Abstract:
A medical device packaging comprising a connector coupled to a longitudinal element having a lumen sized and shaped to receive an shaft of a medical device extending distally from a hub of the elongate member. The connector including a first branch having a lumen open to the lumen in the elongate member and a second branch having lumen open to the lumen in the first branch. A proximal end of the first branch being configured to mate with a distal end of a housing of the medical device to be received in the packaging. The hub of the medical device including laterally extending wings having opposing contours. The medical device including a strain relief member coupled at a distal end of the hub of the medical device.

Description:
FIELD 
       [0001]    The embodiments presented herein relate generally to medical devices with elongate shafts, and more particularly, to packaging that facilitates flushing of the elongate shaft. 
       BACKGROUND 
       [0002]    A catheter is a medical device that may be inserted into a body structure to deliver fluids from an external source to an internal body structure. A catheter generally comprises a flexible shaft extending longitudinally from a proximal end to a distal end and often includes a hub at the proximal end for the connection of other devices or fluid conduits. Catheters, such as microcatheters, designed to thread deep into smaller body structures (e.g., the vascular system, the biliary tree, etc.) are often especially long to enable them to pass through other devices and a succession of vessels to reach target smaller vessels. Such smaller catheters are often more delicate and must be carefully packaged to prevent damage thereto. 
         [0003]    Catheter packaging may includes a long tubular structure designed to house a length of the catheter shaft therein. The tubular structure may take a variety of different shapes such as for example, straight, curved or hooped. Portions of the tubular structure may be fixed to one another such that the tubular element is retained in a particular shape, which may be determined, for example, by the length of the catheter. Some catheters may require hydration and/or activation of a coating prior to use which necessitates flushing the catheter with fluid. For example, the catheter may be treated with a hydrophillic coating which provides lubrication to facilitate insertion when activated by water, saline or body fluid. However, current catheter packaging often does not facilitate effective flushing of fluid along an entire packaged length of the catheter. 
       SUMMARY 
       [0004]    The embodiments described herein are directed to packaging for a medical device such as a catheter that facilitates flushing of the packaged length of the catheter. The packaging comprises a longitudinal element defining a first lumen sized and shaped to receive therein a shaft of an elongate medical device such as a catheter with a desired clearance around an outer diameter of the shaft of the medical device. The length of the longitudinal element can be selected to receive a preferred packaged length of the shaft of the elongate medical device extending distally from a hub at a proximal end thereof. The packaging further comprises a connector attached to the proximal end of the longitudinal element. The connector, which may be a Y- or T-shaped connector, a manifold, or the like, includes a first branch defining therein a second lumen open to a proximal end of the first lumen and extending substantially along a longitudinal axis of the longitudinal element and a second branch defining therein a third lumen open to the second lumen and extending away from the longitudinal axis at a predetermined angle. A proximal end of the first branch including a structure configured to mate with a corresponding feature on a distal end of a housing or hub of the medical device to be received in the packaging to form a substantially fluid tight connection therebetween such that fluid introduced into the third lumen is prevented from exiting the proximal end of the second lumen and is forced move distally through the first lumen to the distal end of the longitudinal element without exiting from the distal end. 
         [0005]    In one embodiment, the hub may act as a handle for maneuvering the elongate shaft of the medical device. The hub includes laterally extending wings with opposing contours. The contours of the wings allow operator fingers to interface with the wings to facilitate handling and rotation in the clockwise or counterclockwise directions. 
         [0006]    In another embodiment, the medical device includes a strain relief member coupled to the elongate shaft and the hub. The strain relief member comprises a helical coil or spring that is covered by a polymeric tube. The tube is formed over the coil in a way that fills in the spaces between the coils resulting in the formation of multiple hinge points. 
         [0007]    Other systems, methods, features and advantages will be or will become apparent to one with skill in the art upon examination of the following figures and detailed description. It is intended that all such additional systems, methods, features and advantages be included within this description, be within the scope of the devices, systems and methods described herein, and be protected by the accompanying claims. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0008]    The figures provided herein are not necessarily drawn to scale, with some components and features being exaggerated for clarity. Each of the figures diagrammatically illustrates aspects of the embodiments. 
           [0009]      FIG. 1  shows a side view of a system according to an exemplary embodiment. 
