Tissue oximetry probe with tissue marking feature

• US 9,392,978 B2
• Filed: 05/03/2013
• Issued: 07/19/2016
• Est. Priority Date: 05/03/2012
• Status: Active Grant

• Current Assignee: ViOptix, Inc.
• Original Assignee: ViOptix, Inc.
• Inventors: Bechtel, Kate LeeAnn, Heanue, Joseph Anthony, Lloyd, Lester John
• Primary Examiner(s): Winakur, Eric
• Assistant Examiner(s): Fardanesh, Marjan
• Application Number:
  US13/887,213
• Publication Number:
  US 20140148662A1
• Time in Patent Office: 1,173 Days
• Field of Search: 600310-344
• US Class Current: 1/1
• 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

An intraoperative tissue oximetry device includes a tissue marker that includes one or more pens or one or more similar ink sources, such that the tissue marker can mark tissue according to oxygen saturation measurements made by the tissue oximetry device, thereby visually delineating regions of potentially viable tissue from regions of potentially nonviable tissue.

Claims

1. A handheld tissue oximetry 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;

a tissue marking component, contained within the housing, wherein the tissue marking component is coupled to the processor;

a battery, contained within the housing, coupled to and supplies power to the processor, memory, and display; 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 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 sensor module comprises;

a dispenser formed on the probe face and connected to the tissue marking component;

a first plurality of detectors structures, formed on the probe face, arranged in a circular arrangement, symmetrically about a point on a line intersecting a circle of the circular arrangement at a first point and a second point;

a second plurality of detector structures, formed on the probe face, arranged asymmetrically about the point on the line in the circular arrangement;

a first source structure, formed on the probe face, positioned at the first point of the circle of the circular arrangement;

a second source structure, formed on the probe face, positioned at the second point of the circle of the circular arrangement;

a first source diode and a second source diode;

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

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

a first detector structure on the circle of the first plurality of detector structures, 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 on the circle of the first plurality of detector structures, arranged symmetrically with respect to the first detector structure about the point on the line, 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, 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 on the circle of the second plurality of detector structures, arranged asymmetrically with respect to the first plurality of detectors structures about the point on the line, 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 on the circle of the second plurality of detector structures, arranged asymmetrically with respect to the first plurality of detectors structures and the third detector structure about the point on the line, 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, fifth, and sixth distances, and the eighth distance is different from the first, second, fifth, and sixth distances, wherein the first distance is greater the 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 process reflectance data received from the detector structures for radiation emitted into tissue to be measured by the source structures, determine an oxygen saturation value for the tissue based on the reflectance data, control the display to display an indicator for the oxygen saturation value, control the tissue marking component for dispensing a first marking material from the dispenser if the oxygen saturation value is within a first range of oxygen saturation values and not within a second range of oxygen saturation values, and the first and second ranges of oxygen saturation values are different ranges.

2. The device of claim 1 wherein the dispenser is at a position other than the center of the circular arrangement.

3. The device of claim 1 wherein the handheld tissue oximetry device is a standalone unit adapted for single-handheld operation by a user.

4. The device of claim 3 wherein the processor is adapted to control the tissue marking component for dispensing a second marking material from the dispenser onto the tissue if the oxygen saturation value is within the second range of oxygen saturation values, and the first and second marking materials have first and second colors that are different colors.

5. The device of claim 4 wherein the first marking material and the second marking material are different materials.

6. The device of claim 4 wherein information for the first and second ranges of the oxygen saturation values are user programmable.

7. The device of claim 4 wherein information for the first and second ranges of the oxygen saturation values are previously stored in the memory.

8. The device of claim 7 comprising:

a user selection device configured to be activated by a user, wherein the user selection device is configured to enable and disable the processor for controlling the tissue marking component for depositing the first marking material via the dispenser.

9. The device of claim 1 wherein the housing comprises a user selection device, accessible from an exterior of the housing, adapted to be activated by a user, and activation of the user selection device controls the tissue marking component to deposit the first marking material onto the tissue to be measure via the dispenser.

10. The device of claim 1 wherein the housing comprises a user selection device configured to initiate movement of the dispenser from a first position to a second position in the sensor module, in the first position the dispenser is configured not to deposit the marking material onto the tissue to be measured and in the second position the dispenser is configured to deposit the marking material onto the tissue to be measured.

11. The device of claim 1 wherein the processor is adapted to control the dispenser to move from a first position to a second position in the sensor module, in the first position the dispenser is configured not to deposit the marking material onto the tissue to be measured, and in the second position the dispenser is configured to deposit the marking material onto the tissue to be measured subsequent to an oxygen saturation measurement.

14. The device of claim 1 wherein the handheld tissue oximetry device is a standalone unit adapted for single-handheld operation by a user.

