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 manner.

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.

Prosthetic heart valves have been developed for repair and replacement of diseased and/or damaged heart valves. Such valves can be percutaneously delivered and deployed at the site of the diseased heart valve through catheter-based systems. Such prosthetic heart valves can be delivered while in a low-profile or compressed/contracted arrangement so that the prosthetic valves can be advanced through the patient's vasculature. Once positioned at the treatment site, the prosthetic valves can be expanded to engage tissue at the diseased heart valve region to, for instance, hold the prosthetic valve in position. While these prosthetic valves offer minimally invasive methods for heart valve repair and/or replacement, challenges remain to providing effective and less invasive prosthetic valve delivery systems, particularly for mitral valve replacement. For example, catheter delivery approaches and techniques for mitral valve replacement have largely utilized a transseptal approach; however, challenges, such as catheter positioning of a heart valve prosthesis in the native mitral valve and size limitations of the catheter that can be successfully delivered via inter-atrial septum puncture, limit both the feasibility of heart valve prosthetic delivery as well as the size of the heart valve prosthesis. Other delivery routes for mitral valve replacement, such as a retrograde approach and trans-apical puncture, have also presented difficulties in precise positioning of heart valve devices and in avoiding injury to myocardium tissue in the left ventricle.

<CIT> discloses a dual valve prosthesis having first and second prosthetic valve components with a linkage that connects the first and second prosthetic valve components together is disclosed. Each of the first and second prosthetic valve components includes a stent structure with a prosthetic valve secured therein. In a disclosed method, the first and second prosthetic valve components include prosthetic mitral and aortic valves, respectively, and the dual heart valve prosthesis is configured to replace both the native mitral and aortic valves of the heart in a single transcatheter heart valve implantation procedure. The linkage between the first and second prosthetic valve components is configured to secure the anterior mitral valve leaflet against a wall of the left ventricle when the dual valve prosthesis is implanted within the heart.

Embodiments hereof are directed to transcatheter delivery systems and catheter assemblies for delivering prosthetic heart valves using a retrograde approach. In particular, the delivery systems and catheter assemblies are suitable for accessing the mitral valve and orienting the prosthetic heart valve device by an approach from the aortic arch, across the aortic valve, and into the left ventricle. In an embodiment, a heart valve prosthesis delivery system can include a delivery catheter comprising i) an elongated tubular component, ii) an arm portion, and iii) an elbow or hinge portion coupling the arm portion to the elongated tubular component, wherein when the elbow portion is in a state of flexion, the arm portion is in a delivery configuration in which the elbow portion forms a distal end of the delivery catheter and in which the arm portion is substantially parallel with a longitudinal axis of the elongated tubular component. The arm portion is configured to carry a heart valve prosthesis. Accordingly, in some embodiments, the heart valve prosthesis delivery system can also include a heart valve prosthesis releasably attached to the arm portion.

In yet another aspect, embodiments of the present technology provide a delivery catheter for intravascular delivery of a heart valve prosthesis to a heart valve of a patient. The delivery catheter includes a delivery catheter comprising an elongated tubular component having a proximal segment and a distal segment, and an articulation assembly at the distal segment. The articulation assembly includes an arm portion coupled to the elongated tubular component by an elbow portion. In a state of flexion, the elbow portion positions the arm portion generally parallel to the elongated tubular component, e.g., for intravascular delivery of the distal segment of the delivery catheter to a target location. In a state of extension, the elbow portion positions the arm portion in a non-axial direction with respect to a longitudinal axis of the elongated tubular component, e.g., for orienting and positioning a heart valve prosthesis within the heart valve of the patient.

In a further aspect not claimed, embodiments of the present technology provide a method of delivering a mitral valve prosthesis to a native mitral valve of a patient. In one embodiment, the method can include intravascularly advancing an elongate tubular component of a delivery catheter from an aortic arch and across an aortic valve to a left ventricle of the patient, wherein the delivery catheter includes an articulation assembly in a delivery state at a distal end thereof. The articulation assembly has an arm portion carrying the mitral valve prosthesis and is coupled to the elongate tubular component by an elbow portion. The method may also include transitioning the elbow portion from a state of flexion to a state of extension to angle the arm portion away from a longitudinal axis of the elongate tubular component and toward the native mitral valve. The method may further include at least partially retracting the elongate tubular component of the delivery catheter to move the arm portion carrying the mitral valve device within the native mitral valve of the patient.

The foregoing and other features and aspects of the present technology can be better understood from the following description of embodiments and as illustrated in the accompanying drawings. The accompanying drawings, which are incorporated herein and form a part of the specification, further serve to illustrate the principles of the present technology. The components in the drawings are not necessarily to scale.

Specific embodiments of the present technology 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 or with respect to a catheter, catheter assembly, or delivery catheter. For example, "distal" or "distally" are a position distant from or in a direction away from the clinician when referring to delivery procedures or along a vasculature. Likewise, "proximal" and "proximally" are a position near or in a direction toward the clinician.

The following detailed description is merely exemplary in nature and is not intended to limit the present technology or the application and uses of the present technology. Although the description of embodiments hereof are in the context of treatment of heart valves and particularly in the context of gaining percutaneous access to a mitral valve, the present technology may also be used in any other body passageways where it is deemed useful.

Embodiments of the present technology as described herein can be combined in many ways to treat or access one or more of many valves of the body including valves of the heart such as the mitral valve. The embodiments of the present technology can be therapeutically combined with many known surgeries and procedures, for example, such embodiments can be combined with known methods of intravascularly accessing the valves of the heart such as the aortic valve and mitral valve with retrograde approaches and combinations of retrograde and antegrade approaches.

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

In a healthy heart, the leaflets LF of the mitral valve MV meet evenly at the free edges or "coapt" to close and prevent back flow of blood during contraction of the left ventricle LV (<FIG>). Referring to <FIG>, the leaflets LF attach the surrounding heart structure via a dense fibrous ring of connective tissue called an annulus AN which is distinct from both the leaflet tissue LF as well as the adjoining muscular tissue of the heart wall. In general, the connective tissue at the annulus AN is more fibrous, tougher and stronger than leaflet tissue. The flexible leaflet tissue of the mitral leaflets LF are connected to papillary muscles PM, which extend upwardly from the lower wall of the left ventricle LV and the interventricular septum IVS, via branching tendons called chordae tendinae CT. In a heart <NUM> having a prolapsed mitral valve MV in which the leaflets LF do not sufficiently coapt or meet, as shown in <FIG>, leakage from the left ventricle LV into the left atrium LA will occur. Several structural defects can cause the mitral leaflets LF to prolapse, and subsequent regurgitation to occur, including ruptured chordae tendinae CT, impairment of papillary muscles PM (e.g., due to ischemic heart disease), and enlargement of the heart and/or mitral valve annulus AN (e.g., cardiomyopathy).

Embodiments of delivery systems, delivery catheters, and associated methods in accordance with the present technology are described in this section with reference to <FIG>. It will be appreciated that specific elements, substructures, uses, advantages, and/or other aspects of the embodiments described herein and with reference to <FIG> can be suitably interchanged, substituted or otherwise configured with one another in accordance with additional embodiments of the present technology.

Provided herein are systems, assemblies, catheters, devices and methods suitable for intravascular delivery of a heart valve prosthesis to a native mitral valve in a heart of a patient. In some embodiments, delivery catheters and methods are presented for the treatment of valve disease as part of procedure steps for minimally invasive implantation of an artificial or prosthetic heart valve, such as a mitral valve. For example, a heart valve delivery system, in accordance with embodiments described herein, can be used to direct and deliver a mitral valve prosthesis via an intravascular retrograde approach across an aortic valve, into a left ventricle and across a diseased or damaged mitral valve in a patient, such as in a patient suffering from mitral valve prolapse illustrated in <FIG>. In another embodiment, a heart valve delivery system, in accordance with embodiments described herein, can be used to direct and deliver a mitral valve prosthesis via a venous transseptal approach across a right atria, through a transseptal wall, into a left atria and across a diseased or damaged mitral valve in a patient. In further embodiments, the delivery systems and delivery catheters disclosed herein are suitable for prosthetic heart valve delivery across other diseased or damaged natural heart valves or prior implanted prosthetic heart valves, such as tricuspid, pulmonary and aortic heart valves.

<FIG> is a side view of a minimally invasive heart valve prosthesis delivery system <NUM> ("delivery system <NUM>") configured in accordance with an embodiment hereof, wherein a compressed prosthetic valve device <NUM> is visible extending within a recessed segment or space <NUM> of a delivery catheter <NUM>, between a distal end <NUM> of an elongate outer tubular component <NUM> and a distal tip <NUM> of the delivery catheter <NUM>. In an embodiment, a self-expanding prosthetic valve device <NUM> is held in its compressed, delivery state by a cinch device or one or more loops of a suture/sutures (not shown), as described below. The delivery system <NUM> may be used to align and deliver the prosthetic valve device <NUM> to a target region of the heart for repair or replacement of a diseased or damaged heart valve of a patient. In some instances, the delivery system <NUM> may be used to deliver and align the prosthetic valve device <NUM> by a retrograde approach to the mitral valve that includes an intravascular path from the aortic arch, across the aortic valve, and into the left ventricle of a patient, and beneficially the delivery catheter <NUM> thereof does not include a capsule or other prosthesis covering component over the compressed prosthetic valve device <NUM> and thereby has improved flexibility and a reduced delivery profile, particularly in a distal segment <NUM> thereof. As well, the delivery catheter <NUM> without a capsule or other prosthesis covering component over the compressed prosthetic valve device <NUM> eliminates the need to retract or advance a capsule or other prosthesis covering component relative to the prosthetic valve device during delivery, and therefore can be more efficiently utilized within the confines of the left ventricle in a retrograde approach. In embodiments hereof, an introducer sheath (not shown) or an outer sheath (not shown) may be used with the delivery catheter <NUM> to minimize intravascular trauma during introduction, tracking and delivery of the delivery catheter <NUM> to a target location.

