Tubular patent foramen ovale (PFO) closure device with catch system

• US 9,149,263 B2
• Filed: 02/16/2010
• Issued: 10/06/2015
• 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: Chanduszko, Andrzej J.
• Primary Examiner(s): Anderson, Gregory
• Assistant Examiner(s): DANG, PHONG SON H
• Application Number:
  US12/706,538
• Publication Number:
  US 20100145382A1
• Time in Patent Office: 2,058 Days
• US Class Current: 1/1
• 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

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. The occluder is formed from a tube, which is cut to produce struts in each side. 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. In some embodiments, at least one of the sides includes a tissue scaffold. 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 deployed so that the occluder exerts a compressive force on the septal tissue and closes the aperture.

Claims

1. A septal defect occluder, comprising:

an elongate body having a longitudinal axis, the elongate body comprising;

a first end;

a second end;

a central portion located between the first end and the second end;

a first compressible side located adjacent to the first end, wherein the first compressible side includes at least two slits that extend generally parallel to the longitudinal axis while the septal defect occluder is configured in an elongated delivery form; and

a second compressible side located adjacent to the second end, wherein the second compressible side includes at least two slits that extend generally parallel to the longitudinal axis while the septal defect occluder is configured in the elongated delivery form,

wherein compression of the first compressible side forms a first strut that bows outwardly defining a first loop joined to the first end of the elongate body at a first end of the first loop and to the central portion at a second end of the first loop and having a bend located thereinbetween which twists,

and wherein compression of the second compressible side forms a second strut that bows outwardly defining a second loop joined to the second end of the elongate body at a first end of the second loop and to the central portion at a second end of the first loop and having a bend located thereinbetween which twists.

2. The septal defect occluder of claim 1, wherein the first loop is substantially concave with respect to the central portion.

3. The septal defect occluder of claim 1, wherein the first strut and the second strut extend axially from the elongate body at angles of less than 90 degrees from the longitudinal axis.

4. The septal defect occluder of claim 3, wherein the angles are less than about 45 degrees from the longitudinal axis.

5. The septal defect occluder of claim 3, wherein the first loop is axially offset from the second loop.

6. The septal defect occluder of claim 1, wherein the first loop includes an outermost portion that directly opposes an outermost portion of the second loop.

7. The septal defect occluder of claim 1, wherein the first or second loop is perpendicular to the longitudinal axis.

8. The septal defect occluder of claim 1, wherein the first strut is rotated about the longitudinal axis by less than approximately 45 degrees with respect to the second strut.

9. The septal defect occluder of claim 1, wherein the first loop is a different diameter than the second loop.

10. The septal defect occluder of claim 1, wherein the first loop and the second loop are formed without rotation about the longitudinal axis of the first end relative to the second end.

11. The septal defect occluder of claim 1, wherein the occluder further comprises tissue scaffolding attached to the loops.

12. The septal defect occluder of claim 11, wherein the tissue scaffolding is bioabsorbable.

13. The septal defect occluder of claim 1, wherein the elongate body is nitinol.

14. A septal defect occluder comprising:

an elongate tubular body defining a longitudinal axis and comprising a first side including a first end portion, a second side including a second end portion, and a central tube portion located between the first side and the second side,

wherein while the septal defect occluder is configured in an elongated delivery form the first side includes at least two slits that extend generally parallel to the longitudinal axis along the tubular body and that define a first strut therebetween,

wherein compression of the first side causes the first strut to form a bent portion that comprises a first loop, and wherein the bent portion of the first strut includes a twisted portion of the first strut.

15. The septal defect occluder of claim 14, wherein the second side includes at least two slits that extend along the tubular body and that define a second strut therebetween,

wherein compression of the second side causes the second strut to form a bent portion that comprises a second loop, and wherein the bent portion of the second strut includes a twisted portion of the second strut.

16. The septal defect occluder of claim 14, wherein the first side includes at least four slits that extend along the tubular body and that define a first strut, a second strut, a third strut, and a fourth strut therebetween,

wherein compression of the first side causes each of the first strut, the second strut, the third strut, and the fourth strut to form bent portions that comprise a first loop, a second loop, a third loop, and a fourth loop respectively, and wherein the bent portions of each of the first strut, the second strut, the third strut, and the fourth strut include twisted portions of the first strut, the second strut, the third strut, and the fourth strut respectively.

17. The septal defect occluder of claim 16, wherein the second side includes at least four slits that extend along the tubular body and that define a fifth strut, a sixth strut, a seventh strut, and an eighth strut therebetween,

wherein compression of the second side causes each of the fifth strut, the sixth strut, the seventh strut, and the eighth strut to form bent portions that comprise a fifth loop, a sixth loop, a seventh loop, and an eighth loop respectively, and wherein the bent portions of each of the fifth strut, the sixth strut, the seventh strut, and the eighth strut include twisted portions of the fifth strut, the sixth strut, the seventh strut, and the eighth strut respectively.

18. The septal defect occluder of claim 17, wherein at least one of the first loop, the second loop, the third loop, or the fourth loop is a different size than at least one of the fifth loop, the sixth loop, the seventh loop, or the eighth loop.