Systems and methods for lesion assessment

• US 10,722,301 B2
• Filed: 11/03/2015
• Issued: 07/28/2020
• Est. Priority Date: 11/03/2014
• Status: Active Grant

• Current Assignee: 460Medical, Inc., George Washington University
• Original Assignee: George Washington University
• Inventors: Amirana, Omar, Armstrong, Kenneth C., Bowen, James, Larson, Cinnamon, Mercader, Marco A., Ransbury, Terrance J., Sarvazyan, Narine
• Primary Examiner(s): Nganga, Boniface N
• Application Number:
  US14/931,262
• Publication Number:
  US 20160120599A1
• Time in Patent Office: 1,729 Days
• CPC Class Codes: A61B 18/1206 Generators therefor
• 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 2018/00029 open
• CPC Class Codes: A61B 2018/00351 Heart
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00642 with feedback, i.e. closed loop control
• CPC Class Codes: A61B 2018/00702 Power or energy
• CPC Class Codes: A61B 2018/00708 switching the power on or off
• CPC Class Codes: A61B 2018/00875 Resistance or impedance
• CPC Class Codes: A61B 2018/00898 Alarms or notifications created in response to an abnormal condition
• CPC Class Codes: A61B 2018/00904 Automatic detection of target tissue
• CPC Class Codes: A61B 2018/00982 combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes
• CPC Class Codes: A61B 2018/00994 combining two or more different kinds of non-mechanical energy or combining one or more non-mechanical energies with ultrasound
• CPC Class Codes: A61B 2218/002 Irrigation
• CPC Class Codes: A61B 5/0036 including treatment, e.g., using an implantable medical device, ablating, ventilating
• CPC Class Codes: A61B 5/0071 by measuring fluorescence emission
• CPC Class Codes: A61B 5/0075 by spectroscopy, i.e. measuring spectra, e.g. Raman spectroscopy, infrared absorption spectroscopy A61B5/0071 takes precedence
• CPC Class Codes: A61B 5/0084 for introduction into the body, e.g. by catheters A61B5/1459 takes precedence
• CPC Class Codes: A61B 5/062 using magnetic field
• CPC Class Codes: A61B 5/6843 Monitoring or controlling sensor contact pressure
• CPC Class Codes: A61B 90/37 : Surgical systems with images on a monitor during operation

Abstract

Ablation visualization and monitoring systems and methods are provided. In some embodiments, such methods comprise applying ablation energy to a tissue to form a lesion in the tissue, illuminating the tissue with a light to excite NADH in the tissue, wherein the tissue is illuminated in a radial direction, an axial direction, or both, monitoring a level of NADH fluorescence in the illuminated tissue to determine when the level of NADH fluorescence decreases from a base level in the beginning of the ablating to a predetermined lower level, and stopping ablation of the tissue when the level of NADH fluorescence reaches the predetermined lower level.

Claims

1. A method for monitoring ablation of cardiac tissue of endocardium comprising:

applying ablation energy to a cardiac tissue to form a lesion in the tissue;

illuminating the cardiac tissue to excite nicotinamide adenine dinucleotide hydrogen (NADH) in the cardiac tissue and determining a base level of NADH fluorescence in the illuminated cardiac tissue;

monitoring a level of NADH fluorescence in the illuminated cardiac tissue during the application of ablation energy to the illuminated cardiac tissue;

reducing the NADH fluorescence in the illuminated cardiac tissue to between 60% and 80% of the base level and achieving a steady state NADH fluorescence; and

upon achieving the steady state NADH fluorescence for between 5 and 10 seconds, stopping ablation of the illuminated cardiac tissue to limit an amount of ablation energy delivered to the cardiac tissue.

2. The method of claim 1 wherein the cardiac tissue is illuminated with light having a wavelength between about 300 nm and about 400 nm.

3. The method of claim 1 further comprising monitoring a level of the reflected light having a wavelength between about 450 nm and 470 nm.

4. The method of claim 1 wherein the ablation energy is selected from the group consisting of radiofrequency (RF) energy, microwave energy, electrical energy, electromagnetic energy, cryoenergy, laser energy, ultrasound energy, acoustic energy, chemical energy, thermal energy, electroporation energy, and combinations thereof.

5. The method of claim 1 further comprising advancing a catheter to the cardiac tissue, the catheter comprising:

a catheter body;

a distal tip positioned at a distal end of the catheter body for delivering ablation energy to the cardiac tissue, the distal tip defining an illumination cavity having one or more openings for exchange of light between the illumination cavity and the tissue; and

one or more optical fibers extending through the catheter body into the illumination cavity of the distal tip, the one or more optical fibers being in communication with a light source and a light measuring instrument to illuminate the cardiac tissue and to relay light energy reflected from the cardiac tissue to the light measuring instrument.

6. The method of claim 1 further comprising illuminating the cardiac tissue in a radial direction and an axial direction with respect to a longitudinal axis of a catheter.

7. The method of claim 1 further comprising providing a real time visual feedback about the lesion formation by displaying the level of NADH fluorescence.

