Septal defect closure device

• US 6,077,291 A
• Filed: 11/26/1996
• Issued: 06/20/2000
• Est. Priority Date: 01/21/1992
• Status: Expired due to Fees

• Current Assignee: Regents of The University of Minnesota (University of Minnesota)
• Original Assignee: Regents of The University of Minnesota (University of Minnesota)
• Inventors: Das, Gladwin S.
• Primary Examiner(s): Jackson, Gary
• Application Number:
  US08/756,776
• Time in Patent Office: 1,302 Days
• Field of Search: 606/142, 606/143, 606/151, 606/157, 606/232, 606/213, 606/215, 606/108, 604/95, 604/159, 604/158, 604/164, 604/11, 604/15-18
• 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 2017/00575 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
• CPC Class Codes: A61B 2090/0811 for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument

Abstract

The present invention provides a system and a method for closing septal defects and the like. The system includes a closure device having a pair of occluding disks, each disk being formed of a membrane and an elastically deformable frame carried about the periphery of the membrane. The frame, which may be formed of a superelastic material, is capable of being collapsed for passage through a catheter and elastically returning to a predetermined shape for tautly holding the membrane. A central portion of the membrane of each disk is attached to a central portion of the other membrane to define a conjoint disk. The method of the invention involves collapsing the frames of the disks, inserting the closure device into a catheter, and positioning the distal end of the catheter adjacent a septal defect. The first disk is then urged out of the distal end of the catheter to permit its frame to elastically return to a predetermined shape, pulling the membrane taut on one side of the defect. The second disk is then similarly deployed on another side of the defect, automatically positioning the conjoint disk within the defect to occlude it.

Claims

1. A septal defect closure device comprising first and second occluding disks, each disk comprising a flexible, biologically compatible membrane capable of being collapsed for passage through a catheter and elastically returning to a predetermined shape for tautly holding a portion of the membrane against a septum;

a central portion of the membrane of the first disk being affixed to a central portion of the membrane of the second disk to define a conjoint disk having a diameter, a maximum dimension of at least one of the first and second disks being between about 1.6 and about 2.5 times the diameter of the conjoint disk.

2. The closure device of claim 1 wherein the central portions of the membranes are bonded directly to one another to define the conjoint disk.

3. The closure device of claim 2 wherein the central conjoint disk is sized to substantially fill a septal defect.

4. The closure device of claim 1 wherein the affixed central portions of the membranes define a generally circular central conjoint disk.

5. The closure device of claim 1 wherein the central portions of the first and second membranes are sewn together to define the conjoint disk.

6. The closure device of claim 1 wherein the central portions of the first and second membranes are fixed to one another by a biologically compatible adhesive.

7. The closure device of claim 1 wherein each of the first and second disks has a periphery, each disk further comprising an elastically deformable frame formed of an elongate wire extending along and attached adjacent to the periphery of the membrane.

8. The closure device of claim 7 wherein the membranes are formed of a superelastic material.

9. The closure device of claim 1 wherein the conjoint disk comprises a tubular segment.

10. The closure device of claim 9 wherein the tubular segment comprises a segment of the membrane of the second disk.

11. The closure device of claim 9 wherein the conjoint disk comprises a piece of another material disposed between the first and second disks.

12. The closure device of claim 1 wherein the conjoint disk comprises a piece of another material disposed between the first and second disks.

13. The closure device of claim 1 wherein the first and second disks are approximately the same size.

14. The closure device of claim 1 wherein the conjoint disk further comprises a biocompatible polymer.

15. The closure device of claim 14 wherein the conjoint disk is substantially impervious to fluids.

16. The closure device of claim 1, further comprising a tether for releasably attaching the closure device to a delivery device.

