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 atria and right ventricle which supplies the pulmonary circulation, and the left atria and left ventricle which supplies oxygenated blood received from the lungs to the remaining body. To ensure that blood flows in one direction through the heart, atrioventricular valves (tricuspid and mitral valves) are present between the junctions of the atria and the ventricles, and semi-lunar valves (pulmonary valve and aortic valve) govern the exits of the ventricles leading to the lungs and the rest of the body. 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 and may cause the heart to work harder to pump the blood through the diseased valve. Valvular insufficiency or regurgitation occurs when the valve does not close completely, 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 valve prostheses can be percutaneously delivered while in a low-profile or radially compressed configuration so that the valve prosthesis can be advanced through the patient's vasculature and deployed at the site of the diseased heart valve through catheter-based systems. Once positioned at the treatment site, the valve prosthesis can be expanded to engage tissue at the diseased heart valve region to, for instance, hold the valve prosthesis in position. <CIT> discloses sealable and repositionable implant devices with in situ accommodation to the local anatomy of the targeted recipient anatomic site, and/or with the ability for post-deployment adjustment to accommodate anatomic changes that might compromise the efficacy of the implant.

However, in some patients, the valve prosthesis may not perform as desired following implantation. For example, the valve prosthesis may not fully seal with the native anatomy at an implantation site of the native valve, resulting in paravalvular leakage (PVL), which can be a serious post-surgical complication.

Accordingly, there is a need for systems and components to minimize the crossing profile of a delivery catheter and provide sealing of a valve prosthesis with the native anatomy.

The invention is a transcatheter prosthesis as defined in claim <NUM>.

Embodiments hereof are directed to a transcatheter prosthesis with a radially compressed configuration for delivery within a vasculature and a radially expanded configuration for deployment within a native anatomy. The transcatheter prosthesis includes a frame, a fixation member and a resilient elongate member. The fixation member encircles at least a portion of the frame. The fixation member is coupled to the frame and is configured to extend outwardly from the frame. The resilient elongate member is slidably disposed within the fixation member. The resilient elongate member has a radially contracted state when in tension and a radially expanded state when relaxed. The resilient elongate member in the radially contracted state is configured to hold the prosthesis in the radially compressed configuration. At least the resilient elongate member in the radially expanded state provides a seal between the prosthesis and the native anatomy when the prosthesis is in the radially expanded configuration.

Embodiments hereof are also directed to a method of deploying and sealing a prosthesis within a native anatomy. A prosthesis with a fixation member and a resilient elongate member is loaded onto a delivery catheter. The resilient elongate member is configured to hold the prosthesis in a radially compressed configuration. The prosthesis, in the radially compressed configuration, is positioned within the native anatomy. The resilient elongate member is released to permit the prosthesis to return to a radially expanded configuration and to permit the resilient elongate member to return to a radially expanded state. The resilient elongate member in the radially expanded state seals and prevents blood flow between the prosthesis and the native anatomy.

The foregoing and other features and advantages of the invention will be apparent from the following description of embodiments thereof as illustrated in the accompanying drawings.

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" are used in the following description with respect to a position or direction relative to the treating clinician. "Distal" or "distally" are a position distant from or in a direction away from the clinician. "Proximal" and "proximally" are a position near or in a direction toward the clinician.

Although the description of embodiments hereof are in the context of treatment of heart valves, such as the aortic or mitral valve, and aortic aneurysms, such as with a stent-graft, the invention may also be used in any other valve locations and body passageways where it is deemed useful.

In an embodiment in accordance herewith shown in <FIG>, a transcatheter prosthesis <NUM> (hereafter referred to as prosthesis <NUM>) includes a frame <NUM>, an outer layer component <NUM> encircling at least a portion of the frame <NUM>, and a sealing component 2042figured to provide a seal between the prosthesis <NUM> and the native anatomy. The prosthesis <NUM> may be manipulated into a radially compressed configuration for delivery, as shown in <FIG>, and thereafter may return to a radially expanded configuration, as shown in <FIG>, when deployed at a desired treatment location. The sealing component <NUM> includes a fixation member <NUM> and an elongate member <NUM>, which is more clearly shown in <FIG>. In some embodiments, the sealing component <NUM> also acts as a cinching component, e.g. the cinching and sealing component <NUM> is configured to hold the prosthesis <NUM> in the radially compressed configuration for delivery to the desired treatment location and is further configured to provide a seal between the prosthesis <NUM> and the native anatomy. In some embodiments, the elongate member <NUM> is a resilient elongate member <NUM>. In some embodiments, when the resilient elongate member <NUM> is in a radially contracted state, the resilient elongate member <NUM> of the cinching and sealing component <NUM> is configured to hold the prosthesis <NUM> in the radially compressed configuration for delivery to the desired treatment location. In some embodiments, when the resilient elongate member <NUM> is in a radially expanded state, which permits the prosthesis <NUM> to return to the radially expanded configuration, the cinching and sealing component <NUM> is further configured to provide a seal between the prosthesis <NUM> and the native anatomy.

As referred to herein, the prosthesis <NUM> may assume a wide variety of configurations. The prosthesis <NUM> may include a bioprosthetic heart valve having tissue leaflets or a synthetic heart valve having polymeric, metallic or tissue-engineered leaflets, and can be specifically configured for replacing valves of the human heart. The prosthesis <NUM> of the present disclosure may be self-expandable, balloon expandable and/or mechanically expandable or combinations thereof. In general terms, the prosthesis <NUM> of the present disclosure may include a stent or stent frame having an internal lumen maintaining a valve structure (tissue or synthetic), with the stent frame having a normal, expanded condition or arrangement and collapsible to a compressed condition or arrangement for loading within the delivery device. For example, the stents or stent frames are support structures that comprise a number of struts or wire segments arranged relative to each other to provide a desired compressibility and strength to the prosthesis <NUM>. The struts or wire segments are arranged such that they are capable of self-transitioning from, or being forced from, a compressed or collapsed arrangement to a normal, radially expanded arrangement. The struts or wire segments can be formed from a shape memory material, such as a nickel titanium alloy (e.g., Nitinol™). The stent frame can be laser-cut from a single piece of material, or can be assembled from a number of discrete components.

If provided, a valve structure of the prosthesis <NUM> can assume a variety of forms, and can be formed, for example, from one or more biocompatible synthetic materials, synthetic polymers, autograft tissue, homograft tissue, xenograft tissue, or one or more other suitable materials. In some embodiments, the valve structure can be formed, for example, from bovine, porcine, equine, ovine and/or other suitable animal tissues. In some embodiments, the valve structure is formed, for example, from heart valve tissue, pericardium, and/or other suitable tissue. In some embodiments, the valve structure can include or form one or more leaflets <NUM>. For example, the valve structure can be in the form of a tri-leaflet bovine pericardium valve, a bi-leaflet valve, or another suitable valve.

