Patent Description:
Heart valves are sometimes damaged by disease or by aging, resulting in problems with the proper functioning of the valve. Heart valve replacement has become a routine surgical procedure for patients suffering from valve dysfunctions. Traditional open surgery inflicts significant patient trauma and discomfort, requires extensive recuperation times, and may result in life-threatening complications.

To address these concerns, efforts have been made to perform cardiac valve replacements using minimally-invasive techniques. In these methods, laparoscopic instruments are employed to make small openings through the patient's ribs to provide access to the heart. While considerable effort has been devoted to such techniques, widespread acceptance has been limited by the clinician's ability to access only certain regions of the heart using laparoscopic instruments.

Still other efforts have been focused upon percutaneous transcatheter (or transluminal) delivery and implantation of replacement cardiac valves to solve the problems presented by traditional open surgery and minimally-invasive surgical methods. In such methods, a stented prosthetic heart valve is compacted for delivery in a catheter and then advanced, for example through an opening in the femoral artery, and through the descending aorta to the heart, where the stented prosthetic heart valve is then deployed in the valve annulus (e.g., the aortic valve annulus).

Various types and configurations of stented prosthetic heart valves are available for percutaneous valve replacement procedures. In general, stented prosthetic heart valve designs attempt to replicate the function of the valve being replaced and thus will include valve leaflet-like structures. Valve prostheses are generally formed by attaching a bioprosthetic valve to a frame made of a wire or a network of wires. Such a stented prosthetic heart valve can be compressed radially to introduce the stented prosthetic heart valve into the body of the patient percutaneously through a catheter. The stented prosthetic heart valve may be deployed by radially expanding it once positioned at the desired treatment site. If the deployed prosthesis is incorrectly positioned relative to the valve annulus, serious complications may arise, including paravalvular leakage (PVL) or the requirement for placement of a permanent pacemaker. <CIT> relates to transcatheter prosthetic heart valve delivery systems with a stretchable stability tube. <CIT> relates to an elastic introducer sheath.

A standard delivery device for percutaneous transcatheter delivery of a stented prosthetic heart valve is shown in <FIG>. <FIG> shows a delivery device <NUM> in a delivery configuration. <FIG> shows delivery device <NUM> with a capsule <NUM> retracted. <FIG> shows planer or longitudinal movement of capsule <NUM> of delivery device <NUM>. Delivery device <NUM> includes a handle <NUM>, an outer stability shaft <NUM>, a proximal shaft <NUM> coupled to capsule <NUM>, and an inner shaft <NUM>. A stented prosthetic heart valve (not shown) in a radially compressed delivery configuration is compressively retained within capsule <NUM> for delivery to the treatment site. A gap distance G1 is the distance between a distal end <NUM> of outer stability shaft <NUM> and a proximal end <NUM> of capsule <NUM>. Gap distance G1 is required to permit retraction of capsule <NUM>, along a longitudinal axis LAd, to fully release the stented prosthetic heart valve (not shown) as shown in <FIG>. Gap distance G1 plus the length of capsule <NUM> combine to form a lever arm L1, as shown in <FIG>. Stated another way, lever arm L1 includes gap distance G1 and the length of capsule <NUM> and extends from distal end <NUM> of outer stability shaft <NUM> to the distal tip of delivery device <NUM>.

Prior to release of the stented prosthetic heart valve (not shown) at the treatment site, it may be desired to adjust the centered position of capsule <NUM> in relation to a valve annulus utilizing a steering mechanism <NUM> of delivery device <NUM>. Steering mechanism <NUM> is actuated with a steering actuator <NUM> of handle <NUM>, as shown in <FIG>. However, lever arm L1 may result in an inaccurate or unpredictable steering of capsule <NUM> and stented prosthetic heart valve retained therein. More particularly, small movements of steering actuator <NUM>, combined with the relatively long length of lever arm L1, translate to a relatively large planar movement PMl1 or PMr1 and a large deflection distance Dd1 from longitudinal axis LAd, of capsule <NUM> and stented prosthetic heart valve retained therein.

Accordingly, there is a need for an improved delivery device design and methods to provide smaller centering adjustment movement of capsule <NUM> for more accurate positioning of a stented prosthetic heart valve to reduce the instances of post procedure complications.

Embodiments hereof relate to a delivery device for percutaneously delivering a stented prosthetic heart valve to the site of a damaged or diseased native valve. The stented prosthetic heart valve is radially expandable from a radially compressed delivery configuration to a radially expanded deployed configuration. The delivery device includes a capsule assembly, a handle, and an outer stability shaft. The capsule assembly includes a capsule and a proximal shaft coupled to a proximal end of the capsule. The capsule includes an expanded configuration wherein the capsule has a first outer diameter and is configured to compressively constrain the stented prosthetic heart valve, and a collapsed configuration wherein the capsule has a second outer diameter smaller than the first outer diameter. The handle includes a housing and an actuator mechanism, wherein the actuator mechanism is coupled to a proximal portion of the proximal shaft and is configured to selectively move the proximal shaft and the capsule relative to the housing to release the stented prosthetic heart valve. The outer stability shaft defines a lumen and is coupled to the handle and configured to receive the proximal shaft within the lumen of the outer stability shaft, the outer stability shaft having an inner diameter, wherein the first outer diameter of the capsule is greater than the inner diameter of the outer stability shaft and the second outer diameter of the capsule is smaller than the inner diameter of the outer stability shaft.

Embodiments hereof also relate to a delivery device for percutaneously delivering a stented prosthetic heart valve to the site of a damaged or diseased native valve. The stented prosthetic heart valve is radially expandable from a radially compressed delivery configuration to a radially expanded deployed configuration. The delivery device includes a capsule assembly, a handle, and an outer stability shaft. The capsule assembly includes a capsule and a proximal shaft coupled to a proximal end of the capsule. The capsule includes an expanded configuration wherein the capsule is configured to compressively constrain the stented prosthetic heart valve in the radially compressed delivery configuration, and a collapsed configuration wherein the capsule does not surround the stented prosthetic heart valve. The handle includes a housing and an actuator mechanism, wherein the actuator mechanism is coupled to a proximal portion of the proximal shaft and is configured to selectively move the proximal shaft and the capsule relative to the housing to release the stented prosthetic heart valve. The outer stability shaft defines a lumen and is coupled to the handle and configured to receive the proximal shaft within the lumen of the outer stability shaft. The proximal end of the capsule is disposed distal to a distal end of the outer stability shaft when the capsule is in the expanded configuration and the capsule is disposed within the lumen of the outer stability shaft when the capsule is in the collapsed configuration.

Embodiments hereof also relate to a method for manipulating a delivery device loaded with a radially expandable stented prosthetic heart valve in a radially compressed delivery configuration, through a patient's vasculature, to a treatment site. The stented prosthetic heart valve includes a stent frame to which a valve structure is attached. The delivery device, in the delivery configuration, includes a capsule constraining the stented prosthetic heart valve and having a first outer diameter, and a proximal shaft extending proximally from a proximal end of the capsule. The delivery device further includes an outer stability shaft surrounding the proximal shaft in the delivery configuration, with a distal end of the outer stability shaft terminating proximal of the capsule. The capsule is retracted proximally to release the stented prosthetic heart valve from the capsule. The capsule slides relative to the outer stability shaft to a collapsed configuration with a second outer diameter smaller than the first outer diameter. The capsule is retracted within the outer stability shaft.

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

As referred to herein, the stented prosthetic heart valves used in accordance with and/or as part of the various systems, devices, and methods of the present disclosure may include a wide variety of different configurations, such as a bioprosthetic heart valve having tissue leaflets or a synthetic heart valve having polymeric, metallic, or tissue-engineered leaflets, and can be specifically configured for replacing any heart valve.

