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

• US 9,326,759 B2
• Filed: 07/02/2013
• Issued: 05/03/2016
• Est. Priority Date: 07/14/2003
• 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: Chanduszko, Andrzej J., Callaghan, David J.
• Primary Examiner(s): Mashack, Mark
• Assistant Examiner(s): Scherbel, Todd J
• Application Number:
  US13/934,031
• Publication Number:
  US 20130296925A1
• Time in Patent Office: 1,036 Days
• Field of Search: 606139-142, 606/151, 606157-158, 606/213, 606/232, 606/215
• 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

Occluder devices for occluding an anatomical aperture, such as an atrial septal defect (ASD) or a patent foramen ovale (PFO) comprise two sides connected by a central tube. The occluder devices are 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 devices include a catch system that maintains its deployed state in vivo. When an occluder device 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 device exerts a compressive force on the septal tissue and closes the aperture.

Claims

1. An occluder device for occluding a defect in a body, the occluder device having a delivery configuration in which the occluder device is adapted to be delivered through the body'"'"'s vasculature and a deployed configuration in which the occluder device is adapted to occlude the defect, the occluder device comprising:

a central tube portion;

a proximal side comprising a proximal end tube portion and a plurality of proximal struts, the plurality of proximal struts comprising (i) a first proximal strut portion directly extending from the central tube portion, (ii) a second proximal strut portion directly extending from the proximal end tube portion, and (iii) a proximal circumferential strut portion extending between the first proximal strut portion and the second proximal strut portion, the proximal end tube portion forming a first terminal end of the occluder device,

wherein the proximal circumferential strut portion is thinner than the first proximal strut portion, and wherein the proximal circumferential strut portion is thinner than the second proximal strut portion; and

a distal side comprising a distal end tube portion and a plurality of distal struts, the plurality of distal struts comprising (i) a first distal strut portion directly extending from the central tube portion, (ii) a second distal strut portion directly extending from the distal end tube portion, and (iii) a distal circumferential strut portion extending between the first distal strut portion and the second distal strut portion, the distal end tube portion forming a second terminal end of the occluder device,

wherein the distal circumferential strut portion is thinner than the first distal strut portion, and wherein the distal circumferential strut portion is thinner than the second distal strut portion,

wherein, in the deployed configuration, the plurality of proximal struts form a plurality of proximal loops that all lie generally entirely within a proximal side plane and the plurality of distal struts form a plurality of distal loops that all lie generally entirely within a distal side plane, and wherein the central tube portion is positioned at an angle with respect to the proximal and distal side planes.

2. The occluder device according to claim 1, wherein the plurality of proximal loops are of different diameter than the plurality of distal loops.

3. The occluder device according to claim 1, wherein the plurality of proximal struts are radially offset with respect to the plurality of distal struts.

4. The occluder device according to claim 1, further comprising a catch system adapted to secure the occluder device in the deployed configuration and to not secure the occluder device in the delivery configuration.

5. The occluder device according to claim 4, wherein the catch system comprises one or more catch elements that cooperate with one or more passageways within the occluder device such that occluder device becomes secured in the deployed configuration by compressive forces exerted by the one or more catch elements on the proximal end tube portion and the distal end tube portion when the proximal side and the distal side are positioned between the one or more catch elements.

6. The occluder device according to claim 5, wherein the catch system comprises two catch elements that are connected to each other by a wire or a string.

7. The occluder device according to claim 1, further comprising a locking member that includes at least two locking pieces adapted to hold the occluder device in the deployed configuration when the locking pieces cooperate with the central tube portion or the proximal end tube portion.

8. The occluder device according to claim 1, wherein each of the plurality of proximal loops and the plurality of distal loops twist when the occluder device transitions from the delivery configuration to the deployed configuration.

9. The occluder device according to claim 1, wherein the angle between the central tube portion and the proximal and distal side planes is non-perpendicular.

10. The occluder device according to claim 1, further comprising tissue scaffolding attached to the plurality of proximal loops or the plurality of distal loops.

11. The occluder device according to claim 10, wherein the tissue scaffolding is a bioresorbable material.

12. The occluder device according to claim 1, wherein the occluder device comprises a bioresorbable material.

13. The occluder device according to claim 1, wherein the occluder device comprises nitinol.

14. The occluder device according to claim 1, wherein the plurality of proximal loops and the plurality of distal loops are unequal in terms of their respective numbers of loops.

15. The occluder device according to claim 1, wherein the angle between the central tube portion and the proximal and distal side planes is in a range of about 0 degrees to about 45 degrees.

