US6071285A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Rapid exchange folded balloon catheter and stent delivery system
Assignee: Medtronic Vascular Inc
•
Filing: 1996-03-25
•
Granted: 2000-06-06
•
Expires: 2016-03-25
Abstract
Abstract The balloon portion of a balloon catheter for implanting a stent structure is at least initially retained laterally to a guide wire by passing the guide wire axially along the balloon inside the stent structure but not through the interior of the balloon or any permanent guide wire lumen at the location of the balloon. The initially deflated balloon may be folded laterally into a plurality of folds, and the guide wire may pass between the folds or outside the folds as desired. Guide wire lumens may be provided distally and/or proximally of the balloon. An elastic sleeve may be provided around the balloon to help keep the balloon folded prior to inflation and to help refold the balloon during and after deflation. If an elastic sleeve is provided, the guide wire may pass along the balloon inside the sleeve.
Inventors
- 👤 Robert D. Lashinski
- 👤 Dennis L. Brooks
- 👤 Philip J. Haarstad
- 👤 Geoffrey A. Orth
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 22:00
CPC Classifications
A; A61; A61F; A61F2/00; A61F2/95; A61F2/958; A61F2002/9583; A61M; A61M25/00; A61M25/01; A61M2025/0183
Claims Analysis
Total Claims: 83
Claim 1
Independent Claim
46 words
A balloon catheter system comprising: an initially deflated inflatable balloon; a guidewire: and a stent structure disposed on said balloon and forming an annulus around said balloon, said guidewire padding axially along said balloon inside the annulus formed by said stent structure but outside said balloon.
Claim 2
Dependent Claim
46 words
A balloon catheter system comprising: an initially deflated inflatable balloon; a guidewire: and a stent structure disposed on said balloon and forming an annulus around said balloon, said guidewire padding axially along said balloon inside the annulus formed by said stent structure but outside said balloon.
Claim 3
Dependent Claim
32 words
The catheter system defined in claim 1 wherein said stent structure is substantially the sole structure at the location of said balloon for positively maintaining said balloon adjacent to said guide wire.
Claim 4
Dependent Claim
48 words
The catheter system defined in claim 2 wherein, in its initially deflated condition, said balloon is folded laterally on itself in a plurality of folds between which said guide wire can pass, and wherein said stent structure maintains said folds in said balloon until said balloon is inflated.
Claim 5
Dependent Claim
48 words
The catheter system defined in claim 1 wherein, in its initially deflated condition, said balloon is folded laterally on itself in a plurality of folds, between which said guide wire can pass, and wherein said stent structure maintains said folds in said balloon until said balloon is inflated.
Claim 6
Dependent Claim
52 words
The catheter system defined in claim 4 wherein said balloon is folded so that an axial clearance is left between folds of the balloon, through which clearance said guide wire can pass axially along said balloon and wherein a portion of said balloon is intermediate said guide wire and said stent structure.
Claim 7
Dependent Claim
39 words
The catheter system defined in claim 5 wherein said clearance is produced by folding said balloon around a mandrel at the desired location of said clearance, heat setting the folded balloon, and withdrawing said mandrel to leave said clearance.
Claim 8
Dependent Claim
82 words
The catheter system defined in claim 6 wherein said balloon has axially opposite proximal and distal ends from which proximal and distal lumens respectively extend, and wherein said mandrel presses radially inwardly on portions of said lumens adjacent to said proximal and distal ends so that heat setting the folded balloon also heat sets the portions of said lumens that are pressed radially inwardly to help promote refolding of the balloon after use of the catheter system to implant the stent structure.
Claim 9
Dependent Claim
76 words
The catheter system defined in claim 5 wherein said balloon has axially opposite proximal and distal ends, and wherein said catheter system further comprises: a distal guide wire lumen extending distally of said distal end of said balloon for allowing a guide wire portion which is distal of said balloon to pass through said distal guide wire lumen, said distal guide wire lumen having a proximal extension which extends into a distal portion of said clearance.
Claim 10
Dependent Claim
31 words
The catheter system defined in claim 8 wherein said extension of said distal guide wire lumen has a proximal end which is distal of a distal end of said stent structure.
Claim 11
Dependent Claim
76 words
The catheter system defined in claim 5 wherein said balloon has axially opposite proximal and distal ends, and wherein said catheter system further comprises: a proximal guide wire lumen extending proximally of said proximal end of said balloon for allowing a guide wire portion which is proximal of said balloon to pass through said proximal guide wire lumen, said proximal guide wire lumen having a distal extension which extends into a proximal portion of said clearance.
