Heart valve anchoring assemblies

Abstract

A heart valve docking assembly includes a shaft having a coil portion, a first anchor formed along the length of the shaft proximal of the coil portion, and a second anchor formed along the length of the shaft proximal of the first anchor. The coil portion includes a delivery state and a deployed state, wherein the coil portion in the deployed state includes at least one coil arranged around a central longitudinal axis of the docking assembly. The first anchor and the second anchor each are configured to radially expand from a radially contracted configuration to a radially expanded configuration wherein outer diameters of the first and second anchors in the radially expanded configuration are larger than outer diameters of the first and second anchors in the radially contracted configuration, respectively.

Description

HEART VALVE ANCHORING ASSEMBLIESCROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 674,802, filed July 24, 2024, and U.S. Provisional Patent Application Serial No. 63 / 712,023, filed October 25, 2024, the entire contents of which are incorporated herein by reference.FIELD

[0002] The present technology is related generally to transcatheter heart valve prostheses, and more specifically to docking assemblies for transcatheter heart valve prostheses.BACKGROUND

[0003] The human heart is a four-chambered, muscular organ that provides blood circulation through the body during a cardiac cycle. The four main chambers include the right atrium and right ventricle which supplies the pulmonary circulation, and the left atrium and left ventricle which supplies oxygenated blood received from the lungs to the remaining body. To ensure that blood flows in one direction through the heart, atrioventricular valves (tricuspid and mitral valves) are present between the junctions of the atria and the ventricles, and semi-lunar valves (pulmonary valve and aortic valve) govern the exits of the ventricles leading to the lungs and the rest of the body, respectively. These valves contain leaflets or cusps that open and shut in response to blood pressure changes caused by the contraction and relaxation of the heart chambers. The leaflets move apart from each other to open and allow blood to flow downstream of the valve, and coapt to close and prevent backflow or regurgitation in an upstream manner.

[0004] Diseases associated with heart valves, such as those caused by damage or a defect, can include stenosis and valvular insufficiency or regurgitation. For example, valvular stenosis causes the valve to become narrowed and hardened which can prevent blood flow to a downstream heart chamber from occurring at the proper flow rate and may cause the heart to work harder to pump the blood through the diseased valve. Valvular insufficiency or regurgitation occurs when the valve does not close completely, allowingblood to flow backwards, thereby causing the heart to be less efficient. A diseased or damaged valve, which can be congenital, age-related, drug-induced, or in some instances, caused by infection, can result in an enlarged, thickened heart that loses elasticity and efficiency. Some symptoms of heart valve diseases can include weakness, shortness of breath, dizziness, fainting, palpitations, anemia and edema, and blood clots, which can increase the likelihood of stroke or pulmonary embolism. Symptoms can often be severe enough to be debilitating and / or life threatening.

[0005] Transcatheter heart valve prostheses have been developed for repair and replacement of diseased and / or damaged heart valves. Such transcatheter heart valve prostheses can be percutaneously delivered and deployed at the site of the diseased heart valve through catheter-based systems. Transcatheter heart valve prostheses can be delivered while in a low profile or compressed / collapsed arrangement so that the transcatheter heart valve prosthesis can be advanced through the patient’s vasculature. Once positioned at the treatment site, the transcatheter heart valve prosthesis can be expanded to engage tissue at the diseased heart valve region to, for instance, hold the transcatheter heart valve prosthesis in position.

[0006] Due to the structure of native atrio-ventricular valves, implanting a transcatheter heart valve prosthesis at a native atrio-ventricular valve may be difficult. Therefore, it may be desirable to provide a docking assembly to assist in supporting a transcatheter heart valve prosthesis at the site of a native atrio-ventricular valve, such as a native mitral valve.BRIEF SUMMARY

[0007] The techniques and devices of this disclosure generally relate to heart valve docking assemblies for use with transcatheter heart valve prostheses.

[0008] In an example hereof, the present disclosure relates to a heart valve docking assembly including a shaft, a first anchor, and a second anchor. The shaft includes a coil portion arranged around a central longitudinal axis of the docking assembly. The first and second anchors are each formed along a length of the shaft proximal of the coil portion, with the second anchor formed proximal of the first anchor. The first and the second anchors are each configured to radially expand from a radially contracted configuration to a radially expanded configuration. An outer diameter of the first and second anchors are each larger in the radially expanded configuration than in the radially contracted configuration.

[0009] In another example hereof, in the heart valve docking assembly of any of the preceding or following examples, the coil portion includes a plurality of coils arranged around the central longitudinal axis of the docking assembly.

[0010] In another example hereof, in the heart valve docking assembly of any of the preceding or following examples, the first anchor portion includes a plurality of first anchoring members shape set to a radially expanded state to form the radially expanded configuration of the first anchor and a radially contracted state to form the radially contracted configuration of the first anchor, and the second anchor portion includes a plurality of second anchoring members shape set to a radially expanded state to form the radially expanded configuration of the second anchor and a radially contracted state to form the radially contracted configuration of the second anchor.

[0011] In another example hereof, in the heart valve docking assembly of any of the preceding or following examples, the shaft includes a first end and a second end, and the second end of the shaft is configured to be releasably coupled to a delivery system.

[0012] In another example hereof, in the heart valve docking assembly of any of the preceding or following examples, the second end of the shaft is configured to be releasably coupled to the delivery system by at least one suture.

[0013] In another example hereof, in the heart valve docking assembly of any of the preceding or following examples, the second end of the shaft is configured to be threadably coupled to the delivery system.

[0014] In another example hereof, in the heart valve docking assembly of any of the preceding or following examples, the shaft further comprises a transition portion disposed between the first anchor and the second anchor, and the transition portion is configured to be disposed through the valve leaflet of the native heart valve when the coil portion is in the deployed state.

[0015] In another example hereof, in the heart valve docking assembly of any of the preceding or following examples, the shaft further comprises a proximal coil portion proximal of the second anchor, wherein the proximal coil portion is configured in a deployed configuration to include at least one coil.

[0016] In another example hereof, a method of repairing a native heart valve comprises: delivering a device to a site of the native heart valve, wherein the device comprises a shaft including a coil portion, a first anchor, and a second anchor, wherein the device is deliveredto the site in a delivery configuration; puncturing a hole through a native leaflet of the native heart valve; advancing the device through the hole; deploying the coil portion to a deployed configuration such that the coil portion wraps around native leaflets and / or chordae of the native heart valve; radially expanding the first anchor from a radially contracted configuration to a radially expanded configuration on a first side of the native leaflet; and radially expanding the second anchor from a radially contracted configuration to a radially expanded configuration on a second side of the native leaflet.

[0017] In another example hereof, in the method of any of the preceding or following examples, the coil portion in the delivery configuration is straightened.

[0018] In another example hereof, in the method of any of the preceding or following examples, the coil portion in the deployed configuration comprises a single coil.

[0019] In another example hereof, in the method of any of the preceding or following examples, the coil portion in the deployed configuration comprises a plurality of coils.

[0020] In another example hereof, in the method of any of the preceding or following examples, the plurality of coils in the deployed configuration have a decreasing radius of curvature in a proximal direction.

[0021] In another example hereof, the method of any of the preceding or following examples further comprises: advancing a stylet into a central passageway of the shaft in the coil portion, wherein the stylet has a first radius of curvature and the coil portion in the deployed configuration has a second radius of curvature smaller than the first radius of curvature, wherein deploying the coil portion comprises: initially deploying the coil portion with the stylet disposed in the central passageway such that the coil portion wraps around the native leaflets and / or the chordae with the first radius of curvature; and removing the stylet such that the coil portion radially contracts from the first radius of curvature to the second radius of curvature.

[0022] In another example hereof, in the method of any of the preceding or following examples further includes, delivering the device comprises delivering the device in a delivery system.

[0023] In another example hereof, in the method of any of the preceding or following examples, puncturing a hole in the native leaflet comprises advancing a guidewire of the delivery system through the device to puncture the native leaflet.

[0024] In another example hereof, in the method of any of the preceding or following examples, delivering the device comprises delivering the device within an outer sheath of the delivery system such that the outer sheath straightens the shaft of the device.

[0025] In another example hereof, in the method of any of the preceding or following examples, deploying the coil portion comprises advancing the coil portion out of the outer sheath.

[0026] In another example hereof, in the method of any of the preceding or following examples, radially expanding the first anchor comprises advancing the first anchor out of the outer sheath or retracting the outer sheath to release the first anchor.

[0027] In another example hereof, the method of any of the preceding or following examples further includes retracting the delivery system to set the first anchor against the first side of the native leaflet.

[0028] In another example hereof, in the method of any of the preceding or following examples, radially expanding the second anchor comprises retracting the outer sheath of the delivery system to transition the second anchor from the radially contracted configuration to the radially expanded configuration on a second side of the native leaflet.

[0029] In another example hereof, the method of any of the preceding or following examples further includes deploying a proximal coil portion of the shaft on the second side of the native leaflet.

[0030] In another example hereof, in the method of any of the preceding or following examples, the native heart valve is a native mitral valve, the first side of the native leaflet is a ventricular side of the native leaflet, and the second side of the native leaflet is an atrial side of the native leaflet.

[0031] In another example hereof, the method of any of the preceding or following examples further includes deploying a prosthetic heart valve within the deployed device.

[0032] In an example hereof, the present disclosure relates to a heart valve prosthesis including a frame, a prosthetic valve, and a plurality of chordae anchors. The frame includes an inflow end and an outflow end, and has a radially collapsed configuration for delivery and a radially expanded configuration for deployment within a native heart valve. The prosthetic valve is coupled to the frame and is configured to block blood flow in one direction to regulate blood flow through a central lumen of the frame. The plurality of chordae anchors extend from the outflow end of the frame and have a delivery state and adeployed state. In the deployed state, the plurality of chordae anchors curve radially outward, circumferentially, and generally perpendicular to a central longitudinal axis of the transcatheter heart valve prosthesis, wherein the plurality of chordae anchors are configured to capture chordae of a native valve leaflet and / or the native valve leaflet.

[0033] In another example hereof, in the heart valve prosthesis of any of the preceding or following examples, the plurality of chordae anchor includes a first chordae anchor and a second chordae anchor.

[0034] In another example hereof, in the heart valve prosthesis of any of the preceding or following examples, the first chordae anchor is circumferentially curved in a first direction and the second chordae anchor is circumferentially curved in a second direction opposite the first direction.

[0035] In another example hereof, in the heart valve prosthesis of any of the preceding or following examples, the plurality of chordae anchors are integrally formed with the frame.

[0036] In another example hereof, in the heart valve prosthesis of any of the preceding or following examples, the plurality of chordae anchors are formed separate from the frame and are coupled to the frame.

[0037] In another example hereof, in the heart valve prosthesis of any of the preceding or following examples, the plurality of chordae anchors extend in a distal direction from the frame with the chordae anchors in the delivery state.

[0038] In another example hereof, in the heart valve prosthesis of any of the preceding or following examples, the plurality of chordae anchors extend from a common or singular circumferential half of the frame.

[0039] In another example hereof, in the heart valve prosthesis of any of the preceding or following examples, the common or singular circumferential half of the frame is configured to be deployed at a posterior leaflet of a native mitral valve.

[0040] In another example hereof, in the heart valve prosthesis of any of the preceding or following examples, the common or singular circumferential half of the frame is configured to be deployed at an anterior leaflet of a native mitral valve.

[0041] In another example hereof, a method of repairing a native heart valve comprises: delivering a transcatheter heart valve prosthesis to a site of the native heart valve in a radially compressed delivery configuration, wherein the transcatheter heart valve prosthesiscomprises a frame, a prosthetic valve coupled to the frame, and a plurality of chordae anchors; puncturing a hole through a native leaflet of the native heart valve; advancing the transcatheter heart valve prosthesis through the hole; deploying the plurality of chordae anchors on an outflow side of the native leaflet; and deploying the frame of the transcatheter heart valve prosthesis within the hole of the native leaflet of the native valve to a radially expanded deployed configuration to tear the native leaflet and such that the plurality of chordae anchors each engage chordae of the native heart valve and / or a portion of the native leaflet to anchor the transcatheter heart valve prosthesis.

[0042] In another example hereof, in the method of any of the preceding or following examples, in the radially compressed delivery configuration, the plurality of chordae anchors extend distally from an outflow end of the frame of the transcatheter heart valve prosthesis.

