Abstract:
A package system and method are provided for storing and shipping of elongated endoluminal devices. In one aspect, the system includes a packaging tray having a first area to maintain the position of a first portion of the elongated endoluminal device and a second portion retaining an opposing portion of the elongate device. The second portion configured to hold the coupling element of the assembly and being radially spaced outward from the first portion.

Description:
FIELD OF THE INVENTION 
       [0001]    The present application claims priority to and the benefit of U.S. Provisional Patent Application No. 61/592,459, filed Jan. 30, 2012, which is hereby incorporated by reference in its entirety. 
         [0002]    The present invention is directed to a holder for retaining an elongated endoluminal device such as a guide wire or catheter. More specifically, the invention is directed to a support tray for retaining an elongated endoluminal device within a package, the support tray is useful for securing the device during shipping, storage, and prior to use on a patient. 
       BACKGROUND OF THE INVENTION 
       [0003]    Elongated endoluminal devices, such as guide wires and catheters are tubular medical devices for insertion into canals, vessels, passageways, or body cavities; often to permit the injection or withdrawal of fluid, to keep a passage open, to take internal measurements, image the vessel from the interior, deliver energy to treat the vessel, among many possible uses. While catheters and guide wires vary in size, shape, and function, they frequently consist of a very long, flexible, and thin tubular portion connected to a more rigid proximal portion. The tubular portion may be a meter or longer in length, and only a fraction of an inch in diameter. The head may be, for example, an inch or two in length and a fraction of an inch in diameter. 
         [0004]    The tubular portion of the catheter is usually hollow, and may have one or more lumens running along its entire length. The lumen or lumens function as a way of inserting various devices into the catheter. For example, catheters frequently travel along a guide wire running through one of the lumens. Alternatively, the lumens may receive mechanical devices, control wires, electrical connectors or wires, optical fibers or other devices for assisting in diagnostic, therapeutic or surgical operations. 
         [0005]    Due to the extremely fine and often delicate nature of the lumens and electrical connections, as well as the tight tolerances associated with many of the applications to which devices are applied, devices must necessarily be handled, stored, and shipped with great care. Mechanical or chemical abrasion to any portion of the exterior of the device can cause problems to the subsequent use of the device. Also, deformation of the device can be a problem if it results in leaving the device damaged or transformed in any way. Thus, significant bending of the device should normally be avoided during the storage of a device to avoid any “memory” of the bend, pinched lumens, or broken electrical connections. Such binding should also be avoided while installing or removing a device from a storage or shipping package. 
         [0006]    Referring now to  FIG. 1 , there is shown an existing packaging system  100 . Protective sheath tubing  102  is wound in a spiral fashion around center  108 . A luer lock  104  is positioned on the outermost termination and can be used for flushing the tubing  102 . The spiral tubing has an outer radius  110  of approximately 4.5 inches, with an outer diameter of approximately 9 inches, and spirals inward to an inner radius  112  of approximately 3.6 inches at inner most termination  106 . A pressure sensing guide wire  114  is disposed within the tubing  102  and exits at termination  106 . The pressure wire  114  continues inward sharply to the entry of coupler  120  disposed at a radius  116  of approximately 3.2 inches. Given the short distance between the termination  106  of tube  102  and the connector  120 , the wire experiences a sharp bending radius of approximately 1.75 inches adjacent curve  124  which is adjacent electrical connectors disposed within the connector  120 . 
         [0007]    Unfortunately, for some types of devices, such as sensitive pressure wires, positioning during packaging and handling during shipping cause damage to the guide wire and/or the associated electrical connections. As a result, the pressure wires are inoperable or inaccurate when an attempt is made to introduce them into the patient on the operating or catheter lab table. 
         [0008]    Thus, there remains a need for packaging systems and techniques that can limit damage to delicate elongated endovascular devices. The devices, systems, and methods disclosed herein overcome one or more of the deficiencies of the prior art. 
       SUMMARY 
       [0009]    In one aspect, the present disclosure provides an elongated endoluminal device package system for receiving an elongated endovascular device having at least one component located adjacent a distal end and at least one connector located adjacent a proximal end. The system provides a first retention area for maintaining the elongated endoluminal device in a first spiral radius configuration, a second retention area for maintaining coupling components of the system that are connected to the elongated device, and a transition area where the wire transitions from the spiral configuration to the coupling components while maintaining a radius of curvature of the elongate device equal to or greater than the radius of curvature of the elongated device in the spiral configuration. In one aspect, the elongated device is a sensing guide wire. In a further aspect, the elongated device is a pressure sensing guide wire. 
         [0010]    The present disclosure further includes a method of packing an elongated endoluminal device in a package system to maintain it in a position as set forth above. In one aspect, the endoluminal device is a an endovascular pressure sensing guide wire. 
         [0011]    Still further, the present disclosure provides a kit having a guide wire maintained in a protected condition. In one aspect, the protected condition of the kit includes limiting the radius of curvature of the elongated member to be not less than the radius of the inner most coil of the protective sheath surrounding the elongate member. 