Claim 12
Dependent Claim
31 words
The catheter system defined in claim 10 wherein said extension of said proximal guide wire lumen has a distal end which is proximal of a proximal end of said stent structure.
Claim 13
Dependent Claim
21 words
The catheter system defined in claim 1 wherein said stent structure is circumferentially expandable in response to inflation of said balloon.
Claim 14
Dependent Claim
58 words
The catheter system defined in claim 1 wherein said balloon has axially opposite proximal and distal ends, and wherein said catheter system further comprises: a distal guide wire lumen extending distally of said distal end of said balloon for allowing a guide wire portion which is distal of said balloon to pass through said distal guide wire lumen.
Claim 15
Dependent Claim
58 words
The catheter system defined in claim 1 wherein said balloon has axially opposite proximal and distal ends, and wherein said catheter system further comprises: a proximal guide wire lumen extending proximally of said proximal end of said balloon for allowing a guide wire portion which is proximal of said balloon to pass through said proximal guide wire lumen.
Claim 16
Dependent Claim
61 words
The catheter system defined in claim 1 wherein said balloon has axially opposite proximal and distal ends, and wherein said catheter system further comprises: an inflation lumen extending proximally from the proximal end of said balloon, said inflation lumen being in fluid communication with the interior of said balloon for supplying pressurized inflation fluid to said balloon for inflating said balloon.
Claim 17
Dependent Claim
39 words
The catheter system defined in claim 15 further comprising: a proximal guide wire lumen extending along said inflation lumen for allowing a guide wire portion which is proximal of said balloon to pass through said proximal guide wire lumen.
Claim 18
Dependent Claim
29 words
The catheter system defined in claim 16 wherein said proximal guide wire lumen extends along only a portion of said inflation lumen that is relatively close to said balloon.
Claim 19
Dependent Claim
16 words
The catheter system defined in claim 1 further comprising: a radio-opaque marker adjacent to said balloon.
Claim 20
Dependent Claim
57 words
The catheter system defined in claim 1 wherein said balloon has axially opposite proximal and distal ends, and wherein said catheter system further comprises: a pusher wire attached to the catheter at a location which is adjacent the distal end of said balloon and extending proximally from said location and from the proximal end of said balloon.
Claim 21
Dependent Claim
15 words
The catheter system defined in claim 19 wherein said pusher wire is made of nitinol.
Claim 22
Dependent Claim
49 words
The catheter system defined in claim 19 wherein said pusher wire has a distal portion which is distal of the distal end of said balloon, said distal portion being formed into an axially extending coil through which a portion of the guide wire distal of said balloon can pass.
Claim 23
Dependent Claim
33 words
The catheter system defined in claim 19 wherein said pusher wire passes axially through the interior of said balloon, and wherein said catheter system further comprises: a radio-opaque marker on said pusher wire.
Claim 24
Dependent Claim
22 words
The catheter system defined in claim 22 wherein said radio-opaque marker is axially adjacent to an axial end of said stent structure.
Claim 25
Dependent Claim
28 words
The catheter system defined in claim 23 further comprising: a second radio-opaque marker on said pusher wire axially adjacent to a second axial end of said stent structure.
Claim 26
Dependent Claim
59 words
The catheter system defined in claim 1 wherein said balloon and said stent structure are formed to provide a clearance through which said guide wire can pass axially along said balloon inside the annulus formed by said stent structure but outside said balloon and wherein a portion of said balloon is intermediate said guide wire and said stent structure.
Claim 27
Dependent Claim
39 words
The catheter system defined in claim 25 wherein said clearance is produced by heat setting said balloon in contact with a mandrel disposed at the desired location of said clearance, and then withdrawing said mandrel to leave said clearance.
Claim 28
Dependent Claim
71 words
The catheter system defined in claim 1 wherein said balloon has axially opposite proximal and distal ends from which proximal and distal lumens respectively extend, wherein in its initially deflated condition said balloon is folded laterally on itself in a plurality of folds, and wherein at least one of said lumens has an axially extending valley-like ramp in its wall which forms an axial continuation of a fold in said balloon.
Claim 29
Dependent Claim
61 words
A balloon catheter system comprising: an initially deflated inflatable balloon; a guidewire; an annular elastic sleeve structure disposed around said balloon for resiliently circumferentially compressing said balloon; and a stent structure disposed on said balloon and forming an annulus around said balloon, said guidewire passing axially along said balloon inside the annulus formed by said stent structure but outside said balloon.
Claim 30
Dependent Claim
61 words
A balloon catheter system comprising: an initially deflated inflatable balloon; a guidewire; an annular elastic sleeve structure disposed around said balloon for resiliently circumferentially compressing said balloon; and a stent structure disposed on said balloon and forming an annulus around said balloon, said guidewire passing axially along said balloon inside the annulus formed by said stent structure but outside said balloon.