8. The method of claim 1, wherein the ablation energy is applied when a NADH fluorescence peak is detected.

9. The method of claim 1 further comprising performing an ultrasound evaluation of cardiac tissue in combination with monitoring the level of NADH fluorescence.

10. The method of claim 1 further comprising monitoring a level of the reflected light having a wavelength between about 375 nm and about 575 nm.

11. The method of claim 1, further comprising determining a proper position of a catheter for applying ablation energy such that the catheter is positioned adjacent to the cardiac tissue, the proper position being determined using base level NADH fluorescence with NADH fluorescence above the base level indicating that the catheter is pushing on the cardiac tissue with excessive force and NADH fluorescence below the base level indicating that the catheter is positioned in a blood pool and not adjacent the cardiac tissue.

12. A system for monitoring tissue ablation comprising:

a catheter comprising;

a catheter body; and

a distal tip positioned at a distal end of the catheter body, the distal tip having one or more openings for passing light energy to a cardiac tissue of endocardium;

an ablation system in communication with the distal tip to deliver ablation energy to the distal tip;

a visualization system comprising a light source, a light measuring instrument, and one or more optical fibers in communication with the light source and the light measuring instrument and extending through the catheter body to the distal tip, wherein the one or more optical fibers are configured to pass light energy to the cardiac tissue to illuminate the cardiac tissue to excite NADH in the cardiac tissue;

a processor in communication with the light measuring instrument, the processor being programmed to;

determine a base level of NADH fluorescence in the illuminated cardiac tissue;

monitor a reduction in the NADH fluorescence in the illuminated cardiac tissue to between 60% and 80% of the base level and a steady state NADH fluorescence; and

wherein, upon achieving the steady state NADH fluorescence for between 5 and 10 seconds, ablation of the illuminated cardiac tissue stops to limit an amount of ablation energy delivered to the cardiac tissue.

13. The system of claim 12 wherein the cardiac tissue is illuminated with light having a wavelength between about 300 nm and about 400 nm.

14. The system of claim 12 wherein the processor monitors a level of the reflected light having a wavelength between about 450 nm and about 470 nm.

15. The system of claim 12 wherein the ablation energy is selected from the group consisting of radiofrequency (RF) energy, microwave energy, electrical energy, electromagnetic energy, cryoenergy, laser energy, ultrasound energy, acoustic energy, chemical energy, thermal energy, electroporation energy, and combinations thereof.

16. The system of claim 12 wherein the catheter is configured to illuminate the cardiac tissue in a radial direction and an axial direction with respect to a longitudinal axis of the catheter.

17. The system of claim 12 further comprising an irrigation system for irrigation of the one or more openings.

18. The system of claim 12 wherein the catheter further comprises one or more ultrasound transducers and one or more electromagnetic location sensors and the system further comprises an ultrasound system in communication with the one or more ultrasound transducers for ultrasound evaluation of the cardiac tissue.

19. The system of claim 12 wherein the catheter further includes one or more electromagnetic location sensors and the system further includes a navigation system in communication with the one or more electromagnetic location sensors for locating and navigating the catheter.

20. The system of claim 12 wherein the system applies the ablation energy when a NADH fluorescence peak is detected.

21. A system for monitoring tissue ablation comprising:

an elongated body;

an ablation system associated with a distal tip of the elongated body for delivering ablation energy to cardiac tissue of endocardium;

a visualization system comprising a light source, a light measuring instrument, and one or more optical fibers in communication with the light source and the light measuring instrument and extending through the elongated body to the distal tip, wherein the one or more optical fibers are configured to pass light energy to the cardiac tissue to illuminate the cardiac tissue to excite NADH in the illuminated cardiac tissue;

a processor in communication with the light measuring instrument, the processor being programmed to;

determine a base level of NADH fluorescence in the illuminated cardiac tissue;

monitor a reduction in the NADH fluorescence in the illuminated cardiac tissue to between 60% and 80% of the base level and a steady state NADH fluorescence; and

wherein, upon achieving the steady state NADH fluorescence for between 5 and 10 seconds, ablation of the illuminated cardiac tissue is stopped to limit an amount of ablation energy delivered to the cardiac tissue.

22. The system of claim 21 wherein the ablation energy is selected from the group consisting of radiofrequency (RF) energy, microwave energy, electrical energy, electromagnetic energy, cryoenergy, laser energy, ultrasound energy, acoustic energy, chemical energy, thermal energy, electroporation energy and combinations thereof.

23. The system of claim 21 wherein the cardiac tissue is illuminated with light having a wavelength between about 300 nm and about 400 nm.

24. The system of claim 21 wherein the processor monitors a level of the reflected light having a wavelength between about 450 nm and about 470 nm.

25. The system of claim 21 wherein the processor monitors a level of the reflected light having a wavelength between about 375 nm and about 575 nm.