           [0010]      FIG. 2  shows a side view of a Y-connector according to the system of  FIG. 1 . 
           [0011]      FIG. 3  shows a top view of a hub according to the system of  FIG. 1 . 
           [0012]      FIGS. 4   a  and  4   b  show opposing side views of the hub of  FIG. 3 . 
           [0013]      FIG. 5  shows a side view of a retaining clip coupled to the Y-connector and the hub of the system of  FIG. 1 . 
           [0014]      FIG. 6  shows a side view of an exemplary embodiment of a medical device. 
           [0015]      FIGS. 7   a  show partial detail views of the medical device in  FIG. 6  taken along line  7 . 
       
    
    
       [0016]    It should be noted that elements of similar structures or functions are generally represented by like reference numerals for illustrative purpose throughout the figures. It should also be noted that the figures are only intended to facilitate the description of the preferred embodiments. 
       DETAILED DESCRIPTION 
       [0017]    The embodiments provided herein may be further understood with reference to the following description and the appended drawings, wherein like elements are referred to with the same reference numerals. The embodiments provided herein relate to medical device packaging. In particular, exemplary embodiments described herein include a catheter and a packaging interface which allows fluid to be flushed along an enclosed length of the catheter within the packaging. Specifically, exemplary embodiments described herein include a connector attached to a packaging that is coupleable with a hub of a catheter and creates a fluid path through the packaging that is biased by flow dynamics. 
         [0018]    As shown in  FIG. 1 , a system  100  according to a first exemplary embodiment comprises a packaging  102  and a catheter  104 . The packaging  102  includes an elongate longitudinal element  106  and a connector  108 , which, as depicted, is configured as a Y-connector. The connector  108  can also be a T-connector, a manifold, and the like. The longitudinal element  106  extends from a proximal end  110  to a distal end  112  and includes a lumen  114  extending there through for accommodating a length of the catheter  104 . The Y-connector  108  is attached to the proximal end  110  of the longitudinal element  106 . The catheter  104  includes a longitudinally extending flexible shaft  116  and a hub  118  attached adjacent to a proximal end  120  of the flexible shaft  116 . The flexible shaft  116  can have various cross-sectional geometries including round, oval and the like. It will be understood by those of skill in the art that the catheter  104  may be any standard catheter used to deliver fluid to and/or remove fluid from an internal body structure via a lumen  122  of the flexible shaft  116 . The Y-connector  108  and the hub  118  are detachably coupleable, creating a fluid-tight, or at least near or substantially fluid tight connection that may be decoupled once the longitudinal element  106  and the flexible shaft  116  have been properly flushed. The connection between the Y-connector  108  and the hub  118  can be made near or substantially fluid tight in instances in which the lubricity of the flush fluid is used to aid in decoupling the hub  118  from the Y-connector  108 . 
         [0019]    The longitudinal element  106  of the packaging  102  is also preferably flexible permitting the longitudinal element  106  to be maintained in any of a variety of shapes and/or configurations. For example, in the embodiment shown, the longitudinal element  106  is maintained in a hoop configuration with a length of the longitudinal element  106  coiled upon itself permitting a greater length of the longitudinal element  106  to be accommodated in a reduced space facilitating storage and/or transport. It will also be understood by those of skill in the art that the longitudinal element  106  may be maintained in any configuration, so long as the longitudinal element  106  accommodates a predetermined packaged length of the flexible shaft  116 . In instances where the flexible shaft  116  does not include a curved distal end, the packaged length may include the entire length of the flexible shaft  116 . In instances where the flexible shaft  116  includes a curved distal end, the packaged length may include a predetermined length that is less than the entire length of the flexible shaft  116 . 
         [0020]    The Y-connector  108 , which is attached to the proximal end  110  of the longitudinal element  106 , includes, as shown in  FIG. 2 , a first portion  132  forming a first stem thereof and a second portion  134  forming a second stem to form the Y-shape. The first portion  132  extends from a proximal end  136  to a distal end  138  and includes a lumen  140  extending there through. The lumen  140  may be substantially aligned with the lumen  114  of the longitudinal element  106 , facilitating insertion of the flexible shaft  116  of the catheter  104  into and there through. The second portion  134  extends from the first portion  132  at an acute angle of about 15° to 90° relative to a longitudinal axis of the first portion  132 , between the proximal and distal ends  134 ,  138 . The second portion  134  includes a port  135  separated from the first portion  132  and located proximally of the point of intersection between the first and second portions  132 ,  134 , respectively. The second portion  134  includes a lumen  142  along a length thereof extending from a proximal end at the port  135  to a distal end open to the lumen  140  of the first portion  132 . Thus, it will be understood by those of skill in the art that the second portion  134  may act as a port for injecting fluid into the Y-connector  108  and through the longitudinal element  106 . 