Claim 31
Dependent Claim
47 words
The catheter system defined in claim 28 wherein said guide wire passes axially along said balloon outside of said sleeve structure, and wherein said stent structure is substantially the sole structure at the location of said balloon for positively maintaining said balloon adjacent to said guide wire.
Claim 32
Dependent Claim
20 words
The catheter system defined in claim 28 wherein said guide wire passes axially along said balloon inside said sleeve structure.
Claim 33
Dependent Claim
52 words
The catheter system defined in claim 30 wherein, in its initially deflated condition, said balloon is folded laterally on itself in a plurality of folds, between which said guide wire can pass, and wherein said sleeve structure and said stent structure maintain said folds in said balloon until said balloon is inflated.
Claim 34
Dependent Claim
52 words
The catheter system defined in claim 28 wherein, in its initially deflated condition, said balloon is folded laterally on itself in a plurality of folds, between which said guide wire can pass, and wherein said sleeve structure and said stent structure maintain said folds in said balloon until said balloon is inflated.
Claim 35
Dependent Claim
25 words
The catheter system defined in claim 28 wherein said sleeve structure and said stent structure are circumferentially expandable in response to inflation of said balloon.
Claim 36
Dependent Claim
18 words
The catheter system defined in claim 28 wherein said sleeve structure is axially spaced from said stent structure.
Claim 37
Dependent Claim
41 words
The catheter system defined in claim 34 wherein said sleeve structure comprises: a proximal portion which is proximal of a proximal end of said stent structure; and a distal portion which is distal of a distal end of said stent structure.
Claim 38
Dependent Claim
16 words
The catheter system defined in claim 28 wherein said stent structure axially overlaps said sleeve structure.
Claim 39
Dependent Claim
20 words
The catheter system defined in claim 36 wherein said stent structure surrounds at least a portion of said sleeve structure.
Claim 40
Dependent Claim
77 words
The catheter system defined in claim 28 wherein said balloon has axially opposite proximal and distal ends from which proximal and distal lumens respectively extend, wherein at least one of said lumens has a port in its wall adjacent said balloon for emergence of said guide wire from the at least one lumen in a direction toward said balloon, and wherein said sleeve extends axially from said balloon to a point which is axially beyond said port.
Claim 41
Dependent Claim
63 words
A balloon catheter system and guide wire system comprising: an initially deflated inflatable balloon; a guide wire passing axially along said balloon without traversing the interior of said balloon; and an annular stent structure disposed around said balloon and said guide wire at the location of said balloon for keeping said balloon adjacent to said guide wire at the location of the balloon.
Claim 42
Dependent Claim
63 words
A balloon catheter system and guide wire system comprising: an initially deflated inflatable balloon; a guide wire passing axially along said balloon without traversing the interior of said balloon; and an annular stent structure disposed around said balloon and said guide wire at the location of said balloon for keeping said balloon adjacent to said guide wire at the location of the balloon.
Claim 43
Dependent Claim
22 words
The system defined in claim 39 wherein said balloon and said stent structure are movable together axially relative to said guide wire.
Claim 44
Dependent Claim
18 words
The system defined in claim 39 wherein said guide wire passes between said balloon and said stent structure.
Claim 45
Dependent Claim
34 words
The system defined in claim 39 wherein, in its initially deflated condition, said balloon is folded laterally into a plurality of folds, and wherein said guide wire passes along said balloon between said folds.
Claim 46
Dependent Claim
21 words
The system defined in claim 42 wherein said stent structure maintains said folds in said balloon until said balloon is inflated.
Claim 47
Dependent Claim
51 words
The system defined in claim 42 wherein said balloon is folded so that an axial clearance is left between folds of the balloon, through which clearance said guide wire can pass axially along said balloon and wherein a portion of said balloon is intermediate said guide wire and said stent structure.
Claim 48
Dependent Claim
38 words
The system defined in claim 44 wherein said clearance is produced by folding said balloon around a mandrel at the desired location of said clearance, heat setting the folded balloon, and withdrawing said mandrel to leave said clearance.
Claim 49
Dependent Claim
80 words
The system defined in claim 45 wherein said balloon has axially opposite proximal and distal ends from which proximal and distal lumens respectively extend, and wherein said mandrel presses radially inwardly on portions of said lumens adjacent to said proximal and distal ends so that heat setting the folded balloon also heat sets the portions of said lumens that are pressed radially inwardly to help promote refolding of the balloon after use of the catheter to implant the stent structure.
