Methods and apparatus for inserting multi-lumen spit-tip catheters into a blood vessel

Abstract

Methods and apparatus are disclosed for inserting flexible, multi-lumen catheters into blood vessels, and in particular, for inserting flexible, split-tip catheters into blood vessels. The invention accomplishes these objects by temporarily stiffening each catheter lumen and tip independently through use of intra-catheter stiffener elements disposed within the catheter lumens. This provides means for advancing the catheter/stiffeners assembly through a subcutaneous tunnel, and over a plurality of guidewires until a distal tip of the catheter is at a desired position within the vessel. The intra-catheter stiffener elements are sufficiently stiffening to allow advancing the catheter over guidewires, but sufficiently flexible to allow bending and looping of the catheter for proper placement within the vessel.

What is claimed is:  
     
         1 . A method for inserting a multi-lumen catheter into a blood vessel comprising: 
 inserting a distal portion of each of a plurality of guidewires into a vessel at a first location;    inserting an intra-catheter stiffening element into a proximal end of each lumen of a multi-lumen catheter, the catheter having a distal portion for placement in the vessel and a proximal end for connection to a treatment device and further having a plurality of lumens;    threading a proximal end of each of the guidewires through a distal end of a respective intra-catheter stiffening element until said guidewire exits the proximal end of the catheter;    advancing the catheter into a desired location within the vessel; and    removing each of the guidewires and each of the intra-catheter stiffener elements from the lumens of the catheter.    
     
     
         2 . The method of  claim 1 , wherein advancing the catheter into a desired location within the vessel further comprises: 
 advancing the catheter over the guidewires until a distal end of the catheter is adjacent to the vessel; and    further advancing the catheter and the guidewires into the vessel until the distal portion of the catheter is at the desired location within the vessel.    
     
     
         3 . The method of  claim 1 , further comprising dilating the blood vessel subsequent to inserting a first guidewire.  
     
     
         4 . The method of  claim 3 , further comprising dilating the blood vessel using a size 6-French sheath/dilator.  
     
     
         5 . The method of  claim 1 , further comprising coupling a proximal end of each said intra- catheter stiffening element to a proximal end of a respective catheter lumen.  
     
     
         6 . The method of  claim 1 , wherein the step of advancing the catheter into a desired location within the vessel comprises twisting the catheter while advancing.  
     
     
         7 . The method of  claim 1 , wherein the catheter has a split-tip.  
     
     
         8 . A method for inserting a multi-lumen catheter into a blood vessel comprising: 
 inserting a distal portion of each of a plurality of guidewires into a vessel at a first location;    forming a subcutaneous tunnel between the first location and a second location;    passing a catheter through the tunnel, the catheter having a distal portion for placement in the vessel and a proximal end for connection to a treatment device and further having a plurality of lumens;    inserting an intra-catheter stiffener element into the proximal end of each of the catheter lumens;    threading a proximal end of each of the guidewires through a distal end of a respective intra-catheter stiffener element until said guidewire exits the proximal end of the catheter;    advancing the catheter into a desired location within the vessel; and    removing each of the guidewires and each of the intra-catheter stiffener elements from the lumens of the catheter.    
     
     
         9 . The method of  claim 8 , wherein advancing the catheter into a desired location within the vessel further comprises: 
 advancing the catheter over the guidewires until a distal end of the catheter is adjacent to the vessel; and    further advancing the catheter and the guidewires into the vessel until the distal portion of the catheter is at the desired location within the vessel.    
     
     
         10 . The method of  claim 8 , further comprising dilating the blood vessel subsequent to inserting a first guidewire.  
     
     
         11 . The method of  claim 10 , further comprising dilating the blood vessel using a size 6-French sheath/dilator.  
     
     
         12 . The method of  claim 8 , wherein forming a subcutaneous tunnel further comprises 
 inserting a distal end of a pointed stylet through the skin at the second location; and    pushing the stylet toward the first location until the distal end of the stylet extends therefrom.    
     
     
         13 . The method of  claim 12 , wherein the step of passing a catheter through the tunnel further comprises: 
 removeably attaching the distal end of the catheter to the proximal end of a stylet;    pulling the stylet toward the first location until the distal end of the catheter extends therefrom; and    releasing the catheter from the stylet.    
     
     
         14 . The method of  claim 12 , wherein the stylet has a shape adapted to tunnel through subcutaneous tissue.  
     
     
         15 . The method of  claim 8 , wherein each intra-catheter stiffener element is inserted into the catheter prior to passage of the catheter through the tunnel.  
     
     
         16 . The method of  claim 8 , wherein each intra-catheter stiffener element is inserted into the catheter after passage of the catheter through the tunnel.  
     
