Process improvements for preparing catheter balloons

A - Human Necessities – 61 – M

Patent

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Details

A61M 25/16 (2006.01) A61M 25/00 (2006.01) A61M 25/10 (2006.01) B29C 49/18 (2006.01) B29C 49/78 (2006.01) B29D 22/00 (2006.01) B29C 35/04 (2006.01) B29C 49/04 (2006.01)

Patent

CA 2160487

This invention is a balloon (14) and method of forming a balloon for a dilatation catheter (10) involving the steps of extruding a polyester resin tubing preform (12), then dry- ing the tubing preform (12) and then blow- ing the tubing (13) into an oriented balloon (14). During the step of blowing the tubing into the balloon the tubing (13) is placed in a mold (28) and blown by pressurizing and ten- sioning the tubing. The cone regions of the balloon (C)(D)(E)(F) and waist regions of the balloon (B)(C)(F)(G) are formed having a re- duced thickness because the axial tension and blowing pressure is selectively varied as a mold (28) containing the balloon (14), and is gradu- ally dipped into a heating medium (70) so as to sequentially blow a first waist (B)(C), a body (D)(E) and a second waist (F)(G). The blowing pressure is lower while the body portion (D)(E) is blown, than it is when either of the first or second waist portion (B)(C)(F)(G) is blown.

La présente invention concerne un ballon (14) et un procédé de confection de ballons destinés à des cathéters à dilatation (10), le procédé se décomposant en plusieurs étapes: extrusion d'une avant-forme de tubage en résine de polyester (12), séchage de l'avant-forme de tubage (12), puis soufflage du tubage (13) en forme de ballon orienté (14). Pendant l'étape de soufflage du tubage (13) en forme de ballon, le tubage (13) est placé dans un moule (28) et soufflé par pressurisation et tension du tubage. Les zones coniques (C-D, E-F) et les zones rétrécies du ballon (B-C, F-G) sont réalisées en épaisseur réduite, la tension axiale et la pression de soufflage étant, d'une part sélectivement modifiées en même temps qu'un moule (28) contenant le ballon (14), et d'autre part progressivement trempés dans un milieu chauffant (70) de façon à souffler un premier rétrécissement (B-C), un corps (D-E) et un second rétrécissement (F-G). La pression de soufflage utilisée pour le soufflage du corps (D-E) est inférieure à la pression de soufflage utilisée pour les première et seconde zones rétrécies (B-C, F-G).

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