EP0436501A1
Expired / Lapsed
EP
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Balloons for medical devices and fabrication thereof
Assignee: Cordis Corp
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Filing: 1989-10-04
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Granted: —
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Expires: 2009-10-04
Abstract
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.
Inventors
- 👤 Leonard Pinchuk
- 👤 Robert S. Shonk
- 👤 Thomas Trotta
Bibliographic Details
Application Number
—
Jurisdiction
EP
Data Source
google_patents
Last Synchronized
2026-10-23 09:54
CPC Classifications
A; A61; A61M; A61M25/00; A61M25/10; A61M25/104; A61L; A61L29/00; A61L29/04; A61L29/06; A61M25/1027; A61M25/1029; A61B; A61B17/00; A61B2017/00743; A61B2017/00778; A61B2017/00783; A61M2025/1043; A61M2025/1086; A61M29/00; A61M29/02
Claims Analysis
Total Claims: 38
Claim 1
Independent Claim
176 words
A balloon for a medical device, the balloon comprising: a length of tubing being mechanically stretchable in two directions and made of a nylon material or of a polyamide material, said length of tubing having been formed into said balloon during a first step of axially elongating said tubing and a second step of 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, thereby said balloon having been formed; 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.
Claim 2
Dependent Claim
26 words
The balloon according to claim 1, wherein said balloon exhibits glass transition properties whereby the balloon is within its glass transition state at human body temperature.
Claim 3
Dependent Claim
22 words
The balloon according to claim 1 or 2, wherein said balloon has a calculated tensile strength of at least about 15,000 psi.
Claim 4
Dependent Claim
27 words
The balloon according to any of claims 1-3, wherein said range of expansion profile maximum inflated sizes is at least about 10 percentage points of radial expansion.
Claim 5
Dependent Claim
32 words
The balloon according to any of claims 1-3, wherein said maximum inflated size of the balloon is greater than 5 percent in excess of the predetermined size of the non-distended working profile.
Claim 6
Dependent Claim
40 words
The balloon according to any of claims 1-3, wherein said maximum inflated size of the balloon has a radius that exceeds said non-distended working size by between in excess of 5 percent and up to about 30 percent or above.
Claim 7
Dependent Claim
25 words
The balloon according to any of claims 1-6, wherein said nylon or polyamide balloon has an intrinsic viscosity of between about 0.8 and about 1.5.
Claim 8
Dependent Claim
15 words
The balloon according to any of claims 1-7, wherein said balloon material is Nylon 12.
Claim 9
Dependent Claim
106 words
The balloon according to any of claims 1-8, wherein said balloon had been made by a process including said axially elongating the length of tubing at approximately room temperature to provide drawn tubing prior to said inflating step, said inflating step including radially expanding the thus drawn tubing at an elevated temperature greater than room temperature, said radially expanding procedure having been followed by cooling the thus radially expanded section to at least about room temperature, axially stretching the thus cooled section to provide a further drawn section, heating and inflating said further drawn section, and thermoforming said thus inflated further drawn section into the balloon.
Claim 10
Dependent Claim
65 words
The balloon according to any of claims 1-8, wherein said balloon had been made by a process including stretching the length of tubing prior to said inflation 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.
Claim 11
Dependent Claim
51 words
The balloon according to claim 10, wherein said process further includes heat setting said balloon after said inflating step by raising said balloon to a temperature in excess of the glass transition temperature of said nylon material or polyamide material and cooling same to a temperature below said glass transition temperature.
Claim 12
Dependent Claim
15 words
The balloon according to claim 11, wherein said glass transition temperature approximates human body temperature.
Claim 13
Dependent Claim
31 words
The balloon according to any of claims 1-12, wherein said balloon had been subjected to at least two radial expansion procedures, and wherein said balloon is substantially free of expansion knurls.
Claim 14
Dependent Claim
54 words
A catheter medical device, comprising: a catheter body; a balloon member positioned along the length of said catheter body; said balloon member being as claimed in any of claims 1-13, and said balloon member has a collapsed profile at which the outer diameter of the balloon approximates the outer diameter of said catheter body.
Claim 15
Dependent Claim
45 words
The catheter according to claim 14, wherein said expansion profile is 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.
Claim 16
Dependent Claim
26 words
The catheter according to claim 14 or 15, wherein said maximum inflated diameter exceeds said predetermined balloon diameter by up to about 30 percent or more.
Claim 17
Dependent Claim
31 words
The catheter according to claim 14 or 15, wherein said maximum inflated diameter exceeds said predetermined balloon diameter by between in excess of 5 percent and about 40 percent or above.
Claim 18
Dependent Claim
20 words
The catheter according to any of claims 13-17, wherein said balloon member material has an intrinsic viscosity of approximately 1.3.
