous triangle in the natural mitral valve and long enough to connect to the connecting flap such that the inflow edge of the prosthetic leaflet is positioned further forward than the outflow edge. The outflow edge of the anterior prosthetic leaflet is positioned further back. This produces prosthetic valve leaflets that are angled relative to the longitudinal axis of the prosthetic valve anchoring frame, and thus, when blood passes through the prosthetic valve, blood is directed towards the posterior wall of the patient's heart to produce the more natural blood flow discussed above. The posterior leaflet is smaller in length and width than the anterior leaflet and is designed to open and close alongside the anterior leaflet to form a one-way valve that prevents regurgitation. Figure 31A Two prosthetic leaflets 3110 and 3112 are shown juxtaposed in the closed position. Furthermore, in this example and any other example, some prosthetic leaflets may be movable, meaning they can move while other prosthetic leaflets remain stationary (meaning they remain fixed). For example, one prosthetic leaflet can move while a second prosthetic leaflet remains stationary.

[0135] Figure 31B It is shown in the open position. Figure 31A The prosthetic valve 3102 has leaflet edges that are not juxtaposed. The outflow edge of the posterior leaflet extends downward away from the expandable frame, while the anterior leaflet sweeps downward from the anterior to posterior portion of the expandable frame to form an angled prosthetic leaflet for posteriorly guiding flow. Additionally, the anterior leaflet may also form an arcuate shape with a radially inwardly facing concave portion.

[0136] Figures 26B to 26CFigures 27 and 31A to 31B illustrate that a prosthetic valve may have means for anchoring the prosthetic valve to a natural anatomical structure, such as a radially expandable frame, and means for forming a unidirectional valve that directs blood flow in a desired direction, such as toward the posterior wall of the patient's natural mitral valve, to provide a more natural blood flow that maintains momentum and blood energy as it flows through the prosthetic valve, through the left ventricle, and out of the patient's aorta into the left ventricular outflow tract, thereby enabling the heart to function more efficiently. The means for guiding flow may be implemented by features designed into the expandable frame or by other means for anchoring, or the flow guiding means may be implemented using the prosthetic valve mechanism.

[0137] Figure 32A A prosthetic valve 3202 with an effective orifice area (EOA) 3214 is shown. The prosthetic valve 3202 can be any prosthetic valve disclosed herein and includes, for example, an atrial flange 3204 and two connecting posts 3206. The prosthetic valve assembly has two prosthetic leaflets, including an anterior leaflet 3208 and a posterior leaflet 3210 connected to the connecting posts 3206. The outflow edges of the prosthetic leaflets are juxtaposed to each other to close the valve along line 3212. In this example, the prosthetic leaflets are sized, shaped, and connected to an expandable frame such that the effective orifice area 3214 is substantially circular and centered within a D-shaped prosthetic valve frame. Therefore, the effective orifice area is centered and substantially concentric with the longitudinal axis of the prosthetic valve.

[0138] Figure 32B Another example of the prosthetic valve 3202 is shown, which is similar to Figure 32A The valve in this case differs primarily in that the effective orifice area 3214 has been offset toward the lower six o'clock posterior portion of the prosthetic valve. This is achieved by attaching the prosthetic valve leaflet to the conjoint post and expandable frame to form... Figures 31A to 31B The anterior leaflet, as described, is used to guide blood flow posteriorly. Other aspects of valve 3202 are generally related to... Figure 32A The same as in the example, containing a D-shaped expandable frame.

[0139] In another instance, the effective orifice area can be offset backward while still maintaining flow substantially parallel to the longitudinal axis, as described in more detail below.

[0140] Figure 33A A prosthetic mitral valve 3302, implanted in a natural mitral valve to control blood flow from the left atrium to the left ventricle (LV), is shown. The posterior wall 3304 of the left ventricle and other basic anatomical structures such as the aortic valve (AV) and aortic valve (Ao) are also shown. The prosthetic valve 3302 can be any prosthetic valve disclosed herein.

[0141] Figure 33BFor example, in Figure 26A Or the standard prosthetic valve seen in any other instance disclosed herein, which does not have a device for directing the flow to the desired area of ​​the heart to maintain a more natural blood flow. Without directing the blood flow, the flow will generally follow a path 3306 parallel to the longitudinal axis of the prosthetic valve, and this results in the blood flow being directed toward the apex AP, which may not be an optimal flow pattern, causing the flow to lose momentum and energy.

