Abstract:
A method of performing a vascular closure whereby closure material is safely injected into the blood vessel and into the vascular opening.

Description:
FIELD OF THE INVENTION  
         [0001]    The present invention generally relates to the field of vascular closure devices. More specifically, this invention may be used to close openings in the vasculature created to perform intravascular procedures. Those skilled in the art will recognize the benefits of applying the present invention to similar fields not discussed herein.  
         BACKGROUND OF THE INVENTION  
         [0002]    A variety of procedures are currently performed which access various portions of the human body through the vasculature. These procedures are begun by puncturing the skin and providing access into an artery or vein. Access to the artery may be provided by cutting open a portion of the body and exposing the artery. That artery may then be accessed by puncturing the artery. Alternatively, access to the artery may be gained by a technique commonly known as the Seldinger technique. Seldinger invented a system which includes a needle, sheath and dilator to provide a resealable access point into the vasculature. Common points of vascular access include the brachial artery accessed just above the elbow, the radial artery approach accessed just above the wrist, or the femoral artery approach accessed just below the groin.  
           [0003]    One of the most common procedures is balloon angioplasty. Balloon angioplasty is typically performed through a sheath placed in a vascular access point. After a sheath is firmly located in the vascular access point, a guide catheter is inserted through the sheath and into the vascular system. The guide catheter is then typically advanced under fluoroscopy to the ostium of the left or right coronary artery.  
           [0004]    After the distal end of the guide catheter is satisfactorily located in the ostium of a coronary artery, a guide wire is inserted through the sheath, inside the guide catheter and advanced through the guide catheter until the distal end of the guide wire emerges from the distal end of the guide catheter. The guide wire is further advanced through the coronary vasculature until it reaches a portion of vasculature which is in need of treatment. Commonly, the vasculature will be partially or completely obstructed by stenotic material which may be comprised of plaque or other material. Typically the distal end of the guide wire is advanced beyond the area of treatment.  
           [0005]    After the guide wire is located in a desired position, a balloon catheter is inserted into the sheath. The balloon catheter is threaded over the guide wire and inside the guide catheter. The distal end of the balloon catheter is advanced to the treatment site and located such that the balloon is positioned within the stenosis. Once the balloon is in position it is inflated with fluid and thereby expanded. Expansion of the balloon forces any stenotic material away from the center of the blood vessel and thereby improves the patency of the artery which is being treated. Once dilatation is complete, the balloon catheter is removed.  
           [0006]    This procedure may be repeated with different size balloons or in multiple sits within the vasculature depending upon patient need. However, once the procedure is complete, the physician will remove the balloon catheter, guide wire, guide catheter and ultimately the sheath itself. Sheaths may range in size from 4-9 French. Depending upon the size of the sheath, a relatively large hole has been made in the artery at the vascular access site. Without further treatment, the patient would likely bleed to death through the hole made when the sheath is removed.  
           [0007]    There are several methods of treating the vascular wound once the sheath has been removed. The most common method of treatment is simple pressure. This method may include a pressure dressing, physical pressure applied by an attendant, or pressure applied by some sort of apparatus. While this method is ultimately effective, it may take several hours to safely close the vascular access site such that the patient is able to move about.  
           [0008]    Alternative systems to pressure have also been developed. These systems commonly known include heat sealing, lasers, suture based systems, or various types of plugs or glues. Plugs may be made in many different shapes and may be created from a variety of materials. No matter what the material or the shape of the plug, accurate placement of the plug is desirable. Placement is particularly import with prior art plug systems which use some portion of the patient&#39;s blood to form a clot or other obstructions. Prior art closure systems such as U.S. Pat. No. 5,626,601 to Gershoney. This particular system uses a balloon which can be inflated to prevent the closure material from entering the vessel. Once the plug material has been injected into the vascular access site and partially solidifies, the balloon is deflated and pulled through the plug material. Another prior art closure invented by Kensey and described in U.S. Pat. No. 5,676,689, uses a biodegradable backstop to prevent a plug from entering the vessel. This backstop is left in the vessel until it eventually degrades. While many systems exist, a system which provides better placement of the plug material may be desirable.  
           [0009]    While one particular vascular procedure has been described as background, one skilled in the art will appreciate that the inventive technique may be used for any variety of intravascular or other intra-body access procedures known in the art.  
         SUMMARY OF THE INVENTION  
         [0010]    The present invention overcomes the deficiencies of the prior art by providing a method to safely deliver a closure system without the use of prior art protection devices the patient. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0011]    [0011]FIG. 1 depicts a cross-section of an embodiment of a closure device inserted into a vascular opening.  
