TRANSCATHETER PROSTHETIC HEART VALVE DELIVERY SYSTEMS AND METHODS OF USE

In some embodiments, a prosthetic heart valve delivery device is provided that includes an outer shaft received over an inner shaft, and rod. The rod is selectively inserted or advanced along a slot in the outer shaft to increase a torqueability of the outer shaft. In some embodiments, a prosthetic heart valve delivery device is provided that includes a handle assembly, an outer shaft received over an inner shaft, a stability shaft received over the outer shaft, and a wire. A leading section of the wire is affixed to the stability shaft, and a trailing section of the wire extends proximally from the stability shaft and is selectively engaged by a locking mechanism of the handle assembly. In a locked state of the locking mechanism, tension is maintained in the wire and generates a bending stiffness in the stability shaft.

FIELD

The present disclosure relates to catheter-based devices and systems for delivering a prosthetic heart valve. More particularly, it relates to transcatheter prosthetic heart valve delivery devices and corresponding methods of use.

BACKGROUND

A human heart includes four heart valves that determine the pathway of blood flow through the heart: the mitral valve, the tricuspid valve, the aortic valve, and the pulmonary valve. The mitral and tricuspid valves are atrio-ventricular valves, which are between the atria and the ventricles, while the aortic and pulmonary valves are semilunar valves, which are in the arteries leaving the heart. Ideally, native leaflets of a heart valve move apart from each other when the valve is in an open position, and meet or “coapt” when the valve is in a closed position. Problems that may develop with valves include stenosis in which a valve does not open properly, and/or insufficiency or regurgitation in which a valve does not close properly. Stenosis and insufficiency may occur concomitantly in the same valve. The effects of valvular dysfunction vary, with regurgitation or backflow typically having relatively severe physiological consequences to the patient.

Diseased or otherwise deficient heart valves can be repaired or replaced using a variety of different types of heart valve surgeries. One conventional technique involves an open-heart surgical approach that is conducted under general anesthesia, during which the heart is stopped and blood flow is controlled by a heart-lung bypass machine.

More recently, minimally invasive approaches have been developed to facilitate catheter-based implantation of the valve prosthesis on the beating heart, intending to obviate the need for the use of classical sternotomy and cardiopulmonary bypass. In general terms, an expandable prosthetic valve is compressed about or within a catheter, inserted inside a body lumen of the patient, such as the femoral artery, and delivered to a desired location in the heart.

The heart valve prosthesis employed with catheter-based, or transcatheter, procedures generally includes an expandable multi-level frame or stent that supports a valve structure having a plurality of leaflets. The frame can be contracted during percutaneous transluminal delivery, and expanded upon deployment at or within the native valve. One type of valve stent can be initially provided in an expanded or uncrimped condition, then crimped or compressed about a balloon portion of a catheter. The balloon is subsequently inflated to expand and deploy the prosthetic heart valve. With other stented prosthetic heart valve designs, the stent frame is formed to be self-expanding. With these systems, the valved stent is crimped down to a desired size and held in that compressed state within a sheath for transluminal delivery. Retracting the sheath from this valved stent allows the stent to self-expand to a larger diameter, fixating at the native valve site. In more general terms, then, once the prosthetic valve is positioned at the treatment site, for instance within an incompetent native valve, the stent frame structure may be expanded to hold the prosthetic valve firmly in place. One example of a stented prosthetic valve is disclosed in U.S. Pat. No. 5,957,949 to Leonhardt et al., which is incorporated by reference herein in its entirety.

The present disclosure addresses problems and limitations associated with the related art.

SUMMARY

Some aspects of the present disclosure are directed to a transcatheter prosthetic heart valve delivery device. The delivery device includes an outer shaft assembly, an inner shaft assembly and a rod. The outer shaft assembly defines a longitudinal axis, a proximal end, and a distal end opposite the proximal end. The outer shaft assembly further defines a central lumen and a slot. The slot extends through a thickness of a side wall of the outer shaft assembly, and is open at the proximal end. The inner shaft assembly is configured to be co-axially received within the central lumen of the outer shaft assembly. The rod is sized to be slidably received within the slot, and defines an upper surface opposite a lower surface. A thickness of the rod between the upper and lower surfaces varies along a length of the rod. The rod is selectively inserted into the slot via the proximal end such that the upper surface is radially opposite the lower surface relative to the longitudinal axis. In some embodiments, the transcatheter prosthetic heart valve delivery device is configured such that insertion of the rod into the slot increases a torqueability of the outer shaft assembly. In some embodiments, the rod defines a corrugated shape along the length thereof. In some embodiments, the delivery device further includes a handle assembly maintaining the inner and outer shaft assemblies. The handle assembly includes a locking mechanism configured to selectively engage the rod to longitudinally lock the rod relative to the outer shaft assembly.

Other aspects of the present disclosure are directed to a method of delivering a prosthetic heart valve to a target site. The method includes receiving a delivery device loaded with a prosthetic heart valve in a compressed state. The delivery device includes an outer shaft assembly and an inner shaft assembly. The outer shaft assembly defines a longitudinal axis, a proximal end, and a distal end opposite the proximal end. The outer shaft assembly further defines a central lumen and a slot. The slot extends through a thickness of a side wall of the outer shaft assembly, and is open at the proximal end. The inner shaft assembly is configured to be co-axially received within the central lumen of the outer shaft assembly and carries the prosthetic heart valve. The delivery device is advanced through a vasculature of a patient such that the distal end approaches a target site with the distal end at a first rotational arrangement relative to the target site. A rod is advanced within the slot while the delivery device is at the first rotational arrangement. A torque is applied onto the outer shaft assembly to rotate the delivery device from the first rotational arrangement to a second rotational arrangement relative to the target site while the rod remains advanced within the slot. Presence of the rod within the slot facilitates rotation of the distal end in response to the applied torque. The delivery device to deploy the prosthetic heart valve at the target site. In some embodiments, the step of advancing the delivery device includes directing the distal end along and beyond an aortic arch of the patient; further, the step of advancing the rod occurs after the step of advancing the delivery device and includes directing a first end of the rod along and beyond the aortic arch.