In various embodiments hereof, the frame <NUM> is self-expanding to return to a radially expanded configuration from a radially compressed configuration. The frame <NUM> may include an inflow section <NUM> and an outflow section <NUM>, as shown in <FIG>. The frame <NUM> further may be described as having a stent-like support structure comprised of a plurality of cells <NUM> formed by a plurality of struts <NUM>. Depending on the intended application of the prosthesis <NUM>, the plurality of cells <NUM> may have sizes that vary along the length of the frame <NUM>, or may have the same size and shape along the length of the frame <NUM>. The frame <NUM> may be formed of any suitable biocompatible material in which a mechanical or shape memory may be imparted including, but not limited to stainless steel, nickel-titanium alloys (e.g. NITINOL), and certain polymeric materials. "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 that forms the frame <NUM> using techniques understood in the art.

As also shown in <FIG> and <FIG>, the outer layer <NUM> of the prosthesis <NUM> may be a flexible and/or non-permeable sheet of material that is attached to the frame <NUM> to encircle at least a portion of an outer surface thereof. In some embodiments, the outer layer <NUM> may be a sealing skirt of a heart valve prosthesis. The outer layer <NUM> may be constructed of one or more suitable biocompatible materials, non-limiting examples of which include synthetic materials, synthetic polymers, polyester, nylon, expanded polytetrafluoroethylene (ePTFE), natural tissue (e.g. porcine, equine, or bovine pericardium), autograft tissue, homograft tissue, xenograft tissue, or other materials suitable for the purposes described herein. A heart valve prosthesis may comprise two or three leaflets that are fastened together at enlarged lateral end regions to form commissural joints, with the unattached edges forming coaptation edges of the valve structure. The leaflets may be fastened to the outer layer <NUM> that in turn is attached or coupled to the frame <NUM>. The outer layer <NUM> may be coupled to the frame <NUM> by methods such as, but not limited to fusing, welding, gluing, or sewing. Although the embodiment of <FIG> and <FIG> show the outer layer <NUM> extending about an entire circumference of the frame <NUM>, and generally extending from a first end <NUM> to a second end <NUM> of the frame <NUM>, in other embodiments the outer layer <NUM> may extend about only a portion of the circumference and/or a greater or lesser length of the frame <NUM>, such as extending over only the inflow section <NUM> or outflow section <NUM>, or portions thereof. In some embodiments, prosthesis <NUM> may not comprise an outer layer <NUM>.

In some embodiments, as shown in <FIG> and <FIG>, the fixation member <NUM> is a curved projection, or fold, either formed in the outer layer <NUM> or attached or coupled to the outer layer <NUM> and/or the frame <NUM> that extends outwardly from an outer surface of the frame <NUM>. In an embodiment, the fixation member <NUM> may be configured to encircle at least a portion of the outer surface of the frame <NUM>. The fixation member <NUM>, as best shown in <FIG> and <FIG>, may be described as defining a channel <NUM> that is sized to slidably receive the resilient elongate member <NUM> therein. In an embodiment, as shown in <FIG>, <FIG>, <FIG> and <FIG>, the fixation member <NUM>, i.e., the curved projection, or fold, formed in the outer layer <NUM> or attached or coupled to the outer layer <NUM> and/or the frame <NUM>, may define a continuous channel <NUM> having a helical path around the outer surface of the frame <NUM> such that the corresponding resilient elongate member <NUM> received therein forms a generally helical path about the outer surface of the frame <NUM>. In another embodiment, the fixation member <NUM>, i.e., the curved projection, or fold, formed in the outer layer <NUM> or attached or coupled to the outer layer <NUM> and/or the frame <NUM>, may define a continuous or non-continuous channel <NUM> having a circular path around the outer surface of the frame <NUM> such that the corresponding resilient elongate member <NUM> received therein forms a generally circular path about the outer surface of the frame <NUM>.

The elongate member <NUM> is threaded or routed though the channel <NUM> of the fixation member <NUM> to encircle the frame <NUM> of the prosthesis <NUM>, and has ends that are secured to each other to form a loop, as shown in <FIG>. In one embodiment, the elongate member <NUM> is a resilient elongate member <NUM> which includes a radially contracted state when the resilient elongate member <NUM> is in tension, as shown in <FIG>, and a radially expanded configuration when relaxed, as shown in <FIG>, <FIG> and <FIG>. When in tension in the radially contracted state, the resilient elongate member <NUM> has a contracted outer diameter ODc, and axially elongates, as shown in <FIG>, to extend from an opening in or access port <NUM> of the fixation member <NUM>, and thereby to extend from the prosthesis <NUM>. In the radially contracted state, the resilient elongate member <NUM> may be tightened around the frame <NUM> to compress the frame into a radially compressed configuration and is configured to hold the prosthesis <NUM> in the radially compressed configuration for delivery to the desired treatment location. When the resilient elongate member <NUM> is relaxed, the resilient elongate member transitions to the radially expanded state to have an expanded outer diameter ODE, and axially shortens, as shown in <FIG>, to extend only within the fixation member <NUM>. In the radially expanded state, or relaxed state, the resilient elongate member <NUM> is configured to both controllably release the frame <NUM> of the prosthesis <NUM> from the radially compressed configuration to the radially expanded configuration, and to substantially fill the channel <NUM> of the fixation member <NUM>. The resilient elongate member <NUM> in the relaxed, radially expanded state thereby outwardly extends, pushes, or supports the fixation member <NUM>, as shown in <FIG>, such that the cinching and sealing component <NUM>, including the fixation member <NUM> with the resilient elongate member <NUM> disposed therein, provides a seal between the prosthesis <NUM> and the native anatomy when the prosthesis <NUM> is in the radially expanded configuration. Thus, in at least one embodiment, the resilient elongate member <NUM> of the cinching and sealing component <NUM> serves a dual purpose to both hold the prosthesis <NUM> in the radially compressed configuration for delivery to the desired treatment location and to seal and help prevent leakage between the prosthesis <NUM> and the native anatomy when the prosthesis <NUM> is deployed at the desired treatment location.

In an embodiment, a first end, portion or segment of the loop of the resilient elongate member <NUM> is coupled to the frame <NUM> or outer layer <NUM> such that tension may be applied on the resilient elongate member <NUM> to transition the resilient elongate member <NUM> from the radially expanded state to radially contracted state. The first end, portion or segment of the loop of the resilient elongate member <NUM> may be coupled to the frame <NUM> or outer layer <NUM> by methods including, but not limited to tying, fusing, welding, sutures, gluing, fastening, or other suitable methods.

The elongate member <NUM> may be formed of one or more biocompatible materials such as, but not limited to, metals, e.g. stainless steel, nickel-titanium alloys (e.g. NITINOL), polymers, e.g. nylon, polybutester, polypropylene, silk, polyester, or other materials suitable for the purposes described herein. The resilient elongate member <NUM> may be formed of one or more elastic and/or shape memory materials. The elongate member <NUM> may comprise one or more sutures, cords, wires, fibers, or filaments. In an embodiment hereof, the resilient elongate member <NUM> may be a fibrous multifilar-bunched member that when relaxed/released will axially shorten and radially expand to the radially expanded state having an expanded outer dimeter ODE. Conversely, when under tension, the resilient elongate member <NUM> will axially lengthen but radially contract to the radially contracted state to have a contracted outer diameter ODC. In an embodiment, as shown in <FIG>, the resilient elongate member <NUM> may be a loose spinning of multiple individual shape memory fibers with a first thickness or expanded outer dimeter ODE. When tensioned, as shown in <FIG>, the individual fibers of the fibrous multifilar-bunched resilient elongate member <NUM> are configured to substantially axially align, contracting or pulling towards a central longitudinal axis LA1 of the resilient elongate member <NUM> to radially contract the member to a second thickness or a contracted outer diameter ODC.

