Tissue compression using surgical clips

Abstract

A compression clip system where compression is used to close a tissue opening, reduce the volume of an organ, ligate dilated blood vessels or compress tissue adjacent to various other types of lesions to induce healing. Compression prevents bleeding and the leakage of body fluids into a body cavity. The opening may be surgery induced as in gastrectomies or formed naturally such as peptic ulcers and hemorrhoids. The system may include a compression clip, a suitable clip applier, a grasper assembly and an endoscope all brought to the compression site via a multi-lumen sleeve.

1 - 40 . (canceled) 
     
     
         41 . A system for use with a surgical compression clip for compressing tissue thereby inducing necrosis in the compressed tissue and subsequent healing of the tissue adjacent to the compression site, wherein the clip comprises a pair of compression elements and at least one force applier element formed of a shape memory material, the clip having an open position and a closed position and configured to receive tissue to be compressed therethrough when in its open position, the force applier element operative for providing a force to said compressing elements, and the compressing elements operative to apply a compression force to the tissue to be compressed when the clip is closed thereabout, so as to cause first tissue necrosis and then healing of the tissue around the compression site, the system comprising:
 an endoscope having an insertion shaft having at least one working channel;   a clip applier for advancing the clip through a working conduit and for positioning the clip near the tissue to be compressed, wherein said working conduit is said at least one working channel of said insertion shaft; and   a grasper assembly selectably extendible through said working conduit, for engaging and pulling the tissue to be compressed through the clip when the clip is in its open position.   
     
     
         42 . A system according to  claim 41  further comprising a multi-lumen sleeve having a primary lumen encasing said endoscope insertion shaft, and at least one secondary lumen and where said working conduit is a preselected one of (i) said at least one working channel of said insertion shaft and (ii) said at least one secondary lumen of said multi-lumen sleeve. 
     
     
         43 . A system according to  claim 41 , wherein said clip applier includes:
 two arm elements selectably engageable with the compression clip, each arm element having a slot and a pin hole;   a position controlling element in mechanical communication with said arm elements, said position controlling element including a first and second pin, where said first pin passes through said position controlling element and said pin hole on each of said two arm elements and said second pin passes through said position controlling element and said slot on each of said arm elements; and   an activating element in mechanical communication with and operable to move said pins in said position controlling element,   thereby to produce substantially scissor-like motion of said arm elements bringing them from their closed adjacent position to their open spaced apart position and vice versa; and   thereby to cause the compression clip to move from its open position to its closed position and vice versa in tandem with the motion of said arm elements of said clip applier.   
     
     
         44 . A system according to  claim 41 , wherein said grasper assembly is comprised of:
 a grasper having a closed and an open position, said grasper comprised of:
 forceps arms for grasping and pulling the portion of the tissue to be compressed; and 
 a wire in mechanical connection with and for controlling and maneuvering said forceps arms and for bringing said forceps arms from their closed position to their open position and vice versa; and 
   a grasper transporting element for transporting said grasper in its closed position to a location near the portion of the tissue to be compressed whereat said grasper is ejected from said transporting element allowing said forceps arms to open to their open position.   
     
     
         45 . A system according to  claim 44 , wherein at least one of said wire and said forceps arms includes a bend, said bend facilitating grasping and pulling the tissue to be compressed through the clip. 
     
     
         46 . A system according to  claim 44 , wherein at least one of said wire and said forceps arms is formed at least partially of a shape memory material. 
     
     
         47 . A system according to  claim 41 , wherein said grasper assembly comprises:
 a flexible resilient vacuum cup having a closed and an open position;   a suction source for generating negative pressure;   a conduit joining said vacuum cup to said suction source;   a grasper transporting element for transporting said vacuum cup in its closed position to a location near the site of the tissue to be compressed where said vacuum cup is ejected from said transporting element allowing said vacuum cup to open to its open position; and   articulation means for bringing said vacuum cup to the site of the tissue to be compressed for engaging the tissue under a suction force, and for subsequently pulling the tissue through the surgical clip.   
     
