COLLECTION AND ANALYSIS OF DATA FOR DIAGNOSTIC PURPOSES

• US 20170236281A1
• Filed: 07/24/2015
• Published: 08/17/2017
• Est. Priority Date: 07/24/2014
• Status: Active Grant

• Current Assignee: University Health Network
• Original Assignee: University Health Network
• Inventors: DACOSTA, Ralph
• Granted Patent: US 10,438,356 B2
• Time in Patent Office: Days
• CPC Class Codes: A61B 5/0071 by measuring fluorescence emission
• CPC Class Codes: A61B 5/0077 Devices for viewing the surface of the body, e.g. camera, magnifying lens
• CPC Class Codes: A61B 5/445 Evaluating skin irritation or skin trauma, e.g. rash, eczema, wound, bed sore
• CPC Class Codes: G01N 21/6486 Measuring fluorescence of biological material, e.g. DNA, RNA, cells G01N21/6428 takes precedence
• CPC Class Codes: G06T 2207/10016 Video; Image sequence
• CPC Class Codes: G06T 2207/10024 Color image
• CPC Class Codes: G06T 2207/10048 Infrared image
• CPC Class Codes: G06T 2207/10064 Fluorescence image
• CPC Class Codes: G06T 2207/30088 Skin; Dermal
• CPC Class Codes: G06T 2207/30096 Tumor; Lesion
• CPC Class Codes: G06T 7/0016 involving temporal comparison
• CPC Class Codes: Y02A 90/10 Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

Abstract

Systems and methods for determining bacterial load in targets and tracking changes in bacterial load of targets over time are disclosed. An autofluorescence detection and collection device includes a light source configured to directly illuminate at least a portion of a target and an area around the target with excitation light causing at least one biomarker in the illuminated target to fluoresce. Bacterial autofluorescence data regarding the illuminated portion of the target and the area around the target is collected and analyzed to determine bacterial load of the illuminated portion of the target and area around the target. The autofluorescence data may be analyzed using pixel intensity. Changes in bacterial load of the target over time may be tracked. The target may be a wound in tissue.

Claims

1. A method of determining bacterial load of a target from fluorescent image data of the target, comprising:

identifying a region of interest in a fluorescent image of a target;

separating RGB images into individual channels;

converting individual green and red image channels from the RGB image to gray scale; and

counting pixels whose gray scale intensity was above a given threshold.

2. The method of claim 1, further comprising applying a red color mask for red fluorescence bacteria;

and removing green fluorescence with an inverted green color mask.

3. The method of claim 1 or claim 2, further comprising binarizing all remaining red pixels and calculating a sum of all “

1”

pixels.

4. The method of any preceding claim, further comprising applying a green color mask for green fluorescence tissue;

and removing red fluorescence with an inverted red color mask.

5. The method of claim 4, further comprising binarizing all remaining red pixels and calculating a sum of all “

1”

pixels.

6. The method of any preceding claim, wherein green fluorescence represents tissue components and wherein red fluorescence represents bacteria.

7. The method of any preceding claim, wherein the target is a wound in tissue.

45. The device of any of claims 0-44, further comprising at least one spectral filtering mechanism configured to filter the optical signals emanating from the illuminated portion of the wound and the area around the wound to enable optical signals having a wavelength corresponding to bacterial autofluorescence and tissue autofluorescence to pass through the at least one spectral filtering mechanism.

46. The device of claim 45, wherein the at least one spectral filtering mechanism is connected to the housing and is selectively movable, relative to the lens of the camera of the mobile communication device, between a first position for white light imaging and a second position for fluorescent imaging.

8. A method of obtaining diagnostic data regarding a target, comprising:

directly illuminating at least a portion of a target with a homogeneous field of excitation light emitted by at least one light source connected to a housing of a handheld device, the housing including an enclosure for receiving a wireless communication device having a digital camera, the at least one light source emitting at least one wavelength or wavelength band causing at least one biomarker in the illuminated portion of the target to fluoresce;

collecting bacterial autofluorescence data regarding the illuminated portion of the target with an image sensor of the digital camera of the wireless communication device, the wireless communication device being secured in the housing; and

analyzing the collected bacterial autofluorescence data using pixel intensity to determine bacterial load of the illuminated portion of the target.

9. The method of claim 8, wherein the target includes a wound in tissue.

10. The method of claim 8 or claim 9, further comprising determining an intervention strategy based at least in part on the bacterial load.

11. The method of any of claims 8-10, further comprising filtering, with at least one optical filter, optical signals emitted in response to illumination of the target with the homogenous field of excitation light, the at least one optical filter being configured to enable optical signals having a wavelength corresponding to bacterial autofluorescence to pass through the filter.

12. The method of any of claims 8-11, further comprising collecting thermal image data regarding the illuminated portion of the target with a thermal sensor of the handheld device.

13. The method of any of claims 8-12, further comprising correlating the fluorescence data and the thermal data to provide an indication of wound infection.