16. An occluder device for occluding a defect in a body, the occluder device having a delivery configuration in which the occluder device is adapted to be delivered through the body'"'"'s vasculature and a deployed configuration in which the occluder device is adapted to occlude the defect, the occluder device comprising:

a proximal end tube portion, a central tube portion defining a tube having a sidewall, a proximal end that is open and, a distal end that is open, and a distal end tube portion, each of the proximal end tube portion, the central tube portion, and the distal end tube portion having an open interior configured for allowing passage of a member therethrough;

a proximal side comprising a plurality of proximal struts, each of the plurality of proximal struts comprising (i) a first proximal strut portion extending from the proximal end of the central tube portion, (ii) a second proximal strut portion extending from the proximal end tube portion, and (iii) a proximal circumferential strut portion extending between the first proximal strut portion and the second proximal strut portion; and

a distal side comprising a plurality of distal struts, each of the plurality of distal struts comprising (i) a first distal strut portion extending from the distal end of the central tube portion, (ii) a second distal strut portion extending from the distal end tube portion, and (iii) a distal circumferential strut portion extending between the first distal strut portion and the second distal strut portion, wherein the proximal end tube portion, the proximal side, the central tube portion, the distal side, and the distal end tube portion forming a monolithic structure such that in the delivery configuration the occluder device defines a substantially tubular structure, and in the deployed configuration, the plurality of proximal struts form a plurality of proximal loops that all lie generally entirely within a proximal side plane and the plurality of distal struts form a plurality of distal loops that all lie generally entirely within a distal side plane, wherein each of the plurality of proximal loops defines an opening parallel to a longitudinal axis of the occluder device, and wherein each of the plurality of distal loops defines an opening parallel to the longitudinal axis of the occluder device.

17. The occluder device according to claim 16, wherein the member is a locking member configured to hold the occluder device in the deployed configuration, and at least one of the proximal end tube portion, the central tube portion, and the distal end tube portion is configured to pass the locking member therethough.

18. The occluder device according to claim 16, wherein the member is a wire, and the open interior of each of the proximal end tube portion, the central tube portion, and the distal end tube portion is configured to pass the wire therethrough.

19. The occluder device according to claim 18, further comprising a wire passing through the open interior of at least one of the proximal end tube portion, the central tube portion, and the distal end tube portion.

20. The occluder device according to claim 16, wherein the plurality of distal struts deploy to radially overlap in an area formed by the distal side and the plurality of proximal struts deploy to radially overlap in an area formed by the proximal side.

21. An occluder device for occluding a defect in a body, the occluder device having a delivery configuration in which the occluder device is adapted to be delivered through the body'"'"'s vasculature and a deployed configuration in which the occluder device is adapted to occlude the defect, the occluder device comprising:

a proximal end tube portion, a central tube portion defining a tube having a sidewall, a proximal end that is open and, a distal end that is open, and a distal end tube portion, each of the proximal end tube portion, the central tube portion, and the distal end tube portion having an open interior configured for allowing passage of a member therethrough;

a proximal side comprising a plurality of proximal struts, each of the plurality of proximal struts comprising (i) a first proximal strut portion extending from the proximal end of the central tube portion, (ii) a second proximal strut portion extending from the proximal end tube portion, and (iii) a proximal circumferential strut portion extending between the first proximal strut portion and the second proximal strut portion; and

a distal side comprising a plurality of distal struts, each of the plurality of distal struts comprising (i) a first distal strut portion extending from the distal end of the central tube portion, (ii) a second distal strut portion extending from the distal end tube portion, and (iii) a distal circumferential strut portion extending between the first distal strut portion and the second distal strut portion, wherein the proximal end tube portion, the proximal side, the central tube portion, the distal side, and the distal end tube portion forming a single piece such that in the delivery configuration the occluder device defines a substantially tubular structure, and in the deployed configuration, the plurality of proximal struts form a plurality of proximal loops that all lie generally entirely within a proximal side plane and the plurality of distal struts form a plurality of distal loops that all lie generally entirely within a distal side plane, wherein each of the plurality of proximal loops defines an opening parallel to a longitudinal axis of the occluder device, and wherein each of the plurality of distal loops defines an opening parallel to the longitudinal axis of the occluder device.

22. The occluder device according to claim 21, wherein the member is a locking member configured to hold the occluder device in the deployed configuration, and at least one of the proximal end tube portion, the central tube portion, and the distal end tube portion is configured to pass the locking member therethrough.

23. The occluder device according to claim 21, wherein the plurality of distal struts deploy to radially overlap in an area formed by the distal side and the plurality of proximal struts deploy to radially overlap in an area formed by the proximal side.