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

• US 20050228432A1
• Filed: 06/20/2005
• Published: 10/13/2005
• Est. Priority Date: 05/13/1998
• Status: Active Grant

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: Juan Carlos Parodi, Mark C. Bates, Michael Hogendijk
• Inventors: Hogendijk, Michael, Bates, Mark C., Parodi, Juan Carlos
• Granted Patent: US 7,927,347 B2
• Time in Patent Office: Days
• US Class Current: 606/194
• 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 17/12045 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 17/22 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 2017/320716 comprising means for preventing embolism by dislodged material
• CPC Class Codes: A61B 2217/005 with suction drainage system
• 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 2230/0006 circular
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2025/09008 having a balloon
• CPC Class Codes: A61M 2025/09175 having specific characteristics at the distal tip
• CPC Class Codes: A61M 2025/1015 having two or more independently movable balloons where the distance between the balloons can be adjusted, e.g. two balloon catheters concentric to each other forming an adjustable multiple balloon catheter system
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2025/109 having balloons for removing solid matters, e.g. by grasping or scraping plaque, thrombus or other matters that obstruct the flow
• 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 2205/75 : with filters
• CPC Class Codes: A61M 25/0045 : multi-layered, e.g. coated coating materials A61L29/08
• 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
• CPC Class Codes: A61M 29/00 : Dilators with or without means for introducing media, e.g. remedies instruments for performing visual medical inspections of cavities or tubes of the body A61B1/00

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 sheath 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 first lumen extending therethrough, a blood outlet port in communication with the first lumen, and a distal occlusion element disposed on the distal end of the catheter, the catheter adapted to be disposed in a patient'"'"'s carotid artery; and

a self-expanding occlusion element having proximal and distal ends, a retrieval wire coupled to the proximal end of the self-expanding occlusion element and an atraumatic tip coupled to the distal end of the self-expanding occlusion element, wherein the self-expanding occlusion element further comprises a contracted state and a deployed state in which the self-expanding occlusion element is configured to occlude flow in a vessel.

2. The apparatus of claim 1 wherein the self-expanding occlusion element is configured to occlude flow in an external carotid artery in the deployed state.

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

4. The apparatus of claim 1 further comprising:

a venous return sheath 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 of the catheter to the blood inlet port of the venous return sheath.

5. The apparatus of claim 4 further comprising a blood filter disposed between the blood outlet port of the catheter and the blood inlet port of the venous return sheath.

6. The apparatus of claim 1 further comprising a dilator having proximal and distal ends and a lumen extending therethrough, wherein the dilator is configured to be disposed within the first lumen of the catheter.

7. The apparatus of claim 6 wherein the self-expanding occlusion element is adapted to be disposed within the lumen of the dilator in the contracted state.

8. The apparatus of claim 6 wherein the dilator comprises a slot at the distal end that is configured to permit movement of the retrieval wire within the slot.

9. The apparatus of claim 6 further comprising a push member having proximal and distal ends, wherein the push member is configured for longitudinal movement within the lumen of the dilator.

10. The apparatus of claim 9 wherein the distal end of the push member is configured to abut the proximal end of the self-expanding occlusion element within the lumen of the dilator.

11. The apparatus of claim 1 wherein the proximal end of the self-expanding element comprises a taper.

12. The apparatus of claim 1 further comprising a second lumen, wherein the retrieval wire is configured for longitudinal movement within the second lumen.

13. The apparatus of claim 12 wherein the second lumen merges with the first lumen along a portion of the distal end of the catheter.

14. A method for removing emboli from a vessel, the method comprising:

providing a catheter having proximal and distal ends, a first lumen extending therethrough, and a distal occlusion element disposed on the distal end of the catheter;

providing a dilator having proximal and distal ends and a lumen extending therethrough, wherein the dilator is disposed within the first lumen of the catheter;

providing a self-expanding occlusion element having proximal and distal ends within the lumen of the dilator;

ejecting the self-expanding occlusion element from the dilator to occlude flow in the external carotid artery;

removing the dilator from within the first lumen of the catheter;

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

inducing reverse flow in the vessel to cause blood and emboli to flow into the first lumen of the catheter.

15. The method of claim 14 wherein inducing reverse flow in the vessel further comprises:

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

causing blood to flow between the first lumen of the catheter and the blood inlet port of the venous return sheath to induce reverse flow in the vessel.

16. The method of claim 14 wherein ejecting the self-expanding occlusion element from the dilator comprises proximally retracting the dilator with respect to a push member that is disposed within the lumen of the dilator.

17. The method of claim 14 further comprising guiding the apparatus using an atraumatic tip coupled to the distal end of the self-expanding occlusion element.

18. The method of claim 14 further comprising contracting the self-expanding occlusion element by proximally retracting a retrieval wire coupled to the proximal end of the self-expanding occlusion element.