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US20050043759A1 Expired / Lapsed US ⏱️ 0.0 years remaining

Tubular patent foramen ovale (PFO) closure device with catch system

Assignee: W.L. Gore and Associates Inc
•
Filing: 2004-07-14
•
Granted: —
•
Expires: 2024-07-14
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Abstract

Abstract The present invention provides a device for occluding an anatomical aperture, such as an atrial septal defect (ASD) or a patent foramen ovale (PFO). The occluder includes two sides connected by a central tube. The occluder is formed from a tube, which is cut to produce struts in each side. Upon the application of force, the struts deform into loops. The loops may be of various shapes, sizes, and configurations, and, in at least some embodiments, the loops have rounded peripheries. In some embodiments, at least one of the sides includes a tissue scaffold. The occluder further includes a catch system that maintains its deployed state in vivo. When the occluder is deployed in vivo, the two sides are disposed on opposite sides of the septal tissue surrounding the aperture and the catch system is deployed so that the occluder exerts a compressive force on the septal tissue and closes the aperture.

Inventors

  • 👤 Andrzej Chanduszko

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-23 00:47
CPC Classifications
A; A61; A61B; A61B17/00; A61B17/0057; A61B2017/00575; A61B2017/00592; A61B2017/00606; A61B2017/00619; A61B2017/00623