     
         17 . The method of  claim 8 , wherein the proximal end of each catheter lumen has a coupler adapted to mate with a coupler disposed at the proximal end of an intra-catheter stiffener element.  
     
     
         18 . The method of  claim 8 , further comprising dilating the vessel to accommodate the distal portion of the catheter.  
     
     
         19 . The method of  claim 18 , further comprising: 
 dilating the vessel with a first dilator; and    dilating the vessel with at least one larger further dilator.    
     
     
         20 . The method of  claim 19 , wherein the larger further dilators are adapted to dilate the vessel to slidably receive the distal portion of the catheter having each catheter lumen stiffened by a respective intra-catheter stiffener element disposed therein.  
     
     
         21 . The method of  claim 19 , wherein the first dilator is a size 12-French dilator.  
     
     
         22 . The method of  claim 19 , wherein the further dilators are any of the group consisting of a size 14-French and a 16-French dilator.  
     
     
         23 . The method of  claim 8 , wherein the step of advancing the catheter further comprises looping the catheter between the first location and the vessel so as to facilitate advancing the distal portion of the catheter into the vessel.  
     
     
         24 . The method of  claim 23 , further comprising pulling the proximal end of the catheter to remove the loop subsequent to advancing the distal portion of the catheter into the vessel.  
     
     
         25 . The method of  claim 8 , wherein the step of advancing the catheter further comprises twisting the catheter to facilitate advancement of the distal portion of the catheter to the desired location within the vessel.  
     
     
         26 . The method of  claim 8 , further comprising coupling the catheter to a hemodialysis treatment device.  
     
     
         27 . The method of  claim 26 , wherein the catheter is a dual-lumen antegrade tunneled hemodialysis catheter.  
     
     
         28 . A method for inserting a multi-lumen catheter into a blood vessel comprising: 
 inserting a distal portion of each of a plurality of guidewires into a vessel at a first location;    placing intra-catheter stiffener elements into each lumen of a multi-lumen catheter;    threading a proximal end of each of the guidewires through a distal end of a respective intra-catheter stiffener element disposed within the catheter lumen until said guidewire exits a proximal end of the intra-catheter stiffener element;    advancing the catheter into a desired location within the vessel;    removing each of the guidewires and each of the intra-catheter stiffener elements from the lumens of the catheter;    forming a subcutaneous tunnel between the first location and a second location;    passing the catheter through the tunnel; and    connecting an adapter to a proximal end of each of the catheter lumens, the adapter configured to connect to a treatment device.    
     
     
         29 . The method of  claim 28 , wherein advancing the catheter into a desired location within the vessel comprises 
 advancing the catheter over the guidewires until the distal end of the catheter is adjacent to the vessel; and    further advancing the catheter and the guidewires into the vessel until the distal end of the catheter is at the desired location within the vessel.    
     
     
         30 . The method of  claim 28 , further comprising dilating the blood vessel subsequent to inserting a first guidewire.  
     
     
         31 . The method of  claim 30 , further comprising dilating the blood vessel using a size 6-French sheath/dilator.  
     
     
         32 . The method of  claim 28 , wherein forming a subcutaneous tunnel further comprises: 
 inserting a distal end of a pointed stylet through the skin at the first location; and    pushing the stylet toward the second location until the distal end of the stylet extends therefrom.    
     
     
         33 . The method of  claim 28 , wherein the step of passing a catheter through the tunnel further comprises: 
 removeably attaching the proximal end of the catheter to the proximal end of a stylet;    pulling the stylet back toward the second location until the proximal end of the catheter extends therefrom; and    releasing the catheter from the stylet.    
     
     
         34 . The method of  claim 33 , wherein the distal end of the stylet has a sharpened point adapted to tunnel through subcutaneous tissue.  
     
     
         35 . The method of  claim 33 , wherein the proximal end of the stylet has a feature adapted to removably affix the proximal end of the catheter.  
     
     
         36 . The method of  claim 28 , wherein each intra-catheter stiffener element releasably attaches to the proximal end of its respective catheter lumen.  
     
     
         37 . The method of  claim 36 , wherein each intra-catheter stiffener element stiffens its respective catheter lumen.  
     
     
         38 . The method of  claim 36 , wherein the proximal end of each catheter lumen has a removable coupler adapted to mate with a coupler disposed at the proximal end of an intra-catheter stiffener element.  
     
     
         39 . The method of  claim 28 , further comprising dilating the vessel to accommodate the distal portion of the catheter.  
     
     
         40 . The method of  claim 39 , further comprising: 
 dilating the vessel with a first dilator; and    dilating the vessel with at least one larger further dilator.    
     
