Heart occlusion devices

• US 10,278,705 B2
• Filed: 10/20/2016
• Issued: 05/07/2019
• 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): Dang, Phong Son H
• Application Number:
  US15/299,173
• Publication Number:
  US 20170035435A1
• Time in Patent Office: 929 Days
• 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. A method for occluding a defect in an anatomical feature using an occluder device defining a proximal end and a distal end and including 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, the method comprising:

traversing a delivery catheter through the defect;

deploying the distal disc by advancing the occluder device from the delivery catheter to expand the distal disc;

deploying the waist section by further advancing the occluder device from the delivery catheter to expand the waist and positing the waist within the defect;

deploying the proximal disc by advancing the occluder device from the delivery catheter to expand the proximal disc and fully deploying the occluder device such that each of the plurality of wires include;

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 a defect in an anatomical feature, 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

releasing the occluder device from the delivery catheter.

2. The method of claim 1, wherein the deploying the distal disc includes expanding the distal disc to include a circular outer perimeter and deploying the proximal disc includes expanding the proximal disc to include a circular outer perimeter.

3. The method of claim 1, wherein fully deploying the occluder device includes conforming the occluder device to the defect.

4. The method of claim 1, wherein releasing the occluder device from the delivery catheter includes releasing a tether from the occluder device.

5. The method of claim 1, wherein the occluder device further comprises a covering arranged on the plurality of wires.

6. The method of claim 5, wherein the covering is configured to cover the distal disc, the proximal disc, and the waist.

7. The method of claim 1, further comprising repositioning the occluder device after releasing the occluder device from the delivery catheter.

8. The method of claim 7, wherein repositioning the occluder device comprises adjusting a position of the occluder device within the defect.

9. The method of claim 1, wherein the defect is an atrial septal defect (“

ASD”

), a patent foramen ovale (“

PFO”

), a ventricular septal defect (“

VSD”

), or a patent ductus arteriosus (“

PDA”

).

10. A method for occluding a defect in an anatomical feature using an occluder device, the method comprising:

arranging a distal disc of the occluder device on a distal side of the defect;

arranging a waist section defining a narrowed region of the occluder device within the defect; and

deploying the occluder device to a fully deployed configuration by arranging a proximal disc of the occluder device on a proximal side of the defect;

wherein the occluder device comprises a plurality of wires having a first linear section extending radially outward from a central axis of the device toward a 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, a third curved transition extending from the narrowed region of the device to a 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.

11. The method of claim 10, wherein the defect is an atrial septal defect (“

ASD”

), a patent foramen ovale (“

PFO”

), a ventricular septal defect (“

VSD”

), or a patent ductus arteriosus (“

PDA”

).

12. The method of claim 11, wherein the occluder device further comprises a covering arranged on the plurality of wires to cover the distal disc, the proximal disc, and the waist.

13. The method of claim 12, wherein the deploying the occluder device to the fully deployed configuration comprises sealing the defect.

14. The method of claim 13, wherein sealing the defect includes the covering promoting tissue ingrowth.

15. The method of claim 10, wherein the deploying the occluder device to the fully deployed configuration comprising conforming the occluder device to the defect.

16. The method of claim 10, wherein the deploying the occluder device to the fully deployed configuration comprising self-expanding the occluder device.

17. The method of claim 16, wherein the plurality of wires comprise a shape memory material.

18. A method for occluding a defect in an anatomical feature using an occluder device having a plurality of wires extending from a proximal end to a distal end, the method comprising:

delivering the occluder device to a location of the defect with the occluder device in an elongated configuration in which the occluder device includes a plurality of wires arranged within a delivery sheath, and

transitioning the occluder device from the elongated configuration to a deployed configuration by extending the plurality of wires from the delivery sheath such that a distal disc of the occluder device is arranged on a distal side of the defect, a waist section defining a narrowed region of the occluder device is arranged within the defect, and a proximal disc of the occluder device is arranged on a proximal side of the defect, the deployed configuration including the plurality of wires forming a first linear section extending radially outward from a central axis of the device toward a 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, a third curved transition extending from the narrowed region of the device to a 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.

19. The method of claim 18, wherein the occluder device further comprises a covering arranged on the plurality of wires to cover the distal disc, the proximal disc, and the waist.

20. The method of claim 18, wherein transitioning the occluder device from the elongated configuration to the deployed configuration comprises causing the occluder device to self-expand.