[0142] Figure 33C A device for guiding blood flow within a prosthetic valve to achieve a more natural flow is illustrated. Here, the prosthetic valve 3302 can be any prosthetic valve with a device for guiding blood flow to the desired location, such as… Figures 26B to 26C Examples are shown in 27 and 31A to 31B. Thus, as flow passes through the prosthetic valve 3302, flow 3306 is directed to the posterior wall 3304 of the patient's heart, and blood then flows down the posterior wall towards the apex (AP), around the apex, and up through the aortic valve (AV) into the left ventricular outflow tract of the aorta. Unbound by any theory, this flow pattern is thought to more closely match natural blood flow and thus provide a physiologically more accurate flow, including maintaining the momentum and sustaining energy of blood flow, which allows the heart to function more efficiently. Therefore, blood flow typically intersects the longitudinal axis of the prosthetic valve.

[0143] Figure 33D Another example of a prosthetic valve is shown, which may be any of those disclosed herein, wherein the effective orifice area may be offset posteriorly away from the center of the prosthetic valve (concentrated or radially distributed along the entire posterior wall based on the prosthetic leaflet design, engagement, number of leaflets, etc.), while still maintaining flow substantially parallel to the longitudinal axis of the prosthetic valve. Here, the effective orifice area is simply moved posteriorly away from the center of the prosthetic valve by adjusting the size, shape, and attachment of the prosthetic leaflets to the anchoring frame. Thus, blood flow 3306 will still be substantially parallel to the longitudinal axis of the prosthetic valve, but blood flow 3306 will also be directed towards the posterior wall of the ventricle, but the flow center is offset and not concentric with the longitudinal axis of the prosthetic valve. Figure 33D Other aspects are generally consistent with Figures 33A to 33C The same as in.

[0144] Notes and Examples

[0145] The following non-limiting examples detail certain aspects of the subject matter of the invention to address challenges and provide the benefits discussed herein.

[0146] While this disclosure focuses on the use of prosthetic valves for the treatment of mitral regurgitation, it is not intended to be limiting. The prosthetic valves disclosed herein can also be used to treat other body valves, including other heart valves or venous valves. Some examples of heart valves include the aortic valve, tricuspid valve, or pulmonary valve.

[0147] Example 1 is a prosthetic valve configured to be disposed within a patient's natural valve located in an anatomical plane. The prosthetic valve comprises: a radially expandable frame and a prosthetic valve mechanism. The radially expandable frame has an expanding configuration and a collapsing configuration. The expanding configuration is configured to engage tissue in the natural valve, and the collapsing configuration is configured for delivery to the natural valve. The frame further includes a first end portion, a second end portion opposite the first end portion, an atrial flange adjacent to the first end portion, a ventricular skirt adjacent to the second end portion, a longitudinal axis extending between the first end portion and the second end portion, and an annular region disposed between the atrial flange and the ventricular skirt. The prosthetic valve mechanism has an outflow orifice adjacent to the second end portion, wherein the outflow orifice has a fluid flow axis extending through the outflow orifice, the fluid flow axis being angled relative to the longitudinal axis, or wherein the atrial skirt is located in a plane intersecting the longitudinal axis.

[0148] Example 2 is the prosthetic valve described in Example 1, wherein the fluid flow axis is not parallel to the longitudinal axis.

[0149] Example 3 is a prosthetic valve as described in any one of Examples 1 to 2, wherein the fluid flow axis intersects the longitudinal axis.

[0150] Example 4 is a prosthetic valve as described in any one of Examples 1 to 3, wherein the atrial flange plane is not parallel to the anatomical plane.

[0151] Example 5 is a prosthetic valve as described in any one of Examples 1 to 4, wherein the atrial flange plane intersects the anatomical plane.

[0152] Example 6 is a prosthetic valve as described in any one of Examples 1 to 5, wherein the atrial flange plane intersects the longitudinal axis.

[0153] Example 7 is a prosthetic valve as described in any one of Examples 1 to 6, wherein the outflow orifice is angled to guide fluid flow through the outflow orifice toward the posterior portion of the patient's heart.

[0154] Example 8 is a prosthetic valve as described in any one of Examples 1 to 7, wherein the outflow orifice guides fluid downstream along the posterior wall of the patient's heart, exiting the outflow orifice, surrounding the apex of the patient's heart, and flowing out of the left ventricular outflow tract of the patient's heart.

[0155] Example 9 is the prosthetic valve of any one of Examples 1 to 8, wherein the fluid flow axis is inclined toward the posterior portion of the patient's heart.

[0156] Example 10 is a prosthetic valve as described in any one of Examples 1 to 9, wherein the outflow orifice faces the posterior portion of the patient's heart.

