Tubular patent foramen ovale (PFO) closure device with catch system

• US 7,678,123 B2
• Filed: 07/14/2004
• Issued: 03/16/2010
• Est. Priority Date: 07/14/2003
• Status: Active Grant

• Current Assignee: WL Gore and Associates Incorporated (W.L. Gore and Associates)
• Original Assignee: NMT Medical Incorporated
• Inventors: Chanduszko, Andrzej J.
• Primary Examiner(s): Ho; (Jackie) Tan-Uyen T
• Assistant Examiner(s): DANG, PHONG SON H
• Application Number:
  US10/890,784
• Publication Number:
  US 20050043759A1
• Time in Patent Office: 2,071 Days
• Field of Search: 606/200, 606/213, 606/151, 606/157, 606/106, 606/107, 604/106
• 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 2017/00619 Locking means for locking the implement in expanded state
• CPC Class Codes: A61B 2017/00623 Introducing or retrieving devices therefor

Abstract

The present invention provides a device for occluding an anatomical aperture, such as an atrial septal defect (ASD) or a patent foramen ovale (PFO). The occluder includes two sides connected by a central tube. The occluder is formed from a tube, which is cut to produce struts in each side. Upon the application of force, the struts deform into loops. The loops may be of various shapes, sizes, and configurations, and, in at least some embodiments, the loops have rounded peripheries. In some embodiments, at least one of the sides includes a tissue scaffold. The occluder further includes a catch system that maintains its deployed state in vivo. When the occluder is deployed in vivo, the two sides are disposed on opposite sides of the septal tissue surrounding the aperture and the catch system is deployed so that the occluder exerts a compressive force on the septal tissue and closes the aperture.

Claims

1. An occluder for a defect adapted to be introduced into the body through the vasculature, the occluder having a proximal side and a distal side that cooperate to close the defect, and the occluder having a central portion disposed between the proximal side and the distal side, at least one of the proximal and distal sides of the occluder including slits axially formed in a tube to form struts, wherein adjacent slits are axially offset from each other around the circumference of the tube and the struts form petals when the axial length of the tube is shortened into a deployed state, and wherein at least one strut joined to the central portion forms a portion of two adjacent petals extending from the at least one strut.

2. The occluder according to claim 1 wherein the slits in the occluder extend along a line parallel to the axis of the tube.

3. The occluder according to claim 1 wherein the slits in the occluder extend along a helical line along the tube.

4. The occluder of claim 1 further comprising a catch system, wherein the catch system is adapted to secure the occluder in a deployed position such that the occluder is not secured during delivery and becomes secured in its delivery profile during the delivery process.

5. The occluder of claim 4 wherein the catch system comprises catch elements that cooperate with a passageway within the occluder such that occluder becomes secured in a deployed state when a portion of the occluder tube is positioned between the catch elements.

6. The occluder of claim 5 wherein the catch elements are balls.

7. The occluder of claim 1 wherein the both the proximal side of the occluder and the distal side of the occluder have loops formed by struts and the occluder is adapted to be secured in the heart with tissue between the proximal side and the distal side of the occluder.

8. The occluder of claim 1 wherein a locking member comprises two locking pieces which are adapted to hold the occluder in the deployed state when the locking pieces cooperate with the central member of the occluder.

9. The occluder of claim 1 wherein the central portion is angled with respect to the plane of the loops of the occluder in the deployed state.

10. The occluder of claim 9 wherein the angle between the central tube and occluder in the deployed state is not approximately 90 degrees.

11. The occluder of claim 1 wherein the occluder further comprises tissue scaffolding attached to the loops.

12. The occluder of claim 1 wherein the loops are formed by slits in a tube and the loops have varying cross section because of the offset slits.

13. An occluder for a defect comprising a tube adapted to be introduced into the body through the vasculature, the occluder having a proximal side and a distal side that cooperate to close the defect, and the occluder having a central portion disposed between the proximal side and the distal side and the central portion remaining disposed along a central axis of the occluder when an axial length of the tube is shortened, at least one of the proximal and distal sides include an arrangement of struts according to the pattern:

n struts for a first axial distance, 2n struts for a second axial distance, and n struts for a third axial distance, wherein at least one of the struts is joined to the central portion at an end of the third axial distance, whereby loops are formed from the struts by the axial shortening of the tube.

14. The occluder of claim 13 wherein the first, second and third axial distances are approximately the same.

15. The occluder of claim 13 wherein the second axial distance is greater than either the first or the third axial distance.