17. A method of closing a septal defect in a septum comprising the steps of:

(a) determining the size of the defect;

(b) selecting a closure device comprising first and second disks, each disk comprising a flexible structure having a periphery, a portion of the structure of the first disk being joined to a portion of the structure of the second disk by a joining segment having a size approximating the size of the defect;

(c) collapsing the first and second disks and inserting the closure device in a catheter having a distal end;

(d) positioning the distal end of the catheter adjacent a septal defect;

(e) urging the first disk of the closure device out of the distal end of the catheter and permitting the first disk to elastically return to a predetermined shape on a first side of the defect; and

(f) urging the second disk of the closure device out of the distal end of the catheter and permitting the second disk to elastically return to a predetermined shape on a second side of the defect, opening of the second disk automatically urging at least the peripheries of the first and second disks against opposite sides of the septum and positioning the joining segment within the defect to substantially fill the defect.

18. The method of claim 17 wherein the joining segment comprises a tubular segment, the closure device being selected such that the maximum dimension of at least one of the disks is at least about 1.6 times the diameter of the defect.

19. The method of claim 17 wherein the second disk is urged out of the distal end of the catheter by retracting the catheter in a proximal direction.

20. The method of claim 17 further comprising retracting the catheter in a proximal direction after the first disk has been urged out of the catheter until the first disk engages the septum.

21. The method of claim 17 wherein the size of the defect is determined using a balloon catheter, the size of the defect being measured as a stretched diameter thereof.

22. The method of claim 17 wherein the closure device further comprises a tether attached thereto, further comprising the step of detaching the tether from a delivery device after urging the second disk out of the catheter.

23. The method of claim 17 wherein the joining segment comprises a conjoint disk, a central portion of the flexible structure of the first disk being affixed directly to a central portion of the flexible structure of the second disk to define said conjoint disk, the closure device being selected such that the maximum dimension of at least one of the disks is at least about 1.6 times the diameter of the defect.

24. A septal defect closure device comprising first and second occluding disks, each disk comprising a membrane formed of a porous, biologically compatible fabric, each of the membranes being capable of being collapsed for passage through a catheter and elastically returning to a predetermined shape for tautly holding a portion of the membrane against a septum, a central portion of the membrane of the first disk being joined to a central portion of the membrane of the second disk with a piece of another material being disposed between the affixed central portions of the first and second disks.

25. The closure device of claim 24 wherein the joined central portions of the first and second disks comprises a conjoint disk.

26. The closure device of claim 25 wherein the conjoint disk comprises a tubular segment.

27. The closure device of claim 25 wherein the conjoint disk has a diameter, a maximum dimension of at least one of the first and second disks being between about 1.6 and about 2.5 times the diameter of the conjoint disk.

28. A method of closing a septal defect in a septum comprising the steps of:

(a) providing a closure device comprising first and second disks, a portion of the first disk being connected to a portion of the second disk by a tubular segment sized to approximate the size of the defect;

(b) collapsing the first and second disks and inserting the closure device in a catheter having a distal end;

(c) positioning the distal end of the catheter adjacent a septal defect;

(d) urging the first disk of the closure device out of the distal end of the catheter and permitting the first disk to elastically return to a predetermined shape on a first side of the defect; and

(e) urging the second disk of the closure device out of the distal end of the catheter and permitting the second disk to elastically return to a predetermined shape on a second side of the defect, opening of the second disk automatically urging the first and second disks against opposite sides of the septum and positioning the tubular member in close proximity to a periphery of the defect.

29. The method of claim 28 wherein each of the flexible membranes comprises a superelastic material, each of the first and second disks returning to its predetermined shape under the elastic restoring force of the superelastic material upon removal of the constraint of the catheter when the disk is urged out of the distal end thereof.

30. A septal defect closure device comprising first and second occluding disks, each disk comprising a flexible, biologically compatible membrane capable of being collapsed for passage through a catheter and elastically returning to a predetermined shape for tautly holding a portion of the membrane against a septum, a central portion of the membrane of the first disk being affixed to a central portion of the membrane of the second disk by a tubular segment of the fabric of the membrane of the second disk.

31. The closure device of claim 30 wherein the tubular segment is sized to substantially fill a septal defect.

32. The closure device of claim 30 wherein each of the first and second disks comprise a superelastic material.