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

• US 6,905,490 B2
• Filed: 11/16/2001
• Issued: 06/14/2005
• Est. Priority Date: 03/13/1998
• Status: Expired due to Term

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: Gore Enterprise Holdings Incorporated (W.L. Gore and Associates)
• Inventors: Parodi, Juan Carlos
• Primary Examiner(s): Sirmons, Kevin C.
• Application Number:
  US09/991,417
• Publication Number:
  US 20020087119A1
• Time in Patent Office: 1,306 Days
• Field of Search: 604 9501- 9503, 604/96.01, 604/103.07, 604/104, 604/500, 604/508, 604/509, 604/523, 604/524, 604/101.01, 604/101.02, 604/101.03, 604/6.14, 604/5.01, 604/6.09, 604/4.01, 600/585, 600/433, 600/434, 600/435, 606/191, 606/194, 606/198, 606/200, 606/108
• US Class Current: 604/509
• 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. A method for removing emboli from a region comprising a bifurcation between a common carotid artery, an internal carotid artery and an external carotid artery, the internal carotid artery having a stenosis, the method comprising:

providing a catheter having proximal and distal ends, a lumen extending therethrough, an inflatable occlusion element disposed on the distal end, and a blood outlet port disposed on the distal end and coupled to the lumen, the occlusion element extending beyond the distal end of the catheter and forming a tapered entrance to the lumen when expanded;

providing a wire having a distal end and a balloon located adjacent the distal end;

inserting the distal end of the catheter into the common carotid artery to locate the occlusion element within the common carotid artery at a position proximal to the bifurcation;

expanding the occlusion element to occlude antegrade flow through the common carotid artery767 and to induce reversal of flow from the external carotid artery to the internal carotid artery, the occlusion element forming a funnel-shape that inhibits aggregation of emboli between a wall of the common carotid artery and the distal end of the catheter;

while flow is reversed in the external carotid artery, advancing the wire through the catheter to position the balloon in the patient'"'"'s external carotid artery at a location just distal of the bifurcation;

inflating the balloon to occlude flow from the external carotid artery to the internal carotid artery; and

aspirating blood from the region of the bifurcation and the internal carotid artery into the lumen of the catheter to remove substantially all emboli from the region while delivering a stent, inserted through the lumen of the catheter, within the stenosis to restore patency to the internal carotid artery.

2. The method of claim 1 further comprising:

providing a blood filter; and

coupling the blood filter in fluid communication between the blood outlet port and the inlet port of the venous return catheter.

3. The method of claim 1 wherein advancing the wire through the catheter comprises advancing the balloon through a separate lumen of the catheter.

4. The method of claim 1 further comprising:

providing a venous return catheter having proximal end with an inlet port, a distal end with an outlet port, and a lumen extending therebetween;

coupling the blood outlet port of the catheter to the inlet port of the venous return catheter; and

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

wherein aspirating blood from the region of the bifurcation and the internal carotid artery into the lumen of the catheter, further comprises causing blood aspirated into the lumen of the catheter to be reinfused to the remote vein via the venous return catheter.

5. The method of claim 4 further comprising:

providing a roller pump;

engaging the roller pump with the venous return catheter; and

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

6. The method of claim 4 wherein the aspirating blood from the region of the bifurcation and the internal carotid artery and reinfusing the aspirated blood into the remote vein is caused solely by a pressure differential between the internal carotid artery and the remote vein.

7. The method of claim 1 further comprising compressing the stenosis with an angioplasty catheter.

8. The method of claim 1 wherein 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.

9. A method for removing emboli from a vessel having a proximal segment that branches into first and second distal segments, the first distal segment having a stenosis and a source of collateral flow, the method comprising:

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

providing a venous return catheter having a proximal end with an inlet port, a distal end with an outlet port, and a lumen extending therebetween;

inserting the distal end of the catheter into the proximal segment to locate the occlusion element within the proximal segment at a position proximal to the stenosis;

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

coupling the blood outlet port to the inlet port of the venous return catheter;

expanding the occlusion element to occlude antegrade flow through the proximal segment and to induce reversal of flow from the second segment to the first segment;

communicating a pressure differential between the proximal segment and the remote vein through the lumen of the catheter and the lumen of the venous return catheter to aspirate blood from the proximal segment and induce reversal of flow through at least the first segment;

while aspirating blood from the proximal segment, delivering a stent within the stenosis, using an interventional instrument inserted through the lumen of the catheter, to restore patency to the first distal segment; and

reinfusing aspirated blood to the remote vein via the venous return catheter.

10. The method of claim 9 further comprising:

providing a wire having a distal end and a balloon affixed to the distal end;

while flow is reversed in the second segment, advancing the wire through the lumen of the catheter so that the balloon is located in the second segment;

inflating the balloon to occlude flow through the second segment.

11. The method of claim 10 wherein advancing the balloon into the second segment comprises advancing the wire through a separate lumen of the catheter.

12. The method of claim 9 comprising compressing the stenosis with an angioplasty catheter.

13. The method of claim 9 further comprising:

providing a roller pump;

engaging the roller pump with the venous return catheter; and

actuating the pump to augment a rate at which blood is aspirated from the proximal segment and reinfused to the remote vein.

14. The method of claim 9 wherein the inflatable occlusion element is configured to extend beyond the distal end of the catheter and form a tapered entrance to the lumen when expanded, so that the occlusion element forms a funnel-shape that inhibits aggregation of emboli between a wall of the proximal segment and the distal end of the catheter, wherein aspirating blood from the proximal segment and at least the first segment removes substantially all emboli liberated from the stenosis.