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US5976192A Expired / Lapsed US ⏱️ 0.0 years remaining

Method of forming an externally supported tape reinforced vascular graft

Assignee: Edwards Lifesciences Corp
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Filing: 1996-12-10
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Granted: 1999-11-02
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Expires: 2016-12-10
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Abstract

Abstract An externally supported, tape-reinforced tubular prosthetic graft and method of manufacturing therefore. The graft comprises a tubular base graft formed of expanded, sintered fluoropolymer material, a strip of reinforcement tape helically wrapped about the outer surface of the tubular base graft and attached thereto, and, an external support member helically wrapped around the outer surface of the reinforcement tape and attached thereto. The helical pitch of the reinforcement tape is different from the helical pitch of the external support member. Preferably, the helical pitch of the reinforcement tape is in a direction which is opposite the direction of the external support member.

Inventors

  • 👤 John McIntyre
  • 👤 Donald Shannon
  • 👤 Chris Kuo
  • 👤 Chris McCollam
  • 👤 Robert Peterson

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-23 16:32
CPC Classifications
A; A61; A61F; A61F2/00; A61F2/02; A61F2/04; A61F2/06; Y; Y10; Y10S; Y10S623/00; Y10S623/901

Claims Analysis

Total Claims: 38
Claim 1
Independent Claim 219 words
A method of manufacturing an externally-supported, tape-reinforced, tubular prosthetic graft, said method comprising the steps of: a) providing a tubular base graft formed of expanded, sintered fluoropolymer material, said tubular base graft having an inner luminal surface and an outer surface, wherein the tubular base graft is manufactured by a method comprising the following steps; i) preparing a fluoropolymer paste by mixing crystalline fluoropolymer powder with a quantity of liquid lubricant; ii) forming the fluoropolymer paste into a tubular workpiece; iii) expanding the tubular workpiece in at least one axis of expansion; iv) drying the tubular workpiece to remove the liquid lubricant therefrom; and v) sintering the tubular workpiece to form said tubular base graft; b) providing at least one strip of reinforcement tape formed of expanded, sintered fluoropolymer film; c) wrapping said reinforcement tape helically around the outer surface of the tubular base graft in a first helical pitch; d) causing the helically wrapped reinforcement tape to become attached to the tubular base graft; e) providing an external support member formed of substantially non-elastic beading; f) helically wrapping the external support member around the helically wrapped reinforcement tape in a second helical pitch which differs from said first helical pitch; and, g) causing the helically wrapped external support member to become attached to the helically wrapped reinforcement tape.
Claim 2
Independent Claim 219 words
A method of manufacturing an externally-supported, tape-reinforced, tubular prosthetic graft, said method comprising the steps of: a) providing a tubular base graft formed of expanded, sintered fluoropolymer material, said tubular base graft having an inner luminal surface and an outer surface, wherein the tubular base graft is manufactured by a method comprising the following steps; i) preparing a fluoropolymer paste by mixing crystalline fluoropolymer powder with a quantity of liquid lubricant; ii) forming the fluoropolymer paste into a tubular workpiece; iii) expanding the tubular workpiece in at least one axis of expansion; iv) drying the tubular workpiece to remove the liquid lubricant therefrom; and v) sintering the tubular workpiece to form said tubular base graft; b) providing at least one strip of reinforcement tape formed of expanded, sintered fluoropolymer film; c) wrapping said reinforcement tape helically around the outer surface of the tubular base graft in a first helical pitch; d) causing the helically wrapped reinforcement tape to become attached to the tubular base graft; e) providing an external support member formed of substantially non-elastic beading; f) helically wrapping the external support member around the helically wrapped reinforcement tape in a second helical pitch which differs from said first helical pitch; and, g) causing the helically wrapped external support member to become attached to the helically wrapped reinforcement tape.
Claim 3
Dependent Claim 87 words
The method of claim 1 wherein step b) comprises manufacturing a quantity of expanded, sintered fluoropolymer tape by a method comprising the steps of: preparing a fluoropolymer paste by mixing a crystalline fluoropolymer powder with a quantity of liquid lubricant; forming the fluoropolymer paste into a film; calendaring the film; drying the film to remove the liquid lubricant therefrom; expanding the film in at least one axis of expansion; sintering the expanded film; and, cutting the expanded, sintered film into strips to thereby form said reinforcement tape.
