US5425744A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Occluder for repair of cardiac and vascular defects
Assignee: Boston Children's Hospital
•
Filing: 1994-04-18
•
Granted: 1995-06-20
•
Expires: 2014-04-18
Abstract
Abstract A device for the percutaneous transluminal repair of septal defects is disclosed. The device comprises first and second expandable occluders fastened to each other, each occluder including a framework having a central hub with elongated struts radiating therefrom. The struts are constructed such that they have a resistance to fatigue that exceeds the maximum fatigue stresses to which the struts will be subjected over a prolonged period in vivo. As such, the device exhibits a significantly decreased likelihood of metal fatigue failures after prolonged exposure in vivo.
Inventors
- 👤 Jack Fagan
- 👤 L. Ven Raman
- 👤 George Duval
- 👤 Gerry Ouellette
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-22 15:51
CPC Classifications
A; A61; A61B; A61B17/00; A61B17/0057; A61B2017/00575; A61B2017/00588; A61B2017/00592; A61B2017/00606
Claims Analysis
Total Claims: 85
Claim 1
Independent Claim
159 words
A device for percutaneous transluminal repair of septal defects comprising: a first occluder having an initial cross sectional configuration smaller than that of the defect to be repaired and a second expanded configuration larger than that of the defect; a second occluder having an initial cross sectional configuration smaller than that of the defect to be repaired and a second expanded configuration larger than that of the defect; and a connector for fastening the first occluder to the second occluder; at least one of said first occluder or said second occluder including a framework comprising a central hub having a plurality of elongated struts radiating therefrom; wherein at least one of said struts has at least three flexural hinge points and at least one end loop, said flexural hinge points including a shoulder flexural hinge point, an elbow flexural hinge point and at least one flexural hinge point located between the end loop and the elbow flexural hinge point.
Claim 2
Independent Claim
159 words
A device for percutaneous transluminal repair of septal defects comprising: a first occluder having an initial cross sectional configuration smaller than that of the defect to be repaired and a second expanded configuration larger than that of the defect; a second occluder having an initial cross sectional configuration smaller than that of the defect to be repaired and a second expanded configuration larger than that of the defect; and a connector for fastening the first occluder to the second occluder; at least one of said first occluder or said second occluder including a framework comprising a central hub having a plurality of elongated struts radiating therefrom; wherein at least one of said struts has at least three flexural hinge points and at least one end loop, said flexural hinge points including a shoulder flexural hinge point, an elbow flexural hinge point and at least one flexural hinge point located between the end loop and the elbow flexural hinge point.
Claim 3
Dependent Claim
25 words
The device of claim 1 wherein said at least one elongated strut comprises a wire having a square, round, rectangular, trapezoidal or triangular cross section.
Claim 4
Dependent Claim
15 words
The device of claim 2 wherein said cross section is approximately 0.005-0015 inches on edge.
Claim 5
Dependent Claim
26 words
The device of claim 2 wherein said at least one elongated strut comprises a wire having a square cross section of approximately 0.008 inches on edge.
Claim 6
Dependent Claim
26 words
The device of claim 2 wherein said at least one elongated strut comprises a wire having a circular cross section of approximately 0.009 inches in diameter.
Claim 7
Dependent Claim
28 words
The device of claim 2 wherein said at least one elongated strut comprises a wire having a rectangular cross section of approximately 0.007 inches by approximately 0.009 inches.
Claim 8
Independent Claim
22 words
The device of any one of claims 1 to 5 wherein said flexural hinge points comprise coiled portions of the elongated strut.
Claim 9
Dependent Claim
17 words
The device of claim 7 wherein said coiled portions have an inner diameter of approximately 0.010-0.025 inches.
Claim 10
Dependent Claim
17 words
The device of claim 7 wherein said coiled portions have an inner diameter of approximately 0.016 inches.
Claim 11
Dependent Claim
14 words
The device of claim 7 wherein said coiled portions include at least two coils.
Claim 12
Dependent Claim
14 words
The device of claim 7 wherein said coiled portions include at least three coils.
Claim 13
Dependent Claim
26 words
The device of claim 1 wherein said at least one elongated strut comprises a wire fabricated of a metallic alloy containing nickel, cobalt, chromium and molybdenum.
