Patent Publication Number: US-2022233315-A1

Title: Motorized medical device delivery system with manual bailout

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     This application claims the benefit of priority of U.S. Provisional Application No. 63/141,749 filed Jan. 26, 2021, the entire disclosure of which is hereby incorporated by reference. 
    
    
     TECHNICAL FIELD 
     The present disclosure pertains to medical device delivery systems. More particularly, the present disclosure pertains to medical device delivery systems that include both one or more electrical motors as well as a mechanical bailout feature to deliver and deploy a medical device. 
     BACKGROUND 
     A wide variety of intracorporeal medical devices have been developed for medical use, for example, intravascular use. Some of these devices include guidewires, catheters, and the like. These devices are manufactured by any one of a variety of different manufacturing methods and may be used according to any one of a variety of methods. Of the known medical devices and methods, each has certain advantages and disadvantages. There is an ongoing need to provide alternative medical devices as well as alternative methods for manufacturing and using medical devices. 
     SUMMARY 
     This disclosure provides design, material, manufacturing method, and use alternatives for medical devices. An example system for delivering an implantable medical device includes a handle housing having a distal end region, a proximal end region and an inner cavity. The system also includes a power supply disposed within the cavity of the handle, the power supply coupled to a first electric drive motor and a second electric drive motor. The system also includes a first linear drive screw coupled to both the first electric drive motor and an actuation shaft within the cavity of the handle. The system also includes a second linear drive screw coupled to both the second electric drive motor and an outer shaft within the cavity of the handle. Further, the first electric drive motor is configured to be disengaged from first linear drive screw such that a first drive tool can be used to engage the first linear drive screw. Additionally, the second electric drive motor is configured to be disengaged from second linear drive screw such that the first drive tool can be used to engage the second linear drive screw. 
     Additionally or alternatively, further comprising an inner cavity access door disposed on a proximal end of the handle housing, and wherein the inner cavity access door is configured to be removed such that the first linear drive screw and the second linear drive screw may be accessed by the first drive tool. 
     Additionally or alternatively, wherein the inner cavity access door is coupled to the second electric drive motor such that removal of the inner cavity access door from the handle housing disengages the second electric drive motor from the second linear drive screw. 
     Additionally or alternatively, further comprising a release lever coupled to the handle, the first electric drive motor and a pull wire assembly. 
     Additionally or alternatively, wherein the pull wire assembly includes a pull wire attached to a latch, and wherein the latch is coupled to the inner cavity access door. 
     Additionally or alternatively, wherein the latch is configured to shift between a first position and a second position, and wherein the latch prevents the inner cavity access door from being released from the handle housing in the first position, and wherein shifting the latch from the first position to the second position releases the inner cavity access door from the handle housing. 
     Additionally or alternatively, wherein actuation of the release lever actuates the pull wire such that the pull wire shifts the latch from the first position to the second position. 
     Additionally or alternatively, wherein engaging the first drive tool with the first linear drive screw allows the first drive tool to manually rotate the first linear drive screw a first direction. 
     Additionally or alternatively, wherein manual rotation of the first linear drive screw in the first direction shifts the actuation shaft in a distal-to-proximal direction. 
     Additionally or alternatively, further comprising a second drive tool configured to engage the first linear drive screw, and wherein engaging the second drive tool with the first linear drive screw allows the second drive tool to manually rotate the first linear drive screw a second direction different than the first direction, and wherein the manual rotation of the first linear drive screw in the second direction shifts the actuation shaft in a proximal-to-distal direction. 
     Additionally or alternatively, wherein the first drive tool includes a first ratchet head, and wherein the first ratchet head is removable from a body portion of the first drive tool, and wherein removing the first ratchet head from the first drive tool uncovers a second engagement head. 
     Additionally or alternatively, wherein the second engagement head of the first drive tool is configured to engage the second linear drive screw. 
     Additionally or alternatively, wherein engaging the second engagement head of the first drive tool with the second linear drive screw allows the first drive tool to manually rotate the second linear drive screw a first direction, and wherein the manual rotation of the second linear drive screw in the first direction shifts the outer shaft in a proximal-to-distal direction. 
     Another system for delivering an implantable heart valve includes a tip assembly having a distal end region and a proximal end region, a guidewire shaft coupled to the distal end region of the tip assembly, a handle housing having a distal end region, a proximal end region and an inner cavity, wherein the handle housing is coupled to the guidewire shaft. The system also includes a first linear drive screw coupled to both a first electric drive motor and an actuation shaft within the cavity of the handle. The system also includes a second linear drive screw coupled to both a second electric drive motor and an outer shaft within the cavity of the handle, wherein the first electric drive motor is configured to be disengaged from first linear drive screw such that a first drive tool can be used to rotate the first linear drive screw and wherein the second electric drive motor is configured to be disengaged from second linear drive screw such that the first drive tool can be used to rotate the second linear drive screw. 
     Additionally or alternatively, wherein engaging the first drive tool with the first linear drive screw allows the first drive tool to manually rotate the first linear drive screw a first direction, and wherein the manual rotation of the first linear drive screw in the first direction shifts the actuation shaft in a distal-to-proximal direction. 
     Additionally or alternatively, further comprising a second drive tool configured to engage the first linear drive screw, and wherein engaging the second drive tool with the first linear drive screw allows the second drive tool to manually rotate the first linear drive screw a second direction different than the first direction, and wherein the manual rotation of the first linear drive screw in the second direction shifts the actuation shaft in a proximal-to-distal direction. 
     Additionally or alternatively, wherein the first drive tool includes a first ratchet head, and wherein the first ratchet head is removable from a body portion of the first drive tool, and wherein removing the first ratchet head from the first drive tool uncovers a second engagement head. 
     Additionally or alternatively, wherein the second engagement head of the first drive tool is configured to engage the second linear drive screw. 