[0043] In another example hereof, in the method of any of the preceding or following examples, in the radially expanded deployed configuration, the plurality of chordae anchors are curved and extend generally perpendicular to the central longitudinal axis of the transcatheter heart valve prosthesis.

[0044] In another example hereof, in the method of any of the preceding or following examples, where delivering the transcatheter heart valve prosthesis comprises delivering the transcatheter heart valve prosthesis in a delivery catheter.

[0045] In another example hereof, in the method of any of the preceding or following examples, puncturing a hole in the native leaflet comprises advancing a guidewire of the delivery catheter to puncture the native leaflet.

[0046] In another example hereof, in the method of any of the preceding or following examples, delivering the transcatheter heart valve prosthesis comprises delivering the transcatheter heart valve prosthesis within a capsule of the delivery catheter such that the capsule straightens the plurality of chordae anchors of the transcatheter heart valve prosthesis.

[0047] In another example hereof, in the method of any of the preceding or following examples, deploying the plurality of chordae anchors of the transcatheter heart valve prosthesis comprises proximally retracting the capsule of the delivery catheter.

[0048] In another example hereof, in the method of any of the preceding or following examples, the native heart valve is a native mitral valve.

[0049] In another example hereof, in the method of any of the preceding or following examples, puncturing the hole in the native leaflet comprises puncturing the hole in a posterior leaflet of the native mitral valve.

[0050] In another example hereof, in the method of any of the preceding or following examples, puncturing the hole in the native leaflet comprises puncturing the hole in an anterior leaflet of the native mitral valve.

[0051] In another example hereof, in the method of any of the preceding or following examples, the plurality of chordae anchors consists of a first chordae anchor and a second chordae anchor.

[0052] In another example hereof, in the method of any of the preceding or following examples, the plurality of chordae anchors are disposed on a common or singular circumferential half of the frame of the transcatheter heart valve prosthesis.

[0053] In another example hereof, in the method of any of the preceding or following examples, the common or singular circumferential half is a posterior half of the frame such that upon deployment, the plurality of anchors both engage chordae of the posterior leaflet of the native heart valve and / or a portion of the native posterior leaflet to anchor the transcatheter heart valve prosthesis.

[0054] The details of one or more aspects of the disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the techniques described in this disclosure will be apparent from the description and drawings, and from the claims.BRIEF DESCRIPTION OF DRAWINGS

[0055] The foregoing and other features and advantages of the present disclosure will be apparent from the following description of embodiments hereof as illustrated in the accompanying drawings. The accompanying drawings, which are incorporated herein and form a part of the specification, further serve to explain the principles of the present disclosure and to enable a person skilled in the pertinent art to make and use the embodiments of the present disclosure. The drawings are not to scale.

[0056] FIG. 1 depicts a schematic illustration of a heart having native valve structures.

[0057] FIG. 2 depicts a schematic sectional illustration of a left ventricle of a heart showing anatomical structures and a native mitral valve.

[0058] FIG. 3 depicts a perspective view of a docking assembly in a deployed configuration, according to an embodiments hereof.

[0059] FIG. 4 depicts a perspective view of the docking assembly of FIG. 3 in a delivery configuration, according to an embodiments hereof.

[0060] FIG. 5 depicts a side view of the docking assembly of FIG. 4 with a first anchor portion and a second anchor portion each in a radially expanded configuration, according to embodiments hereof.

[0061] FIG. 6 depicts a perspective view of a stylet of the docking assembly of FIG. 3, according to embodiments hereof.

[0062] FIG. 7 depicts a side view of a delivery system according to embodiments hereof.

[0063] FIG. 8 depicts a side-cross-sectional view of the delivery system of FIG. 7, according to embodiments hereof.

[0064] FIG. 9 depicts a cross-sectional view taken at line A-A of FIG. 8, according to embodiments hereof.

[0065] FIG. 10 depicts a cross-sectional view taken at line B-B of FIG. 8, according to embodiments hereof.

[0066] FIG. 11 is a flow chart depicting a method for delivering and deploying the docking assembly of FIG. 3, according to embodiments hereof.

[0067] FIGS. 12-20 depict illustrations of several of the steps of the method of FIG. 10 for delivering and deploying the docking assembly of FIG. 3.

[0068] FIG. 21 depicts a perspective view of a docking assembly in a deployed configuration, according to an embodiment hereof.

[0069] FIG. 22 depicts a perspective view of the docking assembly of FIG. 21 in a delivery configuration, according to an embodiments hereof.

[0070] FIG. 23 depicts a perspective view of the docking assembly of FIG. 21 in a deployed configuration, according to an embodiments hereof.

[0071] FIG. 24 depicts the docking assembly of FIG. 21 deployed through a native leaflet of a native mitral valve and coupled to a delivery system.

[0072] FIG. 25 depicts the docking assembly of FIG. 21 deployed at a native mitral valve and detached from the delivery system.

[0073] FIG. 26 depicts a perspective view of a docking assembly in a deployed configuration, according to an embodiments hereof.

[0074] FIG. 27 depicts a perspective view of the docking assembly of FIG. 27 in a delivery configuration, according to an embodiments hereof.

[0075] FIG. 28 depicts a side view of the docking assembly of FIG. 27 with a first anchor portion and a second anchor portion each in a radially expanded configuration, according to embodiments hereof.

[0076] FIG. 29 depicts the docking assembly of FIG. 27 with the distal coil portion thereof deployed at a native mitral valve and the outer sheath of a delivery system being retracted from the proximal coil portion.

[0077] FIG. 30 depicts the docking assembly of FIG. 27 with the proximal coil portion released from the outer sheath and coiled in the left atrium of a heart.

[0078] FIG. 31 depicts the docking assembly of FIG. 27 detached from the delivery system and deploying at a native mitral valve.

[0079] FIG. 32 depicts the docking assembly of FIG. 27 deployed at the native mitral valve and a heart valve prosthesis deploying within the docking assembly,

[0080] FIG. 33 depicts the docking assembly of FIG. 3 being used as a repair device at a native mitral valve.

[0081] FIG. 34 depicts a side view of a transcatheter heart valve prosthesis according to embodiments hereof.

[0082] FIG. 35 depicts a perspective view of an inner frame and prosthetic valve of the heart valve prosthesis of FIG. 34.

[0083] FIG. 36 depicts a side view of a fixation frame of the transcatheter heart valve prosthesis of FIG. 34.

[0084] FIG. 37 depicts a side view of the transcatheter heart valve prosthesis of FIG. 34 in a delivery configuration disposed within a capsule of a delivery catheter.

[0085] FIG. 38 depicts a perspective view of chordae anchors of the transcatheter heart valve prosthesis of FIG. 34, according to embodiments hereof.

[0086] FIG. 39 is a flow chart depicting a method for delivering and deploying the transcatheter heart valve prosthesis of FIG. 34, according to embodiments hereof.

[0087] FIGS. 40A-46B depict illustrations of several of the steps of the method of FIG. 39 for delivering and deploying the transcatheter heart valve prosthesis of FIG. 34.DETAILED DESCRIPTION OF THE INVENTION

[0088] Specific embodiments of the present disclosure are now described with reference to the figures wherein like reference numbers indicate identical or functionally similar elements. The following detailed description describes examples of embodiments of the invention and is not intended to limit the present technology or the application and uses of the present technology. Although the description of embodiments hereof is in the context of a transcatheter heart valve prosthesis docking assembly associated with a transcatheter mitral valve replacement at a native mitral valve, the present technology may also be used for procedures associate with other native heart valves, particularly but not limited to a native tricuspid valve. Furthermore, there is no intention to be bound by any expressed or implied theory presented in the preceding Field, Background, Brief Summary, or the following Detailed Description.

[0089] The terms “distal” and “proximal,” when used in the following description to refer to a native vessel, native valve, or implanted valve prosthesis are with reference to the direction of blood flow. Thus, “distal” and “distally” refer to positions in a downstream direction with respect to the direction of blood flow, and the terms “proximal” and “proximally” refer to positions in an upstream direction with respect to the direction of blood flow. When used in the following description to refer to a catheter or similar device (such as the docking assembly described herein) “distal” and “proximal” are with respect to the location of an operator using the device or the handle of such a device. Thus, distal” and “distally” refer to positions in a direction away from the operator or handle end of the device, and the terms “proximal” and “proximally” refer to positions in a direction toward the operator or handle end of the device.

[0090] In addition, the term “self-expanding” is used in the following description with reference to one or more stent structures and docking assemblies is intended to convey that the structures are shaped or formed from a material that can be provided with a mechanical memory to return the structure from a compressed or constricted delivery configuration to an expanded deployed configuration. Non-exhaustive examples of self-expanding materials include stainless steel, a pseudo-elastic metal such as a nickel titanium alloy or nitinol, various polymers, or a so-called super alloy, which may have a base metal of nickel, cobalt, chromium, or other metal. Mechanical memory may be imparted to a wire or stent structureby thermal treatment to achieve a spring temper in stainless steel, for example, or to set a shape memory in a susceptible metal alloy, such as nitinol.

[0091] Embodiments disclosed herein are directed to heart valve docking assemblies, hereafter referred to as a “docking assembly” or “docking assemblies”, that include a first anchor and a second or atrial anchor deployed on opposite sides of a valve leaflet. The docking assemblies described herein permit the delivery and release of the docking assembly and a heart valve prosthesis through the same delivery system. The docking assembly is delivered through a leaflet puncture for ease in encircling valve leaflets and chordae of the native valve. The docking assemblies are configured to provide a stable structure to which a heart valve prosthesis may be anchored.

[0092] FIG. 1 is a schematic sectional illustration of a heart HE that depicts the four heart chambers (right atrium RA, right ventricle RV, left atrium LA, left ventricle LV) and native valve structures (tricuspid valve TV, mitral valve MV, pulmonary valve PV, aortic valve AV). FIG. 2 is a schematic sectional illustration of a left ventricle LV and left atrium LA of a heart HE showing anatomical structures and a native mitral valve MV. Referring to FIGS. 1 and 2, the heart HE comprises the left atrium LA that receives oxygenated blood from the lungs via the pulmonary veins. The left atrium LA pumps the oxygenated blood through the mitral valve MV and into the left ventricle LV during ventricular diastolic. The left ventricle LV contracts during systole and blood flows outwardly through the aortic valve AV, into the aorta into the remainder of the body.

[0093] In a healthy heart, the valve leaflets LF of the mitral valve MV meet evenly to close and prevent backflow of blood during contractions of the left ventricle LV. Referring to FIG. 2, the valve leaflets LF attach the surrounding heart structure via a dense, fibrous ring of connective tissue, called an annulus AN which is distinct from both the leaflet tissue LF as well as the adjoining muscular tissue of the heart wall. The flexible leaflet tissue of the mitral valve leaflets LF are connected to papillary muscles PM, which extend upwardly from the lower wall of the left ventricle LV, and the inter- ventricular septum IVS, via branching tendons called chordae tendineae CT. In a heart HE having a mitral valve MV in which the valve leaflets LF do not sufficiently coapt or meet, leakage from the left ventricle LV into the left atrium LA may occur. Several structural defects can cause the mitral valve leaflets LF to inadequately coapt in this manner, and subsequent regurgitation to occur, including ruptured chordae tendineae CT, impairment of papillary muscles PM, e.g., due tohis ischemic heart disease, and enlargement of the heart, and / or mitral valve annulus AN, e.g., cardiomyopathy.

[0094] FIGS. 3-19 illustrate a docking assembly 100 according to an embodiment hereof. FIG. 3 illustrates the docking assembly 100 in a deployed configuration. FIG. 4 illustrates the docking assembly 100 in a delivery configuration. FIG. 5 illustrates the docking assembly 100 with a first anchor portion 120 and a second anchor portion 140 each in a radially expanded configuration. FIG. 6 illustrates a stylet 150 of the docking assembly 100. FIGS. 7-10 illustrate an example delivery system for delivering and deploying the docking assembly 100. FIGS. 11-20 a method of deploying of the docking assembly 100, in situ. The docking assembly 100 described herein may be used in conjunction with expandable transcatheter heart valve prostheses, for example, the non-limiting transcatheter heart valve prostheses described in U.S. Patent No. 11,318,083 to McVeigh et al., U.S. Patent No. 9,034,032 to McUean et al. and International Publication No. WO 2014 / 144937 A2 to McUean et al, U.S. Patent Application Publication No. 2012 / 0101572 to Kovalsky et al., U.S. Patent Application Publication No.2012 / 0035722 to Tuval, U.S. Patent Application Publication No. 2006 / 0265056 to Nguyen et al., U.S. Patent Application Publication No. 2007 / 05409266 to Birdsall, and U.S. Patent Application Publication No. 2007 / 05409269 to Dolan et al., each of which is incorporated by reference herein in its entirety. In embodiments herein, the docking assembly 100 is configured to form a coil or spiral, to provide a stable implant site into which the transcatheter heart valve prosthesis may be implanted.