Claim 50
Dependent Claim
74 words
The system defined in claim 44 wherein said balloon has axially opposite proximal and distal ends, and wherein the catheter further comprises: a distal guide wire lumen extending distally of said distal end of said balloon for allowing a guide wire portion which is distal of said balloon to pass through said distal guide wire lumen, said distal guide wire lumen having a proximal extension which extends into a distal portion of said clearance.
Claim 51
Dependent Claim
30 words
The system defined in claim 47 wherein said extension of said distal guide wire lumen has a proximal end which is distal of a distal end of said stent structure.
Claim 52
Dependent Claim
74 words
The system defined in claim 44 wherein said balloon has axially opposite proximal and distal ends, and wherein the catheter further comprises: a proximal guide wire lumen extending proximally of said proximal end of said balloon for allowing a guide wire portion which is proximal of said balloon to pass through said proximal guide wire lumen, said proximal guide wire lumen having a distal extension which extends into a proximal portion of said clearance.
Claim 53
Dependent Claim
30 words
The system defined in claim 49 wherein said extension of said proximal guide wire lumen has a distal end which is proximal of a proximal end of said stent structure.
Claim 54
Dependent Claim
20 words
The system defined in claim 39 wherein said stent structure is circumferentially expandable in response to inflation of said balloon.
Claim 55
Dependent Claim
56 words
The system defined in claim 39 wherein said balloon has axially opposite proximal and distal ends, and wherein the catheter further comprises: a distal guide wire lumen extending distally of said distal end of said balloon for allowing a guide wire portion which is distal of said balloon to pass through said distal guide wire lumen.
Claim 56
Dependent Claim
56 words
The system defined in claim 39 wherein said balloon has axially opposite proximal and distal ends, and wherein the catheter further comprises: a proximal guide wire lumen extending proximally of said proximal end of said balloon for allowing a guide wire portion which is proximal of said balloon to pass through said proximal guide wire lumen.
Claim 57
Dependent Claim
59 words
The system defined in claim 39 wherein said balloon has axially opposite proximal and distal ends, and wherein the catheter further comprises: an inflation lumen extending proximally from the proximal end of said balloon, said inflation lumen being in fluid communication with the interior of said balloon for supplying pressurized inflation fluid to said balloon for inflating said balloon.
Claim 58
Dependent Claim
38 words
The system defined in claim 54 further comprising: a proximal guide wire lumen extending along said inflation lumen for allowing a guide wire portion which is proximal of said balloon to pass through said proximal guide wire lumen.
Claim 59
Dependent Claim
28 words
The system defined in claim 55 wherein said proximal guide wire lumen extends along only a portion of said inflation lumen that is relatively close to said balloon.
Claim 60
Dependent Claim
15 words
The system defined in claim 39 further comprising: a radio-opaque marker adjacent to said balloon.
Claim 61
Dependent Claim
55 words
The system defined in claim 39 wherein said balloon has axially opposite proximal and distal ends, and wherein the catheter further comprises: a pusher wire attached to said catheter at a location which is adjacent the distal end of said balloon and extending proximally from said location and from the proximal end of said balloon.
Claim 62
Dependent Claim
14 words
The system defined in claim 58 wherein said pusher wire is made of nitinol.
Claim 63
Dependent Claim
48 words
The system defined in claim 58 wherein said pusher wire has a distal portion which is distal of the distal end of said balloon, said distal portion being formed into an axially extending coil through which a portion of the guide wire distal of said balloon can pass.
Claim 64
Dependent Claim
31 words
The system defined in claim 58 wherein said pusher wire passes axially through the interior of said balloon, and wherein said catheter further comprises: a radio-opaque marker on said pusher wire.
Claim 65
Dependent Claim
20 words
The system defined in claim 61 wherein said radio-opaque marker is axially adjacent an axial end of said stent structure.
Claim 66
Dependent Claim
26 words
The system defined in claim 62 further comprising: a second radio-opaque marker on said pusher wire axially adjacent a second axial end of said stent structure.
Claim 67
Dependent Claim
58 words
The system defined in claim 39 wherein said balloon and said stent structure are formed to provide a clearance through which said guide wire can pass axially along said balloon inside the annulus formed by said stent structure but outside said balloon and wherein a portion of said balloon is intermediate said guide wire and said stent structure.
Claim 68
Dependent Claim
38 words
The system defined in claim 64 wherein said clearance is produced by heat setting said balloon in contact with a mandrel disposed at the desired location of said clearance, and then withdrawing said mandrel to leave said clearance.
