Wireless, handheld tissue oximetry device

• US 10,456,066 B2
• Filed: 07/26/2016
• Issued: 10/29/2019
• Est. Priority Date: 05/03/2012
• Status: Active Grant

• Current Assignee: ViOptix, Inc.
• Original Assignee: ViOptix, Inc.
• Inventors: Bechtel, Kate LeeAnn, Heanue, Joseph, Lloyd, Lester John, Solomon, Edward
• Primary Examiner(s): Winakur, Eric F
• Assistant Examiner(s): Fardanesh, Marjan
• Application Number:
  US15/220,354
• Publication Number:
  US 20160331288A1
• Time in Patent Office: 1,190 Days
• Field of Search: None
• CPC Class Codes: A61B 2090/065 for measuring contact or contact pressure
• CPC Class Codes: A61B 2090/306 using optical fibres
• CPC Class Codes: A61B 2090/395 with marking agent for marking skin or other tissue
• CPC Class Codes: A61B 2560/0431 Portable apparatus, e.g. comprising a handle or case
• CPC Class Codes: A61B 2560/0475 Special features of memory means, e.g. removable memory cards
• CPC Class Codes: A61B 2562/0271 Thermal or temperature sensors
• CPC Class Codes: A61B 2562/166 the sensor is mounted on a specially adapted printed circuit board
• CPC Class Codes: A61B 5/0059 using light, e.g. diagnosis by transillumination, diascopy, fluorescence A61B5/0093, A61B5/1455, A61B5/02416 and A61B5/0261 take precedence
• 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 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/14551 for measuring blood gases
• CPC Class Codes: A61B 5/14552 Details of sensors specially adapted therefor
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/72 Signal processing specially adapted for physiological signals or for diagnostic purposes character recognition, recognising digital ink, document-oriented image-based pattern recognition G06V30/00; recognition or understanding of postal images G06V30/424
• CPC Class Codes: A61B 5/7246 using correlation, e.g. template matching or determination of similarity
• 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
• CPC Class Codes: A61B 5/74 Details of notification to user or communication with user or patient indicating measured values G01D7/00; user input means input or output arrangements for computers G06F3/00
• CPC Class Codes: A61B 5/7405 using sound
• CPC Class Codes: A61B 5/742 : using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 5/7475 : User input or interface means, e.g. keyboard, pointing device, joystick
• CPC Class Codes: A61B 90/11 : with guides for needles or instruments, e.g. arcuate slides or ball joints
• CPC Class Codes: A61B 90/39 : Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61M 35/003 : Portable hand-held applicators having means for dispensing or spreading integral media hand-held massage devices with liquid delivery A61H7/003

Abstract

A system includes an enclosure having a processor and a memory coupled to the processor. The enclosure includes a display coupled to the processor where the display is visible from an exterior of the enclosure; and a battery within the enclosure coupled to the processor and the display. The enclosure includes a probe tip coupled to an exterior of the enclosure. The probe tip includes first, second, and third sensor openings. A first distance between the first and second sensor openings is different than a second distance between the first and third sensor openings. The enclosure includes code stored in the memory where the code is executable by the processor, and includes code to receive first data associated with the first and second sensor openings, code to receive second data associated with the first and second sensor openings, and code to perform SRS using the first and the second data.

Claims

1. A method comprising:

enclosing in a housing a first printed circuit board comprising a processor and a memory, wherein the memory is coupled to the processor;

providing a display, coupled to the processor and the housing, wherein the display is visible from an exterior side of the housing, wherein a shape of the housing comprises;

a back surface of the housing which during use, rests between a thumb and forefinger of the hand,

a probe tip comprising a relatively planar surface comprising sensor openings, wherein the relatively planar surface is angled at a non-zero angle relative to the back surface,

a top surface of the housing comprising the display, wherein the top surface is angled at a non-zero angle relative to the back surface, and

a tubular hand grip region, comprising the back surface, coupled between the top surface and the probe tip;

forming a structure of the housing to retain the probe tip, wherein the probe tip is coupled to an exterior side of the enclosure, and the probe tip comprises at least a first sensor opening, a second sensor opening, a third sensor opening, and a fourth sensor opening,

wherein a first distance is between the first and second sensor openings, and a second distance is between the first and third sensor openings, a third distance is between the first sensor opening and the fourth sensor opening, and the first distance is different from the second distance, and the third distance is greater than the first distance and the second distance;

providing a first light source for the first sensor opening, wherein the first sensor opening is coupled via an optical fiber to the first light source;

providing light detectors for the second and the third sensor openings, wherein the second and the third sensor openings are coupled via channels to the light detectors, and the optical fiber has a length that is longer than each of the channels;

providing a second light source for the fourth sensor opening, wherein the first sensor opening is coupled via an optical fiber to the second light source;

configuring the probe tip to receive first data associated with the first and the second sensor openings;

configuring the probe tip to receive second data associated with the first and the third sensor openings; and

configuring the processor to perform spatially-resolved spectroscopy using the first and the second data to determine an oxygen saturation value.

