Patent Publication Number: US-2022233313-A1

Title: Medical device including attachable components

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application claims the benefit of priority of U.S. Provisional Application No. 63/141,777 filed Jan. 26, 2021, the entire disclosure of which is hereby incorporated by reference. 
    
    
     TECHNICAL FIELD 
     The present disclosure pertains to medical devices, and methods for manufacturing medical devices. More particularly, the present disclosure pertains to medical devices including an attachable inner member and attachable outer member. 
     BACKGROUND 
     A wide variety of intracorporeal medical devices have been developed for medical use, for example, intravascular use. Some of these devices include heart valves, 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. 
     BRIEF SUMMARY 
     This disclosure provides design, material, manufacturing method, and use alternatives for medical devices. An example system for delivering an implantable heart valve includes an inner shaft having a proximal end region, a distal end region and a first coupling member disposed along a portion of the distal end region, wherein the first coupling member includes a first aperture. The system also includes a support shaft having a proximal end region, a distal end region and a second coupling member disposed along a portion of the proximal end region, wherein the second coupling member includes a stem, wherein the stem includes a groove extending circumferentially around the stem. The system also includes a locking clip coupled to the inner shaft, wherein coupling the inner shaft to the support shaft includes extending at least a portion of the locking clip through the first aperture and into at least a portion of the groove. 
     Alternatively or additionally to any of the embodiments above, wherein the locking clip includes a first locking tab having an inner surface, a first end region and a second end region opposite the first end region, and wherein the first end region includes a first projection extending radially inward from the inner surface of the first locking tab. 
     Alternatively or additionally to any of the embodiments above, wherein the first projection is designed to extend through the first aperture and nest within the groove of the stem. 
     Alternatively or additionally to any of the embodiments above, wherein the first projection has a first engagement surface, the first engagement surface having radius of curvature, and wherein stem includes a second radius of curvature which substantially matches the first radius of curvature of the first engagement surface. 
     Alternatively or additionally to any of the embodiments above, wherein the locking clip includes a second locking tab having an inner surface, a first end region and a second end region opposite the first end region, and wherein the first end region includes a second projection extending radially inward from an inner surface of the second locking tab. 
     Alternatively or additionally to any of the embodiments above, wherein the first coupling member includes a second aperture, and wherein the second projection is designed to extend through the second aperture and nest within the groove of the stem. 
     Alternatively or additionally to any of the embodiments above, wherein the locking clip further includes a first connector and a second connector, and wherein each of the first connector and the second connector extends between the first locking tab and the second locking tab. 
     Alternatively or additionally to any of the embodiments above, wherein the first connector faces the second connector. 
     Alternatively or additionally to any of the embodiments above, wherein the first connector and the second connector are configured to bias the first locking tab toward the second locking tab. 
     Alternatively or additionally to any of the embodiments above, wherein the first projection and the second projection are configured to slide within the groove of the stem. 
     Alternatively or additionally to any of the embodiments above, wherein the first coupling member is configured to rotate relative to the second coupling member when the first projection and the second projection are positioned within the groove of the stem. 
     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 and an inner shaft having a proximal end region, a distal end region and a first coupling member disposed along a portion of the distal end region, wherein the first coupling member includes a first aperture. The system also includes a support shaft having a proximal end region, a distal end region and a second coupling member disposed along a portion of the proximal end region, wherein the second coupling member includes a stem, wherein the stem includes a groove extending circumferentially around the stem. The system also includes a locking clip coupled to the inner shaft, wherein coupling the inner shaft to the support shaft includes extending at least a portion of the locking clip through the first aperture and into at least a portion of the groove. 
     Alternatively or additionally to any of the embodiments above, wherein the locking clip includes a first locking tab having an inner surface, a first end region and a second end region opposite the first end region, and wherein the first end region includes a first projection extending radially inward from the inner surface of the first locking tab. 
     Alternatively or additionally to any of the embodiments above, wherein the first projection is designed to extend through the first aperture and nest within the groove of the stem. 
     Alternatively or additionally to any of the embodiments above, wherein the locking clip includes a second locking tab having an inner surface, a first end region and a second end region opposite the first end region, and wherein the first end region includes a second projection extending radially inward from the inner surface of the second locking tab. 
