Balloons for medical devices and fabrication thereof
First Claim
1. A balloon for a medical device, the balloon comprising:
- a length of tubing made of Nylon 12, said length of tubing having been formed into the balloon during a balloon forming procedure including inflating at least a section thereof with a pressurized fluid in order to radially expand said length of tubing 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 use, said maximum inflated size being greater than said predetermined size of the non-distended working profile; and
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.
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Accused Products
Abstract
Dilatation balloons and catheters including same are provided. The balloons are fabricated of a 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.
135 Citations
37 Claims
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1. A balloon for a medical device, the balloon comprising:
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a length of tubing made of Nylon 12, said length of tubing having been formed into the balloon during a balloon forming procedure including inflating at least a section thereof with a pressurized fluid in order to radially expand said length of tubing 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 use, said maximum inflated size being greater than said predetermined size of the non-distended working profile; and 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.
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2. A balloon for a medical device, the balloon comprising:
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a length of tubing made of a nylon material or of a polyamide material, said length of tubing having been formed into the balloon during a balloon forming procedure including inflating at least a section thereof with a pressurized fluid in order to radially expand said length of tubing 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 use, 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 nylon or polyamide of said balloon is within its glass transition state at human body temperature. - View Dependent Claims (3, 4, 5, 6, 7, 8)
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9. A balloon for a medical device, the balloon comprising:
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a length of tubing made of a nylon material or of a polyamide material which is in its glass transition state at human body temperatures, said length of tubing having been formed into the balloon during a balloon forming procedure including inflating at least a section thereof with a pressurized fluid in order to radially expand said length of tubing 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 use, 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 balloon had been made by a process including stretching the length of tubing prior to said inflating step to thereby provide a balloon hoop expansion ratio of the mean diameter of said balloon to the mean diameter of said thermoformable tubing, and said selected maximum inflated size is a function of said hoop expansion ratio. - View Dependent Claims (10, 11)
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12. A balloon for a medical device, comprising:
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a nylon material or a polyamide material tubing that had been radially expanded to a predetermined balloon diameter, wherein said nylon or polyamide material is Nylon 12; said balloon has a collapsed profile at which the outer diameter of the balloon approximates the outer diameter of said medical device, said balloon further having a non-distended inflation diameter at which the balloon is inflated to its said predetermined balloon diameter, and said balloon also exhibits a distended inflation diameter at which the balloon is stretched to a profile having a diameter that is in excess of said predetermined balloon diameter; and said balloon has a tensile strength greater than medical device balloons that are made of materials other than nylon or polyamide materials and that have an inflated profile exhibiting a distended size. - View Dependent Claims (13, 14, 15, 16, 17)
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18. A balloon for a medical device, comprising:
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a nylon material or a polyamide material tubing that had been radially expanded to a predetermined balloon diameter and that is in its glass transition state at human body temperatures; said balloon has a collapsed profile at which the outer diameter of the balloon approximates the outer diameter of said medical device, said balloon further having a non-distended inflation diameter at which the balloon is inflated to its said predetermined balloon diameter, and said balloon also exhibits a distended inflation diameter at which the balloon is stretched to a profile having a diameter that is in excess of said predetermined balloon diameter; said balloon has a tensile strength greater than medical device balloons that are made of materials other than nylon or polyamide materials and that have an inflated profile exhibiting a distended size; and wherein said nylon or polyamide tubing had been subjected to axial elongation at room temperature, following by radial expansion with pressurized fluid, followed by another axial elongation, which was followed by another radial expansion with pressurized fluid, and wherein said balloon is substantially free of expansion knurls.
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19. A balloon for a medical device catheter, the balloon having been made by a process comprising:
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providing a length of tubing made of a Nylon 12 nylon or polyamide material, said length of tubing having a predetermined original outer diameter and a predetermined original wall thickness; radially expanding a section of said length of tubing into a balloon by inflating said section with a pressurized fluid in order to increase the diameter of said section to at least in excess of twice said original outer diameter of the length of tubing; said balloon has a non-distended inflated profile having a predetermined size as well as a distended size that has a radius greater than that of said predetermined non-distended size, and said distended size has an inflated profile larger than that of said non-distended inflated profile; and said balloon has a tensile strength greater than non-nylon catheter balloons that have an inflated profile exhibiting a distended size. - View Dependent Claims (20, 21, 22, 23, 24, 25)
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26. A catheter medical device, 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 had been radially expanded to a predetermined balloon diameter and that is in its glass transition state at human body temperatures; 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 use, said maximum inflated diameter being in excess of said predetermined balloon diameter; and 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 radial expansion. - View Dependent Claims (27, 28, 29, 30)
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31. A medical catheter, comprising:
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a catheter body; a balloon positioned along the length of said catheter body; said balloon being constructed of a nylon material or of a polyamide material tubing that had been radially expanded to a predetermined balloon diameter, wherein said nylon or polyamide material is Nylon 12; said balloon has a collapsed profile at which the outer diameter of the balloon approximates the outer diameter of said catheter body, said balloon further having a non-distended inflation diameter at which the balloon is inflated to its said predetermined balloon diameter, and said balloon also exhibits a distended inflation diameter at which the balloon is stretched to a profile having a diameter that is in excess of said predetermined balloon diameter; and said balloon has a tensile stress greater than balloons that are made of materials other than nylon or polyamide materials and that have an inflated profile exhibiting a distended size. - View Dependent Claims (32, 33, 36)
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34. A medical catheter comprising:
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a catheter body; a balloon positioned along the length of said catheter body; said balloon being constructed of a tubing that had been radially expanded to a predetermined balloon diameter, said balloon being a nylon material or a polyamide material having a glass transition state at human body temperatures; said balloon has a collapsed profile at which the outer diameter of the balloon approximates the outer diameter of said catheter body, said balloon further having a non-distended inflation diameter at which the balloon is inflated to its said predetermined balloon diameter, and said balloon also exhibits a distended inflation diameter at which the balloon is stretched to a profile having a diameter that is in excess of said predetermined balloon diameter; said balloon has a tensile strength greater than balloons that are made of materials other than nylon or polyamide materials and that have an inflated profile exhibiting a distended size; said distended inflation diameter is an expanded maximum inflated diameter to which the balloon member is stretched without bursting during use, said maximum inflated diameter being in excess of said predetermined balloon diameter; and 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 of radial expansion. - View Dependent Claims (35, 37)
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Specification