Method for making a balloon catheter

• US 5,824,173 A
• Filed: 06/28/1996
• Issued: 10/20/1998
• Est. Priority Date: 01/31/1994
• Status: Expired due to Term

• Current Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Original Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Inventors: Fontirroche, Carlos A., Querns, Stephen J.
• Primary Examiner(s): THURLOW, JEFFERY
• Application Number:
  US08/673,391
• Time in Patent Office: 844 Days
• Field of Search: 264/171.26, 264/171.28, 264/173.19, 264/516, 264/573, 604/96, 29/455.1, 29/516, 29/523, 156/86, 156/296
• US Class Current: 156/86
• CPC Class Codes: A61M 2025/0046 Coatings for improving slidability
• CPC Class Codes: A61M 2025/0047 the inner layer having a higher lubricity
• CPC Class Codes: A61M 2025/0048 with an outer layer made from silicon
• CPC Class Codes: A61M 25/0009 Making of catheters or other medical or surgical tubes
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• 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
• CPC Class Codes: A61M 25/1027 Making of balloon catheters
• CPC Class Codes: A61M 25/1034 Joining of shaft and balloon
• CPC Class Codes: B29C 48/0016 using a plurality of extrusion dies
• CPC Class Codes: B29C 48/09 Articles with cross-sections having partially or fully enclosed cavities, e.g. pipes or channels
• CPC Class Codes: B29C 48/10 flexible, e.g. blown foils
• CPC Class Codes: B29C 48/12 Articles with an irregular circumference when viewed in cross-section, e.g. window profiles
• CPC Class Codes: B29C 48/21 the layers being joined at their surfaces
• CPC Class Codes: Y10T 29/49879 Spaced wall tube or receptacle
• CPC Class Codes: Y10T 29/49927 Hollow body is axially joined cup or tube
• CPC Class Codes: Y10T 29/4994 Radially expanding internal tube

Abstract

A method of making an intravascular balloon catheter that has an elongated shaft defining an inflation lumen and a guidewire lumen, as well as a balloon disposed near the distal end of the shaft. The method may include forming an inner shaft by coextruding a flexible plastic tube by bringing a molten outer plastic layer into contact with a molten inner plastic layer, thereby bonding the plastic layers together during the coextrusion process. The inner plastic layer may be more lubricious than the outer plastic layer.

Claims

1. A method of making a balloon catheter, comprising the steps of:

providing a flexible balloon having proximal and distal ends, and a tubular outer shaft member;

forming a tubular inner shaft member by coextruding a length of flexible plastic tube by bringing a tubular, molten outer plastic layer into contact with a tubular, molten inner plastic layer, thereby bonding said plastic layers together during the coextrusion process; and

thereby forming a unitary, multilayer plastic tube, the plastic material of said inner plastic being more lubricious than the outer plastic layer; and

affixing the balloon proximal end to a distal end of the outer shaft member, and affixing the balloon distal end to a distal end of the inner shaft member, thereby defining an annular inflation lumen between the outer and inner shaft members, and defining a guidewire lumen within the inner shaft member.

2. The method of claim 1, in which said bond comprises the formation of a chemical bond between said plastic layers during the coextrusion process.

3. The method of claim 1, in which the plastic material of said inner layer comprises a vinylic copolymer comprising a minor amount of an unsaturated carboxylic acid or an anhydride thereof, and the material of the outer plastic layer is selected from the group consisting of nylon, polyurethane, and polyester.

4. The method of claim 3, in which said vinylic copolymer comprises a high density polyethylene.

5. A method of making a balloon catheter, comprising the steps of:

forming a proximal shaft member having a proximal guidewire lumen and a proximal inflation lumen arranged in parallel, by coextruding a length of flexible plastic tube by bringing a tubular, molten outer plastic layer into contact with a tubular, molten inner plastic layer to form a unitary, multilayer plastic tube, the inner plastic layer defining the proximal guidewire lumen, and the plastic material of said inner plastic layer being more lubricious than the material of said outer plastic layer, whereby bonding takes place between said plastic layers during the coextrusion process;

coupling the proximal guidewire lumen with a distal inner tube, and coupling the proximal inflation lumen with a distal outer tube surrounding the distal inner tube, thereby defining a distal inflation lumen in fluid communication with the proximal inflation lumen; and

coupling the distal inflation lumen with the interior of a flexible balloon.

6. The method of claim 5, in which the plastic material of said inner layer comprises a vinylic copolymer comprising a minor amount of an unsaturated carboxylic acid or an anhydride thereof, and the material of the outer plastic layer is selected from the group consisting of nylon, polyurethane, and polyester.

7. The method of claim 6, in which said vinylic copolymer comprises a high density polyethylene.