Patent Publication Number: US-10327899-B2

Title: Delivery device for prosthetic heart valve with capsule adjustment device

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     The present application is a continuation-in-part of U.S. patent application Ser. No. 14/656,838 filed Mar. 13, 2015, the contents of which are incorporated by reference herein in their entirety. 
    
    
     FIELD OF THE INVENTION 
     The present invention relates to systems and methods for percutaneous implantation of a prosthetic heart valve. More particularly, it relates to the systems and methods for the fine adjustment and placement of a stented prosthetic heart valve via transcatheter implantation. 
     BACKGROUND 
     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&#39;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&#39;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 of replacement cardiac valves to solve the problems presented by traditional open surgery and minimally-invasive surgical methods. In such methods, a valve prosthesis 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 prosthesis is then deployed in the valve annulus (e.g., the aortic valve annulus). 
     Various types and configurations of prosthetic heart valves are available for percutaneous valve replacement procedures. In general, 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 valve prosthesis can be contracted radially to introduce the valve prosthesis into the body of the patient percutaneously through a catheter. The valve prosthesis can be deployed by radially expanding it once positioned at the desired target site. 
     In addition to the delivery device itself, typical transcatheter heart implantation techniques entail the use of a separate introducer device to establish a portal to the patient&#39;s vasculature (e.g., femoral artery) and through which the prosthetic valve-loaded delivery device is inserted. The introducer device generally includes a relatively short sheath and a valve structure. By inserting the prosthetic heart valve-loaded sheath through the introducer valve and sheath, a low friction hemostasis seal is created around the outer surface of the delivery sheath. While highly desirable, friction between the introducer device and the delivery sheath can be problematic, leading to unexpected movement of the prosthesis prior to release from the delivery device. If the deployed prosthesis is incorrectly positioned relative to the native annulus, serious complication may arise including paravalvular leakage (PVL) or the requirement for placement of a permanent pacemaker. 
     For example,  FIG. 1A  illustrates, in simplified form, an introducer device  10  establishing a portal to a patient&#39;s vasculature  12 , and through which a prosthetic heart valve-loaded delivery shaft  14  has been inserted. As shown, delivery shaft  14  has been manipulated to locate the loaded prosthetic heart valve  16  (generally referenced) near a desired position relative to an aortic valve  18 . An outer delivery sheath  20  contains the prosthetic heart valve  16 . However, it is not always possible to accurately position the delivery device containing the prosthetic heart valve  16  at the desired position. Accordingly, adjustments in the position must be made. Conventionally, adjusting the position of the prosthetic heart valve  16  is accomplished by moving handle  22  proximally or distally. In the example of  FIG. 1B , handle  22  is moved proximally. However, as handle  22  is moved proximally, outer delivery sheath  20  pulls towards the inner wall of the descending aorta  29  and away from outer wall of aortic arch  28 . With this movement, handle  22  has moved, but prosthetic heart valve  16  has not moved relative to aortic valve  18 . Thus, it takes more movement of handle  22  to move prosthetic heart valve  22 . Further, the location of prosthetic heart valve  16  often needs to be adjusted a very small amount, which is difficult to accomplish by pushing or pulling handle  22 . 
     Accordingly, there is a need for an improved adjustment mechanism and method to more accurately position a prosthetic heart valve implanted via transcatheter delivery devices and methods. 
     SUMMARY OF THE INVENTION 
     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 configuration to a radially expanded configuration. The delivery device includes a sheath, a handle, and adjustment device including a fine adjustment mechanism, and an outer stability shaft. The sheath defines a lumen and is configured to compressively constrain the stented prosthetic heart valve. The handle is coupled to the proximal portion of the sheath and includes an actuator mechanism coupled to a proximal portion of the sheath that is configured to selectively move the sheath relative to the housing to release the stented prosthetic heat valve. The adjustment device is coupled to the handle and includes an adjustment lumen through which the sheath and the handle slidably extend. The outer stability shaft is coupled to the adjustment device. The fine adjustment mechanism is configured to selectively move the handle and the sheath relative to the adjustment device and the outer stability shaft. 
     Embodiments hereof also relate to a method for restoring a defective heart valve in a patient. The method includes manipulating a delivery device to guide a prosthetic heart valve through a patient&#39;s vasculature and into the defective heart valve by moving a handle of the delivery device. The delivery device is loaded with a prosthetic heart valve in a radially compressed configuration, the prosthetic heart including a stent frame to which a valve structure is attached. The delivery device includes a delivery sheath, an outer stability shaft, a handle, and an adjustment device. The sheath constrains the prosthetic heart valve in the radially compressed configuration. The outer stability shaft is coaxially received over the delivery sheath and terminates proximal of the prosthetic heart valve when the delivery device is in the delivery configuration. The handle includes a housing and an actuating mechanism coupled to the delivery sheath. The adjustment device is coupled to the handle. Moving the handle causes the adjustment device, delivery sheath, and the outer stability shaft to move. The location of the prosthetic heart valve within the defective heart valve is finely adjusted by manipulating the fine adjustment mechanism of the adjustment device. Manipulating the fine adjustment mechanism causes the handle and the delivery sheath to move relative to the adjustment device and the outer stability shaft. The delivery sheath is withdrawn from the prosthetic heart valve by actuating the actuator mechanism such that the delivery sheath slides relative to the outer stability shaft and the handle to release the prosthetic heart valve from the delivery sheath. With the release of the prosthetic heart valve from the delivery sheath, the prosthetic heart valve self-expands into engagement with the native heart valve. 