     Alternatively or additionally to any of the embodiments above, wherein the first coupling member has a second aperture, and wherein the second projection is designed to extend through the second aperture and nest within the groove of the stem. 
     Alternatively or additionally to any of the embodiments above, wherein the locking clip further includes a first connector and a second connector, and wherein each of the first connector and the second connector extends between the first locking tab and the second locking tab. 
     Alternatively or additionally to any of the embodiments above, wherein the first connector and the second connector are configured to bias the first locking tab toward the second locking tab. 
     Alternatively or additionally to any of the embodiments above, wherein the first coupling member is configured to swivel relative to the second coupling member when the first projection and the second projection are positioned within the groove of the stem. 
     An example method for delivering an implantable heart valve includes attaching a first coupling member of an actuation shaft to a second coupling member of a support shaft using a locking clip of a medical device delivery system, the medical device delivery system including the implantable heart valve. Further, attaching the first coupling member of the actuation shaft to the second coupling member of the support shaft includes positioning a first projection of the locking clip through a first aperture of the first coupling member into a groove of the second coupling member. Additionally, the method also includes advancing the medical device delivery system to a target site adjacent the heart and deploying the implantable heart valve at the target site. 
     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 system; 
         FIG. 2  is a side view of the tip assembly and valve assembly spaced away from the inner shaft and exoskeleton of the medical device of  FIG. 1 ; 
         FIG. 3  is a perspective view of a connection assembly of the medical device of  FIG. 1 ; 
         FIG. 4  is an exploded view of the connection assembly shown in  FIG. 3 ; 
         FIG. 5  is a perspective view of an example component of the connection assembly shown in  FIGS. 3-4 ; 
         FIG. 6  is a perspective view showing multiple translation members and a securement collar of the connection assembly shown in  FIGS. 3-4 ; 
         FIG. 7  is a cross-sectional view of the connection assembly shown in  FIG. 3 . 
     
    
    
     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. 
     DETAILED 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 invention. 
     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 shaft  12 , an exoskeleton  14  extending at least partially through a lumen of the outer shaft  12 , and a medical implant  16  (e.g., a replacement heart valve implant) which may be coupled to the exoskeleton  14  and disposed within a lumen of the outer shaft  12  during delivery of the medical implant  16 . In some embodiments, a medical device handle  18  may be disposed at a proximal end of the outer shaft  12  and/or the exoskeleton  14  and may include one or more actuation mechanisms associated therewith. In other words, one or more tubular members (e.g., the outer shaft  12 , the exoskeleton  14 , etc.) may extend distally from the medical device handle  18 . In general, the medical device handle  18  may be designed to manipulate the position of the outer shaft  12  relative to the exoskeleton  14  and/or facilitate 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 shaft  12 , as seen schematically in  FIG. 1 , for example. Once positioned, the outer shaft  12  may be retracted relative to the medical implant  16  and/or the exoskeleton  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  18  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. 
     In some instances, it may be desirable to design the medical device system  10  such that one or more device components may be disconnected from the medical device handle  18  when initially packaged (e.g., unattached to the exoskeleton  14 , other inner shafts, etc.) whereby the one or more components may be subsequently coupled to the handle  18  after the packaging containing the medical device system  10  has been opened (and prior to a clinician utilizing the medical device system  10  in a medical procedure). For example, in some instances it may be desirable to package the medical implant  16  (e.g., heart valve, heart valve frame, the heart valve support structure, etc.) separately prior to performing the medical procedure. It can be appreciated that packaging the medical implant  16  (e.g., heart valve, heart valve frame, the heart valve support structure, etc.) separately may permit the medical implant  16  (including the heart valve, heart valve frame, the heart valve support structure, etc.) to be sterilized according to a different process, or kept at different temperatures, for example, than the remaining separately-packaged components of the medical device system  10 . 
       FIG. 2  shows an illustration of the medical device system  10  whereby the medical implant  16 , the medical implant support structure  26  (coupled to the medical implant  16 ) and the tip assembly  24  are uncoupled from the handle  18  (it is noted that, for simplicity, the handle  18  is not shown in  FIG. 2 ). It can be appreciated from  FIG. 2  that any one of the medical implant  16 , the medical implant support structure  26  and/or the tip assembly  24  may be packaged separately from the remaining components (e.g., handle  18 , outer shaft  12 , exoskeleton  14 , guidewire shaft  36 , etc.) of the medical device system  10 , as described above. 
