CN107920862B - Systems and methods for heart valve therapy - Google Patents

Abstract

The prosthetic mitral valves described herein can be deployed using transcatheter mitral valve delivery systems and techniques to interface and cooperatively anchor with the anatomy of a native mitral valve. Prosthetic heart valve designs are described herein that interface with native mitral valve structures to form a fluid seal to minimize mitral regurgitation and paravalvular leaks. Prosthetic heart valve designs and techniques for managing blood flow through the left ventricular outflow tract are also described herein. Further, prosthetic heart valve designs and techniques are described herein that reduce the risk of interference between the prosthetic valve and chordae tendineae.

Description

Systems and methods for heart valve therapy

Cross Reference to Related Applications

This application claims the benefit of the following applications: U.S. provisional patent application No.62/067,907, filed on 23/10/2014; U.S. provisional patent application No.14/671,577, filed 3/27/2015; U.S. provisional patent application No.14/673,055, filed 3/30/2015; and U.S. provisional patent application No.14/674,349, filed 3/31/2015. The disclosure of the prior application is considered part of the disclosure of the present application and is incorporated by reference into the disclosure of the present application.

Technical Field

This document relates to prosthetic heart valves, such as prosthetic mitral valves that can be implanted using transcatheter techniques.

Background

The long-term clinical effects of valve regurgitation are believed to be a significant cause of cardiovascular-related morbidity and mortality. Thus, for many therapies designed to treat the mitral valve, one primary objective is to significantly reduce or eliminate regurgitation. By eliminating regurgitation at the mitral valve, the damaging volume overload effect on the left ventricle can be attenuated. Volume overload of Mitral Regurgitation (MR) involves excess kinetic energy required during isosystole to generate total stroke volume in an attempt to maintain forward stroke volume and cardiac output. It also involves the consumption of the pressure potential of the leaking valve during the most energy consuming part of the isovolumetric contraction of the cardiac cycle. In addition, treatment for MR relief may have the effect of reducing high pressure in the left atrium and pulmonary vessels to relieve symptoms of pulmonary edema (congestion) and shortness of breath. These therapies for MR mitigation may also have a positive impact on the filling curve of the Left Ventricle (LV) and the restrictive LV pathology that may result from MR. These pathophysiological issues suggest possible benefits of MR therapy, but also suggest the complexity of the system and the need for therapies with points of interest beyond the MR level or grade.

Certain therapies used to treat MR may exacerbate other (non-MR) existing pathological conditions or develop new pathological conditions. One of the conditions to be treated is mitral stenosis or the formation of an inflow gradient. That is, if a prosthetic valve is used that does not allow sufficient LV inflow without high filling pressures, then some of the benefits of MR mitigation may be lost or lost. Additional conditions to be treated are Left Ventricular Outflow Tract (LVOT) obstruction or the formation of high LVOT pressure gradients. That is, if a prosthetic valve system is used that does not adequately occlude the LVOT, some of the benefits of MR mitigation may be lost or lost. Furthermore, if the surgical procedure results in damage to the atrial tissue during the surgical procedure, this may increase the likelihood of negative physiological effects of atrial fibrillation. Moreover, certain prosthetic valve systems increase the risk of higher LV wall stress by increasing LV size (LV geometry). Due to the integrated relationship of the mitral valve to the LV geometry via the mastoid and chordae tendineae devices, LV wall stress levels may be directly affected, resulting in LV filling and contraction mechanics changes. Thus, in some cases, prosthetic valve systems that deteriorate LV geometry may offset the benefits of MR mitigation due to changes in contractile physiology.

Disclosure of Invention

Prosthetic heart valves, such as prosthetic mitral valves that can be implanted using transcatheter techniques, are described herein. For example, certain embodiments of the transcatheter mitral valve delivery systems and methods described herein may be deployed to interface with and be cooperatively anchored with the native anatomy of the mitral valve. Further, prosthetic heart valves that interface with native mitral valve structures to form a fluid seal to minimize post-implantation MR and paravalvular leaks are described herein. Additionally, prosthetic heart valve systems and techniques are described herein that, in particular embodiments, are configured to manage blood flow through the Left Ventricular Outflow Tract (LVOT) such that the risk of complete or partial occlusion of the LVOT is mitigated. Furthermore, certain embodiments of the prosthetic heart valve systems and techniques described herein may be configured to mitigate the risk of interference between the prosthetic valve and chordae tendineae of the native mitral valve leaflets, which may advantageously facilitate or preserve LV geometry.

Particular embodiments described herein include a mitral valve replacement system for use with a heart. The system can include an expandable anchor assembly configured to be implanted in a native mitral valve, and the expandable anchor assembly can include a first expandable frame that can be adjusted from a delivery configuration to an expanded configuration. The system may also include a first delivery sheath device having a distal end insertable within the left atrium and configured to push the anchor assembly out of the distal end such that the anchor assembly expands within the left atrium to an expanded configuration. Optionally, the system may further include a pushing instrument releasably attached to the expandable anchor frame and configured to longitudinally advance the anchor assembly within the left atrium toward an annulus of the native mitral valve when the anchor assembly is in the expanded configuration. Moreover, the system can include a prosthetic valve assembly including a second expandable frame that is adjustable from a compressed configuration to a deployed configuration to selectively engage the anchor assembly when the anchor assembly is in the expanded configuration.

Certain embodiments described herein include a method for deploying a prosthetic mitral valve system within a native mitral valve of a patient. The method can comprise the following steps: the first delivery sheath is navigated within the patient such that a distal end of the first delivery sheath is positioned within the left atrium. The method may further include pushing an anchor assembly of the prosthetic heart valve system from a distal end of the first delivery sheath such that the anchor assembly at least partially expands when positioned within the left atrium. Additionally, the method may include moving the anchor assembly toward an annulus of the native mitral valve after pushing the anchor assembly into the left atrium.

Various embodiments described herein include prosthetic mitral valve systems. The system may also include a valve assembly, which may include: a frame member defining an outer profile and an inner frame member space; and an occluder disposed in the inner frame member space. The occluding device has an open configuration and a closed configuration. The frame member includes a proximal end frame portion and a distal end frame portion. Optionally, the outer periphery of the distal end frame portion comprises a substantially flat region and a substantially circular region, and wherein at least some portion of the substantially flat region extends toward the inner frame member space.

Particular embodiments described herein include methods of using a prosthetic mitral valve system. The method can comprise the following steps: a valve assembly of a prosthetic mitral valve system is advanced toward an annulus of a native mitral valve. Optionally, the valve assembly may comprise a frame member defining an outer profile and an inner frame member space; and an occluder disposed in the inner frame member space. The frame member includes a proximal end frame portion and a distal end frame portion. The outer periphery of the distal end frame portion optionally includes a substantially flat region and a substantially circular region, and at least some portion of the substantially flat region extends toward the inner frame member space. The method may further comprise anchoring the valve assembly to the native mitral valve such that the substantially planar region is adjacent to anterior native leaflets of the native mitral valve.

Certain embodiments described herein include a prosthetic mitral valve system implantable at a native mitral valve. The prosthetic mitral valve system can include an anchor assembly defining an inner anchor assembly space and a longitudinal axis. The anchor assembly may include an expandable anchor frame including a hub and sub-annular support arms extending from the hub. The sub-annular support arms extend expandable to anchor feet having surfaces configured to engage the sub-annular sulcus of the native mitral valve. The system may also include a valve assembly comprising: an expandable valve frame defining an outer profile and an inner frame member space; and an occluder disposed in the inner frame member space. The valve assembly is releasably engageable with the anchor assembly within the inner anchor assembly space. Optionally, the distance measured parallel to the longitudinal axis from the distal-most end of the anchor assembly to the surface is at least 14 millimeters.

Various embodiments described herein include methods of using a prosthetic mitral valve system. The method may further comprise: an anchor assembly of the prosthetic mitral valve system is advanced toward an annulus of the native mitral valve. The anchor assembly may define an inner anchor assembly space and a longitudinal axis, and the anchor assembly may include an expandable anchor frame including a hub and one or more sub-hoop support arms extending from the hub. Each of the one or more sub-annular support arms may extend to an anchoring foot configured to engage with an sub-annular sulcus of a native mitral valve. The method may further comprise: the anchoring assembly of the prosthetic mitral valve system is engaged with tissue adjacent the native mitral valve such that each anchoring foot engages the sub-annular sulcus and such that the hub is positioned distal to a distal-most region of coaptation between the anterior and posterior leaflets of the native mitral valve.

Particular embodiments described herein include a method for sealing between a prosthetic mitral valve system and native leaflets of a mitral valve. The method can comprise the following steps: anchoring an anchor assembly of the prosthetic mitral valve system with tissue adjacent to an annulus of the native mitral valve. Optionally, the anchor assembly defines an inner anchor assembly space and a longitudinal axis, and the anchor assembly may include an expandable anchor frame including a hub and one or more sub-hoop support arms extending from the hub. Each of the one or more sub-annular support arms may extend to an anchoring foot that engages an sub-annular sulcus of the native mitral valve. The method may further comprise: a valve assembly of the prosthetic mitral valve system is delivered into engagement with the anchor assembly. Optionally, the valve assembly may comprise: an expandable valve frame defining an outer profile and an inner frame member space; and, a tissue layer disposed over at least a portion of the outer contour; and an occluder disposed in the inner frame member space. As each anchor foot of the anchor assembly engages the sub-annular groove, the tissue layer of the valve assembly abuts the native leaflets of the mitral valve.

Various embodiments described herein include prosthetic mitral valve systems. The system may include an anchor assembly including an expandable anchor frame and a set of sub-annular anchor feet configured to engage with a sub-annular groove of a native mitral valve. The system may also include a valve assembly, the valve assembly comprising: an expandable valve frame defining an outer profile and an inner frame member space; and, a tissue layer disposed over at least a portion of the outer contour; and an occluder disposed in the inner frame member space. Optionally, when the anchor foot set of the anchor assembly is engaged with the sub-annular channel, an outwardly facing periphery along the tissue layer of the valve assembly is positioned against the native leaflets of the mitral valve.

Various embodiments described herein include a method for deploying a prosthetic mitral valve system within a native mitral valve of a patient. The method may include navigating the delivery sheath such that a distal end of the delivery sheath is positioned within a left atrium of the patient. Additionally, the method may include pushing an anchor assembly of the prosthetic mitral valve system in the left atrium. The distal pusher instrument may be releasably engaged with the anchor assembly. The method may further comprise: the anchor assembly is engaged with the native mitral valve while the distal pusher instrument remains engaged with the anchor assembly. The method may further include pushing a valve assembly of the prosthetic mitral valve system in the left atrium. Optionally, the valve assembly may be slidably engaged with an exterior of the distal pusher instrument. The method may further comprise: the valve assembly is moved into the interior space defined by the anchor assembly. Such movement optionally includes sliding the valve assembly along an exterior of the distal pusher catheter while the distal pusher catheter remains engaged with the anchor assembly. The method may further comprise, after moving the valve assembly, mounting the valve assembly with the anchor assembly. Additionally, the method can include, after installing the valve assembly, separating the distal pusher instrument from the anchor assembly.

Certain embodiments described herein include an implantable medical device delivery system. The system includes a first deflectable catheter defining a first lumen therethrough, a distal end of the first deflectable catheter being controllably laterally deflectable. The system may also include a first device delivery sheath slidably disposed within the first lumen, and the first device delivery sheath may define a second lumen therethrough. The system may also include a first device control sheath slidably disposed within the second lumen, and the first device control sheath may define a third lumen therethrough and one or more first device control wire lumens. The system may further include a second deflectable catheter slidably disposed within the third lumen, and the second deflectable catheter may define a fourth lumen therethrough with a distal end of the second deflectable catheter controllably laterally deflectable. The system may also include a device pusher catheter slidably disposed within the fourth lumen, and the device pusher catheter may define a fifth lumen therethrough. The distal end of the device pusher catheter may be configured to releasably couple with a first implantable medical device.

Certain embodiments described herein include a method for deploying a prosthetic mitral valve system within a native mitral valve of a patient. The method may further comprise: the anchor assembly of the prosthetic heart valve system is expanded within the left atrium while the anchor assembly is releasably secured to the first delivery catheter such that the anchor assembly is at least partially expanded while positioned within the left atrium. The method also optionally includes, after pushing the anchor assembly into the left atrium, shaking or rotating the anchor assembly within the left atrium by articulating a tip portion of the first delivery catheter.

Various embodiments described herein include a method for deploying a prosthetic mitral valve system within a native mitral valve of a patient. The method may further comprise: when the valve assembly is releasably secured to the valve delivery catheter, the valve assembly of the prosthetic heart valve system is pushed into the left atrium, causing the valve assembly to at least partially expand while positioned within the left atrium. The method also optionally includes, after the valve assembly is advanced into the left atrium, rocking or rotating the valve assembly within the left atrium by articulating a tip portion of a valve delivery catheter.

Some or all of the embodiments described herein may provide one or more of the following advantages. First, certain embodiments of the prosthetic mitral valve systems provided herein can be used in a variety of different skill level surgeons performing a total percutaneous/transcatheter mitral valve replacement procedure that is safe, reliable, and repeatable. For example, in certain embodiments, a prosthetic mitral valve system can form a reliable and consistent anchor/base with which the valve/occluder structure subsequently engages. Thus, prosthetic mitral valve systems can be specifically designed to use the geometry/mechanical structure of the native mitral valve to create sufficient retention capacity. In a particular aspect, the anatomical groove present under the native mitral valve annulus may serve as a site for anchoring the prosthetic mitral valve system, but the anchoring structures may be deployed to maintain native leaflet function of the mitral valve, thereby providing the ability to implant components of the prosthetic mitral valve system entirely separately and in stages. Accordingly, certain embodiments of the prosthetic mitral valve systems described herein are configured to be implanted in a reliable, repeatable, and simplified procedure that is widely applicable to a variety of patients and physicians, while also employing significantly less invasive methods.

