Pleated balloon dilatation catheter and method of use

• US 5,318,587 A
• Filed: 10/02/1992
• Issued: 06/07/1994
• Est. Priority Date: 08/25/1989
• Status: Expired due to Fees

• Current Assignee: Medtronic Ave Incorporated (Medtronic Plc)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Davey, Christopher T.
• Primary Examiner(s): Thaler, Michael H.
• Application Number:
  US07/956,454
• Time in Patent Office: 613 Days
• Field of Search: 606/194, 606/192, 606/193, 606/196, 606/195, 604/96-103
• US Class Current: 606/194
• CPC Class Codes: A61M 2025/1004 Balloons with folds, e.g. folded or multifolded
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/1029 Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
• CPC Class Codes: A61M 25/1038 Wrapping or folding devices for use with balloon catheters
• CPC Class Codes: B29C 55/22 of tubes B29C61/08 takes precedence
• CPC Class Codes: B29C 67/0014 for shaping tubes or blown tubular films
• CPC Class Codes: B29L 2022/022 Balloons
• CPC Class Codes: B29L 2031/7542 Catheters

Abstract

A balloon dilatation catheter is provided with a pleated balloon defining at least three pleats and alternating wings. When the balloon collapses, it tends to assume a pleated configuration which defines a lower profile and is better adapted to pass through narrow channels, such as a guide catheter. The balloon is formed from a polymeric material in a method that involves the steps of extruding a tube having at least three circumferentially spaced, longitudinally extending segments of less wall thickness than the remainder of the tube, and biaxially stretching the tube to a predefined shape while maintaining the longitudinal segments of reduced wall thickness.

Claims

1. An angioplasty dilation catheter comprising:

an elongate flexible shaft having at least one lumen extending therethrough from its proximal to its distal end;

an imperforate, inelastic angioplasty dilatation balloon mounted on the distal end of the shaft and in fluid communication with the lumen, the balloon being formed from an extruded polymeric tube having at least three circumferentially spaced longitudinally extending extruded fold lines of less wall thickness than the remainder of the tube;

a fitting for connecting the lumen with an inflation and deflation device; and

the balloon being adapted for inflation and deflation between an expanded diameter and a collapsed configuration having a reduced cross-sectional profile to facilitate passage of the balloon through a passageway in a body lumen;

the fold lines being constructed so that when the balloon is caused to collapse, the fold lines will be drawn radially inwardly thereby to define radially inward folds and the portions of the balloon between the fold lines will define radially outward folds.

2. A dilatation catheter as defined in claim 1 wherein the balloon, when deflated, forms at least three pleats about the shaft.

3. A balloon dilatation catheter as defined in claim 1 wherein the balloon is formed from polyethylene terephthalate.

4. A balloon dilatation catheter as defined in claim 1 wherein the balloon is formed from polyethylene.

5. A balloon dilatation catheter as defined in claim 1 wherein the balloon is formed from polyvinyl chloride.

6. A dilatation catheter as defined in claim 1 wherein the catheter comprises a percutaneous transluminal coronary angioplasty catheter.

7. A balloon for an angioplasty dilatation catheter comprising:

the balloon being formed by radial expansion of an extruded tubular polymeric member having an inperforate wall and having at least three extruded fold lines of reduced wall thickness extending longitudinally of the tube;

the balloon being formed to collapse under the influence of reduced internal pressure into a configuration defined by at least three longitudinally extending pleats and alternating wings, the extruded fold lines being constructed so that when the balloon is caused to collapse, the fold lines will define radially inwardly disposed folds and the regions between the fold lines will define radially outwardly disposed folds; and

the wings being flexible and being bendable as to be capable of wrapping about a longitudinally extending dimension of the balloon, thereby to define a smaller cross-sectional profile for the balloon.

8. A method for performing a dilatation procedure in a lumen of a patient comprising:

inserting a guiding conduit to a region to be dilated;

providing a dilatation catheter having an imperforate, inelastic angioplasty dilatation balloon formed from an extruded polymeric tube having at least three circumferentially spaced longitudinally extending extruded fold lines of less wall thickness than the remainder of the tube such that said balloon collapses under the influence of negative pressure extending pleats and alternating wings;

deflating the balloon to the collapsed configuration to cause the fold lines to be drawn radially inwardly thereby to define radially inward folds with the portions of the balloon between the fold lines defining radially outward folds;

passing the catheter with the collapsed balloon through the guide conduit and out the distal end of the guide conduit;

inflating the balloon to perform a dilatation and then deflating the balloon to the collapsed configuration; and

removing the catheter through the guiding conduit while the wings of the balloon ar wrapped about the catheter.

9. A dilatation catheter comprising:

an elongate flexible shaft having at least one lumen extending therethrough from its proximal to its distal end;

an imperforate dilatation balloon mounted on the distal end of the shaft and in fluid communication with the lumen, the balloon having at least one segment of a less wall thickness than the remainder of the balloon, the balloon being constructed to be inflated to a pressure sufficient to perform a dilatation, said segment of less wall thickness being defined by a longitudinally extending line along the balloon wall whereby the balloon will burst along said longitudinally extending line; and

a fitting for connecting the lumen with an inflation and deflation device;

the wall thickness in the reduced wall thickness providing a weakened area of the balloon adapted to burst when the balloon is subjected to a pressure that exceeds a predetermined maximum pressure no greater than about 18 bars.

10. A dilatation catheter as defined in claim 9 wherein said pressure for performing a dilatation comprises at least about 75 psi.