Claim 4
Dependent Claim 68 words
The method of claim 1 wherein step c) comprises: laying the reinforcement tape against the outer surface of the tubular base graft at a predetermined angle relative to the longitudinal axis of the tubular base graft and concurrently rotating the tubular base graft about its longitudinal axis so as to helically wrap said reinforcement tape around the outer surface of the tubular base graft in a helical pitch.
Claim 5
Dependent Claim 31 words
The method of claim 1 wherein step d) comprises heating the helically wrapped reinforcement tape and tubular base graft to cause the reinforcement tape to become laminated to the base graft.
Claim 6
Dependent Claim 15 words
The method of claim 1 wherein step e) comprises: providing a quantity of PTFE beading.
Claim 7
Dependent Claim 84 words
The method of claim 1 wherein step f) comprises: laying the external support member against the outer surface of the reinforcement tape-wrapped tubular base graft at a second predetermined angle relative to the longitudinal axis of the tubular base graft and concurrently rotating the tubular base graft about its longitudinal axis thereby causing the external support member to become helically wrapped around the reinforcement tape in a second helical pitch which differs from the first helical pitch at which the reinforcement tape was wrapped.
Claim 8
Dependent Claim 34 words
The method of claim 1 wherein step g) comprises heating the external support member and the reinforcement tape to a temperature which causes the external support member to become laminated to the reinforcement tape.
Claim 9
Dependent Claim 150 words
The method of claim 1 wherein: step c) comprises laying the reinforcement tape against the outer surface of the tubular base graft at a first predetermined angle relative to the longitudinal axis of the tubular base graft and rotating the tubular base graft about its longitudinal axis so as to helically wrap said reinforcement tape around the outer surface of the tubular base graft in a first helical pitch; and, wherein step f) comprises: laying the external support member against the outer surface of the reinforcement tape-wrapped tubular base graft at a second predetermined angle relative to the longitudinal axis of the tubular base graft and concurrently rotating the tape-wrapped tubular base graft about its longitudinal axis thereby causing the external support member to become helically wrapped about the reinforcement tape in a second helical pitch which differs from said first helical pitch at which the reinforcement tape was wrapped.
Claim 10
Dependent Claim 50 words
The method of claim 8 wherein said first and second predetermined angles are of the same number of degrees relative to the longitudinal axis, but are in different directions relative to the longitudinal axis, thereby resulting in a directional difference between said first helical pitch and said second helical pitch.
Claim 11
Dependent Claim 49 words
The method of claim 8 wherein said first and second pre-determined angles are of differing angular size relative to the longitudinal axis of said base graft, thereby resulting in differences in the first helical pitch of the reinforcement tape and the second helical pitch of the external support member.
Claim 12
Independent Claim 235 words
A method of manufacturing an externally-supported, tape-reinforced, tubular prosthetic graft, said method comprising the steps of: a) providing a tubular base graft formed of expanded, sintered fluoropolymer material, said tubular base graft having an inner luminal surface and an outer surface; b) providing at least one strip of reinforcement tape formed of expanded, sintered fluoropolymer film, the tape being provided by manufacturing a quantity of expanded, sintered fluoropolymer tape by a method comprising the steps of: i) preparing a fluoropolymer paste by mixing a crystalline fluoropolymer powder with a quantity of liquid lubricant; ii) forming the fluoropolymer paste into a film; iii) calendaring the film; iv) drying the film to remove the liquid lubricant therefrom; v) expanding the film in at least one axis of expansion; vi) sintering the expanded film; and, vii) cutting the expanded, sintered film into strips to thereby form said reinforcement tape c) wrapping said reinforcement tape helically around the outer surface of the tubular base graft in a first helical pitch; d) causing the helically wrapped reinforcement tape to become attached to the tubular base graft; e) providing an external support member formed of substantially non-elastic beading; f) helically wrapping the external support member around the helically wrapped reinforcement tape in a second helical pitch which differs from said first helical pitch; and, g) causing the helically wrapped external support member to become attached to the helically wrapped reinforcement tape.
Claim 13
Independent Claim 235 words
