Abstract:
A vascular introducer sheath includes a sheath body having an interior lumen for accommodating a dilator. The vascular introducer further includes a guidewire positioning means operatively associated with the interior lumen of the sheath body for directing a guidewire in either a vascular direction or an arterial direction within a venous system.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims benefit of priority from U.S. Provisional Patent Application No. 61/342,367 filed Apr. 13, 2010, which is incorporated by reference herein in its entirety. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    1. Field of the Invention 
         [0003]    The subject invention is directed generally to a vascular introducer sheath, and more particularly, to a vascular introducer sheath that is adapted and configured to facilitate bi-directional access to the venous system. 
         [0004]    2. Background of the Related Art 
         [0005]    Vascular introducers are well know in the art and have been employed for inserting catheters, guidewires and the like into patients. A typical procedure provides for insertion of a dilator or needle within a sheath into the vasculature of a patient. After insertion, the dilator may be removed leaving the sheath protruding from the patient&#39;s vein. A diagnostic or therapeutic catheter (e.g. a central venous access catheter) or guide wire is then inserted through the sheath into the patient. The sheath is then typically longitudinally sheared and removed from the catheter or guidewire and the patient such as by applying opposing force to opposed wings or tabs of the introducer device. See for example U.S. Pat. No. 5,741,233 to Riddle et al. which is incorporated by reference in its entirety. 
         [0006]    In prior art vascular introducers, the sheath permits uni-directional introduction of a guidewire into the venous system. This prevents the sheath from going to the opposite side of the vessel to conduct any procedures. If the opposite side of the vessel needs to be accessed, it requires another separate entry in the artery vessel. It would be beneficial however to provide an introducer sheath that is adapted and configured to facilitate bi-directional introduction of a guidewire into the venous system, i.e., in either a vascular or an arterial direction. 
       SUMMARY OF THE INVENTION 
       [0007]    The subject invention is directed to a bi-directional vascular introducer sheath that includes a sheath body having an interior lumen for accommodating a dilator and a J-shaped guidewire positioning device. The guidewire positioning device is operatively associated with the interior lumen of the sheath body and is adapted and configured to direct a guidewire in either a vascular direction or an arterial direction within the venous system. 
         [0008]    In one embodiment of the subject invention, a distal portion of the sheath body has a J-shaped configuration and an aperture is formed in the distal portion of the sheath body at a joint of the J-shaped configuration to facilitate bi-directional positioning of a guidewire using the J-shaped guidewire positioning device. 
         [0009]    In another embodiment of the subject invention, a distal portion of the sheath body is longitudinally split and is adapted to move between a naturally spread open position and a longitudinally closed position. Preferably, a movable ring maintains the split distal portion of the sheath body in the closed position. Once the split sheath has spread to an open position, the J-shaped guidewire positioning device facilitates bi-directional positioning of a guidewire. Alternatively or in addition to using the movable ring to facilitate spreading of the split distal portion of the sheath body, it is envisioned that a distal portion of the sheath body may be made from a material which moves to a preset spread open condition upon exposure to body temperature. In this regard, it is envisioned that at least a distal portion of the sheath body may be made from a shape memory alloy. 
