Catheter System and Method for Boring through Blocked Vascular Passages

• US 20090270888A1
• Filed: 04/23/2008
• Published: 10/29/2009
• Est. Priority Date: 04/23/2008
• Status: Active Grant

• Current Assignee: Avinger Inc.
• Original Assignee: Avinger Inc.
• Inventors: Simpson, John B., Patel, Himanshu N.
• Granted Patent: US 8,062,316 B2
• Time in Patent Office: Days
• 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 groves or slots, and the cutting head contains protruding blades or projections that fit into these helical groves 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 groves 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 catheter for delivering a guidewire across an occlusion, the catheter comprising;

a catheter tube;

a rotatable cutting head comprising a helical protrusion;

a protective sheath at the distal end of the catheter tube comprising one or more slot through the sheath, wherein the rotatable cutting head is configured to extend distally from the protective sheath by rotating the helical protrusion out of the slot;

a torque communicating connector configured to apply a torque to the rotatable cutting head from the proximal end of the catheter to rotate and extend the cutting head distally forward at least partially outside of said protective sheath; and

a guidewire passageway extending proximally to distally through the catheter tube.

3. The catheter of claim 1, in which at least some of the one or more slots are helical.

4. The catheter of claim 1, in which the forward extension of the cutting head is restricted by one or more motion stop elements.

5. The catheter of claim 1, in which the forward extension of the cutting head is not restricted by the catheter tube.

6. The catheter of claim 1, wherein the catheter tube contains the torque communicating connector, and wherein application of torque to said torque communicating connector causes said rotatable cutting head to rotate.

7. The catheter of claim 1, wherein the torque communicating connector comprises controlled electronic motor.

9. The catheter of claim 1, wherein the guidewire passageway is configured to exit distally through an opening in the center of the rotatable cutting head.

10. The catheter of claim 1, wherein the guidewire passageway is configured to exit distally from the catheter before the portion of the catheter tube that contains the rotatable cutting head.

11. The catheter of claim 1, wherein said rotatable cutting head contains one or more blade edges.

12. The catheter of claim 1, further comprising a sensor to monitor the progress of the extension of said cutting head outside of said catheter.

13. The catheter of claim 1, further comprising a transducer to enhance the cutting effectiveness of said cutting head by emitting ultrasonic vibration, radiofrequency (RF) energy, or light energy.

14. The catheter of claim 1, wherein the cutting head has a radiopaque signature that is different from the radiopaque signature of the catheter.

2. (canceled)

8. (canceled)

15. (canceled)

16. (canceled)

17. A catheter for delivering a guidewire across an occlusion, the catheter comprising:

a catheter tube;

a hollow sheath at the distal portion of said catheter tube comprising one or more helical slots through the wall of the sheath;

a rotatable cutting head positioned at least partially inside said hollow sheath, wherein the rotatable cutting head is configured to extend distally from the hollow sheath and retract into the hollow sheath by rotating out of the slots of the hollow sheath;

a torque communicating connector configured to apply torque to rotate the rotatable cutting head from the distal end of the catheter; and

a guidewire passageway extending through the catheter tube and out of the distal end of the hollow sheath.

18. The catheter of claim 17, in which said rotatable cutting head contains at least one helical protrusion which is configured to engage with said helical slots so that mechanical interaction between at least one protrusion on said rotatable cutting head and the one or more helical slots advances said cutting head in or out said hollow sheath head.

19. The catheter of claim 17, wherein said catheter tube and said torque communicating connector are hollow and the guidewire passageway extends through both the catheter tube and the torque communicating connector.

20. The catheter of claim 17, further comprising a feedback controlled electronic motor configured to apply torque to the torque communicating connector to rotate the rotatable cutting head.

22. The catheter of claim 17, wherein the guidewire passageway is configured to exit distally through an opening in the center of the rotatable cutting head.

24. The catheter of claim 17, wherein said rotatable cutting head contains one or more blade edges.

25. The catheter of claim 17, further comprising a sensor to measure the progress of the advancement of said cutting head outside of said hollow sheath.

26. The catheter of claim 17, further comprising a transducer to enhance the cutting effectiveness of said cutting head by emitting ultrasonic vibration, radiofrequency (RF) energy, or light energy.

27. The catheter of claim 17, wherein the cutting head has a radiopaque signature that is different from the radiopaque signature of the hollow sheath.

21. (canceled)

23. (canceled)

28. (canceled)

29. (canceled)

30. A catheter for delivering a guidewire across an occlusion, the catheter comprising:

a hollow catheter tube;

a hollow sheath head affixed at the distal portion of said catheter tube;

said hollow sheath head containing an opening and one or more helical slots or groves;

a rotatable cutting head positioned at least partially inside said hollow sheath head;

said rotatable cutting head containing at least one protrusion which is capable of engaging with said helical slots or groves; and

a torque communicating connector, wherein application of torque to said torque communicating connector causes said rotatable cutting head to rotate; and

a guidewire passageway extending through the catheter tube and through the rotatable cutting head.

31. The catheter of claim 30, further comprising microprocessor controlled electronic motor, wherein the microprocessor controlled electronic motor is configured to compensate for differences in rotation between the rotation of the electric motor and the rotation of the cutting head.

35. The catheter of claim 30, wherein said rotatable cutting head contains one or more blade edges.

36. The catheter of claim 30, further comprising a sensor to monitor the progress of the advancement of said cutting head outside of said hollow sheath head opening.

38. The catheter of claim 30, wherein the cutting head has a radiopaque signature that is different from the radiopaque signature of the hollow sheath head.

32. (canceled)

33. (canceled)

34. (canceled)

37. (canceled)

39. (canceled)

40. (canceled)

41. A method to deliver a guidewire across an atherosclerotic occlusion or lesion in a vascular lumen, said method comprising:

threading a catheter tube through said vascular lumen to said occlusion or lesion;

rotating a torque communicating connector positioned within said catheter tube to rotate a rotatable cutting head at the distal end of said catheter tube, wherein the cutting head comprises one or more helical protrusions;

extending said rotatable cutting head from a sheath head at the distal end of said catheter tube, said sheath head comprising one or more helical slots through the wall of the sheath head configured for shielding said rotatable cutting head from contact with said vascular lumen and said occlusion or lesion when the cutting head is retracted;

advancing said catheter tube across said occlusion or lesion to cut occluding material without removing the occluding material; and

passing a guidewire through a guidewire passageway extending distally through the catheter tube.

43. The method of claim 41, in which the rotation of the torque communicating connector is adjusted to compensate for differences in the rotation of the torque communicating connector and the rotation of the cutting head.

45. The method of claim 41, further comprising dispensing a therapeutic agent or visualization dye agent through the catheter tube.

46. The method of claim 41, in which the catheter tube is threaded through said vascular lesion before extending said guide wire.

47. The method of claim 41, in which the occlusion or lesion is cut by one or more blade edges mounted on said rotatable cutting head.

48. The method of claim 41, further comprising applying ultrasonic vibration, radiofrequency (RF) energy, or light energy to the cutting head, occlusion, or lesion.

49. The method of claim 41, in which said method is used to insert a guidewire across a blocked coronary artery or peripheral limb artery, and in which the blocked artery is then further treated by atherectomy, stenting, or balloon angioplasty during the same procedure.

42. (canceled)

44. (canceled)