Method of forming intra-aortic balloon catheters

• US 5,718,861 A
• Filed: 06/07/1995
• Issued: 02/17/1998
• Est. Priority Date: 12/20/1993
• Status: Expired due to Term

• Current Assignee: Arrow International Investment Corporation (Teleflex Incorporated)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Majeski, Peter T., Levendusky, Joseph A., Andrews, Robert R., Edelman, William, O'Brien, Robert L.
• Primary Examiner(s): Tentoni, Leo B.
• Application Number:
  US08/484,894
• Time in Patent Office: 986 Days
• Field of Search: 264/235, 264/301, 264/334, 264/346
• US Class Current: 264/235
• 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 25/1029 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 25/1034 Joining of shaft and balloon
• CPC Class Codes: A61M 60/139 inside the aorta, e.g. intra-aortic balloon pumps
• CPC Class Codes: A61M 60/274 the inlet and outlet being the same, e.g. para-aortic counter-pulsation blood pumps
• CPC Class Codes: A61M 60/295 Balloon pumps for circulatory assistance
• CPC Class Codes: A61M 60/495 Electromagnetic force
• CPC Class Codes: A61M 60/515 Regulation using real-time patient data
• CPC Class Codes: A61M 60/531 using blood pressure data, e.g. from blood pressure sensors
• CPC Class Codes: A61M 60/843 Balloon aspects, e.g. shapes or materials
• CPC Class Codes: A61M 60/857 Implantable blood tubes
• CPC Class Codes: A61M 60/865 Devices for guiding or inserting pumps or pumping devices into the patient's body
• CPC Class Codes: B29C 41/14 Dipping a core B29C41/10 takes precedence
• CPC Class Codes: B29C 55/22 of tubes B29C61/08 takes precedence
• CPC Class Codes: B29L 2031/7542 Catheters

Abstract

A method of forming intra-aortic balloons includes forming a balloon blank having a sleeve section at its proximal end. To reduce the diameter of the sleeve section of the balloon, the sleeve section is stretched longitudinally by gripping a first portion of the balloon blank at the distal end of the sleeve section, gripping a second portion of the balloon blank at the opposite end of the sleeve section and moving at least one of the gripped portions away from the other so as to reduce the diameter of the sleeve section. A heating element is positioned within the sleeve section to relieve the stress in the sleeve after stretching, by heating the sleeve section. The sleeve section is then cooled in order to preserve the sleeve section in its reduced diameter state thereby forming an intra-aortic balloon having a balloon blank with a reduced diameter sleeve section.

Claims

1. A method of forming intra-aortic balloons for assembly in vascular catheter systems comprising the steps of forming a balloon blank having a sleeve section at one end, stretching such sleeve section longitudinally to reduce the diameter thereof, heating said stretched sleeve section to relieve the stress in said sleeve section while so stretched, and cooling said sleeve section, thereby to preserve said sleeve section in its reduced diameter state wherein said balloon blank including said reduced diameter sleeve section forms said intra-aortic balloon.

2. The invention as in claim 1 wherein said balloon blank is formed of plastic by dip casting on a mandrel.

3. The invention as in claim 1 including the steps of forming said balloon blank by dip casting a plastic material on a mandrel with said sleeve section being formed on said mandrel at one end of said blank, and removing said blank from said mandrel by axial sliding over said mandrel in a direction wherein said sleeve section is stretched over said mandrel in the course of such removal.

4. The invention as in claim 1 wherein said stretching step is carried out by gripping a first portion of said balloon blank at the distal end of said sleeve section, gripping a second portion of said balloon blank at the opposite end of said sleeve section, and moving at least one of said gripped portions away from the other.

5. The invention as in claim 4 wherein said first portion is gripped between an internal mandrel and a surrounding clamp, and said second portion of said balloon is gripped in a clamp.

6. The invention as in claim 5 wherein stretching step is carried out prior to engagement of said second portion in said clamp.

7. The invention as in claim 5 wherein said stretching step is carried out by moving one of said mandrel and said clamp away from the other after said balloon portions are gripped therein.

8. The invention as in claim 4 and including positioning a heating element within said sleeve section, and wherein said heating step is effected by said heating element from within said sleeve section.

9. The invention as in claim 1 and wherein said heating step is effected by a heating element disposed interiorly of said sleeve section.