Non-invasive surgical ligation clip system and method of using

Abstract

A surgical ligation clip capable of remote deployment through a cannula to engage an anatomical structure.

1 . (canceled) 
     
     
         2 . A method of using a clip system for applying a clip device to mammalian tissue, comprising:
 inserting a clip device having a single-wire body through a needle bore of a needle, wherein the clip device deforms to a lateral dimension smaller than an inner dimension of the needle bore so that the entire clip device advances into the needle bore for delivery out of a distal opening of the needle, the clip device including:
 a first clamping arm and a second clamping arm opposing the first clamping arm and being biased toward the first clamping arm, the first and second clamping arms including proximal portions that abut against one another and distal ends that are movable away from one another, wherein the first and second clamping arms cross over each other; and 
 a flexing head coupled to proximal ends of the first and second clamping arms, the flexing head being adjustable between a first shape in which the first and second clamping arms extend generally parallel to one another and a stressed shape in which at least the distal ends of the first and second clamping arms are spaced apart while the proximal portions of the first and second clamping arms abut against one another, wherein the flexing head comprises a first flexing section that extends between a proximal end of the flexing head the proximal portion of the first clamping arm and a second flexing section that extends between the proximal end of the flexing head and the proximal portion of the second clamping arm; 
 delivering the distal opening of the needle to a targeted internal tissue site to be ligated; and 
 advancing the clip device distally out of the distal opening of the needle so that the flexing head adjusts toward the first shape so that the first and second clamping arms shift toward one another to provide a clamping force at the targeted internal tissue site to be ligated. 
   
     
     
         3 . The method of  claim 2 , wherein, during inserting the clip device through the needle bore, the needle engages the flexing head to releasably retain the flexing head in the stressed shape. 
     
     
         4 . The method of  claim 2 , wherein, during inserting the clip device through the needle bore, the clip device superelastically deforms to a lateral dimension smaller than an inner dimension of the needle bore. 
     
     
         5 . The method of  claim 2 , wherein the needle bore of the needle extends longitudinally to a distal opening of the needle. 
     
     
         6 . The method of  claim 2 , further comprising engaging a push rod with the clip device when the clip device is inserted into the bore of the needle. 
     
     
         7 . The method of  claim 6 , wherein the push rod comprises a clip lock to releasably engage the flexing head of the clip device when the clip device is inserted into the bore of the needle. 
     
     
         8 . The method of  claim 2 , the first flexing section of the clip device mirrors the shape of the second flexing section relative to a longitudinal axis. 
     
     
         9 . The method of  claim 8 , wherein the first clamping arm is aligned with the second clamping arm along the longitudinal axis so that the first clamping arm contacts the second clamping arm without crossing over the longitudinal axis. 
     
     
         10 . The method of  claim 2 , wherein the single-wire body of the clip device comprises a cross-sectional shape in a lateral plane of the clip device, and wherein the cross-sectional shape in the lateral plane is D-shaped. 
     
     
         11 . The method of  claim 2 , wherein the clip device is configured to engage an anatomical structure when the first and second clamping arms shift toward one another. 
     
     
         12 . The method of  claim 2 , wherein the proximal portions of the first clamping arm and the second clamping arm abut against one another when the flexing head is in the stressed shape. 
     
     
         13 . The method of  claim 12 , wherein the distal ends of the first clamping arm and the second clamping arm comprise blunt tips. 
     
     
         14 . The method of  claim 2 , wherein the clip device comprises a material that exhibits superelasticity characteristics at a temperature of about 37 degrees C., the flexing head exhibiting superelasticity characteristics when the flexing head returns toward the first shape after being deformed to the stressed shape while the entire clip device is disposed in the needle bore. 
     
     
         15 . The clip system of  claim 2 , further comprising a push rod movably disposed in the needle bore to deliver the clip device distally from the needle bore and out of the distal opening. 
     
     
         16 . The method of  claim 2 , wherein the first clamping arm comprises wave-shaped grips that are matable with complementary wave-shaped grips of the second clamping arm. 
     
     
         17 . The method of  claim 2 , wherein in the clip device comprises a superelastic alloy material that is mechanically processed to provide a predetermined clamping force between the first and second clamping arms. 
     
     
         18 . The method of  claim 2 , wherein the first flexing section consists of a first wire portion having a single solid cross-section between the proximal end of the flexing head and the proximal portion of the first clamping arm, and the second flexing section consists of a second wire portion having a single solid cross-section between the proximal end of the flexing head and the proximal portion of the second clamping arm. 
     
     
         19 . A method of using a clip system for applying a clip device to mammalian tissue, comprising:
 inserting a clip device having a single-wire body through a needle bore of a needle, wherein the clip device deforms to a lateral dimension smaller than an inner dimension of the needle bore so that the entire clip device advances into the needle bore for delivery out of the distal opening of the needle, the clip device including:
 a first clamping arm and a second clamping arm opposing the first clamping arm and being biased toward the first clamping arm, the first and second clamping arms including proximal portions that abut against one another and distal ends that are movable away from one another, wherein the first and second clamping arms cross over each other; and 
 a flexing head coupled to proximal ends of the first and second clamping arms, the flexing head being adjustable between a first shape in which the first and second clamping arms extend generally parallel to one another and a stressed shape in which at least the distal ends of the first and second clamping arms are spaced apart while the proximal portions of the first and second clamping arms abut against one another, wherein the flexing head comprises a first flexing section that extends between a proximal end of the flexing head the proximal portion of the first clamping arm and a second flexing section that extends between the proximal end of the flexing head and the proximal portion of the second clamping arm, wherein the first flexing section consists of a first wire portion having a single solid cross-section between the proximal end of the flexing head and the proximal portion of the first clamping arm, and the second flexing section consists of a second wire portion having a single solid cross-section between the proximal end of the flexing head and the proximal portion of the second clamping arm; and 
   delivering the distal opening of the needle to a targeted internal tissue site to be ligated.   
     
     
         20 . The method of  claim 19 , comprising advancing the clip device distally out of the distal opening of the needle so that the flexing head adjusts toward the first shape so that the first and second clamping arms shift toward one another to provide a clamping force at the targeted internal tissue site to be ligated. 
     
     
         21 . The method of  claim 20 , the first flexing section of the clip device mirrors the shape of the second flexing section relative to a longitudinal axis.