    
    
     
       BRIEF DESCRIPTION OF DRAWINGS 
         FIGS. 1A-1B  are simplified illustrations of conventional transcatheter delivery of a stented prosthetic heart valve. 
         FIG. 2A  is a side illustration of a stented prosthetic heart valve useful with systems, devices, and methods of the present disclosure and in a normal, expanded configuration. 
         FIG. 2B  is a side illustration of the prosthetic heart valve of  FIG. 2A  in a radially compressed configuration. 
         FIG. 3  is a side illustration of the delivery device of the present disclosure. 
         FIG. 4  is a cutaway illustration of an adjustment device of the delivery device of  FIG. 3 . 
         FIG. 5  is an exploded perspective illustration of the delivery device of  FIG. 3 . 
         FIG. 6  is a cutaway illustration of the delivery device of  FIG. 3 . 
         FIGS. 7A-7E  are illustrations of the adjustment of the location of a capsule of the delivery device of  FIG. 3 . 
         FIGS. 8A-8B  are simplified illustrations of a method of adjusting the location of a stented prosthetic heart valve during transcatheter delivery using the delivery device of  FIG. 3 . 
         FIG. 9  is a side illustration of another embodiment of the delivery device of the present disclosure. 
         FIG. 10  is a cutaway illustration of an adjustment device of the delivery device of  FIG. 9 . 
         FIG. 10A  is a close-up view of the adjustment device of  FIG. 10 . 
         FIG. 11  is an exploded perspective illustration of the delivery device of  FIG. 9 . 
         FIG. 12  is a cutaway illustration of the delivery device of  FIG. 9 . 
         FIG. 12A  is a schematic cross-sectional view of a portion of the delivery device of  FIG. 9 . 
         FIGS. 13A-13E  are illustrations of the adjustment of the location of a capsule of the delivery device of  FIG. 9 . 
     
    
    
     DETAILED DESCRIPTION 
     Specific embodiments of the present invention are now described with reference to the figures, wherein like reference numbers indicate identical or functionally similar elements. The terms “distal” and “proximal”, when used in the following description to refer to a catheter 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. 
     The following detailed description is merely exemplary in nature and is not intended to limit the invention or the application and uses of the invention. Furthermore, there is no intention to be bound by any expressed or implied theory presented in the preceding technical field, background, brief summary, or the following detailed description. 
     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 (tissue or synthetic), with the stent having a normal, expanded configuration that is collapsible to a compressed configuration for loading within a delivery device. The stent is usually constructed 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 prosthetic heart valve sold under the trade name CoreValve® available from Medtronic CoreValve, LLC. Other non-limiting examples of the transcatheter heart valve prostheses useful with the systems, devices, and methods of the present disclosure are described in U.S. Pat. Nos. 7,662,186; and 7,740,655, which are incorporated in their entirety by reference herein. 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 in mind, one non-limiting example of a stented prosthetic heart valve  30  useful with systems, devices, and methods of the present disclosure is illustrated in  FIG. 2A . As a point of reference, the prosthetic heart valve  30  is shown in a normal, pre-set, or expanded configuration in the view of  FIG. 2A .  FIG. 2B  illustrates the prosthetic heart valve  30  in a compressed configuration (e.g., when compressively retained within an outer catheter or sheath). Prosthetic heart valve  30  includes a stent, or stent frame  32 , and a valve structure  34 . The valve structure  34  is assembled to stent frame  32  and provides two or more (typically three) leaflets  36 . Stent frame  32  may assume differing forms and construction based upon application needs as described in greater detail in U.S. Pat. No. 8,579,963, which is incorporated in its entirety by reference herein. 
     With the above understanding of the stented prosthetic heart valve  30  in mind, one embodiment of a delivery device  100 , in accordance with the present disclosure, for percutaneously delivering and implanting a prosthetic heart valve  30 , is shown in  FIG. 3 . Delivery device  100  may assume differing forms and construction based upon application needs as described in greater detail in U.S. Pat. Nos. 8,579,963; 8,491,650; and 8,465,541, which are incorporated in their entirety by reference herein. 
     Delivery device  100  includes a handle  180 , an adjustment device  150 , an outer stability shaft  110 , a delivery sheath assembly  102 , and an inner shaft assembly  104  as shown in  FIG. 3 . Each of these components is described in greater detail below. Delivery device  100  is configured to be used for transcatheter valve implantation. Other embodiments of the delivery device and adjustment device are possible. Delivery device  100 , described in greater detail below, is merely an exemplary embodiment of a transcatheter delivery device and modifications can be made to the embodiments described herein without departing from the spirit and scope of the present invention. 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. 
     Components in accordance with the embodiment of delivery device  100  of  FIG. 3  are presented in greater detail in  FIGS. 4-6 . Various features of the components of delivery device  100  reflected in  FIGS. 4-6  and described below can be modified or replaced with differing structures and/or mechanisms. The present disclosure is in no way limited to delivery sheath assembly  102 , inner shaft assembly  104 , outer stability shaft  110 , adjustment device  150 , and handle  180  shown and described below. In more general terms, delivery devices in accordance with the principles of the present disclosure provide features capable of compressively retaining a self-expanding, stented prosthetic heart valve (e.g., the capsule  108 ), along with an mechanism and method for finely adjusting the position of a self-expanding, stented prosthetic heart valve (e.g., adjustment device  150 ) within a defective heart valve. 