In general terms, the stented prosthetic heart valve of the present disclosure includes a stent supporting a valve structure which may be constructed from tissue and/or synthetic materials, with the stented prosthetic heart valve having a radially expanded deployed configuration that is collapsible to a radially compressed delivery configuration for loading within a delivery device. The stented prosthetic heart valve is usually constructed from a self-expanding material that is configured to self-deploy or expand when released from the delivery device. For example, the stented prosthetic heart valve useful with the present disclosure can be a stented prosthetic heart valve sold under the trade name CoreValve® available from Medtronic CoreValve, LLC. Other non-limiting examples of the stented prosthetic heart valves useful with the systems, devices, and methods of the present disclosure are described in <CIT>and <CIT>. The stents or stent frames are support structures that comprise a number of struts or wire portions arranged relative to each other to provide a desired compressibility and strength to the prosthetic heart valve. In general terms, the stents or stent frames of the present disclosure are generally tubular support structures having an internal area in which valve structure leaflets will be secured.

With the above understanding of the stented prosthetic heart valve in mind, a delivery device <NUM> is shown in <FIG> and <FIG>. Delivery device <NUM> includes an outer stability shaft <NUM> and a capsule <NUM> for percutaneously delivering and implanting a stented prosthetic heart valve (not shown) according to an embodiment of the present invention. <FIG> illustrates delivery device <NUM> prior to retraction of capsule <NUM>, with capsule <NUM> being in an expanded configuration, and <FIG> illustrates delivery device <NUM> after retraction of capsule <NUM> (not shown in <FIG>) with capsule <NUM> being in a collapsed configuration within outer stability shaft <NUM>, as will be described in more detail herein. Capsule <NUM> is thus configured to transition between the expanded configuration in which capsule <NUM> is disposed distal to outer stability shaft <NUM> such that the capsule surrounds and compressively retains a stented prosthetic heart valve, and the collapsed configuration in which the capsule is proximally retracted into outer stability shaft <NUM>. Since capsule <NUM> is configured to be collapsed on retraction thereof into outer stability shaft <NUM>, capsule <NUM> may be disposed directly adjacent to the distal end of stability shaft <NUM> as will be described in more detail herein.

Delivery device <NUM> includes a handle <NUM>, outer stability shaft <NUM>, a capsule assembly <NUM>, and an inner shaft assembly <NUM>. Components in accordance with the embodiment of delivery device <NUM> of <FIG> and <FIG> are presented in greater detail in <FIG>. Various features of the components of delivery device <NUM> reflected in <FIG> and described below can be modified or replaced with differing structures and/or mechanisms. Delivery device <NUM>, described in greater detail below, is merely an exemplary embodiment of a transcatheter delivery device according to an embodiment hereof and modifications can be made to the embodiments described The present disclosure is in no way limited to capsule assembly <NUM>, inner shaft assembly <NUM>, outer stability shaft <NUM>, and handle <NUM>, shown and described below. Components of delivery device <NUM> may assume different forms and construction based upon application needs as described in greater detail in <CIT>and <CIT>. Therefore, the following detailed description is not meant to be limiting. Further, the systems and functions described below can be implemented in many different embodiments of hardware. Any actual hardware described is not meant to be limiting. The operation and behavior of the systems and methods presented are described with the understanding that modifications and variations of the embodiments are possible given the level of detail presented.

Handle <NUM> includes a housing <NUM> and an actuator mechanism <NUM> retained therein. More particularly, handle <NUM> is configured to maintain portions of actuator mechanism <NUM> within a cavity (not shown), defined by housing <NUM>, as shown in <FIG> and <FIG>. In the embodiment shown in <FIG>, housing <NUM> further forms a longitudinal slot <NUM> through which actuator mechanism <NUM> extends for interfacing by a user. Handle <NUM> provides a surface for convenient handling and grasping by a user, and can have a generally cylindrical shape as shown. While handle <NUM> of <FIG> is shown with a cylindrical shape, it is not meant to limit the design, and other shapes and sizes are contemplated based on the application requirements. Handle <NUM> can assume a variety of configurations described in greater detail in <CIT>. Actuator mechanism <NUM> is generally constructed to provide selective retraction/advancement of capsule assembly <NUM> and can have a variety of constructions and/or devices capable of providing the desired user interface. Actuator mechanism <NUM> is further described in <CIT>, previously incorporated by reference.

Capsule assembly <NUM> is coaxially and slidably disposed between inner shaft assembly <NUM> and outer stability shaft <NUM>. Stated another way, capsule assembly <NUM> may be longitudinally moved relative to inner shaft assembly <NUM> and outer stability shaft <NUM> as described in more detail herein. With reference to <FIG>, capsule assembly <NUM> includes capsule <NUM> and a proximal shaft <NUM>, and defines a lumen <NUM> extending from a proximal end <NUM> of proximal shaft <NUM> to a distal end <NUM> of capsule <NUM>. Although capsule assembly <NUM> is described herein as including capsule <NUM> and proximal shaft <NUM>, capsule <NUM> may simply be an extension of proximal shaft <NUM>. The length and thickness of capsule <NUM> are determined by the requirements of the specific application. Proximal shaft <NUM> is configured for fixed connection to capsule <NUM> at a connection point <NUM> at a proximal end <NUM> of capsule <NUM> for example, and not by way of limitation, by fusing, welding, adhesive, sutures, or other means suitable for the purposes described herein, and extends proximally from capsule <NUM>, with proximal shaft <NUM> configured for fixed connection to handle <NUM>. More particularly, proximal shaft <NUM> of capsule assembly <NUM> extends proximally into housing <NUM> of handle <NUM> and a proximal portion <NUM> of proximal shaft <NUM> is rigidly connected to actuator mechanism <NUM> of handle <NUM>. Proximal portion <NUM> is coupled to actuator mechanism <NUM> such that movement of actuator mechanism <NUM> causes capsule assembly <NUM> to move relative to outer stability shaft <NUM> and inner shaft assembly <NUM>. Proximal shaft <NUM> may be coupled to actuator mechanism <NUM>, for example, and not by way of limitation by adhesives, welding, clamping, and other coupling devices as appropriate. Capsule assembly <NUM> is thus movable relative to handle <NUM>, outer stability shaft <NUM>, and inner shaft assembly <NUM> by actuator mechanism <NUM>. However, if actuator mechanism <NUM> is not moved and handle <NUM> is moved, capsule assembly <NUM> moves with handle <NUM>, not relative to handle <NUM>.

Inner shaft assembly <NUM> extends within lumen <NUM> of capsule assembly <NUM>. Inner shaft assembly <NUM> includes an inner shaft <NUM>, a retention member <NUM>, and a tip <NUM>. Inner shaft <NUM> extends from a proximal end <NUM> of inner shaft <NUM> to a distal end <NUM> of inner shaft <NUM>. Distal end <NUM> of inner shaft <NUM> connects or is attached to retention member <NUM>, and retention member <NUM> connects or is attached to tip <NUM>. The components of inner shaft assembly <NUM> combine to define a continuous lumen <NUM>, which is sized to receive an auxiliary component such as a guidewire (not shown). Although inner shaft assembly <NUM> is described herein as including inner shaft <NUM>, retention member <NUM>, and tip <NUM>, retention member <NUM> and tip <NUM> may simply be an extension of inner shaft <NUM>. Inner shaft <NUM> of inner shaft assembly <NUM> extends proximally through housing <NUM> of handle <NUM>, and is rigidly connected to handle <NUM> such that lumen <NUM> provides access for auxiliary components (e.g., a guidewire) therein. Inner shaft <NUM> may be coupled to handle <NUM>, for example, and not by way of limitation, by adhesives, welding, clamping, and other coupling devices as appropriate. During sliding or longitudinal movement of capsule assembly <NUM> relative thereto, inner shaft assembly <NUM> is fixed relative to handle <NUM>. Inner shaft assembly <NUM> can assume a variety of configurations described in greater detail in <CIT>.

