Embolic protection system and method including filtering elements

• US 6,383,206 B1
• Filed: 12/30/1999
• Issued: 05/07/2002
• Est. Priority Date: 12/30/1999
• Status: Expired due to Term

• Current Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Inventors: Huter, Scott J., Huter, Benjamin C., Gillick, Matthew J., Stalker, Kent C. B., Patel, Anuja
• Primary Examiner(s): Robert, Eduardo C.
• Application Number:
  US09/475,599
• Time in Patent Office: 859 Days
• Field of Search: 606/200, 606/114, 606/127, 606/191, 606/1
• 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 2002/018 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: A61F 2230/0093 Umbrella-shaped, e.g. mushroom-shaped

Abstract

A system used in a blood vessel when an interventional procedure is being performed in a stenosed or occluded region to capture any embolic material which may be created and released into the bloodstream during the procedure. The system includes filtering elements which are capable of occluding a blood vessel distal to an interventional procedure site, while enabling the blood to flow past the occlusion and filtering the blood to capture embolic material which may be released into the blood during a therapeutic interventional procedure. The filtering elements include an expandable member which is capable of being expanded distal to the area of treatment at the interventional procedure site for occluding the blood vessel and for enabling the blood to pass therethrough while preventing emboli from passing therethrough. The system also includes a sheath movable distally and proximally to enable the filtering elements to expand into position distal to the interventional procedure site for capturing embolic material and to collapse the filtering elements to retain the captured embolic material therein.

Claims

1. A system for capturing embolic material which may be released into a blood vessel during a therapeutic interventional procedure, comprising:

a shaft, adapted to be positionable within the blood vessel and distal to an interventional procedure site, wherein the shaft has proximal and distal ends; and

a filter, adapted to be located in a distal end portion of the shaft, to be deployed distal to the interventional procedure site, and to pass blood therethrough and to capture embolic material which may be released into the blood in the blood vessel during the interventional procedure, wherein the filter includes elements for filtering embolic material, adapted to be expandable to capture embolic material, and to be collapsible to retain the captured embolic material, and wherein the filtering elements include a plurality of bristles permanently attached and extending from a section of the distal end portion of the shaft, and adapted to capture embolic material.

2. The system of claim 1, wherein the filtering elements further include a net located distal of the plurality of bristles and adapted to be deployed to capture embolic material.

3. The system of claim 1, wherein the shaft comprises a guide wire.

4. The system of claim 1 further comprising an interventional instrument catheter adapted to be movable along the shaft so as to pass an interventional instrument to the interventional procedure site.

5. The system of claim 1, further comprising an expansion and contraction enabling element for enabling the filtering elements to expand and contract, adapted to be movable proximally to enable the filtering elements to expand, and movable distally to cover the filtering elements and enable the filtering elements to contract.

6. The system of claim 5, wherein the expansion and contraction enabling element comprise a sheath adapted to extend over the bristles so as to fold the bristles down over each other and retain the embolic material captured on the bristles.

7. The system of claim 5, further comprising an interventional instrument adapted to be deployed at the interventional procedure site, comprising a self-expanding stent adapted to be releasably mounted on the shaft proximal of the filter and enclosed in the expansion and contraction enabling element, wherein the expansion and contraction enabling element is further adapted upon movement proximally to enable the self-expanding stent to expand.

8. The system of claim 7, wherein the filtering elements comprise a net, located distal of the self-expanding stent and adapted to be deployed to capture embolic material.

9. The system of claim 1, further comprising an expansion and contraction enabling element for enabling the filtering elements to expand and contract, adapted to be movable distally to enable the filtering elements to expand, and movable proximally to cover the filtering elements and enable the filtering elements to contract.

10. The system of claim 1, wherein the blood flows in a blood flow direction in the blood vessel, and the bristles extend from the shaft in a direction which is generally the opposite of the blood flow direction.

11. The system of claim 1, wherein the bristles extend from the shaft in a direction which is generally the same as the direction of the flow of the blood in the blood vessel.

12. The system of claim 1, wherein the embolic material to be captured thereby include a smallest dimension, and the bristles are spaced apart a distance generally less than the smallest dimension.

