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

• US 7,004,173 B2
• Filed: 12/05/2001
• Issued: 02/28/2006
• Est. Priority Date: 12/05/2000
• Status: Expired due to Fees

• Current Assignee: Cardinal Health Switzerland 515 GmbH (Cardinal Health, Inc.)
• Original Assignee: LuMend, Inc. (Cardinal Health, Inc.)
• Inventors: Clark, Benjamin J., Kupiecki, David J., Seybold, Brent D., Emery, Jeffrey L., Sparks, Kurt D., Salinas, Sergio, Pinson, C. Danielle, Madsen, Allen W., Keleher, Michael D., Selmon, Matthew R.
• Primary Examiner(s): HO, TAN-UYEN THI
• Application Number:
  US10/010,410
• Publication Number:
  US 20020103459A1
• Time in Patent Office: 1,546 Days
• Field of Search: 606/159, 606/108, 600/585, 600/435, 604/523, 604/500, 128/898
• US Class Current: 128/898
• 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 17/320783 through side-hole, e.g. sliding or rotating cutter inside catheter
• 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 2017/22077 with a part piercing the tissue A61B2017/22044 takes precedence
• CPC Class Codes: A61B 2017/22094 for crossing total occlusions, i.e. piercing
• CPC Class Codes: A61B 2017/22095 accessing a blood vessel true lumen from the sub-intimal space
• CPC Class Codes: A61B 2090/378 using ultrasound
• CPC Class Codes: A61B 2090/3782 transmitter or receiver in catheter or minimal invasive instrument
• CPC Class Codes: A61B 90/37 Surgical systems with images on a monitor during operation

Abstract

A catheter system and corresponding methods are provided for accessing a blood vessel true lumen from a sub-intimal plane of the vessel. The catheter system includes visualization elements for determining the orientation of the true lumen with respect to the sub-intimal plane at an identified entry site from a position in the sub-intimal plane. The entry site is distal to a chronic total occlusion (CTO). The catheter system also includes a system for physically securing tissue of the sub-intimal plane at the entry site to the catheter system. The attaching system reduces or eliminates catheter float within the sub-intimal space. The catheter system further includes re-entry devices to establish and maintain a path from the sub-intimal plane back into the vessel true lumen.

Claims

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.