Second, certain embodiments of the prosthetic mitral valve systems described herein facilitate effective and durable MR mitigation without negative physiological consequences to the cardiopulmonary system (heart, lungs, peripheral vessels), including stenosis, LV wall stress, and atrial fibrillation. Moreover, the system can provide a safe and durable anchoring effect at the native mitral valve to provide effective mitral regurgitation therapy as well as provide a structure to provide a sealing benefit and avoid significant damage to the chordae interface of the native mitral valve leaflets.

Third, in particular embodiments, the prosthetic mitral valve system can be delivered to the native mitral valve using a technique in which the expandable frame of the anchoring member at least partially expands within the left atrium prior to reaching the mitral valve location. As such, in addition to facilitating the delivery of anchors, a cardiac surgeon or other user can see the expanding members (and their orientation) within the heart before they are advanced to the annulus of the mitral valve (thereby giving the user the opportunity to laterally pivot (rotate, rock, reorient) the expanded members before they reach the annulus).

Fourth, certain embodiments of the prosthetic mitral valve systems described herein can be configured to extend partially into the left ventricle after implantation, but can include a contoured shape configured to reduce the likelihood of occluding blood flow through the LVOT. Thus, even if some parts of the prosthetic mitral valve system extend into the left atrium above the mitral valve annulus (supra-annular) and other parts extend into the left ventricle below the mitral valve annulus (sub-annular), the prosthetic mitral valve system is designed for such native LVOT and thus reduces the risk of full or partial leakage of LVOT.

Fifth, in certain embodiments, the prosthetic mitral valve system can include two distinct expandable components (e.g., an anchor assembly and a valve assembly) that are delivered separately to the implantation site, and the two components can abut and engage native heart tissue at the mitral valve. For example, a first component (e.g., an anchor assembly) may be configured to engage heart tissue at or near the native mitral valve annulus and a second component (e.g., a valve assembly) may be configured to provide a sealing interface with native valve leaflets of the mitral valve.

The details of one or more embodiments of the invention are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the embodiments will be apparent from the description and drawings, and from the claims.

Drawings

Fig. 1 is a perspective view of a portion of a prosthetic mitral valve deployment system in a cross-sectional view of a native human heart, according to some embodiments.

Fig. 2 shows a perspective view of the prosthetic mitral valve anchor assembly in the left atrium of the heart after the anchor assembly exits the anchor delivery system of the deployment system of fig. 1.

Fig. 3 illustrates a perspective view of the anchor assembly of fig. 2 after rotation in the left atrium to orient the anchor assembly substantially perpendicular to the native mitral valve.

Fig. 4 shows a perspective view of the anchor assembly of fig. 3 partially advanced through the native mitral valve to position the projections of the anchor assembly below the subcyclic groove of the native mitral valve.

FIG. 5 shows a perspective view of the anchor assembly in a similar arrangement to that shown in FIG. 4, but in a cross-sectional view of a commissure of the heart.

Fig. 6 shows a perspective view after retracting the anchor assembly of fig. 5 to position the projections of the anchor assembly in the sub-annular groove of the native mitral valve.

FIG. 7 illustrates a perspective view of the anchor assembly of FIG. 6 after retraction of certain components of the deployment system.

Fig. 8 is a top view of a native mitral valve and depicts the sulcus perimeter of the sub-annular sulcus of fig. 7 (without the anchoring assembly).

Fig. 9 illustrates a perspective top view of the example anchoring system of fig. 2-6, in accordance with certain embodiments.

FIG. 10 illustrates a perspective view of the anchor assembly of FIG. 9 with a cover material disposed over a portion of the anchor frame.

Fig. 11A shows a perspective top view of the anchor assembly of fig. 9 implanted within a native mitral valve (with the mitral valve leaflets in a closed state), and fig. 11B shows a corresponding anatomical top view of the anchor assembly of fig. 11A.

Fig. 12A shows a perspective top view of the anchor assembly of fig. 9 implanted within the native mitral valve of fig. 11A (with the mitral valve leaflets in an open state), and fig. 12B shows a corresponding anatomical top view of the anchor assembly of fig. 12A.

Fig. 13 shows a perspective view of the anchor assembly of fig. 7 implanted within a native mitral valve and a valve assembly delivery sheath extending into the left atrium.

Fig. 14 shows a perspective view of the valve assembly in the left atrium after partially exiting the valve assembly delivery sheath of fig. 13. The valve assembly is configured in a first (partially expanded) arrangement.

Fig. 15 shows a perspective view of the valve assembly of fig. 14 with the valve deployment system manipulated in preparation for installation of the valve assembly within the anchor assembly.

Fig. 16 shows a perspective view of the valve assembly of fig. 15 positioned within the anchor assembly (while still in the first (partially expanded arrangement).

Fig. 17 illustrates a perspective view of the valve assembly of fig. 16 with the valve assembly expanded within the anchor assembly and separated from the deployment system.

Fig. 18 illustrates an anterior side view of a valve frame of the valve assembly of fig. 17, in accordance with certain embodiments.

Fig. 19 shows a bottom view of the valve frame of fig. 18.

Fig. 20 is an exploded rear side view of the anchor assembly and valve assembly of fig. 17, in accordance with certain embodiments.

Fig. 21 is a top view of an exemplary prosthetic mitral valve system including a valve assembly engaged with an anchor assembly, in accordance with certain embodiments.

Fig. 22 is a bottom view of the example prosthetic mitral valve system of fig. 21.

Fig. 23 shows a top view of the prosthetic mitral valve system of fig. 21 implanted within a native mitral valve. The occluder portion of the prosthetic mitral valve system is shown in a closed state.

Fig. 24 shows a top view of the prosthetic mitral valve system of fig. 21 implanted within a native mitral valve. The occluder portion of the prosthetic mitral valve system is shown in an open state.

Fig. 25 is a side cross-sectional top view of a heart showing the mitral, aortic, tricuspid, and pulmonary valves.

Fig. 26 is a schematic illustration of a cross-section of a native mitral valve including a mitral valve annulus.

Fig. 27 illustrates an anterior side view of a valve assembly according to some embodiments. The sealing area of the anterior portion of the valve assembly is calibrated on the valve assembly.

Fig. 28 illustrates a posterior side view of a valve assembly according to some embodiments. The sealing area of the posterior portion of the valve component is calibrated on the valve component.

Fig. 29 illustrates a side view of a valve assembly according to some embodiments. The sealing area of the lateral side of the valve assembly is calibrated on the valve assembly.

Fig. 30 is a schematic depiction of the relationship of the anterior portion of the valve assembly to the annulus of a native mitral valve.

Fig. 31 is a schematic depiction of the relationship of the commissure regions of the valve assembly to the annulus of the native mitral valve.

Fig. 32 is a schematic depiction of the relationship of the commissure regions of the valve assembly to the annulus of the native mitral valve.

Fig. 33 is a cross-sectional view of the left side of the heart showing the relationship of an exemplary valve assembly to the annulus of the mitral valve and the annulus of the aortic root.

Fig. 34 is a fluorescence image of a native mitral valve, an aortic valve, and a left ventricular outflow tract of a heart with an example prosthetic valve therein. The image also shows the flow of blood from the left ventricle through the left ventricular outflow tract to the aorta.

Fig. 35 is a fluorescence image of a native mitral valve, aortic valve, and left ventricular outflow tract of a heart with an example prosthetic valve therein. The image also shows blood flowing from the left ventricle through the left ventricular outflow tract to the aorta.

Fig. 36 is a schematic depiction of the annulus of the native mitral valve and the annulus of the aortic root.

Fig. 37 is a cross-sectional view of a commissure of the heart showing the anchor assembly of the prosthetic mitral valve engaged in the subcyclic groove of the native mitral valve. Chordae tendineae in the left ventricle are also depicted.

Fig. 38 is a side cross-sectional view of the left ventricle of the heart showing the anchor assembly of the prosthetic mitral valve engaged in the subcyclic groove of the native mitral valve. Chordae tendineae in the left ventricle are also depicted.

FIG. 39 is a perspective view of the anchor assembly showing a control wire that can be threaded through portions of the anchor assembly.

FIG. 40 is another perspective view of the anchor assembly showing the control wire being threaded through a portion of the anchor assembly.

Fig. 41 is a side view of the valve assembly frame showing the control wires passing through portions of the valve assembly frame.

FIG. 42 is a schematic view of a threading pattern of proximal control wires corresponding to the valve assembly frame embodiment of FIG. 41.

FIG. 43 is a schematic view of a middle body control wire of an embodiment of a valve assembly frame corresponding to FIG. 41.

Detailed reference numerals in the various figures represent like elements.

Detailed Description

The present disclosure describes embodiments of prosthetic heart valve systems, such as prosthetic mitral valve systems and transcatheter systems and methods for implanting prosthetic heart valve systems. In certain embodiments, the prosthetic mitral valve system can be deployed to interface with and anchor in cooperation with the native anatomy of the mitral valve (and optionally, in a manner that allows the chordae tendineae of the native mitral valve leaflets to continue to function natively, even after deployment of the anchoring members). A prosthetic mitral valve system as used herein can be deployed to interface with a native mitral valve structure to form a fluid seal to minimize MR and paravalvular leaks after implantation. As described in greater detail below, fig. 1-17 and 39-43 describe transcatheter mitral valve delivery systems and methods with which a prosthetic mitral valve system can be deployed to interface with and cooperatively anchor with the anatomy of a native mitral valve. Also, in fig. 18-32, prosthetic mitral valve features are depicted with which the prosthetic valve interfaces with the native mitral valve structure to form a fluid seal, thereby reducing the likelihood of MR and paravalvular leaks. In fig. 33-36, prosthetic mitral valve features and techniques for managing blood flow through the Left Ventricular Outflow Tract (LVOT) are described. In fig. 37-38, prosthetic mitral valve features and techniques for mitigating the risk of interference between the prosthetic valve and chordae tendineae are described.

Referring to fig. 1, an exemplary transcatheter mitralvalve delivery system 100 can be directed through a patient's blood vessel to access a patient'sheart 10. Thetranscatheter delivery system 100 facilitates implantation of a prosthetic mitral valve into a beatingheart 10 using percutaneous, vascular dissection, or minimally invasive techniques (without the need for open chest surgery). In certain embodiments, thetranscatheter delivery system 100 is used in conjunction with one or more imaging modalities, such as x-ray fluoroscopy, echocardiography, magnetic resonance imaging, computed Tomography (CT), and the like.

Heart 10 (depicted in cross-section from a rear perspective) includesright atrium 12,right ventricle 14, leftatrium 16, and leftventricle 18. Thetricuspid valve 13 separates theright atrium 12 from theright ventricle 14. Themitral valve 17 separates theleft atrium 16 from theleft ventricle 18. The atrial septum 15 separates theright atrium 12 from theleft atrium 16. Theinferior vena cava 11 merges with theright atrium 12. It should be appreciated that this depiction of theheart 10 is somewhat formatted. The same is true of fig. 2 to 4. Fig. 1-4 provide a general depiction of an access to amitral valve 17 used in certain embodiments. However, fig. 5 and the following commissural cross-sectional views more accurately depict the orientation of the prosthetic mitral valve relative to theheart 10.

In the depicted embodiment, thedelivery system 100 includes aguidewire 110, a primarydeflectable catheter 120, and ananchor delivery sheath 130. Additional components of thedelivery system 100 are described further below. Theanchor delivery sheath 130 is slidably (and rotatably) disposed within the lumen of the primarydeflectable catheter 120. Theguidewire 110 is slidably disposed within the lumen of theanchor delivery sheath 130. In this depiction, theanchor delivery sheath 130 is partially extended relative to the primarydeflectable catheter 120, allowing the flaredportion 132 to expand outward, as described further below.

In the depicted embodiment, theguidewire 110 is installed within theheart 10 prior to delivery of other components of thesystem 100. In some embodiments, theguidewire 110 has a diameter of about 0.035 inches (about 0.89 mm). In some embodiments, theguidewire 110 has a diameter in the range of about 0.032 inches to about 0.038 inches (about 0.8mm to about 0.97 mm). In some embodiments, theguidewire 110 has a diameter of less than 0.032 inches (about 0.80 mm) or greater than 0.038 inches (about 0.97 mm). In certain embodiments, theguidewire 110 is made of a material such as, but not limited to, nitinol, stainless steel, high tensile strength stainless steel, and the like, and combinations thereof. Theguidewire 110 can include various tip designs (e.g., J-tip, straight tip, etc.), tapers, coatings, coverings, radio-opaque (RO) markers, and other features.

In some embodiments, theguidewire 110 is inserted percutaneously into the femoral vein of the patient. Theguidewire 110 is routed into theinferior vena cava 11 and into theright atrium 12. After an opening is formed in the septum 15 (e.g., transseptal puncture of the fossa ovalis), theguidewire 110 is routed into theleft atrium 16. Finally, theguidewire 110 is routed through themitral valve 17 into theleft ventricle 18. In some embodiments, theguidewire 110 may be installed into theheart 10 along other anatomical routes. Theguidewire 110 then serves as a rail over which other components of thedelivery system 100 can be passed.

In the depicted embodiment, the primarydeflectable catheter 120 is installed by pushing the primarydeflectable catheter 120 over theguidewire 110. In some embodiments, a dilator tip is used in conjunction with the primarydeflectable catheter 120 as the primarydeflectable catheter 120 is advanced over theguidewire 110. Alternatively, a balloon catheter may be used as the initial expansion means. After the distal end of the primarydeflectable catheter 120 reaches theleft atrium 16, the dilator tip can be withdrawn. In certain embodiments, the distal end of the primarydeflectable catheter 120 is steerable. Using steering, the distal end of the primarydeflectable catheter 120 can be oriented as desired in order to navigate the patient's anatomy. For example, the primarydeflectable catheter 120 may be angled within theright atrium 12 to navigate the primarydeflectable catheter 120 from theinferior vena cava 11 to the atrial septum 15.

