Vascular access catheter with lateral leading edges

Abstract

A vascular access catheter and a method for inserting the catheter into a blood vessel. The catheter comprising a catheter body enclosing a lumen, and a catheter tip comprising a distal edge surrounding an opening opened to the lumen. The distal edge includes a pair of lateral leading edges, each of the lateral leading edges is curved downwardly and proximally from a respective front portion of the distal edge. The vascular access catheter can be provided in a vascular access kit further comprising access needle with hollow needle body and beveled tip ending with sharp needle edge.

What is claimed is: 
     
         1 . A vascular access catheter, comprising:
 an elongated tubular catheter body enclosing a lumen, the catheter body has a plane of symmetry coinciding with a median plane and includes a catheter tip ending with a catheter distal end and comprising a distal edge at the catheter distal end surrounding an opening opened to the lumen, the distal edge includes: (a) a pair of lateral leading edges located at opposing sides of the median plane, each of the lateral leading edges is curved downwardly and proximally from a respective front portion of the distal edge, (b) a bottom edge portion extending between and below the lateral leading edges and spanning a bottom portion of the opening, and (c) a top edge portion extending between and above the lateral leading edges and spanning a top portion of the opening;   wherein the lateral leading edges are configured to penetrate through an aperture in a bodily tissue and to gradually expand the aperture downwardly in parallel to the median plane, when the catheter tip is pushed distally through the aperture, before the bottom edge portion penetrates through the aperture.   
     
     
         2 . The vascular access catheter according to  claim 1 , wherein the bodily tissue is a skin tissue, and the catheter tip is configured to pass through the aperture into a blood vessel over an access needle after the aperture is formed by the access needle. 
     
     
         3 . The vascular access catheter according to  claim 2 , configured for gradually stretching the skin tissue while expanding the aperture for reducing pain associated with catheter penetration through skin into a blood vessel over a needle. 
     
     
         4 . The vascular access catheter according to  claim 1 , wherein the bottom edge portion and/or the top edge portion is curved generally proximally. 
     
     
         5 . The vascular access catheter according to  claim 1 , configured such that the lateral leading edges penetrate through the aperture before the bottom edge portion and the top edge portion, when pushed through the aperture at an acute angle relative to an outer surface of the bodily tissue. 
     
     
         6 . The vascular access catheter according to  claim 1 , wherein each of the lateral leading edges is curved upwardly and proximally from the respective front portion of the distal edge. 
     
     
         7 . The vascular access catheter according to  claim 1 , wherein the lumen is cylindrical along a portion of the catheter body proximally to the catheter tip and tapers along a portion of the catheter tip. 
     
     
         8 . The vascular access catheter according to  claim 1 , wherein radius of curvature of each of the lateral leading edges is smallest adjacent to the respective front portion and/or greatest adjacent to the bottom edge portion. 
     
     
         9 . The vascular access catheter according to  claim 1 , wherein radius of curvature of each of the lateral leading edges gradually increases between the respective front portion and the bottom edge portion. 
     
     
         10 . The vascular access catheter according to  claim 1 , wherein the bottom edge portion includes or merges with a sliding surface, the sliding surface is at least partially parallel, or inclined at a shallow angle, to the bottom edge portion. 
     
     
         11 . The vascular access catheter according to  claim 10 , wherein the sliding surface forms a shaped area bounded by and between a distal parabola and a proximal parabola, the distal parabola has a smaller focal length than the proximal parabola. 
     
     
         12 . The vascular access catheter according to  claim 10 , wherein the sliding surface is at least partially curved. 
     
     
         13 . A vascular access kit, comprising:
 the vascular access catheter according to  claim 1 , and   an access needle comprising a beveled tip ending with a distal sharp needle edge.   
     
     
         14 . The kit according to  claim 13 , comprising coupling means configured to fixedly connect the catheter body to the access needle, wherein the beveled tip protrudes distally from the lumen through the opening, such that a plane of symmetry of the access needle coincides with the median plane and the beveled tip is inclined distally and downwardly towards the distal sharp needle edge from a top needle end extending through the opening top portion to a bottom needle end extending through the opening bottom portion. 
     
     
         15 . The kit according to  claim 14 , wherein the catheter is configured to accommodate the access needle through the lumen and the opening in at least two configurations comprising a tissue-penetration configuration wherein the beveled tip fully extends from the lumen distally to the catheter distal end, and a safety configuration wherein the beveled tip fully resides within the lumen proximally to the catheter distal end. 
     
     
         16 . A method for inserting a catheter into a blood vessel using the kit of  claim 13 , the method comprising:
 providing the vascular access catheter connected to the access needle, wherein the beveled tip protrudes distally from the lumen through the opening, such that a plane of symmetry of the access needle coincides with the median plane and the beveled tip is inclined distally and downwardly towards the distal sharp needle edge from a top needle end extending through the opening top portion to a bottom needle end extending through the opening bottom portion;   forming an aperture in a skin tissue covering the blood vessel with the beveled tip;   pushing the catheter body through the aperture at an acute angle relative to an outer surface of the skin tissue, thereby expanding the aperture sideways perpendicularly to the median plane with the pair of lateral leading edges followed by gradually expanding the aperture downwardly in parallel to the median plane until the bottom edge portion penetrates through the aperture.   
     
     
         17 . The method according to  claim 16 , wherein the top edge portion penetrates through the aperture following full or partial penetration of the bottom edge portion. 
     
     
         18 . The method according to  claim 16 , comprising inserting the beveled tip and/or the catheter tip into the blood vessel until visualizing blood drawn from the blood vessel into the access needle and/or the catheter body. 
     
     
         19 . The method according to  claim 18 , wherein the inserting is followed by pushing the catheter body distally relative to access needle and removing the access needle from the blood vessel. 
     
     
         20 . The method according to  claim 18 , wherein the inserting is followed by penetrating across a wall of the blood vessel such that the beveled tip protrudes distally from the blood vessel, then drawing the beveled tip back into the blood vessel until visualizing blood drawn from the blood vessel into the access needle and/or the catheter body, and then pushing the catheter body distally relative to access needle and removing the access needle from the blood vessel.