     
         48 . A system for compressing tissue to induce necrosis and subsequent healing of the tissue around the compression site, the system comprising:
 an endoscope having an insertion shaft having at least one working channel, said endoscope selected from a group of endoscopes consisting of rigid and flexible endoscopes;   a compression clip having an open position and a closed position, said clip configured to receive tissue to be compressed therethrough when in its open position, and operative to apply a compression force thereto when closed thereabout;   a clip applier for advancing said clip through a working conduit and for positioning said clip near the tissue to be compressed, wherein said working conduit is said at least one working channel of said insertion shaft; and   a grasper assembly selectably extendible through said working conduit, for engaging and pulling the tissue to be compressed, the engaged tissue being positioned in said clip when said clip is in its open position,   said compression clip further comprising a pair of generally elongated compressing elements for compressing the tissue to be compressed, said compressing elements formed and configured for being disengageably joined to said clip applier, and said compression clip is operable to compress the tissue extending therethrough, thereby inducing necrosis and subsequent healing of the tissue around the compression site.   
     
     
         49 . A system according to  claim 48 , further comprising a a multi-lumen sleeve having a primary lumen encasing said endoscope insertion shaft, and at least one secondary lumen wherein said working conduit is a preselected one of (i) said at least one channel of said insertion shaft and (ii) said at least one secondary lumen of said multi-lumen sleeve. 
     
     
         50 . A system according to  claim 48 , wherein said compression clip includes at least one shape memory force applier element formed of shape memory material, said at least one force applier element operative for providing a force to said pair of compressing elements for compressing tissue held therebetween. 
     
     
         51 . A system according to  claim 50 , wherein said compressing elements and said at least one shape memory force applier element form a planar configuration in both the clip's open and closed positions and said compressing elements of said surgical clip apply a compressive force to the tissue to be compressed, the compressive force acting in the plane of said clip and in a line between said compressing elements. 
     
     
         52 . A system according to  claim 50 , wherein said system further includes a pair of generally elongated securing elements and wherein said at least one shape memory force applier element is positioned between, and in mechanical connection with, said operatively associated securing and compressing elements, and wherein said at least one shape memory force applier element and said pairs of securing and compressing elements all lie in substantially the same plane in both the first open and second closed positions of said clip and wherein an axis of securing for holding the tissue to be compressed is formed by, and is tangential to, said securing elements and an axis of compression for compressing tissue to be compressed is formed by, and tangent to, said compression elements, the lines of securing and of compression not being collinear lines. 
     
     
         53 . A system according to  claim 48 , said clip further comprising a pair of generally elongated securing elements each having formed thereon a pair of mutually opposing gripping portions adapted to secure therebetween the tissue to be compressed, said securing elements operationally associated with said compressing elements, said securing elements formed and configured for being disengageably joined to said clip applier. 
     
     
         54 . A system according to  claim 53  wherein said gripping portions of said securing elements include toothed first edges which are in proximity to each other when said clip is in its closed position and wherein said toothed first edges of said securing elements are spaced apart from each other when said clip is in its open position. 
     
     
         55 . A system according to  claim 48 , wherein said grasper assembly is comprised of:
 a grasper having a closed and an open position, said grasper comprised of:
 forceps arms for grasping and pulling the tissue to be compressed; and 
 a wire in mechanical connection with and for controlling and maneuvering said forceps arms and for bringing said forceps arms from their closed position to their open position and vice versa; and 
   a grasper transporting element for transporting said grasper in its closed position to a location near the tissue to be compressed whereat said grasper is ejected from said transporting element allowing said forceps arms to open to their open position.   
     
     
         56 . A system according to  claim 55 , wherein at least one of said wire and said forceps arms includes a bend, said bend facilitating grasping and pulling the tissue to be compressed through said clip. 
     
