Septal closure device with centering mechanism

• US 10,485,525 B2
• Filed: 05/11/2016
• Issued: 11/26/2019
• Est. Priority Date: 04/05/2007
• Status: Active Grant

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Inventors: Cahill, Ryan
• Primary Examiner(s): David, Shaun L
• Assistant Examiner(s): Lauer, Christina C
• Application Number:
  US15/152,053
• Publication Number:
  US 20160249899A1
• Time in Patent Office: 1,294 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 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 2017/00619 Locking means for locking the implement in expanded state
• CPC Class Codes: A61B 2017/00623 Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2017/00654 entirely comprised between the two sides of the opening
• CPC Class Codes: A61B 2017/00676 promotion of self-sealing of the puncture

Abstract

In one aspect, the present invention provides a device for occluding an aperture in a body, for example, a patent foramen ovale (PFO), including a first side adapted to be disposed on one side of the septum and a second side adapted to be disposed on the opposite side of the septum. The device has an elongated, low-profile delivery configuration and a shortened, radially expanded deployment configuration. The first and second sides are adapted to occlude the aperture upon deployment of the device at its intended delivery location. The device also includes a radially expandable center portion. In some embodiments, the center portion includes a plurality of ribs provided by slits in device. The ribs expand radially when the device is deployed. The expandable center portion facilitates the positioning of the device in the aperture. The device can be secured in the deployed configuration using a catch system.

Claims

1. An occluder having an elongated configuration and a deployed configuration, the occluder comprising:

a proximal end, a distal end, and a plurality of struts extending therebetween;

a proximal section formed by proximal portions of the plurality of struts, the proximal portions of the plurality of struts forming a plurality of proximal loops, each of the plurality of proximal loops overlapping with adjacent ones of the plurality of proximal loops at single discrete locations in the deployed configuration;

a distal section formed by distal portions of the plurality of struts, the distal portions of the plurality of struts forming a plurality of distal loops, each of the plurality of distal loops overlapping with adjacent ones of the plurality of distal loops at single discrete locations in the deployed configuration; and

a central section arranged between the proximal section and the distal section formed by curved central portions of each of the plurality of struts wherein the curved central portions are non-overlapping in the deployed configuration and the plurality of struts are unbraided in the elongated configuration and in the deployed configuration.

2. The occluder of claim 1, wherein the curved central portions connect the proximal section and the distal section.

3. The occluder of claim 1, wherein the central section includes an external diameter greater than an external diameter of the proximal end and the distal end in the deployed configuration.

4. The occluder of claim 3, wherein the external diameter of the central section is less than an external diameter of the proximal section and the distal section in the deployed configuration.

5. The occluder of claim 1, wherein the central section expands in transitioning from the elongated configuration to the deployed configuration.

6. The occluder of claim 5, wherein the central portion exhibits substantially uniform expansion in transitioning from the elongated configuration to the deployed configuration.

7. The occluder of claim 1, further comprising a covering encapsulating the plurality of proximal loops, the plurality of distal loops, and the central section.

8. The occluder of claim 7, wherein the covering is configured to facilitate the ingrowth of tissue.

9. An occluder having an elongated configuration and a deployed configuration, the occluder comprising:

a proximal end, a distal end, and a plurality of struts extending therebetween to form proximal section, a distal section, and a central section arranged between the proximal section and the distal section;

in the deployed configuration,

the proximal section includes a plurality of proximal loops formed by proximal portions of the plurality of struts with each of the plurality of proximal loops overlapping with adjacent ones of the plurality of proximal loops within an area of the proximal section,

the distal section includes a plurality of distal loops formed by distal portions of the plurality of struts with each of the plurality of distal loops overlapping with adjacent ones of the plurality of distal loops within an area of the distal section,

the central section includes non-overlapping curved central portions of each of the plurality of struts forming a substantially circular perimeter; and

in the elongated configuration,

each of the proximal loops are non-overlapping in the area of the proximal section and each of the distal loops are non-overlapping in the area of the distal section and the curved central portions are non-overlapping.

10. The occluder of claim 9, further comprising a delivery assembly configured to compress the occluder in the elongated configuration.

11. The occluder of claim 9, wherein the proximal section, the distal section, and the central section include internal apertures.

12. The occluder of claim 9, further comprising a covering encapsulating the plurality of proximal loops, the plurality of distal loops, and the central section.

13. The occluder of claim 12, wherein the covering comprises ePTFE and is configured to facilitate the ingrowth of tissue.