Claims Analysis

Total Claims: 47
Claim 1
Independent Claim 74 words
1 . An occluder for a defect adapted to be introduced into the body through the vasculature, the occluder having a proximal side and a distal side that cooperate to close the defect, at least one of the proximal and distal sides of the occluder including slits axially formed in the tube to form struts, wherein adjacent slits are offset and the struts form petals when the axially length of the tube is shortened.
Claim 2
Dependent Claim 74 words
1 . An occluder for a defect adapted to be introduced into the body through the vasculature, the occluder having a proximal side and a distal side that cooperate to close the defect, at least one of the proximal and distal sides of the occluder including slits axially formed in the tube to form struts, wherein adjacent slits are offset and the struts form petals when the axially length of the tube is shortened.
Claim 3
Dependent Claim 25 words
2 . The occluder according to claim 1 wherein the slits in the occluder extend along an line parallel to the axis of the tube.
Claim 4
Dependent Claim 22 words
3 . The occluder according to claim 1 wherein the slits in the occluder extend along a helical line along the tube.
Claim 5
Dependent Claim 41 words
4 . The occluder of claim 1 wherein a catch system is adapted to secure the occluder in a deployed position such that the occluder is not secured during delivery and becomes secured in its delivery profile during the delivery process.
Claim 6
Dependent Claim 44 words
5 . The occluder of claim 4 wherein the catch system comprises catch elements that cooperate with a passageway within the occluder such that occluder becomes secured in a deployed state when a portion of the occluder tube is positioned between the catch elements.
Claim 7
Dependent Claim 13 words
6 . The occluder of claim 5 wherein the catch elements are balls.
Claim 8
Dependent Claim 52 words
7 . The occluder of claim 1 wherein the both the proximal side of the occluder and the distal side of the occluder have loops formed by struts and the occluder is adapted to be secured in the heart with tissue between the proximal side and the distal side of the occluder.
Claim 9
Dependent Claim 38 words
8 . The occluder of claim 1 wherein a locking member comprises two locking pieces which are adapted to hold the occluder in the deployed state when the locking pieces cooperate with the central member of the occluder.
Claim 10
Dependent Claim 35 words
9 . The occluder of claim 1 wherein the occluder includes a central portion and the central portion is angled with respect to the plane of the loops of the occluder in the deployed state.
Claim 11
Dependent Claim 25 words
10 . The occluder of claim 9 wherein the angle between the central tube and occluder in the deployed state is not approximately 90 degrees.
Claim 12
Dependent Claim 18 words
11 . The occluder of claim 1 wherein the occluder further comprises tissue scaffolding attached to the loops.
Claim 13
Dependent Claim 29 words
12 . The occluder of claim 1 wherein the loops are formed by slits in a tube and the loops have varying cross section because of the offset slits.
Claim 14
Dependent Claim 90 words
13 . An occluder for a defect comprising a tube adapted to be introduced into the body through the vasculature, the occluder having a proximal side and a distal side that cooperate to close the defect, at least one of the proximal and distal sides include an arrangement of struts according to the pattern: n struts for a first axial distance, 2n slits for a second axial distance, and n struts for a third axial distance, whereby loops are formed from the struts by the axial shortening of the tube.
Claim 15
Dependent Claim 90 words
13 . An occluder for a defect comprising a tube adapted to be introduced into the body through the vasculature, the occluder having a proximal side and a distal side that cooperate to close the defect, at least one of the proximal and distal sides include an arrangement of struts according to the pattern: n struts for a first axial distance, 2n slits for a second axial distance, and n struts for a third axial distance, whereby loops are formed from the struts by the axial shortening of the tube.
Claim 16
Dependent Claim 19 words
14 . The occluder of claim 13 wherein the first, second and third axial distances are approximately the same.
Claim 17
Dependent Claim 23 words
15 . The occluder of claim 13 wherein the second axial distance is greater than either the first or the second axial distance.
Claim 18
Dependent Claim 52 words
16 . The occluder of claim 13 wherein the both the proximal side of the occluder and the distal side of the occluder have loops formed by struts and the occluder is adapted to be secured in the heart with tissue between the proximal side and the distal side of the occluder.
Claim 19
Dependent Claim 37 words
17 . The occluder of claim 16 wherein a catch element is adapted to secure the occluder in a deployed position such that the occluder is not secured during delivery and becomes secured during the delivery process.
Claim 20
Dependent Claim 42 words
18 . The occluder of claim 16 wherein the catch system comprises balls that cooperate with a passageway within the occluder such that occluder becomes secured in a deployed state when a portion of the occluder tube is positioned between the balls.
Claim 21
Dependent Claim 42 words
19 . The occluder of claim 13 further comprising a locking member that includes at least two locking pieces which are adapted to hold the occluder in the deployed state when the locking pieces cooperate with the central member of the occluder.
Claim 22
Dependent Claim 35 words
20 . The occluder of claim 13 wherein the occluder includes a central portion and the central portion is angled with respect to the plane of the loops of the occluder in the deployed state.
Claim 23
Dependent Claim 25 words
21 . The occluder of claim 13 wherein the angle between the central tube and occluder in the deployed state is not approximately 90 degrees.
Claim 24
Dependent Claim 18 words
22 . The occluder of claim 13 wherein the occluder further comprises tissue scaffolding attached to the loops.
Claim 25
Dependent Claim 21 words
23 . The occluder of claim 13 wherein the tube is formed of a sheet that is rolled into a tube.
Claim 26
Dependent Claim 33 words
24 . The occluder of claim 13 wherein the n is 2 and the tube splits into a hemispherical section and then splits into a quarter section and rejoins to a hemispherical section.
Claim 27
Dependent Claim 20 words
25 . The occluder of claim 13 wherein the loops twist when the axial length of the tube is reduced.
Claim 28
Dependent Claim 125 words
26 . An occluder for a defect comprising a tube, a proximal side of the tube adapted to be disposed on the proximal side of the defect and a distal side of the tube adapted to be disposed on the distal side of the defect, a plurality of struts formed from the tube on one of the proximal and distal sides of the tube by a series of slits disposed in the tube along an axial direction, wherein the struts have first length that has a cross-section comprising half the tube, a second length that is split into a cross-section of the tube comprising a quarter of the tube and then a third length that is split into a cross-section comprising half of the tube.