     
         57 . A system according to  claim 55 , wherein at least one of said wire and said forceps arms is formed at least partially of a shape memory material. 
     
     
         58 . A system according to  claim 48 , wherein said grasper assembly comprises:
 a flexible resilient vacuum cup having a closed and an open position;   a suction source for generating negative pressure;   a conduit joining said vacuum cup to said suction source;   a grasper transporting element for transporting said vacuum cup in its closed position to a location near the tissue to be compressed where said vacuum cup is ejected from said transporting element allowing said vacuum cup to open to its open position; and   articulation means for bringing said vacuum cup, when in its open position, to the tissue to be compressed for engaging the tissue under a suction force, and for subsequently pulling the tissue through said surgical clip.   
     
     
         59 . A system according to  claim 48 , wherein said clip further includes a pair of compressing elements and at least two shape memory force applier elements formed of shape memory material where one of said force applier elements is constructed as a latch which is operable to engage with an engagement means formed on one end of one of said pair of compressing elements, said latch thereby exerting a force on the tissue to be compressed when the tissue is held between said compressing elements. 
     
     
         60 . A system according to  claim 59 , wherein said clip further includes a wire snare. 
     
     
         61 . A system according to  claim 48  wherein said compression clip comprises:
 a pair of generally linear compression elements for securing tissue therebetween and for applying to the secured tissue a compression force, wherein said compression clip has an initial, open position in which said linear compression elements may be positioned about the tissue to be secured therebetween, and a final, closed position whereat said compression elements are substantially parallel to each other, thereby to apply a compressive force to the secured tissue; and 
 force means formed from a shape memory material and disposed between said pair of compression elements and operative to transmit operational forces therebetween. 
 
     
     
         62 . A system according to  claim 61 , wherein said force means includes at least one active hinge member disposed between said linear compression elements. 
     
     
         63 . A method for compressing tissue thereby inducing necrosis in the compressed tissue and subsequent healing of the tissue surrounding the compression site, said method comprising the steps of:
 placing an endoscope in a body cavity and advancing the endoscope to and positioning it near the site of the tissue to be compressed; and   positioning a compression clip near the site of the tissue to be compressed; and   extending a grasping instrument for grasping and pulling the tissue to be compressed, the grasped tissue being positioned in the compression clip when the clip is in its open position and compressed when the clip is in its closed position thereby producing necrosis in the compressed tissue and then healing of the tissue surrounding the compression site,   wherein said step of extending includes the step of grasping sufficient tissue to include sufficient margins around the site of the tissue to be compressed to ensure successful compression without leakage.   
     
     
         64 . A method according to  claim 63 , wherein said step of positioning includes positioning the clip around a perforation in the tissue to be compressed and then in said step of closing, compressing the tissue around the perforation thereby causing closure of the perforation. 
     
     
         65 . A method according to  claim 63 , wherein said step of extending the grasping instrument is advanced and brought to the site of the tissue to be compressed through a working channel of the endoscope and in said step of positioning the compression clip is advanced and brought to the site of the tissue to be compressed through a second working channel of the endoscope. 
     
     
         66 . A method according to  claim 63 , wherein said step of extending the grasping instrument is advanced and brought to the site of the tissue to be compressed through a working channel of the endoscope and in said step of positioning the compression clip is advanced and brought to the site of the tissue to be compressed through a secondary lumen of the multi-lumen sleeve, wherein the primary lumen of the sleeve encases the endoscope and wherein the aforementioned secondary lumen is the secondary lumen closest to the site of the tissue to be compressed. 
     
     
         67 . A method according to  claim 63 , further comprising the step of activating a vacuum source so as to effect the action of grasping in said step of extending by a suction operated grasping instrument. 
     
     
         68 . A method according to  claim 63 , wherein said step of extending precedes said step of positioning and in said step of positioning the clip is positioned around the grasped and pulled tissue to be compressed.