Device for occluding vascular defects

• US 8,313,505 B2
• Filed: 02/29/2008
• Issued: 11/20/2012
• Est. Priority Date: 03/19/2004
• Status: Active Grant

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories)
• Original Assignee: AGA Medical Corporation (Abbott Laboratories)
• Inventors: Amplatz, Kurt, Glimsdale, Matt, Gu, Xiaoping, Oslund, John, Santer, Jana
• Primary Examiner(s): SEVERSON, RYAN J
• Application Number:
  US12/040,260
• Publication Number:
  US 20080200945A1
• Time in Patent Office: 1,726 Days
• Field of Search: 606/200, 606/198, 606/151, 606/191, 606/194
• US Class Current: 606/200
• 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 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12122 within the heart for closing a cardiac septal defect A61B17/0057
• CPC Class Codes: A61B 17/12163 having a string of elements connected to each other
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• 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 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/12127 Double occlusion, e.g. for creating blood-free anastomosis site

Abstract

Embodiments of the present invention provide devices and methods for treating abnormalities. For example, a device according to one embodiment includes a plurality of planes of occlusion, at least one plane of occlusion comprising a plurality of layers of occlusive material. The device is configured to at least partially occlude an abnormality.

Claims

1. A medical device for occluding an abnormality, the medical device comprising:

an expanded preset configuration having proximal and distal ends, the expanded preset configuration comprising a disk at each of the proximal and distal ends and a central portion disposed between the disks, each of the disks and the central portion disposed along a central axis extending between the proximal and distal ends,

wherein each of the disks comprises a plurality of planes of occlusion and the central portion comprises at least one central plane of occlusion, at least one of the planes of occlusion of the disks or the central portion comprising a plurality of separate layers of braided metal fabric, wherein each of the planes of occlusion of the disks and the central portion is oriented generally transverse to the central axis and is configured to be oriented generally transverse to blood flow such that the layers of braided metal fabric are configured to substantially occlude blood flow therethrough so as to occlude the abnormality in less than about 10 minutes, and

wherein at least one of the plurality of planes of occlusion at the proximal or distal ends has a larger cross-sectional area than the at least one central plane of occlusion in the expanded preset configuration.

2. The medical device of claim 1, wherein the medical device is configured to substantially occlude the abnormality in less than about 5 minutes.

3. The medical device of claim 1, wherein the medical device is configured to substantially occlude the abnormality in less than about 3 minutes.

4. The medical device of claim 1, wherein the medical device comprises at least five planes of occlusion.

5. The medical device of claim 1, wherein at least one of the plurality of planes of occlusion comprises at least three layers of braided metal fabric.

6. The medical device of claim 1, wherein at least one of the plurality of planes of occlusion at the proximal or distal ends is configured to overlie an opening of the abnormality.

7. The medical device of claim 1, wherein the at least one central plane of occlusion is configured to be at least partially positioned within an opening defined by the abnormality.

8. The medical device according to claim 1, wherein at least one of the plurality of planes of occlusion of the disks or the at least one central plane of occlusion is oval or crescent shaped in cross section.

9. The medical device according to claim 1, wherein at least one of the plurality of planes of occlusion of the disks or the at least one central plane of occlusion is non-circular in shape in cross section.

10. The medical device of claim 1, wherein the medical device is configured for delivery over a guide wire.

11. The medical device of claim 1, wherein at least one of the disks at the proximal or distal ends is configured to articulate about the central portion.

12. The medical device of claim 11, further comprising a waist extending between one of the plurality of planes of occlusion at the proximal or distal end and the at least one central plane of occlusion, the waist having a smaller cross-sectional area than both the one of the plurality of planes of occlusion at the proximal or distal end and the at least one central plane of occlusion, and wherein the one of the plurality of planes of occlusion at the proximal or distal ends is configured to articulate with respect to the at least one central plane of occlusion about the waist.

13. The medical device of claim 1, wherein each of the disks at the proximal and distal ends and the central portion has an oval-shaped cross section.

14. The medical device of claim 1, wherein the plurality of layers of braided metal fabric extend substantially between the proximal and distal ends.

15. The medical device of claim 14, wherein each of the plurality of layers of braided metal fabric comprises a tubular member.

16. The medical device of claim 14, wherein the plurality of layers of braided metal fabric are disposed concentrically to one another.

17. The medical device of claim 1, wherein the expanded preset configuration is deformable to a lesser cross-sectional dimension for delivery to the abnormality, at least one of the plurality of layers of braided metal fabric having a memory property such that the medical device tends to self expand and return to the expanded preset configuration when unconstrained.

18. The medical device of claim 1, wherein each of the plurality of planes of occlusion at the proximal and distal ends and the central plane of occlusion is oriented generally transverse and coaxial to the central axis.

19. The medical device of claim 1, wherein at least one of the layers of braided metal fabric comprises Nitinol.

20. A method for occluding an abnormality with a medical device, the method comprising:

constraining the medical device of claim 1 to a smaller diameter than the expanded preset configuration;

delivering the medical device proximate to the abnormality; and

deploying the medical device proximate to the abnormality such that the plurality of planes of occlusion and the at least one central plane of occlusion are oriented generally transverse to blood flow and such that the layers of braided metal fabric substantially occlude blood flow therethrough so as to occlude the abnormality.

21. The method of claim 20, wherein constraining comprises stretching the medical device along a longitudinal axis thereof to the smaller diameter.

