Balloon protector sleeve

• US 6,749,584 B2
• Filed: 11/09/2001
• Issued: 06/15/2004
• Est. Priority Date: 08/17/2001
• Status: Active Grant

• Current Assignee: REVA Medical LLC
• Original Assignee: REVA Medical Inc.
• Inventors: Steinke, Tom, Briggs, Leonard F.
• Primary Examiner(s): Casler, Brian L.
• Assistant Examiner(s): Han, Mark K
• Application Number:
  US10/010,787
• Publication Number:
  US 20030093086A1
• Time in Patent Office: 949 Days
• Field of Search: 604/93.01, 604/96.01, 604/103.05, 604/171, 604/172, 604/264, 604/265, 604/523, 606/108, 606/192, 606/194, 606/195, 606/198, 623/1.11, 623/1.12, 623/1.18, 623/1.19, 623/1.2
• US Class Current: 604/103.05
• 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 25/104 used for angioplasty

Abstract

A protector sleeve is disclosed for protecting an expandable member disposed on a catheter during pre-deployment handling. In one embodiment, the protector sleeve includes a tubular member with proximal and distal portions and preferably an elastomer seal therebetween, wherein the proximal portion of the tubular member is designed to slidably engage the expandable member in its collapsed state, while the distal portion permits fluid access to a catheter lumen, e.g., a guidewire lumen, without exposing the protected expandable member to the fluid.

Claims

1. A protector sleeve for protecting an expandable member on a catheter having an inner lumen and a distal tip, wherein the expandable member is in a collapsed state prior to deployment, said protector sleeve comprising:

a tubular member having proximal and distal portions and a sealing member therebetween, wherein said proximal and distal portions and said sealing member are formed from a single continuous material, said proximal portion being adapted to slidably engage the catheter and cover the collapsed expandable member, wherein a coaxial separation between the proximal portion of the tubular member and the collapsed expandable member is sized to substantially prevent liquids from entering the coaxial separation;

wherein said sealing member is adapted to engage the distal tip of the catheter, such that a substantially fluid-tight seal is created between the sealing member and the distal tip; and

said distal portion of the tubular member defining a passageway adapted to fluidly couple with the inner lumen of the catheter, such that the inner lumen may be flushed with a liquid while the collapsed expandable member proximal to the sealing member remains substantially dry.

2. The protector sleeve of claim 1, wherein said distal portion of the tubular member is sufficiently long to prevent a flushing device from contacting the distal tip of the catheter.

3. The protector sleeve of claim 1, wherein the collapsed expandable member comprises an inflatable balloon in a radially collapsed state.

4. The protector sleeve of claim 1, wherein the collapsed expandable member comprises a expandable stent in a radially collapsed state.

5. A pre-deployment protector sleeve for protecting a soluble polymeric coating applied to a portion of a catheter having an inner lumen and a distal tip, comprising:

a tubular member having proximal and distal portions and a sealing member therebetween, said proximal portion being adapted to slidably engage the catheter and cover the polymeric coating, wherein a coaxial separation between the proximal portion of the tubular member and the polymeric coating is sized to substantially prevent liquids from entering the coaxial separation;

wherein said sealing member is adapted to engage the distal tip of the catheter, such that a substantially fluid-tight seal is created between the sealing member and the distal tip; and

said distal portion of the tubular member defining a passageway adapted to fluidly couple with the inner lumen of the catheter, such that the inner lumen may be flushed with a liquid while the polymeric coating proximal to the sealing member remains substantially dry;

wherein said soluble polymeric coating covers an expandable member mounted on the catheter.

6. A pre-deployment protector sleeve for protecting a soluble polymeric coating applied to a portion of a catheter having an inner lumen and a distal tip, comprising:

a tubular member having proximal and distal portions and a sealing member therebetween, said proximal portion being adapted to slidably engage the catheter and cover the polymeric coating, wherein a coaxial separation between the proximal portion of the tubular member and the polymeric coating is sized to substantially prevent liquids from entering the coaxial separation;

wherein said sealing member is adapted to engage the distal tip of the catheter, such that a substantially fluid-tight seal is created between the sealing member and the distal tip; and

said distal portion of the tubular member defining a passageway adapted to fluidly couple with the inner lumen of the catheter, such that the inner lumen may be flushed with a liquid while the polymeric coating proximal to the sealing member remains substantially dry;

wherein said soluble polymeric coating further comprises a bioactive substance.

7. A method for protecting an expandable member mounted on a catheter having an inner lumen and a distal tip, wherein the expandable member is in a collapsed state prior to deployment, the method comprising:

providing a protector sleeve comprising a tubular member having proximal and distal portions and a sealing member therebetween, wherein said sealing member is adapted to engage the distal tip of the catheter, such that a substantially fluid-tight seal is created between the sealing member and the distal tip, and wherein said distal portion of the tubular member defines a passageway adapted to fluidly couple with the inner lumen of the catheter, such that the inner lumen may be flushed with a liquid while the collapsed expandable member proximal to the sealing member remains substantially dry; and

sliding the protector sleeve over the collapsed expandable member, such that the distal tip of the catheter engages the sealing member.

8. The method of claim 7, further comprising inserting a portion of a flushing device into the passageway of said distal portion, and flushing the inner lumen of the catheter.