Systems and methods for lesion assessment

Patent metadata

Field	Value
Publication number	US-10722301-B2
Application number	US-201514931262-A
Country	US
Kind code	B2
Filing date	Nov 3, 2015
Priority date	Nov 3, 2014
Publication date	Jul 28, 2020
Grant date	Jul 28, 2020

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.

First claim

What is claimed is:

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 fo

Assignees

• Univ George Washington
• Luxcath Llc
• 460Medical Inc

Inventors

• Amirana Omar
• Armstrong Kenneth C
• Bowen James
• Larson Cinnamon
• Mercader Marco A
• Ransbury Terrance J
• Sarvazyan Narine

Classifications

• A61B5/0036

  including treatment, e.g., using an implantable medical device, ablating, ventilating · CPC title

• A61B5/0084

  for introduction into the body, e.g. by catheters (A61B5/1459 takes precedence) · CPC title

• A61B5/0071

  by measuring fluorescence emission · CPC title

• A61B2018/00708

  switching the power on or off · CPC title

• A61B2018/00577

  Ablation · CPC title