[0095] In embodiments hereof, the docking assembly 100 includes an elongate component or shaft 102 that may be made of a shape memory material such that the shaft 102 may be straightened for delivery and return to a general coil shape upon deployment, as described below. In embodiments, the shaft may have laser cut patterns to allow the desired shape to be formed. Accordingly, the docking assembly 100 includes a delivery configuration for delivery to the site of a native valve, and a deployed configuration when deployed at the site of the native valve. The docking assembly 100 may be delivered and deployed to a native valve by methods, procedures, and devices known to those familiar in the art.

[0096] FIG. 3 illustrates a docking assembly 100 in the deployed configuration for use at the site of a native valve, for example, a native mitral valve. The shaft 102 includes a firstor distal end 104, and a second or proximal end 106. In embodiments, the shaft 102 may include a central passageway 108 extending from the first end 104 to the second end 106. In embodiments, the distal end 104 of the shaft 102 may have an opening such that the central passageway 108 is in fluid communication with the blood stream of the heart HE. In other embodiments, the distal end 104 may be closed such that the central passageway 108 is not in fluid communication with the blood stream of the heart HE. The shaft 102 includes a coil portion 110, a first anchor portion 120, a second anchor portion 140, and a transition portion 130 between the first and second anchor portions 120, 140. In embodiments herein, the shaft 102 may be made from any number of suitable biocompatible materials, e.g., stainless steel, nickel titanium alloys such as nitinol, cobalt chromium alloys such as MP35N, other alloys such as ELGILOY® (Elgin, Ill.), various polymers, pyrolytic carbon, silicone, polytetrafluoroethylene (PTFE), Polyethylene terephthalate (PET), or any number of other materials or combination of materials.

[0097] The coil portion 110 of the shaft 102 is a shape-set component including a straightened or delivery state and a coiled or deployed state. The coil portion 110 has a generally coiled or spiral shape when in the deployed state and is configured to return to the deployed state when not physically retained in the delivery state. The coil portion 110 includes a first or distal end 112 and a second or proximal end 114. The first end 112 is collocated with the first end 104 of the overall shaft 102 and the second portion 114 of the coil portion 110 is adjacent the first anchor portion 120. The coil portion 110 is configured to wrap around native leaflets and / or chordae of a native valve to provide a stable implant site for a transcatheter heart valve prosthesis. In embodiments herein, the radius of curvature of the coil portion 110 at the second end 114 is smaller than the radius of curvature of the coil portion 110 at the first end 112 when the coil portion 110 is in the deployed state. The smaller radius of curvature of the coil portion 110 at the second end 114 and greater radius of curvature of the coil portion 110 at the first end 112 may be advantageous for encircling the native leaflets of the native valve. In the embodiments of FIGS. 3-18, the coil portion 110 includes one coil 116. In an embodiment, the coil 116 may be less than a full turn or about a single full turn about a central longitudinal axis CLA of the docking assembly 100 in the deployed configuration. In an embodiment, the coil 116 may include a turn in a range of about 270° to about 360°. However, in other embodiments, such as but not limited to the example described below, the coil 116 may turn more the 360°.

[0098] The first anchor portion 120 includes a first end 122 coupled to the second end 114 of the coil portion 110 and a second end 124 coupled to the transition portion 130. In embodiments herein, the first anchor portion 120 includes at least one anchoring member 126, as shown in FIGS. 4-5. The first anchor portion 120 includes a radially contracted configuration, as shown in FIG. 4, and a radially expanded configuration, as shown in FIG. 5. In embodiments herein, the first anchor portion 120 is shape-set to self-expand to the radially expanded configuration when the docking assembly 100 is in the deployed configuration. The first anchor portion 120 is configured to be disposed on a distal or outflow side of a valve leaflet of a native valve and is configured to stabilize and anchor the docking assembly 100, in situ, as described below. Each anchoring member 126 of the first anchor portion 120 includes a radially contracted state and a radially expanded state. The first anchor portion 120 in the radially contracted configuration includes each anchoring member 126 in the radially contracted state, and the first anchor portion 120 in the radially expanded configuration includes each anchoring member 126 in the radially expanded state. Thus, when all the anchoring members 126 are in the radially expanded state, the first anchor portion 120 is in the radially expanded configuration. The first anchor portion 120 has a first outside diameter OD 1 in the radially contracted configuration, with each anchoring member 126 in the contracted state, as shown in FIG. 4, and a second a third outside diameter OD3 in the radially expanded configuration, with each anchoring member 126 in the radially expanded state, as shown in FIG. 5. In embodiments herein, the first outer diameter OD 1 is smaller than the second outer diameter OD2. In embodiments the first outer diameter OD1 may be generally equal to the outer diameter of the shaft 102 at the coil portion 110. In a non-limiting example, each anchoring member 126 may be laser cut from the shaft 102 at the first anchor portion 120 of the shaft 102 and shape set to the radially expanded state. In another embodiment, the first end 122 or the second end 124 of each anchoring member 126 may be removed or is not coupled to the shaft 102 such that each anchoring member 126 in the expanded state is a spline. Each anchoring member 126 is shown as cut-out around the anchoring member 126 such that in the radially contracted configuration, the shaft 102 at the anchoring members 126 is circumferentially continuous except for lines around each anchoring member 126. In other embodiments, the shaft 102 at the anchoring members 126 may be circumferentially discontinuous such that the anchoring members 126 alternate with removed portions of the shaft 102 around the circumference of the shaft 102. Further, inother embodiments each anchoring member 126 may be formed of, for example, and not by way of limitation, a braided material, an expandable polymer, and / or a covering that sits on an outer surface of the shaft 102 and / or is fastened to the shaft 102.

[0099] The second anchor portion 140 includes a first end 142 coupled to the transition portion 130 and a second end 144 proximal of the first end 142. As shown in FIGS. 4-5, the second anchor portion 140 is similar to the first anchor portion 120. Accordingly, the second anchor portion 140 includes at least one anchoring member 146, a radially contracted configuration, as shown in FIG. 4 and a radially expanded configuration, as shown in FIG. 5. The second anchor portion 140 is shape-set to self-expand to the radially expanded configuration when the docking assembly 100 is in the deployed configuration. The second anchor portion 140 differs from the first anchor portion 120 in that the second anchor portion 140 is configured to be disposed on a proximal, or inflow side of the valve leaflet of the native valve. Each anchoring member 146 includes a radially contracted state and a radially expanded state. The second anchor portion 140 in the radially contracted configuration includes each anchoring member 146 in the radially contracted state, and the second anchor portion 140 in the radially expanded configuration includes each anchoring member 146 in the radially expanded state. In embodiments herein, the second anchor portion 140 has a second outside diameter OD2 when in the radially contracted configuration, as shown in FIG. 4, and a fourth outside diameter OD4 when the second anchor portion 140 in the radially expanded configuration, as shown in FIG. 5. In embodiments herein, the second outer diameter OD2 is smaller than the fourth outer diameter OD4. In embodiment herein, the second outer diameter OD2 may be generally equal to the outer diameter of the shaft 102 at coil portion 110. In a non-limiting example, each anchoring member 146 may be laser cut from the shaft 102 at the second anchor portion 140. In another embodiment, the first end 142 or the second end 144 of each anchoring member 146 may be detached or uncoupled from the shaft 102 such that each anchoring member 146 in the expanded state is a spline. Each anchoring member 126 is shown as cut-out around the anchoring member 146 such that in the radially contracted configuration, the shaft 102 at the anchoring members 146 is circumferentially continuous except for lines around each anchoring member 146. In other embodiments, the shaft 102 at the anchoring members 146 may be circumferentially discontinuous such that the anchoring members 146 alternate with removed portions of the shaft 102 around the circumference of the shaft 102. Further, inother embodiments each anchoring member 146 may be formed of, for example, and not by way of limitation, a braided material, an expandable polymer, and / or a covering that sits on an outer surface of the shaft 102 and / or is fastened to the shaft 102.

[0100] In the embodiments of FIGS. 3-18, each anchoring member 126, 146 in the radially contracted state has an outer surface that is generally longitudinally parallel to the central longitudinal axis CLA of the shaft 102. Each anchoring member 126, 146 in the radially expanded state has an outer surface that is a curve with a convex or elliptical curvature extending radially outward from the central longitudinal axis CLA of the shaft 102.

[0101] In the embodiment of FIGS. 3-18, the docking assembly 100 includes four anchoring members 126 and four anchoring members 146. Each anchoring member 126, 146 is of an equivalent shape. The anchoring members 126 are equally spaced circumferentially from adjacent anchoring members 126 and the anchoring members 146 are equally spaced circumferentially from adjacent anchoring members 146. Further, each anchoring member 126 is circumferentially aligned with one of the anchoring members 146. The anchoring members 126 and anchoring members 146 may also be referred to as splines. It shall be understood that the anchoring members 126 and 146 are only examples and are not meant to be limiting. In embodiments herein, the first and second anchor portions 120, 140 may each include one or more anchoring members 126, 146, respectively, of any suitable shape, configuration, spacing, circumferential and radial orientation, in any combination. Thus, the characteristics of the first and anchoring members 126, 146 of the first and second anchor portions 120, 140, respectively, may be selected to optimize the docking assembly 100 for the native anatomy of the desired deployment location. For example, in other non-limiting embodiments, the first and / or the second anchor portions may include one anchoring member, with the anchoring member configured to extend circumferentially around a portion or annularly around the entirety of the circumference of the shaft 102 at the respective anchor portion. In another embodiment, the first and / or the second anchor portions may include two anchoring members, for example, disposed 180 degrees apart from each other. In yet another embodiment, each anchoring member 126 may be circumferentially offset from each adjacent anchoring member 146 (z.e., staggered or not axially aligned). In embodiments, the first anchor portion 120 and / or the second anchorportion 140 may include a covering or filling to ensure blood flow does not travel through the leaflet via the shaft 102 and / or openings between the anchoring members.

[0102] The transition portion 130 of the elongate component 102 includes a first end 132 and a second end 134. The transition portion 130 is disposed between the first anchor portion 120 and the second anchor portion 140. Accordingly, the first end 132 of the transition portion 130 is coupled to the second end 124 of the first anchor portion 120, and the second end 134 of the transition portion 130 is coupled to the first end 142 of the second anchor portion 140. The transition portion 130 is configured to be disposed through the valve leaflet of the native heart valve when the docking assembly is in the deployed configuration at the desired native valve location. In embodiments, a length of the transition portion 130 could be as short as 0.1mm or as long as 25mm to ensure that the distance between the adjacent portions of the first and second anchor portions 120, 140 are able to securely conform to the native leaflet and / or annulus of the native valve for adequate anchoring. In a non-limiting example, the length of the transition portion 130 may be in a range of about I -3mm such that the transition portion 130 may be slightly smaller than the thickness of the native leaflet.