     As discussed above,  FIG. 2  illustrates that the tip assembly  24  is uncoupled (e.g., unattached) from the medical implant  16 , the medical implant support structure  26  and the remainder of the medical device delivery system  10 . For example, in the packaging of the medical device system  10 , the tip assembly may be packaged separately from the remainder of the medical device system  10 . However,  FIG. 2  further illustrates that the tip assembly  24  may eventually be coupled to the handle member  18  (and remainder of the medical device system  10 ) via a tubular guidewire member  36  (as illustrated by the dotted line  45 ). 
     In some examples, the tubular guidewire member  36  may extend proximally within the lumen of an exoskeleton  14  and couple to the handle member  18  (it is noted that the exoskeleton  14  will be discussed in greater detail below). Additionally, the tubular guidewire member  36  may include a lumen which permits a guidewire to extend and translate therein. In other words, when fully assembled, 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  36 . Further, as discussed above, the tubular guidewire member  36  may extend from the handle member  18 , through the lumen of the exoskeleton  14 , through the implant medical and terminate at the tip assembly  24 . Additionally, to attach the tubular guidewire member  36  to the tip assembly  24 , the tubular guidewire member  36  may be advanced through the medical implant support structure  26  and the medical implant  16 . Further, the tip assembly  24  and the tubular guidewire member  36  may be designed such that they “quick connect” (e.g., snap, attach, engage, etc.) together. Examples of attaching the tip assembly to a tubular guidewire member  36  are disclosed in U.S. patent application Ser. No. ______ (corresponding to Attorney Docket No. 2001.2057100), the entirety of which is incorporated by reference. 
     As discussed above,  FIG. 2  further illustrates the medical implant  16  (e.g., a heart valve) coupled to a medical implant support structure  26 .  FIG. 2  illustrates that the medical implant  16  and the medical implant support structure  26  are uncoupled (e.g., unattached) from the remainder of the medical device delivery system  10 . In the configuration shown, it can be appreciated that the medical implant support structure  26  may include one or more components and/or features which are designed to maintain the medical implant  16  in a pre-delivery configuration prior to attaching the medical implant  16  and medical implant support structure  26  to the remainder of the medical device system  10 . 
     While  FIG. 2  illustrates the medical implant  16  and the medical implant support structure  26  unattached to the remainder of the medical device system  10 , it can be appreciated that the medical implant  16  and the medical implant support structure  26  may be coupled to the remainder of the medical device system  10  (e.g., handle  18 ) via one or more shaft members and/or coupling members (as illustrated by the dotted line  49 ). The coupling of the medical implant  16  and the medical implant support structure  26  to the medical device system  10  will be described below. 
     For example, as discussed above,  FIG. 2  illustrates that the medical device system  10  may include an exoskeleton  14  extending within the outer shaft  12 . The exoskeleton  14  may include one more lumens extending therein. One or more inner shafts may extend through the exoskeleton  14 . For example, the exoskeleton  14  may include a lumen through which an actuation shaft  17  may extend (the actuation shaft  17  will be described in greater detail below). 
     Further, in some examples, the exoskeleton  14  may include a plurality of discrete members or articulating links. For example, the exoskeleton  14  may include a plurality of bead members  41  and a plurality of barrel members  43 . Other discrete members are contemplated that may have differing shapes and/or configurations. In general, the discrete members (e.g., the bead members  41  and the barrel members  43 ) are engaged with one another and are designed to increase the compression resistance, the tension resistance, or both of the exoskeleton  14  while also affording a desirable amount of flexibility and kink resistance such that the one or more inner shafts extending through the exoskeleton can be navigated through the anatomy. The bead members  41  and the barrel members  43  may be arranged in a number of different configurations. In at least some instances, the bead members  41  and the barrel members  43  alternate along the exoskeleton  14 . Other arrangements and/or patterns are contemplated. Example exoskeletons are disclosed in U.S. Patent Publication No. US20180140323, the entirety of which is incorporated by reference. 
