Catheter apparatus and methods for treating vasculatures

• US 8,764,730 B2
• Filed: 06/22/2011
• Issued: 07/01/2014
• Est. Priority Date: 06/26/2007
• Status: Active Grant

• Current Assignee: Roxwood Medical, Inc. (Boston Scientific Corporation)
• Original Assignee: Roxwood Medical, Inc. (Boston Scientific Corporation)
• Inventors: Taber, Mark
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): EISEMAN, ADAM JARED
• Application Number:
  US13/166,623
• Publication Number:
  US 20110251591A1
• Time in Patent Office: 1,105 Days
• Field of Search: 600/585, 604/510, 604/523, 604/526, 604/527, 604/528, 604/530, 604/532, 604/536
• US Class Current: 604/533
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 2017/22094 for crossing total occlusions, i.e. piercing
• CPC Class Codes: A61M 2025/0046 Coatings for improving slidability
• CPC Class Codes: A61M 2025/0293 Catheter, guide wire or the like with means for holding, centering, anchoring or frictionally engaging the device within an artificial lumen, e.g. tube natural lumen, e.g. vessels A61M25/04
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2025/1045 for treating bifurcations, e.g. balloons in y-configuration, separate balloons or special features of the catheter for treating bifurcations
• CPC Class Codes: A61M 2025/109 having balloons for removing solid matters, e.g. by grasping or scraping plaque, thrombus or other matters that obstruct the flow
• CPC Class Codes: A61M 25/0026 Multi-lumen catheters with stationary elements catheter assemblies comprising a catheter in combination with a guide tube, sheath or sleeve A61M2025/0681; catheters comprising telescoping coaxial elements A61M2025/0175
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/0071 Multiple separate lumens multiple separate lumens throughout the catheter A61M25/0026
• CPC Class Codes: A61M 25/0074 Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• CPC Class Codes: A61M 25/008 Strength or flexibility characteristics of the catheter tip
• CPC Class Codes: A61M 25/0082 Catheter tip comprising a tool
• CPC Class Codes: A61M 25/01 Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence
• CPC Class Codes: A61M 25/02 Holding devices, e.g. on the body
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 25/09041 Mechanisms for insertion of guide wires
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters

Abstract

A catheter apparatus may have a flexible shaft, guidewire lumens passing through the shaft, and a positioning device for positioning the guidewires relative to an external lumen. The positioning device may be an expansible scaffold covered with a retractable sheath. The positioning device may also be one or more balloons that are inflated through an inflation port in the shaft. The catheter apparatus may be operated by inserting a guide catheter into a vasculature with a chronic total occlusion, inserting the catheter apparatus into the guide catheter, and advancing the guidewires through the guidewire lumens and into contact with a chronic total occlusion. The positioning device may be activated before and/or between attempts to pass the guidewires through the chronic total occlusion to interrogate various parts of the chronic total occlusion.

Claims

1. A method of operating a catheter apparatus comprising:

providing a catheter apparatus comprising;

a multi-lumen main catheter shaft;

one or more guidewire lumen shafts extending from a distal end of the multi-lumen main catheter shaft with lumens within the one or more guidewire lumen shafts contiguous with at least one of the multi-lumens of the multi-lumen main catheter shaft;

an expansible support structure coupled to the distal end of the multi-lumen main catheter shaft;

a sheath at least partially surrounding the expansible support structure;

one or more loops each corresponding to one of the one or more guidewire lumens, wherein the one or more loops are coupled to the expansible support structure, and wherein the one or more loops project inward toward an interior of the expansible support structure; and

wherein the one or more guidewire lumen shafts are threaded through the corresponding one or more loops;

inserting the catheter apparatus into a vasculature with a chronic total occlusion;

withdrawing the sheath from the expansible support structure;

advancing a guidewire one or more guidewires through the one or more guidewire lumens and into contact with the chronic total occlusion; and

withdrawing the expansible support structure from the vasculature.

