Helical embolic protection device

• US 8,252,018 B2
• Filed: 09/14/2007
• Issued: 08/28/2012
• Est. Priority Date: 09/14/2007
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: Valaie, Arman H.
• Primary Examiner(s): Jackson, Gary
• Assistant Examiner(s): SCHUBERT, CHRISTOPHER
• Application Number:
  US11/855,593
• Publication Number:
  US 20090076538A1
• Time in Patent Office: 1,810 Days
• Field of Search: 623/1.11, 606/200
• US Class Current: 606/200
• CPC Class Codes: A61B 2017/320716 comprising means for preventing embolism by dislodged material
• 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 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section

Abstract

An embolic protection device for capturing emboli during treatment of a stenotic lesion in a body vessel is disclosed. The device comprises an elongated shaft having a proximal portion and a distal portion extending from the proximal portion. The device further comprises an expandable filter formed helically about the distal portion of the elongated shaft. The expandable filter is configured to helically close defining a collapsed state for delivery and retrievable of the device. The expandable filter is configured to helically open defining an expanded state for capturing emboli during treatment of the stenotic lesion in the body vessel. The expandable filter has at least one filter portion helically extending from the elongated shaft at a predetermined angle defining an opening when the filter is in the expanded state.

Claims

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

an elongated shaft having a proximal portion and a distal portion extending from the proximal portion; and

an expandable filter formed helically about the distal portion of the elongated shaft, the expandable filter formed integrally with the elongated shaft such that the elongated shaft and the expandable filter have a one-piece construction, the expandable filter being configured to helically close defining a collapsed state for delivery and retrieval of the device, the expandable filter being configured to helically open defining an expanded state for capturing emboli during treatment of the stenotic lesion in the body vessel, the expandable filter having a plurality of filter portions each helically and separately extending from the elongated shaft, the filter portions being directly adjacent to each other, each of the plurality of filter portions defining a proximally faced opening when the expandable filter is in the expanded state, the plurality of filter portions being of a one-piece construction with the elongated shaft and having filter holes formed therethrough, wherein each of the plurality of filter portions defines a conical shape and overlaps with an adjacent filter portion.

2. The device of claim 1 wherein the opening of each filter portion has an outer diameter, the outer diameter increasing distally longitudinally relative to the elongated shaft to define the expandable filter having a distally flared profile.

3. The device of claim 1 wherein the expandable filter extends along a longitudinal axis, the expandable filter being helically closed in the collapsed state when the elongated shaft is rotated about the longitudinal axis in a first direction, the expandable filter being helically opened in the expanded state when the elongated shaft is rotated about a second direction.

4. The device of claim 1 wherein the expandable filter comprises at least one of the following materials:

nitinol, elastomeric materials, polymeric materials.

5. The embolic protection device of claim 1 wherein the filter portions are not in direct contact with each other.

6. The embolic protection device of claim 5 wherein the plurality of filter portions comprises at least three filter portions.

7. The embolic protection device of claim 5 wherein the plurality of filter portions comprises at least four filter portions.

8. The embolic protection device of claim 1 wherein the plurality of filter portions comprises at least three filter portions.

9. The embolic protection device of claim 1 wherein the plurality of filter portions comprises at least four filter portions.

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

a balloon catheter having a tubular body portion and an expandable balloon attached to and in fluid communication with the tubular body portion for angioplasty at the stenotic lesion, the expandable balloon having distal and proximal portions;

and

an embolic protection device coaxially disposed within the balloon catheter during treatment of the stenotic lesion in the body vessel, the device comprising;

an elongated shaft having a proximal portion and a distal portion extending from the proximal portion; and

