US6077291A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Septal defect closure device
Assignee: University of Minnesota System
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Filing: 1996-11-26
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Granted: 2000-06-20
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Expires: 2016-11-26
Abstract
Abstract The present invention provides a system and a method for closing septal defects and the like. The system includes a closure device having a pair of occluding disks, each disk being formed of a membrane and an elastically deformable frame carried about the periphery of the membrane. The frame, which may be formed of a superelastic material, is capable of being collapsed for passage through a catheter and elastically returning to a predetermined shape for tautly holding the membrane. A central portion of the membrane of each disk is attached to a central portion of the other membrane to define a conjoint disk. The method of the invention involves collapsing the frames of the disks, inserting the closure device into a catheter, and positioning the distal end of the catheter adjacent a septal defect. The first disk is then urged out of the distal end of the catheter to permit its frame to elastically return to a predetermined shape, pulling the membrane taut on one side of the defect. The second disk is then similarly deployed on another side of the defect, automatically positioning the conjoint disk within the defect to occlude it.
Inventors
- 👤 Gladwin S. Das
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 11:56
CPC Classifications
A; A61; A61B; A61B17/00; A61B17/0057; A61B2017/00575; A61B2017/00592; A61B2017/00597; A61B2017/00606; A61B2017/00623; A61B90/00; A61B90/08; A61B2090/0807; A61B2090/0811
Claims Analysis
Total Claims: 37
Claim 1
Independent Claim
104 words
A septal defect closure device comprising first and second occluding disks, each disk comprising a flexible, biologically compatible membrane capable of being collapsed for passage through a catheter and elastically returning to a predetermined shape for tautly holding a portion of the membrane against a septum; a central portion of the membrane of the first disk being affixed to a central portion of the membrane of the second disk to define a conjoint disk having a diameter, a maximum dimension of at least one of the first and second disks being between about 1.6 and about 2.5 times the diameter of the conjoint disk.
Claim 2
Dependent Claim
104 words
A septal defect closure device comprising first and second occluding disks, each disk comprising a flexible, biologically compatible membrane capable of being collapsed for passage through a catheter and elastically returning to a predetermined shape for tautly holding a portion of the membrane against a septum; a central portion of the membrane of the first disk being affixed to a central portion of the membrane of the second disk to define a conjoint disk having a diameter, a maximum dimension of at least one of the first and second disks being between about 1.6 and about 2.5 times the diameter of the conjoint disk.
Claim 3
Dependent Claim
24 words
The closure device of claim 1 wherein the central portions of the membranes are bonded directly to one another to define the conjoint disk.
Claim 4
Dependent Claim
19 words
The closure device of claim 2 wherein the central conjoint disk is sized to substantially fill a septal defect.
Claim 5
Dependent Claim
21 words
The closure device of claim 1 wherein the affixed central portions of the membranes define a generally circular central conjoint disk.
Claim 6
Dependent Claim
24 words
The closure device of claim 1 wherein the central portions of the first and second membranes are sewn together to define the conjoint disk.
Claim 7
Dependent Claim
26 words
The closure device of claim 1 wherein the central portions of the first and second membranes are fixed to one another by a biologically compatible adhesive.
Claim 8
Dependent Claim
41 words
The closure device of claim 1 wherein each of the first and second disks has a periphery, each disk further comprising an elastically deformable frame formed of an elongate wire extending along and attached adjacent to the periphery of the membrane.
Claim 9
Dependent Claim
15 words
The closure device of claim 7 wherein the membranes are formed of a superelastic material.
Claim 10
Dependent Claim
14 words
The closure device of claim 1 wherein the conjoint disk comprises a tubular segment.
Claim 11
Dependent Claim
20 words
The closure device of claim 9 wherein the tubular segment comprises a segment of the membrane of the second disk.
Claim 12
Dependent Claim
23 words
The closure device of claim 9 wherein the conjoint disk comprises a piece of another material disposed between the first and second disks.
Claim 13
Dependent Claim
23 words
The closure device of claim 1 wherein the conjoint disk comprises a piece of another material disposed between the first and second disks.