         [0012]    It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory in nature and are intended to provide an understanding of the present disclosure without limiting the scope of the present disclosure. In that regard, additional aspects, features, and advantages of the present disclosure will be apparent to one skilled in the art from the following detailed description. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0013]    The accompanying drawings illustrate embodiments of the devices and methods disclosed herein and together with the description, serve to explain the principles of the present disclosure. Throughout this description, like elements, in whatever embodiment described, refer to common elements wherever referred to and referenced by the same reference number. The characteristics, attributes, functions, interrelations ascribed to a particular element in one location apply to those elements when referred to by the same reference number in another location unless specifically stated otherwise. 
           [0014]    The figures referenced below are drawn for ease of explanation of the basic teachings of the present disclosure only; the extensions of the figures with respect to number, position, relationship and dimensions of the parts to form the preferred embodiment will be explained or will be within the skill of the art after the following description has been read and understood. Further, the exact dimensions and dimensional proportions to conform to specific force, weight, strength and similar requirements will likewise be within the skill of the art after the following description has been read and understood. 
           [0015]    The following is a brief description of each figure used to describe the present invention, and thus, is being presented for illustrative purposes only and should not be limitative of the scope of the present invention. 
           [0016]      FIG. 1  is a top view of a prior packaging system. 
           [0017]      FIG. 2  is a perspective view of a support tray according to one embodiment of the present disclosure. 
           [0018]      FIG. 3  is an alternative perspective view of the support tray of  FIG. 2 . 
           [0019]      FIG. 4  is a top view of the support tray of  FIG. 2 . 
           [0020]      FIG. 5  is a bottom view of the support tray of  FIG. 4 . 
           [0021]      FIG. 6  is a side view of the support tray of  FIG. 4   
           [0022]      FIG. 7  is a top view of a package system kit according to one embodiment of the present disclosure. 
       
    
    
     DETAILED DESCRIPTION 
       [0023]    For the purposes of promoting an understanding of the principles of the present disclosure, reference will now be made to the embodiments illustrated in the drawings, and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the disclosure is intended. Any alterations and further modifications to the described devices, instruments, methods, and any further application of the principles of the present disclosure are fully contemplated as would normally occur to one skilled in the art to which the disclosure relates. In particular, it is fully contemplated that the features, components, and/or steps described with respect to one embodiment may be combined with the features, components, and/or steps described with respect to other embodiments of the present disclosure. For simplicity, in some instances the same reference numbers are used throughout the drawings to refer to the same or like parts. 
         [0024]    Referring now to  FIGS. 2-6 , there is illustrated a package support tray  200 . The support tray is formed of a rigid body having a series of spiraling channels  202 ,  204 ,  206  and  208  extending outwardly in increasing radii from center point  288 . The innermost spiral channel  202  has an inner radius  290  of approximately 3.91 inches. The channel radius expands to outer channel  208  having an outer radius  292  of approximately 4.56 inches. A protective tube terminus mounting  210  is provided within terminal channel  212 . Terminus mount  210  includes at least two flanges  211  and  213  that removably retain a protective tube  702 , such as shown in  FIG. 7 , within the channel  210 . Torque device cavity  214  extends from channel  212  and leads into connector cavity  216 . The end of channel  212  is positioned approximately 5 inches from center  288  along radius  294 . 
         [0025]    As shown in  FIG. 7 , the torque device cavity  214  receives the torque device  760  and the connector cavity  216  is sized to receive the connector  780 . Referring now to  FIG. 4 , the connector cavity includes an enlarged annular ring  219  and a series of flexible flanges  217   a,    217   b  and  217   c  configured releasably secure the connector in the connector cavity  216 . Together with the side walls forming the cavity  216 , the annular ring  219  and flanges  217  form an interference connection to prevent the connector  780  from moving with respect to the support tray  200  until released by the user. In contrast, the torque device cavity  214  loosely holds the torque device such that when connector  780  is removed from cavity  216 , the torque device may freely leave cavity  214 . In this manner, the packaging system support tray  200  avoids unnecessary stress or bending of the guide wire as the user frees the torque device from the tray. 
         [0026]    Lid  220  is joined to the main body  201  by a flexible flange  222  and has an outer annular side wall  221 . Lid  220  is sized to cover compartment  226  defined by circumferentially extending lower side walls  228  and upper side wall  229 . The outer side wall  221  of the lid engages the inner side wall  229  of the recess to form an interference fit that retains the lid in the closed position. Lid  220  includes a tab  224  that can be grasped by a user to overcome the force of the interference fit to thereby open the lid. The lid also includes an indicator “2” as shown by reference number  260  in  FIGS. 4 and 7 . 
