Catch system with locking cap for patent foramen ovale (PFO) occluder

• US 8,870,913 B2
• Filed: 03/27/2007
• Issued: 10/28/2014
• Est. Priority Date: 03/31/2006
• 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: Opolski, Steven W., Kladakis, Stephanie M., Cahill, Ryan
• Primary Examiner(s): Dornbusch, Dianne
• Assistant Examiner(s): ORKIN, ALEXANDER J
• Application Number:
  US11/728,906
• Publication Number:
  US 20070250115A1
• Time in Patent Office: 2,772 Days
• Field of Search: 606/213, 606/215, 606/151, 606/157, 606/158, 606/214, 606/216
• US Class Current: 606/213
• 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 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• 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

Devices, delivery systems and delivery techniques for an occlusion device for the closure of physical anomalies, such as an atrial septal defect, a patent foramen ovale (PFO), and other septal and vascular defects are described. The devices, delivery systems and delivery techniques relate particularly to, but are not limited to, a patent foramen ovale (PFO) occluder made from a polymer tube. In certain embodiments, the occluder includes a catch system that holds the occluder in the deployed, expanded profile. The catch system includes a locking funnel cap. In some embodiments, the locking funnel cap forces the proximal ends of the occluder in a radially inward position to lock the catch member in place and prevent the occluder from moving from its deployed configuration.

Claims

1. A collapsible medical device for occluding an aperture in a body, the medical device having a first configuration with a reduced profile and a second configuration with an expanded profile, the medical device having a proximal side and a distal side, the medical device being adapted to be delivered through a delivery system into a desired delivery location, the medical device comprising:

an occluder portion movable from a reduced profile configuration to an expanded profile configuration, the occluder portion having a proximal end and a distal end, the occluder portion including an axial passage along the length of the occluder portion; and

a catch member for holding the occluder portion in the expanded profile configuration, the catch member adapted to be disposed in the axial passage of the occluder portion, the catch member having a proximal end, a distal end, and an axial length between the proximal and distal ends, the distal end of the catch member being adapted to engage the distal end of the occluder portion, the proximal end of the catch member being adapted to engage the proximal end of the occluder portion in the expanded profile configuration; and

a separate locking cap adapted to engage the proximal end of the occluder portion in the expanded profile configuration,

wherein the locking cap has a proximal portion and a distal portion, and the distal portion of the locking cap includes first internal threads for threadably connecting to the proximal end of the occluder and the proximal end of the occluder includes external threads, and wherein a proximal portion of the locking cap includes second internal threads for threadably connecting to a delivery system.

2. The medical device of claim 1, wherein the catch member includes a proximal flange that engages the proximal end of the occluder portion.

3. The medical device of claim 1, wherein first internal threads have a first diameter adjacent to the distal end of the locking cap and a second diameter less than the first diameter away from the distal end of the locking cap.

4. The medical device of claim 3, wherein at least a portion of an interior cavity of the locking cap defined by first internal threads has a funnel shape.

5. The medical device of claim 1, wherein the proximal end of the occluder portion is compressible in a radially inward direction and is compressed when the locking cap is secured.

6. The medical device of claim 5, wherein the proximal end of the occluder portion includes an axial notch.

7. The medical device of claim 6, wherein the axial notch remains partially open when the locking cap is secured.

8. The medical device of claim 1, wherein the catch member and locking cap are made of a bioabsorbable material.

9. The medical device of claim 1, wherein the catch member and locking cap are made of a bioabsorbable polymer.

10. A collapsible medical device for occluding an aperture in a body, the medical device having a first configuration with a reduced profile and a second configuration with an expanded profile, the medical device having a proximal side and a distal side, the medical device being adapted to be delivered through a delivery system into a desired delivery location, the medical device comprising:

an occluder portion movable from a reduced profile configuration to an expanded profile configuration, the occluder portion having a reduced axial length in the expanded profile configuration, the occluder portion having a proximal end and a distal end, the occluder portion including an axial passage along the length of the occluder portion;

a catch member for holding the occluder portion in the expanded profile configuration, the catch member being adapted to be disposed in the axial passage of the occluder portion, the catch member having a proximal end, a distal end, and an axial length between the proximal and distal ends, the distal end of the catch member including a distal flange for holding the distal end of the occluder portion, the proximal end of the catch member including a catching surface for engaging the proximal end of the occluder portion in the expanded profile configuration, wherein the catch member includes a proximal flange that engages the proximal end of the occluder portion; and

a separate locking cap that engages the proximal end of the occluder portion in the expanded profile configuration and prevents the proximal flange from being drawn into the axial passage, wherein the locking cap has a proximal portion and a distal portion, and the distal portion of the locking cap includes first internal threads for threadably connecting to the proximal end of the occluder and the proximal end of the occluder includes external threads, and wherein a proximal portion of the locking cap includes second internal threads for threadably connecting to a delivery system.

11. The medical device of claim 10, wherein first internal threads have a first diameter adjacent to the distal end of the locking cap and a second diameter less than the first diameter away from the distal end of the locking cap.

12. The medical device of claim 11, wherein at least a portion of an interior cavity defined by first internal threads has a funnel shape.

13. The medical device of claim 10, wherein the proximal end of the occluder portion is compressible in a radially inward direction and is compressed when the locking cap is secured.

14. The medical device of claim 13, wherein the proximal end of the occluder portion includes an axial notch.

15. The medical device of claim 14, wherein the axial notch remains partially open when the locking cap is secured.

16. The medical device of claim 10, wherein the catch member and locking cap are made of a bioabsorbable material.

17. The medical device of claim 16, wherein the catch member and locking cap are made of a bioabsorbable polymer.