Other aspects of the present disclosure are directed to a transcatheter prosthetic heart valve delivery device. The delivery device includes a handle assembly, an outer shaft assembly, an inner shaft assembly, a stability shaft and a wire. The handle assembly includes a locking mechanism. The outer shaft assembly extends from the handle assembly and defines a central lumen. The outer shaft assembly includes a distal region and a proximal region. The inner shaft assembly extends from the handle assembly and is configured to be co-axially received within the central lumen. The stability shaft extends from the handle assembly and defines a central passage sized to slidably receive the proximal region of the outer shaft assembly. The stability shaft terminates at a distal end opposite the handle assembly. The wire defines a leading section opposite a trailing section. The leading section is affixed to the stability shaft proximate the distal end. The trailing section extends proximally beyond the stability shaft and is arranged to be selectively engaged by the locking mechanism. The locking mechanism is operable to selectively lock the trailing section relative to the handle assembly such that the delivery device provides an unlocked state in which the trailing section freely slides relative to the handle assembly and a locked state in which the trailing section is locked relative to the handle assembly to maintain tension in the wire. In some embodiments, the delivery device is configured such that in the locked state, tension in the wire generates a bending stiffness in the stability shaft.

Other aspects of the present disclosure are directed to a method of delivering a prosthetic heart valve to a target site. The method includes receiving a delivery device loaded with a prosthetic heart valve in a compressed state. The delivery device includes a handle assembly, an outer shaft assembly, an inner shaft assembly, a stability shaft and a wire. The handle assembly includes a locking mechanism. The outer shaft assembly extends from the handle assembly and defines a central lumen. The outer shaft assembly includes a distal region and a proximal region. The inner shaft assembly extends from the handle assembly and is configured to be co-axially received within the central lumen. The stability shaft extends from the handle assembly and defines a central passage sized to slidably receive the proximal region of the outer shaft assembly. The stability shaft terminates at a distal end opposite the handle assembly. The wire defines a leading section opposite a trailing section. The leading section is affixed to the stability shaft proximate the distal end. The trailing section extends proximally beyond the stability shaft and is arranged to be selectively engaged by the locking mechanism. The prosthetic heart valve is disposed over the inner shaft assembly and is contained within a capsule of the outer shaft assembly. The delivery system is advanced through a vasculature of a patient with the locking mechanism in an unlocked state such that the trailing section of the wire freely slides relative to the handle assembly during the step of advancing. The locking mechanism is transitioned from the unlocked state to a locked state such that the trailing section is locked relative to the handle assembly and tension in the wire is maintained. The outer shaft assembly is retracted relative to the inner shaft assembly and relative to the stability shaft to deploy the prosthetic heart valve. In this regard, the locking mechanism remains in the locked state during the step of proximally retracting. In some embodiments, tension in the wire generates an increased bending stiffness in the stability shaft.

DETAILED DESCRIPTION

Specific embodiments of the present disclosure are now described with reference to the figures, wherein like reference numbers indicate identical or functionally similar elements.

Aspects of the disclosure are beneficial for use with prosthetic heart valves and heart valve repair methods including the implantation of a prosthetic heart valve, particularly, prosthetic heart valves delivered via a transcatheter procedure. As referred to herein, prosthetic heart valves can include a bioprosthetic heart valve structure having tissue leaflets or a synthetic heart valve having polymeric, metallic or tissue-engineered leaflets, and can be specifically configured for replacing or repairing valves of the human heart. In one non-limiting example, the valve of the human heart is an aortic valve, although the systems and methods of the present disclosure can be useful with the mitral, tricuspid, or pulmonary heart valve. The prosthetic heart valves of the present disclosure may be self-expandable, balloon expandable and/or mechanically expandable or combinations thereof. In general terms, the prosthetic heart valves of the present disclosure 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 prosthetic valve. 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 optionally 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.

In some embodiments, aspects of the present disclosure relate to delivery device for implanting a prosthetic heart valve at a target site. One example of a transcatheter prosthetic heart valve delivery device20in accordance with principles of the present disclosure is shown inFIG.1. The delivery device20includes an inner shaft assembly30, an outer shaft assembly32, one or more rods34, and a handle assembly36. Details on the various components are provided below. In general terms, however, the delivery device20can, in many respects, be any standard construction delivery device, such as, but not limited to, multi-lumen or coaxial construction delivery devices useful for percutaneously delivering and implanting a stented prosthetic heart valve. In some embodiments, the delivery device20is configured to provide a loaded or delivery state in which a self-expandable prosthetic heart valve is loaded over the inner shaft assembly30in a radially collapsed condition, and retained within a capsule40of the outer shaft assembly32. For example, the inner shaft assembly30can include or provide a valve retainer configured to selectively receive a corresponding feature (e.g., posts or eyelets) provided with the prosthetic heart valve stent frame. The outer shaft assembly32can be manipulated to proximally withdraw the capsule40from over the prosthetic heart valve via operation of the handle assembly36, permitting the prosthesis to release from the inner shaft assembly30. In other embodiments, the capsule40may not be required, such as when using a balloon expandable prosthetic heart valve, or a self-expandable prosthetic heart valve with other means to retain the prosthetic heart valve in radially collapsed condition. With these and other examples, an optional balloon42(schematically illustrated inFIG.1) can be provided with or carried by the inner shaft assembly30. In a loaded state, the prosthetic heart valve is crimped over the balloon42in a deflated condition; the balloon42is subsequently inflated to effect deployment of the prosthetic heart valve. Regardless of the prosthetic heart valve retention and deployment design features incorporated into the delivery device20, the rod(s)34are selectively received and/or advanced within a corresponding slot (not shown) of the outer shaft assembly32to increase an ability of the outer shaft assembly30to transmit torque (i.e., torqueability) as described below. This enhanced torqueability can be beneficial to a user under many circumstances, for example to arrange the loaded prosthetic heart valve in a desired rotational position relative to native anatomy. The delivery device20can optionally include other components that assist or facilitate or control delivery and/or deployment, such as an outer stability tube (not shown).

As a point of reference, various features of the components30-36reflected inFIG.1and described below can be modified or replaced with differing structures or mechanisms. Thus, the present disclosure is in no way limited to the inner shaft assembly30, the outer shaft assembly32, the handle assembly36, etc., as shown and described below. More generally, then, some delivery devices in accordance with principles of the present disclosure provide features capable of retaining a self-deploying stented prosthetic heart valve (e.g., the capsule40) and/or capable of deploying a balloon expandable prosthetic heart valve (e.g., the balloon42), along with one or more components (e.g., the rod(s)34) capable of increasing a torqueability of the outer shaft assembly32. In yet other embodiments, the rod(s)34and corresponding assembly techniques described below can be useful with any large bore catheter (that is not otherwise carrying a prosthetic heart valve) intend to be advanced around a bend and under circumstances where torqueing the catheter around the bend is desired.