A method of manufacturing an externally-supported, tape-reinforced, tubular prosthetic graft, said method comprising the steps of: a) providing a tubular base graft formed of expanded, sintered fluoropolymer material, said tubular base graft having an inner luminal surface and an outer surface; b) providing at least one strip of reinforcement tape formed of expanded, sintered fluoropolymer film, the tape being provided by manufacturing a quantity of expanded, sintered fluoropolymer tape by a method comprising the steps of: i) preparing a fluoropolymer paste by mixing a crystalline fluoropolymer powder with a quantity of liquid lubricant; ii) forming the fluoropolymer paste into a film; iii) calendaring the film; iv) drying the film to remove the liquid lubricant therefrom; v) expanding the film in at least one axis of expansion; vi) sintering the expanded film; and, vii) cutting the expanded, sintered film into strips to thereby form said reinforcement tape c) wrapping said reinforcement tape helically around the outer surface of the tubular base graft in a first helical pitch; d) causing the helically wrapped reinforcement tape to become attached to the tubular base graft; e) providing an external support member formed of substantially non-elastic beading; f) helically wrapping the external support member around the helically wrapped reinforcement tape in a second helical pitch which differs from said first helical pitch; and, g) causing the helically wrapped external support member to become attached to the helically wrapped reinforcement tape.
Claim 14
Dependent Claim 68 words
The method of claim 11 wherein step c) comprises: laying the reinforcement tape against the outer surface of the tubular base graft at a predetermined angle relative to the longitudinal axis of the tubular base graft and concurrently rotating the tubular base graft about its longitudinal axis so as to helically wrap said reinforcement tape around the outer surface of the tubular base graft in a helical pitch.
Claim 15
Dependent Claim 31 words
The method of claim 11 wherein step d) comprises heating the helically wrapped reinforcement tape and tubular base graft to cause the reinforcement tape to become laminated to the base graft.
Claim 16
Dependent Claim 15 words
The method of claim 11 wherein step e) comprises: providing a quantity of PTFE beading.
Claim 17
Dependent Claim 84 words
The method of claim 11 wherein step f) comprises: laying the external support member against the outer surface of the reinforcement tape-wrapped tubular base graft at a second predetermined angle relative to the longitudinal axis of the tubular base graft and concurrently rotating the tubular base graft about its longitudinal axis thereby causing the external support member to become helically wrapped around the reinforcement tape in a second helical pitch which differs from the first helical pitch at which the reinforcement tape was wrapped.
Claim 18
Dependent Claim 34 words
The method of claim 11 wherein step g) comprises heating the external support member and the reinforcement tape to a temperature which causes the external support member to become laminated to the reinforcement tape.
Claim 19
Dependent Claim 149 words
The method of claim 11 wherein: step c) comprises laying the reinforcement tape against the outer surface of the tubular base graft at a first predetermined angle relative to the longitudinal axis of the tubular base graft and rotating the tubular base graft about its longitudinal axis so as to helically wrap said reinforcement tape around the outer surface of the tubular base graft in a first helical pitch; and, step f) comprises laying the external support member against the outer surface of the reinforcement tape-wrapped tubular base graft at a second predetermined angle relative to the longitudinal axis of the tubular base graft and concurrently rotating the tape-wrapped tubular base graft about its longitudinal axis thereby causing the external support member to become helically wrapped about the reinforcement tape in a second helical pitch which differs from said first helical pitch at which the reinforcement tape was wrapped.
Claim 20
Dependent Claim 50 words
The method of claim 17 wherein said first and second predetermined angles are of the same number of degrees relative to the longitudinal axis, but are in different directions relative to the longitudinal axis, thereby resulting in a directional difference between said first helical pitch and said second helical pitch.
Claim 21
Dependent Claim 49 words
The method of claim 17 wherein said first and second pre-determined angles are of differing angular size relative to the longitudinal axis of said base graft, thereby resulting in differences in the first helical pitch of the reinforcement tape and the second helical pitch of the external support member.
Claim 22
Independent Claim 154 words
