Balloon sheath

• US 5,843,027 A
• Filed: 12/04/1996
• Issued: 12/01/1998
• Est. Priority Date: 12/04/1996
• Status: Expired due to Term

• Current Assignee: CardioVascular Dynamics, Inc. (Radiance Medical Systems, Inc.)
• Original Assignee: CardioVascular Dynamics, Inc. (Radiance Medical Systems, Inc.)
• Inventors: Shimada, Lynn, Elicker, Robert J., Stone, Gregg, Crocker, Michael
• Primary Examiner(s): Coggins, Wynn Wood
• Assistant Examiner(s): Blyveis, Deborah
• Application Number:
  US08/767,107
• Time in Patent Office: 727 Days
• Field of Search: 604/96, 606/108, 606/192, 606/194
• US Class Current: 604/509
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61M 2025/1075 having a balloon composed of several layers, e.g. by coating or embedding
• CPC Class Codes: A61M 2025/1081 having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00

Abstract

Disclosed is a tuvular sheath which is adapted to fit coaxially over an inflatable balloon. The sheath functions to alter the expansion characteristics of the balloon. In one preferred embodiment, the sheath converts the inflation profile of a dilatation balloon from a compliant mode to a noncompliant mode. Advantageously, the balloon sheath may be used in stent placement procedures, to accurately size the stent within a body lumen, while providing protection against balloon rupture. In one embodiment, the balloon sheath comprises a two-layered tubular structure, with an outer elastic layer surrounding an inner inelastic layer. Also disclosed are methods of altering the expansion characteristics of a balloon using the balloon sheath.

Claims

1. A method of sizing a stent to an interior body lumen, comprising the steps of:

providing a tubular balloon sheath;

inserting the balloon sheath coaxially between a dilatation balloon and a tubular stent; and

inflating the inflation balloon within the sheath so that the sheath constrains the dilatation balloon to a relatively noncompliant inflation profile.

2. The method of claim 1, wherein said balloon sheath comprises at least an inner layer and an outer layer.

3. The method of claim 2, wherein said inner layer comprises an inelastic material, and said outer layer comprises an elastic material.

4. The method of claim 2, wherein said inner layer comprises polyethylene terephthalate.

5. The method of claim 1, wherein the insertion step comprises positioning the dilatation balloon within a partially expanded stent in the lumen, then advancing the balloon sheath distally along the catheter by advancing an axially moveable push wire attached to the sheath until the sheath covers the dilatation balloon.

6. The method of claim 1, wherein said balloon sheath comprises a radiopaque marker.

7. The method of claim 1, wherein a pushwire extends proximally from said balloon sheath, and said inserting step includes axially moving the pushwire.