Drug delivery PTCA catheter and method for drug delivery
First Claim
1. An intravascular drug delivery dilatation catheter comprising:
- an elongated, flexible, tubular catheter shaft having a proximal end and a distal end with a first, second and third lumen each extending therealong, said shaft having first and second inflatable balloons longitudinally spaced from one another proximate said distal end and with a drug delivery region disposed between said first and second balloons, said first and second lumens being in fluid communication with said first and second balloons, respectively, and said third lumen being in fluid communication with said drug delivery region, said second balloon when inflated having an outer contoured surface for creating a fluid flow path from said drug delivery region and along said second balloon outer surface when said second balloon is inflated in a patient'"'"'s blood vessel.
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Accused Products
Abstract
An intravascular material delivery dilation catheter having a pair of longitudinally spaced inflatable balloons with a drug delivery region defined therebetween. The catheter is ideally suited for use after a PTCA procedure, wherein the proximate balloon seals the blood vessel while the distal balloon is uniquely contoured when inflated to define fluid communication paths therepast and proximate a blood vessel to be treated. The distal balloon, when inflated, has four lobes but could also be textured. Each lobe is separated from the next by a groove, which groove in combination with the blood vessel inner wall forms a fluid communication path therebetween. Upon inflation of both balloons in a blood vessel, a medicament such as heparin can be injected, via the drug delivery region between the inflated balloons, wherein the medicament flows past the distal balloon at a selected rate. Accordingly, a medicament can be injected directly to a treatment site rather than injected as a bolus dose, thus, a smaller dosage may be employed to minimize side effects. Alternatively, perfusion can be accomplished by only partially inflating the proximate balloon to constrict flow therepast, or eliminating the proximate balloon entirely, where the drug delivery region is disposed upstream of the contoured distal balloon.
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Citations
34 Claims
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1. An intravascular drug delivery dilatation catheter comprising:
an elongated, flexible, tubular catheter shaft having a proximal end and a distal end with a first, second and third lumen each extending therealong, said shaft having first and second inflatable balloons longitudinally spaced from one another proximate said distal end and with a drug delivery region disposed between said first and second balloons, said first and second lumens being in fluid communication with said first and second balloons, respectively, and said third lumen being in fluid communication with said drug delivery region, said second balloon when inflated having an outer contoured surface for creating a fluid flow path from said drug delivery region and along said second balloon outer surface when said second balloon is inflated in a patient'"'"'s blood vessel. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10)
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11. An intravascular drug delivery catheter, comprising:
an elongated, flexible, tubular catheter shaft having a proximal end and a distal end with a first and second lumen extending therealong, said shaft having an inflatable balloon disposed at the distal end thereof and with a drug delivery region disposed between said proximal end and said balloon, said first lumen being in fluid communication with said balloon and said second lumen being in communication with said drug delivery region, said balloon when inflated having an outer contoured surface for creating a fluid flow path from said drug delivery region and along said balloon outer surface when said balloon is inflated in a patient'"'"'s blood vessel. - View Dependent Claims (12, 13, 14, 15, 16, 17, 18, 19, 20)
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21. A method of delivering a dispersant into a selected portion of a patient'"'"'s blood vessel comprising steps of:
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(a) providing an elongated, flexible catheter having first and second inflatable balloons longitudinally spaced from one another proximate a distal end of said catheter with a drug delivery region disposed between said first and second balloons; (b) inserting said catheter into the patient'"'"'s blood vessel such that said second balloon is disposed adjacent an inner wall of said blood vessel along said selected portion thereof; (c) inflating said first balloon to seal against the blood vessel inner wall; (d) inflating said second balloon such that a first portion thereof is disposed closely proximate but spaced from said blood vessel'"'"'s inner wall; (e) injecting said dispersant through said drug delivery region into the blood vessel between said first and second balloon such that the dispersant flows between and past said inflated second balloon and said blood vessel inner wall. - View Dependent Claims (22, 23, 24)
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25. A method of delivering a dispersant into a selected portion of a patient'"'"'s blood vessel, comprising the steps of:
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(a) providing a catheter having a first and second longitudinally spaced flow impeding members with a drug delivery region defined therebetween; (b) disposing said catheter in said patient'"'"'s blood vessel such that said first flow impeding member is positioned upstream of said blood vessel selected portion and said second flow impeding member is positioned downstream thereof and closely proximate said blood vessel selected portion; (c) impeding flow in said blood vessel at said first flow impeding member, and impeding flow in said blood vessel at said second flow impeding member such that a fluid can flow past said second flow impeding member and adjacent the blood vessel selected portion; and (d) dispensing a dispersant from the catheter drug delivery region such that said dispersant flows past said second flow impeding member and closely proximate said blood vessel selected portion. - View Dependent Claims (26, 27, 28, 29, 30, 31)
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32. A method of delivering a dispersant into a selected portion of a patient'"'"'s blood vessel, comprising the steps of:
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(a) providing a catheter having a proximate end and a distal end, a first flow impeding member at said distal end, and a drug delivery region disposed between said catheter proximate end and said flow impeding member; (b) disposing said catheter in said patient'"'"'s blood vessel such that said flow impeding member is positioned proximate said blood vessel selected portion and said drug delivery region is positioned upstream thereof; (c) impeding flow in said blood vessel at said flow impeding member such that fluid can flow past said flow impeding member and adjacent said blood vessel selected portion; and (d) dispensing a dispersant from the catheter drug delivery region such that said dispersant flows past said flow impeding member and closely proximate said blood vessel selected portion. - View Dependent Claims (33, 34)
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Specification