As shown in <FIG>, the delivery system <NUM> includes the delivery catheter <NUM> having a handle component <NUM> operatively coupled to a remainder thereof as described herein. A first tubular component or elongated shaft <NUM> of the delivery catheter <NUM> is slidable or translatable relative to the outer tubular component <NUM>. Further, the first tubular component <NUM> is configured to extend from at least a distal end <NUM> of the handle component <NUM> to a distal segment <NUM> of the delivery catheter <NUM>, as described in more detail below. The delivery system <NUM> is sized and configured to be advanced through the vasculature in a minimally invasive manner. In embodiments incorporating hydraulic expanding components and/or for delivering/deploying a balloon-expandable prosthetic heart valve device, the delivery system <NUM> includes an inflation fluid source <NUM>, as shown in <FIG>, operatively coupled to the handle component <NUM> or other portion of the delivery catheter <NUM>, to facilitate communication between a hydraulic expanding component and/or a balloon assembly (not shown) and the source of inflation fluid <NUM>.

The delivery catheter <NUM> further includes an articulation assembly <NUM> disposed within the distal segment <NUM> thereof, and extended from a distal end <NUM> of the first tubular component <NUM>. The articulation assembly <NUM> is configured for orienting and positioning the prosthetic valve device <NUM> within or adjacent to a native heart valve (e.g., mitral valve) and for deployment of the valve device <NUM>. In an embodiment, the first tubular component <NUM> can have a generally hollow body that extends between the handle component <NUM> and the articulation assembly <NUM>.

<FIG> is an enlarged partial side view of the distal segment <NUM> of the delivery catheter <NUM> in a delivery configuration with the articulation assembly <NUM> having a low profile or closed state in accordance with an embodiment hereof. <FIG> is an enlarged partial side view of the delivery catheter <NUM> of <FIG> in a deployed configuration with the articulation assembly <NUM> having an outwardly angled or open state in accordance with an embodiment hereof. Referring to <FIG> together, the articulation assembly <NUM> includes an arm portion <NUM> coupled to, or extending from, the distal end <NUM> of the first tubular component <NUM> by an elbow or hinge portion <NUM>. The elbow portion <NUM> forms a distal end <NUM> of the articulation assembly <NUM> when the delivery catheter <NUM> is in the delivery configuration as shown in <FIG> and <FIG>. The distal segment <NUM> of the delivery catheter <NUM> can be configured to be delivered intravascularly to a target location (e.g., target heart chamber) of a human patient in the delivery configuration with the articulation assembly <NUM> having the low-profile, substantially straightened or closed state shown in <FIG>. Upon delivery to a target location, when the delivery catheter <NUM> is in the deployed configuration of <FIG>, the articulation assembly <NUM>, in accordance with embodiments hereof, is further configured to be transformed into the outwardly angled or opened state in which the arm portion <NUM> is angled away from the first tubular component <NUM> via an outward opening or extension of the elbow portion <NUM>.

Referring to <FIG>, when the delivery catheter <NUM> is in the delivery configuration, the arm portion <NUM> is positioned generally parallel with a longitudinal axis LA1 of the first tubular component <NUM>, and is configured to carry the prosthetic valve device <NUM> in a low-profile or closed state for delivery through the vasculature. Accordingly, the articulation assembly <NUM> is configurable into the low-profile or closed configuration in which the elbow portion <NUM> is in a state of flexion and wherein an angle (not shown) formed between the arm portion <NUM> and the first tubular component <NUM> is substantially <NUM> degrees (<FIG>). Stated another way, when the articulation assembly <NUM> is in the low-profile or closed configuration, the elbow portion is closed such that the arm portion <NUM> and the first tubular component <NUM> are substantially parallel (<FIG>). Referring to <FIG> and <FIG> together, an outward opening of the elbow portion <NUM>, in which the elbow portion <NUM> may be referred to as being in a state of extension relative to the first tubular component <NUM>, permits the arm portion <NUM> to angle away from the longitudinal axis LA1 of the first tubular component <NUM> thereby transitioning the delivery catheter <NUM> to the deployed configuration (<FIG>).

In the delivery configuration, the delivery catheter <NUM> is configured to be introduced within a patient's vasculature to position the prosthetic heart valve <NUM> at a target location such as a heart chamber (e.g., left ventricle) adjacent a damaged or diseased heart valve (e.g., mitral valve). Upon advancement/delivery to the target location (e.g., left ventricle), the delivery catheter <NUM> is transformable to a deployed configuration (<FIG>) with the articulation assembly <NUM> having an outwardly angled or open state (e.g., the arm portion <NUM> is angled away from the longitudinal axis LA1 of the first tubular component <NUM>) for aligning and positioning the prosthetic valve device <NUM> within the damaged or diseased heart valve for repair or valve replacement. Referring to <FIG>, an extension angle AEX formed between the arm portion <NUM> and the first tubular component <NUM> is greater than <NUM> degrees. For example, the extension angle AEX can be between about <NUM>° and about <NUM>°, between about <NUM>° and about <NUM>°, between about <NUM>° and about <NUM>°, or less than about <NUM>°. In other embodiments, the extension angle AEX can be greater than about <NUM>°. In the deployed/open state, as shown in <FIG>, the articulation assembly <NUM> of the delivery catheter <NUM> positions the prosthetic valve device <NUM> in a non-parallel orientation with respect to the first tubular component <NUM> and, in some embodiments, can be further adjusted (e.g., the adjustment of the extension angle AEX) to selectively align the prosthetic valve device <NUM> with a native valve region such as, for example, within or adjacent a native valve annulus or a region of leaflet coaptation of the damaged or diseased heart valve.

In another embodiment shown in <FIG>, the delivery catheter <NUM> is modified to include a first tubular component <NUM>' that is longitudinally slidable or translatable relative to the second tubular component <NUM>. First tubular component <NUM>' is translatable via remote actuation, e.g., via an actuator such as a knob, pin, or lever, of the handle component <NUM>. In the deployed/open state, the valve device <NUM> can be selectively aligned with the native mitral valve via longitudinal translational adjustment of the first tubular component <NUM>' within the recessed segment <NUM>. Stated another way, a clinician can slidably advance the first tubular component <NUM>' in a distal direction (e.g., in the direction of arrow <NUM>) to move the arm portion <NUM> in the deployed state in the distal direction and, likewise, a clinician can retract the first tubular component <NUM>' in a proximal direction (e.g. in the direction of arrow <NUM>) to move the arm portion <NUM> in the deployed state in the proximal direction to thereby adjust the alignment of the valve device <NUM> with the native mitral valve for subsequent deployment therein.

The arm portion <NUM> may be transitioned between the closed (delivery) state and the open (deployed) state (that correspond to the delivery and deployed configurations of the delivery catheter <NUM>) using a variety of suitable mechanisms or techniques (e.g., shape memory, mechanical actuation of the elbow portion <NUM> using push/pull wires, and/or using a hydraulic mechanism). In an embodiment, the articulation assembly <NUM> may be integral with the distal end <NUM> of the first tubular component <NUM> and together have a tubular structure with a shape memory to transform into the open (deployed) state when unrestricted or untensioned. In another embodiment, the articulation assembly <NUM> may be a separate, tubular structure having a shape memory, to return to an open (deployed) state), that is coupled to the first tubular component <NUM>. For example, in one embodiment, at least a portion of the articulation assembly <NUM> has been shape-set to provide the elbow portion <NUM> with a curved shape, that when unrestrained, orients the arm portion <NUM> in a non-parallel direction, or at an angle, with respect to the longitudinal axis LA1 of the first tubular structure <NUM>. In another embodiment, a tubular structure may be shape-set such that the first tubular component <NUM>, the elbow portion <NUM> and the arm portion <NUM> are generally straight (e.g., are in axial alignment with the longitudinal axis LA1), and wherein the elbow portion <NUM> has a lower stiffness than each of the arm portion <NUM> and the first tubular component <NUM> such that the elbow portion <NUM> may be preferentially bent when the arm portion <NUM> is restrained against the first tubular component <NUM>. The arm portion <NUM> may then be actuated or restrained by various methods such as, but not limited to a tether line <NUM>, described in greater detail below.

