Methods and apparatus for crossing vascular occlusions

• US 6,221,049 B1
• Filed: 10/27/1999
• Issued: 04/24/2001
• Est. Priority Date: 01/13/1998
• Status: Expired due to Term

• Current Assignee: Cardinal Health Switzerland 515 GmbH (Cardinal Health, Inc.)
• Original Assignee: LuMend, Inc. (Cardinal Health, Inc.)
• Inventors: Aguilar, Amiel, French, Ronald, Milo, Charles F., Co, Fred, Selmon, Matthew R., Campello, Mark
• Primary Examiner(s): KENNEDY, SHARON E
• Application Number:
  US09/427,966
• Time in Patent Office: 545 Days
• Field of Search: 604/164.01, 604/164.05, 604/164.11, 604/164.13, 604/165-1-1, 604/166.01, 604/171, 604/172, 604/198, 604/272, 604/507, 604/508, 604/510, 604/528, 606/108, 606/159, 600/585
• US Class Current: 604/164.13
• CPC Class Codes: A61B 17/3207 Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/00252 for by-pass connections, i.e. connections from heart chamber to blood vessel or from blood vessel to blood vessel
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/22044 with a pointed tip
• CPC Class Codes: A61B 2017/22077 with a part piercing the tissue A61B2017/22044 takes precedence
• CPC Class Codes: A61B 2017/22095 accessing a blood vessel true lumen from the sub-intimal space
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61B 2090/3925 ultrasonic
• CPC Class Codes: A61M 2025/018 Catheters having a lateral opening for guiding elongated means lateral to the catheter
• CPC Class Codes: A61M 2025/0197 for creating an artificial passage within the body, e.g. in order to go around occlusions
• CPC Class Codes: A61M 25/01 Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence

Abstract

Methods and apparatus for crossing totally to substantially occluded blood vessels by passing a redirectable wire such as a guidewire from a relatively proximal point past the occlusion within a subintimal space formed between the intimal layer and the adventitial layer of a blood vessel wall. The wire may be advanced to a point distal to the occlusion, and thereafter deflected back into the blood vessel lumen, typically using a deflecting catheter which is advanced over the guidewire after it has been positioned within the subintimal space. The deflecting catheter may include a flapper valve assembly or preformed actuator wire for redirecting the guidewire. After the guidewire is returned to the blood vessel lumen, the deflecting catheter may be withdrawn, and the guidewire may be available for introduction of other interventional and diagnostic catheters for performing procedures such as stenting.

Claims

1. A method for crossing a substantially occluded blood vessel, said method comprising:

selecting a guidewire with a deflectable distal tip configured for advancement within a lumen of a blood vessel wall;

creating a longitudinal dissection plane within a wall the blood vessel by inserting the guidewire into blood vessel wall from within the blood vessel lumen at a proximal location relative to a vascular occlusion;

forming a channel along the dissection plane within the blood vessel wall by advancing the guidewire within the blood vessel wall in a relatively distal direction; and

selectively deflecting the distal tip of the guidewire at a relatively distal location relative to the proximal location back into the blood vessel lumen.

2. A method as recited in claim 1, wherein the blood vessel is an artery.

3. A method as recited in claim 2, wherein the artery is coronary artery.

4. A method as recited in claim 1, further comprising performing an interventional or diagnostic procedure over the guidewire.

5. A method as recited in claim 1, further comprising advancing an interventional or diagnostic catheter over the deflected guidewire from a position relatively proximal to the occlusion, through the channel, and back into the blood vessel lumen.

6. A method as recited in claim 1, further comprising imaging the occlusion and blood vessel lumen to identify their relative location to the guidewire.

7. A method as recited in claim 6, wherein the blood vessel is an artery and the imaging step comprises imaging from a position in a vein adjacent to the artery.

8. A method as recited in claim 1, wherein the distal tip of the guidewire is deflected by providing the guidewire tip with a resilient curved end, and distally advancing the guidewire from a constraining lumen into the blood vessel lumen.