Occlusion device having five or more arms

• US 7,115,135 B2
• Filed: 01/22/2003
• Issued: 10/03/2006
• Est. Priority Date: 01/22/2003
• Status: Expired due to Fees

• Current Assignee: Encore Medical Inc.
• Original Assignee: Cardia, Inc.
• Inventors: Marino, Joseph A., Corcoran, Michael P.
• Primary Examiner(s): Bui, Vy Q
• Application Number:
  US10/348,701
• Publication Number:
  US 20040143291A1
• Time in Patent Office: 1,350 Days
• Field of Search: 606/151, 606/152, 606/153, 606154-155, 606/200
• 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 2017/00862 elastic or resilient
• CPC Class Codes: A61B 2017/00867 shape memory effect

Abstract

An occlusion device having at least five arms. Though the number of arms is increased, the diameter of each arm is reduced. As a result, the increased number of arms provides the desired tension as the occlusion device is deployed and provides the desired strength to hold the occlusion device in place and properly occlude the defect. At the same time, the reduced diameter of the arms improves the cycle life of the occlusion device. Furthermore, the increased number of arms provides for better sealing across the defect and reduces residual shunting.

Claims

1. An improved occlusion device, the occlusion device comprising:

a center post;

first and second fixation devices connected to the center post and having an open configuration and a folded configuration, the first and second fixation devices comprising at least five arms, each arm including an atraumatic tip at an outer end, wherein the arms of at least one fixation device are not all of equal length so that when the fixation devices are in a folded configuration the atraumatic tips do not cluster at a same location, and wherein the arms are generally straight and extend radially outward from the center post when the fixation devices are in an open configuration; and

first and second sheets attached to the first and second fixation devices respectively.

2. The occlusion device of claim 1 wherein a length of the arms of the first fixation device is not equal to a length of the arms of the second fixation device.

3. The occlusion device of claim 2 wherein the arms of the first fixation device do not have equal lengths.

4. The occlusion device of claim 3 wherein the arms of the second fixation device do not have equal lengths.

5. The occlusion device of claim 1 wherein the arms have diameters between about 0.003 inches to about 0.050 inches.

6. The occlusion device of claim 1 wherein the first fixation device is offset at an angle of about 30 degrees from the second fixation device.

7. The occlusion device of claim 1 wherein each arm is spaced at an equal angle from the adjacent arm.

8. The occlusion device of claim 1 wherein the outer perimeter of the sheets correspond to a polygon and the number of sides of the polygon is equal to the number of arms of the fixation devices.

9. The occlusion device of claim 1 wherein the first and second fixation devices comprise six arms.

10. The occlusion device of claim 9 wherein each of the six arms are formed by three wires extending through holes in the center post.

11. An occlusion device with improved seating ability, the occlusion device comprising:

a center post;

first and second fixation devices emanating from the center post and having an open configuration and a folded configuration, wherein the first and second fixation devices comprise at least six arms, each arm including an atraumatic tip at an outer end, wherein at least one arm of the first fixation device has a length not equal to a length of the other arms of the first fixation device so that when the fixation devices are in a folded configuration the atraumatic tips do not cluster at a same location, and wherein the arms are generally straight and extend radially outward from the center post when the fixation devices are in an open configuration; and

first and second sails attached to the first and second fixation devices, respectively.

12. The occlusion device of claim 11 wherein an angle between each arm of the first and second fixation devices is about equal.

13. The occlusion device of claim 11 wherein a length of the arms of the first fixation device is not equal to a length of the arms of the second fixation device.

14. The occlusion device of claim 11 wherein at least one arm of the second fixation device has a length not equal to a length of the other arms of the second fixation device.

15. The occlusion device of claim 11 wherein the first fixation device is offset from the second fixation device at an angle of about 30 degrees.

16. The occlusion device of claim 11 wherein the arms have diameters between about 0.003 inches to about 0.050 inches.

17. The occlusion device of claim 11 and further comprising holes in the center post through which the first and second fixation devices extend.

18. The occlusion device of claim 11 wherein the first and second fixation device comprise eight arms.

19. The occlusion device of claim 11 wherein the first and second fixation devices comprise ten arms.

20. The occlusion device of the claim 11 wherein the number of sides of the first and second sails is equal to the number of arms of the fixation devices.

21. An occlusion device deliverable through a catheter, the occlusion device comprising:

a center post;

a first fixation device configured to be placed on a first side of a septal defect and having an open configuration and a folded configuration, the first fixation device comprising at least five arms, each arm including an atraumatic tip located at an outer end; and

a second fixation device configured to be positioned on a second side of a septal defect and having an open configuration and a folded configuration, the second fixation device comprising at least five arms, each arm including an atraumatic tip located at an outer end; and

wherein the arms of the first and second fixation devices have lengths such that when the arms are in a collapsed position for delivery through the catheter, the atraumatic tips located at the outer ends of the arms are at staggered locations, and wherein the arms are generally straight and extend radially outward from the ceter post when the fixation devices are in an open configuration.