13. The system of claim 1, wherein the bristles are spaced apart a distance which varies from the proximal to the distal end of the shaft section to capture embolic material of different sizes.

14. The system of claim 1, wherein the filtering elements further include a net located distal of the plurality of bristles and adapted to be deployed to capture generally small embolic material.

15. The system of claim 1, wherein the bristles are spaced apart a distance generally less than a smallest dimension of the embolic material to be captured thereby.

16. A method of capturing embolic material which may be released into a blood vessel during a therapeutic interventional procedure, in a system which comprises a shaft, adapted to be positionable within the blood vessel and distal to an interventional procedure site, wherein the shaft has proximal and distal ends, and a filter, adapted to be located in a distal end portion of the shaft, to be deployed distal to the interventional procedure site, and to pass blood therethrough and to capture embolic material which may be released into the blood in the blood vessel during the interventional procedure, wherein the filter includes elements for filtering embolic material, adapted to be expandable to capture embolic material, and to be collapsible to retain the captured embolic material, wherein the filtering elements include a plurality bristles permanently attached and extending from a section of the distal end portion of the shaft, and adapted to capture embolic material, wherein the method comprises:

positioning the shaft in the interventional procedure site such that the filter is located within the blood vessel in the region at a location distal to the interventional procedure site;

expanding the plurality of bristles within the blood vessel at the location distal to the interventional procedure site so as to enable the capture of embolic material;

performing the interventional procedure, which may release embolic material into the blood;

filtering the blood through the plurality of bristles so as to capture embolic material which may be released into the blood upon performing the interventional procedure; and

collapsing the filtering elements so as to retain the captured embolic material.

17. The method of claim 16, wherein the filtering elements further include a net located distal of the bristles and adapted to be deployed to capture embolic material, and wherein filtering further comprises filtering the blood through the net to capture embolic material.

18. A system for capturing embolic material which may be released into a blood vessel during a therapeutic interventional procedure, comprising:

a shaft, adapted to be positionable within the blood vessel and distal to an interventional procedure site, wherein the shaft has proximal and distal ends; and

a filter, adapted to be located in a distal end portion of the shaft, to be deployed distal to the interventional procedure site, and to pass blood therethrough and to capture embolic material which may be released into the blood in the blood vessel during the interventional procedure, wherein the filter includes elements for filtering embolic material, adapted to be expandable to capture embolic material, and to be collapsible to retain the captured embolic material, wherein the filtering elements include a plurality of bristles, extending from a section of the distal end portion of the shaft, and adapted to capture embolic material, and wherein the filtering elements further include a net located distal of the plurality of bristles and adapted to be deployed to capture embolic material.

19. The system of claim 18, wherein the blood flows in a blood flow direction in the blood vessel, and the bristles extend from the shaft in a direction which is generally the opposite of the blood flow direction.

20. The system of claim 18, wherein the shaft section includes proximal and distal ends, and the bristles are spaced apart a distance which varies from the proximal to the distal end of the shaft section to capture embolic material of different sizes.

21. A system for capturing embolic material which may be released into a blood vessel during a therapeutic interventional procedure, comprising:

a shaft, adapted to be positionable within the blood vessel and distal to an interventional procedure site, wherein the shaft has proximal and distal ends; and

a filter, adapted to be located in a distal end portion of the shaft, to be deployed distal to the interventional procedure site, and to pass blood therethrough and to capture embolic material which may be released into the blood in the blood vessel during the interventional procedure, wherein the filter includes elements for filtering embolic material, adapted to be expandable to capture embolic material, and to be collapsible to retain the captured embolic material, wherein the filtering elements include a plurality of bristles, extending from a section of the distal end portion of the shaft, and adapted to capture embolic material, wherein the filtering elements further include a net located distal of the bristles and adapted to be deployed to capture generally small embolic material.

22. The system of claim 21, further comprising an interventional instrument catheter adapted to be movable along the shaft so as to pass an interventional instrument to the interventional procedure site.

23. The system of claim 21, further comprising an expansion and contraction enabling element for enabling the filtering elements to expand and contract, adapted to be movable distally to enable the filtering elements to expand, and movable proximally to cover the filtering elements and enable the filtering elements to contract.

