Apparatus and methods for reducing embolization during treatment of carotid artery disease

• US 20020087119A1
• Filed: 11/16/2001
• Published: 07/04/2002
• Est. Priority Date: 03/13/1998
• Status: Active Grant

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: Arteria Medical Science, Inc.
• Inventors: Parodi, Juan Carlos
• Granted Patent: US 6,905,490 B2
• Time in Patent Office: Days
• US Class Current: 604/103.07
• 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 2/014 Retrograde blood flow filters, i.e. device inserted against the blood flow direction
• CPC Class Codes: A61F 2230/0006 circular
• 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 2025/1031 Surface processing of balloon members, e.g. coating or deposition; Mounting additional parts onto the balloon member's surface
• CPC Class Codes: A61M 2025/1052 : for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2025/1065 : having a balloon which is inversely attached to the shaft at the distal or proximal end
• 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 25/1027 : Making of balloon catheters
• CPC Class Codes: A61M 25/1029 : Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
• 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 comprising a catheter having an occlusion element, an aspiration lumen, and a blood outlet port in communication with the lumen, a guide wire having a balloon, a venous return catheter with a blood inlet port, and tubing that couples the blood outlet port to the blood inlet port. Apparatus is also provided for occluding the external carotid artery to prevent reversal of flow into the internal carotid artery. The pressure differential between the artery and the vein provides reverse flow through the artery, thereby flushing emboli. A blood filter may optionally be included in-line with the tubing to filter emboli from blood reperfused into the patient.

Claims

1. Apparatus for removing emboli during an angioplasty or stenting procedure, the apparatus comprising:

a catheter having proximal and distal ends, a lumen extending therethrough, and a blood outlet port in communication with the lumen, the catheter adapted to be disposed in a patient'"'"'s carotid artery;

an occlusion element disposed on the distal end of the catheter and having an opening that communicates with the lumen, the occlusion element having a contracted state suitable for transluminal insertion and an expanded state wherein the occlusion element occludes antegrade flow in the vessel;

a venous return catheter having proximal and distal ends, a lumen extending therethrough, and a blood inlet port in communication with the lumen; and

tubing that couples the blood outlet port to the blood inlet port.

2. The apparatus of claim 1 further comprising a wire having a distal end and a balloon disposed on the distal end, wherein the wire and balloon are sized to pass through the lumen of the catheter.

3. The apparatus of claim 1 further comprising a blood filter coupled between the blood outlet port and the blood inlet port.

4. The apparatus of claim 1 wherein the occlusion element is an inflatable member.

5. The apparatus of claim 4 wherein the inflatable element has a pear-shape with a wall thickness that varies along the length of the inflatable member.

6. The apparatus of claim 4 wherein a portion of the pear-shaped inflatable member extends beyond the distal end of the catheter in the contracted position and forms an atraumatic bumper.

7. The apparatus of claim 1 wherein the occlusion element comprises a self-expanding basket.

8. The apparatus of claim 1 wherein the catheter comprises:

a non-stick tubular member;

a layer of wire braid disposed surrounding the non-stick tubular member; and

a layer of thermoplastic polymer disposed on the layer of wire braid.

9. The apparatus of claim 1 wherein the catheter further comprises a second lumen through which the wire and inflatable balloon may be inserted.

10. The apparatus of claim 1 further comprising a pump that removes blood through the catheter and reperfuses blood via the venous return catheter.

11. The apparatus of claim 2 further comprising a resilient wedge affixed to the wire proximal of the balloon to reduce snagging of the balloon following a stenting procedure.

13. The method of claim 12 further comprising:

providing a blood filter; and

coupling the blood filter in fluid communication between the blood outlet port and the blood inlet port.

14. The method of claim 12 further comprising:

providing a wire having a balloon;

while flow is reversed in the vessel, advancing the balloon of the wire into the patient'"'"'s external carotid artery;

inflating the balloon of the wire to prevent reverse flow from the external carotid artery from entering the internal carotid artery.

15. The method of claim 12 further comprising, while causing blood to flow between the blood outlet port and the blood inlet port, performing an interventional procedure with an interventional instrument inserted through the hemostatic port.

16. The method of claim 12 wherein the occlusion element comprises a balloon, and deploying the occlusion element comprises inflating the balloon.

17. The method of claim 12 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 catheter.

18. The method of claim 14 wherein advancing the balloon of the wire into the patient'"'"'s external carotid artery comprises advancing the balloon through a separate lumen of the catheter.

19. The method of claim 12 further comprising:

providing a pump; and

actuating the pump to increase a rate of flow of blood between the blood outlet port and the blood inlet port.

20. The method of claim 15 wherein performing an interventional procedure with an interventional instrument comprises delivering a stent within the vessel and the wire further comprises a resilient wedge, the method further comprising urging the resilient wedge against the stent during removal of the wire and balloon.

12. A method for removing emboli from a vessel comprising:

providing a catheter having proximal and distal ends, a lumen extending therethrough, an occlusion element disposed on the distal end, a hemostatic port coupled to the lumen, and a blood outlet port coupled to the lumen;

providing a venous return catheter having proximal and distal ends, a lumen extending therethrough, and a blood inlet port coupled to the lumen;

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

inserting the distal end of the venous return catheter into a remote vein;

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

causing blood to flow between the blood outlet port and the blood inlet port to induce reverse flow in, and remove emboli from, the vessel.