Devices and methods for protecting a patient from embolic material during surgery

• US 6,224,620 B1
• Filed: 11/18/1999
• Issued: 05/01/2001
• Est. Priority Date: 05/08/1997
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Embolx, Inc.
• Inventors: Maahs, Tracy D.
• Primary Examiner(s): Thaler, Michael H.
• Assistant Examiner(s): Trinh, Hoa B.
• Application Number:
  US09/443,581
• Time in Patent Office: 530 Days
• Field of Search: 606/200, 606/191, 606/195, 606/198, 128/898, 604/96, 696/159
• 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 blood filter device and delivery system, comprising a tubular member with a filter. The tubular member includes a distal end adapted to enter an artery, and a port for receiving the filter. The filter includes 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 removably received by the tubular member. The tubular member may be introduced into a blood vessel, and the expandable filter device may be deployed through the tubular member 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 filter may be removed from the tubular member, and a new filter may then be received therein. Also described is a cannula having a proximal end, a distal end, and a lumen therebetween, the cannula further comprising a port disposed on an outer surface of the cannula for receiving a medical instrument, optionally a filter, for passage into the aorta or other suitable vessel.

Claims

1. A method of protecting a patient, comprising the steps of:

introducing a tubular member into the patient'"'"'s vessel, the tubular member having a lumen that extends from a proximal end to a distal end;

inserting a filter into the proximal end of the tubular member;

advancing the filter through the lumen into the vessel;

deploying the filter;

removing the filter from the vessel;

removing the filter from the tubular member; and

inserting a second filter into the tubular member after the step of removing the filter wherein embolic material is generated and filtered before the filter is removed from the vessel.

2. The method of claim 1, wherein the tubular member is fixed to an outer surface of a cannula.

3. The method of claim 2, wherein the cannula has a proximal end adapted to receive blood from a bypass-oxygenator machine.

4. The method of claim 1, wherein the filter 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.

5. The method of claim 1, wherein the tubular member provides a hemostatic seal between the filter and the lumen.

6. The method of claim 1, wherein the expansion frame comprises a substantially circular belt of self-expanding material.

7. The method of claim 1, wherein the tubular member further comprises a suture flange.

8. The method of claim 2, wherein the lumen of the tubular member is separate from a lumen of the cannula.

9. The method of claim 1, wherein the vessel is an artery.

10. The method of claim 9, wherein the artery is an aorta.

11. A method of performing surgery on a patient, comprising the steps of:

introducing a tubular member into the patient'"'"'s artery, the tubular member having a lumen that extends from a proximal end to a distal end, wherein the tubular member is fixed to an outer surface of a cannula;

inserting a first medical device into the proximal end of the tubular member;

advancing the first medical device through the lumen into the artery;

deploying the first medical device;

removing the first medical device from the artery; and

inserting a second medical device into the tubular member after the step of removing the first medical device.

12. The method of claim 11, wherein the medical device is a filter.

13. The method of claim 11, wherein the lumen of the tubular member merges and communicates with a lumen of the cannula.

14. The method of claim 11, wherein the lumen of the tubular member is separate from a lumen of the cannula.

15. The method of claim 11, wherein the artery is the patient'"'"'s aorta.