The inner shaft assembly30can have various constructions appropriate for supporting a stented prosthetic heart valve. In general terms, the inner shaft assembly30is sized and shaped to extend or be co-axially received within a central lumen of the outer shaft assembly32. The inner shaft assembly30includes an inner shaft50and a distal tip52. Depending upon a configuration of the delivery device20(e.g., for use with a self-expanding prosthetic heart valve or for use with a balloon expandable prosthetic heart valve), the inner shaft assembly30can further include or carry the optional balloon42and/or a valve retainer (not shown). The inner shaft50extends from a proximal end54to a distal end56. While the inner shaft50is illustrated as being an integrally formed body, in other embodiments, two or more shaft members with differing constructions can be separately formed and subsequently assembly to serve as the inner shaft50. The distal end56is secured to the distal tip52. The distal tip52can define a distally tapering outer surface adapted to promote atraumatic contact with bodily tissue. Where provided, the balloon42can be secured relative to the inner shaft50and/or the outer shaft assembly32in various manners as is known in the art, and can be fluidly connected to an inflation source in various manners (e.g., an inflation lumen can be defined in or along the inner shaft50that is fluidly connected to an interior of the balloon42; an inflation passageway can be established between the inner and outer shaft assemblies30,32; etc.). The inner shaft assembly30can optionally include additional features that may or may not be directly implicated by the view; for example, the inner shaft assembly30can form a lumen (e.g., a guidewire lumen) extending from the proximal end54to and through the distal tip52.

The outer shaft assembly32has an elongated shape, defining a longitudinal axis A. The outer shaft assembly32defines a central lumen60(hidden inFIG.1, but shown, for example, inFIG.2) extending from a proximal end62to an opposing, distal end64(i.e., extending along the longitudinal axis A). In some examples, the outer shaft assembly32includes the capsule40extending distally from a shaft70. With these and similar embodiments, the capsule40and the shaft70can be comprised of differing materials and/or constructions, with the capsule40having a longitudinal length approximating (e.g., slightly greater than) a length of the prosthetic heart valve to be used with the delivery device20. For example, the capsule40can have a more stiffened construction as compared to a stiffness of the shaft70. In other embodiments, the capsule40and the shaft70can have a more uniform construction. In yet other embodiments, the capsule40can be omitted.

Regardless of whether the capsule40is provided, the outer shaft assembly32defines one or more slots72as shown inFIG.2. As a point of reference, at least a portion of the outer shaft assembly32can be formed as or can include a tubular side wall80. A shape of the side wall80defines an interior face82opposite an exterior face84. The central lumen60is defined or bounded by the interior face82. The side wall80has a thickness between the interior and exterior faces82,84. With these conventions in mind, the slot(s)72are defined in and along a thickness of the side wall80. WhileFIG.2reflects four of the slots72, any other number, either greater or lesser is also acceptable. With embodiments in each two (or more) of the slots72are provided, the slots72can be equidistantly spaced from one another about a circumference of the side wall80. Alternatively, a non-uniform spacing can be provided. Further, where two (or more) of the slots72are provided, each of the slots72can have an identical construction as shown; alternatively, the slots72can vary from one another in terms of size and/or shape. Regardless, the slot(s)72are configured to slidably receive a corresponding one of the rods34(FIG.1) as described in greater detail below.

With reference betweenFIGS.1and2, regardless of the number provided, each of the slots72extends to and is open at the proximal end62of the outer shaft assembly32in some embodiments. Alternatively, one or more of the slots72can terminate distal the proximal end62, but extends through and is open at the exterior face84(e.g., at a port for receiving one of the rods34). In some embodiments, each of the slots72terminate proximal the distal end64(or, with embodiments in which the outer shaft assembly32includes the capsule40, the slots72can terminate proximal the capsule40). Alternatively, one or more of the slots72can extend to and be open at the distal end64. In some embodiments, and for reasons made clear below, in some embodiments, the slot(s)72extend distally from a location proximate or at the proximal end62to location at least 75% of a length of the outer shaft assembly32.

One embodiment of the rod34is shown inFIGS.3,4A and4B. In general terms, the rod34has an elongated shape, and is sized to be slidably received within a corresponding one of the slots72(FIG.2). Further, the rod34is formed of a relatively stiff and resilient material (e.g., metal, plastic, fiber composite, etc.) and is configured to exhibit a flexibility characteristic or property in a first plane or direction that is substantively different from a flexibility in a second plane orthogonal to the first plane. As a point of reference, in the perspective view ofFIG.3, directional axes X, Y and Z are identified; the X axis corresponds with a width dimension or direction of the rod34; the Y axis is perpendicular to the Y axis and corresponds with a length dimension or direction of the rod34; the Z axis is perpendicular to the X and Y axes, and corresponds with a thickness or height dimension or direction of the rod34.FIG.4Ais a side view of the rod34, corresponding with a plane defined by the Y, Z axes;FIG.4Bis a top view of the rod, corresponding with a plane defined by the X, Y axes. The plane of the view ofFIG.4Ais orthogonal or transverse to the plane of the view of theFIG.4B. With these conventions in mind, a flexibility of the rod34in the plane ofFIG.4Ais greater than a flexibility of the rod34in the plane ofFIG.4B.

Alternatively stated, the rod34defines a first end90opposite a second end92, a lower surface94(referenced generally inFIG.3and hidden inFIG.4B) opposite an upper surface96, and a first side surface98opposite a second side surface100(hidden inFIGS.3and4A). The width of the rod34is defined as the distance between the first and second side surfaces98,100(i.e., dimension along the X axis). In some embodiments, the width (i.e., dimension along the X axis) of the rod34is substantially uniform (i.e., within 5% of a truly uniform width) along the length (i.e., from the first end90to the second end92). Further, in some embodiments, a major plane defined by each of the first and second side surfaces98,100is substantially perpendicular (i.e., within 5% of a truly perpendicular relationship) with a major plane defined by the lower surface94. Finally, the elongated shape of the rod34defines a central axis A. With these designations in mind, the orthogonal plane flexibility characteristics can be described by a flexibility of the rod34in a first plane perpendicular to the central axis A and intersecting the lower and upper surfaces94,96(e.g., the plane ofFIG.4A, a plane defined by the Y and Z axes) being greater than a flexibility of the rod34in second plane that is orthogonal to the first plane and that intersects the first and second side surfaces (e.g., the plane ofFIG.4B, a plane defined by the X and Y axes).

