Catheter system for vascular re-entry from a sub-intimal space

1. A method for forming a pathway from a sub-intimal space of a blood vessel into a true lumen of the blood vessel, comprising:

positioning a catheter system within the sub-intimal space at a position proximate to a target entry site into the true lumen, the catheter system including at least one lumen in communication with at least one port in a distal region of the catheter system, the catheter system further including an internal incising element that is translatable across a portion of the port;

determining a radial position of the true lumen with respect to the port at the target entry site from a position in the sub-intimal plane using an imaging device of the catheter system; and

forming an incision in tissue separating the sub-intimal space from the true lumen using the internal incising element, the incision having separate and distinct end points and forming a pathway between the sub-intimal space and the true lumen, wherein the tissue remains external to the port subsequent to forming the incision.

2. The method of claim 1 , wherein the imaging device is a rotational imaging device.

3. The method of claim 1 , wherein the imaging device is an ultrasonic device.

4. The method of claim 1 , wherein the imaging device is an optical coherence tomography (OCT) device.

5. The method of claim 1 , wherein the incising element is integral to the imaging device.

6. The method of claim 1 , wherein the incising element is separate from and arranged concentrically outside the imaging device.

7. The method of claim 1 , wherein determining the radial position includes use of an imaging device that is a fixed integral part of a body of the catheter system.

8. The method of claim 1 , wherein determining the radial position includes use of a fluoroscopic marker on the catheter system.

9. The method of claim 8 , wherein the fluoroscopic marker is located on a body of the catheter system.

10. The method of claim 8 , wherein the fluoroscopic marker is located on one or more working elements of the catheter system.

11. The method of claim 1 , further comprising evacuating fluid from the sub-intimal space and securing the tissue separating the sub-intimal space from the true lumen at the port by applying vacuum to the catheter lumen.

12. The method of claim 11 , further comprising invaginating the tissue separating the sub-intimal space from the true lumen into the port and into a distal interior region of the catheter system upon application of the vacuum.

13. The method of claim 1 , further comprising advancing a working element into the true lumen through the incision.

14. The method of claim 13 , wherein the working element includes at least one of a guide wire and a cannula.

15. A method for forming a pathway from a sub-intimal space of a blood vessel into a true lumen of the blood vessel, comprising:

positioning a catheter system within the sub-intimal space at a position proximate to a target entry site into the true lumen, the catheter system including at least one lumen in communication with at least one port in a distal region of the catheter system, the catheter system further including an internal incising element that is translatable across a portion of the port; and

forming an incision in tissue separating the sub-intimal space from the true lumen using the internal incising element, the incision having separate and distinct end points and forming a pathway between the sub-intimal space and the true lumen, wherein the tissue remains external to the port subsequent to forming the incision.

16. A method for forming a pathway from a sub-intimal space of a blood vessel into a true lumen of the blood vessel, comprising:

positioning a catheter system within the sub-intimal space at a position proximate to a target entry site into the true lumen, the catheter system including at least one lumen in communication with at least one port in a distal region of the catheter system, the catheter system further including an internal excising element that is translatable across a portion of the port;

determining a radial position of the true lumen with respect to the port at the target entry site from a position in the sub-intimal plane using an imaging device of the catheter system;

advancing the internal excising element along a portion of the port; and

excising an area of tissue separating the sub-intimal space from the true lumen using the internal excising element, the excised area of tissue generating a pathway from the sub-intimal space to the true lumen.

17. A method for forming a pathway from a sub-intimal space of a blood vessel into a true lumen of the blood vessel, comprising:

positioning a catheter system within the sub-intimal space at a position proximate to a target entry site into the true lumen, the catheter system including at least one lumen in communication with at least one port in a distal region of the catheter system, the catheter system further including an internal excising element that is translatable across a portion of the port;

advancing the internal excising element along a portion of the port; and

excising an area of tissue separating the sub-intimal space from the true lumen using the internal excising element, the excised area of tissue generating a pathway from the sub-intimal space to the true lumen.

18. A method for establishing a pathway through a chronic total occlusion of a blood vessel, the pathway connecting a first region of a true lumen of the blood vessel which is proximal to the occlusion to a second region of the true lumen of the blood vessel distal to the occlusion via an extra-luminal pathway within the vessel, comprising:

forming a track longitudinally from the first region of the true lumen through the occlusion and into a sub-intimal space distal to the occlusion;

positioning a catheter system within the sub-intimal space using the track, the catheter system including at least one lumen in communication with at least one port in a distal region of the catheter system, the catheter system further including an internal incising element that is translatable across a portion of the port;

determining a radial position of the true lumen with respect to the port using an imaging device of the catheter system; and

forming an incision in tissue separating the sub-intimal space from the true lumen using the internal incising element, the incision having separate and distinct end points and forming a pathway between the sub-intimal space and the true lumen, wherein the tissue remains external to the port subsequent to forming the incision.

19. A method for establishing a pathway through a chronic total occlusion of a blood vessel, the pathway connecting a first region of a true lumen of the blood vessel which is proximal to the occlusion to a second region of the true lumen distal to the occlusion via an extra-luminal pathway within the vessel, comprising:

forming a track longitudinally from the first region of the true lumen through the occlusion and into a sub-intimal space distal to the occlusion;

positioning a catheter system within the sub-intimal space using the track, the catheter system including at least one lumen in communication with at least one port in a distal region of the catheter system;

determining a radial position of the true lumen with respect to the port using an imaging device of the catheter system;

applying a vacuum through the catheter lumen and the port, evacuating fluid from the sub-intimal space and bringing the sub-intimal tissue into intimate contact with the port; and

advancing a working element through the port and through the tissue separating the sub-intimal space and the second region of the true lumen and generating a pathway from the sub-intimal space to the second region of the true lumen.