Embolic protection device having inflatable frame

• US 20070038241A1
• Filed: 07/31/2006
• Published: 02/15/2007
• Est. Priority Date: 08/04/2005
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated)
• Inventors: Pal, Dharmenda
• Granted Patent: US 8,187,298 B2
• Time in Patent Office: Days
• US Class Current: 606/200
• CPC Class Codes: A61F 2/0105 Open ended, i.e. legs gathered only at one side
• 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 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence

Abstract

An embolic protection device for capturing emboli during treatment of a stenotic lesion in a body vessel is provided. The device includes an inflatable frame having a deployed state and an undeployed state and a filter attached to the inflatable frame for capturing emboli. The inflatable frame includes a distal portion having a predetermined shape and extending freely to a closed distal end when the inflatable frame is in the deployed state. The filter includes a lip attached to the inflatable frame to define an open end of the filter when the inflatable frame is in the deployed state, a body extending from the lip and disposed about the inflatable frame, and a closed tail configured to capture the emboli during treatment of the stenotic lesion.

Claims

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

an inflatable frame having a deployed state and an undeployed state, the inflatable frame including a distal portion having a predetermined shape and extending freely to a closed distal end when the inflatable frame is in the deployed state; and

a filter attached to the inflatable frame for capturing emboli.

2. The device of claim 1 wherein the inflatable frame is inflated in the deployed state and deflated in the undeployed state.

3. The device of claim 1 wherein the distal portion is made of shape memory material defining the predetermined shape when~the inflatable frame is in the deployed state.

4. The device of claim 1 wherein the distal portion defines at least one helical portion when the inflatable frame is in the deployed state, the at least one helical portion having a helical configuration extending freely to the distal end.

5. The device of claim 1 wherein the distal portion defines a plurality of helical portions when the inflatable frame is in the deployed state, each having a helical configuration.

6. The device of claim 1 wherein the inflatable frame further includes a proximal portion defining a proximal opening in fluid communication with the distal portion of the inflatable frame for supplying fluid thereto.

7. The device of claim 1 wherein the filter includes a lip attached to the inflatable frame to define an open end of the filter when the inflatable frame is in the deployed state, a body extending from the lip and disposed about the inflatable frame, and a closed tail positioned distally of the inflatable frame and configured to capture the emboli during treatment of the stenotic lesion.

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

9. 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 fluidly connected to the tubular body; and

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

an inflatable frame having a deployed state and an undeployed state, including a distal portion having a predetermined shape and extending freely to a closed distal end when the inflatable frame is in the deployed state; and

a filter including a lip attached to the inflatable frame to define an open end of the filter when the inflatable frame is in the deployed state, a body extending from the lip and disposed about the inflatable frame, and a closed tail configured to capture the emboli during treatment of the stenotic lesion.

10. The assembly of claim 9 wherein the inflatable frame is inflated in the deployed state and deflated in the undeployed state.

11. The assembly of claim 9 wherein the distal portion is made of shape memory material defining the predetermined shape when the inflatable frame is in the deployed state.

12. The assembly of claim 9 wherein the distal portion defines at least one helical portion when the inflatable frame is in the deployed state, the at least one helical portion having a helical configuration extending freely to the distal end.

13. The assembly of claim 9 wherein the distal portion defines a plurality of helical portions when the inflatable frame is in the deployed state, each having a helical configuration.

14. The assembly of claim 9 wherein the inflatable frame further includes a proximal portion defining a proximal opening in fluid communication with the distal portion of the inflatable frame for supplying fluid thereto.

15. The assembly of claim 9 wherein the filter includes a lip attached to the inflatable frame to define an open end of the filter when the inflatable frame is in the deployed state, a body extending from the lip and disposed about the inflatable frame, and a closed tail positioned distally of the inflatable frame and configured to capture the emboli during treatment of the stenotic lesion.

16. The assembly of claim 9 wherein the filter comprises a net material for capturing emboli from the stenotic lesion.

17. The assembly of claim 9 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 a 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.

18. The assembly of claim 17 wherein the inner catheter further includes a proximal end, the proximal end having a hub in fluid communication with the expandable balloon for inflation and deflation of the balloon.

19. A method for capturing emboli during treatment of a stenotic lesion in a body vessel, comprising:

percutaneously introducing a balloon catheter in the body vessel, the balloon catheter having a tubular body portion and an expandable balloon in fluid communication with the tubular body;

disposing an embolic protection device coaxially within the balloon catheter such that an inflatable frame and a filter of the embolic protection device are in an undeployed state, the inflatable frame including a proximal portion defining a proximal opening and a distal portion extending freely to a closed distal end, the filter including a lip attached to the inflatable frame, a body extending from the lip, and a closed end; and

delivering fluid to the proximal opening of the inflatable frame, thereby inflating the inflatable frame and the filter to the deployed state such that the lip of the filter defines an open end and the distal portion of the inflatable frame defines a predetermined shape.