FALLOPOSCOPE AND METHOD FOR OVARIAN CANCER DETECTION

• US 20180014773A1
• Filed: 02/03/2016
• Published: 01/18/2018
• Est. Priority Date: 02/03/2015
• Status: Active Grant

• Current Assignee: Arizona Board of Regents (University of Arizona)
• Original Assignee: Arizona Board of Regents (University of Arizona)
• Inventors: Barton, Jennifer, Utzinger, Urs, Tate, Tyler, Keenan, Maureen, Black, John
• Granted Patent: US 10,939,864 B2
• Time in Patent Office: Days
• CPC Class Codes: A61B 1/000094 extracting biological structures
• CPC Class Codes: A61B 1/00082 Balloons
• CPC Class Codes: A61B 1/0051 with controlled bending of insertion part
• CPC Class Codes: A61B 1/0052 Constructional details of control elements, e.g. handles
• CPC Class Codes: A61B 1/0057 Constructional details of force transmission elements, e.g. control wires
• CPC Class Codes: A61B 1/043 for fluorescence imaging
• CPC Class Codes: A61B 1/063 for monochromatic or narrow-band illumination
• CPC Class Codes: A61B 1/0638 providing two or more wavelengths
• CPC Class Codes: A61B 1/0676 at distal tip of an endoscope
• CPC Class Codes: A61B 1/0684 using light emitting diodes [LED]
• CPC Class Codes: A61B 1/07 using light-conductive means, e.g. optical fibres
• CPC Class Codes: A61B 1/303 for the vagina, i.e. vaginoscopes
• CPC Class Codes: A61B 5/0035 adapted for acquisition of images from more than one imaging mode, e.g. combining MRI and optical tomography
• CPC Class Codes: A61B 5/0066 Optical coherence imaging
• 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 5/4325 of the uterine cavities, e.g. uterus, fallopian tubes, ovaries
• CPC Class Codes: A61B 5/6847 mounted on an invasive device
• CPC Class Codes: A61B 5/6851 Guide wires
• CPC Class Codes: A61B 5/7282 : Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence

Abstract

A falloposcope is described, as is a method of screening a patient for fallopian tube and/or ovarian cancer with the Falloposcope. The falloposcope has an optical imaging subsystem capable of performing optical and fluorescence imaging, and an optical coherence tomography (OCT) channel, with a diameter of about 0.7 millimeter. The method includes inserting the falloposcope through a lumen of vagina, cervix, uterus, and fallopian tube such that a tip of the falloposcope is in proximity to a first fallopian tube or ovary of the patient; providing at least one fluorescence stimulus wavelength through an illumination fiber of the falloposcope, while imaging light at one or more fluorescence emission wavelengths through a coherent fiber bundle to form fluorescence emissions images; and determining suspect tissue from the fluorescence emission images. The OCT channel is also used to examine abnormalities in in-vivo female tissue, both to determine suspect tissue and analyze suspect abnormal tissue from fluorescence observations.

Claims

1. A method of observing an object comprising:

emitting light of a first fluorescence stimulus wavelength from a tip of a falloposcope, the tip of the falloposcope in proximity to the object, while imaging light at a first fluorescence emission wavelength, to form at least one first fluorescence emissions image of the object the falloposcope having a body adapted to passage through a lumen of a fallopian tube;

imaging the object at the first fluorescence stimulus wavelength to form a first stimulus wavelength image;

placing an optical coherence tomography (OCT) channel of the falloposcope adjacent the suspect abnormalities and performing optical coherence tomography to further analyze the suspect abnormalities; and

determining suspect abnormalities of the object from at least one first fluorescence emission image, the first stimulus wavelength image, and the optical coherence tomography.

2. The method of claim 1, wherein the falloposcope tip has a diameter of less than one millimeter, and the falloposcope is adapted for insertion of its tip through a lumen of a fallopian tube.

3. The method of claim 2, wherein imaging light at a first fluorescence emission wavelength is performed through a lens and a coherent fiber bundle of the falloposcope.

4. The method of claim 2, wherein generating light of the first stimulus wavelength is performed by providing light from a laser through a stimulus light fiber of the falloposcope.

5. The method of claim 2 wherein emitting light of the first stimulus wavelength is performed by energizing a light emitting semiconductor device located near the falloposcope tip.

7. The method of claim 27, wherein the step of inserting a falloposcope through a lumen is performed by observing the falloposcope and a portion of lumen with a hysteroscope.

8. The method of claim 7, further comprising inflating lateral everting balloon to aid positioning the OCT channel adjacent the suspect abnormalities.

9. The method of claim 8, further comprising using a steering wire controlled by a knob on a steering handle to help position the falloposcope tip.

10. The method of claim 2, further comprising inserting a guide wire through the lumen to a determined position, and inserting the falloposcope over the guide wire.

11. The method of claim 2, wherein positioning the falloposcope tip near an object comprises inserting the falloposcope through lumens of vagina, cervix, uterus, and fallopian tube of a patient such that the falloposcope tip is in proximity to a first fallopian tube or ovary of the patient, wherein the observed object is the first fallopian tube or ovary of the patient, and wherein the suspect abnormalities are tissue of the fallopian tube or ovary having characteristics consistent with cancerous tissue.

