Infusion device and method

Abstract

Devices and methods for performing improved percutaneous myocardial revascularization (PMR) procedures. One device includes a preassembled PMR drug delivery catheter and a drug neutralizing vial. The vial assembly allows prepping the PMR catheter by flushing drug through distal needle, and into a vial cavity where the drug is neutralized by a neutralizing agent. One set of devices includes needles having protrusions secured to the distal regions of drug delivery tubes. One needle has outward protruding barbs engaging the inner tube wall while another needle has outward threads which can screw into the tube inner wall. Radiopaque marker bands are also included in the present invention which are asymmetrically distributed on the catheter shaft, allowing a treating physician to determine under fluoroscopy whether the catheter distal region is pointed away or toward the treating physician, as well as determining whether the catheter distal region is rotated toward or away from the treating physician. PMR devices include catheters having dual injection needles, for both injecting a drug into the heart wall and a radiopaque contrast media to mark the already treated sites. One PMR injection device has multiple stops for allowing controlled, variable needle depth penetration with a single distal needle tip.

1 . A catheter comprising: 
 an elongate shaft having a central longitudinal axis, a radial dimension extending outward from said central axis, and a distal region, wherein a plane bisecting said shaft through said longitudinal axis defines a shaft first portion and a shaft second portion opposite said shaft first portion; and    a radiopaque marker disposed in said shaft distal region, wherein said radiopaque marker is asymmetric about said bisecting plane, such that said catheter distal portion appears differently under fluoroscopy when viewed from an angle less than ninety degrees (90°) to said plane than when viewed from an angle greater than ninety degrees (90°) to said plane.    
   
   
       2 . A catheter as in  claim 1 , wherein said marker is asymmetric with respect to a transverse bisecting plane through said shaft and marker.  
   
   
       3 . A catheter as in  claim 1 , wherein said marker includes more than one region, and said regions are contiguous with each other.  
   
   
       4 . A catheter as in  claim 1 , wherein said marker includes a first portion transverse to said central longitudinal axis and a second portion parallel to said longitudinal axis.  
   
   
       5 . A catheter as in  claim 1 , wherein said marker includes more than one region, and said regions are not all contiguous with each other.  
   
   
       6 . A catheter as in  claim 1 , wherein said radiopaque marker includes a first arcuate portion disposed about said shaft and a second linear portion disposed along said shaft and substantially parallel to said shaft longitudinal axis.  
   
   
       7 . A catheter as in  claim 6 , wherein said first arcuate portion includes an annular portion about said shaft and contiguous with said second marker portion.  
   
   
       8 . A catheter as in  claim 1 , wherein said marker includes a first portion extending along said shaft length parallel to said central longitudinal axis and a second portion extending transversely to said shaft central axis.  
   
   
       9 . A catheter as in  claim 8 , wherein said shaft has a length and a circumference, wherein said marker first portion includes an arcuate shell extending along said shaft length in an annular fashion around less than all of said shaft length in an annular fashion around less than all of said shaft circumference, wherein said second marker portion is an annular band extending transversely to said central axis.  
   
   
       10 . A catheter as in  claim 1 , wherein said first marker portion includes a first arcuate shell on one side of said bisection plane, wherein said second marker portion includes a second arcuate shell disposed on the other side of said bisection plane relative to said first arcuate shell, wherein said first and second arcuate shells are disposed over different lengths on said shaft.  
   
   
       11 . A catheter as in  claim 10 , wherein said catheter shaft has a bend, and said marker is disposed proximal of said bend.  
   
   
       12 . A catheter as in  claim 10 , wherein said arcuate shells are substantially annular.