Stretch-blow molding method for manufacturing balloons for medical devices
First Claim
1. A process for fabricating medical device balloons, the process comprising:
- feeding an elongated tubularly shaped parison into and through a molding apparatus including an upstream biaxial orientation chamber and a downstream blow molding chamber until one portion of the parison is in the upstream chamber and another portion of the parison is in the downstream blow molding chamber;
axially stretching to longitudinally orient at least the portion of the parison within the upstream chamber to provide an axially oriented parison length;
biaxially orienting the axially oriented parison length within the upstream chamber by infusing pressurized fluid thereinto to provide a biaxially oriented parison length;
axially stretching at least the portion of the biaxially oriented parison length until its diameter is decreased while moving the biaxially oriented parison length into the downstream chamber; and
blow molding the biaxially oriented and axially stretched parison length by infusing pressurized fluid thereinto while same is within the downstream blow molding chamber to provide a molded parison useful as a medical device balloon.
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Accused Products
Abstract
Apparatus and methods for forming dilatation balloons and catheters including same are provided. The balloons are fabricated of a biaxially orientable material such as a nylon or a polyamide material, and they have an inflated, non-distended working profile as well as a stretched inflated profile which is achieved by applying pressure through a dilatation catheter or the like that is in excess of that needed to achieve the inflated, non-distended profile and which is adequate to effect dilatation or the like up to a maximum pre-bursting pressure application. The maximum pre-bursting size of the balloon can be tailored depending upon the needs of the particular balloon within a wide range of possible maximum pre-bursting sizes. The apparatus and methods facilitate fabrication of the balloons which are subjected to longitudinal elongation or axial orientation and biaxial or radial orientation.
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Citations
11 Claims
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1. A process for fabricating medical device balloons, the process comprising:
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feeding an elongated tubularly shaped parison into and through a molding apparatus including an upstream biaxial orientation chamber and a downstream blow molding chamber until one portion of the parison is in the upstream chamber and another portion of the parison is in the downstream blow molding chamber; axially stretching to longitudinally orient at least the portion of the parison within the upstream chamber to provide an axially oriented parison length; biaxially orienting the axially oriented parison length within the upstream chamber by infusing pressurized fluid thereinto to provide a biaxially oriented parison length; axially stretching at least the portion of the biaxially oriented parison length until its diameter is decreased while moving the biaxially oriented parison length into the downstream chamber; and blow molding the biaxially oriented and axially stretched parison length by infusing pressurized fluid thereinto while same is within the downstream blow molding chamber to provide a molded parison useful as a medical device balloon. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9)
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10. A process for fabricating medical device balloons, the process comprising:
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feeding an elongated tubularly shaped parison through a molding apparatus including a free-blow biaxial orientation chamber and a downstream blow molding chamber; longitudinally stretching to axially orient the parison within the free-blow chamber to provide an axially oriented parison length; biaxially orienting the axially oriented parison length by infusing pressurized fluid thereinto while same is within the free-blow chamber to provide a biaxially oriented parison length; axially stretching the biaxially oriented parison length; blow molding the biaxially oriented and axially stretched parison length, said blow molding step including raising the temperature of the biaxially oriented and axially stretched parison within the downstream blow molding chamber and infusing the pressurized fluid into a portion of the elongated parison that is upstream of the free-blow chamber whereby the pressurized fluid flows through the parison within the free-blow chamber and then into the biaxially oriented and axially stretched parison within the downstream blow molding chamber; closing off the parison between the free-blow chamber and blow molding chamber to prevent passage of pressurized fluid therebetween, and biaxially orienting the longitudinally oriented parison at an elevated temperature within the free-blow chamber to form another biaxially oriented parison length; and axially stretching said another biaxially oriented parison length, followed by blow molding same within the blow molding chamber at an elevated temperature to provide a molded parison useful as an angioplasty balloon. - View Dependent Claims (11)
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Specification