Interactive angioplasty

• US 6,027,486 A
• Filed: 06/26/1996
• Issued: 02/22/2000
• Est. Priority Date: 05/02/1996
• Status: Expired due to Fees

• Current Assignee: CardioVascular Dynamics, Inc. (Radiance Medical Systems, Inc.)
• Original Assignee: Radiance Medical Systems, Inc.
• Inventors: Walker, Claire, Crocker, Michael
• Primary Examiner(s): YASKO JR, JOHN D
• Application Number:
  US08/670,683
• Time in Patent Office: 1,336 Days
• Field of Search: 604/500, 604/509, 604/510, 604/505, 604/96, 604/97, 604/98, 604/99, 604/100, 604/101, 604/104, 604/523, 604/536, 604/532, 606/192, 606/194
• US Class Current: 604/500
• CPC Class Codes: A61M 2025/1059 having different inflatable sections mainly depending on the response to the inflation pressure, e.g. due to different material properties
• CPC Class Codes: A61M 2025/1072 having balloons with two or more compartments
• CPC Class Codes: A61M 2025/1075 having a balloon composed of several layers, e.g. by coating or embedding
• CPC Class Codes: A61M 2025/1084 having features for increasing the shape stability, the reproducibility or for limiting expansion, e.g. containments, wrapped around fibres, yarns or strands
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/10184 Means for controlling or monitoring inflation or deflation
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A dilatation catheter includes an inflation balloon having a variable diameter inflation profile. The balloon has a first inflation profile, in which it exhibits a substantially cylindrical central working profile. The first inflation profile of the balloon is achieved by inflating the balloon to a first inflation pressure. The balloon has a second inflation profile which is achieved by increasing the inflation pressure to a second, higher pressure. In the second inflation profile, a proximal segment and a distal segment of the balloon have a first inflated diameter and a central focal segment, separating the proximal and distal segments, has a second inflated diameter, such that the second inflated diameter is greater than the first inflated diameter. Methods of using the catheter are also disclosed.

Claims

1. A method of treating a site in a body lumen, comprising the steps of:

providing a catheter having an elongate, flexible, tubular body and a dilatation balloon on the body, the balloon inflatable to a first inflation profile wherein at least one reference segment, and a focal segment of said balloon are inflatable to a first diameter and a second inflation profile wherein the focal segment of said balloon is inflatable to a second greater diameter while the reference segment remains at a diameter which is less than the second diameter;

positioning the catheter within a body lumen so that the balloon is adjacent a treatment site;

inflating the balloon to a first inflation pressure, wherein said reference and said focal segment are expected to inflate to said first inflation profile;

observing the actual inflation profile of the balloon at the first inflation pressure;

comparing the observed inflation profile to the expected inflation profile at the first inflation pressure; and

selecting a subsequent treatment in response to the comparison of the actual inflation profile at the first inflation pressure to the expected profile at the first inflation pressure.

2. A method as in claim 1, wherein the subsequent treatment comprises inflating the balloon to a second inflation pressure at which the focal section is inflated to the second diameter and the reference section remains at a diameter which is less than the second diameter.

3. A method of determining the inflated diameter of a treatment site in a body lumen, comprising the steps of:

providing a catheter having an elongate, flexible, tubular body and a dilatation balloon on the body, the balloon having at least one reference zone inflatable to a first diameter, and a focal zone inflatable to said first diameter at a first pressure and inflatable to a second larger diameter at a second, higher pressure, said reference zone remaining substantially at the first diameter at said second pressure;

positioning the catheter within a body lumen so that the focal zone is adjacent a treatment site;

inflating the balloon;

observing the diameter of the focal zone compared to the reference zone;

inflating the balloon to a sufficient pressure to advance the focal zone to the second diameter;

observing the inflation pressure at which said focal zone inflates to the second diameter; and

comparing the observed pressure to predetermined inflation characteristics values for said balloon to determine the diameter of said balloon at the treatment site at the observed inflation pressure.