Embolic protection device

• US 8,221,446 B2
• Filed: 03/14/2006
• Issued: 07/17/2012
• Est. Priority Date: 03/15/2005
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: Pal, Dharmendra, Kuppurathanam, Shyam
• Primary Examiner(s): McDermott, Corrine M
• Assistant Examiner(s): MASHACK, MARK F
• Application Number:
  US11/375,434
• Publication Number:
  US 20060229660A1
• Time in Patent Office: 2,317 Days
• Field of Search: 606/198, 606/200, 606191-192, 606194-195, 623/23.72, 623/23.76, 623/1.13, 623/1.36
• US Class Current: 606/200
• 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 2230/008 paraboloidal
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

An embolic protection device for deployment in a body vessel is provided, including a filtering body having a lip and extending therefrom to a tail and a frame connected to the lip for supporting the filtering body. The filtering body includes first and second openings formed therethrough, the first opening having a first area for maintaining fluid flowpaths through the device, the second opening having a second area for filtering emboli in the body vessel. The first area is greater than the second area.

Claims

1. An embolic protection device for filtering emboli in a body vessel in which blood flows in a first direction along a blood flow path, the body vessel defining a central longitudinal axis, the device comprising:

a filtering body having a lip including a perimeter, the filtering body extending therefrom to a tail having an end face, the filtering body being configured to be folded into a closed state for delivery or retrieval and expanded into an open state for filtering emboli, the filtering body having a first plurality of openings formed therethrough and positioned generally spaced apart from each other and a second plurality of openings formed therethrough and positioned generally spaced apart from each other, the first plurality of openings being located adjacent to the lip, the second plurality of openings being located along the end face of the tail of the filtering body, the end face having a substantially perpendicular orientation that is substantially perpendicular to the first direction of the blood flow, the filtering body providing a flow resistance when the tail is folded, the substantially perpendicular orientation of the end face causing the filtering body to fully open into the open state when placed in the body vessel in the blood flow path, the first plurality of openings each having a first area for maintaining fluid flowpaths through the device and the second plurality of openings each having a second area for filtering emboli in the body vessel, wherein the first area is greater than the second area in both the closed state and the open state, and wherein the first plurality of openings is generally more spaced apart from each other than the second plurality of openings; and

a frame connected to the lip for supporting the filtering body, wherein the frame includes a wire formed into a loop that extends around the perimeter of the lip, wherein the frame perpendicularly opens in a radial direction along a plane perpendicular to the central longitudinal axis defining an opened state of the frame;

wherein the device further comprises a material promoting biofixation between the filtering body and the body vessel; and

wherein the material promoting biofixation includes extracellular matrix material that functions as a remodeling bioscaffold between an outer surface of the filtering body and an inner surface of the body vessel.

2. An embolic protection device as in claim 1, the filtering body further including a third plurality of intermediate openings located between the lip and the tail, the intermediate openings generally decreasing in size along a line extending from the lip to the tail.

3. An embolic protection device as in claim 2, wherein the first plurality of openings is configured such that a fluid flowrate through the filtering body is substantially unhindered when the second plurality of openings becomes obstructed.

4. An embolic protection device as in claim 1, wherein the second plurality of openings is radially closer than the first plurality of openings to the central longitudinal axis of the body vessel.

5. An embolic protection device as in claim 1, the filtering body having a generally tapered shape.

6. An embolic protection device as in claim 1, wherein the first area is at least two times larger than the second area.

7. An embolic protection device as in claim 1, the frame further including a retrieval member extending proximally therefrom to retrieve the embolic protection device from the body vessel.

8. An embolic protection device as in claim 1,

further comprising a tether connected to the tail of the filtering body and being movable along the longitudinal axis to create a collection area within the filtering body for collecting emboli.

9. An embolic protection device as in claim 8, wherein the collection area is radially offset from the longitudinal axis.

10. An embolic protection device as in claim 1, wherein the material encircles the filtering body outer surface adjacent to the lip of the filter.

11. An embolic protection device as in claim 10, wherein the material is substantially located only along a portion of the filtering body adjacent to the lip of the filter.

12. An embolic protection device as in claim 1, wherein the extracellular matrix material includes small intestinal submucosa.

13. An embolic protection device as in claim 1, wherein each of the first and second plurality of openings is generally circular in shape.

14. An assembly for removing emboli from a body vessel in which blood flows in a first direction along a blood flow path, the body vessel defining a central longitudinal axis, the assembly comprising:

an emboli dislodging catheter configured for dislodging the emboli from an inner wall of the body vessel;

an outer catheter for delivering the emboli dislodging catheter into the body vessel;

an embolic protection device positioned distally of the emboli dislodging catheter for collecting the dislodged emboli in the body vessel, the embolic protection device including a filtering body having a lip including a perimeter, the filtering body extending therefrom to a tail having an end face, the filtering body being configured to be folded into a closed state for delivery or retrieval and expanded into an open state for filtering emboli, the filtering body having a first plurality of openings formed therethrough and positioned generally spaced apart from each other and a second plurality of openings formed therethrough and positioned generally spaced apart from each other, the first plurality of openings being located adjacent to the lip, the second plurality of openings being located along the end face of the tail of the filtering body, the end face having a substantially perpendicular orientation that is substantially perpendicular to the first direction of the blood flow, the filtering body providing a flow resistance when the tail is folded, the substantially perpendicular orientation of the end face causing the filtering body to fully open into the open state when placed in the body vessel in the blood flow path, the first plurality of openings each having a first area for maintaining fluid flowpaths through the device and the second plurality of openings each having a second area for filtering emboli in the body vessel, wherein the first area is greater than the second area in both the closed state and the open state, and wherein the first plurality of openings is generally more spaced apart from each other than the second plurality of openings; and

a frame connected to the lip for supporting the filtering body, wherein the frame includes a wire formed into a loop that extends around the perimeter of the lip, wherein the frame perpendicularly opens in a radial direction along a plane perpendicular to the central longitudinal axis defining an opened state of the frame;

wherein the device further comprises a material promoting biofixation between the filtering body and the body vessel; and

wherein the material promoting biofixation includes extracellular matrix material that functions as a remodeling bioscaffold between an outer surface of the filtering body and an inner surface of the body vessel; and

a guide wire slidably coupled with the embolic protection device to guide the embolic protection device within the body vessel.

15. An assembly as in claim 14, further comprising a connecting wire unitarily formed with the frame, the connecting wire being slidably coupled to the guidewire for effective delivery of the embolic protection device into the blood vessel.