22. The method of claim 20, wherein deploying comprises deploying the medical device such that at least one of the plurality of planes of occlusion at the proximal or distal ends is configured to overlie an opening of the abnormality.

23. The medical device of claim 20, wherein deploying comprises deploying the medical device such that the at least one central plane of occlusion is at least partially positioned within an opening defined by the abnormality.

24. The method of claim 20, wherein delivering comprises delivering the medical device over a guide wire.

25. The method of claim 20, wherein delivering comprises delivering the device arterially or venously proximate to the abnormality.

26. A medical device for occluding an abnormality comprising:

an expanded preset configuration having proximal and distal ends, the expanded preset configuration comprising a disk at each of the proximal and distal ends and a central portion disposed between the disks, each of the disks and the central portion disposed along a central axis extending between the proximal and distal ends,

wherein each of the disks comprises a plurality of planes of occlusion and the central portion comprises at least one central plane of occlusion, wherein each of the planes of occlusion of the disks and the central portion is oriented generally transverse to the central axis and is configured to be oriented generally transverse to blood flow, at least one of the planes of occlusion of the disks or the central portion comprising a plurality of separate layers of braided metal fabric, wherein at least one of the plurality of planes of occlusion at the proximal or distal end is configured to be positioned within a vessel or an organ and overlie an opening of the abnormality, and wherein the at least one central plane of occlusion is configured to be at least partially positioned within the opening defined by the abnormality such that the layers of braided fabric are configured to substantially occlude blood flow therethrough so as to occlude the opening, and

wherein at least one of the plurality of planes of occlusion at the proximal or distal ends has a larger cross-sectional area than the at least one central plane of occlusion in the expanded preset configuration.

27. The medical device of claim 26, wherein at least one of the plurality of planes of occlusion at the proximal end is configured to be positioned within a first vessel or an organ, at least one of the plurality of planes of occlusion at the distal end is configured to be positioned within a second vessel or an organ, and the at least one central plane of occlusion is configured to be positioned within an opening extending between the first and second vessels or organs.

28. The medical device of claim 26, wherein at least one of the plurality of layers of braided metal fabric comprises Nitinol.

29. The medical device according to claim 26, wherein at least one of the plurality of planes of occlusion of the disks or the at least one central plane of occlusion is oval or crescent shaped in cross section.

30. The medical device according to claim 26, wherein at least one of the plurality of planes of occlusion of the disks or the at least one central plane of occlusion is non-circular in shape in cross section.

31. A medical device for occluding an abnormality, the medical device comprising:

an expanded preset configuration having proximal and distal ends, the expanded preset configuration comprising a disk at each of the proximal and distal ends and a central portion disposed between the disks, each of the disks and the central portion disposed along a central axis extending between the proximal and distal ends,

wherein each of the disks comprises a plurality of planes of occlusion and the central portion comprises at least one central plane of occlusion, at least one of the planes of occlusion of the disks or the central portion comprising a plurality of separate layers of braided metal fabric, wherein the medical device is configured to be delivered through a catheter having an outer diameter of less than 9 French for percutaneous delivery to the vascular abnormality, and wherein each of the planes of occlusion of the disks and the central portion is oriented generally transverse to the central axis and is configured to be oriented generally transverse to blood flow such that the layers of braided metal fabric are configured to substantially occlude blood flow therethrough so as to occlude the abnormality, and

wherein at least one of the plurality of planes of occlusion at the proximal or distal ends has a larger cross-sectional area than the at least one central plane of occlusion in the expanded preset configuration.

32. The medical device of claim 31, wherein the medical device is configured to be delivered through a catheter having an outer diameter of less than 7 French for percutaneous delivery to the vascular abnormality.

33. The medical device of claim 31, wherein the medical device is configured to be delivered through a catheter having an outer diameter of less than 6 French for percutaneous delivery to the vascular abnormality.

34. The medical device of claim 31, wherein the medical device is configured to be delivered through a catheter having an outer diameter of less than 5 French for percutaneous delivery to the vascular abnormality.

35. The medical device of claim 31, wherein at least one of the plurality of layers of braided metal fabric comprises Nitinol.

36. A medical device for occluding an abnormality, the medical device comprising:

an expanded preset configuration having proximal and distal ends, the expanded preset configuration comprising a disk at each of the proximal and distal ends and a central portion disposed between the disks,

wherein each of the disks comprises a plurality of planes of occlusion and the central portion comprises at least one central plane of occlusion, at least one of the planes of occlusion of the disks or the central portion comprising a plurality of separate layers of braided metal fabric, wherein each of the planes of occlusion of the disks and the central portion is configured to be oriented generally transverse to blood flow such that the layers of braided metal fabric are configured to substantially occlude blood flow therethrough so as to occlude the abnormality in less than about 10 minutes,

wherein at least one of the plurality of planes of occlusion at the proximal or distal ends has a larger cross-sectional area than the at least one central plane of occlusion in the expanded preset configuration,

the medical device further comprising;

a waist extending between one of the plurality of planes of occlusion at the proximal or distal end and the at least one central plane of occlusion, the waist having a smaller cross-sectional area than both the one of the plurality of planes of occlusion at the proximal or distal end and the at least one central plane of occlusion, and wherein the one of the plurality of planes of occlusion at the proximal or distal ends is configured to articulate with respect to the at least one central plane of occlusion about the waist.