Atrial filter implants

• US 20030057156A1
• Filed: 03/08/2002
• Published: 03/27/2003
• Est. Priority Date: 03/08/2001
• Status: Abandoned Application

• Current Assignee: Atritech Inc. (Boston Scientific Corporation)
• Original Assignee: Atritech Inc. (Boston Scientific Corporation)
• Inventors: Peterson, Dean, Sutton, Gregg S., Welch, Jeffrey
• Application Number:
  US10/094,730
• Publication Number:
  US 20030057156A1
• Time in Patent Office: Days
• US Class Current: 210/645
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12045 double occlusion, e.g. during anastomosis
• CPC Class Codes: A61B 17/12122 within the heart for closing a cardiac septal defect A61B17/0057
• 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 2017/00615 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
• CPC Class Codes: A61B 2017/12059 Joint of soluble material
• CPC Class Codes: A61B 2017/12072 the heat created by laser light
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/0076 ellipsoidal or ovoid
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2230/0093 Umbrella-shaped, e.g. mushroom-shaped

Abstract

Implant devices for filtering blood flowing through atrial appendage ostiums have elastic cover and anchoring substructures. The substructures may include reversibly folding tines or compressible wire braid structures. The devices are folded to fit in catheter tubes for delivery to the atrial appendages. The devices elastically expand to their natural sizes when they are expelled from the catheter tubes. Filter elements in the covers block emboli from escaping through the ostiums

The devices with tine substructures may have H-shaped cross sections. These devices seal the appendages by pinching an annular region of ostium tissue between the cover and the anchoring substructures. The shallow deployment depth of these H-shaped devices allows use of an universal device size for atrial appendages of varying lengths or depths. The devices may include remotely activated fixtures for refolding the tines for device recovery or position adjustment.

Claims

1. A device for filtering blood flow through a body aperture, comprising:

a cover comprising a filter, said cover disposed on a multiplicity of tines extending radially outward from a device axis;

an anchoring structure comprising a plurality of anchoring tines, said plurality of tines extending radially outward from said axis; and

a connecting structure along said axis joining said cover and said anchoring structure,

wherein said device has a substantially H-shaped cross-section, and wherein said cover and said anchoring structure are placed on opposite sides of said body aperture.

2. The device of claim 1 wherein said tines are biased so that said multiplicity of tines press said cover against body tissue surrounding said aperture, and said plurality of anchoring tines are biased to press against body tissue surrounding said aperture from the side opposite said cover.

3. The device of claim 1 wherein said filter comprises a blood-permeable filter.

4. The device of claim 3 wherein said blood-permeable filter comprises material selected from the group of fluoropolymers, silicone, urethane, metal fibers, polymer fibers, polyester fabric, and combinations thereof.

5. The device of claim 1 wherein said tines can be folded substantially parallel to said device axis.

6. The device of claim 1 wherein said tines comprise elastic material selected from the group of metals, plastics, polymers, metal alloys, shape-memory alloys, and combinations thereof.

7. The device of claim 6 wherein said tines comprise nitinol.

8. The device of claim 1 wherein said tines and said connecting structure are fabricated from a solid tubular preform.

9. The device of claim 8 wherein said solid tubular preform comprises a shape-memory alloy tube.

10. The device of claim 1 wherein said anchoring structure provides interference fit with a body cavity on one side of said aperture.

11. The device of claim 10 wherein said anchoring tines are shaped to present substantially flat surfaces for contact with said body cavity walls.

12. A method for filtering blood flowing through the ostium of an atrial appendage, comprising:

providing a device having a substantially H-shaped cross section, said device comprising a cover disposed on a multiplicity of tines extending radially from a device axis, said cover including a filter;

an anchoring structure joined to said cover by a connecting structure that is along said device axis, said anchoring structure comprising a plurality of anchoring tines extending radially from said axis;

inserting a portion of said device in said atrial appendage;

positioning said cover and said anchoring structure on opposite sides of said ostium.

13. The method of claim 12 wherein said positioning comprises pinching ostium tissue between said cover and said anchoring structure to direct blood flow through said filter.

