Articulating suturing device and method

Abstract

Devices, systems, and methods for suturing of body lumens allow the suturing of vascular puncture sites located at the distal end of a percutaneous tissue tract. An elongated articulated foot near a distal end of a shaft is inserted through the penetration and actuated so that the foot extends along the lumenal axis. The foot carries suturing attachment cuffs, and needles are advanced from the shaft through the vessel wall outside of the penetration and into engagement with the needle cuffs after the foot has been drawn proximally up against the endothelial surface of the blood vessel. The cross-section of the shaft within the tissue tract can be minimized by laterally deflecting the needles as they leave the shaft, while tapered depressions within the foot can guide the advancing needles into engagement with the cuffs. The cuffs lockingly engage the needles and can be withdrawn proximally along the needle paths and through the tissue tract so as to form a loop of suture across the puncture. The articulating foot may be realigned with the shaft and withdrawn proximally through the tissue tract without dilating the tissue tract.

What is claimed is:  
     
         1 . A method for suturing a puncture in a blood vessel wall, the method comprising: 
 providing a monofilament suture having a first end and a bight spaced from the first end;    advancing the first end of the suture through the blood vessel wall;    advancing the first end of the suture through the bight; and    tensioning the suture across the puncture.    
     
     
         2 . The method of  claim 1  wherein the bight of the suture includes at least one loop, and wherein providing the monofilament suture having a first end and a bight spaced from the first end comprises forming the bight with at least one loop, and heating the at least one loop to set the bight.  
     
     
         3 . The method of  claim 2  wherein heating the formed bight to set the bight comprises heating the formed bight at a temperature from about 190° Farenheit to about 280° Farenheit.  
     
     
         4 . The method of  claim 1  further comprising providing a shaft carrying the bight and positioning a portion of the shaft through the puncture.  
     
     
         5 . The method of  claim 4  wherein the shaft has a needle guide, and wherein the method further comprises advancing a needle from the needle guide to form a needle path through the vessel wall, wherein advancing the first end of the suture through the blood vessel wall includes advancing the first end of the suture along the needle path.  
     
     
         6 . The method of  claim 5  wherein the bight encircles the needle and wherein advancing the first end of the suture through the bight includes advancing the needle through the bight.  
     
     
         7 . The method of  claim 6  wherein the shaft includes a pivotable foot that carries the first end of the suture, wherein the method further comprises deploying the foot adjacent the vessel wall so that the foot extends laterally from the shaft, and wherein advancing the needle from the needle guide to form a needle path includes advancing the needle to the foot to connect with the first end of the suture.  
     
     
         8 . A device for suturing a puncture in a blood vessel wall, the device comprising: 
 a shaft;    a length of suture carried by the shaft, the suture having a first end and a bight spaced from the first end, the bight releasably disposed on the shaft; and    a needle on the shaft, the bight encircling the needle, the needle being operatively associated with the first end of the suture to advance the first end of the suture through the bight to form a knot.    
     
     
         9 . The device of  claim 8  wherein the suture is a monofilament suture and the bight includes at least one loop and is formed by heating the at least one loop to set the bight.  
     
     
         10 . The device of  claim 9  wherein the loop is heated to a temperature between about 190° Farenheit and about 280° Farenheit.  
     
     
         11 . The device of  claim 8  wherein the suture is a monofilament suture and the bight is pre-formed to remain in a looped position while disposed on the shaft.  
     
     
         12 . The device of  claim 11  wherein the bight includes more than one loop.  
     
     
         13 . The device of  claim 12  wherein the loops of the bight are pre-arranged so as to define a surgical knot.  
     
     
         14 . A method of forming a pretied knot for a suturing device, the method comprising: 
 providing a length of monofilament suture having a first end;    wrapping a portion of the length of monofilament suture around a mandrel to form a looped configuration spaced from the first end; and    heating the wrapped portion to a temperature below the melting point of the monofilament suture such that upon removal of the mandrel, the wrapped portion remains in the looped configuration.    
     
     
         15 . The method of  claim 14  wherein the looped configuration defines a surgical knot when the first end of the length of monofilament suture is advanced through the looped configuration.  
     
     
         16 . The method of  claim 14  wherein heating the wrapped portion comprises applying heat at temperature between about 190° Farenheit to about 280° Farenheit.  
     
     
         17 . The method of  claim 16  wherein applying heat is performed for about 3 to about 5 seconds.  
     
     
         18 . The method of  claim 17  wherein applying heat is performed with a blowing heat source having a flow rate of about 10 scfh to about 30 scfh.  
     
     
         18 . The method of  claim 17  wherein the monofilament suture is polypropylene.  
     
     
         19 . The method of  claim 17  wherein the monofilament suture is size 3/0.  
     
     
         20 . The method of  claim 16  wherein applying heat is performed in an oven.  
     
     
         21 . The method of  claim 20  wherein applying heat is performed for about 1 minute to about 15 minutes.  
     
     
         22 . The method of  claim 21  wherein the monofilament suture is polypropylene.  
     
     
         23 . The method of  claim 22  wherein the monofilament suture is size 3/0.