         [0021]    It will be understood by those of skill in the art that the flexible shaft  116  may be of a variety of lengths and diameters so long as the flexible shaft  116  is insertable into the body. The length and the diameter or cross-sectional dimensions of the flexible shaft  116  may be selected depending on a purpose of the catheter  104  and a target location to which the flexible shaft  116  will be inserted. For example, where catheter  104  is a microcatheter, the flexible shaft  116  may be very long and of a small diameter in order to intravascularly access the target location. It will also be understood by those of skill in the art that the lumen  122  of the flexible shaft  116  may be sized to track over a guidewire for insertion into the body of a patient. 
         [0022]    As shown in  FIGS. 3-4 , the hub  118  may act as a handle for maneuvering the flexible shaft  116  of the catheter  104  and/or as a proximal port for facilitating communication between the lumen  122  of the flexible shaft  116  and other medical devices used to withdraw and/or inject fluid into and/or out of the body via the catheter  104 . Thus, it will be understood by those of skill in the art that the hub  118  may include a body  148  to facilitate maneuvering the flexible shaft  116  and a channel  124  for accommodating the proximal end  120  of the flexible shaft  116  such that any medical device attached to a connector  126  extending from a proximal end  128  of the body  148  of the hub  108  directs fluid through the lumen  122  of the shaft  116  between the attached medical device and a target location in the body. 
         [0023]    In an exemplary embodiment, a configuration of the body  148  of the catheter hub  118  facilitates handling, tracking and manipulation of the device during clinical procedure. The body  148  preferably includes contoured wings  147  and  149  extending outwardly from the channel  124 . As depicted in  FIGS. 4   a  and  4   b , the wings  147  and  149  are constructed with an opposing contour from the other. The contours of the wings  147  and  149  allow the operators fingers to fit into the wings  147  and  149  to facilitate handling and rotation in the clockwise, or counterclockwise directions. 
         [0024]    The hub  118  further includes a mating element  130  at a distal end  150  of the body  148 , coupleable with the Y-connector  108  to form an at least partially fluid tight connection. The distal mating element  130  may include, for example, a protrusion insertable into the proximal end  136  of the Y-connector  108 . Thus, it will be understood by those of skill in the art that the diameter of the distal mating element  130  may be substantially similar to or only slightly smaller than a diameter of the lumen  140  at the distal end  136  of the Y-connector  108  so that when the hub  118  and the Y-connector  108  are coupled, the coupling produces a tight fit. It will also be understood by those of skill in the art that the distal mating element  130  may further include a feature facilitating removable coupling of the distal mating element  130  with the proximal end  136  of the Y-connector  108 . For example, the distal mating element  130  may further include a protrusion  144  extending around at least a portion of a perimeter of the distal element  130  which snaps into a correspondingly shaped recess or groove  146  in the lumen  140  of the Y-connector  108 . The distal element  130  may be removed from the Y-connector  108  by exerting a pulling force on either the hub  118  and/or the Y-connector  108 . It will be understood by those of skill in the art, however, that the hub  118  and the Y-connector  108  may include any mating mechanism so long as the hub  118  and the Y-connector  108  are detachably coupleable in an at least partially or near fluid tight connection. 
         [0025]    This connection forms an obstruction or “choke” preventing fluid from leaking out of the Y-connector  108  proximally toward the proximal end  120  of the shaft  116 , urging fluid inserted into the port  135  through the Y-connector  108  distally along a length of the longitudinal element  106 . Thus, once the hub  118  and the Y-connector  108  have been coupled, a user may inject fluid (e.g., water or saline) into the Y-connector via the port  135  of the second portion  134  passing the fluid through the lumen  142  into the lumen  140  and distally into the lumen  114  along the length of the longitudinal element  106  flushing the full length of the enclosed flexible shaft  116 . 
