Method and catheter system for delivering medication with an everting balloon catheter

• US 6,039,721 A
• Filed: 12/03/1997
• Issued: 03/21/2000
• Est. Priority Date: 07/24/1996
• Status: Expired due to Term

• Current Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Original Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Inventors: Knudtson, Merril L., Johnson, Kirk
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): RODRIGUEZ, CRIS LOIREN
• Application Number:
  US08/984,576
• Time in Patent Office: 839 Days
• Field of Search: 604/271, 604/523, 604/103, 604/96, 604/101, 604/508, 604/509, 604/510, 604/500, 606/194, 606/192
• US Class Current: 604/508
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61M 2025/1068 having means for varying the length or diameter of the deployed balloon, this variations could be caused by excess pressure
• CPC Class Codes: A61M 25/0119 Eversible catheters
• CPC Class Codes: A61M 25/1006 Balloons formed between concentric tubes
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A balloon catheter having concentric, elongate lumen and guide tubes defining a lumen therebetween. An annular balloon has its proximal end secured to the lumen tube and its distal end secured to the guide tube. Relative axial movement of the tubes adjusts the balloon between retracted and extended positions. Processes for using the balloon catheter are also disclosed including performing angioplastic procedures on a plurality of stenoses of differing longitudinal extents during a single catheterization procedure, implanting self expanding stents in blood vessels treating occluded blood vessels and apply medications to diseased blood vessels.

Claims

1. A process of applying a medication to a diseased portion of a blood vessel with a catheter having a balloon connected to distal ends of inner and outer tubes, comprising:

providing a balloon catheter having an inner and outer tube which are longitudinally adjustable with respect to each other, and a balloon affixed at opposing ends of the balloon to a distal end of one of the inner and outer tubes;

the balloon defining a medication portion, and a lumen being defined between the inner and outer tubes;

applying a coating of medication to the medication portion of a surface of the balloon;

positioning distal ends of the inner and outer tubes in closely spaced relationship and folding the balloon on itself such that the balloon assumes an annular everted shape defining inner and outer balloon layers, wherein the entire balloon surrounds some portion of one of the inner and outer tubes;

the medication portion of the balloon being arranged on the inner layer which is internal, and the balloon having a shielding portion of the balloon on the outer layer which surrounds the remainder of the balloon;

inserting the catheter into the vessel and positioning the balloon adjacent the diseased portion of the blood vessel;

inflating the balloon by delivering fluid through the lumen defined between the tubes and communicating with the balloon;

continuing the inflation until the shielding portion engages the vessel adjacent the diseased portion;

longitudinally adjusting the inner and outer tubes relatively to unfold the balloon as the inflation continues, thereby bringing the medication portion into contact with the diseased portion of the blood vessel, to apply the medication to the diseased portion; and

deflating the balloon and removing the catheter from the vessel.

2. A process of applying a medication to a diseased portion of a blood vessel with a catheter having a balloon connected to distal ends of inner and outer tubes, comprising:

providing a balloon catheter having an inner and outer tube which are longitudinally adjustable with respect to each other, and a balloon affixed at opposing ends of the balloon to a distal end of one of the inner and outer tubes;

a lumen being defined between the inner and outer tubes;

positioning the distal ends of the inner and outer tubes in closely spaced relationship with the balloon folded on itself to form an annular everted shape defining inner and outer folds, the balloon defining a medication portion on the inner fold having a medication coating the inner fold surface while a shielding portion on the outer fold of the balloon surrounds the remainder of the balloon, wherein the entire balloon surrounds some portion of one of the inner and outer tubes;

inserting the catheter into the vessel and positioning the balloon adjacent the diseased portion;

inflating the balloon by delivering fluid through a lumen defined between the tubes and communicating with the balloon;

continuing the inflation until the shielding portion engages the vessel adjacent the diseased portion;

longitudinally adjusting the inner and outer tubes relatively to unfold the balloon as the inflation continues, thereby bringing the medication portion into contact with the diseased portion to apply the medication to the diseased portion; and

deflating the balloon and removing the catheter from the vessel.