IP Library Granted Patent US 11,559,352
Granted Patent B2
US 11,559,352 · App. 16/879,956 · Granted Jan 24, 2023

Systems and methods for lesion assessment

Inventors: Omar Amirana (Cambridge, MA); Kenneth C. Armstrong (Cary, NC); James Bowen (Belmont, NC); Cinnamon Larson (Carrboro, NC); Marco A. Mercader (Arlington, VA); Terrance J. Ransbury (Chapel Hill, NC); Narine Sarvazyan (Potomac, MD)
Assignees: The George Washington University; 460Medical, Inc.
A61B18/1492A61B5/0036A61B5/0071A61B5/0075A61B5/0084A61B5/6843A61B18/1206A61B90/37A61B5/062A61B2018/00029A61B2018/00351A61B2018/00577A61B2018/00642A61B2018/00702A61B2018/00708A61B2018/00875A61B2018/00898A61B2018/00904A61B2018/00982A61B2018/00994A61B2218/002
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Quick Facts
Patent No.
US 11,559,352
App. No.
16/879,956
Granted
Jan 24, 2023
Kind
B2
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 (38)

1. A method for monitoring ablation comprising:

monitoring a level of NADH fluorescence in a tissue, illuminated with a light source to produce NADH fluorescence, during an application of ablation energy to the tissue;

detecting a reduction in the NADH fluorescence in the tissue to at least 60% of a base level of NADH fluorescence in the tissue and a steady state NADH fluorescence; and

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

2. The method of claim 1 , wherein the tissue is illuminated with light having a wavelength between about 300 nm and about 400 nm to produce the NADH fluorescence.

3. 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.

4. The method of claim 1 , further comprising providing a real time visual feedback about a lesion formation in the tissue due to the ablation energy by displaying the level of NADH fluorescence.

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

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

7. 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 tissue;

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 tissue to illuminate the tissue to excite NADH in the tissue; and

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

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

monitor a reduction in the NADH fluorescence in the illuminated tissue to at least 60% of the base level and a steady state NADH fluorescence; and

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

8. The system of claim 7 , wherein the tissue is illuminated with light having a wavelength between about 300 nm and about 400 nm.

9. The system of claim 7 , wherein the processor monitors a level of reflected fluorescence light having a wavelength between about 450 nm and about 470 nm.

10. The system of claim 7 , 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.

11. The system of claim 7 , wherein the catheter is configured to illuminate the tissue in a radial direction or an axial direction with respect to a longitudinal axis of the catheter.

12. The system of claim 7 , further comprising an irrigation system for irrigation of the one or more openings.

13. The system of claim 7 , 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 tissue.

14. The system of claim 7 , 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.

15. The system of claim 7 , wherein the catheter comprises a balloon at the distal tip.

16. A system for monitoring tissue ablation comprising:

a light source configured to illuminate a tissue;

a light measuring instrument; and

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

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

monitor a reduction in the NADH fluorescence in the illuminated tissue to at least 60% of the base level and a steady state NADH fluorescence; and

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

17. The system of claim 16 , further comprising an ablation system configure to deliver the ablation energy 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.

18. The system of claim 16 , further comprising one or more optical fibers in communication with the light source and the light measuring instrument and extending through an elongated body of a catheter to a distal tip, wherein the one or more optical fibers are configured to pass light energy to the tissue to illuminate the tissue to excite NADH in the illuminated tissue.

19. The system of claim 16 , wherein the tissue is illuminated with light having a wavelength between about 300 nm and about 400 nm.

20. The system of claim 16 , wherein the processor monitors a level of the reflected light having a wavelength between about 375 nm and about 575 nm.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 21, 2020
From: MERCADER, MARCO A.; SARVAZYAN, NARINE
To: THE GEORGE WASHINGTON UNIVERSITY
Reel/Frame 053827/0586 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 21, 2020
From: LUXCATH, LLC
To: 460MEDICAL, INC.
Reel/Frame 053827/0718 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 21, 2020
From: AMIRANA, OMAR; ARMSTRONG, KENNETH C.; BOWEN, JAMES; LARSON, CINNAMON; RANSBURY, TERRANCE J.
To: LUXCATH, LLC
Reel/Frame 053827/0867 →
Continuity (3)
Continuation 14931262 · Nov 3, 2015
Provisional Application 62074619 · Nov 3, 2014
Related Publication 20200352645A1 · Nov 12, 2020
Cited By (5)
US 12,295,795 US 12,343,114 US 12,539,043 US 12,557,989 US 12,653,389