     In the embodiment of  FIGS. 4-6 , delivery sheath assembly or sheath  102  includes a capsule  108  and a shaft  118 , and defines a lumen  112  extending from a proximal end  130  to a distal end  132  of delivery sheath assembly  102 . The length and thickness of capsule  108  are determined by the requirements of the specific application and are described in greater detail in U.S. Pat. No. 8,579,963, previously incorporated by reference herein. Shaft  118  is configured for fixed connection to capsule  108  at connection point  116 , and extends proximally from capsule  108 , with shaft  118  configured for fixed connection of delivery sheath assembly  102  to handle  180 . Although delivery sheath assembly  102  is described herein as including capsule  108  and shaft  118 , capsule  108  may simply be an extension of shaft  118  and the delivery sheath assembly  102  may be described simply as sheath  102 . 
     Inner shaft assembly  104  can assume a variety of configurations described in greater detail in U.S. Pat. No. 8,579,963, previously incorporated by reference herein. In general, inner shaft assembly  104  includes a proximal inner shaft  114 , a retention member  120 , and a tip  121 . Proximal inner shaft  114  connects to retention member  120 , and retention member  120  connects to tip  121 . Proximal inner shaft  114  is configured for fixed connection of inner shaft assembly  104  to handle  180 . The components of inner shaft assembly  104  combine to define a continuous lumen  122 , which is sized to receive an auxiliary component such as a guide wire (not shown). Although inner shaft assembly  104  is described herein as including proximal inner shaft  114 , retention member  120 , and tip  121 , retention member  120  and tip  121  may simply be an extension of proximal inner shaft  114  and the inner shaft assembly  104  may be described simply as inner shaft  104 . 
     Outer stability shaft  110  can assume a variety of configurations described in greater detail in U.S. Pat. No. 8,579,963, previously incorporated by reference herein. In general, outer stability shaft  110  is configured for fixed connection to adjustment device  150 . Outer stability shaft  110  serves as a stability shaft for delivery device  100 , and has a proximal end  124 , a distal end  126 , and a passageway  128  extending between ends  124  and  126 . The passageway is sized to coaxially receive delivery sheath assembly  102 , and in particular shaft  118 , in a manner permitting the sliding of shaft  118  relative to outer stability shaft  110 . 
     Handle  180  can assume a variety of configurations described in greater detail in U.S. Pat. No. 8,579,963, previously incorporated by reference, and modified herein. In general, handle  180  includes a housing  182 , an actuator mechanism  184 , a handle extension  186 , and teeth  188  on handle extension  186 . Housing  182  retains actuator mechanism  184 . Sheath  102  is coupled to actuator mechanism  184  such that movement of actuator mechanism  182  causes sheath  102  to move relative to outer stability shaft  110  and inner shaft assembly  104 , as described below. Handle extension  186  extends from the distal end of housing  182 . 
     In the embodiment of  FIGS. 5-6 , handle  180  provides a surface for convenient handling and grasping by a user, and can have a generally cylindrical shape as shown. While the handle of  FIGS. 5-6  is shown with a cylindrical shape, it is not meant to limit the design, and other shapes and sizes are contemplated based on application requirements. 
     Handle  180  is configured to maintain portions of the actuator mechanism  184  within a cavity  183  defined by housing  182 . In the embodiment shown in  FIGS. 5-6 , housing  180  further forms a longitudinal slot  185  through which actuator mechanism  184  extends for interfacing by a user. Handle extension  186  extends distally from housing  182  and provides a mounting surface for teeth  188 . For example, and not by way of limitation, teeth  188  may be formed integrally as part of handle extension  186  or may be coupled to handle extension  186  by adhesives, welding, clamping, and other coupling devices as appropriate. While  FIGS. 5-6  show teeth  188  located on one side of handle extension  186 , this is not meant to limit the design, and teeth  188  may be located elsewhere on handle extension  186 . 
     Adjustment device  150 , as shown in the embodiment of  FIGS. 4-6 , includes an adjustment housing  151 , an adjustment mechanism  152 , and an extension  160  at the distal end of adjustment device  150 . The components of adjustment device  150  combine to define a continuous lumen  159  through adjustment device  150 . The proximal portion of lumen  159  is configured to accept handle extension  186  of handle  180 . A distal portion of lumen  159  defined by extension  160  is configured to accept the proximal end of outer stability shaft  110 . Outer stability shaft  110  may be coupled to extension  160  by adhesives, welding, clamping, and other coupling devices, as appropriate. 
     Adjustment device  150  provides a surface for convenient handling and grasping by a user, and can have a generally cylindrical shape as shown. While adjustment device  150  of  FIGS. 4-6  is shown with a cylindrical shape, it is not meant to limit the design, and other shapes and sizes are contemplated based on application requirements. Adjustment device  150  is configured to maintain portions of adjustment mechanism  152  within a cavity defined by housing  151 . In the embodiment shown in  FIG. 5 , housing  151  further includes a longitudinal slot  161  through which adjustment mechanism  152  extends for interfacing by a user. 
