System and method for establishing vascular access

Abstract

Systems, kits, and methods for establishing vascular access are described. A system typically includes a radially expandable sleeve, a dilator, and a guidewire. The methods comprise positioning the guidewire through an initial tissue tract, passing the radially expandable sleeve over the guidewire through the tissue tract to a target blood vessel, and thereafter passing the dilator over the guidewire and through the radially expandable sleeve to effect radial expansion of the sleeve. Use of the sleeve reduces the risk of injuring tissue surrounding the tissue tract by lessening the axial forces imparted to the tissue. Kits comprise at least the radially expandable sleeve together with instructions for use.

1 . A method for establishing vascular access comprising the steps of:
 introducing a distal end of a guidewire into a target vessel;   introducing a radially expandable sleeve over the guidewire such that a distal end of the sleeve lies within the target vessel; and   introducing a dilator over a proximal end of the guidewire and into a proximal end of the sleeve, and advancing the dilator distally along the guidewire and into the sleeve to effectuate radial expansion of the sleeve.   
   
   
       2 . The method of  claim 1 , further comprising the step of providing a dilator including an outer sheath at least partially surrounding a removable inner member, and removing the inner member of the introduced dilator, whereby the outer sheath of the dilator is left in place within the sleeve. 
   
   
       3 . The method of  claim 1 , further comprising the step of providing a dilator defining a longitudinal lumen therethrough having an internal dimension between approximately 0.46 mm and approximately 1.0 mm. 
   
   
       4 . The method of  claim 3 , wherein the step of providing a dilator includes providing a dilator having an outer dimension between approximately 1.0 mm and approximately 3.3 mm. 
   
   
       5 . The method of  claim 4 , wherein the step of providing a dilator includes providing a dilator having an outer dimension between approximately 1.3 mm and approximately 2.5 mm. 
   
   
       6 . The method of  claim 1 , further comprising the step of providing a radially expandable sleeve including a tubular braid formed of a mesh of non-elastic filaments which shorten axially as they are expanded radially. 
   
   
       7 . A method for establishing access to a vascular lumen, the method comprising the steps of:
 positioning a guidewire through tissue such that a distal end thereof is disposed within the vascular lumen;   providing an access assembly including a sleeve introducer positioned within a radially expandable sleeve;   introducing the access assembly over the guidewire such that a distal end of the sleeve lies within a target vessel; and   introducing a dilator over the sleeve introducer such that the dilator is disposed between the sleeve introducer and the radially expandable sleeve, wherein the dilator has a diameter that is larger than an initial diameter of the radially expandable sleeve, whereby the dilator radially enlarges a tissue tract formed in the tissue and facilitates access to the vascular lumen.   
   
   
       8 . The method of  claim 7 , further including the step of removing the sleeve introducer and the guidewire from the vascular lumen, thereby leaving the dilator in place within the sleeve. 
   
   
       9 . The method of  claim 7 , wherein the step of positioning a sleeve introducer within a radially expandable sleeve includes positioning a sleeve introducer having a tapered distal member with a shaft extending proximally therefrom within the radially expandable sleeve, the distal member being configured and dimensioned to facilitate passage of the access assembly through a tissue tract formed in the tissue to the vascular lumen. 
   
   
       10 . The method of  claim 9 , wherein the step of positioning a sleeve introducer within a radially expandable sleeve includes positioning a sleeve introducer including a shaft defining a lumen therethrough that is configured to receive the guidewire. 
   
   
       11 . The method of  claim 10 , wherein the step of positioning a sleeve introducer within a radially expandable sleeve includes positioning a sleeve introducer in which the tapered distal member of the sleeve introducer has a proximal end defining a radial dimension substantially equal to an outer radial dimension defined by the distal end of the radially expandable sleeve. 
   
   
       12 . The method of  claim 9 , wherein the step of introducing a dilator includes introducing a dilator defining a longitudinal lumen therethrough configured to receive the shaft of the sleeve introducer. 
   
   
       13 . The method of  claim 12 , wherein the step of introducing a dilator includes introducing a dilator defining a longitudinal lumen therethrough with an internal dimension between approximately 0.46 mm and approximately 1.0 mm. 
   
   
       14 . The method of  claim 12 , wherein the step of introducing a dilator includes introducing a dilator having an outer radial dimension along its entire length that is larger than an inner radial dimension of the sleeve such that insertion of the dilator into the sleeve effectuates radial expansion of the sleeve. 
   
   
       15 . The method of  claim 14 , wherein the step of positioning a sleeve introducer within a radially expandable sleeve includes positioning a sleeve introducer within a radially expandable sleeve having a tubular braid formed of a mesh of non-elastic filaments which shorten axially as they are expanded radially. 
   
   
       16 . The method of  claim 14 , wherein the step of introducing a dilator includes introducing a dilator having an outer dimension between approximately 1.0 mm and approximately 3.3 mm. 
   
   
       17 . An improved method of establishing percutaneous access to a target vessel over a guidewire positioned within a tissue tract and having a distal end positioned within the target vessel, wherein the improved method comprises the steps of:
 positioning a sleeve introducer within a radially expandable sleeve to form an access assembly;   introducing and advancing the access assembly over the guidewire such that a distal end of the radially expandable sleeve lies within the target vessel; and   introducing a dilator over the sleeve introducer and into the radially expandable sleeve to thereby enlarge the tissue tract and facilitate expanded access to the target vessel.   
   
   
       18 . The improved method of  claim 17 , wherein the step of positioning a sleeve introducer within a radially expandable sleeve includes positioning a sleeve introducer having a tapered distal member with a shaft extending proximally therefrom, the tapered distal member being configured and dimensioned to facilitate passage of the access assembly through the tissue tract to the target vessel. 
   
   
       19 . The improved method of  claim 18 , wherein the step of positioning a sleeve introducer within a radially expandable sleeve includes positioning a sleeve introducer wherein the shaft defines a lumen therethrough that is configured to receive the guidewire. 
   
   
       20 . The method of  claim 19 , wherein the step of positioning a sleeve introducer within a radially expandable sleeve includes positioning a sleeve introducer wherein the distal member of the sleeve introducer has a proximal end defining a radial dimension substantially equal to an outer radial dimension defined by the distal end of the sleeve, wherein the distal member tapers distally from the proximal end thereof.