In another embodiment shown in <FIG>, a resilient elongate member <NUM>' is a braided material comprising one or more fibers that are spirally wrapped around a central core of one or more elastic fibers. When relaxed, the braided wrap allows the elastic core fibers to axially shorten or reduce in length and radially expand to the radially expanded state having an expanded outer diameter ODE shown by resilient elongate member 108A. When placed under tension, the braided spiral wrap becomes taut and squeezes the elastic core thereby axially stretching or lengthening the resilient elongate member <NUM>' and radially contracting it to the radially contracted state having a contracted outer diameter ODC shown by resilient elongate member 108B.

In another embodiment shown in <FIG>, a resilient elongate member <NUM>" is a tubular structure created from a woven braid or mesh of shape memory material. When relaxed, the resilient elongate member <NUM>" allows for axial shortening and radial expansion to the radially expanded state an expanded outer diameter ODE, as shown in <FIG>. When the resilient elongate member <NUM>" is placed in tension, the resilient elongate member <NUM>" axially lengthens and radially contracts to the radially contracted state.

With an understanding of the components of the prosthesis <NUM>, the interaction of the various components is now described as to: holding the prosthesis <NUM> in the radially compressed configuration for delivery to a desired treatment location, controllably releasing the prosthesis <NUM> at the desired treatment location, and providing a seal between the prosthesis <NUM> and the native anatomy at the desired treatment location with the prosthesis <NUM> in the radially expanded configuration. In an embodiment, initially tension is placed on the resilient elongate member <NUM>, such as by fixing the prosthesis <NUM> to a delivery device and then pulling on the resilient elongate member <NUM>. With the resilient elongate member <NUM> in tension, the resilient elongate member <NUM> axially elongates and radially contracts and thereby compresses at least a portion of the frame <NUM> of the prosthesis <NUM> to transition at least a portion of the prosthesis to the radially compressed configuration of <FIG> for delivery to a desired treatment location. Once positioned at the desired treatment location, tension on the resilient elongate member <NUM> is released to permit controllable expansion of the frame <NUM> of the prosthesis <NUM> to permit the prosthesis to return to the radially expanded configuration of <FIG>. The resilient elongate member <NUM> further transitions to the radially expanded state and substantially fills the channel <NUM> of the fixation member <NUM>. As the channel <NUM> of the fixation member <NUM> is filled by the radially expanded resilient elongate member <NUM>, the fixation member <NUM> extends outward. Thus, the sealing component <NUM> including the fixation member <NUM> with the resilient elongate member <NUM> disposed therein in the radially expanded state provides a seal between the prosthesis <NUM> and the native anatomy when the prosthesis <NUM> is in the radially expanded configuration, as shown in <FIG>.

In another embodiment hereof, a transcatheter prosthesis <NUM> (hereafter referred to as prosthesis <NUM>) includes a frame or stent-like support structure <NUM> and a cinching and sealing component <NUM>, as shown in <FIG>. The cinching and sealing component <NUM> includes a plurality of fixation members, such as fixation members 206A, 206B, 206C, 206D, 206E, 206F (hereafter referred to as fixation members 206A-206F or fixation member <NUM> for simplicity) and a plurality of resilient elongate members 208A, 208B, 208C (hereafter referred to as resilient elongate members 208A-208C or resilient elongate member <NUM> for simplicity). The prosthesis <NUM>, the frame <NUM>, and the resilient elongate member <NUM> of the cinching and sealing component <NUM> are substantially similar to the prosthesis <NUM>, the frame <NUM>, and the resilient elongate member <NUM> of the cinching and sealing component <NUM> previously described. Therefore, similar construction and alternatives of those features will not be repeated, and only new or modified features pertaining to the embodiment of <FIG> will be described in detail.

In the embodiment of <FIG>, the cinching and sealing component <NUM> includes six (<NUM>) fixation members 206A-206F and three (<NUM>) resilient elongate members 208A-208C but more or fewer of each may be incorporated without departing from the scope hereof. Each fixation member 206A-206F is coupled to the frame <NUM> and configured to form a channel, loop or ring extending outwardly from an outer surface of the frame <NUM>. Each fixation member 206A-206F is configured with sufficient looseness, similar to a belt loop on a pair of pants for instance, to slidably receive the corresponding resilient elongate member 208A-208C. In the embodiment of <FIG>, a pair of fixations members, such as fixation members 206A, 206B, fixation members 206C, 206D, or fixation members 206E, 206F are spaced apart about a circumference of the frame and a corresponding resilient elongate member 208A, 208B, 208C, respectively, is disposed within the corresponding pair of fixation members. In an embodiment, a plurality of fixation members, i.e., two, three, four, five or more fixation members, may be aligned and spaced apart from each other about a circumferences of the frame <NUM> at the same longitudinal position of the frame, such that the corresponding resilient elongate member received therein forms a generally circular path about the outer circumference of the frame <NUM>.

In an embodiment, each fixation member 206A-206F may be a loop, suture, fold, strip or band of a biocompatible material, as described above, either attached or coupled to an outer layer and/or the frame <NUM>, or formed from an outer layer, as described earlier. In another embodiment, each fixation member 206A-206F may be one or more loops, sutures, folds, strips or bands of a material such as, but not limited to synthetic materials, synthetic polymers, natural polymers, nylon, ePTFE, polybutester, polypropylene, silk, polyester, animal tissue (e.g. porcine, equine, or bovine pericardium), autograft tissue, homograft tissue, xenograft tissue, shape memory materials, metals, stainless steel, nickel-titanium alloys (e.g. NITINOL), or other materials suitable for the purposes described herein. Each fixation member 206A-206F may be coupled to an outer layer, as described earlier, and/or the frame <NUM> by a variety of methods, non-limiting examples of which include sewing, fusing, welding, gluing, fastening, or otherwise tied. In another embodiment, each fixation member 206A-206F may be formed from or include a portion of the frame <NUM>. In accordance with embodiments hereof, fixation members 206A-206F, which are shown in <FIG> as relatively thin strips of material, may wider and/or longer than shown in <FIG> to suit a particular application.

As shown in <FIG>, the cinching and sealing component <NUM> includes a first resilient elongate member 208A slidably disposed through a first fixation member 206A and a second fixation member 206B, a second resilient elongate member 208B slidably disposed through a third fixation member 206C and a fourth fixation member 206D, and a third resilient elongate member 208C slidably disposed through a fifth fixation member 206E and a sixth fixation member 206F. As described with respect to the embodiment of prosthesis <NUM> above, the cinching and sealing component <NUM> is configured to hold the prosthesis <NUM> in the radially compressed configuration for delivery to a desired treatment location. The cinching and sealing component <NUM>, and more specifically, the first, second, and third resilient elongate members 208A, 208B, 208C are each further configured to provide a seal between the prosthesis <NUM> and the native anatomy when the prosthesis <NUM> is in the radially expanded configuration at the desired treatment location and the first, second, and third resilient elongate members 208A, 208B, 208C are each in a radially expanded state.

