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

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

Heart valve prostheses have been developed for repair and replacement of diseased and/or damaged heart valves. Such heart valve prostheses can be percutaneously delivered, positioned and deployed at the site of the diseased heart valve through catheter-based delivery systems. Heart valve prostheses can be delivered while in a low-profile or radially collapsed configuration so that the heart valve prosthesis can be advanced through the patient's vasculature. Once positioned at the treatment site, the heart valve prosthesis can be expanded to engage tissue at the diseased heart valve region to, for instance, hold the heart valve prosthesis in position. However, challenges exist with reducing the crossing profile of heart valve prostheses for use in, for example, transseptal approaches to a native mitral valve.

To address the crossing profile concern, the heart valve prosthesis may be split into two separate components. Splitting the heart valve prosthesis into two separate components allows each component to be collapsed separately to a reduced crossing profile. However, splitting the heart valve prosthesis into two separate components presents challenges to the successful repair and replacement of the native heart valve. In particular, leaflet function of the native valve is impaired as the two-piece valve is deployed. Accordingly, there is a need for delivery systems and methods that provide a mechanism to act as a temporarily heart valve during delivery and positioning of a two-piece heart valve prosthesis.

Embodiments hereof relate to a delivery system for percutaneously delivering a heart valve prosthesis to a site of a native heart valve. <CIT> relates to a two-step heart valve implantation. <CIT> relates to a modular percutaneous valve structure. <CIT> relates to a minimally invasive heart valve replacement. <CIT> relates to an annuloplasty with enhanced anchoring to the annulus based on tissue healing.

The delivery system includes a delivery catheter and a heart valve prosthesis. The delivery catheter includes an outer sheath, an inner shaft, and an orifice restriction mechanism. In some embodiments, the orifice restriction mechanism is a pulsatile balloon. The inner shaft is slidably disposed within the outer sheath. The orifice restriction mechanism is coupled to a distal portion of the inner shaft. In some embodiments, wherein the orifice restriction mechanism is a pulsatile balloon, the pulsatile balloon has a first state and an inflated second state. The heart valve prosthesis includes a valve member and a docking member. The valve member and the docking member each have a radially collapsed configuration and a radially expanded configuration. The orifice restriction mechanism is configured to be positioned within the docking member after the docking member is in the radially expanded configuration within an annulus of the native heart valve. The orifice restriction mechanism is further configured to temporarily replicate the operation of the native heart valve when positioned within the docking member in the radially expanded configuration within the annulus of the native heart valve until the valve member is positioned within the docking member.

Embodiments hereof further relate to a delivery system for percutaneously delivering a heart valve prosthesis to a site of a native heart valve. The delivery system includes a heart valve prosthesis and a delivery catheter assembly comprising one or more catheters and one or more sheath assemblies. The heart valve prosthesis includes a valve member and a docking member, each having a radially collapsed configuration and a radially expanded configuration. The delivery catheter system includes an inner shaft assembly, a docking sheath assembly, and a valve sheath assembly. The inner shaft assembly has an inner shaft and an orifice restriction mechanism. In some embodiments, the delivery catheter system includes a single catheter comprising the docking sheath assembly and the valve sheath assembly. In some embodiments, the delivery catheter system includes two catheters wherein a first catheter comprises the docking sheath assembly and a second catheter comprises the valve sheath assembly. In some embodiments, the docking sheath assembly and the valve sheath assembly are the same sheath assembly. In some embodiments, the docking sheath assembly and the valve sheath assembly are different sheath assemblies. The docking sheath assembly has an inner sheath and an outer sheath. The inner sheath of the docking sheath assembly is configured to slidably receive the inner shaft assembly. The outer sheath of the docking sheath assembly is configured to slidably receive the inner sheath and is further configured to retain the docking member of the heart valve prosthesis in the radially collapsed configuration for delivery to a desired treatment location. The valve sheath assembly has an inner sheath and an outer sheath. The inner sheath of the valve sheath assembly is configured to slidably receive the inner shaft assembly. The outer sheath of the valve sheath assembly is configured to slidably receive the inner sheath. The outer sheath of the valve sheath assembly is further configured to retain the valve member of the heart valve prosthesis in the radially collapsed configuration for delivery to a desired treatment location. The orifice restriction mechanism is coupled to a distal portion of the inner shaft. The orifice restriction mechanism has a first state and a second state. The orifice restriction mechanism is configured to be positioned within the docking member of the heart valve prosthesis in the radially expanded configuration at an annulus of the native heart valve. The orifice restriction mechanism is further configured to restrict blood flow through the native heart valve when in the second state and positioned within the docking member of the heart valve prosthesis in the radially expanded configuration at the annulus of the native heart valve. In some embodiments, the orifice restriction mechanism is a pulsatile balloon mechanism.

A delivery catheter assembly includes an inner shaft, an outer sheath, and an orifice restriction mechanism, e.g., a pulsatile balloon. In some embodiments, a delivery catheter with a heart valve prosthesis including a docking member and a valve member each retained in a radially collapsed configuration is advanced to a native valve of a heart. The docking member of the heart valve prosthesis is positioned within an annulus of the native heart valve. The outer sheath of the delivery catheter is retracted to release the orifice restriction mechanism, e.g., a pulsatile balloon, and the docking member. The docking member is expanded to the radially expanded configuration. The orifice restriction mechanism is positioned within the docking member at the annulus of the native heart valve. In some embodiments, wherein the orifice restriction mechanism is a pulsatile balloon, the pulsatile balloon is cyclically transitioned between a first state and an inflated second state. The cyclic transitions are synchronized with the cardiac cycle of the heart. When the clinician is ready to position the valve member within the docking member, the pulsatile balloon is transitioned to the first state. The delivery catheter is advanced to position the valve member of the heart valve prosthesis within the docking member at the annulus of the native heart valve. The outer sheath is retracted to release the valve member of the heart valve prosthesis. The valve member expands to a radially expanded configuration.

A delivery system with a docking member of a heart valve prosthesis in a radially collapsed configuration is advanced through a native heart valve and into an adjacent chamber of a heart. The delivery system includes an inner shaft inner shaft assembly and a docking sheath assembly. The inner shaft assembly has an inner shaft and an orifice restriction mechanism in a first state. The docking sheath assembly has an outer sheath and an inner sheath. The outer sheath is configured to slidably receive the inner sheath, and the inner sheath is configured to slidably receive the inner shaft. The docking sheath assembly further includes the docking member of the heart valve prosthesis in a radially collapsed configuration at a distal portion thereof. The docking sheath assembly is retracted to release the orifice restriction mechanism. The docking sheath assembly is manipulated to position the docking member of the heart valve prosthesis within an annulus of the native heart valve. The outer sheath of the docking sheath assembly is retracted to release the docking member. The docking member expands to a radially expanded configuration. The delivery system is retracted to position the orifice restriction mechanism within the docking member at the annulus of the native heart valve. The orifice restriction mechanism is transitioned from the first state to a second state. The docking sheath assembly is exchanged for a valve sheath assembly. The valve sheath assembly has an outer sheath and an inner sheath slidingly disposed over the inner shaft. The valve sheath assembly further includes a valve member of the heart valve prosthesis in a radially collapsed configuration at a distal portion thereof. The valve member of the heart valve prosthesis is positioned adjacent the native heart valve. When the clinician is ready to position the valve member within the docking member, the delivery system is advanced to position the valve member of the heart valve prosthesis within the docking member at the annulus of the native heart valve. The outer sheath of the valve sheath assembly is retracted to release the valve member. The valve member expands to a radially expanded configuration within the docking member. The orifice restriction mechanism is transitioned from the second state to the first state.

