Daisy design for occlusion device

• US 7,582,104 B2
• Filed: 12/08/2004
• Issued: 09/01/2009
• Est. Priority Date: 12/08/2004
• Status: Active Grant

• Current Assignee: Encore Medical Inc.
• Original Assignee: Cardia, Inc.
• Inventors: Marino, Joseph A., Corcoran, Michael P.
• Primary Examiner(s): Manahan; Todd E
• Assistant Examiner(s): DOWE, KATHERINE MARIE
• Application Number:
  US11/007,542
• Publication Number:
  US 20060122646A1
• Time in Patent Office: 1,728 Days
• Field of Search: 606/213, 606/232, 606/151, 606215-217, 623/1.13, 623/1.22
• US Class Current: 606/215
• 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 2017/00867 shape memory effect for prostheses A61F2210/0014

Abstract

The present invention is an occlusion device having a collapsible frame which allows the occlusion device to be more easily centered in a defect and retrieved in situ. The occlusion device comprises a first post configured to be located on a first side of a defect, a second post configured to be located on a second side of the defect, and a fixation device connected to the first and second posts. The fixation device is used to hold the occlusion device in place across a defect, and comprises several segments. The segments are shaped so that each segment comprises a loop, causing the fixation device to resemble a “daisy design.”

Claims

1. A device for use in occluding an aperture, the device comprising:

a first post;

a second post;

a plurality of arms, each arm comprising a first radial section extending outward from the first post, a second radial section extending outward from the second post and a loop comprising a greater than 360 degree helical turn connecting the first and second radial sections; and

first and second sheets attached to each arm, each sheet having an inside face and an outside face, the inside faces facing inwardly toward one another, and the outside faces of the first and second sheets facing outwardly away from one another and toward the first and second posts, respectively,

wherein the first sheet is positioned along an inside length of each first radial section and the second sheet is positioned along an inside length of each second radial section such that each first and second radial section extends radially along and contacts at least a portion of the outside face before extending over an outer peripheral edge of the first and second sheets, respectively, and the loops extend between the inside faces of first and second sheets, each loop having a radial innermost portion that passes through and engages an edge of the aperture so that the loops create a flexible inner diameter capable of self-centering the device with respect to the aperture.

2. The device of claim 1 wherein each arm is a wire formed of nickel titanium.

3. The device of claim 1 wherein each arm is formed to have shape memory.

4. The device of claim 1 wherein each arm is formed of stranded wire.

5. The device of claim 1 wherein the device comprises six arms.

6. The device of claim 1, wherein the loop comprises an approximately 540 degree turn.

7. The device of claim 1, wherein the first and second posts are cylindrical hubs.

8. An occlusion device for closing an aperture, the occlusion device comprising:

a first post;

a second post;

a fixation device comprising a plurality of fixation segments, wherein each fixation segment comprises;

a first radial portion connected to the first post,

a second radial portion connected to the second post, and

a loop comprising an approximately 540 helical degree turn extending between the first and second radial portions; and

first and second occluding sheets each having an inside face and an outside face, the inside faces facing inwardly toward one another, and the outside faces of the first and second occluding sheets facing outwardly away from one another and toward the first and second posts, respectively, the occluding sheets positioned inside the fixation device such that the first and second radial portions of each fixation segment extend radially along and contact at least a portion of the outside face before extending over an outer peripheral edge of the first and second occluding sheets, respectively, and the loops extend between the inside faces of first and second occluding sheets, each loop having a radial innermost portion that passes through and engages an edge of the aperture so that the loops create a flexible inner diameter capable of self-centering the device with respect to the aperture.

9. The occlusion device of claim 8 wherein the first post further comprises a grasping knob.

10. The occlusion device of claim 8 wherein the first sheet is connected to the fixation device using sutures at the first radial portions of the fixation segments.

11. The occlusion device of claim 8 wherein the first sheet is connected to the fixation device using sutures at the first radial portions of the fixation segments and the second sheet is connected to the fixation device using sutures at the second radial portions of the fixation segments.

12. The occlusion device of claim 8 wherein the plurality of fixation segments comprises six arms.

13. The occlusion device of claim 8 wherein the plurality of fixation segments are formed of stranded wire.

14. The occlusion device of claim 13 wherein each fixation segment has a shape memory.

15. The occlusion device of claim 13 wherein the plurality of fixation segments are formed of nickel titanium.

16. The occlusion device of claim 8 wherein the plurality of fixation segments are connected to the first post so that each fixation segment is about 60 degrees from an adjacent fixation segment.

17. The occlusion device of claim 8 wherein the plurality of fixation segments comprises three wires.

18. The occlusion device of claim 8 wherein the first and second posts have holes therein, and the fixation segments are connected to the first and second posts at the holes.

19. The occlusion device of claim 18 wherein the holes comprise three holes arranged vertically along each of the first and second posts.

20. An occlusion device, the occlusion device comprising:

a first post;

a second post;

a collapsible support frame connected between the first and second posts, wherein the support frame comprises a plurality of wire segments, each wire segment including a coil comprising an approximately 540 degree helical turn, each coil having a radial innermost portion for passing through and engaging an edge of a defect so that the coils create a flexible inner diameter capable of self-centering the device with respect to the defect; and

first and second occluding sheets each sheet having an inside face and an outside face, the inside faces facing inwardly toward one another, and the outside faces of the first and second occluding sheets facing outwardly away from one another and toward the first and second posts, respectively, the occluding sheets disposed within the collapsible support frame such that each wire segment emanates from the first post, extends radially along and contacts at least a portion of the first outside face, extends over an outer peripheral edge of the first occluding sheet, forms the coil between the inside faces of first and second occluding sheets, extends over an outer periphery of the second occluding sheet, extends radially along and contacts at least a portion of the second outside face, and terminates at the second center post.

21. The occlusion device of claim 20 wherein the wire segments are formed of a material having shape memory.

22. The occlusion device of claim 20 wherein the wire segments are formed of stranded wire.

23. The occlusion device of claim 20 wherein the wire segments are arranged so that each wire segment is about 60 degrees from an adjacent wire segment.

24. The occlusion device of claim 20 wherein the wire segments are formed of three wires.

25. The occlusion device of claim 24 wherein the collapsible support frame is connected to the first and second posts so that the three wires are arranged vertically along each of the first and second posts.

26. The occlusion device of claim 20 wherein the first occlusion sheet and the second occlusion sheet are connected to the collapsible frame using sutures.