Referring to the embodiment shown in <FIG> and <FIG>, extension of the elbow portion <NUM> may be permitted by loosening or slackening a tether device <NUM> attached to the arm portion <NUM> and deployable via remote actuation, e.g., via an actuator <NUM> (<FIG>), such as a knob, pin, or lever carried by the handle component <NUM>. Referring to <FIG> together, the tether device <NUM> includes the tether line <NUM> (such as elongated cord, wire or a suture) that extends from the handle component <NUM> (or other proximal position of the delivery catheter <NUM> that is controllable from outside of the body), through a hole <NUM> or recess formed in a distal portion of the first tubular component <NUM>, and to an attachment point <NUM> on the arm portion <NUM>. As shown in <FIG> and <FIG>, the tether line <NUM> is secured (such as by a loop) to the arm portion <NUM> at the attachment point <NUM>. When transitioning the articulation assembly <NUM> from the closed (delivery) state to the open (deployed) state, the tether line <NUM> can be relaxed or slackened via the actuator <NUM>, allowing the shape-set elbow portion <NUM> to resume or return to its shape memory state and thereby causing the arm portion <NUM> to be angled away from the first tubular component <NUM> (e.g., in a non-parallel direction with respect to the longitudinal axis LA1). Once deployed, adjustment of the extension angle AEX is possible by tightening (e.g., retracting) or relaxing/slackening (e.g., advancing) the tether line <NUM> until a desired extension angle AEX is achieved that orients or aligns the prosthetic valve device <NUM> for deployment in a target native valve. Likewise, the articulation assembly <NUM> transitions from the open (deployed) state to the closed (delivery) state when the tether line <NUM> is retracted, causing flexion of the elbow portion <NUM> until the arm portion <NUM> is generally parallel with the longitudinal axis LA1 (e.g., the extension angle AEX is substantially <NUM> degrees).

Referring to <FIG> and <FIG>, the articulation assembly <NUM> and/or the first tubular component <NUM> can be a tubular structure having a shape memory property comprising a nickel titanium alloy (e.g., nitinol) multi-filar stranded wire with a lumen therethrough, such as, for example, as sold under the trademark HELICAL HOLLOW STRAND (HHS), and commercially available from Fort Wayne Metals of Fort Wayne, Indiana. In another embodiment, the articulation assembly <NUM> and/or the first tubular component <NUM> can be a nitinol tube with a laser cut pattern in an elbow portion (e.g. interrupted spiral) that permits articulation thereof. The articulation assembly and/or portions thereof (e.g., the arm portion <NUM>, the elbow portion <NUM>) may be formed from a variety of different types of materials, may be arranged in a single or dual-layer configuration, and may be manufactured with a selected tension, compression, torque, pitch direction, or other characteristics. The HHS material, for example, may be cut using a laser, electrical discharge machining (EDM), electrochemical grinding (ECG), or other suitable means to achieve a desired finished component length and geometry.

Forming the articulation assembly <NUM> of nitinol multi-filar stranded wire(s) or other similar materials is expected to provide a desired level of support and rigidity to the articulation assembly <NUM> without additional reinforcement wire(s) or other reinforcement features within the articulation assembly <NUM>, thereby providing support to the prosthetic valve device <NUM> during delivery and implantation. In one embodiment, the curved shape structure of the elbow portion <NUM> can be formed from a shape memory material (e.g., nitinol) wire or tube that is shaped around a mandrel (not shown) using conventional shape-setting techniques known in the art. A desired stiffness of the articulation assembly <NUM> and/or variable stiffness of the arm and elbow portions <NUM>, <NUM> can be provided using variations in a braid or weave pattern, coiled structures, woven structures and/or wire density. For example, the stiffness of the first tubular component <NUM> and/or the articulation assembly <NUM> shown in <FIG> and <FIG> can vary along a length of the first tubular component <NUM>, the arm and elbow portions <NUM>, <NUM> and/or in transition regions therebetween. In an embodiment hereof, as described above, for example, regions at or near the arm portion <NUM> and the first tubular component <NUM> may have a greater stiffness than regions comprising the elbow portion <NUM>.

In other embodiments, the first tubular component <NUM> and/or other components of the articulation assembly <NUM> may be composed of different materials and/or have a different arrangement. For example, the elbow portion <NUM> may be formed from other suitable shape memory materials (e.g., wire or tubing besides HHS or nitinol, shape memory polymers, electro-active polymers) that are pre-formed or pre-shaped into the desired deployed state. Alternatively, the first tubular component <NUM> and/or other components of the articulation assembly <NUM> may be formed from multiple materials such as a composite of one or more polymers and metals. In still other embodiments, and as discussed in greater detail below, the articulation assembly <NUM> may not be self-expanding and is transformed between the delivery and deployed states using other suitable mechanisms or techniques (e.g., actuation of a push wire, actuation via fluid pressure and/or partial inflation, etc.).

Referring to <FIG> together, the articulation assembly <NUM> terminates with a first atraumatic tip <NUM> to facilitate introduction and movement of the arm portion <NUM> within the target heart chamber and towards the target valve region (e.g., when in the open (deployed) state) in a manner that prevents or reduces trauma to the surrounding heart tissue structures (e.g., chordae tendinae, papillary muscles, leaflets, annulus, etc.). The first atraumatic tip <NUM> can be a flexible curved or tapered tip. The curvature of the first atraumatic tip <NUM> can be varied depending upon the particular sizing/configuration of the articulation assembly <NUM> and/or the prosthetic valve device <NUM>. In some embodiments, the first atraumatic tip <NUM> may also comprise one or more radiopaque markers (not shown) and/or one or more sensors (not shown) for facilitating positioning and placement of the articulation assembly <NUM> and/or the prosthetic valve device <NUM> by the clinician or operator. In one embodiment, the first atraumatic tip <NUM> can be part of the articulation assembly <NUM> (e.g., an extension of or integral with the arm portion <NUM>). In one example, the first atraumatic tip <NUM> can be a more flexible tapered portion (e.g., about <NUM> to about <NUM>) of a terminal end of the arm portion <NUM>. In another embodiment, the first atraumatic tip <NUM> can be a separate component that may be affixed to a terminal end <NUM> of the arm portion <NUM> and/or articulation assembly <NUM> via adhesive, crimping, over-molding, or other suitable techniques. The first atraumatic tip <NUM> can be made from a polymer material (e.g., a polyether block amide copolymer sold under the trademark PEBAX, or a thermoplastic polyether urethane material sold under the trademarks ELASTHANE or PELLETHANE), or other suitable materials having the desired properties, including a selected durometer. In other embodiments, the first atraumatic tip <NUM> may be formed from different material(s) and/or have a different arrangement. In other embodiments, the first atraumatic tip <NUM> may be steerable, i.e., include a steering mechanism, in order to aid in the alignment and adjustment of a position of the valve device <NUM> within the native valve region. In an embodiment, the steering mechanism may include a pull-wire, such as a pull-wire <NUM> discussed below, coupled to the first atraumatic tip <NUM> that it is actuatable to steer the tip.

Referring to back to <FIG>, the delivery catheter <NUM> also includes a second tubular component or elongated shaft <NUM> extending parallel with the first tubular component <NUM> from the handle component <NUM> to the distal segment <NUM> of the delivery catheter <NUM>. The second tubular component <NUM> can also have a generally hollow body that extends between the handle component <NUM> and the distal segment <NUM> and which can define therethrough a lumen (not shown) configured to slidably receive a guidewire (not shown). As would be understood by one of skill in the art, the delivery catheter <NUM> having the articulation assembly <NUM> may be tracked over an indwelling guidewire to a target location adjacent a damaged or diseased heart valve when in the delivery configuration of <FIG> and <FIG>. The first and second tubular components <NUM>, <NUM> may be formed from the same or similar types of materials and include similar manufacturing features that impart a selected tension, compression, torque, pitch direction, and/or other characteristics. In certain embodiments, the second tubular component <NUM> provides an elongated shaft configured to receive a guidewire in a lumen (not shown) provided therethrough. In other embodiments, the second tubular component <NUM> may be steerable itself such that the distal segment <NUM> of the delivery catheter <NUM> may be tracked to the treatment site without the aid of a guidewire (not shown).

As shown in <FIG>, the delivery catheter <NUM> can further include a second atraumatic tip or distal tip <NUM>, coupled to a distal end <NUM> of the second tubular component <NUM>. The second atraumatic tip <NUM> provides a flexible curved or tapered tip to the delivery catheter <NUM> to permit it to be advanced through the vasculature without causing intravascular trauma during introduction, tracking and delivery of the delivery catheter, and specifically the prosthetic valve device <NUM>, to a target location. The second atraumatic tip <NUM> is a separate component that may be affixed to the distal end <NUM> of the second tubular component <NUM> via adhesive, crimping, over-molding, or other suitable techniques. As illustrated in <FIG>, the second atraumatic tip <NUM> has a cross-sectional dimension or outer diameter D<NUM> generally similar to and aligned with a cross-sectional dimension or outer diameter D<NUM> of the outer tubular component <NUM>, and is spaced from the distal end <NUM> of the outer tubular component <NUM> such that a recessed segment <NUM> of the delivery catheter <NUM> is defined there between. The second atraumatic tip <NUM> can be made from similar materials as those described above for the first atraumatic tip <NUM>.

In one embodiment, the second atraumatic tip <NUM> can include a passage (not shown) aligned with the lumen of the second tubular component <NUM> for facilitating an over-the-wire ("OTW") delivery of the delivery catheter <NUM> to a target location. For example, the second atraumatic tip <NUM> may define a distal opening or port <NUM> for receiving a guidewire for delivery of the delivery catheter <NUM> using OTW techniques. In other embodiments, a delivery catheter in accordance herewith may be adapted to have a guidewire lumen along only a distal segment thereof so as to be suitable for use with rapid-exchange ("RX") techniques. In additional embodiments, the first and/or second atraumatic tips <NUM>, <NUM> or other features associated with the first and/or second tubular components <NUM>, <NUM> and/or articulation assembly <NUM> (e.g., arm portion <NUM>, elbow portion <NUM>) can include radiopaque markers and/or be formed of radiopaque materials (e.g., barium sulfate, bismuth trioxide, bismuth subcarbonate, powdered tungsten, powdered tantalum, or various formulations of certain metals, including gold and platinum) that are capable of being fluoroscopically imaged to allow a clinician to determine if the articulation assembly <NUM> is appropriately placed and/or deployed within or adjacent the target heart valve (e.g., mitral valve).