Specific embodiments of the present invention are now described with reference to the figures, wherein like reference numbers indicate identical or functionally similar elements. The terms "distal" and "proximal", when used in the following description to refer to a catheter and/or other system components hereof are with respect to a position or direction relative to the treating clinician. Thus, "distal" and "distally" refer to positions distant from or in a direction away from the treating clinician, and the terms "proximal" and "proximally" refer to positions near or in a direction toward the treating clinician.

Although the description of embodiments hereof is in the context of delivery systems for delivering a heart valve prosthesis within a native mitral valve, the delivery systems described herein can also be used in other valves of the body, or for delivering a heart valve prosthesis within a failed previously implanted heart valve prosthesis.

The present invention in various embodiments relate to a delivery system for delivering, positioning and deploying a two-piece heart valve prosthesis at a site of a native heart valve. <FIG> is a perspective view of an exemplary two-piece heart valve prosthesis <NUM> for use in embodiments hereof, wherein the heart valve prosthesis <NUM> is in a radially expanded configuration. The heart valve prosthesis <NUM> is illustrated herein in order to facilitate description of delivery catheters and systems to be utilized in conjunction therewith according to embodiments hereof. While the heart valve prosthesis <NUM> illustrated herein is of a specific construction and structure, it is not meant to be limiting, and alternate heart valve prostheses can be used with the methods and devices described herein. The heart valve prosthesis <NUM> is merely exemplary. It is understood that any number of alternate heart valve prostheses can be used with the methods and devices described herein. Further, while described herein as a heart valve prosthesis, this is done as an example for convenience, and the heart valve prosthesis may assume various configurations for use at other locations within the heart and the body.

In the embodiment of <FIG>, the heart valve prosthesis <NUM> includes a docking member <NUM>, also referred to herein as an anchoring member or anchor stent, and a valve member <NUM>, also referred to herein as a valve stent in accordance with an embodiment hereof. The docking member <NUM> and the valve member <NUM> are each shown in a radially expanded configuration in <FIG>. The docking member <NUM> is configured to be positioned and expanded to the radially expanded configuration at an annulus of a native heart valve. After deployment of the docking member <NUM>, the valve member <NUM> is configured to be positioned within the radially expanded docking member <NUM> and expanded to a radially expanded configuration. The docking member <NUM> and the valve member <NUM> combine to replicate the operation of the native heart valve.

The docking member <NUM>, as shown in <FIG>, is a stent or frame, which can have, for example, a flared, funnel-like or hyperboloid shape. Accordingly, the docking member <NUM> defines a lumen <NUM> extending from an inflow end 108A to an outflow end 110A thereof. The docking member <NUM> includes the radially collapsed configuration for delivery and the radially expanded configuration when deployed. The docking member <NUM> is configured to engage tissue at the annulus of the native heart valve when in the radially expanded configuration. The docking member <NUM> is further configured to provide a secure mounting surface with which the valve member <NUM> may engage, when the valve member <NUM> is in the radially expanded configuration within the lumen <NUM> of the docking member <NUM>. Embodiments of the docking member <NUM> may include structural components such as, but not limited to a plurality of struts or wire portions arranged relative to each other to provide a desired compressibility and strength. As described herein, the docking member <NUM> is self-expanding from the radially collapsed configuration to the radially expanded configuration. "Self-expanding" as used herein means that a structure has been formed or processed to have a mechanical or shape memory to return to the radially expanded configuration. Mechanical or shape memory may be imparted to the structure using techniques understood in the art. Alternatively, the docking member <NUM> may be balloon expandable or mechanically expandable. The docking member <NUM> may be made from materials such as, but not limited to stainless steel, nickel-titanium alloys (e.g. NITINOL), or other suitable materials.

Also shown in <FIG>, the valve member <NUM> of the heart valve prosthesis <NUM> includes a generally cylindrical frame or valve support <NUM> and a prosthetic valve <NUM> coupled to, mounted within, or otherwise carried by the valve support <NUM>. The valve member <NUM> is configured for placement within the lumen <NUM> of the docking member <NUM> such that the heart valve prosthesis <NUM> replicates the function of the native heart valve when deployed at the annulus of the native heart valve. The valve member <NUM> includes a radially collapsed configuration for delivery and the radially expanded configuration when deployed. Embodiments of the valve support <NUM> may include various structural components such as, but not limited to a plurality of struts or wire portions arranged relative to each other to provide a desired compressibility and strength. While the valve support <NUM> is described herein as self-expanding from the radially collapsed configuration to the radially expanded configuration, this is not meant to limit the design, and in other embodiments, the valve support <NUM> may be balloon expandable or mechanically expandable. The valve support <NUM> may be made from materials such as, but not limited to stainless steel, nickel-titanium alloys (e.g. NITINOL), or other suitable materials.

As previously described, the heart valve prosthesis <NUM> includes the prosthetic valve <NUM> within the interior of the valve member <NUM>. In an embodiment hereof, the prosthetic valve <NUM> is positioned adjacent to the inflow end 108B of the valve member <NUM>. The prosthetic valve <NUM> is configured as a one-way valve to allow blood flow in one direction and thereby regulate blood flow therethrough. The prosthetic valve <NUM> is capable of blocking flow in one direction to regulate flow therethrough via valve leaflets that may form a bicuspid or tricuspid replacement valve. More particularly, if the heart valve prosthesis <NUM> is configured for placement within a native heart valve having two leaflets such as the mitral valve, the prosthetic valve <NUM> may include two valve leaflets to form a bicuspid replacement valve that closes with pressure on the outflow and opens with pressure on the inflow. In other embodiments in accordance herewith, the prosthetic valve <NUM> may be a tricuspid replacement valve or may be a single leaflet replacement valve. The valve leaflets are sutured or otherwise securely and sealingly attached to an inner circumference of the valve member <NUM>.

The valve leaflets of prosthetic valve <NUM> may be made of natural pericardial material obtained from, for example, heart valves, aortic roots, aortic walls, aortic leaflets, pericardial tissue, bypass grafts, blood vessels, intestinal submucosal tissue, umbilical tissue and the like from humans or animals, such as tissue from bovine, equine or porcine origins. Alternatively, the valve leaflets of prosthetic valve <NUM> may be made of synthetic materials suitable for use as heart valve prosthesis leaflets in embodiments hereof including, but are not limited to polyester, polyurethane, cloth materials, nylon blends, and polymeric materials.

Embodiments hereof relate to delivery catheters or devices for percutaneously delivering a two-piece heart valve prosthesis (e.g., the heart valve prosthesis <NUM> described above) to a native heart valve. As will be described in more detail herein, the delivery catheter includes an orifice restriction mechanism, e.g., a temporary valve, that is configured to temporarily mimic or replicate the operation of the native heart valve during deployment of the two-piece heart valve prosthesis. More specifically, after the docking member <NUM> of the heart valve prosthesis <NUM> is deployed within the annulus of a native heart valve, the orifice restriction mechanism or temporary valve according to embodiments hereof is configured to temporarily replace the function of the native heart valve until the valve member <NUM> of the heart valve prosthesis <NUM> is deployed within the docking member <NUM>.

<FIG> illustrate a delivery system <NUM> according to an embodiment hereof in which the orifice restriction mechanism is a pulsatile balloon <NUM> that is configured to inflate and deflate in synchronization with the cardiac cycle of the heart. As shown in <FIG>, the delivery system <NUM> includes a delivery catheter <NUM> and the heart valve prosthesis <NUM> previously described herein. The delivery catheter <NUM> includes a handle <NUM>, an outer sheath <NUM>, an inner shaft <NUM>, a distal tip <NUM>, and a pulsatile balloon <NUM>. In this embodiment, the separate components of the heart valve prosthesis <NUM>, i.e., the docking member <NUM> and the valve member <NUM>, are spaced axially on a distal portion of the delivery catheter <NUM>. The docking member <NUM> is mounted distal to the valve member <NUM>, with each of the valve member <NUM> and the docking member <NUM> in a radially collapsed configuration for delivery to a desired treatment location. The delivery system <NUM> is configured to deliver and implant the heart valve prosthesis <NUM> according to an embodiment of the present invention.

