Abstract:
Disclosed is a tearaway sheath introducer. The sheath includes a sheath hub disposed on an end thereof, wherein the sheath is configured to receive a dilator therethrough, further wherein the dilator comprises a hub with a locking mechanism. The sheath hub is configured to retain a cap set having a molded valve therein. The cap set and the valve can be ultrasonically welded to the sheath hub such that the cap set and the valve are integral to the sheath hub. The valve prevents blood from coming out of a patient&#39;s incision site after the dilator is removed from the sheath, but before a catheter is inserted. In this way, the present invention improves the process of introducing catheters into the blood vessels.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims the benefit of U.S. Provisional Patent Application No. 62/340,231, filed May 23, 2016, which is hereby incorporated by reference in its entirety. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The present invention relates generally to medical devices, namely, catheters. More particularly, the present invention is directed to a tearaway sheath introducer having a valve that is molded onto a cap. 
       BACKGROUND OF THE INVENTION 
       [0003]    Tearaway sheath is generally used to introduce soft catheters (e.g., dialysis catheters) into the blood vessels. More specifically, an introducer sheath with a dilator device is passed over the guide wire to enlarge the venotomy or an incision site on a patient. Once the venotomy is enlarged, the dilator is removed, and then the catheter is inserted into the sheath. Thereafter, the sheath is removed by being split apart. The existing method, however, is disadvantageous in that a patient&#39;s blood could spurt from the vessel when the dilator is removed and before the catheter is inserted into the sheath. Additionally, air or other outside elements could be aspirated into the vessel, which is not desirable. In this regard, the invention described herein addresses these problems. 
       SUMMARY OF THE INVENTION 
       [0004]    The following discloses a simplified summary of the specification in order to provide a basic understanding of some aspects of the specification. This summary is not an extensive overview of the specification. It is intended to neither identify key or critical elements of the specification nor delineate the scope of the specification. Its sole purpose is to disclose some concepts of the specification in a simplified form as a prelude to the more detailed description that is disclosed later. 
         [0005]    In one embodiment, the present invention comprises a sheath with a sheath hub disposed on an end thereof, wherein the sheath is configured to receive a dilator therethrough, further wherein the dilator comprises a hub with a locking mechanism. The sheath hub comprises a cap set having a molded valve thereon. In some embodiments, the cap set and the valve are ultrasonically welded to the sheath hub. The sheath with the dilator is passed over a guide wire at an incision site of a patient. The valve is composed of a resilient material so that it is configured to allow the dilator to be pulled out therefrom while preventing blood from escaping after the dilator is removed, but before the catheter is inserted. In this way, the present invention improves the process of introducing catheters into the blood vessels by preventing blood from coming out and outside elements from being introduced into the sheath. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0006]      FIG. 1  depicts a tipped sheath that is molded with a hub to house a valve. 
           [0007]      FIG. 2  shows a view of two cap sections assembled together to form a complete cap set. 
           [0008]      FIG. 3  shows a view of a valve of the present invention. 
           [0009]      FIG. 4  shows a rear view of the valve after it is molded onto the cap set. 
           [0010]      FIG. 5  shows a front view of the valve after it is molded onto the cap set. 
           [0011]      FIG. 6  shows a view of a dilator with a hub. 
           [0012]      FIG. 7  shows a view of the complete assembly of the tearaway sheath introducer. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0013]    Referring now to  FIG. 1 , there is shown an exemplary embodiment of the tipped sheath  100  of the present invention. In a preferred embodiment, the sheath  100  is composed of high-density polyethylene (HDPE) or another suitable material. The sheath  100  comprises a substantially open tubular structure  101 , defining an interior volume, wherein the tubular structure  101  comprises a circular cross section having a uniform diameter over its length. The tubular structure  101  comprises a first end and a second end, wherein the second end comprises a hub  103  molded thereon. In some embodiments, the hub  103  comprises a base member that connect to the tubular structure  101 , wherein the base member comprises a substantially cylindrical shape. The tubular structure  101  is centrally located on the hub  103 , wherein the hub  103  comprises an opening  104  that aligns with the second end of the tubular structure  101  to provide access to the interior of the tubular structure  101 . 
         [0014]    The opening  104  provides access to a mold cavity  106  of the hub  103  for holding a cap set therein. The mold cavity  106  includes an outer diameter and an inner diameter, wherein the outer diameter is greater than the inner diameter. The mold cavity  106  is shaped and dimensioned to fit a cap set therein. The hub  103  comprises a pair of elongated tabs  107  thereon, wherein the pair of elongated tabs  107  comprises a first tab and a second tab. 
