Re-entry catheter

• US 6,719,725 B2
• Filed: 12/03/2002
• Issued: 04/13/2004
• 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: French, Ronald G., Co, Fred H., Hill, Richard E., Milo, Charles F., Selmon, Matthew R.
• Primary Examiner(s): Kennedy, Sharon
• Application Number:
  US10/308,568
• Publication Number:
  US 20030120195A1
• Time in Patent Office: 497 Days
• Field of Search: 604/164.01, 604/164.07, 604/164.09, 604/164.11, 604/164.13, 604/165.01, 604/165.02, 604/165.04, 604/170.03, 604/264, 604/272, 604/523, 604/263, 604/158-161, 600/585, 600/433, 600/434
• US Class Current: 604/164.01
• 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 After the guidewire is returned to the blood vessel lumen, the deflecting catheter may be withdrawn and the guidewire is available for introduction of other interventional and diagnostic catheters.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 re-entry catheter for use in forming a pathway between an extraluminal space within a blood vessel and a lumen of the blood vessel, comprising:

a catheter body including a proximal end, a distal end, and at least one guide wire lumen configured to track over a guide wire to a treatment site;

a catheter endpiece coupled to the distal end of the catheter body, the catheter endpiece including a lateral port in communication with the lumen, wherein the lateral port is proximal to the distal end of the catheter endpiece, the catheter endpiece further including a deflection mechanism in communication with the lumen and the lateral port; and

a working element having a proximal end and a distal end, wherein the distal end of the working element is configured to deploy through the lateral port for delivery from a first vascular location within the extraluminal space to a second vascular location within the true lumen of the blood vessel.

2. The catheter system of claim 1, wherein the working element includes a cannula having a lumen.

3. The catheter system of claim 1, wherein the working element includes a guide wire.

4. The catheter system of claim 1, wherein the working element includes a cannula and a guide wire, wherein the guide wire is slidably disposed within the cannula.

5. The catheter system of claim 1, further comprising a distal port positioned at the distal end of the catheter endpiece.

6. The catheter system of claim 1, wherein the distal end of the working element includes a preformed resilient tip.

7. The catheter system of claim 1, further comprising a guide wire.

8. The catheter system of claim 1, further comprising an active visualization element.

9. The catheter system of claim 1, further comprising a fluoroscopic marking system.

10. A re-entry catheter for use in forming a pathway between an extraluminal space within a blood vessel and a true lumen of the blood vessel, comprising:

a catheter body including a proximal end, a distal end, and at least one lumen configured to track over a guide wire to a treatment site, wherein an inside diameter of the lumen is uniform;

a catheter endpiece coupled to the distal end of the catheter body, the catheter endpiece including at least one port in communication with the lumen, and

a working element having a proximal end and a distal end, wherein the distal end of the working element is configured to deploy through the port for delivery from a first vascular location within the extraluminal space to a second vascular location within the true lumen of the blood vessel when the working element is advanced distally through the port.

11. The catheter system of claim 10, wherein the working element includes a cannula having a lumen.

12. The catheter system of claim 10, wherein the working element includes a guide wire.

13. The catheter system of claim 10, wherein the working element includes a cannula and a guide wire, wherein the guide wire is slidably disposed within the cannula.

14. The catheter system of claim 10, wherein the port is positioned at the distal end of the catheter endpiece.

15. The catheter system of claim 10, wherein the port is positioned proximal to the distal tip of the catheter endpiece.

16. The catheter system of claim 10, wherein the at least one port includes a first port positioned at the distal end of the catheter endpiece, and a second port positioned proximal to the distal tip of the catheter endpiece.

17. The catheter system of claim 10, wherein the distal end of the working element includes a preformed resilient tip.

18. The catheter system of claim 10, further comprising a guide wire.

19. The catheter system of claim 10, further comprising an active visualization element.

20. The catheter system of claim 10, further comprising a fluoroscopic marking system.

21. The catheter system of claim 10, further comprising a deflection mechanism in communication with the lumen and the least one port.

22. A re-entry catheter for use in forming a pathway between an extraluminal space within a blood vessel and a true lumen of the blood vessel, comprising:

a catheter body including a proximal end, a distal end, at least one lumen, and a distal termination, wherein the distal termination includes an internal deflection mechanism in communication with the lumen and at least one lateral port; and

a guide wire that is slidably disposed within the lumen and configured for deployment from a first vascular location within the extraluminal space to a second vascular location within the true lumen of the blood vessel using the lumen and the lateral port.

23. The catheter system of claim 22, wherein the catheter body is configured for use in peripheral vasculature.

24. The catheter system of claim 22, wherein the catheter body is configured for use in coronary vasculature.

25. The catheter system of claim 22, wherein the guide wire is configured for use in peripheral vasculature.

26. The catheter system of claim 22, wherein the guide wire is configured for use in coronary vasculature.

27. The catheter system of claim 22, wherein the guide wire includes a sharpened distal tip.

28. The catheter system of claim 22, further comprising a visualization device for use in identifying a re-entry location and positioning the lateral port towards the re-entry location.

29. The catheter system of claim 28, wherein the guide wire includes the visualization device.

30. The catheter system of claim 28, wherein the catheter body includes the visualization device.

31. A re-entry catheter for use in forming a pathway between an extraluminal space within a blood vessel and a true lumen of the blood vessel, comprising:

a wire configured for advancing into the extraluminal space to a location proximate to a target re-entry site of a lumen of the blood vessel;

a catheter body including at least one distally positioned port, wherein an outside diameter of the catheter body is uniform, the catheter body configured for advancing over the wire into the extraluminal space to the location proximate to a target re-entry site; and

a cannula configured to form a path from the extraluminal space to a second vascular location within the true lumen of the blood vessel, wherein the wire is retracted into the cannula following placement of the catheter body at the location, wherein the cannula is configured for advancing through the at least one distally positioned port of the catheter body and through the target re-entry site to form a pathway from the extraluminal space within a blood vessel into the true lumen of the blood vessel, and the guide wire is delivered through the cannula to the second vascular location.

32. A re-entry catheter for use in forming a pathway between an extraluminal space within a blood vessel and a lumen of the blood vessel, comprising:

a catheter body including at least one guide wire lumen and at least one distal port, wherein an inside diameter of the guide wire lumen is uniform, wherein a guide wire is positioned in the guide wire lumen and the catheter body is configured to be advanced over the guide wire into the extraluminal space to a re-entry target location of the blood vessel lumen; and

a visualization device for use in positioning the at least one port of the catheter body towards the re-entry target location, wherein the catheter body is configured to deliver the guide wire from the extraluminal space to the blood vessel lumen when the guide wire is advanced through the at least one port to form the pathway from the extraluminal space into the blood vessel lumen.

33. A re-entry catheter for use in forming a pathway between an extraluminal space within a blood vessel and a lumen of the blood vessel, comprising:

a catheter body including at least one lumen and at least one distal port, wherein an inside diameter of the lumen is uniform, wherein a guide wire is positioned in the catheter body and the catheter body is configured to be advanced over the guide wire into the extraluminal space to a re-entry target location of the blood vessel lumen;

a visualization device configured to position the at least one distal port of the catheter body towards the re-entry target location;

a cannula slidably disposed within the at least one lumen, wherein the cannula is configured to deploy from the at least one distal port of the catheter upon advancement and to generate a pathway from the extraluminal space into the blood vessel lumen; and

a guide wire positioned in the slidably disposed cannula and configured for advancement through the pathway created by the cannula and into the blood vessel lumen.