Referring again to <FIG>, the first resilient elongate member 208A is configured to hold a first portion <NUM>, or an inflow section <NUM> of the prosthesis <NUM> in the radially compressed configuration. The second resilient elongate member 208B is configured to hold a second portion <NUM>, or an outflow section <NUM> of the prosthesis <NUM> in the radially compressed configuration. The third resilient elongate member 208C is configured to hold a third portion <NUM> in the radially compressed configuration. The third portion <NUM> is disposed between the first portion <NUM> and the second portion <NUM> of the prosthesis <NUM>. In an embodiment, the third portion <NUM> may contain a prosthetic valve. Each resilient elongate member 208A-208C is disposed through the corresponding pair of fixation members such that each resilient elongate member encircles the prosthesis <NUM> in a generally circular path.

In embodiments hereof, each resilient elongate member (e.g. resilient elongate member <NUM>, <NUM>) may be tensioned by a tensioning mechanism configured to tension or relax/release the resilient elongate member as described below. In embodiments hereof, the tensioning mechanism may be a component of a delivery catheter configured to tension and relax/release the resilient elongate member.

With reference to <FIG> and <FIG>, an exemplary delivery catheter <NUM> with a tensioning mechanism <NUM> (<FIG>) suitable for use with the prosthesis <NUM> is shown. The delivery catheter <NUM> is shown in a delivery configuration in <FIG> with the prosthesis <NUM> loaded and held in the radially compressed configuration on a distal portion <NUM> thereof by a resilient elongate member <NUM>. The delivery catheter <NUM> generally includes a handle <NUM>, an elongate tubular shaft <NUM>, and a distal tip <NUM>. The elongate tubular shaft <NUM> includes a proximal end <NUM> and a distal end <NUM>, and may be a multi-layer or multi-component structure as would be understood by one of ordinary skill in the art. The elongate tubular shaft further includes a lumen <NUM> extending from the proximal end <NUM> to the distal end <NUM>, which is best shown in <FIG>. The lumen <NUM> is configured to slidably receive at least a tensioning mechanism <NUM>. The distal tip <NUM> is coupled to the distal end <NUM> of the elongate tubular shaft <NUM>. The lumen <NUM> of the elongate tubular shaft <NUM> may further be sized to slidably receive a guidewire (not shown) such that the delivery catheter <NUM> may be advanced in an over-the-wire (OTW) configuration to the desired treatment location, or alternatively may include a separate lumen for receiving a guidewire. In some embodiments, the elongate tubular shaft <NUM> includes a plurality of lumens <NUM> for receiving one or more elongate members <NUM>. The delivery catheter <NUM> may assume different forms, construction and features described, for example, and not by way of limitation, in <CIT>, <CIT>. , <CIT>, and/or <CIT>.

The tensioning mechanism <NUM> is described herein with respect to the prosthesis <NUM>, however it will be understood that embodiments of the tensioning mechanism <NUM> may be used with other prostheses. <FIG> depicts a resilient elongate member <NUM> partially extending within the lumen <NUM> and out of a port <NUM> in the elongate tubular shaft <NUM>, and the tensioning mechanism <NUM> disposed within a portion of the lumen <NUM> of the elongate tubular shaft <NUM>, with a remainder of the delivery catheter <NUM> and the prosthesis <NUM> removed for illustrative purposes only. In an embodiment, the tensioning mechanism <NUM> includes a tensioning member <NUM>, e.g. suture, filament, wire, fiber, shaft, rod or cord that is releasably coupled to the resilient elongate member <NUM>. The tensioning member <NUM> extends to a proximal end of the delivery catheter <NUM> and is longitudinally translatable to permit the resilient elongate member <NUM> to transition from the radially contracted state when in tension to the radially expanded state when relaxed. Within the lumen <NUM>, the tensioning member <NUM> is threaded through the loop-shaped resilient elongate member <NUM> to be engaged with or coupled thereto. The tensioning member <NUM> is configured such that tension or pull force applied proximally to the tensioning member <NUM> correspondingly tensions or proximally pulls the resilient elongate member <NUM>. Tension on the resilient elongate member <NUM> axially elongates the resilient elongate member <NUM>, and transitions the member from the radially expanded state to the radially contracted state. Moreover, as the resilient elongate member <NUM> elongates and is drawn into the lumen <NUM> with the application of tension thereon, the resilient elongate member <NUM> applies a radially compressive force on the prosthesis <NUM> and the prosthesis <NUM> transitions to the radially compressed configuration. Thus, tension on the resilient elongate member <NUM> transitions the radially elongate member <NUM> from the radially expanded state to the radially contracted state and radially compresses and holds the prosthesis <NUM> in the radially compressed configuration. Release, slacking or relaxing of tension on the tensioning cord <NUM> correspondingly relaxes, slackens or releases the resilient elongate member <NUM>, transitioning the resilient elongate member <NUM> to the radially expanded state and permitting the prosthesis <NUM> to controllably expand to the radially expanded configuration. As the prosthesis <NUM> radially expands and the resilient elongate member <NUM> axially elongates and transitions to the radially expanded state, the resilient elongate member <NUM> is drawn out of the lumen <NUM> via the port <NUM> to be disposed about the outer surface of the prosthesis <NUM>. During or after the prosthesis <NUM> is returned to its radially expanded configuration, the resilient elongate member <NUM> may be decoupled from the tensioning member <NUM> of the tensioning mechanism <NUM>.

While the prosthesis <NUM> is shown with one resilient elongate member <NUM>, it will be understood that this is not meant to be limiting, and more than one resilient elongate member <NUM> may be utilized, as shown for example in the embodiment of <FIG>. Accordingly as shown by example in <FIG>, two resilient elongate members 108A, 108B may be releasably coupled to a respective tensioning member 318A, 318B of a tensioning mechanism <NUM>" to be coupled thereto within lumen <NUM>, and to extend out of respective ports 322A, 322B in order to engage a prosthesis thereabout. Alternatively, more than one resilient elongate member <NUM> may be releasably coupled to the same tensioning member <NUM> and/or may extend though a single corresponding port <NUM> into the lumen <NUM>.