     Another system for delivering an implantable heart valve includes a handle housing having a distal end region, a proximal end region and an inner cavity, wherein the handle housing is coupled to the guidewire shaft. The system also includes a first linear drive screw coupled to both a first electric drive motor and an actuation shaft within the cavity of the handle. The system also includes a second linear drive screw coupled to both a second electric drive motor and an outer shaft within the cavity of the handle, wherein the first electric drive motor is configured to be disengaged from first linear drive screw such that a first drive tool can be used to rotate the first linear drive screw a first direction. Further, a second drive tool can be used to rotate the first linear drive screw a second direction different from the first direction, wherein the first drive tool includes a second engagement head configured to rotate the second linear drive screw after the second electric drive motor is disengaged therefrom. 
     Additionally or alternatively, wherein the first drive tool includes a first ratchet head, and wherein the first ratchet head is removable from a body portion of the first drive tool, and wherein removing the first ratchet head from the first drive tool uncovers the second engagement head. 
     The above summary of some embodiments is not intended to describe each disclosed embodiment or every implementation of the present disclosure. The Figures, and Detailed Description, which follow, more particularly exemplify these embodiments. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The disclosure may be more completely understood in consideration of the following detailed description in connection with the accompanying drawings, in which: 
         FIG. 1  is a side view of an example medical device delivery system; 
         FIG. 2  is a partial cross-sectional view of a portion of the example medical device delivery system of  FIG. 1 ; 
         FIG. 3  is a partial cross-sectional view of a portion of the example medical device delivery system of  FIG. 1 ; 
         FIG. 4  is a partial cross-sectional view of a portion of the example medical device delivery system of  FIG. 1 ; 
         FIG. 5  is a perspective view of an example handle of the medical device delivery system of  FIG. 1 ; 
         FIG. 6  is a side view of an example handle of the medical device delivery system of  FIG. 1 ; 
         FIG. 7  is a perspective view of the example handle of the medical device delivery system of  FIG. 6 ; 
         FIG. 8  is a side view of a portion of an example handle of the medical device delivery system of  FIG. 1 ; 
         FIG. 9  is a side view of a portion of an example handle of the medical device delivery system of  FIG. 1 ; 
         FIG. 10  is a perspective view of a portion of an example handle of the medical device delivery system of  FIG. 1 ; 
         FIG. 11  is a perspective view of a portion of an example handle of the medical device delivery system of  FIG. 1 ; 
         FIG. 12  is a perspective view of two example manual drive tools; 
         FIG. 13  is a perspective view of an example manual drive tool aligned with an example handle of the medical device delivery system of  FIG. 1 ; 
         FIG. 14  is a perspective view of a portion of an example handle of the medical device delivery system of  FIG. 1 ; 
         FIG. 15  is a perspective view of another example manual drive tool; 
         FIG. 16  is a perspective view of an example manual drive tool aligned with an example handle of the medical device delivery system of  FIG. 1 ; 
         FIG. 17  is a perspective view of a portion of an example handle of the medical device delivery system of  FIG. 1 . 
     
    
    
     While the disclosure is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the disclosure to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the disclosure. 
     DESCRIPTION 
     For the following defined terms, these definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification. 
     All numeric values are herein assumed to be modified by the term “about”, whether or not explicitly indicated. The term “about” generally refers to a range of numbers that one of skill in the art would consider equivalent to the recited value (e.g., having the same function or result). In many instances, the terms “about” may include numbers that are rounded to the nearest significant figure. 
     The recitation of numerical ranges by endpoints includes all numbers within that range (e.g. 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5). 
     As used in this specification and the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term “or” is generally employed in its sense including “and/or” unless the content clearly dictates otherwise. 
     It is noted that references in the specification to “an embodiment”, “some embodiments”, “other embodiments”, etc., indicate that the embodiment described may include one or more particular features, structures, and/or characteristics. However, such recitations do not necessarily mean that all embodiments include the particular features, structures, and/or characteristics. Additionally, when particular features, structures, and/or characteristics are described in connection with one embodiment, it should be understood that such features, structures, and/or characteristics may also be used connection with other embodiments whether or not explicitly described unless clearly stated to the contrary. 
     The following detailed description should be read with reference to the drawings in which similar elements in different drawings are numbered the same. The drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the disclosure. 
     Diseases and/or medical conditions that impact the cardiovascular system are prevalent throughout the world. Traditionally, treatment of the cardiovascular system was often conducted by directly accessing the impacted part of the body. For example, treatment of a blockage in one or more of the coronary arteries was traditionally treated using coronary artery bypass surgery. As can be readily appreciated, such therapies are rather invasive to the patient and require significant recovery times and/or treatments. More recently, less invasive therapies have been developed. For example, therapies have been developed which allow a blocked coronary artery to be accessed and treated via a percutaneous catheter (e.g., angioplasty). Such therapies have gained wide acceptance among patients and clinicians. 
     Some relatively common medical conditions may include or be the result of inefficiency, ineffectiveness, or complete failure of one or more of the valves within the heart. For example, failure of the aortic valve or the mitral valve can have a serious effect on a human and could lead to serious health condition and/or death if not dealt with properly. Treatment of defective heart valves poses other challenges in that the treatment often requires the repair or outright replacement of the defective valve. Such therapies may be highly invasive to the patient. Disclosed herein are medical devices that may be used for delivering a medical device to a portion of the cardiovascular system in order to diagnose, treat, and/or repair the system. At least some of the medical devices disclosed herein may be used to deliver and implant a replacement heart valve (e.g., a replacement aortic valve, replacement mitral valve, etc.). In addition, the devices disclosed herein may deliver the replacement heart valve percutaneously and, thus, may be much less invasive to the patient. The devices disclosed herein may also provide a number of additional desirable features and benefits as described in more detail below. 