In certain embodiments, the primarydeflectable catheter 120 has an outer diameter of about 28Fr (about 9.3 mm). In certain embodiments, the primarydeflectable catheter 120 has an outer diameter in the range of about 26Fr to about 34Fr (about 8.7mm to about 11.3 mm). In certain embodiments, the primarydeflectable catheter 120 has an outer diameter in the range of about 20Fr to about 28Fr (about 6.7mm to about 9.3 mm).

The primarydeflectable catheter 120 may comprise a tubular polymeric or metallic material. For example, in certain embodiments, the primarydeflectable catheter 120 may be formed from a polymeric material such as, but not limited to, polytetrafluoroethylene (PTFE), fluorinated Ethylene Propylene (FEP),

Nylon, nylon,

And the like and combinations thereof. In alternative embodiments, the primarydeflectable catheter 120 may be made of a metallic material such as nitinol, stainless steel alloys, titanium alloys, and the like, and combinations thereof. In certain embodiments, the primarydeflectable catheter 120 may be made from a combination of these polymers and metallic materials (e.g., a polymer layer with metal braids, coil reinforcements, reinforcement members, and the like, as well as combinations thereof).

Theexample delivery system 100 also includes ananchor delivery sheath 130. In some embodiments, theanchor delivery sheath 130 is mounted within the lumen of the primary deflectable catheter 120 (over the guidewire 110) and advanced through the primarydeflectable catheter 120 after the primarydeflectable catheter 120 is positioned with its distal end in theleft atrium 16. As described further below, in certain embodiments, theanchor delivery sheath 130 is preloaded with the prosthetic valve anchor assembly and other components of thedelivery system 100.

In certain embodiments, theanchor delivery sheath 130 may be made of the materials described above with reference to the primarydeflectable catheter 130. In certain embodiments, theanchor delivery sheath 130 has an outer diameter in the range of about 20Fr to about 28Fr (about 6.7mm to about 9.3 mm). In certain embodiments, theanchor delivery sheath 130 has an outer diameter in the range of about 14Fr to about 24Fr (about 4.7mm to about 8.0 mm).

In the depicted embodiment,anchor delivery sheath 130 includes a flareddistal end 132. In some embodiments, such a flareddistal end 132 is not included. The flareddistal end 132 can collapse to a lower profile when constrained within the maindeflectable catheter 120. When the flareddistal end 132 is urged from the maindeflectable catheter 120, the flareddistal end 132 self-expands into a flared shape. In some embodiments, the material of the flareddistal end 132 includes a fold or fold, may be a continuously flared end or may be separated into segments such as petals, and may include one or more resilient elements that bias the flareddistal end 132 to assume the flared configuration in the absence of a restraining force (such as from being restrained within the primary deflectable catheter 120). Flareddistal end 132 may be advantageous, for example, for recapturing the anchor assembly within the lumen ofanchor delivery sheath 130 after the anchor assembly is pushed from flareddistal end 132.

In some embodiments, the maximum outer diameter of the flareddistal end 132 is in the range of about 30Fr to about 34Fr (about 10.0mm to about 11.3 mm). In some embodiments, the maximum outer diameter of the flareddistal end 132 ranges from about 32Fr to about 44Fr (about 10.7mm to about 14.7 mm). In some embodiments, the maximum outer diameter of the flareddistal end 132 ranges from about 24Fr to about 30Fr (about 8.0mm to about 10.0 mm). In some embodiments, the maximum outer diameter of the flareddistal end 132 is less than about 24Fr (about 8.0 mm) or greater than about 44Fr (about 14.7 mm).

Referring to fig. 2, additional components of theexample delivery system 100 may include aproximal control sheath 140, a secondarydeflectable catheter 150, and adistal pusher catheter 160. Theproximal control sheath 140 is slidably disposed within the lumen of theanchor delivery sheath 130. A secondarydeflectable catheter 150 is slidably disposed within the lumen of theproximal control sheath 140. Thedistal pusher catheter 160 is slidably disposed within the lumen of the secondarydeflectable catheter 150. These components of thedelivery system 100 can be operated by a clinical operator to control the position and orientation of theanchor assembly 200. Theanchor assembly 200 is slidably disposed over theguidewire 110.

In certain embodiments of thedelivery system 100, one or more of theproximal control sheath 140, the secondarydeflectable catheter 150, thedistal pusher catheter 160, and theanchor assembly 200 are loaded within theanchor delivery sheath 130 before theanchor delivery sheath 130 is advanced to the primarydeflectable catheter 120, as shown in fig. 1. That is, in some instances, theproximal control sheath 140, the secondarydeflectable catheter 150, thedistal pusher catheter 160, and/or theanchor assembly 200 have been installed within theanchor delivery sheath 130 after theanchor delivery sheath 130 has been advanced distally into the primarydeflectable catheter 120 to achieve the arrangement shown in fig. 1. In other embodiments, one or more of theproximal control sheath 140, the secondarydeflectable catheter 150, thedistal pusher catheter 160, and theanchor assembly 200 are advanced distally into theanchor delivery sheath 130 after theanchor delivery sheath 130 has been advanced into the primarydeflectable catheter 120 to achieve the arrangement shown in fig. 1.

Thedistal pusher catheter 160 is releasably coupled with thehub 210 of theanchor assembly 200. The proximal end of theanchor assembly 200 is also releasably coupled to theproximal control sheath 140 by one ormore control wires 142. Although the depicted embodiment includes onecontrol wire 142, in other embodiments, two, three, four, five, or more than five control wires may be included.

Referring to fig. 39 and 40, thecontrol wire 142 is shown in an example engagement pattern with theanchor assembly 200. In the depicted embodiment, thecontrol wire 142 passes through multiple proximal portions of theanchor assembly 200. In the depicted embodiment, thecontrol wire 142 is configured as a lasso arrangement. Thus, tensioning of thecontrol wire 142 will cause at least the proximal end of theanchor assembly 200 to contract. Conversely, removing tension from thecontrol wire 142 will allow theanchor assembly 200 to expand. In some embodiments, thecontrol wire 142 passes through eyelets disposed on various portions of theanchor assembly 200. In certain embodiments, thecontrol wire 142 passes through attachment features disposed on various portions of the covering or frame of theanchor assembly 200. Thecontrol wire 142 can be tensioned or relaxed to achieve a desired degree of expansion of the proximal end of the anchor assembly 200 (e.g., the atrial retention features 240a, 240b, 240c, and 240d and/or the undulating annular lower ring 250).Multiple control wires 142 may also be used to achieve asymmetric controlled expansion of theanchor assembly 300.

Referring again to fig. 2, the position of theanchor assembly 200 may be controlled by manipulating thedistal pusher catheter 160 and/or theproximal control sheath 140. For example, in the depicted embodiment,anchor assembly 200 can be expelled from anchor delivery sheath 130 (as shown in fig. 2) by movingdistal pusher catheter 160 and/orproximal control sheath 140 distally relative to anchordelivery sheath 130. In certain embodiments, theanchor assembly 200 is caused to be pushed out by pulling theanchor delivery sheath 130 back proximally while substantially maintaining the position of thedistal pusher catheter 160 and/or theproximal control sheath 140. In some embodiments, the combination of pulling theanchor delivery sheath 130 back proximally while extending the position of thedistal pusher catheter 160 and/or theproximal control sheath 140 distally causes theanchor assembly 200 to be jostled.

Upon constraining of theanchor assembly 200 out of theanchor delivery sheath 130, theanchor assembly 200 expands from the low-profile delivery configuration to a partially expanded configuration (as shown in fig. 2). The degree of expansion of theanchor assembly 200 may be controlled, at least in part, by the relative positioning of theproximal control sheath 140 with respect to thedistal pusher catheter 160. For example, as theproximal control sheath 140 is moved proximally relative to thedistal pusher catheter 160, theanchor assembly 200 axially elongates and radially contracts. Conversely, as theproximal control sheath 140 is moved distally relative to thedistal pusher catheter 160, theanchor assembly 200 axially shortens and radially expands. In certain embodiments, such control over the radial size of theanchor assembly 200 is used during deployment of theanchor assembly 200 within the nativemitral valve 17, as described further below. As will be described further below, thecontrol wire 142 may also be used to control the same radial expansion of the anchor assembly 300 (without changing the relative distance of theproximal control sheath 140 with respect to the distal pusher catheter 160).

It should be appreciated that the prosthetic mitral valves provided herein include ananchor assembly 200 and a separable valve assembly (e.g., with reference to fig. 14-20). Prior to deployment of the valve assembly, theanchor assembly 200 is deployed to form an interfaced arrangement within the nativemitral valve 17. In other words, after theanchor assembly 200 is implanted within the nativemitral valve 17, the valve assembly can then be deployed within theanchor assembly 200 and within the native mitral valve 17 (as described further below). Thereafter, the prosthetic mitral valve provided herein can be said to be deployed using a staged implantation approach, i.e., theanchor assembly 200 is deployed in one stage and the valve assembly is deployed in a subsequent stage. In certain embodiments, deployment of the valve assembly occurs immediately after deployment of the anchor assembly 200 (e.g., in the same medical procedure). In certain embodiments, deployment of the valve assembly occurs hours, days, weeks, or months after deployment of theanchor assembly 200.

The staged implantation method of the prosthetic mitral valve provided herein is facilitated in that when theanchor assembly 200 itself is implanted within the nativemitral valve 17, the nativemitral valve 17 continues to function substantially as before implantation of theanchor assembly 200 without significantly affecting cardiovascular physiology. This is because, as described further below, theanchor assembly 200 interfaces and anchors within the structure of the nativemitral valve 17 without significantly interfering with the leaflets or chordae tendineae of the nativemitral valve 17.

Still referring to fig. 2, in the depicted arrangement, the distal end of the secondarydeflectable catheter 150 is at least partially located inside theanchor assembly 200. The secondarydeflectable catheter 150 can be manipulated by a clinical operator to reversibly bend the distal end of the secondarydeflectable catheter 150. Since the secondarydeflectable catheter 150 is bent by the clinician, other components of thedelivery system 100 may bend along with the secondarydeflectable catheter 150. For example, one or more of thedistal pusher 160 and theproximal control sheath 140 may bend in response to bending of thedeflectable catheter 150. Since theanchor assembly 200 is coupled to thedistal pusher 160 and theproximal control sheath 140, theanchor assembly 200 can be rotated by bending the secondarydeflectable catheter 150.

With reference to fig. 3, as described above, secondarydeflectable catheter 150 may articulate (also referred to as steer, deflect, bend, etc.) to pivot (rock, rotate, etc.)anchor assembly 200 in a lateral direction whileanchor assembly 200 is withinleft atrium 16. Such rotation of theanchor assembly 200 facilitates, for example, orienting theanchor assembly 200 in a desired relationship relative to the nativemitral valve 17 in preparation for implantation of theanchor assembly 200 within the nativemitral valve 17. In certain embodiments, it is desirable to orient theanchor assembly 200 with its longitudinal axis substantially perpendicular to the nativemitral valve 17. Lateral pivoting of theanchor assembly 200 partially or fully expanded within theatrium 16 may be advantageous as the assembly is a relatively large and stiff catheter assembly, as compared to pivoting theanchor assembly 200 in a lateral direction while theanchor assembly 200 is still constrained within the delivery sheath.

In preparation for engaging theanchor assembly 200 with the nativemitral valve 18, a clinical operator can manipulate the radial size of theanchor frame 200 such that theanchor frame 200 can pass through the nativemitral valve 17 without damaging the nativemitral valve 17. For example, the clinician may move theproximal control sheath 140 proximally relative to thedistal pusher catheter 160 to radially contract theanchor assembly 200. With theanchor assembly 200 radially contracted, theanchor frame 200 can be safely passed through the nativemitral valve 17 without damaging the nativemitral valve 17.

Referring to fig. 4, while the secondarydeflectable catheter 150 remains in its curved configuration, as described with reference to fig. 3, thedistal pusher catheter 160 and theproximal control sheath 140 can be advanced simultaneously. Because thedistal pusher catheter 160 is releasably coupled to thehub 210 of theanchor assembly 200 and because theproximal control sheath 140 is releasably coupled to the proximal end of theanchor assembly 200 via one or more wires 142a and 142b, the simultaneous advancement of thedistal pusher catheter 160 and theproximal control sheath 140 causes theanchor assembly 200 to advance.Anchor assembly 200 is advanced such that the distal end ofanchor assembly 200 is withinleft ventricle 18 and the proximal end ofanchor assembly 200 is withinleft atrium 16. Thus, some portion of theanchor assembly 200 is on each side of the nativemitral valve 17.

In the depicted embodiment, theanchor assembly 200 includes four anchor feet: leftforefoot 220a, leftrearfoot 220b,right rearfoot 220c, andright forefoot 220d. In certain embodiments, fewer or more anchoring feet may be included (e.g., two, three, five, six, or more than six). In certain embodiments, theanchor feet 220a, 220b, 220c, and 220d are portions of theanchor assembly 200 that are configured to contact thesub-annular groove 19 of the nativemitral valve 17. Accordingly, the anchoringfeet 220a, 220b, 220c and 220d have atraumatic surfaces generally comparable to the feet. However, in certain embodiments, one or more of the anchoringlegs 220a, 220b, 220c, and 220d are configured to penetrate tissue and may have anchoring features such as barbs, loops, hooks, and the like.

In the arrangement of fig. 4, theanchor feet 220a, 220b, 220c and 220d are positioned below the lowerannular channel 19. In this arrangement, the radial size of theanchor assembly 200 may be increased to align theanchor feet 220a, 220b, 220c and 220d with thesub-annular groove 19. For example, the clinician may move theproximal control sheath 140 distally relative to thedistal pusher catheter 160 to radially expand theanchor assembly 200 to align theanchor feet 220a, 220b, 220c, and 220d with thesub-annular channel 19. This alignment may be performed in preparation for seating theanchor feet 220a, 220b, 220c and 220d in thesub-annular groove 19.