     Adjustment mechanism  152  includes a first toothed wheel  154  and a second toothed wheel  158 , as shown in  FIGS. 4-6 . First toothed wheel  154  has teeth  153 . Second toothed wheel  158  has teeth  156 . First toothed wheel  154  is disposed within housing  151  on a first pivot axis  155  such that first toothed wheel  154  rotates about first pivot axis  155 . The upper radius of first toothed wheel  154  extends through longitudinal slot  161  in housing  151  for user interface. Second toothed wheel  158  is disposed within housing  151  on a second pivot axis  157  such that second toothed wheel  158  rotates about second pivot axis  157 . Teeth  156  on second toothed wheel  158  are configured to engage with teeth  188  on handle extension  186 , as described in more detail below. First toothed wheel  154  and second toothed wheel  158  are configured such that teeth  153  of first toothed wheel  154  engage with teeth  156  of second toothed wheel  158 . While  FIGS. 4-6  show adjustment mechanism  152  having a specific number of teeth  153  on first toothed wheel  154  and a specific number of teeth  156  on second toothed wheel  158 , this is not meant to limit the design and the number of teeth  153  and  156  may assume other configurations. 
     Adjustment mechanism  152  is generally constructed to provide selective retraction/advancement of handle  180 , delivery sheath assembly  102 , and inner shaft assembly  104  relative to housing  151  of adjustment device  150  and outer stability shaft  110 . Adjustment mechanism  152  can have a variety of constructions and/or devices capable of providing the desired user interface and the current embodiment shown in  FIGS. 4-6  is not meant to limit the design, but rather provide an example of one possible embodiment. For example, other embodiments of adjustment device  152  may utilize only first toothed wheel  152  to engage teeth  188  on handle extension  186 . 
     When delivery device  100  is assembled, handle extension  186  resides within the proximal portion of lumen  159  of adjustment device  150 , and is configured such that teeth  188  on handle extension  186  engage teeth  156  of second toothed wheel  158  of adjustment device  150 . Handle extension  186  is sized such that it may fit within lumen  159  of adjustment device  150  and retract/advance within lumen  159  with user actuation of adjustment mechanism  152  of adjustment device  150 . 
     Actuator mechanism  184  is generally constructed to provide selective retraction/advancement of the delivery sheath assembly  102  and can have a variety of constructions and/or devices capable of providing the desired user interface. One example of an actuator mechanism  184  is further described in U.S. Pat. No. 8,579,963, previously incorporated by reference herein. 
     Construction of delivery device  100  is reflected in  FIGS. 5-6  and includes delivery sheath assembly  102  being coaxially and slidably disposed between inner shaft assembly  104  and outer stability shaft  110 .  FIG. 6  shows delivery device  100  in the delivery configuration, with a prosthetic heart valve in a radially compressed configuration loaded within capsule  108 . As shown in  FIG. 6 , capsule  108  is coaxially disposed over retention member  120  of inner shaft assembly  104 . Inner shaft assembly  104  is rigidly connected to housing  182 . Delivery sheath assembly  102  is movably connected to housing  182  via actuator mechanism  184 . Outer stability shaft  110  is rigidly connected to adjustment device  150 , as described previously. Generally speaking, delivery sheath assembly  102  can be retracted in a proximal direction relative to inner shaft assembly  104 , outer stability shaft  110 , and housing  182  from the delivery configuration of  FIG. 6  to a deployed configuration wherein capsule  108  is retracted proximally such that capsule  108  does not surround the prosthetic heart valve. This allows the prosthetic heart valve to radially expand for engagement with the native heart valve (not shown). 
     Inner shaft assembly  104  extends within lumen  112  of sheath  102 . Proximal inner shaft  114  of inner shaft assembly  104  extends proximally through lumen  159  of adjustment device  150 , continuing proximally through housing  182 , and is rigidly connected to handle  180  such that lumen  122  provides access for auxiliary components (e.g., a guide wire) therein. Proximal inner shaft  114  may be coupled to handle  180 , for example, and not by way of limitation, by adhesives, welding, clamping, and other coupling devices as appropriate. Inner shaft assembly  104  is fixed relative to handle  180 . 
     Delivery sheath assembly  102  extends within passageway  128  of outer stability shaft  110 . Shaft  118  of delivery sheath assembly  102  extends proximally through lumen  159  of adjustment device  150 , continuing proximally into housing  182  of handle  180 , and is rigidly connected to actuator mechanism  184  of handle  180 . Shaft  118  may be coupled to actuator mechanism  184  by adhesives, welding, clamping, and other coupling devices as appropriate. Delivery sheath assembly  102  is movable relative to handle  180  and adjustment device  150  by actuator mechanism  184 . However, if actuator mechanism  184  is not moved and handle  180  is moved, delivery sheath assembly  102  moves with handle  180 , not relative to handle  180 , as explained in more detail below. 