Outer stability shaft <NUM> is disposed over a portion of capsule assembly <NUM>. Outer stability shaft <NUM> extends distally from handle <NUM>, and encompasses and surrounds a portion of the length of proximal shaft <NUM>, thus stabilizing at least a portion of proximal shaft <NUM> as shown in <FIG> such that outer stability shaft <NUM> provides stability to delivery device <NUM>. Outer stability shaft <NUM> has a proximal end <NUM> and a distal end <NUM> that defines a lumen <NUM> therein. Lumen <NUM> of outer stability shaft <NUM> is sized to coaxially receive capsule assembly <NUM>, and in particular proximal shaft <NUM>, in a manner permitting the sliding of proximal shaft <NUM> relative to outer stability shaft <NUM>. Outer stability shaft <NUM> is configured for fixed connection to handle <NUM>. More particularly, handle <NUM> has a distal end <NUM> configured to accept proximal end <NUM> of outer stability shaft <NUM>. Outer stability shaft <NUM> may be coupled to handle <NUM>, for example, and not by way of limitations, by adhesives, welding, clamping, and other coupling devices, as appropriate. Outer stability shaft <NUM> can assume a variety of configurations described in greater detail in <CIT>.

According to embodiments hereof, capsule <NUM> is configured to be collapsible upon retraction thereof into outer stability shaft <NUM>. <FIG> shows delivery device <NUM> with capsule <NUM> in the expanded configuration, in which a stented prosthetic heart valve (not shown) in a radially compressed delivery configuration is loaded therein. As shown in <FIG> and <FIG>, when in the expanded configuration, capsule <NUM> has an outer diameter ODe and is coaxially disposed over retention member <NUM> of inner shaft assembly <NUM>. Outer diameter ODe is greater than an inner diameter IDa of outer stability shaft <NUM>. However, when capsule <NUM> is in the collapsed configuration, as shown in <FIG> and <FIG>, capsule <NUM> has an outer diameter ODc, which is smaller than inner diameter IDa of outer stability shaft <NUM>. More particularly, as previously described, capsule assembly <NUM>, including capsule <NUM> and proximal shaft <NUM>, can be retracted in a proximal direction relative to inner shaft assembly <NUM>, outer stability shaft <NUM>, and housing <NUM> of handle <NUM> such that capsule <NUM> is proximally retracted into outer stability shaft <NUM> as shown in <FIG>. When retracted, capsule <NUM> collapses to outer diameter ODc, which is smaller than inner diameter IDa of outer stability shaft <NUM>. Thus, capsule <NUM> transitions from the expanded configuration of <FIG> to the collapsed configuration of <FIG> when retracted into lumen <NUM> of outer stability shaft <NUM>. Capsule <NUM> retracts into lumen <NUM> of outer stability shaft <NUM> such that capsule <NUM> does not surround the stented prosthetic heart valve (not shown), and the stented prosthetic heart valve (not shown) radially expands to its radially expanded deployed configuration. Thus, capsule <NUM> is in its expanded configuration prior to retraction of capsule assembly <NUM> and release of the stented prosthetic heart valve, and capsule <NUM> is in its collapsed configuration after retraction of capsule assembly <NUM> and release of the stented prosthetic heart valve. <FIG> shows an end view comparison of capsule <NUM> in the expanded and collapsed configurations. In the expanded configuration, capsule <NUM> with outer diameter ODe is shown in relation to lumen <NUM> of inner shaft <NUM>, lumen <NUM> of proximal shaft <NUM>, and lumen <NUM> of outer stability shaft <NUM> (obscured in <FIG> by capsule <NUM> in the expanded configuration). In the collapsed configuration, capsule <NUM> with outer diameter ODc is shown in relation to lumen <NUM> of inner shaft <NUM>, lumen <NUM> of proximal shaft <NUM> (obscured by capsule <NUM> in the collapsed configuration), and outer stability shaft <NUM>.

Since capsule <NUM> is configured to be collapsible upon retraction thereof into outer stability shaft <NUM>, distal end <NUM> of outer stability shaft <NUM> may be disposed directly adjacent to proximal end <NUM> of capsule <NUM>. Stated another way, since capsule <NUM> is configured to be collapsible upon retraction thereof into outer stability shaft <NUM>, it is not required to leave a gap between distal end <NUM> of outer stability shaft <NUM> and proximal end <NUM> of capsule <NUM> sufficient to permit retraction of capsule <NUM>. Rather, outer stability shaft <NUM> extends such that gap distance G2, as shown in <FIG>, between proximal end <NUM> of capsule <NUM> and distal end <NUM> of outer stability shaft <NUM>, is minimized and in the range of <NUM> to <NUM>. Gap distance G2 accommodates a smooth but relatively short taper between capsule <NUM> and proximal shaft <NUM> as shown in <FIG>. As such, as used herein, "directly adjacent" includes when distal end <NUM> of outer stability shaft <NUM> is disposed between <NUM> and <NUM> relative to proximal end <NUM> of capsule <NUM>. In an embodiment, distal end <NUM> of outer stability shaft <NUM> may abut against or contact proximal end <NUM> of capsule <NUM>.

<FIG> illustrate how capsule <NUM> is configured to be collapsible upon retraction thereof into outer stability shaft <NUM> (not shown in <FIG>) according to an embodiment hereof. More particularly, capsule <NUM> includes a wire structure <NUM>, a liner <NUM>, and a jacket <NUM>. Wire structure <NUM> is coupled between liner <NUM> and jacket <NUM>, for example, and not by way of limitation, by lamination, embedding, or other methods suitable for the purposes described herein. Liner <NUM> may be constructed, for example, and not by way of limitation, of Teflon®, polytetrafluoroethylene (PTFE), polyethylene, polyethylene terephthalate (PET), polyester, or other materials suitable for the purposes of the present disclosure. Jacket <NUM> may be constructed, for example, and not by way of limitation, of polyurethane (e.g. Peliethane©, ElasthaneTIVI, Texin®, Tecothane®), polyamide polyether block copolymer (e.g. Pebax®, nylon <NUM>), polyethylene, or other materials suitable for the purposes of the present disclosure. The material for jacket <NUM> may also include materials to add radiopacity so that capsule <NUM> can be radio detectable (radiopaque). Wire structure <NUM> may be formed, for example, and not by way of limitation, of nickel titanium, Nitinol, nickel-cobalt-chromium-molybdenum (MP35N), stainless steel, high spring temper steel, or any other metal or elastomer or composite having elastic properties to permit extension and recoil suitable for purposes of the present disclosure. Wire structure <NUM> is of a shape memory material with a pre-set shape. In an embodiment, wire structure <NUM> has a pre-set shape in the collapsed configuration with outer diameter ODc, as shown in <FIG>. Wire structure <NUM> allows capsule <NUM> to expand to outer diameter ODe when in the expanded configuration, as shown in <FIG>, with the stented prosthetic heart valve (not shown) in the radially compressed delivery configuration within capsule <NUM>. Due to the shape memory material and pre-set shape thereof, wire structure <NUM> causes capsule <NUM> to actively recoil to the reduced outer diameter ODc after release of the stented prosthetic heart valve from capsule <NUM>. As previously stated, outer diameter ODe is greater than outer diameter ODc and outer diameter ODc is smaller than the inner diameter IDa of outer stability shaft <NUM>.