[0103] In embodiments, the docking assembly 100 may include a stylet 150 removably disposed within the central passageway 108 of the elongate component 102. The stylet 150 may be a tubular structure including a first end 152, a second end 154, and may include a central passageway 156 between the first end 152 and the second end 154, as shown in FIG. 6. The central passageway 156 is configured to slidably receive a guidewire GW. The stylet 150 is configured with a radius of curvature that is larger or greater than the radius of curvature of the coil portion 110 of the elongate component 102 in the deployed state. The radius of curvature of the stylet 150 disposed within the coil portion 110 permits the coil portion 110 to have an increased radius during deployment to easily track and encircle or surround the valve leaflets and chordae of the native heart valve. Once the coil portion 110 is properly positioned at the native heart valve, the stylet 150 may be removed to permit the coil portion 110 to radially contract to the deployed state, as described below. In an embodiment, the stylet 150 may be configured to be advanced through the central passageway 108 of the elongate component 102 once the elongate component has been positioned adjacent to the native heart valve. The stylet 150 may be removed from the docking assembly 100, and more specifically the coil portion 110 of the shaft 102, when thecoil portion 110 is in the desired position surrounding the valve leaflets and the chordae at the native heart valve. In an embodiment, the stylet 150 may extend from the shaft 102 to a proximal end of a delivery system such that the stylet 150 may be manipulated by the treating clinician. When the stylet 150 is removed from the coil portion 110 of the shaft 102, the coil portion 110 is permitted to radially contract and engage tissue of the adjacent valve leaflets of the native heart valve, thereby establishing a stable anchor platform for a heart valve prosthesis, as described below. Thus, the potential benefit of the stylet 150 is that it may allow for the radius of curvature of the coil portion 110 at the second end 114 to be the same or substantially the same as the radius of curvature of the coil portion 110 at the first end 112 when the coil portion 110 is in the deployed state with the stylet 150 removably disposed within the central passageway 108 of the elongate component 102. FIGS. 7-10 illustrate a delivery system 200 that may be utilized to deliver and deploy a docking assembly, such as the docking assembly 100, at the site of a native heart valve. FIG. 7 shows a side view of the delivery system 200. FIG. 8 shows the delivery system 200 with the docking assembly 100 releasably coupled to a distal end 212 of an inner shaft 210 of the delivery system 200. In FIG. 7, an outer sheath 204 of the delivery system has been retracted to show the inner shaft 210. One skilled in the art will recognize that FIGS. 7-10 illustrate one example of a delivery system, that the systems, assemblies, and methods disclosed herein can be used with other delivery systems, and that existing components illustrated in FIGS. 7-10 may be removed and / or additional components may be added to the delivery system 200. The delivery system 200 includes a handle 202, an outer sheath 204 and an inner shaft 210. The outer sheath 204 includes a distal end 206, a proximal end (not shown) and an outer sheath lumen 208 extending from the proximal end (not shown) to the distal end 206. The outer sheath lumen 208 is configured to slidably receive the inner shaft 210 and the docking assembly in the delivery configuration therein. The outer sheath 204 is operably coupled to the handle 202. The inner shaft 210 is disposed within the outer sheath lumen 208 of the outer sheath 204. The inner shaft 210 includes a proximal end (not shown), a distal end 212, and an inner shaft lumen 214 extending from the proximal end (not shown) to the distal end 212. The inner shaft lumen 214 is sized to receive an auxiliary component such as a stylet, such as the stylet 150 described previously, and a guidewire GW. The distal end 212 of the inner shaft 210 may be releasably coupled to the second end 144 of the second anchor portion 140 of the docking assembly 100.

[0104] As shown in FIGS. 8-10, when the delivery system 200 is assembled with the docking assembly 100, the inner shaft 210 is disposed within the outer sheath lumen 208 of the outer sheath 204, proximal of the docking assembly 100. The stylet 150 may be removably disposed within the inner shaft lumen 214 of the inner shaft 210. Though not shown in FIGS. 7-10, a guidewire may be disposed within the central passageway 156 of the stylet 150. As shown in FIG. 10, the docking assembly 100 is disposed within the outer sheath lumen 208 of the outer sheath 204, distal of the inner shaft 210. The stylet 150 may be disposed within the inner shaft lumen 214 of the inner shaft and the central passageway 108 of the docking assembly 100. Thus, the outer sheath 204 is movable relative to the docking assembly 100 / inner shaft 210, the stylet 150 is movable relative to the outer sheath 204 and the docking assembly 100 / inner shaft 210, and the guidewire GW is movable relative to the outer sheath 204, the docking assembly 100 / inner shaft 210, and the stylet 150.

[0105] FIGS. 11-20 illustrate a method 1000 for deploying the docking assembly 100 at the site of a native mitral valve, in accordance with embodiments hereof. While described herein as deploying the docking assembly at the site of a native mitral valve, this is not meant to be limiting, and the method described herein may be utilized at other native heart valve locations. FIG. 11 shows a flow chart with an overview of the method 1000 for deploying the docking assembly 100. FIGS. 12-20 illustrate steps of the method 1000 for deploying the docking assembly 100 and illustrate the interaction of the delivery system 200 and the docking assembly 100 to deploy the docking assembly 100.

[0106] In a step 1002, shown in FIG. 12, the delivery system 200 is advanced through the vasculature of a patient to a native mitral valve MV utilizing established methods and procedures. The distal end 214 of the outer sheath 204 of the delivery system 200 is disposed within a left atrium LA of the heart HE.

[0107] In a step 1004, a guidewire GW is distally advanced through the delivery system 200 / docking assembly 100 to puncture or perforate one of the valve leaflets LF of the native mitral valve MV, as shown in FIG. 12. It is preferred that the puncture be at the base of the valve leaflet LF (i. e. , closer to the annulus AN, rather than the free edge FE of the valve leaflet LF) to provide a more stable puncture provide for simplified positioning of the docking assembly 100 behind the chordae CT of the native mitral valve MV. In other embodiments, the puncture may be through the annulus.

[0108] As shown in FIG. 13, in a step 1006 a distal portion of the outer sheath 204 of the delivery system 200 is distally advanced over the guidewire GW, through the puncture hole in the valve leaflet LF, and into the left ventricle LV of the heart HE.

[0109] In a step 1008, the stylet 150 of the docking assembly 100 is distally advanced into the coil portion 110 of the elongate component 102 of the docking assembly 100, as shown in FIG. 14. The stylet 150 provides the coil portion 110 of the elongate component 102 with a greater or increased radius of curvature when the coil portion 110 and the stylet 150 are release from the outer sheath 204, as compared to the radius of curvature of the coil portion 110 without the stylet 150 disposed therein.

[0110] In a step 1010, the docking assembly 100 is distally advanced through the outer sheath 204 of the delivery system 200 and into the left ventricle LV, as shown in FIG. 15. More precisely, the docking assembly 100 is distally advanced such that the coil portion 110 of the shaft 102 exits the outer sheath 204 of the delivery system 200 and enters the left ventricle LV. As the coil portion 110 of the elongate component 102 of the docking assembly 100 advances from the outer sheath 204 of the delivery system 200, the coil 116 of the coil portion 110 surrounds the valve leaflets LF and the chordae CT of the native mitral valve MV. The stylet 150 is disposed within the coil portion 110 of the elongate component 102 and provides a larger radius of curvature than the coil portion 110 alone such that the coil portion 110 more easily encircles or surrounds the valve leaflets LF and chordae CT of the native mitral valve MV. The docking assembly 100 is distally advanced by distally advancing the inner shaft 210 of the delivery system 200 relative to the outer sheath 204 of the delivery system 200.

[0111] In a step 1012, as shown in FIG. 16, when the coil portion 110 of the docking assembly 100 is at a desired position at the native mitral valve MV, that is, when the first (distal) anchor portion is positioned adjacent the ventricular side of the native valve leaflet LF, the outer sheath 204 of the delivery system 200 is proximally retracted and / or the inner shaft 210 of the delivery system 200 is advanced relative to the outer sheath 204 to release the first anchor portion 120 of the elongate component 102 of the docking assembly 100. When the first anchor portion 120 is released from the outer sheath 204 of the delivery system 200, each anchoring member 126 of the first anchor portion 120 of the docking assembly 100 radially expands to the radially expanded state, and accordingly, the firstanchor portion 120 transitions to the radially expanded configuration on the downstream (ventricular) side of the valve leaflet LF of the native mitral valve MV.

[0112] In a step 1014 of the method 1000, the docking assembly 100 and the delivery system 200 is proximally retracted such that the second (proximal) end 124 of the first anchor portion 120 engages tissue on the downstream (ventricular) side of the native valve leaflet LF, as shown in FIG. 17. The docking assembly 100 may be proximally retracted by proximally retracting the inner shaft 210 of the delivery system 200, which is releasably coupled to the docking assembly 100. Stated another way, the inner shaft 210 of the delivery system 200 and the docking assembly 100 releasably coupled thereto is proximally retracted to “set” the first anchor portion 120 on the downstream (ventricular) side of the native valve leaflet LF. As used herein, the word “set” indicates the second end 124 of the first anchor portion 120 engages tissue of the native valve leaflet LF.

[0113] In a step 1016, with the first anchor portion 120 set or engaged with the downstream (ventricular) side of the native valve leaflet LF, the outer sheath 204 of the delivery system 200 is proximally retracted to release the second anchor portion 140 of the docking assembly 100 on the upstream (atrial) side of the native valve leaflet LF, as shown in FIG. 18. When the second anchor portion 140 is released from the outer sheath 204 of the delivery system 200, each anchoring member 146 of second anchor portion 140 radially expands to the radially expanded state, and the second anchor portion 140 transitions to the radially expanded configuration. As each anchoring member 146 radially expands, the first (distal) end 142 of the second anchor portion 140 engages tissue on the upstream (atrial) side of the valve leaflet LF of the native mitral valve MV. Thus, as shown in FIG. 18, the first anchor portion 120 and the second anchor portion 140 are on opposite sides of the valve leaflet LF of the native mitral valve MV, with the transition portion 130 of the shaft 102 disposed through the native valve leaflet LF. The frictional and / or compressive forces of the first anchor portion 120 and the second anchor portion 140 engaged on the opposite sides of the valve leaflet LF anchor the docking assembly 100 at the native mitral valve MV. Stated another way, the valve leaflet LF is sandwiched between the first anchor portion 120 and the second anchor portion 140 to provide support and anchoring for the docking assembly 100.

[0114] In a step 1018, the stylet 150 ofthe docking assembly 100 is proximally retracted to remove the stylet 150 from the central passageway 108 of the shaft 102 of the dockingassembly 100, as shown in FIG. 19. As the stylet 150 is removed from the coil portion 110 of the shaft 102 of the docking assembly 100, the coil portion 110 transitions to the smaller radius of curvature to which the coil portion 110 was set shaft (i.e. radially contracts) and engages tissue of the valve leaflets LF and / or native chordae of the native mitral valve MV, thereby transitioning the coil portion 110 to the deployed state and the docking assembly 100 to the deployed configuration.

[0115] In a step 1020, the docking assembly 100 is released from the delivery system 200. In embodiments herein, the second (proximal) end 144 of the second anchor portion 140 of the docking assembly 100 may be coupled to a distal end 212 of the inner shaft 210 by at least one suture SU. The treating clinician may sever the at least one suture SU to release the docking assembly 100 from the inner shaft 210 of the delivery system 200. In other embodiments, the shaft 102 may include a portion proximal of the second anchoring portion 140 which is coupled to the inner shaft 210. Further, the docking assembly 100 may be removably coupled to the inner shaft 210 or other component of the delivery system 200 by other methods other than a suture, as would be understood by those skilled in the art. For example, and not by way of limitation, the docking assembly 100 may be threadably coupled to the delivery system 200 such that rotation of the inner shaft 210 relative to the docking assembly 100 uncouples the docking assembly 100 from the delivery system 200.

[0116] With the docking assembly 100 released from the delivery system 200, the docking assembly 100 is anchored at the native mitral valve MV by the first and second anchor portions 120, 140 of the elongate component 102, disposed on opposite sides of the valve leaflet LF, as shown in FIG. 20. The delivery system 200 may then be removed from the patient’s vasculature and / or the same delivery system 200 (or portions thereof, e.g., the outer sheath 204) may be used for delivering a prosthetic valve inside the docking assembly 100.

[0117] While described herein with the guidewire distally advanced through the delivery system and the docking assembly to puncture or perforate one of the valve leaflets of the native valve, this is not meant to be limiting. In another non-limiting embodiment, a separate catheter system may be utilized for puncturing the valve leaflet with the guidewire. The guidewire may be retained in place through the valve leaflet and the delivery system with the docking assembly may be advanced over the guidewire.