         [0015]    In the illustrated embodiment, the tabs  107  comprise rounded terminal ends. The tabs  107  extend outward in opposite directions so that they are substantially collinear to one another. The tabs  107  can be pulled apart such that the first tab and the second tab become separated. Accordingly, the hub  103  can comprise a seam where the first tab and the second tab meet and separate. In some embodiments, the tabs comprise ridges  102  thereon. The hub  103  further comprises a plurality of posts  105  that protrude around the opening  104  thereof, wherein the posts  105  are separated at regular intervals. 
         [0016]    Referring now to  FIG. 2 , there is shown an exemplary embodiment of the cap set  200  of the present invention. The cap set  200  comprises a first section  203  and a second section  206  that are assembled together, wherein the first section  203  and the second section  206  are substantial mirror images of each other. In this regard, the cap set  200  comprises a seam where the first section  203  and the second section  206  meet and separate. Each of the sections  203 ,  206  comprises a semicircle so as to form an open circular shape or an annular shape when assembled together and viewed from the top. The opening in the center of the cap set  200  form a valve housing for retaining the valve therein. 
         [0017]    In the illustrated embodiment, each of the sections  203 ,  206  comprises a semicylindrical section  204  having a flange  202  orthogonal thereto, wherein the flange  202  comprises a plurality of apertures  201  thereon. The outer perimeter of the flange  202  is greater than the outer perimeter of the semicylindrical section  204 , while the inner perimeter of the flange  202  is equal to the inner perimeter of the semicylindrical section  204 . The flange  202  is configured to fit within the outer diameter of the mold cavity  106  ( FIG. 1 ) of the sheath hub  103  ( FIG. 1 ) and the semicylindrical section  204  is configured to fit within the inner perimeter of the mold cavity  106  ( FIG. 1 ) of the sheath hub  103  ( FIG. 1 ). 
         [0018]    It is noted that the two sections  203 ,  206  of the cap set  200  are not bonded or adhered together. Instead, the cap sections  203 ,  206  are held together when the semicylindrical section  204  of the cap sections  203 ,  206  are set into the mold cavity  106  ( FIG. 1 ) at the opening  104  ( FIG. 1 ) of the sheath hub  103  ( FIG. 1 ) and the apertures  201  receive the posts  105  ( FIG. 1 ) therethrough. In this regard, the apertures  201  are positioned so that each one aligns with one of the posts  105  ( FIG. 1 ) disposed on the sheath hub  103  ( FIG. 1 ) near the opening  104  ( FIG. 1 ) thereof and receive the posts  105  ( FIG. 1 ) at least partially therethrough, thereby securing the cap set  200  to the sheath hub  103  ( FIG. 1 ) and preventing the cap set  200  from moving within the sheath hub  103  ( FIG. 1 ). 
         [0019]    Additionally, the semicylindrical section  204  of each of the sections  203 ,  206  can comprise one or more openings  205  or cutouts thereon for aligning within or fitting into the mold cavity  106  ( FIG. 1 ) of the sheath hub  103  ( FIG. 1 ). Similarly, the flange  202  can comprise one or more openings and/or cutouts that can align with other components of the present tearaway sheath introducer and/or a dilator. 
         [0020]    Referring now to  FIG. 3 , there is shown a view of the valve of the present invention. The valve  300  is composed of a resilient material that can be manipulated and returned to its normal position automatically. The valve  300  comprises a disk-like shape (e.g., having a circular cross section) with a defined front side  301  opposite a back side. The surface  303  of the front side  301  comprises a depressed portion  302  for allowing the dilator or a catheter to be inserted and exited therethrough. As shown in  FIGS. 4 and 5 , the valve material is injected into the mold cavity of the cap set  200  ( FIG. 2 ) so as to hold the two cap sections  203 ,  206  together. In this way, the diameter of the valve  300  is substantially equal to the inner diameter of the semicylindrical section  204  and the flange  202  of the cap sections  200  ( FIG. 2 ). 