Flexibility characteristics of the rod34can further be described with reference to loads or forces applied to the rod34. For example, where identical point forces or loads F1, F2are applied to the first and second ends90,92, respectively, in the plane ofFIG.4Aand a mid-point M is fixed point (i.e., the forces F1, F2are applied to upper surface96with a fulcrum on the lower surface94at the mid-point M), the rod34will readily flex; where the same forces F1, F2are applied to the first and second ends90,92in the plane ofFIG.4B(i.e., the forces F1, F2are applied to the second side surface100with a fulcrum on the first side surface98at the mid-point M), the rod34will not readily flex. Alternatively stated, the rod34is configured such that the rod34overtly resists, and does not deform or flex, when the forces F1, F2are applied to the ends90,92in the plane ofFIG.4B, but does not overtly resist, and will deform or flex, when the same forces F1, F2are applied in the plane ofFIG.4A. Thus,FIG.5Arepresents an effect of the forces F1, F2as applied to the upper surface96and a fulcrum is at the mid-point M along the lower surface94(i.e., in the plane ofFIG.4A); the rod34deforms or flexes (i.e., the rod34transitions from the arrangement ofFIG.4Ato the arrangement ofFIG.5A).FIG.5Brepresents the effect of the same forces F1, F2when applied to the second side surface100and a fulcrum is at the mid-point M along the first side surface98(i.e., in the plane ofFIG.4B); the rod34does not deform or flex (i.e., an arrangement of the rod34inFIGS.4B and5Bis essentially the same).

The rods of the present disclosure can assume various forms or formats that exhibit the orthogonal plane flexibility characteristics described above. For example, in the non-limiting embodiment ofFIGS.4A and4B, the rod34can be shaped to define a varying thickness (i.e., dimension along the Z axis) along a length thereof. Alternatively stated, a thickness of the rod34is defined between the lower and upper surfaces94,96; the thickness varies along the length of the rod34(i.e., from the first end90to the second end92). In some embodiments, the varying thickness attribute can be described as the rod34having a corrugated shape along the length thereof. In some embodiments, the varying thickness attribute can be described as the lower surface94being substantially flat or planar (i.e., within 5% of a truly flat or planar surface), whereas the upper surface96has a wavy-like shape. In some embodiments, the varying thickness attribute can be described as the upper surface96defining a series of protrusions102relative to the lower surface94. Other shapes or constructions can also be employed.

Regardless of an exact construction, the rod34is sized and shaped to be slidably received in one of the slots72of the outer shaft assembly32as shown inFIG.6. In some embodiments, the rod34is or can be arranged within the slot72such that the upper surface96is radially opposite the lower surface94relative to the longitudinal axis A. Alternatively stated, the rod34is or can be arranged such that the lower surface94is closer to the longitudinal axis A as compared to the upper surface96; the opposing side surfaces98,100are circumferentially aligned relative to the longitudinal axis A. With this construction, and commensurate with the descriptions above, the rod34serves to enhance a torqueability of the outer shaft assembly32, overtly reinforcing the outer shaft assembly32relative to, or off-setting, an applied rotational force or torque. In this regard, it will be recalled that the rod34is configured to have minimal flexibility in the plane ofFIG.4B. That is to say, the rod34does not easily deform, flex, or deflect in response to rotational or torque-type forces applied to the opposing side surfaces98,100. Relative to the arrangement ofFIG.6, then, the rod34resists or “stiffens” the outer shaft assembly32relative to a torque T applied onto the outer shaft assembly. Thus, and with additional reference to the simplified representation ofFIG.7A, a rotational force or torque T applied to the outer shaft assembly32near or proximate the proximal end62is readily transferred to or near the distal end64due to the presence of the rod34. Thus, rotation of the proximal end62results in a substantially similar rotation of the distal end64. Were the rod34not present, the torque T applied at the proximal end62would not readily transfer to or near the distal end32(e.g., the outer shaft assembly32may twist or deform along a length thereof). However, the flexible nature of the rod34in an orthogonal plane (i.e., the plane ofFIG.4A) allows the rod34to readily conform to bends or curves in the outer shaft assembly32during insertion/advancement. Thus, for example, under circumstances where the outer shaft assembly32is forced to the assume a non-linear shape in extension from the proximal end62to the distal end64as shown inFIG.7B, as the rod34is advanced (within the slot72(FIG.6)) distally toward the distal end64, the rod34readily flexes and “tracks” to the shape or contour of the outer shaft assembly32.

Returning toFIG.1, the handle assembly36can assume various forms appropriate for user handling and operation of the delivery device20. In some embodiments, the handle assembly36includes a housing110and one or more actuator mechanisms112(referenced generally). The housing110generally provides a surface for convenient handling and grasping by a user, and may have the generally cylindrical shape as shown, although other shapes and sizes are also acceptable. The housing110maintains the actuator mechanism112, with the handle assembly36configured to facilitate sliding movement of the outer shaft assembly32relative to the inner shaft assembly30(and/or vice-versa). In one simplified construction of the actuator mechanism112, a user interface or actuator114is slidably retained by the housing110, and is coupled to the proximal end62of the outer shaft assembly32. The proximal end54of the inner shaft assembly30is secured to the housing110. With this optional construction, sliding movement of the actuator114co-axially advances/retracts the outer shaft assembly32relative to the inner shaft assembly30. Although shown as a slide mechanism, other constructions and/or devices may be used to retrace/advance the outer shaft assembly32relative to the inner shaft assembly30(and/or vice-versa), such as, but not limited to, rotating mechanisms, sliding mechanisms that are coaxially disposed over the inner shaft assembly30, combinations of rotating and sliding mechanisms, and other advancement/retraction mechanisms apparent to those of ordinary skill in the art. The handle assembly36can optionally include one or more additional components or mechanism; for example with embodiments in which the inner shaft assembly30includes or carries the balloon42, the handle assembly36can optionally include or carry features that facilitate delivery of an inflation medium to the balloon42. In other embodiments, the handle assembly36does not include an actuator for moving the outer shaft assembly32relative to the inner shaft assembly30(or vice-versa), such as with embodiments in which the capsule40is omitted.

In some embodiments, the handle assembly36can include or carry one or more mechanisms or features that facilitate insertion and/or advancement and retraction of the rod(s)34relative to the outer shaft assembly32(and in particular the corresponding slot72(FIG.2)). For example,FIG.8Ais a simplified representation of the outer shaft assembly32assembled to, and extending distally from, the handle assembly36. The housing110forms or defines a passage120that, upon final assembly, is aligned with one of the slots72in the outer shaft assembly32(it being understood that where the outer shaft assembly32provides two or more of the slots72, the housing110will define a corresponding number of the passages120, each aligned with a respective one of the slots72). The passage120is sized to slidably receive one of the rods34(FIG.1), and is open to an exterior of the housing110(e.g., opening122). In some embodiments, the handle assembly36can include a locking mechanism124that is generally configured to selectively engage the rod34as described in greater detail below.

