Device and methods for preventing formation of thrombi in the left atrial appendage

• US 20050070952A1
• Filed: 08/05/2004
• Published: 03/31/2005
• Est. Priority Date: 09/12/2003
• Status: Active Grant

• Current Assignee: WL Gore and Associates Incorporated (W.L. Gore and Associates)
• Original Assignee: NMT Medical Incorporated
• Inventors: Devellian, Carol A.
• Granted Patent: US 8,097,015 B2
• Time in Patent Office: Days
• 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 17/12122 within the heart for closing a cardiac septal defect A61B17/0057
• CPC Class Codes: A61B 17/12159 Solid plugs; being solid before insertion
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 2017/00243 cardiac
• 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 2017/00601 Implements entirely comprised between the two sides of the opening
• CPC Class Codes: A61B 2017/00615 Implements with an occluder on one side of the opening and holding means therefor on the other
• CPC Class Codes: A61B 2017/00632 Occluding a cavity, i.e. closing a blind opening
• CPC Class Codes: A61B 2017/1205 Introduction devices

Abstract

The embodiments of the present invention provide a device that modifies the left atrial appendage (LAA) to reduce the likelihood of thrombus formation therein. The device includes a liner that reduces the volume of the LAA and remodels the interior geometry and surfaces of the LAA thereby minimizing the crenellations in the LAA that impede blood flow. According to some embodiments, the device further includes an anchor component. The anchor component helps to expand the liner upon deployment of the device in-vivo and further prevents dislodgement and migration of the device, by ensuring the device is properly seated and completely sealed against the walls and ostium of the LAA.

Claims

1. A device for promoting drainage of the vascular flow from the left atrial appendage of a heart, the left atrial appendage having an internal wall, said device comprising:

a liner having a proximal end and a distal end, the liner adapted to be positioned adjacent to a plurality of surfaces of the interior wall of the left atrial appendage such that the liner smoothes the plurality of surfaces of the interior wall; and

an anchor component attached to at least a portion of the liner, the anchor component adapted for securing at least a portion of the device within the left atrial appendage.

2. The device of claim 1, wherein the liner comprises one of a natural and biologic tissue.

3. The device of claim 1, wherein the liner comprises collagenous material.

4. The device of claim 3, wherein the collagenous material is treated to remove cellular components.

5. The device of claim 1, wherein the liner is expandable.

6. The device of claim 1, wherein the anchor component is self-expandable.

7. The device of claim 1, wherein the liner further comprises a lip to seal at least a portion of the liner in the ostium of the LAA.

8. The device of claim 1 wherein the liner has at least one of a plurality of shapes such as, for example, spherical, tubular and conical.

9. The device of claim 1, wherein the liner comprises material promoting cellular in-growth, for example, at least one of synthetic polymers, Teflon-based materials (ePTFE), polyvinyl alcohol (PVA), knitted polyesters, woven polyesters, metallic materials, metallic meshes, polyurethanes, and silicone.

10. The device of claim 1, wherein the anchor component has one of a plurality of shapes, for example, a sleeve-like structure, a tubular stent-like structure, a helical coil, a polymeric tube, a conical structure and a metallic mesh.

11. The device of claim 1, wherein the anchor component is adapted to further comprise surface characteristics and attachment structures, for example, hooks and surface roughness to augment dislodgement resistance.

12. The device of claim 1, wherein the anchor component further comprises a lip at a proximal end to seat and seal at least a portion of the device against the ostium of the left atrial appendage.

13. The device of claim 1, wherein the anchor component comprises material selected from a group comprising metals, shape memory materials, synthetic polymers, and bioresorbable materials.

14. The device of claim 1, wherein the anchor component is adapted to exert radial pressure on at least one wall of the left atrial appendage.

15. The device of claim 1, wherein the anchor component is adapted to being affixed to at least a portion of an interior surface of the left atrial appendage.

16. The device of claim 1, wherein the liner has a material stiffness characteristic that adapts the liner to the surface of the interior wall of the LAA and smooth the plurality of the surfaces of the interior wall.

17. A method for enhancing vascular flow within the left atrial appendage of a heart, said method comprising the steps of:

positioning a device to prevent formation of thrombi through a catheter system in a proximal end of the left atrial appendage, the proximal end having an ostium, the device having a liner and an anchor component;

expanding the liner of the device in the left atrial appendage (LAA) by using the expandable anchor component wherein the liner extends from the proximal end of the LAA to a distal end of the LAA; and

remodeling a plurality of internal surfaces of the internal wall of the LAA using the liner thereby reducing the volume of the LAA and minimizing a plurality of crenellations in the LAA to enhance vascular flow within the LAA.