     Outer stability shaft  110  is disposed within distal portion of lumen  159  and is coupled to extension  160 . For example, and not by way of limitation, outer stability shaft  110  may be coupled to extension  160  by adhesives, welding, clamping, and other coupling devices as appropriate. Although outer stability shaft  110  is described as being attached to extension  160 , outer stability shaft  110  may be coupled to housing  151  of adjustment device  150 , and extension  160  may be excluded. Outer stability shaft  110  extends distally from adjustment device  150 , and encompasses a portion of the length of shaft  118 , thus stabilizing at least a portion of shaft  118  without impeding sliding/transitioning of capsule  108  from the delivery configuration to the deployed configuration. Outer stability shaft  110  is fixed longitudinally relative to adjustment device  150 . 
     With the above understanding of components in mind, operation and interaction of components of the present disclosure may be explained.  FIG. 4  illustrates adjustment device  150 . Adjustment mechanism  152  of adjustment device  150  is configured such that, as first toothed wheel  154  is rotated in a first direction, teeth  153  on first toothed wheel  154  engage with teeth  156  on second toothed wheel  158  such that rotation of first toothed wheel  154  causes rotation of second toothed wheel  158  in a second direction opposite the first direction. Teeth  156  of second toothed wheel  158  engage teeth  188  on handle extension  186  such that handle extension  186 , and thus handle  180 , moves relative to housing  151  of adjustment device  150 . Inner shaft assembly  104  and delivery sheath assembly  102 , being coupled to handle  180 , also move relative to housing  151  of adjustment device  150 . The engagement of teeth  156  on second toothed wheel  158  with teeth  188  on handle extension  186  also translates the rotational movement of second toothed wheel  158  to longitudinal movement of handle extension  186 . 
     Handle  180  resides partially within the proximal end of adjustment lumen  159  of adjustment housing  151  such that teeth  188  on handle extension  186  are oriented parallel to longitudinal axis LA of adjustment device  150 . First toothed wheel  154  and second toothed wheel  158  are oriented relative to longitudinal axis LA such that rotation of first toothed wheel  154  is parallel to longitudinal axis LA (i.e., first pivot axis  155  is transverse to longitudinal axis LA). In the embodiment shown, second toothed wheel  158  is also oriented relative to longitudinal axis LA such that rotation of second toothed wheel  158  is parallel to longitudinal axis LA (i.e., second pivot axis  157  is transverse to longitudinal axis LA). Adjustment mechanism  154  is configured to selectively move handle  180 , delivery sheath assembly  102 , and inner shaft assembly  104  relative to housing  151  of adjustment device  150  and outer stability shaft  110  a distance in the range of 1-50 mm, preferably in the range of 10-40 mm, and most preferably in the range of 20-30 mm. up to 25.0 mm. 
       FIGS. 7A-7E  schematically show delivery device  100  in operation. In  FIGS. 7A-7E  the exposed portion of first toothed wheel  154  is rotated in a first direction  200 , towards the distal end of adjustment device  150 . Adjustment mechanism  152  is configured such that, as toothed wheel  154  is rotated in first direction  200 , teeth  153  on first toothed wheel  154  engage teeth  156  on second toothed wheel  158  to rotate second toothed wheel  158  in direction  202 . Teeth  156  of second toothed wheel  158  engage teeth  188  on handle extension  186  such that handle extension  186 , and thus handle  180 , move in distal direction  204 , while housing  151  of adjustment device  150  remains stationary. Delivery sheath assembly  102  and inner shaft assembly  104 , being coupled to handle  180 , also move in distal direction  204 . Although  FIGS. 7A-7E  only show movement of first toothed wheel  154  in first direction  200 , resulting movement of handle  180 , inner shaft assembly  104 , and delivery sheath assembly  102  in distal direction  204 , movement of first toothed wheel  154  in second direction  202  results in movement of second toothed wheel  158  in first direction  200 , and movement of handle  180 , inner shaft assembly  104 , and delivery sheath assembly  102  in a proximal direction opposite distal direction  204 . Movement direction, either distally or proximally, of handle  180 , delivery sheath assembly  102 , and inner shaft assembly  104 , relative to housing  151  of adjustment device  150  is dependent upon the direction of rotation of first toothed wheel  154 . Rotational direction of first toothed wheel  154  is selected by operator manipulation. 
       FIGS. 9-13E  illustrate another embodiment of a delivery device  300  in accordance with the present disclosure. Delivery device  300  includes a handle  380 , an adjustment device  350 , an outer stability shaft  310 , a delivery sheath assembly  302 , and an inner shaft assembly  304 , as shown in  FIG. 9 . Outer stability shaft  310 , delivery sheath assembly  302 , and inner shaft assembly  304  are similar to outer stability shaft  110 , delivery sheath assembly  102 , and inner shaft assembly  104  of delivery device  100 , described previously. Handle  380  and adjustment device  350  are described in greater detail below. 
     Handle  380  can assume a variety of configurations described in greater detail in U.S. Pat. No. 8,579,963, previously incorporated by reference herein. In general, handle  380  includes a housing  382 , an actuator mechanism  384 , a handle extension  386 , and a pin  388  extending from handle extension  386 . Housing  382  is configured to retain actuator mechanism  384  therein. Delivery sheath assembly  302  is coupled to actuator mechanism  384  such that movement of actuator mechanism  384  causes delivery sheath assembly  302  to move relative to outer stability shaft  310  and inner shaft assembly  304 , similar to delivery sheath assembly  102 , actuator mechanism  184 , outer stability shaft  110 , and inner shaft assembly  104 , as previously described with respect to delivery device  100 . While a particular actuator mechanism and location of such an actuator mechanism is described herein, other actuator mechanisms may be used and may be located on different portions of the delivery device, as appropriate. 
