Balloons for medical devices and fabrication thereof
First Claim
1. A balloon for a medical device, the balloon comprising:
- a length of biaxially orientable tubing made of a nylon material or of a polyamide material, said length of tubing having been formed into the balloon during a biaxial orienting procedure including inflating at least a section thereof with a pressurized fluid in order to at least double its outer diameter;
said balloon has a non-distended working profile having a predetermined size to which the balloon inflates without significant stretching thereof, and said balloon has an expansion profile having a maximum inflated size to which the balloon stretches without bursting during dilatation, said maximum inflated size being greater than said predetermined size of the non-distended working profile;
said expansion profile of the balloon had been tailored whereby said balloon has a maximum inflated size selected from a range of maximum inflated sizes that are a function of balloon processing conditions; and
said nylon material or polyamide material, when thus formed into said balloon, exhibits glass transition properties whereby the balloon material is within its glass transition state at human body temperature.
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Accused Products
Abstract
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-distened 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.
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Citations
17 Claims
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1. A balloon for a medical device, the balloon comprising:
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a length of biaxially orientable tubing made of a nylon material or of a polyamide material, said length of tubing having been formed into the balloon during a biaxial orienting procedure including inflating at least a section thereof with a pressurized fluid in order to at least double its outer diameter; said balloon has a non-distended working profile having a predetermined size to which the balloon inflates without significant stretching thereof, and said balloon has an expansion profile having a maximum inflated size to which the balloon stretches without bursting during dilatation, said maximum inflated size being greater than said predetermined size of the non-distended working profile; said expansion profile of the balloon had been tailored whereby said balloon has a maximum inflated size selected from a range of maximum inflated sizes that are a function of balloon processing conditions; and said nylon material or polyamide material, when thus formed into said balloon, exhibits glass transition properties whereby the balloon material is within its glass transition state at human body temperature. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10)
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11. A dilatation balloon, comprising:
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a length of thermoformable polymeric material tubing that had been biaxially oriented to a balloon having a predetermined balloon diameter; said dilatation balloon has a collapsed profile at which the outer diameter of the dilatation balloon approximates the outer diameter of a component of a medical device, said dilatation balloon further having a non-distended, inflated working diameter at which the dilatation balloon is inflated to its said predetermined balloon diameter, and said dilatation balloon also exhibits a maximum stretched inflation diameter to which the dilatation balloon is expandable without bursting under needed dilatation conditions, said maximum stretched inflation diameter being in excess of said predetermined balloon diameter;
said tubing material of the dilatation balloon has tailorability properties whereby said maximum stretched inflation diameter had been selected during biaxial orientation to fall within a range of maximum stretched inflation diameter values, and said dilatation balloon maximum stretched inflation diameter had been selected from within said range of maximum stretched inflation diameter values; andsaid thermoformable polymeric material tubing, thus formed as said dilatation balloon, has a calculated tensile strength of at least about 15,000 psi, is within its glass transition state at human body temperature, and has a said maximum stretched inflation diameter which exceeds said predetermined balloon diameter by between above about 5 percent and about 40 percent or above. - View Dependent Claims (12)
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13. A dilatation catheter, comprising:
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a catheter body; a balloon member positioned along the length of said catheter body; said balloon member being constructed of a thermoformable nylon material or of a polyamide material tubing that is in its glass transition state of human body temperatures and that had been biaxially oriented to provide a predetermined balloon diameter; said balloon member has a collapsed profile at which the outer diameter of the balloon approximates the outer diameter of said catheter body, said balloon member further having a non-distended working diameter to which the balloon is inflated to its said predetermined balloon diameter without significant stretching thereof, and said balloon member also exhibits an expanded maximum inflated diameter to which the balloon member is stretched without bursting during dilatation, said maximum inflated diameter being in excess of said predetermined balloon diameter; said tubing material of the balloon member has tailorability properties whereby said maximum inflated diameter had been selected to fall within a range of maximum inflated diameters that are a function of a hoop expansion ratio of the balloon member, said hoop expansion ratio being the approximate ratio of said predetermined balloon diameter to the diameter of said tubing prior to biaxial orientation; and wherein said balloon exhibits glass transition properties whereby the balloon is within its glass transition state at human body temperature. - View Dependent Claims (14, 15, 16, 17)
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Specification