Retrievable septal defect closure device

• US 20050033327A1
• Filed: 08/31/2004
• Published: 02/10/2005
• Est. Priority Date: 09/07/1999
• Status: Active Grant

• Current Assignee: ev3 Endovascular, Inc. (Medtronic Plc)
• Original Assignee: ev3 Endovascular, Inc. (Medtronic Plc)
• Inventors: Kusleika, Richard S., Gainor, John, Helgerson, Jeff, Olson, Dennis L. II
• Granted Patent: US 7,377,936 B2
• Time in Patent Office: Days
• 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 2017/00597 Implements comprising a membrane
• 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

Abstract

The present invention provides a septal defect closure device (10) having a first occluding disk (30) having a first flexible membrane (32) attached to a first frame (34) and a second occluding disk (20) having a second flexible membrane (22) attached to a separate second frame (24). The first frame has at least two outwardly extending loops joined to one another by flexible joints. These loops are attached to the first membrane to define taut fabric petals when the first disk is in a deployed configuration. A central portion of the first membrane is joined to the central portion of the second membrane via a joining segment, which may comprise a conjoint disk. The flexible joints of the first frame are received within the joining segment. This septal defect closure device provides enhanced retrievability.

Claims

1. A method of deploying a defect closure device, comprising:

providing an elongate delivery catheter having a lumen;

providing a closure device having expandable proximal and distal frames, the proximal and distal frames being coupled to each other and wherein the distal frame includes at least one flexible joint configured to facilitate collapse of the distal frame upon retrieval; and

reversibly delivering the closure device from the catheter such that the proximal and distal frames can be fully expanded on opposite sides of the defect and wherein the closure device can be retracted back into the lumen by withdrawing a drawstring attached to the proximal frame to collapse the proximal frame and by collapsing the distal frame along the at least one flexible joint.

2. The method of claim 1, further comprising withdrawing the drawstring for retracting the closure device back into the lumen.

3. The method of claim 1, wherein a distal end of the catheter is advanced distal to the defect before retracting the distal frame of the closure device back into the catheter.

4. The method of claim 3, wherein the distal frame engages the distal end of the catheter for collapsing the distal frame along the at least one flexible joint.

5. The method of claim 1, further comprising proximal and distal membranes disposed along the proximal and distal frames, the proximal and distal membranes being joined along a central attachment region.

6. The method of claim 5, wherein the central attachment region forms a conjoint disk.

7. The method of claim 1, further comprising a plunger for delivering the closure device from the catheter.

8. The method of claim 1, wherein two drawstrings are attached along a periphery of the proximal frame.

9. The method of claim 8, wherein the two drawstrings are configured to pull radially inward along the periphery of the proximal frame for collapsing the proximal frame.

10. A method of deploying and retrieving a defect closure device, comprising:

providing an elongate delivery catheter having a lumen;

providing a closure device having expandable proximal and distal frames, the proximal and distal frames being covered with fabric, the fabric forming a conjoint disk between the proximal and distal frames;

advancing a plunger distally through the lumen for urging the closure device out from the catheter such that the proximal and distal frames are fully expanded on opposite sides of the defect; and

retracting the closure device back into the lumen by withdrawing a drawstring attached to a periphery of the proximal frame for collapsing the proximal frame and engaging the distal frame along the distal end of the catheter for causing the distal frame to collapse along at least one flexible joint positioned within the conjoint disk.

11. A retrievable closure device for sealing a defect in a human heart, comprising:

a proximal occluding disk including a proximal membrane disposed along an expandable proximal frame;

a distal occluding disk including a distal membrane disposed along an expandable distal frame, the distal frame including at least one flexible joint configured to facilitate collapse of the distal occluding disk upon retrieval; and

at least one drawstring coupled to the proximal occluding disk;

wherein the proximal and distal occluding disks can be fully expanded on opposite sides of the defect and wherein the closure device is retrievable back into a lumen of a delivery catheter by withdrawing the drawstring for collapsing the proximal frame and by collapsing the distal frame along the at least one flexible joint.

12. The closure device of claim 11, wherein the distal membrane is conjoined to the proximal membrane along a central attachment region.

13. The closure device of claim 12, wherein the at least one flexible joint is retained within the central attachment region.

14. The closure device of claim 12, wherein the central attachment region is sized to substantially fill the defect to be occluded.

15. The closure device of claim 14, wherein the central attachment region is a conjoint disk having a diameter ranging from about 5 mm to about 30 mm.

16. The closure device of claim 11, wherein said proximal and distal frames are made of a superelastic material.

17. The closure device of claim 11, wherein two drawstrings are coupled to the proximal occluding disk.

18. The closure device of claim 17, wherein the drawstrings are releasably coupled to locations along a periphery of the proximal frame.

19. The closure device of claim 18, wherein the drawstrings are configured to pull radially inward along the periphery for collapsing the proximal frame.

20. The closure device of claim 18, wherein the drawstrings extend through at least two eyelets disposed along the periphery of the proximal frame.

21. The closure device of claim 20, wherein the eyelets function as torsion springs for facilitating the expansion of the proximal frame at the defect.

22. The closure device of claim 11, wherein the proximal and distal frames are elastically biased into an expanded position.

23. The closure device of claim 11, wherein the proximal and distal occluding disks are configured for independent deployment on opposite sides of the defect.

24. The closure device of claim 11, wherein the proximal and distal occluding disks are each generally round in shape when in an expanded position.

25. The closure device of claim 11, wherein the proximal and distal membranes are configured for preventing blood flow through the defect.

26. The closure device of claim 11, wherein the proximal and distal membranes are formed of a relatively porous material for permitting ingrowth of collagen and fibrous tissue into the material.

27. The closure device of claim 11, further comprising a plunger for urging the closure device out from the delivery catheter during deployment.

28. The closure device of claim 11, wherein the proximal and distal occluding disks are attached only along central regions of the proximal and distal membranes.