Systems and methods for analysis and treatment of an occluded body lumen

• US 8,260,390 B2
• Filed: 10/15/2009
• Issued: 09/04/2012
• Est. Priority Date: 10/15/2008
• Status: Expired due to Fees

• Current Assignee: CorNova, Inc.
• Original Assignee: Angiolight, Inc.
• Inventors: Tang, Jing
• Primary Examiner(s): Perkey, W. B.
• Application Number:
  US12/579,751
• Publication Number:
  US 20100094109A1
• Time in Patent Office: 1,055 Days
• Field of Search: 600/341, 600/473, 600/478
• US Class Current: 600/341
• CPC Class Codes: A61B 17/3207 Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016
• CPC Class Codes: A61B 2017/00061 spectrum
• CPC Class Codes: A61B 2017/00066 intensity
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2017/22042 Details of the tip of the guide wire
• 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 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

Systems and methods are provided for probing an occluded body lumen, including a flexible conduit insertable into the body lumen, at least one delivery waveguide and at least one collection waveguide integrated with the flexible conduit and arranged to deliver and collect radiation about a distal end of said flexible conduit, at least one radiation source connected to a transmission input of the at least one delivery waveguide, at least one optical detector connected to a transmission output of at least one collection waveguide, a spectrometer connected with the at least one optical detector, and constructed and arranged to scan radiation and perform spectroscopy, and a controller programmed to process data from said spectrometer and provide information for directing said flexible conduit through obstacles within the occluded body lumen.

Claims

1. A system that probes and treats an occluded body lumen comprising:

a flexible conduit that is suitable for insertion into a body lumen, the conduit elongated along a longitudinal axis and having a proximal end and a distal end;

at least one delivery waveguide and at least one collection waveguide integrated with the flexible conduit and constructed and arranged to deliver and collect radiation about the distal end of said flexible conduit;

at least one radiation source connected to a transmission input of the at least one delivery waveguide, the radiation source constructed and arranged to provide radiation at a wavelength in a range of about 250 to 2500 nanometers;

at least one optical detector connected to a transmission output of the at least one collection waveguide;

a spectrometer connected to said at least one optical detector, said spectrometer constructed and arranged to scan radiation and perform spectroscopy at the wavelength of the radiation provided by the radiation source, said spectrometer configured to perform spectroscopy of at least one of the methods comprising fluorescence, light scatter, speckle correlometry, Raman, and diffuse reflectance spectroscopy; and

a controller programmed to process data from said spectrometer and provide information for directing said flexible conduit through obstacles within the occluded body lumen.

2. The system of claim 1 wherein the spectrometer is configured to perform spectroscopy selected from the group of methods consisting of fluorescence and diffuse reflectance spectroscopy.

3. The system of claim 1 wherein the at least one delivery waveguide and at least one collection waveguide are configured to scan and collect radiation longitudinally beyond the distal end of said flexible conduit.

4. The system of claim 3 wherein the spectrometer and controller are configured for measuring the presence of blood components longitudinally beyond the distal end of said flexible conduit.

5. The system of claim 4 wherein said blood components comprise hemoglobin.

6. The system of claim 5 wherein said radiation source is configured to supply radiation including a wavelength of 450 nanometers and wherein the spectrometer is configured and arranged to detect a fluorescence radiation including a wavelength of about 520 nanometers.

7. The system of claim 1 wherein said spectrometer is configured to perform diffuse reflectance spectroscopy scanning one or more discrete wavelengths including one of about 532 nanometers.

8. The system of claim 7 wherein said one or more discrete wavelengths consists of one of about 532 nanometers, one of about 407 nanometers, and at least one of between about 800 and 1000 nanometers.

9. The system of claim 8 wherein said system is programmed to calculate a ratio of absorbance data from the collection of said one or more wavelengths and compare the ratio with predetermined data including relationships between pre-calculated ratios of corresponding absorbance data to the presence of blood components within a lumen.

10. The system of claim 1 further comprising a display connected to said controller, wherein said controller and said display are adapted to identify in real-time the areas of the occluded lumen that are traversable.

11. The system of claim 1 wherein said flexible conduit further comprises an angioplasty balloon.

12. The system of claim 1 wherein said flexible conduit has a maximum outer diameter of between about 0.5 and about 0.67 millimeters.