an expandable filter formed helically about the distal portion of the elongated shaft, the expandable filter formed integrally with the elongated shaft such that the elongated shaft and the expandable filter have a one-piece construction, the expandable filter being configured to helically close defining a collapsed state for delivery and retrieval of the device, the expandable filter being configured to helically open defining an expanded state for capturing emboli during treatment of the stenotic lesion in the body vessel, the expandable filter having a plurality of filter portions each helically and separately extending from the elongated shaft at a predetermined angle relative to the elongated shaft, the filter portions being directly adjacent to each other, each of the plurality of filter portions defining a proximally faced opening when the expandable filter is in the expanded state, each of the plurality of filter portions having filter holes formed therethrough, each of the plurality of filter portions having a proximal end and a distal end, wherein the proximal end defines the opening in the expanded state, the proximal end being an open end free from contact of any other structure, wherein each of the plurality of filter portions defines a conical shape and overlaps with an adjacent filter portion.

11. The assembly of claim 10 wherein the balloon catheter includes an outer lumen and an inner lumen, the outer lumen being in fluid communication with the balloon for inflating and deflating the balloon, the inner lumen formed therethrough for percutaneous guidance through the body vessel.

12. The assembly of claim 10 further comprising:

an inner catheter having a distal end throughwhich the balloon catheter is disposed for deployment in the body vessel;

a wire guide configured to be disposed through the inner lumen of the balloon catheter for percutaneous guidance through the body vessel; and

an introducer sheath throughwhich the inner catheter is inserted for percutaneous insertion to the body vessel.

13. The assembly of claim 10 wherein the inner catheter further includes a proximal end, the proximal end having a hub in fluid communication with the balloon for fluid to be passed therethrough for inflation and deflation of the balloon during treatment of the stenotic lesion.

14. The device of claim 10 wherein the opening of each filter portion has an outer diameter, the outer diameter increasing distally longitudinally relative to the elongated shaft to define the expandable filter having a distally flared profile.

15. The device of claim 10 wherein the expandable filter extends along a longitudinal axis, the expandable filter being helically closed in the collapsed state when the elongated shaft is rotated about the longitudinal axis in a first direction, the expandable filter being helically opened in the expanded state when the elongated shaft is rotated about a second direction.

16. The device of claim 10 wherein the expandable filter comprises at least one of the following materials:

nitinol, elastomeric materials, polymeric materials.

17. The embolic protection assembly of claim 10 wherein the filter portions are not in direct contact with each other.

18. The embolic protection assembly of claim 10 wherein the plurality of filter portions comprises at least three filter portions.

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

percutaneously introducing a balloon catheter in the body vessel, the balloon catheter having a tubular body portion and an expandable balloon attached to and in fluid communication with the tubular body portion for angioplasty at the stenotic lesion;

disposing an embolic protection device in a collapsed state coaxially within the balloon catheter, the device comprising;

an elongated shaft having a proximal portion and a distal portion extending from the proximal portion; and

an expandable filter formed helically about the distal portion of the elongated shaft, the expandable filter formed integrally with the elongated shaft such that the elongated shaft and the expandable filter have a one-piece construction, the expandable filter being configured to helically close defining the collapsed state for delivery and retrieval of the device, the expandable filter being configured to helically open defining an expanded state for capturing emboli during treatment of the stenotic lesion in the body vessel, the expandable filter having a plurality of filter portions each helically and separately extending from the elongated shaft at a predetermined angle relative to the elongated shaft, the filter portions being directly adjacent to each other, each of the plurality of filter portions defining a proximally faced opening when the expandable filter is in the expanded state, the plurality of filter portions being of a one-piece construction with the elongated shaft and having filter holes formed therethrough, wherein each of the plurality of filter portions defines a conical shape and overlaps with an adjacent filter portion; and

deploying the device in the expanded state by turning the elongated shaft about a first direction relative to the elongated shaft downstream from the stenotic lesion to helically open the expandable filter and capture emboli during treatment of the stenotic lesion.

20. The method of claim 19 wherein the opening of each filter portion has an outer diameter, the outer diameter increasing distally longitudinally relative to the elongated shaft to define the expandable filter having a distally flared profile.

21. The method of claim 19 wherein the filter portions are not in direct contact with each other.