16. The occluder of claim 13 wherein both the proximal side of the occluder and the distal side of the occluder have loops formed by struts and the occluder is adapted to be secured in the heart with tissue between the proximal side and the distal side of the occluder.

17. The occluder of claim 16 further comprising a catch system, wherein the catch system is adapted to secure the occluder in a deployed position such that the occluder is not secured during delivery and becomes secured during the delivery process.

18. The occluder of claim 17 wherein the catch system comprises balls that cooperate with a passageway within the occluder such that occluder becomes secured in a deployed state when a portion of the occluder tube is positioned between the balls.

19. The occluder of claim 13 further comprising a locking member that includes at least two locking pieces which are adapted to hold the occluder in the deployed state when the locking pieces cooperate with the central member of the occluder.

20. The occluder of claim 13 wherein the central portion is angled with respect to the plane of the loops of the occluder in the deployed state.

21. The occluder of claim 13 wherein the angle between the central tube and occluder in the deployed state is not approximately 90 degrees.

22. The occluder of claim 13 wherein the occluder further comprises tissue scaffolding attached to the loops.

23. The occluder of claim 13 wherein the tube is formed of a sheet that is rolled into a tube.

24. The occluder of claim 13 wherein the n is 2 and the tube splits into a hemispherical section and then splits into a quarter section and rejoins to a hemispherical section.

25. The occluder of claim 13 wherein the loops twist when the axial length of the tube is reduced.

26. An occluder for a defect comprising a tube, a proximal side of the tube adapted to be disposed on the proximal side of the defect and a distal side of the tube adapted to be disposed on the distal side of the defect, a plurality of struts formed from the tube on at least one of the proximal and distal sides of the tube by a series of slits disposed in the tube along an axial direction, wherein the struts have a first length that has a cross-section comprising half the tube, a second length that is split into a cross-section of the tube comprising a quarter of the tube and then a third length that is split into a cross-section comprising half of the tube.

27. The occluder of claim 26 wherein the first, second and third axial distances are approximately the same.

28. The occluder of claim 26 wherein the second axial distance is greater than either the first or the third axial distance.

29. The occluder of claim 26 wherein the both the proximal side of the occluder and the distal side of the occluder have loops formed by struts and the occluder is adapted to be secured in the heart with tissue between the proximal side and the distal side of the occluder.

30. The occluder of claim 29 further comprising a catch system, wherein the catch system is adapted to secure the occluder in a deployed position such that the occluder is not secured in a deployed state during delivery and becomes secured during the delivery process.

31. The occluder of claim 30 wherein the catch system comprises catch elements that cooperate with a passageway within the occluder such that occluder becomes locked in a deployed state when a portion of the occluder tube is positioned between the catch elements.

32. The occluder of claim 31 wherein the catch elements are balls.

33. A method for deploying an occluding member that includes a series of loops formed by struts in a tube, the struts being formed by a series of slits which are configured to form the loops when the axial length of the occluder is shortened into a deployed state, wherein adjacent slits are axially offset from each other around the circumference of the tube, the steps comprising:

a) inserting a catheter into a lumen of the body for delivering the occluder, the catheter including a delivery system,

b) deploying a distal end of the occluder by pulling on the delivery wire so that the distal part of the occluder forms loops which are disposed along a surface around a defect to be occluded,

c) pulling a catch element through an axially central passage of the occluder to lock the distal part of the device in a deployed state,

d) deploying a proximal end of the occluder by pulling on the delivery wire so that the proximal part of the occluder forms loops which are disposed along a second surface around the defect to be occluded,

e) pulling the catch element through an axially central passage of the occluder to secure proximal part of the device in a deployed state, and,

f) disengaging the delivery wire from the occluder and removing the catheter from the delivery location.

34. The method of claim 33 wherein the catch element is a ball and the central passage is configured to secure the ball in the deployed state, wherein, step c) further comprises pulling the ball through the central passage and securing the occluder by adapting the ball and central passage to allow for passage through the central passage toward the proximal direction and not in the distal direction.

35. The method of claim 33 wherein the catch element is a ball and the central passage is configured to secure the ball in the deployed state, wherein, step e) further comprises pulling the ball through the central passage and securing the occluder by adapting the ball and the central passage to allow for the passage of the ball through the central passage toward the proximal direction and not in the distal direction.

36. The method of claim 33 wherein the central passage has multiple diameters so that a force required to pull the ball through the central passage to secure the device at step c) is different than the force required to pull the ball through the central passage to lock the device in step e).

37. The method of claim 33 where in the occluder is adapted to be delivered as a PFO closure device.