         [0010]    These and other aspects of the vascular introducer sheath of the subject invention will become more readily apparent from the following description taken in conjunction with the drawings. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0011]    So that those having ordinary skill in the art to which the subject invention pertains will more readily understand how to make and use the female connector of the subject invention, preferred embodiments thereof will be described in detail hereinbelow with reference to the drawings, wherein: 
           [0012]      FIG. 1  is an illustration of a vascular introducer configured in accordance with a preferred embodiment of the subject invention which includes a J-shaped bi-directional introducer sheath having a side port, and adapted to accommodate a guidewire positioning device which is oriented in a first direction; 
           [0013]      FIG. 2  shows the guidewire positioning device of  FIG. 1  oriented in a second direction relative to the introducer sheath; 
           [0014]      FIG. 3  is an illustration of another embodiment of the bi-directional vascular introducer sheath of the subject invention, wherein the distal section of the sheath is split and is initially held together by a movable support ring during vascular introduction; 
           [0015]      FIG. 4  shows the proximal movement of the support ring shown in  FIG. 3  during vascular introduction; 
           [0016]      FIG. 5  shows the split sheath of  FIG. 3  prior to spreading into an open position in the blood vessel; 
           [0017]      FIG. 6 . illustrates the split vascular sheath of  FIG. 3  spreading into an open position within a blood vessel; 
           [0018]      FIG. 7  illustrates the split vascular sheath of  FIG. 6  with the guidewire positioning device oriented in a first direction; 
           [0019]      FIG. 8  illustrates the split vascular sheath of  FIG. 6  with the guidewire positioning device oriented in a second direction; and 
           [0020]      FIGS. 9 and 10  illustrate yet another embodiment of the bi-directional introducer sheath of the subject invention, wherein the sheath is dimensioned and configured to accommodate the guidewire positioning device in first and second opposite directions. 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0021]    Referring now to the drawings wherein like reference numeral identify similar structural features of the vascular introducer sheath of the subject invention, there is illustrated in  FIG. 1  a vascular introducer  10  configured in accordance with a preferred embodiment of the subject invention. Introducer sheath  10  includes a generally J-shaped bi-directional sheath  12  having a side port  14  located at the joint of the J-shaped sheath. Sheath  12  is adapted and configured to accommodate a rigid J-shaped tubular guidewire positioning device  16 . In a first orientation, the guidewire positioning device  16  directs a guidewire  18  out the distal end of the sheath in a first direction into a blood vessel  20 . As shown in  FIG. 2 , when the guidewire positioning device  16  is rotated or otherwise oriented in a second position, the guidewire  18  is directed out the side port  14  in a second opposite direction within blood vessel  20 . Introducer sheath  12  also includes a balloon anchor  22  associated with the inner vessel wall and an annular disk anchor  24  associated with an outer vessel wall or the skin for sealing and anchoring. 
         [0022]    Referring now to  FIG. 3 , there is illustrated another embodiment of a bi-directional vascular introducer sheath of the subject invention, which is designated generally by reference numeral  100 . Sheath  100  has a distal section  112  that is longitudinally split along diametrically opposed cut-lines and is initially held together by a movable support ring  114  during vascular introduction. As shown in  FIGS. 4 through 6 , the split distal section  112  of sheath  100  is spread into an open position as the support ring  114  is moved proximally during introduction of the sheath into a blood vessel  20 . Once spread into an open position, the split distal section  112  of sheath  100  anchors the sheath against the inner wall of the blood vessel, preferably in conjunction with the support ring  114  positioned with respect to the outer wall of the blood vessel. It is also contemplated that, when the split distal section  112  of sheath  100  is spread into an open position, the split distal section  112  may be opened flush with the wall of the artery. In use, as shown in  FIGS. 7 and 8 , a J-shaped guidewire positioning device  116  may be oriented within the interior lumen of split sheath  112  in first and second opposite directions to direct a guidewire  118  into the venous system in first and second opposite directions. 
         [0023]    Alternatively or in addition to using the movable support ring  114  to facilitate spreading of the split distal section  112  of the sheath  100  into an anchoring position within blood vessel  20 , it is envisioned that the distal section  112  of sheath  100  may be made from a material which moves to the preset spread open condition upon exposure to body temperature. In this regard, it is envisioned that at least the distal portion  112  of the sheath  100  may be made from a shape memory alloy. 
         [0024]    Referring now to  FIGS. 9-10 , there is illustrated yet another embodiment of the bi-directional introducer sheath of the subject invention, which is designated generally by reference numeral  200 . Sheath  200  includes an elongated distal portion  212  having an interior lumen that is dimensioned and configured to accommodate a J-shaped guidewire positioning device  216 , which is shown oriented in first and second directions to facilitate introduction of a guidewire  118  in opposite directions within a blood vessel  20 . 
         [0025]    While the subject invention of the present disclosure has been described with respect to preferred and exemplary embodiments, those skilled in the art will readily appreciate that various changes and/or modifications can be made to the invention without departing from the spirit or scope of the invention as described herein.