18. The method of claim 17, wherein the liner of the device comprises one of a natural and biological tissue.

19. The method of claim 17, wherein the liner comprises a collagenous material.

20. The method of claim 17, further comprising sealing at least a portion of the ostium of the left atrial appendage by a lip of the liner.

21. The method of claim 17, wherein the liner comprises material promoting cellular in-growth, for example, at least one of synthetic polymers, Teflon-based materials (ePTFE), polyvinyl alcohol (PVA), knitted polyesters, woven polyesters, metallic materials, metallic meshes, polyurethanes, and silicone.

22. The method of claim 17, wherein the anchor component has one of a plurality of shapes, for example, a sleeve-like structure, a tubular stent-like structure, a helical coil, a polymeric tube, a conical structure and a metallic mesh.

23. The method of claim 17, wherein the anchor component is adapted to further comprise surface characteristics and attachment structures, for example, hooks and surface roughness to augment dislodgement resistance.

24. The method of claim 17, wherein the anchor component is self-expanding in vivo.

25. The method of claim 17, wherein the anchor component is expanded with the assistance of a mechanical device.

26. A kit comprising:

a device to prevent formation of thrombi in the left atrial appendage; and

instructions for setting forth a method as in claim 17.

27. A method for manufacturing a device for preventing formation of thrombi in an anatomical appendage, said method comprising the steps of:

providing a liner having a proximal end and a distal end; and

affixing an anchor component to at least a portion of the proximal end of the liner.

28. The method of claim 27, wherein the liner comprises material selected from a group comprising a natural and a biologic tissue.

29. The method of claim 27, wherein the liner comprises material promoting cellular in-growth, for example, at least one of synthetic polymers, Teflon-based materials (ePTFE), polyvinyl alcohol (PVA), knitted polyesters, woven polyesters, metallic materials, metallic meshes, polyurethanes, and silicone.

30. The method of claim 27, wherein the anchor component has one of a plurality of shapes, for example, a sleeve-like structure, a tubular stent-like structure, a helical coil, a polymeric tube, a conical structure and a metallic mesh.

31. The method of claim 27, wherein the anchor component is adapted to further comprise surface characteristics and attachment structures, for example, hooks and surface roughness to augment dislodgement resistance.

32. The method of claim 27, wherein the liner has at least one of a plurality of shapes such as, for example, spherical, tubular and conical.

33. The method of claim 27, wherein the anchor component further comprises a lip at a proximal end to seat and seal at least a portion of the device against an ostium of the appendage.

34. The method of claim 27, wherein the liner further comprises a lip to seal at least a portion of the liner to an ostium of the appendage.

35. The method of claim 27, wherein the anchor component is affixed to at least a portion of the liner by, for example, one of sewing, gluing, laminating and thermally ligating.

36. The method of claim 27, wherein the anchor component comprises material selected from a group consisting of metals, shape memory materials, synthetic polymers, and bioresorbable materials.

37. The method of claim 27, wherein the anatomical appendage is a left atrial appendage in a heart.

38. The method of claim 27, wherein the anchor component is adapted for exerting radial pressure on at least one of a wall of the appendage.

39. A method for deploying in-vivo a device for minimizing the formation of thrombi in a left atrial appendage (LAA) of a heart, the method comprising the steps of:

inserting a catheter into the right atrium of the heart through a lumen of the body for delivering the device, the catheter including a delivery system;

puncturing the septal tissue and placing a guidewire through the septal puncture and into the left atrium;

positioning a dilator over the guidewire through the catheter, advancing the dilator and catheter through the septal puncture until they reach an ostium of the LAA;

removing the dilator and guidewire;

inserting the device having a liner and anchor component, the device inserted in a collapsed form into the catheter; and

deploying the device into the ostium of the LAA.

40. The method of claim 39, further comprising at least one of viewing and measuring the size and shape of the LAA using a scope positioned through the lumen.

41. The method of claim 39, wherein the step of deploying comprises the anchor component of the device expanding in-vivo into a distal end of the LAA and in turn expanding the liner attached at least to a portion of the anchor component wherein the liner is positioned proximate to a plurality of surfaces of interior walls.

42. The method of claim 41, wherein the anchor component is self-expanding.

43. The method of claim 41, wherein the anchor component is expanded with the assistance of a mechanical device.