     The figures illustrate selected components and/or arrangements of a medical device system  10 , shown schematically in  FIG. 1  for example. It should be noted that in any given figure, some features of the medical device system  10  may not be shown, or may be shown schematically, for simplicity. Additional details regarding some of the components of the medical device system  10  may be illustrated in other figures in greater detail. A medical device system  10  may be used to deliver and/or deploy a variety of medical devices to a number of locations within the anatomy. In at least some embodiments, the medical device system  10  may include a replacement heart valve delivery system (e.g., a replacement aortic valve delivery system) that can be used for percutaneous delivery of a medical implant  16  (shown in the detailed view of  FIG. 1 ), such as a replacement/prosthetic heart valve. This, however, is not intended to be limiting as the medical device system  10  may also be used for other interventions including valve repair, valvuloplasty, delivery of an implantable medical device (e.g., such as a stent, graft, etc.), and the like, or other similar interventions. 
     The medical device system  10  may generally be described as a catheter system that includes an outer sheath  12 , an inner catheter  14  extending at least partially through a lumen of the outer sheath  12 , and a medical implant  16  (e.g., a replacement heart valve implant) which may be coupled to the inner catheter  14  and disposed within a lumen of the outer sheath  12  during delivery of the medical implant  16 . In some embodiments, a medical device handle  17  may be disposed at a proximal end of the outer sheath  12  and/or the inner catheter  14  and may include one or more actuation mechanisms associated therewith. In other words, one or more tubular members (e.g., the outer sheath  12 , the inner catheter  14 , etc.) may extend distally from the medical device handle  17 . In general, the medical device handle  17  may be designed to manipulate the position of the outer sheath  12  relative to the inner catheter  14  and/or aid in the deployment of the medical implant  16 . 
     In use, the medical device system  10  may be advanced percutaneously through the vasculature to a position adjacent to an area of interest and/or a treatment location. For example, in some embodiments, the medical device system  10  may be advanced through the vasculature to a position adjacent to a defective native valve (e.g., aortic valve, mitral valve, etc.). Alternative approaches to treat a defective aortic valve and/or other heart valve(s) are also contemplated with the medical device system  10 . During delivery, the medical implant  16  may be generally disposed in an elongated and low profile “delivery” configuration within the lumen and/or a distal end of the outer sheath  12 , as seen schematically in  FIG. 1 , for example. Once positioned, the outer sheath  12  may be retracted relative to the medical implant  16  and/or the inner catheter  14  to expose the medical implant  16 . In some instances, the medical implant  16  may be self-expanding such that exposure of the medical implant  16  may deploy the medical implant  16 . Alternatively, the medical implant  16  may be expanded/deployed using the medical device handle  17  in order to translate the medical implant  16  into a generally shortened and larger profile “deployed” configuration suitable for implantation within the anatomy. When the medical implant  16  is suitably deployed within the anatomy, the medical device system  10  may be disconnected, detached, and/or released from the medical implant  16  and the medical device system  10  can be removed from the vasculature, leaving the medical implant  16  in place in a “released” configuration. 
     It can be appreciated that during delivery and/or deployment of an implantable medical device (e.g., the medical implant  16 ), portions of the medical device system (e.g., the medical device system  10 ) may be required to be advanced through tortuous and/or narrow body lumens. Therefore, it may be desirable to utilize components and design medical delivery systems (e.g., such as the medical device system  10  and/or other medical devices) that reduce the profile of portions of the medical device while maintaining sufficient strength (compressive, torsional, etc.) and flexibility of the system as a whole. 
       FIG. 2  illustrates the medical device system  10  in a partially deployed configuration. As illustrated in  FIG. 2 , the outer sheath  12  of the medical device system  10  has been retracted in a proximal direction to a position proximal of the medical implant  16 . In other words, the outer sheath  12  has been retracted (e.g., pulled back) in a proximal direction such that it uncovers the medical device implant  16  from a compact, low-profile delivery position to a partially-deployed position. 
     In at least some examples contemplated herein, the medical device implant  16  may be designed to self-expand once released from under the outer sheath  12 . However, as shown in  FIG. 2 , the medical device system  10  may be designed such that the implant  16  may be restricted from expanding fully in the radial direction. For example,  FIG. 2  shows medical device implant  16  having a partially deployed position denoted as a length “L 1 .” 
       FIG. 2  further illustrates that in some examples, the implant  16  may include one or more support members  22  coupled to the proximal end  18  of the implant  16 . Further,  FIG. 2  illustrates that in some examples, the implant  16  may include one or more translation members  24  coupled to the distal end  20  of the implant  16 . Additionally, in some examples (such as that illustrated in  FIG. 2 ), the translation members  24  and support members  22  may work together to maintain the implant in a partially-deployed position after the outer sheath  12  has been retracted to uncover the implant  16 . For example,  FIG. 2  illustrates that the support members  22  may be designed such that the distal end of each of the support members  22  may be coupled to the proximal end of the implant  16  and that the proximal end of each of the support members  22  may be coupled to the distal end of the inner catheter  14 . For example,  FIG. 2  illustrates that the proximal ends of the support members  22  may be attached to a containment fitting  29  which is rigidly fixed to the distal end of the inner catheter  14 . It can be further appreciated that in some instances, the support members  22  may be designed to limit the proximal movement of the proximal end  18  of the implant  16  relative to the distal end of the inner catheter  14 . 
     Additionally, the translation members  24  may be designed to translate in a distal-to-proximal direction such that the translation of the translation members (via operator manipulation at the handle, for example) may “pull” the distal end  20  of the implant closer to the proximal end  18  of the implant  16 . 
     For example,  FIG. 3  illustrates the distal-to-proximal translation of the translation members  24 . It can be appreciated that if the support members  22  limit the proximal movement of the proximal end  18  of the implant  16  while the translation members  24  are translated proximally, the implant  16  may both foreshorten (along the longitudinal axis of the implant  16 ) and also expand radially outward. The foreshortening and radial expansion of implant  16  can be seen by comparing the shape and position of the implant  16  in  FIG. 2  to the shape and position of the implant  16  in  FIG. 3 . The position of the implant  16  shown in  FIG. 3  may be described as a fully deployed positioned of the implant  16  (versus the partially deployed positioned of the implant  16  shown in  FIG. 2 ). Further,  FIG. 3  depicts the length of the fully deployed implant  16  as “L 2 ”, whereby the distance L 2  is less than the distance L 1  shown in  FIG. 2 . 
