Granted Patent B2

US 12,207,870 · App. 17/343,059 · Granted Jan 28, 2025

Inventors: Daniel Frank Massimini (Brooklyn Park, MN); Roger W. McGowan (Otsego, MN); Haiping Shao (Plymouth, MN); Darrin Dale Beekman (Osseo, MN); Christopher A. Cook (Laguna Niguel, CA)

Assignees: BOSTON SCIENTIFIC SCIMED, INC.; BOLT MEDICAL, INC.

A61B18/245A61B5/0075A61B18/042A61B18/1492A61B2018/0022A61B2018/00345

Abstract

Claims (40)

1. A catheter system for treating a vascular lesion within or adjacent to a vessel wall, the catheter system comprising:

an energy source that generates energy;

a balloon that is positionable substantially adjacent to the vascular lesion, the balloon having a balloon wall that defines a balloon interior, the balloon being configured to retain a balloon fluid within the balloon interior;

an energy guide that is configured to receive energy from the energy source and guide the energy into the balloon interior, the energy from the energy source being emitted at a guide distal end of the energy guide to energize a plasma generator so that plasma is generated in the balloon fluid within the balloon interior, the plasma generation causing rapid bubble formation and imparting pressure waves upon the balloon wall substantially adjacent to the vascular lesion; and

a tissue identification system that is configured to spectroscopically analyze tissue within the vascular lesion, the tissue identification system using the energy guide to direct energy from the energy source toward the vascular lesion.

2. The catheter system of claim 1 wherein the tissue identification system is configured to utilize spectroscopic tissue identification to provide real-time feedback regarding tissue type and quantity within the vascular lesion.

3. The catheter system of claim 1 wherein the energy source generates pulses of energy that are guided along the energy guide into the balloon interior to induce the plasma formation in the balloon fluid within the balloon interior.

4. The catheter system of claim 1 wherein the energy source is a laser source that provides pulses of laser energy, and the energy guide includes an optical fiber.

5. The catheter system of claim 1 wherein the energy source is a high voltage energy source that provides pulses of high voltage.

6. The catheter system of claim 1 wherein the energy guide includes an electrode pair including spaced apart electrodes that extend into the balloon interior; and wherein pulses of high voltage from the energy source are applied to the electrodes and form an electrical arc across the electrodes.

7. The catheter system of claim 1 wherein the tissue identification system includes a spectroscopic light source that is configured to provide electromagnetic energy in the form of a spectroscopic source beam that is used to diagnostically interrogate the tissue within the vascular lesion.

8. The catheter system of claim 7 wherein the spectroscopic light source is a broadband light source with a targeted wavelength range that is based at least in part on optical characteristics of the tissue being analyzed.

9. The catheter system of claim 7 wherein the spectroscopic light source is a coherent, monochromatic light source with a targeted wavelength that is based at least in part on optical characteristics of the tissue being analyzed.

10. The catheter system of claim 7 wherein the tissue identification system includes a light guide that receives the spectroscopic source beam and guides the spectroscopic source beam from a guide proximal end to a guide distal end that is positioned within the balloon interior.

11. The catheter system of claim 10 wherein the tissue identification system further includes a modulator that optically couples the spectroscopic source beam into the light guide.

12. The catheter system of claim 11 wherein the modulator further couples the energy from the energy source into the energy guide.

13. The catheter system of claim 10 wherein the spectroscopic source beam is retained within an input fiber that is coupled to the spectroscopic light source.

14. The catheter system of claim 13 wherein the input fiber is directly mechanically coupled to the light guide so that the spectroscopic source beam is optically coupled into the light guide.

15. The catheter system of claim 13 wherein the tissue identification system further includes coupling optics so that the spectroscopic source beam is optically coupled into the light guide.

16. The catheter system of claim 13 wherein the light guide includes a plurality of guide cores; and wherein the spectroscopic source beam is optically coupled into a first guide core of the plurality of guide cores.

17. The catheter system of claim 10 wherein the light guide directs the spectroscopic source beam toward the vascular lesion.

18. The catheter system of claim 17 wherein the light guide includes a diverter that is coupled to the guide distal end to direct the spectroscopic source beam toward the vascular lesion.

19. The catheter system of claim 7 wherein at least a portion of the spectroscopic source beam is returned by the tissue being analyzed as a returning identification beam that is directed back toward the guide distal end of the light guide.

20. The catheter system of claim 19 wherein the returning identification beam is guided by the light guide from the guide distal end to the guide proximal end, and is then directed toward a light detector that is configured to capture and quantify detected characteristics of the returning identification beam.

21. The catheter system of claim 20 wherein the modulator directs the returning identification beam toward the light detector, and wherein the returning identification beam is retained within an output fiber that is coupled to the light detector.

22. The catheter system of claim 21 wherein the output fiber is directly mechanically coupled to the light guide so that the returning identification beam is optically coupled from the light guide into the output fiber.

23. The catheter system of claim 21 wherein the tissue identification system further includes coupling optics so that the returning identification beam is optically coupled from the light guide into the output fiber.

24. The catheter system of claim 20 wherein the light detector generates a signal based on the detected characteristics of the returning identification beam and sends the signal to control electronics.

25. The catheter system of claim 24 wherein the control electronics analyze the signal to determine the tissue type and quantity within the vascular lesion.

26. The catheter system of claim 1 wherein the tissue identification system utilizes at least one of specular reflectance spectroscopy, diffuse reflectance spectroscopy, fluorescence spectroscopy and Raman spectroscopy.

27. The catheter system of claim 1 wherein the tissue identification system utilizes at least two of specular reflectance spectroscopy, diffuse reflectance spectroscopy, fluorescence spectroscopy and Raman spectroscopy.

28. A method for treating a vascular lesion within or adjacent to a vessel wall, the method comprising the steps of:

positioning a balloon substantially adjacent to the vascular lesion, the balloon having a balloon wall that defines a balloon interior;

retaining a balloon fluid within the balloon interior;

generating energy with an energy source so that the energy from the energy source is received with an energy guide;

guiding the energy into the balloon interior with the energy guide, the energy from the energy source being emitted at a guide distal end of the energy guide to energize a plasma generator so that a plasma is formed generated in the balloon fluid within the balloon interior, the plasma generation causing rapid bubble formation and imparting pressure waves upon the balloon wall substantially adjacent to the vascular lesion; and

spectroscopically analyzing tissue within the vascular lesion with a tissue identification system, the tissue identification system using the energy guide to direct energy from the energy source toward the vascular lesion.

29. The catheter system of claim 1 wherein the balloon includes a drug-eluting coating.

30. The method of claim 28 wherein the step of generating energy includes the energy source being a laser source that provides pulses of laser energy; and wherein the step of guiding the energy includes the energy guide including an optical fiber.

31. The method of claim 28 wherein the step of spectroscopically analyzing includes providing electromagnetic energy from a spectroscopic light source in the form of a spectroscopic source beam, and diagnostically interrogating the tissue within the vascular lesion with the spectroscopic source beam.

Assignments (2)

Continuity (2)

References Cited (400)