2. The method of claim 1, further comprising withdrawing the one or more guidewires and advancing the one or more guidewires through the one or more guidewire lumens and into contact with the chronic total occlusion until a suitable site for passing the one or more guidewires through the chronic total occlusion is found.

3. The method of claim 2, further comprising advancing the sheath over the expansible support structure and then withdrawing the catheter apparatus from the vasculature.

4. The method of claim 1, wherein the one or more loops are coupled to the expansible support structure by loop connections.

5. The method of claim 1, wherein the expansible support structure comprises closed cells.

6. The method of claim 5, wherein the one or more loops are located on closed cells separated by one closed cell.

7. The method of claim 5, wherein a proximal closed cell is coupled to the multi-lumen main catheter shaft.

8. The method of claim 5, wherein the closed cells comprise zigzag struts.

9. The method of claim 8, further comprising connectors between the struts of a closed cell and the struts of a neighboring closed cell.

27. The method of claim 1, wherein the catheter apparatus comprises three guidewire lumen shafts.

28. The method of claim 1, wherein the one or more loops are fixedly coupled to the expansible support structure.

10. A method of operating a catheter apparatus comprising:

providing a catheter apparatus comprising;

a shaft,

one or more guidewire lumens passing longitudinally through the shaft,

an expansible distal portion of the shaft, and

a retractable sheath surrounding at least a portion of the expansible distal portion of the shaft;

inserting a guide catheter into a vasculature with a chronic total occlusion;

inserting the catheter apparatus into the guide catheter;

retracting the retractable sheath past the expansible distal portion of the shaft;

allowing the expansible distal portion of the shaft to expand to position the guidewire lumens relative to the expansible distal portion;

advancing a guidewire through the one or more guidewire lumens and into contact with the chronic total occlusion; and

withdrawing the expansible distal portion of the shaft from the vasculature.

11. The method of claim 10, further comprising withdrawing the guidewires and advancing the guidewires through the guidewire lumens into contact with the chronic total occlusion repeatedly until a suitable site for passing the guidewires through the chronic total occlusion is found.

12. The method of claim 11, further comprising advancing the sheath over the expansible distal portion of the shaft and withdrawing the catheter apparatus from the vasculature.

13. The method of claim 10, wherein the expansible distal portion of the shaft is a metal mesh.

29. The method of claim 10, wherein the catheter apparatus comprises three guidewire lumens.

30. The method of claim 10, wherein the method further comprises advancing the guidewire lumen proximate to the chronic total occlusion.

31. The method of claim 10, wherein the expansible distal portion is a scaffold.

32. The method of claim 10, wherein the expansible distal portion has a distal and proximal end and wherein each of the one or more guidewire lumens is coupled by a loop to towards the distal end and by a loop towards the proximal end.

33. The method of claim 10, wherein the expansible distal portion has openings through which blood may flow.

14. A method of introducing one or more guidewires to a vasculature with a chronic total occlusion comprising:

inserting a catheter apparatus into the vasculature with the chronic total occlusion, wherein said catheter apparatus comprises;

a distal end, a proximal end and a central axis;

one or more guidewire lumens extending from the distal end of the apparatus, wherein said guidewire lumens are disposed radially from the central axis; and

an expansible scaffold structure coupled to distal end of the apparatus;

wherein the expansible scaffold surrounds and is coupled to the one or more guidewire lumens;

expanding the expansible scaffold support structure to position the guidewire lumens relative to the scaffold structure;

advancing one or more guidewires through the one or more guidewire lumens and into contact with the chronic total occlusion; and

withdrawing the expansible scaffold from the vasculature.

15. The method of claim 14, wherein one or more guidewire lumens are coupled to the expansible scaffold structure by passing through one more or more loops coupled to the expansible scaffold, wherein the one or more loops project inward toward the interior of the expansible scaffold structure.

16. The method of claim 14, wherein the step of expanding comprises withdrawing a sheath, wherein the sheath at least partially surrounds the expansible scaffold prior to withdrawal.

