Septal closure device with centering mechanism

• US 9,949,728 B2
• Filed: 03/09/2015
• Issued: 04/24/2018
• 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:
  US14/642,238
• Publication Number:
  US 20150182209A1
• Time in Patent Office: 1,142 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. A device for occluding a defect in a body, the device comprising:

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

a proximal end portion;

a proximal convergence area that is positioned distal of the proximal end portion;

a plurality of proximal-side struts that extend between the proximal end portion and the proximal convergence area to define a proximal side;

a distal convergence area that is positioned distal of the proximal convergence area;

a plurality of central struts that extend between the proximal convergence area and the distal convergence area to define a central portion, wherein portions of the plurality of central struts are non-overlapping and form a substantially cylindrical area while the occluder body is configured in the deployed configuration;

a distal end portion that is positioned distal of the distal convergence area; and

a plurality of distal-side struts that extend between the distal convergence area and the distal end portion to define a distal side,

wherein each of the proximal end portion, the proximal convergence area, the distal convergence area, and the distal end portion are disposed generally coaxially in relation to the longitudinal axis while the occluder body is configured in the delivery configuration,

wherein while the occluder body is configured in the delivery configuration each of;

(i) the plurality of proximal-side struts, (ii) the plurality of central struts, and (iii) the plurality of distal-side struts are arranged radially outward from the longitudinal axis while each of;

(a) the proximal end portion, (b) the proximal convergence area, (c) the distal convergence area, and (d) the distal end portion remain disposed generally coaxially in relation to the longitudinal axis and in the deployed configuration, a portion of each of the plurality of proximal-side struts overlap with a portion of at least one of the plurality of proximal-side struts adjacent thereto at a discrete location and a portion of each of the plurality of distal-side struts overlap with a portion of at least one of the plurality of distal-side struts adjacent thereto at a discrete location.

2. The device of claim 1, wherein in the deployed configuration the plurality of proximal-side struts form a plurality of proximal-side petal-shaped loops and the plurality of distal-side struts form a plurality of distal-side petal-shaped loops.

3. The device of claim 2, wherein an expanded radius of the central portion is less than an expanded radius of the plurality of proximal-side petal-shaped loops and is less than an expanded radius of the plurality of distal-side struts while the occluder is in the deployed configuration.

4. The device of claim 2, 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.

5. The device of claim 2, wherein a total number of proximal-side petal-shaped loops of the plurality of proximal-side petal-shaped loops is unequal to a total number of distal-side petal-shaped loops of the plurality of distal-side petal-shaped loops.

6. The device of claim 2, wherein the plurality of proximal-side petal-shaped loops are radially offset from the plurality of distal-side petal-shaped loops.

7. The device of claim 1, wherein the occluder body is formed from a tube,

wherein each of the plurality of proximal-side struts, the plurality of distal-side struts, and the plurality of central struts are defined by slits in the tube,

and wherein each of the proximal end portion, the proximal convergence area, the distal convergence area, and the distal end portion comprise portions of the tube that do not include slits such that at least the distal convergence area and the proximal convergence area are configured to maintain a non-expanded tubular profile upon a reconfiguration of the occluder body from the delivery configuration to the deployed configuration.

8. The device of claim 1, wherein the central portion comprises a different number of struts than at least one of the distal and proximal sides of the occluder body.

9. A device for occluding a defect in a body, the device comprising:

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

a proximal end portion;

a proximal convergence area that is positioned distal of the proximal end portion;

a plurality of proximal-side struts that extend between the proximal end portion and the proximal convergence area to define a proximal side;

a distal convergence area that is positioned distal of the proximal convergence area;

a plurality of central struts that extend between the proximal convergence area and the distal convergence area to define a central portion, and portions of the plurality of central struts are non-overlapping and form a substantially circular perimeter while the occluder body is configured in the deployed configuration;

a distal end portion that is positioned distal of the distal convergence area; and

a plurality of distal-side struts that extend between the distal convergence area and the distal end portion to define a distal side,

wherein each of the proximal end portion, the proximal convergence area, the distal convergence area, and the distal end portion are disposed generally coaxially in relation to the longitudinal axis while the occluder body is configured in the delivery configuration,

wherein while the occluder body is configured in the delivery configuration each of;

(i) the plurality of proximal-side struts, (ii) the plurality of central struts, and (iii) the plurality of distal-side struts are arranged radially outward from the longitudinal axis while each of;

(a) the proximal end portion, (b) the proximal convergence area, (c) the distal convergence area, and (d) the distal end portion remain disposed generally coaxially in relation to the longitudinal axis and in the deployed configuration, a portion of each of the plurality of proximal-side struts overlap with a portion of at least one of the plurality of proximal-side struts adjacent thereto at a discrete location and a portion of each of the plurality of distal-side struts overlap with a portion of at least one of the plurality of distal-side struts adjacent thereto at a discrete location,

wherein the occluder body is formed from a tube, wherein slits in the tube define each of;

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

10. The device of claim 9, wherein in the deployed configuration the plurality of proximal-side struts form a plurality of proximal-side petal-shaped loops and the plurality of distal-side struts form a plurality of distal-side petal-shaped loops.

11. The device of claim 10, wherein an expanded radius of the central portion is less than an expanded radius of the plurality of proximal-side petal-shaped loops and is less than an expanded radius of the plurality of distal-side struts while the occluder is in the deployed configuration.

12. The device of claim 10, 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.

13. The device of claim 10, wherein a total number of proximal-side petal-shaped loops of the plurality of proximal-side petal-shaped loops is unequal to a total number of distal-side petal-shaped loops of the plurality of distal-side petal-shaped loops.

14. The device of claim 10, wherein the plurality of proximal-side petal-shaped loops are radially offset from the plurality of distal-side petal-shaped loops.

15. The device of claim 9, wherein the plurality of central struts are parallel with the longitudinal axis while the occluder body is configured in the delivery configuration.

16. The device of claim 9, wherein the central portion comprises a different number of struts than at least one of the distal and proximal sides of the occluder body.

17. The device of claim 9, wherein each of (i) the proximal end portion, (ii) the proximal convergence area, (iii) the distal convergence area, and (iv) the distal end portion comprise portions of the tube that do not include slits.