     Additionally,  FIG. 2  illustrates that, in some examples, the distal end of the exoskeleton  14  may include a first exoskeleton coupling member  30 . As will be described in greater detail below, the first exoskeleton coupling member  30  may include one or more features which are designed to attach to a second exoskeleton coupling member  28 . As further illustrated in  FIG. 2 , the second exoskeleton coupling member  28  may be attached to the proximal end of one or more components of the medical implant support structure  26 . Therefore, it can be appreciated that coupling the first exoskeleton coupling member  30  to the second exoskeleton coupling member  28  may connect the exoskeleton  14  to the medical implant  16  via the medical implant support structure  26 . 
     Additionally, as will be described in greater detail below,  FIG. 2  illustrates that the medical device system  10  may include an exoskeleton locking collar  34 . The exoskeleton locking collar  34  may be disposed along an outer surface of the exoskeleton  14 . As will be described in greater detail below, the exoskeleton locking collar  34  may be utilized to couple (e.g., attach, lock, engage, etc.) the first exoskeleton coupling member  30  to the second exoskeleton coupling member  28 . 
     It is noted that  FIG. 2  illustrates the outer shaft  12  of the medical device system  10  having been retracted in a proximal direction to a position proximal of both the first exoskeleton coupling member  30 , the exoskeleton locking collar  34 , a portion of the actuation shaft  17  and a portion of the tubular guidewire member  36 . It can be appreciated that when all the components of the medical device system  10  (including the medical implant  16 , the medical implant support structure  26  and the tip assembly  24 ) are assembled, the outer shaft  12  may be advanced distally such that it covers the medical implant  16 , the medical implant support structure  26  and a portion of the tip assembly  24 . 
     Additionally, as discussed above,  FIG. 2  illustrates that the medical device system  10  may include an actuation shaft  17  extending within a portion of the exoskeleton  14 .  FIG. 2  further illustrates that, in some examples, the distal end of the actuation shaft  17  may include a first actuation shaft coupling member  19 . As will be described in greater detail below, the first actuation shaft coupling member  19  may include one or more features which are designed to attach to a second actuation shaft coupling member  20 . As further illustrated in  FIG. 2 , the second actuation coupling member  20  may be attached to the proximal end of one or more translation members  22  (e.g., push-pull members). Therefore, it can be appreciated that coupling the first actuation shaft coupling member  18  to the second actuation coupling member  20  may connect the actuation shaft  17  to the medical implant  16  via the one or more translation members  22  (as illustrated by the dotted line  47 ). 
     In some examples, an operator may be able to manipulate the translation members  22  via the handle  18  (which is coupled to the translation members  22  via the actuation shaft  17 , first actuation coupling member  19  and second actuation coupling member  20 ). For example, the handle  18  may be designed to control the translation of the translation members  22 . Further, actuation of the translation members  22  may help deploy the medical implant  16  at a target site adjacent the heart. Example translation members are disclosed in U.S. patent application Ser. No. 16/396,089, the entirety of which is incorporated by reference. 
     Additionally, as will be described in greater detail below,  FIG. 2  illustrates that the medical device system  10  may include an actuation shaft locking clip  32 . The actuation shaft locking clip  32  may be disposed along an outer surface of the actuation shaft  17 . In some examples, the actuation shaft locking clip  32  may be attached to the first actuation coupling member  19 . However, in other examples the actuation shaft locking clip  32  may be free from the first actuation coupling member  19 . As will be described in greater detail below, the actuation shaft locking clip  32  may be utilized to couple (e.g., attach, lock, engage, etc.) the first actuation shaft coupling member  19  to the second actuation coupling member  20 . 
     In some instances, the order of connecting separately packaged components may include first advancing the guidewire shaft  36  through the medical implant. Next, the first actuation coupling member  19  may be attached to the second actuation coupling member  20 . After this connection is made, the actuation shaft  17  may be retracted such that the first exoskeleton coupling member  30  may be attached to the implant support structure  26  via the second exoskeleton coupling member  28 . Finally, the nosecone  24  may be attached to the distal end region of the guidewire shaft  36 . 
