Cerebral protection during carotid endarterectomy and downstream vascular protection during other surgeries

• US 5,876,367 A
• Filed: 12/05/1996
• Issued: 03/02/1999
• Est. Priority Date: 12/05/1996
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Embolx, Inc.
• Inventors: McKenzie, John, Root, Jonathan D., Kaganov, Alan L.
• Primary Examiner(s): Thaler, Michael H.
• Application Number:
  US08/759,591
• Time in Patent Office: 817 Days
• Field of Search: 606/200, 606/159, 604/8, 604/9, 604/284
• US Class Current: 604/8
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61F 2/0105 Open ended, i.e. legs gathered only at one side
• CPC Class Codes: A61F 2/011 Instruments for their placement or removal
• 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 2230/0093 Umbrella-shaped, e.g. mushroom-shaped
• CPC Class Codes: A61M 2025/0079 Separate user-activated means, e.g. guidewires, guide tubes, balloon catheters or sheaths, for sealing off an orifice, e.g. a lumen or side holes, of a catheter
• CPC Class Codes: A61M 2025/1097 with perfusion means for enabling blood circulation only while the balloon is in an inflated state, e.g. temporary by-pass within balloon
• CPC Class Codes: A61M 25/0097 characterised by the hub connectors A61M39/10

Abstract

A shunt and method of use for maintaining distal blood flow during an arteriotomy procedure is disclosed. The shunt includes a first tubular member having a proximal end, a distal end, and a lumen therebetween. The proximal end has an opening in communication with the lumen, and the proximal opening is adapted to receive blood from a first region of an artery. The distal end has an opening in communication with the lumen, and the distal opening is adapted to release blood into a second region of the artery. The shunt includes a second tubular member having a proximal end, a distal end, and a lumen therebetween which either merges and communicates at its distal end with the lumen of the first tubular member, or rides separate and parallel to it. The shunt also includes a hemostatic valve attached to the proximal end of the second tubular member, the valve acting to prevent loss of blood from the lumen of the second tubular member and to permit the introduction of a medical device into the lumen of the second tubular member and into the artery. In use, the distal opening of the shunt is inserted into the second region of an artery and secured to the lumen of the artery. A blood filter device is deployed within the artery. The proximal opening of the shunt is inserted into the first region of the artery and secured to the lumen of the artery. Endarterectomy is performed on the region of the artery which lies between the proximal opening and the distal opening of the shunt, and embolic material dislodged during the procedure is captured by the filter.

Claims

1. A shunt for maintaining distal blood flow during an arteriotomy procedure, comprising:

a first tubular member having a proximal end, a distal end, and a lumen therebetween, the proximal end having an opening in communication with the lumen, the proximal opening is adapted to receive blood from a first region of an artery, the distal end having an opening in communication with the lumen, the distal opening is adapted to release blood into a second region of the artery;

a second tubular member having a proximal end, a distal end, and a lumen therebetween which merges at an angle of substantially less than 90° and

communicates at its distal end with the lumen of the first tubular member, thereby allowing introduction of a medical device into the lumen of the first tubular member;

a hemostatic valve attached to the proximal end of the second tubular member, the valve acting to prevent loss of blood from the lumen of the second tubular member and to permit the introduction of the medical device into the lumens of the second and first tubular members; and

a blood filter disposed on an elongated instrument and inserted through the hemostatic valve into the lumen of the second tubular member.

2. A method for maintaining distal blood flow during an arteriotomy procedure, comprising the steps of:

providing a shunt comprising a tubular member having a proximal opening, a distal opening, a first lumen therebetween and a second lumen having a first opening which merges and communicates with the first lumen of the tubular member and a second opening adapted to receive a blood filter device;

inserting the distal opening of the shunt into a first region of a carotid artery and securing the shunt against the lumen of the carotid artery;

inserting the blood filter into the second opening of the second lumen;

advancing the blood filter into and beyond the lumen of the tubular member;

expanding the blood filter to cover a substantial portion of the cross-sectional area of the carotid artery;

inserting the proximal opening into a second region of the carotid artery and securing the shunt against the lumen of the carotid artery; and

performing endarterectomy on a region of the carotid artery which lies between the proximal opening and the distal opening of the shunt.

3. The method of claim 2, wherein the blood filter device is deployed after the distal opening and proximal opening are inserted and secured to the carotid artery.

4. The method of claim 2, wherein the blood filter device is inserted into the carotid artery downstream of a bifurcation.

5. The method of claim 2, wherein the blood filter device is deployed before the distal opening and proximal opening are inserted and secured to the artery.

6. The method of claim 2, wherein the proximal opening is inserted and secured to the second region of the artery before the distal opening is inserted and secured to the first region of the artery.

7. The method of claim 2, wherein the step of expanding the blood filter device comprises the step of expanding an inflation seal to which the blood filter is attached.

8. The method of claim 2, wherein the step of securing the shunt against the lumen of the carotid artery includes securing the shunt using a clamp.

9. The method of claim 2, wherein the step of securing the shunt against the lumen of the carotid artery includes securing the shunt using a balloon occluder.

10. A method for maintaining distal blood flow during an arteriotomy procedure, comprising the steps of:

providing a shunt comprising a tubular member having a proximal opening, a distal opening, a first lumen therebetween, and a second lumen having a first segment which lies substantially parallel to the first lumen of the tubular member and a second segment which branches away from the first lumen of the tubular member;

inserting the distal opening of the shunt into a first region of a carotid artery and securing the shunt against the lumen of the carotid artery;

inserting the blood filter into the second segment of the second lumen;

advancing the blood filter into and beyond the first segment of the second lumen;

expanding the blood filter to cover a substantial portion of the cross-sectional area of the carotid artery;

inserting the proximal opening into a second region of the carotid artery and securing the shunt against the lumen of the carotid artery; and

performing endarterectomy on a region of the carotid artery which lies between the proximal opening and the distal opening of the shunt.

11. The method of claim 10, wherein the step of expanding the blood filter comprises the step of expanding an inflation seal to which the blood filter is attached.

12. The method of claim 10, wherein the blood filter device is inserted into the carotid artery downstream of a bifurcation.

13. The method of claim 10, wherein the blood filter device is deployed after the distal opening and proximal opening are inserted and secured to the carotid artery.

14. The method of claim 10, wherein the blood filter is deployed before the distal opening and proximal opening are inserted and secured to the artery.

15. The method of claim 10, wherein the proximal opening is inserted and secured to the second region of the artery before the distal opening is inserted and secured to the first region of the artery.

16. The method of claim 10, wherein the step of securing the shunt against the lumen of the carotid artery includes securing the shunt using a clamp.

17. The method of claim 10, wherein the step of securing the shunt against the lumen of the carotid artery includes securing the shunt using a balloon occluder.