         [0026]    According to a further embodiment, as shown in  FIG. 5 , the system  100  further comprises a retention clip  152  ensuring that the hub  118  and the Y-connector  108  do not come apart during the flushing process. The retention clip  152  extends substantially longitudinally from a proximal end  154  including a first element  158  for attaching to the hub  118  and a distal end  156  including a second element  160  for attaching to the Y-connector  108 . The first element  158  is sized and shaped to accommodate the connector  126  extending from the proximal end  128  of the hub  118  such that, in an operative position, the first element  158  abuts the proximal end  128  of the body  148 . The second element  160  is sized and shaped to accommodate a portion  164  of the Y-connector  108  along the first portion  132 , distally of the second portion  134 . 
         [0027]    An o-ring  162  or other compressible protrusion may be positioned distally about the periphery of the second portion  134  along the first portion  132  such that the second element  160  abuts the O-ring  162 . Additionally, the o-ring  162  ensures compression of the hub  118  and the Y-connector  108  while allowing for tolerance ranges between the hub  118 , the Y-connector  108  and the retention clip  152 . A length of the retention clip  152  is preferably selected to be substantially similar to a distance from the proximal end  128  of the body  148  of the hub  118  to a point distal of the second portion  134  of the Y-connector  108  when the hub  118  and the Y-connector are in the coupled configuration. Thus, it will be understood by those of skill in the art that the o-ring  162  may be positioned according to the length of the retention clip  152  to achieve a desired compression between the hub  118  and the Y-connector  108 . The compression between the hub  118  and the Y-connector  108 , formed by the retention clip  152  prevents the coupling between the hub  118  and the Y-connector  108  from becoming unintentionally detached during the flushing process. 
         [0028]    Turning to  FIGS. 6 and 7 , a further embodiment of a medical device includes a strain relief member  210  for a catheter device  200 . As with the catheter described above, the catheter device  200  includes an elongate shaft  202  extending from a hub  204 . The hub  204  includes a connector  209  extending from its proximal end  208  and a distal element  207  extending from its distal end  206 . As depicted in  FIG. 7   a , the strain relief member  210  includes a helical coil or spring  220  that is covered by a jacket or cover  216 . The jacket  216  is preferably formed from a polymeric material over the coil  220  in a way that fills in the spaces between the coils resulting in the formation of multiple hinge points  218 . This can be accomplished by shrinking the polymeric tube  216  over the coil  220  or alternatively by injection molding the jacket  216  over the coil  220 . 
         [0029]    Once the jacket  216  is formed over the coil  220 , the strain relief member or sub-assembly  210  is placed over the proximal end of the catheter shaft  202 . A proximal end  212  of the strain relief sub-assembly  210  is coupled to the catheter shaft  202  and the distal element  207  of the hub  204  and the distal end  214  of the strain relief sub-assembly  210  is coupled to the catheter shaft  202 . Coupling of the proximal end  212  of the strain relief sub-assembly  210  to the catheter shaft  202  and distal element  207  of the hub  204  is preferably done either through insert molding or adhesive bonding. Transfer of the rotational force from the hub  204  to the shaft  202  is enabled by attaching both ends  212  and  214  of the strain relief sub-assembly  210 , and the transfer of rotation is further enhanced by the presence of the coil  220  in the jacket  216 . 
         [0030]    The primary function of relieving stress at the point of attachment of the shaft  202  to the hub  204  is maintained by the configuration of the strain relief sub-assembly  210 . Stress relief is enhanced by the formation of the “hinge points”  212  between the coils of the coil  220 . 
         [0031]    In alternative embodiments shown in  FIGS. 7   b  and  7   c , the single coil  220  is replaced by two counter wound springs  222  and  224  ( FIG. 7   b ) or a braid  226  ( FIG. 7   c ). 
         [0032]    Alternatively, the entire length of the strain relief sub-assembly  210  could be attached to the outside of the catheter shaft  202  by thermally melting the materials together or via adhesive bonding. 
         [0033]    It will be apparent to those skilled in the art that various modifications and variations can be made in the structure and the methodology of the present invention, without departing from the spirit or scope of the invention. Thus, it is intended that the present invention cover the modifications and variations of this invention provided they come within the scope of the appended claims and their equivalents.