Claim 14
Dependent Claim
19 words
The device of claim 12 wherein said alloy comprises approximately 35% nickel, 35% cobalt, 20% chromium and 9.75% molybdenum.
Claim 15
Dependent Claim
15 words
The device of claim 12 wherein said alloy further comprises manganese, carbon, beryllium and iron.
Claim 16
Dependent Claim
23 words
The device of claim 14 wherein said alloy comprises at least approximately 14% nickel, 39% cobalt, 19% chromium, 6% molybdenum and 1.5% manganese.
Claim 17
Dependent Claim
18 words
The device of claim 15 wherein said alloy further comprises up to approximately 0.15% carbon and 0.1% beryllium.
Claim 18
Dependent Claim
19 words
The device of claim 12 wherein said alloy is annealed to a degree sufficient to cause precipitation hardening thereof.
Claim 19
Dependent Claim
18 words
The device of claim 17 wherein said annealing is carried out at a temperature between approximately 450°-1000° F.
Claim 20
Dependent Claim
19 words
The device of claim 12 wherein said wire has been cold-worked to reduce its cross-sectional area by approximately 30-80%.
Claim 21
Independent Claim
177 words
A device for percutaneous transluminal repair of septal defects comprising: a first occluder having an initial cross sectional configuration smaller than that of the defect to be repaired and a second expanded configuration larger than that of the defect; a second occluder having an initial cross sectional configuration smaller than that of the defect to be repaired and a second expanded configuration larger than that of the defect; and a connector for fastening the first occluder to the second occluder; each of the first occluder and second occluder comprising a framework having a central hub with a plurality of elongated struts radiating therefrom; the framework fabricated of a wire having a square, rectangular, round, trapezoidal or triangular cross section and having a metallic alloy composition comprising nickel, cobalt, chromium and molybdenum; each of said elongated struts further including three flexural hinge points and an end loop, said flexural hinge points including a shoulder flexural hinge point, an elbow flexural hinge point and a flexural hinge point located between the end loop and the elbow flexural hinge point.
Claim 22
Independent Claim
177 words
A device for percutaneous transluminal repair of septal defects comprising: a first occluder having an initial cross sectional configuration smaller than that of the defect to be repaired and a second expanded configuration larger than that of the defect; a second occluder having an initial cross sectional configuration smaller than that of the defect to be repaired and a second expanded configuration larger than that of the defect; and a connector for fastening the first occluder to the second occluder; each of the first occluder and second occluder comprising a framework having a central hub with a plurality of elongated struts radiating therefrom; the framework fabricated of a wire having a square, rectangular, round, trapezoidal or triangular cross section and having a metallic alloy composition comprising nickel, cobalt, chromium and molybdenum; each of said elongated struts further including three flexural hinge points and an end loop, said flexural hinge points including a shoulder flexural hinge point, an elbow flexural hinge point and a flexural hinge point located between the end loop and the elbow flexural hinge point.
Claim 23
Dependent Claim
21 words
The device of claim 20 wherein the metallic alloy composition is annealed to a degree sufficient to cause precipitation hardening thereof.
Claim 24
Dependent Claim
22 words
The device of claim 20 wherein the metallic alloy composition comprises an alloy selected from the group consisting of MP35N and Elgiloy.
Claim 25
Dependent Claim
17 words
The device of claim 20 wherein the flexural hinge points comprise coiled portions of the elongated strut.
Claim 26
Dependent Claim
15 words
The device of claim 20 wherein said cross section is approximately 0.005-0.015 inches on edge.
Claim 27
Dependent Claim
26 words
The device of claim 20 wherein said at least one elongated strut comprises a wire having a square cross section of approximately 0.008 inches on edge.
Claim 28
Dependent Claim
26 words
The device of claim 20 wherein said at least one elongated strut comprises a wire having a circular cross section of approximately 0.009 inches in diameter.
Claim 29
Dependent Claim
28 words
The device of claim 20 wherein said at least one elongated strut comprises a wire having a rectangular cross section of approximately 0.007 inches by approximately 0.009 inches.
Claim 30
Dependent Claim
17 words
The device of claim 20 wherein said flexural hinge points comprise coiled portions of the elongated strut.