A method of manufacturing an externally-supported, tape-reinforced, tubular prosthetic graft, said method comprising the steps of: a) providing a tubular base graft formed of expanded, sintered fluoropolymer material, said tubular base graft having an inner luminal surface and an outer surface; b) providing at least one strip of reinforcement tape formed of expanded, sintered fluoropolymer film; c) wrapping said reinforcement tape helically around the outer surface of the tubular base graft in a first helical pitch; d) heating the helically wrapped reinforcement tape and tubular base graft to cause the reinforcement tape to become laminated to the tubular base graft; e) providing an external support member formed of substantially non-elastic beading; f) helically wrapping the external support member around the helically wrapped reinforcement tape in a second helical pitch which differs from said first helical pitch; and, g) causing the helically wrapped external support member to become attached to the helically wrapped reinforcement tape.
Claim 23
Independent Claim 154 words
A method of manufacturing an externally-supported, tape-reinforced, tubular prosthetic graft, said method comprising the steps of: a) providing a tubular base graft formed of expanded, sintered fluoropolymer material, said tubular base graft having an inner luminal surface and an outer surface; b) providing at least one strip of reinforcement tape formed of expanded, sintered fluoropolymer film; c) wrapping said reinforcement tape helically around the outer surface of the tubular base graft in a first helical pitch; d) heating the helically wrapped reinforcement tape and tubular base graft to cause the reinforcement tape to become laminated to the tubular base graft; e) providing an external support member formed of substantially non-elastic beading; f) helically wrapping the external support member around the helically wrapped reinforcement tape in a second helical pitch which differs from said first helical pitch; and, g) causing the helically wrapped external support member to become attached to the helically wrapped reinforcement tape.
Claim 24
Dependent Claim 68 words
The method of claim 20 wherein step c) comprises: laying the reinforcement tape against the outer surface of the tubular base graft at a predetermined angle relative to the longitudinal axis of the tubular base graft and concurrently rotating the tubular base graft about its longitudinal axis so as to helically wrap said reinforcement tape around the outer surface of the tubular base graft in a helical pitch.
Claim 25
Dependent Claim 15 words
The method of claim 20 wherein step e) comprises: providing a quantity of PTFE beading.
Claim 26
Dependent Claim 84 words
The method of claim 20 wherein step f) comprises: laying the external support member against the outer surface of the reinforcement tape-wrapped tubular base graft at a second predetermined angle relative to the longitudinal axis of the tubular base graft and concurrently rotating the tubular base graft about its longitudinal axis thereby causing the external support member to become helically wrapped around the reinforcement tape in a second helical pitch which differs from the first helical pitch at which the reinforcement tape was wrapped.
Claim 27
Dependent Claim 34 words
The method of claim 20 wherein step g) comprises heating the external support member and the reinforcement tape to a temperature which causes the external support member to become laminated to the reinforcement tape.
Claim 28
Dependent Claim 149 words
The method of claim 20 wherein: step c) comprises laying the reinforcement tape against the outer surface of the tubular base graft at a first predetermined angle relative to the longitudinal axis of the tubular base graft and rotating the tubular base graft about its longitudinal axis so as to helically wrap said reinforcement tape around the outer surface of the tubular base graft in a first helical pitch; and, step f) comprises laying the external support member against the outer surface of the reinforcement tape-wrapped tubular base graft at a second predetermined angle relative to the longitudinal axis of the tubular base graft and concurrently rotating the tape-wrapped tubular base graft about its longitudinal axis thereby causing the external support member to become helically wrapped about the reinforcement tape in a second helical pitch which differs from said first helical pitch at which the reinforcement tape was wrapped.
Claim 29
Dependent Claim 50 words
The method of claim 25 wherein said first and second predetermined angles are of the same number of degrees relative to the longitudinal axis, but are in different directions relative to the longitudinal axis, thereby resulting in a directional difference between said first helical pitch and said second helical pitch.
Claim 30
Dependent Claim 49 words
The method of claim 25 wherein said first and second pre-determined angles are of differing angular size relative to the longitudinal axis of said base graft, thereby resulting in differences in the first helical pitch of the reinforcement tape and the second helical pitch of the external support member.
Claim 31
Independent Claim 154 words