[0118] FIGS. 21-26 illustrate a docking assembly 300, according to an embodiment hereof. The docking assembly 300 is similar to the docking assembly 100 shown in FIG. 3- 20 except as described herein. Therefore, all of the details described above are incorporated into the description of FIGS. 21-26 and the same reference numerals are used. Thus, generally, as described above, the docking assembly 300 includes the shaft 102, the first end 104, the second end 106, and in embodiments, the central passageway 108. The shaft 102 includes the coil portion 110, the first anchor portion 120, the transition portion 130, and the second anchor portion 140. However, the docking assembly 300 of FIGS. 21-26 differs from the docking assembly 100 in that the coil portion 110 includes a plurality of wraps or coils 316 when the coil portion 110 is in the deployed state. In the non-limiting embodiment of FIGS. 21-23, the coil portion 110 includes a first coil 316A, a second coil 316B, and a third coil 316C. The first coil 316A is disposed downstream of a second coil 316B, and the second coil 316B is disposed downstream of a third coil 316C when the coil portion 110 is in the deployed state. The second coil 316B and the third coil 316C each circumferentially extend 360° around the central longitudinal axis CLA of the docking assembly 300 in the deployed configuration. The first coil 316A may circumferentially extend around the central longitudinal axis CLA of the docking assembly 300 in the deployed configuration in a range of 45 ° to 360° . In an embodiment, the radius of curvature of the first coil 316A is larger than the radius of curvature of the second coil 316B and the third coil 316C, thereby encircling the valve leaflets and / or chordae of the native heart valve easier. In other words, the larger radius of curvature of the first coil 316A ensures that the first coil 316A extends around the native valve leaflets and / or chordae rather the between the native leaflets and / or chordae. The radius of curvature may become smaller as more of the coil portion 110 is advanced out of the outer sheath 204 of the delivery system 200 to more firmly engage with the native valve leaflets and provide a stable docking assembly 300 for a transcatheter heart valve prosthesis. In embodiments herein, a stylet may not be utilized with coil portions having a plurality of coils. Thus, the docking assembly 300 need not include a stylet, but this is not meant to be limiting and a stylet may be utilized.

[0119] While described herein with three coil portions, it will be understood that in embodiments herein, the docking assembly 300 may include a greater or lesser number of coil portions.

[0120] A method for delivering and deploying the docking assembly 300 is essentially the same as the method 1000 described above with respect to the docking assembly 100. Therefore, all of the steps of the method will not be repeated here and the method 1000 described and shown with respect to FIGS. 11-20 are incorporated into the present embodiment. However, if a stylet is not utilized, the step of removing the stylet would not be included. Further, when distally advancing the docking assembly 300 from the outer sheath 204, similar to the step 1008 of the method 1000 and as shown in FIG. 15, the docking assembly 300 is advanced such that multiple coils encircle the native valve leaflets LF and / or chordae CT. These multiple coils are shown in FIG. 24, which is after the first and second anchor portions 120, 140 have been deployed, and is similar to FIG. 19 ofthe method 1000. FIG. 25 shows the docking assembly 300 deployed at the native mitral valve MV and detached from the delivery system 200.

[0121] FIGS. 26-31 show a docking assembly 400 according to another embodiment hereof. The docking assembly 400 is the same as the docking assembly 100 shown in FIG. 3-20 except as described herein. Therefore, all of the details described above with respect to FIGS. 3-20 are incorporated into the description of FIGS. 26-31 and the same reference numerals are used where appropriate. Thus, as described above, the docking assembly 400 includes the shaft 102, the first end 104, the second end 106, and in embodiments, the central passageway 108. The shaft 102 includes the coil portion 110, the first anchor portion 120, the transition portion 130, and the second anchor portion 140. However, the docking assembly 400 of FIGS. 26-31 differs from the docking assembly 100 in that the shaft 102 also includes a proximal coil portion 460.

[0122] The proximal coil portion 460 includes a first (distal) end 462 and a second (proximal) end 464, as shown in FIGS. 26-28. The first end 462 ofthe proximal coil portion 460 is coupled to the second end 144 of the second anchor portion 140. The second end 464 of the proximal coil portion 460 is configured to be releasably coupled a delivery system, for example, to the distal end of the inner shaft 210 of the delivery system 200. In embodiments herein, the proximal coil portion 460 is a shape-set component including a deployed (coiled) state and a delivery (straightened) state. The proximal coil portion 460 is shape-set to return to the deployed state, which is a coiled shape. In an embodiment, the proximal coil portion 460 is configured to be deployed within an atrium of the heart to stabilize the docking assembly 400 at the desired position of a native heart valve. Morespecifically, the proximal coil portion 460 in the deployed state is configured to engage tissue in the atrium of a heart to stabilize the docking assembly 400 in the deployed configuration at the site of the native heart valve. In such a configuration, the first anchor portion 120 and the second anchor portion 140 may be removed, as the proximal coil 460 would act as an anchor. In an embodiment, the proximal coil portion 460 may include radius of curvature similar to the coil portion 110 such that the proximal coil portion 460 may anchor and / or support a prosthetic valve to thereby permit the prosthetic valve to be implanted in a more upstream position relative to the native valve. In the embodiments of FIGS. 26-36, the proximal coil portion 460 includes one coil 466. In an embodiment, the coil 466 may include a turn in a range of 90° to 360°.

[0123] A method of delivering and deploying the docking assembly 400 is similar to the method 1000 described above for delivering and deploying the docking assembly 100. Therefore, all of the steps described above will not be repeated here and are incorporated into the description of the delivery and deployment of the docking assembly 400. However, in the method of delivering and deploying the docking assembly 400, after the second (proximal) anchor 140 is deployed, instead of detaching the docking assembly 400 from the inner shaft 210, the outer sheath 204 is retracted to expose the proximal coil portion 460, as shown in FIG. 29. Thereafter, in another step of the method, the outer sheath 204 may be further proximally retracted and / or the proximal coil portion 460 may be distally advanced (such as be distally advancing the inner shaft 210) to release the proximal coil portion 460 from the outer sheath 204 of the delivery system 200, as shown in FIG. 30. As the proximal coil portion 460 is released from the outer sheath 204, the proximal coil portion 460 returns to its shape set deployed (coiled) state, as shown in FIG. 31.

[0124] In another step of the method, similar to the step 1020 in the method 1000, the docking assembly 400 is released from the delivery system 200. In an embodiment, the second (proximal) end 464 of the proximal coil portion 460 of the docking assembly 400 is detached from a distal end 212 of the inner shaft 210. The docking assembly 400 may be attached to the distal end 212 of the inner shaft 210 in various ways. For example, and not by way of limitation, a suture may couple the docking assembly 400 to the inner shaft 210 such that severing the suture detaches (uncouples) the docking assembly 400 from the inner shaft 210. However, as explained above, this is not meant to be limiting, and other ways to couple the docking assembly 400 to the delivery system 200 may be utilized. For example,and not by way of limitation, the docking assembly 400 may be threadably coupled to the delivery system 200 such that rotation of the inner shaft 210 relative to the docking assembly 400 uncouples the docking assembly 400 from the delivery system 200. When the docking assembly 400 is released from the delivery system 200, the docking assembly 400 remains anchored at the native mitral valve MV by the first and second anchor portions 120, 140 of the elongate component 102, disposed on opposite sides of the valve leaflet LF, and is stabilized by the proximal coil portion 460 in the left atrium LA, as shown in FIG. 31.

[0125] The docking assembly 400 has been described with a coiled portion 110 similar to the coiled portion 110 of the docking assembly 100. However, this is not meant to be limiting, and the coil portion 110 of the docking assembly 100 (multiple coils) may be used with the docking assembly 400. In other words, the proximal coil portion 460 of the docking assembly 400 may be used with the docking assembly 100 or the docking assembly 300. Further, the stylet 150 may or may not be used with the docking assembly 400.

[0126] The docking assemblies 100, 300, 400 described above have been described to provide support for a heart valve prosthesis delivered to the native heart valve. FIG. 32 shows a heart valve prosthesis HVP delivered and deployed to the native mitral valve MV within the docking assembly 400. The heart valve prosthesis HVP may also be delivered and deployed within the docking assemblies 100 or 300.

[0127] Although the docking assemblies 100, 300, 400 have been described herein as being utilized as docking assemblies for heart valve prostheses, this is not meant to be limiting. In other embodiments, the docking assemblies 100, 300, 400 may be used as repair devices for native heart valves. In particular, in certain cases, native heart valves, such as the native mitral valve, experience regurgitation due to tethered chordae or native valve leaflets that do not fully close. In such circumstances, the assemblies 100, 300, 400 may be used as repair devices to tighten chordae to bring papillary muscles together and / or bring the native valve leaflets closer together to reduce regurgitation and / or prevent systolic anterior motion (SAM), as shown in FIG. 33 and as indicated by the arrows Al and A2 in FIG. 33.

[0128] Embodiments disclosed herein are directed to transcatheter heart valve prostheses with chordae anchors. The transcatheter heart valve prostheses are delivered and deployed through a leaflet of a native valve, for example a posterior leaflet of a native mitral valve. The chordae anchors extend radially outward from an outflow end of a frame of thetranscatheter heart valve prosthesis when in a deployed state. When the transcatheter heart valve prosthesis is deployed and radially expands at the site of a native valve, the frame of the transcatheter heart valve prosthesis tears or lacerates the leaflet through which the transcatheter heart valve prosthesis is deployed and the chordae anchors engage chordae and leaflet portions of the native valve. As the transcatheter heart valve prosthesis continues to radially expand to the deployed configuration, the chordae anchors pull the gathered chordae and leaflet portions to the commissures of the native valve to anchor the transcatheter heart valve prosthesis within the native anatomy. The chordae anchors permit the frame of the transcatheter heart valve prosthesis to be minimized in length such that the frame extends less into the left ventricle of the heart to minimize the risk of left ventricular outflow tract obstruction (LVOTO).

[0129] FIGS. 34-38 illustrate a transcatheter heart valve prosthesis 500 upon which the embodiments of chordae anchors herein may be utilized. The transcatheter heart valve prosthesis 500 is illustrated herein to facilitate description of the present disclosure. The following description of the transcatheter heart valve prosthesis 500 is not intended to limit the disclosure or the application and uses of the disclosure . It is understood that any number of alternate transcatheter heart valve prostheses may be used with the chordae anchors and the methods described herein.

[0130] The transcatheter heart valve prosthesis 500 is configured with a radially expanded or deployed configuration, as shown in FIG. 34, and a radially collapsed or delivery configuration for delivery within a vasculature, as shown in FIG. 37. The transcatheter heart valve prosthesis 500 is configured to return to the radially expanded configuration when deployed (z.e., is self-expanding). When the transcatheter heart valve prosthesis 500 is in the radially collapsed delivery configuration, the transcatheter heart valve prosthesis 500 has a low profile suitable for delivery to a native heart valve via a suitable delivery catheter that may be tracked to the deployment site of the native heart valve of a heart via any one of a transseptal, retrograde, or transapical approach. In an embodiment, the transcatheter heart valve prosthesis 500 includes an inner frame 502 surrounded by and coupled to a fixation frame 504. A prosthetic valve 506 is disposed within and coupled to the inner frame 502.

[0131] The inner frame 502 and the fixation frame 504 described herein as elements of the transcatheter heart valve prosthesis 500 may be made from any number of suitablebiocompatible materials, e.g., stainless steel, nickel titanium alloys such as nitinol, cobalt chromium alloys such as MP35N, other alloys such as ELGILOY® (Elgin, Ill.), various polymers, pyrolytic carbon, silicone, polytetrafluoroethylene (PTFE), or any number of other materials or combination of materials.

[0132] As best shown in FIG. 35, the inner frame 502 may be a tubular stent-like structure that defines a lumen 508 from an inflow end 510 of the inner frame 502 to an outflow end 512. The inner frame 502 is configured to support the prosthetic valve 506 therein. The inner frame 502 includes a plurality of crowns 514, a plurality of struts 516, and a plurality of nodes 517 defining a plurality of side openings 518. Though not shown in FIGS. 34-35 for the sake of clarity, the inner frame 502 may include a skirt coupled to an inner surface and / or an outer surface of the inner frame 502, as will be understood by those knowledgeable in the art. Such a skirt may also be coupled to the prosthetic valve 506.

[0133] The prosthetic valve 506 of the transcatheter heart valve prosthesis 500 is capable of regulating flow therethrough via the valve leaflets 520 that may form a replacement valve . FIG. 35 illustrates a prosthetic valve component having three (3) leaflets, although prosthetic valve components with more or fewer leaflets may be used in embodiments hereof. Adjoining pairs of the valve leaflets 520 are attached to one another at their lateral ends to form leaflet commissures 522A, 522B, 522C. When deployed in situ, the prosthetic valve 506 in a closed state is configured to block blood flow in one direction to regulate blood flow through the lumen 508 of the inner frame 502. The valve leaflets 520 may be formed of various flexible materials including, but not limited to natural pericardial material such as tissue from bovine, equine or porcine origins, or synthetic materials such as polytetrafluoroethylene (PTFE), DACRON® polyester, pyrolytic carbon, regenerative tissue approaches, or other biocompatible materials.

