Integrated vascular device with puncture site closure component and sealant and methods of use

Abstract

Apparatus and methods are provided for use in sealing a vascular puncture site. The invention comprises an integrated vascular device having a sheath with a closure component and puncture sealant. The closure component is disposed on and advanceable over the exterior of the sheath and may comprise any of a variety of apparatus suited for closing a vascular puncture. Once the closure component has been actuated to close the puncture, sealant is introduced to seal the puncture. The sheath and closure component are then removed from the patient.

1 . A method of closing an opening in tissue, comprising: 
 disposing a sheath within a tissue tract, wherein a distal end of the sheath is disposed within an opening formed in tissue;    performing a medical procedure through a lumen of the sheath;    closing the opening with a closure component, the closure component comprising at least two sharpened tips for engagement with tissue adjacent the opening, the sharpened tips having an expanded delivery configuration and a retracted deployed configuration to close the opening; and    applying a sealing means to the opening to effect closure of the opening.    
   
   
       2 . The method according to  claim 1 , wherein the step of applying a sealing means comprises applying a sealing means selected from a group consisting of RF energy, thermal energy, electrical induction, infrared light, ultrasonic vibration, microwave or laser irradiation, clips, sutures, or adhesives.  
   
   
       3 . The method according to  claim 1 , further comprising the step of delivering a sealant to the opening.  
   
   
       4 . The method according to  claim 1 , further comprising the step of disposing a clip adjacent the opening to further seal the opening closed.  
   
   
       5 . The method according to  claim 1 , wherein the closing step further comprises rotating the closure component after engaging the sharpened tips with the tissue.  
   
   
       6 . The method according to  claim 1 , wherein the sharpened tips are associated with elastically deformed prongs.  
   
   
       7 . The method according to  claim 6 , wherein the step of closing the opening further comprises moving a member within the closure component proximally to enable the elastically deformed needles to resiliently contract.  
   
   
       8 . A method of closing an opening in tissue, comprising: 
 disposing a sheath within a tissue tract, wherein a distal end of the sheath is disposed within an opening formed in tissue;    performing a medical procedure through a lumen of the sheath;    positioning a closure component to close the opening, the closure component comprising at least two sharpened tips for engagement with tissue adjacent the opening, the sharpened tips having an expanded delivery configuration and a retracted deployed configuration;    closing the opening formed in the tissue; and    applying a sealing means to the opening to effect closure of the opening.    
   
   
       9 . The method according to  claim 8 , wherein positioning the closure component comprises sliding the closure component along the sheath until the at least two sharpened tips engage with tissue.  
   
   
       10 . The method according to  claim 8 , wherein closing the opening comprises moving a member within the closure component proximally to move the at least two sharpened tips towards one another.  
   
   
       11 . The method according to  claim 8 , wherein closing the opening comprises rotating the closure component after engaging the at least two sharpened tips with the tissue.  
   
   
       12 . A method of closing an opening in tissue, comprising: 
 disposing a sheath within a tissue tract, the sheath comprising a proximal end, a distal end disposable within an opening formed in tissue, and a lumen extending from the proximal end toward the distal end;    performing a medical procedure through the lumen of the sheath;    positioning a closure component upon the tissue adjacent to the opening, the closure component comprising at least two sharpened tips for engagement with tissue, the sharpened tips having an expanded delivery configuration and a retracted deployed configuration;    closing the opening formed in the tissue; and    applying a sealing means to the opening to effect closure of the opening.    
   
   
       13 . The method according to  claim 12 , wherein applying the sealing means comprises: 
 disposing a sealing device, which supports a clip, through the lumen of the shaft;    deploying the clip from the sealing device to effect closure of the opening.    
   
   
       14 . The method according to  claim 13 , wherein disposing the sealing device comprises moving the sealing device through the lumen until at least two sharpened tips of the clip contacts the tissue.  
   
   
       15 . The method according to  claim 13 , further comprising delivering a sealant to the opening.  
   
   
       16 . The method according to  claim 13 , wherein the sealing device comprises a first jaw and a second jaw pivotal relative to the first jaw, the first jaw and the second jaw selectively retaining the clip.  
   
   
       17 . The method according to  claim 15 , wherein deploying the clip comprises moving the second jaw relative to the first jaw to release the clip.  
   
   
       18 . The method according to  claim 13 , wherein closing the opening comprises moving a member within the closure component proximally to move the at least two sharpened tips towards one another.  
   
   
       19 . The method according to  claim 18 , wherein the at least two sharpened tips are associated with elastically deformed needles, and wherein moving the member releases the elastically deformed needles and moves the at least two sharpened tips towards one another.  
   
   
       20 . The method according to  claim 13 , wherein closing the opening comprises rotating the closure component after engaging the at least two sharpened tips with the tissue.