Claim 29
Dependent Claim 125 words
26 . An occluder for a defect comprising a tube, a proximal side of the tube adapted to be disposed on the proximal side of the defect and a distal side of the tube adapted to be disposed on the distal side of the defect, a plurality of struts formed from the tube on one of the proximal and distal sides of the tube by a series of slits disposed in the tube along an axial direction, wherein the struts have first length that has a cross-section comprising half the tube, a second length that is split into a cross-section of the tube comprising a quarter of the tube and then a third length that is split into a cross-section comprising half of the tube.
Claim 30
Dependent Claim 19 words
27 . The occluder of claim 26 wherein the first, second and third axial distances are approximately the same.
Claim 31
Dependent Claim 23 words
28 . The occluder of claim 26 wherein the second axial distance is greater than either the first or the second axial distance.
Claim 32
Dependent Claim 52 words
29 . The occluder of claim 26 wherein the both the proximal side of the occluder and the distal side of the occluder have loops formed by struts and the occluder is adapted to be secured in the heart with tissue between the proximal side and the distal side of the occluder.
Claim 33
Dependent Claim 41 words
30 . The occluder of claim 29 wherein a catch system is adapted to secure the occluder in a deployed position such that the occluder is not secured in a deployed state during delivery and becomes secured during the delivery process.
Claim 34
Dependent Claim 43 words
31 . The occluder of claim 30 wherein the catch sytem comprises catch elements that cooperate with a passageway within the occluder such that occluder becomes locked in a deployed state when a portion of the occluder tube is positioned between the balls.
Claim 35
Dependent Claim 13 words
32 . The occluder of claim 31 wherein the catch elements are balls.
Claim 36
Dependent Claim 208 words
33 . A method for deploying an occluding member that includes a series of loops formed by struts in a tube, the struts being formed by a series of offset slits which are configured to form loops when the axial length of the occluder is shortened, the steps comprising: a) inserting a catheter into a lumen of the body for delivering the occluder, the catheter including a delivery system, b) deploying a distal end of the occluder by pulling on the delivery wire so that the distal part of the occluder forms loops which are disposed along a surface around a defect to be occluded, c) pulling a catch element through an axially central passage of the occluder to lock the distal part of the device in a deployed state, d) deploying a proximal end of the occluder by pulling on the delivery wire so that the proximal part of the occluder forms loops which are disposed along a second surface around the defect to be occluded, e) pulling the catch element through an axially central passage of the occluder to secure proximal part of the device in a deployed state, and, f) disengaging the delivery wire from the occluder and removing the catheter from the delivery location.
Claim 37
Dependent Claim 208 words
33 . A method for deploying an occluding member that includes a series of loops formed by struts in a tube, the struts being formed by a series of offset slits which are configured to form loops when the axial length of the occluder is shortened, the steps comprising: a) inserting a catheter into a lumen of the body for delivering the occluder, the catheter including a delivery system, b) deploying a distal end of the occluder by pulling on the delivery wire so that the distal part of the occluder forms loops which are disposed along a surface around a defect to be occluded, c) pulling a catch element through an axially central passage of the occluder to lock the distal part of the device in a deployed state, d) deploying a proximal end of the occluder by pulling on the delivery wire so that the proximal part of the occluder forms loops which are disposed along a second surface around the defect to be occluded, e) pulling the catch element through an axially central passage of the occluder to secure proximal part of the device in a deployed state, and, f) disengaging the delivery wire from the occluder and removing the catheter from the delivery location.
Claim 38
Dependent Claim 72 words
34 . The method of claim 33 wherein the catch element is a ball and the occluder has a central passage that is configured to secure the ball in the deployed state, wherein, step c) further comprises pulling the ball through the central passage and securing the occluder by adapting the ball and passageway to allow for passage through the central passageway toward the proximal direction and not in the distal direction.
Claim 39
Dependent Claim 78 words
35 . The method of claim 33 wherein the catch element is a ball and the occluder has a central passage that is configured to secure the ball in the deployed state , wherein, step e further comprises pulling the ball through the central passage and securing the occluder by adaping the ball and the passageway to allow for the passage of the ball through the central passageway toward the proximal direction and not in the distal direction.
Claim 40
Dependent Claim 55 words
36 . The method of claim 33 wherein the central passageway has multiple diameters so that a force required to pull the ball through the central passageway to secure the device at step c) is different than the force required to pull the ball through the central passageway to lock the device in step e).
Claim 41
Dependent Claim 21 words
37 . The method of claim 33 where in the occluder is adapted to be delivered as a PFO closure device.
Claim 42
Dependent Claim 65 words
38 . The method of claim 33 wherein at least one of the proximal and distal sides of the tube forming the occluder includes slits axially formed in the tube that form struts, wherein adjacent slits are offset and the struts form petals when the axially length of the tube is shortened and the process of deployment includes shortening the tube along its axial length.
Claim 43
Dependent Claim 55 words
39 . An occluder formed of a tube with slits axially disposed in the tube and extending to the end of the tube, the slits form struts between the slits, wherein when the tube is axially shortened, loops are formed by the struts and the struts are joined at the end to form the loops.
Claim 44
Dependent Claim 55 words
39 . An occluder formed of a tube with slits axially disposed in the tube and extending to the end of the tube, the slits form struts between the slits, wherein when the tube is axially shortened, loops are formed by the struts and the struts are joined at the end to form the loops.
Claim 45
Dependent Claim 14 words
40 . The occluder of claim 39 wherein the struts are joined by adhesive.
Claim 46
Dependent Claim 14 words
41 . The occluder of claim 39 wherein the struts are joined by welding.
Claim 47
Dependent Claim 26 words
42 . The occluder of claim 39 wherein the struts have axially facing ends and the axially facing ends are welded together to form the loops.

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