Embolic protection device with an integral basket and bag

• US 20070016246A1
• Filed: 07/11/2006
• Published: 01/18/2007
• Est. Priority Date: 07/12/2005
• Status: Active Grant

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated)
• Inventors: Lentz, David, Pal, Darmendra
• Granted Patent: US 7,766,934 B2
• Time in Patent Office: Days
• US Class Current: 606/200
• CPC Class Codes: A61F 2/0108 Both ends closed, i.e. legs gathered at both ends
• CPC Class Codes: A61F 2002/016 made from wire-like elements
• 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

Abstract

An embolic protection device includes a basket defined by a section of a set of wires arranged as a plurality of struts. These struts are coupled together at their distal ends as well as to the distal end of a core wire or mandrel. Another section of the wires spirals around the core wire to define a hollow channel in which the core wire can reciprocate. Thus, pulling or pushing a proximal end of the core wire relative to the struts expands or contracts the basket. A filter bag is attached to the basket for capturing clots when the basket is in an expanded configuration.

Claims

1. An embolic protection device for capturing emboli during treatment of a stenotic lesion in a body vessel, the device comprising:

a set of wires, a section of which is arranged as struts defining a basket with a distal end and a proximal end, the basket having an expanded state and a collapsed state, the set of wires including a spiraled section that defines a hollow channel extending from the proximal end of the basket to a proximal end of the spiraled section;

a core wire with a distal end coupled to the distal end of the basket, the core wire extending from the distal end of the basket through the hollow channel to a proximal end of the core wire that extends beyond the proximal end of the spiraled section; and

a filter bag with a lip attached to the struts only at attachments located on the struts generally where the basket achieves its maximum diameter when the basket is in the expanded state for capturing emboli,

movement of the core wire in the proximal direction relative to the spiraled section causing the basket, and hence the filter bag, to open to the expanded state, and movement of the core wire in the distal direction relative to the spiraled section causing the basket, and hence to the filter bag, to close to the collapsed state.

2. The device of claim 1 wherein the number of struts is four.

3. The device of claim 1 wherein the opening of the filter bag faces toward the stenotic lesion.

4. The device of claim 1 wherein the filter bag is made of a mesh material.

5. The device of claim 1 wherein the filter bag is made of connective tissue including extracellular matrix.

6. The device of claim 5 wherein the extracellular matrix is made of small intestinal submucosa.

7. The device of claim 1 wherein the set of wires is made of shape memory material with a transition temperature.

8. The device of claim 1 wherein the set of wires is made of superelastic material.

9. The device of claim 8 wherein the superelastic material is Nitinol.

10. An embolic protection device for capturing emboli during treatment of a stenotic lesion in a body vessel, the device comprising:

a basket with a set of struts extending from a distal end to a proximal end of the basket, the basket having an expanded state and a collapsed state;

spiraled wires that define a hollow channel extending from the proximal end of the basket to a proximal end of the spiraled wires;

a core wire with a proximal end and a distal end coupled to the distal end of the basket, the core wire extending from the distal end of the basket through the hollow channel to the proximal end of the core wire, the proximal end of the core wire extending beyond the proximal end of the spiraled wires; and

a filter bag with a lip attached to the struts only at attachments located on the struts generally where the basket achieves its maximum diameter when the basket is in the expanded state for capturing emboli,

movement of the core wire in the proximal direction relative to the spiraled wires causing the basket, and hence the filter bag, to open to the expanded state, and movement of the core wire in the distal direction relative to the spiraled wires causing the basket, and hence to the filter bag, to close to the collapsed state.

11. The device of claim 10 wherein the number of struts is four.

12. The device of claim 10 wherein the opening of the filter bag faces toward the stenotic lesion.

13. The device of claim 10 wherein the filter bag is made of a mesh material.

14. The device of claim 10 wherein the filter bag is made of connective tissue including extracellular matrix.

15. The device of claim 14 wherein the extracellular matrix is made of small intestinal submucosa.

16. The device of claim 10 wherein the struts are made of shape memory material with a transition temperature.

17. The device of claim 10 wherein the struts are made of superelastic material.

18. The device of claim 17 wherein the superelastic material is Nitinol.

19. A method for embolic protection during treatment of a stenotic lesion in a body vessel, the method comprising:

disposing an embolic protection device in an undeployed state in the body vessel, the device comprising;

a basket with a set of struts extending from a distal end to a proximal end of the basket;

spiraled wires that define a hollow channel extending from the proximal end of the basket to a proximal end of the spiraled wires;

a core wire with a distal end coupled together with the distal end of the basket, the core wire extending from the distal end of the basket through the hollow channel to a proximal end of the core wire that extends beyond the proximal end of the spiraled wires; and

a filter bag with a lip attached to the struts only at attachments located on the struts approximately where the basket achieves its maximum diameter when the basket is in an expanded state for capturing emboli; and

moving the core wire relative to the spiraled wires to deploy the device in a deployed state downstream from the stenotic lesion to capture emboli during treatment of the stenotic lesion.

20. The method of claim 19 further comprising moving the core wire relative to the spiraled wires to close the basket to a collapsed state for retrieving the embolic protection device from the body vessel.