         [0027]    Referring now to  FIG. 7 , there is shown a pre-packaged kit including the support tray  200 , protective tubing  702 , guide wire  750 , torque device  760 , wire connector  780 , and signal cable  788 . In comparison to the packaging of  FIG. 1 , the support tray  200  is about one half the size, thus requiring less material to manufacture the support tray. The steps for packaging include positioning the guide wire  750  within the protective tubing  702  with the distal most end of the guide wire positioned proximate distal tube end  704 . As shown in  FIG. 7 , tubing  702  includes two tubing sections spaced from one another by gap  706 . The tubing  702  is then spiral coiled into the configuration shown in  FIG. 7  with clips  703  maintaining the spacing between adjacent coils. The coil assembly is then positioned in the support tray  702  with the tubing  702  extending in as many channels  202 - 208  as necessary. During mounting onto the support tray, the gap  706  in the tubing is positioned over reservoir  250  and lower clip  703  is positioned in recess  217 . The illustrated wire is approximately 185 cm in length and uses two channels, while a 300 cm long wire would use all four channels. The guide wire is in the range of 0.018 to 0.010 inches in diameter with the illustrated wire having a diameter of typical 0.0145 inches. The proximal end of the pressure sensing wire  750  is positioned through the torque device  760  and into an electrical connector device  780 . In the illustrated embodiment, the coupling device has a lock mechanism that is moved to the locked position to firmly hold the wire  750  within the connector during shipping. The connector  780  includes a signal cable  788  for connection to a system interface module that is positioned in cavity  226  with lid  220  closed for shipping. 
         [0028]    With the pressure wire  750  positioned in the components, the tubing  720  is pushed into channels  202 - 208  past the series of flexible flanges  203   a,    203   b  and  203   c  that extend along the channels to releasably hold the tubing in the channels. As best seen in  FIG. 4 , the tray includes a series of flexible flanges similar to flanges  203  alternating between two and three flanges as the channels extend from one side of the tray to the opposite side of the tray. The terminal end is positioned in terminus mount  210  which includes at least flanges  211  and  213  that removably retain tube  702 . Similarly, torque device  760  is positioned in cavity  214  and connector  780  is pushed past flanges  217   a,    217   b  and  217   c  to be releasably retained in cavity  216  with the enlarged locking mechanism ring positioned in annular groove  219 . The excess cord of the signal cable  788  is positioned in cavity  226  and lid  220  is closed to retain the cable in position during shipping. 
         [0029]    The support tray  200  permits the device to be spirally wound and supported with the exposed proximal portion of the wire extending to the coupler undergoing a radius of curvature that is greater than the more centrally or interior windings of the wire. Thus, the wire is maintained in a lower bending stress position during shipping, particularly those components near the sensitive elements of the proximal end of the pressure wire. 
         [0030]    As shown in  FIG. 7 , the tray has a position for the wire and connected coupler that is disposed radially outward from the central point  288  a distance that is greater than the radial distance of the inner most or outer most winding of the spirally wound protective tubing. Thus, the system of  FIG. 7  provides a protective package and guide wire kit that is ready for use when unpacked adjacent a patient. 
         [0031]    When unpacking the kit of  FIG. 7 , the user is directed to follow the steps “1”, “2” and “3” engraved on the support tray  200 . Step “1” shown at reference number  240 , is to connect a syringe to the distal end  704  of tubing (which may be provided with a luer lock, not shown) to flush the distal portion of the tubing and sensing components at the distal end of the guide wire. The flushing fluid exits the tubing  702  at gap  706  and enters reservoir  252  which has a drain opening  250 . In this manner, the fluid can be captured and prevented from accidently getting onto other components. More specifically, the tray  200  has been designed to keep fluids used during the flushing procedure away from the connector  780  open end receiving the guide wire as the electrical connections between the guide wire and connector may be adversely effected by fluid. In another design feature, reservoir  218  is recessed below the lower most portion of connector cavity  216  to drain any fluid that may inadvertently enter cavity  216 . 
         [0032]    After completing step 1, the engraving step “2” at reference  260  directs the user to open lid  220 . The user can then withdraw signal cable  788  and connect the connector to a patient interface module to check the sensor and make any calibrations. After step “2” is completed, the user proceeds to step “3” at reference number  270 . The user must vertically remove the connector  780  and the direction of the arrow shown at step “3” directs the user how to remove connector  780  along with the torque device  760 . The user continues to move the connector  780  in the direction of the arrow to withdraw the pressure sensing guide wire from the protective tubing  702  until the entire wire is exposed. At this point the user may now use the guide wire. 
         [0033]    It will be understood that the support tray and package system can be utilized with a variety of sensing guide wires, catheters or other elongated medical devices. In addition, the package systems can also support therapeutic devices including angioplasty balloon devices, arthectomy devices and other elongated flexible devices. 
         [0034]    Persons of ordinary skill in the art will appreciate that the embodiments encompassed by the present disclosure are not limited to the particular exemplary embodiments described above. In that regard, although illustrative embodiments have been shown and described, a wide range of modification, change, and substitution is contemplated in the foregoing disclosure. It is understood that such variations may be made to the foregoing without departing from the scope of the present disclosure. Accordingly, it is appropriate that the appended claims be construed broadly and in a manner consistent with the present disclosure.