[0157] Example 11 is a prosthetic valve as described in any one of Examples 1 to 10, wherein the prosthetic valve mechanism includes a plurality of prosthetic valve leaflets coupled to the radially expandable frame, wherein at least one of the plurality of prosthetic valve leaflets has an upstream edge and a downstream edge, wherein the upstream edge is arranged more forward relative to the downstream edge and the downstream edge is arranged more rearward relative to the upstream edge, thereby angulating at least one of the plurality of prosthetic valve leaflets to intersect the longitudinal axis of the radially expandable frame at an angle, which guides blood flow to the posterior portion of the patient's heart.

[0158] Example 12 is the valve of any one of Examples 1 to 11, wherein the plurality of prosthetic leaflets are composed of two prosthetic valve leaflets.

[0159] Example 13 is a method for placing a prosthetic valve in a patient's heart, the method comprising: providing a prosthetic valve having a radially expandable frame and a prosthetic valve mechanism, the radially expandable frame having an atrial flange adjacent to one end; the prosthetic valve mechanism having an outflow orifice adjacent to a second end opposite to the first end; radially expanding the frame to engage with a natural valve in the patient's heart; and guiding fluid flow through the prosthetic valve mechanism and out of the outflow orifice toward a posterior portion of the patient's heart.

[0160] Example 14 is the method of Example 13, wherein guiding the fluid flow includes guiding the fluid flow along a path intersecting the longitudinal axis of the prosthetic valve.

[0161] Example 15 is the method of any one of Examples 13 to 14, wherein guiding the fluid flow includes guiding the fluid flow along a path not parallel to the longitudinal axis of the prosthetic valve.

[0162] Example 16 is a prosthetic valve configured to be disposed in a patient's natural valve. The prosthetic valve includes a radially expandable frame and a prosthetic valve mechanism. The radially expandable frame has an expansion configuration for engaging tissue in the natural valve and a folded configuration for delivery to the natural valve. The frame includes a first end, a second end opposite to the first end, an atrial flange adjacent to the first end, a ventricular skirt adjacent to the second end, and an annular region disposed between the atrial flange and the ventricular skirt. The prosthetic valve mechanism is used to control fluid flow through the prosthetic valve mechanism.

[0163] Example 17 is the prosthetic valve described in Example 16, which further includes a cover disposed on at least a portion of the frame, the cover being welded to at least a portion of the frame.

[0164] Example 18 is the prosthetic valve described in any one of Examples 16 to 17, wherein the covering is attached to the frame without closure.

[0165] Example 19 is a prosthetic valve as described in any one of Examples 16 to 18, wherein the covering comprises fabric, tissue, polymer, or a combination thereof.

[0166] Example 20 is a prosthetic valve as described in any one of Examples 16 to 19, wherein the prosthetic valve mechanism comprises a plurality of prosthetic valve leaflets and a plurality of connecting posts, each connecting post having a free end and an opposite end connected to the expandable frame, wherein the plurality of prosthetic valve leaflets are connected to the plurality of connecting posts, and wherein the free ends of the plurality of connecting posts are radially inwardly angled to form outflow orifices with a diameter smaller than that of the ventricular skirt.

[0167] Example 21 is a method for treating a natural valve in a patient's heart, the method comprising: providing a prosthetic valve having a radially expandable frame and a prosthetic valve mechanism, the radially expandable frame including a first end portion, a second end portion opposite to the first end portion, an atrial flange adjacent to the first end portion, a ventricular skirt adjacent to the second end portion, and an annular region disposed between the atrial flange and the ventricular skirt; the prosthetic valve mechanism for controlling fluid flow through the prosthetic valve mechanism; radially expanding the atrial flange to engage with an atrial surface of the natural valve; radially expanding the annular region and the ventricular skirt; and controlling fluid flow through the prosthetic valve mechanism having a plurality of prosthetic valve leaflets connected to a plurality of engagement posts connected to the radially expandable frame.

[0168] Example 22 is the method of Example 21, which further includes rolling the prosthetic valve onto the delivery catheter, wherein the cover is coupled to the expandable frame using a seamless method.

[0169] Example 23 is the method of any one of Examples 21 to 22, wherein controlling the fluid flow includes passing the fluid through an outflow orifice in the prosthetic valve mechanism, the diameter of which is smaller than the diameter of the ventricular skirt.

[0170] Example 24 is the method of any one of Examples 21 to 23, wherein the plurality of connecting posts have free ends and opposite ends connected to the expandable frame, and wherein the free ends of the plurality of connecting posts are radially inwardly angled to form the outflow orifice.