In another embodiment, a tensioning mechanism <NUM>' includes a first or tensioning plate <NUM> and a second or cutting plate <NUM>, as shown in <FIG>. The tensioning mechanism <NUM>' is disposed within and at a distal portion of the lumen <NUM> of the delivery catheter <NUM>. The resilient elongate member <NUM> is threaded or routed through a pair of holes in each of the first and second plates <NUM>, <NUM>, as shown in <FIG> and in a side view in <FIG>. The first plate <NUM> is coupled to the proximal end of the delivery catheter <NUM> by a tensioning member <NUM>, e.g., a rod or other suitable device such as a suture, filament, wire, fiber, shaft, or cord, such that the first plate <NUM> may be selectively longitudinally translated within the lumen <NUM> via the tensioning member <NUM>. Accordingly, when the first plate <NUM> is pulled proximally in a direction of arrow <NUM>, as shown in <FIG> and <FIG>, the resilient elongate member <NUM> is correspondingly pulled in the direction of arrow <NUM>, placing the resilient elongate member <NUM> in tension and transitioning the resilient elongate member <NUM> to the radially contracted state. Conversely, when the first plate <NUM> is pushed or allowed to translate distally in a direction of arrow <NUM>, the resilient elongate member <NUM> is correspondingly relaxed, and tension is gradually reduced and eliminated, such that the resilient elongate member <NUM> is permitted to radially expand and axially shorten as it transitions to the radially expanded state. In one embodiment, the second plate <NUM> is fixed in place in the lumen <NUM>. Eventually as the first plate <NUM> is translated distally to contact the second plate <NUM>, the resilient elongate member <NUM> is caught between the first plate <NUM> and a cutter <NUM> of the second plate <NUM>, wherein the cutter <NUM> severs or cuts the resilient elongate member <NUM>, as shown in <FIG>. Once the resilient elongate member <NUM> is severed, the resilient elongate member <NUM> transitions to the radially expanded state and the prosthesis <NUM> transitions to the radially expanded state. The cutter <NUM> may be a blade, edge or other cutting device suitable for severing the resilient elongate member <NUM>.

The interaction of the various components to deliver and deploy the prosthesis <NUM> at the desired treatment location are now described. Initially, the prosthesis <NUM> is loaded onto a distal portion <NUM> of the delivery catheter <NUM>, as shown in <FIG>. The resilient elongate member <NUM> in the radially contracted state (in tension) holds the prosthesis <NUM> in the radially compressed configuration for delivery to the desired treatment site.

Once positioned at the desired treatment location, the tensioning mechanism <NUM> is operated to relax or release tension on the resilient elongate member <NUM>. When relaxed, the resilient elongate member <NUM> transitions to the radially expanded state and permits the controlled expansion of the prosthesis <NUM> to the radially expanded configuration of <FIG>. As the prosthesis <NUM> expands radially and the resilient elongate member <NUM> expands to the radially expanded state, the resilient elongate member <NUM> is drawn out of the lumen <NUM> of the delivery catheter <NUM> and is disposed about the outer surface of the frame <NUM> of the prosthesis <NUM>. Further, as the resilient elongate member <NUM> transitions to the radially expanded state, the resilient elongate member <NUM> fills the channel <NUM> of the fixation member <NUM>, extending the fixation member <NUM> outward to provide a seal between the prosthesis <NUM> and the native anatomy when the prosthesis <NUM> is in the radially expanded configuration, as shown in <FIG>.

During deployment of the prosthesis <NUM> at the desired treatment location, the resilient elongate member <NUM> is uncoupled from the tensioning mechanism <NUM>.

<FIG>, <FIG>, <FIG> and <FIG> depict a transcatheter prosthesis system <NUM> (hereafter referred to as the system <NUM>) including a transcatheter prosthesis <NUM> (hereafter referred to as prosthesis <NUM> for simplicity), a plurality of elongate cinching members 404A, 404B and a delivery catheter <NUM> according to an embodiment hereof. The system <NUM> is configured to deliver, position and deploy the prosthesis <NUM> at a desired treatment location.

The prosthesis <NUM> includes a frame or stent-like support structure <NUM>, a valve component <NUM>, as described earlier, coupled to and supported by the frame <NUM>, an outer layer component (not shown), as described earlier, and a sealing component <NUM> configured to provide a seal between the prosthesis <NUM> and the native anatomy. The sealing component <NUM> includes a fixation member <NUM> configured to extend outwardly from an outer surface of the frame <NUM>, and an elongate member <NUM> encircling at least a portion of the frame <NUM> according to an embodiment of the present invention, as shown in <FIG> and <FIG>. The prosthesis <NUM> includes a radially compressed configuration for delivery and a radially expanded configuration of <FIG> when deployed at a desired treatment location.

In embodiments hereof, the frame <NUM> is self-expanding to return to a radially expanded configuration from a radially compressed configuration. The frame <NUM> includes an inflow section <NUM> and an outflow section <NUM>, as shown in <FIG>. The frame <NUM> further includes a plurality of cells <NUM> formed by a plurality of struts <NUM>. The cells <NUM> may have sizes that vary along the length of the frame <NUM>.

In embodiments hereof, the valve component <NUM> may comprise two, three, or four individual leaflets <NUM> assembled to simulate the leaflets of a native valve, as best shown in <FIG>. The components of the valve component <NUM> are formed of various materials, non-limiting examples of which include mammalian tissue such as porcine, equine or bovine pericardium, or a synthetic or polymeric material.

Referring back to <FIG>, in an embodiment, the fixation member <NUM> is a band of material or fabric configured to form a channel segment. The fixation member <NUM> is coupled to or formed from and configured to extend outwardly from the outer surface of the frame <NUM> or an outer layer, as described earlier, and is further configured with sufficient looseness to slidably receive the elongate member <NUM>. The fixation member <NUM> may be constructed of materials, as described earlier, such as, but not limited to nickel-titanium alloys (e.g. NITINOL), nylon, polybutester, polypropylene, silk, polyester or other materials suitable for the purposes described herein. The fixation member <NUM> may be coupled to or formed from the frame <NUM> by a methods, as described earlier, such as, but not limited to fusing, welding, gluing, suturing or otherwise tied. Although the embodiment of <FIG> shows one (<NUM>) fixation member <NUM>, this is not meant to be limiting, and more than one fixation member <NUM> may be utilized. Moreover, while shown and described herein as with a channel segment shape, the fixation member <NUM> may alternatively be formed, as described earlier, such as, but not limited to a loop, ring, band, or channel.