Claim 31
Dependent Claim
17 words
The device of claim 28 wherein said coiled portions have an inner diameter of approximately 0.010-0.025 inches.
Claim 32
Dependent Claim
17 words
The device of claim 28 wherein said coiled portions have an inner diameter of approximately 0.016 inches.
Claim 33
Dependent Claim
14 words
The device of claim 28 wherein said coiled portions include at least two coils.
Claim 34
Dependent Claim
14 words
The device of claim 28 wherein said coiled portions include at least three coils.
Claim 35
Dependent Claim
19 words
The device of claim 20 wherein said alloy comprises approximately 35% nickel, 35% cobalt, 20% chromium and 9.75% molybdenum.
Claim 36
Dependent Claim
15 words
The device of claim 20 wherein said alloy further comprises manganese, carbon, beryllium and iron.
Claim 37
Dependent Claim
23 words
The device of claim 34 wherein said alloy comprises at least approximately 14% nickel, 39% cobalt, 19% chromium, 6% molybdenum and 1.5% manganese.
Claim 38
Dependent Claim
18 words
The device of claim 35 wherein said alloy further comprises up to approximately 0.15% carbon and 0.1% beryllium.
Claim 39
Dependent Claim
19 words
The device of claim 20 wherein said wire has been cold-worked to reduce its cross-sectional area by approximately 30-80%.
Claim 40
Dependent Claim
17 words
The device of claim 20 wherein said annealing is carried out at temperature between approximately 450°-1000° F.
Claim 41
Independent Claim
148 words
A device for percutaneous transluminal repair of septal detects comprising: a first occluder having an initial cross sectional configuration smaller than that of the defect to be repaired and a second expanded configuration larger than that of the defect; a second occluder having an initial cross sectional configuration smaller than that of the defect to be repaired and a second expanded configuration larger than that of the defect; and a connector for fastening the first occluder to the second occluder; each of the first occluder and second occluder comprising a framework having a central hub with a plurality of elongated struts radiating therefrom; each of said elongated struts further including three flexural hinge points and an end loop, said flexural hinge points including a shoulder flexural hinge point, an elbow flexural hinge point and a flexural hinge point between the elbow flexural hinge point and the end loop.
Claim 42
Independent Claim
148 words
A device for percutaneous transluminal repair of septal detects comprising: a first occluder having an initial cross sectional configuration smaller than that of the defect to be repaired and a second expanded configuration larger than that of the defect; a second occluder having an initial cross sectional configuration smaller than that of the defect to be repaired and a second expanded configuration larger than that of the defect; and a connector for fastening the first occluder to the second occluder; each of the first occluder and second occluder comprising a framework having a central hub with a plurality of elongated struts radiating therefrom; each of said elongated struts further including three flexural hinge points and an end loop, said flexural hinge points including a shoulder flexural hinge point, an elbow flexural hinge point and a flexural hinge point between the elbow flexural hinge point and the end loop.
Claim 43
Dependent Claim
24 words
The device of claim 39 wherein said means comprises elongated struts comprise a wire having a square, round, rectangular, trapezoidal or triangular cross section.
Claim 44
Dependent Claim
13 words
The device of claim 40 wherein said cross section is approximately 0.005-0.015 inches.
Claim 45
Dependent Claim
21 words
The device of claim 40 where said elongated struts comprise a wire having a square cross section of approximately 0.008 inches.
Claim 46
Dependent Claim
23 words
The device of claim 40 wherein said elongated struts comprise a wire having a circular cross section of approximately 0.009 inches in diameter.
Claim 47
Dependent Claim
25 words
The device of claim 40 wherein said elongated struts comprise a wire having a rectangular cross section of approximately 0.007 inches by approximately 0.009 inches.
Claim 48
Independent Claim
22 words
The device of any one of claims 40 to 44 wherein said flexural hinge points comprise coiled portions of the elongated strut.
Claim 49
Dependent Claim
17 words
The device of claim 45 wherein said coiled portions have an inner diameter of approximately 0.010-0.025 inches.
Claim 50
Dependent Claim
17 words
The device of claim 45 wherein said coiled portions have an inner diameter of approximately 0.016 inches.