As best shown in <FIG>, the handle <NUM> includes a housing <NUM> and an actuation mechanism <NUM> for interfacing by a user. The handle <NUM> provides a surface for convenient handling and grasping by a user, and while the handle <NUM> of <FIG> is shown with a generally cylindrical shape, this is by way of example and not limitation, and other shapes and sizes may be utilized. Further, while the handle <NUM> is shown with a specific style of actuation mechanism <NUM>, this is also by way of example and not limitation, and various actuation mechanisms may be utilized including, but not limited to an axially-slidable lever, a rotary rack and pinion gear, or other applicable actuation mechanisms.

Also shown in <FIG>, the outer sheath <NUM> includes a proximal end <NUM>, a distal end <NUM>, and a lumen <NUM> extending from the proximal end <NUM> to the distal end <NUM> of the outer sheath <NUM>. The lumen <NUM> of the outer sheath <NUM> is sized to receive the inner shaft <NUM>. A distal portion <NUM> of the outer sheath <NUM> is configured to retain the valve member <NUM> and the docking member <NUM> of the heart valve prosthesis <NUM> in their radially collapsed configurations for delivery to the desired treatment location. The distal portion <NUM> is further configured to encapsulate or cover the pulsatile balloon <NUM> in a first state, also referred to as the uninflated state, therein for delivery to the desired treatment site. While the distal portion <NUM> is described herein as a distal portion of the outer sheath <NUM>, in an embodiment, the distal portion <NUM> may be a separate component, such as a capsule, coupled to the distal end <NUM> of the outer sheath <NUM>. Moreover, although the outer sheath <NUM> is described herein as a single component, this is by way of example and not limitation, and the outer sheath <NUM> may include multiple components such as, but not limited to proximal and distal shafts or other components suitable for the purposes described herein. In an embodiment, the proximal end <NUM> of the outer sheath <NUM> is configured for fixed connection to the handle <NUM>. More specifically, the proximal end <NUM> may extend proximally into the housing <NUM> of the handle <NUM> and a proximal portion <NUM> of the outer sheath <NUM> may be operably coupled to the actuation mechanism <NUM> of the handle <NUM>. The proximal portion <NUM> is operably coupled to the actuation mechanism <NUM> such that movement of the actuation mechanism <NUM> causes the outer sheath <NUM> and the distal portion <NUM> to move relative to the inner shaft <NUM>. The outer sheath <NUM> is thus movable relative to the handle <NUM> and the inner shaft <NUM> by the actuation mechanism <NUM>. However, if the actuation mechanism <NUM> is not moved and the handle <NUM> is moved, the outer sheath <NUM> moves with the handle <NUM>, not relative to the handle <NUM>. The outer sheath <NUM> may be constructed of materials such as, but not limited to polyurethane (e.g. Peliethane@, Elasthane™, Texin®, Tecothane®), polyamide polyether block copolymer (e.g. Pebax®, nylon <NUM>), polyethylene, or other materials suitable for the purposes of the present disclosure. The proximal portion <NUM> of the outer sheath <NUM> may be operably coupled to the actuation mechanism <NUM>, for example, and not by way of limitation by adhesives, bonding, welding, fusing, mechanical connection, or other coupling devices as appropriate.

The inner shaft <NUM> of the delivery catheter <NUM> extends within the lumen <NUM> of the outer sheath <NUM>, as shown in <FIG>. The inner shaft <NUM> includes a lumen <NUM> extending from a proximal end <NUM> to a distal end <NUM> of the inner shaft <NUM>. The lumen <NUM> is sized to receive auxiliary components, such as a guidewire. At least a portion of the inner shaft <NUM> is configured for fixed connection to the handle <NUM>. In an embodiment, the proximal end <NUM> of the inner shaft <NUM> may extend through the housing <NUM> and be coupled to the handle <NUM>. During sliding or longitudinal movement of the outer sheath <NUM> relative thereto, the inner shaft <NUM> is fixed relative to the handle <NUM>. Although the inner shaft <NUM> is described herein as a single component, this is by way of example and not limitation, and the inner shaft <NUM> may include multiple components such as, but not limited to proximal and distal shafts or other components suitable for the purposes described herein. The inner shaft <NUM> may be formed of materials such as but not limited to polyurethane (e.g. Peliethane@, Elasthane™, Texin®, Tecothane®), polyamide polyether block copolymer (e.g. Pebax®, nylon <NUM>), polyethylene, or other materials suitable for the purposes described herein. The inner shaft <NUM> may be coupled to the handle <NUM> by adhesives, bonding, welding, fusing, mechanical connection, or other coupling methods as appropriate.

The inner shaft <NUM> further includes an inflation lumen <NUM>, as shown in <FIG>. The inflation lumen <NUM> is defined within a wall of the inner shaft <NUM>, as best shown in the cross-sectional view of the inner shaft <NUM> of <FIG>. The inflation lumen <NUM> includes a proximal end <NUM> and a distal end <NUM> in fluid communication with an inflation port <NUM>, as shown in <FIG>. The inflation port <NUM> is in fluid communication with an interior of the pulsatile balloon <NUM>.

The distal tip <NUM> is coupled to the distal end <NUM> of the inner shaft <NUM>. With additional reference to <FIG>, the distal tip <NUM> includes a proximal end <NUM>, a distal end <NUM>, and a lumen <NUM> extending from the proximal end <NUM> to the distal end <NUM> of the distal tip <NUM>. The lumen <NUM> is sized to receive auxiliary components, such as a guidewire. The proximal end <NUM> of the distal tip <NUM> is coupled to the distal end <NUM> of the inner shaft <NUM> such that the lumen <NUM> of the distal tip <NUM> is longitudinally aligned and in fluid communication with the lumen <NUM> of the inner shaft <NUM>. Thus, the inner shaft <NUM> with the distal tip <NUM> coupled thereto form a continuous lumen from the proximal end <NUM> of the inner shaft to the distal end <NUM> of the distal tip. The distal tip <NUM> may be coupled to the inner shaft <NUM> by methods such as, but not limited to adhesives, bonding, welding, fusing, mechanical connection, or other coupling methods as appropriate.

The pulsatile balloon <NUM> is mounted over a distal portion of the inner shaft <NUM>. More particularly, as shown in <FIG>, the pulsatile balloon <NUM> includes a proximal end <NUM> coupled to the inner shaft <NUM> and a distal end <NUM> coupled to the inner shaft <NUM>. The pulsatile balloon <NUM> includes the uninflated or first state wherein the pulsatile balloon <NUM> is not inflated, as shown in <FIG>, which is a side view of a distal portion of the delivery catheter <NUM> with the outer sheath <NUM> proximally retracted. For sake of clarity, the docking member <NUM> of the heart valve prosthesis <NUM> is omitted in <FIG>. Stated another way, the outer sheath <NUM> has been proximally retracted and the docking member <NUM> of the heart valve prosthesis <NUM> has been omitted from the illustration to clearly show the pulsatile balloon <NUM> in the uninflated state. When the docking member <NUM> is not omitted and the outer sheath <NUM> is not retracted for clarity, the docking member <NUM> in the radially collapsed configuration would be disposed about the pulsatile balloon <NUM> in the uninflated state and the pulsatile balloon <NUM> and the docking member <NUM> would be received within the outer sheath <NUM>.