2. The method of claim 1 wherein a fourth distance is between the second and fourth sensor openings, and a fifth distance is between the third and fourth sensor openings, the fourth distance is different from the first distance, and the fifth distance is different from the second distance.

3. The method of claim 2 comprising:

configuring the probe tip to receive third data associated with the second sensor and fourth sensor openings;

configuring the probe tip to receive fourth data associated with the third sensor and fourth sensor openings,

wherein configuring the processor to perform spatially-resolved spectroscopy also uses the third and fourth data in determining the oxygen saturation value.

4. The method of claim 1 wherein a shape of the housing comprises:

a front surface comprising a button, wherein the front surface is coupled between the top surface and tubular hand grip region.

5. A handheld tissue oximeter device comprising:

a housing comprising;

a processor, contained within the housing;

a memory, contained within the housing, wherein the memory is coupled to the processor;

a display, coupled to the processor, wherein the display is visible from an exterior of the housing; and

a sensor module, coupled to the processor, wherein the sensor module comprises a probe face that is retained by the tip portion of the housing at a relatively fixed position with respect to the housing and that is placed against and faces tissue to be measured, and the probe face comprises;

a first source structure and a second source structure, formed on the probe face;

a first detector structure, formed on the probe face, wherein a first distance is from the first detector structure to the first source structure, a second distance is from the first detector structure to the second source structure, and the first distance is greater than the second distance;

a second detector structure, formed on the probe face, wherein a third distance is from the second detector structure to the first source structure, a fourth distance is from the second detector structure to the second source structure, and the fourth distance is greater than the third distance, and

the first distance is the same as the fourth distance, and the second distance is the same as the third distance;

a third detector structure, formed on the probe face, wherein a fifth distance is from the third detector structure to the first source structure, a sixth distance is from the third detector structure to the second source structure, the fifth distance is different from the first distance and the second distance, and the sixth distance is different from the first distance and the second distance; and

a fourth detector structure, formed on the probe face, wherein a seventh distance is from the fourth detector structure to the first source structure, an eighth distance is from the fourth detector structure to the second source structure, the seventh distance is different from the first, second, and fifth distances, and the eighth distance is different from the first, second, and sixth distances,

the first distance is greater than the second, third, fifth, sixth, seventh, and eighth distances, and the second distance is less than the fifth, sixth, seventh, and eight distances, and

the processor is adapted to collect first information from the first detector structure in response to radiation emitted from the first source structure, the processor is adapted to collect second information from the second detector structure in response to radiation emitted from the first source structure, the first information is reflective of the tissue to be measured at a first depth below a surface of the tissue, the second information is reflective of the tissue to be measured at a second depth below the surface of the tissue, and the second depth is less than the first depth.

6. The device of claim 5 wherein the tissue to be measured at the first depth is above a subcutaneous fat layer and muscle layer that are below the surface of the tissue.

7. The device of claim 5 wherein the processor is adapted to collect third information from the third detector structure in response to radiation emitted from the first source structure, the processor is adapted to collect fourth information from the fourth detector structure in response to radiation emitted from the first source structure, the third information is reflective of the tissue to be measured at a third depth below the surface of the tissue, the fourth information is reflective of the tissue to be measured at a fourth depth below the surface of the tissue, and the third and fourth depths are between the first and second depths.

8. The device of claim 5 wherein the processor is adapted to collect third information from the third detector structure in response to radiation emitted from the second source structure, the processor is adapted to collect fourth information from the fourth detector structure in response to radiation emitted from the second source structure, the third information is reflective of the tissue to be measured at a third depth below the surface of the tissue, the fourth information is reflective of the tissue to be measured at a fourth depth below the surface of the tissue, and the third and fourth depths are between the first and second depths.

9. The device of claim 5 wherein the sensor module comprises:

a first source diode and a second source diode;

a first optical fiber, coupled between the first source structure and the first source diode; and

a second optical fiber, coupled between the second source structure and the second source diode.

10. The device of claim 9 wherein the first detector structure comprises a first photodetector positioned on the probe face, the second detector structure comprises a second photodetector positioned on the probe face, the third detector structure comprises a third photodetector positioned on the probe face, and the fourth detector structure comprises a fourth photodetector positioned on the probe face.