While wire structure <NUM> has been previously described with a pre-set shape in the collapsed configuration with outer diameter ODc, this is not meant to limit the design, and wire structure <NUM> can alternatively have a pre-set shape in the expanded configuration with outer diameter ODe, or any other configuration between the collapsed and expanded configuration based upon the application.

Liner <NUM> is circumferentially continuous and forms a lumen <NUM>, as shown in <FIG>. Wire structure <NUM> and jacket <NUM> are non-circumferentially continuous and includes a jacket gap <NUM> visible in the expanded configuration, as shown in <FIG>. In the collapsed configuration, as shown in <FIG>, capsule <NUM> includes a liner overlap region <NUM> and a jacket overlap region <NUM>. Liner overlap region <NUM> includes a liner gap portion <NUM> defined by an inner fold <NUM> and an outer fold <NUM> of liner <NUM>. Liner gap portion <NUM> can be at least partially covered by jacket <NUM>. Liner <NUM> extends around an inner edge <NUM> to form inner fold <NUM>. Jacket overlap region <NUM> is defined by inner edge <NUM> and an outer edge <NUM> of jacket <NUM>. In the expanded configuration, inner edge <NUM> and outer edge <NUM> are separated circumferentially to form jacket gap <NUM>, as shown in <FIG>. In such a configuration, inner fold <NUM> and outer fold <NUM> are flattened or stretched apart to allow liner gap portion <NUM> to extend across jacket gap <NUM>.

As previously stated, wire structure <NUM> has a pre-set shape that allows capsule <NUM> to collapse to reduced outer diameter ODc after release of the stented prosthetic heart valve from capsule <NUM>. More particularly, as shown in <FIG>, wire structure <NUM> includes a repeating longitudinal pattern and is shown in a flat, or uncurved, state. For example, and not by way of limitation, wire structure <NUM> may include a sinusoid pattern <NUM> (<FIG>), a square pattern <NUM> (<FIG>), a modified square pattern <NUM> including a spine <NUM> (<FIG>), a modified square pattern <NUM> including a preferential bend portion (<FIG>), and a modified square pattern <NUM> including a stepped portion (<FIG>). Sinusoid pattern <NUM>, as shown in <FIG>, includes a series of alternating adjacent straight portions 202a and 202b. Each straight portion 202a is joined to a first adjacent straight portion 202b by a first bent end portion 204a, and to a second adjacent straight portion 202b by a second bent end portion 204b. Conversely, each straight portion 202b is joined to two straight portions 202a by first bent end portion 204a and second bent end portion 204b.

Square pattern <NUM>, as shown in <FIG>, includes a series of alternating adjacent straight portions 262a and 262b. Each straight portion 262a is joined to a first adjacent straight portion 262b by a first end portion 264a, and to a second adjacent straight portion 262b by a second end portion 264b. Conversely, each straight portion 262b is joined to two straight portions 262a by first end portion 264a and second end portion 264b.

Modified square pattern <NUM>, as shown in <FIG>, includes a series of alternating adjacent straight portions 272a and 272b. Each straight portion 272a is joined to a first adjacent straight portion 272b by a first end portion 274a, and to a second adjacent straight portion 272b by a second end portion 274b. Conversely, each straight portion 272b is joined to two straight portions 272a by first end portion 274a and second end portion 274b. A spine <NUM> extends along end portions 274b. Spine <NUM> adds additional tensile rigidity to wire structure <NUM>. End portions 274b adjacent spine <NUM> may be coupled to spine <NUM>, for example, and not by way of limitation, by welding, adhesives, or other materials suitable for the purposes described herein.

Modified square pattern <NUM>, as shown in <FIG>, includes a series of alternating adjacent straight portions 282a and 282b. Each straight portion 282a is joined to a first adjacent straight portion 282b by a first end portion 284a, and to a second adjacent straight portion 282b by either a second end portion 284b or a preferential bending portion 284c. Conversely, each straight portion 282b is joined to two straight portions 282a by first end portion 284a and either second end portion 284b or preferential bending portion 284c. A spine <NUM> extends along end portions 284b and preferential bending portion(s) 284c. Preferential bending portion(s) 284c provides increased flexibility to wire structure <NUM> in the area of preferential bending portion(s) 284c by forming a disjointed or segmented portion of modified square pattern <NUM> which has no straight portions 282a and 282b. More particularly, in an embodiment, preferential bending portion(s) 284c provides the capsule with flexibility to bend during tracking and delivery. Stated another way, the capsule is permitted to bend at preferential bending portion(s) 284c due to the absence of straight portions 282a and 282b along the length of preferential bending portion(s) 284c. In another embodiment, preferential bending portion(s) 284c provides the capsule with two different expansions zones (i.e., an expansion zone on both sides of the preferential bending portion). Although illustrated at an intermediate portion of wire structure <NUM>, the position of preferential bending portion(s) 284c may vary. In addition, although shown with only one preferential bending portion 284c, wire structure <NUM> may include a plurality of preferential bending portions 284c spaced apart along the length of spine <NUM>. Spine <NUM> adds additional tensile rigidity to wire structure <NUM>. End portion 284b and preferential bending portion(s) 284c adjacent spine <NUM> may be coupled to spine <NUM>, for example, and not by way of limitation, by welding, adhesives, or other materials suitable for the purposes described herein.

Modified square pattern <NUM>, as shown in <FIG>, includes a series of alternating adjacent straight portions 292a and 292b having a first length L1 along a distal portion <NUM> of wire structure <NUM>. Modified square pattern <NUM> further includes a series of alternating adjacent straight portions 292c and 292d having a second length L2 along a proximal portion <NUM> of wire structure <NUM>. In the embodiment of <FIG>, the first length L1 of each straight portion 292a and 292b is greater than the second length L2 of each straight portion 292c and 292d. For distal portion <NUM> of wire structure <NUM>, each straight portion 292a is joined to a first adjacent straight portion 292b by a first end portion 294a, and to either a second adjacent straight portion 292b, or for the straight portion 292a at a proximal end of distal portion <NUM> to a second adjacent straight portion 292c, by a second end portion 294b. Conversely, each straight portion 292b is joined to two straight portions 292a by first end portion 294a and second end portion 294b. For the proximal portion <NUM> of wire structure <NUM>, each straight portion 292c is joined to a first adjacent straight portion 292d by a first end portion 294a, and to either a second adjacent straight portion 282d, or for the straight portion 292c at a distal end of proximal portion <NUM> to a second adjacent straight portion 292b, by a second end portion 294b. Conversely, each straight portion 292d is joined to two straight portions 292c by first end portion 294a and second end portion 294b. As shown in <FIG>, the first length L1 and the second length L2 of straight portions 292a/292b and 292c/292d, respectively, form a stepped profile with a first diameter D1 over the distal portion <NUM> and a second diameter D2 over the proximal portion <NUM>. First diameter D1 is greater than second diameter D2. The stepped profile of modified square pattern <NUM> in turn provides the capsule with a stepped profile (not shown), the stepped profile capsule being configured to receive a stented prosthetic heart valve therein as described previously. More specifically, the stepped profile capsule accommodates a stented prosthetic heart valve with larger diameter at a distal portion thereof. For example, a stented prosthetic heart valve may have an additional component at the distal portion thereof that causes the distal portion of the stented prosthetic heart valve to have a larger diameter such as, but not limited to a sealing component configured to prevent paravalvular leakage (PVL) such as a skirt, a cuff, or a sleeve. A sealing component increases the collapsed diameter of the stented prosthetic heart valve over the area of the stented prosthetic heart valve to which it is coupled. Therefore, in the example of <FIG>, the wire structure <NUM> with an increased first diameter D1 over distal portion <NUM> accommodates a stented prosthetic heart valve with larger diameter at a distal portion thereof. While the stepped configuration is described herein with a greater diameter over the distal portion <NUM>, this is not meant to be limiting and the greater diameter portion may be disposed over proximal portion <NUM>, or over other portions there between based upon the application. In addition, although shown with a single stepped portion, wire structure <NUM> may include a plurality of stepped portions spaced apart along the length of a spine <NUM> to provide a plurality of outer diameters. Further, rather than a single abrupt stepped portion as shown, wire structure <NUM> may include a plurality of small, adjacent stepped portions that collectively form a single tapered stepped portion. Spine <NUM> extends along end portions 294b. Spine <NUM> adds additional tensile rigidity to wire structure <NUM>. End portions 294b adjacent spine <NUM> may be coupled to spine <NUM>, for example, and not by way of limitation, by welding, adhesives, or other materials suitable for the purposes described herein.