With the above construction, the rod34(FIG.1) can be inserted into the slot72of the outer shaft assembly32via the passage120. That is to say, in some embodiments, the delivery device20(FIG.1) is provided to an end user with the rod(s)34separate from or not otherwise carried by the handle assembly36(or the outer shaft assembly32). With these and related embodiments, where use of the rod34is desired (e.g., to reinforce the outer shaft assembly32), the user simply inserts the rod34into the opening122and advances the rod34distally through the passage120and into the slot72as generally reflected byFIG.8B. In other embodiments, the delivery device20is provided to an end user with the rod(s)34disposed within the corresponding passage120and advanced only a small distance, if at all, into the corresponding slot72. Where reinforcement of the outer shaft assembly32is desired, the user then distally advances the rod34along the corresponding slot72. Regardless, the optional locking mechanism124can be operated by a user to secure or lock the rod34relative to the housing110, and thus relative to the outer shaft assembly32, at a desired longitudinal arrangement, for example by exerting a locking force onto the rod34along the passage120as generally reflected byFIG.8B. The locking mechanism124can assume various forms (e.g., a spring-loaded actuator, a rotating mechanism, etc.), and in other embodiments can be omitted. With these and other embodiments, when reinforcement of the outer shaft assembly32is no longer necessary or not otherwise desired by the user, the rod34can be proximally retracted along the slot72and the passage120.

Returning toFIG.1, the transcatheter prosthetic heart valve delivery device20is useful for percutaneously delivering and deploying a prosthetic heart valve to any of the four native heart valves. In general terms, methods of the present disclosure are the same as or similar to techniques conventionally employed whereby a prosthetic heart valve is loaded to the delivery device20, manipulated through a vasculature of the patient to target site, and then deployed at the target site. In some examples, the delivery device20is beneficially employed with procedures in which rotation of the loaded prosthetic heart valve at or near the target site is desired as described below.

For example,FIG.9Areflects, in simplified form, one example of the delivery device20loaded with a prosthetic heart valve130in a compressed state. With the example ofFIG.9A, the prosthetic heart valve130includes a self-expanding stent132that is crimped over the inner shaft assembly30and secured to an optional valve retainer134provided with inner shaft assembly30. The outer shaft assembly32includes the optional capsule40that is located over the prosthetic heart valve130, maintaining the prosthetic heart valve130in the compressed state. The handle assembly36is schematically shown, and generally reflects that the outer shaft assembly32can be proximally retracted relative to the inner shaft assembly30(and thus relative to the prosthetic heart valve130). As mentioned above, in other embodiments, the prosthetic heart valve130can instead include a balloon expandable stent; with these and related embodiments, the capsule40may or may not be provided, and prosthetic heart valve130can be compressed over a balloon (not shown) as loaded to the delivery device20. For example,FIG.9Bis a representation of the delivery device20′ formatted for use with a balloon expandable prosthetic heart valve130′. The delivery device20′ includes the balloon42. A proximal region136of the balloon42overlies a distal region138of the outer shaft assembly32, and the prosthetic heart valve130′ is compressed or crimped onto the deflated balloon42. As a point of reference, while the outer shaft assembly32is shown as being tapered or stepped to a smaller diameter to accommodate the balloon42, in other embodiments a thickness or outer diameter of the outer shaft assembly32along the distal region138can be increased to house the rod(s)34(FIG.1). Regardless of an exact format of the delivery device20,20′, in the initial loaded condition ofFIGS.9A and9B, the rod(s)34(FIG.1) have not been inserted or distally advanced within the outer shaft assembly32.

The loaded delivery device20is then manipulated to percutaneously deliver the prosthetic heart valve130(in the compressed state) through a vasculature of the patient to a target site. For example,FIG.10Aillustrates the loaded delivery device20having been advanced through a patient's vasculature140to deliver the prosthetic heart valve130(hidden, but referenced generally inFIG.10A) to an aortic valve target site142(e.g., at the stage of delivery ofFIG.10A, the tip52is proximate the aortic valve target site142). In some embodiments, an introducer144can be used to assist in establishing a portal to a bodily lumen (e.g., femoral artery) of the patient. Regardless, the user manipulates the handle assembly36to direct the compressed prosthetic heart valve130through or along the vasculature140. In many instances, the vasculature140encountered by the delivery device20can be highly tortuous. For example, in accessing the aortic valve target site142, the compressed prosthetic heart valve130must track along or traverse the aortic arch. During this tracking stage of the delivery process, then, the rod(s)34are removed from, or not otherwise advanced through, the outer shaft assembly32(as generally shown). In this state, the delivery device20readily passes through or tracks along the vasculature140.

In the delivery stage ofFIG.10A, the prosthetic heart valve130is proximate the target site142and is still secured to the delivery device20. Prior to complete deployment from the delivery device20at the target site142, the user may desire to spatially rotate the prosthetic heart valve130. For example, the user may evaluate a rotational arrangement of the prosthetic heart valve130relative to native anatomy of the target site142and decide that a different rotational arrangement is preferred. Under these and other circumstances, the rod(s)34are then advanced within the outer shaft assembly32as described above, increasing an overall stiffness of the outer shaft assembly32. In this regard, the rod(s)34can readily track along the curves or bends formed in the outer shaft assembly32. With the rod(s)34in place, a torque or rotational force applied by the user onto the handle assembly36is transferred to the distal region of the outer shaft assembly32, thereby rotating the prosthetic heart valve130. In some embodiments, a nearly 1:1 response between rotation of the handle assembly36and the prosthetic heart valve130can be provided with the delivery device20located in the patient's anatomy. Once a desired rotational arrangement of the prosthetic heart valve130has been achieved, the rod(s)34can be retracted or removed, followed by operation of the delivery device20to deploy the prosthetic heart valve130at the target site142.