       FIG. 3  is a perspective view showing a connection assembly  15 . Specifically,  FIG. 3  illustrates the first actuation coupling member  19  coupled to the second actuation coupling member  20 . As shown in  FIG. 3 , the proximal end of the first actuation coupling member  19  may be attached to the distal end of the actuation shaft  17 . It can be appreciated from  FIG. 3  that the first actuation coupling member  19  may include a lumen (not visible in  FIG. 3 , but shown in  FIG. 4 ) extending therein. It can be further appreciated from  FIG. 3  that the distal end region of the second actuation coupling member  20  may include a stem (not visible in  FIG. 3 , but shown in  FIG. 4 ) which is configured to be inserted into the lumen of the first actuation coupling member  19 . A more detailed description of the first actuation coupling member  19  coupled to the second actuation coupling member  20  is provided below. 
     Additionally,  FIG. 3  illustrates the actuation shaft locking clip  32  disposed along the outer surface of the first actuation coupling member  19 . As will be described in greater detail below, the actuation shaft locking clip  32  may be designed such that both the actuation shaft  17  and the proximal end region of the first actuation coupling member  19  may extend through a portion of the actuation shaft locking clip  32  (e.g., a portion of the actuation shaft locking clip  32  may extend circumferentially around the outer surface of the first actuation coupling member  19 ). Additionally,  FIG. 3  illustrates that the actuation shaft locking clip  32  may include two locking tabs designed to extend through an aperture of the first actuation coupling member  19  and engage a portion of the stem of the second actuation member coupling member  20 . Further details of the actuation locking clip  32  and its engagement with both the first actuation coupling member  19  and the second actuation coupling member  20  are discussed below. 
       FIG. 3  further illustrates that the proximal end of the second actuation coupling member  20  may be attached to the distal ends of each of the translation members  22  described above. For example, it can be appreciated from  FIG. 3  that the proximal end of the second actuation coupling member  20  may include a lumen (not visible in  FIG. 3 ) within which the distal end region of each of the translation members  22  may be inserted. Additional details of the engagement of the second actuation coupling member  20  with the translation members  22  is described below. 
       FIG. 4  illustrates an exploded view of the connection assembly  15  shown in  FIG. 3 . Specifically,  FIG. 4  illustrates the translation members  22  (coupled to one another via a securement collar  54 ) aligned with the second actuation coupling member  20 , the second actuation coupling member  20  aligned with the first actuation coupling member  19 , and the actuation shaft locking clip  32  positioned proximal of the first actuation coupling member  19  and disposed along the actuation shaft  17 . 
       FIG. 4  illustrates the translation members  22  aligned with the lumen  48  of the second actuation coupling member  20 . It is noted that  FIG. 4  illustrates three translation members  22  positioned adjacent to one another (however, one of the translation members  22  is partially obstructed from view as it is positioned behind two other translation members  22  in the illustration).  FIG. 4  further illustrates that the translation members  22  may be secured to one another via a securement collar  54 . The securement collar  54  may extend around all or a portion of the outer surface of the translation members  22 . Details of the engagement of the securement collar  54  and the translation members  22  is discussed with respect to  FIG. 7  below. 
       FIG. 4  further illustrates the second actuation coupling member  20  having a proximal end region  51  and a distal end region  44 . Additionally, the second actuation coupling member  20  may include a lumen  48  extending within a portion of the proximal end region  51 . As discussed above, the lumen  48  of the second actuation coupling member  20  may be sized to permit the distal end regions (including the securement collar  54 ) of the translation members  22  to be inserted therein. It can be further appreciated from  FIG. 4  that the distal ends of the translation members  22  may include a tapered (e.g., chamfered, beveled, angled, etc.) distal end which may permit easier insertion of the distal ends of the translation members  22  into the lumen  48  of the second actuation coupling member  20 . 
     In some instances, the translation members  22  may be secured to the second actuation coupling member  20  via welding the securement collar  54  directly to the second actuation coupling member  20 . Further, in some examples, the aperture  50  may be utilized during the welding process to assure that the securement collar  54  is properly aligned with the second actuation coupling member  20 . 
     As discussed above,  FIG. 4  illustrates that the distal end region  44  of the second actuation coupling member  20  may be referred to as a stem extending away from the proximal end region  51 . As shown in  FIG. 4 , the stem  44  may include an outer diameter which is less than the diameter of the lumen  48  of the proximal end region  51 . Additionally, in some examples, the second actuation coupling member  20  may include a tapered lip  55  which is positioned between the proximal end region  51  and the stem  44 . 