The below discussion refers to sinusoidal portion <NUM> of wire structure <NUM>, however, square pattern <NUM> or modified square patterns <NUM>, <NUM>, <NUM> could also be used for wire structure <NUM>. As shown in <FIG>, <FIG>, along the length of capsule <NUM>, the straight portions of wire structure <NUM> are curved about a longitudinal axis LA2 into a C- shaped wire structure <NUM> forming a series of non-continuous circumferential loops. To form the non-continuous circumferential loops, a first loop portion <NUM> of straight portions 202a and 202b joined by first bent end portion 204a is curved in a first radial direction <NUM>. A second loop portion <NUM> of straight portions 202a and 202b joined by second bent end portion 204b is curved in a second radial direction <NUM>. First loop portions <NUM> and second loop portions <NUM> form a series of alternating non-continuous circumferential loops extending along longitudinal axis LA2. In the collapsed configuration of capsule <NUM>, first loop portions <NUM> and second loop portions <NUM> overlap circumferentially as demonstrated by a wire region <NUM>, as shown in <FIG>. When capsule <NUM> is in the collapsed configuration, first loop portions <NUM> are positioned within second loop portions <NUM> in wire region such that the second loop portions <NUM> cover the first loop portions <NUM>. When capsule <NUM> is in the expanded configuration, first loop portions <NUM> and second loop portions <NUM> do not overlap and do not include wire region <NUM>. Stated another way, as capsule <NUM> transitions between the collapsed configuration and the expanded configuration, circumferential portions <NUM> and <NUM> of wire structure <NUM> expand and collapse, thereby expanding and collapsing wire region <NUM>.

Capsule <NUM>, as shown in <FIG>, is designed to allow for local expansion and subsequent recoil to retain and release the stented prosthetic heart valve as previously described. While introducing the stented prosthetic heart valve to capsule <NUM> for delivery to the treatment site within the patient, capsule <NUM> can transition from the collapsed configuration having outer diameter ODc (<FIG>) to the expanded configuration having outer diameter ODe (<FIG>) to accommodate the stented prosthetic heart valve (not shown). This increase in diameter is accomplished by first loop portions <NUM> and second loop portions <NUM> of wire structure <NUM>, as shown in <FIG>, and inner edge <NUM> and outer edge <NUM> of jacket <NUM>, as shown in <FIG> diverging circumferentially to increase the effective diameter of capsule <NUM>. As capsule <NUM> increases in diameter, inner fold <NUM> and outer fold <NUM> are flattened or stretched apart to allow liner gap portion <NUM> to span across jacket gap <NUM>. Thus, liner gap portion <NUM> extends across jacket gap <NUM> and maintains a circumferentially continuous structure. Upon release of the stented prosthetic heart valve (not shown) at the treatment site within the patient, capsule <NUM> transitions from the expanded configuration, having outer diameter ODe, to the collapsed configuration, having outer diameter ODc. As previously described, the collapsed configuration, with outer diameter ODc, of capsule <NUM> is smaller than the inner diameter IDa of outer stability shaft <NUM>.

<FIG> and <FIG> illustrate another embodiment of a capsule <NUM> that is configured to be collapsible upon retraction thereof into an outer stability shaft <NUM> (not shown in <FIG>) according to an embodiment hereof. Capsule <NUM> may be utilized in delivery device <NUM> as described above with respect to delivery device <NUM>. As described above with respect to capsule <NUM> and proximal shaft <NUM>, capsule <NUM> is coupled to a proximal shaft <NUM>, shown in <FIG>. Capsule <NUM> includes a generally tubular polymeric structure <NUM> and a plurality of reinforcing members <NUM>. As best shown in <FIG>, reinforcing members <NUM> are axially spaced longitudinal metallic or polymeric wires or rods disposed within and providing compressive strength to capsule <NUM>. Reinforcing members <NUM> are arranged parallel to longitudinal axis LAd and coupled to an inner surface of polymeric structure <NUM>. Reinforcing members <NUM> may be, for example, and not by way of limitation, stainless steel, Nitinol, nylon, polybutylester, or other materials suitable for the purposes described herein. Reinforcing members <NUM> are coupled to polymeric structure <NUM>, for example, and not by way of limitation, by fusing, welding, adhesive, sutures, or other means suitable for the purposed described herein. While <FIG> show four (<NUM>) reinforcing members <NUM> within polymeric structure <NUM>, this is not meant to limit the design and more or fewer reinforcing members may be employed. Further, reinforcing members <NUM> may be coupled to an outer surface of polymeric structure <NUM>.

In an embodiment, polymeric structure <NUM> of capsule <NUM> is of a shape memory material with a pre-set shape in a relaxed or intermediate configuration of <FIG> in which no forces are applied thereto. In the relaxed configuration, capsule <NUM> has a third outer diameter ODr. Polymeric structure <NUM> is an elastic structure that allows capsule <NUM> to stretch or expand to an expanded configuration in which capsule <NUM> has a first outer diameter ODe as shown in <FIG>, when a stented prosthetic heart valve (not shown) in a radially compressed delivery configuration is disposed therein. Stated another way, when a stented prosthetic heart valve is positioned therein, polymeric structure <NUM> and reinforcing members <NUM> attached thereto radially expand to accommodate the stented prosthetic heart valve. The elastic properties of polymeric structure <NUM> also allow capsule <NUM> to actively recoil back to third outer diameter OD, of the relaxed configuration after release of the stented prosthetic heart valve (not shown). First outer diameter ODe of capsule <NUM> is greater than third outer diameter OD, of capsule <NUM>. Further, the elastic properties of polymeric structure <NUM> also allow capsule <NUM> to fold to a collapsed or folded configuration in which capsule <NUM> has a second outer diameter ODc as shown in <FIG>, when capsule <NUM> is retracted into outer stability shaft <NUM>. Outer stability shaft <NUM> has an inner diameter IDa. As capsule <NUM> is retracted into outer stability shaft <NUM>, outer stability shaft <NUM> imparts compressive radial force on capsule <NUM>, resulting in portions of polymeric structure <NUM> disposed between adjacent reinforcing members <NUM> folding inward, towards longitudinal axis LAd of capsule <NUM>, and reducing capsule <NUM> to second outer diameter ODc. Polymeric structure <NUM> may be of a thin-walled polymeric material, for example, and not by way of limitation, polyester, elasthane or any other material suitable for the purpose described herein.

