Method and Apparatus for Ablative Recanalization of Blocked Vasculature

• US 20080039830A1
• Filed: 08/14/2007
• Published: 02/14/2008
• Est. Priority Date: 08/14/2006
• Status: Abandoned Application

• Current Assignee: Stereotaxis, Inc.
• Original Assignee: Stereotaxis, Inc.
• Inventors: Munger, Gareth, Pandey, Ashwini, Viswanathan, Raju
• Application Number:
  US11/838,794
• Publication Number:
  US 20080039830A1
• Time in Patent Office: Days
• US Class Current: 606/33
• 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 2017/003 Steerable
• CPC Class Codes: A61B 2034/107 Visualisation of planned trajectories or target regions
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2090/376 using X-rays, e.g. fluoroscopy
• CPC Class Codes: A61B 2090/378 using ultrasound
• CPC Class Codes: A61B 34/10 Computer-aided planning, simulation or modelling of surgical operations
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 34/73 Manipulators for magnetic surgery

Abstract

A method of treating vessel occlusions including chronic total occlusions (CTO) of the coronary arteries, and to generally remove tissue material, is presented that relies on remotely actuated navigation of an interventional RF-capable ablation device to the occlusion and controlled application of ablative RF energy. The combined use of remote navigation-based precision control of the distal end of the device and application of ablative energy enables crossing of elongated lesions and CTOs, calcified lesions and CTO'"'"'s, lesions and CTO'"'"'s located at vessel branches, and in general the removal of tissue material at a chosen tissue location.

Claims

1-17. -17. (canceled)

18. A system for recanalization of blocked vasculature, comprising:

i. a remote navigation system for remote actuation of an interventional device within a patient'"'"'s lumen to an occlusion;

ii. a remotely actuated interventional device capable of Radio Frequency power delivery to tissue;

iii. remote actuation means for orienting the interventional device distal end with respect to the occlusion in the vasculature;

iv. means for applying Radio Frequency energy to the occlusion in order to create a pathway through the occlusion; and

v. means to expand the radial dimensions of the pathway thus created.

19. The system of claim 18, where the system further includes a means of local characterization of tissue in the occluded vessel.

20. The system of claim 18, where the remote navigation system is a magnetic navigation system.

21. The system of claim 20, where the interventional device includes magnetic material that responds to remote actuation and which is characterized by (i) a remnant magnetization of at least 0.6 Tesla, and (ii) a Curie temperature of at least 300°

C.

22. The interventional device of claim 21, where the device includes an electrode at the distal tip for Radio Frequency power delivery that is separated from the magnetic material by a spacer element between 0.1 mm and 4 mm in length.

23. The interventional device of claim 21, where the magnetic material is also an electrode capable of Radio Frequency power delivery.

24. (canceled)

25. (canceled)

26. (canceled)

27. (canceled)

28. A method of performing tissue ablation to remove tissue material in a subject body, comprising:

(i) magnetically navigating the distal end of a magnetically endowed interventional device, capable of Radio Frequency (RF) power delivery, to a tissue location;

(ii) orienting the distal end of the interventional device;

(iii) applying ablative RF energy to the tissue location in pulsed form while navigating the interventional device; and

(iv) iterating through steps i) to iii) to remove tissue material.

29. The method of claim 28, where the RF energy is applied in a frequency range of between about 300 KHz and about 800 KHz.

30. The method of claim 28, where the RF energy is applied in a frequency range of between about 2 MHz and about 6 MHz.

31. The method of claim 28, where the RF energy is applied with a voltage of less than about 1100 V.

32. The method of claim 28, where the current corresponding to the RF energy delivery is less than about 1.5 A.

33. The method of claim 28, where the RF pulses are applied with a pulse duration between about 0.1 μ

s and about 5 seconds.

34. The method of claim 28, where the repetition time between one RF pulse and an immediately successive one is between about 20 μ

s and about 1 second.

35. A system for performing tissue ablation to remove tissue material in a subject body, comprising:

(i) a remote navigation system for remotely navigating the distal end of an interventional device endowed with remote actuation means and capable of Radio Frequency (RF) power delivery, to a tissue location; and

(ii) a Radio Frequency generator connected to the interventional device and capable of delivering pulsed Radio Frequency energy through said device to the tissue location.

36. The system of claim 35, where the RF energy is applied in a frequency range of between about 300 KHz and about 800 KHz.

37. The system of claim 35, where the RF energy is applied in a frequency range of between about 2 MHz and about 6 MHz.

38. The system of claim 35, where the RF energy is applied with a voltage of less than about 1100 V.

39. The system of claim 35, where the current corresponding to the RF energy delivery is less than about 1.5 A.

40. The system of claim 35, where the RF pulses are applied with a pulse duration between about 0.1 μ

s and about 5 seconds.

41. The system of claim 35, where the repetition time between one RF pulse and an immediately successive one is between about 20 μ

s and about 1 second.