[0171] Example 25 is a prosthetic valve configured to be disposed in a patient’s natural valve located in an anatomical plane. The prosthetic valve includes: means for anchoring the prosthetic valve in the patient’s natural valve; and means for controlling blood flow through the prosthetic valve, wherein the means for controlling blood flow guides the blood flow toward the posterior wall of the patient’s heart, downward along the posterior wall toward the apex of the patient’s heart, and upward from the apex toward the aorta.

[0172] Example 26 is a prosthetic valve configured to be disposed within a patient's natural valve located in an anatomical plane. The prosthetic valve comprises: a radially expandable frame and a prosthetic valve mechanism. The radially expandable frame has an expanding configuration and a collapsing configuration. The expanding configuration is configured to engage tissue in the natural valve, and the collapsing configuration is configured for delivery to the natural valve. The frame further includes a first end portion, a second end portion opposite the first end portion, an atrial flange adjacent to the first end portion, a ventricular skirt adjacent to the second end portion, a longitudinal axis extending between the first and second end portions, and an annular region disposed between the atrial flange and the ventricular skirt. The prosthetic valve mechanism has an outflow orifice adjacent to the second end portion, wherein the outflow orifice has an effective orifice area center radially offset from the longitudinal axis, such that blood flowing through the prosthetic valve flows substantially parallel to the longitudinal axis and is directed toward the posterior wall of the ventricle of the patient's heart.

[0173] In Example 27, the apparatus or method described in any one or any combination of Examples 1 to 26 may be optionally configured such that all of the described elements or options may be used or selected from.

[0174] The detailed description above includes reference to the accompanying drawings, which form part of the detailed description. The drawings illustrate, by way of example, specific examples in which the invention may be practiced. These examples are also referred to herein as "embodiments". Such examples may include elements other than those shown or described. However, the inventors also contemplate examples in which only those elements shown or described are provided. Furthermore, the inventors also contemplate examples using any combination or arrangement of those elements (or one or more aspects) shown or described herein with respect to a particular example (or one or more aspects thereof) or with respect to other examples (or one or more aspects thereof).

[0175] In the event of any inconsistency between the usage in this document and any other document incorporated by reference, the usage in this document shall prevail.

[0176] In this document, as is common in patent documents, nouns without quantifiers are used to include one or more than one, independent of any other instance or usage of "at least one" or "one or more". In this document, unless otherwise stated, the term "or" is used to mean a non-exclusive "or", such that "A or B" includes "A but not B", "B but not A", and "A and B". In this document, the terms "comprising / including" and "in which" are used as concise English equivalents of the corresponding terms "comprising / including" and "in which". Furthermore, in the appended claims, the terms "comprising / including" and "including / including" are open-ended, meaning that a system, apparatus, article, composition, formulation, or method that includes elements other than those listed after such terms in the claims is still considered to fall within the scope of the claims. Additionally, in the appended claims, the terms "first", "second", and "third", etc., are used only as designations and are not intended to impose numerical requirements on their objects.

[0177] The above description is intended to be illustrative and not restrictive. For example, the above examples (or one or more aspects thereof) may be used in combination with each other. Further examples may be used by those skilled in the art, for instance, after reviewing the above description. The abstract is provided to enable the reader to quickly determine the nature of the technical disclosure. It should be understood that the submitted abstract is not intended to interpret or limit the scope or meaning of the claims. Furthermore, in the above detailed description of the invention, multiple features may be combined together to simplify the disclosure. This should not be construed as meaning that unclaimed disclosed features are essential to any claim. Rather, the subject matter of the invention may include fewer than all features of a particular disclosed example. Therefore, the appended claims are incorporated herein as examples or embodiments, wherein each claim is a separate, independent embodiment, and such embodiments are contemplated to be combined with each other in various combinations or arrangements. The scope of the invention should be determined by reference to the appended claims and the full scope of equivalents conferred by such claims.