In operation, the delivery catheter <NUM> can be configured to allow locational adjustment of the orientation and placement of the prosthetic valve device <NUM> for repair or replacement of a diseased or damaged native valve or prior implanted prosthetic valve in a patient, such as in a patient suffering from mitral valve prolapse illustrated in <FIG>. For example, the articulation assembly <NUM> can be adjusted via extension and flexion of the elbow portion <NUM>, as discussed above, allowing fine control over the orientation and placement of the prosthetic valve device <NUM> with respect to the target native valve structure. Further, the articulation assembly <NUM> can stably position a prosthetic valve device <NUM> within a native mitral valve using a retrograde approach (e.g., through the aortic valve into the left ventricle) in an atraumatic manner (e.g., without unintentional damage to the aortic valve, left ventricle or native mitral valve tissue). Accordingly, the catheters and methods described can also provide a clinician or operator with improved control and placement of the prosthetic valve device <NUM> for implantation at the native mitral valve during delivery across the aortic valve using a retrograde approach.

<FIG> are sectional cut-away views of the heart <NUM> illustrating a retrograde approach for delivering and positioning a mitral valve prosthesis 101A using the delivery system <NUM> of <FIG> and in accordance with an embodiment hereof. Referring to <FIG> together, the distal segment <NUM> of the delivery catheter <NUM> having the articulation assembly <NUM> is shown positioned in the left ventricle LV, and the outer tubular component <NUM> housing the first and second tubular components <NUM>, <NUM> of the delivery catheter <NUM> is shown in an intravascular path extending from the aortic arch AA, through the ascending aorta A, and crossing the aortic valve AV. Intravascular access to the aortic arch AA and ascending aorta A can be achieved via a percutaneous access site in a femoral, brachial, radial, or axillary artery. Referring back to <FIG>, and as is known in the art, the handle component <NUM>, as well as some length of a proximal segment of the delivery catheter <NUM>, are exposed externally of the patient for access by a clinician, even as the articulation assembly <NUM> carrying the mitral valve prosthesis 101A has been advanced fully to the targeted site (e.g., left ventricle LV) in the patient. By manipulating the handle component <NUM> (<FIG>) of the delivery catheter <NUM> from outside the vasculature, a clinician may advance and remotely manipulate and steer the distal segment <NUM> of the delivery catheter <NUM> through the sometimes tortuous intravascular path.

Referring back to <FIG>, the articulation assembly <NUM> of the delivery catheter <NUM> may be advanced into the left ventricle LV and positioned generally below (e.g., downstream) of the mitral valve MV. Optionally, and as shown in <FIG>, a guidewire <NUM> may be used over which the delivery catheter <NUM> (e.g., via the second tubular component <NUM> and second atraumatic tip <NUM>) may be slidably advanced. In a next delivery step shown in <FIG>, the articulation assembly <NUM> is transitioned from the closed (delivery) state to the open (deployed) state in which the arm portion <NUM> is angled away from the longitudinal axis LA1 of the first tubular component <NUM>. As described above, actuation of the tether device <NUM> provides slack in the tether line <NUM> thereby allowing extension of the elbow portion <NUM> (e.g., to bias toward or return to a pre-shaped or shape set configuration). As illustrated, the extension angle AEX is less than <NUM>° when orienting the mitral valve prosthesis 101A with respect to the native mitral valve MV. In this phase of delivery, the mitral valve prosthesis 101A is positioned within the left ventricle LV and generally below (e.g., downstream) of the native mitral valve MV. In a next delivery step shown in <FIG>, the delivery catheter <NUM> is partially retracted along the intravascular path to bring the arm portion <NUM> carrying the mitral valve prosthesis 101A into proximity to and/or apposition with the mitral valve annulus AN and/or leaflets LF. For example, movement of the delivery catheter <NUM> in the proximal direction (along arrow <NUM>) translates to movement of the arm portion <NUM> in the direction of arrow <NUM> toward the mitral valve anatomy.

In another embodiment shown in <FIG>, the second atraumatic tip <NUM> can include a steering mechanism configured to manipulate/steer the distal segment <NUM> of the delivery catheter <NUM>. The steering mechanism may include a pull-wire <NUM> coupled to the second atraumatic tip <NUM>. The pull-wire <NUM> may extend within the outer tubular component <NUM> and to the handle component <NUM> (<FIG>) where it is actuatable via remote actuation, e.g., via an actuator such as a knob, pin, or lever. In an embodiment, with articulation assembly <NUM> in the delivery/closed state, the distal segment <NUM> can be selectively adjusted (via the pull-wire <NUM> acting upon the tip <NUM>) in a first direction (e.g. along arrow <NUM>) within the left ventricle, for e.g., to provide adequate space for transition of the articulation assembly <NUM> from the delivery/closed state to the deployed/open state. In an embodiment, with articulation assembly <NUM> in the deployed/open state, the valve prosthesis 501A can be aligned with the native valve region with adjustment of the distal segment <NUM> via the pull-wire <NUM> acting upon the tip <NUM>. Accordingly, a clinician can deflect the second atraumatic tip <NUM> in a first direction (e.g., along arrow <NUM>) to move the arm portion <NUM> and the valve prosthesis 501A when in the deployed state further into the left ventricle in the direction of arrow <NUM> and out of the native mitral valve region. Likewise, a clinician can deflect the distal second atraumatic tip <NUM> in a second direction (e.g., in the direction of arrow <NUM>) to move the arm portion <NUM> (in the deployed state) and the valve prosthesis 501A in the direction of arrow <NUM> and into the native mitral valve region.

Once the mitral valve prosthesis 101A is positioned within the mitral valve MV, the mitral valve prosthesis 101A can be deployed for implantation. In one embodiment, the mitral valve prosthesis 101A can include a self-expanding frame that is restrained in a low-profile or compressed configuration during delivery and positioning of the device. The self-expanding frame of the mitral valve prosthesis 101A can be retained in the compressed configuration and controllably released for expansion/implantation, for example, using a cinch device <NUM> that is only shown in <FIG> for ease of illustration. The cinch device <NUM> can have one or more loops disposed about at least a portion of the self-expanding frame such that constriction or expansion/removal of the one or more loops controls compression or expansion of the frame. Examples of suitable cinch devices for retaining self-expanding prosthetic frames are described in <CIT>. Upon successful implantation of the mitral valve prosthesis 101A, the cinch device <NUM> is fully removed and the delivery catheter <NUM> is advanced (e.g., in the direction of arrow <NUM>) to disengage the arm portion <NUM> from the mitral valve region in the direction of arrow <NUM> and move it further into the left ventricle LV.

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 mitral valve prosthesis 101A at the target native valve region. For example, once the articulation assembly <NUM> is positioned within the left ventricle LV (<FIG>), such image guidance technologies can be used to transition the articulation assembly <NUM> into the open (deployed) state wherein the extension of the elbow portion <NUM> causes the arm portion <NUM> to orient the mitral valve prosthesis 101A toward the mitral valve MV such that an inflow region 501A of the mitral valve prosthesis 101Ais aligned with the region of coaptation of the leaflets (<FIG> and <FIG>). In another embodiment, selected outer surfaces of the articulation assembly <NUM> and the distal segment <NUM> can be treated such that the echogenicity of the articulation assembly <NUM> and the distal segment <NUM> is enhanced. Image guidance technologies can be further used during partial retraction of the delivery catheter <NUM> in a proximal direction along arrow <NUM> (e.g., without removing the articulation system <NUM> from the left ventricle LV) to move the inflow region 501A and/or other portions of the mitral valve prosthesis 101A into position within and/or adjacent to the native mitral valve MV for deployment and implantation (<FIG>). Additionally, image guidance technologies can be used to deploy and implant the mitral valve prosthesis 101A within the mitral valve anatomy prior to removal of the delivery catheter <NUM> from the body of the patient. In some embodiments, image guidance components (e.g., IVUS, OCT) can be coupled to the distal segment <NUM> of the delivery catheter <NUM> to provide three-dimensional images of the vasculature proximate to the target heart valve region to facilitate positioning, orienting and/or deployment of the mitral valve prosthesis 101A within the heart valve region.

To adjust the position of the mitral valve prosthesis 101A with respect to the mitral valve MV, a clinician can incrementally advance (e.g., push) or retract (e.g., pull) the handle component <NUM> (<FIG>) of the delivery catheter <NUM> to adjust the position of the arm portion <NUM> within the left ventricle LV and/or within the mitral valve MV. Accordingly, a clinician can advance the delivery catheter <NUM> in a distal direction (e.g., along arrow <NUM>) to move the arm portion <NUM> when in the deployed state further into the left ventricle LV (<FIG>). Likewise, a clinician can retract the delivery catheter <NUM> in a proximal direction (e.g., in the direction of arrow <NUM>) to move the arm portion <NUM> (in the deployed state) in the direction of arrow <NUM> and into the native mitral valve region (<FIG>). Referring to <FIG>, after the mitral valve prosthesis 101A is allowed to expand (not shown), the delivery system <NUM> can still be connected to the mitral valve prosthesis 101A (e.g., system eyelets, not shown, are connected to the device eyelets) so that the operator can further control the placement of the mitral valve prosthesis 101A as it returns toward the expanded configuration. Alternatively, the mitral valve prosthesis 101A may not be connected to the delivery system <NUM> by anything other than the cinch device <NUM>, such that the mitral valve prosthesis 101A deploys and is fully released from the delivery system <NUM> once the cinch device <NUM> is removed.