         [0012]    [0012]FIG. 2 depicts a cross-section of a vascular opening where a closure material is injected into the vascular opening using the closure device of FIG. 1.  
         [0013]    [0013]FIG. 3 depicts the closure method of FIG. 2 wherein the closure device has been further removed from the vascular opening. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0014]    The following detailed description should be read with reference to the drawings in which like elements in different drawing are numbered identically. The drawings, which are not necessarily to scale, depict selected embodiments and are not intended to limit the scope of the invention.  
         [0015]    Examples of constructions, materials, dimensions, and manufacturing processes are provided for selected elements. All other elements employ that which is known to those skilled in the field of the invention. Those skilled in the art will recognize that many of the examples provided have suitable alternatives that may also be used.  
         [0016]    An embodiment of the inventive method, may be used with a vascular closure device as described in U.S. Pat. No. 6,159,232 which is herein incorporated by reference.  
         [0017]    Referring now to FIG. 1, a vascular opening  5  is depicted in a human body. Blood vessel  10  may have a vessel opening  20  which may be aligned with a skin opening  30  in the skin  45  of a patient. Skin opening  30  may be in any portion of the body which corresponds to a desired intravascular procedure. Vascular opening  5  may include but is not limited to an opening in the femoral artery located near the groin, an opening in the brachial artery located near the elbow, an opening in the radial artery located near the wrist, or an opening in the jugular artery located near the neck.  
         [0018]    Located between the skin opening  30  and the vessel opening  20  is a tissue tract  40 . Tissue tract  40  may vary in length depending upon the particular point of the vasculature which is being accessed and the relative distance between the skin  45  and the vessel  10 . The diameter of tissue tract  40  may roughly correspond to the diameters of vessel opening  20  and skin opening  30 . The diameter of vessel opening  20  and skin opening  30  may vary depending upon the particular intravascular procedure which may be performed and the vascular access point. Typical vessel opening  20  may be 4-9 French.  
         [0019]    Most intravascular procedures may include a sheath  50  which may be inserted into blood vessel  10  via tissue tract  40 . Sheaths are well known in the art and are commercially available in a variety of sizes and lengths. An example of a sheath is the Pinacle® sold by Boston Scientific Corporation.  
         [0020]    Following the intravascular procedure, a closure device  60  may be inserted through sheath  50  until distal end  65  is positioned within blood vessel  10 . A syringe  70  may be connected to a proximal end  67  of closure device  60 . Alternatively, any system commonly known in the art may be used to remove blood from the blood vessel  10 . Blood which is removed from the blood vessel  10  may be treated to create a closure material. Closure material may be formed by the invention disclosed in U.S. Pat. No. 6,159,232 or other procedures known in the art.  
         [0021]    While FIG. 1 is depicted with sheath  50 , the inventive method may also be performed without sheath  50  or after sheath  50  has been removed. FIG. 2 depicts closure device  60  in vessel  10  without sheath  50  present. Closure material  75  may then be injected as closure device  60  is removed from vascular opening  5 . Closure material  75  may be injected continuously while closure device  60  is removed from vascular opening  5 . Sheath  50  may generally be removed along a path depicted by arrow  80 .  
         [0022]    Alternatively, a bolus of closure material  75  may be injected prior to closure device  60  moving. Once injection of closure material  75  has been stopped, closure device  60  may be retracted proximally, but not withdrawn from the vascular opening  5 , and another bolus of closure material  75  may be injected. This process may be repeated in a step-wise fashion as desired by the user.  
         [0023]    [0023]FIG. 3 shows closure device  60  further removed from vascular opening  5  in the general direction indicated by arrow  80 . Distal end  65  has been withdrawn from vessel  10  along tissue tract  40 . While distal end  65  is moving, closure material  75  may be injected. Closure material  75  may thereby be partially injected into vessel  10  and also into tissue tract  40 . By injecting closure material  75  while closure device  60  is removed, the user of the inventive method may insure that closure material  75  is injected just outside of vessel opening  20 . Further injection of closure material  75  may occur as device  60  is completely removed or may only occur near vessel opening  20 . Following the completion of injecting of closure material  75 , pressure or a bandage may be applied to vascular opening  5  depending upon the effectiveness of closure material  75 .  
         [0024]    While the specification describes the preferred designs, materials, methods of manufacture and methods of use, those skilled in the art will appreciate the scope and spirit of the invention with reference to the appended claims.