     Additionally, it can be appreciated that the translation members  24  may be designed to be able extend in a proximal-to-distal direction such that they elongate (e.g., lengthen) the implant  16  (along its longitudinal axis). In other words, the implant  16  may be able to shift between a partially deployed position (shown in  FIG. 2 ) and a fully deployed position (shown in  FIG. 3 ) through the translation (either proximal or distal) of the translation members  24  along the longitudinal axis as the support members  22  limit the movement of the proximal end  18  of the implant  16 . 
     It should be noted that the above description and illustrations regarding the arrangement, attachment features and operation of the support members  22  and the translation members  24  as they engage and function relative to the implant  16  is schematic. It can be appreciated that the design (e.g., arrangement, attachment features, operation, etc.) of the both support member  22  and the translation members  24  as they relate and function relative to the implant  16  may vary. For example, it is possible to design, arrange and operate the translation members  24  and the support members  22  in a variety of ways to achieve the partial and full deployment configurations of the implant  16  described herein. 
     In some examples, an operator may be able to manipulate the translation members  24  via the handle  17 . For example, the handle  17  may include an actuation member designed to control the translation of the translation members  24 .  FIG. 2  illustrates that the handle member  17  may be coupled to the translation members  24  via an actuation shaft  30  and a coupling member  28 . Additionally,  FIG. 2  further illustrates that a distal end of actuation shaft  30  may be coupled to the proximal end of the coupling member  28 . Further, while not shown in  FIG. 2 , it can be appreciated that the actuation shaft  30  may extend within the entire length of the inner catheter  14  from the coupling member  28  to the handle member  17 . 
     For purposes of discussion herein, the inner catheter  14  may also be referred to as an inner member or liner  14 . The liner  14  may include a number of different features shown in the figures described herein. For example, the liner  14  may include a lumen  25 . Further, the translation members  24 , coupler  28 , actuation shaft  30 , tubular guidewire member  34  (described below), and grouping coil  32  (described below) may be disposed within the lumen  25 . These are just examples. The inner liner  14  may vary in form. For example, the inner liner  14  may include a single lumen, multiple lumens, or lack a lumen. 
     As described above,  FIG. 2  and  FIG. 3  illustrate the translation of translation members  24  in a distal-to-proximal direction (which shortens and radially expands the implant  16 , as described above). However,  FIG. 3  further illustrates that translation of the translation members  24  in a distal-to-proximal direction is accomplished by translation of the actuation shaft  30  and coupling member  28  within the lumen  25  of the inner catheter  14 . For example, as the actuation shaft  30  is retracted (e.g., pulled proximally within lumen  25  of the inner catheter  14 ), it retracts the coupling member  28  proximally, which, in turn, retracts the translation members  24  in a proximal direction. 
     In some instances, it may be desirable to maintain the translation members  24  in a substantially linear configuration as they are translated within the lumen  25  of the inner catheter  14 . In some examples, therefore, medical device system  10  may include a component designed to limit and/or prevent the translation members  24  from twisting around each other within the lumen  25  of the inner catheter  14 . For example,  FIG. 2  and  FIG. 3  illustrate a grouping coil  32  wound around the translation members  24  such that the grouping coil  32  maintains the translation members  24  in a substantially liner configuration (and thereby limits and/or prevents the translation members  24  from twisting within lumen  25 ) as the translation members  24  are translated through the lumen  25  of the inner catheter  14 . 
       FIG. 2  and  FIG. 3  further illustrate that the proximal end of the grouping coil  32  may be positioned adjacent the distal end of the coupling member  28  and that the distal end of the grouping coil  32  may be positioned adjacent the distal end of the inner catheter  14 . In particular, the distal end of the grouping coil  32  may be prevented from extending distally beyond the distal end of the inner catheter  14  by the containment fitting  29 . In other words, the distal end of the grouping coil  32  may contact the containment fitting  29 . 
     It can be further appreciated that the grouping coil  32  may be positioned within the lumen  25  of the inner catheter  14  such that the grouping coil  32  may elongate and shorten (e.g., a length of the grouping coil may adjust) within the lumen  25  of the inner catheter  14 . For example, as the coupling member  28  is translated in a proximal direction (shown in  FIG. 3  as compared to  FIG. 2 ), the grouping coil  32  may elongate while continuing to group and/or contain the translation members  24  in a substantially linear configuration. 
       FIG. 2  and  FIG. 3  further illustrate that the medical device system  10  may include a tubular guidewire member  34  extending within the lumen  25  of the inner catheter  14 . The tubular guidewire member  34  may include a lumen which permits a guidewire to extend and translate therein. In other words, the medical device system  10  may be advanced to a target site within a body over a guidewire extending within the lumen of the tubular guidewire member  34 . Further, the tubular guidewire member  34  may extend from the handle  17 , through the lumen  25  of the inner member  14 , through the implant  16  and terminate at a nosecone  36 . 
     It can be appreciated from the above discussion that the outer member  12 , the inner shaft  14 , the actuation shaft  30  (which is coupled to the translation members  24 ) and the tubular guidewire member  34  may all extend from a position adjacent the medical implant  16  to a position in which they enter the handle  17 . For example,  FIG. 4  shows that the outer sheath  12 , the inner shaft  14 , the actuation shaft  30  (which is coupled to the translation members  24 ) and the tubular guidewire member  34  may extend from an example medical implant  16  (which may be similar in form and function to the medical implant described above) and enter a distal end  46  of the handle member  17 . 