Further adjustments with respect to the orientation of the arm portion <NUM> (and thereby the mitral valve prosthesis 101A) can be made by adjusting the extension angle AEX via actuation of the tether device <NUM>. Referring to <FIG> and <FIG>, tensioning (e.g., retracting) and relaxing (e.g., advancing) the tether line <NUM> can decrease and increase the extension angle AEX, respectively, to alter the trajectory of the arm portion <NUM> when subsequently moved in a upward direction along arrow <NUM>. Further adjustment of the tether line <NUM> can be made once the mitral valve prosthesis 101A is positioned within the native mitral valve MV and during the deployment of the mitral valve prosthesis. With reference to <FIG> together, a clinician can, in real time, determine a desired target point at which to position the mitral valve prosthesis 101A within the mitral valve MV (e.g., at a center of the valve, at a region of leaflet coaptation, etc.) and retract/advance the delivery catheter <NUM> to move the arm portion <NUM> along arrows <NUM> and/or <NUM>, and retract or advance the tether line <NUM> to adjust the extension angle AEX and thereby adjust the trajectory of a subsequently advanced arm portion <NUM>.

Following delivery, placement and implantation of the mitral valve prosthesis 101A within the mitral valve MV (or other desired valve location), the delivery catheter <NUM> and remaining guidewire (if any) can be removed from the heart <NUM> and out of the body of the patient. For example, once successful implantation of the mitral valve prosthesis 101A is achieved, the articulation assembly <NUM> can be returned to the closed (delivery) state via flexion of the elbow portion <NUM> (e.g., retraction of the tether line <NUM>) and the distal segment <NUM> of the delivery catheter <NUM> can be retracted proximally through the vasculature and removed from the body, as would be understood by one of skill in the art. In some instances, a protective sheath, other than the outer tubular component <NUM>, may be advanced at least partially over the distal segment <NUM> of the delivery catheter <NUM> to protect the vascular structure during removal of the delivery catheter <NUM>.

<FIG> and <FIG> are enlarged partial sectional views of a distal segment <NUM> of a delivery catheter <NUM> for use with the heart valve prosthesis delivery system <NUM> of <FIG> shown in delivery and deployed states, respectively, and in accordance with another embodiment hereof. The delivery catheter <NUM> includes features generally similar to the features of the delivery catheter <NUM> described above with reference to <FIG>. For example, the delivery catheter <NUM> includes a first tubular component <NUM> and an articulation assembly <NUM> at a distal end <NUM> of the first tubular component <NUM>, wherein the articulation assembly <NUM> is reversibly receivable within a recessed segment or space <NUM> of the distal segment <NUM>. The articulation assembly <NUM>, shown in <FIG> in a closed (delivery) state and in <FIG> in an open or outwardly angled (deployed) state, includes an arm portion <NUM>, having an atraumatic tip or end <NUM>, configured to carry a prosthetic valve device (not shown) and an elbow or hinge portion <NUM> coupling the arm portion <NUM> to the first tubular component <NUM>. However, in the embodiment shown in <FIG> and <FIG>, the delivery catheter <NUM> does not include a tether device <NUM> (<FIG>) for actuating the transition of the articulation assembly <NUM> between the open/delivery and closed/deployed states.

In the embodiment illustrated in <FIG> and <FIG>, the delivery catheter <NUM> includes a second tubular component <NUM> coupled to a distal tip portion <NUM> having a proximal facing recess <NUM> or bore that is configured to receive the elbow portion <NUM> when in flexion (e.g., in the delivery state). Accordingly, the elbow portion <NUM> is restrained in flexion between an outer wall <NUM> of the second tubular member <NUM> and a flange <NUM> that forms the recess <NUM> within the distal tip portion <NUM>. As described above with respect to the articulation assembly <NUM> shown in <FIG>, the articulation assembly <NUM> can be comprised of a material (e.g., nitinol) and processed to have a shape-set or shape memory, such that when not restrained, will return the articulation assembly <NUM> to a non-biased state. Accordingly, the elbow portion <NUM> can be in flexion when restrained within the recess <NUM> (<FIG>), and in a degree of extension or outwardly angled when restraint on the articulation assembly <NUM> is at least partially removed (<FIG>).

Referring to <FIG>, the second tubular component <NUM> can include an outer tubular member <NUM> and an inner tubular member <NUM> that resides within the outer tubular member <NUM> and which extends distally beyond a terminal end <NUM> of the outer tubular member <NUM> and through the distal tip portion <NUM>. The inner tubular member <NUM> can be longitudinally translatable relative to the outer tubular member <NUM> to advance or retract the distal tip portion <NUM> with respect to the distal end <NUM> of the outer tubular member <NUM>. The inner tubular member <NUM> may be affixed to the distal tip portion <NUM> via adhesive or other suitable technique. Furthermore, the inner tubular member <NUM> can define a guidewire lumen <NUM> through the second tubular component <NUM> and the distal tip portion <NUM> to facilitate OTW or RX delivery of the delivery catheter <NUM> to a target location (e.g., within the left ventricle LV).

In an alternative arrangement, the second tubular component <NUM> does not include the inner tubular member <NUM> and the distal tip portion <NUM> can be attached directly to the terminal end <NUM> of the outer tubular member <NUM>. In this arrangement, the second tubular component <NUM> can be longitudinally translatable relative to the delivery catheter <NUM> within the outer tubular component <NUM> of the delivery catheter <NUM>, for example, to advance or retract the distal tip portion <NUM> with respect to the articulation assembly <NUM>, thereby releasing or restraining the self-expanding elbow portion <NUM> of the articulation assembly <NUM> by corresponding movement thereof.

Referring to <FIG> and <FIG> together, the distal tip portion <NUM> is configured to advance distally along arrow <NUM> and with respect to the second tubular component <NUM> and/or the delivery catheter <NUM> such that the elbow portion <NUM> is at least partially released from the restraint or confines of the recess <NUM>. The elbow portion <NUM> is released from restraint proportionally to the distance the distal tip portion <NUM> outwardly moves in the direction of arrow <NUM>. Stated another way, the arm portion <NUM> moves outwardly in the direction of arrow <NUM> (e.g., away from a longitudinal axis LA2 of the first tubular member <NUM>) as the distal tip portion <NUM> is advanced in the direction of arrow <NUM> (<FIG>). Accordingly, the extension angle AEX increases as the articulation assembly <NUM> is transitioned from the closed (delivery) state (e.g., wherein the extension angle AEX is substantially <NUM> degrees) to the open (deployed) state. When orienting the arm portion <NUM> to deliver a prosthetic valve device <NUM> to the mitral valve using a retrograde approach, the extension angle AEX can be less than about <NUM> degrees. Once deployed, the extension angle AEX of the articulation assembly <NUM> may be incrementally adjusted by advancing or retracting the distal tip portion <NUM> until the prosthetic valve device (not shown) is aligned with the native heart valve (e.g., the mitral valve). Returning the delivery catheter <NUM> from the deployed configuration to the delivery configuration can be accomplished by longitudinally translating the inner tubular member <NUM> in a proximal direction such that the distal tip portion <NUM> is retracted. The elbow portion <NUM> of the articulation assembly <NUM> may be recaptured within the proximal facing recess <NUM> such that the arm portion <NUM> returns to a position generally parallel to the first tubular component <NUM>.

<FIG> is a partial side view of a distal segment <NUM> of a delivery catheter <NUM> for use with a heart valve prosthesis delivery system <NUM> shown in a delivery configuration and in accordance with yet another embodiment hereof. <FIG> is a partial sectional view of the delivery catheter <NUM> of <FIG> shown in a deployed configuration. The delivery catheter <NUM> includes features generally similar to the features of the delivery catheter <NUM> described above with reference to <FIG>. For example, the delivery catheter <NUM> includes an elongated tubular component <NUM> and an articulation assembly <NUM> at a distal end of the elongated tubular component <NUM>. The delivery catheter <NUM> also includes a tether device <NUM> generally similar to the tether device <NUM> (<FIG>) for actuating the transition of the articulation assembly <NUM> between the closed/delivery (<FIG>) and open/deployed (<FIG>) states. However, in the embodiment shown in <FIG> and <FIG>, the delivery catheter <NUM> does not include a second tubular component <NUM> (<FIG>).

In the embodiment illustrated in <FIG> and <FIG>, the delivery catheter <NUM> includes a second atraumatic tip <NUM> coupled to a distal end portion <NUM> of the delivery catheter <NUM> to prevent intravascular trauma during delivery of the prosthetic valve device <NUM> to a target location. The second atraumatic tip <NUM> can be a separate component that may be affixed to the distal end portion <NUM> of the delivery catheter <NUM> via adhesive, crimping, over-molding, or other suitable techniques, and can be formed from the same or similar materials as discussed previously with respect to the first and second atraumatic tips <NUM>, <NUM>. In some instances, the distal end portion <NUM> of the delivery catheter <NUM> may also generally correspond to at least a portion of the elbow portion <NUM> of the articulation assembly <NUM>.