A desire or need to adjust a rotational arrangement of the prosthetic heart valve130relative to the target site142can arise under various circumstances. For example,FIG.10Billustrates, in simplified form, the compressed prosthetic heart valve130loaded within the delivery device20and located proximate the aortic valve target site142. Generally, patient anatomy at and adjacent the aortic valve142includes an aorta160, sinotubular junction (“STJ”)162, native valve leaflets164, aortic valve annulus166, sinus region168, coronary arteries (or “coronaries”)170each having a coronary ostium172, and left ventricle174. In some instances, a size of the prosthetic heart valve130and/or the patient's anatomy (e.g., short and/or narrow sinuses) may result in a structure of the prosthetic heart valve130being proximate the coronary ostia172upon final implant, for examples struts of the stent frame132. The potential for obstruction of the coronary ostia172is further heightened when the prosthetic heart valve130is being deployed or implanted within a previously implanted prosthesis. Thus, a user may desire to rotationally arrange the prosthetic heart valve130relative to the native anatomy so as to minimize obstructions to the coronary ostia172. For example, and as shown inFIG.10C, a user may desire to rotate the prosthetic heart valve130relative to the native anatomy so as to align openings in the stent132with the coronary ostia172; when so-aligned, an interventional device180(e.g., access catheter) can more easily access the coronary arteries170as part of a subsequent procedure. The delivery devices20(FIG.1) of the present disclosure facilitate desired rotation of the prosthetic heart valve130to meet these, and many other, needs.

Another embodiment of a transcatheter prosthetic heart valve delivery device200in accordance with principles of the present disclosure is shown inFIG.11. The delivery device200includes an inner shaft assembly210, an outer shaft assembly212, a stability shaft214, at least one wire216, and a handle assembly218. Details on the various components are provided below. In general terms, however, the delivery device200can, in many respects, be any standard construction delivery device, such as, but not limited to, multi-lumen or coaxial construction delivery devices useful for percutaneously delivering and implanting a stented prosthetic heart valve. In some embodiments, the delivery device200is configured to provide a loaded or delivery state in which a self-expandable prosthetic heart valve (not shown) is loaded over the inner shaft assembly210in a radially collapsed condition, and compressively retained within a capsule230of the outer shaft assembly212. The outer shaft assembly212can be manipulated to proximally withdraw the capsule230from over the prosthetic heart valve via operation of the handle assembly218, permitting the prosthesis to release from the inner shaft assembly210. The stability shaft214is received over the outer shaft assembly212, and serves to frictionally isolate the outer shaft assembly212from a separate introducer device (not shown) as part of a transcatheter prosthetic heart valve delivery and deployment procedure. As is understood by one of ordinary skill, the stability shaft214acts as a distance stabilizing member to help set and maintain the distance between the handle assembly218and the introducer positioned in the patient's artery to thereby promote accurate deployment of the prosthetic heart valve at a target site. The stability shaft214also reduces the likelihood of unexpected movements of the capsule230at the target site. With this in mind, the wire216is affixed to the stability shaft214and extends to the handle assembly218. The handle assembly218can be operated by a user to selectively engage or lock the wire216, with a resulting tension in the wire216creating or generating an enhanced bending stiffness in the stability shaft214. The elevated bending stiffness can be desirable or beneficial in many scenarios, for example to overcome forces encountered when retracting the capsule to deploy the prosthetic heart valve.

As a point of reference, various features of the components210-218reflected inFIG.11and described below can be modified or replaced with differing structures or mechanisms. Thus, the present disclosure is in no way limited to the inner shaft assembly210, the outer shaft assembly212, the handle assembly218, etc., as shown and described below. More generally, then, some delivery devices in accordance with principles of the present disclosure provide features capable of retaining a self-deploying stented prosthetic heart valve (e.g., the capsule230), along with one or more components (e.g., the wire(s)216) capable of selectively increasing a bending stiffness of the stability shaft214.

The inner shaft assembly210can have various constructions appropriate for supporting a stented prosthetic heart valve. In general terms, the inner shaft assembly210is sized and shaped to extend within a central lumen of the outer shaft assembly212. The inner shaft assembly210includes an inner shaft240and a distal tip242. The inner shaft240extends from a proximal end244to a distal end246. While the inner shaft240is illustrated as being an integrally formed body, in other embodiments, two or more shaft members with differing constructions can be separately formed and subsequently assembly to serve as the inner shaft240. The distal end246is secured to the distal tip242. The distal tip242can define a distally tapering outer surface adapted to promote atraumatic contact with bodily tissue. The inner shaft assembly210can optionally include additional features that may or may not be directly implicated by the view; for example, the inner shaft assembly210can form a lumen (e.g., a guidewire lumen) extending from the proximal end244to and through the distal tip242.

The outer shaft assembly212defines a central lumen (hidden) extending from a proximal end250to an opposing, distal end252. The outer shaft assembly212includes the capsule230extending distally from a shaft260. With these and similar embodiments, the capsule230and the shaft260can be comprised of differing materials and/or constructions, with the capsule230having a longitudinal length approximating (e.g., slightly greater than) a length of the prosthetic heart valve (not shown) to be used with the delivery device200. For example, the capsule230can have a more stiffened construction as compared to a stiffness of the shaft260. In other embodiments, the capsule230and the shaft260can have a more uniform construction.

The stability shaft214can generally have any construction conventionally employed. The stability shaft214extends from a distal end270to a proximal end272and forms a central lumen274(referenced generally) sized to be slidably received over the outer shaft assembly212. In some embodiments, the stability shaft214can be formed of a polymeric material with an associated reinforcement layer.

As described below, the wire(s)216can be secured to the stability shaft214in various manners. In some embodiments, the stability shaft214incorporates one or more features that promote connection with the wire(s)216. For example, and as shown inFIG.12, the stability shaft214can form or define one or more slots276in addition to the central lumen274. As a point of reference, at least a portion of the stability shaft214can be formed as or can include a tubular side wall280. A shape of the side wall280defines an interior face282opposite an exterior face284. The central lumen274is defined or bounded by the interior face282. The side wall280has a thickness between the interior and exterior faces282,284. With these conventions in mind, the slot(s)276are defined in and along a thickness of the side wall280. The number of slots276corresponds with the number of wires216(FIG.11). Thus, whileFIG.12reflects two of the slots276, any other number, either greater or lesser is also acceptable. With embodiments providing two of the slots276, the slots276can be arranged at approximately 90 degrees from one another (relative to a circumference of the stability shaft214) for reasons made clear below. Alternatively, other arrangements can be provided. Regardless, the slot(s)276are configured to receive a corresponding one of the wires216as described in greater detail below.

