Septal stabilization device

• US 20040143294A1
• Filed: 01/22/2003
• Published: 07/22/2004
• Est. Priority Date: 01/22/2003
• Status: Abandoned Application

• Current Assignee: Cardia, Inc.
• Original Assignee: Cardia, Inc.
• Inventors: Marino, Joseph A., Corcoran, Michael P.
• Application Number:
  US10/349,744
• Publication Number:
  US 20040143294A1
• Time in Patent Office: Days
• 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 2017/00243 cardiac
• 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

Abstract

A septal stabilization device for stabilizing a septum. The septal stabilization device comprises right and left fixation devices to which are attached sheets of PVA foam. The fixation devices and sheets limit the motion of the septum and have the added benefit of promoting new tissue growth. The septal stabilization device is sized so that it is large enough to provide stabilization of a septum, yet is not so large that it may cause tissue damage to other portions of the heart.

Claims

1. A method of stabilizing a septum, the method comprising:

choosing a location on the septum at which to locate a septal stabilization device;

placing a first part of the septal stabilization device on a first side of the septum at the chosen location; and

placing a second part of the septal stabilization device on a second side of the septum at the chosen location.

2. The method of claim 1 and further comprising:

inserting a catheter into a hole in the septum;

advancing the septal stabilization device through the catheter so that the first part of the septal stabilization device is placed on the first side of the septum;

withdrawing the catheter through hole in the septum; and

advancing the septal stabilization device through the catheter so that the second part of the septal stabilization device is placed on the second side of the septum.

3. The method of claim 2 and further comprising creating the hole in the septal wall at the chosen location.

4. The method of claim 2 and further comprising choosing a size of the septal stabilization device that ensures the septal stabilization device will prevent atrial septal aneurism.

5. The method of claim 1 and further comprising occluding a septal defect.

6. The method of claim 1 and further comprising choosing a size of the septal stabilization device.

7. The method of claim 6 wherein choosing a size of the septal stabilization device comprises choosing a size of a center post of the stabilization device.

8. The method of claim 6 wherein choosing a size of the septal stabilization device comprises choosing a size of the first and second parts.

9. A method of stabilizing a septum, the method comprising:

inserting a catheter into the heart;

positioning the catheter through a hole in a septal wall;

deploying a first side of a septal stabilization device on a first side of the septal wall;

withdrawing the catheter through the hole in the septal wall; and

deploying a second side of the septal stabilization device on a second side of the septal wall;

wherein the first and second sides of the septal stabilization device are sized to allow them to stabilize the septum.

10. The method of claim 9 and further comprising:

creating the hole in the septal wall through which the catheter is positioned.

11. The method of claim 10 and further comprising:

placing a guide wire at the hole;

advancing the catheter along the guide wire until the catheter is positioned in the hole; and

removing the guide wire.

12. The method of claim 9 wherein positioning the catheter through a hole in the septal wall comprises positioning the catheter in a pre-existing septal defect.

13. The method of claim 9 wherein the pre-existing septal defect comprises a patent foramen ovale.

14. The method of claim 9 wherein the pre-existing septal defect comprises a septum with multiple fenestration.

15. The method of claim 9 wherein deploying the septal stabilization device on the first side of the septal wall and on the second side of the septal wall further serves to occlude a septal defect.

16. The method of claim 9 and further comprising deploying a second stabilization device.

17. The method of claim 9 and further comprising deploying an occlusion device.

18. A septal stabilization device, the septal stabilization device comprising:

a center post;

a first fixation device connected to the center post;

a second fixation device connected to the center post; and

first and second sheets attached to the first and second fixation devices, wherein the first and second sheets are held along the septum by the first and second fixation devices and serve to stabilize the septum.

19. The septal stabilization device of claim 18 wherein the first and second sheets comprise polyvinyl alcohol foam.

20. The septal stabilization device of claim 18 wherein the first and second fixation devices comprises stranded wire support arms.

21. The septal stabilization device of claim 18 wherein the first and second fixation devices comprise six arms.

22. The septal stabilization device of claim 18 wherein the first and second fixation devices are attached to the center post directly adjacent one another so that there is no distance on the center post between the first and second fixation devices.

23. The septal stabilization device of claim 18 wherein the distance on the center post between the first and second fixation devices is less than about 3 millimeters.

24. The septal stabilization device of claim 18 wherein the center post comprises a groove configured to be grasped by a guide forceps.

25. The septal stabilization device of claim 18 wherein the first and second fixation devices and the first and second sheets are configured to allow the device to be folded and inserted into a catheter.

26. The septal stabilization device of claim 18 wherein the first and second sheets are connected to the first and second fixation devices with sutures.

27. The septal stabilization device of claim 26 wherein the first and second fixation devices further comprise atraumatic tips and the first and second sheets are connected to the first and second fixation devices using sutures at the tips.

28. The septal stabilization device of claim 26 wherein the size of the first and second sheets is between about 18 and about 45 millimeters.

29. The septal stabilization device of claim 28 wherein a size of the first sheet is not equal to a size of a second sheet.