         [0021]    The back side of the valve  300  is biased toward the semicylindrical section  204  of the cap set  200  ( FIG. 2 ) while the front side  301  of the valve  300  is biased toward the flange  202  of the cap set  200  ( FIG. 1 ). In this way, the flange  202  surrounds the depressed portion  302  on the front surface  303  of the valve  300 . The back side of the valve  300  is substantially coplanar or flush with the lower end of the semicylindrical section  204  of the cap set  200  ( FIG. 2 ). The front side  301  of the valve  300  is slightly recessed into the valve housing of the cap set  200  ( FIG. 2 ). The valve  300  can only separate when it is slitted across, preferably where the two cap sections  203 ,  206  meet and separate (i.e., the seam between the two sections  203 ,  206 ). It is noted that the valve  300  does not extend beyond the cap sections  203 ,  206 . Additionally, the valve  300  is not molded separately. The cap set  200  ( FIG. 2 ) and the valve  300  are placed into the sheath hub  103  ( FIG. 1 ) with the posts  105  ( FIG. 1 ) aligned with the apertures  201  ( FIG. 2 ) disposed on the flanges  202  of the cap sections  203 ,  206 , and then ultrasonically welded together. 
         [0022]    Referring now to  FIG. 6 , there is shown a view of the dilator  600  with a hub  602  that is configured to fit onto the cap set  200  ( FIG. 2 ) and lock in place during insertion. The dilator  600  comprises a substantially tubular structure  601  with a circular cross-section, wherein the diameter of the dilator is slightly less than the diameter of the sheath  101  ( FIG. 1 ) so as to allow the tubular structure  601  of the dilator  600  to be inserted into the tubular structure  101  ( FIG. 1 ) of the sheath  100  ( FIG. 1 ). Additionally, the dilator comprises a first end and a second end, wherein the second end comprises a hub  602  thereon. 
         [0023]    The lower end  604  of the dilator hub  602  is configured to mate with the inner perimeter of the flange  202  ( FIG. 2 ) of the cap set  200  ( FIG. 2 ). In this regard, the lower end  604  of the dilator hub  602  comprises protrusions and/or cutouts that can be aligned with the protrusions and/or cutouts disposed on the flange  202  ( FIG. 2 ) of the cap set  200  ( FIG. 2 ). Furthermore, the hub  602  comprises a locking mechanism  603  (e.g., threaded elements) such that the dilator  600  can be temporarily locked or fitted to any apparatus that may be required to be attached to the dilator  600  during the insertion process. 
         [0024]    Referring now to  FIG. 7 , there is shown a view of the complete tearaway sheath introducer assembly  700 . The tubular structure  601  of the dilator is inserted into the tubular structure  101  of the sheath so that the dilator hub  602  sits on the sheath hub  103 . The distance between the first and second end of the tubular structure  601  of the dilator is greater than the distance between the first and second end of the tubular structure  101  of the sheath so that the first end of the tubular structure  601  of the dilator extends beyond the first end of the tubular structure  101  of the sheath. 
         [0025]    The cap set and the valve are inserted into the mold cavity of the sheath hub  103 . Thus, the tubular structure  601  of the dilator is inserted through the valve so as to allow the lower end of the dilator hub  602  to be positioned directly within the flange  202  of the cap set. In this regard, the lower end of the dilator hub  602  is adjacent to the valve. Additionally, because the valve is slightly recessed into the valve housing of the cap set, the lower end of the dilator hub  602  can be substantially coplanar or flush with the flange  202  of the cap set. 
         [0026]    In use, the complete assembly  700  is inserted over a guide wire. The dilator can be connected to any apparatus via the locking mechanism  603  at a terminal end thereof. The dilator  601  is then removed and exited through the valve, leaving the sheath  101  in the blood vessel. Due to the resilient nature of the valve, the valve is configured to prevent blood from coming out after the dilator is removed, but before a catheter is inserted. Once the catheter is fully inserted through the valve and into the sheath, the sheath hub  103  is separated or broken into two halves at the seam, separating the two tabs. 
         [0027]    It is therefore submitted that the instant invention has been shown and described in what is considered to be the most practical and preferred embodiments. It is recognized, however, that departures may be made within the scope of the invention and that obvious modifications will occur to a person skilled in the art. With respect to the above description then, it is to be realized that the optimum dimensional relationships for the parts of the invention, to include variations in size, materials, shape, form, function and manner of operation, assembly and use, are deemed readily apparent and obvious to one skilled in the art, and all equivalent relationships to those illustrated in the drawings and described in the specification are intended to be encompassed by the present invention. 
         [0028]    Therefore, the foregoing is considered as illustrative only of the principles of the invention. Further, since numerous modifications and changes will readily occur to those skilled in the art, it is not desired to limit the invention to the exact construction and operation shown and described, and accordingly, all suitable modifications and equivalents may be resorted to, falling within the scope of the invention.