       FIG. 5  illustrates a perspective view of the handle  17  described above. It can be appreciated the handle  17  may include a distal end region  46  and a proximal end region  44 . Further,  FIG. 5  illustrates the outer sheath  12  extending away from the distal end region  46  of the handle  17 . As will be described in greater detail below, the outer shaft  12  may extend into the distal end region  46  of the handle  17  and attach to one or more internal components of the handle  17 , whereby actuation of the one or more internal components may translate the outer shaft  12  relative to the implant  16 . Additionally, several components of the medical device system  10  may extend within the outer sheath  12  and into the handle  17 . For example, the actuation shaft  30  (which is coupled to the translation members  24  via the coupler  28 ) may extend with the outer sheath  12  and into the handle  17 , whereby actuation of the actuation shaft  30  may translate the translation members  22  to shorten or lengthen the implant  16 , as described above. 
     It can be appreciated that the handle  17  may generally include one or more electrical components (e.g., a power source, electrical motors, etc.) which serve as the primary mechanism for which the handle actuates one or more shafts (e.g., actuation shaft  20 , outer sheath  12 , etc.) to deploy the implant  16 . In other words, the handle  17  may be designed such that after the implant is tracked to the deployment site with the heart, the user deploys the implant  16  via manipulation of the electrically powered handle  17 . For example, the user may actuate a control switch (e.g., button, component, etc.) which sends power from one or more batteries to one or more electric motors. The user may then manipulate one or more buttons which may signal the electric motors to translate the one or more shafts (e.g., actuation shaft  20 , outer sheath  12 , etc.) in a proximal or distal direction to deliver, deploy, or, in certain instances, recapture the implant  16 . As will be described in greater detail below, the handle  17  may include a first electric motor which is coupled to the outer sheath  12  (and therefore, translates the outer sheath  12  in a proximal or distal direction) and may also include a second electric motor which is coupled to the actuation shaft  30  (and therefore, translates the actuation shaft  30  and the translation member  22  in a proximal or distal direction). 
     However, it can be appreciated that while the primary operation of the handle  17  may be accomplished via the electrical power system, in the case of power loss, motor failure, or other mechanical failure, it may desirable to allow the user to manipulate the outer sheath  12  and/or the actuation shaft  30  manually. In other words, it may be desirable to design the handle  17  to include a “bailout” mechanism whereby the user can disengage the electrical motors from the outer sheath  12  and/or the actuation shaft  30  and, using one or more ancillary drive tools, manually actuation the outer sheath  12  and/or the actuation shaft  30 . The following description will describe a procedure in which a user may undertake to disengage (e.g., uncouple) the electrical motors from the outer sheath  12  and/or the actuation shaft  30  and, using one or more ancillary tools, manually actuation the outer sheath  12  and/or the actuation shaft  30 . 
       FIGS. 6-7  and illustrate an example first step user may undertake to disengage (e.g., uncouple) the electrical motors from the outer sheath  12  and/or the actuation shaft  30 . Specifically,  FIG. 6  illustrates a side view of the handle  17  shown in  FIG. 5 . For simplicity, the outer sheath  12  has been removed from the illustration, however, it can be appreciated that the outer sheath  12  (and the components extending therein), may enter the handle  17  at the distal end region  46 , as shown in  FIG. 5  (it is noted that, for illustrative purposes, the handle  17  has been flipped end-for-end in  FIGS. 6-9  as compared to the illustration in  FIGS. 1 and 4-6 ). Additionally,  FIG. 6  illustrates the handle  17  may include a cover  48 , which is located along a medial region of the handle  17  between the distal end region  46  and the proximal end region  44 . 
       FIG. 7  illustrates a perspective view of the handle  17  shown in  FIG. 6 . Additionally,  FIG. 7  illustrates that the cover  48  has been opened, revealing several inner components of the handle  17 . Specifically,  FIG. 7  illustrates the underside of the cover  48  may include a boss  49  which is designed to insert (e.g., engage) a recess  50 . It can be appreciated that the recess  50  may include electrical circuitry which is coupled to a battery. Additionally, it can be appreciated that the handle  17  may be designed to require the boss  49  to be inserted into the recess  50  for power to flow from the battery to the remainder of the downstream electrical components of the handle  17 . In other words, insertion of the boss  49  into the recess  50  may complete an electrical circuit, which allows power to flow from the battery, and accordingly, removing the boss  49  from the recess  50  may stop power from flowing from the battery to the remainder of the handle  17 . 
     Therefore, it can be appreciated that a first step to disengage (e.g., uncouple) the electrical motors from the outer sheath  12  and/or the actuation shaft  30  may include a user to open the cover  48 , thereby cutting power to the electrical motors of the handle  17 .  FIG. 7  also illustrates that the handle  17  may include an actuation lever  52  positioned adjacent to the recess  50 . The function of the actuation lever  52  is described in greater detail below. 
       FIGS. 8-9  illustrates another example first step user may undertake to disengage (e.g., uncouple) the electrical motors from the outer sheath  12  and/or the actuation shaft  30 . For example,  FIGS. 8-9  illustrate a side view of the handle  17  described above. It is noted that, for clarity, both the cover  48  and a bottom portion of handle&#39;s  17  housing have been removed to further illustrate several inner components of the handle  17 . 
     As described above,  FIG. 8  illustrates that the handle  17  includes a bailout actuation lever  52  positioned adjacent to the recess  50  (described above). Further,  FIG. 8  illustrates that the actuation lever  52  may be coupled to a translation member electric motor  55  via a dowel pin connection  53 . As will be described in greater detail below, translation member electric motor  55  may also be coupled to a pull wire  54  which extends away from the electric motor  55  toward the proximal end region  44  of the handle  17 . 
       FIG. 9  illustrates the actuation of the actuation lever  52 . In particular,  FIG. 9  illustrates that the actuation lever  52  may be actuated (as depicted by the arrow  56 ) in a clockwise direction from a first position (shown in  FIG. 8 ) to a second position (shown in  FIG. 9 ). Actuating the lever  52  may serve multiple functions. For example, actuating the lever  52  to the position shown in  FIG. 9  may prevent the cover  48  (described above) from being inadvertently closed during the procedure in which the user is manually actuating the outer sheath  12  and/or the actuation shaft  30 . It can be appreciated that if the cover  48  were to close, power would flow from the battery to the electric motors. Powering the electric motors during the manual actuation procedure is not desirable. Hence, the lever  52  is positioned such that when actuated, it prevents the cover  48  from being closed. 