       FIG. 4  further illustrates that the stem  44  may include a channel  46  (e.g., groove) which extends circumferentially around the circumference of the stem  44 . The channel  46  may be described as a portion of the stem  44  which extends radially inward from an outer surface of the stem  44 . Further,  FIG. 4  illustrates that the channel  46  may be positioned along the stem  44  such that it is positioned approximately midway along the length of the stem  44 . However, this is not intended to be limiting. The channel  46  may be positioned along any portion of the stem  44 . Additionally,  FIG. 4  illustrates that the stem  44  may include a tapered (e.g., chamfered, beveled, angled, etc.) distal end  53  which may permit easier insertion of the distal end of the stem  44  into the lumen  52  of the first actuation coupling member  19 . 
       FIG. 4  further illustrates the first actuation coupling member  19  aligned with the second actuation coupling member  20 . As discussed above, the first actuation coupling member  19  may include a lumen  52  which may be configured to accept the stem  44  of the second actuation coupling member  20  therein. In other words, the lumen  52  may include a diameter which is sized to the permit the outer diameter of the stem  44  be inserted therein. 
       FIG. 4  further illustrates that the first actuation coupling member  19  may include a first aperture  42   a  which extends from the outer surface of the first actuation coupling member  19 , through the wall of the first actuation coupling member  19  to an inner surface of the first actuation coupling member  19 . In other words, the first aperture  42   a  extends from the outer surface of the first actuation coupling member  19  and opens into the lumen  52  of the first actuation coupling member  19 . In additional to the first aperture  42   a , it can be appreciated that the first actuation coupling member  19  may include a second aperture  42   b  (not visible in  FIG. 4 ) positioned approximately 180 degrees from the first aperture  42   a . In other words, the first aperture  42   a  may be both longitudinally and transversely aligned with the second aperture  42   b.    
       FIG. 4  further illustrates that the first actuation coupling member  19  may include a first face  56   a . The first face  56   a  may be longitudinally aligned with the first aperture  42   a  of the first actuation coupling member  19 . In other words, the first face  56   a  may include a first end which begins at the first aperture  42   a  and extends away from the first aperture  42   a . Therefore, a portion of the first face  56   a  may form a portion of a first channel  57   a  which extends through a portion of the wall of the first actuation coupling member  19 . While  FIG. 4  shows the first channel  57   a , it can be appreciated that the first actuation coupling member  19  may include a second channel  57   b  (not visible in  FIG. 4 ) positioned approximately 180 degrees from the first channel  57   a . The second channel  57   b  may be longitudinally aligned with the second aperture  42   b  (not visible in  FIG. 4 ). 
       FIG. 4  further illustrates the actuation shaft locking clip  32  disposed along the actuation shaft  17 . As shown in  FIG. 4 , the actuation shaft locking clip  32  may include a first locking tab  38   a  and a second locking tab  38   b . The first locking tab  38   a  may be positioned approximately 180 degrees from the second locking tab  38   b . As shown in  FIG. 4 , the distal end of the first locking tab  38   a  may include a first locking projection  40   a  which extends radially inward from an outer surface of the first locking tab  38   a . Similarly, the distal end of the second locking tab  38   b  may include a second locking projection  40   b  which extends radially inward from an outer surface of the first locking tab  38   a . Referring back to  FIG. 3 , each of the first locking projection  40   a  and the second locking projection  40   b  may be configured to extend through the first aperture  42   a  and the second aperture  42   b , respectively, of the first actuation coupling member  19 . Further, as will be discussed in greater detail below, each of the first locking projection  40   a  and the second locking projection  40   b  may engage the channel  46  of the stem  44  of the second actuation coupling member  20 . 
       FIG. 5  illustrates a detailed view of the actuation shaft locking clip  32 . As described above, the actuation shaft locking clip  32  may include a first locking tab  38   a  and a second locking tab  38   b . A first end  65  of the first locking tab  38   a  may include a first locking projection  40   a . As illustrated in  FIG. 5 , the first locking projection  40   a  may include a curved inner surface  62   a  extending across the width of the first locking projection  40   a . Similarly, a first end  67  of the second locking tab  38   b  may include a second locking projection  40   b . As illustrated in  FIG. 5 , the second locking projection  40   a  may include a curved inner surface  62   b  extending across the width of the second locking projection  40   b . It can be appreciated that the radius of curvature of each of the first curved inner surface  62   a  and the second curved inner surface  62   b  (as measure from a longitudinal axis  70  of the locking clip  32 ) may match the radius of curvature of the stem  44  of the second actuation coupling member  20 . 
