Heart occlusion devices

• US 9,474,517 B2
• Filed: 03/31/2016
• Issued: 10/25/2016
• Est. Priority Date: 03/07/2008
• Status: Active Grant

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Inventors: Amin, Zahid, Cully, Edward H., Cutright, Warren, Larsen, Coby C., Masters, Steven J., Shaw, Edward E.
• Primary Examiner(s): Anderson, Gregory
• Assistant Examiner(s): DANG, PHONG SON H
• Application Number:
  US15/086,449
• Publication Number:
  US 20160213358A1
• Time in Patent Office: 208 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12122 within the heart for closing a cardiac septal defect A61B17/0057
• CPC Class Codes: A61B 17/12145 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00597 Implements comprising a membrane
• CPC Class Codes: A61B 2017/00606 Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
• CPC Class Codes: A61B 2017/00615 Implements with an occluder on one side of the opening and holding means therefor on the other
• CPC Class Codes: A61B 2017/00623 Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2017/00632 Occluding a cavity, i.e. closing a blind opening
• CPC Class Codes: A61B 2017/00853 low friction, hydrophobic and corrosion-resistant fluorocarbon resin coating (ptf, ptfe, polytetrafluoroethylene)
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/12054 Details concerning the detachment of the occluding device from the introduction device
• CPC Class Codes: A61B 2017/12095 Threaded connection

Abstract

This disclosure is directed to an aperture occlusion device and a method for occluding an aperture, including a perimembranous ventricular septal defect. The aperture occlusion device includes a wire frame element. The wire frame forms geometric shapes that include an occluder region and a securing region. The occluder region and the securing region are separated by an attachment region including a waist. The occluder region and securing region can include membranous coverings. The device can be attached to a delivery hub. The wires forming the occluder region and securing region can have a shape-memory capability such that they can be collapsed and distorted in a sheath during delivery, but resume and maintain their intended shape after delivery.

Claims

1. An occluder device for occluding a defect in an anatomical feature, the occluder device defining a proximal end and a distal end, the occluder device comprising a plurality of wires each extending continuously between the proximal and distal ends of the device and forming a proximal disc defining a proximal outer perimeter of the device, a distal disc defining a distal outer perimeter of the device, and a waist arranged between the proximal disc and the distal disc and defining a narrowed region of the device between the proximal and distal outer perimeters, each of the plurality of wires including:

a first linear section extending radially outward from a central axis of the device toward

the proximal outer perimeter of the device,

a first curved transition extending between the first linear section and the proximal outer

perimeter of the device,

a second curved transition extending from the proximal outer perimeter of the device

toward the central axis of the device,

a central curved transition extending through the narrowed region of the device such that the narrowed region of the device is configured to extend through the defect in the anatomical feature, the plurality of wires being non-overlapping through the central axis,

a third curved transition extending from the narrowed region of the device to the distal outer perimeter of the device, the central curved transition positioned between the second and third curved transitions,

a fourth curved transition extending from the distal outer perimeter of the device toward

the central axis of the device, and

a second linear section extending radially inward from the fourth curved transition toward

the central axis of the device; and

a proximal covering arranged on the proximal disc;

a distal covering arranged on the distal disc.

2. The occluder device of claim 1, wherein

the proximal disc comprises a substantially circular outer perimeter, and

the distal disc comprises a substantially circular outer perimeter.

3. The occluder device of claim 1, wherein the waist comprises an open area.

4. The occluder device of claim 1, wherein the waist comprises a greater diameter than a diameter of at least one of the proximal end and a diameter of the distal end.

5. The occluder device of claim 1, further comprising a hub arranged at one of the proximal end and the distal end.

6. An occluder device for occluding a defect in an anatomical feature, the occluder device defining a proximal end and a distal end, the occluder device comprising a plurality of wires each extending continuously between the proximal and distal ends of the device and forming a proximal disc defining a proximal outer perimeter of the device, a distal disc defining a distal outer perimeter of the device, and a waist arranged between the proximal disc and the distal disc and defining a narrowed region of the device between the proximal and distal outer perimeters, each of the plurality of wires including:

a first linear section extending radially outward from the central axis of the device toward the proximal outer perimeter of the device,

a first curved transition extending between the first linear section and the proximal outer perimeter of the device,

a second curved transition extending from the proximal outer perimeter of the device toward the central axis of the device,

a central curved transition extending through the narrowed region of the device such that the narrowed region of the device is configured to extend through the defect in the anatomical feature, the plurality of wires being non-overlapping through the central axis,

a third curved transition extending from the narrowed region of the device to the distal outer perimeter of the device, the central curved transition positioned between the second and third curved transitions,

a fourth curved transition extending from the distal outer perimeter of the device toward the central axis of the device, and

a second linear section extending radially inward from the fourth curved transition toward the central axis of the device.

7. The occluder device of claim 6, further comprising a covering arranged on the plurality of wires.

8. The occluder device of claim 7, wherein the covering is configured to cover the distal disc, the proximal disc, and the waist.

9. The occluder device of claim 7, wherein the covering is configured to stabilize the occluder device.

10. The occluder device of claim 6, wherein each of the distal disc and the proximal disc comprise a substantially circular outer perimeter.