Abstract:
Provided is a medical device for restoring the integrity of vessels comprising a closure button insertable therein, where the closure button is adapted to plug a hole or port in a vessel to prevent blood loss, for use in an intervertebral disc herniation, or for use in a crushed vertebral body.

Description:
PRIORITY  
       [0001]     The application claims priority from the disclosure of U.S. Provisional Patent Application Ser. No. 60/736,813, entitled “Arterial Closure Button,” filed Nov. 15, 2005, which is herein incorporated by reference in its entirety. 
     
    
     BACKGROUND  
       [0002]     Versions of the present invention relate to restoring the integrity of vessels and, more particularly, to restoring the integrity of arteries and veins with a closure button. A variety of medical devices have been created and used, but no one prior to the inventor(s) has created or used the invention described in the appended claims. 
     
    
     BRIEF DESCRIPTION OF THE FIGURES  
       [0003]     In accordance with versions herein, it is believed the present invention will be better understood from the following description taken in conjunction with the accompanying drawings. The drawings and detailed description that follow are intended to be merely illustrative and are not intended to limit the scope of the invention.  
         [0004]      FIG. 1  presents a cross-sectional view of an insertion tube having a closure button inserted therein shown inserted into a vessel before deployment of the closure button;  
         [0005]      FIG. 2  presents a cross-sectional view of the closure button of  FIG. 1  shown deployed within a vessel;  
         [0006]      FIG. 3  presents a cross-sectional view of the closure button of  FIG. 1  shown being pulled against the inner wall of the vessel while the insertion tube of  FIG. 1  is pushed against the outer wall of the vessel;  
         [0007]      FIG. 4  presents a perspective view of one version of a closure button having traction spikes thereon;  
         [0008]      FIG. 5  presents a cross-sectional view of the closure button of  FIG. 4  taken along line  5 - 5  shown with a central projection having an eyelet therethrough adapted to receive a suture;  
         [0009]      FIG. 6  presents a cross-sectional view of one version of a closure button having a retention member coupled thereto.  
         [0010]      FIG. 7  presents a cross-sectional view of one version of a closure button being used in an intervertebral application.  
         [0011]      FIG. 8  presents a cross-sectional view of one version of a closure button being used in a vertebra. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0012]     Versions of a closure button disclosed herein are adapted to seal or restore the integrity of veins and arteries. For example, the closure button may be used to seal a femoral artery that has been used for access during a cardiac catheter procedure. During such a procedure, access is generally gained by way of an 18 g needle or 4F to 6F stylet/dilators. After the procedure the femoral artery needs to be closed. In one version, the closure button is a permanently implanted device that seals the opening in the arterial wall and prevents blood loss therethrough.  
         [0013]     The closure button may be configured in any suitable shape such as, for example, an oval shape, a circular shape, an umbrella-like shape, a multi-sided shape, a tube, a shape matching the internal structure of a bone or a vessel, or combinations thereof. The closure button may also be, for example, an inflatable balloon. The closure button may be configured from any suitable material such as, for example, a polymeric material. The closure button may have a memory retention capability where, upon deployment, the closure button will return to its native state. In a further version, the closure button may open with any suitable spring or hinge system that may be manually or automatically deployed upon insertion into a vessel.  
         [0014]     Referring to  FIGS. 1-3 , in one version the closure button  10  is configured from an elastomeric material and is folded into an insertion tube  14 . The insertion tube  14  is then inserted into the hole or access port  16  in an artery, vein, or vessel  12 . Upon insertion, the closure button  10  may be pushed distally, with a rod  18 , or the like, out of the insertion tube  14  and into the lumen  20  of the vessel  12 . Once pushed out of the insertion tube  14 , the elastomeric closure button  10  may be deployed and may expand within the vessel  20 . After deployment, the closure button  10  may be pulled adjacent the vessel  12  wall, thereby restoring the integrity of the vessel  12  and/or blocking the flow of blood therethrough. In one version, the natural internal pressure of the vessel  12  may used to hold the closure button  10  flat or substantially flat against the outer wall.  
         [0015]     In an alternate version, referring to  FIGS. 4-5 , the closure button  100  may be tethered or otherwise secured to the arterial wall with, for example, a suture  102 . In the illustrated version, the closure button  100  includes a central projection  104  having an eyelet  106  therethrough where, for example, a tether or suture  102  may be threaded through the eyelet  106  and sutured to the skin of the patient or to pull the closure button  100  against the vessel wall. It is contemplated that the tether and/or closure button may be constructed from a bioabsorbable material that will disintegrate within the body over time.  
         [0016]     Referring to  FIG. 6 , the closure button  200  may include a retention member  202  coupled with the closure button  200 , where the closure button  200 , the retention member  202 , and the coupling  204  therebetween resemble a spool or dumb bell shape. The retention member  202  includes any suitable mode, manner, or device for securing the closure button  200  in place and may be, for example, a round or oval disk positioned adjacent to the vessel  12  wall. The retention member  202  may apply pressure to the outer wall of the vessel  12  as needed to ensure the closure button  200  is against the interior wall and/or to prevent slippage.  
         [0017]     Referring back to  FIGS. 4-5 , the closure button  100  may be, for example, folded and deployed in the shape of an umbrella. The surface  108  of the closure button  100  that is in contact with the interior vessel  12  wall may be rough, contain spikes, traction members  100 , or the like, to prevent slippage off of the vessel  12  wall. It will be appreciated that any suitable surface or projection increasing the friction and/or connection between closure button  100  and the vessel  12  wall is contemplated. It will be appreciated that any suitable combination of elements disclosed herein is contemplated.  
         [0018]     Referring to  FIG. 7 , it will be appreciated that a closure button  300  may be used in any suitable field including for herniated discs. As illustrated, the closure button  300  may be inserted into the nucleus  304  of a vertebral disk  302  through the fibrous annular ring  306 . The closure button  300  may be inserted in accordance with versions described herein to reduce the effect of the herniation, to repair the herniation, or for any other suitable therapeutic benefit.  
         [0019]     Referring to  FIG. 8 , it will be appreciated that the closure button may be used in one or a plurality of vertebra. As illustrated, the closure button may be used for a fractured, crushed, and/or collapsed vertebra. The closure button may be used as a temporary seal preceding the placement or delivery of a fluid, such as bone cement, into a vertebra. The placement of the closure button may prevent or diminish the amount of bone cement permitted to leak therefrom. After the material is set, the closure button may be left in place or may be removed.