Referring to fig. 5, a cross-section of a commissure ofheart 10 provides another perspective view ofanchor assembly 200 in the same arrangement as shown in fig. 4 with respect to nativemitral valve 17. Such a commissure cross-section ofheart 10 is taken throughmitral valve 17, along a plane throughleft atrium 16 andleft ventricle 18 parallel to a line intersecting two commissures of mitral valve 17 (as described further below with reference to fig. 8). In fig. 5-7 and 13-17 below, a commissural cross-section ofheart 10 will be used to describedelivery system 100 and methods for deploying a prosthetic mitral valve provided herein. The views of fig. 5-7 and 13-17 are slightly tilted so as to provide better visualization of theanchor assembly 200.

Anchoringlegs 220a, 220b, 220c and 220d are positioned below thelower ring groove 19. In this position, the anchoringfeet 220a, 220b, 220c and 220d are positioned below the systolic and diastolic excursions of the leaflets of the nativemitral valve 17. In this orientation, the anchoringlegs 220a, 220b, 220c, and 220d can be aligned with the inferiorannular channel 19 in preparation for the anchoringlegs 220a, 220b, 220c, and 220d to sit within the inferiorannular channel 19.

Referring to fig. 6, thedistal pusher 160 and theproximal control sheath 140 may be retracted relative to the secondarydeflectable catheter 150 and the primarydeflectable catheter 120 simultaneously. Thus, theanchor feet 220a, 220b, 220c and 220d become seated in the under-ring groove 19. In this position, the anchoringfeet 220a, 220b, 220c and 220d are positioned below the systolic and diastolic excursions of the leaflets of the nativemitral valve 17, and other structures of theanchor assembly 200 do not impede leaflet movement. Thus, with theanchor assembly 200 coupled to the structure of themitral valve 17 as described above, themitral valve 17 can continue to function as before theanchor assembly 200 was placed. Furthermore, the manner in which theanchor assembly 200 interfaces with the nativemitral valve 17 does not cause the native mitral valve to deform. Thus, the nativemitral valve 17 may continue to function as before theanchor assembly 200 is placed.

Referring to fig. 7, with theanchor assembly 200 engaged with the nativemitral valve 17, components of thedelivery system 100 can be withdrawn from theanchor assembly 200. For example, thecontrol wire 142 can be detached from the proximal end of theanchor assembly 200. Thereafter, theproximal control sheath 140 can be withdrawn. The secondarydeflectable catheter 150 can also be withdrawn. Indeed, if desired, theproximal control sheath 140, secondarydeflectable catheter 150, andanchor delivery sheath 130 can be completely withdrawn from the primarydeflectable catheter 120. In contrast, in certain embodiments, thedistal pusher catheter 160 advantageously remains attached to thehub 210 of theanchor assembly 200. As will be described further below, in certain embodiments, thedistal pusher catheter 160 serves as a track on which the valve assembly is deployed inside theanchor assembly 200. However, in certain embodiments, theanchor assembly 200 is completely detached from thedelivery system 100 and thedelivery system 100 is removed from the patient. After theanchor assembly 200 has been deployed for a period of hours, days, weeks, or months, the valve assembly may be installed into theanchor assembly 200 to complete installation of the prosthetic mitral valve.

Referring to fig. 8 and 9, the anatomy of the nativemitral valve 17 includes certain consistent and predictable structural features that may be used to engage theanchor assembly 200 in a patient. For example, the nativemitral valve 17 includes theaforementioned subcyclic groove 19. In addition, the nativemitral valve 17 includes a D-shapedannulus 28,anterolateral commissures 30a,posteromedial commissures 30b, left fibrous trigones 134a, and rightfibrous trigones 134b. In addition, the nativemitral valve 17 includes ananterior leaflet 20 and a three-part posterior leaflet 22. Theposterior leaflet 22 includes anouter scallop 24a, amiddle scallop 24b, and aninner scallop 24c. The free edges of theposterior leaflet 22 and theanterior leaflet 20 meet along acommissure line 32.

The D-shapedannulus 28 defines a particular structure from which theanterior leaflet 20 and theposterior leaflet 22 extend and articulate. Left and rightfibrous triangles 134a and 134b are located near the left and right ends of theanterior leaflet 20 and generally adjacent theouter scallop 24a and theinner scallop 24c of theposterior leaflet 22. The inferiorannular groove 19 extends along theannulus 28, between the left and right fibrous trigones 134a, 134b, along theposterior leaflet 22.

A strong, stable anchoring location is typically provided by the area at or near the high collagenannular triangles 134a and 134b. The muscle regions in the area at or near thetriangles 134a and 134b also provide good tissue ingrowth matrix for enhanced stability and migration resistance of theanchor assembly 200. Thus, the regions at or near thetriangles 134a and 134b define the left and rightanterior anchor zones 34a and 34b, respectively. Left and rightanterior anchor zones 34a and 34b provide advantageous target locations for placement of left and rightanterior feet 220a and 220d, respectively.

The depicted embodiment of theanchor assembly 200 also includes aleft forefoot 220b and aright forefoot 220c. As previously described, the left and rightposterior feet 220b, 220c may also be advantageously positioned in thesub-annular groove 19 so as to provide a balanced and atraumatic coupling of theanchor assembly 200 to the nativemitral valve 17. Thus, a leftposterior anchor zone 34b and a rightanterior anchor zone 34c are defined in thesub-annular channel 19. The left and rightposterior anchor regions 34b and 34c can receive the left and rightposterior feet 220b and 220c, respectively. In some embodiments, the location of the leftposterior anchor zone 34b and the rightanterior anchor zone 34c may be different than depicted while still remaining within thesub-annular groove 19. It should be understood that the depictedanchor assembly 200 is only one non-limiting example of an anchor assembly provided within the scope of the present disclosure.

In certain embodiments, theanchor assembly 200 includes an supra-annular structure and an infra-annular structure. For example, the sub-annular structure of theanchor assembly 200 includes theaforementioned anchor feet 220a, 220b, 220c, and 220d and thehub 210. In certain embodiments, as described above,hub 210 serves as the connecting structure of delivery system 100 (e.g., with reference to fig. 2). Further,hub 210 may act as a stable structural component from which left, right front lowerring support arms 230a, 230b, 230c, and 230d extend to anchorfeet 220a, 220b, 220c, and 220d, respectively.

In certain embodiments, such as the depicted embodiment, the on-loop structure of theanchor assembly 200 includes: a left anterioratrial retention feature 240a, a left posterioratrial retention feature 240b, a right posterioratrial retention feature 240c, and an anterioratrial retention feature 240d; a front anchor arch 250a, a left anchor arch 250b, a rear anchor arch 250c, and aright anchor arch 250d; and a connectingbridge 260. The front, left, rear, andright anchor arches 250a, 250b, 250c, 250d are joined to one another to form an undulating annularupper ring 250, the annularupper ring 250 serving as an annular structural element for theanchor assembly 200. As will be described further below, the over-the-loop 250 also defines an opening to an interior space of theanchor assembly 200 that is configured to receive and engage the valve assembly. The atrial retention features 240a, 240b, 240c, and 240d are configured to contact a scaffolding supraannular tissue surface above the mitral valve annulus to stabilize theanchor assembly 200 in an supraannular region generally opposite theanchor feet 220a, 220b, 220c, and 220d, respectively.

In certain embodiments, thebridge 260 provides enhanced stability and fatigue resistance to vertically-oriented forces on the accompanying prosthetic valve assembly when the valve (not shown) is closed and blocking pressurized blood during systole. Theanchor assembly 200 may also include one ormore holes 226 in the frame portion adjacent the foot, which are additional control points for delivery and retrieval of the assembly, or may be used to fixedly position the delivery frame.

In certain embodiments, such as the depicted embodiment, the supra-annular structure and the infra-annular structure of theanchor assembly 200 are interconnected by an outer anteriorinter-annular connection 270a, an outer posteriorinter-annular connection 270b, an inner posteriorinter-annular connection 270c, and an inner anteriorinter-annular connection 270 d. For example, the lateral anteriorinter-ring connection 270a connects the lateralanterior anchoring foot 220a with the lateral anterioratrial retention feature 240a. In addition, lateral anteriorinter-annular connection 270a connects lateralanterior anchor foot 220a with anterior anchor arch 250a and left anchor arch 250b. In the depicted embodiment, each of the otherinter-ring connections 270b, 270c, and 270d interconnects portions of the upper and lower ring structures in a manner similar to the outer frontinter-ring connection 270 a. For example, the lateral anteriorinter-ring connection 270b connects the lateralanterior anchoring foot 220b with the left andposterior anchoring arches 250b and 250c; an outer anteriorinter-ring connection 270c connects the outeranterior anchoring foot 220c with the posterior and right anchoringarches 250c and 250d; and, a lateral anteriorinter-annular junction 270d connects the lateralanterior anchoring foot 220d with the right andanterior anchoring arches 250d and 250a.

In certain embodiments, the elongate member of theanchor assembly 200 is formed from a single piece of precursor material (e.g., a sheet or tube) that is cut, expanded, and connected to thehub 210. For example, certain embodiments are made from a tube that is laser cut (or machined, chemically etched, water jet cut, etc.) and then expanded and heat set to its final expanded size and shape. In certain embodiments, theanchor assembly 200 is compositionally formed from a plurality of elongate members (e.g., wires or cutting members) that are coupled together with thehub 210 and to one another to form theanchor assembly 200.

The elongate member of theanchor assembly 200 may comprise various materials and combinations of materials. In certain embodiments, nitinol (NiTi) is used as the elongate member of theanchor assembly 200, although other materials such as stainless steel, L605 steel, polymer, MP35N steel, stainless steel, titanium, cobalt/nickel alloy, polymeric material, pyhnox, elgiloy, or any other suitable biocompatible material and combinations thereof may be used. The superelasticity of NiTi makes it a particularly good candidate material for the elongate member ofanchor assembly 200 because, for example, niTi can be heat set to a desired shape. That is, niTi may be heat set such thatanchor assembly 200 tends to self-expand to a desired shape whenanchor assembly 200 is unconstrained, such as whenanchor assembly 200 is deployed out ofanchor delivery sheath 130.Anchor assembly 200, for example, made of NiTi, may have a spring property that allowsanchor assembly 200 to resiliently collapse or "squeeze" into a low-profile delivery configuration and then reconfigure into the expanded configuration shown in fig. 9. Theanchor assembly 200 may be generally conformable, fatigue resistant, and elastic such that theanchor assembly 200 can conform to the topography of the surrounding tissue when theanchor assembly 200 is deployed in the native mitral valve of a patient.

In certain embodiments, the diameter or width/thickness of one or more of the elongate members forming theanchor assembly 200 may be in the range of about 0.008 "to about 0.015" (about 0.20mm to about 0.40 mm), or about 0.009 "to about 0.030" (about 0.23mm to about 0.76 mm), or about 0.01 "to about 0.06" (about 0.25mm to about 1.52 mm), or about 0.02 "to about 0.10" (about 0.51mm to about 2.54 mm), or about 0.06 "to about 0.20" (about 1.52mm to about 5.08 mm). In some embodiments, the elongate members forming theanchor assembly 200 may have a smaller or larger diameter or width/thickness. In certain embodiments, each of the elongate members forming theanchor assembly 200 has substantially the same diameter or width/thickness. In certain embodiments, one or more of the elongate members forming theanchor assembly 200 have a different diameter or width than one or more of the other elongate members of theanchor assembly 200. In certain embodiments, one or more portions of one or more of the elongate members forming theanchor assembly 200 may be tapered, widened, narrowed, curved, rounded, waved, spiraled, angled, and/or otherwise non-linear and/or non-uniform along the entire length of the elongate members of theanchor assembly 200. These features and techniques may also be incorporated with the valve components of the prosthetic mitral valves provided herein.

In certain embodiments, the diameter, thickness, and/or width of the elongate member forming theanchor assembly 200 may be varied in order to vary the force applied by theanchor assembly 200 in specific regions thereof, to increase or decrease flexibility of theanchor assembly 200 in specific regions, to promote migration resistance, and/or to control the compression process (crushability) in preparation for deployment and the expansion process during deployment of theanchor assembly 200.

In certain embodiments, one or more of the elongate members forming theanchor assembly 200 may have a circular cross-section. In certain embodiments, one or more of the elongate members forming theanchor assembly 200 may have a rectangular cross-sectional shape or other cross-sectional shapes that are not rectangular. Examples of cross-sectional shapes of the elongate members forming theanchor assembly 200 may include circular, C-shaped, square, oval, rectangular, elliptical, triangular, D-shaped, trapezoidal, including irregular cross-sectional shapes formed by braided or stranded configurations, and the like. In certain embodiments, one or more of the elongate members forming theanchor assembly 200 may be substantially flat (i.e., such that the width to thickness ratio is about 2. In certain examples, one or more of the elongate members forming theanchor assembly 200 can be formed using centerless grinding techniques such that the diameter of the elongate members varies along the length of the elongate members.

Theanchor assembly 200 may include features intended to enhance one or more desired functional performance characteristics of the prosthetic mitral valve device. For example, certain features of theanchor assembly 200 may be used to enhance the conformability of the prosthetic mitral valve device. Such features may facilitate improved performance of the prosthetic mitral valve device by allowing the device to conform to, for example, irregular tissue topography and/or dynamically changing tissue topography. Such conformability characteristics may be advantageous in providing effective and durable performance of the prosthetic mitral valve device. In certain embodiments of theanchor assembly 200, certain portions of theanchor assembly 200 are designed to be more compliant than other portions of thesame anchor assembly 200. That is, the conformability of asingle anchor assembly 200 may be designed to be different in various regions of theanchor assembly 200.

In certain embodiments, theanchor assembly 200 includes features to enhance radiographic visibility in vivo. In certain embodiments, portions of theanchor assembly 200, such as one or more of theanchor feet 220a, 220b, 220c, and 220d, may have one or more radiopaque markers attached thereto. In certain embodiments, some or all of theanchor assemblies 200 may be coated (e.g., sputter coated) with a radiopaque coating.

