Embolic protection device having a reticulated body with staggered struts

• US 20060287670A1
• Filed: 06/19/2006
• Published: 12/21/2006
• Est. Priority Date: 06/20/2005
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated)
• Inventors: Pal, Dharmendra
• Granted Patent: US 7,850,708 B2
• Time in Patent Office: Days
• US Class Current: 606/200
• CPC Class Codes: A61F 2/01 Filters implantable into blood vessels
• 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 2230/008 paraboloidal
• CPC Class Codes: A61M 25/0662 Guide tubes

Abstract

An embolic protection device for capturing emboli during treatment of a stenotic lesion in a body vessel is disclosed. The device comprises a basket and a filter attached to the basket. The basket has a deployed state and an undeployed state. The basket includes a reticulated body having an outer diameter. The reticulated body includes a plurality of struts connected together in a singly staggered configuration distally along a longitudinal axis to a distal end. The plurality of struts of the reticulated body is configured to fold along the longitudinal axis. The basket has a proximal stem proximally extending from the body. The filter portion has a lip attached to the distal end defining an opening of the filter portion when the basket is in the deployed state for capturing emboli. The filter portion extends from the lip to a filter end.

Claims

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

a basket having a deployed state and an undeployed state, the basket including a reticulated body having an outer diameter, the reticulated body including a plurality of struts connected together in a singly staggered configuration distally along a longitudinal axis to a distal end, the plurality of struts of the reticulated body being configured to fold along the longitudinal axis, the basket having a proximal stem proximally extending from the body; and

a filter portion having a lip attached to the distal end defining an opening of the filter portion when the basket is in the deployed state for capturing emboli, the filter portion extending from the lip to a filter end.

2. The device of claim 1 wherein the distal end distally extends from the reticulated body along the outer diameter.

3. The device of claim 1 wherein the number of struts on the reticulated body increases in a singly staggered configuration along the longitudinal axis of the reticulated body.

4. The device of claim 3 wherein the number of struts at the proximal stem of the body is one strut and the number of struts at the distal end is up to 10 struts.

5. The device of claim 1 wherein the outer diameter of the body is substantially constant and extends between the proximal stem and distal end of the reticulated body.

6. The device of claim 1 wherein the reticulated body distally increases in width in a singly staggered configuration in the undeployed state.

7. The device of claim 1 wherein each of the plurality of struts is connect to another strut at a pivotal joint, the pivotal joints being configured to allow each of the struts to singly fold distally along the longitudinal axis from the deployed state to the undeployed state.

8. The device of claim 1 wherein the opening of the filter portion faces toward the stenotic lesion proximal to the closed end thereof.

9. The device of claim 1 wherein the filter portion comprises a net material for capturing emboli from the stenotic lesion.

10. The device of claim 1 wherein the reticulated body is made of shape memory material configured to expand the reticulated body in the deployed state at a first temperature and collapse the reticulated body in the undeployed state at a second temperature.

11. 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;

a basket having a deployed state and an undeployed state, the basket including a reticulated body having an outer diameter, the reticulated body including a plurality of struts connected together in a singly staggered configuration distally along a longitudinal axis to a distal end, the basket having a proximal stem proximally extending from the body; and

a filter portion having a lip attached to the distal end defining an opening of the filter portion when the basket is in the deployed state for capturing emboli, the filter portion extending from the lip to a filter end.

12. The assembly of claim 11 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.

13. The assembly of claim 11 further comprising:

an inner catheter having a distal end through which 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 through which the inner catheter is inserted for percutaneous insertion to the body vessel.

14. The assembly of claim 11 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.

15. The assembly of claim 11 wherein the distal end distally extends from the reticulated body along the outer diameter.

16. The assembly of claim 11 wherein the number of struts on the reticulated body increases in a singly staggered configuration along the longitudinal axis of the reticulated body.

17. The assembly of claim 16 wherein the number of struts at the proximal stem of the body is one strut and the number of struts at the distal end is up to 10 struts.

18. The assembly of claim 11 wherein the outer diameter of the body is substantially constant and extends between the proximal stem and distal end of the reticulated body.

19. The assembly of claim 11 wherein the reticulated body distally increases in width in a singly staggered configuration in the undeployed state.

20. The assembly of claim 11 wherein each of the plurality of struts is connect to another strut at a pivotal joint, each pivotal joint being configured to provide the respective struts pivotal movement between the undeployed state and the deployed state.

21. The assembly of claim 11 wherein the opening of the filter portion faces toward the stenotic lesion proximal to the closed end thereof.

22. The assembly of claim 11 wherein the filter portion comprises a net material for capturing emboli from the stenotic lesion.

23. The assembly of claim 11 wherein the reticulated body is made of shape memory material configured to expand the reticulated body in the deployed state at a first temperature and collapse the reticulated body in the undeployed state at a second temperature.

24. 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 an undeployed state coaxially within the balloon catheter, the device comprising;

a basket including a reticulated body having an outer diameter, the reticulated body including a plurality of struts connected together in a singly staggered configuration distally along a longitudinal axis to a distal end, the basket having a proximal stem proximally extending from the body; and

a filter portion having a lip attached to the distal end defining an opening of the filter portion when the basket is in the deployed state for capturing emboli, the filter portion extending from the lip to a filter end; and

deploying the device in a deployed state downstream from the stenotic lesion to capture emboli during treatment of the stenotic lesion.