Catheter for delivering therapeutic and/or diagnostic agents to the tissue surrounding a bodily passageway
First Claim
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1. A catheter for delivering therapeutic and/or diagnostic agents directly into tissue surrounding a bodily passageway, comprising:
- an elongated body having a distal portion and a proximal portion, said distal portion including a distal surface;
means for directing said elongated body through said bodily passageway so that said distal portion is positioned at a predetermined location therein;
first and second lumens communicating between said distal surface and said proximal portion of said elongated body, said first lumen communicating with said distal surface through a needle exit opening disposed therein;
a needle cannula slidably disposed in said first lumen, said needle cannula comprising a distal portion and a proximal portion, said proximal portion being adapted to be connected to means for dispensing said therapeutic and/or diagnostic agents;
said needle cannula being adapted for movement between (i) a first retracted position wherein said distal portion of said needle cannula is withdrawn inboard of said distal surface, and (ii) a second extended position wherein said distal portion of said needle cannula extends a predetermined distance outboard of said distal surface; and
a balloon fixedly and sealably secured to said distal portion of said elongated body and in fluid communication with said second lumen for dilating said bodily passageway when said balloon is inflated and compacting plaque that has been deposited in said passageway, said balloon extending both longitudinally and circumferentially along only a side portion of said distal portion of said catheter so as to be in opposing radial alignment with said needle exit opening such that when said balloon is fully inflated (i) fluid flow is not restricted through said bodily passageway, and (ii) said needle cannula may be extended said predetermined distance into said tissue surrounding said bodily passageway at a predetermined location.
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Abstract
A catheter for delivering therapeutic and/or diagnostic agents directly into the tissue surrounding a bodily passageway. The catheter comprises at least one needle cannula able to be projected outboard of the catheter so as to deliver the desired agents to the tissue. The catheter also preferrably includes one or more inflatable balloons.
551 Citations
16 Claims
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1. A catheter for delivering therapeutic and/or diagnostic agents directly into tissue surrounding a bodily passageway, comprising:
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an elongated body having a distal portion and a proximal portion, said distal portion including a distal surface; means for directing said elongated body through said bodily passageway so that said distal portion is positioned at a predetermined location therein; first and second lumens communicating between said distal surface and said proximal portion of said elongated body, said first lumen communicating with said distal surface through a needle exit opening disposed therein; a needle cannula slidably disposed in said first lumen, said needle cannula comprising a distal portion and a proximal portion, said proximal portion being adapted to be connected to means for dispensing said therapeutic and/or diagnostic agents; said needle cannula being adapted for movement between (i) a first retracted position wherein said distal portion of said needle cannula is withdrawn inboard of said distal surface, and (ii) a second extended position wherein said distal portion of said needle cannula extends a predetermined distance outboard of said distal surface; and a balloon fixedly and sealably secured to said distal portion of said elongated body and in fluid communication with said second lumen for dilating said bodily passageway when said balloon is inflated and compacting plaque that has been deposited in said passageway, said balloon extending both longitudinally and circumferentially along only a side portion of said distal portion of said catheter so as to be in opposing radial alignment with said needle exit opening such that when said balloon is fully inflated (i) fluid flow is not restricted through said bodily passageway, and (ii) said needle cannula may be extended said predetermined distance into said tissue surrounding said bodily passageway at a predetermined location. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 10, 11, 12, 13, 14, 15, 16)
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9. A method for delivering therapeutic and/or diagnostic agents directly into tissue surrounding a bodily passageway, said method comprising the steps of:
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(1) providing a catheter comprising; an elongated body having a distal portion and a proximal portion, said distal portion including a distal surface; means for directing said elongated body through said bodily passageway so that said distal portion is positioned at a predetermined location therein; a first lumen communicating between said distal surface and said proximal portion of said elongated body, said first lumen communicating with said distal surface through a needle exit opening disposed therein; a needle cannula slidably disposed in said first lumen, said needle cannula comprising a distal portion and a proximal portion, said proximal portion being adapted to be connected to means for dispensing said therapeutic and/or diagnostic agents; said needle cannula being adapted for movement between (i) a first retracted position wherein said distal portion of said needle cannula is withdrawn inboard of said distal surface, and (ii) a second extended position wherein said distal portion of said needle cannula extends a predetermined distance outboard of said distal surface; and a balloon fixedly and sealably secured to said distal portion of said elongated body and in fluid communication with an inflation/deflation lumen for dialating said bodily passageway and compacting plaque that has been deposited therein, said balloon extending both longitudinally and circumferentially along only a side portion of said distal portion of said catheter so as to be in opposing radial alignment with said needle exit opening such that when said balloon is fully inflated (i) fluid flow is not restricted through said bodily passageway, and (ii) said needle cannula may be extended said predetermined distance into said tissue surrounding said bodily passageway at a predetermined location; (2) positioning said needle cannula in its said first retracted position and placing said balloon in its deflated state; (3) positioning said catheter in said predetermined location in said bodily passageway; (4) inflating said balloon so as to fixedly position said catheter within said bodily passageway; (5) moving said needle cannula from said first fully retracted position to said second extended position, whereby a distal end of said needle cannula penetrates tissue surrounding said bodily passageway; (6) dispensing said therapeutic and/or diagnostic agents from said distal end of said needle cannula; (7) moving said needle cannula from said second extended position back into said first retracted position; (8) deflating said balloon; and (9) removing said catheter from said bodily passageway.
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Specification