11. The device of claim 9 wherein the sensor module comprises:

a first photodetector, a second photodetector, a third photodetector, and a fourth photodetector;

a first waveguide, coupled between the first detector structure and the first photodetector;

a second waveguide, coupled between the second detector structure and the second photodetector;

a third waveguide, coupled between the third detector structure and the third photodetector; and

a fourth waveguide, coupled between the fourth detector structure and the fourth photodetector.

12. The device of claim 5 wherein the first source structure comprises a first source diode, and the second source structure comprises a second source diode.

13. The device of claim 5 wherein the sensor module comprises:

a first photodetector, a second photodetector, a third photodetector, and a fourth photodetector;

a first waveguide, coupled between the first detector structure and the first photodetector;

a second waveguide, coupled between the second detector structure and the second photodetector;

a third waveguide, coupled between the third detector structure and the third photodetector; and

a fourth waveguide, coupled between the fourth detector structure and the fourth photodetector.

14. The device of claim 13 wherein the sensor module comprises an aperture mask, and the aperture mask comprises the first waveguide, the second waveguide, the third waveguide, and the fourth waveguide.

15. The device of claim 5 wherein based on the first distance being different from the second distance, the processor is adapted to determine an oxygen saturation value based on a first data received from the first source structure and a second data received from the second source structure.

16. The device of claim 15 wherein the probe tip comprises a temperature sensing unit configured to generate temperature information that represents the temperature of the first source structure, and wherein the processor is configured to adjust a duty cycle of an oscillating control signal supplied to the first source structure to adjust the luminosity generated by the first source structure based on the temperature information if the temperature of the first source structure changes.

17. The device of claim 5 wherein the processor calculates an oxygen saturation value using spatially-resolved spectroscopy measurements from at least two detector structures having two different distances from a source structure,

a first received data is received from the third detector structure in response to light emitted from the first source structure, the third detector structure being at the fifth distance from the first source structure,

a second received data is received from the fourth detector structure in response to light emitted from the first source structure, the fourth detector structure being at the seventh distance from the first source structure, and

the processor calculates the oxygen saturation value using the first and second received data using spatially-resolved spectroscopy where the fifth and seventh distances are different from each other.

18. The device of claim 5 wherein the handheld tissue oximeter device is a standalone unit,

when the handheld tissue oximeter device is used, the housing comprising the processor, memory, and display of the device is cradled between a thumb and forefinger of a hand of a user while the display is at a proximal end of the device and the tip portion of the housing extends in a distal direction to a distal end of the device, and

while the device is in the user'"'"'s hand, the user positions the probe face that is at the distal end of the device on the tissue to be measured.

19. The device of claim 5 wherein the first and second source structures and first, second, third, and fourth detector structures are arranged in a circular arrangement.

20. The device of claim 5 wherein the first and second detector structures are arranged symmetrically about a point on a line intersecting the first and second source structures, and

the third and fourth detector structures are arranged asymmetrically about the point on the line intersecting the first and second source structures.

21. The device of claim 20 wherein the first, second, third, and fourth detector structures and the first and second source structures are arranged in a circular arrangement.

22. The device of claim 5 wherein the first distance is greater than about 2.5 millimeters and less than about 4 millimeters.

23. The device of claim 22 wherein the second distance is less than about 1.5 millimeters.

24. The device of claim 22 wherein the second distance is less than about 1 millimeter.

25. The device of claim 5 wherein a ninth distance is from the first source structure to the second source structure, and the ninth distance is greater than the first, second, fifth, sixth, seventh, and eighth distances.

26. The device of claim 5 wherein the processor uses information collected from the first and second detector structures and not from the third and fourth detector structures to determine an offset due to a difference in source power between the first source structure and the second source structure.

27. A handheld tissue oximeter device comprising:

a housing comprising;

a processor, contained within the housing;

a memory, contained within the housing, wherein the memory is coupled to the processor;

a display, coupled to the processor, wherein the display is visible from an exterior of the housing; and

a tip portion of the housing;

a sensor module, coupled to the processor, wherein the sensor module comprises a probe face that is retained by the tip portion at a relatively fixed position with respect to the housing and that is placed against and faces tissue to be measured;

a first source structure and a second source structure, each formed on the probe face and arranged in a linear arrangement on a line;

a first source diode and a second source diode, each coupled to the processor;

a first radiation directing element and a second radiation directing element, optically coupled, respectively, to the first and second source diodes;

a first optical fiber optically coupled between the first radiation directing element and the first source structure;