Still referring to fig. 8 and 9, as described hereinabove, the anchoringlegs 220a, 220b, 220c and 220d are sized and shaped to engage thesub-annular groove 19 of themitral valve 17. In certain embodiments, theforefoot feet 220a and 220d are spaced apart from one another at a distance of about 30mm to about 45mm, or about 20mm to about 35mm, or about 40mm to about 55 mm. In certain embodiments, therear feet 220b and 220c are spaced apart from each other by a distance of about 20mm to about 30mm, alternatively about 10mm to about 25mm, alternatively about 25mm to about 40 mm.

In certain embodiments, the anchoringfeet 220a, 220b, 220c, and 220d have a height of about 8mm to about 12mm, or greater than about 12 mm. In certain embodiments, the anchoringfeet 220a, 220b, 220c, and 220d have a thickness of about 6mm² To about 24mm² The grooves of (c) engage the surface area (when the fabric is covered). In certain embodiments, theanchor feet 220a, 220b, 220c, and 220d each have substantially the same groove engaging surface area. In certain embodiments, one or more of the anchoringlegs 220a, 220b, 220c, and 220d has a groove-engaging surface area that is different from one or more of the other anchoringlegs 220a, 220b, 220c, and 220d. The anchoringfeet 220a, 220b, 220c, and 220d may have a width in the range of about 1.5mm to about 4.0mm or more, and a length in the range of about 3mm to about 6mm or more. The size and shape of the anchoringfeet 220a, 220b, 220c, and 220d is such that the anchoringassembly 200 does not significantly impair the native function of the mitral valve chordae tendineae, native mitral valve leaflets, and papillary muscles, even after the anchoring assembly is anchored at the mitral valve site.

As previously described, theanchor assembly 200 is designed to avoid interfering with the function of the nativemitral valve 17. Thus, theanchor assembly 200 can be implanted within the nativemitral valve 17 at some time prior to deployment of the replacement valve assembly therein without degrading the function of thevalve 17 in the time period between anchor implantation and valve implantation (whether this time is minutes or even days or months). To avoid such interference between theanchor assembly 200 and the nativemitral valve 17, theinter-annular connections 270a, 270b, 270c, and 270d pass approximately through the apposingwires 32. More particularly, the left anteriorinter-loop connector 270a passes through thecommissure line 32 adjacent theanterolateral commissure 30 a. In a similar manner, the right anteriorinter-annular connecting portion 270d passes through thecommissure line 32 adjacent the posteriormedial commissure 30 b. In some embodiments, the left and right posteriorinter-annular connections 270b, 270c pass through the nativemitral valve 17 at a location that is biased posteriorly from the native commissure lines 32. Theposterior leaflet 22 will tend to yieldingly wrap around the left and right posteriorinter-annular attachment portions 270b, 270c to facilitate sealing of themitral valve 17 to which theanchor assembly 200 is coupled.

Referring to fig. 10, in certain embodiments, theanchor assembly 200 includes acover material 270 disposed on one or more portions of theanchor assembly 200. Thecover material 270 may provide various benefits. For example, in certain embodiments, thecover material 270 can facilitate tissue ingrowth and/or endothelialization, thereby enhancing the migration resistance of theanchor assembly 200 and preventing thrombus formation on the blood contacting elements. In another example, as described further below, the coveringmaterial 270 can be used to facilitate coupling between theanchor assembly 200 and a valve assembly received therein. The coveringmaterial 270 also prevents or minimizes abrasion and/or fretting between theanchor assembly 200 and thevalve assembly 300. The coveringmaterial 270 also prevents wear associated with wearing of extra-valvular tissue.

In the depicted embodiment, the coveringmaterial 270 is disposed substantially over theentire anchor assembly 200. In certain embodiments, the coveringmaterial 270 is disposed on one or more portions of theanchor assembly 200, while one or more other portions of theanchor assembly 200 do not have the coveringmaterial 270 disposed thereon. Although the depicted embodiment includes thecover material 270, thecover material 270 is not required in all embodiments. In certain embodiments, two or more portions of thecover material 270, which may be separate and/or different from each other, may be disposed on theanchor assembly 200. That is, in certain embodiments, a particular type of coveringmaterial 270 is disposed on certain areas of theanchor assembly 200 and a different type of coveringmaterial 270 is disposed on other areas of theanchor assembly 200.

In certain embodiments, the coveringmaterial 270 or portions thereof comprise a fluoropolymer, such as an expanded polytetrafluoroethylene (ePTFE) polymer. In some embodiments of the present invention, the, the coveringmaterial 270 or portion thereof comprises polyester, silicone, urethane, ELAST-EONTM (silicone and urethane polymers), another biocompatible polymer, or,

Polyethylene terephthalate (PET), copolymers, or combinations and sub-combinations thereof. In certain embodiments, thecover material 270 is manufactured using techniques such as, but not limited to, extrusion, expansion, heat treatment, sintering, knitting, braiding, weaving, chemical treatment, and the like.In certain embodiments, the coveringmaterial 270, or portions thereof, includes biological tissue. For example, in certain embodiments, the coveringmaterial 270 may include natural tissue, such as (but not limited to) bovine, porcine, ovine, or equine pericardium. In certain such embodiments, the tissue is chemically treated with glutaraldehyde, formaldehyde, or triglycidyl amine (TGA) solution, or other suitable tissue crosslinking agent.

In the depicted embodiment, thecover material 270 is disposed on both the interior and exterior of theanchor assembly 200. In certain embodiments, the coveringmaterial 270 is disposed only on the exterior of theanchor assembly 200. In certain embodiments, the coveringmaterial 270 is disposed only on the interior of theanchor assembly 200. In certain embodiments, certain portions of theanchor assembly 200 are covered by the coveringmaterial 270 in a different manner than other portions of theanchor assembly 200.

In certain embodiments, thecover material 270 is attached to at least some portions of theanchor assembly 200 using an adhesive. In certain embodiments, PEP (fluorinated ethylene propylene) is used as an adhesive to attach the coveringmaterial 270 to theanchor assembly 200 or portions thereof. For example, an FEP coating may be applied to some or all of the portions of theanchor assembly 200, and the FEP may serve as a bonding agent to adhere the coveringmaterial 270 to theanchor assembly 200. In some embodiments, wrapping, stitching, ligaturing, tying, and/or clips, and the like, may be used to attach the coveringmaterial 270 to theanchor assembly 200. In certain embodiments, a combination of techniques is used to attach thecover material 270 to theanchor assembly 200.

In certain embodiments, the coveringmaterial 270 or portions thereof has a microporous structure that provides a tissue ingrowth scaffold for a durable seal and/or to supplement the anchoring strength of theanchor assembly 200. In certain embodiments, thecover material 270 is made of a film material that inhibits or reduces the transmission of blood through thecover material 270. In certain embodiments, thecover material 270 or portions thereof have a material composition and/or configuration that inhibits or prevents tissue ingrowth and/or endothelialization onto thecover material 270.

In certain embodiments, thecover material 270 may be modified by one or more chemical or physical processes that enhance certain physical properties of thecover material 270. For example, a hydrophilic coating may be applied to thecover material 270 to improve the wettability and echogenicity of thecover material 270. In certain embodiments, the coveringmaterial 270 may be modified by chemical modifications that promote or prevent endothelial cell attachment, endothelial cell migration, endothelial cell proliferation, and prevention of thrombosis. In certain embodiments, thecover material 270 may be modified with covalently attached heparin or impregnated with one or more drugs that are released in situ.

In certain embodiments, thecover material 270 is pre-perforated to modulate fluid flow through thecover material 270 and/or to influence the propensity of tissue ingrowth onto thecover material 270. In certain embodiments, thecover material 270 is treated to make thecover material 270 more rigid or to add a surface texture. For example, in certain embodiments, the coveringmaterial 270 is treated with FEP powder to provide ahardened covering material 270 or a roughened surface on the coveringmaterial 270. In some embodiments, selected portions of thecover material 270 are also processed, while other portions of thecover material 270 are not processed. Other material processing techniques of thecover material 270 may also be employed to provide beneficial mechanical properties and tissue response interactions. In some embodiments, portions of thecover material 270 may have one or more radiopaque markers attached thereto to enhance in vivo radiographic visibility.

Referring now to fig. 11A and 12A, theanchor assembly 200 is shown implanted within the nativemitral valve 17. Fig. 11B and 12B are photographs corresponding to fig. 11A and 12A, respectively. In fig. 11A, themitral valve 17 is shown in a closed state. In fig. 12A, themitral valve 17 is shown in an open state. These illustrations are from the perspective of the left atrium as viewed towards themitral valve 17. For example, in fig. 12A,chordae tendineae 40 can be seen through the open leaflets of themitral valve 17.

These figures illustrate the relationship of the supra-annular and infra-annular structures of theanchor assembly 200 to its nativemitral valve 17. For example, the closed state of the nativemitral valve 17 in fig. 11A allows for viewing of supra-annular structures such as the left anterioratrial retaining feature 240a, the left posterioratrial retaining feature 240b, the right posterioratrial retaining feature 240c, and the right anterioratrial retaining feature 240d. Further, anterior anchor arch 250a, left anchor arch 250b, posterior anchor arch 250c,right anchor arch 250d, and connectingbridge 260 are visible. However, the sub-annular structures are not visible in fig. 11A because they are hidden from view by theanterior leaflet 20 and the threeposterior leaflets 24a, 24b, and 24c.

In contrast, in fig. 12A, some of the sub-annular structures of theanchor assembly 200 are visible because the nativemitral valve 17 is open. Thesub-annular support arms 230a, 230b, 230c and 230d and thehub 210 are seen, for example, through the openmitral valve 17. However, the anchoringfeet 220a, 220b, 220c and 220d are still not visible because of their location within the sub-annular groove of themitral valve 17.

Referring to fig. 13, after implantation of theanchor assembly 200 within the native mitral valve 17 (e.g., performed in accordance with fig. 1-7 described above), thevalve delivery sheath 170 of thedelivery system 100 can be used to deploy the valve assembly within theanchor assembly 200. With thedistal pusher catheter 160 coupled with thehub 210 of theanchor assembly 200, thedistal pusher catheter 160 may be used to guide the valve assembly to the interior of theanchor assembly 200, as described above with reference to fig. 7.

In some embodiments, with the maindeflectable catheter 120 positioned with its distal end in theleft atrium 16, thevalve delivery sheath 170 is mounted within the lumen of the main deflectable catheter 120 (on the distal pusher catheter 160) and advanced through the maindeflectable catheter 120. As described further below, in certain embodiments, thevalve delivery sheath 170 is preloaded with the prosthetic valve assembly and other components of thedelivery system 100. The primarydeflectable catheter 120 may be the same catheter used to deliver theanchor assembly 200, or it may be a different catheter (but for simplicity may still be referred to herein as the primary deflectable catheter 120).

In certain embodiments, thevalve delivery sheath 170 can be made of the materials described above with reference to the primarydeflectable catheter 120. In certain embodiments, thevalve delivery sheath 170 has an outer diameter in the range of about 20Fr to about 28Fr (about 6.7mm to about 9.3 mm). In certain embodiments, thevalve delivery sheath 170 has an outer diameter in the range of about 14Fr to about 24Fr (about 4.7mm to about 8.0 mm).

In the depicted embodiment, thevalve delivery sheath 170 includes a flareddistal end 172. In some embodiments, such a flareddistal end 172 is not included. When constrained within the primarydeflectable catheter 120, the flareddistal end 172 may collapse to a lower profile. The flareddistal end 172 can self-expand into a flared shape as the flareddistal end 172 is pushed out of the maindeflectable catheter 120. In some embodiments, the material of the flareddistal end 172 comprises a fold or fold, may be a continuously flared end or may be divided into sections such as petals, and may include one or more resilient elements that bias the flareddistal end 172 to assume the flared configuration in the absence of a restraining force (such as to be restrained within the primary deflectable catheter 120). After the valve assembly has been extruded from the flareddistal end 172, the flareddistal end 172 can be advantageously used, for example, to recapture the valve assembly within the lumen of thevalve delivery sheath 170.

In certain embodiments, the maximum outer diameter of the flareddistal end 172 ranges from about 30Fr to about 34Fr (about 10.0mm to about 11.3 mm). In certain embodiments, the maximum outer diameter of the flareddistal end 172 ranges from about 32Fr to about 44Fr (about 10.7mm to about 14.7 mm). In certain embodiments, the maximum outer diameter of the flareddistal end 172 ranges from about 24Fr to about 30Fr (about 8.0mm to about 10.0 mm). In some embodiments, the maximum outer diameter of the flareddistal end 172 is less than about 24Fr (about 8.0 mm) or greater than about 44Fr (about 14.7 mm).

Referring to fig. 14, in certain embodiments, while thevalve delivery catheter 180 remains substantially stationary to express thevalve assembly 300 from the lumen of thevalve delivery sheath 170, thevalve delivery sheath 170 can be withdrawn into the maindeflectable catheter 120.Valve delivery sheath 170 andvalve delivery catheter 180 are additional components in certain embodiments of theexample delivery system 100.

Thevalve assembly 300 is releasably coupled to thevalve delivery catheter 180 and held in a low-profile configuration. In certain embodiments, the distal and proximal ends of thevalve assembly 300 are releasably coupled to thevalve delivery catheter 180. In certain embodiments, only one of the distal or proximal ends of thevalve assembly 300 is releasably coupled to thevalve delivery catheter 180. In particular embodiments, one or more control wires can be included to releasably couple one or more portions of thevalve assembly 300 to thevalve delivery catheter 180.