Claim 51
Dependent Claim
14 words
The device of claim 45 wherein said coiled portions include at lest two coils.
Claim 52
Dependent Claim
23 words
The device of claim 40 wherein said elongated struts comprise a wire fabricated of a metallic alloy containing nickel, cobalt, chromium and molybdenum.
Claim 53
Dependent Claim
19 words
The device of claim 49 wherein said alloy comprises approximately 35% nickel, 35% cobalt, 20% chromium and 9.75% molybdenum.
Claim 54
Dependent Claim
15 words
The device of claim 49 wherein said alloy further comprises manganese, carbon, beryllium and iron.
Claim 55
Dependent Claim
23 words
The device of claim 51 wherein said alloy comprises at least approximately 14% nickel, 39% cobalt, 19% chromium, 6% molybdenum and 1.5% manganese.
Claim 56
Dependent Claim
18 words
The device of claim 52 wherein said alloy further comprises up to approximately 0.15% carbon and 0.1% beryllium.
Claim 57
Dependent Claim
19 words
The device of claim 49 wherein said alloy is annealed to a degree sufficient to cause precipitation hardening thereof.
Claim 58
Dependent Claim
18 words
The device of claim 54 wherein said annealing is carried out at a temperature between approximately 450°-1000° F.
Claim 59
Dependent Claim
19 words
The device of claim 49 wherein said wire has been cold-worked to reduce its cross-sectional area by approximately 30-80%.
Claim 60
Independent Claim
164 words
A device for percutaneous transluminal repair of septal detects comprising: a first occluder having an initial cross sectional configuration smaller than that of the defect to be repaired and a second expanded configuration larger than that of the defect; a second occluder having an initial cross sectional configuration smaller than that of the defect to be repaired and a second expanded configuration larger than that of the defect; and a connector for fastening the first occluder to the second occluder; each of the first occluder and second occluder comprising a framework having a central hub with a plurality of elongated struts radiating therefrom; the framework fabricated of a wire having a square, rectangular, round, trapezoidal or triangular cross section; each of said elongated struts further including three flexural hinge points and an end loop, said flexural hinge points including a shoulder flexural hinge point, an elbow flexural hinge point and a flexural hinge point between the elbow flexural hinge point and the end loop.
Claim 61
Independent Claim
164 words
A device for percutaneous transluminal repair of septal detects comprising: a first occluder having an initial cross sectional configuration smaller than that of the defect to be repaired and a second expanded configuration larger than that of the defect; a second occluder having an initial cross sectional configuration smaller than that of the defect to be repaired and a second expanded configuration larger than that of the defect; and a connector for fastening the first occluder to the second occluder; each of the first occluder and second occluder comprising a framework having a central hub with a plurality of elongated struts radiating therefrom; the framework fabricated of a wire having a square, rectangular, round, trapezoidal or triangular cross section; each of said elongated struts further including three flexural hinge points and an end loop, said flexural hinge points including a shoulder flexural hinge point, an elbow flexural hinge point and a flexural hinge point between the elbow flexural hinge point and the end loop.
Claim 62
Dependent Claim
15 words
The device of claim 57 wherein said cross section is approximately 0.005-0.015 inches on edge.
Claim 63
Dependent Claim
26 words
The device of claim 57 wherein said at least one elongated strut comprises a wire having a square cross section of approximately 0.008 inches on edge.
Claim 64
Dependent Claim
26 words
The device of claim 57 wherein said at least one elongated strut comprises a wire having a circular cross section of approximately 0.009 inches in diameter.
Claim 65
Dependent Claim
28 words
The device of claim 57 wherein said at least one elongated strut comprises a wire having a rectangular cross section of approximately 0.007 inches by approximately 0.009 inches.
Claim 66
Dependent Claim
17 words
The device of claim 61 wherein said coiled portions have an inner diameter of approximately 0.010-0.025 inches.
Claim 67
Dependent Claim
17 words
The device of claim 57 wherein said flexural hinge points comprise coiled portions of the elongated strut.
Claim 68
Dependent Claim
17 words
The device of claim 63 wherein said coiled portions have an inner diameter of approximately 0.016 inches.