a second optical fiber optically coupled between the second radiation directing element and the second source structure, wherein the first optical fiber transmits radiation emitted by the first source structure and passed through the first radiation directing element to the first source structure, and the second optical fiber transmits radiation emitted by the second source structure and passed through the second radiation directing element to the second source structure;

a first detector structure, formed on the probe face, wherein a first distance is from the first detector structure to the first source structure, a second distance is from the first detector structure to the second source structure, and the first distance is greater than the second distance;

a second detector structure, formed on the probe face, wherein a third distance is from the second detector structure to the first source structure, a fourth distance is from the second detector structure to the second source structure, and the fourth distance is greater than the third distance;

a third detector structure, formed on the probe face, wherein a fifth distance is from the third detector structure to the first source structure, a sixth distance is from the third detector structure to the second source structure, the fifth distance is different from the first distance and the second distance, and the sixth distance is different from the first distance and the second distance; and

a fourth detector structure, formed on the probe face, wherein a seventh distance is from the fourth detector structure to the first source structure, an eighth distance is from the fourth detector structure to the second source structure, the seventh distance is different from the first, second, and fifth distances, and the eighth distance is different from the first, second, and sixth distances,

the first, second, third, and fourth detector structures are arranged asymmetrically about a point on the line on which the first and second source structures are arranged,

the first distance is different from the second, third, and fourth distances,

the second distance is different from the third and fourth distances,

the third and fourth distances are different,

the first distance is greater than the second, third, fifth, sixth, seventh, and eighth distances, and the second distance is less than the third, fifth, sixth, seventh, and eighth distances,

a ninth distance is from the first source structure to the second source structure, and the ninth distance is greater than the first, second, fifth, sixth, seventh, and eighth distances, and

the processor is adapted to collect first information from the first detector structure in response to radiation emitted from the first source structure, the processor is adapted to collect second information from the second detector structure in response to radiation emitted from the first source structure, the first information is reflective of the tissue to be measured at a first depth below a surface of the tissue, the second information is reflective of the tissue to be measured at a second depth below the surface of the tissue, and the second depth is less than the first depth.

28. The device of claim 27 wherein the tissue to be measured at the first depth is above a subcutaneous fat layer and muscle layer that are below the surface of the tissue.

29. The device of claim 27 wherein the processor is adapted to collect third information from the third detector structure in response to radiation emitted from the first source structure, the processor is adapted to collect fourth information from the fourth detector structure in response to radiation emitted from the first source structure, the third information is reflective of the tissue to be measured at a third depth below the surface of the tissue, the fourth information is reflective of the tissue to be measured at a fourth depth below the surface of the tissue, and the third and fourth depths are between the first and second depths.

30. The device of claim 27 wherein the processor is adapted to collect third information from the third detector structure in response to radiation emitted from the second source structure, the processor is adapted to collect fourth information from the fourth detector structure in response to radiation emitted from the second source structure, the third information is reflective of the tissue to be measured at a third depth below the surface of the tissue, the fourth information is reflective of the tissue to be measured at a fourth depth below the surface of the tissue, and the third and fourth depths are between the first and second depths.

31. The device of claim 27 wherein the first detector structure is a first photodetector.

32. The device of claim 27 wherein the first and fourth distances are greater than about 2.5 millimeters and less than about 4 millimeters.

33. The device of claim 32 wherein the second and third distance are less than about 1.5 millimeters.

34. The device of claim 33 wherein the second distance is less than about 1 millimeter.

35. The device of claim 27 wherein the first distance is the same as the fourth distance.

36. The device of claim 35 wherein the second distance is the same as the third distance.

37. The device of claim 27 wherein the processor is further configured to calculate an estimated oxygen saturation value from first and second data from the first and second source structures is dependent on the first distance and the second distance being different.

38. The device of claim 27 wherein the sensor module comprises a first photodetector and a first waveguide, coupled between the first detector structure and the first photodetector.

39. The device of claim 38 wherein the sensor module comprises an aperture plate, and the aperture plate comprises the first waveguide.

40. The device of claim 27 wherein the processor is adapted to retrieve from the memory and use a first plurality of calibration coefficients to correct absolute intensities of radiation collected by each of the first, second, third, and fourth detector structures for each wavelength of radiation emitted by the first source structure, and

the processor is adapted to retrieve from the memory and use a second plurality of calibration coefficients to correct absolute intensities of radiation collected by each of the first, second, third, and fourth detector structures for each wavelength of radiation emitted by the second source structure.

41. The device of claim 40 wherein the first and second pluralities of calibration coefficients are previously stored in the memory and the processor does not determine the first and second pluralities of calibration coefficients.