Catheter system and method for boring through blocked vascular passages

• US 8,361,097 B2
• Filed: 10/19/2011
• Issued: 01/29/2013
• Est. Priority Date: 04/23/2008
• Status: Active Grant

• Current Assignee: Avinger Inc.
• Original Assignee: Avinger Inc.
• Inventors: Patel, Himanshu N., Simpson, John B.
• Primary Examiner(s): Severson, Ryan
• Assistant Examiner(s): NGUYEN, TIN DUC
• Application Number:
  US13/277,167
• Publication Number:
  US 20120041307A1
• Time in Patent Office: 468 Days
• Field of Search: 606/159, 606/194, 606/180, 606/80, 606/185, 606/171, 606/170, 30/295, 301/43, 301/51, 604/22, 604/164.01
• US Class Current: 606/159
• CPC Class Codes: A61B 17/22012 in direct contact with, or very close to, the obstruction or concrement for removing obstructions in blood vessels by laser A61B18/245
• CPC Class Codes: A61B 17/32002 with continuously rotating, oscillating or reciprocating cutting instruments
• CPC Class Codes: A61B 17/32075 Pullback cutting; combined forward and pullback cutting, e.g. with cutters at both sides of the plaque
• CPC Class Codes: A61B 17/320758 with a rotating cutting instrument, e.g. motor driven A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 18/24 with a catheter A61B18/26, A61B18/28 take precedence
• CPC Class Codes: A61B 2017/00336 with a protective sleeve, e.g. retractable or slidable
• CPC Class Codes: A61B 2017/00398 using powered actuators, e.g. stepper motors, solenoids
• CPC Class Codes: A61B 2017/22094 for crossing total occlusions, i.e. piercing

Abstract

A rotating cutting head catheter for passage through chronic total occlusions or other refractory atherosclerotic plaque from diseased arteries is disclosed. The catheter'"'"'s rotating cutting head is designed to reside safely within an outer protective sheath when not in use. The outer protective sheath contains one or more helical grooves or slots, and the cutting head contains protruding blades or projections that fit into these helical grooves or slots. Application of torque to an inner catheter or wire attached to the cutting head applies spin to the cutting head, and the force of the sheath'"'"'s helical grooves or slots against the cutting head'"'"'s protruding blades or projections advances the cutting head outward from the protective sheath. Once extended, the cutting head may now rotate freely. The device may use a guidewire to direct the cutting head to the desired position.

Claims

1. A method of delivering a guidewire across an atherosclerotic occlusion or lesion in a vascular lumen while protecting the vascular lumen, said method comprising:

passing a distal end of a catheter tube having a rotatable cutting head and a sheath through the vascular lumen to the occlusion or lesion, wherein the rotatable cutting head is retracted within the sheath during the passing step such that one or more helical cutting surfaces extending proximally along the rotatable cutting head are engaged with one or more helical slots extending laterally through a sidewall of the sheath;

extending the rotatable cutting head from the sheath such that the one or more helical cutting surfaces extend at least partially out of the sheath;

rotating the rotatable cutting head;

advancing said rotating cutting head across said occlusion or lesion to pass through occluding material without removing the occluding material; and

passing a guidewire through a guidewire passageway extending through the catheter tube after the distal end of the catheter tube has passed beyond the atherosclerotic occlusion so that the guidewire spans the atherosclerotic occlusion or lesion.

2. The method of claim 1, wherein the rotatable cutting head is rotated by rotation of a drive shaft extending the length of the catheter.

3. The method of claim 1, further comprising varying the direction of rotation of the rotatable cutting head as it is advanced across the occlusion or lesion.

4. The method of claim 1, further comprising alternately rotating the rotatable cutting head clockwise and counterclockwise as the rotating cutting head is advanced across the occlusion or lesion.

5. The method of claim 1, further comprising dispensing a therapeutic agent or visualization dye agent through the catheter tube.

6. The method of claim 1, wherein the advancing step comprises cutting the occlusion or lesion with the one or more helical cutting surfaces on said rotatable cutting head.

7. The method of claim 1, further comprising applying ultrasonic vibration, radiofrequency (RF) energy, or light energy to the cutting head, occlusion, or lesion.

8. The method of claim 1, further comprising using the guidewire spanning the atherosclerotic occlusion or lesion to treat the occlusion or lesion by atherectomy, stenting, or balloon angioplasty during the same procedure.

9. The method of claim 1, further comprising imaging the vascular lumen as the rotatable cutting head is advanced.

10. A method of delivering a guidewire across an atherosclerotic occlusion or lesion in a vascular lumen while protecting the vascular lumen, said method comprising:

passing a distal end of a catheter tube having a rotatable cutting head and a sheath through the vascular lumen to the occlusion or lesion, wherein the rotatable cutting head is retracted within the sheath during the passing step such that one or more helical cutting surfaces extending proximally along the rotatable cutting head are engaged with one or more helical slots extending laterally through a sidewall of the sheath;

extending the rotatable cutting head from the sheath such that the one or more helical cutting surfaces extend at least partially out of the sheath;

rotating the rotatable cutting head alternately clockwise and counterclockwise;

advancing said rotating cutting head across said occlusion or lesion to pass through occluding material without removing the occluding material;

imaging the vascular lumen as the rotatable cutting head is advanced; and

passing a guidewire through a guidewire passageway extending through the catheter tube after the distal end of the catheter tube has passed beyond the atherosclerotic occlusion so that the guidewire spans the atherosclerotic occlusion or lesion.

11. A method of delivering a guidewire across an atherosclerotic occlusion or lesion in a vascular lumen while protecting the vascular lumen, said method comprising:

passing a distal end of a catheter tube having a rotatable cutting head and a sheath through the vascular lumen to the occlusion or lesion, wherein the rotatable cutting head is retracted within the sheath during the passing step such that one or more helical cutting surfaces extending proximally along the rotatable cutting head are engaged with one or more helical slots extending laterally through a sidewall of the sheath to shield the one or more helical cutting surfaces from contact with the vascular lumen;

extending the rotatable cutting head from the sheath such that the one or more helical cutting surfaces extend at least partially out of the sheath;

rotating the rotatable cutting head;

advancing said rotating cutting head across said occlusion or lesion to pass through occluding material without removing the occluding material; and

passing a guidewire through a guidewire passageway extending through the catheter tube after the distal end of the catheter tube has passed beyond the atherosclerotic occlusion so that the guidewire spans the atherosclerotic occlusion or lesion.

12. The method of claim 11, wherein the rotatable cutting head is rotate by rotation of a drive shaft extending the length of the catheter.

13. The method of claim 11, further comprising varying the direction of rotation of the rotatable cutting head as it is advanced across the occlusion or lesion.

14. The method of claim 11, further comprising dispensing a therapeutic agent or visualization dye agent through the catheter tube.

15. The method of claim 11, further comprising applying ultrasonic vibration, radiofrequency (RF) energy, or light energy to the cutting head, occlusion, or lesion.

16. The method of claim 11, further comprising using the guidewire spanning the atherosclerotic occlusion or lesion to treat the occlusion or lesion by atherectomy, stenting, or balloon angioplasty during the same procedure.

17. The method of claim 11, further comprising imaging the vascular lumen as the rotatable cutting head is advanced.