The pulsatile balloon <NUM> further includes the inflated second state, wherein the pulsatile balloon <NUM> is inflated via inflation fluid delivered under pressure through the inflation lumen <NUM> to the interior of the pulsatile balloon <NUM>, as shown in <FIG>. In <FIG>, the outer sheath <NUM> has been proximally retracted, the docking member <NUM> of the heart valve prosthesis <NUM> has been released and radially expanded to the radially expanded state and for ease of illustration, has thus been omitted, and the pulsatile balloon <NUM> is in the inflated second state. The pulsatile balloon <NUM> is configured to transition from the uninflated state to the inflated second state and back in a repetitive cycle synchronized to the cardiac cycle of the heart such that the pulsatile balloon <NUM> temporarily replicates the function of the native mitral valve. "Temporarily" as used herein refers to a component that has use for a limited period of time and is not permanent. "Replicates" as used herein refers to a prosthetic component or structure that is configured to reproduce the operation or functionality of a native component or structure that the prosthetic component or structure is configured to replace. Thus, in embodiments hereof, the pulsatile balloon <NUM> temporarily operates as the native heart valve, preventing, or at least limiting backflow or regurgitation through the native mitral valve until the valve member <NUM> is disposed in the radially expanded configuration within the docking member <NUM> in the radially expanded configuration at the annulus of the native heart valve. In an example, the heart valve prosthesis <NUM> is a mitral heart valve prosthesis <NUM> and the pulsatile balloon <NUM> prevents, or at least partially restricts backflow or regurgitation through the native mitral valve during diastolic phases of the cardiac cycle of the heart, and allows blood flow through the native mitral valve during systolic phases of the cardiac cycle of the heart.

As shown in the embodiment of <FIG>, the pulsatile balloon <NUM> is coaxially disposed under the docking member <NUM>. However, this is not meant to limit the design, and the pulsatile balloon <NUM> may be disposed at other locations of the inner shaft <NUM> including but not limited to positions distal of the docking member <NUM>, proximal of the docking member <NUM> and distal of the valve member <NUM>, proximal of the valve member <NUM>, or any other position suitable for the purposes described herein. Moreover, while the pulsatile balloon <NUM> is shown in <FIG> disposed proximal of the distal tip <NUM>, in another embodiment, the pulsatile balloon <NUM> may be a portion of the distal tip <NUM>.

Even further, in embodiments wherein the docking member <NUM> is balloon expandable, the docking member <NUM> may be mounted on an outer surface of the pulsatile balloon <NUM>, as shown in <FIG>, and the pulsatile balloon <NUM> transitioned from the uninflated state to the inflated second state such that the pulsatile balloon <NUM> expands the docking member <NUM> to the radially expanded configuration. When in the inflated second state, the pulsatile balloon <NUM> may have a generally cylindrical or disc shape, however this is not meant to be limiting, and other shapes of the pulsatile balloon <NUM> in the inflated second state are anticipated. The pulsatile balloon <NUM> may be a standard construction non-compliant or semi-compliant balloon constructed of any suitable material such as, but not limited to polyethylene terephthalate (PET), nylon, or polyurethane. In embodiments wherein the valve member <NUM> is balloon expandable, the valve member <NUM> may be mounted on an outer surface of the pulsatile balloon <NUM> or alternatively may be mounted on an outer surface of a second balloon (not shown).

<FIG> are sectional cut-away views of a heart HE illustrating a method for delivering and positioning the heart valve prosthesis <NUM> using the delivery system <NUM> of <FIG> in accordance with an embodiment hereof. With reference to <FIG>, the delivery system <NUM> is shown after having been introduced into the vasculature via a percutaneous entry point, e.g., the Seldinger technique, and tracked through the vasculature and into the left ventricle LV of the heart HE with the docking member <NUM> in proximity to and/or apposition within an annulus AN of a native mitral valve MV. Intravascular access to the right atrium may be achieved via a percutaneous access site to femoral venous access up to the inferior venal cava, or other known access routes. Thereafter, a guidewire GW is advanced through the circulatory system, eventually arriving at the heart HE. The guidewire GW is directed into the right atrium, traverses the right atrium and is made to puncture, with the aid of a transseptal needle or pre-existing hole, an atrial septum, thereby entering the left atrium LA. Once the guidewire GW is positioned, the endoluminal entry port and the atrial septum are dilated to permit entry of a guide catheter GC into the left atrium LA. Thereafter, the delivery catheter <NUM> is advanced over the guidewire GW and through a delivery shaft of the guide catheter GC into the left atrium LA through the punctured atrial septum and positioned proximate or upstream to the native mitral valve MV. Although described as a transfemoral antegrade approach for percutaneously accessing the mitral valve MV, the heart valve prosthesis <NUM> may be positioned within the desired area of the heart HE via other different methods such as a transseptal antegrade approach via a thoracotomy for accessing the mitral valve MV. In addition, although described with the use of the guide catheter GC and the guidewire GW, in another embodiment hereof the delivery catheter <NUM> may access the left atrium LA without the use of the guidewire GW and/or the guide catheter GC.

The delivery system <NUM> is advanced to the site of the native mitral valve MV until the docking member <NUM> is positioned within the annulus AN of the native mitral valve MV. Referring back to <FIG>, it will be understood that the delivery system <NUM> is assembled with the valve member <NUM> and the docking member <NUM> of the heart valve prosthesis <NUM> each in the radially collapsed configuration disposed about the inner shaft <NUM> at axially spaced apart locations and retained in the radially collapsed configuration by the distal portion <NUM> of the outer sheath <NUM>. Further, the pulsatile balloon <NUM> is in the first or uninflated state about the inner shaft <NUM> and within the distal portion <NUM> of the outer sheath <NUM>.

In a next delivery step, the handle <NUM> (not shown in <FIG>) of the delivery catheter <NUM> is manipulated such that the outer sheath <NUM> of the delivery catheter <NUM> is proximally retracted to release the pulsatile balloon <NUM> and the docking member <NUM> disposed thereon. When released, the docking member <NUM> expands radially outward such that the docking member <NUM> engages and contacts the tissue at the annulus AN of the native mitral valve MV, as illustrated in <FIG>. As the docking member <NUM> radially expands into apposition with the annulus AN of the native mitral valve MV, at least a portion of the docking member <NUM> engages the leaflets LF of the native mitral valve MV. Once the docking member <NUM> is deployed, the leaflets LF of the native mitral valve MV are pinned back by the deployed docking member <NUM> and therefore leaflet function is impaired by the deployed docking member <NUM>.

Referring next to <FIG>, inflation fluid under pressure is cyclically pumped into and out of the inflation lumen <NUM> (not shown in <FIG>) and the inflation port <NUM> (not shown in <FIG>) in synchronization with the systolic and diastolic phases of the cardiac cycle of the heart, such that the pulsatile balloon <NUM> continuously transitions or alternates between the inflated second state (as shown in <FIG>) during systole and the uninflated state (as shown in <FIG>) during diastole. The inflation fluid may be supplied under pressure, for example, and not by way of limitation, by a pulsatile pump (not shown in <FIG>) synchronized with the cardiac cycle of the heart. When the pulsatile balloon <NUM> is in the inflated second state during systole of the heart, the pulsatile balloon <NUM> blocks, or at least partially restricts blood flow through the deployed docking member <NUM>. When the pulsatile balloon <NUM> transitions to the uninflated state during diastole of the heart, blood flow is not blocked or is free to flow through the deployed docking member <NUM>. Thus, the continuous transition or alternation of the pulsatile balloon <NUM> acts as a temporary mitral valve as the valve member <NUM> of the heart valve prosthesis <NUM> is prepared to be positioned and deployed.

When the clinician is ready to position and deploy the valve member <NUM> within the docking member <NUM> at the annulus AN of the native mitral valve MV, the cyclic pressure on the inflation fluid is released and inflation fluid flows out of the pulsatile balloon <NUM>, though the inflation port <NUM> (not shown in <FIG>) and the inflation lumen <NUM> (not shown in <FIG>) such that the pulsatile balloon <NUM> transitions to the uninflated state. The delivery catheter <NUM> is distally advanced to place the valve member <NUM> within the annulus AN of the native mitral valve MV and within the docking member <NUM>, as shown in <FIG>. As the delivery catheter <NUM> is advanced to position the valve member <NUM> within the docking member <NUM>, the pulsatile balloon <NUM> (which is disposed over and coupled to the inner shaft <NUM>) is concurrently advanced out of the docking member <NUM> and into the left ventricle LV of the heart HE.