     Additionally, actuation of the lever  52  may initiate the process of disengaging (e.g., uncoupling) the electric motors from the inner handle components which are coupled to the outer sheath  12  and the actuation shaft  30  (the inner components which are coupled to the outer sheath  12  and the actuation shaft  30  are illustrated and described in greater detail below). For example,  FIG. 9  shows that actuation of the lever  52  may shift a pin connection  53  which couples the translation member motor  55  to the lever  52 . Specifically, actuation of the lever  52  may shift the translation member motor  55  in a proximal-to-distal direction (e.g., away from the proximal end region  44  of the handle  17  toward the distal end region  46  of the handle  17 ). Further, shifting the motor  55  may also actuate a pull wire  51  which may be coupled to both the lever  52  and the motor  55 . Therefore, actuation of the lever  52  may shift the motor  55  in a proximal-to-distal direction while also simultaneously pulling the pull wire  51  in a proximal-to-distal direction. 
       FIG. 10  illustrates a perspective view of the underside of the handle  17  (as described above, the bottom portion of the handle&#39;s  17  outer housing has been removed to reveal the interior handle componentry).  FIG. 10  illustrates that after the lever  52  has been actuated (as described above), the translation member motor  55  shifts in a proximal-to-distal direction ( FIG. 10  further illustrates the lever  52  engaged with the pin  53  of the motor  55 ) which disengages a drive pin  60  of the motor  55  from a proximal portion  68  of a translation member lead screw  62 . At this point, the electric motor  55  may no longer rotate the translation member lead screw  62 . 
     As will be described in greater detail below, when engaged, the electric translation motor  55  may rotate the translation member lead screw  62 . Additionally, rotation of the translation member lead screw  62  may translate a translation member nut assembly  69  along the translation member lead screw  62 . In other words, because the translation member nut assembly  69  may be threadedly coupled to the translation member lead screw  62 , rotation of the translation member lead screw  62  may translate the translation member nut assembly  69  in either a distal-to-proximal direction or a proximal-to-distal direction along the translation member lead screw  62  (it can be appreciated that the nut assembly  69  may be shifted in different directions depending on which direction the translation member lead screw  62  is rotated). 
     While not shown in  FIG. 10 , it can be appreciated from  FIG. 10  that the translation member nut assembly  69  may be coupled to the actuation shaft  30  shown in  FIGS. 2-4 . Accordingly, because the actuation shaft is coupled to the translation members  24  (shown in  FIGS. 2-4 ), actuation of the translation member nut assembly  69  may translate the translation member  24 , thereby shortening or lengthening the implant  16 . 
     As described above,  FIG. 10  illustrates the rotating the lever  52  may pull the pull wire  51  in a proximal-to-distal direction. Pulling the pull wire  51  in a proximal-to-distal direction may actuate a latch  72  which releases a bailout door  57 . The bailout door  57  may be coupled to the outer sheath electric motor  59  via a flex circuit cable  73 . Additionally, a spring  58  may be disposed between the bailout door  57  and the outer sheath motor  59 . When the pull wire is retracted via actuation of the lever  52  (as described above) the latch  72  is flexed, thereby releasing the bailout door  57  and permitting the spring  58  to expand. It can be appreciated that expansion of the spring  58  pushes the bailout door  57  out of the proximal end  44  of the handle  17  (expansion of the spring  58  and the initial ejection of the bailout door  57  from the handle housing is depicted by reference numeral  67 ). 
     Similarly to that described above with respect to the translation member lead screw  62 , when engaged, the outer sheath electric motor  59  may rotate the outer sheath lead screw  64  ( FIG. 10  illustrates a output shaft  63  of the outer sheath electric motor  59  engaged with a proximal end portion of the outer sheath lead screw  64 ). Additionally, rotation of the outer sheath lead screw  64  may translate an outer sheath nut assembly  70  along the outer sheath lead screw  64 . In other words, because the outer sheath nut assembly  70  may be threadedly coupled to the outer sheath lead screw  64 , rotation of the outer sheath lead screw  64  may translate the outer sheath nut assembly  70  in either a distal-to-proximal direction or a proximal-to-distal direction along the outer sheath lead screw  64  (it can be appreciated that the nut assembly  70  may be shifted in different directions depending on which direction the outer sheath lead screw  64  is rotated). 
     It can be appreciated from the above discussion that after the translation member motor  55  and outer sheath motor  59  are disengaged from the translation member lead screw  62  and the outer sheath lead screw  64 , respectively, manipulation of the implant  16  and/or the outer sheath  12  may need to be accomplished via manual manipulation of the translation member lead screw  62  and/or the outer sheath lead screw  64 . Therefore, in order to access the translation member lead screw  62  and the outer sheath lead screw  64 , the bailout door  57  (described herein) may need to be removed from the handle  17 . 
       FIG. 11  illustrates the bailout door  57  removed from the handle  17 . As described above, because the bailout door  57  is attached to the outer sheath electric motor  59  via the flex circuit cable  73 , removing the bailout door  57  from the handle  17  may also remove the outer sheath electric motor  59  from the handle  17 . It can be further appreciated from  FIG. 11  that removing the bailout door  57  form the handle  17  may exposes a translation lead screw opening  74  and an outer sheath screw opening  76 . It can be appreciated the translation lead screw opening  74  may permit access (via a first lead screw tool described below) to a proximal engagement portion of the translation member lead screw  62 . Likewise, it can be appreciated the outer sheath lead screw opening  76  may permit access (via a second lead screw tool described below) to a proximal engagement portion  66  of the outer sheath lead screw  62 . 
