Catheter apparatus and methods for treating vasculatures

• US 10,471,234 B2
• Filed: 01/14/2015
• Issued: 11/12/2019
• 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): Eiseman, Adam J
• Application Number:
  US14/596,950
• Publication Number:
  US 20150126967A1
• Time in Patent Office: 1,763 Days
• 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 catheter apparatus comprising:

a catheter having a proximal end and a distal end;

a first guidewire lumen and a second guidewire lumen, the first guidewire lumen and second guidewire lumen at the distal end of the catheter; and

a removable, expansible support structure having a tapered proximal end and a longitudinal axis, the removable, expansible support structure allowing the first guidewire lumen and the second guidewire lumen to diverge upon expansion of the expansible support structure,

wherein the expansible support structure is self-expandable, and

wherein, upon expansion, a distal portion of at least one of the first guidewire lumen and the second guidewire lumen are substantially parallel with the longitudinal axis of the expansible support structure.

2. The catheter apparatus of claim 1, wherein the first guidewire lumen and second guidewire lumen diverge to predetermined positions.

3. The catheter apparatus of claim 1, further comprising a retractable sheath surrounding the first guidewire lumen and the second guidewire lumen.

4. The catheter apparatus of claim 3, wherein the retractable sheath is configured to expand the expansible support structure.

5. The catheter apparatus of claim 3, wherein the retractable sheath is withdrawn from around the removable, expansible support structure to expand the removable, expansible support structure.

6. The catheter apparatus of claim 5, wherein the retractable sheath is advanced around the removable, expansible support structure to compress the removable, expansible support structure.

7. The catheter apparatus of claim 1, wherein the first guidewire lumen and the second guidewire lumen are coupled to the removable, expansible support structure.

8. The catheter apparatus of claim 1, wherein the first guidewire lumen and the second guidewire lumen are positioned at a distal end of the removable, expansible support structure.

9. The catheter apparatus of claim 1, wherein the first guidewire lumen and the second guidewire lumen are positioned at least partially within the removable, expansible support structure.

10. The catheter apparatus of claim 1, wherein the first guidewire lumen and the second guidewire lumen are adapted to be positioned eccentrically relative to an inner wall of an external lumen.

11. The catheter apparatus of claim 1, further comprising a multi-lumen main catheter shaft, wherein the first guidewire lumen and the second guidewire lumen extend from a distal end of the multi-lumen main catheter shaft.

12. The catheter apparatus of claim 11, wherein the first guidewire lumen is contiguous with at least one of the multi-lumens of the multi-lumen main catheter shaft and the second guidewire lumen is contiguous with at least one of the multi-lumens of the multi-lumen main catheter shaft.

13. The catheter apparatus of claim 1, further comprising one or more loops each corresponding to one of the first guidewire lumen and the second guidewire lumen, 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.

14. The catheter apparatus of claim 13, wherein the first guidewire lumen and the second guidewire lumen are threaded through the corresponding one or more loops.

15. The catheter apparatus of claim 13, wherein the one or more loops are coupled to the expansible support structure by loop connections.

16. The catheter apparatus of claim 1, wherein the removable, expansible support structure is non-implantable.

17. The catheter apparatus of claim 1, wherein the first guidewire lumen and the second guidewire lumen extend at least to a distal opening of the removable, expansible support structure.

18. The catheter apparatus of claim 1, wherein the removable, expansible support structure comprises nitinol or a shape-memory material.

19. The catheter apparatus of claim 1, wherein the removable, expansible support structure comprises closed cells, the closed cells comprising zigzagged struts.

20. A method for operating a catheter apparatus comprising:

inserting the catheter apparatus according to claim 1;

diverging the first guidewire lumen and the second guidewire lumen by expanding the removable, expansible support structure.

21. The method of claim 20, wherein the first guidewire lumen and second guidewire lumen diverge to predetermined positions.

22. The method of claim 20, further comprising a retractable sheath surrounding the first guidewire lumen and the second guidewire lumen.

23. The method of claim 22, wherein the retractable sheath is configured to expand the removable, expansible support structure.

24. The method of claim 20, further comprising threading the first guidewire lumen through at least one first loop and threading the second guidewire lumen through at least one second loop.

25. The method of claim 20, wherein the first guidewire lumen and the second guidewire lumen are positioned at a distal end of the removable, expansible support structure.

26. The method of claim 20, wherein the first guidewire lumen and the second guidewire lumen are positioned at least partially within the removable, expansible support structure.

27. A catheter apparatus comprising:

a catheter having a proximal end and a distal end;

a first guidewire lumen and a second guidewire lumen, the first guidewire lumen and second guidewire lumen at the distal end of the catheter;

a removable, expansible support structure having a tapered proximal end, the removable, expansible support structure allowing the first guidewire lumen and the second guidewire lumen to diverge upon expansion of the expansible support structure; and

one or more loops each corresponding to one of the first guidewire lumen and the second guidewire lumen, 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.

28. The catheter apparatus of claim 27, the support structure further comprising a longitudinal axis and wherein, upon expansion, a distal portion of at least one of the first guidewire lumen and the second guidewire lumen are substantially parallel with the longitudinal axis of the expansible support structure.

29. The catheter apparatus of claim 27, the expansible support structure further comprising struts and wherein the one or more loops are coupled to an intersection of struts.

30. The catheter apparatus of claim 27, the one or more loops further comprising loop supports coupling each of the one or more loops to the expansible support structure.

31. The catheter apparatus of claim 27, wherein each of the first guidewire lumen and the second guidewire lumen are configured to remain within the one or more loops during expansion and compression of the expansible support structure.

32. A catheter apparatus comprising:

a catheter having a proximal end and a distal end;

a first guidewire lumen and a second guidewire lumen, the first guidewire lumen and second guidewire lumen at the distal end of the catheter; and

a removable, expansible support structure having a tapered proximal end and a longitudinal axis, the removable, expansible support structure allowing the first guidewire lumen and the second guidewire lumen to diverge upon expansion of the expansible support structure,

wherein the removable, expansible support structure comprises closed cells, the closed cells comprising zigzagged struts, and

wherein, upon expansion, a distal portion of at least one of the first guidewire lumen and the second guidewire lumen are substantially parallel with the longitudinal axis of the expansible support structure.