Referring next to <FIG>, once the valve member <NUM> is positioned within the deployed docking member <NUM>, the handle <NUM> (not shown in <FIG>) of the delivery catheter <NUM> is manipulated such that the outer sheath <NUM> of the delivery catheter <NUM> is proximally retracted to release the valve member <NUM>. When released, the valve member <NUM> expands radially to the radially expanded configuration such that the valve member <NUM> engages and contacts the docking member <NUM> deployed at the annulus AN of the native mitral valve MV.

Following the radial expansion of the valve member <NUM>, the outer sheath <NUM> is advanced distally to encapsulate the pulsatile balloon <NUM> in the uninflated state. Encapsulation of the pulsatile balloon <NUM> by the outer sheath <NUM> assists in atraumatic retraction and removal of the delivery catheter <NUM>.

In the embodiment described above, the separate components of heart valve prosthesis <NUM>, i.e., the docking member <NUM> and the valve member <NUM>, are concurrently delivered by a single delivery catheter, i.e., delivery catheter <NUM>. However, in another embodiment hereof illustrated in <FIG>, the docking member <NUM> and the valve member <NUM> may be separated and sequentially delivered by separate delivery catheters. More particularly, <FIG> illustrate a delivery system <NUM> according to an embodiment hereof in which the temporary valve is an orifice restriction mechanism <NUM> that is configured to at least partially occlude an annulus of a native heart valve such that the orifice restriction mechanism <NUM> temporarily replicates, at least partially replicates, the function of leaflets of the native heart valve to prevent regurgitation. <FIG> is a side view of the delivery system <NUM>. The delivery system <NUM> is configured to deliver and implant the heart valve prosthesis <NUM> described previously herein. The delivery system <NUM> includes an inner shaft assembly <NUM> which is shown in greater detail in <FIG>, a docking sheath assembly <NUM> which is shown in greater detail in <FIG> and is configured to deliver the docking member <NUM>, a valve sheath assembly <NUM> which is shown in greater detail in <FIG> and is configured to deliver the valve member <NUM>, and the heart valve prosthesis <NUM>. More particularly, as will be explained in more detail herein, the docking sheath assembly <NUM> and the valve sheath assembly <NUM> are configured to be exchangeable over the inner shaft assembly <NUM>. Stated another way, each of the docking sheath assembly <NUM> and the valve sheath assembly <NUM> is configured to be coaxially and slidably disposed over an inner shaft <NUM> of the inner shaft assembly <NUM>. The docking sheath assembly <NUM> is initially disposed over the inner shaft <NUM> of the inner shaft assembly <NUM> and utilized to deliver and implant the docking member <NUM> of the heart valve prosthesis <NUM>. After the docking member <NUM> is deployed, the docking sheath assembly <NUM> is removed and the valve sheath assembly <NUM> is then distally advanced over the inner shaft <NUM> of the inner shaft assembly <NUM>. The valve sheath assembly <NUM> is then utilized to deliver and implant the valve member <NUM> of the heart valve prosthesis <NUM>. In <FIG>, the inner shaft assembly <NUM> is shown with the docking sheath assembly <NUM> disposed over the inner shaft <NUM> of the inner shaft assembly <NUM> and the valve sheath assembly <NUM> is shown ready to be exchanged with the docking sheath assembly <NUM>.

Each of the inner shaft assembly <NUM>, the docking sheath assembly <NUM>, and the valve sheath assembly <NUM> will now be described in more detail in turn. More particularly, the inner shaft assembly <NUM> of the delivery system <NUM> will be described in more detail with references to <FIG>. As shown in the exploded view of <FIG>, the inner shaft assembly <NUM> of the delivery system <NUM> includes a handle <NUM>, the inner shaft <NUM>, a distal tip <NUM>, and the orifice restriction mechanism <NUM>. The handle <NUM> provides a surface for convenient handling and grasping by a user. While the handle <NUM> of <FIG> and <FIG> is shown with a cylindrical shape, this is by way of example and not limitation, and other shapes and sizes may be utilized.

The inner shaft <NUM> of the inner shaft assembly <NUM> includes a lumen <NUM> extending from a proximal end <NUM> to a distal end <NUM> of the inner shaft <NUM>, as shown in <FIG>. The lumen <NUM> is sized to receive auxiliary components, such as a guidewire. At least a portion of the inner shaft <NUM> is configured for fixed connection to the handle <NUM>. In an embodiment, the proximal end <NUM> of the inner shaft <NUM> may extend through and be coupled to the handle <NUM>. Although the inner shaft <NUM> is described herein as a single component, this is by way of example and not limitation, and the inner shaft <NUM> may include multiple components such as, but not limited to proximal and distal shafts or other components suitable for the purposes described herein. The inner shaft <NUM> may be formed of materials such as but not limited to polyurethane (e.g. Peliethane@, Elasthane™, Texin®, Tecothane®), polyamide polyether block copolymer (e.g. Pebax®, nylon <NUM>), polyethylene, or other materials suitable for the purposes described herein. The inner shaft <NUM> may be coupled to the handle <NUM> by adhesives, bonding, welding, fusing, mechanical connection, or other coupling methods as appropriate.

The distal tip <NUM> of the inner shaft assembly <NUM> includes a proximal end <NUM>, a distal end <NUM>, and a lumen <NUM> extending from the proximal end <NUM> to the distal end <NUM>. The lumen <NUM> is sized to receive auxiliary components, such as a guidewire. The proximal end <NUM> of the distal tip <NUM> is coupled to the distal end <NUM> of the inner shaft <NUM> such that the lumen <NUM> of the distal tip <NUM> is longitudinally aligned and in fluid communication with the lumen <NUM> of the inner shaft <NUM>. Thus, the inner shaft <NUM> with the distal tip <NUM> coupled thereto forms a continuous lumen from the proximal end <NUM> of the inner shaft <NUM> to the distal end <NUM> of the distal tip <NUM>. The distal tip <NUM> may be coupled to the inner shaft <NUM> by methods such as, but not limited to adhesives, bonding, welding, fusing, mechanical connection, or other coupling methods as appropriate.

The inner shaft <NUM> further includes an inflation lumen <NUM>, as shown in <FIG>. The inflation lumen <NUM> is defined within a wall of the inner shaft <NUM>, as shown in the cross-sectional view of the inner shaft <NUM> of <FIG>. The inflation lumen <NUM> includes a proximal end <NUM> and a distal end <NUM> in fluid communication with an inflation port <NUM>, as best shown in <FIG>. The inflation port <NUM> is in fluid communication with an interior of the orifice restriction mechanism <NUM>. The inner shaft <NUM> extends through the handle <NUM>. The inner shaft <NUM> is fixed relative to the handle <NUM>. The inner shaft <NUM> may be formed of materials such as but not limited to polyurethane (e.g. Peliethane@, Elasthane™, Texin®, Tecothane®), polyamide polyether block copolymer (e.g. Pebax®, nylon <NUM>), polyethylene, or other materials suitable for the purposes described herein. The inner shaft <NUM> may be coupled to the handle <NUM> by adhesives, bonding, welding, fusing, mechanical connection, or other coupling methods as appropriate.