Referring to <FIG>, the elongated tubular component <NUM> can include an outer tubular member <NUM> and an inner tubular member <NUM> that resides within the outer tubular member <NUM>. An end segment of the outer tubular member <NUM> may form an elbow portion <NUM> and an arm portion <NUM> of the delivery catheter <NUM>, as similarly described above with reference to tubular component <NUM>. <FIG> is an enlarged cross-sectional view of the distal segment <NUM> of the delivery catheter <NUM> of <FIG> at plane line C-C. Referring to <FIG> together, the inner tubular member <NUM> can also have a generally hollow body that extends between the handle component <NUM> (<FIG>) and the distal segment <NUM> and which can define therethrough a guidewire lumen <NUM> configured to slidably receive a guidewire (not shown) for delivering the delivery catheter <NUM> to a target location in the heart. As shown in <FIG>, the guidewire lumen <NUM> generally aligns with a passage <NUM> through the second atraumatic tip <NUM> for facilitating an OTW or RX delivery of the delivery catheter <NUM> to a target location. For example, the second atraumatic tip <NUM> may define a distal opening <NUM> for receiving a guidewire for tracking of the delivery catheter <NUM> over a guidewire using OTW or RX techniques. A lumen <NUM> defined by the outer tubular member <NUM> accommodates the inner tubular member <NUM> as well as other features of the delivery catheter <NUM> such as, for example, tether lines <NUM> of the tether device <NUM>. In other arrangements, not shown, the lumen <NUM> may also accommodate other structures such as a guidewire (not shown) that is advanced through the articulation assembly <NUM> (e.g., the elbow portion <NUM> and the arm portion <NUM>) and exits the first atraumatic tip <NUM> to facilitate delivery of the prosthetic valve device <NUM> within the target native valve (e.g., mitral valve).

<FIG> and <FIG> are side views of distal segments <NUM>, <NUM> of delivery catheters <NUM>, <NUM> for use with the heart valve prosthesis delivery system <NUM> of <FIG> shown in deployed configurations in accordance with further embodiments hereof. The delivery catheters <NUM>, <NUM> include features generally similar to the features of the delivery catheter <NUM> described above with reference to <FIG>. For example, the delivery catheters <NUM>, <NUM> include a first tubular component <NUM>, <NUM> and an articulation assembly <NUM>, <NUM> at a distal end <NUM>, <NUM> of the first tubular component <NUM>, <NUM>. The delivery catheters <NUM>, <NUM> also include a second tubular component <NUM>, <NUM> and a second atraumatic tip <NUM>, <NUM> generally similar to the second tubular component <NUM> and the second atraumatic tip <NUM> of the delivery catheter <NUM> (<FIG>).

The articulation assemblies <NUM>, <NUM>, shown in <FIG> and <FIG> in an open or angled outward (deployed) state (e.g., when the delivery catheters <NUM>, <NUM> are in deployed configurations), include an arm portion <NUM>, <NUM> configured to carry a prosthetic valve device <NUM> and an elbow portion <NUM>, <NUM> coupling the arm portion <NUM>, <NUM> to the first tubular component <NUM>, <NUM>. However, in the embodiments shown in <FIG> and <FIG>, the articulation assemblies <NUM>, <NUM> do not have a shape memory, or stated another way, the elbow portions <NUM>, <NUM> are not shape-set to return to an open or outwardly angled state when unrestrained.

In the embodiment illustrated in <FIG>, the elbow portion <NUM> comprises a hinged joint <NUM>, such as a ball-and-socket hinge mechanism. As shown, a ball component <NUM> is coupled/attached to a proximal end <NUM> of the arm portion <NUM>, and a corresponding recessed socket <NUM> is formed a terminal end of the first tubular component <NUM> to accommodate the ball component <NUM>. Accordingly, the ball component <NUM> may rotate within the recessed socket <NUM> to transition the arm portion <NUM> along an extension path between closed and opened states. Referring to <FIG>, the arm portion <NUM> is reversible between an outward extended or open state and an inward closed state by translation of one or more elongated elements with sufficient columnar stiffness to act as push/pull mechanisms, such as one or more sufficiently stiff wire <NUM>. The wire <NUM> is at least partially disposed within the first tubular component <NUM> of the delivery catheter <NUM>. The wire <NUM> can be attached to a cuff or collar <NUM> about the arm portion <NUM> to form an attachment point <NUM> for affecting the position of the arm portion <NUM> with respect to the first tubular component <NUM>. In one embodiment, the wire <NUM> extends from the handle component <NUM> (<FIG>) and can be deployable via remote actuation, e.g., via an actuator <NUM> (<FIG>). The wire <NUM> exits the first tubular component <NUM> through a hole <NUM> or recess formed in the first tubular component <NUM> and extends to the attachment point <NUM> (e.g., the wire <NUM> is coupled to the collar <NUM>) on the arm portion <NUM>.

When transitioning of the articulation assembly <NUM> from the closed (delivery) state to the open (deployed) state is desired, the wire <NUM> can be advanced via the actuator <NUM>, causing extension of the elbow portion <NUM> by pushing the arm portion <NUM> in a direction away from the first tubular component <NUM>. Once deployed, adjustment of the extension angle AEX is possible by retracting or advancing the wire <NUM> until a desired extension angle AEX is achieved that orients the prosthetic valve device <NUM> for deployment in a target native valve. Likewise, the articulation assembly <NUM> transitions from the open (deployed) state to the closed (delivery) state when the wire <NUM> is retracted, causing flexion of the elbow portion <NUM> by activation of the hinged joint <NUM>, until the arm portion <NUM> is generally parallel with a longitudinal axis LA3 (e.g., the extension angle AEX is substantially <NUM> degrees).

Referring back to the embodiment illustrated in <FIG>, the elbow portion <NUM> comprises a flexible bellows connector <NUM> having concertinaed sides to allow expansion and contraction as well as lateral and angular movement. In one embodiment, the bellows connector <NUM> allows the arm portion <NUM> to be reversibly opened or closed using a pressurized fluid source such as an inflation fluid source <NUM> (<FIG>) that can be operatively coupled to the delivery catheter <NUM>. For example, the first tubular component <NUM> can define and/or house an inflation lumen (not shown) through which pressurized air or other fluid can flow. As the pressurized fluid flows through the bellows connector <NUM>, a partial pressure increase in the flexible region can cause outward extension of the bellows connector <NUM>, thereby transitioning the arm portion <NUM> into an open (delivery) state. Once deployed, adjustment of the extension angle AEX may be obtained by reducing or increasing fluid pressure within the bellows connector, e.g., by controlling fluid flow from the inflation fluid source <NUM> (<FIG>). Likewise, the articulation assembly <NUM> can be configured to transition from the open (deployed) state to the closed (delivery) state when fluid flow is ceased. In certain arrangements, the bellows connector <NUM> can be accompanied by a hinge mechanism (not shown) along the length of the bellows connector <NUM> which is strong enough to accept the pressure generated thrust but will allow angular movement in a single plane (e.g., along a desired extension path). In an alternative arrangement, the delivery catheter <NUM> can include a wire mechanism similar to the wire <NUM> and collar <NUM> described with respect to the embodiment of <FIG> instead of or in addition to the pressurized fluid source for extending the bellows connector <NUM> during deployment of the articulation assembly <NUM>.

While the elbow portions <NUM>/<NUM> are described with reference to <FIG> as either a hinged joint <NUM> or a flexible bellows connector <NUM>, this is not meant to be limiting, and the elbow portion may be comprised of additional designs including, but not limited to a wound coil, or other designs suitable for the purposes described herein.

Further illustrated in <FIG> is a tether device <NUM> for returning the arm portion <NUM> to a closed (delivery) state. As described above with respect to the method steps for deployment of the mitral valve prosthesis 101A (<FIG>), the tether device <NUM> can have a tether line <NUM> that has a loop <NUM> that is disposed about a midportion of the arm portion <NUM>. The tether line <NUM> can extend from a hole <NUM> in the first tubular component <NUM> and to the handle component <NUM> (<FIG>) where it is actuatable via remote actuation, e.g., via an actuator <NUM> (<FIG>). As well, as previously described above, the prosthetic valve device may be held in its compressed delivery state by a cinch device (not shown), wherein examples of suitable cinch devices for retaining self-expanding prosthetic frames are described in <CIT>. Upon successful implantation of the prosthetic valve device <NUM>, any cinch device is fully removed.

Embodiments of delivery systems, delivery catheters, and associated methods in accordance with the present technology incorporating balloon-expandable prosthetic valve devices are described below with reference to <FIG> and <FIG>.

<FIG> illustrate a distal segment <NUM> of a delivery catheter <NUM> for use with the heart valve prosthesis delivery system <NUM> of <FIG> in accordance with another embodiment hereof. Referring to <FIG>, the delivery catheter <NUM> includes features generally similar to the features of the delivery catheter <NUM> described above with reference to <FIG>. For example, the delivery catheter <NUM> includes a first tubular component <NUM> and an articulation assembly <NUM> at a distal end <NUM> of the first tubular component <NUM>. The delivery catheter <NUM> also include a second tubular component <NUM> and a second atraumatic tip <NUM> generally similar to the second tubular component <NUM> and the second atraumatic tip <NUM> of the delivery catheter <NUM> (<FIG>). As shown in <FIG>, the second tubular component <NUM> and the second atraumatic tip <NUM> provide a guidewire lumen (not shown) therethrough for slidably receiving a guidewire <NUM> for OTW or RX delivery of the delivery catheter <NUM>.