     
         41 . The method of  claim 40 , wherein the larger further dilators are adapted to dilate the vessel to slidably receive the distal portion of the catheter having each catheter lumen stiffened by a respective intra-catheter stiffener element disposed therein.  
     
     
         42 . The method of  claim 40 , wherein the first dilator is a size 12-French dilator.  
     
     
         43 . The method of  claim 40 , wherein the further dilators are any of the group consisting of a size 14-French and 16-French dilator.  
     
     
         44 . The method of  claim 28 , further comprising coupling the catheter to a hemodialysis device.  
     
     
         45 . The method of  claim 44 , wherein the catheter is a dual-lumen retrograde tunneled hemodialysis catheter.  
     
     
         46 . A kit for applying a multi-lumen catheter into a blood vessel comprising: 
 a plurality of guidewires, each adapted to have a distal portion inserted in a blood vessel; and    a plurality of intra-catheter stiffener elements, each of the intra-catheter stiffener elements sized to be slidably disposed within a lumen of a multi-lumen catheter and each having a lumen sized to slide over a guidewire.    
     
     
         47 . The kit of  claim 46 , further comprising a vessel dilator adapted to be advanced into the blood vessel over a first inserted guidewire, the vessel dilator sized to dilate the blood vessel to accommodate insertion of further ones of the guidewires.  
     
     
         48 . The kit of  claim 47 , wherein the vessel dilator is a size 6-French sheath/dilator.  
     
     
         49 . The kit of  claim 49 , further comprising at least one further vessel dilator sized to dilate a blood vessel to accommodate insertion of a catheter.  
     
     
         50 . The kit of  claim 49 , wherein the further vessel dilators are any size of the group consisting of size 12-French, 14-French and 16-French.  
     
     
         51 . The kit of  claim 46 , wherein the intra-catheter stiffener elements have a tapered distal portion.  
     
     
         52 . The kit of  claim 46 , wherein each intra-catheter stiffener element has a coupler disposed at a proximal end adapted to releasably couple to a coupler disposed at the proximal end of a respective catheter lumen.  
     
     
         53 . The kit of  claim 52 , wherein the intra-catheter stiffener elements are releasably coupled to a proximal end of the catheter lumens.  
     
     
         54 . The kit of  claim 52 , wherein the intra-catheter stiffener elements have a predefined length corresponding to a length of a catheter selected for use in a particular application.  
     
     
         55 . The kit of  claim 54 , wherein the catheter is a hemodialysis catheter.  
     
     
         56 . The kit of  claim 46 , further comprising a multi-lumen catheter.  
     
     
         57 . The kit of  claim 56 , wherein the intra-catheter stiffener elements are pre-disposed within the lumens of the catheter.  
     
     
         58 . A kit for applying a multi-lumen catheter into a blood vessel comprising: 
 a multi-lumen catheter comprising a distal portion to be placed in a blood vessel and a coupler disposed at a proximal end of each catheter lumen; and    a plurality of intra-catheter stiffener elements, each of the intra-catheter stiffener elements sized to be slidably disposed within a lumen of the catheter and each having a lumen sized to slide over a guidewire, the intra-catheter stiffener elements having a tapered distal portion and a proximal end having a coupler adapted to mate with the coupler at the proximal end of a catheter lumen.    
     
     
         59 . The kit of  claim 58 , further comprising a vessel dilator adapted to be advanced into the blood vessel over a first inserted guidewire, the vessel dilator sized to dilate the blood vessel to accommodate insertion of further ones of the guidewires.  
     
     
         60 . The kit of  claim 59 , wherein the vessel dilator is a size 6-French sheath/dilator.  
     
     
         61 . The kit of  claim 60 , further comprising at least one further vessel dilator sized to dilate a blood vessel to accommodate insertion of a catheter.  
     
     
         62 . The kit of  claim 61 , wherein the further vessel dilators are any size of the group consisting of 12-French, 14-French and 16-French.  
     
     
         63 . The kit of  claim 58 , wherein the intra-catheter stiffener elements have a predefined length corresponding to a length of the catheter selected.  
     
     
         64 . The kit of  claim 58 , wherein the intra-catheter stiffener elements have an exterior shape sized to be received by an interior shape of the catheter lumens.  
     
     
         65 . The kit of  claim 58 , wherein the intra-catheter stiffener elements are pre-disposed within the lumens of the catheter.  
     
     
         66 . The kit of  claim 58 , wherein the catheter is a hemodialysis catheter.  
     
     
         67 . The kit of  claim 58 , wherein the distal portion of the catheter has a split-tip.