In this embodiment, the orifice restriction mechanism <NUM> is a balloon. The orifice restriction mechanism <NUM> may be a standard construction non-compliant or semi-compliant balloon constructed of any suitable material such as, but not limited to polyethylene terephthalate (PET), nylon, or polyurethane. The orifice restriction mechanism <NUM> includes a proximal end <NUM> coupled to the inner shaft <NUM> and a distal end <NUM> coupled to the inner shaft <NUM>, as shown in <FIG>. The orifice restriction mechanism <NUM> further includes a first or delivery state wherein the orifice restriction mechanism <NUM> is not inflated, as shown in <FIG> and a second or restriction state, wherein the orifice restriction mechanism <NUM> is inflated, as shown in <FIG>. The orifice restriction mechanism <NUM> transitions from the first state to the second state via inflation fluid delivered under pressure through the inflation lumen <NUM> of the inner shaft <NUM> and the inflation port <NUM> to the interior of the orifice restriction mechanism <NUM>. When in the second state, the orifice restriction mechanism <NUM> may have a generally cylindrical or disc shape. A diameter of the orifice restriction mechanism <NUM> in the second state is less than a diameter of a native heart valve within which it is disposed, as described in greater detail below, such that the orifice restriction mechanism <NUM> will not prevent blood flow though the native heart valve when disposed therein, but rather only restrict the blood flow to minimize regurgitation. In another embodiment hereof, a diameter of the orifice restriction mechanism <NUM> in the second state is configured to prevent blood flow though the deployed docking member <NUM> when disposed therein. While described as a cylinder or disc, the orifice restriction mechanism <NUM> may have other shapes, such as, but not limited to an oval or other shape suitable for the purposes described herein.

In the embodiment of <FIG>, the orifice restriction mechanism <NUM> is disposed distal of the docking member <NUM>. However, this is not meant to limit the design, and the orifice restriction mechanism <NUM> may be disposed at other locations of the inner shaft <NUM> including but not limited to positions proximal of the docking member <NUM>, coaxially disposed under the docking member <NUM>, or any other position suitable for the purposes described herein. Moreover, while the orifice restriction mechanism <NUM> is shown in <FIG> disposed proximal of the distal tip <NUM>, in another embodiment, the orifice restriction mechanism <NUM> may be a portion of the distal tip <NUM>.

Although the inner shaft assembly <NUM> is illustrated above with the orifice restriction mechanism <NUM> as a balloon, the orifice restriction mechanism may be a different structure configured to restrict the blood flow to minimize regurgitation. For example, in another embodiment shown in <FIG>, an orifice restriction mechanism <NUM> is a plurality of flaps or petals <NUM> disposed about an outer surface of the inner shaft <NUM>. Each flap <NUM> includes a first end <NUM> and a second end <NUM>. The plurality of flaps <NUM> are spaced radially about a distal portion of the inner shaft <NUM> with the first end <NUM> of each flap <NUM> pivotably coupled, attached or secured to the inner shaft <NUM> and the second end <NUM> of each flap <NUM> free, uncoupled, or unattached relative to the inner shaft <NUM>. Each flap <NUM> may be of a petal shape, as shown in <FIG>. Alternatively, each flap <NUM> may be of any shape suitable for the purposes described herein. While shown with two flaps <NUM>, this is not meant to limit the design, and more or fewer flaps <NUM> may be utilized. In embodiments with a greater number of flaps <NUM>, the plurality of flaps <NUM> may be disposed about the inner shaft <NUM> such that each flap <NUM> overlaps or coapts with an adjacent flap <NUM>. Each flap <NUM> of the orifice restriction mechanism <NUM> may be formed of materials such as, but not limited to fabrics, meshes, polyethylene terephthalate (PET), nylon, silicone, or polyurethane. The first end <NUM> of each flap <NUM> may be coupled to the inner shaft <NUM> by methods such as, but not limited to adhesives, welding, fusing, mechanical connection, or other coupling methods as appropriate.

The orifice restriction mechanism <NUM> includes a first or delivery state in which each flap <NUM> is disposed with the second end <NUM> disposed distal of the first end <NUM> and adjacent the inner shaft <NUM>, as shown in <FIG>. With the orifice restriction mechanism <NUM> in the first state, the orifice restriction mechanism <NUM> may be retained within the inner sheath <NUM> of the docking sheath assembly <NUM> for delivery to a desired treatment site. The orifice restriction mechanism <NUM> further includes a second or restriction state. When in the second state, each flap <NUM> is proximally pivoted about the first end <NUM>, to position a first central longitudinal axis LA1 of each flap <NUM> generally traverse to a second central longitudinal axis LA2 of the inner shaft <NUM>, as shown in <FIG>. When disposed within an annulus of a native heart valve, each flap <NUM> is pivotable between the first state and the second state by blood flow such that backflow, or regurgitation is minimized. In an example, when the orifice restriction mechanism <NUM> is disposed in an annulus of a native mitral heart valve, the plurality of flaps <NUM> pivot to the second state during systole and to the first state during diastole of the heart. The length of each flap <NUM>, defined as the distance from the first end <NUM> to the second end <NUM>, may vary according to application such that a diameter of the orifice restriction mechanism <NUM> in the second state is less than a diameter of a native heart valve into which it will be disposed and temporarily operate.

In another embodiment shown in <FIG>, an orifice restriction mechanism <NUM> is a radially expandable tubular or tube-like member <NUM> having a first end <NUM> coupled, attached or secured to a distal end portion of a first inner shaft <NUM> and a second end <NUM> coupled, attached or secured to a distal end portion of a second inner shaft <NUM>, wherein the second inner shaft <NUM> is slidably received within a lumen <NUM> of the first inner shaft <NUM>. The orifice restriction member <NUM> may be radially expandable and radially collapsible by telescopic movement in and out of the second inner shaft <NUM> relative to the first inner shaft <NUM>. The orifice restriction member <NUM> may include one or more spines or ribs spaced radially about a portion of the member <NUM>. The orifice restriction member <NUM> may be formed of materials such as, but not limited to fabrics, meshes, metals, polymers, polyethylene terephthalate (PET), nylon, silicone, or polyurethane. The first end <NUM> of member <NUM> may be coupled to the first inner shaft <NUM> by methods such as, but not limited to adhesives, welding, fusing, mechanical connection, or other coupling methods as appropriate. The second end <NUM> of member <NUM> may be coupled to the second inner shaft <NUM> by methods such as, but not limited to adhesives, welding, fusing, mechanical connection, or other coupling methods as appropriate.

The orifice restriction mechanism <NUM> includes a first or delivery state in which member <NUM> is elongated axially, as shown in <FIG>. With the orifice restriction mechanism <NUM> in the first state, the orifice restriction mechanism <NUM> may be retained within the inner sheath <NUM> of the docking sheath assembly <NUM> for delivery to a desired treatment site. The orifice restriction mechanism <NUM> further includes a second or restriction state. When in the second state, member <NUM> is expanded radially, as shown in <FIG> by proximal movement of the second inner shaft <NUM> relative to the first inner shaft <NUM>. When disposed within an annulus of a native heart valve, member <NUM> is changeable between the first state and the second state by movement of the second inner shaft <NUM> relative to the first inner shaft <NUM> such that backflow of blood, or regurgitation is minimized. In an example, when the orifice restriction mechanism <NUM> is disposed in an annulus of a native mitral heart valve, member <NUM> is switched from the second state during systole to the first state during diastole of the heart. The length of member <NUM>, defined as the distance from the first end <NUM> to the second end <NUM>, may vary according to application such that a diameter of the orifice restriction mechanism <NUM> in the second state is less than a diameter of a native heart valve into which it will be disposed and temporarily operate.

The docking sheath assembly <NUM> of the delivery system <NUM> will now be described in more detail with reference to the exploded view of <FIG>. More particularly, the docking sheath assembly <NUM> includes a handle <NUM>, an outer sheath <NUM> and an inner sheath <NUM>. As previously stated, the docking sheath assembly <NUM> is configured to be coaxially and slidably disposed over the inner shaft <NUM> of the inner shaft assembly <NUM> of <FIG> and is further configured to deliver and implant the docking member <NUM> of the heart valve prosthesis <NUM>.