The elongate member <NUM> is sized to be long enough to encircle all or at least a portion of the outer surface of the frame <NUM> when the prosthesis <NUM> is in the radially expanded configuration, and is slidably disposed through the fixation member <NUM>. In an embodiment, the elongate member <NUM> may be a resilient elongate member <NUM>, as described in previous embodiments. In an embodiment, in contrast to a resilient elongate member described in the previous embodiments, the elongate member <NUM> may not be configured to have a radially contracted state when the elongate member <NUM> is in tension, and a radially expanded configuration when the elongate member <NUM> is relaxed. In an embodiment, the elongate member <NUM> may be an elongate cinching and sealing member used to cinch or hold the frame <NUM> of the prosthesis <NUM> in a radially compressed configuration for delivery to a desired treatment location and to create a seal between the prosthesis <NUM> and the native anatomy when the prosthesis <NUM> is in the radially expanded configuration at the desired treatment location. In an embodiment, the elongate member <NUM> is an elongate sealing member that is only used as a seal and not used to cinch or hold the frame <NUM> in a compressed configuration. The elongate member <NUM> is configured to slide along the fixation member <NUM> into a sealing position around the circumference of the prosthesis <NUM> as the prosthesis <NUM> is radially expanded during its deployment. When the prosthesis <NUM> is in the radially compressed configuration for delivery at least a portion of the elongate member <NUM> extends from an opening or access port 442C in the elongate tubular shaft <NUM> as shown in <FIG>, and when the prosthesis <NUM> is in the radially expanded configuration to encircle at least a portion of the prosthesis <NUM> as shown in <FIG>. In an embodiment, the elongate member <NUM> may be described as having slack when the prosthesis <NUM> is in the radially compressed configuration, and in an embodiment may be partially held within the lumen <NUM>, for example, by a releasable tension member <NUM>, which may comprise a suture, fiber, filament, wire, shaft, rod, or cord. In an embodiment, the tension member <NUM> may provide just enough tension to remove slack from the elongate member <NUM> when the prosthesis <NUM> is in the radially compressed configuration for delivery. However, when the frame <NUM> of the prosthesis <NUM> transitions to the radially expanded configuration and the tension member <NUM> is withdrawn, the elongate member <NUM> may be pulled out of the lumen <NUM> into position, such as by sliding through the fixation member <NUM>, to encircle a portion of the frame <NUM> in order to provide a seal between the prosthesis <NUM> and a native anatomy when the prosthesis <NUM> is in a radially expanded configuration. In an embodiment, the elongate member <NUM> may be tensioned using a tension mechanism including the tension member <NUM> to compress and hold a portion of the prosthesis <NUM> in the radially compressed configuration for delivery to the desired treatment location. The tension mechanism is configured to provide a desired amount of tension and/or relaxation/release for the elongate member <NUM>. In one embodiment, the releasable tension mechanism may include a cutting mechanism, as describe earlier, to cut the elongate member <NUM> to thereby release the elongate member <NUM> from the tension member <NUM>. Cutting the elongate member <NUM> to release it from the tension member <NUM> may be desired if the elongate member <NUM> is configured to only seal a portion of the circumference of the prosthesis <NUM>. In an alternative embodiment, it may be desirable not to cut the elongate member <NUM> if the elongate member <NUM> is configured to form a complete seal around the entire circumference of the prosthesis <NUM>.

In an embodiment, the elongate member <NUM> may be a resilient elongate member, as described above with reference resilient elongate member <NUM>, having a radially contracted state when in tension and a radially expanded state when relaxed, wherein that the resilient elongate member provides a seal between the prosthesis <NUM> and the native anatomy when the prosthesis is in the radially expanded configuration and the resilient elongate member is in the radially expanded state, and wherein when the elongate resilient member is in the radially contracted state is configured to cinch or hold at least a portion of the prosthesis <NUM> in a radially compressed configuration for delivery.

Although <FIG> shows one (<NUM>) elongate member <NUM> passing through one (<NUM>) fixation member <NUM> and encircling the inflow section <NUM> of the frame <NUM> in a generally circular path, this is not meant to be limiting, and more than one (<NUM>) elongate member <NUM> may be utilized, passing through more or fewer fixation members <NUM> at other locations of the prosthesis <NUM> and in other paths about the frame <NUM>. The elongate member <NUM> may be formed, as previously described, of one or more biocompatible materials such as, but not limited to metals, e.g. stainless steel, nickel-titanium alloys (e.g. NITINOL), polymers, e.g. nylon, polybutester, polypropylene, silk, polyester or other materials suitable for the purposes described herein.

Each elongate cinching member 404A, 404B of the transcatheter system <NUM> may be a suture, fiber, filament, wire, or cord configured to hold a portion of the prosthesis <NUM> in the radially compressed configuration for delivery to the desired treatment location. Each elongate cinching member 404A, 404B includes a first end (not shown) extending to a proximal end of a delivery catheter <NUM> and a second end 423A, 423B, shown in <FIG> and described below. Each elongate cinching member 404A, 404B is releasable to permit the corresponding portion of the prosthesis <NUM> held in the radially compressed configuration to return to the deployed or radially expanded configuration.

More particularly, as shown in <FIG>, each elongate cinching member 404A, 404B encircles the prosthesis <NUM> such that pulling or tensioning the elongate cinching member 404A, 404B radially compresses the prosthesis <NUM>, and releasing/relaxing each elongate cinching member 404A, 404B controls the expansion and deployment of the corresponding portion of the prosthesis <NUM>. Each elongate cinching member 404A, 404B encircles or extends circumferentially in a generally circular path about the outer surface of the frame <NUM> of the prosthesis <NUM>. Each elongate cinching member 404A, 404B may be formed of one or more biocompatible materials such as, but not limited to metals, e.g. stainless steel, nickel-titanium alloys (e.g. NITINOL), polymers, e.g. nylon, polybutester, polypropylene, silk, polyester or other materials suitable for the purposes described herein. Further details and examples of suitable elongate cinching materials and configurations for retaining self-expanding transcatheter prostheses are described in <CIT>.

In embodiments hereof, the plurality of elongate cinching members 404A, 404B may be tensioned by a cinching mechanism <NUM> configured to tension or relax/release the plurality of elongate cinching members 404A, 404B such that the plurality of elongate cinching members 404A, 404B radially compress or permit radial expansion of the prosthesis <NUM>. In embodiments hereof, the cinching mechanism <NUM> is a component of the delivery catheter <NUM>. However, this is not meant to be limiting, and other configurations of cinching mechanisms not formed as a component of a delivery catheter are possible.

The delivery catheter <NUM> is shown in a delivery configuration in <FIG> with the prosthesis <NUM> loaded and held in the radially compressed configuration by a first and second elongate cinching member 404A, 404B and, in some embodiments, by the elongate member <NUM>. The delivery catheter <NUM> includes a handle <NUM>, an elongate tubular shaft <NUM>, and a distal tip <NUM>. The elongate tubular shaft <NUM> includes a proximal end <NUM>, a distal end <NUM>, and a lumen <NUM> extending from the proximal end <NUM> to a distal portion of the elongate tubular shaft <NUM>. The lumen <NUM> is configured to slidably receive the cinching mechanism <NUM>, examples of which are described below and shown in <FIG> and <FIG>, and the elongate member <NUM>. The distal tip <NUM> is coupled to the distal end <NUM> of the elongate tubular shaft <NUM>. The elongate tubular shaft <NUM> may further include a guidewire lumen <NUM> extending from the proximal end <NUM> to the distal end of the distal tip <NUM>, sized to slidably receive a guidewire (not shown) such that the delivery catheter <NUM> may be advanced in an over-the-wire (OTW) configuration to the desired treatment location. The delivery catheter <NUM> may assume different forms, construction and features described, for example, and not by way of limitation, in <CIT>, <CIT>. , <CIT>, <CIT>, and/or <CIT>.

The prosthesis <NUM> is disposed along a distal segment of the elongate tubular shaft <NUM>, as shown in <FIG>. The first elongate cinching member 404A encircles, or surrounds the inflow section <NUM> of the prosthesis <NUM> and is configured to hold the inflow section <NUM> in the radially compressed configuration for delivery to the desired treatment location. The second elongate cinching member 404B encircles, or surrounds the outflow section <NUM> of the prosthesis <NUM> and is configured to hold the outflow section <NUM> in the radially compressed configuration for delivery to the desired treatment location. Thus, the first and second elongate cinching members 404A, 404B compressively hold at least a portion of the prosthesis <NUM> in the radially compressed configuration for delivery to the desired treatment location. In some embodiments, the elongate member <NUM> is an elongate cinching and sealing member that also compressively holds at least a portion of the prosthesis <NUM> in the radially compressed configuration for delivery to the desired treatment location. In other embodiments, the elongate member <NUM> may be only used as an elongate sealing member and does not hold any portion of the prosthesis <NUM> in the radially compressed configuration.