Claim 19
Dependent Claim
133 words
A process for tailoring expansion properties of a balloon for a medical device, the process comprising: longitudinally stretching a length of tubing having an initial diameter and made of material capable of being tailored by the steps hereof to provide drawn tubing; radially expanding the thus drawn tubing to a balloon member, said balloon member having a non-distended working diameter and having a hoop expansion ratio, which hoop expansion ratio is an approximate ratio of said non-distended working diameter to said initial diameter of the tubing; and said radially expanding step including selecting said hoop expansion ratio such that the balloon member exhibits a maximum inflated diameter to which the balloon stretches without bursting during use, said maximum inflated diameter increasing in a manner which is indirectly proportional to said hoop expansion ratio.
Claim 20
Dependent Claim
18 words
The process according to claim 19, wherein said hoop expansion ratio is between about 3 and about 6.
Claim 21
Dependent Claim
78 words
The process according to claim 19 or 20, further including heat setting said balloon member by raising the temperature of the balloon member to a heat setting temperature above the glass transition temperature of the tubing material, followed by cooling the balloon member to a temperature below the glass transition temperature, and said heat setting step tailors the balloon member whereby said maximum inflated diameter increases in a manner which is directly proportional to said heat setting temperature.
Claim 22
Dependent Claim
20 words
The process according to claim 21, wherein said heat setting temperature is between about 90° C. and about 180° C.
Claim 23
Dependent Claim
17 words
The process according to claim 21 or 22, wherein said glass transition temperature approximates human body temperature.
Claim 24
Dependent Claim
20 words
The process according to claim 21, 22 or 23, wherein said temperature below the glass transition temperature approximates room temperature.
Claim 25
Dependent Claim
57 words
The process according to any of claim 19-24, wherein said radially expanding step is followed by a step of longitudinally extending said length to form a drawn radially expanded section, followed by inflating said drawn radially expanded section to a modified profile and size, further followed by setting said modified profile and size to form the balloon.
Claim 26
Dependent Claim
23 words
The process according to claim 25, wherein said step of inflating the drawn radially expanded section includes controlling same within a molding cavity.
Claim 27
Dependent Claim
130 words
A balloon for a medical device, comprising: a nylon material or a polyamide material tubing that had been radially expanded to a predetermined balloon diameter; 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.
Claim 28
Dependent Claim
21 words
The balloon according to claim 27, wherein said distended diameter exceeds said predetermined balloon diameter by a limited and controlled amount.
Claim 29
Dependent Claim
23 words
The balloon according to claim 27, wherein said distended diameter exceeds said predetermined balloon diameter by up to about 30 percent or greater.
Claim 30
Dependent Claim
24 words
The balloon according to claim 27, wherein said distended diameter exceeds said predetermined balloon diameter by between about 5 percent and about 30 percent.
Claim 31
Dependent Claim
17 words
The balloon according to any of claims 27-30, wherein said nylon or polyamide material is Nylon 12.
Claim 32
Dependent Claim
55 words
The balloon according to any of claims 27-31, wherein said nylon or polyamide tubing had been subjected to axial elongation at room temperature, followed by radial expansion with pressurized fluid, followed by another axial elongation, which is followed by another radial expansion with pressurized fluid, and wherein said balloon is substantially free of expansion knurls.
Claim 33
Dependent Claim
15 words
The balloon according to any of claims 27-32, wherein said balloon is an angioplasty balloon.
Claim 34
Dependent Claim
95 words
The balloon according to any of claims 27-33, wherein said distended inflation diameter is a maximum stretched inflation diameter to which the balloon is expandable without bursting, said maximum stretched inflation diameter being in excess of said predetermined balloon diameter; and said tubing material of the balloon has tailorability properties whereby said maximum stretched inflation diameter had been selected during formation of the balloon to fall within a range of maximum stretched inflation diameter values, and said balloon maximum stretched inflation diameter had been selected from within said range of maximum stretched inflation diameter values.
Claim 35
Dependent Claim
49 words
The balloon according to claim 34, wherein said range of maximum stretched inflation diameter values are a function of a hoop expansion ratio of the balloon, said hoop expansion ratio being the approximate ratio of said predetermined balloon diameter to the diameter of said tubing prior to radial expansion.
Claim 36
Dependent Claim
21 words
The balloon according to any of claims 27-35, wherein said nylon or polyamide material has an intrinsic viscosity of approximately 1.3.
Claim 37
Dependent Claim
23 words
The balloon according to any of claims 27-36, wherein said balloon has a tensile strength of between about 15,000 and about 30,000 psi.
Claim 38
Dependent Claim
27 words
A medical catheter, comprising: a catheter body; a balloon positioned along the length of said catheter body; said balloon being as claimed in any of claims 27-37.
References Cited (Backward Citations)
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