Distal protection device for filtering and occlusion

• US 7,527,637 B2
• Filed: 01/07/2005
• Issued: 05/05/2009
• Est. Priority Date: 01/07/2005
• Status: Expired due to Fees

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Gasson, Jonathan G., Steingisser, Allan, Sater, Ghaleb
• Primary Examiner(s): Manahan; Todd E
• Assistant Examiner(s): Houston; Elizabeth
• Application Number:
  US11/031,327
• Publication Number:
  US 20060155322A1
• Time in Patent Office: 1,579 Days
• Field of Search: 606/200, 606191-194, 606/198, 604/96.01, 604/103.03, 600 1- 3, 600/9, 600/10, 600/12, 600/13
• US Class Current: 606/200
• 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 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61F 2/013 Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
• 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 2230/0067 conical
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61M 2025/0062 having features to improve the sliding of one part within another by using lubricants or surfaces with low friction

Abstract

An intravascular, distal protection device including a braided mesh that may be selectively transformed between a collapsed configuration, a filter configuration and an occlusive configuration by mechanical or thermal operation. Alternatively, the distal protection device may include a non-inflatable occlusion valve located within the mesh and actuated by the same mechanical operation that transforms the braided mesh.

Claims

1. A distal protection device comprising:

an elongate core wire;

an elongate tubular shaft slidably disposed about the core wire; and

a protection element including a braided tubular mesh having a plurality of pores having transverse dimensions, wherein each pore of the mesh is selectively transformable between a filter configuration and an occlusive configuration, the mesh having at least one inlet opening adjacent a mesh proximal end, the mesh being mounted coaxially about the core wire such that a mesh distal end is coupled about a core wire distal end and the mesh proximal end is coupled about a shaft distal end;

wherein, relative longitudinal movement between the proximal and distal ends of the mesh end causes transformation of the protection element between a collapsed configuration, the filter configuration wherein each pore of the mesh is substantially open and the occlusive configuration wherein the mesh is longitudinally contracted to reduce the transverse dimensions of the plurality of pores such that each pore of the mesh is substantially closed.

2. The distal protection device according to claim 1, wherein relative longitudinal movement between the proximal and distal ends of the mesh operatively corresponds to relative longitudinal movement between the shaft and the core wire.

3. The distal protection device according to claim 1, wherein the mesh is made of a thermal shape-memory alloy.

4. The distal protection device according to claim 3, wherein the shape-memory alloy comprises nitinol.

5. The distal protection device according to claim 3, further comprising:

an electric power source disposed, during use, outside a patient;

a first electric lead electrically coupled between the power source and a first location on the mesh; and

a second electric lead electrically coupled between the power source and a second location on the mesh.

6. The distal protection device according to claim 5, wherein the core wire forms the first electric lead.

7. The distal protection device according to claim 6, further comprising insulative material disposed about the core wire.

8. The distal protection device according to claim 5, wherein the shaft forms the second electric lead.

9. The distal protection device according to claim 8, wherein the shaft is metal.

10. The distal protection device according to claim 8, wherein the shaft comprises a conductive material embedded in a polymer.

11. The distal protection device according to claim 5, further comprising an insulative coating on the mesh.

12. The distal protection device according to claim 3, further comprising a heat source interposed in the mesh and thermally coupled thereto.

13. The distal protection device according to claim 12, wherein the heat source includes at least one resistive heating element and an external electric power supply is electrically coupled thereto.

14. The distal protection device according to claim 1, wherein the core wire includes a flexible distal tip.

15. The distal protection device according to claim 1, wherein the mesh distal end is rotatably coupled about the core wire distal end.

16. A distal protection device comprising:

an elongate core wire;

an elongate tubular shaft slidably disposed about the core wire; and

a protection element including a braided tubular mesh having at least one inlet for admitting blood flow into an interior of the mesh, the inlet being located adjacent a mesh proximal end, the mesh being mounted coaxially about the core wire such that a mesh distal end is coupled about a core wire distal end and the mesh proximal end is coupled about a shaft distal end;

wherein relative longitudinal movement between the proximal and distal ends of the mesh end causes transformation of the protection element between a collapsed configuration, a filter configuration, and an occlusive configuration, and

wherein the protection element includes a non-inflatable occlusion valve comprising a plurality of blades disposed within the mesh for blocking blood flow into the interior of the mesh via the at least one inlet when the protection element is in the occlusive configuration.

17. The distal protection device according to claim 16, wherein the occlusion valve further comprises:

the plurality of blades having flexible proximal ends coupled adjacent the mesh proximal end, the plurality of blades being radially arranged and overlapping each other to seal against the at least one inlet when the protection element is in the occlusive configuration, the plurality of blades being disposed closely about the core wire when the protection element is in the collapsed configuration; and

an expander fixed to the core wire within the mesh such that, when the core wire is drawn proximally into the shaft, the expander deforms the plurality of blades into the occlusive configuration.

18. A method of using a distal protection device comprising the steps of:

providing a distal protection device including an elongate core wire;

a tubular shaft slidably disposed about the core wire; and

an expandable, braided tubular mesh having a distal end attached about the core wire, a proximal end attached about the shaft, at least one inlet adjacent the mesh proximal end, and a plurality of pores having transverse dimensions, wherein each pore of the mesh is selectively transformable between a filtering configuration and an occlusive configuration;

locating the distal protection device within a vessel;

sliding the shaft distally relative to the core wire such that the mesh radially expands from a collapsed configuration to the filtering configuration wherein a portion of an outer surface of the mesh is placed in apposition to a vessel wall and wherein each pore of the mesh is substantially open; and

sliding the shaft farther distally relative to the core wire such that the mesh contracts axially into the occlusive configuration wherein the sliding causes transverse dimensions of each pore of the mesh to be reduced such that each pore of the mesh is substantially closed.

19. The method of using a distal protection device according to claim 18, further comprising the step of:

aspirating the mesh, when in the filtering configuration, to remove trapped embolic particles.

20. The method of using a distal protection device according to claim 18, further comprising the steps of:

sliding the shaft proximally relative to the core wire such that the mesh is axially extended from the occlusive configuration into the filtering configuration;

sliding the shaft farther proximally relative to the core wire such that the mesh contracts radially from the filtering configuration into the collapsed configuration; and

removing the distal protection device from the vessel.