       FIG. 12  illustrates a first lead screw tool  80  and a second lead screw tool  81 . The first lead screw tool  80  may include a handle  82 , a ratchet head portion  84  and a body portion  88  extending between the handle  82  and the ratchet head portion  84 . The ratchet head portion  84  may further include a distal engagement tip  86 . As will be illustrated in greater detail below, the ratchet head portion  84  of the first lead screw tool  80  may be removable from the body portion  88 . Further, the second lead screw tool  81  may include a handle  83 , a ratchet head portion  85  and a body portion  89  extending between the handle  83  and the ratchet head portion  85 . The ratchet head portion  85  may further include a distal engagement tip  87 . In some examples, the ratchet head portion  84  of the first lead screw tool  80  and the ratchet head portion  85  of the second lead screw tool  81  may be designed such that they may only rotate in one direction. Further details of the engagement of the first lead screw tool  80  with the translation member lead screw  62  and the engagement of the second lead screw tool  82  with the outer sheath lead screw  64  is described below. 
     As described above, after the translation member motor  55  has been disengaged from the translation member lead screw  62  and the outer sheath motor  59  has been disengaged from the outer sheath lead screw  64 , a user may utilize both first lead screw tool  80  and/or the second lead screw tool  81  to manually rotate the translation member lead screw  62  and the outer sheath motor  59 , respectively. 
       FIG. 13  illustrates an example step in which a user may utilize the first lead screw tool  80  to engage and manually rotate the translation member lead screw  62 . As described above,  FIG. 13  illustrates that the bailout door  57  has been removed from the handle  17 . Because the bailout door  57  is coupled to the outer sheath electric motor  59  via the flex circuit  73 , removing the bailout door  57  may also remove the outer sheath electric motor  59 . 
     Additionally,  FIG. 13  illustrates the first lead screw tool  80  aligned with the translation lead screw opening  74  (the second lead screw tool  81  is shown to distinguish it from the first lead screw tool  80 ). Either the first lead screw tool  80  or the second lead screw tool  81  may be inserted into the translation member lead screw opening  74  to engage the translation member lead screw  62 . A more detailed discussion of the engagement of the first lead screw tool  80  or the second lead screw tool  81  with the translation lead screw  62  is set forth with respect to  FIG. 14 . 
     For simplicity,  FIG. 14  illustrates the translation member lead screw  62  and the outer sheath lead screw  64  spaced away from the handle  17 . Further,  FIG. 14  illustrates that the first lead screw tool  80  may be inserted through the translation lead screw opening  74  to engage the distal engagement tip  86  into the proximal end region of the translation member lead screw  62 . Rotation of the first lead screw tool  80  may rotate the translation member lead screw  62  such that the translation member nut assembly  69  is shifted in a proximal-to-distal direction relative to the implant  16 . Shifting the translation member nut assembly  69  in a proximal-to-distal direction may shift the translation members  24  in a proximal-to-distal direction, thereby elongating the implant  16 . The translation member nut assembly  69  may cease to translate when the translation member nut assembly contacts a translation member hard stop  90 . 
     Alternatively,  FIG. 14  illustrates that the second lead screw tool  81  may be inserted through the translation lead screw opening  74  (shown in  FIG. 13 ) to engage its distal engagement tip  87  into the proximal end region of the translation member lead screw  62 . Rotation of the second lead screw tool  81  may rotate the translation member lead screw  62  in an opposite direction as compared to the first lead screw tool  80 , thereby shifting the translation member nut assembly  69  in a distal-to-proximal direction relative to the implant  16  (thereby shortening the implant  16 ). Shifting the translation member nut assembly  69  in a distal-to-proximal direction may shift the translation members  24  in a distal-to-proximal direction, thereby shortening the implant  16 . 
     It can be appreciated that a user may decide whether to use either the first lead screw tool  80  to elongate the implant  16  (via turning the translation member lead screw  62  a first direction) or the second lead screw tool  81  to shorten the implant  16  (via turning the translation member lead screw  62  in the opposite direction versus the first lead screw too  80 ) depending on the user&#39;s desired outcome for a particular medical procedure. For example, in some procedures, a user may realize that, after the implant  16  has already been partially deployed, it may be necessary to recapture the implant  16  in the outer sheath  12 . Recapturing a partially deployed implant  16  in the outer sheath  12  may permit the implant  16  to be repositioned and redeployed. Positioning the implant  16  in an optimal position to be recaptured by the outer sheath  12  may be accomplished by using the first lead screw tool  80  to shifting the translation members  24  in a proximal-to-distal direction (e.g., thereby lengthening the implant  16 ). The optimum lengthening of the implant  16  for recapture by the outer sheath  12  may be set to coincide with the translation member nut assembly  69  ceasing to translate when the translation member nut assembly  69  contacts the translation member hard stop  90 . 
     Alternatively, if a user desires to fully deploy the implant  16 , the user may utilize the second lead screw tool  81  to shift the translation members  24  in a distal-to-proximal direction (thereby shortening the implant  16 ) to a point at which the translation members  24  are disengaged from the implant  16  (e.g., the implant  16  is released from the delivery system  10 ). 
     As discussed above, after utilizing either the first lead screw tool  80  or the second lead screw tool  81  to manipulate the translation members (thereby either shortening the implant  12  for deployment or lengthening the implant  12  for recapture), the user may then utilize the first lead screw tool  80  to rotate the outer sheath lead screw  64  and translate the outer sheath  12 . In examples when a user is choosing to recapture the implant  16 , advancing the outer sheath  12  in a proximal-to-distal direction may result in the outer sheath  12  being advanced over the implant  12 , thereby recapturing the implant  16  within the lumen of the outer sheath  12 . Alternatively, after releasing the implant  12  from the delivery system  10 , a user may advance the outer sheath  12  distally to swallow the remaining delivery system components (e.g., actuation shaft  30 , translation members  24 , etc.) within the lumen of the outer sheath  12  prior to removing the delivery system  10  from the patient&#39;s body. 