27. The method of claim 1 further comprising:

emitting light of a second fluorescence stimulus wavelength from the tip of the falloposcope while imaging light at a second fluorescence emission wavelength, to form at least one second fluorescence emissions image of the object;

imaging the object at the second fluorescence stimulus wavelength to form a second stimulus wavelength image.

6. (canceled)

12. A method of screening an object for an abnormality comprising:

positioning a falloposcope having an optical coherence tomography (OCT) channel through such that a tip of the falloposcope is in proximity to the object;

using an everting balloon to press the OCT channel against the object

using the OCT channel to perform optical coherence tomography and

determining an abnormality from the optical coherence tomography.

13. The method of claim 12, wherein the step of positioning a falloposcope such that a tip of the falloposcope is in proximity to the object is performed by observing the falloposcope and an opening with a hysteroscope.

14. The method of claim 13, further comprising inflating an everting balloon to aid positioning the OCT channel adjacent the object.

15. The method of claim 14, further comprising using a steering wire controlled by a knob on a steering handle to help position the falloposcope tip.

16. The method of claim 12, further comprising inserting a guide wire through a lumen to a determined position, and inserting the falloposcope over the guide wire.

17. The method of claim 14, wherein positioning the falloposcope tip near an object comprises inserting the falloposcope through lumens of vagina, cervix, uterus, and fallopian tube such that a tip of the falloposcope is in proximity to a first fallopian tube or ovary of the patient, wherein the object is the first fallopian tube or ovary of the patient, and the abnormality is tissue of the fallopian tube or ovary having characteristics consistent with cancerous tissue.

18. A falloposcope comprising:

an elongated body having a first end and a head end, the head end and elongated body having a diameter of less than one millimeter;

an afferent and efferent optical coherence tomography (OCT) channel having optical fiber coupleable to an OCT apparatus source and interferometer through the elongated body from the first end to a side-looking OCT port near the head end, the OCT apparatus comprising a source of coherent light and an interferometer that receives light through an optical fiber from the OCT port;

a lateral everting balloon disposed opposite the OCT port;

an optical imaging channel having;

an image sensor selected from the group consisting of an electronic camera at the head end of the body and a coherent fiber bundle extending from a first end of the bundle near the first end of the body through the body to a lens assembly at the head end of the body, the lens assembly configured to focus images on an end of the coherent fiber bundle, and an electronic camera coupled to image light received from the coherent fiber bundle; and

an illuminator selected from the group consisting of at least one semiconductor light emitting device at the head end of the body and an illumination fiber extending at least from the first end of the body to the head end configured to pass light from an illuminator coupled to the illumination fiber near the first end of the body to the head end of the body;

wherein the illuminator is adapted to provide illumination selectable from options including at least visible light, and light of at least a first fluorescence stimulus wavelength;

wherein the electronic camera has at least a mode responsive to a broad spectrum of light and a first fluorescence emissions mode wherein the camera does not respond to light of the first fluorescence stimulus wavelength but does respond to light of a first fluorescence emissions wavelength longer than the first fluorescence emissions wavelength; and

an image processor, the image processor adapted to control the illuminator and to process images received from the camera.

19. A falloposcope of claim 18, further comprising:

a hysteroscope, the hysteroscope having a body and an optical system comprising;

a hysteroscope illuminator adapted to provide light near a first end of the hysteroscope body,

a hysteroscope camera adapted to image objects near the first end of the hysteroscope body and to provide images to a display coupled to a second end of the hysteroscope body, and

a lumen extending through the hysteroscope body to the first end of the hysteroscope body;

wherein the falloposcope of claim 18 extends through the lumen of the hysteroscope body.

20. A falloposcope of claim 18, wherein the illuminator is further adapted to emit light of at least a second fluorescence stimulus wavelength, the second stimulus wavelength different from the first fluorescence stimulus wavelength.

21. A falloposcope of claim 18, wherein the electronic camera has a second fluorescence imaging mode wherein the camera does not respond to light of the second fluorescence stimulus wavelength but does respond to light of a second fluorescence emissions wavelength longer than the second fluorescence emissions wavelength.

22. A falloposcope of claim 18, further comprising a steering wire configured to bend the elongated body near the head end of the elongated body upon manipulation of a control attached to a manipulation handle of the falloposcope.

23. A falloposcope of claim 18, wherein the image processor is adapted to use images obtained from the camera in the first fluorescence emissions wavelength and images obtained from the camera in broad spectrum mode to determine suspect abnormalities viewed in the images.

25. A falloposcope of claim 21, wherein the image processor is further adapted to use optical coherence tomography (OCT) data acquired through the OCT apparatus to evaluate tissue adjacent the OCT port.

24. (canceled)

26. A falloposcope, comprising:

an elongated body having circumferential diameter less than one millimeter;

an afferent and efferent optical coherence tomography (OCT) channel having an optical fiber extending through the elongated body;

an illuminator coupled to an illumination fiber near the first end of the body to the head end of the body to provide illumination selectable between ultraviolet and visible light and at least a first fluorescence stimulus wavelength;

an image sensor including a lens assembly configured to focus images on an end of a coherent fiber bundle running through the elongated body, and an electronic camera coupled to image light received from the coherent fiber bundle, the sensor being mode responsive to a broad spectrum of light and a first fluorescence emissions mode and not responsive to light of the first fluorescence stimulus wavelength; and

an image processor adapted to control the illuminator and generate enhanced images from images received by the image processor from the image sensor.