Three-needle closure device

Abstract

The present invention relates to a three-needle type vascular closure system. The closure system utilizes three needles in the form of a guiding device, an expandable needle, and a hooking device. The guiding device is used to make the initial opening in the vessel, where the opening provides access for a sheath through which a medical procedure is to be performed. The expandable needle is inserted into the vessel in which it expands radially from the needle to form a target. The hooking device is also inserted into the vessel and is used to hook the expandable needle so as to form an internal union between the hooking device and the expandable needle. The needles can then be retracted thereby extending a suture from the hooking device and forming an internal suture pass that can be used to approximate the tissue surrounding the initial opening in the vessel. In one embodiment, the suture is passed across the vessel opening prior to dilation of the vessel opening.

1 . A vascular closure system, comprising:
 a sheath including a plurality of hollow lobes;   a guiding device disposed within one of the hollow lobes;   an expandable needle disposed within a different one of the hollow lobes; and   a hooking device disposed within yet another different one of the hollow lobes, wherein the hooking device is configured to hook the expandable needle.   
   
   
       2 . The vascular closure system of  claim 1  wherein the sheath includes three hollow cylindrical lobes. 
   
   
       3 . The vascular closure system of  claim 1  wherein the sheath comprises a distal profile capable of dilating tissue. 
   
   
       4 . The vascular closure system of  claim 1  wherein the guiding device further comprises:
 an access needle; and   a guide wire configured to conform to the shape of the interior surface of a vessel.   
   
   
       5 . The vascular closure system of  claim 1  wherein the guiding device further comprises:
 an access needle; and   a bent guide wire configured to conform to the shape of the interior surface of a vessel.   
   
   
       6 . The vascular closure system of  claim 1  wherein the guiding device comprises an expandable foot. 
   
   
       7 . The vascular closure system of  claim 1  wherein the guiding device is configured to be inserted into a first opening in a vessel, the expandable needle is configured to be inserted into a second opening in the vessel, and the hooking device is configured to be inserted into a third opening in the vessel. 
   
   
       8 . The vascular closure system of  claim 1  wherein the sheath includes three lobes, a left lobe, a center lobe and a right lobe, and wherein the guiding device is disposed within the center lobe, the expandable needle is disposed within the left lobe, and the hooking device is disposed within the right lobe. 
   
   
       9 . The vascular closure system of  claim 1  wherein the expandable needle further comprises:
 a needle tip configured to pierce the surface of a vessel;   an expandable mesh that includes an expanded state and an extended state;   an insertion rod configured to insert the expandable needle without expanding the expandable mesh; and   an actuator configured to expand the expandable mesh into the expanded state.   
   
   
       10 . The vascular closure system of  claim 1  wherein the hooking device further comprises:
 a curved hollow needle configured to pierce the surface of a vessel;   a suture extending through the curved hollow needle; and   a piercing toggle connected to the suture and disposed on an end of the curved hollow needle such that a contiguous piercing surface is formed with the end of the curved hollow needle and the piercing toggle.   
   
   
       11 . The vascular closure system of  claim 1  wherein the hooking device further comprises:
 a tubular curved hollow needle configured to pierce the surface of a vessel;   a degradable suture extending through the curved hollow needle; and   a piercing toggle connected to the suture and disposed on an end of the curved hollow needle such that a contiguous piercing surface is formed with the end of the curved hollow needle and the piercing toggle, wherein the piercing toggle is shaped to provide an efficient hooking surface.   
   
   
       12 . A vascular closure system, comprising:
 a sheath including three hollow lobes;   a guiding device disposed within one of the hollow lobes, wherein the guiding device further includes:
 an access needle; 
 a guide wire configured to conform to the shape of the interior surface of a vessel; 
   an expandable needle disposed within a different one of the hollow lobes, wherein the expandable needle further includes:
 a needle tip configured to pierce the surface of a vessel; 
 an expandable mesh that includes an expanded state and an extended state; 
 an insertion rod configured to insert the expandable needle without expanding the expandable mesh; 
 an actuator configured to expand the expandable mesh into the expanded state; 
 a hooking device disposed within yet another different one of the hollow lobes, wherein the hooking device is configured to hook the expandable needle, wherein the hooking device further includes: 
 a curved hollow needle configured to pierce the surface of a vessel; 
 a suture extending through the curved hollow needle; and 
 a suture extending through the curved hollow needle and a toggle connected to the suture and disposed on the end of the curved hollow needle. 
   
   
   
       13 . A method of performing a medical procedure via a vessel opening, comprising:
 extending a suture across a vessel opening;   pushing the suture to a side of the vessel opening;   dilating the opening by inserting a sheath into the vessel opening;   performing a medical procedure via the sheath subsequent to at least the step of extending a suture across a vessel opening;   removing the sheath from the vessel opening;   cinching the suture to approximate tissue surrounding the vessel opening.