Patent foramen ovale closure device and method

• US 20070270905A1
• Filed: 05/10/2007
• Published: 11/22/2007
• Est. Priority Date: 05/18/2006
• Status: Abandoned Application

• Current Assignee: Cook Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated)
• Inventors: Osborne, Thomas A.
• Application Number:
  US11/801,665
• Publication Number:
  US 20070270905A1
• 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 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00579 Barbed implements
• CPC Class Codes: A61B 2017/0061 Implements located only on one side of the opening
• CPC Class Codes: A61B 2017/00893 pharmaceutically effective

Abstract

A device and method for closure of a body channel of a patient, such as a patent foramen ovale. The device includes a frame member having a collapsed condition and an expanded condition. The frame member is sized and arranged to be percutaneously insertable into an area of the foramen ovale when in the collapsed condition, and to substantially span the foramen ovale when in the expanded condition. A promoter carried by the frame member, such as a clot-promoting composition and/or a tissue growth-promoting composition, is capable of promoting biological formation with the tissue bordering the foramen ovale to effect a closure of the foramen ovale.

Claims

1. A device for closure of a patent foramen ovale of a patient, comprising:

a frame member having a collapsed condition and an expanded condition, the frame member sized and arranged to be percutaneously insertable into an area of the foramen ovale when in the collapsed condition, and to substantially span the foramen ovale when in the expanded condition; and

a promoter carried by the frame member, the promoter capable of promoting biological formation to effect a closure of the foramen ovale.

2. The device of claim 1, wherein the frame member comprises a pair of elongated members joined by at least one joinder point, said elongated members positioned substantially adjacent one another when the frame member is in the collapsed condition, and positioned such that an opening is defined therebetween when the frame member is in the expanded condition, said promoter comprising a covering material, a first portion of the covering material engaged with one of the elongated members and a second portion of the covering material engaged with the other elongated member, the covering material positioned to substantially span the opening when the frame member is in the expanded condition.

3. The device of claim 2, wherein the covering material comprises a composition capable of promoting clot formation in the foramen ovale.

4. The device of claim 3, wherein the clot-promoting composition comprises a fibrous material.

5. The device of claim 4, wherein the fibrous material comprises polyester or silk fibers.

6. The device of claim 2, wherein the covering material comprises a tissue growth-promoting composition capable of promoting growth with tissue adjacent the foramen ovale.

7. The device of claim 6, wherein the tissue growth-promoting composition comprises at least one of a small intestine submucosa and a collagen-based material.

8. The device of claim 2, wherein the frame member further comprises an anchoring member for anchoring the frame member to tissue adjacent the frame member when the frame member is in the expanded condition.

9. The device of claim 8, wherein the anchoring member comprises at least one hook capable of anchoring to the adjacent tissue.

10. The device of claim 8, wherein the anchoring member comprises at least one coil sized and configured for anchoring the device in the foramen ovale.

11. The device of claim 10, wherein said coil includes a plurality of clot-promoting fibers engaged thereto.

12. The device of claim 1, further comprising at least one radiopaque marker engaged with the frame member.

13. The device of claim 1, wherein the frame member comprises a pair of elongated members joined by at least one joinder point, the elongated members positioned substantially adjacent one another when the frame member is in the collapsed condition, and positioned such that an opening is defined therebetween when the frame member is in the expanded condition, the promoter comprising a plurality of clot-promoting fibers engaged with the frame members.

14. The device of claim 13, wherein the frame member comprises two joinder points, said joinder points positioned at opposite axial ends of the frame member, the fibers being engaged with at least one of the frame members between said joinder points.

15. The device of claim 1, further comprising an extensible member extending from the frame member, the extensible member having a coupler at an end thereof.

16. A method for closure of a channel defined by adjacent tissue structures within the body of a patient, comprising:

providing a closure device, said closure device comprising a frame member, said frame member having a collapsed condition and capable of self-expansion to an expanded condition, and a promoter carried by the frame member, the promoter capable of promoting biological formation upon deployment of said closure device in the channel;

introducing said closure device into a vicinity of said channel;

advancing the closure device into the channel; and

expanding the closure device to span the channel.

17. The method of claim 16, wherein the channel comprises a foramen ovale of the patient, said method further comprising:

loading the closure device into a delivery sheath in the collapsed condition;

percutaneously introducing the delivery sheath and loaded closure device into an atria of the heart of a patient;

advancing the delivery sheath and closure device such that the closure device spans the foramen ovale; and

withdrawing the delivery sheath while maintaining the closure device in position spanning the foramen ovale, whereby the closure device self-expands to said expanded condition.

18. The method of claim 17, said method further comprising:

verifying the placement of the closure device across the foramen ovale prior to withdrawing the delivery sheath.

19. The method of claim 17, wherein the promoter comprises a composition capable of promoting clot formation in said foramen ovale.

20. The method of claim 17, wherein the promoter comprises a tissue growth-promoting composition capable of promoting growth with tissue adjacent said foramen ovale when the closure device is in the expanded condition.