       FIG. 15  illustrates the first lead screw tool  80  in a different configuration from that described above. Specifically,  FIG. 15  illustrates that the first lead screw tool  80  may be designed such that the ratchet head  84  may be removed from the body portion  88 .  FIG. 15  further illustrates that the first lead screw tool  80  may include an additional engagement tip  92  which may be nested within the ratchet head  84 . Additionally, the engagement tip  92  may be designed to engage the outer sheath lead screw  64 . 
       FIG. 16  illustrates an example step in which a user may utilize the first lead screw tool  80  to engage and manually rotate the outer sheath lead screw  64 . As described above,  FIG. 16  illustrates that the bailout door  57  has been removed from the handle  17 . Because the bailout door  57  is coupled to the outer sheath electric motor  59  via the flex circuit  73 , removing the bailout door  57  may also remove the outer sheath electric motor  59 . Additionally,  FIG. 16  illustrates the first lead screw tool  80  aligned with the outer sheath lead screw opening  76 . 
     Similarly to  FIG. 14 ,  FIG. 17  illustrates the outer sheath lead screw  64  and the translation member lead screw  62  spaced away from the handle  17 . Further,  FIG. 17  illustrates that the first lead screw tool  80  may be inserted through the outer sheath lead screw opening  76  to engage the distal engagement tip  92  into the proximal end region of the outer sheath lead screw  64 . Rotation of the first lead screw tool  80  may rotate the outer sheath lead screw  64  such that the outer sheath nut assembly  70  is shifted in a proximal-to-distal direction relative to the implant  16 . Shifting the outer sheath nut assembly  70  in a proximal-to-distal direction may shift the outer sheath  12  in a proximal-to-distal direction, thereby permitting the outer sheath  12  to recapture the implant  12  or swallow the remaining delivery system components. The outer sheath nut assembly  70  may cease to translate when the outer sheath nut assembly  70  contacts a distal stop  94  located in the handle  17 . 
     The materials that can be used for the various components of the medical devices and/or systems  10  and  200  disclosed herein may include those commonly associated with medical devices. However, this is not intended to limit the devices and methods described herein, as the discussion may be applied to other components of the medical devices and/or systems  10 ,  200  disclosed herein including the various shafts, liners, components described relative thereto. 
     The medical device  10 ,  200  may be made from a metal, metal alloy, polymer (some examples of which are disclosed below), a metal-polymer composite, ceramics, combinations thereof, and the like, or other suitable material. Some examples of suitable polymers may include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, for example, DELRIN® available from DuPont), polyether block ester, polyurethane (for example, Polyurethane 85A), polypropylene (PP), polyvinylchloride (PVC), polyether-ester (for example, ARNITEL® available from DSM Engineering Plastics), ether or ester based copolymers (for example, butylene/poly(alkylene ether) phthalate and/or other polyester elastomers such as HYTREL® available from DuPont), polyamide (for example, DURETHAN® available from Bayer or CRISTAMID® available from Elf Atochem), elastomeric polyamides, block polyamide/ethers, polyether block amide (PEBA, for example available under the trade name PEBAX®), ethylene vinyl acetate copolymers (EVA), silicones, polyethylene (PE), high density polyethylene (HDPE), polyester, Marlex high-density polyethylene, Marlex low-density polyethylene, linear low density polyethylene (for example REXELL®), ultra-high molecular weight (UHMW) polyethylene, polypropylene, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly paraphenylene terephthalamide (for example, KEVLAR®), polysulfone, nylon, nylon-12 (such as GRILAMID® available from EMS American Grilon), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (for example, SIBS and/or SIBS 50A), polycarbonates, ionomers, biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers thereof, polymer/metal composites, and the like. In some embodiments the sheath can be blended with a liquid crystal polymer (LCP). 
     Some examples of suitable metals and metal alloys include stainless steel, such as 304V, 304L, and 316LV stainless steel; mild steel; nickel-titanium alloy such as linear-elastic and/or super-elastic nitinol; other nickel alloys such as nickel-chromium-molybdenum alloys (e.g., UNS: N06625 such as INCONEL® 625, UNS: N06022 such as HASTELLOY® C-22®, UNS: N10276 such as HASTELLOY® C276®, other HASTELLOY® alloys, and the like), nickel-copper alloys (e.g., UNS: N04400 such as MONEL® 400, NICKELVAC® 400, NICORROS® 400, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035 such as MP35-N® and the like), nickel-molybdenum alloys (e.g., UNS: N10665 such as HASTELLOY® ALLOY B2®), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, and the like; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS: R30003 such as ELGILOY®, PHYNOX®, and the like); platinum enriched stainless steel; titanium; combinations thereof; and the like; or any other suitable material. 
     In at least some embodiments, portions or all of the medical device  10 ,  200  may also be doped with, made of, or otherwise include a radiopaque material. Radiopaque materials are understood to be materials capable of producing a relatively bright image on a fluoroscopy screen or another imaging technique during a medical procedure. This relatively bright image aids the user of the medical device  10 ,  200  in determining its location. Some examples of radiopaque materials can include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloy, polymer material loaded with a radiopaque filler, and the like. Additionally, other radiopaque marker bands and/or coils may also be incorporated into the design of the medical device  10 ,  200  to achieve the same result. 
     In some embodiments, a degree of Magnetic Resonance Imaging (MM) compatibility is imparted into the medical device  10 ,  200 . For example, the medical device  10 ,  200  may include a material that does not substantially distort the image and create substantial artifacts (e.g., gaps in the image). Certain ferromagnetic materials, for example, may not be suitable because they may create artifacts in an MM image. The medical device  10 ,  200  may also be made from a material that the Mill machine can image. Some materials that exhibit these characteristics include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS: R30003 such as ELGILOY®, PHYNOX®, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035 such as MP35-N® and the like), nitinol, and the like, and others. 
     It should be understood that this disclosure is, in many respects, only illustrative. Changes may be made in details, particularly in matters of shape, size, and arrangement of steps without exceeding the scope of the disclosure. This may include, to the extent that it is appropriate, the use of any of the features of one example embodiment being used in other embodiments. The disclosure&#39;s scope is, of course, defined in the language in which the appended claims are expressed.