14. The method of claim 13 wherein said inserting further comprises folding said tines substantially parallel to said device axis;

delivering said device with folded tines through a catheter tube; and

expelling said device from said catheter tube to allow said tines to unfold.

15. A device for filtering blood flowing through the ostium of an atrial appendage, comprising:

a cover comprising a filter, wherein said cover extends across said ostium; and

an anchoring structure comprising a plurality of anchoring tines extending radially from a connecting structure that joins said anchoring structure to said cover,

wherein said anchoring structure has a substantially V-shaped cross-section with a vertex pointing away from said cover, and said anchoring structure engages the interior walls of said atrial appendage to retain said device in position.

16. The device of claim 15 wherein said anchoring tines are biased so that said anchoring structure engages said interior walls with a hook-like action to resist outward movement of said device.

17. The device of claim 15 wherein said anchoring tines can be folded substantially along said connecting structure.

18. The device of claim 15 wherein said anchoring tines comprise elastic material selected from the group of metals, plastics, polymers, metal alloys, shape-memory alloys, and combinations thereof.

19. The device of claim 18 wherein said anchoring tines comprise the shape memory alloy nitinol.

20. The device of claim 15 wherein said tines and said connecting structure are fabricated from a solid tubular preform.

21. The device of claim 15 wherein said cover further comprises a multiplicity of tines extending radially away from said connecting structure.

22. The device of claim 21 wherein said multiplicity of tines are biased so that said tines press said cover against atrial wall tissue surrounding said ostium.

23. The device of claim 21 wherein said multiplicity of tines and said anchoring structure comprise a shape-memory alloy.

24. The device of claim 15 wherein said filter comprises material selected from the group of fluoropolymers, silicone, urethane, metal fibers, polymer fibers, polyester fabric, and combinations thereof.

25. A device for filtering blood flow through a body aperture, comprising:

a cover comprising a filter, an anchoring structure; and

a connecting structure joining said cover and said anchoring structure; and

a slideable recovery tube disposed on said connecting structure,

wherein said cover and said anchoring structure reversibly fold along said connecting structure, and wherein said recovery tube slides to a first position to fold said cover and said anchoring structure and said recovery tube slides to a second position to unfold said cover and said anchoring structure.

26. The device of claim 25 wherein said cover and said anchoring structure further comprise tines that radially extend from said connecting structure and that can be folded substantially along said connecting structure.

27. The device of claim 26 wherein said recovery tube comprises a slot through which a folded tine unfolds and extends radially away from said connecting structure when said recovery tube slides to said second position.

28. The device of claim 26 wherein said recovery tube comprises ends which press down and slide over said tines to fold them along said connecting structure when said recovery tube slides to said first position.

29. The device of claim 25 wherein said recovery tube and said connecting structure further comprises detents, wherein said detents can be engaged to lock movement of said recovery tube and said connecting structure.

30. A delivery system for reversible implantation of the device of claim 29, comprising:

a catheter tube in which said device fits when said recovery tube is at said first position;

a first shaft slideable through said catheter tube, said first shaft having a first collet that can engage said detents to lock the movement of said connecting structure to the movement of said first shaft;

a second shaft slideable through said catheter tube, said second shaft having a second collet that can engage said detents to couple the movement of said recovery tube to the movement of said second shaft; and

a third shaft for moving said device through said catheter tube.

31. A method for reversibly placing an implant device in a body cavity through a catheter tube, comprising:

providing an implant device comprising;

a tubular section;

structures that can be reversibly folded along said tubular section; and

a sliding tube disposed on said tubular section,

wherein said sliding tube slides to a first position to fold said structures and slides to a second position to unfold said structures, and wherein said tubular section and said sliding tube further comprise detents that can be engaged to lock their movements;

moving said device with said sliding tube at said first position through said catheter tube to said body cavity; and

sliding said sliding tube to said second position to unfold said structures.