[0134] FIG. 36 illustrates an embodiment of the fixation frame 504. The fixation frame 504 may be a generally tubular stent-like structure that functions as an anchor for the transcatheter heart valve prosthesis 500 to secure its deployed position within a native annulus. The fixation frame 504 includes an inflow end 524 and an outflow end 526. The outflow end 526 of the fixation frame 504 may be coupled to the outflow end 512 of the inner frame 502. However, in other embodiments, the inflow ends 510, 524 of the inner frame 502 and the fixation frame 504 may be coupled together; or alternatively any portions of the frames between the inflow ends 510, 524 and outflow ends 512, 526 of the innerframe 502 and the fixation frame 504 may be coupled together. The fixation frame 504 includes a plurality of crowns 528 and a plurality of struts 530 defining a plurality of nodes 532 and a plurality of side openings or cells 534. In embodiments, the fixation frame 504 may include a fixation skirt (not shown) attached to and lining a portion of an inner surface and / or outer surface of the fixation frame 504.

[0135] In FIG. 36, row numbers have been added to the reference numerals for the crowns 528, the struts 530, the nodes 532, and the side openings 534 to indicate the row number of each type of frame component starting with the inflow end 524. In the embodiment shown, the fixation frame 504 includes a total of five rows of crowns 528 and nodes 532. Beginning at the inflow end 524 of the frame 504, row Ro describes the row of inflow crowns 528R0 at the inflow end 524 of the frame 504. Connected to the inflow crowns 528R0 by a row of struts is a row Ri of nodes 532R1. Connected to the row Ri of nodes 532R1 by another row of struts 530 is a row R2 of nodes 532R2. Connected to the row R2 of nodes 532R2 by another row of struts 530 is a row R3 of nodes 532R3. Connected to the row R3 of nodes 532R3 by another row of struts 530 is a row R4 of outflow crowns 5258R4 at the outflow end 526 of the fixation frame 504.

[0136] In the embodiment shown, rows of crowns 528, struts 530, and nodes 532 define three rows of cells 534. Thus, in the embodiment shown, a first row of cells 534A is defined adjacent the inflow end 524 of the fixation frame 504, a third row of cells 534C is defined adjacent the outflow end 526 of the fixation frame 504, and second row of cells 534B is defined between the first and third rows of cells 534A, 534C. In the embodiment shown, each cell 534A of the first row of cells 534A is larger than each cell 534C of the third row of cells 534C. This different number of cells may also be defined by the inflow end 524 including fewer inflow crowns 528R0 than the outflow crowns 528R4 at the outflow end 526 of the fixation frame. In an example, the inflow end 524 includes eight inflow crowns 528R0 and the outflow end 526 includes sixteen outflow crowns 528R4. The larger sized first cells 534A provide flexibility to accommodate various shapes of atrium while still providing sufficient stiffness to stabilize the fixation frame 504 against the atrial walls. The smaller sized third cells 534B are configured with sufficient radial stiffness to stabilize the fixation frame 504 within the native annulus, and / or native leaflets, and to prevent paravalvular leakage (PVL). However, this is not meant to be limiting, and more or fewerinflow and outflow crowns may be utilized. Further, more or few rows of crowns, nodes, and / or cells may be utilized.

[0137] In embodiments, the transcatheter heart valve prosthesis 500 may further include other elements such as, but not limited to a brim that extends outwardly from the inflow end 524 of the fixation frame 504, as will be understood by those knowledgeable in the art.

[0138] Further, although the heart valve prosthesis 500 has been described as having the inner frame 502 and the fixation (outer) frame 504, this is not meant to be limiting, the heart prosthesis 500 may include a single frame with the prosthetic valve 506 disposed within and coupled thereto.

[0139] FIG. 34 and FIGS. 36-38 show an embodiment of chordae anchors 550 of the transcatheter heart valve prosthesis 500. Each chordae anchor 550 is configured to anchor the transcatheter heart valve prosthesis 500 within a native mitral valve when the transcatheter heart valve prosthesis 500 is in the radially expanded configuration. In greater detail, each chordae anchor 550 is configured to generally engage, z.e., encircle, gather, or capture chordae of the leaflet, as well as potentially portions of the leaflet itself, of a native valve as the heart valve prosthesis 500 expands. In embodiments, when the heart valve prosthesis 500 is fully expanded, the chordae anchors 550 will have gathered the chordae and / or portions of the tom leaflet radially outward and generally toward the native commissures of the native valve to help ensure the chordae are taut during systole and the heart valve prosthesis 500 may adequately anchor to the native anatomy and prevent embolization into the atrium. The chordae anchors 550 may also capture portions of the native valve leaflet that has been lacerated, as described below. Pulling the chordae / leaflets towards the native commissures enable a more central (sub-valvular) anchoring to minimize or prevent canting of the transcatheter heart valve prosthesis 500.

[0140] In the embodiment shown, the transcatheter heart valve prosthesis 500 includes two chordae anchors 550A, 550B. While only one chordae anchor 550 is visible in FIGS. 34 and 36, it will be understood that the transcatheter heart valve prosthesis 500 includes two chordae anchors 550, as shown at least in FIGS. 37, 38, and 43A-46B, and that FIGS. 34 and 36 are side views showing only one of the two chordae anchors 550. In an embodiment, the first chordae anchor 550A is on a first posterior side of the fixation frame 504 and the second chordae anchor 550B is on a second posterior side of the fixation frame 504. In other words, In other words, in the embodiment shown, the chordae anchors 550 areboth disposed on a posterior half of the transcatheter heart valve prosthesis 500 to accommodate for the shorter length (nadir to cusp) of the posterior leaflet relative to the anterior leaflet and is configured to be deployed in the posterior leaflet of the mitral valve. In other words, the locations that the chordae anchors 550 are coupled to the fixation frame 504 are less than 180 degrees apart from each other around the circumference of the fixation frame 504. Stated another way, in the embodiment shown, both chordae anchors 550 are disposed on a common or singular circumferential side or half of the fixation frame 504 relative to a mid-point of the fixation frame 504 or the central longitudinal axis CLA. In embodiments, the common or singular side is the side that sits posteriorly when the frame 504 is deployed. In embodiments, the locations that the anchors 550 are coupled to the fixation frame 504 may vary based on the valve and / or leaflets being targeted for delivery, but generally the locations may be between 270 and 90 degrees apart from each other, or between 180 and 90 degrees apart from each other, or about 180 degrees apart from each other around the circumference of the frame 504 measured between the convex sides of the of the anchors 550. Furthermore, it is understood that that chordae anchors 550 are being described as attached to the fixation frame 504, but the chordae anchors 550 could be attached to the inner frame 502, or both of the inner frame 502 and fixation frame 504, or alternatively, in a single frame embodiment, the chordae anchors 550 would be attached to the frame.

[0141] In embodiments, the second chordae anchor 550B is a mirror of the first chordae anchor 550A. Thus, the second chordae anchor 550B faces and curves in the generally opposite direction to the first chordae anchor 550A. Stated another way, the first chordae anchor 550A curves in a first circumferential direction from the first end thereof coupled to the fixation frame 504 to the second, free end thereof, and the first chordae anchor 550B curves in a second circumferential direction, opposite the first circumferential direction (i.e., does not have rotational symmetry), from the first end thereof coupled to the fixation frame 504 to the second, free end. Each chordae anchor 550 is configured to transition between a radially collapsed or delivery state for delivery, as shown in FIG. 37, and a radially expanded or deployed state when deployed, as shown in FIG. 36. In FIG. 37, the transcatheter heart valve prosthesis 500 is disposed in a capsule CA of a delivery catheter DC in the radially collapsed or delivery state. In the embodiment shown, the chordae anchors 550 in the radially collapsed or delivery state are extended distally from the outflow end 526 of thefixation frame 504, i.e., generally parallel to the central longitudinal axis LA of the transcatheter heart valve prosthesis 500. However, in other configurations, the chordae anchors 550 in the radially collapsed or delivery state may compress, rotate or pivot circumferentially (z. e. , in an annular plane generally perpendicular to the central longitudinal axis of the transcatheter heart valve prosthesis 500) such that the chordae anchors 550 in the delivery state have a smaller radius than in the deployed state.

[0142] When the transcatheter heart valve prosthesis 500 is in the deployed state, the first and second chordae anchors 550A, 550B each curves in an annular plane, generally perpendicular to a central longitudinal axis LA off the transcatheter heart valve prosthesis 500, as shown in FIG. 36. In embodiments herein, the inner frame 502, the fixation frame 504, the first chordae anchor 550A, and the second chordae anchor 550B are each selfexpanding. In other words, the inner frame 502, the fixation frame, the first chordae anchor 550A, and the second chordae anchor 550B are configured to return to the radially expanded configuration when released from an outside force, such as a catheter.

[0143] In an embodiment, as shown in FIG. 38, each chordae anchor 550 is curved and includes a head 552, a first arm 554, and a second arm 556. The head 552 of each chordae anchor 550 includes a first end 558 and a second end 560. The first arm 554 includes a first end 562 and a second end 564, and the second arm 556 includes a first end 566 and a second end 568. In embodiments, the respective first ends 562, 566 of the first and second arms 554, 556 are each coupled to adjacent corresponding outflow crowns 528R4 of the fixation frame 504 as shown in FIG. 36. However, this is not meant to be limiting, and in an embodiment, the respective first ends 562, 566 of the first and second arms 554, 556 may each be coupled to non-adjacent outflow crowns 528B or may be coupled to the same outflow crown 528B.

[0144] The first and second arms 554, 556 each extend in a curve from the respective first ends 562, 566 at the outflow end 526 of the fixation frame 504 to the respective second ends 564, 568 of the first and second arms 554, 556. The second ends 564, 568 of the first and second arms 554, 556 converge together with the first end 558 of the head 552 of the chordae anchor 550. In embodiments, each chordae anchor 550 is a C-shaped curve when the chordae anchor is in the deployed state. Accordingly, the chordae anchor 550A is a c- shaped curve and the second chordae anchor 550B is a mirrored or horizontally flipped C- shaped curve. While each chordae anchor 550 is shown in FIGS. 34-38 with a first arm 554and a second arm 556, it shall be understood that in embodiments each chordae anchor 550 may include only a first arm or a second arm.

[0145] Each chordae anchor 550 described herein as an element of the transcatheter heart valve prosthesis 500 may be made from any number of suitable biocompatible materials, e.g., stainless steel, nickel titanium alloys such as nitinol, cobalt chromium alloys such as MP35N, other alloys such as ELGILOY® (Elgin, Ill.), various polymers, pyrolytic carbon, silicone, polytetrafluoroethylene (PTFE), or any number of other materials or combination of materials. In some embodiments, each chordae anchor 550 may be a separate piece coupled to the corresponding outflow crown 528B of the fixation frame 504 by, for example, and not by way of limitation, rivets, sutures, soldering, welding, staples, or other fasteners, mechanical interlocking, snap fit, friction, or interference fit, or any combination thereof. In other embodiments, each chordae anchor 550 may be formed integrally (i.e., in one piece) with the fixation frame 504 or the inner frame 502.

[0146] With an understanding of the components of the transcatheter heart valve prosthesis 500, the interactions of the various components and methods for delivering and deploying the transcatheter heart valve prosthesis 500 to replace a native mitral valve are described with respect to FIGS. 39-46B. FIG. 39 is a flow chart showing a method 600 for delivering and deploying the transcatheter heart valve prosthesis 500. FIGS. 40A-46B shows steps of the method 600 for delivery and deploying the transcatheter heart valve prosthesis 500 at the site of a native mitral valve. FIGS. 40A, 41A, 42A, 43A, 44A, 45A, and 46A each illustrate a schematic side cutaway view of the heart. FIGS. 40B, 4 IB, 42B, 43B, 44B, 45B and 46B each illustrate a schematic cross-sectional view of the outflow side of the native mitral native MV. In embodiments herein, the chordae anchors 550 of the transcatheter heart valve prosthesis 500 are configured to anchor and stabilize the transcatheter heart valve prosthesis 500 at the annulus of the native mitral valve MV and to reduce the risk of left ventricular outflow tract obstruction (LVOTO). One skilled in the art will realize that FIGS. 39-46B illustrate one example of a method of delivering and deploying the transcatheter heart valve prosthesis 500 and that certain steps of the method may be removed or combined, and that additional steps of the method may be performed in keeping with scope of the present disclosure. While described herein as delivering and deploying the transcatheter heart valve prosthesis 500 at the site of a native mitral valve, this is not meant to be limiting, and the method described herein may be utilized at othernative heart valve locations such as the native tricuspid valve. Furthermore, while described herein as delivering and deploying the transcatheter heart valve prosthesis 500 in the posterior leaflet of a native mitral valve, this is not meant to be limiting, and the methods described herein may be utilized for any of the native heart valve leaflets (e.g. posterior leaflet, anterior leaflet, septal leaflet) of the native mitral or tricuspid valves.

