Expandable cage embolic material filter system and method

• US 6,575,995 B1
• Filed: 07/14/2000
• Issued: 06/10/2003
• Est. Priority Date: 07/14/2000
• Status: Expired due to Term

• Current Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Inventors: Denison, Andy Edward, Huter, Benjamin Curtis
• Primary Examiner(s): Milano, Michael J.
• Assistant Examiner(s): PHANIJPHAND, GWEN G
• Application Number:
  US09/616,190
• Time in Patent Office: 1,061 Days
• Field of Search: 606/200, 606/159
• 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

Abstract

A system used in a blood vessel when an interventional procedure is being performed in a stenosed or occluded region, which is capable of enabling an expandable cage assembly therein, adapted to filter the blood in a blood vessel, to be expandable, so as to capture any embolic material that may be created and released into the bloodstream during the interventional procedure. The system includes a catheter which is positionable in a blood vessel at the interventional procedure site. The system further includes an expandable cage assembly, which is expandable and which may be deployed in the blood vessel distal to the interventional procedure site, which includes a plurality of struts, adapted to be expandable from unexpanded condition thereof, wherein each of the plurality of struts includes an element for varying the stiffness along the length thereof, for enabling the expandable cage assembly to be expandable, portions thereof which are in contact in the unexpanded condition, wherein the expandable cage assembly is capable of expanding, while preventing the unexpanded in contact portions thereof from sticking together during expansion and deployment thereof.

Claims

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

a catheter, including an elongated shaft, adapted to be positionable within the blood vessel and distal to an interventional procedure site, wherein the catheter shaft includes a distal end; and

a filter device, adapted to be located in the distal end portion of the catheter 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 device includes an expandable cage assembly, adapted to be expandable to capture embolic material, and to be collapsible to retain the captured embolic material, wherein the expandable cage assembly includes a plurality of struts, adapted to be expanded from unexpanded condition thereof, and a filter material for filtering embolic material, extending about the plurality of struts, and means for varying the stiffness along the length of the expandable cage assembly for enabling the expandable cage assembly to expand freely responsive thereto, comprising variable dimensions of the plurality of struts along substantially the entire thereof.

2. The system of claim 1, wherein the expandable cage assembly is generally parabolic-shaped.

3. The system of claim 1, wherein the filter material is generally conical-shaped.

4. The system of claim 1, wherein the plurality of struts each include a variable thickness along the length thereof, and the variable dimensions comprise the variable thickness of each of the plurality of struts along the length thereof.

5. The system of claim 1, wherein the plurality of struts comprise a plurality of sets of opposed struts, and the variable dimensions comprise variable inside diameters between sets of opposed struts along the length thereof.

6. The system of claim 5, wherein each of the plurality of struts is uniform in thickness.

7. The system of claim 5, wherein each of the plurality of struts is variable in thickness.

8. The system of claim 1, wherein the plurality of struts comprise a plurality of sets of opposed struts, and the variable dimensions comprise variable outside diameters between sets of opposed struts along the length thereof.

9. The system of claim 8, wherein each of the plurality of struts is uniform in thickness.

10. The system of claim 8, wherein each of the plurality of struts is variable in thickness.

11. The system of claim 1, wherein the plurality of struts each includes a free end and a fixed end, further comprising the marker tip at a free end of each strut adapted to enable observation thereof so as to enable verification of the opening or closing of the expandable cage assembly.

12. The system of claim 1, wherein each of the plurality of struts includes a distal portion, and the filter material extends about the strut distal portion.

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

a catheter, including an elongated shaft, adapted to be positionable within the blood vessel and distal to an interventional procedure site, wherein the catheter shaft includes a distal end; and

a filter device, adapted to be located in the distal end portion of the catheter 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 device includes an expandable cage assembly, adapted to be expandable to capture embolic material, and to be collapsible to retain the captured embolic material, wherein the expandable cage assembly includes a plurality of struts, adapted to be expanded from unexpanded condition thereof, and a filter material for filtering embolic material, extending about the plurality of struts, and means for varying the stiffness along the length of the expandable cage assembly for enabling the expandable cage assembly to expand responsive thereto, comprising variable dimensions of the plurality of struts along substantially the entire length thereof.

14. The system of claim 13, wherein the plurality of struts comprise a plurality of sets of opposed struts, and the variable means comprise variable dimensions which comprise variable inside diameters between sets of opposed struts along the length thereof.

15. The system of claim 13, wherein the plurality of struts comprise a plurality of sets of opposed struts, and the variable means comprise variable dimensions which comprise variable outside diameters between sets of opposed struts along the length thereof.

16. The system of claim 13, wherein the plurality of struts each includes a free end and a fixed end, further comprising the marker tip at a free end of each strut, adapted to be radiopaque to enable observation thereof so as to enable verification of the opening or closing of the expandable cage assembly.

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

a catheter, including an elongated shaft, adapted to be positionable within the blood vessel and distal to an interventional procedure site, wherein the catheter shaft includes a distal end; and

means for filtering embolic material, adapted to be located in the distal end portion of the catheter 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 filtering means include an expandable cage assembly, adapted to be expandable to capture embolic material, and to be collapsible to retain the captured embolic material, wherein the expandable cage assembly includes a plurality of struts, adapted to be expanded from unexpanded condition thereof, and a filter material for filtering embolic material, extending about the plurality of struts, and means for varying the stiffness along the length of the expandable cage assembly for enabling the expandable cage assembly to expand freely responsive thereto, comprising variable dimensions of the plurality of struts along substantially the entire length thereof.

18. The system of claim 17, wherein the plurality of struts each include a variable thickness along the length thereof, and the variable dimensions comprise the variable thickness of each of the plurality of struts along the length thereof.

19. The method of claim 17, wherein expanding further comprises expanding the plurality of struts and the filter material extending thereabout responsive to the variable dimensions along the length thereof.

20. The method of claim 19, wherein the plurality of struts comprise a plurality of sets of opposed struts, and the variable dimensions comprise variable inside diameters between sets of opposed struts along the length thereof, and expanding further comprises expanding the plurality of sets of opposed struts responsive to the variable inside diameters therebetween along the length thereof.

21. A method of capturing embolic material which may be released into a blood vessel during a therapeutic interventional procedure, in a system which comprises catheter, including an elongated shaft, adapted to be positionable within the blood vessel and distal to an interventional procedure site, wherein the catheter shaft includes a distal end, and a filter device, adapted to be located in the distal end portion of the catheter 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 device includes an expandable cage assembly, adapted to be expandable to capture embolic material, and to be collapsible to retain the captured embolic material, wherein the expandable cage assembly includes a plurality of struts, adapted to be expanded from unexpanded condition thereof, and a filter material for filtering embolic material, extending about the plurality of struts, and means for varying the stiffness along the length of the expandable cage assembly for enabling the expandable cage assembly to expand responsive thereto, comprising variable dimensions of the plurality of struts along substantially the entire length thereof, wherein the method comprises:

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

expanding the expandable cage assembly within the blood vessel at the location distal to the interventional procedure site responsive to the stiffness varying means so as to capture embolic material;

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

filtering the blood through the expandable cage assembly so as to capture embolic material which may be released into the blood upon performing the interventional procedure; and

collapsing the expandable cage assembly so as to retain the captured embolic material.