12. A handheld tissue oximetry 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;

a tissue marking component, contained within the housing, wherein the tissue marking component is coupled to the processor; and

a battery, contained within the housing, coupled to and supplies power to the processor, memory, and display; 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 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 sensor module comprises;

a first dispenser formed on the probe face and connected to the tissue marking component;

a first plurality of detector structures, formed on the probe face, arranged in a circular arrangement, asymmetrically about a point on a line intersecting a circle of the circular arrangement at a first point and a second point;

a second plurality of detector structures, formed on the probe face, arranged in the circular arrangement, asymmetrically about the point on the line;

a first source structure, formed on the probe face, positioned at the first point of the circle of the circular arrangement;

a second source structure, formed on the probe face, positioned at the second point of the circle of the circular arrangement;

a first source diode and a second source diode;

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

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

a first detector structure on the circle of the first plurality of detector structures, 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 on the circle of the first plurality of detector structures, arranged asymmetrically with respect to the first detector structure about the point on the line, 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 on the circle of the second plurality of detector structures, arranged asymmetrically with respect to the first plurality of detectors structures about the point on the line, 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 on the circle of the second plurality of detector structures, arranged asymmetrically with respect to the first plurality of detectors structures and the third detector structure about the point on the line, 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, fifth, and sixth distances, and the eighth distance is different from the first, second, fifth, and sixth distances,

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 fifth, sixth, seventh, and eight distances, and

wherein the processor is adapted to process reflectance data received from the detector structures, determine an oxygen saturation value for the tissue based on the reflectance data, control the display to display an indicator for the oxygen saturation value, and control the tissue marking component for dispensing a first marking material from the dispenser if the oxygen saturation value is within a first range of oxygen saturation values and not within a second range of oxygen saturation values, and the first and second ranges of oxygen saturation values are different ranges.

13. The device of claim 12 wherein the dispenser is at a position within the circular arrangement.

15. The device of claim 12 wherein the processor is adapted to control the tissue marking component for dispensing a second marking material from the dispenser onto the tissue if the oxygen saturation value is within a second range of oxygen saturation values, the first marking material has a first color, the second marking material has a second color, and the first and second colors are different colors.

16. The device of claim 15 wherein information for the first and second ranges of the oxygen saturation values are previously stored in the memory.

17. The device of claim 15 wherein information for the first and second ranges of the oxygen saturation are user programmable.

18. The device of claim 12 wherein the first dispenser is positioned at about a center of the circle of the circular arrangement.

19. The device of claim 12 comprising a second dispenser, coupled to the tissue making component, formed on the probe face, wherein the first and second dispensers are positioned outside of the circle of the circular arrangement.

20. The device of claim 12 comprising a user selection device configured to be activated by a user, wherein the user selection device is configured to enable and disable the processor for controlling the tissue making component for depositing the first marking material via the first dispenser.

21. The device of claim 12 comprising a user selection device configured to be activated by a user, wherein activation of the user selection device controls the tissue making component to deposit the marking material onto the tissue to be measured via the first dispenser.

22. The device of claim 12 comprising a user selection device configured to initiate movement of the first dispenser from a first position to a second position in the sensor module, wherein in the first position the dispenser is configured not to deposit the first marking material onto the tissue, and in the second position the dispenser is configured to deposit the first marking material onto the tissue.

23. The device of claim 12 wherein the processor is adapted to initiate movement of the first dispenser from a first position to a second position in the sensor module, subsequent to an oxygen saturation measurement, in the first position the dispenser is configured not to deposit the first marking material onto the tissue, and in the second position the dispenser is configured to deposit the first marking material onto the tissue.

24. A method of operating a handheld tissue oximeter device comprising:

emitting light into tissue from a first source structure and a second source structure, wherein the first and second source structures are formed on a probe face of a sensor module that is retained by a tip portion of an oximeter probe housing at a relatively fixed position with respect to the oximeter probe housing and that is placed against and faces the;

detecting the light subsequent to reflection of the light from the tissue using a first detector structure, a second detector structure, a third detector structure, and a fourth detector structure each formed on the probe face in a circular arrangement and asymmetric about a point on a line that intersects a circle of the circular arrangement at two points, 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 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 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,

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, fifth, and sixth distances, and the eighth distance is different from the first, second, fifth, and sixth distances,

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 fifth, sixth, seventh, and eight distances; and

powering the first and second source structures with a battery housed within the oximeter probe housing to emit the light into the tissue;

powering the first, second, third, and fourth detector structures with the battery to detect the light reflected from the tissue;

generating reflectance data, based on detecting the light by the detector structure, by way of a processor contained within the oximeter probe housing and coupled to and powered by the battery;

using the processor, determining an oxygen saturation value for the tissue based on the reflectance data;

using the processor, determining a range of oxygen saturation values from a plurality of ranges of oxygen saturation values which the oxygen saturation value is in, wherein the plurality of ranges of oxygen saturation values are previously stored in a memory coupled to the processor, coupled to and powered by the battery, and housed within the housing; and

marking the tissue with ink based on the range in which the oxygen saturation value is in using ink stored in a reservoir contained within the oximeter probe housing and an inking tip positioned on the probe face.

25. The method of claim 24 wherein the dispenser is at a position other than the center of the circular arrangement.