Devices and methods for preventing distal embolization using flow reversal in arteries having collateral blood flow

• US 6,840,949 B2
• Filed: 03/12/2003
• Issued: 01/11/2005
• Est. Priority Date: 07/25/2001
• Status: Expired due to Term

• Current Assignee: Zoll Circulation Incorporated (Asahi Kasei Corporation)
• Original Assignee: Coaxis Incorporated (Trimble Inc.)
• Inventors: Barbut, Denise R.
• Primary Examiner(s): Woo, Julian W.
• Assistant Examiner(s): NGUYEN, VI X
• Application Number:
  US10/387,983
• Publication Number:
  US 20030171769A1
• Time in Patent Office: 671 Days
• Field of Search: 606/200, 606/194, 606/159, 606/191, 606/198, 606/114, 606/127, 604/96.01, 604/107.01, 604/264, 604/101.01, 604/101.05
• US Class Current: 606/194
• CPC Class Codes: A61B 17/12045 double occlusion, e.g. during anastomosis
• 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 2017/00243 cardiac
• CPC Class Codes: A61B 2017/12127 Double occlusion, e.g. for creating blood-free anastomosis site
• 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: A61F 2/01 Filters implantable into blood vessels
• CPC Class Codes: A61F 2/0105 Open ended, i.e. legs gathered only at one side
• 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 2/014 Retrograde blood flow filters, i.e. device inserted against the blood flow direction
• 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 2025/1095 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 25/1011 Multiple balloon catheters

Abstract

The invention provides a medical device having a catheter and one or more expandable constricting/occluding members. The catheter is adapted for use with therapeutic or diagnostic devices, including an angioplasty/stent catheter and an atherectomy catheter. The constrictor/occluder is mounted at the distal end of the catheter. Manometers may be mounted distal to one or more constrictors for measuring pressure distal to the constrictor(s). Methods of using the devices are disclosed for preventing distal embolization during extracranial or intracranial carotid artery, vertebral artery, or coronary artery procedures, or procedures involving any vessel having collateral flow by reversing flow in the diseased vessel.

Claims

1. A method for flow reversal in an artery of the head or neck having a proximal segment that branches into first and second distal segments, the first distal segment having a lesion and a source of collateral flow, the method comprising the steps of:

inserting the distal end of a catheter into the proximal segment, the catheter having a proximal end, a distal end, and an expandable device on a distal region of the catheter;

locating the expandable device within the proximal segment;

expanding the expandable device to at least partially obstruct the proximal segment,

wherein the second distal segment is at least partially open and wherein flow in the first distal segment is reversed to pass over the lesion and into the second distal segment.

2. The method of claim 1, wherein the proximal segment is a common carotid artery, the first distal segment is an internal carotid artery, and the second distal segment is an external carotid artery.

3. The method of claim 1, wherein the proximal segment is a left main coronary artery, the first distal segment is a left anterior descending coronary artery, and the second distal segment is a left circumflex coronary artery.

4. The method of claim 1, wherein the proximal segment is a common femoral artery, the first distal segment is a profunda femoris, and the second distal segment is a superficial femoral artery.

5. The method of claim 1, wherein the proximal segment is a common iliac artery, the first distal segment is the internal iliac artery, and the second distal segment is an external iliac artery.

6. The method of claim 1, further comprising the steps of inserting a second expandable device in the second distal segment and expanding the second expandable device to at least partially obstruct the second distal segment.

7. The method of claim 1, further comprising the step of inserting a filter in the second distal segment to capture debris in the second distal segment.

8. The method of claim 1, further comprising the step of injecting an angiographic dye to confirm flow reversal.

9. The method of claim 1, further comprising the step of treating the lesion with an interventional catheter.

10. The method of claim 9, wherein the catheter is an angioplasty catheter.

11. The method of claim 9, wherein the catheter is an atherectomy catheter.

12. The method of claim 9, wherein the catheter is a stent deployment catheter.

13. The method of claim 1, further comprising the step of treating the lesion by thromboendarterectomy.

14. The method of claim 1, further comprising the step of treating the lesion by bypass graft using woven prosthetic tube.

15. The method of claim 1, further comprising the step of treating the lesion by bypass graft using an autogenous vein anastomosed end-to-side to the vessel above and below the obstruction.

16. The method of claim 1, further comprising the step of treating the lesion by resection with graft replacement.

17. The method of claim 1, wherein the catheter further comprises a pressure measuring mechanism.

18. The method of claim 17, wherein the pressure measuring mechanism is a manometer.

19. The method of claim 17, wherein the pressure measuring mechanism is a pressure lumen that communicates with an external manometer.