As shown in <FIG>, the handle <NUM> includes a housing <NUM> and an actuation mechanism <NUM> for interfacing by a user. The handle <NUM> provides a surface for convenient handling and grasping by a user, and while the handle <NUM> of <FIG> is shown with a cylindrical shape, this is by way of example and not limitation, and other shapes and sizes may be used based on the application requirements. Further, while the handle <NUM> is shown with a specific style of actuation mechanisms <NUM>, this is also by way of example and not limitation, and various actuation mechanisms may be utilized including, but not limited to an axially-slidable lever, a rotary rack and pinion gear, or other applicable actuation mechanisms.

Also shown in <FIG>, the outer sheath <NUM> includes a proximal end <NUM>, a distal end <NUM>, and a lumen <NUM> extending from the proximal end <NUM> to the distal end <NUM> of the outer sheath <NUM>. The lumen <NUM> is sized to receive the inner sheath <NUM>. A distal portion <NUM> of the outer sheath <NUM> is configured to retain the docking member <NUM> of the heart valve prosthesis <NUM> in the radially collapsed configuration for delivery to the desired treatment location. While the distal portion <NUM> is described herein as a distal portion of the outer sheath <NUM>, in an embodiment, the distal portion <NUM> may be a separate component, such as a capsule, coupled to the distal end <NUM> of the outer sheath <NUM>. Moreover, although the outer sheath <NUM> is described herein as a single component, this is by way of example and not limitation, and the outer sheath <NUM> may include multiple components such as, but not limited to proximal and distal shafts, or other components suitable for the purposes described herein. The proximal end <NUM> of the outer sheath <NUM> is configured for fixed connection to the handle <NUM>. In an embodiment, the proximal end <NUM> of the outer sheath <NUM> may extend proximally into the housing <NUM> of the handle <NUM> and a proximal portion <NUM> of the outer sheath <NUM> may be operably coupled to the actuation mechanism <NUM> of the handle <NUM>. The proximal portion <NUM> is operably coupled to the actuation mechanism <NUM> such that movement of the actuation mechanism <NUM> causes the outer sheath <NUM> and the distal portion/distal portion <NUM> to move relative to the inner sheath <NUM> and the handle <NUM>. However, if the actuation mechanism <NUM> is not moved and the handle <NUM> is moved, the outer sheath <NUM> moves with the handle <NUM>, not relative to the handle <NUM>. The outer sheath <NUM> may be constructed of materials such as, but not limited to polyurethane, polyether block amide (PEBA), polyamide, polyether block copolymer, polyethylene, or other materials suitable for the purposes of the present disclosure. The proximal portion <NUM> of the outer sheath <NUM> may be coupled to the actuation mechanism <NUM>, for example, and not by way of limitation by adhesives, welding, clamping, linkages or other coupling methods as appropriate.

As further shown in <FIG>, the inner sheath <NUM> of the docking sheath assembly <NUM> extends within the outer sheath <NUM> and includes a proximal end <NUM>, a distal end <NUM>, and the lumen <NUM> extending from the proximal end <NUM> to the distal end <NUM> of the inner sheath <NUM>. The lumen <NUM> is sized to receive the inner shaft assembly <NUM>. A distal portion of the inner sheath <NUM> is configured to cover or encapsulate the orifice restriction mechanism <NUM> in the first state for delivery to the desired treatment location. The proximal end <NUM> of the inner sheath <NUM> is configured for fixed connection to the handle <NUM>. In an embodiment, the proximal end <NUM> of the inner sheath <NUM> may extend through the housing <NUM> and be coupled to the handle <NUM>. During sliding or longitudinal movement of the outer sheath <NUM> relative thereto, the inner sheath <NUM> is fixed relative to the handle <NUM>. Although the inner sheath <NUM> is described herein as a single component, this is by way of example and not limitation, and the inner sheath <NUM> may include multiple components such as, but not limited to proximal and distal shafts, or other components suitable for the purposes described herein. The inner sheath <NUM> may be formed of materials such as but not limited to polyurethane (e.g. Peliethane@, Elasthane™, Texin®, Tecothane®), polyamide polyether block copolymer (e.g. Pebax®, nylon <NUM>), polyethylene, or other materials suitable for the purposes described herein. The inner sheath <NUM> may be coupled to the handle <NUM> by adhesives, bonding, welding, fusing, mechanical connection, or other coupling methods as appropriate.

The outer sheath <NUM> may further include a slot <NUM> disposed through a wall of the outer sheath <NUM>, the slot <NUM> extending distally from the proximal end <NUM> of the outer sheath <NUM> over a proximal portion thereof. The inner sheath <NUM> may further include a slot <NUM> disposed through a wall of the inner sheath <NUM>. The slot <NUM> extends from the proximal end <NUM> of the inner sheath <NUM> extending distally over a proximal portion thereof. Each of the slots <NUM> and <NUM> is configured to provide access to the inflation lumen <NUM> of the inner shaft <NUM> when the inner shaft <NUM> is received within the lumen <NUM> of the inner sheath <NUM> of the docking sheath assembly <NUM>. Slots <NUM>, <NUM> are longitudinally and circumferentially aligned in order to provide access to the inflation lumen <NUM> of the inner shaft <NUM> for connection to a source of inflation. In other embodiments, other mechanisms may be provided in order to provide access to the inflation lumen <NUM> of the inner shaft <NUM> for connection to a source of inflation.

The valve sheath assembly <NUM> of the delivery system <NUM> will now be described in more detail with reference to the exploded view of <FIG>. More particularly, the valve sheath assembly <NUM> is similar to the docking sheath assembly <NUM> except that the valve sheath assembly <NUM> is configured to deliver and implant the valve member <NUM> of the heart valve prosthesis <NUM> rather than the docking member <NUM> of heart valve prosthesis <NUM>. The valve sheath assembly <NUM> includes a handle <NUM>, an outer sheath <NUM> and an inner sheath <NUM> which are similar to the handle <NUM>, the outer sheath <NUM>, and the inner sheath <NUM>, respectively, of the docking sheath assembly <NUM>. Therefore, details of their construction and alternatives will not be repeated. The outer sheath <NUM> of the valve sheath assembly <NUM> includes a proximal end <NUM>, a distal end <NUM>, and a lumen <NUM> extending from the proximal end <NUM> to the distal end 377of the outer sheath <NUM>. A distal portion <NUM> of the outer sheath <NUM> is configured to retain the valve member <NUM> of the heart valve prosthesis <NUM> in the radially collapsed configuration for delivery to the desired treatment location. The inner sheath <NUM> of the valve sheath assembly <NUM> includes a proximal end <NUM>, a distal end <NUM>, and a lumen <NUM> extending from the proximal end <NUM> to the distal end <NUM> of the inner sheath <NUM>. The lumen <NUM> of the inner sheath <NUM> is sized to receive the inner shaft <NUM> of the inner shaft assembly <NUM>. The valve sheath assembly <NUM> may further include a slot <NUM> through a wall of the outer sheath <NUM> and a slot <NUM> through a wall in the inner sheath <NUM>, which are similar to the slots <NUM> and <NUM> of the docking sheath assembly <NUM>, described previously. Each of the slots <NUM> and <NUM> is configured to provide access to the inflation lumen <NUM> of the inner shaft <NUM> when the inner shaft <NUM> is received within the lumen <NUM> of the inner sheath <NUM> of the valve sheath assembly <NUM>. Slots <NUM>, <NUM> are longitudinally and circumferentially aligned in order to provide access to the inflation lumen <NUM> of the inner shaft <NUM> for connection to a source of inflation.