Claim 14
Dependent Claim
17 words
The closure device of claim 1 wherein the first and second disks are approximately the same size.
Claim 15
Dependent Claim
15 words
The closure device of claim 1 wherein the conjoint disk further comprises a biocompatible polymer.
Claim 16
Dependent Claim
15 words
The closure device of claim 14 wherein the conjoint disk is substantially impervious to fluids.
Claim 17
Dependent Claim
20 words
The closure device of claim 1, further comprising a tether for releasably attaching the closure device to a delivery device.
Claim 18
Independent Claim
214 words
A method of closing a septal defect in a septum comprising the steps of: (a) determining the size of the defect; (b) selecting a closure device comprising first and second disks, each disk comprising a flexible structure having a periphery, a portion of the structure of the first disk being joined to a portion of the structure of the second disk by a joining segment having a size approximating the size of the defect; (c) collapsing the first and second disks and inserting the closure device in a catheter having a distal end; (d) positioning the distal end of the catheter adjacent a septal defect; (e) urging the first disk of the closure device out of the distal end of the catheter and permitting the first disk to elastically return to a predetermined shape on a first side of the defect; and (f) urging the second disk of the closure device out of the distal end of the catheter and permitting the second disk to elastically return to a predetermined shape on a second side of the defect, opening of the second disk automatically urging at least the peripheries of the first and second disks against opposite sides of the septum and positioning the joining segment within the defect to substantially fill the defect.
Claim 19
Independent Claim
214 words
A method of closing a septal defect in a septum comprising the steps of: (a) determining the size of the defect; (b) selecting a closure device comprising first and second disks, each disk comprising a flexible structure having a periphery, a portion of the structure of the first disk being joined to a portion of the structure of the second disk by a joining segment having a size approximating the size of the defect; (c) collapsing the first and second disks and inserting the closure device in a catheter having a distal end; (d) positioning the distal end of the catheter adjacent a septal defect; (e) urging the first disk of the closure device out of the distal end of the catheter and permitting the first disk to elastically return to a predetermined shape on a first side of the defect; and (f) urging the second disk of the closure device out of the distal end of the catheter and permitting the second disk to elastically return to a predetermined shape on a second side of the defect, opening of the second disk automatically urging at least the peripheries of the first and second disks against opposite sides of the septum and positioning the joining segment within the defect to substantially fill the defect.
Claim 20
Dependent Claim
41 words
The method of claim 17 wherein the joining segment comprises a tubular segment, the closure device being selected such that the maximum dimension of at least one of the disks is at least about 1.6 times the diameter of the defect.
Claim 21
Dependent Claim
27 words
The method of claim 17 wherein the second disk is urged out of the distal end of the catheter by retracting the catheter in a proximal direction.
Claim 22
Dependent Claim
32 words
The method of claim 17 further comprising retracting the catheter in a proximal direction after the first disk has been urged out of the catheter until the first disk engages the septum.
Claim 23
Dependent Claim
29 words
The method of claim 17 wherein the size of the defect is determined using a balloon catheter, the size of the defect being measured as a stretched diameter thereof.
Claim 24
Dependent Claim
36 words
The method of claim 17 wherein the closure device further comprises a tether attached thereto, further comprising the step of detaching the tether from a delivery device after urging the second disk out of the catheter.
Claim 25
Dependent Claim
72 words
The method of claim 17 wherein the joining segment comprises a conjoint disk, a central portion of the flexible structure of the first disk being affixed directly to a central portion of the flexible structure of the second disk to define said conjoint disk, the closure device being selected such that the maximum dimension of at least one of the disks is at least about 1.6 times the diameter of the defect.
Claim 26
Dependent Claim
97 words
A septal defect closure device comprising first and second occluding disks, each disk comprising a membrane formed of a porous, biologically compatible fabric, each of the membranes being capable of being collapsed for passage through a catheter and elastically returning to a predetermined shape for tautly holding a portion of the membrane against a septum, a central portion of the membrane of the first disk being joined to a central portion of the membrane of the second disk with a piece of another material being disposed between the affixed central portions of the first and second disks.