[0147] In a step 602 of the method 600, shown in FIGS. 40A-40B, a delivery catheter 700 including the transcatheter heart valve prosthesis 500 in the radially compressed delivery configuration disposed within a capsule 702 of the delivery catheter 700 is advanced through the vasculature of a patient to a native mitral valve MV utilizing established methods and procedures. As noted above, the transcatheter heart valve prostheses 500 may be self-expanding and may be delivered to the site of the native mitral valve by various delivery catheters including various deployment outer sheaths or capsules including a proximally retracting capsule, a distally advancing capsule, or a split capsule having both a proximally retracting portion and a distally advancing portion. A distal end 704 of the delivery catheter 700 is disposed within a left atrium LA of the heart HE, on an upstream side of a posterior leaflet PLF of the native mitral valve MV. The distal end 704 of the delivery catheter 700 is positioned adjacent to a nadir NA or base of the posterior leaflet PLF of the native mitral valve MV.

[0148] In a step 604 of the method 600, a guidewire GW is distally advanced through the delivery catheter 700 (or an ancillary catheter) to puncture or perforate the posterior leaflet PLF at or near the nadir NA of the posterior leaflet PLF and a distal portion of the guidewire GW is advanced through the puncture hole and into the left ventricle LV of the heart HE, as shown in FIGS. 41A-41B.

[0149] In a step 606 of the method 600, a distal portion of the capsule 702 of the delivery catheter 700 is distally advanced through the puncture hole in the posterior leaflet PLF of the native mitral valve MV and into the left ventricle LV, as shown in FIGS. 42A-42B. By disposing the capsule 702 of the delivery catheter 700 through the puncture hole in the posterior leaflet PLF, the first and second chordae anchors 550A, 550B (not visible in FIGS. 42A and 42B) of the transcatheter heart valve prosthesis 500 may be deployed behind, or on a posterior side PS of the chordae CH of the native mitral valve MV, and on a downstream side of the posterior leaflet PLF.

[0150] In a step 608 of the method 600, the capsule 702 of the delivery catheter 700 is proximally retracted in a direction indicated by an arrow 750 in FIG. 43 A to release the first and second chordae anchors 550A, 550B of the transcatheter heart valve prosthesis 500. In an embodiment, the transcatheter heart valve prosthesis 500 may be distally advanced out of the capsule 702 in a direction opposite the arrow 750. When released, the first and second chordae anchors 550A, 550B transition from the delivery state to the deployed state. In greater detail, as the capsule 702 exposes the first and second chordae anchors 550A, 550B of the transcatheter heart valve prosthesis 500, the first and second chordae anchors 550A, 550B radially expand at the outflow end 526 of the fixation frame 504. The first and second chordae anchors 550A, 550B each radially expand and pivot from the delivery state with the first and second chordae anchors 550A, 550B each generally parallel to the central longitudinal axis LA, as shown in FIG. 37, and begin to transition to the deployed state with the first and second chordae anchors 550A, 550B each generally perpendicular to the central longitudinal axis LA. As each chordae anchor 550 transitions from the delivery state, each chordae anchor 550 curves in a direction towards the anterior leaflet ALF, as shown in FIG. 43B and pivots proximally in the direction of the outflow end 526 of the fixation frame 504. In embodiments where the chordae anchors 550 are circumferentially compressed in the delivery state, the chordae anchors 550 will begin to expand away from the central longitudinal axis LA. The first and second chordae anchors 550A, 550B are each rotationally oriented on the posterior side PS of the transcatheter heart valve prosthesis 500 for improved engagement of native chordae of the posterior leaflet PLF as the transcatheter heart valve prosthesis 500 radially expands. As the first and second chordae anchors 550A, 550B each radially expand on the posterior side PS of the chordae CH of the posterior leaflet PLF, each chordae anchor 550 curves in a direction towards the anterior leaflet ALF on generally opposite sides of the fixation frame 504 of the transcatheter heart valve prosthesis 500.

[0151] In a step 610 of the method 600, as shown in FIGS. 44A-44B, the capsule 702 of the delivery catheter 700 continues to be proximally retracted in the direction of the arrow 750 of FIG. 44A and the transcatheter heart valve prosthesis 500 continues to deploy and radially expand. Because the outflow end of the transcatheter heart valve prosthesis 500 is disposed through the puncture hole in the posterior leaflet PLF, rather than between the posterior and anterior leaflets as traditionally deployed, the outward radial force of the radialexpansion of the transcatheter heart valve prosthesis 500 within the puncture hole in the posterior leaflet PLF tears tissue of the posterior leaflet PLF. As the fixation frame 504 of the transcatheter heart valve prosthesis 500 continues to radially expand, the first and second chordae anchors 550A, 550B continue to transition to the deployed state on the outflow side of the native mitral valve MV. It shall be noted that the respective first ends 562, 566 of the first and second arms 554, 556 of the first and second chordae anchors 550A, 550B are coupled to or radially extend from the outflow end 526 of the fixation frame 504 at or on a posterior side of a midpoint MP, or on a first half of the transcatheter heart valve prosthesis 500, as shown in FIG. 44B.

[0152] As shown in FIGS. 45A-45B, as the transcatheter heart valve prosthesis 500 continues to radially expand, the fixation frame 504 abuts a posterior wall PW of the annulus AN of the native mitral valve MV and further radial expansion is directed in the direction of the anterior wall AW. The posterior leaflet PLF is tom or lacerated to a free edge FE and the chordae CH of the posterior leaflet PLF are bunched or gathered or captured by the corresponding chordae anchors 550A, 550B of the transcatheter heart valve prosthesis 500. A first posterior leaflet portion PLF 1 and chordae CH coupled thereto are captured by the first chordae anchor 550A on a first side of the transcatheter heart valve prosthesis 500, and a second posterior leaflet portion PLF2 and chordae CH coupled thereto are captured by the second chordae anchor 550B on a second side of the transcatheter heart valve prosthesis 500.

[0153] FIGS. 46A-46B illustrate the transcatheter heart valve prosthesis 500 in the deployed configuration at the site of the native mitral valve MV. The delivery catheter 700 has been omitted in FIG. 46A for clarity. The first and second posterior leaflet portions PLF1, PLF2 are each wrapped over the corresponding first and second chordae anchors 550A, 550B. The first and second chordae anchors 550A, 550B have each gathered and pulled the corresponding chordae CHI, CH2 and the corresponding posterior leaflet portion PLF1, PLF2 towards the commissure plane of the native mitral valve MV to anchor the transcatheter heart valve prosthesis 500 to the native anatomy. The first and second chordae anchors 550A, 550B offer a generally central or sub-valvular anchoring to prevent canting, angling, or sloping of the transcatheter heart valve prosthesis 500 within the annulus AN of the native mitral valve MV. The first and second chordae anchors 550A, 550B wrap around and / or under an outflow side of the corresponding posterior leaflet portions PLF1, PLF2,capturing corresponding chordae thereof, to stabilize the transcatheter heart valve prosthesis 500, prevent atrial embolization, and prevent migration of the transcatheter heart valve prosthesis 500 during ventricular systole. In embodiments herein, the stability offered by the chordae anchors 550 engaging the chordae CHI, CH2 and the posterior leaflet portions PLF1, PLF2 permits the fixation frame 504 to not extend to a roof of the posterior wall of the left atrium LA, thereby eliminating the potential of the fixation frame 504 being disposed adjacent to or potentially blocking the pulmonary veins and / or the left atrial appendage.

[0154] With the transcatheter heart valve prosthesis 500 released from the delivery catheter 700 and in the deployed configuration at the native mitral valve MV, the delivery catheter 700 may then be removed from the patient’s vasculature utilizing established procedures.

[0155] While described herein with the guidewire distally advanced through the delivery system to puncture or perforate one of the valve leaflets of the native valve, this is not meant to be limiting. In another non-limiting embodiment, a separate catheter system may be utilized for puncturing the valve leaflet with the guidewire. The guidewire may be retained in place through the valve leaflet and the delivery catheter with the transcatheter heart valve prosthesis 500 may be advanced over the guidewire.

[0156] It should be understood that, depending on the example, certain acts or events of any of the processes or methods described herein may be performed in a different sequence, may be added, merged, or left out altogether (e.g, all described acts or events may not be necessary to carry out the techniques).

[0157] While various embodiments have been described above, it should be understood that they have been presented only as illustrations and examples of the present technology, and not by way of limitation. It will be apparent to persons skilled in the relevant art that various changes in form and detail may be made therein without departing from the spirit and scope of the present technology. Thus, the breadth and scope of the present technology should not be limited by any of the above-described embodiments but should be defined only in accordance with the appended claims and their equivalents. It will also be understood that each feature of each embodiment discussed herein, and of each reference cited herein, may be used in combination with the features of any other embodiment. All patents and publications discussed herein are incorporated by reference herein in their entirety.

[0158] The following examples are illustrative of the techniques described herein.

[0159] Example 1. A heart valve docking assembly, comprising: a shaft including; a coil portion including delivery state and a deployed state, wherein the coil portion in the deployed state includes at least one coil arranged around a central longitudinal axis of the docking assembly; a first anchor formed along the length of the shaft proximal of the coil portion, wherein the first anchor is configured to radially expand from a radially contracted configuration to a radially expanded configuration wherein a first anchor outer diameter is larger in the radially expanded configuration -than in the radially contracted configuration; and a second anchor integrally formed along the length of the shaft proximal of the first anchor, wherein the second anchor is configured to radially expand from a radially contracted configuration to a radially expanded configuration wherein a second anchor outer diameter is larger in the radially expanded configuration than in the radially contracted configuration.

[0160] Example 2. The heart valve docking assembly of Example 1, wherein the coil portion includes a plurality of coils arranged around the central longitudinal axis of the docking assembly.

[0161] Example 3. The heart valve docking assembly of Example 1 or Example 2, wherein the first anchor portion includes a plurality of first anchoring members shape set to a radially expanded state to form the radially expanded configuration of the first anchor and a radially contracted state to form the radially contracted configuration of the first anchor, and wherein the second anchor portion includes a plurality of second anchoring members shape set to a radially expanded state to form the radially expanded configuration of the second anchor and a radially contracted state to form the radially contracted configuration of the second anchor.

[0162] Example 4. The heart valve docking assembly of any of Examples 1 to 3, wherein the shaft includes a first end and a second end, wherein the second end of the shaft configured to be releasably coupled to a delivery system.

[0163] Example 5. The heart valve docking assembly of Example 4, wherein the second end of the shaft is configured to be releasably coupled to the delivery system by at least one suture.

[0164] Example 6. The heart valve docking assembly of Example 4, wherein the second end of the shaft is configured to be threadably coupled to the delivery system.

[0165] Example 7. The heart valve docking assembly of any one of Examples 1 to 6. wherein the shaft further comprises a transition portion disposed between the first anchor and the second anchor, and wherein the transition portion is configured to be disposed through the valve leaflet of the native heart valve when the coil portion is in the deployed state.

[0166] Example 8. The heart valve docking assembly of any one of Examples 1 to 7, wherein the shaft further comprises a proximal coil portion proximal of the second anchor, wherein the proximal coil portion is configured in a deployed configuration to include at least one coil.

[0167] Example 9. A method of repairing a native heart valve comprising: delivering a device to a site of the native heart valve, wherein the device comprises a shaft including a coil portion, a first anchor, and a second anchor, wherein the device is delivered to the site in a delivery configuration; puncturing a hole through a native leaflet of the native heart valve; advancing the device through the hole; deploying the coil portion to a deployed configuration such that the coil portion wraps around native leaflets and / or chordae of the native heart valve; radially expanding the first anchor from a radially contracted configuration to a radially expanded configuration on a first side of the native leaflet; and radially expanding the second anchor from a radially contracted configuration to a radially expanded configuration on a second side of the native leaflet.

[0168] Example 10. The method of Example 9, wherein the coil portion in the delivery configuration is straightened.