<FIG> are sectional cut-away views of a heart HE illustrating a method for delivering and positioning the heart valve prosthesis <NUM> using the delivery system <NUM> of <FIG> in accordance with an embodiment hereof. With reference to <FIG>, the delivery system <NUM> is shown after having been introduced via the Seldinger technique or other suitable percutaneous entry technique into the vasculature. Intravascular access may be achieved as described previously with the method of <FIG>.

In <FIG>, the delivery system <NUM> has been tracked through the vasculature and into the left ventricle LV of the heart HE. As previously described herein, the delivery system <NUM> is initially assembled with the docking sheath assembly <NUM> coaxially disposed over the inner shaft <NUM> of the inner shaft assembly <NUM>. The docking member <NUM> is in the radially collapsed configuration disposed about the inner sheath <NUM> of the docking sheath assembly <NUM> and retained in the radially collapsed configuration by the distal portion <NUM> of the outer sheath <NUM> of the docking sheath assembly <NUM>. The orifice restriction mechanism <NUM> is in the first state about the inner shaft <NUM> of the inner shaft assembly <NUM> and retained within a distal portion of the lumen <NUM> of the inner sheath <NUM> of the docking sheath assembly <NUM>. With reference to <FIG>, the orifice restriction mechanism <NUM> has been positioned in the left ventricle LV adjacent the annulus AN of the native mitral valve MV and the docking sheath assembly <NUM> has been proximally retracted such that the inner sheath <NUM> (obscured from <FIG> by the outer sheath <NUM>) of the docking sheath assembly <NUM> uncovers the orifice restriction mechanism <NUM> which is in the first state. The docking sheath assembly <NUM> has been proximally retracted until the docking member <NUM> is positioned within the annulus AN of the native mitral valve MV.

With reference now to <FIG>, the handle <NUM> (not shown in <FIG>) of the docking sheath assembly <NUM> is then manipulated to retract the outer sheath <NUM> of the docking sheath assembly <NUM>, thereby releasing the docking member <NUM> from the distal portion <NUM> of the outer sheath <NUM>. When released from the distal portion <NUM>, the docking member <NUM> expands radially outward such that the docking member <NUM> engages tissue at the annulus AN of the native mitral valve MV. As the docking member <NUM> radially expands into apposition with the annulus of the native mitral valve, at least a portion of the docking member <NUM> engages the leaflets LF of the native mitral valve MV. Once the docking member <NUM> is deployed, the leaflets LF of the native mitral valve MV are pinned back by the deployed docking member <NUM> and therefore leaflet function is impaired by the deployed docking member <NUM>.

As illustrated next in <FIG>, with the docking member <NUM> radially expanded within the annulus AN of the native mitral valve MV, the delivery system <NUM>, including the inner shaft assembly <NUM> and the docking sheath assembly <NUM>, is proximally retracted to position the orifice restriction mechanism <NUM> in the first state within the docking member <NUM>. In other embodiments, only the inner shaft assembly <NUM> may be proximally retracted to position the orifice restriction mechanism <NUM> in the first state within the docking member <NUM>.

Once the orifice restriction mechanism <NUM> is positioned within the deployed docking member <NUM>, inflation fluid under pressure is pumped into the inflation lumen <NUM> (not shown in <FIG>) and the inflation port <NUM> (not shown in <FIG>) to transition the orifice restriction mechanism <NUM> from the first state to the second state within the docking member <NUM>, as shown in <FIG>. When the orifice restriction mechanism <NUM> transitions to the second state, blood flow is at least partially restricted through the native mitral valve MV. More specifically, the orifice restriction mechanism <NUM> temporarily replicates, or at least partially replicates, the function of leaflets LF of the native mitral valve MV to prevent regurgitation as the valve member <NUM> of the heart valve prosthesis <NUM> is prepared to be positioned and deployed.

With the orifice restriction mechanism <NUM> in the second state within the deployed docking member <NUM>, the inner shaft assembly <NUM> remains stationary and is not moved while the docking sheath assembly <NUM> is proximally retracted, removed, and exchanged with the valve sheath assembly <NUM>. More specifically, the docking sheath assembly <NUM> is proximally retracted and removed, the valve sheath assembly <NUM> is then positioned to be coaxially disposed over the inner shaft assembly <NUM>, and the valve sheath assembly <NUM> is then advanced distally over the inner shaft assembly <NUM> to position the valve member <NUM> within the left atrium LA proximate the native mitral valve MV as shown in <FIG>.

Referencing <FIG>, when the clinician is ready to position and deploy the valve component <NUM> within the docking member <NUM> at the annulus AN of the native mitral valve MV, the delivery system <NUM>, including the inner shaft assembly <NUM> and the valve sheath assembly <NUM>, is distally advanced to place the valve member <NUM> within the deployed docking member <NUM>. As the delivery system <NUM> is advanced, the orifice restriction mechanism <NUM> is distally advanced out of the annulus AN of the native mitral valve MV and into the left ventricle LV.

In a next step, with the valve member <NUM> is positioned within the docking member <NUM>, the handle <NUM> (not shown in <FIG>) of the valve sheath assembly <NUM> is manipulated to proximally retract the outer sheath <NUM> of the valve sheath assembly <NUM> to releasing the valve member <NUM> from the capsule <NUM> of the outer sheath <NUM>. When released from the capsule <NUM>, the valve member <NUM> expands radially to the radially expanded configuration such that the valve member <NUM> engages the deployed docking member <NUM>, as shown in <FIG>.

Following the successful positioning of the heart valve prosthesis <NUM>, inflation fluid pressure is released and the orifice restriction mechanism <NUM> transitions from the second state to the first state. With the orifice restriction mechanism <NUM> in the first state, the valve sheath assembly <NUM> is distally advanced to receive the orifice restriction mechanism <NUM> in the first state within the lumen <NUM> of the inner sheath <NUM> of the valve sheath assembly <NUM>. Thus, the inner sheath <NUM> of the valve sheath assembly <NUM> covers or encapsulates the orifice restriction mechanism <NUM> in the first state. Encapsulation of the orifice restriction mechanism <NUM> by the valve sheath assembly <NUM> assists in the atraumatic retraction and removal of the valve sheath assembly <NUM> and the inner shaft assembly <NUM> of the delivery system <NUM>.

While the method of <FIG> is described with the orifice restriction mechanism of <FIG> and the method of <FIG> is described with the orifice restriction mechanism of <FIG>, it will be understood by one of ordinary skill in the art that other embodiments of the orifice restriction mechanism may be utilized with a similar method, including, but not limited to the orifice restriction mechanism <NUM> of <FIG> or the orifice restriction mechanism <NUM> of <FIG>. In addition, although the methods of <FIG> and <FIG> each utilize the heart valve prosthesis <NUM> of <FIG>, it will be understood by one of ordinary skill in the art that other embodiments of heart valve prostheses may be utilized with a similar method and that similar methods may be used at other locations.

Claim 1:
A delivery system (<NUM>, <NUM>) for percutaneously delivering a heart valve prosthesis to a site of a native heart valve, the delivery system comprising:
a delivery catheter (<NUM>, <NUM>) including:
an outer sheath (<NUM>, <NUM>);
an inner shaft (<NUM>, <NUM>) slidably disposed within the outer sheath; and
an orifice restriction mechanism (<NUM>, <NUM>) coupled to a distal portion of the inner shaft, wherein the orifice restriction mechanism has a first state and an inflated second state; and
a heart valve prosthesis (<NUM>) including a valve member (<NUM>) having a radially collapsed configuration and a radially expanded configuration, and a docking member (<NUM>) having a radially collapsed configuration and a radially expanded configuration,
wherein the orifice restriction mechanism (<NUM>, <NUM>) is configured to be positioned within the docking member of the heart valve prosthesis after the docking member is in the radially expanded configuration within an annulus of the native heart valve, and wherein the orifice restriction mechanism is configured to temporarily replicate the operation of the native heart valve until the valve member is positioned within the docking member.