26. The system of claim 21 further comprising an irrigation system associated with the distal tip of the elongated body.

27. The system of claim 21 further comprising a balloon disposed at the distal tip of the elongated body.

28. A system for monitoring-tissue ablation comprising:

an elongated body having a distal tip;

an ablation system for delivering electroporation energy to cardiac tissue of endocardium;

a visualization system comprising a light source, a light measuring instrument, and one or more optical fibers in communication with the light source and the light measuring instrument and extending through the elongated body to the distal tip, wherein the one or more optical fibers are configured to pass light energy to the cardiac tissue to illuminate the cardiac tissue to excite NADH in the illuminated cardiac tissue;

a processor in communication with the light measuring instrument, the processor being programmed to;

determine a base level of NADH fluorescence in the illuminated cardiac tissue;

monitor a reduction in the NADH fluorescence in the illuminated cardiac tissue to between 60% and 80% of the base level and a steady state NADH fluorescence; and

wherein, upon achieving the steady state NADH fluorescence for between 5-10 seconds, ablation of the illuminated cardiac tissue stops to limit an amount of ablation energy delivered to the cardiac tissue.

29. A method for treating atrial fibrillation of cardiac tissue of endocardium comprising:

applying ablation energy to a cardiac tissue using an ablation catheter to form a lesion in the tissue at a location determined to treat atrial fibrillation;

illuminating the cardiac tissue to excite NADH in the cardiac tissue and determining a base level of NADH fluorescence in the illuminated cardiac tissue;

monitoring a level of NADH fluorescence in the illuminated cardiac tissue during the application of ablation energy to the illuminated cardiac tissue;

stopping ablation of the illuminated cardiac tissue when the NADH fluorescence in the illuminated cardiac tissue reaches a reduction from the base level between 60% and 80% and achieves a steady state NADH fluorescence for a period of time between 5-10 seconds to limit an amount of ablation energy delivered to the cardiac tissue.

30. The method of claim 29, further comprising interrogating the cardiac tissue to confirm adequate ablation at the location of the lesion to change electrical signals in the cardiac tissue to treat atrial fibrillation by identifying areas of the cardiac tissue with inadequate lesion formation using NADH fluorescence as the catheter is moved along a surface of the cardiac tissue.

31. A system for treating atrial fibrillation using tissue ablation comprising:

an elongated body;

an ablation system associated with a distal tip of the elongated body for delivering ablation energy to cardiac tissue of endocardium to treat atrial fibrillation;

a visualization system comprising a light source, a light measuring instrument, and one or more optical fibers in communication with the light source and the light measuring instrument and extending through the elongated body to the distal tip, wherein the one or more optical fibers are configured to pass light energy to the cardiac tissue to illuminate the cardiac tissue to excite NADH in the illuminated cardiac tissue and to relay light energy reflected from the cardiac tissue to the light measuring instrument;

a processor in communication with the light measuring instrument, the processor being programmed to;

determine a base level of NADH fluorescence in the illuminated cardiac tissue;

monitor a level of NADH fluorescence in the illuminated cardiac tissue during the application of ablation energy to the illuminated cardiac tissue,

wherein ablation of the illuminated cardiac tissue is stopped when the NADH fluorescence in the illuminated cardiac tissue reaches a reduction from the base level between 60% and 80% and achieves a steady state NADH fluorescence for a period of time between 5-10 seconds to limit an amount of ablation energy delivered to the cardiac tissue.

32. The system of claim 31, wherein the distal tip of the elongated body is configured to interrogate the cardiac tissue to confirm adequate ablation to change electrical signals in the cardiac tissue to treat atrial fibrillation by identifying areas of the cardiac tissue with inadequate lesion formation using NADH fluorescence as the distal tip of the elongated body is moved along a surface of the cardiac tissue.

33. A system for treating atrial fibrillation using tissue ablation comprising:

an elongated body having a distal tip;

an ablation system for delivering electroporation energy to cardiac tissue of endocardium to treat atrial fibrillation;

a visualization system comprising a light source, a light measuring instrument, and one or more optical fibers in communication with the light source and the light measuring instrument and extending through the elongated body to the distal tip, wherein the one or more optical fibers are configured to pass light energy to the cardiac tissue to illuminate the cardiac tissue to excite NADH in the illuminated cardiac tissue and to relay light energy reflected from the cardiac tissue to the light measuring instrument;

a processor in communication with the light measuring instrument, the processor being programmed to;

determine a base level of NADH fluorescence in the illuminated cardiac tissue;

monitor a level of NADH fluorescence in the illuminated cardiac tissue during the application of ablation energy to the illuminated cardiac tissue,

wherein ablation of the illuminated cardiac tissue is stopped when the NADH fluorescence in the illuminated cardiac tissue reaches a reduction from the base level between 60% and 80% and achieves a steady state NADH fluorescence for a period of time between 5-10 seconds to limit an amount of ablation energy delivered to the cardiac tissue.

34. The system of claim 33, wherein the distal tip of the elongated body is configured to interrogate the cardiac tissue to confirm adequate ablation to change electrical signals in the cardiac tissue to treat atrial fibrillation by identifying areas of the cardiac tissue with inadequate lesion formation using NADH fluorescence as the distal tip of the elongated body is moved along a surface of the cardiac tissue.