Claim 27
Dependent Claim
97 words
A septal defect closure device comprising first and second occluding disks, each disk comprising a membrane formed of a porous, biologically compatible fabric, each of the membranes being capable of being collapsed for passage through a catheter and elastically returning to a predetermined shape for tautly holding a portion of the membrane against a septum, a central portion of the membrane of the first disk being joined to a central portion of the membrane of the second disk with a piece of another material being disposed between the affixed central portions of the first and second disks.
Claim 28
Dependent Claim
21 words
The closure device of claim 24 wherein the joined central portions of the first and second disks comprises a conjoint disk.
Claim 29
Dependent Claim
14 words
The closure device of claim 25 wherein the conjoint disk comprises a tubular segment.
Claim 30
Dependent Claim
40 words
The closure device of claim 25 wherein the conjoint disk has a diameter, a maximum dimension of at least one of the first and second disks being between about 1.6 and about 2.5 times the diameter of the conjoint disk.
Claim 31
Independent Claim
187 words
A method of closing a septal defect in a septum comprising the steps of: (a) providing a closure device comprising first and second disks, a portion of the first disk being connected to a portion of the second disk by a tubular segment sized to approximate the size of the defect; (b) collapsing the first and second disks and inserting the closure device in a catheter having a distal end; (c) positioning the distal end of the catheter adjacent a septal defect; (d) urging the first disk of the closure device out of the distal end of the catheter and permitting the first disk to elastically return to a predetermined shape on a first side of the defect; and (e) urging the second disk of the closure device out of the distal end of the catheter and permitting the second disk to elastically return to a predetermined shape on a second side of the defect, opening of the second disk automatically urging the first and second disks against opposite sides of the septum and positioning the tubular member in close proximity to a periphery of the defect.
Claim 32
Independent Claim
187 words
A method of closing a septal defect in a septum comprising the steps of: (a) providing a closure device comprising first and second disks, a portion of the first disk being connected to a portion of the second disk by a tubular segment sized to approximate the size of the defect; (b) collapsing the first and second disks and inserting the closure device in a catheter having a distal end; (c) positioning the distal end of the catheter adjacent a septal defect; (d) urging the first disk of the closure device out of the distal end of the catheter and permitting the first disk to elastically return to a predetermined shape on a first side of the defect; and (e) urging the second disk of the closure device out of the distal end of the catheter and permitting the second disk to elastically return to a predetermined shape on a second side of the defect, opening of the second disk automatically urging the first and second disks against opposite sides of the septum and positioning the tubular member in close proximity to a periphery of the defect.
Claim 33
Dependent Claim
55 words
The method of claim 28 wherein each of the flexible membranes comprises a superelastic material, each of the first and second disks returning to its predetermined shape under the elastic restoring force of the superelastic material upon removal of the constraint of the catheter when the disk is urged out of the distal end thereof.
Claim 34
Dependent Claim
83 words
A septal defect closure device comprising first and second occluding disks, each disk comprising a flexible, biologically compatible membrane capable of being collapsed for passage through a catheter and elastically returning to a predetermined shape for tautly holding a portion of the membrane against a septum, a central portion of the membrane of the first disk being affixed to a central portion of the membrane of the second disk by a tubular segment of the fabric of the membrane of the second disk.
Claim 35
Dependent Claim
83 words
A septal defect closure device comprising first and second occluding disks, each disk comprising a flexible, biologically compatible membrane capable of being collapsed for passage through a catheter and elastically returning to a predetermined shape for tautly holding a portion of the membrane against a septum, a central portion of the membrane of the first disk being affixed to a central portion of the membrane of the second disk by a tubular segment of the fabric of the membrane of the second disk.
Claim 36
Dependent Claim
18 words
The closure device of claim 30 wherein the tubular segment is sized to substantially fill a septal defect.
Claim 37
Dependent Claim
18 words
The closure device of claim 30 wherein each of the first and second disks comprise a superelastic material.
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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) | 2003-06-20 | 2003-12-20 | 2004-06-20 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2007-06-20 | 2007-12-20 | 2008-06-20 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2011-06-20 | 2011-12-20 | 2012-06-20 | $7700.00 | Window Closed / Lapsed |