Methods and apparatus for crossing total occlusions in blood vessels

• US 20010012924A1
• Filed: 03/15/2001
• Published: 08/09/2001
• Est. Priority Date: 01/13/1998
• Status: Active Grant

• Current Assignee: Cardinal Health Switzerland 515 GmbH (Cardinal Health, Inc.)
• Original Assignee: LuMend, Inc. (Cardinal Health, Inc.)
• Inventors: French, Ronald G., Co, Fred H., Hill, Richard E., Milo, Charles F., Selmon, Matthew R.
• Granted Patent: US 6,511,458 B2
• Time in Patent Office: Days
• US Class Current: 604/164.08
• 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 2025/0096 being laterally outward extensions or tools, e.g. hooks or fibres
• CPC Class Codes: A61M 25/01 Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence

Abstract

Total occlusions are crossed by passing a guidewire or other penetrating wire from a point proximal to the occlusion into a subintimal space between the intimal layer and adventitial layer of the blood vessel wall. The wire is 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. After the guidewire is returned to the blood vessel lumen, the deflecting catheter may be withdrawn and the guidewire is available for introduction of other interventional and diagnostic catheters.

Claims

1. A method for crossing a total occlusion in a blood vessel, said method comprising:

forming a track from a lumen in the blood vessel into a space between an intimal layer and an adventitial layer of the blood vessel, said track extending from proximal of the total occlusion to past the total occlusion; and

selectively forming a passage from the track back into the blood vessel lumen at a location distal to the total occlusion.

5. A method as in any of

claims 1

to

4

, wherein the blood vessel is an artery.

6. A method as in

claim 5

, wherein the artery is a coronary artery.

7. A method as in any of

claims 1

to

4

, further comprising performing an interventional or diagnostic procedure over a wire disposed in the subintimal space.

9. A method as in any of

claims 1

to

4

, further comprising imaging the occlusion and blood vessel lumen to identify the location distal to the total occlusion.

10. A method as in

claim 9

, wherein the imaging step comprising imaging from within the subintimal space or blood vessel.

11. A method as in

claim 9

, wherein the imaging step comprises imaging from a position external to the subintimal space and the blood vessel.

12. A method as in

claim 9

, wherein the blood vessel is a coronary artery and the imaging step comprises imaging from a position in a vein adjacent to the coronary artery.

24. A kit comprising:

a wire;

a wire deflector having a lumen which deflects a wire laterally; and

instructions setting forth use of the wire deflector according to any of

claims 1

to

4

.

25. A kit as in

claim 24

, wherein the wire, the wire deflector, and the instructions are packaged together in a single container.

26. A kit as in

claim 24

, further comprising a wire.

2. A method for crossing a total occlusion, said method comprising:

forming a track from a lumen in the blood vessel into a space between an intimal layer and an adventitial layer of the blood vessel, said track extending from proximal of the total occlusion to past the total occlusion, and

deflecting a wire from the track back into the blood vessel at a location distal to the total occlusion.

8. A method as in either

claim 2

or

claim 4

, further comprising advancing an interventional or diagnostic catheter over the deflected wire from proximal to the occlusion, through the subintimal space, back into the blood vessel lumen.

3. A method for crossing a total occlusion in a blood vessel, said method comprising:

advancing a wire through a lumen of the blood vessel into a space between an intimal layer and an adventitial layer of the blood vessel to create a track in said space past the total occlusion; and

selectively forming a passage from the track back into the blood vessel lumen at a location distal to the total occlusion.

4. A method for crossing a total occlusion in a blood vessel, said method comprising:

advancing a wire through a lumen of the blood vessel into a space between an intimal layer and an adventitial layer of the blood vessel; and

deflecting a wire from the subintimal space back into the blood vessel lumen a location distal to the total occlusion.

13. A method as in

claim 4

, wherein a single wire is both advanced into the subintimal space and deflected back into the blood vessel lumen.