14. The method of any of claims 8-13, wherein the autofluorescence data includes at least one of wound contamination data, wound colonization data, critical colonization of wound data, wound infection data, and bacterial species data.

15. The method of any of claims 8-14, wherein collected bacterial autofluorescence data includes at least one RGB image, and further comprising:

separating the at least one RGB image into individual channels;

converting individual green and red image channels from the at least one RGB image to gray scale; and

counting pixels whose gray scale intensity was above a given threshold.

16. The method of claim 15, further comprising applying a red color mask for red fluorescence bacteria;

and removing green fluorescence with an inverted green color mask.

17. The method of claim 15 or claim 16, further comprising binarizing all remaining red pixels and calculating a sum of all “

1”

pixels.

18. The method of any of claims 15-17, further comprising applying a green color mask for green fluorescence tissue;

and removing red fluorescence with an inverted red color mask.

19. The method of claim 18, further comprising binarizing all remaining red pixels and calculating a sum of all “

1”

pixels.

20. The method of any of claims 8-19, further comprising collecting tissue autofluorescence data regarding the illuminated portion of the wound and the area around the wound with the image sensor.

21. The method of any of claims 8-20, wherein green fluorescence represents tissue components and wherein red fluorescence represents bacteria.

22. The method of any of claims 8-21, further comprising producing image maps of fluorescence intensities in the illuminated portion of the target, displayed in color.

23. A system for acquiring data regarding a wound in tissue, comprising:

at least one light source configured to directly illuminate a target surface with a homogeneous field of excitation light, the target surface including at least a portion of a wound and an area around the wound;

an optical sensor configured to detect signals responsive to illumination of the illuminated portion of the wound and the area around the wound, each signal indicative of at least one of endogenous fluorescence, exogenous fluorescence, absorbance, and reflectance in the illuminated portion of the wound and the area around the wound;

a processor configured to receive the detected signals and to analyze the detected signal data using pixel intensity and to output data regarding the bacterial load of the illuminated portion of the wound and area around the wound; and

a display for displaying the output data regarding the illuminated portion of the wound and the area around the wound output by the processor.

24. The system according to claim 23, wherein the output data comprises at least one representation of the illuminated portion of the wound and the area around the wound.

25. The system according to claim 23 or claim 24, wherein the at least one representation comprises at least one fluorescent representation of bacteria and tissue components present in the illuminated portion of the wound and the area around the wound.

26. The system according to any one of claims 23-25, wherein the processor is configured to analyze the at least one fluorescent representation in order to recognize, classify, and/or quantify various components of the illuminated portion of the wound and the area around the wound, based on the received signals or the output representation.

27. The system of any one of claims 23-26, wherein the processor is further configured to calculate fluorescence intensities, and using the calculated intensities:

produce image maps of fluorescence intensities in the illuminated portion of the wound and the area around the wound, displayed in color; and

/or

identify the presence and biodistribution of bacteria within the illuminated portion of the wound and the area around the wound.

28. The system of any one of claims 23-27, further comprising a thermal sensor configured to detect thermal information regarding the illuminated portion of the wound and the area around the wound.

29. The system of claim 28, wherein the at least one representation further comprises a thermal image of the illuminated portion of the wound and the area around the wound.

30. The system of claim 29, wherein the at least one representation further comprises a white light image of the illuminated portion of the wound and the area around the wound.

31. The system of claim 30, wherein the thermal image provides temperature data regarding the illuminated portion of the wound and the area around the wound, the white light image provides wound size data regarding the illuminated portion of the wound and the area around the wound, and the fluorescent representations comprise at least one fluorescent image, the at least one fluorescent image providing at least one of wound size data, bacterial load data, and wound healing data.

32. The system of any one of claims 23-31, wherein the processor is further configured to identify at least one of a wound cleaning protocol, a wound debridement protocol, a wound sampling protocol, a wound treatment protocol, and other wound intervention strategy based at least in part on the output data.

33. The system of any one of claims 23-33, wherein the processor is further configured to identify an indication of at least one of wound infection, wound healing, and a wound healing failure based at least in part on the output data.

34. The system of claim 33, wherein the processor is configured to correlate fluorescence data indicative of infection with temperature data indicative of wound infection.

35. The system of claim 34, wherein fluorescence data indicative of infection includes at least one of wound contamination data, wound colonization data, critical colonization of wound data, and wound infection data.

36. The system of any one of claims 23-35, wherein the processor is further configured to spatially and temporally co-register each unique fluorescence, absorbance, and/or white light reflectance characteristic detected by the optical sensor relative to at least one of wound topography, wound anatomy, wound area, wound depth, wound volume, wound margins, and necrotic tissue in a composite image.

37. The system of any one of claims 23-36, further comprising a wound analysis component comprising image analysis and/or manipulation software, configured to receive and manipulate data received from the optical sensor and the thermal sensor and to output diagnostic data that includes at least one of a wound healing rate;

a biodistribution of bacteria in and around the wound;

one or more colored maps that display simultaneously the biological components of the wound and surrounding normal tissues including connective tissues, blood, vascularity, bacteria, and microorganisms; and

visualization, in substantially real-time, of the health, healing and infectious status of the wound area.