Returning toFIG.11, the wire216can assume various forms appropriate for supporting or reinforcing the stability shaft214. In some embodiments, the wire216is formed of metal (e.g., stainless steel), hardened plastic, composite material, etc. The wire216terminates at opposing, leading and trailing ends290,292. The wire216can have various cross-sectional shapes, for example circular (FIG.13A), flat or rectangular (FIG.13B), irregular, etc. The cross-sectional shape can be substantially uniform along the wire216in extension between the ends290,292; in other embodiments, the wire216can have a varying cross-sectional shape (e.g., one or more segments of the wire216can have a flattened cross-sectional shape, whereas other segment(s) have a rounded or circular cross-sectional shape).

FIG.14provides a simplified illustration of the stability shaft214and one of the wires216upon final assembly. The wire216is located with the slot276, with the leading end290located at or in close proximity (e.g., within 5 centimeters) to the distal end270. In some embodiments, a length of the wire216(i.e., linear distance from the leading end290to the trailing end292) is greater than a length of the stability shaft214(i.e., linear distance from the distal end270to the proximal end272). With this configuration, the trailing end292of the wire216is located away from, or proximally beyond, the proximal end272of the stability shaft214for reasons made clear below.

While the wire216is disposed within the slot276, only a portion of the wire216is directly affixed to the stability shaft214. For example, a material bond294is shown inFIG.14between a surfaces of the stability shaft214and the wire216near or at the leading end290. The material bond294can assume various forms appropriate for fixing that section of the stability shaft214, otherwise in contact with the bond294, with the stability shaft276(e.g., the material body294can be an adhesive, lamination of material of the stability shaft276to a surface of the wire216, mechanical or ultrasonic bond, an attachment body, etc.).

From the above descriptions, in the assembled state ofFIG.14, the wire216can be viewed or designated as defining a leading section300, a trailing section302opposite the leading section300, and an intermediate section304between the trailing and leading sections300,302. The leading section300includes the leading end290and is directly affixed to the stability shaft214. The trailing section302includes the trailing end292and extends proximally beyond the proximal end272of the stability shaft214. The intermediate section304extends from the leading section300through the slot276to the proximal end272, and is free of direct, physical fixation to the stability shaft214. Thus, apart from direct fixation at the leading section300, the stability shaft214can deform or deflect or slide relative to the intermediate section304of the wire216(so long as the trailing section302is not otherwise spatially fixed relative to the proximal end272). In some embodiments, a length of the intermediate section304is greater than a length of the leading section300; for example, the intermediate section304is at least 1.5× longer than the leading section300, alternatively at least 2× longer, alternatively at least 3× longer.

WhileFIG.14reflects an optional construction in which the stability shaft214forms the slot276for receive the wire216, other configurations are also acceptable that may or may not include the wire216being located within a thickness of the stability shaft214. For example, in other embodiments, the wire216can be located along an exterior of the stability shaft214with only a small section (e.g., akin to the leading section300) directly, physically affixed to the stability shaft214. With these and related embodiments, an intermediate section of the wire216can be loosely connected to the stability shaft214and a trailing section extends proximally beyond the proximal end272.

Returning toFIG.11, the handle assembly218can assume various forms appropriate for user handling and operation of the delivery device200. In some embodiments, the handle assembly216includes a housing310, an outer shaft actuator mechanism312(referenced generally), and a locking mechanism314(referenced generally). The housing310generally provides a surface for convenient handling and grasping by a user, and may have the generally cylindrical shape as shown, although other shapes and sizes are also acceptable. The housing310maintains the outer shaft actuator mechanism312, with the handle assembly218configured to facilitate sliding movement of the outer shaft assembly212relative to the inner shaft assembly210(and/or vice-versa). In one simplified construction of the outer shaft actuator mechanism312, a user interface or actuator320is slidably retained by the housing310, and is coupled to the proximal end250of the outer shaft assembly212. The proximal end244of the inner shaft assembly210is secured to the housing310. With this optional construction, sliding movement of the actuator320co-axially advances/retracts the outer shaft assembly212relative to the inner shaft assembly210. Although shown as a slide mechanism, other constructions and/or devices may be used to retrace/advance the outer shaft assembly212relative to the inner shaft assembly210(and/or vice-versa), such as, but not limited to, rotating mechanisms, sliding mechanisms that are coaxially disposed over the inner shaft assembly210, combinations of rotating and sliding mechanisms, and other advancement/retraction mechanisms apparent to those of ordinary skill in the art.

The locking mechanism314is carried by the housing310, and can assume various forms. In general terms, the locking mechanism is configured to interface with the wire216, providing a user with the ability to selectively lock the wire(s)216relative to the housing310, and the optional ability to tension the wire(s)216. Where the delivery device200includes two (or more) of the wires216, the locking mechanism314can be configured to simultaneously interface with all of the wires216. Alternatively, multiple locking mechanisms314can be provided, one for each of the wires216.

One example of the locking mechanism314is shown is simplified form inFIG.15, along with the stability shaft214and the wire216as connected with the housing310. Commensurate with the explanations above, the trailing section302of the wire216extends proximally from the stability shaft214into an interior of the housing310. The locking mechanism314includes a lock unit320(referenced generally) and an actuator322. The lock unit320is slidably disposed within a channel324formed or carried by the housing310, and is configured to selectively engage the trailing section302of the wire216. For example, housing310can include or carry surface features that route the trailing section302to the channel324for passage through the lock unit320. The lock unit320is operable to provide a locked state and an unlocked state. In the locked state, the wire216is rigidly grasped or clamped by the lock unit320, and cannot slide relative to the lock unit320(e.g., the lock unit320can include a clamping device, toothed surface(s), etc., that, when directed into engagement with the wire216, robustly engages the wire216). In some embodiments, a cross-sectional shape of the wire216along at least the trailing section302can be relatively flat or rectangular to be more easily grasped. Regardless, in the unlocked state, the wire216can freely slide relative to the lock unit320. The actuator322is operable by a user to switch or actuate the lock unit320between the locked and unlocked states. Further, the actuator322is slidably maintained relative to the housing310and can be manipulated by a user to slide or otherwise move the lock unit320along the channel324between opposing, leading and trailing sides326,328.