[0169] Example 11. The method of Example 9 or Example 10, wherein the coil portion in the deployed configuration comprises a single coil.

[0170] Example 12. The method of Example 9 or Example 10, wherein the coil portion in the deployed configuration comprises a plurality of coils.

[0171] Example 13. The method of Example 12, wherein the plurality of coils in the deployed configuration have a decreasing radius of curvature in a proximal direction.

[0172] Example 14. The method of any one of Examples 9 to 11, further comprising: advancing a stylet into a central passageway of the shaft in the coil portion, wherein the stylet has a first radius of curvature and the coil portion in the deployed configuration has a second radius of curvature smaller than the first radius of curvature, wherein deploying the coil portion comprises: initially deploying the coil portion with the stylet disposed in thecentral passageway such that the coil portion wraps around the native leaflets and / or the chordae with the first radius of curvature; and removing the stylet such that the coil portion radially contracts from the first radius of curvature to the second radius of curvature.

[0173] Example 15. The method of any one of Examples 9 to 12, where delivering the device comprises delivering the device in a delivery system.

[0174] Example 16. The method of Example 15, wherein puncturing a hole in the native leaflet comprises advancing a guidewire of the delivery system through the device to puncture the native leaflet.

[0175] Example 17. The method of Example 15 or Example 16, wherein delivering the device comprises delivering the device within an outer sheath of the delivery system such that the outer sheath straightens the shaft of the device.

[0176] Example 18. The method of Example 17, wherein deploying the coil portion comprises advancing the coil portion out of the outer sheath.

[0177] Example 19. The method of Example 17 or Example 18, wherein radially expanding the first anchor comprises advancing the first anchor out of the outer sheath or retracting the outer sheath to release the first anchor.

[0178] Example 20. The method of any one of Examples 15 to 19, further comprising retracting the delivery system to set the first anchor against the first side of the native leaflet.

[0179] Example 21. The method of any one of Examples 15 to 19, wherein radially expanding the second anchor comprises retracting the outer sheath of the delivery system to transition the second anchor from the radially contracted configuration to the radially expanded configuration on a second side of the native leaflet.

[0180] Example 22. The method of any one of Examples 8 to 21, further comprising deploying a proximal coil portion of the shaft on the second side of the native leaflet.

[0181] Example 23. The method of any one of Examples 8 to 22, wherein the native heart valve is a native mitral valve, the first side of the native leaflet is a ventricular side of the native leaflet, and the second side of the native leaflet is an atrial side of the native leaflet.

[0182] Example 24. The method of any one of Examples 8 to 23, further comprising deploying a prosthetic heart valve within the deployed device.

[0183] Example 25. A transcatheter heart valve prosthesis comprising: a frame having an inflow end and an outflow end, the frame having a radially collapsed configuration fordelivery and a radially expanded configuration for deployment within a native heart valve; a prosthetic valve disposed within and coupled to the frame, the prosthetic valve being configured to block blood flow in one direction to regulate blood flow through a central lumen of the frame; and a plurality of chordae anchors extending from the outflow end of the frame, the plurality of chordae anchors having a delivery state and a deployed state, and wherein in the deployed state the plurality of chordae anchors curve radially outward, circumferentially, and generally perpendicular to a central longitudinal axis of the transcatheter heart valve prosthesis, wherein the plurality of chordae anchors are configured to capture chordae of a native valve leaflet and / or the native valve leaflet.

[0184] Example 26. The transcatheter heart valve prosthesis of Example 25, wherein the plurality of chordae anchor includes a first chordae anchor and a second chordae anchor.

[0185] Example 27. The transcatheter heart valve prosthesis of Example 26, wherein the first chordae anchor is circumferentially curved in a first direction and the second chordae anchor is circumferentially curved in a second direction that is generally opposite the first direction.

[0186] Example 28. The transcatheter heart valve prosthesis of any one of Examples 25 to 27, wherein the plurality of chordae anchors are integrally formed with the frame.

[0187] Example 29. The transcatheter heart valve prosthesis of any one of Examples 25 to 27, wherein the plurality of chordae anchors are formed separate from the frame and are coupled to the frame.

[0188] Example 30. The transcatheter heart valve prosthesis of any one of Examples 25 to 29, wherein the plurality of chordae anchors extend in a distal direction from the frame with the chordae anchors in the delivery state.

[0189] Example 31. The transcatheter heart valve prosthesis of any of Examples 25 to 30, wherein the plurality of chordae anchors extend from a common or singular circumferential half of the frame.

[0190] Example 32. The transcatheter heart valve prosthesis of Example 31, wherein the common or singular circumferential half of the frame is configured to be deployed at a posterior leaflet of a native mitral valve.

[0191] Example 33. The transcatheter heart valve prosthesis of Example 31, wherein the common or singular circumferential half of the frame is configured to be deployed at an anterior leaflet of a native mitral valve.

[0192] Example 34. A method of repairing a native heart valve comprising: delivering a transcatheter heart valve prosthesis to a site of the native heart valve in a radially compressed delivery configuration, wherein the transcatheter heart valve prosthesis comprises a frame, a prosthetic valve coupled to the frame, and a plurality of chordae anchors; puncturing a hole through a native leaflet of the native heart valve; advancing the transcatheter heart valve prosthesis through the hole; deploying the plurality of chordae anchors on an outflow side of the native leaflet; and deploying the frame of the transcatheter heart valve prosthesis within the hole of the native leaflet of the native valve to a radially expanded deployed configuration to tear the native leaflet and such that the plurality of chordae anchors each engage chordae of the native heart valve and / or a portion of the native leaflet to anchor the transcatheter heart valve prosthesis.

[0193] Example 35. The method of Example 34, wherein in the radially compressed delivery configuration, the plurality of chordae anchors extend distally from an outflow end of the frame of the transcatheter heart valve prosthesis.

[0194] Example 36. The method of Example 34 or Example 35, wherein the radially expanded deployed configuration, the plurality of chordae anchors are curved and extend generally perpendicular to the central longitudinal axis of the transcatheter heart valve prosthesis.

[0195] Example 37. The method of any one of Examples 34 to 36, where delivering the transcatheter heart valve prosthesis comprises delivering the transcatheter heart valve prosthesis in a delivery catheter.

[0196] Example 38. The method of Example 37, wherein puncturing a hole in the native leaflet comprises advancing a guidewire of the delivery catheter to puncture the native leaflet.

[0197] Example 39. The method of Example 37 or Example 38, wherein delivering the transcatheter heart valve prosthesis comprises delivering the transcatheter heart valve prosthesis within a capsule of the delivery catheter such that the capsule straightens the plurality of chordae anchors of the transcatheter heart valve prosthesis.

[0198] Example 40. The method of Example 39, wherein deploying the plurality of chordae anchors of the transcatheter heart valve prosthesis comprises proximally retracting the capsule of the delivery catheter.

[0199] Example 41. The method of any one of Examples 34 to 40, wherein the native heart valve is a native mitral valve.

[0200] Example 42. The method of Example 41, wherein puncturing the hole in the native leaflet comprises puncturing the hole in a posterior leaflet of the native mitral valve.

[0201] Example 43. The method of Example 41, wherein puncturing the hole in the native leaflet comprises puncturing the hole in an anterior leaflet of the native mitral valve

[0202] Example 44. The method of any one of Examples 34 to 43, wherein the plurality of chordae anchors consists of a first chordae anchor and a second chordae anchor.

[0203] Example 45. The method of any one of Examples 34 to 44, wherein the plurality of chordae anchors are disposed on a common or singular circumferential half of the frame of the transcatheter heart valve prosthesis.

[0204] Example 46. The method of Example 45, wherein the common or singular circumferential half is a posterior half of the frame such that open deployment, the plurality of anchors both engage chordae of the posterior leaflet of the native heart valve and / or a portion of the posterior leaflet to anchor the transcatheter heart valve prosthesis.

Claims

CLAIMSWhat is claimed is:

1. A heart valve docking assembly (100, 300, 400) comprising: a shaft (102) including; a coil portion (110) including delivery state and a deployed state, wherein the coil portion in the deployed state includes at least one coil arranged around a central longitudinal axis of the docking assembly; a first anchor (120) formed along the length of the shaft proximal of the coil portion, wherein the first anchor is configured to radially expand from a radially contracted configuration to a radially expanded configuration wherein a first anchor outer diameter is larger in the radially expanded configuration than in the radially contracted configuration; and a second anchor (140) integrally formed along the length of the shaft proximal of the first anchor, wherein the second anchor is configured to radially expand from a radially contracted configuration to a radially expanded configuration wherein a second anchor outer diameter is larger in the radially expanded configuration than in the radially contracted configuration.

2. The system of claim 1, wherein the coil portion (100) includes a plurality of coils (316) arranged around the central longitudinal axis of the docking assembly.

3. The heart valve docking assembly of claim 1 or claim 2, wherein the first anchor (120) includes a plurality of first anchoring members (126) shape set to a radially expanded state to form the radially expanded configuration of the first anchor and a radially contracted state to form the radially contracted configuration of the first anchor, and wherein the second anchor (140) includes a plurality of second anchoring members (146) shape set to a radially expanded state to form the radially expanded configuration of the second anchor and a radially contracted state to form the radially contracted configuration of the second anchor.

4. The heart valve docking assembly of any one of claims 1 to 3, wherein the shaft (102) includes a first end (104) and a second end (106), wherein the second end of the shaft configured to be releasably coupled to a delivery system (200).

5. The heart valve docking assembly of claim 4, wherein the second end (106) of the shaft (102) is configured to be releasably coupled to the delivery system (200) by at least one suture (SU) or threadably coupled to the delivery system.

6. The heart valve docking assembly of any one of claims 1 to 5, wherein the shaft (102) further comprises a transition portion (130) disposed between the first anchor and the second anchor, and wherein the transition portion is configured to be disposed through the valve leaflet (LF) of the native heart valve when the coil portion (110) is in the deployed state.

7. The heart valve docking assembly (400) of any one of claims 1 to 6, wherein the shaft (102) further comprises a proximal coil portion (460) proximal of the second anchor (140), wherein the proximal coil portion is configured in a deployed configuration to include at least one coil.

8. A transcatheter heart valve prosthesis (500) comprising: a frame having an inflow end and an outflow end, the frame having a radially collapsed configuration for delivery and a radially expanded configuration for deployment within a native heart valve; a prosthetic valve (506) disposed within and coupled to the frame, the prosthetic valve being configured to block blood flow in one direction to regulate blood flow through a central lumen of the frame; and a plurality of chordae anchors (550) extending from the outflow end of the frame, the plurality of chordae anchors having a delivery state and a deployed state, and wherein in the deployed state the plurality of chordae anchors curve radially outward, circumferentially, and generally perpendicular to a central longitudinal axis of thetranscatheter heart valve prosthesis, wherein the plurality of chordae anchors are configured to capture chordae of a native valve leaflet and / or the native valve leaflet.

9. The transcatheter heart valve prosthesis of claim 8, wherein the plurality of chordae anchors (550) includes a first chordae anchor (550A) and a second chordae anchor (550B).

10. The transcatheter heart valve prosthesis of claim 9, wherein the first chordae anchor (550A) is circumferentially curved in a first direction and the second chordae anchor(55 OB) is circumferentially curved in a second direction that is generally opposite the first direction.

11. The transcatheter heart valve prosthesis of any one of claims 8 to 10, wherein the plurality of chordae anchors (550) are integrally formed with the frame (502, 504) or are formed separate from the frame and are coupled to the frame.

12. The transcatheter heart valve prosthesis of any one of claims 8 to 11, wherein the plurality of chordae anchors (550) extend in a distal direction from the frame (502, 504) with the chordae anchors in the delivery state.

13. The transcatheter heart valve prosthesis of any one of claims 8 to 12, wherein the plurality of chordae anchors (550) extend from a common or singular circumferential half of the frame.

14. The transcatheter heart valve prosthesis of claim 13, wherein the common or singular circumferential half of the frame is configured to be deployed at a posterior leaflet of a native mitral valve, or wherein the common or singular circumferential half of the frame is configured to be deployed at an anterior leaflet of a native mitral valve.

15. The transcatheter heart valve prosthesis of any one of claims 8 to 14, wherein the frame comprises an inner frame (502) and a fixation frame (504) surrounding the inner frame, wherein the prosthetic valve (506) is disposed within and coupled to the inner frame (502) and the plurality of chordae anchors (550) are coupled to the fixation frame (504).

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