# US 6,206,868 B1 · Protective device and method against embolization during treatment of carotid artery disease

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- Number: US 6,206,868 B1
- Document ID: US6206868B1
- Status: Granted
- Kind: B1
- Application number: 09/333,074
- Filed: 1999-06-14
- Granted: 2001-03-27
- Earliest claimed: 1998-05-13
- Assignees: Arteria Medical Science, Inc.
- Inventors: Juan Carlos Parodi
- Web page: https://patentgrep.com/patent/US6206868B1

## CPC

- A61B 17/12: for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
- 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)}
- A61B 17/12045: {double occlusion, e.g. during anastomosis}
- A61B 17/12109: {in a blood vessel}
- A61B 17/12136: {Balloons}
- A61B 17/12172: {having a pre-set deployed three-dimensional shape (methods of manufacturing A61B2017/00526)}
- A61B 17/22: Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
- 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})
- A61M 25/1002: {characterised by balloon shape (A61M25/1006, A61M25/1009 take precedence)}
- A61M 25/104: {used for angioplasty}
- A61B 8/06: Measuring blood flow
- 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)}
- A61B 2017/00243: {cardiac}
- A61B 2017/22067: {Blocking; Occlusion (A61B2017/22054 takes precedence)}
- A61B 2017/2215: {having an open distal end}
- A61B 2017/320716: {comprising means for preventing embolism by dislodged material}
- A61B 2217/005: with suction drainage system
- A61F 2/011: {Instruments for their placement or removal}
- A61F 2/013: {Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting}
- A61M 25/005: {with embedded materials for reinforcement, e.g. wires, coils, braids}
- A61M 2025/0002: {with a pressure sensor at the distal end}
- A61M 2025/0681: {Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube}
- A61M 2025/1052: {for temporarily occluding a vessel for isolating a sector}
- A61M 2025/1093: {having particular tip characteristics}
- 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}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)

## 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

### Claim 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.

### Claim 2 (depends on 1)

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

### Claim 3 (depends on 1)

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.

### Claim 4 (depends on 1)

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.

### Claim 5 (depends on 1)

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.

### Claim 6 (depends on 1)

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.

### Claim 7 (depends on 1)

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.

### Claim 8 (depends on 7)

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.

### Claim 9 (depends on 1)

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.

### Claim 10 (depends on 9)

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.