32. The method of claim 31 further comprising:

providing a first shaft slideable through said catheter tube, said first shaft having a first collet that can engage said detents to lock the movement of tubular section to the movement of said first shaft;

providing a second shaft slideable through said catheter tube, said second shaft having a second collet that can engage said detents to couple the movement of said sliding tube to the movement of said second shaft; and

providing a third shaft for moving said device through said catheter tube;

using said third shaft to move said device with said tube in said first position through said catheter tube into said body cavity;

using said first shaft to lock the movement of said tubular section;

using said second shaft to couple the movement of said sliding tube to the movement of said second shaft; and

sliding said second shaft to move said sliding tube between said first and second positions.

33. A method of reversing the placement of an implant device placed in a body cavity by the method of claim 32 comprising;

using said first shaft to lock movement of said tubular section;

using said second shaft to couple the movement of said sliding tube to the movement of said second shaft;

sliding said second shaft to move said tube to said first position; and

using said third shaft to move said device with said tube in said first position into said catheter tube.

34. A device for filtering blood flowing through the ostium of an atrial appendage, comprising:

a proximal portion;

a distal portion joined with said proximal portion; and

a filter disposed on said proximal portion, wherein said distal portion comprises a cylindrical braided wire structure and said proximal portion comprises a closed end of said cylindrical braided wire structure, wherein said filter is disposed on said proximal portion, and wherein said braided wire structure is shaped for an interference fit in said atrial appendage and said proximal portion extends across said ostium.

35. The device of claim 34 wherein said wire braided structure is elastic and said structure can be reversibly compacted for delivery through a catheter tube.

36. The device of claim 34 wherein said closed end comprises a band closing a tubular end of said cylindrical braided wire structure.

37. The device of claim 35 wherein said band comprises a fixture for attaching a delivery shaft to said device.

38. The device of claim 34 wherein said cylindrical braided wire structure comprises wires selected from the group of metal wires, plastic wires, polymer wires, metal alloy wires, shape-memory alloy wires, and combinations thereof.

39. The device of claim 38 wherein said cylindrical braided wire structure comprises nitinol wires.

40. The device of claim 34 wherein said filter comprises material selected from the group of fluoropolymers, silicone, urethane, metal fibers, polymer fibers, polyester fabric, and combinations thereof.

41. The device of claim 34 wherein said filter comprises material interwoven with said cylindrical wire braid structure.

42. The device of claim 41 wherein said interwoven material comprises material selected from the group of metal wires, plastic wires, polymer wires and combinations thereof.

43. The device of claim 34 wherein said filter comprises material selected from the group of fluoropolymers, silicone, urethane, metal fibers, polymer fibers, polyester fabric, and combinations thereof.

44. The device of claim 34 wherein said cylindrical braided wire structure further comprises

a braid with interwire hole sizes substantially smaller than harmful-sized emboli.

45. The device of claim 34 wherein said filter comprises a cover attached to said proximal portion, wherein said cover engages atrial wall tissue surrounding said ostium, and wherein said cover includes a filter element.

46. A device for filtering blood flowing through the ostium of an atrial appendage, comprising:

a proximal portion;

a distal portion joined with said proximal portion; and

wherein said distal portion comprises a cylindrical braided wire structure and said proximal portion comprises a closed end of said cylindrical braided wire structure, wherein said braided wire structure is shaped for an interference fit in said atrial appendage and said proximal portion extends across said ostium, and wherein said braided wire structure comprises a braid with interwire hole sizes substantially smaller than harmful-sized emboli.

47. The device of claim 46 wherein said wire braided structure is elastic and said structure can be reversibly compacted for delivery through a catheter tube.

48. The device of claim 46 wherein said cylindrical braided wire structure comprises wires selected from the group of metal wires, plastic wires, polymer wires, metal alloy wires, shape-memory alloy wires, and combinations thereof.

49. The device of claim 48 wherein said cylindrical braided wire structure comprises nitinol wires.

50. A method of implanting the device of claim 47 in body cavity to filter blood flow comprising:

delivering said device with compacted structures through a catheter tube; and

expelling said device from said catheter tube to allow said compacted structures to expand.