The articulation assembly <NUM> further includes an elbow portion <NUM> which couples an arm portion <NUM> to the first tubular component <NUM>. In one embodiment, the articulation assembly <NUM> is shape set to return to an open state such that a restraint mechanism (e.g., tether device <NUM> shown in <FIG>, etc.) is used to retain the elbow portion <NUM> in a state of flexion in which the arm portion <NUM> is generally parallel to the first tubular component <NUM> (not shown). In another arrangement, the elbow portion does not have a shape memory (is not shape set) and the elbow portion <NUM> can be a hinge mechanism that is actuated by a wire, fluid pressure, or other mechanism as previously described.

The delivery catheter <NUM> differs from the delivery catheter <NUM> for at least the reason that i) the articulation assembly <NUM> deploys in two phases, and ii) the arm portion incorporates a balloon assembly <NUM> over which a balloon-expandable prosthetic valve device <NUM> is disposed and crimped in a low profile delivery configuration, wherein the balloon assembly <NUM> is configured for deploying the balloon-expandable prosthetic valve device <NUM> within the native valve region (e.g., mitral valve) as described below. In a first phase of deployment, the arm portion <NUM> angles away from the longitudinal axis LA4 of the first tubular component <NUM> by an extension angle AEX (<FIG>). In a second phase of deployment, a length L<NUM> of the arm portion <NUM> (<FIG>) is extended to a deployed length L<NUM> (<FIG>). The deployed length L<NUM> facilitates positioning of the balloon-expandable prosthetic valve device <NUM> within the native valve region, such as the mitral valve.

The arm portion <NUM> is configured to carry the balloon-expandable prosthetic valve device <NUM> along the length L<NUM> thereof (<FIG>). <FIG> is a sectional side view of the arm portion <NUM> of the articulation assembly <NUM> of <FIG>. Referring to <FIG> and <FIG> together, the arm portion <NUM> includes an outermost tubular member <NUM> and an inflation tubular member <NUM> residing in the outermost tubular member <NUM>. The outermost tubular member <NUM> can be integral with the elbow portion <NUM> and the first tubular component <NUM> as shown in <FIG>. In other arrangements, the outermost tubular member <NUM> can be a separate component that is coupled to the elbow portion <NUM>. The inflation tubular member <NUM> extends from the handle component <NUM> (<FIG>) of the delivery catheter <NUM>, through the first tubular component <NUM>, the elbow portion <NUM>, and to a proximal arm segment <NUM>. As can best be seen in <FIG>, the inflation tubular member <NUM> can be longitudinally translatable relative to the outermost tubular member <NUM> to extend or shorten the length L<NUM>, L<NUM> of the arm portion <NUM> at the proximal arm segment <NUM>. Stated another way, advancement of the inflation tubular member <NUM> with respect to the outermost tubular member <NUM> advances the prosthetic valve device <NUM> in a non-axial direction with respect to the longitudinal axis LA4 of the first tubular component <NUM>. In an alternative embodiment, the inflation tubular member <NUM> may be rotatable relative to the outermost tubular member <NUM>. The inflation tubular member <NUM> may be rotatable via remote actuation, e.g., via an actuator such as a knob, pin, or lever carried by the handle component <NUM>. In the deployed/open state, the valve device <NUM> can be rotationally aligned with the native valve region with rotational adjustment of the inflation tubular member <NUM>.

Referring back to <FIG>, the delivery catheter <NUM> further includes an inflation lumen <NUM> along the length of the inflation tubular member <NUM>, and which begins at the handle component <NUM> (<FIG>) and terminates in fluid communication with a balloon <NUM> of the balloon assembly <NUM>. The inflation lumen <NUM> facilitates pressurized air or other fluid flow from the inflation fluid source <NUM> (<FIG>) to the balloon <NUM> of the arm portion <NUM>. The balloon <NUM> may be an inflatable device or vessel over which the balloon-expandable prosthetic valve device <NUM> is positioned. For example, the prosthetic valve device <NUM> can be crimped on (e.g., around) the unexpanded balloon <NUM> on the arm portion <NUM>. The balloon <NUM> can be attached to the inflation tubular member <NUM> at the proximal arm segment <NUM> as shown in the <FIG>. The balloon <NUM> can further be attached to a first atraumatic tip <NUM> at a distal arm segment <NUM> to provide a sealed containment vessel for fluid expansion and deployment of the balloon-expandable prosthetic valve device <NUM>. The balloon <NUM> may be affixed to the inflation tubular member <NUM> at the proximal arm segment <NUM> and/or to the first atraumatic tip <NUM> at the distal arm segment <NUM> via adhesive, crimping, over-molding, or other suitable techniques. As shown in <FIG>, during deployment as the inflation tubular member <NUM> is advanced by a distance D<NUM> with respect to the outermost tubular member <NUM> for extending the length Li (<FIG>) of the arm portion <NUM> to the extended length L<NUM> (<FIG>), the balloon <NUM>, the prosthetic valve device <NUM> and the first atraumatic tip <NUM> are moved in the direction of the arrow <NUM> to facilitate positioning of the prosthetic valve device <NUM> within a target heart valve.

Optionally, an innermost tubular member <NUM> can reside within the inflation tubular member <NUM> and extend from the handle component <NUM> (<FIG>) of the delivery catheter <NUM> through the balloon assembly <NUM> and first atraumatic tip <NUM> to provide a guidewire lumen <NUM> therethrough (<FIG>). Referring back to <FIG> and <FIG>, a guidewire <NUM> can be received through the guidewire lumen <NUM> (<FIG>) to facilitate positioning of the prosthetic valve device <NUM> within the target heart valve during deployment. Operatively, during deployment of the balloon-expandable prosthetic valve device <NUM>, pressurized fluid from the inflation fluid source <NUM> can flow through the inflation lumen <NUM> to expand the balloon <NUM> sufficiently to fully deploy the prosthetic valve device <NUM> within the native valve region for implantation.

<FIG> illustrates a modified delivery catheter <NUM> with the self-expanding prosthetic valve device <NUM> held on a distal arm portion <NUM>' in its compressed, delivery state (by a cinch device or one or more loops of a suture/sutures) in accordance with another embodiment hereof. Referring to <FIG>, the modified delivery catheter <NUM> includes features generally similar to the features of the delivery catheter <NUM> described above with reference to <FIG>, as well as some of the features thereof described with reference to <FIG>. The modified delivery catheter <NUM> includes a distal member <NUM>' of the arm portion <NUM>' that is longitudinally translatable and/or rotatable relative to an outermost tubular member <NUM>'. The distal member <NUM>' of the arm portion <NUM>'is longitudinally translatable and/or rotatable via remote actuations, e.g., via actuators such as knobs, pins, or levers carried by the handle component <NUM>. In the deployed/open state, the valve device <NUM> can be longitudinally and/or rotationally aligned with the native valve region. For example, movement of the distal member <NUM>' in a distal or proximal direction (along arrows <NUM> and <NUM> respectively) translates to movement in the direction toward or away from the native valve region, respectively. Rotational adjustment of the distal member <NUM>' in a first or second rotational direction (along arrows <NUM> or <NUM> respectively) permits rotational alignment of the valve prosthesis <NUM> within the native valve region.

<FIG> illustrate a distal segment <NUM> of a delivery catheter <NUM> for use with a heart valve prosthesis delivery system such as the delivery system <NUM> of <FIG> in accordance with a further embodiment hereof. Referring to <FIG> together, the delivery catheter <NUM> includes features generally similar to the features of the delivery catheter <NUM> described above with reference to <FIG>. For example, the delivery catheter <NUM> includes a first tubular component <NUM> and an articulation assembly <NUM> at a distal end <NUM> of the first tubular component <NUM>. The delivery catheter <NUM> also include a second tubular component <NUM> and a second atraumatic tip <NUM> generally similar to the second tubular component <NUM> and the second atraumatic tip <NUM> of the delivery catheter <NUM> (<FIG>).

Also similar to the delivery catheter <NUM> (<FIG>), the delivery catheter <NUM> partially deploys in a first phase from a delivery configuration (<FIG>) to a partially deployed configuration (<FIG>) in which an arm portion <NUM> angles away from a longitudinal axis LA5 of the first tubular component <NUM> by an extension angle AEX (<FIG>) provided by an elbow portion <NUM>. The delivery catheter <NUM> also deploys in a second phase by extending an arm portion length L<NUM> (<FIG>) to an extended length L<NUM> (<FIG>). However, the delivery catheter <NUM> differs from the delivery catheter <NUM> in that the delivery catheter <NUM> does not include a separate inflation tubular member <NUM> for extending a length L<NUM> of the arm portion <NUM>.