A method of manufacturing an externally-supported, tape-reinforced, tubular prosthetic graft, said method comprising the steps of: a) providing a tubular base graft formed of expanded, sintered fluoropolymer material, said tubular base graft having an inner luminal surface and an outer surface; b) providing at least one strip of reinforcement tape formed of expanded, sintered fluoropolymer film; c) wrapping said reinforcement tape helically around the outer surface of the tubular base graft in a first helical pitch; d) causing the helically wrapped reinforcement tape to become attached to the tubular base graft; e) providing an external support member formed of substantially non-elastic beading; f) helically wrapping the external support member around the helically wrapped reinforcement tape in a second helical pitch which differs from said first helical pitch; and, g) heating the external support member and the reinforcement tape to a temperature which causes the external support member to become laminated to the reinforcement tape.
Claim 32
Independent Claim 154 words
A method of manufacturing an externally-supported, tape-reinforced, tubular prosthetic graft, said method comprising the steps of: a) providing a tubular base graft formed of expanded, sintered fluoropolymer material, said tubular base graft having an inner luminal surface and an outer surface; b) providing at least one strip of reinforcement tape formed of expanded, sintered fluoropolymer film; c) wrapping said reinforcement tape helically around the outer surface of the tubular base graft in a first helical pitch; d) causing the helically wrapped reinforcement tape to become attached to the tubular base graft; e) providing an external support member formed of substantially non-elastic beading; f) helically wrapping the external support member around the helically wrapped reinforcement tape in a second helical pitch which differs from said first helical pitch; and, g) heating the external support member and the reinforcement tape to a temperature which causes the external support member to become laminated to the reinforcement tape.
Claim 33
Dependent Claim 68 words
The method of claim 28 wherein step c) comprises: laying the reinforcement tape against the outer surface of the tubular base graft at a predetermined angle relative to the longitudinal axis of the tubular base graft and concurrently rotating the tubular base graft about its longitudinal axis so as to helically wrap said reinforcement tape around the outer surface of the tubular base graft in a helical pitch.
Claim 34
Dependent Claim 15 words
The method of claim 28 wherein step e) comprises: providing a quantity of PTFE beading.
Claim 35
Dependent Claim 84 words
The method of claim 28 wherein step f) comprises: laying the external support member against the outer surface of the reinforcement tape-wrapped tubular base graft at a second predetermined angle relative to the longitudinal axis of the tubular base graft and concurrently rotating the tubular base graft about its longitudinal axis thereby causing the external support member to become helically wrapped around the reinforcement tape in a second helical pitch which differs from the first helical pitch at which the reinforcement tape was wrapped.
Claim 36
Dependent Claim 149 words
The method of claim 28 wherein: step c) comprises laying the reinforcement tape against the outer surface of the tubular base graft at a first predetermined angle relative to the longitudinal axis of the tubular base graft and rotating the tubular base graft about its longitudinal axis so as to helically wrap said reinforcement tape around the outer surface of the tubular base graft in a first helical pitch; and, step f) comprises laying the external support member against the outer surface of the reinforcement tape-wrapped tubular base graft at a second predetermined angle relative to the longitudinal axis of the tubular base graft and concurrently rotating the tape-wrapped tubular base graft about its longitudinal axis thereby causing the external support member to become helically wrapped about the reinforcement tape in a second helical pitch which differs from said first helical pitch at which the reinforcement tape was wrapped.
Claim 37
Dependent Claim 50 words
The method of claim 32 wherein said first and second predetermined angles are of the same number of degrees relative to the longitudinal axis, but are in different directions relative to the longitudinal axis, thereby resulting in a directional difference between said first helical pitch and said second helical pitch.
Claim 38
Dependent Claim 49 words
The method of claim 32 wherein said first and second pre-determined angles are of differing angular size relative to the longitudinal axis of said base graft, thereby resulting in differences in the first helical pitch of the reinforcement tape and the second helical pitch of the external support member.

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 2002-11-01 2003-05-03 2003-11-02 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 2006-11-01 2007-05-03 2007-11-02 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 2010-11-01 2011-05-03 2011-11-02 $7700.00 Window Closed / Lapsed

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