     In the embodiment of  FIGS. 9-13E , handle  380  provides a surface for convenient handling and grasping by a user, and can have a generally cylindrical shape as shown. While the handle of  FIGS. 9-13E  is shown with a cylindrical shape, it is not meant to limit the design, and other shapes and sizes may be used. 
     In an embodiment, and as described previously with respect to handle  180 , actuator mechanism  184 , and cavity  183  of delivery device  100 , handle  380  of delivery device  300  is configured to maintain portions of the actuator mechanism  384  within a cavity  383  defined by housing  382 . In the embodiment shown in  FIGS. 9-13E , housing  382  further forms a longitudinal slot  385  through which actuator mechanism  384  extends for interfacing by a user. Handle extension  386  extends distally from housing  382  and provides a mounting surface for pin  388 . 
     Pin  388  is a generally cylindrical shape and includes a first end  389 . Pin  388  extends radially outward from an outer surface of handle extension  386  such that pin  388  is disposed generally perpendicular to longitudinal axis LA 1  of delivery device  300 . Pin  388  may be formed as an integral part of handle extension  386  or may be coupled to handle extension  386  by methods such as, but not limited to adhesives, welding, clamping, and other coupling methods as appropriate. While  FIGS. 9-13E  show pin  388  located on one side of handle extension  386 , this is not meant to limit the design, and pin  388  may be located elsewhere on handle extension  386 . Additionally, while pin  388  is shown in  FIGS. 9-13E  with a generally cylindrical shape, this is not meant to limit the design and different shapes for pin  388  suitable for purposes of the present disclosure may be utilized. While first end  389  of pin  388  is shown as a flat disc, this is not meant to limit the design and other shapes may be utilized, such as, but not limited to, conical, square, or any corresponding shape suitable for the purposes described herein. 
     Adjustment device  350 , as shown in the embodiment of  FIGS. 9-13E , includes an adjustment housing  351 , an adjustment mechanism  352 , and an extension  360  at a distal end  355  of adjustment device  350 . The components of adjustment device  350  combine to define a continuous lumen  359  through adjustment device  350 . A proximal portion  361  of lumen  359  is configured to accept handle extension  386  of handle  380 . A distal portion of lumen  359 , defined by extension  360  is configured to accept a proximal end  324  of outer stability shaft  310 . Outer stability shaft  310  may be coupled to extension  360  by adhesives, welding, clamping, and other coupling devices, as appropriate. 
     Adjustment device  350  provides a surface for convenient handling and grasping by a user, and can have a generally cylindrical shape as shown. While adjustment device  350  of  FIGS. 9-13E  is shown with a cylindrical shape, it is not meant to limit the design, and other shapes and sizes may be used. While extension  360  is shown in  FIGS. 9-13E  with a cylindrical shape, this is not meant to limit the design and other shapes may be utilized including a tapered cone, or other shapes suitable for the purposes descried herein. 
     Housing  351  of adjustment device  350  includes a proximal end  363  a distal end  364 . As shown in  FIGS. 10 and 10A , a proximal portion of housing  351  includes a recess or channel  366 . Channel  366  is a recessed portion of an outer surface of housing  351  disposed between a proximal shoulder  370  and a distal shoulder  371 . Channel  366  is configured to receive an adjustment ring  353  of adjustment mechanism  352  such that adjustment ring  353  may rotate about an outer surface  373  of housing  351  at channel  366  and such that adjustment ring  353  is prevented from moving proximally or distally by shoulders  370 ,  371 , respectively. A longitudinal slot  354  is disposed through the wall of housing  351  at channel  366 . Longitudinal slot is generally parallel to longitudinal axis LA 1  of delivery device  300 . Longitudinal slot  354  is a through-slot such that it extends from outer surface  373  of channel  366  inward towards longitudinal axis LA 1  and into proximal portion  361  of lumen  359  of housing  351 . Longitudinal slot  354  is configured to accept pin  388  of handle extension  386  therethrough. 
     Adjustment mechanism  352  includes adjustment ring  353 , as shown in  FIGS. 9-13E . Adjustment mechanism  352  is configured to provide selective retraction/advancement of handle  380 , delivery sheath assembly  302 , and inner shaft assembly  304  relative to housing  351  of adjustment device  350  and outer stability shaft  310 . Adjustment mechanism  352  can have a variety of constructions and/or devices capable of providing the desired user interface and the current embodiment shown in  FIGS. 9-13E  is not meant to limit the design, but rather provide an example of one possible embodiment. 