13. The system of claim 1 wherein said flexible conduit has a maximum outer diameter of less than about 0.5 millimeters.

14. The system of claim 1 wherein said flexible conduit is a guidewire.

15. The system of claim 14 wherein said guidewire comprises one or more fiber connectors detachable from the proximate end of said guidewire so as to allow said guidewire to completely pass through a catheter.

16. The system of claim 1 wherein said flexible conduit has a maximum outer diameter of about 0.3 millimeters or less.

17. The system of claim 1 wherein said flexible conduit includes a distal end with a portion pre-bent at an angle so as to allow increased maneuverability through an occluded lumen.

18. The system of claim 17 wherein the portion pre-bent at an angle is bent at an angle between 15 and 45 degrees.

19. The system of claim 1 wherein the at least one delivery waveguide and at least one collection waveguide comprise fiber optic tips manufactured to emit or collect radiation circumferentially around approximately 90 degrees or more of the end of the fiber optic tips.

20. The system of claim 1 wherein a transmission output of at least one delivery waveguide is longitudinally separated from a transmission input of at least one collection waveguide.

21. The system of claim 1 wherein said at least one delivery waveguide and at least one collection waveguide consist of a single waveguide.

22. A method for directing a flexible conduit through obstacles within an occluded body lumen, the method comprising:

providing a flexible conduit that is suitable for insertion into a body lumen, said flexible conduit integrated with at least one delivery waveguide arranged to deliver radiation about the distal end of said conduit and at least one collection waveguide arranged to collect radiation about the distal end of said conduit;

maneuvering the conduit in proximity to an occluded region of the body lumen;

executing spectroscopic analysis of the occluded region using radiation at a wavelength in a range of about 250 to 2500 nanometers by radiating areas of the occluded region with the radiation that is supplied at the transmission output of the at least one delivery waveguide, the supplied radiation distributed about the distal end of said flexible conduit, and wherein radiation is returned to the transmission input of the at least one collection waveguide, said spectroscopic analysis comprising at least one of fluorescence, light scatter, speckle correlometry, Raman, and diffuse reflectance spectroscopy;

processing data from said spectroscopic analysis in order to locate tissue and fluids ahead of said flexible conduit that is traversable; and

maneuvering the flexible conduit through traversable tissue and fluids.

23. The method of claim 22 wherein said spectroscopic analysis and processing data from spectroscopic analysis comprises determining areas of blood components that allow relatively less impeded traversal of said flexible conduit.

24. The method of claim 23 wherein determining areas of blood components that allow relatively less impeded traversal of said flexible conduit comprises determining areas of relatively greater hemoglobin content.

25. The method of claim 22 wherein said spectroscopic analysis comprises delivering a wavelength of 450 nanometers and detecting a fluorescence radiation including a wavelength of 520 nanometers.

26. The method of claim 22 wherein said spectroscopic analysis comprises diffuse reflectance spectroscopy scanning of one or more discrete delivery wavelengths including one of about 532 nanometers.

27. The method of claim 26 wherein said spectroscopic analysis comprises discretely scanning wavelengths consisting of one of about 532 nanometers, one of about 407 nanometers, and at least one between 800 and 1000 nanometers.

28. The method of claim 26 wherein said spectroscopic analysis comprises scanning two or less wavelengths including at least one of about 532 nanometers.

29. The method of claim 22 wherein said processing data from said spectroscopic analysis comprises calculating a ratio of absorbance data from the collection of said one or more wavelengths with predetermined data including relationships between pre-calculated ratios of corresponding absorbance data to the presence of blood components within a lumen.

30. The method of claim 22 wherein a display is provided that identifies in real-time the areas of the occluded lumen that are traversable.

31. The method of claim 30 wherein the areas of the occluded lumen are demarked by forward-positioned segments about the circumference of said conduit.

32. The method of claim 22 wherein said flexible conduit includes a distal end with a portion pre-bent at an angle so as to allow increased maneuverability through said occluded lumen.

33. The method of claim 32 wherein the step of maneuvering the flexible conduit through traversable tissue and fluids comprises rotating said pre-bent portion toward an area identified as traversable.

34. The method of claim 22 wherein said flexible conduit comprises an angioplasty balloon and wherein the method further comprises the step of inflating said angioplasty balloon after maneuvering the flexible conduit through the traversable tissue and fluids.

35. The method of claim 22 wherein said flexible conduit is a guidewire having a proximate end with detachable optical connectors and wherein said proximate end with detachable optical connectors is detached following the step of maneuvering the flexible conduit through the traversable tissue and fluids.