Large-bore wound closure and tissue coupling systems and methods

Abstract

Surgical assemblies and related methods are provided for using an actuator to deploy an coupler configured to close a tissue puncture or natural opening in the body, or to create an anastomosis. The surgical assembly includes an actuator including an elongate shaft, a deployable coupler coupled to a distal end of the elongate shaft. The deployable coupler includes a plurality of proximal slits therein configured to form a proximal wing and a plurality of distal slits therein configured to form a distal wing. The actuator assembly is configured to transform the deployable coupler from a delivery configuration in which the proximal wing and the distal wing are substantially parallel to the elongate shaft to a fully-deployed configuration in which one of the proximal and distal wings is substantially perpendicular to the elongate shaft and the other one of the proximal and distal wings is skew to the elongate shaft.

What is claimed is: 
     
         1 . A surgical assembly, comprising:
 an actuator assembly including an elongate shaft; and   a deployable coupler coupled to a distal end of the elongate shaft, the deployable coupler including a plurality of proximal slits therein configured to form a proximal wing and a plurality of distal slits therein configured to form a distal wing;   wherein the actuator assembly is configured to transform the deployable coupler from a delivery configuration in which the proximal wing and the distal wing are substantially parallel to the elongate shaft to a fully-deployed configuration in which one of the proximal and distal wings is substantially perpendicular to the elongate shaft and the other one of the proximal and distal wings is skew to the elongate shaft.   
     
     
         2 . The surgical assembly of  claim 1 , wherein each of the plurality of proximal slits comprises first and second cuts having substantially equal lengths, and wherein the substantially equal lengths causes the proximal wing to be substantially perpendicular to the elongate shaft in the deployed configuration. 
     
     
         3 . The surgical assembly of  claim 1 , wherein each of the plurality of distal slits comprises first and second cuts having substantially unequal lengths, and wherein the substantially unequal lengths causes the distal wing to be substantially skew to the elongate shaft in the deployed configuration. 
     
     
         4 . The surgical assembly of  claim 1 , wherein transformation of the deployable coupler from the delivery configuration to the deployed configuration causes the proximal wing and the distal wing to fold about mid regions thereof. 
     
     
         5 . The surgical assembly of  claim 1 , wherein the plurality of proximal slits and the plurality of distal slits are substantially s-shaped. 
     
     
         6 . The surgical assembly of  claim 1 , further comprising a secondary handle configured to couple to a proximal end of the actuator assembly, the secondary handle having a distally extending plug configured to be passed through a central lumen at least partially defined by the elongate shaft and to be positioned within a central bore of the deployable coupler. 
     
     
         7 . The surgical assembly of  claim 6 , wherein the distally extending plug is configured to seal the central bore. 
     
     
         8 . A surgical assembly, comprising:
 a delivery tool including an elongate shaft extending from a distal end thereof; and   a deployable coupler coupled to a distal end of the elongate shaft, the deployable coupler having a distal wing defined by first proximal and distal cuts and a proximal wing defined by second proximal and distal cuts;   wherein the delivery tool is configured to transform the deployable coupler between a delivery configuration in which the elongate shaft is substantially parallel to the distal and proximal wing and a deployed configuration in which the elongate shaft is substantially transverse to the distal and proximal wing; and   wherein a deployment angle of the distal wing is at least partially defined by a length ratio of the first proximal and distal cuts and a deployment angle of the proximal wing is at least partially defined by a length ratio of the second proximal and distal cuts.   
     
     
         9 . The surgical assembly of  claim 8 , wherein the length ratio of the first proximal and distal cuts is substantially equal to 1 and is configured to cause the deployment angle of distal wing to be approximately 90 degrees. 
     
     
         10 . The surgical assembly of  claim 8 , wherein the length ratio of the second proximal and distal cuts is substantially greater than 1 and is configured to cause the deployment angle of the proximal wing to be substantially acute. 
     
     
         11 . A surgical coupler, comprising:
 a first tubular portion having a first plurality of longitudinal cuts, each of the longitudinal cuts in the first plurality of longitudinal cuts having a proximal cut and a distal cut having a length ratio of approximately 1:1;   a second tubular portion having a second plurality of longitudinal cuts, each of the longitudinal cuts in the second plurality of longitudinal cuts having a proximal cut and a distal cut having a length ratio substantially less than 1:1;   a connector portion disposed between the first and central tubular portions; and   wherein the first and second tubular portions and the connector portion define a central lumen.   
     
     
         12 . The surgical coupler of  claim 11 , wherein the first tubular portion is configured to reversibly form a wing that is substantially perpendicular to a longitudinal axis of the central lumen. 
     
     
         13 . The surgical coupler of  claim 11 , wherein the second tubular portion is configured to reversibly form a wing that is substantially skew to a longitudinal axis of the central lumen. 
     
     
         14 . The surgical coupler of  claim 11 , wherein the connector portion has a diameter that is greater than a diameter of the first tubular portion and a diameter of the second tubular portion. 
     
     
         15 . The surgical coupler of  claim 14 , wherein the diameter of the first tubular portion is less than the diameter of the second tubular portion. 
     
     
         16 . The surgical coupler of  claim 11 , wherein the surgical coupler is configured to couple with an actuator tool, the actuator tool being configured to reversibly form the first and second tubular portions into wing. 
     
     
         17 . The surgical coupler of  claim 16 , wherein the actuator tool is configured to receive a plug configured to prevent fluid flow into the central lumen. 
     
     
         18 . A method, comprising:
 inserting a delivery sheath over a guidewire through a puncture in an artery to position a deployable coupler coupled to a distal end of the delivery sheath within the artery;   pivoting the delivery sheath from an insertion orientation, in which blood can travel up the coupler, to an angled orientation, in which blood is prevented from traveling up the coupler;   actuating an actuator coupled to a proximal end of the delivery sheath to deploy a distal wing, the distal wing being positioned within the artery adjacent to the puncture;   actuating the actuator to deploy a proximal wing on the deployable coupler such that the proximal wing is positioned outside of the artery adjacent to the puncture;   removing the guidewire from delivery sheath; and   advancing a plug into a central lumen of the deployable coupler to seal the puncture.   
     
     
         19 . The method of  claim 18 , wherein the plug is operatively coupled to a secondary handle having a deployment lever thereon configured to deploy the plug into the deployable coupler. 
     
     
         20 . The method of  claim 19 , further comprising, after the plug is advanced into the central lumen, actuating the deployment lever to cause the plug to separate from the secondary handle. 
     
     
         21 . The method of  claim 18 , further comprising positioning the coupler relative to a puncture site using an external imaging system, the external imaging system detecting a radiopacity of the coupler.