As shown in <FIG>, the arm portion <NUM> includes a bellows connector <NUM> at a proximal arm segment <NUM>. The bellows connector <NUM> can be attached at a first end <NUM> to an outermost tubular member <NUM> and to a balloon <NUM> at a second end <NUM>. In the first phase of deployment, the bellows connector <NUM> is in a contracted state and has a length L<NUM> (<FIG> and <FIG>). Inflation fluid provided by an external inflation fluid source <NUM> (<FIG>) through a lumen (not shown) provided by the outermost tubular member <NUM> increases a partial pressure within the proximal arm segment <NUM>, thereby extending the bellows connector <NUM> to a length L<NUM> in an extended state (<FIG>). As the arm portion <NUM> reaches or transforms to the extended state (e.g., having length L<NUM>), the arm portion <NUM> is moved into position within the native heart valve where continued and/or increased fluid flow from the inflation fluid source <NUM> (<FIG>) inflates the balloon <NUM> to expand and deploy the balloon-expandable prosthetic valve device <NUM>, which is carried over the balloon <NUM> of the delivery catheter <NUM>. Alternatively, the arm portion <NUM> can be moved toward and/or within the native valve region prior to providing pressurized fluid flow to extend the bellows connector <NUM> (e.g., which would further advance the prosthetic valve device <NUM> into a desired position). In one embodiment, the delivery catheter <NUM> can include an innermost tubular member <NUM> (shown in dashed lines) that extends from the handle component <NUM> (<FIG>) of the delivery catheter <NUM>, through the balloon <NUM> and, optionally, through a first atraumatic tip <NUM> to provide a guidewire lumen (not shown) therethrough. Referring to <FIG>, a guidewire <NUM> can be received through the guidewire lumen to facilitate positioning of the balloon-expandable prosthetic valve device <NUM> within a target heart valve during deployment.

<FIG> are sectional cut-away views of the heart <NUM> illustrating a retrograde approach for delivering and positioning the balloon-expandable mitral valve prosthesis 1101A using the delivery catheter <NUM> of <FIG> and in accordance with an embodiment hereof. Referring to <FIG> together, the distal segment <NUM> of the delivery catheter <NUM> is shown positioned in the left ventricle LV, and the outer tubular component <NUM> housing the first and second tubular components <NUM>, <NUM> of the delivery catheter <NUM> is shown in an intravascular path extending from the aortic arch AA, through the ascending aorta A, and crossing the aortic valve AV. As discussed above, intravascular access to the aortic arch AA and ascending aorta A can be achieved via a percutaneous access site in a femoral, brachial, radial, or axillary artery. Similar to the delivery catheter <NUM> shown in <FIG>, the delivery catheter <NUM> can include the handle component <NUM> coupled to a proximal segment (not shown) of the delivery catheter <NUM> that is at least partially exposed externally of the patient as the distal segment <NUM> of the delivery catheter <NUM> carrying the mitral valve prosthesis 1101A is advanced to the left ventricle LV in the patient. By manipulating the handle component (not shown) of the delivery catheter <NUM> from outside the vasculature, a clinician may advance the delivery catheter <NUM> by remotely manipulating the distal segment <NUM> of the delivery catheter <NUM>.

Referring back to <FIG>, the articulation assembly <NUM> of the delivery catheter <NUM> may be advanced into the left ventricle LV and positioned generally below (e.g., downstream of) the mitral valve MV. Optionally, and as shown in <FIG>, a guidewire <NUM> may be used over which the delivery catheter <NUM> (e.g., via the second tubular component <NUM>) may be slidably advanced. Upon delivery of the articulation assembly <NUM> to the left ventricle LV, the articulation assembly <NUM> can be actuated (e.g., via tether device, push/pull wire, hydraulically, etc.) to move the arm portion <NUM> in the direction of the arrow <NUM> (<FIG>) such that the arm portion <NUM> is angled away from the longitudinal axis LA5 of the first tubular component <NUM> (<FIG>). As illustrated in <FIG>, the extension angle AEX is less than <NUM>° when orienting the mitral valve prosthesis 1101A with respect to the native mitral valve MV.

Referring to <FIG>, and in a next deployment step, the delivery catheter <NUM> is partially retracted along the intravascular path (e.g., in the direction of arrow <NUM>) to bring the arm portion <NUM> carrying the mitral valve prosthesis <NUM>101Ainto proximity to and/or within the native mitral valve region (e.g., in apposition with the mitral valve annulus AN and/or leaflets LF). For example, movement of the delivery catheter <NUM> in the proximal direction (along arrow <NUM>) translates to movement of the arm portion <NUM> in the direction of arrow <NUM> toward the mitral valve MV. Once the mitral valve prosthesis 1101A is positioned within or suitably near the mitral valve MV, and in a next step of deployment, the clinician can initiate pressurized fluid flow through the delivery catheter <NUM> from the inflation fluid source <NUM> (<FIG>).

As illustrated in <FIG>, inflation fluid provided by the external inflation fluid source <NUM> (<FIG>), through a lumen (not shown) defined by the outermost tubular member <NUM>, increases a partial pressure within the proximal arm segment <NUM>, and transitions the bellows connector <NUM> from the contracted state (<FIG>) having the length Ls to the extended state (<FIG>) having the length L<NUM>. Extension of the bellows connector <NUM> further advances the mitral valve prosthesis 1101A into the mitral valve region while the delivery catheter <NUM> otherwise remains stationary (e.g., stably positioned). As inflation fluid continues to flow through the delivery catheter <NUM>, the balloon <NUM> expands and initiates outward expansion of the balloon-expandable frame of the mitral valve prosthesis 1101A within the native mitral valve region (shown in <FIG>).

During deployment, adjustment of the position of the mitral valve prosthesis 1101A with respect to the mitral valve MV, can be accomplished by manipulating the handle component (not shown) of the delivery catheter <NUM> to incrementally advance and/or retract the distal segment <NUM> of the delivery catheter <NUM> to adjust the position of the arm portion <NUM> within the left ventricle LV and/or within the mitral valve MV. Accordingly, a clinician can advance the delivery catheter <NUM> in a distal direction (e.g., along arrow <NUM>) to move the arm portion <NUM> in the direction of arrow <NUM> when in the deployed state (e.g., further into the left ventricle LV) (<FIG>). Likewise, a clinician can retract the delivery catheter <NUM> in a proximal direction (e.g., in the direction of arrow <NUM>) to move the arm portion <NUM> in the deployed state (in the direction of arrow <NUM>) into the native mitral valve region (<FIG>). Referring to <FIG>, and while the mitral valve prosthesis 1101A is expanding by inflation of the balloon <NUM>, the operator can further control the placement of the mitral valve prosthesis 1101A within the mitral valve MV by incrementally advancing/retracting the delivery catheter <NUM> as described.

As discussed above, 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 mitral valve prosthesis 1101A at the target native valve region. With reference to <FIG> together, a clinician can, in real time, determine a desired target point at which to position the mitral valve prosthesis 1101A within the mitral valve MV (e.g., at a center of the valve, at a region of leaflet coaptation, etc.) and retract and/or advance the delivery catheter <NUM> to move the arm portion <NUM> along arrows <NUM> and/or <NUM>, respectively.

Following delivery, placement and implantation of the mitral valve prosthesis 1101A within the mitral valve MV (or other desired valve location), the articulation assembly <NUM> can be withdrawn from the mitral valve MV by withdrawing inflation fluid from the delivery catheter <NUM> to collapse the balloon <NUM> and the bellows connector <NUM>, and by advancing the delivery catheter <NUM> in the direction of arrow <NUM>. Once the arm portion <NUM> is downstream of the mitral valve MV, the arm portion <NUM> may be returned to the closed delivery state and the delivery catheter <NUM> and remaining guidewire (if any) can be removed from the heart <NUM> and out of the body of the patient.

Features of the heart valve delivery systems, delivery catheters and delivery catheter components described above and illustrated in <FIG> can be modified to form additional embodiments configured in accordance herewith. For example, the delivery system <NUM> can provide delivery of any of the delivery catheters having articulation assemblies described and illustrated in <FIG> to a targeted heart region (e.g., left ventricle), and can further incorporate additional delivery elements such as straightening sheaths and/or guide wires controllable, for example, using the handle component <NUM>. Similarly, the catheter assemblies described above having a first tubular component and a second tubular component, may only include the first tubular component. Furthermore, embodiments shown configured for carrying self-expanding prosthetic valve devices may also be configured to carry balloon-expandable prosthetic valve devices and vice versa. Additionally, catheter assemblies having only one guidewire lumen can be provided with more than one lumen.

Furthermore, while the delivery catheters described above are discussed as being suitable for delivering a mitral valve prosthesis to the native mitral valve using a retrograde approach, it will be understood that the delivery catheters may also be suitable for delivering heart valve devices for repair and/or replacement of other heart valves (e.g., pulmonary valve, tricuspid valve, etc.). Various arrangements of the delivery catheters described herein may also be used to deliver other therapeutic or medical tools within body lumens. For example, targeted and/or aligned delivery of intraluminal camera devices, surgical tools, two-part prosthetic devices such as a valve member with a separate docking member, etc. are contemplated with described articulation assemblies.

Various method steps described above for delivery and positioning of prosthetic valve devices (e.g., mitral valve prosthesis) within a native heart valve of a patient also can be interchanged to form additional embodiments of the present technology. For example, while the method steps described above are presented in a given order, alternative embodiments may perform steps in a different order. The various embodiments described herein may also be combined to provide further embodiments.

Claim 1:
A delivery catheter (<NUM>) for intravascular delivery of a heart valve prosthesis to a heart valve of a patient, the delivery catheter comprising:
an elongated tubular component (<NUM>) having a distal segment (<NUM>) and an articulation assembly (<NUM>) at the distal segment, wherein the articulation assembly includes an arm portion (<NUM>) coupled to the elongated tubular component by an elbow portion (<NUM>),
wherein in a state of flexion, the elbow portion positions the arm portion generally parallel to the elongated tubular component for intravascular delivery of the distal segment of the delivery catheter, and
wherein in a state of extension, the elbow portion positions the arm portion in an outwardly angled direction with respect to a longitudinal axis of the elongated tubular component.