Claims

1. A prosthetic valve configured to be disposed in a native valve of a patient, the native valve lying in an anatomical plane, the prosthetic valve comprising: a radially expandable frame and a prosthetic valve mechanism coupled to the radially expandable frame, the radially expandable frame having an expanded configuration configured to engage tissue in the native valve and a collapsed configuration configured for delivery to the native valve, the frame further comprising a first end, a second end opposite the first end, an atrial flange proximate the first end, a ventricular skirt proximate the second end, a longitudinal axis extending between the first end and the second end, an annular region disposed between the atrial flange and the ventricular skirt; the prosthetic valve mechanism having an outflow orifice proximate the second end, wherein the atrial flange comprises a D-shaped perimeter having a straight portion and a curved portion, the curved portion connected to opposite ends of the straight portion; wherein the outflow orifice has a fluid flow axis extending through the outflow orifice, the fluid flow axis being angularly disposed relative to the longitudinal axis, or wherein the atrial flange lies in a plane that intersects the longitudinal axis; wherein the prosthetic valve mechanism comprises a plurality of prosthetic valve leaflets and a plurality of commissure posts having free ends and opposite ends coupled to the radially expandable frame, wherein the plurality of prosthetic valve leaflets are coupled to the plurality of commissure posts, and wherein the free ends of the plurality of commissure posts are angularly radially inward to form the outflow orifice, and a diameter of the outflow orifice is less than a diameter of the ventricular skirt; and wherein the outflow orifice directs fluid downstream out of the outflow orifice along a posterior wall of the patient's heart, around a patient's apex, and out of a left ventricular outflow tract of the patient's heart.

2. The valve of claim 1, wherein the fluid flow axis is curved relative to the longitudinal axis.

3. The valve of claim 1, wherein the fluid flow axis intersects the longitudinal axis.

4. The valve of claim 1, wherein the plane in which the atrial flange lies is non-parallel to the anatomical plane.

5. The valve of claim 1, wherein the plane in which the atrial flange lies intersects the anatomical plane.

6. The valve of claim 1, wherein the plane in which the atrial flange lies intersects the longitudinal axis.

7. The valve of claim 1, wherein the outflow orifice is angled so as to direct fluid flow through the outflow orifice to a posterior portion of the patient's heart.

8. The valve of claim 1, wherein the fluid flow axis is inclined toward a posterior portion of the patient's heart.

9. The valve of claim 1, wherein the outflow orifice faces a posterior portion of the patient's heart.

10. The valve of claim 1, wherein the prosthetic valve mechanism comprises a plurality of prosthetic valve leaflets coupled to the radially expandable frame, wherein at least one of the plurality of prosthetic valve leaflets has an upstream edge and a downstream edge, wherein the upstream edge is disposed more anteriorly relative to the downstream edge, the downstream edge is disposed more posteriorly relative to the upstream edge, thereby disposing at least one of the plurality of prosthetic valve leaflets at an angle to a longitudinal axis of the radially expandable frame, which directs blood flow to a posterior portion of the patient's heart.

11. The valve of claim 10, wherein the plurality of prosthetic valve leaflets consists of two prosthetic valve leaflets.

12. A prosthetic valve configured for placement in a patient's heart, the prosthetic valve comprising: a radially expandable frame comprising a first end, a second end opposite the first end, an atrial flange adjacent the first end, a ventricular skirt adjacent the second end, a longitudinal axis extending between the first end and the second end, an annular region disposed between the atrial flange and the ventricular skirt; and a prosthetic valve mechanism having an outflow orifice adjacent the second end, the atrial flange comprises a D-shaped perimeter having a straight portion and a curved portion, the curved portion connected to opposite ends of the straight portion, and the prosthetic valve mechanism comprises a plurality of prosthetic valve leaflets and a plurality of commissure posts having free ends and opposite ends coupled to the expandable frame, wherein the plurality of prosthetic valve leaflets are coupled to the plurality of commissure posts, and wherein the free ends of the plurality of commissure posts are angled radially inward to form an outflow orifice having a diameter that is less than a diameter of the ventricular skirt; wherein the frame of the prosthetic valve is configured to radially expand into engagement with a native valve in the patient's heart; and wherein the prosthetic valve is configured to direct fluid flow through the prosthetic valve mechanism and out the outflow orifice to a posterior portion of the patient's heart, wherein directing the fluid flow comprises directing the fluid flow along a pathway that is not parallel to a longitudinal axis of the prosthetic valve.

13. The valve of claim 12, wherein the pathway of the fluid flow intersects the longitudinal axis of the prosthetic valve.

14. The valve of claim 12, wherein the radially expandable frame has an expanded configuration to engage tissue in the native valve and a collapsed configuration for delivery to the native valve.

15. The valve of claim 12, wherein the outflow orifice directs fluid downstream away from the outflow orifice along a posterior wall of the patient's heart, around a patient's apex, and out of a left ventricular outflow tract of the patient's heart.

16. The valve of claim 12, further comprising a covering disposed over at least a portion of the frame, the covering welded to at least a portion of the frame.

17. The valve of claim 16, wherein the covering is attached to the frame without suturing.

18. The valve of claim 16, wherein the covering comprises fabric, tissue, polymer, or a combination thereof.

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