38. The system of any one of claims 23-37, wherein the optical sensor is an image sensor of a camera of a wireless communication device, and further comprising a housing configured to receive and secure the wireless communication device therein.

39. The system of claim 38, wherein the at least one light source is mounted on the housing.

40. A portable, handheld device for imaging and collection of data relating to a wound in tissue, the device comprising:

a housing comprising an enclosure configured to receive a mobile communication device;

at least one light source coupled to the housing and configured to directly illuminate at least a portion of a wound and an area around the wound with a homogeneous field of light;

a mobile communication device secured in the enclosure of the housing, the mobile communication device comprising an embedded digital camera and having a touchscreen display disposed on a first side of the device and a lens of the camera disposed on a second side of the device opposite the first side, wherein the mobile communication device is received in the housing such that an image sensor of the digital camera is positioned to detect optical signals responsive to illumination of the portion of the wound and the area around the wound with the homogeneous field of light, each of the optical signals being indicative of at least one of endogenous fluorescence, exogenous fluorescence, reflectance, and absorbance in the illuminated portion of the wound and the area around the wound, and wherein, when the mobile communication device is secured in the enclosure, at least a portion of the touchscreen display is accessible and viewable by a user; and

a processor configured to receive the detected optical signals, to analyze detected signal data using pixel intensity, and to output data regarding the bacterial load of the illuminated portion of the wound and area around the wound.

41. The device of claim 40, wherein the detected optical signals include RGB images, and wherein the processor is further configured to:

separate RGB images into individual channels;

convert individual green and red image channels from the RGB images to gray scale; and

count pixels whose gray scale intensity is above a given threshold.

42. The device of claim 40 or claim 41, wherein the processor is further configured to apply a red color mask for red fluorescence bacteria;

and to remove green fluorescence with an inverted green color mask.

43. The device of any of claims 40-42, wherein the processor is further configured to binarize all remaining red pixels and calculate a sum of all “

1”

pixels.

44. The device of any of claims 40-43, wherein the processor is further configured to apply a green color mask for green fluorescence tissue;

and to remove red fluorescence with an inverted red color mask.

47. The device of any of claims 40-46, further comprising a thermal sensor configured to obtain thermal information regarding the illuminated portion of the wound and the area around the wound.

48. The device of claim 47, wherein the processor is further configured to correlate the thermal data with the bacterial load data.

49. A method of obtaining diagnostic data regarding a target, comprising:

directly illuminating at least a portion of a target and an area around the target with a homogeneous field of excitation light emitted by at least one light source connected to a housing of a handheld device, the housing including an enclosure for receiving a wireless communication device having a digital camera, the at least one light source emitting at least one wavelength or wavelength band causing at least one biomarker in the illuminated portion of the target and area around the target to fluoresce;

collecting bacterial autofluorescence data regarding the illuminated portion of the target and the area around the target with an image sensor of the digital camera of the wireless communication device, the wireless communication device being secured in the housing;

analyzing the collected bacterial autofluorescence data to determine bacterial load of the illuminated portion of the target and area around the target; and

tracking changes in bacterial load of the target over time.

50. The method of claim 49, further comprising determining an intervention strategy based at least in part on the bacterial load of the illuminated portion of the target and area around the target.

51. The method of claim 50, further comprising adjusting the intervention strategy based on changes in the bacterial load of the illuminated portion of the target and area around the target over time.

52. The method of any of claims 49-51, wherein the target comprises a wound in tissue.

53. The method of claim 52, further comprising collecting thermal image data regarding the illuminated portion of the wound and the area around the wound with a thermal sensor of the handheld device.

54. The method of any of claims 52 and 53, further comprising correlating the autofluorescence data and the thermal data to provide an indication of wound infection.

55. The method of any of claims 52-54, wherein the autofluorescence data includes at least one of wound contamination data, wound colonization data, critical colonization of wound data, wound infection data, and bacterial species data.

56. The method of any of claims 49-55, wherein collected bacterial autofluorescence data includes at least one RGB image, and further comprising:

separating the at least one RGB image into individual channels;

converting individual green and red image channels from the at least one RGB image to gray scale; and

counting pixels whose gray scale intensity was above a given threshold.

57. The method of claim 56, further comprising applying a red color mask for red fluorescence bacteria;

and removing green fluorescence with an inverted green color mask.

58. The method of any of claims 49-58, further comprising guiding swabbing of the illuminated portion of the wound and the area around the wound based on the bacterial load.

59. The method of any of claims 49-58, further comprising assessing the effectiveness of at least one of a target cleaning protocol, a target sampling protocol, a target debridement protocol, a target treatment protocol, and other target intervention strategy based on changes in the bacterial load of the illuminated portion of the target and area around the target over time.

60. The method of claim 52, further comprising directing application of a therapy to the illuminated portion of the wound and area around the wound based on the bacterial load of the illuminated portion of the wound and area around the wound.