With this one example embodiment, then, in the unlocked state, because the trailing section302can freely slide relative to the handle assembly218, where a pulling force P is exerted on the wire216, tension is not generated in the wire216. For example, recalling that the leading section300of the wire216is affixed to the stability shaft214, as the stability shaft214is caused to bend or articulate (such as when traversing a patient's vasculature), the pulling force P is exerted on the leading section300. Under these circumstances, a remainder of the wire216is allowed to freely slide relative to the handle assembly218and is not brought into tension. Thus, in the unlocked state, the wire216generates minimal, if any, additional stiffness in the stability shaft214. In the locked state, the locked state, the lock unit320is clamped onto the trailing section302. When the pulling force P is applied to the leading section300, the wire216is caused to slide distally. The lock unit320moves with the wire216, sliding along the channel324until brought into contact with the leading side326. An interface between the lock unit320and the leading side326prevents further movement of the lock unit320, and thus of the trailing section302. As a result, the applied pulling force P generates tension in the wire216, with this tension effectively increasing a bending stiffness of the stability shaft214. Further, while in the locked state, a user can generate or increase tension in the wire216by manipulating the actuator322to slide the lock unit320(and thus the trailing section302) in a direction of the trailing side328of the channel324. Because the leading section300is affixed to the stability shaft214, this force movement exerts a tension force T onto the wire206.

The locking mechanism314can assume other forms that may or may not include lock unit320and/or actuator322as shown and described. Any device or mechanism appropriate for selectively locking the wire216relative the handle assembly218in a manner that maintains tension in the wire216in a locked state and does not maintain tension in an unlocked state is acceptable.

Returning toFIG.11, the transcatheter prosthetic heart valve delivery device200is useful for percutaneously delivering and deploying a prosthetic heart valve to any of the four native heart valves. In general terms, methods of the present disclosure are the same as or similar to techniques conventionally employed whereby a prosthetic heart valve is loaded to the delivery device200, manipulated through a vasculature of the patient to target site, and then deployed at a the target site. In some examples, the delivery device20is beneficially employed with procedures in which rotation of the loaded prosthetic heart valve at or near the target site is desired as described below.

For example,FIG.16reflects, in simplified form, one example of the delivery device200loaded with a prosthetic heart valve350in a compressed state. With the example ofFIG.16, the prosthetic heart valve350includes a self-expanding stent352that is crimped over the inner shaft assembly210and secured to an optional valve retainer354provided with inner shaft assembly210. The outer shaft assembly212is received over the inner shaft assembly210. The capsule230is positioned over the prosthetic heart valve350, maintaining the prosthetic heart valve350in the compressed state. Finally, the stability shaft214is coaxially arranged over the outer shaft assembly212, with the distal end270proximally spaced from the capsule230. Though not visible in the view of theFIG.16, the wire(s)216are secured relative to the stability shaft214as described above.

The loaded delivery device200is then manipulated to percutaneously deliver the prosthetic heart valve350(in the compressed state) through a vasculature of the patient to a target site. For example,FIG.17illustrates the loaded delivery device200having been advanced through a patient's vasculature360to deliver the prosthetic heart valve350(compressed within the capsule230) to an aortic valve target site362(e.g., at the stage of delivery ofFIG.17, the capsule230is proximate the aortic valve target site362). In some embodiments, an introducer (not shown) can be used to assist in establishing a portal to a bodily lumen (e.g., femoral artery) of the patient. In many instances, the vasculature360encountered by the delivery device200can be highly tortuous. For example, to attain the aortic valve target site362, the components of the delivery device200, including the stability shaft214, must track along or at least partially traverse the aortic arch364. During this tracking stage of the delivery process, then, the locking mechanism314is operated in the unlocked state. Under these conditions, the wire216is not under tension, and thus does not impede the stability shaft214from freely following curvatures of the aortic arch364for example. Thus, in the arrangement ofFIG.17, the stability shaft214is in contact with an outer curvature of the anatomy (i.e., anatomy of the aortic arch364).

To deploy the prosthetic heart valve350(hidden) from the delivery device200, the handle assembly218can be operated to proximally retract the outer shaft assembly212to withdraw the capsule230from over the prosthetic heart valve350). The stability shaft214facilitates this movement (with the outer shaft assembly212proximally retracting relative to the stability shaft214), acting as a distance stabilizing member to help set and maintain the distance between the handle assembly218and the introducer (not shown) to thereby promote accurate deployment of the prosthetic heart valve350at the target site362. Under some circumstances, a user may desire to increase a bending stiffness of the stability shaft214prior to and during proximal retraction of the outer shaft assembly212. For example, as the capsule230is retracted and exposed portions of the prosthetic heart valve350being to self-expand and contact native anatomy, the prosthetic heart valve350exerts a distal pulling force onto the delivery device200, biasing the delivery device200away from the arrangement ofFIG.17. This unexpected movement can, in turn, allow the prosthetic heart valve350from the desired deployment position relative to the target site362(e.g., the distal pulling force exerted on the delivery device200can be sufficient to move the capsule230/prosthetic heart valve350away from the aortic valve target site362in a direction of the left ventricle; in other words, the capsule230/prosthetic heart valve350has a tendency to “dive” or move down into the annulus of the aortic valve target site362). To address these concerns, once the capsule230has been located at the desired deployment position (and prior to retracting capsule230), the locking mechanism314is actuated to the locked state, applying tension to the wire216. This tension adds bending stiffness to the stability shaft214, resulting in the stability shaft214(and thus the delivery device200) becoming more rigidly “locked” to the native anatomy (e.g., contact with an outer curvature of the aortic arch364). If desired, the user can increase tension in the wire216, and thus bending stiffness in the stability shaft214, by manipulating the actuator322to slide the lock unit320as described above. Enhanced bending stiffness in the stability shaft214can be sufficient to overcome or resist forces exerted on the delivery device200as the capsule230is subsequently retracted/the prosthetic heart valve350begins to self-expand. Following deployment of the prosthetic heart valve350, the locking mechanism314can be returned to the unlocked state to facilitate removal of the delivery device200from the patient.

With this one example method, tension in the wire216is utilized to enhance a bending strength of the stability shaft214in a direction generally corresponding to outer curvature of the aortic arch364. With optional embodiments in which two (or more) of the wires216are provided (e.g., commensurate with the two slots276shown inFIG.12) and a separate locking mechanism is provided for each of the wires216, a user can select the best-situation one of the wires216(i.e., the wire216that is otherwise closest to tracking along the outer curvature of the aortic arch364) to maintain/apply tension.

The delivery device200can be useful with a number of other procedures or methods in addition to the transcatheter aortic valve delivery/deployment described above. Methods of the present disclosure can include any procedure in which the delivery device200is employed to direct any type of prosthetic heart valve to any particular target site, and during which the locking mechanism314is operated to selectively maintain or apply tension in the wire216.

Although the present disclosure has been described with reference to preferred embodiments, persons skilled in the art will recognize that changes can be made in form and detail without departing from the spirit and scope of the present disclosure.