<FIG> is an enlarged sectional view of a distal portion of the elongate tubular shaft <NUM> removed from the remainder of the delivery catheter <NUM> for clarity. <FIG> illustrates the cinching mechanism <NUM> according to an embodiment hereof. The cinching mechanism <NUM> includes the first and second elongate cinching members 404A, 404B, and a release pin <NUM>. A portion of the cinching mechanism <NUM> is slidably disposed within the lumen <NUM> and is configured to radially compress at least a portion of the prosthesis <NUM> to the radially compressed configuration of <FIG> for delivery to a desired treatment location. The cinching mechanism <NUM> is further configured to permit the release or deployment of the prosthesis <NUM> from the radially compressed configuration to the radially expanded configuration at the desired treatment location. As best shown in <FIG>, each elongate cinching member 404A, 404B extends distally from the proximal end of the delivery catheter <NUM>, through the lumen <NUM>, exiting the lumen <NUM> though a respective opening or port 442A, 442B in the elongate tubular shaft <NUM>, encircles the prosthesis <NUM> (not shown in <FIG> for clarity), and extends back through the respective opening or port 442A, 442B into the lumen <NUM>, where the second end 423A, 423B of the elongate cinching member 404A, 404B is releasably coupled to the release pin <NUM>, as shown in <FIG>. The release pin <NUM> is operably coupled to the proximal end of the delivery catheter <NUM>. The cinching mechanism <NUM> is further configured such that remote actuation of the release pin <NUM> (e.g. via an actuator such as a knob, or lever of the delivery catheter <NUM>) with the prosthesis <NUM> in the radially compressed configuration releases the elongate cinching member 404A, 404B, thereby permitting the prosthesis <NUM> to expand to the radially expanded configuration. Once the prosthesis <NUM> is in the radially expanded configuration, each elongate cinching member 404A, 404B may be retracted proximally to remove the respective elongate cinching member 404A, 404B from its position about the prosthesis <NUM>.

<FIG> shows a cinching mechanism <NUM>' with the elongate member <NUM> of the prior embodiments according to another embodiment hereof. In the embodiment of <FIG>, each elongate cinching member 404A, 404B extends distally from the proximal end of the delivery catheter <NUM>, through the lumen <NUM>, exiting the lumen <NUM> though a respective opening or port 442A, 442B in the elongate tubular shaft <NUM>, encircles the prosthesis <NUM> (not shown in <FIG> for clarity), and extends back through the respective opening or port 442A, 442B and proximally within the lumen <NUM> to the proximal end of the delivery catheter <NUM>. Each cinching member 404A, 404B is configured to be releasably held in tension at a proximal end of the delivery catheter <NUM> such that the prosthesis <NUM> is held in the radially compressed configuration for delivery to a desired treatment location. Each cinching member 404A, 404B is further configured to be releasable to permit the corresponding portion of the prosthesis <NUM> to controllably expand to the radially expanded configuration. Once the prosthesis <NUM> is in the radially expanded configuration, a first end of each elongate cinching member 404A, 404B may be released and a corresponding second end of each elongated cinching member 404A, 404B retracted proximally to remove the respective elongate cinching member 404A, 404B from its position about the prosthesis <NUM>.

With an understanding of the components of the transcatheter prosthesis system <NUM>, it is now possible to describe the interaction of the various components to deliver, position and deploy the prosthesis <NUM> the desired treatment location. The prosthesis <NUM> is loaded onto the delivery catheter <NUM>, as shown in <FIG>. The first and second elongate cinching members 404A, 404B combine to hold at least a portion of the prosthesis <NUM> in the radially compressed configuration for delivery to the desired treatment site, and the elongate member <NUM>, which can be a resilient elongate member, an elongate cinching and sealing member, or an elongate sealing member, is threaded through the fixation member <NUM> and coupled to a tension member <NUM> with the lumen <NUM> of the delivery catheter <NUM>.

The transcatheter prosthesis system <NUM> is advanced through a vasculature. Once the prosthesis <NUM> is positioned at the desired treatment location, the cinching mechanism <NUM> and cord <NUM> are released and the prosthesis <NUM> expands to the radially expanded configuration. The elongate member <NUM> being in a slackened state during delivery is pulled free of the lumen <NUM> through the opening or port 442C by the expanding frame <NUM> to encircle the frame <NUM> when the prosthesis <NUM> expands to the radially expanded configuration, as shown in <FIG>. At all times, the elongate member <NUM> is slidably coupled through the fixation member <NUM>. Accordingly, the elongate member <NUM> provides a seal between the prosthesis <NUM> and the native anatomy when the prosthesis <NUM> is in the radially expanded configuration shown in <FIG>.

With the prosthesis <NUM> is deployed and sealed at the desired treatment location, the elongate cinching members 404A, 404B may be removed from their positons around the prosthesis <NUM>.

While the cinching mechanism <NUM> has been described with two (<NUM>) elongate cinching members 404A, 404B, it will be understood that more or fewer elongate cinching members 404A, 404B may be utilized. Additional details and examples of suitable cinching mechanisms for retaining self-expanding transcatheter prostheses are described in <CIT>.

While the sealing component <NUM> has been described with a fixation member <NUM> and an elongate member <NUM>, it will be understood that one or more fixation members <NUM> and/or more elongate members <NUM> may be utilized. While the elongate member <NUM> has been described as being distal of the elongate cinching members 404A, 404B, it will be understood that one or more elongate members <NUM> can be positioned proximal of one or more elongate cinching members 404A, 404B.

<FIG> shows a transcatheter prosthesis system <NUM> including a transcatheter prosthesis <NUM> (hereafter referred to as prosthesis <NUM>) and a delivery catheter <NUM> according to another embodiment hereof. The prosthesis <NUM> includes a fixation member <NUM> and an elongate sealing member <NUM> that is coupled to a releasable tension member, which may comprise a suture, fiber, filament, wire, shaft, rod, or cord, within a lumen of the delivery catheter <NUM>, as similarly described in the embodiments of <FIG>. The prosthesis <NUM>, the fixation member <NUM> and the elongate sealing member <NUM> are similar to the prosthesis <NUM>, the fixation member <NUM> and the elongate member <NUM>, when used solely as an elongate sealing member, as described previously. Therefore, construction and alternatives of the prosthesis <NUM>, the fixation member <NUM> and the elongate sealing member <NUM> will not be repeated. In the embodiment of the transcatheter prosthesis system <NUM>, the prosthesis <NUM> is held in the radially compressed configuration by a distal portion <NUM>, such as a capsule or distal portion of an outer sheath, of the delivery catheter <NUM>.

As shown in <FIG>, the delivery catheter <NUM>, suitable for delivering and deploying the prosthesis <NUM> with the prosthesis <NUM> in the radially compressed configuration within the distal portion <NUM> of an outer sheath <NUM>. In an embodiment, the distal portion <NUM> may be referred to as a capsule and may be constructed as described in <CIT>, <CIT>. , and/or <CIT>.