Claim 69
Dependent Claim
70 words
The system defined in claim 39 wherein said balloon has axially opposite proximal and distal ends from which proximal and distal lumens respectively extend, wherein in its initially deflated condition said balloon is folded laterally on itself in a plurality of folds, and wherein at least one of said lumens has an axially extending valley-like ramp in its wall which forms an axial continuation of a fold in said balloon.
Claim 70
Dependent Claim
22 words
The system defined in claim 39 further comprising: an annular elastic sleeve structure around said balloon for resiliently circumferentially compressing said balloon.
Claim 71
Dependent Claim
17 words
The system defined in claim 67 wherein said sleeve structure is axially spaced from said stent structure.
Claim 72
Dependent Claim
40 words
The system defined in claim 68 wherein said sleeve structure comprises: a proximal portion which is proximal of a proximal end of said stent structure; and a distal portion which is distal of a distal end of said stent structure.
Claim 73
Dependent Claim
14 words
The system defined in claim 67 wherein said stent structure surrounds said sleeve structure.
Claim 74
Dependent Claim
19 words
The system defined in claim 70 wherein said guide wire passes between said sleeve structure and said stent structure.
Claim 75
Dependent Claim
73 words
The system defined in claim 67 wherein said balloon has axially opposite proximal and distal ends from which proximal and distal lumens respectively extend, wherein at least one of said lumens has a port in its wall adjacent said balloon for emergence of said guide wire from said lumen in a direction toward said balloon, and wherein said sleeve extends axially from said balloon to a point which is axially beyond said port.
Claim 76
Dependent Claim
110 words
A stent delivery catheter system comprising: an annular stent structure; a balloon having an interior, proximal and distal ends, and an initially deflated configuration wherein the balloon is laterally folded in on itself in a plurality of folds, the annular stent structure retaining the balloon in the initially deflated configuration; a guidewire; a proximal lumen communicating with the interior of the balloon; and a guidewire lumen having a distal end disposed proximally of the proximal end of the balloon member, the guidewire disposed for translation through the guidewire lumen so as to exit the distal end of the guidewire lumen and pass between the plurality of folds of the balloon.
Claim 77
Dependent Claim
110 words
A stent delivery catheter system comprising: an annular stent structure; a balloon having an interior, proximal and distal ends, and an initially deflated configuration wherein the balloon is laterally folded in on itself in a plurality of folds, the annular stent structure retaining the balloon in the initially deflated configuration; a guidewire; a proximal lumen communicating with the interior of the balloon; and a guidewire lumen having a distal end disposed proximally of the proximal end of the balloon member, the guidewire disposed for translation through the guidewire lumen so as to exit the distal end of the guidewire lumen and pass between the plurality of folds of the balloon.
Claim 78
Dependent Claim
24 words
The delivery catheter system as defined in claim 73 further comprising a distal guide wire lumen disposed from the distal end of the balloon.
Claim 79
Dependent Claim
22 words
The delivery catheter system as defined in claim 73 wherein the balloon maintains the initially deflated configuration until said balloon is inflated.
Claim 80
Dependent Claim
109 words
A balloon catheter system comprising: a balloon having an interior, proximal and distal ends, and an initially deflated configuration wherein the balloon is laterally folded in on itself in a plurality of folds; an elastic annular member disposed around the balloon to retain the balloon in the initially deflated configuration; a proximal lumen communicating with the interior of the balloon; a guidewire; and a guidewire lumen having a distal end disposed proximally of the proximal end of the balloon, the guidewire disposed for translation through the guidewire lumen so as to exit the distal end of the guidewire lumen and pass between the plurality of folds of the balloon.
Claim 81
Dependent Claim
109 words
A balloon catheter system comprising: a balloon having an interior, proximal and distal ends, and an initially deflated configuration wherein the balloon is laterally folded in on itself in a plurality of folds; an elastic annular member disposed around the balloon to retain the balloon in the initially deflated configuration; a proximal lumen communicating with the interior of the balloon; a guidewire; and a guidewire lumen having a distal end disposed proximally of the proximal end of the balloon, the guidewire disposed for translation through the guidewire lumen so as to exit the distal end of the guidewire lumen and pass between the plurality of folds of the balloon.
Claim 82
Dependent Claim
24 words
The balloon catheter system as defined in claim 76 further comprising a distal guide wire lumen disposed from the distal end of the balloon.
Claim 83
Dependent Claim
22 words
The balloon catheter system as defined in claim 76 wherein the balloon maintains the initially deflated configuration until said balloon is inflated.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 2003-06-06 | 2003-12-06 | 2004-06-06 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2007-06-06 | 2007-12-06 | 2008-06-06 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2011-06-06 | 2011-12-06 | 2012-06-06 | $7700.00 | Window Closed / Lapsed |