Referring to fig. 41-43, thevalve assembly 300 is releasably coupled to thevalve delivery catheter 180 via proximal andmid-body control wires 342a, 342 b. Thecontrol wires 342a and 342b pass through one or more lumens within thevalve delivery catheter 180. Thecontrol wires 342a and 342b exit thevalve delivery catheter 180 and pass through eyelets on the proximal end of thevalve assembly 300 and the main body mid-portion, respectively. Thecontrol wires 342a and 342b then pass back into thevalve delivery catheter 180. By manipulating thecontrol wires 342a and 342b, a clinical operator can control thevalve assembly 300. For example, by manipulating the tension and position of thecontrol wires 342a and 342b within thedelivery catheter 180, expansion and contraction of thevalve assembly 300 can be controlled, and separation of thevalve assembly 300 from the valve delivery catheter can be controlled.

Referring again to fig. 14, the lumen of thevalve delivery catheter 180 slidably surrounds thedistal pusher catheter 160. Thus, advancement of thevalve delivery catheter 180 causes thevalve assembly 300 to advance on thedistal pusher catheter 160 toward theanchor assembly 200.

Referring to fig. 15 and 16, thedelivery system 100 may be manipulated by a clinical operator to perform lateral pivoting (rocking, rotating, etc.) of thevalve assembly 300 within theleft atrium 16. Rotation of thevalve assembly 300 changes the alignment of thevalve assembly 300 from being generally axially aligned with the distal end of the primarydeflectable catheter 120 to being generally axially aligned with the anchor assembly 200 (ready to install thevalve assembly 300 inside the anchor assembly 200).

In certain embodiments, the aforementioned rotation of thevalve assembly 300 can be performed as follows. As shown in fig. 15, due to the effect of the primarydeflectable catheter 120 on thevalve delivery catheter 180, the axis of thevalve assembly 300 is initially generally aligned with the axis of the distal end of the primarydeflectable catheter 120. From this arrangement, simultaneous reverse movement between thedistal pusher catheter 160 and thevalve delivery catheter 180 can be performed by the clinician to rotate thevalve assembly 300. That is, as thedistal pusher catheter 160 is pulled proximally, thevalve delivery catheter 180 is pushed distally. Due to this reverse movement, thevalve assembly 300 rotates in a relatively small radius, as required by the constraint of theleft atrium 16. Thereafter, thevalve delivery catheter 180 can be further advanced such that thevalve assembly 300 is coaxially positioned within theanchor assembly 200, as shown in fig. 16.

Referring now also to fig. 17, in certain embodiments, prior to or during expansion of thevalve assembly 300, thevalve assembly 300 and theanchor assembly 200 become coaxially, linearly (along their axes), and rotationally aligned with each other, resulting in engagement between thevalve assembly 300 and theanchor assembly 200. Thereafter, thedelivery system 100 can be withdrawn from theheart 10 and the prosthetic mitral valve can perform its function.

Coaxial alignment between thevalve assembly 300 and theanchor assembly 200 as described above is achieved with thevalve delivery catheter 180 slidably disposed on thedistal pusher catheter 160. Linear alignment between thevalve assembly 300 and theanchor assembly 200 can be achieved by interaction between thedistal end feature 182 of thevalve delivery catheter 180 and thehub 210 of theanchor assembly 200. For example, in certain embodiments, abutment of thedistal end feature 182 with thehub 210 may result in proper linear alignment between thevalve assembly 300 and theanchor assembly 200.

Relative rotational alignment (about its axis) between thevalve assembly 300 and theanchor assembly 200 can be achieved in various ways. For example, in certain embodiments, thevalve delivery catheter 180 is mechanically keyed to thedistal pusher catheter 160 to be slidably secured in a desired rotational alignment between thevalve assembly 300 and theanchor assembly 200. In certain embodiments, other types of mechanical features (e.g., pins/holes, protrusions/sockets, etc.) can be included to facilitate the desired rotational/spin alignment between thevalve assembly 300 and theanchor assembly 200. Alternatively or additionally, the position and/or pattern on thevalve assembly 300 and on theanchor assembly 200 to indicate the relative rotational orientation (about its axis) of thevalve assembly 300 and theanchor assembly 200 includes radiopaque markers. In certain embodiments (e.g., when thevalve delivery catheter 180 is "twistable"), thevalve delivery catheter 180 can be rotated about its axis until the marker is in place relative to theanchor assembly 200 prior to final expansion of thevalve assembly 300. Fluoroscopy may be used to obtain the radiopaque markers and the corresponding desired orientation of thevalve assembly 300 and theanchor assembly 200.

Referring to fig. 18 and 19, anexample valve assembly 300 is shown without any covering or valve/occluder leaflets shown. Thus, thevalve assembly frame 301 of thevalve assembly 300 is shown. Fig. 18 shows an anterior side view of thevalve assembly frame 301, and fig. 19 shows a bottom view of thevalve assembly frame 301. Thevalve assembly 300 can be constructed using the various materials and fabrication techniques described above with reference to the anchor frame 200 (e.g., with reference to fig. 9). It should be understood that the depictedvalve assembly 300 is only one non-limiting example of a valve assembly provided within the scope of the present disclosure.

Thevalve assembly 300 includes aproximal end 302 and adistal end 304. The valve assembly includes a flaredouter skirt 303 and defines aninner mouth 305. When thevalve assembly 300 is implanted within a native mitral valve, theproximal end 302 is located above the annulus (within the left atrium) and thedistal end 304 is located below the annulus (in the left ventricle). Theproximal end 302 defines a generally circular access port of thevalve assembly 300, as described further below.

In the depicted embodiment, thevalve assembly 300 is flared generally in a distal direction. In other words, thedistal end 304 flares outward as compared to theproximal end 302. Thus, theproximal end 302 defines a smaller outer profile than thedistal end 304. However, certain areas of thedistal end 304 bow inwardly. In particular, for example, the posteriormedial commissure corner 330a and anteriorlateral commissure corner 330b of thevalve assembly 300 can be inwardly bowed. It should be appreciated that flaring of thedistal end 304 as compared to theproximal end 302 is just one example configuration of the profile of thevalve assembly 300. In certain embodiments, for example, the shoulder (a portion of thevalve assembly 300 having a largest outer circumference) is located proximal to the middle of thevalve assembly 300.

Thevalve assembly 300 also includes ananterior side 306 between a posteriormedial commissure corner 330a and an anteriorlateral commissure corner 330 b. When thevalve assembly 300 is implanted in a native mitral valve, theanterior side 306 faces the anterior leaflet of the native mitral valve. Thefront side 306 of thedistal end 304 defines a generally flat surface, while the other sides of thedistal end 304 are rounded. Thus, the circumference of thedistal end 304 is generally D-shaped. The D-shaped circumference of thedistal end 304 provides avalve assembly 300 with a favorable outer profile to interface and seal with the native mitral valve. As described further below, sealing is achieved by coaptation between the D-shaped periphery ofdistal end 304 and the leaflets of the native mitral valve, and in some embodiments, the D-shaped periphery ofskirt 303 and the native valve annulus.

In the depicted embodiment, theproximal end 302 of thevalve assembly 300 includes threeatrial leaflet arches 310a, 310b, and 310c that together define a rolling circle at theproximal end 302. Each of theleaflet arches 310a, 310b, and 310c includes an apex having anattachment hole 312a, 312b, and 312c, respectively. In certain embodiments, theattachment holes 312a, 312b, and 312c are used to couple the proximal end of thevalve assembly 300 to a delivery catheter (e.g., thevalve delivery catheter 180 of fig. 14-16).

Thevalve assembly 300 also includes threecommissure posts 320a, 320b, and 320c, each extending distally from the intersection of the threeleaflet arches 310a, 310b, and 310 c. The commissure posts 320a, 320b, and 320c are positioned about 120 apart from each other. The commissure posts 320a, 320b, and 320c each have a series of holes that can be used to attach the leaflets, such as by suturing. The threeleaflet arches 310a, 310b, and 310c and the threecommissure posts 320a, 320b, and 320c are regions on thevalve assembly 300 to which three prosthetic valve leaflets become attached to constitute a three leaflet occluder (see, e.g., fig. 22-25).

As best seen in fig. 19, the threeleaflet arches 310a, 310b and 310c and thecommissure posts 320a, 320b and 320c define a generally cylindrical frame of a three leaflet occluder configuration. As such, thevalve assembly 300 provides a proven advantageous frame for a three leaflet occluder. The three-leaflet occluder provides open flow during diastole and flow occlusion during systole.

Referring to fig. 20, an exploded view of an exemplary prostheticmitral valve 400 includes ananchor assembly 200 and avalve assembly 300. This figure provides a posterior side view of theanchor assembly 200 and thevalve assembly 300.

Thevalve assembly 300 includes acover 340. Cover 340 may be made of any material and constructed using any of the techniques described above with reference to cover 270. Further, in certain embodiments, covering 340 may comprise natural tissue, such as (but not limited to) bovine, porcine, ovine, or equine pericardium. In certain such embodiments, glutaraldehyde, formaldehyde or triglycidyl amine solutions, or any other suitable crosslinking agent is used to crosslink the histochemistry.

When thevalve assembly 300 and theanchor assembly 200 are coupled together, thevalve assembly 300 structurally interlocks within the interior of the anchor assembly 200 (e.g., in certain embodiments, utilizing the tapered structure of thevalve assembly 300 within the annulus and interior space of the anchor assembly 200). In particular, in certain embodiments, thevalve assembly 300 is housed within the interior space between the upperannular ring 250 and the lowerannular support arms 230a, 230b, 230c, and 230 d. As described above, the interlocking arrangement between thevalve assembly 300 and theanchor assembly 200 is achieved by positioning thevalve assembly 300 inside theanchor assembly 200 in a low-profile configuration and allowing thevalve assembly 300 to expand inside the anchor assembly 200 (e.g., see fig. 16 and 17).

Referring to fig. 21 and 22, a deployed configuration of an example prostheticmitral valve 400 includes thevalve assembly 300 engaged within theanchor assembly 200. Fig. 21 shows a top (atrial) view of the prostheticmitral valve 400 and fig. 22 shows a bottom (ventricular) view of the prostheticmitral valve 400.

In certain embodiments, such as the depicted embodiment, thevalve assembly 300 includes threeleaflets 350a, 350b, and 350c that perform the occluding function of the prostheticmitral valve 400. The cusps of the threeleaflets 350a, 350b, 350c are secured to thetri-atrial leaflet arches 310a, 310b, 310c and to thetri-commissure posts 320a, 320b, 320c (see fig. 18 and 19). The free edges of theleaflets 350a, 350b, 350c can seal by engaging each other during systole and open during diastole.

The threeleaflets 350a, 350b, 350c can comprise natural or synthetic materials. For example, the threeleaflets 350a, 350b, and 350c can comprise any of the materials described above with reference to thecover 340, including natural tissue, such as (but not limited to) bovine, porcine, ovine, or equine pericardium. In certain such embodiments, glutaraldehyde, formaldehyde or triglycidyl amine solutions or other suitable crosslinking agents are used to crosslink histochemistry. In certain embodiments,leaflets 350a, 350b, and 350c have a thickness in the range of about 0.005 "to about 0.020" (about 0.13mm to about 0.51 mm) or about 0.008 "to about 0.012" (about 0.20mm to about 0.31 mm). In certain embodiments, theleaflets 350a, 350b, and 350c have a thickness of less than about 0.005 "(about 0.13 mm) or greater than about 0.020" (about 0.51 mm).

In certain embodiments, configurations other than a three-leaflet occluder may be used to perform the occluding function of the prostheticmitral valve 400. For example, a two-leaflet, four-leaflet, or mechanical valve configuration may be used in some embodiments.

Referring to fig. 23 and 24, a prostheticmitral valve 400 is shown implanted within a nativemitral valve 17. In fig. 13, the prostheticmitral valve 400 is shown in a closed state (occluding). In fig. 24, the prostheticmitral valve 400 is shown in an open state. These views are from the left atrium looking towards themitral valve 17. For example, in fig. 24, thehub 210 andsub-annular support arms 230a, 230b, 230c, and 230d of theanchor assembly 200 are visible through theopen leaflets 350a, 350b, and 350c of the prostheticmitral valve 400, while in fig. 23, thehub 210 andsub-annular support arms 230a, 230b, 230c, and 230d are not visible because theclosed leaflets 350a, 350b, and 350c block thehub 210 from view.

Fig. 25-33 depict additional aspects related to sealing between a native mitral valve structure and an implantable prosthetic mitral valve described herein. During systole, ventricular to atrial sealing is relevant for effective treatment of MR via implantation of a prosthetic mitral valve. Furthermore, during diastole, atrial-to-ventricular sealing between the native mitral valve structure and the prosthetic mitral valve described herein is relevant for preventing or reducing paravalvular leakage and good sealing and long-term stability. The prosthetic mitral valves described herein are designed with various structures that provide an effective seal with the native mitral valve structure.

One feature that enhances the sealing of the prosthetic mitral valves provided herein relates to the shape of the prosthetic valve frame relative to the shape of the native mitral valve. As described above, the annulus of the native mitral valve is largely D-shaped (e.g., with reference to fig. 8). Further, as described above, the distal end of the prosthetic mitral valve described herein is D-shaped (e.g., with reference to fig. 19). In other words, the portion of the prosthetic valve designed to interface with the native valve annulus has a D-shaped profile that resembles the shape of the annulus. This similarity in shape can provide a particular sealing effect in the area of the outer andinner scallops 24a, 24c of the posterior leaflet 22 (see fig. 8).

Another feature that enhances the sealing of the prosthetic mitral valve provided herein relates to the sizing of the prosthetic valve relative to the size of the native mitral valve, particularly during systole. In certain embodiments, the selected prosthetic valve will intentionally have an outer contour that is equal to or slightly larger than the annulus size of the native mitral valve (when unconstrained). That is, in the region on the surface of the valve intended to be adjacent to the native valve annulus, the valve size may result in a line-to-line fit or a slight interference fit with the native valve annulus. Thus, in certain embodiments, atrial to ventricular sealing during diastole is provided by a line-to-line or slight interference fit between the valve and the native valve annulus.