While polymeric structure <NUM> has been described herein as having a pre-set shape in the relaxed configuration of <FIG> with third outer diameter ODr, polymeric structure <NUM> can alternatively have the pre-set shape in the expanded configuration of <FIG> with first outer diameter ODe, the pre-set shape in the collapsed configuration of <FIG> with second outer diameter ODc, or any other configuration between the collapsed and expanded configuration based upon the application. When the polymeric structure has a pre-set shape in the expanded configuration, loading forces on the stented prosthetic heart valve are minimized and when the polymeric structure has a pre-set shape in the collapsed configuration, deployment forces on the stented prosthetic heart valve are minimized by reducing the force required to pull the polymeric structure into the outer stability shaft.

In another embodiment, as described above with respect to delivery device <NUM>, capsule <NUM>, and polymeric structure <NUM>, polymeric structure <NUM> of capsule <NUM> of delivery device <NUM> is of a shape memory material with a pre-set shape in an expanded configuration of <FIG> in which no forces are applied thereto. In the expanded configuration, capsule <NUM> has a first outer diameter ODe. Polymeric structure <NUM> is a non-elastic structure that allows capsule <NUM> to impart compressive radial forces on a stented prosthetic heart valve (not shown) in a radially compressed delivery configuration disposed therein. Polymeric structure <NUM> allows capsule <NUM> to fold to a collapsed or folded configuration in which capsule <NUM> has a second outer diameter ODc as shown in <FIG>, when capsule <NUM> is retracted into outer stability shaft <NUM>. Outer stability shaft <NUM> has an inner diameter IDa. As capsule <NUM> is retracted into outer stability shaft <NUM>, outer stability shaft <NUM> imparts compressive radial force on capsule <NUM>, resulting in portions of polymeric structure <NUM> disposed between adjacent reinforcing members <NUM> folding inward, towards longitudinal axis LAd of capsule <NUM>, and reducing capsule <NUM> to second outer diameter ODc. Polymeric structure <NUM> may be of a thin-walled polymeric material, for example, and not by way of limitation, polypropylene or any other materials suitable for the purpose described herein.

In any embodiment hereof, an outer stability shaft of a delivery device may be modified to include a steering mechanism to enable the centering of a delivery device within a valve annulus. For example, <FIG> illustrate a steering mechanism <NUM> coupled to an outer stability shaft <NUM> of delivery device <NUM>. Delivery device <NUM> is similar to delivery device <NUM> as previously described herein. Delivery device <NUM> includes a capsule assembly <NUM>, outer stability assembly <NUM>, and inner shaft assembly <NUM>, as shown in <FIG>. Similar to capsule assembly <NUM>, capsule assembly <NUM> includes a capsule <NUM> and a proximal shaft <NUM> as previously described. Steering mechanism <NUM> of delivery device <NUM> includes a steering actuator <NUM> at a handle <NUM>, as shown in <FIG>, and a plurality of pull cable shafts <NUM> defining a plurality of lumen <NUM> with a plurality of pull cables <NUM> disposed therein, as shown in <FIG>. Pull cables <NUM> include a proximal end (not shown) coupled to steering actuator <NUM> of handle <NUM> and a distal end (not shown) coupled to a distal end <NUM> of outer stability shaft <NUM>, and disposed within respective lumens <NUM>, therein. Cable shafts <NUM> may be connected to an inner surface of outer stability shaft <NUM> for example, and not by way of limitation, by fusing, welding, adhesive, sutures, or other means suitable for the purposed described herein. Proximal ends (not shown) of pull cables <NUM> may be connected to steering actuator <NUM> of handle <NUM> for example, and not by way of limitation, by fusing, welding, adhesive, sutures, or other means suitable for the purposed described herein. Distal ends (not shown) of pull cables <NUM> may be connected to distal end <NUM> of outer stability shaft <NUM> for example, and not by way of limitation, by welding, adhesive, sutures, or other means suitable for the purposed described herein. While the steering embodiment of <FIG> show pull cable shafts <NUM> and respective pull cables <NUM> disposed directly across from each other, or at <NUM> degrees from each other on an interior surface of outer shaft <NUM>, this is not meant to be limiting and other configurations of pull shafts <NUM> and respective pull cables <NUM> are envisioned. For example, and not by way of limitation, pull shafts <NUM> and their respective pull cables <NUM> may be disposed at <NUM> degrees from each other such that outer shaft <NUM> may be steered in two (<NUM>) planes.

Delivery device <NUM> includes a capsule <NUM> configured to be collapsed on retraction thereof into outer stability shaft <NUM>. As capsule <NUM> is configured to be collapsed on retraction thereof into outer stability shaft <NUM>, capsule <NUM> is disposed directly adjacent to distal end <NUM> of outer stability shaft <NUM>, as shown in <FIG>, with the capsule in an expanded configuration and <FIG>, with capsule <NUM> in a collapsed configuration. Capsule <NUM> being disposed directly adjacent to distal end <NUM> of outer stability shaft <NUM> minimizes a gap distance G2, thus minimizing a lever arm L2. Steering actuator <NUM> of delivery device <NUM> may be user manipulated left or right relative to a longitudinal axis LAd of handle <NUM>. Steering mechanism <NUM> is configured such that user manipulation left or right of steering actuator <NUM> is translated though pull cables <NUM>, as shown in <FIG>, to a user definable single planar movement PMl2 or PMr2 relative to longitudinal axis LAd, and a deflection distance Dd2 of distal end <NUM> of outer shaft <NUM>, as shown in <FIG>. Since capsule <NUM> is disposed directly adjacent to distal end <NUM> of outer stability shaft <NUM>, a minimized lever arm L2 is reduced or shortened relative to lever arm L1 discussed with respect to <FIG>. The minimized lever arm L2 results in improved steering accuracy and smaller planer movement PMl2 and PMr2 and smaller deflection distance Dd2 of capsule <NUM> and a stented prosthetic heart valve therein, relative to the planer movements and deflection distance discussed with respect to <FIG>. Stated another way, with collapsible capsule <NUM> disposed directly adjacent to distal end <NUM> of outer stability shaft <NUM>, small movements of steering actuator <NUM>, combined with the minimized length of lever arm L2 resulting thereof, translate to relatively small planar movement PMl2 or PMr2 and small, precise deflection distance Dd2 of capsule <NUM> and the stented prosthetic heart valve retained therein.

A method of manipulating a delivery device with a stented prosthetic heart valve loaded therein, in accordance with an embodiment hereof, is schematically represented in <FIG>. Using established percutaneous transcatheter delivery procedures, delivery device <NUM> is introduced into a patient's vasculature and positioned at a treatment site of a damaged or diseased native valve, which in this embodiment is a native aortic valve <NUM>. Delivery device <NUM> includes a handle (not shown), outer stability shaft <NUM>, proximal shaft <NUM>, inner shaft <NUM>, and capsule assembly <NUM> as previously described. Delivery device <NUM> is advanced through the aorta <NUM> (including the aortic arch <NUM> (passing the innominate or brachiocephalic artery <NUM>, the left common carotid artery <NUM>, and the left subclavian artery <NUM>, ascending aorta <NUM>, sinotubular junction <NUM>, aortic sinuses <NUM>) to a valve annulus <NUM> and between native valve leaflets <NUM> of the damaged or disease native aortic valve <NUM>, as shown in <FIG>. Although described herein with delivery device <NUM>, it will be apparent to one of ordinary skill that methods described herein may utilize a delivery device according to any embodiment described herein. In <FIG>, capsule <NUM> of capsule assembly <NUM> is in the expanded configuration and is positioned over a stented prosthetic heart valve <NUM> (obscured from view in <FIG>).

