Septal closure device with centering mechanism

• US 9,005,242 B2
• Filed: 04/04/2008
• Issued: 04/14/2015
• Est. Priority Date: 04/05/2007
• Status: Active Grant

• Current Assignee: WL Gore and Associates Incorporated (W.L. Gore and Associates)
• Original Assignee: WL Gore and Associates Incorporated (W.L. Gore and Associates)
• Inventors: Cahill, Ryan
• Primary Examiner(s): Anderson, Gregory
• Assistant Examiner(s): LAUER, CHRISTINA C
• Application Number:
  US12/062,904
• Publication Number:
  US 20080249562A1
• Time in Patent Office: 2,566 Days
• Field of Search: 606/213, 606/151, 606/215
• US Class Current: 606/215
• 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 for a defect in a body, the occluder comprising:

an occluder body that defines a longitudinal axis, the occluder body being reconfigurable, by an axially compressive force, from an elongated delivery configuration to a shortened and radially expanded deployed configuration, the occluder body comprising;

a proximal side;

a central portion that is positioned distal of the proximal side; and

a distal side that is positioned distal of the central portion,

wherein the proximal side comprises a proximal end portion and a plurality of proximal-side struts that extend between the proximal end portion and a proximal end of the central portion,

wherein the distal side comprises a distal end portion and a plurality of distal-side struts that extend between a distal end of the central portion and the distal end portion,

wherein the central portion comprises a plurality of central struts that each extend between the proximal end of the central portion and the distal end of the central portion,

wherein the proximal end of the central portion comprises a plurality of proximal convergence areas and the distal end of the central portion comprises a plurality of distal convergence areas,

wherein, when the occluder body is configured in the delivery configuration, each central strut of the plurality of central struts is arranged generally parallel to the longitudinal axis such that the plurality of central struts define a first cylinder having a first diameter,

wherein, when the occluder body is configured in the deployed configuration, the proximal side comprises a plurality of proximal-side petal-shaped loops, the distal side comprises a plurality of distal-side petal-shaped loops, and the plurality of central struts are arranged in a zigzag pattern to define a second cylinder having a second diameter that is greater than the first diameter.

2. The occluder of claim 1, wherein locations of the proximal convergence areas and the distal convergence areas alternate in a circumferential direction of the central portion between the distal end of the central portion and the proximal end of the central portion.

3. The occluder of claim 1, wherein when the plurality of central struts are arranged in the zigzag pattern each central strut of the plurality of central struts is not parallel to the longitudinal axis.

4. The occluder of claim 1, wherein the occluder body is formed from a tube that is cut to produce a plurality of slits that define one or more of:

(1) the plurality of proximal-side struts, (2) the plurality of distal-side struts, and (3) the plurality of central struts,

wherein a first slit of the plurality of slits that defines a proximal-side strut of the plurality of proximal-side struts extends into the central portion, and

wherein a second slit of the plurality of slits that defines a distal-side strut of the plurality of distal-side struts extends into the central portion.

5. The occluder of claim 4, wherein at least one slit of the plurality of slits that defines a proximal-side strut of the plurality of proximal-side struts is longer than at least one other slit of the plurality of slits that defines the proximal-side strut of the plurality of proximal-side struts.

6. The occluder of claim 4, wherein the tube comprises material selected from at least one of metals, shape memory materials, alloys, polymers, bioabsorbable polymers, and combinations thereof.

7. The occluder of claim 4, wherein in the deployed configuration an overall diameter of the proximal side is unequal to an overall diameter of the distal side.

8. The occluder of claim 4, wherein at least some of the plurality of slits that define the plurality of proximal-side struts overlap axially with at least some of the plurality of slits that define the plurality of distal-side struts.

9. The occluder of claim 1, wherein, while the occluder body is reconfiguring from the delivery configuration to the deployed configuration, the plurality of proximal-side struts bow and twist outward to form the plurality of proximal-side petal-shaped loops, and the plurality of distal-side struts bow and twist outward to form the plurality of distal-side petal-shaped loops.

10. The occluder of claim 1, wherein, while the occluder body is reconfiguring from the delivery configuration to the deployed configuration, the plurality of central struts expand radially to configure the occluder body to secure the occluder in an aperture of the defect.

11. The occluder of claim 1, wherein in the deployed configuration the proximal side and the distal side are each diametrically larger than the second diameter.

12. The occluder of claim 1, wherein in the delivery configuration the proximal side and the distal side are each generally equal in diameter to the first diameter.

13. The occluder of claim 4, wherein the proximal end portion, the distal end portion, the plurality of proximal convergence areas, and the plurality of distal convergence areas each comprise portions of the tube that do not include slits.

14. The occluder of claim 1, wherein each proximal-side petal-shaped loop of the plurality of proximal-side petal-shaped loops overlaps with one or more other proximal-side petal-shaped loops of the plurality of proximal-side petal-shaped loops.

15. The occluder of claim 1, wherein the plurality of proximal-side petal-shaped loops are radially offset from the plurality of distal-side petal-shaped loops.

16. The occluder of claim 1, wherein at least some edges of the plurality of proximal-side petal-shaped loops or the plurality of distal-side petal-shaped loops are blunted.

17. The occluder of claim 1, wherein a cross-sectional dimension of a strut of at least one of the plurality of proximal-side petal-shaped loops or the plurality of distal-side petal-shaped loops varies along the strut.

18. The occluder of claim 1, further comprising a catch member disposed in the occluder, the catch member having a tubular catch body, a distal flange for engaging the distal end portion, and a proximal catch mechanism for engaging the proximal end portion.