     Adjustment ring  353  of adjustment mechanism  352  is a generally tubular configuration and includes a first end  367  and a second end  368 . Adjustment ring  353  further includes a lumen  374  extending from first end  367  to second end  368 . Adjustment ring  353  further includes a helical groove or thread  369  disposed on an inner surface of adjustment ring  353 . As described above, adjustment ring  353  is disposed about an outer surface of housing  351  at channel  366  such that housing  351  is disposed within lumen  374  of adjustment ring  353 , as shown in  FIGS. 10A and 12A . Adjustment ring  353  is configured to rotate about housing  351 . Adjustment ring  353  may include indentations  372  or other surface modifications on an outer surface thereof as a guide for a user or to assist a user to rotate of adjustment ring  353   
     Helical thread  369  may be of any suitable design corresponding to first end  389  of pin  388  of handle  380 . Helical thread  369  of adjustment ring  353  is configured to engage first end  389  of pin  388  of handle  380  therein. Helical thread  369  may be formed for example, and not by way of limitation, as an integral portion of adjustment ring  353  or separate unit coupled to adjustment ring  353  for example, and not by way of limitation, by adhesives, welding, or other methods as appropriate. While helical thread is shown in  FIGS. 9-13E  with a specific gender, handedness, thread form, thread angle, lead, pitch, and start, this is not meant to limit the design and other configurations and combinations may be utilized. 
     When delivery device  300  is assembled, handle extension  386  resides within proximal portion  361  of lumen  359  of adjustment device  350 , and is configured such that pin  388  on handle extension  386  extends though longitudinal slot  354  of housing  351  and engages helical thread  369  of adjustment ring  353  of adjustment mechanism  352 . Handle extension  386  is sized such that it may fit within proximal portion  361  of lumen  359  of adjustment device  350  and retract/advance within proximal portion  361  with user actuation of adjustment mechanism  352  of adjustment device  350 . With delivery device  300  so assembled, rotational movement of adjustment ring  353  causes helical thread  369  to move along pin  388 . However, adjustment ring  353  cannot travel longitudinally because it is limited by shoulders  370 ,  371 . Further, pin  388  cannot rotate with adjustment ring  353  because pin  388  is disposed through longitudinal slot  354 . Thus, when adjustment ring  353  is rotated, pin  388  moves longitudinally along longitudinal slot  354 . Since pin  388  is attached to handle extension  386 , handle extension  386 , and thus handle  380 , move longitudinally with pin  388 . Thus, rotational movement of adjustment ring  353  is converted to translational or longitudinal movement of pin  388  and handle  380 . 
     Delivery sheath assembly  302 , inner shaft assembly  304 , outer stability shaft  310 , a capsule  308 , housing  382 , and actuator mechanism  384  of delivery device  300  are similar in construction and configuration to delivery device  100  with respect to delivery sheath assembly  102 , inner shaft assembly  104 , outer stability shaft  110 , capsule  108 , housing  182 , and actuator mechanism  184 , as previously described. Generally speaking, delivery sheath assembly  302  of delivery device  300  can be retracted in a proximal direction relative to inner shaft assembly  304 , outer stability shaft  310 , and housing  382 . Stated another way, delivery sheath assembly  302  is coaxially and slidably disposed between inner shaft assembly  304  and outer stability shaft  310 . Capsule  308  is coaxially disposed over retention member  320  of inner shaft assembly  304 . Inner shaft assembly  304  is rigidly connected to housing  382 . Delivery sheath assembly  302  is movably connected to housing  382  via actuator mechanism  384 . Outer stability shaft  310  is rigidly connected to adjustment device  350 . 
     With the above understanding of components in mind, operation and interaction of components of the present embodiment may be explained. Adjustment mechanism  352  of adjustment device  350  is configured such that, as adjustment ring  353  is rotated in a first direction  400 , helical thread  369  rotates with adjustment ring  353  and engages pin  388  such that rotation of adjustment ring  353  causes longitudinal movement of pin  388  disposed therein in a distal direction  400 . Pin  388  moves longitudinally within longitudinal slot  354 . Longitudinal movement of pin  388  translates longitudinal movement to handle extension  386  such that handle extension  386 , and thus handle  380 , moves relative to housing  351  of adjustment device  350 . Inner shaft assembly  304  and delivery sheath assembly  302 , being coupled to handle  380 , also move relative to housing  351  of adjustment device  350 . Stated another way, the engagement of helical thread  369  of adjustment ring  353  with pin  388  on handle extension  386  translates the rotational movement of adjustment ring  353  to longitudinal movement of handle  380 , inner shaft  304 , and delivery sheath assembly  302 . 
     Handle  380  resides partially within proximal portion  361  of adjustment lumen  359  of adjustment housing  351  such that pin  388  on handle extension  386  is oriented radially outward and perpendicular to longitudinal axis LA 1  of adjustment device  300 . Longitudinal slot  354  of adjustment mechanism  352  is parallel to longitudinal axis LA 1 , and longitudinal movement of pin  388  is parallel to longitudinal axis LA 1 . Adjustment mechanism  352  is configured to selectively move handle  380 , delivery sheath assembly  302 , and inner shaft assembly  304  relative to housing  351  of adjustment device  350  and outer stability shaft  310  a distance in the range of 1-50 mm, preferably in the range of 10-40 mm, and most preferably in the range of 20-30 mm. 