Claim 69
Dependent Claim
14 words
The device of claim 63 wherein said coiled portions include at least two coils.
Claim 70
Dependent Claim
14 words
The device of claim 63 wherein said coiled portions include at least three coils.
Claim 71
Independent Claim
175 words
A device for percutaneous transluminal repair of septal defects comprising: a first occluder having an initial cross sectional configuration smaller than that of the defect to be repaired and a second expanded configuration larger than that of the defect; a second occluder having an initial cross sectional configuration smaller than that of the defect to be repaired and a second expanded configuration larger than that of the defect; and a connector for fastening the first occluder to the second occluder; each of the first occluder and second occluder comprising a framework having a central hub with a plurality of elongated struts radiating therefrom; the framework fabricated of a wire having a metallic alloy composition comprising nickel, cobalt, chromium and molybdenum; each of said elongated struts further including three flexural hinge points, wherein at least one of said struts has at least one end loop, said flexural hinge points including a shoulder flexural hinge point, an elbow flexural hinge point and a flexural hinge point located between the end loop and the elbow flexural hinge point.
Claim 72
Independent Claim
175 words
A device for percutaneous transluminal repair of septal defects comprising: a first occluder having an initial cross sectional configuration smaller than that of the defect to be repaired and a second expanded configuration larger than that of the defect; a second occluder having an initial cross sectional configuration smaller than that of the defect to be repaired and a second expanded configuration larger than that of the defect; and a connector for fastening the first occluder to the second occluder; each of the first occluder and second occluder comprising a framework having a central hub with a plurality of elongated struts radiating therefrom; the framework fabricated of a wire having a metallic alloy composition comprising nickel, cobalt, chromium and molybdenum; each of said elongated struts further including three flexural hinge points, wherein at least one of said struts has at least one end loop, said flexural hinge points including a shoulder flexural hinge point, an elbow flexural hinge point and a flexural hinge point located between the end loop and the elbow flexural hinge point.
Claim 73
Dependent Claim
21 words
The device of claim 67 wherein the metallic alloy composition is annealed to a degree sufficient to cause precipitation hardening thereof.
Claim 74
Dependent Claim
18 words
The device of claim 68 wherein said annealing is carried out at a temperature between approximately; 450°-1000° F.
Claim 75
Dependent Claim
22 words
The device of claim 67 wherein the metallic alloy composition comprises an alloy selected from the group consisting of MP35N and Elgiloy.
Claim 76
Dependent Claim
17 words
The device of claim 67 wherein the flexural hinge points comprise coiled portions of the elongated strut.
Claim 77
Dependent Claim
22 words
The device of claim 71 wherein the metallic alloy composition comprises an alloy selected from the group consisting of MP35N and Elgiloy.
Claim 78
Dependent Claim
17 words
The device of claim 71 wherein said coiled portions have an inner diameter of approximately 0.010-0.025 inches.
Claim 79
Dependent Claim
17 words
The device of claim 71 wherein said coiled portions have an inner diameter of approximately 0.016 inches.
Claim 80
Dependent Claim
14 words
The device of claim 71 wherein said coiled portions include at least two coils.
Claim 81
Dependent Claim
14 words
The device of claim 71 wherein said coiled portions include at least three coils.
Claim 82
Dependent Claim
20 words
The device of claim 67 wherein said wire has been cold worked to reduce its cross-sectional area by approximately 30-80%.
Claim 83
Dependent Claim
15 words
The device of claim 67 wherein said alloy further comprises manganese, carbon, beryllium and iron.
Claim 84
Dependent Claim
23 words
The device of claim 78 wherein said alloy comprises at least approximately 14% nickel, 39% cobalt, 19% chromium, 6% molybdenum and 1.5% manganese.
Claim 85
Dependent Claim
18 words
The device of claim 79 wherein said alloy further comprises up to approximately 0.15% carbon and 0.1% beryllium.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
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| 3.5 Years (Year 4) | 1998-06-19 | 1998-12-19 | 1999-06-20 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2002-06-19 | 2002-12-19 | 2003-06-20 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2006-06-19 | 2006-12-19 | 2007-06-20 | $7700.00 | Window Closed / Lapsed |