Occlusion device with flexible polymeric connector

• US 7,749,238 B2
• Filed: 06/19/2006
• Issued: 07/06/2010
• Est. Priority Date: 06/19/2006
• Status: Active Grant

• Current Assignee: Encore Medical Inc.
• Original Assignee: Cardia, Inc.
• Inventors: Marino, Joseph A., Corcoran, Michael P.
• Primary Examiner(s): Erezo; Darwin P
• Assistant Examiner(s): RYCKMAN, MELISSA K
• Application Number:
  US11/455,427
• Publication Number:
  US 20070293891A1
• Time in Patent Office: 1,478 Days
• Field of Search: 606/151, 606/157, 606/158, 606/213
• US Class Current: 606/151
• 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 2017/00623 Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2017/00867 shape memory effect

Abstract

An occlusion device includes a center assembly having a flexible section formed by a polymeric connector. The flexible polymeric connector gives the center assembly improved torque and flexure characteristics, which allows the occlusion device to better conform to the contours of the heart.

Claims

1. An occlusion device comprising:

a first occluding body;

a second occluding body; and

a center assembly comprising a flexible polymeric tube having a sidewall and a central lumen extending from a proximal end to a distal end of the tube, a proximal hub inserted into the central lumen at the proximal end of the tube, and a distal hub inserted into the central lumen at the distal end of the tube, wherein the first occluding body includes a plurality of arms that extend through the sidewall at the proximal end of the tube and through the proximal hub to attach the first occluding body to the proximal hub, and wherein the second occluding body includes a plurality of arms that extend through the sidewall at the distal end of the tube and through the distal hub to attach the second occluding body to the distal hub.

2. The occlusion device of claim 1 wherein an overall diameter of the flexible tube is less than about 5 millimeters.

3. The occlusion device of claim 1 wherein the center assembly further comprises a safety tether located within the flexible tube and extending between the proximal hub and the distal hub.

4. The occlusion device of claim 3 wherein the safety tether comprises a wire.

5. The occlusion device of claim 3 wherein the safety tether comprises a braided fabric.

6. The occlusion device of claim 1 wherein the flexible tube further comprises a plurality of peripheral lumens extending from the proximal end to the distal end.

7. The occlusion device of claim 6 wherein the flexible tube further comprises a plurality of wires extending through the plurality of peripheral lumens.

8. An occlusion device comprising:

a flexible polymeric tube having a sidewall and a central lumen extending from a proximal end to a distal end of the tube;

a proximal hub inserted into the central lumen at the proximal end of the tube;

a distal hub inserted into the central lumen at the distal end of the tube;

a first collapsible support frame having a plurality of arms that extend through the sidewall at the proximal end of the tube and through the proximal hub to attach the first collapsible support frame to the proximal hub;

a second collapsible support frame having a plurality of arms that extend through the sidewall at the distal end of the tube and through the distal hub to attach the second collapsible support frame to the distal hub;

a tether providing a safety connection between the tube, the proximal hub and the distal hub;

a first sheet attached to the first collapsible support frame; and

a second sheet attached to the second collapsible support frame.

9. The occlusion device of claim 8 wherein the first collapsible support frame is oriented relative to the second collapsible support frame to offset the arms of the first collapsible support frame from the arms of the second collapsible support frame.

10. The occlusion device of claim 8 wherein an outer diameter of the polymeric tube is less than about 5 millimeters.

11. The occlusion device of claim 8 wherein the polymeric tube is formed of elastomer.

12. The occlusion device of claim 11 wherein the polymeric tube further comprises a plurality of peripheral lumens extending from the proximal end to the distal end.

13. The occlusion device of claim 12 wherein the polymeric tube further comprises a plurality of wires extending through the plurality of peripheral lumens.

14. The occlusion device of claim 8 wherein the tether comprises a wire.

15. The occlusion device of claim 8 wherein the tether comprises a braided fabric.

16. An occlusion device comprising:

a first occluding body;

a second occluding body; and

a center assembly comprising a flexible polymeric tube having a sidewall and a central lumen extending from a proximal end to a distal end of the tube, a proximal hub inserted into the central lumen at the proximal end of the tube, and a distal hub inserted into the central lumen at the distal end of the tube, wherein the first occluding body includes a plurality of arms that extend through the sidewall at the proximal end of the tube and through the proximal hub to attach the first occluding body to the proximal hub, and wherein the second occluding body includes a plurality of arms that extend through the sidewall at the distal end of the tube and through the distal hub to attach the second occluding body to the distal hub.

17. The occlusion device of claim 16 wherein the center assembly further comprises a safety tether extending between the proximal hub and the distal hub.

18. The occlusion device of claim 17 wherein the safety tether extends through both the proximal end and the distal end of the tube.