Another feature that enhances the prosthetic mitral valve seal provided herein relates to the relative geometric orientation of the sealing surfaces on the prosthetic valve relative to the annulus of the native mitral valve. While in some embodiments some seals are provided by mechanical cooperation between the outer contour of the valve and the receiving structure of the native mitral valve, in some embodiments significant seals are provided by the engagement between the native leaflets and the sealing surfaces on the periphery of the prosthetic valve (thereby forming a contact seal during diastole and a left ventricular compression seal during systole). This type of seal may be referred to herein as a leaflet sealing against the valve body. As described further below, the prosthetic mitral valves provided herein provide a sealing surface that is geometrically oriented relative to the native valve annulus such that sealing of the leaflets against the valve body is provided. While the leaflet to valve body seal is not an entirely mechanical compression type seal or a seal that attaches to native tissue (active fixation) type, in certain embodiments, such mechanical or attachment type seals may be incorporated alternatively or additionally.

In some embodiments, effective leaflet-to-valve body sealing (not based entirely on compression or attachment) may require that some native leaflets move to the sealing surface of the valve body. Thus, a valve shape that mimics the shape of a native mitral valve is advantageous. As described above, in certain embodiments, the outer periphery of the valve assemblies provided herein has a D-shaped periphery that is generally associated with the D-shaped annulus of the native mitral valve. Thus, the distance of movement of the native valve leaflets to the valve sealing surface can be minimized (or in some embodiments substantially eliminated) and thus sealing can be enhanced.

In addition, effective leaflet-to-valve body sealing exhibits continuous coaptation between the native leaflets and the prosthetic valve body around the entire circumference of the prosthetic valve body. As described further below, the prosthetic mitral valve provided herein is contoured to interface with the native leaflets so as to provide continuous coaptation around the entire circumference of the prosthetic valve. To accomplish this, in certain embodiments, certain regions of the prosthetic mitral valve have a contour that is different from the contours of other regions of certain valves (e.g., corresponding to different anatomical structures in various portions of the native mitral valve).

Referring to fig. 25, a lateral cross-sectional atrial view ofheart 10 showsmitral valve 17,aortic valve 510,tricuspid valve 520, andpulmonary valve 530. As described above with reference to fig. 8, themitral valve 17 includes ananterior leaflet 20, a posterior leaflet 22 (including aninner scallop 24a, amiddle scallop 24b, and anouter scallop 24 c), a leftfibrous triangle 134a, and a rightfibrous triangle 134b.

With regard to the sealing between the prosthetic and native mitral valves, the different anatomical features of the various parts of the nativemitral valve 17 make it advantageous to consider thetricuspid valve 17 as having three different sealing regions, which together make up the entiremitral valve 17. The three different sealing areas are: ananterior region 25a, aposterior region 25b, and twocommissure regions 25c. Thefront region 25a extends substantially linearly between theleft triangle 134a and theright triangle 134b.Rear region 25b includes the rear ofmiddle scallop 24b andouter scallop 24a andinner scallop 24c. Thecommissure regions 25c extend between theanterior region 25a and theposterior region 25 b. The commissure regions 25 generally include anterior portions of thecommissures 30a and 30b and theouter scallops 24a and theinner scallop 24c. These three sealingareas 25a, 25b and 25c will refer again to fig. 28 to 33.

Referring to fig. 26, a schematic cross-sectional view of the nativemitral valve 17 valve shows the position of thetricuspid valve annulus 28. Three collective variables (S, W, and H) are also shown that can be used to quantify the relative geometric orientation of the sealing surface on the prosthetic valve with respect to theannulus 28 of the nativemitral valve 17. The term "sealing surface" as used herein is defined as the surface area on the prosthetic valve that is intended to make sealing contact with the structure of the nativemitral valve 17, in particular the leaflets of the nativemitral valve 17. Thus, the sealing surface is the area on the prosthetic valve that is used to facilitate sealing of the leaflets to the valve body.

The geometric variable S quantifies the radial distance from theannulus 28 to the adjacent prosthetic valve frame surface. A negative S value indicates that theannulus 28 and the adjacent prosthetic valve surface are spaced apart from each other. For example, an S value of minus 2mm indicates that there is a 2mm space between theannulus 28 and the adjacent prosthetic valve surface. When S equals zero, it indicates that thevalve annulus 28 and the adjacent prosthetic valve surface are in contact with each other in a line-to-line mating relationship. When S is positive, it indicates that theannulus 28 is in an interference fit relationship with an adjacent prosthetic valve surface. In other words. When S is positive, some compressive force is applied to theannulus 28 by the adjacent prosthetic valve surface.

The geometric variable H quantifies the distance from the upper limit (upper edge) to the lower limit (lower edge) of the sealing surface of the prosthetic valve. The H value is measured downwards (refer to the figure). For example, an H value of 10mm indicates that the sealing surface of the prosthetic valve terminates 10mm below the upper limit of the sealing surface for a particular sealing region. In another example, an H value of 7mm indicates that the lower limit of the sealing surface is 7mm below theannulus 28 when the upper limit is at theannulus 28. Generally, the upper limit of the sealing surface on the prosthetic valve is slightly above or below the annulus 28 (e.g., about 2mm above or about 2mm below theannulus 28 in certain embodiments).

The geometric variable W quantifies the radial distance from the upper limit of the sealing surface to the lower limit of the sealing surface of the prosthetic valve. A negative W value indicates that the lower limit of the sealing surface is radially inward relative to the upper limit of the sealing surface (e.g., at least a portion of the sealing surface is flared or bowed inward at the distal end). A positive W value indicates that a lower limit of the sealing surface is radially outward relative to an upper limit of the sealing surface (e.g., at least a portion of the sealing surface flares or arches outwardly at a distal end). A value of zero W indicates that the lower limit of the sealing surface is located at the same radial position as the upper limit of the sealing surface.

Referring to fig. 27, an anterior side view of thevalve assembly 300 includes ananterior sealing surface 360a according to some embodiments. In the depicted embodiment, theanterior sealing surface 360a spans the lower portion of the anterior side of thevalve assembly 300. Theanterior sealing surface 360a comprises a surface area on the anterior side of theprosthetic valve assembly 300 intended to be in sealing contact with the structure of the native mitral valve. Theanterior sealing surface 360a includes structural support from thevalve frame 301 and a tissue surface 361. Theanterior tissue surface 361a provides a sealing interface height (H) but its flexible nature reduces the amount of LVOT blockage, as will be described below. For example, at least a portion of theanterior sealing surface 360a is intended to be in sealing contact with the anterior leaflet of the native mitral valve.

Referring to fig. 28, a posterior side view of thevalve assembly 300 includes aposterior sealing surface 360b according to some embodiments. In the depicted embodiment, theposterior sealing surface 360b spans the lower portion of the posterior side of thevalve assembly 300. Theposterior sealing surface 360b comprises a surface area on the posterior side of theprosthetic valve assembly 300 that is intended to be in sealing contact with the structure of the native mitral valve. For example, at least a portion of theposterior sealing surface 360b is intended to be in sealing contact with the posterior leaflet of the native mitral valve.

Referring to fig. 29, a commissural (lateral) side view of thevalve assembly 300 includes acommissural sealing surface 360c according to some embodiments. This view is slightly biased to the anterior side of thevalve assembly 300. In the depicted embodiment, the commissure sealing surfaces 360c span the lower portion of the commissure sides of thevalve assembly 300. Thecommissure sealing surface 360c includes a surface area on the outside of theprosthetic valve assembly 300 that is intended to be in sealing contact with the structure of the native mitral valve. For example, at least a portion of thecommissure sealing surface 360c is intended to be in tissue sealing contact with an inner or outer scallop of the posterior leaflet of the native mitral valve or the leaflet in the commissure region of the native mitral valve.

Referring to fig. 30, the geometric relationship between the native mitral valve annulus and the anterior sealing surface of the prosthetic mitral valve according to certain embodiments is represented by the S, H, and W values as described above in the development with reference to fig. 26. For example, in certain embodiments, the S value of the anterior sealing surface of the prosthetic mitral valve ranges from about 0 millimeters to about plus 2 millimeters. In other words, the S value of the anterior sealing surface is in the range of about line-to-line contact to about 2mm interference with respect to the native mitral valve annulus. It should be appreciated that in this context, an interference fit does not necessarily mean that the native valve annulus is stretched or deformed due to such interference. But rather, the prosthetic valve assembly will be obstructed by the annulus without expanding to its unconstrained, fully expanded size. While in the depicted embodiment, the S value ranges from about negative 2 millimeters to about positive 1 millimeter, in certain embodiments, the S value ranges from about negative 2 millimeters to about positive 1 millimeter, or from about negative 1 millimeter to about positive 3 millimeters or from about zero millimeters to about positive 4 millimeters. In some embodiments, the S value may be more negative than about negative 2 millimeters or more positive than about positive 4 millimeters.

In some embodiments, the prosthesis is bicuspidThe H value of the anterior sealing surface of the valve is about 14 mm. In other words, in certain embodiments, the distance from the upper edge of the front sealing surface to the lower edge of the front sealing surface is about 14 millimeters. More specifically, the H value of the front sealing surface can be divided into two parts: (1) Upper part H_LVOT And (2) a lower part H_TISSUE 。H_LVOT The values generally correspond to the distance from the upper edge of the anterior sealing surface to the lower end of thevalve frame 301 at various locations along theanterior sealing surface 360a (see fig. 27). H_TISSUE The values correspond from the lower end of thevalve frame 301 at various locations along theanterior sealing surface 360a to the lower end of theanterior tissue surface 361a at those locations. Although in the depicted embodiment, H_LVOT Value sum H_TISSUE The values are equal to each other, in some embodiments, in H_LVOT Value and H_TISSUE The ratio between values is about 3.

While in the depicted embodiment, the total H value is about 14 millimeters, in certain embodiments, the H value ranges from about 8 millimeters to about 10 millimeters, or from about 10 millimeters to about 12 millimeters, or from about 12 millimeters to about 14 millimeters, or from about 14 millimeters to about 16 millimeters, or from about 13 millimeters to about 15 millimeters. In certain embodiments, the H value may be less than about 8 millimeters or greater than about 16 millimeters.

In certain embodiments, the W value of the anterior sealing surface of the prosthetic mitral valve is about negative 2 millimeters. In other words, in certain embodiments, the radial distance from the upper edge of the anterior sealing surface to the lower edge of the anterior sealing surface on the prosthetic valve is about minus 2 millimeters. A W value of minus 2 millimeters indicates that the lower edge of the front sealing surface is positioned about 2 millimeters radially inward of the upper edge of the front sealing surface. This also means that the sub-annular anterior valve component flares or bows inward, such as represented by valvebody contour line 362 a. Although in the depicted embodiment, the value of W is about 2 millimeters, in certain embodiments, the value of W is in a range of about negative 6 millimeters to about negative 4 millimeters, or about negative 4 millimeters to about negative 2 millimeters or about negative 2 millimeters to about zero millimeters or about zero millimeters to about positive 2 millimeters or about negative 3 millimeters to about negative 1 millimeters. In certain embodiments, the value of W may be more negative than about negative 6 millimeters or more positive than about positive 2 millimeters.

Referring to fig. 31, the geometric relationship between the native mitral valve annulus and the commissure sealing surfaces of the prosthetic mitral valve according to certain embodiments may be represented by S, H, and W as described above in the development of fig. 26. For example, in certain embodiments, the commissure sealing surfaces of the prosthetic mitral valve have an S-value in a range from about 0 millimeters to about plus 2 millimeters. In other words, the S-value of the commissure sealing surfaces ranges from about line-to-line contact to about 2mm interference, relative to the native mitral valve annulus. It should be appreciated that in this context, an interference fit does not necessarily mean that the native valve annulus is stretched or deformed due to such interference. But rather, the prosthetic valve assembly will be obstructed by the annulus from expanding to its unconstrained, fully expanded size. While in the depicted embodiment, the S value ranges from about negative zero millimeters to about positive 2 millimeters, in certain embodiments, the S value ranges from about negative 2 millimeters to about positive 1 millimeter, or from about negative 1 millimeter to about positive 3 millimeters or from about zero millimeters to about positive 4 millimeters. In some embodiments, the S value may be more negative than about negative 2 millimeters or more positive than about positive 4 millimeters.

In certain embodiments, the H-value of the commissure sealing surfaces of the prosthetic mitral valve ranges from about 8 millimeters to about 14 millimeters. In other words, in certain embodiments, the distance from the native valve annulus to the lower (inferior) edge of the commissure seal surfaces ranges from about 8 millimeters to about 14 millimeters. This range, from about 8 millimeters to about 14 millimeters, is due at least in part to the shape of the commissure corners 364 (see fig. 29) that make up the portion of the commissure seal surface. Thus, the lower edge of the commissural sealing surface varies across the lateral width of the commissural sealing surface only due to the nature of the shape of the commissural sealing surface. While in the depicted embodiment, the H value ranges from about 8 millimeters to about 14 millimeters, in certain embodiments the H value ranges from about 4 millimeters to about 10 millimeters, or from about 6 millimeters to about 12 millimeters, or from about 8 millimeters to about 14 millimeters, or from about 10 millimeters to about 16 millimeters, or from about 7 millimeters to about 15 millimeters. In certain embodiments, the H value may be less than 4 millimeters or greater than about 15 millimeters.

In certain embodiments, the commissure sealing surfaces of the prosthetic mitral valve have a W value of about minus 2 millimeters. In other words, in certain embodiments, the radial distance from the upper (upper) edge of the commissure seal surface of the prosthetic valve to the lower (lower) edge of the seal surface is about minus 2 millimeters. A W value of minus 2 millimeters indicates that the lower edge of the commissure seal surfaces is located about 2 millimeters radially inward of the upper edge of the commissure seal surfaces. This also means that the sub-annular commissure valve components flare or bow inward, such as shown by valvebody contour line 362 b. While in the depicted embodiment, the value of W is about negative 2 millimeters, in certain embodiments, the value of W is in a range of about negative 6 millimeters to about negative 4 millimeters, or in a range of about 4 millimeters to about negative 2 millimeters, or in a range of about negative 2 millimeters to about zero millimeters, or in a range of about zero millimeters to about positive 2 millimeters, or in a range of about negative 3 millimeters to about negative 1 millimeter. In certain embodiments, the value of W may be more negative than about negative 6 millimeters or more positive than about positive 2 millimeters.