14. A method as in

claim 4

, further comprising exchanging a first wire which is advanced into the subintimal space for a second wire which is deflected back into the blood vessel lumen.

15. A method as in

claim 4

, wherein the wire deflecting step comprises:

deflecting a cannula from the subintimal space into the blood vessel lumen; and

passing the wire through a path defined by the cannula.

16. A method as in

claim 15

, wherein the wire deflecting step further comprises advancing the cannula over the wire after said wire is disposed within the subintimal space and before the cannula is deflected.

17. A method as in

claim 16

, wherein the cannula-deflecting step comprises advancing a resilient curved end of the cannula from a constraining lumen into the blood vessel lumen.

18. A method as in

claim 4

, wherein the wire deflecting step comprises advancing a deflecting catheter over the wire which has been advanced into the subintimal space.

19. A method as in

claim 18

, further comprising passing a cannula thorough a lateral opening of the deflecting catheter and penetrating the cannula through the intimal layer, wherein the wire is thereafter advanced through a lumen of the cannula.

20. A method as in

claim 19

, wherein the wire deflecting step comprises:

retracting the wire into the cannula lumen before the cannula is passed through the lateral opening of the catheter; and

advancing the wire through the cannula after said cannula has been passed through the lateral opening of the catheter.

21. A method as in

claim 19

, wherein the deflecting step comprises:

withdrawing the wire from the cannula; and

introducing a second catheter into the cannula and through said cannula after said cannula has been passed through the lateral opening of the catheter.

22. A method as in either

claim 20

or

claim 21

, wherein the catheter and cannula are withdrawn from over the wire after said wire has deflected into the blood vessel lumen.

23. An improved method for advancing a guidewire thorough a subintimal space between an intimal layer and an adventitial layer and past a total occlusion in a blood vessel, wherein the improvement comprises selectively deploying the guidewire through a passage from the subintimal space back into the blood vessel lumen.

27. A wire deflection system comprising:

a catheter body having a proximal end, a distal end, and at least one lumen extending through at least a distal portion thereof, wherein said lumen has a distal opening and a lateral opening; and

a cannula having a proximal end, a distal end, and at least one lumen extending through a distal portion thereof, wherein said distal portion has a pre-formed resilient curve and wherein said distal portion of the cannula is slidably disposed in the lumen of the catheter body to assume (a) a straightened configuration with said cannula lumen axially aligned within the distal opening of the catheter body when the cannula is proximally retracted within the catheter body and (b) a curved configuration with the cannula extending laterally through the lateral opening of the catheter body when the cannula is distally advanced within the catheter body.

28. A system as in

claim 27

, further comprising a wire configured to pass through the cannula lumen.

29. A system as in

claim 27

, wherein the wire has a sharpened distal tip.

30. A system as in

claim 27

, wherein the wire comprises means for imaging tissue surrounding the wire.

31. A system as in

claim 27

, wherein the cannula comprises a self-penetrating distal end.

32. A system as in

claim 31

, wherein the self-penetrating distal end comprises a sharpened distal tip.

33. A system as in

claim 27

, wherein the cannula comprises a radiopaque marker near its distal end.

34. A system as in

claim 27

, wherein the catheter body has a fluoroscopically visible marker near its distal end wherein said marker permits visual determination of the rotational orientation of the distal end of the catheter body.

35. A system as in

claim 27

, wherein the catheter body is reinforced to enhance its torsional rigidity.

36. A system as in

claim 27

, further comprising a distal nose cone attached to the distal end of the catheter body, wherein said nose cone defines the distal and lateral openings.

37. A system as in

claim 27

, wherein the pre-formed curve in the distal end of the cannula extends over an arc in the range from 15°

to 135°

.

38. A system as in either

claim 27

or

37

, wherein the pre-formed curve has a radius in the range from 1 mm to 20 mm.

39. A system as in

claim 27

, further comprising a hub rotationally secured to a proximal end of the catheter body.