Next, actuator mechanism <NUM> of handle <NUM> (not shown on <FIG>) is operated proximally to retract capsule assembly <NUM>. In particular, proximal shaft <NUM> and capsule <NUM> are moved proximally to withdraw capsule <NUM> from its position surrounding stented prosthetic heart valve <NUM>, and retract capsule <NUM> into lumen <NUM> (not shown on <FIG>) of outer stability shaft <NUM>, as shown in <FIG>. As capsule <NUM> is retracted proximally, capsule <NUM> transitions from the expanded configuration with outer diameter ODe to the collapsed configuration with outer diameter ODc. As previously described herein, outer diameter ODc of capsule <NUM> is smaller than outer diameter ODe of capsule <NUM> and is also smaller than inner diameter IDa of outer stability shaft <NUM>. Of note, as stented prosthetic heart valve <NUM> expands, it traps native leaflets <NUM> against the wall of valve annulus <NUM>.

Once stented prosthetic heart valve <NUM> is fully deployed and in the radially expanded deployed configuration (with native valve leaflets <NUM> disposed between the wall of valve annulus <NUM> and an outer surface of stented prosthetic heart valve <NUM>), as shown in <FIG>, delivery device <NUM> may be retracted and removed from the patient's vasculature using established procedures.

Another method of manipulating a delivery device with a stented prosthetic heart valve loaded therein, in accordance with an embodiment hereof, is schematically represented in <FIG>. The method steps of <FIG> are described with respect to delivery device <NUM> that includes steering mechanism <NUM> as described above. Using established percutaneous transcatheter delivery procedures, delivery device <NUM> is introduced into a patient's vasculature and positioned longitudinally at the site of a damaged or diseased native valve, which in this embodiment is the native aortic valve <NUM>. Delivery device <NUM> includes a handle (not shown), outer stability shaft <NUM>, proximal shaft <NUM>, inner shaft <NUM>, steering mechanism <NUM> (not shown in <FIG>), and capsule assembly <NUM> as previously described. Delivery device <NUM> is advanced through the aorta <NUM> (including the aortic arch <NUM> (passing the innominate or brachiocephalic artery <NUM>, the left common carotid artery <NUM>, and the left subclavian artery <NUM>, ascending aorta <NUM>, sinotubular junction <NUM>, aortic sinuses <NUM>) to valve annulus <NUM> and between native valve leaflets <NUM> of the damaged or disease native aortic valve <NUM>, as shown in <FIG>. In <FIG>, capsule <NUM> of capsule assembly <NUM> is in the expanded configuration and is positioned over stented prosthetic heart valve <NUM> (obscured from view in <FIG>). Capsule <NUM> is not centered on longitudinal axis LAv of valve annulus <NUM>.

Next the centered position of capsule <NUM> relative to longitudinal axis LAv of valve annulus <NUM> may be adjusted using steering mechanism <NUM> (not shown in <FIG>) coupled to outer stability shaft <NUM>. Steering actuator <NUM> (not shown) of steering mechanism <NUM> (not shown) of delivery device <NUM> is manipulated by the user to move capsule <NUM> in direction PMl2 the deflection distance Dd2 to center capsule <NUM> on longitudinal axis LAv at the desired deployment location, as shown in <FIG>. With capsule <NUM> being collapsible and disposed directly adjacent to distal end <NUM> (not shown) of outer stability shaft <NUM> as previously described rather than spaced apart therefrom, small movements of steering actuator (not shown), translate to relatively small planar movement PMl2 and relatively small, precise deflection distance Dd2 of capsule <NUM> and stented prosthetic heart valve <NUM> (obscured in <FIG>) retained therein. Determination of desired deployment location and centering may be based upon known methods, for example, and not by way of limitation, such as sonography and radiopaque markers.

With capsule <NUM> in the desired delivery location and centered on valve annulus <NUM>, as shown in <FIG>, stented prosthetic heart valve <NUM> is now deployed. Actuator mechanism <NUM> of handle <NUM> (not shown in <FIG>) is operated proximally to retract capsule assembly <NUM>. In particular, proximal shaft <NUM> and capsule <NUM> are moved proximally to withdraw capsule <NUM> from its position surrounding stented prosthetic heart valve <NUM>, and retract capsule <NUM> into lumen <NUM> (not shown on <FIG>) of outer stability shaft <NUM>, as shown in <FIG>. As capsule <NUM> is retracted proximally, capsule <NUM> transitions from the expanded configuration with outer diameter ODe to the collapsed configuration with outer diameter ODc. As described previously, outer diameter ODc of capsule <NUM> is smaller than outer diameter ODe of capsule <NUM> and is also smaller than inner diameter IDa of outer stability shaft <NUM>. As stented prosthetic heart valve <NUM> expands, it traps native leaflets <NUM> against the wall of valve annulus <NUM>.

Once stented prosthetic heart valve <NUM> is fully deployed and in the radially expanded deployed configuration, (with native valve leaflets <NUM> disposed between the wall of valve annulus <NUM> and an outer surface of stented prosthetic heart valve <NUM>), as shown in <FIG>, delivery device <NUM> may be retracted and removed from the patient's vasculature using established procedures.

<FIG> show a delivery device <NUM> according to another embodiment hereof. Similar to delivery device <NUM>, delivery device <NUM> includes outer stability shaft <NUM>, capsule assembly <NUM>, and inner shaft assembly <NUM>. Outer stability shaft <NUM>, capsule assembly <NUM>, and inner shaft assembly <NUM> of delivery device <NUM> are described above with respect to delivery device <NUM>, and therefore construction and description of these components will not be repeated in detail. However, unlike delivery device <NUM>, delivery device <NUM> further includes a delivery capsule assembly <NUM>.

Delivery capsule assembly <NUM> is coaxially and slidably disposed between inner shaft assembly <NUM> and capsule assembly <NUM>. Stated another way, delivery capsule assembly <NUM> may be longitudinally moved relative to inner shaft assembly <NUM>, capsule assembly <NUM>, and outer stability shaft <NUM>. With reference to <FIG>, delivery capsule assembly <NUM> includes a delivery capsule <NUM> and a delivery shaft <NUM>, and defines a lumen <NUM> extending from a proximal end <NUM> of delivery shaft <NUM> to a distal end <NUM> of delivery capsule <NUM>. Although delivery capsule assembly <NUM> is described herein as including delivery capsule <NUM> and delivery shaft <NUM>, delivery capsule <NUM> may simply be an extension of delivery shaft <NUM>. The length and thickness of delivery capsule <NUM> are determined by the requirements of the specific application. Delivery shaft <NUM> is configured for fixed connection to delivery capsule <NUM> at a connection point <NUM> at a proximal end <NUM> of delivery capsule <NUM> for example, and not by way of limitation, by fusing, welding, adhesive, sutures, or other means suitable for the purposes described herein, and extends proximally from delivery capsule <NUM>, with delivery shaft <NUM> configured for fixed connection to a handle <NUM>. Handle <NUM> is similar to handle <NUM> described previously, except that handle <NUM> includes a second actuator mechanism <NUM> for actuating delivery capsule assembly <NUM>. In an embodiment, second actuator mechanism <NUM> extends through longitudinal slot <NUM> for interfacing by a user. Second actuator mechanism <NUM> is generally constructed to provide selective retraction/advancement of delivery capsule assembly <NUM> and can have a variety of constructions and/or devices capable of providing the desired user interface. Second actuator mechanism <NUM> is further described in <CIT>.