17. The method of claim 14, wherein the one or more guidewire lumens extend beyond the distal end of the catheter apparatus.

18. The method of claim 14, further comprising withdrawing the one or more guidewires and advancing the one or more guidewires through the one or more guidewire lumens and into contact with the chronic total occlusion until a suitable site for passing the one or more guidewires through the chronic total occlusion is found.

19. The method of claim 18, further comprising advancing the sheath over the expansible scaffold and withdrawing the catheter apparatus from the vasculature.

20. The method of claim 15, wherein the one or more loops are coupled to the expansible scaffold by loop connections.

21. The method of claim 14, wherein the guidewire lumens are disposed in a radially fixed position relative to the central axis.

34. The method of claim 14, wherein said catheter apparatus comprises three guidewire lumens.

22. A method of introducing one or more guidewires to a vasculature with a chronic total occlusion:

inserting a catheter apparatus into the vasculature with the chronic total occlusion, wherein said catheter apparatus comprises

a proximal end and a distal end

one or more guidewire lumens, and

an expansible distal portion, wherein the distal portion surrounds the one or more guidewire lumens;

allowing the expansible distal portion to expand,

allowing the guidewire lumens to expand with the expansible distal portion into a predetermined position;

advancing guidewires through the one or more guidewire lumens and into contact with the chronic total occlusion; and

withdrawing the expansible distal portion from the vasculature.

23. The method of claim 22, wherein the one or more guidewire lumens are disposed in a radially fixed position relative to a central axis of the expansible distal portion.

24. The method of claim 22, wherein the step of allowing the expansible distal portion to expand comprises retracting a retractable sheath which surrounds at least a portion of the expansible distal portion until the retractable sheath no longer surrounds the portion of the expansible distal portion.

25. The method of claim 22, further comprising advancing the sheath over the expansible distal portion and withdrawing the catheter apparatus from the vasculature.

26. The method of claim 22, further comprising withdrawing the guidewires and eccentrically advancing the guidewires through the guidewire lumens into contact with the chronic total occlusion repeatedly until a suitable site for passing the guidewires through the chronic total occlusion is found.

35. The method of claim 22, wherein said catheter apparatus comprises three guidewire lumens.

36. The method of claim 22, wherein the one or more guidewire lumens are connected to the expansible distal portion to allow the guidewire lumens to expand with the expansible distal portion.

37. The method of claim 22, wherein the expansible distal portion is a scaffold.

38. The method of claim 22, wherein the expansible distal portion has a distal end and a proximal end and wherein each of the one or more guidewire lumens is coupled by a loop proximate the distal end and by a loop proximate the proximal end.

39. The method of claim 22, wherein the expansible distal portion has openings through which blood may flow.

40. A method of introducing a guidewire to a vasculature with a chronic total occlusion:

providing a catheter apparatus comprising;

a catheter shaft, an expansible distal portion of the catheter shaft,

a guidewire lumen shaft passing longitudinally through the catheter shaft and coupled to the expansible distal portion of the catheter shaft, and

a retractable sheath surrounding at least a portion of the expansible distal portion of the shaft;

retracting the retractable sheath from the expansible distal portion of the catheter shaft to allow the expansible distal portion of the catheter shaft to expand in order to position the guidewire lumen shaft relative to the expansible distal portion;

advancing a guidewire through the guidewire lumen shaft and into the vasculature; and

withdrawing the expansible distal portion of the catheter shaft from the vasculature.

41. The method of claim 40, wherein the expansible distal portion is a scaffold.

42. The method of claim 40, wherein the expansible distal portion has a distal end and a proximal end and wherein the guidewire lumen shaft is coupled by a loop proximate the distal end and by a loop proximate the proximal end.

43. The method of claim 40, wherein the expansible distal portion has a proximal member and a distal member that substantially surround the guidewire lumen shaft.

44. The method of claim 40, wherein the expansible distal portion has openings through which blood may flow.

45. The method of claim 40, wherein the method further comprises advancing the guidewire lumen into the vasculature to an obstruction.