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US5556383A Expired / Lapsed US ⏱️ 0.0 years remaining

Block copolymer elastomer catheter balloons

Assignee: Boston Scientific Scimed Inc
•
Filing: 1995-03-02
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Granted: 1996-09-17
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Expires: 2015-03-02
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Abstract

Abstract Balloons for medical devices, particularly balloon angioplasty catheters, are made from particular block copolymer thermoplastic elastomers in which the block copolymer is made up of hard segments of a polyester or polyamide and soft segments of polyether; the polyester hard segments are polyesters of an aromatic dicarboxylic acid and a C2-C4 diol; the polyamide hard segments are polyamides of C6 or higher carboxylic acids and C6 or higher organic diamines or of C6 or higher aliphatic omega -amino- alpha -acids, and the polyether soft segments are polyethers of C2-C10, diols; the block copolymer has a low flexural modulus, namely less than 150,000 psi; the block copolymer has a hardness, Shore D scale, of greater than 60; and the percentage by weight of the block polymer attributable to the hard segments is between about 50% and about 95%. The polymers provide high strength, thin wall, compliant and semi-compliant balloons, which leads to a low profile catheter. The low profile catheters have very good initial crossing, good trackability, good recrossing after first inflation.

Inventors

  • 👤 Lixiao Wang
  • 👤 Jianhua Chen

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-23 03:53
CPC Classifications
A; A61; A61M; A61M25/00; A61M25/10; A61M25/1027; A61L; A61L29/00; A61L29/04; A61L29/06; A61L29/14; A61M25/1029; B; B29; B29C; B29C49/00; B29C49/42; B29C49/78; B29C49/783; B29C2049/7831; B29C49/64; B29C49/6409; B29C49/6418; B29C49/64195; B29L; B29L2031/00; B29L2031/753; B29L2031/7542

Claims Analysis

Total Claims: 18
Claim 1
Independent Claim 173 words
A balloon for a medical device formed from a length of tubing of a polymer material by radial expansion of the tubing under pressure, the polymer material comprising a block copolymer thermoplastic elastomer characterized as follows: the block copolymer is represented by the formula: ##STR2## in which PA is a polyamide hard segment of molecular weight in the range of 500-8,000; PE is a polyether soft segment of molecular weight in the range of 500-2,500 and the repeating number n is between 5 and 10, the polyamide hard segments are polyamides of C 6 or higher carboxylic acids and C 6 or higher organic diamines or of C 6 or higher aliphatic ω-amino-α-acids, and the polyether soft segments are polyethers of C 2 -C 10 diols; the block copolymer has a flexural modulus of less than about 150,000 psi; the block copolymer has a hardness, Shore D scale, of greater than 60; and the percentage by weight of the block polymer attributable to the hard segments is between about 50% and about 95%.
Claim 2
Dependent Claim 173 words
A balloon for a medical device formed from a length of tubing of a polymer material by radial expansion of the tubing under pressure, the polymer material comprising a block copolymer thermoplastic elastomer characterized as follows: the block copolymer is represented by the formula: ##STR2## in which PA is a polyamide hard segment of molecular weight in the range of 500-8,000; PE is a polyether soft segment of molecular weight in the range of 500-2,500 and the repeating number n is between 5 and 10, the polyamide hard segments are polyamides of C 6 or higher carboxylic acids and C 6 or higher organic diamines or of C 6 or higher aliphatic ω-amino-α-acids, and the polyether soft segments are polyethers of C 2 -C 10 diols; the block copolymer has a flexural modulus of less than about 150,000 psi; the block copolymer has a hardness, Shore D scale, of greater than 60; and the percentage by weight of the block polymer attributable to the hard segments is between about 50% and about 95%.
Claim 3
Dependent Claim 46 words
A balloon as in claim 1 wherein the block copolymer segment, PA, is an aliphatic polyamide of one or more C 10 -C 12 aliphatic acids and one or more C 10 -C 12 aliphatic diamines or of a C 10 -C 12 aliphatic ω-amino -α-acid.
Claim 4
Dependent Claim 35 words
A balloon as in claim 1 wherein the polyamide segment, PA, is selected from the group consisting of nylon 12, nylon 11, nylon 9, nylon 6, nylon 6/12, nylon 6/11, nylon 6/9 and nylon 6/6.
Claim 5
Dependent Claim 35 words
A balloon as in claim 1 wherein the polyamide segment, PA, is nylon 12 of a molecular weight of 3,000-5,000, and the polyether segment, PE, is poly(tetramethylene ether) of molecular weight between 500 and 1250.
Claim 6
Dependent Claim 22 words
A balloon as in claim 1 wherein the polyamide segments, PA, comprise between 80 and 90% by weight of the polyamide/polyether polyester.
Claim 7
Dependent Claim 24 words
A balloon as in claim 1 wherein said polyether segment, is selected from the group consisting of poly(tetramethylene ether), poly(pentamethylene ether) and poly(hexamethylene ether).
Claim 8
Dependent Claim 18 words
A balloon as in claim 1 wherein the wall strength of the balloon is at least 15,000 psi.
Claim 9
Dependent Claim 28 words
A balloon as in claim 7 wherein the wall thickness, single wall basis, is no more than 0.0015 inches and said wall strength is greater than 18,000 psi.
Claim 10
Dependent Claim 16 words
A balloon as in claim 8 wherein said wall thickness is no more than 0.0009 inches.
Claim 11
Dependent Claim 15 words
A balloon as in claim 7 wherein said wall strength is greater than 20,000 psi.
Claim 12
Dependent Claim 56 words
A balloon as in claim 4 having a compliant to semi-compliant distension profile whereby as inflation pressure is increased from 6 atm to 12 atm, the balloon expands from a nominal diameter at the 6 atm pressure to an increased diameter at the 9 atm pressure which is at least 7% greater than said nominal diameter.
Claim 13
Dependent Claim 22 words
A balloon as in claim 11 wherein the increased diameter at 12 atm is at least 10% greater than said nominal diameter.
Claim 14
Dependent Claim 19 words
A balloon as in claim 11 wherein the increased diameter is at least 16% greater than said nominal diameter.
Claim 15
Dependent Claim 28 words
A balloon as in claim 11 having a nominal diameter of between 1.5 mm and 10.0 mm, the balloon having a burst pressure of at least 10 atm.
Claim 16
Dependent Claim 28 words
A balloon as in claim 1 having a nominal diameter of between 1.5 mm and 4.0 mm, the balloon having a burst pressure of at least 12 atm.
Claim 17
Dependent Claim 31 words
A balloon as in claim 1 wherein the block copolymer is further characterized by a ultimate tensile strength of at least 6,000 psi and an ultimate elongation of at least 300%.
Claim 18
Dependent Claim 33 words
A dilation catheter having a elongated tubular body, a balloon mounted on a distal end thereof and means for inflation of the balloon, wherein the balloon is a balloon as in claim 1.

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 1999-09-17 2000-03-18 2000-09-17 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 2003-09-17 2004-03-18 2004-09-17 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 2007-09-17 2008-03-18 2008-09-17 $7700.00 Window Closed / Lapsed

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