Intravascular drug delivery dilatation catheter

• US 4,994,033 A
• Filed: 05/25/1989
• Issued: 02/19/1991
• Est. Priority Date: 05/25/1989
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Schneider Electric SE
• Inventors: Van Tassel, Robert A., Shockey, Rick L.
• Primary Examiner(s): NOT, DEFINED
• Assistant Examiner(s): NOT, DEFINED
• Application Number:
  US07/356,520
• Time in Patent Office: 635 Days
• Field of Search: 604/52, 604/53, 604/96, 604/101, 604/102, 604/103, 604/264, 604/280, 606/191, 606/192, 606/194, 128/207.15
• US Class Current: 604/101.02
• CPC Class Codes: A61B 2017/22082 after introduction of a substance
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61M 16/0456 one cuff within another
• CPC Class Codes: A61M 16/0481 through the cuff wall
• CPC Class Codes: A61M 2025/1013 with concentrically mounted balloons, e.g. being independently inflatable
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

An intravascular catheter designed to apply a liquid medicament or other substance to a stenotic lesion as the blood vessel is undergoing dilatation to facilitate the restoration and long-term maintenance of patency to the blood vessel. It comprises three concentrically arranged flexible plastic tubes and a pair of concentrically arranged expander members located at the distal end of the tubes. The space between the outer wall of the inner tube and the inner wall of the intermediate tube is in fluid communication with the interior of the first expander member while the space between the outer wall of the intermediate tube and the inner wall of the outer tube is in fluid communication with the interior of the second expander member. A plurality of minute holes are formed through the second expander member such that when the liquid medicament is introduced into the lumen of the outer tube while an inflation fluid is introduced into the lumen of the intermediate tube, both expander members inflate with the drug or other substance being ejected out through the tiny pores of the outermost expander member while continued inflation of the inner expander member provides the necessary pressure for dilatation of the lesion.

Claims

1. An intravascular material delivery dilatation catheter comprising:

first, second and third elongated, flexible, hollow, plastic tubular members of descending diameter concentrically disposed relative to one another and each having a proximal end, a distal end and defining a lumen extending between the proximal end and the distal end, the distal end of the third tubular member extending beyond the distal ends of the first and second tubular members;

inner hollow expansible sleeve means bonded at one end to the third tubular member near the distal end thereof and at the other end to the distal end of the second tubular member, the interior of the inner hollow expansible sleeve means further being in fluid communication with the portion of the lumen defined by the second tubular member outside the third tubular member;

outer hollow expansible membrane sleeve means bonded at one end near the distal end of the third tubular member and at the other end to the distal end of the first tubular member, the interior of the outer hollow sleeve means further being in fluid communication with the portion of the lumen of the first tubular member defined between the first and second tubular members, the outer hollow sleeve means including a pattern of minute openings extending radially therethrough; and

manifold means connected to the proximal ends of the first and second tubular members for introducing an inflation fluid into the lumen of the second tubular member outside the third tubular member and a liquid dispersant into the lumen of the first tubular member outside the second tubular member whereby an amount of dispersant can be caused to perfuse through the minute openings in the outer sleeve means as the inner hollow sleeve means is expanded by the inflation fluid.

2. The drug delivery dilatation catheter of claim 1 further characterized by a guidewire insertable through the lumen defined by the third tubular member.

3. The material delivery dilatation catheter of claim 1 wherein the inner and outer sleeve means comprise biaxially oriented thermoplastic membranes.

4. The material delivery dilatation catheter of claim 3 wherein the membranes comprise a polyethylene terephthalate.

5. A method for treating an atherosclerotic lesion on the interior wall of a blood vessel comprising the steps of:

providing a dilatation catheter comprising

first, second and third elongated, flexible, hollow plastic tubular members concentrically disposed relative to one another and each having a proximal end, a distal end defining a lumen extending between the proximal end and the distal end;

inner hollow expander membrane sleeve bonded at one end to the third tubular member near the distal end thereof and at the other end to the distal end of the second tubular member, the interior of the inner hollow expander defined by the sleeve being in fluid communication with the lumen of said second tubular member outside the third tubular member;

outer hollow expander membrane sleeve bonded at one end near the distal end of the third tubular member and at the other end to the distal end of the first tubular member, the interior of the outer hollow expander sleeve being in fluid communication with the lumen defined between the first and second tubular members, the outer hollow expander sleeve including a pattern of minute openings extending radially therethrough; and

manifold means connected to the proximal ends of the first and second tubular members for introducing an inflation fluid into the lumen of the second tubular member and a liquid medicament into the lumen of the first tubular member in a manner whereby the medicament can perfuse through the openings in the outer expander sleeve as the inner sleeve expands;

routing the dilatation catheter through the patient'"'"'s vascular system until the expander sleeves are juxtaposed relative to the lesion;

inflating the inner expander member to apply pressure against said lesion; and

simultaneously perfusing a dispersant through the outer expander member and onto the lesion.

6. The method of claim 5 wherein the dispersant is a drug containing liquid.

7. The method of claim 6 wherein the dispersant is a liquid plastic adapted to solidify in situ.

8. The method of claim 5 including the step of introducing a guidewire through the patient'"'"'s vascular system to the site of the lesion prior to introducing the dilatation catheter.