More particularly, delivery shaft <NUM> of delivery capsule assembly <NUM> extends proximally into housing <NUM> of handle <NUM> and a proximal portion <NUM> of delivery shaft <NUM> is rigidly connected to delivery actuator mechanism <NUM> of handle <NUM>. Proximal portion <NUM> is coupled to delivery actuator mechanism <NUM> such that movement of delivery actuator mechanism <NUM> causes delivery capsule assembly <NUM> to move relative to outer stability shaft <NUM> capsule assembly <NUM>, and inner shaft assembly <NUM>. Delivery shaft <NUM> may be coupled to delivery actuator mechanism <NUM>, for example, and not by way of limitation by adhesives, welding, clamping, and other coupling devices as appropriate. Delivery capsule assembly <NUM> is thus movable relative to handle <NUM>, outer stability shaft <NUM>, capsule assembly <NUM>, and inner shaft assembly <NUM> by delivery actuator mechanism <NUM>. However, if delivery actuator mechanism <NUM> is not moved and handle <NUM> is moved, delivery capsule assembly <NUM> moves with handle <NUM>, not relative to handle <NUM>.

According to embodiments hereof, delivery capsule <NUM> is configured to be collapsible upon retraction thereof into capsule assembly <NUM>. Delivery capsule <NUM> is a thin-walled capsule designed to minimize crossing profile of the stented prosthetic heart valve loaded therein for introduction into a body. Delivery capsule <NUM> may be formed of materials such as, but no limited to materials similar to those used in the construction of angioplasty balloons, such as polyethylene terephthalate (PET), nylon, or other materials suitable for the purposes described herein. <FIG> shows delivery device <NUM> with delivery capsule <NUM> in the expanded configuration, in which a stented prosthetic heart valve (not shown) is held in a radially compressed delivery configuration therein. Stated another way, delivery capsule <NUM> in the expanded configuration functions to retain or hold the stented prosthetic heart valve in the radially compressed configuration for delivery thereof. When retracted, delivery capsule <NUM> collapses into capsule assembly <NUM> due to the thin-walled material of delivery capsule <NUM>. Thus, delivery capsule <NUM> transitions from the expanded configuration to the collapsed configuration when retracted into capsule assembly <NUM>. Delivery capsule <NUM> retracts into lumen <NUM> of capsule assembly <NUM> such that delivery capsule <NUM> does not surround the stented prosthetic heart valve, and the stented prosthetic heart valve radially expands to its radially expanded deployed configuration.

Capsule assembly <NUM> is coaxially and slidably disposed between delivery capsule assembly <NUM> and outer stability shaft <NUM>. In an embodiment, capsule assembly <NUM> and more specifically capsule <NUM> may be utilized to provide additional support to delivery capsule <NUM> during tracking through a vasculature to a treatment site. For example, delivery capsule <NUM> having a minimized crossing profile may be disposed over a stented prosthetic heart valve during introduction into the body and capsule <NUM> may be in its collapsed configuration within outer stability shaft <NUM> during introduction into the body. After introduction into the body, capsule <NUM> may be advanced from the collapsed configuration within outer stability shaft <NUM> until capsule <NUM> is in its expanded configuration and disposed over delivery capsule <NUM> to provide additional support during advancement to the treatment site. <FIG> shows delivery device <NUM> with delivery capsule <NUM> in the expanded configuration, in which a stented prosthetic heart valve (not shown) is held in a radially compressed delivery configuration therein, and capsule <NUM> is also in the expanded configuration and disposed over delivery capsule <NUM>.

In another embodiment, capsule assembly <NUM> and more specifically capsule <NUM> is configured for recapture of a partially deployed stented prosthetic heart valve. More particularly, in situations where the stented prosthetic heart valve is partially released from delivery capsule <NUM> and recapture by the weaker (relative to capsule <NUM>) delivery capsule <NUM> is not possible at body temperature, the stronger (relative to delivery capsule <NUM>) capsule <NUM> may be advanced to recapture the partially deployed stented prosthetic heart valve. Thus, delivery capsule <NUM> having a minimized crossing profile is utilized for radially collapsing a stented prosthetic heart valve and tracking it through a vasculature, while capsule <NUM> is utilized on an as-needed basis for recapture and repositioning of a partially deployed stented prosthetic heart valve.

In embodiments described above, capsule <NUM> in the expanded configuration functions to retain or hold the stented prosthetic heart valve in a radially compressed configuration for delivery thereof. However, in other embodiments, capsule <NUM> may utilized solely in a protective manner for the stented prosthetic heart valve and other means may be utilized for expanding the stented prosthetic heart valve. For example, in another embodiment hereof, capsule <NUM> is configured to protect a balloon expandable stented prosthetic heart valve and the surrounding native anatomy as capsule <NUM> with the stented prosthetic heart valve disposed therein is advanced to a treatment site. Thus, capsule <NUM> is for protection only, as the stented prosthetic heart valve is not self-expanding and therefore does not require the capsule <NUM> to radially collapse and restrain the stented prosthetic heart valve when disposed therein. Once the stented prosthetic heart valve is at the treatment site, the capsule assembly <NUM> is retracted to expose the stented prosthetic heart valve. The stented prosthetic heart valve may then be steered to the desired treatment position and expanded by balloon inflation, as will be understood by one skilled in the art. In yet another embodiment, the stented prosthetic heart valve is self-expanding and restrained by a cinch mechanism or sutures for delivery to a desired treatment site. Examples of suitable cinch mechanisms for retaining self-expanding valve prostheses are described in <CIT>. In such an embodiment, capsule <NUM> is configured only for protection of the stented prosthetic heart valve and the native anatomy during introduction and advancement of the stented prosthetic heart valve to the treatment site. Once the stented prosthetic heart valve is at the treatment site, capsule assembly <NUM> is retracted and collapsed in outer stability shaft <NUM> to expose the stented prosthetic heart valve. The stented prosthetic heart valve is then deployed at the treatment site by releasing the sutures such that the stented prosthetic heart valve radially expands at the treatment site.

Claim 1:
A delivery device (<NUM>) for percutaneously delivering a stented prosthetic heart valve, the stented prosthetic heart valve being radially expandable from a radially compressed delivery configuration to a radially expanded deployed configuration, the delivery device comprising:
a capsule assembly (<NUM>), wherein the capsule assembly (<NUM>) includes a capsule (<NUM>) and a proximal shaft (<NUM>) coupled to a proximal end (<NUM>) of the capsule (<NUM>), the capsule (<NUM>) including an expanded configuration wherein the capsule (<NUM>) has a first outer diameter and a collapsed configuration wherein the capsule (<NUM>) has a second outer diameter smaller than the first outer diameter;
a handle (<NUM>) including a housing (<NUM>) and an actuator mechanism (<NUM>), wherein the actuator mechanism (<NUM>) is coupled to a proximal portion (<NUM>) of the proximal shaft (<NUM>) and is configured to selectively move the proximal shaft (<NUM>) and the capsule (<NUM>) relative to the housing (<NUM>) to release the stented prosthetic heart valve; and
an outer stability shaft (<NUM>) defining a lumen (<NUM>), the outer stability shaft (<NUM>) coupled to the handle (<NUM>) and configured to receive the proximal shaft (<NUM>) within the lumen of the outer stability shaft (<NUM>), the outer stability shaft (<NUM>) having an inner diameter, wherein the first outer diameter of the capsule (<NUM>) is greater than the inner diameter of the outer stability shaft (<NUM>) and the second outer diameter of the capsule (<NUM>) is smaller than the inner diameter of the outer stability shaft (<NUM>).