     As will be shown below with respect to  FIG. 7 , the first and second locking projections  40   a / 40   b  may extend thought first and second apertures  42   a / 42   b  and engage the channel  46  of the stem  44  of the second actuation locking member  20 . This engagement may couple the actuation shaft  17  (and the first actuation coupling member  19 ) to the second actuation locking member  20  while also permitting the actuation shaft  17  to rotate with respect to the second actuation locking member  20 . 
       FIG. 5  further illustrates that first locking tab  38   a  and the second locking tab  38   b  may extend longitudinally along the longitudinal axis  70  to second end  68 . Further, the second end  68  of the actuation locking clip  32  may include a first curved portion  64   a  and a second curved portion  64   b . Each of the first curved portion  64   a  and the second curved portion  64   b  may extend along the longitudinal axis  70  of the actuation locking clip  32 . The first curved portion  64   a  and the second curved portion  64   b  of the locking clip  32  may provide a radially-inward force which biases the first locking tab  38   a  and second locking tab  38   b  (and hence, the first locking projection  40   a  and the second locking projection  40   b ) toward the channel  46 , thereby preventing the first locking tab  38   a  and second locking tab  38   b  (and hence, the first locking projection  40   a  and the second locking projection  40   b ) from flexing radially away from the channel  46 . 
     Additionally,  FIG. 5  illustrates that the second end  68  may be sized and shaped to permit the proximal end region of the first actuation coupling member  20  to extend therethrough. In other words, as shown in  FIGS. 3-4 , in a locked configuration, the second end  68  of the actuation shaft locking clip  32  may extend around the circumference of the first actuation coupling member  19  (e.g., the second end  68  of the locking clip  32  may extend around the outer surface of the first actuation coupling member  19 ). 
     It can further be appreciated from  FIG. 5  that the actuation shaft locking clip  32  may include a first inner surface  66   a  and a second inner surface  66   b . The first inner surface  66   a  may face the second inner surface  66   b . As will be shown in greater detail below, the first inner surface  66   a  may be designed to extend along the first face  56   a  of the first actuation coupling member  20  while the second inner surface  66   b  may be designed to extend along the second face  56   b  of the first actuation coupling member  20 . 
       FIG. 6  illustrates a partial exploded view of the securement collar  54  spaced away from the distal end regions of the translation members  22 . As shown in  FIG. 6 , the distal end region of each of the translation members  22  may include a notched portion  60 . 
     It can be appreciated from  FIG. 6 , that each of the notched portions  60  may be circumferentially offset from one another approximately 120 degrees. Additionally,  FIG. 6  illustrates that the securement collar  54  may include an inner surface  59 . Further, the inner surface  59  may include multiple flat surfaces  58 , each of which may be offset 120 degrees from one another. It can be further appreciated that when the securement collar  54  is coupled to the translation members  22 , each of the flat surfaces  58  may mate with each of the notched portion  60 , respectively, of the securement collar  54 . 
     It can be further appreciated that the securement collar  54  may include a gap  69  which prevents the securement collar  54  from extending continuously around its longitudinal axis  70  (it is noted that the securement collar  54  shares the same longitudinal axis  70  as the locking clip  32  described above). Therefore, the securement collar  54  may be designed to flex such that it may flex around and onto (e.g., it may snap onto) the translation members  22  (collectively) whereby each of the flat surfaces  58  engage each of the notched regions  60 , respectively. 
       FIG. 7  illustrates a cross-section of the connection assembly  15  shown in  FIG. 3  above. As described above,  FIG. 7  illustrates two translation members  22  (it can be appreciated that the third translation member  22  is hidden behind the two visible translation members  22  shown in  FIG. 7 ) inserted into the lumen  48  of the proximal end region  51  of the second actuation coupling member  20 . Further,  FIG. 7  illustrates the securement collar  54  positioned within the notched portions  60  of the translation members  22 . As discussed above, the securement collar  54  may be welded directly to the second actuation coupling member  20 . 
