Patent foramen ovale (PFO) closure device with linearly elongating petals

• US 9,861,346 B2
• Filed: 03/27/2007
• Issued: 01/09/2018
• Est. Priority Date: 07/14/2003
• Status: Active Grant

• Current Assignee: WL Gore and Associates Incorporated (W.L. Gore and Associates)
• Original Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Inventors: Callaghan, David J.
• Primary Examiner(s): ORKIN, ALEXANDER J
• Application Number:
  US11/728,694
• Publication Number:
  US 20070244518A1
• Time in Patent Office: 3,941 Days
• Field of Search: 606157, 606213, 606215, 606151, 606158, 606214, 606216
• 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 2017/00606 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 2017/00862 elastic or resilient for sutures A61B2017/0618
• CPC Class Codes: A61B 2017/12054 Details concerning the detachment of the occluding device from the introduction device

Abstract

The present invention provides a device for occluding an anatomical aperture, such as an atrial septal defect (ASD) or a patent foramen ovale (PFO). The occluder includes two sides connected by a central tube. In some embodiments, the occluder is formed from filaments that are joined together to define a substantially cylindrical form with openings defining struts. Upon the application of force, the struts deform into loops. The loops may be of various shapes, sizes, and configurations, and, in at least some embodiments, the loops have rounded peripheries. The occluder further includes a catch system that maintains its deployed state in vivo. When the occluder is deployed in vivo, the two sides are disposed on opposite sides of the septal tissue surrounding the aperture and the catch system is engaged so that the occluder closes the aperture.

Claims

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

an occluder body that is reconfigurable between an elongated tubular cylindrical delivery configuration and a shortened deployed configuration, the occluder body comprising a plurality of filaments, each filament of the plurality of filaments comprising (i) a proximal end portion, (ii), a distal end portion, (iii) a central portion disposed between the proximal end portion and the distal end portion, (iv) a proximal free segment disposed between the proximal end portion and the central portion, and (v) a distal free segment disposed between the central portion and the distal end portion,

the proximal end portion of each filament of the plurality of filaments being bonded together and aligned to form the proximal end portion and defining a generally tubular cylindrically shaped joint, the central portion of each filament of the plurality of filaments being bonded together and aligned to form the central portion and defining a generally tubular cylindrically shaped joint, and the distal end portion of each filament of the plurality of filaments being bonded together and aligned to form the distal end portion and defining a generally tubular cylindrically shaped joint,

wherein, when the occluder body is in the deployed configuration, the proximal free segment of each filament of the plurality of filaments forms a proximal loop, and the distal free segment of each filament of the plurality of filaments forms a distal loop,

wherein each of the proximal loops of each filament of the plurality of filaments overlaps with adjacent proximal loops of the plurality of filaments at a discrete location within an occlusive proximal face formed by the proximal loops,

wherein each of the distal loops of each filament of the plurality of filaments overlaps with adjacent distal loops of the plurality of filaments at a discrete location within an occlusive distal face formed by the distal loops,

wherein the occlusive distal face and the occlusive proximal face cooperate to occlude the defect and wherein each filament of the plurality of filaments comprises a discrete wire.

2. The device of claim 1, wherein, when the occluder body is in the delivery configuration, each filament of the plurality of filaments extends generally parallel to a longitudinal axis of the occluder body and the generally tubular shape is a cylindrical shape in the delivery configuration.

3. The device of claim 1, wherein, when the occluder body is in the deployed configuration, each of:

(a) the proximal end portion, (b) the central portion, and (c) the distal end portion are generally coaxially aligned with a longitudinal axis of the occluder body.

4. The device of claim 1, further comprising a catch system, wherein the catch system is adapted to secure the occluder body in the deployed configuration such that the occluder is not secured during delivery and becomes secured during deployment.

5. The device of claim 1, wherein the occluder further comprises tissue scaffolding attached to at least one of the proximal side of the occluder or the distal side of the occluder.

6. The device of claim 1, wherein one or more of the proximal loops of the plurality of filaments is of different size than one or more of the distal loops of the plurality of filaments.

7. The device of claim 1, wherein none of the proximal loops of the plurality of filaments and none of the distal loops of the plurality of filaments includes a cut surface.

8. The device of claim 1, wherein a first filament of the plurality of filaments has a semi-circular cross-section.

9. The device of claim 1, wherein a first filament of the plurality of filaments and a second filament of the plurality of filaments have different cross-sections.

10. The device of claim 1, wherein a first filament of the plurality of filaments is coated with a therapeutic agent.