Modular filter with delivery system

• US 6,051,015 A
• Filed: 10/28/1998
• Issued: 04/18/2000
• Est. Priority Date: 05/08/1997
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Embol X Inc (Edwards Lifesciences Corporation)
• Inventors: Maahs, Tracy D.
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): Trinh, Vikki
• Application Number:
  US09/181,790
• Time in Patent Office: 538 Days
• Field of Search: 606/159, 606/200, 606/170, 606/171, 606/180, 606/108, 606/195-198, 606/194, 128/898, 604/104
• US Class Current: 606/200
• CPC Class Codes: A61F 2/011 Instruments for their placement or removal
• CPC Class Codes: A61F 2/012 Multiple filtering units
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/0071 spherical
• CPC Class Codes: A61F 2230/0076 ellipsoidal or ovoid

Abstract

A modular blood filter device and delivery system, comprising an arterial cannula with a modular filter device. The arterial cannula includes a distal end adapted to enter an artery, and a side port for receiving a modular filter cartridge. The modular filter cartridge includes a tubular cartridge, and a shaft having a handle on one end and an expandable filter device on the other end. The expandable filter device includes filter mesh and an expansion frame capable of assuming enlarged and contracted conditions. The shaft is inserted into the cartridge, thereby containing the expandable filter device therein. The cartridge may then be removably received by the side port on the cannula. The cannula may be introduced into a blood vessel, and the expandable filter device may be deployed through the cannula into the vessel. The expansion frame may be expanded to the enlarged condition to capture embolic material in the mesh, may be collapsed to the contracted condition, and may be removed from the vessel. The modular filter cartridge may be removed from the cannula, and a new modular filter cartridge may then be received therein.

Claims

1. A medical device for filtering embolic material, comprising:

a cannula having an outer surface, a distal end adapted to enter a vessel, the distal end having a distal opening, and a lumen which extends from the proximal end to the distal end and communicates with the distal opening;

a port on the outer surface of the cannula, the port having a passage therein extending distally and communicating with a distal opening in the port; and

a modular filter cartridge inserted through the passage of the port, wherein the modular filter cartridge comprises;

a shaft having a proximal end and a distal end, wherein the distal end of said shaft is inserted in said port while the proximal end of said shaft extends outside of said port;

an expansion frame mounted on the distal end of the shaft, wherein said frame is expandable between a contracted condition and an enlarged condition, wherein said expansion frame is deployable through the distal opening of said passage; and

a filter attached to the expansion frame.

2. The medical device of claim 1, wherein the modular filter cartridge provides a hemostatic seal between the expandable filter and the port.

3. The medical device of claim 1, wherein the expansion frame comprises a substantially circular belt of self-expanding material.

4. The medical device of claim 3, wherein the self-expanding material is spring stainless steel.

5. The medical device of claim 3, wherein the self-expanding material is Nitinol or shape-memory material.

6. The medical device of claim 1, wherein the expansion frame comprises an umbrella structure.

7. The medical device of claim 1, wherein the expansion frame comprises a plurality of struts.

8. The medical device of claim 1, wherein the expansion frame comprises a plurality of compressed springs.

9. The medical device of claim 1, wherein the cannula further includes a suture flange.

10. The medical device of claim 1, wherein the vessel is an artery.

11. The medical device of claim 1, wherein the cannula has a proximal end adapted to receive blood from a bypass-oxygenator machine.

12. The medical device of claim 1, wherein the port is located adjacent a distal region of the cannula.

13. The medical device of claim 1, wherein the passage is separate from the lumen of the cannula.

14. A method of temporarily filtering embolic material from the blood in a blood vessel, said method comprising the steps of:

providing a cannula having a lumen which extends from a proximal end to a distal end, and a port on the outer surface of the cannula, said port having a passage therein extending distally;

introducing the distal end of the cannula into a vessel;

inserting a modular filter cartridge into the port;

advancing a filter through the passage into the blood vessel;

deploying the filter within the vessel; and

removing the filter from the vessel,

wherein embolic material is generated and filtered before the filter is removed from the vessel.

15. The method of claim 14, comprising the additional step of removing the modular filter cartridge from the port.

16. The method of claim 15, comprising the additional step of inserting a second modular filter cartridge into the port of the cannula after the step of removing the modular filter.

17. The method of claim 14, wherein the modular filter cartridge provides a hemostatic seal between the expandable filter and the port.

18. The method of claim 14, wherein the modular filter cartridge comprises:

a shaft having a proximal end and a distal end;

an expansion frame mounted on the distal end of the shaft which is expandable between a contracted and enlarged condition; and

a filter mesh attached to the expansion frame.

19. The method of claim 14, wherein the passage in the filter port communicates with the lumen in the cannula.

20. The method of claim 18, wherein the expansion frame comprises a substantially circular belt of self-expanding material.

21. The method of claim 20, wherein the self-expanding material is spring stainless steel.

22. The method of claim 20, wherein the self-expanding material is Nitinol.

23. The method of claim 14, further comprising the step of inserting the filter into the port on the cannula.

24. The method of claim 14, wherein the passage in the filter port is separate from the lumen in the cannula.

25. The method of claim 14, wherein the filter comprises a mesh disposed about a frame, and wherein the cannula further comprises a flange adjacent a distal opening of the passage, and extending distally of the distal opening, and wherein the flange is shaped to cover a portion of the frame extending distal of the distal opening.

26. A medical device for filtering embolic material, comprising:

a cannula having an outer surface, a distal end adapted to enter a vessel, the distal end having a distal opening, and a lumen which extends from the proximal end to the distal end and communicates with the distal opening;

a port on the outer surface of the cannula, the port having a passage therein extending distally and communicating with a distal opening in the port;

a flange adjacent a distal opening of the port, and extending distally of the distal opening of the port; and

a modular filter cartridge insertable through the passage of the port, the modular filter cartridge comprising an expandable filter mounted on an expansion frame, wherein said expansion frame is expandable between a contracted condition and an enlarged condition, wherein said expansion frame is deployable through the distal opening of said passage,

wherein the flange covers a portion of the frame extending distal of the distal opening of the port.

27. The medical device of claim 26, wherein the modular filter cartridge comprises:

a shaft having a proximal end and a distal end, wherein the distal end of said shaft is insertable in said port while the proximal end of said shaft extends outside of said port;

said expansion frame mounted on the distal end of the shaft; and

said filter attached to the expansion frame.