Referring to fig. 32, the geometric relationship between the native mitral valve annulus and the posterior sealing surface of the prosthetic mitral valve according to certain embodiments may be represented by S, H, and W as described above in the development of fig. 26. For example, in certain embodiments, the posterior sealing surface of the prosthetic mitral valve has an S value in a range from about 0 millimeters to about plus 2 millimeters. In other words, the S value of the posterior sealing surface ranges from about line-to-line contact to about 2mm interference with respect to the native mitral valve annulus. It should be appreciated that in this context, an interference fit does not necessarily mean that the native valve annulus is stretched or deformed due to such interference. But rather, the prosthetic valve assembly will be obstructed by the annulus from expanding to its unconstrained, fully expanded size. While in the depicted embodiment, the S value ranges from about zero millimeters to about positive 2 millimeters, in certain embodiments the S value ranges from about negative 2 millimeters to about positive 1 millimeter, or from about negative 1 millimeter to about positive 3 millimeters or from about zero millimeters to about positive 4 millimeters. In some embodiments, the S value may be more negative than about negative 2 millimeters or more positive than about positive 4 millimeters.

In certain embodiments, the posterior sealing surface of the prosthetic mitral valve has an H value of about 8 millimeters. In other words, in certain embodiments, the distance from the native valve annulus to the lower (inferior) edge of the posterior sealing surface is about 8 millimeters. While in the depicted embodiment, the H value is about 8 millimeters, in certain embodiments, the H value is in a range of about 4 millimeters to about 6 millimeters, or in a range of about 6 millimeters to about 8 millimeters, or in a range of about 8 millimeters to about 10 millimeters, or in a range of about 10 millimeters to about 12 millimeters or in a range of about 7 millimeters to about 9 millimeters. In certain embodiments, the H value may be less than 4 millimeters or greater than about 12 millimeters.

In certain embodiments, the commissure sealing surfaces of the prosthetic mitral valve have a W value of about plus 2 millimeters. In other words, in certain embodiments, the radial distance from the upper (upper) edge of the posterior sealing surface to the lower (lower) edge of the sealing surface on the prosthetic valve is about plus 2 millimeters. A W value of plus 2 millimeters indicates that the lower edge of the back sealing surface is about 2 millimeters radially outward of the upper edge of the back sealing surface. This also means that the sub-annular posterior valve component flares or bows outward, such as shown by valvebody contour line 362 c. While in the depicted embodiment, the value of W is about positive 2 millimeters, in certain embodiments, the value of W is in a range of about negative 4 millimeters to about negative 2 millimeters, or in a range of about negative 2 millimeters to about zero millimeters, or in a range of about zero millimeters to about positive 2 millimeters, or in a range of about positive 2 millimeters to about positive 4 millimeters, or in a range of about positive 1 millimeter to about positive 3 millimeters. In certain embodiments, the value of W may be more negative than about negative 2 millimeters or more positive than about positive 3 millimeters.

Referring to fig. 33, during systole,aortic valve 510 receives blood flow fromleft ventricle 18. Blood flows to theaortic valve 510 via the Left Ventricular Outflow Tract (LVOT) 512. In some cases, a prosthetic mitral valve 600 (anchor assembly not shown for simplicity) implanted in the nativemitral valve 17 may block theLVOT 512, as represented byobstruction 514, resulting in reduced ejection of blood from theleft ventricle 18. As described herein, the prosthetic mitral valve provided by the present disclosure can be configured to reduce or eliminateLVOT obstruction 514.

Referring to fig. 34 and 35, after a fluoroscopy dye is injected into the left ventricle to enhance visualization of blood flow and blood flow blockage, a firstfluoroscopy image 700 and a secondfluoroscopy image 730 are obtained. The image shows blood flow from the left ventricle through the Left Ventricular Outflow Tract (LVOT) to the aorta.

The firstfluoroscopic image 700 shows a reducedblood flow area 710 from the prostheticmitral valve 720 caused by LVOT obstruction. The secondfluoroscopic image 730 shows theimproved blood flow 740 through the LVOT. Theimproved blood flow 740 may be due to reduced occlusion caused by the prostheticmitral valve 750. For example, in certain embodiments, the prostheticmitral valve 750 can be positioned or designed such that less of the structure of thevalve 750 is below the native mitral valve annulus, resulting in less of the structure of thevalve 750 being within the LVOT. In addition, the prostheticmitral valve 750 can be positioned or designed such that less of the structure of thevalve 750 is within the LVOT, such as by tapering, bowing, or shaping the structure away from the LVOT.

Referring again to fig. 33, the portion of the prostheticmitral valve 600 that faces theaortic valve 510 is ananterior sealing surface 625a. Thus, the geometric orientation of theanterior sealing surface 625a relative to theLVOT 512 is a factor related to whether the prostheticmitral valve 600 is causing theobstruction 514.

Referring also to fig. 36, the geometric relationship between theLVOT 512, the nativemitral valve annulus 28, and the anterior sealing surface variables (S-value, H-value, and W-value, as described with reference to fig. 25, 26, and 30) may be used to quantify theLVOR obstruction 514. The angle between theLVOT 512 and the nativemitral valve annulus 28 is determined as θ. The R-value is a variable responsible for variations from the expected/ideal position location of the prosthetic valve relative to the native valve annulus.

Using geometry, theLVOT blockage 514 distance (identified as "O" in the following equation) may be calculated using the following equation:

equation #1:

wherein:

o is the calculated distance of LVOT blockage;

r is the distance from the native valve annulus to the top of the anterior sealing surface;

θ is the angle between the native valve annulus and the LVOT;

w is the radial distance from the upper edge of the sealing surface to the lower edge of the sealing surface on the prosthetic valve;

H_LVOT is the distance from the upper edge of the sealing surface on the prosthetic valve to the lower structural (frame) edge of the sealing surface; and

s is the radial distance from the mitral valve annulus to the adjacent prosthetic valve surface.

The following example is provided to illustrateequation #1 above.

Examples of the invention	R(mm)	S(mm)	HLVOT (mm)	W(mm)	θ°	O(mm)
							1	0	2	8	-2	164	2.2
2	0	0	8	-2	119	6.0
							3	0	2	8	-4	119	6.0
4	0	2	5	-4	119	3.4
							5	0	0	14	-2	164	1.9

By comparingexamples #1 and #5 with examples #2, #3, and #4, it can be determined that O (LVOT blocking) tends to be smaller when θ is larger. By comparing example #3 with example #4, a larger H can be seen_LVOT Tends to result in higher O. By comparing example #2 with example #3, it is possible to determine a larger S valueThe effect may be offset by a more negative value of W. In summary, one of ordinary skill in the art can use these teachings to select an R value, S value, H value for a given θ (based on patient anatomy)_LVOT -value and W value in order to achieve acceptable O (LVOT blocking).

Referring to fig. 37 and 38, theanchor assembly 200 can be engaged with the nativemitral valve 17 such that thefeet 220a, 220b, 220c, and 220d are seated in thesubcircular channel 19 of the nativemitral valve 17, while theleaflets 20 and 22 andchordae tendineae 40 are substantially unobstructed by theanchor assembly 200. As described above, theanchor assembly 200 is designed to be implanted within the nativemitral valve 17 without significantly interfering with thenative valve 17 so that thenative valve 17 can continue to function as it did prior to placement of theanchor assembly 200. To achieve this, theleaflets 20 and 22 andchordae tendineae 40, and in particular, thechordae tendineae 40 attached to theanterior leaflet 20 need to be substantially unobstructed by theanchor assembly 200.

In some embodiments, the positioning of thehub 210 relative to the anatomical features of themitral valve 17 is important to facilitate substantiallyunobstructed leaflets 20 and 22 andchordae tendineae 40. For example, thedepth 810 of thehub 210 in theleft ventricle 18 is an important consideration. To substantially prevent interference with theleaflets 20 and 22 andchordae tendineae 40, thedepth 810 should be at least slightly below the coaptation depth of themitral valve 17. The coaptation depth is the maximum vertical distance from the annulus of themitral valve 17 to the coaptation region between thenative leaflets 20 and 22. Thus, positioning thehub 210 below the coaptation depth will facilitate substantiallyunobstructed leaflets 20 and 22 andchordae tendineae 40. In certain embodiments, thedepth 810 is in the range of about 14mm to about 20mm, or in the range of about 10mm to about 16mm, or in the range of about 12mm to about 18mm, or in the range of about 16mm to about 22mm. In certain embodiments, thedepth 810 is less than about 10mm or greater than about 22mm.

The positioning of thehub 210 relative to the coaptation line between theleaflets 20 and 22 (e.g., thecoaptation line 32 shown in fig. 8) is also important to facilitate substantiallyunobstructed leaflets 20 and 22 andchordae tendinae 40. For example, in some embodiments,positioning hub 210 in substantially vertical alignment with the coaptation line will serve to substantially prevent interference withleaflets 20 and 22 andchordae tendineae 40.

In certain embodiments, the angular positioning of the left, right, and right anterior inferior annuli supportarms 230a, 230b, 230c, and 230d relative to the nativemitral valve 17 is important to facilitate substantiallyunobstructed leaflets 20 and 22 andchordae tendineae 40. In some embodiments, thesub-annular support arms 230a, 230b, 230c, and 230d are arranged symmetrically about the left ventricular Long Axis (LAX) 840. That is, theLAX 840 bisects the anteriorsupport arm angle 830 and the posteriorsupport arm angle 820.

To minimize interference with theanterior leaflet 20 andchordae tendineae 40, theanterior support arms 220a and 220d are positioned substantially between thechordae tendineae 40. In certain embodiments, frontsupport arm angle 830 is in the range of about 100 ° to about 135 °, alternatively in the range of about 80 ° to about 120 °, and alternatively in the range of about 120 ° to about 160 °. To minimize interference with theposterior leaflet 22 andchordae tendineae 40, in some embodiments, theposterior support arms 220a and 220b can extend substantially between thechordae tendineae 40. In certain embodiments, the rearsupport arm angle 820 ranges from about 50 ° to about 120 °, alternatively from about 40 ° to about 80 °, alternatively from about 60 ° to about 100 °, alternatively from about 80 ° to about 120 °, alternatively from about 100 ° to about 140 °.

Several embodiments of the invention have been described. Nevertheless, it will be understood that various modifications may be made without departing from the scope of the disclosure. Accordingly, other embodiments are within the scope of the following claims.

Claims (7)

1. A prosthetic mitral valve system, comprising:

a valve assembly, comprising:

a frame member defining an outer profile and an inner frame member space; and

an occluder disposed within the inner frame member space, the occluder having an open configuration and a closed configuration,

wherein the frame member comprises a proximal end frame portion and a distal end frame portion, wherein an outer periphery of the distal end frame portion comprises a substantially flat region and a substantially circular region, and wherein at least some portion of the substantially flat region extends distally toward the inner frame member space;

an anchor assembly defining an inner anchor assembly space, wherein the valve assembly is selectively matable with the inner anchor assembly space; wherein the anchor assembly comprises an expandable anchor frame comprising a hub and sub-annular support arms extending from the hub, wherein the sub-annular support arms extend to anchor feet having surfaces configured to engage with the sub-annular groove of a native mitral valve.

2. The prosthetic mitral valve system of claim 1, wherein a distance measured parallel to a longitudinal axis of the valve assembly from a distal-most end of the anchor assembly to the surface is at least 14 millimeters.

3. The prosthetic mitral valve system of claim 1, wherein the distal end frame portion comprises: a generally D-shaped outer perimeter, and wherein the proximal end frame portion comprises: a circular valve orifice located radially inward of the generally D-shaped outer peripheral region and carrying valve leaflets defining a circular perimeter at the circular valve orifice.

4. A prosthetic mitral valve system implantable at a native mitral valve, the prosthetic mitral valve system comprising:

an anchor assembly defining an inner anchor assembly space and a longitudinal axis, the anchor assembly comprising an expandable anchor frame comprising a hub and sub-annular support arms extending from the hub, wherein the sub-annular support arms extend to anchor feet having surfaces configured to engage with sub-annular grooves of a native mitral valve; and

a valve assembly, comprising:

an expandable valve frame defining an outer profile and an inner frame member space; and

an occluder disposed within the inner frame member space, the occluder having an open configuration and a closed configuration,

wherein the valve assembly is releasably engaged with the anchor assembly within the inner anchor assembly space, and wherein a distance measured parallel to the longitudinal axis from a distal-most end of the anchor assembly to the surface is at least 14 millimeters.

5. The prosthetic mitral valve system of claim 4, wherein the valve assembly comprises a distal end frame portion having a generally D-shaped outer perimeter, and wherein the valve assembly comprises a proximal end frame portion having a circular valve orifice located radially inward of the generally D-shaped outer perimeter region and carrying valve leaflets defining a circular perimeter at the circular valve orifice.

6. A prosthetic mitral valve system comprising:

an anchor assembly comprising an expandable anchor frame and a set of sub-annular anchor feet configured to engage with a sub-annular sulcus of a native mitral valve; and

a valve assembly, comprising: an expandable valve frame defining an outer profile and an inner frame member space; a tissue layer disposed over at least a portion of the outer contour; and an occluder disposed in the inner frame member space,

wherein when the set of anchor feet of the anchor assembly are engaged with the sub-annular channel, a peripheral layer facing outward along the tissue layer of the valve assembly is positioned against a native leaflet of the mitral valve.

7. The prosthetic mitral valve system of claim 6, wherein the valve assembly comprises a distal end frame portion having a generally D-shaped outer perimeter, and wherein the valve assembly comprises a proximal end frame portion having a circular valve orifice located radially inward of the generally D-shaped outer perimeter region and carrying valve leaflets defining a circular perimeter at the circular valve orifice.

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