Systems and methods for assessment of contact quality

• US 10,143,517 B2
• Filed: 11/03/2015
• Issued: 12/04/2018
• Est. Priority Date: 11/03/2014
• Status: Active Grant

• Current Assignee: 460Medical, Inc.
• Original Assignee: LuxCath, LLC (Allied Minds Plc)
• Inventors: Ransbury, Terrance J., Armstrong, Kenneth C., Amirana, Omar, Larson, Cinnamon, Bowen, James
• Primary Examiner(s): PEFFLEY, MICHAEL F
• Application Number:
  US14/931,325
• Publication Number:
  US 20160120602A1
• Time in Patent Office: 1,127 Days
• 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 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 2017/00057 Light
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/0212 using an instrument inserted into a body lumen, e.g. catheter
• CPC Class Codes: A61B 2018/20361 with redirecting based on sensed condition, e.g. tissue analysis or tissue movement
• CPC Class Codes: A61B 2018/2285 with removable, replacable, or exchangable tips
• CPC Class Codes: A61B 2090/065 for measuring contact or contact pressure
• CPC Class Codes: A61B 2090/3784 both receiver and transmitter being in the instrument or receiver being also transmitter
• CPC Class Codes: A61B 2218/002 Irrigation

Abstract

Ablation and visualization systems and methods to access quality of contact between a catheter and tissue are provided. In some embodiments, a method for monitoring tissue ablation of the present disclosure comprises advancing a distal tip of an ablation catheter to a tissue in need of ablation; illuminating the tissue with UV light to excite NADH in the tissue, wherein the tissue is illuminated in a radial direction, an axial direction, or both; determining from a level of NADH fluorescence in the illuminated tissue when the distal tip of the catheter is in contact with the tissue; and delivering ablation energy to the tissue to form a lesion in the tissue.

Claims

1. A method for monitoring tissue ablation comprising:

advancing a distal tip of an ablation catheter to a tissue in need of ablation;

illuminating the tissue to excite nicotinamide adenine dinucleotide hydrogen (NADH) in the tissue;

delivering ablation energy to the tissue to form a lesion in the tissue;

receiving an NADH fluorescence signal during the delivering ablation energy; and

displaying an amplitude of the NADH fluorescence signal during the delivering ablation energy, wherein the amplitude of the NADH fluorescence signal is indicative of a stability of a contact between the distal tip of the ablation catheter and the tissue.

2. The method of claim 1 further comprising monitoring the amplitude of the NADH fluorescence signal during the delivering ablation energy to confirm that the distal tip remains in contact with the tissue.

3. The method of claim 1 further comprising stopping ablation of the tissue when the contact between the distal tip and the tissue is not stable.

4. The method of claim 1 further comprising collecting a spectrum of fluorescence light reflected from the illuminated tissue to distinguish tissue type.

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

6. The method of claim 2 wherein the step of monitoring comprises monitoring a level of the reflected light having a wavelength between about 450 nm and about 470 nm to identify peak NADH fluorescence.

7. The method of claim 1 wherein the catheter comprises a catheter body;

the distal tip being positioned at a distal end of the catheter body for delivering ablation energy to the tissue, the distal tip defining an illumination cavity having one or more openings for exchange of light between the illumination cavity and 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 tissue and to relay light energy reflected from the tissue to the light measuring instrument.

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

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

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

11. The method of claim 1 further comprising performing an ultrasound evaluation of the tissue in combination with monitoring the amplitude of the NADH fluorescence signal.

12. The method of claim 1, further comprising determining a normalized magnitude of the amplitude of the NADH fluorescence signal and displaying variations in a magnitude of the amplitude of the NADH fluorescence signal to the normalized magnitude of the amplitude of the NADH fluorescence signal.

13. The method of claim 12, wherein the variations in magnitude are used to determine stability of contact between the distal tip and the tissue.

14. The method of claim 2 wherein the step of monitoring comprises monitoring a level of the reflected light having a wavelength between about 375 nm and about 575 nm to identify peak NADH fluorescence.

16. 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.

15. 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;

a processor in communication with an ablation energy source, the light source and the light measuring instrument, the processor being programmed to;

receive NADH fluorescence data from the tissue illuminated with a light through the distal tip of the catheter during the delivery of ablation energy to the tissue; and

display an amplitude of an NADH fluorescence signal during the delivery of ablation energy, wherein the amplitude of the NADH fluorescence signal is indicative of a stability of a contact between the distal tip of the catheter and the tissue.

17. The system of claim 15 wherein the processor is programmed to monitor the amplitude of the NADH fluorescence signal during the delivery of ablation energy to confirm that the distal tip remains in contact with the tissue.

18. The system of claim 15 wherein the tissue is illuminated with light having a wavelength between about 300 nm and about 400 nm.

19. The system of claim 15 wherein the processor monitors a level of a reflected light having a wavelength between about 450 nm and about 470 nm.

20. The system of claim 15 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.

21. The system of claim 15 wherein the catheter is configured to illuminate the tissue in a radial direction and an axial direction with respect to a longitudinal axis of the catheter.

22. The system of claim 15 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.

23. The system of claim 15 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.

24. The system of claim 15 wherein the processor is programmed to determine a normalized magnitude of the amplitude of the NADH fluorescence signal and to display variations in a magnitude of the amplitude of the NADH fluorescence signal to the normalized magnitude of the amplitude of the NADH fluorescence signal, wherein the variations in magnitude are used to determine stability of contact between the distal tip and the tissue.

25. 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 a tissue;

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

a processor in communication with the visualization system, the processor being programmed to;

receive NADH fluorescence data from the tissue during the delivery of ablation energy to the tissue; and

display an amplitude of an NADH fluorescence signal during the delivery of ablation energy, wherein the amplitude of the NADH fluorescence signal is indicative of a stability of a contact between the distal tip of the elongated body and the tissue.

26. The system of claim 25 wherein the processor is programmed to monitor the amplitude of the NADH fluorescence signal during the delivery of ablation energy to confirm that the distal tip remains in contact with the tissue.

27. The system of claim 25 wherein the tissue is illuminated with light having a wavelength between about 300 nm and about 400 nm.

28. The system of claim 27 wherein the processor monitors a level of a reflected light having a wavelength between about 450 nm and about 470 nm.

29. The system of claim 27 wherein the processor monitors a level of a reflected light having a wavelength between about 375 nm and about 575 nm.

30. The system of claim 25 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.

31. The system of claim 25 wherein the processor is programmed to determine a normalized magnitude of the amplitude of the NADH fluorescence signal and to display variations in a magnitude of the amplitude of the NADH fluorescence signal to the normalized magnitude of the amplitude of the NADH fluorescence signal.

32. The system of claim 31, wherein the variations in magnitude are used to determine stability of contact between the distal tip and the tissue.

33. The system of claim 25 further comprising a balloon disposed at the distal tip of the elongated body.