24. The system of claim 21, wherein the blood flows in a blood flow direction in the blood vessel, and the bristles extend from the shaft in a direction which is generally the opposite of the blood flow direction.

25. A method of capturing embolic material which may be released into a blood vessel during a therapeutic interventional procedure, in a system which comprises a shaft, adapted to be positionable within the blood vessel and distal to an interventional procedure site, wherein the shaft has proximal and distal ends, and a filter, adapted to be located in a distal end portion of the shaft, to be deployed distal to the interventional procedure site, and to pass blood therethrough and to capture embolic material which may be released into the blood in the blood vessel during the interventional procedure, wherein the filter includes elements for filtering embolic material, adapted to be expandable to capture embolic material, and to be collapsible to retain the captured embolic material, wherein the filtering elements include a plurality of bristles, extending from a section of the distal end portion of the shaft, and adapted to capture embolic material, and wherein the filtering elements further include a net located distal of the bristles and adapted to be deployed to capture embolic material, wherein the method comprises:

positioning the shaft in the interventional procedure site such that the filter is located within the blood vessel in the region at a location distal to the interventional procedure site;

expanding the filtering elements within the blood vessel at the location distal to the interventional procedure site so as to enable the capture of embolic material;

performing the interventional procedure, which may release embolic material into the blood;

filtering the blood through the filtering elements so as to capture embolic material which may be released into the blood upon performing the interventional procedure, further comprising filtering the blood through the bristles to capture embolic material, and filtering the blood through the net to capture embolic material; and

collapsing the filtering elements so as to retain the captured embolic material.

26. A method of capturing embolic material which may be released into a blood vessel during a therapeutic interventional procedure, in a system which comprises a shaft, adapted to be positionable within the blood vessel and distal to an interventional procedure site, wherein the shaft has proximal and distal ends, and a filter, adapted to be located in a distal end portion of the shaft, to be deployed distal to the interventional procedure site, and to pass blood therethrough and to capture embolic material which may be released into the blood in the blood vessel during the interventional procedure, wherein the filter includes elements for filtering embolic material, adapted to be expandable to capture embolic material, and to be collapsible to retain the captured embolic material, wherein the filtering elements include a plurality of bristles, extending from a section of the distal end portion of the shaft, and adapted to capture embolic material, wherein the filtering elements further include a net located distal of the bristles and adapted to be deployed to capture generally small embolic material, wherein the method comprises:

positioning the shaft in the interventional procedure site such that the filter is located within the blood vessel in the region at a location distal to the interventional procedure site;

expanding the bristles within the blood vessel at the location distal to the interventional procedure site so as to capture embolic material;

performing the interventional procedure, which may release embolic material into the blood;

filtering the blood through the bristles so as to capture embolic material which may be released into the blood upon performing the interventional procedure, further comprising filtering the blood through the net to capture embolic material; and

collapsing the bristles so as to retain the captured embolic material.

27. The method of claim 26, further comprising an interventional instrument catheter adapted to be movable along the shaft so as to pass an interventional instrument to the interventional procedure site, further comprising positioning the interventional procedure catheter at the interventional procedure site.

28. The method of claim 26, further comprising an expansion and contraction enabling element for enabling the filtering elements to expand and contract, adapted to be movable distally to enable the filtering elements to expand, and movable proximally to cover the filtering elements and enable the filtering elements to contract, further comprising moving the expansion and contraction enabling element distally to enable the filtering elements to expand.

29. The method of claim 26, wherein the bristles extend from the shaft in a direction which is generally the opposite of the direction of the flow of the blood in the blood vessel, and wherein expanding further comprises expanding the bristles so that the bristles extend in a direction which is generally opposite the direction of the flow of blood in the blood vessel.

30. The method of claim 26, wherein the shaft section includes proximal and distal ends, and the bristles are spaced apart a distance which varies from the proximal to the distal end of the shaft section to capture embolic material of different sizes, and wherein filtering further comprises filtering the blood through the variably spaced-apart bristles so as to capture embolic material.