       FIG. 7  further illustrates the stem  44  of the second actuation coupling member  20  positioned within the lumen  52  of the first actuation coupling member  19 .  FIG. 7  further illustrates the first locking projection  40   a  extending through the first aperture  42   a  of the first actuation coupling member  19 . As described above,  FIG. 7  also illustrate the second locking projection  40   b  extending through the second aperture  42   b  of the first actuation coupling member  19 . As discussed above,  FIG. 7  further illustrates that the first aperture  40   a  may be rotated approximately 180 degrees from the second aperture  40   b  along the circumference of the outer surface of the first actuation coupling member  19 . In other words, the first aperture  40   a  may be directly aligned with and (positioned directly across from) the second aperture  40   b.    
     Additionally,  FIG. 7  shows the first locking projection  40   a  of the actuation shaft locking clip  32  extending through the first aperture  40   a  and resting within the channel  46  of the stem  44  of the second actuation coupling member  20 . Similarly,  FIG. 7  illustrates the second locking projection  40   b  of the actuation shaft locking clip  32  extending through the second aperture  40   b  and engaging the channel  46  of the stem  44  of the second actuation coupling member  20 . It can be appreciated that, in some instances, the first locking projection  40   a  and the second locking projection  40   b  may each resemble a finger which passes through the wall (via the first aperture  40   a  and the second aperture  40   b , respectively) of the first actuation coupling member  19  and nests within the channel  46  of the stem  44  of the second actuation coupling member  20 . 
     It can be further appreciated that when the first locking projection  40   a  and the second locking projection  40   b  are positioned within the channel  46 , the locking clip  32  is prevented from moving distally relative to the first actuation coupling member  19 . In other words, when positioned within the channel  46 , the first locking projection  40   a  and the second locking projection  40   b  may abut the wall defining the first aperture  40   a  and the second aperture  40   b , respectively, and are thereby prevented from moving in a distal direction (e.g., a direction toward the second actuation coupling member  20 ). 
     Further, the engagement of the first locking projection  40   a  and the second locking projection  40   b  within the channel  46  (via extending through the first aperture  40   a  and the second aperture  40   b , respectively) may prevent the second actuation coupling member  20  from being pulled away from the second actuation coupling member  20 . As described above, the first curved portion  64   a  and the second curved portion  64   b  of the locking clip  32  may provide a radially-inward force which biases the first locking tab  38   a  and second locking tab  38   b  (and hence, the first locking projection  40   a  and the second locking projection  40   b ) toward the channel  46 , thereby preventing the first locking tab  38   a  and second locking tab  38   b  (and hence, the first locking projection  40   a  and the second locking projection  40   b ) from flexing radially away from the channel  46 . In other words, the first curved portion  64   a  and the second curved portion of the locking clip  32  provide a force toward the longitudinal axis of the first actuation locking member  19  which is designed to maintain the first locking projection  40   a  and the second locking projection  40   b  within the channel  46  and thereby prevent the stem  44  from being pulled out of the lumen  52  of the first actuation coupling member  19 . 
     Additionally, it can be appreciated that when the first locking projection  40   a  and the second locking projection  40   b  are nested within the channel  46 , the second actuation coupling member  20  may be permitted to swivel (e.g., spin along its longitudinal axis) relative to both the first locking actuation member  19  and the actuation shaft locking clip  32 . Because the first locking projection  40   a  and the second locking projection  40   b  extend through the first aperture  40   a  and the second aperture  40   b , respectively, the first actuation coupling member  20  and the locking clip  32  may rotate together around the stem  44  of the second actuation coupling member  20 , while the first locking projection  40   a  and the second locking projection  40   b  remain engaged within the channel and slide within the channel  46 . 
     Some example materials that can be used for the various components of the medical device system  10  are described herein. However, this is not intended to limit the devices and methods described herein, as the other materials may be utilized for the medical device system  10  and components thereof. 
     Additionally, medical device system  10  and components thereof 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  85 A), 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  50 A), 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 system  10  and components thereof 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 shaft 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 system  10  and components thereof to achieve the same result. 
     In some embodiments, a degree of Magnetic Resonance Imaging (Mill) compatibility is imparted into the shaft. For example, the medical device system  10  and components thereof 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 MRI image. The medical device system  10  and components thereof may also be made from a material that the MM 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.