       FIGS. 13A-13E  schematically show delivery device  300  in operation. In  FIGS. 13A-13E , adjustment ring  353  is rotated in first direction  400 . Adjustment mechanism  352  is configured such that, as adjustment ring  353  is rotated in first direction  400 , helical thread  369  rotates in first direction  400 . Helical thread  369  of adjustment ring  353  engages pin  388  of handle extension  386  such that pin  388 , handle extension  386 , and thus handle  380 , moves in a distal direction  404 , while housing  351  of adjustment device  350  remains stationary. Delivery sheath assembly  302  and inner shaft assembly  304 , being coupled to handle  380 , also move in distal direction  404 . Although  FIGS. 13A-13E  only show rotation of adjustment ring  353  in first direction  400 , resulting in movement of handle  380 , inner shaft assembly  304 , and delivery sheath assembly  302  in distal direction  404 , rotation of adjustment ring  353  in a second direction  402 , wherein second direction  402  is opposite first direction  400 , results in rotational movement of helical thread  369  in second direction  402 , and movement of handle  380 , inner shaft assembly  304 , and delivery sheath assembly  302  in a proximal direction  406 . Movement direction, either distally or proximally, of handle  380 , delivery sheath assembly  302 , and inner shaft assembly  304 , relative to housing  351  of adjustment device  350  is dependent upon the direction of rotation of adjustment ring  353 . Rotational direction of adjustment ring  353  is selected by operator manipulation. 
     In some embodiments, delivery device  100  can be used in conjunction with an introducer device  10  as shown in  FIGS. 8A-8B . Introducer devices generally include an introducer sheath  13  and a valve  11 . The introducer sheath  13  is typically a resilient body. To access a bodily lumen (e.g., femoral artery) of the patient, an incision is formed in the patient&#39;s skin, and introducer sheath  13  inserted through the incision and into the desired bodily lumen. Valve  11  fluidly closes the connection with the bodily lumen external the patient. Delivery device  100  is then inserted into the bodily lumen via introducer device  10 . 
     As generally reflected in  FIG. 8A , introducer sheath  13  has an inner diameter greater than outer stability shaft  110  (as well as capsule  108 ), such that capsule  108  can readily be delivered through the bodily lumen, directed to other branches of the patient&#39;s vasculature  12 , and then into the defective heart valve implantation site  18  (e.g., aortic heart valve). In this regard, introducer valve  11  frictionally contacts outer stability shaft  110 , thereby establishing a low friction hemostasis seal around outer stability shaft  110 . Outer stability shaft  110  isolates delivery sheath assembly  102  from introducer sheath  13  and valve  11 . While outer stability shaft  110  is in physical contact with portions of introducer device  10 , the delivery sheath assembly  102  does not directly contact introducer device  10 . Further, outer stability shaft  110  overtly supports shaft  118  in traversing the tortuous vasculature, minimizing occurrences of kinks forming in shaft  118  when, for example, moving across the aortic arch  28 . 
     Once the prosthetic heart valve  30  is positioned near the deployment site, as shown in  FIG. 8A , the position of capsule  108  and retention member  120  may be finely adjusted to the desired location within the native heart valve  18  via user manipulation of adjustment mechanism  152 . Because outer stability shaft  110  is not moved when adjustment mechanism  152  is manipulated, outer stability shaft  110  does not move within the aorta as described with respect to  FIGS. 1A and 1B . Thus, movement of handle  180  by adjustment mechanism  152  is directly translated to movement of capsule  108  and retention member  120 , with the prosthetic heart valve disposed within capsule  108 . Determination of optimal deployment location is based upon known methods such as, but not limited to sonography and radioopaque markers. As shown in  FIG. 8A , capsule  108  has been roughly positioned proximally of native aortic valve  18 , but is not in the desired implantation location. 
     Thus, a user interface for adjustment mechanism  152  of adjustment device  150  is manipulated by the user to manipulate capsule  108  to the desired deployment location. For the delivery device of the embodiment of  FIG. 7 , first toothed wheel  154  of adjustment mechanism  152  is rotated in direction  200 , towards the distal end of adjustment device  150 , such that handle  180 , delivery sheath assembly  102  (including capsule  108 ), and inner shaft assembly  104  advance incrementally towards the desired deployment location, as shown in  FIG. 8B . The movement of handle  180 , delivery sheath assembly  102  (including capsule  108 ), and inner shaft assembly  104  is relative to adjustment device  150  and outer stability shaft  110 , as described above. 
     To deploy prosthetic heart valve  16  from delivery device  100  at the desired deployment location, actuator mechanism  184  of handle  180  is operated proximally to retract delivery sheath assembly  102 . In particular, shaft  118  and capsule  108  are moved proximally to withdraw capsule  108  from its position surrounding prosthetic heart valve  30 , thereby permitting prosthetic heart valve  30  to self-deploy from delivery device  100 . 
     Although the method is described herein using delivery device  100 , it will be apparent to one of ordinary skill that methods described herein may utilize delivery device  300 . For delivery device  300  of the embodiment of  FIGS. 9-13E , the step of rotating first toothed wheel  154  of adjustment mechanism  152  is replaced with the step of rotating adjustment ring  353  of adjustment mechanism  352  about the longitudinal axis of the delivery device  300  such that handle  380 , delivery sheath assembly  302  (including capsule  308 ), and inner shaft assembly  304  advance or retract incrementally towards the desired deployment location 
     While only some embodiments have been described herein, it should be understood that it has been presented by way of illustration and example only, and not limitation. Various changes in form and detail can be made therein without departing from the spirit and scope of the invention, and each feature of the embodiment discussed herein, and of each reference cited herein, can be used in combination with the features of any other embodiment. All patents and publications discussed herein are incorporated by reference herein in their entirety.