Protective device and method against embolization during treatment of carotid artery disease

• US 6,206,868 B1
• Filed: 06/14/1999
• Issued: 03/27/2001
• Est. Priority Date: 03/13/1998
• Status: Expired due to Term

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: Arteria Medical Science, Inc.
• Inventors: Parodi, Juan Carlos
• Primary Examiner(s): Kennedy, Sharon
• Assistant Examiner(s): Sirmons, Kevin C.
• Application Number:
  US09/333,074
• Time in Patent Office: 652 Days
• Field of Search: 606/200, 606/191, 606/194, 606/195, 604/509, 604/500, 604/101.01
• US Class Current: 604/500
• CPC Class Codes: A61B 17/12 for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord specially adapted for vas deferens or fallopian tubes A61F6/20; materials for ligaturing blood vessels A61L17/00
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12045 double occlusion, e.g. during anastomosis
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• 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: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61B 2017/2215 having an open distal end
• CPC Class Codes: A61B 2017/320716 comprising means for preventing embolism by dislodged material
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61B 8/06 Measuring blood flow measuring volume flow in general G01F, e.g. G01F1/66, G01F1/72; measuring speed of fluids in general G01P5/00
• 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: A61M 2025/0002 with a pressure sensor at the distal end
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2025/1093 having particular tip characteristics
• CPC Class Codes: A61M 2025/1095 : with perfusion means for enabling blood circulation while the balloon is in an inflated state or in a deflated state, e.g. permanent by-pass within catheter shaft
• CPC Class Codes: A61M 25/005 : with embedded materials for reinforcement, e.g. wires, coils, braids
• CPC Class Codes: A61M 25/10 : Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1002 : characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/104 : used for angioplasty

Abstract

Methods and apparatus are provided for removing emboli during an angioplasty, stenting or surgical procedure using a catheter having an occlusion element disposed on its distal end, a suction device, and an aspiration lumen communicating therebetween. The occlusion element is configured to be placed proximal of a stenosis and deployed to occlude antegrade flow, so that flow is reversed in the vessel when the suction device is selectively activated. The aspiration lumen is sized so that an interventional device, such as an angioplasty catheter, may be readily advanced therethrough to the site of a stenosis. The suction device may be activated intermittently at key stages of the procedure to provide reverse flow through the vessel, and the catheter may include bypass holes for limiting suction levels and/or providing intermittent antegrade flow.

Claims

1. A method for removing emboli from a vessel during treatment of a stenosis, the method comprising:

providing an emboli removal catheter having proximal and distal ends, a lumen extending therethrough, an occlusion element disposed on the distal end, and a suction device coupled to the lumen;

providing an angioplasty catheter having a balloon;

inserting the distal end of the emboli removal catheter transluminally to a position proximal to the stenosis;

deploying the occlusion element to occlude antegrade flow through the vessel;

actuating the suction device to induce reverse flow in the vessel;

while flow is reversed in the vessel, advancing the balloon of the angioplasty catheter across the stenosis;

actuating the balloon of the angioplasty catheter to dilate the stenosis; and

when the balloon of the angioplasty catheter is deflated, actuating the suction device to induce regional reversal of flow in the vessel to remove emboli generated by actuating the balloon.

2. The method of claim 1 wherein the occlusion element comprises a balloon, and deploying the occlusion element comprises inflating the balloon.

3. The method of claim 1 wherein the occlusion element comprises a self-expanding basket, and deploying the occlusion element comprises retracting a sheath relative to the distal end of the emboli removal catheter.

4. The method of claim 1 wherein advancing the balloon of the angioplasty catheter across the stenosis further comprises advancing the angioplasty catheter through the lumen of the emboli removal catheter.

5. The method of claim 1 further comprising:

providing a pressure sensor;

coupling the pressure sensor to the angioplasty catheter;

detecting an inflation pressure in the balloon of the angioplasty catheter; and

actuating the suction device responsive to the detected inflation pressure.

6. The method of claim 1 further comprising:

providing a flow sensor;

coupling the flow sensor to the lumen of the emboli removal catheter;

detecting a flow rate in the lumen; and

actuating the suction device responsive to the detected flow rate.

7. The method of claim 1 wherein the emboli removal catheter further comprises at least one through-wall bypass hole disposed in the emboli removal catheter proximal of the occlusion element, the method further comprising suctioning blood through the bypass hole when the balloon of the angioplasty catheter is fully inflated.

8. The method of claim 7 further comprising passing blood through the bypass hole to provide antegrade flow in the vessel when the balloon of the angioplasty catheter is deflated.

9. The method of claim 1 wherein the angioplasty catheter further comprises a guide wire lumen and at least one through-wall bypass hole that communicates with the guide wire lumen, the method further comprising suctioning blood through the guide wire lumen and bypass hole to induce reverse flow in the vessel distal to the balloon of the angioplasty catheter when the balloon of the angioplasty catheter is fully inflated.

10. The method of claim 9 further comprising passing blood through the bypass hole and guide wire lumen to provide antegrade flow in the vessel, distal to the balloon of the angioplasty catheter, when the suction device not actuated.