22. The occlusion device of claim 21 wherein a length of the arms of the first fixation device is not equal to a length of the arms of the second fixation device.

23. The occlusion device of claim 21 wherein the arms of the first fixation device are not all of equal length.

24. The occlusion device of claim 23 wherein the arms of the second fixation device are not all of equal length.

25. The occlusion device of claim 21 wherein a diameter of the arms is about 0.003 inches to about 0.050 inches.

26. The occlusion device of claim 21 wherein the first fixation device is offset at an angle of about 30 degrees from the second fixation device.

27. The occlusion device of claim 21 wherein each arm is spaced at an equal angle from the adjacent arm.

28. The occlusion device of the claim 21 and further comprising first and second sails attached to the first and second fixation devices.

29. The occlusion device of claim 21 wherein the first and second fixation devices comprise six arms.

30. The occlusion device of claim 21 and further comprising a center post to which the first and second fixation devices are attached.

31. The occlusion device of claim 21 wherein the arms of the first and second fixation device are formed to have a stiffness that ensures proper occlusion of the defect and provides the desired tension, yet does not decrease fatigue life of the fixation devices.

32. An occlusion device for occluding a septal defect, the occlusion device comprising:

a center post;

a first fixation device configured to be placed on a first side of a septal defect and having an open configuration and a folded configuration, the first fixation device comprising a plurality of arms which do not have equal lengths, each arm including an atraumatic tip at an outer end; and

a second fixation device configured to be positioned on a second side of a septal defect and having an open configuration and a folded configuration, the second fixation device comprising a plurality of arms which do not have equal lengths, each arm including an atraumatic tip at an outer end; and

wherein when the fixation devices are in a folded configuration the atraumatic tips do not cluster at a same location, and wherein the arms are generally straight and extend radially outward from the center post when the fixation devices are in an open configuration.

33. The occlusion device of claim 32 wherein the length of the arms of the first fixation device is not equal to the length of the arms of the second fixation device.

34. The occlusion device of claim 32 wherein the plurality of arms comprises five arms.

35. The occlusion device of claim 32 wherein the plurality of arms comprises six arms.

36. An improved occlusion device, the occlusion device comprising:

a center post;

first and second fixation devices connected to the center post and having an open configuration and a folded configuration, the first and second fixation devices and comprising at least five arms, each arm having an atraumatic tip at an outer end, wherein the arms of the first fixation device are not all of equal lengths so that when the fixation devices are in a folded configuration the atraumatic tips do not cluster at the same location, and where the arms are generally straight and extend radially outward from the center post when the fixation devices are in an open configuration; and

first and second sheets attached to the first and second fixation devices respectively.

37. The occlusion device of claim 36 wherein the arms of the second fixation device are not all of equal lengths.

38. The occlusion device of claim 36 wherein each of the first and second fixation devices comprises six arms and a first arm and a fourth arm of the first fixation device have a first length, a second arm and a fifth arm of the first fixation device have a second length, and a third arm and a sixth arm of the first fixation device have a third length.

39. The occlusion device of claim 38 wherein a first arm and a fourth arm of the second fixation device have a first length, a second arm and a fifth arm of the second fixation device have a second length, and a third arm and a sixth arm of the second fixation device have a third length.

40. An improved occlusion device, the occlusion device comprising:

a center post; and

first and second fixation devices connected to the center post and having an open configuration and a folded configuration, the first and second fixation devices each comprising six arms, each arm including an atraumatic tip at an outer end, wherein the six arms extend through holes in the center post and the arms of at least one fixation device are not all of equal length so that when the fixation device is in a folded configuration the atraumatic tips do not cluster at a same location, and wherein the arms are generally straight and extend radially outward from the center post when the fixation devices are in an open configuration; and

first and second sheets attached to the first and second fixation devices respectively.

41. The occlusion device of claim 40, wherein the six arms are formed by three wires.

42. An occlusion device for occluding a septal defect, the occlusion device comprising:

a center post;

a first fixation device configured to be placed on a first side of a septal defect and having an open configuration and a folded configuration, the first fixation device comprising at least five arms, each arm including an atraumatic tip at an outer end, wherein the arms of the first fixation device are not all of one length so that when the fixation device is in a folded configuration the atraumatic tips do not cluster at the same location, and wherein the arms are generally straight and extend radially outward from the center post when the fixation devices are in an open configuration; and

a second fixation device configured to be positioned on a second side of a defect and having an open configuration and a folded configuration, the second fixation device comprising at least five arms, each arm including an atraumatic tip at an outer end, wherein the arms of the second fixation device are not all of one length so that when the fixation device is in a folded configuration the atraumatic tips do not cluster at the same location, and wherein the arms are generally straight and extend outward from the center post when the fixation devices are in an open configuration.