The delivery catheter <NUM> includes a handle <NUM>, an elongate tubular shaft <NUM>, a distal tip <NUM> and the outer sheath <NUM>. The elongate tubular shaft <NUM> includes a proximal end <NUM>, a distal end <NUM> guidewire lumen <NUM>. The guidewire lumen <NUM> extends the length of the catheter <NUM> and is sized to slidably receive a guidewire (not shown in <FIG>).

The outer sheath <NUM> includes the distal portion <NUM>, which forms a distalmost portion or segment thereof. The outer sheath <NUM> includes a lumen <NUM> extending from a proximal end to a distal end thereof. The elongate tubular shaft <NUM> extends within the lumen <NUM>. The distal portion <NUM> is configured to hold the prosthesis <NUM> in the radially compressed configuration for delivery. The outer sheath <NUM> is proximally retractable relative to the elongate tubular shaft <NUM> to release and deploy the prosthesis <NUM> from the distal portion <NUM>. More precisely, the outer sheath <NUM> is coupled to a retraction mechanism of the delivery catheter <NUM>. Various retraction mechanisms may be utilized, such as, but not limited to an axially-slidable lever, a rotatable rack and pinion gear, or other mechanisms suitable for the purposes described herein.

Accordingly, and as shown in <FIG>, the prosthesis <NUM> is loaded onto the delivery catheter <NUM> with the distal portion <NUM> holding the prosthesis <NUM> in the radially compressed configuration and the elongate sealing member <NUM> disposed about the outer surface of the frame <NUM> of the prosthesis <NUM> and extending within the lumen of the elongate tubular shaft <NUM> for delivery. Once the prosthesis <NUM> is positioned at the desired treatment location, the distal portion <NUM> is retracted proximally, and the elongate sealing member <NUM> is drawn out of a lumen of the delivery catheter <NUM> via an opening or port (not shown) during expansion of the prosthesis <NUM> to the radially expanded configuration. In one embodiment, a tension member comprising a fiber, filament, wire, shaft, rod, or cord (not shown) releases the elongate sealing member <NUM>, to permit the elongate sealing member <NUM> to be drawn out of the lumen of the delivery catheter <NUM> during expansion of the prosthesis <NUM> to the radially expanded configuration. As the prosthesis <NUM> expands radially, the elongate sealing member <NUM>, which is slidable relative to the fixation member <NUM>, gradually encircles the outer surface of the prosthesis to provide a seal between the prosthesis <NUM> and the native anatomy.

<FIG> and <FIG> are sectional cut-away views of a vessel VE illustrating a method of delivering, deploying and sealing the prosthesis <NUM> of <FIG> in accordance with an embodiment hereof. With reference to <FIG> and <FIG>, a distal segment of a delivery catheter <NUM> is shown positioned at the vessel VE, with the prosthesis <NUM> loaded thereon and held in the radially compressed configuration by the cinching and sealing component <NUM>. Intravascular access to the vessel VE or valve may be achieved via a percutaneous entry point in an artery or vein, e.g. femoral, brachial, radial, or auxiliary artery, a. the Seldinger technique, extending through the vasculature to the desired treatment location. Alternatively, access to a native heart valve may be achieved via a percutaneous entry point in a heart wall. As will be understood, a handle (not shown in <FIG> and <FIG>), as well as a length of a proximal section (not shown in <FIG> and <FIG>) of the delivery catheter <NUM> are exposed external of the patient for access and manipulation by a clinician, even as the prosthesis <NUM> is positioned at the desired treatment location. Although not shown in <FIG>, optionally, a guidewire and/or a guide catheter may be utilized with the delivery catheter <NUM>, with the delivery catheter <NUM> slidably advanced over the guidewire and/or within the guide catheter.

Once the prosthesis <NUM> in the radially compressed configuration is positioned at the desired treatment location, and in a next delivery step, the delivery catheter <NUM> is manipulated to release or relax tension on the resilient elongate cinching and sealing member <NUM>, obscured by view by the fixation member <NUM>, thereby permitting the controlled expansion of the prosthesis <NUM> from the radially collapsed configuration of <FIG> to the radially expanded configuration of <FIG>. Additionally, once tension is released from the resilient elongate member <NUM>, the resilient elongate member <NUM> transitions to the radially expanded state, filling and expanding the fixation member <NUM> outward such that the resilient elongate member <NUM> and the fixation member <NUM> of the cinching and sealing component <NUM> provides a seal preventing blood flow between the prosthesis <NUM> and the native anatomy of the vessel VE or valve annulus and/or leaflets.

During deployment or following full deployment of the prosthesis <NUM>, the resilient elongate member <NUM> is uncoupled from the tensioning mechanism <NUM>.

Following the delivery, placement and deployment of the prosthesis <NUM> at the desired location, the delivery catheter <NUM> and remaining guidewire and/or guide catheter (if any) may be removed using established transcatheter procedures.

Image guidance, e.g., intracardiac echocardiography (ICE), fluoroscopy, computed tomography (CT), intravascular ultrasound (IVUS), optical coherence tomography (OCT), or another suitable guidance modality, or combination thereof, may be used to aid the clinician's delivery and positioning of the prosthesis <NUM> at the target region.

While the method of <FIG> and <FIG> illustrate the prosthesis <NUM> deployed within a vessel VE, this is not meant to be limiting, and the method in combination with other transcatheter prostheses (e.g. a transcatheter valve prosthesis) may be utilized at other locations such as, but not limited to a heart valve, e.g. aortic, mitral, pulmonic, or tricuspid, and an aortic aneurysm.

The valve prostheses <NUM>, <NUM>, <NUM>, and <NUM> are illustrated herein to facilitate description of the devices and methods according to embodiments hereof. It is understood that any number of alternate valve prostheses can be used with the devices and methods described herein. Moreover, each prosthesis may incorporate or exclude a valve component based upon the specific application.

While various embodiments have been described above, it should be understood that they have been presented only as illustrations and examples of the present invention, and not by way of limitation. It will be apparent to persons skilled in the relevant art that various changes in form and detail can be made therein without departing from the scope of the invention. Thus, the scope of the present invention should not be limited by any of the above-described exemplary embodiments, but should be defined only in accordance with the appended claims.

Claim 1:
A transcatheter prosthesis (<NUM>, <NUM>) having a radially compressed configuration for delivery within a vasculature and a radially expanded configuration for deployment within a native anatomy comprising:
a frame (<NUM>, <NUM>);
a fixation member (<NUM>, <NUM>) extending outwardly from an outer surface of the frame (<NUM>, <NUM>); and
a resilient elongate member (<NUM>, <NUM>) slidably disposed within the fixation member (<NUM>, <NUM>), the resilient elongate member (<NUM>, <NUM>) having a radially contracted state when in tension and a radially expanded state when relaxed,
wherein the resilient elongate member (<NUM>, <NUM>) in the radially contracted state is configured to hold the prosthesis in the radially compressed configuration and,
wherein at least the resilient elongate member (<NUM>, <NUM>) in the radially expanded state provides a seal between the prosthesis and the native anatomy when the prosthesis is in the radially expanded configuration, and
wherein the resilient elongate member (<NUM>, <NUM>) has a generally helical path about the outer surface of the frame (<NUM>, <NUM>).